Draft remarks for NC Hearing June 12

CNR: Draft remarks for NC Hearing June 12

Hemp drugs: Hearing Wednesday 2 EDT in North Carolina, streamed at https://ncleg.gov/LegislativeCalendarEvent/132863#videoHeader

Constructive comments welcomed. Sometimes they let the public speak.

Mr. Chairman, Thank you.  

My name is Pat Oglesby.  I’m a lawyer with the Center for New Revenue in Chapel Hill. Some of you all are old enough to remember Bob Dole and Lloyd Bentsen.  I was a staffer for the nonpartisan Joint Committee on Taxation when they chaired it.     I’ve been a paid advisor to several states on cannabis tax policy.  

As you’re discovering, hemp-derived cannabinoids create both costs and externalities.  That’s why North Carolina should tax these substances – ideally by THC content – as part of a comprehensive cannabis strategy. 

Louisiana, Minnesota, Tennessee, and West Virginia are four states that already collect extra excise taxes on these substances.  Taxes that range from 3 percent to 11 percent of retail price.

But that’s just one approach. An alternative and more effective tax is one being used in Connecticut, Illinois, and all Canadian provinces. They tax legalized cannabis products by the volume of THC they contain. This THC tax aims straight at the target you want to hit.

Whichever taxes you choose — taxes based on price or taxes based on THC levels – there’s a risk of overdoing it.  If you tax too heavily, illicit sellers will bypass the tax and you won’t get the revenue you hope for.  I don’t work for industry, but I do know that other states have learned this lesson the hard way: Overtaxing backfires.  

The journey you’re on won’t be easy. But please know that I will do what I can to help. 


#CBD #Hemp

Draft remarks for NC Hearing June 12


June 11, 2024 11:10 pm

2022 Warning Letters – Health Fraud

FDA: 2022 Warning Letters – Health Fraud 2022 Warning Letters – Health Fraud Anonymous (not verified) Tue, 04/23/2024 – 12:52

Detailed Description
2022 Warning Letters – Health Fraud

Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* – related violations. For all FDA Warning Letters, click here.

Letter Issue Date Firm Name Issuing Office Subject
12/05/2022 Thriftmaster Texas, LLC. d/b/a ThriftMaster Global Holdings, Inc. and TM Global Biosciences, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated Human Foods
11/16/2022 Infusionz, LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/16/2022 Newhere Inc dba CBDFX Center for Food Safety and Applied Nutrition (CFSAN) Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/16/2022 11-11-11 Brands Center for Food Safety and Applied Nutrition (CFSAN) Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/16/2022 Naturally Infused LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/16/2022 CBD American Shaman, LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11/16/2022 Essential Elements Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
11/16/2022 iwi Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
11/16/2022 BergaMet North America LLC Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
11/16/2022 Healthy Trends Worldwide, LLC Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
11/16/2022 Chambers’ Apothecary Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
11/16/2022 Anabolic Laboratories Inc Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
11/14/2022 The Truth Company, LLC Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
11/14/2022 Calroy Health Sciences, LLC Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
11/07/2022 Todos Medical Ltd aka Todos Medical USA Inc Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/01/2022 Alternative Health Distribution LLC d/b/a CannaAid Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
10/28/2022 Amazon.com, Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
10/28/2022 Latin Foods Market Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
10/28/2022 Walmart Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
10/24/2022 Lakpura LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
09/23/2022 Saffron USA LLC Division of Human and Animal Food Operations East IV Unapproved New Drugs/Misbranded
09/23/2022 Muscle Sports Products, LLC Office of Human and Animal Food Operations East – Division 1 Unapproved New Drugs/Misbranded
09/20/2022 South Pork Ranch Equipment LLC Center for Veterinary Medicine Unapproved New Animal Drug/Adulterated
08/15/2022

The Elderberry Fairy & Co., LLC

closeout letter: 04/28/2023

Office of Human and Animal Food Operations East Division 6 Unapproved New Drugs/Misbranded
08/04/2022

Leaf of Life LLC

closeout letter: 01/23/2023

Office of Human and Animal Food- West Division II Unapproved New Drugs/Misbranded
08/04/2022 FluxxLab LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/04/2022 Amazon.com, Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
08/04/2022 JB Exchange Inc./Justified Laboratories Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
08/04/2022 Ariella Naturals Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
07/29/2022 Deggeh Foods, Inc. Office of Human and Animal Food Operations East – Division 1 Unapproved New Drugs/Misbranded
07/05/2022 Living Foods LLC Office of Human and Animal Food- West Division II Unapproved New Drugs/Misbranded
07/01/2022 MKS Enterprise, LLC Center for Food Safety and Applied Nutrition (CFSAN) Interstate Commerce/Food/Adulterated
07/01/2022 Thirsty Run LLC / US Royal Honey LLC Center for Food Safety and Applied Nutrition (CFSAN) Internet Marketing of Unapproved and Misbranded Drugs
07/01/2022 1am USA Incorporated dba Pleasure Products USA Center for Food Safety and Applied Nutrition (CFSAN) Internet Marketing of Unapproved and Misbranded Drugs
06/30/2022 Herbsens Botanicals Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
06/30/2022 Klarity Kratom Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
06/30/2022 Kratom Exchange Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
06/30/2022 Omni Consumer Products LLC d/b/a YoKratom Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
06/30/2022 MONQ, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
06/14/2022 H2 Beverages, Inc. Division of Human and Animal Food Operations West III Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/10/2022 Young Living Essential Oils Corporate Office of Human and Animal Food Operations – West Division 4 New Drug/Misbranded
06/08/2022 New Sun Inc. Office of Human and Animal Foods- East Division 3 Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/26/2022 Hope Botanicals, LLC Center for Veterinary Medicine Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/26/2022 Plantacea, LLC dba Kahm Center for Veterinary Medicine Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/26/2022 Haniel Concepts, Inc. DBA Free State Oils, LLC Center for Veterinary Medicine Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/26/2022 Golden Lab LLC Office of Human and Animal Food Operations East Division IV Unapproved New Drugs/Misbranded
05/19/2022 Santhigram Kerala Ayurvedic Co. of U.S., Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs
05/19/2022 Ayuryoga, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drug
05/16/2022 Equine Podiatry Solutions, LLC Center for Veterinary Medicine Unapproved New Animal Drug Products
05/04/2022 BioMD Plus LLC Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022 M Six Labs, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022 Kingdom Harvest Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022 Delta 8 Hemp Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022 ATLRx, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
04/20/2022 C R Supplements, LLC Office of Human and Animal Food Operations – West Division 6 Unapproved New Drugs/Misbranded
04/19/2022 Kleenhanz, LLC Center for Drug Evaluation and Research | CDER Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)
04/13/2022 Elements Brands Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Skin Authority, L.L.C. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 AMBI Enterprises LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Genomma Lab USA, Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 M & M Beauty and Wellness, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 True Earth Health Products, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 SkinPro Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Skin PS Brands Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Clinical Formula LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Dr. Thomas Balshi/Intilight Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Ultimark Products Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/06/2022 Sensory Cloud, Inc Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/05/2022 CofixRx, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Greenway Herbal Products LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Cureganics Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Functional Remedies, LLC D/B/A Synchronicity Hemp Oil Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 UPSY LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Heaven’s Organic LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 CBD Social Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Nature’s Highway Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/25/2022 Iodine Products Inc Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/24/2022 Applied Biological Laboratories Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
03/15/2022 Honey Feast, Inc. Office of Human and Animal Food Operations East Division IV New Drug/Misbranded
03/15/2022 Iotech International, LLC Center for Drug Evaluation and Research | CDER Unapproved New Drug and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/10/2022 Soda Pharm Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/07/2022 Viraldine, LLC Center for Drug Evaluation and Research | CDER Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
02/23/2022 Princess Lifestyles, LLC Office of Human and Animal Food Operations –West Division 5 Unapproved New Drugs/Misbranded
02/17/2022 Vital Health & Wellness Office of Human and Animal Foods Operations-East V New Drug/Misbranded
02/11/2022 Rena’s Organic Office of Human and Animal Foods Division 4 East Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
02/09/2022 Bea Lydecker’s Naturals, Inc. Division of Human and Animal Food Operations West VI Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
02/04/2022 Crystal Clear Supplements Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
02/03/2022 Pharmacy2Home/LandiCom Holding LTD Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
02/01/2022 New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
01/19/2022 Glenn Burkett Naples Corporation Office of Human and Animal Food Operations East Division IV Unapproved New Drugs/Misbranded
01/03/2022 Amcyte Pharma, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
*The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.

 

 

 

Short Title
2022 Warning Letters – Health Fraud

Source Organization

Publish Date
Tue, 04/23/2024 – 14:13

Review Date
Wed, 04/23/2025 – 12:00

Last Reviewed Date
Tue, 04/23/2024 – 12:00

Site Structure

Next Review Date
1 Year

Navigational Page
Off

Bulk Approved
Off

Display Short Description
Off

First Publish Date
Tue, 04/23/2024 – 13:29

Generic Boolean
Off

Regulated Product*

Language

Number of Related Information to Display
3

Add Subscription Box
Off

Display Short Title
Off

#CBD #Hemp http://www.fda.gov/consumers/health-fraud-scams/2022-warning-letters-health-fraud April 23, 2024 4:52 pm

Regulate MJ Like Hemp or Regulate Hemp Like MJ

Either regulate Marijuana tightly like in Hemp, or regulate Hemp loosely like in Marijuana

While the current state of marijuana regulation in the states is a sad, bad joke, with open and flagrant THC inflation fraud and the tacit approval of regulators, THC testing in hemp is highly-controlled.

In hemp, a law enforcement officer collects the sample and delivers it to a state drug lab, maintaining legal chain of custody in case of prosecution over literally tenths of one percent THC, 0.3% THC is compliant but 0.4% isn’t in most jurisdictions. That’s 100-times less than the THC percentage many claim for marijuana.

And now some are making delta-8, -9, and -10 THC from hemp CBD often from cheap Chinese isolate or crude, with dozens of bizarre “Frankenoids” created in the process. And since there has been little federal enforcement it appears “legal,” although states are banning it one-by-one. The next Farm Bill will likely put that to bed.

It’s a crazy world, up is down and left is right.

And Talking Joints Memo quoted me on it:

“Last week, Richard Rose, a legend in the hemp world and author of The Richard Rose Report… This Week newsletter on the subject, mocked the general state of his industry:

We tell them we want to feed and clothe people so they legalize and then we end up making dirty bathtub THC for vape pens to be sold to teens in southern states. There’s a huge lesson to be learned from all this,” Rose wrote. “Either regulate marijuana like hemp or regulate hemp like marijuana.””

Read more at: https://talkingjointsmemo.com/tension-and-confusion-mount-over-hemp-derived-thc-products-in-mass/

Here are current studies on the hemp delta-8/Frankenoid problem. TL;DR: the issue is not the delta-8/9/10 per se, it’s the bizarre chemicals the dirty process creates. It’s as much hemp as a synthetic vitamin B pill is a leaf of spinach.

Cannabidiol-Derived Cannabinoids: The Unregulated Designer Drug Market Following the 2018 Farm Bill

Cannabinoids 2023, A guide to the current cannabinoids

Delta-8-THC craze concerns chemists, Unidentified by-products and lack of regulatory oversight spell trouble for cannabis products synthesized from CBD

Missouri company at center of cannabis recall used hemp instead of marijuana in products

Industry’s failure to address intoxicating hemp products is height of irresponsibility

Where Is Delta-8 THC Legal and Where Is It Banned?

List of “Frankenoids”

From Institut für Hanfanalytik of Austria, on the semi-synthetic cannabinoid byproduct “Frankenoids” created by using strong acids, chemicals or metals on “legal hemp” CBD to create forms of “legal” THC such as delta-8, -9, and -10. Those byproducts have unknown effects long-term. I suggest visiting the link for a more complete list of phytocannabinoids and neocannabinoids:

SSC – Semi-Synthetic Cannabinoids – Conversion Products

SSC refers to a group of substances converted from natural cannabinoids using simple chemical processes (mostly hydrogenation). Therefore, products containing SSC are called conversion products. SSCs usually have the typical properties of cannabinoids (e.g., psychoactivity) but were not regulated by law when they appeared on the European market (2021/2022). In the meantime, many psychoactive SSCs are subject to legal regulations in European countries (Austria, France, Poland, Finland, etc.) and may no longer be traded. Scientific studies on the mechanisms of action of SSCs are still lacking.

HHC – Hexahydrocannabinol

HHC is a psychoactive derivative of THC. It is produced by hydrogenation of THC, retaining the basic structure of THC Chemical structures d9-THC vs. HHC vs. THCP Although often presented this way, it is not biosynthesized in the cannabis plant. Those two publications that found HHC in minimal traces in heavily aged plant material also tend to suggest an aging process. Within the EU, the EMCDDA 2023 “Technical Report: HHC and related substances” is of legal relevance, which excludes biosynthesis and, thus, the natural origin of HHC.

HHC-O – Hexahydrocannabinol Acetat

HHCO is an HHC derivative. It is believed to act as a pro-drug, similar to THC-O, which is hydrolyzed to HHC in the body after consumption. Scientific studies on HHCO are still lacking.

HHCP – Hexahydrocannabiphorol

HHCP is a very strongly psychoactive substance. It is assumed that the more substantial psychotropic effect compared to HHC is mainly due to the extended alkyl side chain (7 carbon atoms instead of 5 as in HHC).

CBND – Cannabinodiol

CBND is a psychoactive cannabinoid. In American forum posts, it is heralded as one of the successors of HHC, which is why we have categorized it as SSC. Chemically, it was first found in low concentrations in hemp flowers in 1974. It is mentioned in only a few scientific publications. Its structure corresponds to a complete aromatization of CBD, analogous to the structures of CBN to THC. This would rather speak for a degradation product. Apart from its psychoactive property, there are no data on the mode of action of CBND.

CBN-O – Cannabinol-O-Acetate

CBN-O is a derivative of CBN. It is believed to act as a pro-drug, similar to THC-O, which is hydrolyzed to CBN in the body and then exerts its effects as CBN. Scientific studies still need to be included.

H4CBD – Tetrahydrocannabidiol, Hydrated CBD, Cyclohexyl-CBD

H4CBD is obtained by catalytic hydrogenation of CBD. In the wake of the international price drop of CBD, starting in 2022, a CBD product with a higher price was created and offered as H4CBD under a new name. H4CBD is believed to have the same properties as CBD but to a greater degree. Scientific studies are still lacking.

THC-O – THC-O-Acetate

THC-O is the acetate ester of THC. It is a metabolic pro-drug, i.e., hydrolyzed in the body to THC, which only develops its effect as THC after hydrolysis. The strength of the psychoactive effect depends on whether it was synthesized from d9-THC or d8-THC.

THCP – Tetrahydrocannabiphorol

THCP is a potent psychoactive synthetic homolog of THC. It is believed that, like HHC, the extended alkyl side chain (7 carbon atoms instead of 5 as in THC) results in a stronger psychotropic effect than THC. Isomers with the double bond in position delta 8 and delta 9 are probably.

By-products and impurities from SSC production

SSC products may be contaminated with either extraction residues or synthetic by-products and may contain traces of heavy metals originating from the catalyst used for hydrogenation. Here are some substances involved in the production processes of semi-synthetic cannabinoids. Depending on the process and substance, they are desirable intermediates or undesirable byproducts and are sometimes still present as impurities in finished products for end users. These byproducts get the most attention as an unexpected laboratory result, both in product testing as part of quality assurance and in post-consumer drug testing.

d6a10a-THC – d6a10a-Tetrahydrocannabinol – d3-Tetrahydrocannabinol

Depending on the manufacturing process, d6a10a-THC may be an intermediate or by-product in the production of HHC. Depending on the ratio of the two enantiomers (R, S), d6a,10a-THC has little to hardly any psychoactive effect.

d8-iso-THC – trans-d8-iso-Tetrahydrocannabinol and d4(8)-iso-THC – trans-d4,8-iso-Tetrahydrocannabinol

d8-iso-THC and d4(8)-iso-THC are formed during the cyclization of CBD to THC.

d10-THC – d10-Tetrahydrocannabinol

d10-THC is a THC isomer with approximately 30-40% of the psychoactive potency of d9-THC. D10-THC has rarely been detected, and then only as a trace component, in cannabis plants. Therefore, d10-THC is presumably a degradation product similar to CBN. However, it is also frequently found as an impurity in synthetic d8-THC produced from CBD. For this reason, we have categorized d10-THC as a byproduct. From another perspective, it can also be considered a degradation product or SSC.

d11-THC – Delta-11-Tetrahydrocannabinol – exo-THC – Pentahydrocannabinol – PHC

d11-THC is a synthetic isomer of THC that is produced, among other substances, as an impurity in the production of dronabinol (d9-THC). It can be synthesized as SSC from d8-THC in several ways. In experiments with mice, d11-THC has shown a psychoactive strength of only about 25% compared to d9-THC. Chemically, d11-THC is no longer a “tetrahydro”-cannabinoid because the double bond is outside the name-giving ring between positions 9 and 11. See Figure 1 IUPAC numbering. When viewed from the ring, the double bond is on the outside (exo), and only 5 carbon atoms are hydrogenated in the ring itself. Therefore, the compound could be called pentahydrocannbinol.

Read more at: https://www.hanfanalytik.at/en/cannabinoids-2023

Proposed Federal Regulation Framework

This is a proposed Federal Regulation Framework for Cannabis policy in the U.S., the efforts of the Federal Regulatory Framework (FRF) Working Group, a collaboration between the Foundation of Cannabis Unified Standards (FOCUS) and the Association of Food and Drug Officials (AFDO).

The Working Group’s goal is to develop a comprehensive and relevant roadmap for the regulatory framework of these unique consumer packaged goods (CPG), addressing critical challenges and enhancing consumer confidence in the safety of the products they purchase and consume. The complexity within the food and beverage industry stems from cannabis not having approval as a food additive, and as a result, cannabis companies are producing new consumer products categorized as food without comprehensive regulation or oversight by food safety experts and regulatory bodies.

It’s a great start, here are my suggestions for improvement:

1) In hemp, there is no “0” nor should there be. While a Type V is theoretically possible, where is an example today? And further, why “0”? Even if hemp today is 3,000 ppm (0.3%), if the testing LOQ is say 1 ppm (0.00001%) then why is “0.000000” necessary? It’s just reefer madness, use of seed certified to be compliant by a government agency should suffice.

2) Food and ingredients must be separated into pre- and post-harvest, USDA and FDA. Otherwise, it’s like FDA regulating soybean farming or USDA regulating UHT soymilk; it makes no sense.

3) In this age of delta-8/9/10 gummies sold to teens in gas stations in the south, hemp food needs “THC-free” labeling if compliant, such as what alcohol-free and fat-free enjoy if <0.5% and <0.5g, respectively. That’ll be on Congress to fix, like it did those two.

4) The Tenth Amendment complicates the Therapeutic/Psychotropic issue immensely, and it is ignored here. “Sub Agency” could be a federal Office of Cannabis under NIH or FDA, or maybe it’s the state which already has an entire marijuana regulatory infrastructure funded and in place?

Read more at: https://www.food-safety.com/articles/9104-cultivating-cannabis-regulations-ensuring-food-safety-in-an-evolving-industry

Whack-a-mole Drugs

CNR: Whack-a-mole Drugs

New psychoactive substances like Tianeptine or “gas station heroin” are popping up in North Carolina, and our Legislature is struggling with the problem.  https://www.wbtv.com/2024/02/14/nc-lawmakers-working-ban-gas-station-drug-that-mimics-effects-opioids/

But as soon as the Legislature bans substances, copycat drugs pop up, maybe with a molecule in a complex organic compound changed here or there.

To go beyond listing dangerous drugs that are out there already, I’m trying to find catch-all language that would list or cover “whack-a-mole” new drugs that people would discover or invent.

It took me years to get up to speed on marijuana taxation, so I don’t imagine I can grasp new psychoactive substances very readily.  Here’s what I’ve found so far, mainly to show how little I know.  There is language from New Zealand and from the United Kingdom that may be helpful.

New Zealand has this language:

Broadly speaking, a psychoactive substance is anything:

·  that is capable of producing a psychoactive effect in an individual who uses the substance (ie, affects the mind of the user in any way) AND

·  whose primary purpose is to induce a psychoactive effect in an individual who uses the substance or product AND

·  that is not a medicine, controlled drug, precursor substance, herbal remedy, food, dietary supplement, tobacco product or alcohol.

https://www.health.govt.nz/our-work/regulation-health-and-disability-system/psychoactive-substances-regulation/definitions-and-history-psychoactive-substances

New Zealand’s effort is not getting glowing reviews, but I wonder if it’s better than nothing.  

https://www.health.govt.nz/publication/review-psychoactive-substances-act-2013

The UK has a similar approach:

Meaning of “psychoactive substance” etc

(1)In this Act “psychoactive substance” means any substance which—

(a)is capable of producing a psychoactive effect in a person who consumes it, and

(b)is not an exempted substance (see section 3).

(2)For the purposes of this Act a substance produces a psychoactive effect in a person if, by stimulating or depressing the person’s central nervous system, it affects the person’s mental functioning or emotional state; and references to a substance’s psychoactive effects are to be read accordingly.

https://www.cps.gov.uk/legal-guidance/psychoactive-substances#:~:text=The%20Psychoactive%20Substances%20Act%202016,is%20seven%20years%27%20imprisonment).

I don’t know how the UK system is working.  There are criticisms (and details) at  https://en.wikipedia.org/wiki/Psychoactive_Substances_Act_2016.

A friend from CANN-RA, the Cannabis Regulators Association,writes:

ASTM has a standard defining “intoxicating cannabinoids” out for balloting. It starts by categorizing all cannabinoids as “potentially intoxicating” until there’s evidence on which to make a determination. But the standard focuses only on CB1-mediated intoxication (effects like THC), so if something is intoxicating by a different mechanism, it counts as “non-intoxicating.” It also doesn’t necessarily account for human metabolism: If test tube studies show that the substance doesn’t activate human CB1 receptors, it’s non-intoxicating… even if enzymes in the liver or blood convert the substance into an intoxicating derivative when a person ingests it. And it has a very narrow definition of cannabinoid that doesn’t include a lot of synthetic cannabinoids. This is in the “too narrow” category.

The New Zealand standard looks like it may go the other direction, being too broad. Or maybe it’s really broad on the surface, but in practice the exceptions make it hard to navigate. Regulation of psychoactive substances is really not coherent, because the regulatory approach to each emerges out of the historical and cultural context that gave rise to the regulation. Caffeine is a popular drug, but is not a “psychoactive substance” under this definition because it is widely accepted and has been folded into regulation as a food, dietary supplement, and medicine. Tobacco and alcohol each have their own unique regulatory structures because of their long history of use in America. On the other hand, I’m not at all clear where betel (areca nut) falls under America’s regulatory system because it wasn’t historically widely used or noticed here, despite being the fourth most commonly used drug worldwide (behind caffeine, alcohol, and tobacco). Kava happened to be present in the dietary supplement market prior to 1994, so it’s grandfathered into that regulatory scheme, although I suspect it would not be allowed as a new dietary ingredient if it didn’t pre-date DSHEA and was submitted as a new dietary ingredient for consideration today. Under New Zealand’s scheme, I’m not sure where something like nitrous oxide would fall: It’s definitely psychoactive, but is it’s primary purpose to induce psychoactive effects or as a propellant for whipped cream? Or is it exempt anyway because it’s a medicine (used as an anaesthetic), despite the psychoactive use being outside of the medical context.

+++

I suppose there would need to be a body or agency of some kind that makes ongoing determinations very quickly as new drugs pop up.  

The DEA handled fentanyl:  “When a new analog appeared on the streets, the DEA would list it as illegal, and the illicit labs would respond by creating a new, legal analog. This deadly game of ‘Whack-A-Mole’  . . . continued until 2018 when the DEA listed all drugs related to fentanyl as illegal — a move referred to as class-wide scheduling.”    

https://nij.ojp.gov/topics/articles/fighting-uphill-war-against-illicit-drugs-and-overdose-deaths-detecting-emerging

But the DEA hasn’t acted on tianeptine or other drugs that are problematic.


#CBD #Hemp

Whack-a-mole Drugs


March 1, 2024 6:55 pm

NCTR Participation at 2023 SOT Annual Meeting

FDA: NCTR Participation at 2023 SOT Annual Meeting NCTR Participation at 2023 SOT Annual Meeting Anonymous (not verified) Wed, 02/21/2024 – 15:53

Detailed Description
SOT 62nd Annual Meeting and ToxExpo featured more than 70 scientific sessions, 2,000 presentations, 250 exhibitors, and 5,000 attendees

Audience

The SOT 62nd Annual Meeting and ToxExpo featured more than 70 scientific sessions, 2,000 presentations, 250 exhibitors, and 5,000 attendees.

 

2023 SOT Platform, Poster, or Workshop Sessions

Title

NCTR Author

NCTR Division

POSTER SESSION: ALTERNATIVES TO MAMMALIAN MODELS I “Lessons Learned in Establishing a Reliable and Low-Cost Assay for Urea Production in Human Primary Hepatocytes Cultured in a Liver Chip for the Study of Drug Hepatotoxicity” Shi, Q. DSB
POSTER SESSION: ALTERNATIVES TO MAMMALIAN MODELS I “AnimalGAN: A Generative AI Alternative to Animal Clinical Pathology Testing” Chen, X. DBB
POSTER SESSION: ALTERNATIVES TO MAMMALIAN MODELS I “Cardiotoxicity Assessment of HESI Reference Compounds Using Human iPSC-CMs” Bagam, P. DSB
POSTER SESSION: ALTERNATIVES TO MAMMALIAN MODELS I “Performance of the Three-Dimensional HepaRG Micronucleus Assay for In Vitro Genotoxicity Testing” Guo, X. DGMT
POSTER SESSION: EPIDEMIOLOGY AND PUBLIC HEALTH “A Systematic Analysis and Data Mining of Opioid-Related Adverse Events Submitted to the FAERS Database” Le, H. DBB
POSTER SESSION: EPIDEMIOLOGY AND PUBLIC HEALTH “Assessment of Modified Sandwich Estimator for Generalized Estimating Equations with Application to Opioid Poisoning in MIMIC-IV ICU Patients” Rogers, P. DBB
POSTER SESSION: EPIDEMIOLOGY AND PUBLIC HEALTH “RxNorm for Drug Name Normalization: A Case Study of Prescription Opioids in the US FDA Adverse Events Reporting System” Zou, W. DBB
POSTER SESSION: REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY I “Assessing the Developmental Toxicity of Busulfan in an In Vitro Human Placental Barrier-Embryo Co-culture System” Wang, Y. DGMT
POSTER SESSION: CARCINOGENICITY “DNA Methylation and Transcriptomic Alterations Induced by Extended Treatment of Normal Human MCF10A Mammary Gland Epithelial Cells with Non-cytotoxic Doses of Lorcaserin” Willett, R. DBT
PLATFORM SESSION: EXPLORING TIME AND CELL DIVERSITY IN TOXICOGENOMICS SPACE

“Effect of Food-Grade Titanium Dioxide on DNA Methylation in Human Cells”

Wells, C. DBT
WORKSHOP SESSION: UNDERSTANDING THE CONCEPT OF SIMILARITY AND ITS APPLICATIONS TO TOXICOLOGICAL RESEARCH AND RISK ASSESSMENT “Structure Similarity Based on Chemical Descriptors, Fingerprints, and Structural Alerts” Hong, H. DBB
POSTER SESSION: DNA DAMAGE AND REPAIR “Evaluation of Newly Developed 14 Human TK6-Derived Cell Lines That Individually Express a Human Cytochrome P450 for Toxicity Studies” Mei, N. DGMT
POSTER SESSION: DNA DAMAGE AND REPAIR “Nitrosamine Drug Impurities Induce Genotoxicity in Human Lymphoblastoid TK6 Cells” Li, X. DGMT
POSTER SESSION: DNA DAMAGE AND REPAIR “Actein Contributes to Black Cohosh Extract-Induced Genotoxicity in Human TK6 Cells” Le, Y. DGMT
POSTER SESSION: DNA DAMAGE AND REPAIR “Assessment of DNA Damage-Induced by 10 Nitrosamine Impurities Using 2D and 3D HepaRG Models” Seo, J.-E. DGMT
POSTER SESSION: DNA DAMAGE AND REPAIR “Evaluation of the DNA Mutagenicity of N-hydroxycytidine in Mouse Lymphoma Cells by HiFi and Clone Sequencing” Revollo, J. DGMT
POSTER SESSION: DNA DAMAGE AND REPAIR “HiFi Sequencing for Detecting In Vivo Somatic Mutation” Dobrovolsky, V. DGMT
POSTER SESSION: DNA DAMAGE AND REPAIR “HiFi Sequencing Detects the On- and Off-Target Effects of a Cytosine-to-Thymine Base Editor in E. coli Miranda, J. DGMT
POSTER SESSION: BIOTRANSFORMATION/CYTOCHROME P450 “Study of the Roles of Cytochrome P450 (CYPs) in the Metabolism and Cytotoxicity of Perhexiline” Chen, S. DBT
POSTER SESSION: COMPUTATIONAL TOXICOLOGY I “Using Language Model to Facilitate COVID-19-Associated Neurological Disorder Literature Analysis: A BERTox Research” Wu, L. DBB
POSTER SESSION: COMPUTATIONAL TOXICOLOGY I “Development of Random Forest Model for Predicting SARS-CoV-2 Main Protease Binders as Potential Candidates for Repurposing to COVID-19 Treatment” Xu, L. DBB
POSTER SESSION: COMPUTATIONAL TOXICOLOGY I “Opioid Agonist/Antagonist Database (OADB): A Database to Facilitate Opioid Drug Development” Dong, F. DBB
POSTER SESSION: COMPUTATIONAL TOXICOLOGY I “Machine Learning Models for Rat Multigeneration Reproductive Toxicity Prediction” Liu, J. DBB
POSTER SESSION: COMPUTATIONAL TOXICOLOGY II “Machine Learning for Predicting Risk of Drug-Induced Autoimmune Diseases by Structural Alerts and Daily Dose” Chen, M. DBB
POSTER SESSION: SYSTEMS BIOLOGY “Assessment of the Toxicity of Cannabidiol (CBD) in Rats upon Oral Developmental Exposure” Camacho, L. DBT
POSTER SESSION: REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY III “Cannabidiol-Induced Transcriptomic Changes and Cellular Senescence in Human Sertoli Cells” Li, Y. DBT
POSTER SESSION: REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY III “COVID-19 Effects on Pregnancy, Prenatal, and Postnatal Development” Bidarimath, M. DSB
POSTER SESSION: SAFETY ASSESSMENT: PHARMACEUTICAL-DRUG DEVELOPMENT II “Obtain Drug Safety Rankings through Meta-analysis of Clinical Trial Data Using Penalized Bayesian Model” Wang, D. DBB
POSTER SESSION: BIOMARKERS “T2-MRI Mapping as a Minimally Invasive Correlate of Central Nervous System (CNS) Toxicity in a Cuprizone Model: A Biomarker Study” Imam, S. DNT
POSTER SESSION: EPIGENETICS “Effect of the Weight-Loss Drug Lorcaserin on DNA Methylation in Mammary Glands of Sprague Dawley Rats” Roudachevski, I. DBT
PLATFORM SESSION: ENHANCING TOXICOLOGY WITH MACHINE LEARNING “PathologAI – A Deep Learning Framework for Whole Slide Classification in Preclinical Pathology” Xu, J. DBB
POSTER SESSION: ALTERNATIVES TO MAMMALIAN MODELS II
Chair: Qiang Shi (DSB)
“Whole Genome Sequencing Analysis of Mutagenicity of N-Nitrosodiethylamine Using Caenorhabditis elegans Models” Chen, T. DGMT
POSTER SESSION: BIOINFORMATICS “Deep Learning-Based Genotype Imputation for Enhancing Toxicogenomic Data” Song, M. DBB
POSTER SESSION: BIOINFORMATICS “Statistical Methods for Exploring Spontaneous Adverse Event Reporting Databases for Drug-Host Factor Interactions” Lu, Z. DBB
POSTER SESSION: BIOINFORMATICS “Development of a Large List of Drugs for the Study of Nephrotoxicity in Drug Discovery” Connor, S. DBB
POSTER SESSION: BIOINFORMATICS “Random Forest Model for Predicting μ Opioid Receptor Binding Activity for Assisting Development of Opioid Drugs” Li, Z. DBB
POSTER SESSION: BIOINFORMATICS “DeepAmes: Deep Learning-Powered Ames Test Prediction Using Model-Level Representation” Li, T. DBB
POSTER SESSION: RISK ASSESSMENT II “Informing Selection of Drugs for COVID-19 Treatment through Analysis of Adverse Events” Guo, W.  DBB
POSTER SESSION: NEUROTOXICITY: DEVELOPMENTAL I “Cytokine-Mediated Chemotherapy-Induced Cognitive Impairment in Cisplatin and Methotrexate Treated Sprague Dawley Rats” Yeary, J. DNT
POSTER SESSION: NEUROTOXICITY: DEVELOPMENTAL I “Examining Immune Modulatory Effects of Perinatal Cannabidiol Exposure in Sprague Dawley Rats” Gill, W. DNT
POSTER SESSION: NEUROTOXICITY: DEVELOPMENTAL I “The Neurotoxic Potential of a Single Dose of Ketamine in Adolescent and Adult Rats” Talpos, J. DNT
POSTER SESSION: NEUROTOXICITY: DEVLEOPMENTAL II “Behavioral Effects of Cisplatin and Methotrexate Treatment in Juvenile Sprague Dawley Rats” Flanigan, T. DNT
POSTER SESSION: NEUROTOXICITY: DEVLEOPMENTAL II “Investigation of the Developmental Neurotoxicity of Opioids Using Human-Induced Pluripotent Stem Cells” Cai, C. DSB
POSTER SESSION: NEUROTOXICITY: GENERAL “A Modified Approach of Fluoro-Jade C Labeling for Neurotoxicity Assessments” Gu, Q. DNT
POSTER SESSION: IMMUNOTOXICITY I “Sex-Based Differences in Inflammatory Responses to Silver Nanoparticles” Canup, B. DBT
WORKSHOP SESSION 1195: MOVING STEM CELL-DERIVED NEW APPROACH METHODS TOWARD REGULATORY ACCEPTANCE
Chair: Li Pang (DSB)
“Predicting Interindividual Variability of Doxorubicin Cardiotoxicity with Induced Pluripotent Stem Cell-Derived Cardiomyocytes” Pang, L. DSB
POSTER SESSION: BIOLOGICAL MODELING “A Multiscale Physiologically Based Pharmacokinetic (PBPK) Model to Predict the Plasma Concentration and the Tissue Distribution of Doxorubicin” Li, M. DBT
POSTER SESSION: BIOLOGICAL MODELING “Using Various Machine-Learning Algorithms to Determine the Best Method for Predicting Population Physiologically Based Pharmacokinetic Model Plasma Profiles” Fairman, K. DBT
POSTER SESSION: KIDNEY “Evaluating Renal Pathology in Post-COVID-19 Human Autopsy Tissues” Masters, E. DSB
POSTER SESSION: SKIN AND DERMAL TOXICITY “Parallel Evaluation of Alternative Skin Barrier Models and Excised Human Skin for Dermal Absorption Studies In Vitro” Salminen, A. DBT
POSTER SESSION: LIVER I: IN VIVO
Chair: Si Chen (DBT)
“Gene Expression Changes Predict the Severity of NAFLD-Like Liver Injury in Male Collaborative Cross Mice” Tryndyak, V. DBT
POSTER SESSION: LIVER II: IN VIVO “hnRNP-Q and hnRNP-L Influence Drug Metabolism and Toxicity by Regulating mRNA Processing of Drug Metabolizing Enzymes and Nuclear Receptors in HepaRG Cells” Li, D. DBB
POSTER SESSION: LIVER II: IN VIVO “hnRMP-Q and hnRMP-L Influence Drug Metabolism and Toxicity by Regulating mRNA Processing of Drug Metabolizing Enzymes and Nuclear Receptors in HepaRG Cells” Li, D. DBB
POSTER SESSION: RESPIRATORY TOXICOLOGY I “Establishing a Continuous Aerosol Exposure Method for Evaluating the Respiratory Toxicity of Ortho-Phthalaldehyde” Sun, Y. DGMT
POSTER SESSION: LATE-BREAKING 2-4 “Potential Link of High-Fat Diet on the Expression of Alzheimer’s Disease-Related Genes in the Ileal Mucosa of Alzheimer’s Disease Model of Rats” Karn, K. DM
POSTER SESSION: LATE-BREAKING 2-4 “The Effects of Cannabidiol and Its Main Metabolites on Human Neural Stem Cells” Latham, L. DNT
POSTER SESSION: LATE-BREAKING 2-4 “Comparison of the Effects of Delta-9 Tetrahydrocannabinol and Cannabidiol on Human Neural Stem Cells” Liu, F. DNT
POSTER SESSION: LATE-BREAKING 2-4 “Assessment of Potential Developmental Neurotoxicity of Purified Cannabidiol in Sprague Dawley Rats” Shen, A. DNT

 

Communication Type

Short Title
NCTR Participation at 2023 Society of Toxicology

Source Organization

Short Description
Society of Toxicology (SOT) Annual Meeting and ToxExpo, March 19-23, 2023

Publish Date
Wed, 02/21/2024 – 17:00

Review Date
Fri, 02/21/2025 – 00:00

Last Reviewed Date
Wed, 02/21/2024 – 00:00

Site Structure

Next Review Date
1 Year

Navigational Page
Off

Bulk Approved
Off

Display Short Description
On

First Publish Date
Wed, 02/21/2024 – 16:17

Generic Boolean
Off

Language

Number of Related Information to Display
3

Add Subscription Box
Off

Display Short Title
Off

#CBD #Hemp http://www.fda.gov/about-fda/science-research-nctr/nctr-participation-2023-sot-annual-meeting February 21, 2024 8:53 pm

Quoted in Christian Science Monitor

CNR: Quoted in Christian Science Monitor

Good article by Simon Westlake, https://www.csmonitor.com/USA/2024/0123/Growing-like-a-weed-Taking-stock-10-years-after-legalization-began

While a handful of smaller conservative states rejected pro-cannabis ballot measures in 2022, there’s no sign of a wider national rollback. In November 2023, Republican-run Ohio voted to become the 24th state to legalize pot. “Nobody has retracted or retreated,” says Pat Oglesby, a tax lawyer who teaches a cannabis policy class at the University of Virginia. “I think the momentum is for a loosening, not a tightening, of state marijuana sales.” 

+++

Another policy tool is taxation. New York and Connecticut levy excise taxes on cannabis that increase with potency, just as liquor is taxed at higher rates than beer. But regulators have also found that high taxes on cannabis, while healthy for state coffers, can make illegal weed more attractive. A combination of high taxes, stringent regulations, and a lack of dispensaries has hamstrung California’s legal recreational market, while illegal producers are thriving.  

California faces a law enforcement challenge in shutting down its entrenched illegal industry, says Mr. Oglesby, the tax lawyer, who has advised the state’s regulators. “Cops don’t want to arrest people,” he says. “And juries might not convict them.” 


#CBD #Hemp

Quoted in Christian Science Monitor


January 24, 2024 1:06 pm

East Fork Cultivars – 654211 – 12/22/2023

FDA: East Fork Cultivars – 654211 – 12/22/2023 East Fork Cultivars – 654211 – 12/22/2023 Anonymous (not verified) Tue, 12/26/2023 – 06:28

Company Name

FEIN

Short Title
East Fork Cultivars

WARNING LETTER

December 22, 2023

East Fork Hemp, LLC
6258 SE Foster Rd
Portland, Oregon 97206

RE: # 654211

Dear Mason Walker and Tricia Chin:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://eastforkcultivars.com/ and https://eastforkhemp.com/ in September 2023 and has determined that you take orders there for various products which you promote as products containing cannabidiol (CBD).1 We also reviewed your social media websites at https://www.facebook.com/EastForkCultivars/ and https://www.instagram.com/eastforkcultivars/, where you direct consumers to your websites, https://eastforkcultivars.com/ and https://eastforkhemp.com/, to purchase your products. The claims on your websites establish that your CBD products including, but not limited to, all strengths and varieties of your Rescue Rub CBD, CBD Oil, and Peak CBD Solution tinctures for humans (also referred to as “your CBD products”) are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).

Unapproved New Drugs and Misbranded Drugs

Based on our review of your website and social media websites listed above, your CBD products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Examples of claims observed on your websites that establish the intended use of your CBD products as drugs include, but may not be limited to, the following:

From your website https://eastforkcultivars.com/blog:

  • A March 15, 2022 blog post titled “Cannabis And COVID-19: Understanding New Scientific Studies” which contains claims such as “Each aspect offered new evidence that CBD (cannabidiol) can inhibit infection by SARS-CoV-2. In human cells, CBD above a certain threshold concentration was effective at blocking replication early in the infection cycle and six hours after the virus had already infected the cell. (It did not affect the ability of SARS-CoV-2 to enter the cell.) In live mice, pretreatment with CBD for one week prior to infection with SARS-CoV-2 suppressed infection both in their lung and nasal passages, indicating that CBD can prevent viral replication in live animals.”
  • A November 12, 2020 blog post titled “CBD, COVID-19, And The Novel Coronavirus” which contains claims such as “On the more promising side of research, a research team based out of Augusta University (GA) found a potential protective role for CBD as part of the treatment of COVID-19. . .. The researchers concluded, ‘Our results… may extend CBD as part of the treatment of COVID-19 by reducing the cytokine storm, protecting pulmonary tissues, and re-establishing inflammatory homeostasis.’”

From your website https://eastforkhemp.com/ and your February 15, 2023 posts on your social media websites https://www.facebook.com/EastForkCultivars/ and https://www.instagram.com/eastforkcultivars/:

  • From the post titled “Does CBD Need THC to Work?” which contains claims such as “Experimental evidence is limited and more research is needed, but studies on pain and inflammation, breast cancer, epilepsy, and other conditions have found a greater therapeutic effectiveness of whole-plant or full-spectrum cannabis products than isolated cannabinoids.”

From your social media website https://www.instagram.com/eastforkcultivars/:

  • A March 17, 2022 post which references your March 15, 2022 blog post: “University of Chicago Study:⁠ – Offered new evidence that CBD can inhibit infection by SARS-CoV-2.⁠ – The COVID-blocking effects of CBD were demonstrated ONLY by high concentrations of CBD isolate.⁠ – CBDA, CBDV and THC were also tested, but did NOT show the same infection-blocking ability as CBD.”

⁠From your social media website https://www.facebook.com/EastForkCultivars/:

  • A November 15, 2020 post which references your November 12, 2020 blog post: “CBD, COVID-19, and the Novel Coronavirus

Have you heard people saying that cannabis can prevent infection by the novel coronavirus, or that CBD is a possible treatment for COVID-19? . . .
Specifically, the potential therapeutic ECS mechanisms include: reducing overactive inflammatory mechanisms (including cytokine storm) that worsen COVID-19; and…
Head to our blog to keep reading this article by our Director of Education and Director of Cannabis Class, Anna Symonds: https://eastforkcultivars.com/…/cbd-covid19-and…”

Your CBD products are not generally recognized as safe and effective for their above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for your CBD products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

In addition, your CBD products are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Your CBD products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your CBD products are not exempt from the requirement that their labeling bear adequate directions for use because no FDA-approved applications are in effect for these products. The introduction or delivery for introduction into interstate commerce of misbranded drugs is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to [email protected].

Sincerely,
/S/

CAPT Tina Smith
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

__________________________

1 You can find specific information about how FDA regulates CBD at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.

Tue, 12/26/2023 – 09:20
Review Date
Thu, 12/26/2024 – 09:20

Source Organization

Recipient Name
Mason Walker, Co-Owner and CEO

Recipient Title
Tricia Chin, Co-Owner

Last Reviewed Date
Tue, 12/26/2023 – 09:20

Site Structure

Letter Issue Date
December 22, 2023

Issuing Office Building Name
Office of Unapproved Drugs and Labeling Compliance

Next Review Date
1 Year

Detailed Description
Finished Pharmaceuticals/Unapproved New Drug/Misbranded

[email protected]
[email protected]
Delivery Method

MARCS CMS ID

Bulk Approved
Off

Address

United States

Display Short Description
Off

Regulated Product*

Sender Address

United States

Recipient Address

1420 Queen of Bronze Rd
Takilma, OR 97523
United States

Language

Address

United States

Add Subscription Box
Off

Secondary Issuing Offices

United States

#CBD #Hemp http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/east-fork-cultivars-654211-12222023 December 26, 2023 11:28 am

Caulkins on Cannabis: Illicit Market Share and Social Equity

CNR: Caulkins on Cannabis: Illicit Market Share and Social Equity

Here from the public record is my friend Jon Caulkins’s written submission to the Pennsylvania Legislature on cannabis legalization – about expectations for the illicit market and about social equity.

On the illicit market:  “I think two-thirds legal and one-third illegal is a reasonable expectation for after the market has stabilized a few years after state-licensed supply opens and before national legalization. That ballpark estimate comes with several elaborations and two warnings.”

On social equity:  Although “Most discussion focuses on” “[e]nsuring equitable access to cannabis licenses,” “[t]hat is a mistake.” 

And there’s a warning that regulating the marijuana industry won’t be easy.


#CBD #Hemp

Caulkins on Cannabis: Illicit Market Share and Social Equity


November 8, 2023 1:16 pm

FDA Roundup: November 3, 2023

FDA: FDA Roundup: November 3, 2023 FDA Roundup: November 3, 2023 Anonymous (not verified) Fri, 11/03/2023 – 13:13

Short Title
FDA Roundup: November 3, 2023

FDA Statement
No

Press Release Date
November 03, 2023

Detailed Description
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Short Description
FDA Roundup: November 3, 2023

Body

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

  • On Thursday, the FDA announced that its Center for Devices and Radiological Health (CDRH) is seeking input from the public on advancing health equity and facilitating access to digital health technologies for detecting prediabetes and type 2 diabetes, particularly in racial and ethnic minorities. CDRH is uniquely positioned to advance the development of high-quality, safe, and effective technologies to meet the needs of all patients and consumers, including diverse populations. 
  • On Thursday, the FDA proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. This action is part of our regulatory authority over ingredients added to food, which includes reassessing previously evaluated food ingredients and addressing safety concerns. Brominated vegetable oil (BVO) is a vegetable oil that is modified with bromine. As authorized, it is used in small amounts to keep the citrus flavoring from floating to the top in some beverages. The FDA is issuing a proposed rule now because the agency has recent data from studies it conducted that demonstrate adverse health effects in animals at levels more closely approximating real-world human exposure. Based on these data and remaining unresolved safety questions, the FDA can no longer conclude that the use of BVO in food is safe.
  • On Thursday, the FDA issued a guidance, which is being implemented immediately, titled: Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions. The guidance provides recommendations for limited modifications affecting the safety or effectiveness of a device approved through the FDA’s PMA or HDE program, where the modification is necessary to address current manufacturing limitations, potential shortages, or supply chain issues.
  • On Wednesday, the FDA revised the EUA for Paxlovid to facilitate the transition from the U.S. government’s distribution of Paxlovid labeled for use under the EUA to Pfizer’s distribution of the commercial (NDA-labeled) Paxlovid. The FDA has updated the frequently asked questions about Paxlovid during this transition period and encourages people to visit the HHS Paxlovid landing page for additional information.
  • On Wednesday, the FDA released a CDER From Our Perspective summarizing a recently published article in Open Exploration titled, “A U.S. FDA Perspective on Cannabis Research and Drug Development.” In the article, the FDA presents a breakdown of cannabis and cannabis-derived product (CCDP) applications the agency has received over the past 50 years, summarizes our experiences and challenges in reviewing CCDP research applications, and provides recommendations and resources for those interested in studying CCDPs in human clinical trials. For more information, please visit FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development
  • On Tuesday, the FDA approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC). View full prescribing information for Keytruda.
  • On Tuesday, the FDA issued a Safety Alert advising restaurants and food retailers not to sell and to dispose of oysters and consumers not to eat oysters from Fanny Bay Oysters based in British Columbia, Canada harvested on 10/17/2023 from harvest area 14-8 Landfile #278757 and shipped to distributors in California and Washington due to Vibrio parahaemolyticus test results.
Content Owner

Contributing Office

Publish Date
Fri, 11/03/2023 – 15:05

Review Date
Sun, 11/03/2024 – 00:00

Last Reviewed Date
Fri, 11/03/2023 – 00:00

Site Structure

Next Review Date
1 Year

Source Organization

Bulk Approved
Off

Hide main image
hide

Display Short Description
Off

Regulated Product*

Language

Media Contact
Media Contact Name
FDA Office of Media Affairs

Media Contact Phone
888-INFO-FDA

Media Contact Email

First Publish Date
Fri, 11/03/2023 – 15:05

Add Subscription Box
Off

Boilerplate
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Quote Attribution

Announcement Type
FDA News Release

#CBD #Hemp http://www.fda.gov/news-events/press-announcements/fda-roundup-november-3-2023 November 3, 2023 5:13 pm

From Our Perspective

FDA: From Our Perspective From Our Perspective

Site Structure

Anonymous (not verified) Thu, 11/02/2023 – 15:05

Navigational Page
On

Last Reviewed Date
Thu, 11/02/2023 – 00:00

Next Review Date
1 Year

Short Description
Insights from CDER leadership and experts on public health actions

Short Title
From Our Perspective

Detailed Description
Insights from CDER leadership and experts on public health actions

Body

FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development

By: Cassandra L. Taylor, public health advisor, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Schuyler Pruyn, project manager, Office of Executive Programs, CDER

FDA has a long history of reviewing clinical research for cannabis (such as marijuana and hemp) and cannabis-derived products (such as cannabidiol or CBD). Since the early 1970s, FDA has received more than 800 investigational new drug applications (INDs) for, and pre-investigational new drug applications (pre-INDs) related to cannabis and cannabis-derived products (CCDP). Over the last 10 years, there has been increased interest in studying CCDPs as medical treatment options. We have received double the number of IND and pre-IND applications during this time. We also have seen increased clinical research of new types of cannabis products and routes of administration (ROA), which is the way the drug is administered in the body.

More with Cassandra L. Taylor and Schuyler Pruyn

 

Previous From Our Perspectives

2023

2022

2021

2020

Source Organization

Bulk Approved
Off

Hide main image
hide

Display Short Description
Off

Regulated Product*

Sorting Order
10

Language

Place Paragraphs below the Datatable
Off

Add Subscription Box
Off

Display Short Title
On

#CBD #Hemp http://www.fda.gov/drugs/news-events-human-drugs/our-perspective November 2, 2023 7:05 pm

August 2023 510(K) Clearances

August 2023 510(K) Clearances August 2023 510(K) Clearances Anonymous (not verified) Wed, 09/06/2023 – 10:00

Detailed Description
August 2023 510(K) Clearances

 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2023   DEVICE: Maxiocel Chitosan Wound Dressing Advamedica Inc.                   510(k) NO: K212766(Traditional) ATTN: Leo  Mavely                 PHONE NO : 1 973 7187575  Harvard Square, 1 Mifflin Place, SSE DECISION MADE: 24-AUG-23 Cambridge MA  02138               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system Roche Diabetes Care GmbH          510(k) NO: K213131(Traditional) ATTN: Wolfgang  Handel            PHONE NO : 49 621 7598331  Sandhofer Strasse 116             SE DECISION MADE: 10-AUG-23 Mannheim  DE 68305                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Accu-Chek Solo micropump system with interoperable technology Roche Diabetes Care GmbH          510(k) NO: K213134(Traditional) ATTN: Wolfgang  Handel            PHONE NO : 49 621 7598331  Sandhofer Strasse 116             SE DECISION MADE: 10-AUG-23 Mannheim  DE 68305                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MedicloseTM System Health Value Creation BV, trading 510(k) NO: K213271(Traditional) ATTN: Kim  Sondeijker             PHONE NO : 31 43 3882948  Oxfordlaan 55                     SE DECISION MADE: 31-AUG-23 Maastricht  NL 6229 EV            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MONTAGE Settable, Resorbable Hemostatic Bone Putty Orthocon, Inc.                    510(k) NO: K213418(Traditional) ATTN: Howard  Schrayer            PHONE NO : 914 3572600  1 Bridge Street, Suite 121        SE DECISION MADE: 30-AUG-23 Irvington NY  10533               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes Becton Dickinson and Company      510(k) NO: K213670(Traditional) ATTN: Katherine Kenner Lemus      PHONE NO : 801 5419274  1 Becton Drive                    SE DECISION MADE: 25-AUG-23 Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Alinity h-series System Abbott Laboratories               510(k) NO: K220031(Traditional) ATTN: Neha  Vatsyayan             PHONE NO : 408 3134401  4551 Great America Pkwy           SE DECISION MADE: 04-AUG-23 Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit KRONUS, Inc.                      510(k) NO: K220085(Traditional) ATTN: Delaney  Sauer              PHONE NO : 208 3774800  170 S. Seneca Springs Way Suite 10SE DECISION MADE: 24-AUG-23 Star ID  83669                    510(k) STATEMENT                                                       DEVICE: Monaghan medical filtered mouthpiece kit Monaghan Medical Corporation      510(k) NO: K220145(Traditional) ATTN: Cari J Reil                 PHONE NO : 518 5617330  153 Industrial Boulevard          SE DECISION MADE: 24-AUG-23 Plattsburgh NY  12901             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Eco Abutment, Multiunit Abutment DIO Corporation                   510(k) NO: K220253(Traditional) ATTN: Cho  Hye-won                PHONE NO : 82 51 7457836  66, Centumseo-ro                  SE DECISION MADE: 18-AUG-23 Busan  KR 48058                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SQA-iO Sperm Quality Analyzer Medical Electronic Systems LTD    510(k) NO: K220828(Traditional) ATTN: Marcia  Deutsch             PHONE NO : 972 54 7708618  Alon Hatavor 20, Zone 6, Caesarea SE DECISION MADE: 07-AUG-23 Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Nova HD+ Aura Wellness, LLC                510(k) NO: K220938(Traditional) ATTN: Scott  Blomberg             PHONE NO : 502 7141993  11530 Electron Drive              SE DECISION MADE: 22-AUG-23 Louisville KY  40299              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Immunoglobulin G (IgG) Beckman Coulter Laboratory Systems510(k) NO: K221114(Traditional) ATTN: Tracy  Jin                  PHONE NO : 86 512 68955129  No. 181 West Su Hong Road, Suzhou SE DECISION MADE: 02-AUG-23 Suzhou  CN 215021                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Titus Titanium Cervical by SAGICO SAGICO VA USA, LLC                510(k) NO: K221138(Traditional) ATTN: James  Gibson               PHONE NO : 813 8150613  2189 W.Busch Blvd                 SE DECISION MADE: 04-AUG-23 Tampa FL  33612                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: circul™ pro Ring BodiMetrics, LLC                  510(k) NO: K221361(Traditional) ATTN: Mark  Goettling             PHONE NO : 818 2686828  1601 N. Sepulveda Blvd, Suite 839 SE DECISION MADE: 29-AUG-23 Manhattan Beach CA  90266         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants Globus Medical Inc.               510(k) NO: K221894(Traditional) ATTN: Kelly  Baker                PHONE NO : 610 9301800  2560 General Armistead Ave.       SE DECISION MADE: 03-AUG-23 Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, In510(k) NO: K221925(Dual Track) ATTN: Jessica E. Stahle           PHONE NO : 207 7306353  10 Southgate Road                 SE DECISION MADE: 10-AUG-23 Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Q21 NeuroField Inc.                   510(k) NO: K221959(Traditional) ATTN: Nicholas J. Dogris          PHONE NO : 760 8724200  386 West Lane                     SE DECISION MADE: 31-AUG-23 Bishop CA  93514                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Nitrile Patient Examination Gloves, Powder Free, Pink Color Shandong YINGHNG Medical Products 510(k) NO: K222103(Traditional) ATTN: Emily  Dong                 PHONE NO : 86 53 66136888  No.15 East Road, Hongrun Industry SE DECISION MADE: 24-AUG-23 Qingzhou  CN 262500               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Protective Gown AAMI Level 4 Kenpax International Limited      510(k) NO: K222128(Traditional) ATTN: Solomon  Chen               PHONE NO : 909 4387898  Flat 5, 5/F, Wing On Plaza, 62 ModSE DECISION MADE: 08-AUG-23 Hong Kong  CN 999077              510(k) STATEMENT                                                       DEVICE: HemoScreen Hematology Analyzer PixCell Medical Technologies, Ltd.510(k) NO: K222148(Traditional) ATTN: Yaara Ben Yosef             PHONE NO : 972 4 9593516  6 Hayezira St.                    SE DECISION MADE: 16-AUG-23 Yoknaem Ilit  IL 2069202          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ACR Screw System BioMaterials Korea, Inc           510(k) NO: K222245(Traditional) ATTN: Young-yeop  Kim             PHONE NO : 82 31 7904511  #329, #331, #413 150, Jojeong-daerSE DECISION MADE: 21-AUG-23 Hanam-si  KR 12930                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) Siemens Healthcare Diagnostics Inc510(k) NO: K222439(Traditional) ATTN: Joy  Anoop                  PHONE NO : 516 2323307___  511 Benedict Avenue               SE DECISION MADE: 08-AUG-23 Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Air Smart Extra Spirometer FeelLife Health Inc.              510(k) NO: K222443(Traditional) ATTN: May  Xiao                   PHONE NO : 0755 66867080  Room 1903, Building A, No.9 FurongSE DECISION MADE: 09-AUG-23 Shenzhen  CN 518104               510(k) STATEMENT                                                       DEVICE: Alveoair Digital Spirometer Roundworks Technologies Private Li510(k) NO: K222525(Traditional) ATTN: Prashant  Patel             PHONE NO : 91 750 7776273  Office No. B 302, Building No. B, SE DECISION MADE: 28-AUG-23 Wakad, Pune  IN 411047            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BD Kiestra IdentifA Becton, Dickinson and Company     510(k) NO: K222563(Traditional) ATTN: Laura  Stewart              PHONE NO : 410___ 5044252  7 Loveton Circle Mail Code 694    SE DECISION MADE: 31-AUG-23 Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Premier Resolution System Trinity Biotech (Primus Corporatio510(k) NO: K222635(Traditional) ATTN: Kaitlyn  Eastman            PHONE NO : 716 4837423  4231 E. 75th Terrace              SE DECISION MADE: 04-AUG-23 Kansas City MO  64132             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Oral/Enteral Syringe with ENFit connector Anhui Tiankang Medical Technology 510(k) NO: K222772(Traditional) ATTN: Zhang  Yong                 PHONE NO : 86 1370 5505106  No. 228, Weiyi Road, Economic DeveSE DECISION MADE: 17-AUG-23 Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Feeding Tube Anhui Tiankang Medical Technology 510(k) NO: K222773(Traditional) ATTN: Zhang  Yong                 PHONE NO : 86 1370 5505106  No. 228, Weiyi Road, Economic DeveSE DECISION MADE: 17-AUG-23 Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 072 Aspiration System Q’Apel Medical, Inc.              510(k) NO: K222786(Traditional) ATTN: Kim  Ky                     PHONE NO : 510 8284757  4245 Technology Drive             SE DECISION MADE: 25-AUG-23 Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: HAVAb IgG II ABBOTT LABORATORIES               510(k) NO: K222850(Traditional) ATTN: Dominic  Tunzi              PHONE NO : 224 6683644  100 Abbott Park Road              SE DECISION MADE: 10-AUG-23 Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BlueStar CGM insulin dose calculator Welldoc, Inc.                     510(k) NO: K222888(Traditional) ATTN: Ian  Cadieux                PHONE NO : 619 8940873  10221 Wincopin Circle, Ste #150   SE DECISION MADE: 11-AUG-23 Columbia MD  21044                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Oneday Mini Implant System Oneday Biotech Co., Ltd.          510(k) NO: K222946(Traditional) ATTN: Jae Hyun Song               PHONE NO : 82 53 5812835  135 C Seongseodongro Dalseogu     SE DECISION MADE: 23-AUG-23 Daegu  KR 42721                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BioProtect Balloon Implant™ System BioProtect, Ltd.                  510(k) NO: K222972(Traditional) ATTN: Itay  Barnea                PHONE NO : 97 52 8677373  8 Tsor st                         SE DECISION MADE: 25-AUG-23 Tzur Yigal  IL 4486200            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs Sentienx Sdn Bhd                  510(k) NO: K222993(Traditional) ATTN: Sahrudin Shah Bin Abu Bakar PHONE NO : 60 378 903338  Lot 7, Jalan Hi-Tech 12, Zon IndusSE DECISION MADE: 18-AUG-23 Kulim  MY 09090                   510(k) STATEMENT                                                       DEVICE: Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors Gm Dos Reis Industria E Comerico L510(k) NO: K223114(Traditional) ATTN: Iara  Guimaraes             PHONE NO : 55 19 37659900  Avenida Pierre Simon De La Place 6SE DECISION MADE: 02-AUG-23 Campinas  BR 13069320             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MENIX®; MENIX® DUO S.B.M. SAS (Science & Bio Material510(k) NO: K223122(Traditional) ATTN: Anne  Cospin-Latapie        PHONE NO : 33 562 422101  ZI du Monge                       SE DECISION MADE: 03-AUG-23 Lourdes  FR 65100                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) Covidien                          510(k) NO: K223130(Traditional) ATTN: Anila  Tarte                PHONE NO : 978 4966694  6135 Gunbarrel Avenue             SE DECISION MADE: 30-AUG-23 Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VisiRad XR Imidex Inc.                       510(k) NO: K223133(Traditional) ATTN: Kris  Zeschin               PHONE NO : 303 9022171___  3513 Brighton Blvd., Suites 456 7 SE DECISION MADE: 03-AUG-23 Denver CO  80216                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: APS Metal Plate & Screw System A Plus Biotechnology Co., Ltd     510(k) NO: K223150(Traditional) ATTN: Frank  Hsu                  PHONE NO : 886 2 22499222 710 2F-2, No. 120, Qiaohe Rd., ZhongheSE DECISION MADE: 24-AUG-23 New Taipei City  TW 23584         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sleepiz One+ Sleepiz AG                        510(k) NO: K223163(Third Party - Traditional) ATTN: Marta  Stepien              PHONE NO : 41 76 7837350___  Hornbachstrasse 23                SE DECISION MADE: 18-AUG-23 Zurich  CH 8008                   510(k) SUMMARY AVAILABLE FROM FDA                                   THIRD PARTY REVIEW  DEVICE: Spirair Nasal Septal Strap Spirair, Inc.                     510(k) NO: K223167(Traditional) ATTN: James  Kintzing             PHONE NO : 703 9999462  6084 Monterey Hwy, 108            SE DECISION MADE: 17-AUG-23 San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AIRAscore AIRAmed GmbH                      510(k) NO: K223180(Traditional) ATTN: Maximilian  Stalter         PHONE NO : 49 7071 5393366  Konrad-Adenauer-Str. 13           SE DECISION MADE: 25-AUG-23 Tübingen  DE 72072                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Spinery™ RF Ablation System Axon Spine Medical System         510(k) NO: K223303(Traditional) ATTN: Salvatore  Accardo          PHONE NO : 39 335 5300347  Via Lepanto 84                    SE DECISION MADE: 30-AUG-23 Pompei  IT 80045                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ochsner Connected Inhaler Sensor Ochsner Clinic Foundation         510(k) NO: K223367(Traditional) ATTN: Hakm  Murad                 PHONE NO : 504 8427785  1514 Jefferson Hwy                SE DECISION MADE: 30-AUG-23 New Orleans LA  70121             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Citric Complete Liquid Citric Acid Concentrate Nipro Renal Solutions USA, Corp.  510(k) NO: K223431(Traditional) ATTN: Vincent  DeGrandchamp       PHONE NO : 267 6784390  509 Fishing Creek Road            SE DECISION MADE: 04-AUG-23 Lewisberry PA  17339              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ArtiFascia Nurami Medical Ltd.               510(k) NO: K223445(Traditional) ATTN: Hannoch  Marksheid          PHONE NO : 972 74 7408822  Ha'Namal 36                       SE DECISION MADE: 10-AUG-23 Haifa  IL 3303203                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Otsuka Digital Feedback Device-RW Otsuka America Pharmaceutical, Inc510(k) NO: K223463(Traditional) ATTN: Nancy  Teague               PHONE NO : 240 6833560___  2440 Research Boulevard           SE DECISION MADE: 11-AUG-23 Rockville MD  20850               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Nexis® compressive screws Novastep                          510(k) NO: K223468(Abbreviated) ATTN: Gilles  Audic               PHONE NO : 33 29 9338650  2, allée Jacques Frimot           SE DECISION MADE: 30-AUG-23 Rennes  FR 350000                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: V-PRO maX 2 Low Temperature Sterilization System Steris Corporation                510(k) NO: K223476(Traditional) ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437___  5960 Heisley Rd                   SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AQUAbase nX, AQUAbase nX HT B. Braun Medical Inc.             510(k) NO: K223479(Traditional) ATTN: Rushtin  Chaklader          PHONE NO : 610 5962789  901 Marcon Blvd                   SE DECISION MADE: 16-AUG-23 Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SuperBall Meniscal Repair System Arcuro Medical Ltd.               510(k) NO: K223500(Traditional) ATTN: Lee  Ranon                  PHONE NO : 972 72 2607000  17 Tchelet St.                    SE DECISION MADE: 10-AUG-23 Misgav  IL 2017400                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) Good Doctors Co., Ltd.            510(k) NO: K223507(Traditional) ATTN: Heeseop  Lim                PHONE NO : 714 2025789  #208, B-Dong, 283 Bupyeong-Daero, SE DECISION MADE: 04-AUG-23 Incheon  KR 21315                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Carex Hybrid Personal Lubricant Karex Industries Sdn. Bhd.        510(k) NO: K223519(Abbreviated) ATTN: Lai Peng Lim                PHONE NO : 60 7 6881996  PTD 7906 & 7907, Taman Pontian JaySE DECISION MADE: 11-AUG-23 Pontian  MY 82000                 510(k) STATEMENT                                                       DEVICE: ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing Smith & Nephew Medical Limited    510(k) NO: K223526(Traditional) ATTN: Hannah  Sharp               PHONE NO : 44 077 40531714  101 Hessle Road                   SE DECISION MADE: 18-AUG-23 Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Little Wave Clik, Rogue XP, Little Wave XP, Spark Ki Mobility LLC                   510(k) NO: K223527(Traditional) ATTN: Mark  Murphy                PHONE NO : 715 3036447  5201 Woodward Drive               SE DECISION MADE: 31-AUG-23 Stevens Point WI  54481           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Little Wave Arc; Little Wave Flip Ki Mobility LLC                   510(k) NO: K223533(Traditional) ATTN: Mark  Murphy                PHONE NO : 715 3036447 ______ 5201 Woodward Drive               SE DECISION MADE: 31-AUG-23 Stevens Point WI  54481           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Integrity Implant Anika Therapeutics, Inc.          510(k) NO: K223538(Traditional) ATTN: Wei  Zhao                   PHONE NO : 978 8885948  32 Wiggins Ave.                   SE DECISION MADE: 17-AUG-23 Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Dreem 3S Beacon Biosignals, Inc.           510(k) NO: K223539(Traditional) ATTN: Delphine  Lemoine           PHONE NO : 33 6 32047992  22 Boston Wharf Rd., 7th Floor, unSE DECISION MADE: 18-AUG-23 Boston MA  02210                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TubaVent Balloon Dilatation System Spiggle & Theis Medizintechnik Gmb510(k) NO: K223542(Traditional) ATTN: Claudia  Winterschladen     PHONE NO : 49 2206 908165  Burghof 4                         SE DECISION MADE: 03-AUG-23 Overath  DE 51491                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Water for Inhalation in 1L Flexoval ® bottles. Hometa Inc                        510(k) NO: K223551(Traditional) ATTN: Raza  Mohammed              PHONE NO : 443 5545486  300 Great Oaks Blvd, Suite 325    SE DECISION MADE: 03-AUG-23 Albany NY  12203                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine Brainlab AG                       510(k) NO: K223553(Traditional) ATTN: Sadwini  Suresh             PHONE NO : 49 8999 15680  Olof-Palme-Str.9                  SE DECISION MADE: 02-AUG-23 Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Plato 17 Microcatheter Scientia Vascular Inc             510(k) NO: K223560(Traditional) ATTN: Max  Alfonso                PHONE NO : 888 3859016  3487 West 2100 South Suite 100    SE DECISION MADE: 21-AUG-23 West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Onera Sleep Test System (Onera STS) Onera B.V.                        510(k) NO: K223573(Traditional) ATTN: Ruben de Francisco Martin   PHONE NO : 31 0 403082177  Torenallee 42-54                  SE DECISION MADE: 18-AUG-23 Eindhoven  NL 5617BD              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) Philips Medizin Systeme Boeblingen510(k) NO: K223574(Traditional) ATTN: Siegfried  Breitling        PHONE NO : 49 151 20044377  Hewlett-Packard-Strasse 2         SE DECISION MADE: 22-AUG-23 Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pre-Filled Normal Saline Flush Syringe Anhui Tianyang Pharmaceutical Co.,510(k) NO: K223584(Traditional) ATTN: Zhang  Shunlin              PHONE NO : 86 158 05509075  46 Tiantong Road, Tianchang City, SE DECISION MADE: 12-AUG-23 Tianchang  CN                     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Access Folate Assay Beckman Coulter, Inc.             510(k) NO: K223590(Traditional) ATTN: Dr. Kuljeet  Kaur           PHONE NO : 1 952 4651914___  1000 Lake Hazeline Drive          SE DECISION MADE: 23-AUG-23 Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 23andMe® Personal Genome Service® (PGS®) Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) 23andMe, Inc.                     510(k) NO: K223597(Traditional) ATTN: Marianna  Frendo            PHONE NO : 650 6869288  349 Oyster Point Blvd             SE DECISION MADE: 31-AUG-23 South San Francisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterilization Wrap Wuhan Zonsen Medical Products Co.,510(k) NO: K223600(Traditional) ATTN: Linna  Ye                   PHONE NO :  No 8 Jinchao Rd, Zhucheng Street  SE DECISION MADE: 25-AUG-23 Wuhan  CN                         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LifeShield™ Infusion Safety Software Suite ICU Medical, Inc.                 510(k) NO: K223606(Traditional) ATTN: Pernell  Abrantes           PHONE NO : 224 7062229  600 N. Field Drive                SE DECISION MADE: 24-AUG-23 Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Plum Duo™ Infusion System ICU Medical, Inc.                 510(k) NO: K223607(Traditional) ATTN: Yuliya  Matlin              PHONE NO : 224 7062419  600 N. Field Drive                SE DECISION MADE: 24-AUG-23 Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: GEM Premier 7000 with IQM3 Instrumentation Laboratory Company510(k) NO: K223608(Traditional) ATTN: Gabriella  Erdosy           PHONE NO : 781 8614571  180 Hartwell Road                 SE DECISION MADE: 10-AUG-23 Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Rubicon™ Control Support Catheter (H749394323506A1) Boston Scientific Corporation     510(k) NO: K223633(Traditional) ATTN: Mary-Jo  Foley              PHONE NO : 353 0915 17427  One Scimed Place Maple Grove      SE DECISION MADE: 08-AUG-23 Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VisAble.IO TechsoMed                         510(k) NO: K223639(Traditional) ATTN: Dalia  Dickman, PhD         PHONE NO : 972 54 5595951  Meir Weisgal 2                    SE DECISION MADE: 28-AUG-23 Rehovot  IL 7654055               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SaintView Inviz Corporation                 510(k) NO: K223660(Traditional) ATTN: Priscilla  Chung            PHONE NO : 714 2025789  307, Biomedical Components Center,SE DECISION MADE: 14-AUG-23 Gwangju  KR                       510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Surgeon Controlled Arm Levita Magnetics International Cor510(k) NO: K223673(Traditional) ATTN: Alberto  Rodriguez-Navarro, PHONE NO : 650 2410320  4055-A Campbell Avenue            SE DECISION MADE: 04-AUG-23 Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Disposable Needle Guides and Grids Advance Medical Designs, Inc.     510(k) NO: K223689(Traditional) ATTN: David  Mackie               PHONE NO : 1 770 4223125 244 1241 Atlanta Industrial Drive     SE DECISION MADE: 02-AUG-23 Marietta GA  30066                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Kyphoplasty Balloon Catheter Jiangsu Changmei Medtech Co., Ltd.510(k) NO: K223709(Traditional) ATTN: Yang  Lifan                 PHONE NO : 86 186 51969542  No.27, Xinke West Road, Luoyang ToSE DECISION MADE: 16-AUG-23 Changzhou  CN 213104              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ANNE One Sibel Health Inc.                 510(k) NO: K223711(Traditional) ATTN: Sarah  Coughlin             PHONE NO : 224 2518859  6650 W Touhy Ave.                 SE DECISION MADE: 10-AUG-23 Niles IL  60714                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Better Care Plastic Technology Co.510(k) NO: K223713(Traditional) ATTN: Zhu  Chunyan                PHONE NO : 86 311 66766067  Fuqian Xi Road, West district of SSE DECISION MADE: 07-AUG-23 Shenze County  CN 050000          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Lavieen Won Tech Co., Ltd.                510(k) NO: K223727(Traditional) ATTN: Hyun Sik Yoon               PHONE NO : 82 10 67505346  64 Techno 8-ro                    SE DECISION MADE: 25-AUG-23 Yuseong-gu  KR 34028              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ECGenius System Cath Vision ApS                   510(k) NO: K223787(Traditional) ATTN: Mads  Matthiesen            PHONE NO : 45 31 470730  Titangade 11                      SE DECISION MADE: 04-AUG-23 Copenhagen N  DK 2200             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Reusable Temperature Probe, Disposable Temperature Probe Shenzhen SINO-K Medical Technology510(k) NO: K223807(Traditional) ATTN: Lao  Chengxin               PHONE NO : 86 137 15333326  Room401,Bldg2, Veteran Ind.City,GoSE DECISION MADE: 25-AUG-23 Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Aveta System 2.0 Meditrina, Inc.                   510(k) NO: K223813(Traditional) ATTN: Csaba  Truckai              PHONE NO : 408 4714877  1190 Saratoga Avenue, Suite 180   SE DECISION MADE: 21-AUG-23 San Jose CA  95129                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Self-Cath Closed System Coloplast                         510(k) NO: K223821(Traditional) ATTN: Preeti  Jain                PHONE NO : 612 4135614___  1601 West River Road North        SE DECISION MADE: 02-AUG-23 Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: eRapid Nebulizer System PARI Respiratory Equipment, Inc.  510(k) NO: K223840(Traditional) ATTN: Michael  Judge              PHONE NO : 804 2537274  2412 Pari Way                     SE DECISION MADE: 11-AUG-23 Midlothian VA  23112              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NuEra Tight RF Family BIOS s.r.l.                       510(k) NO: K223856(Traditional) ATTN: Manuela  Brambilla          PHONE NO : 0039 02 27304275  Via Guido Rossa 10/12             SE DECISION MADE: 11-AUG-23 Vimodrone  IT 20055               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: IDS ACTH II Immunodiagnostic Systems Limited  510(k) NO: K223867(Traditional) ATTN: Mick  Henderson             PHONE NO : 44 191___ 5190660  10 Didcot Way,  Boldon Business PaSE DECISION MADE: 18-AUG-23 Boldon  GB NE35 9PD               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BAROguard Paragonix Technologies            510(k) NO: K223874(Traditional) ATTN: Nathan  Yetton              PHONE NO : 1 617 8177790  Suite 408, 639 Granite St.        SE DECISION MADE: 15-AUG-23 Braintree MA  02184               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Daye Tampon Annes Daye Ltd                    510(k) NO: K223883(Traditional) ATTN: Valentina  Milanova         PHONE NO : 447 366 456294  The Biscuit Factory, 100 Drummond SE DECISION MADE: 18-AUG-23 London  GB SE16 4DG               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VitalFlowTM Centrifugal Pump Michigan Critical Care Consultants510(k) NO: K223898(Traditional) ATTN: Martha  Rumford             PHONE NO : 734 9959089  2555 Bishop Circle West           SE DECISION MADE: 25-AUG-23 Dexter MI  48130                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: InterCollagen® Guide SigmaGraft Inc.                   510(k) NO: K223912(Traditional) ATTN: Elcin  Chang                PHONE NO : 1 714 5250112  575 Sally Place                   SE DECISION MADE: 17-AUG-23 Fullerton CA  92831               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SOMNUM (V.1.1.2.) Honeynaps Co., Ltd                510(k) NO: K223922(Traditional) ATTN: Tony  Lee                   PHONE NO : 82 108 9220937  4F, Marine Tech B/D, 529, NonhyeonSE DECISION MADE: 16-AUG-23 Seoul  KR 06126                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LW Implant System Ossvis Co., Ltd.                  510(k) NO: K223924(Traditional) ATTN: Young Jae Kim               PHONE NO : 82 31 3600082  7F and B1, 38, Burim-ro 170beon-giSE DECISION MADE: 08-AUG-23 Anyang-si  KR 14055               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Silk'n Titan Allways Silk'n Beauty Ltd.                510(k) NO: K230013(Traditional) ATTN: Amit  Goren                 PHONE NO : 972 4 9097470  Tabor Building, Shaar Yokneam     SE DECISION MADE: 30-AUG-23 Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption Tonica Elektronik A/S             510(k) NO: K230014(Traditional) ATTN: Jan  Kjøller                PHONE NO : 45 2 4899976  Lucernemarken 15                  SE DECISION MADE: 25-AUG-23 Farum  DK DK-3520                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential Ansell Healthcare Products, LLC.  510(k) NO: K230079(Traditional) ATTN: Don  Cronk                  PHONE NO : 775 4707106  2301 Robb Drive                   SE DECISION MADE: 23-AUG-23 Reno NV  89523                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors Responsive Arthroscopy LLC        510(k) NO: K230094(Traditional) ATTN: Garrett  Ahlborg            PHONE NO : 612 5326800  701 N. 3rd Street, Suite 208      SE DECISION MADE: 25-AUG-23 Minneapolis MN  55401             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Dentis s-Clean Regular Abutment Dentis Co., Ltd                   510(k) NO: K230126(Traditional) ATTN: Gyu Ri Kim                  PHONE NO : 82 53 5893541  99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 04-AUG-23 Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Mick Valencia Applicator Set Mick Radio-Nuclear Instruments, In510(k) NO: K230155(Traditional) ATTN: James  Hurlman              PHONE NO : 914 6670291  521 Homestead Avenue              SE DECISION MADE: 30-AUG-23 Mount Vernon NY  10550            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SoundBite® Crossing System XS Peripheral Soundbite Medical Solutions, Inc. 510(k) NO: K230159(Traditional) ATTN: Diane  Marceau              PHONE NO : 514 9562525 3352 2300 Alfred Nobel, Suite 230      SE DECISION MADE: 28-AUG-23 Montreal  CA H4S 2A4              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare510(k) NO: K230162(Traditional) ATTN: Xin  Gao                    PHONE NO : 86 21670 768885386  No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 01-AUG-23 Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé  (20101 Male CH10 - large packaging), Luja Coudé  (20102 Male CH12 - large packaging), Luja Coudé  (20104 Male CH14 - large packaging), Luja Coudé  (20106 Male CH16 - large packaging) Coloplast                         510(k) NO: K230165(Traditional) ATTN: Troy  Thome                 PHONE NO : 612 3569917  1601 West River Road North        SE DECISION MADE: 25-AUG-23 Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pulse Oximeter Beijing Choice Electronic Technolo510(k) NO: K230172(Traditional) ATTN: Haiying  Zhao               PHONE NO : 86 10 88794631  No. 9 Shuangyuan road, Badachu Hi-SE DECISION MADE: 12-AUG-23 Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) Versant Medical Physics and Radiat510(k) NO: K230221(Traditional) ATTN: Darrell R. Fisher           PHONE NO : 509 5393223___  119 N. Church Street              SE DECISION MADE: 28-AUG-23 Kalamazoo MI  49007               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ZenPro 40 Bluecore Company Co Ltd           510(k) NO: K230268(Traditional) ATTN: Bill  Choi                  PHONE NO : 82 517 474318  Ace Hightech 21 #1203 48, Centurm SE DECISION MADE: 10-AUG-23 Busan  KR 48059                   510(k) STATEMENT                                                       DEVICE: PMT Expandable Cage (PMT EXP) Providence Medical Technology, Inc510(k) NO: K230297(Traditional) ATTN: Edward  Liou                PHONE NO : 415 9239376  4234 Hacienda Drive, Suite 150    SE DECISION MADE: 11-AUG-23 Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Celsi Monitor Hadleigh Health Technologies      510(k) NO: K230298(Traditional) ATTN: Molly  McCabe               PHONE NO : 510 6733653  30 Castro Avenue                  SE DECISION MADE: 16-AUG-23 San Rafael CA  94901              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Polyisoprene Surgical Gloves Puyang Linshi Medical Supplies Co.510(k) NO: K230304(Traditional) ATTN: Catherine  Liu              PHONE NO : 86 198 39327898  East of Panjin Road and North of FSE DECISION MADE: 09-AUG-23 Puyang  CN 457001                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) New Era Medicare Sdn. Bhd.        510(k) NO: K230314(Traditional) ATTN: Fatin Nor Irdina binti AhmadPHONE NO : 60 149 072860  Plot 2621-2624                    SE DECISION MADE: 16-AUG-23 Teluk Intan  MY 36000             510(k) STATEMENT                                                       DEVICE: Phototherapy System  (OL-PDT950) Shanghai Omni Laser Skinology Co.,510(k) NO: K230342(Traditional) ATTN: Avril  Ouyang               PHONE NO : 86 021 54847192  Floor 3, Building 3, NO.227, MingqSE DECISION MADE: 16-AUG-23 Shanghai  CN 201612               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation 510(k) NO: K230355(Traditional) ATTN: Janine F Reyes              PHONE NO : 714 6697853  1385 Shimoshigami                 SE DECISION MADE: 30-AUG-23 Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VitalFlow™ Console Michigan Critical Care Consultants510(k) NO: K230364(Traditional) ATTN: Martha  Rumford             PHONE NO : 734 9959089  2555 Bishop Circle West           SE DECISION MADE: 25-AUG-23 Dexter MI  48130                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC.           510(k) NO: K230376(Traditional) ATTN: Rick  Ferreira              PHONE NO : 877 4003740  1435 North Hayden Road, Suite 100 SE DECISION MADE: 07-AUG-23 Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Surgical Face Masks, Model: EFMDS-L50Pn BLU Iris USA                          510(k) NO: K230380(Traditional) ATTN: Michael  Cruz               PHONE NO : 602 7071770  11111 80th Ave.                   SE DECISION MADE: 03-AUG-23 Pleasant Prairie WI  53158        510(k) STATEMENT                                                       DEVICE: PolyWear® Personal Protective Level 3 Gown Polyconversions, INC              510(k) NO: K230384(Traditional) ATTN: William  Smith              PHONE NO : 309 6623614  3202 Apollo Drive                 SE DECISION MADE: 11-AUG-23 Champaign IL  61822               510(k) STATEMENT                                                       DEVICE: Wrist Type Blood Pressure Monitor (W05,W1101L) Shenzhen Jamr Technology Co., Ltd.510(k) NO: K230409(Traditional) ATTN: Haiyu  Zhang                PHONE NO : 86 186 75539961  A101-301, D101-201, Jamr Science &SE DECISION MADE: 25-AUG-23 Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Cadwell Guardian Cadwell Industries, Inc.          510(k) NO: K230415(Traditional) ATTN: Jason  Ford                 PHONE NO : 509 7356481  909 North Kellogg Street          SE DECISION MADE: 17-AUG-23 Kennewick WA  99336               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sequel Tampon with Plastic Applicator Tampro Inc                        510(k) NO: K230419(Traditional) ATTN: Greta  Meyer                PHONE NO : 215 2609081  3749 Buchanan Street #316         SE DECISION MADE: 03-AUG-23 San Fransisco CA  94123           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Dr. pen Microneedling System Guangzhou Ekai Electronic Technolo510(k) NO: K230420(Traditional) ATTN: Guihua  Chen                PHONE NO : 86 020 81177539  3/F Building E No.81 Zijing Road, SE DECISION MADE: 11-AUG-23 Guangzhou  CN 510000              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 Ambu A/S                          510(k) NO: K230428(Traditional) ATTN: Karina  Matthiesen          PHONE NO : 45 7225 2094  Baltorpbakken 13                  SE DECISION MADE: 10-AUG-23 Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Syringe Bulk Tray Shanghai Kindly Enterprise Develop510(k) NO: K230447(Traditional) ATTN: Hualong  Liu                PHONE NO : 86 02169 118232  No.658 Gaochao Road               SE DECISION MADE: 16-AUG-23 Shanghai  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Cove Strip SeaSpine Orthopedics Corporation  510(k) NO: K230486(Traditional) ATTN: Cindy  Toyama               PHONE NO : 949 8557175  2 Goodyear                        SE DECISION MADE: 21-AUG-23 Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EL27-Compact; Sterile EHL-Probes Walz Elektronik GmbH              510(k) NO: K230488(Traditional) ATTN: Bernd  Vollmer              PHONE NO : 49 745 22020  Walddorfer Strasse 40             SE DECISION MADE: 31-AUG-23 Rohrdorf  DE 72229                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Visual-ICE Cryoablation System Boston Scientific Corporation     510(k) NO: K230551(Traditional) ATTN: Amy  McKinney               PHONE NO : 651 2875096  One Scimed Place                  SE DECISION MADE: 08-AUG-23 Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor Joytech Healthcare Co.,Ltd        510(k) NO: K230566(Traditional) ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767  No.365, Wuzhou Road Yuhang EconomiSE DECISION MADE: 25-AUG-23 Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) Medcare Saglik Urunleri Sanayi Ve 510(k) NO: K230577(Traditional) ATTN: Muge  Ersahin               PHONE NO : 90 232 28116  Fatih Mah. Camlik Cad No 54       SE DECISION MADE: 16-AUG-23 Izmir  TR 35410                   510(k) STATEMENT                                                       DEVICE: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl WRP Asia Pacific Sdn. Bhd.        510(k) NO: K230578(Traditional) ATTN: Saravanan  Ramasamy         PHONE NO : 60 387 061486  Lot 1, Jalan 3, Kawasan PerusahaanSE DECISION MADE: 31-AUG-23 Sepang  MY 43900                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Smart Wedge algorithm Edwards Lifesciences, LLC         510(k) NO: K230579(Traditional) ATTN: Jennifer  Wilbur            PHONE NO : 949 7564436  1 Edwards Way                     SE DECISION MADE: 18-AUG-23 Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TOPA12 Portable X-ray Unit NEUF Inc.                         510(k) NO: K230581(Traditional) ATTN: Woo Sang Lee                PHONE NO : 82 61 7402830  #103 Production Bldg. 13, YulchonsSE DECISION MADE: 16-AUG-23 Suncheon-si  KR 58034             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Aer-O-Scope Colonoscope System GI View Ltd.                      510(k) NO: K230588(Traditional) ATTN: Sharon  Goldfarb            PHONE NO : 972 54 6454034  5 Shoham St.                      SE DECISION MADE: 17-AUG-23 Ramat Gan  IL 5251001             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) Teleflex Medical                  510(k) NO: K230603(Traditional) ATTN: Kristen  Bisanz             PHONE NO : 404 2909807  3015 Carrington Mill Blvd.        SE DECISION MADE: 30-AUG-23 Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SPICCA Cervical Fusion Cages Southern Medical (Pty) Ltd        510(k) NO: K230607(Traditional) ATTN: Nathan  Wright              PHONE NO : 719 3510248  Building 10, Southern Implants OffSE DECISION MADE: 14-AUG-23 Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SPICCA Stand-Alone Cervical Fusion Cages Southern Medical (Pty) Ltd        510(k) NO: K230608(Traditional) ATTN: Dalene  Styger              PHONE NO : 27 12 6676243  55 Regency Drive Route 21 CorporatSE DECISION MADE: 14-AUG-23 Irene  ZA 0178                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) Dongguan Shin Yi Healthcare Produc510(k) NO: K230610(Traditional) ATTN: Shuge  Zhao                 PHONE NO : 86 769 8336138  No. 17 Ban Hu Road, Huang Jiang ToSE DECISION MADE: 23-AUG-23 Dong Guan  CN 523750              510(k) STATEMENT                                                       DEVICE: SKEEPER Smartsound Corporation            510(k) NO: K230613(Traditional) ATTN: Jungho  Lee                 PHONE NO : 82 257 52252  171, Yangjaecheon-ro, Gangnam-gu  SE DECISION MADE: 02-AUG-23 Seoul  KR 06302                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter Gentuity, LLC                     510(k) NO: K230620(Traditional) ATTN: Padmini  Gagnon             PHONE NO : 508 4251560  142 North Road, Suite G           SE DECISION MADE: 08-AUG-23 Sudbury MA  01776                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ReliOn Premier BLU Blood Glucose Monitoring System i-SENS, Inc.                      510(k) NO: K230625(Special) ATTN: H.S.  Yoo                   PHONE NO : 82 29 100516  43, Banpo-Daero 28 Gil Seocho-Gu  SE DECISION MADE: 10-AUG-23 Seoul  KR 06646                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01); Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01), Portrait™ RR Electrode Patch (Portrait RRP01) GE Medical Systems Information Tec510(k) NO: K230626(Traditional) ATTN: Joel  Kent                  PHONE NO : 617 8510943  9900 Innovation Drive             SE DECISION MADE: 11-AUG-23 Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VersiHD with GuideMe software NxStage Medical, Inc.             510(k) NO: K230632(Traditional) ATTN: Denise  Oppermann           PHONE NO : 781 9969103  350 Merrimack St.                 SE DECISION MADE: 11-AUG-23 Lawrence MA  01843                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Electronic Blood Pressure Monitor Dongguan kangweile Electronic Tech510(k) NO: K230642(Traditional) ATTN: Zhixin  Gao                 PHONE NO : 86 769 82677482  4th floor, building D, Yizhong SciSE DECISION MADE: 11-AUG-23 Dongguan  CN 523770               510(k) STATEMENT                                                       DEVICE: Density Jeisys Medical Inc.               510(k) NO: K230663(Traditional) ATTN: Bora  Kim                   PHONE NO : 82 10 30197221  307 Daeryung Techno Town 8th      SE DECISION MADE: 14-AUG-23 Seoul  KR 08501                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Annabella Breast Pump Annabella Ltd.                    510(k) NO: K230672(Traditional) ATTN: Uri  Yaffe                  PHONE NO : 97 254 5555484  23/5 Hataas                       SE DECISION MADE: 04-AUG-23 KFAR SABA  IL 4442525             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Tandry Locking Plate System Microware Precision Co., Ltd.     510(k) NO: K230690(Traditional) ATTN: Harrison  Du                PHONE NO : 886 4 24636275 100 No. 12, Keyuan 2nd Rd., Situn DistSE DECISION MADE: 17-AUG-23 Taichung  TW 40763                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co. KG   510(k) NO: K230733(Traditional) ATTN: Gregory  Gohl               PHONE NO : 269 3701476  Boetzinger Strasse 41             SE DECISION MADE: 05-AUG-23 Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Disposable Ureteral Access Sheath YouCare Technology Co., Ltd. (Wuha510(k) NO: K230748(Traditional) ATTN: Bing  Hu                    PHONE NO : 86 27 87926396 830___ Tangxunhu North Street            SE DECISION MADE: 02-AUG-23 Wuhan  CN 430000                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TK Pre-Filled Normal Saline Flush Syringe Anhui Tiankang Medical Technology 510(k) NO: K230756(Traditional) ATTN: Bai  Baodong                PHONE NO : 86 1350 5557811  No. 228 Weiyi Road, Economic DevelSE DECISION MADE: 12-AUG-23 Tianchang  CN                     510(k) STATEMENT                                                       DEVICE: Precice Ankle Salvage System NuVasive Specialized Orthopedics, 510(k) NO: K230765(Traditional) ATTN: Miriam  Cervantes           PHONE NO : 909 2297836  101 Enterprise, Suite 100         SE DECISION MADE: 29-AUG-23 Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Withings Scan Monitor 2.0 Withings                          510(k) NO: K230812(Traditional) ATTN: Khushboo  Surendran         PHONE NO : 857 2052072  2 rue Maurice Hartmann            SE DECISION MADE: 23-AUG-23 Issy-Les-Moulineaux  FR 92130     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Powdered Free Sterile Natural Rubber Latex Surgical Gloves The Egyptian Company For Medical &510(k) NO: K230832(Traditional) ATTN: Alaa  Elsayed               PHONE NO : 201 0000 80163  Industrial Zone 7. Part 7062A&B   SE DECISION MADE: 16-AUG-23 Sadat City  EG                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EXTRON 5; EXTRON 7 DRTECH Corporation                510(k) NO: K230871(Traditional) ATTN: Kim  Minjeong               PHONE NO : 82 031 7797783  Suite No. 1, 2 Floor/Suite No. 2, SE DECISION MADE: 17-AUG-23 Seongnam-si  KR 13216             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments Southern Implants (Pty) Ltd       510(k) NO: K230873(Traditional) ATTN: Colin  Saffy                PHONE NO : 27 12 6671046  1 Albert Road                     SE DECISION MADE: 01-AUG-23 Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: qXR-PTX-PE Qure.ai Technologies              510(k) NO: K230899(Traditional) ATTN: Ayushi  Mahendra            PHONE NO : 91 22 68505800  Level 7, Commerz II, InternationalSE DECISION MADE: 22-AUG-23 Mumbai  IN 400063                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter Vein 360 LLC                      510(k) NO: K230928(Traditional) ATTN: Suzanne  Meyer              PHONE NO : 513 5541300  4460 Lake Forest Dr Suite 230     SE DECISION MADE: 25-AUG-23 Blue Ash OH  452423741            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Arthrex Radiopaque FiberTape Cerclage sutures Arthrex, Inc                      510(k) NO: K230976(Traditional) ATTN: Stacy  Valdez               PHONE NO : 1 239 6435553 72010 1370 Creekside Boulevard          SE DECISION MADE: 24-AUG-23 Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Yomi Robotic System Neocis Inc.                       510(k) NO: K231018(Traditional) ATTN: Joshua  Davis               PHONE NO : 508 2940749  2800 Biscayne Blvd Suite 600      SE DECISION MADE: 14-AUG-23 Miami FL  33137                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AquaBeam Robotic System PROCEPT BioRobotics Corporation   510(k) NO: K231024(Traditional) ATTN: Sara  Muddell               PHONE NO : 650 2327217  900 Island Drive, Suite 101       SE DECISION MADE: 30-AUG-23 Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 12MP Color LCD Monitor C1216W, C12*** ("*" = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) Shenzhen Beacon Display Technology510(k) NO: K231026(Traditional) ATTN: Li  Yafei                   PHONE NO : 86 248 8087610  15F, Building 6, Hengda Shishang HSE DECISION MADE: 18-AUG-23 Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Unicare (K-UNICARE-USA) TensCare Ltd                      510(k) NO: K231053(Traditional) ATTN: Saskia  Eldridge-Hinmers    PHONE NO : 44 137 2723434  9 Blenheim Road                   SE DECISION MADE: 18-AUG-23 Epsom  GB KT199BE                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: V-Laser WON TECH Co., Ltd.                510(k) NO: K231054(Special) ATTN: Hyun Sik Yoon               PHONE NO : 82 10 67505346  64 Techno 8-ro, Yuseong-gu        SE DECISION MADE: 14-AUG-23 Daejeon  KR 34028                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 1.5T HD T/R Knee Array (10-F34127) Shenzhen RF Tech Co., Ltd.        510(k) NO: K231085(Traditional) ATTN: Wang  Gary                  PHONE NO : 0086__ 7552 6641989  2-F,BLD4 Juhui Industrial Park,TiaSE DECISION MADE: 18-AUG-23 Shenzhen  CN 518132               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Guided Surgery Kit Implant Direct Sybron Manufacturin510(k) NO: K231087(Traditional) ATTN: Reina  Choi                 PHONE NO : 1 818 3073132  3050 East Hillcrest Drive         SE DECISION MADE: 16-AUG-23 Thousand Oaks CA  91362           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AlphaVent Suture Anchors Stryker Endoscopy                 510(k) NO: K231093(Traditional) ATTN: Katie  Farraro              PHONE NO : 408___ 4647396  5900 Optical Ct.                  SE DECISION MADE: 30-AUG-23 San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Annalise Enterprise CTB Triage-OH Annalise-AI Pty Ltd               510(k) NO: K231094(Traditional) ATTN: Haylee  Bosshard            PHONE NO : 61 4932 66602  Level P, 24 Campbell St.          SE DECISION MADE: 15-AUG-23 Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Automatic Continuous Effusion Shunt (ACES) System ACES System Pleural Dynamics, Inc.            510(k) NO: K231096(Traditional) ATTN: Martin  Mayse               PHONE NO : 314 5181786  952 Medina Road                   SE DECISION MADE: 18-AUG-23 Wayzata MN  55391                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LineSider® Spinal System Integrity Implants Inc.           510(k) NO: K231098(Traditional) ATTN: Alexa  Kamer                PHONE NO : 561 5293861  354 Hiatt Drive                   SE DECISION MADE: 07-AUG-23 Palm Beach Gardens FL  33418      510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System Zimmer Switzerland Manufacturing G510(k) NO: K231114(Traditional) ATTN: Annemie Kausch Rehor        PHONE NO : 41 795 615986  Sulzerallee 8                     SE DECISION MADE: 09-AUG-23 Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) Phoenix Innovative Healthcare Manu510(k) NO: K231123(Traditional) ATTN: Michael  Stuart             PHONE NO : 954 8804274  EL-209, Shil Mahape Road ElectroniSE DECISION MADE: 30-AUG-23 Navi Mumbai  IN 400710            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Eblator Device E Surgical, LLC                   510(k) NO: K231126(Traditional) ATTN: Michael  Blomeyer           PHONE NO : 775___ 4331808___  150 Isidor Court Unit 203         SE DECISION MADE: 02-AUG-23 Sparks NV  89441                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Enzyme Packed Cartridge - RELiZORB Alcresta Therapeutics, Inc.       510(k) NO: K231156(Traditional) ATTN: Matthew  King               PHONE NO : 603 4599755  130 Turner Street, Building 3, SuiSE DECISION MADE: 30-AUG-23 Waltham MA  02453                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Conductive carbon film electrode Guangzhou Xinbo Electronic Co., Lt510(k) NO: K231164(Traditional) ATTN: Sammy  Li                   PHONE NO : 86 020 34822409  No.23 Building, The Second Phase, SE DECISION MADE: 09-AUG-23 Guangzhou  CN 511450              510(k) STATEMENT                                                       DEVICE: Conductive Silicone Rubber Electrode Guangzhou Xinbo Electronic Co., Lt510(k) NO: K231167(Traditional) ATTN: Sammy  Li                   PHONE NO : 86 020 34822409  No.23 Building, The Second Phase HSE DECISION MADE: 09-AUG-23 Guangzhou  CN 511450              510(k) STATEMENT                                                       DEVICE: BPBIO750 InBody Co, Ltd.                   510(k) NO: K231174(Traditional) ATTN: Kichul  Cha                 PHONE NO : 82 02 5013939  15, Heugam-Gil , Ipjang-Myueon, SeSE DECISION MADE: 02-AUG-23 Cheonan-Si  KR 31025              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Non absorbable Surgical Polyester Suture Shandong Haidike Medical Products 510(k) NO: K231183(Traditional) ATTN: Yan  Wang                   PHONE NO : 86 530 4660062  Tianfu Road, Dongcheng District, SSE DECISION MADE: 25-AUG-23 Heze  CN 274300                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App Cochlear                          510(k) NO: K231204(Traditional) ATTN: Denis  DiMartino            PHONE NO : 508 3044356  10350 Park Meadows Drive          SE DECISION MADE: 18-AUG-23 Lone Tree CO  80124               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray GuruNanda LLC                     510(k) NO: K231205(Traditional) ATTN: Puneet  Nanda               PHONE NO : 714 4100466  6645 Caballero Blvd.              SE DECISION MADE: 22-AUG-23 Buena Park CA  90620              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co. KG   510(k) NO: K231208(Traditional) ATTN: Gregory  Gohl               PHONE NO : 269 3701476  Boetzinger Strasse 41 D-79111     SE DECISION MADE: 14-AUG-23 Freiburg  DE                      510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ventrax™ Delivery System  (VTR851) Merit Medical Systems, Inc.       510(k) NO: K231246(Traditional) ATTN: Jenny  Soderquist           PHONE NO : 801 2084579  1600 West Merit Parkway           SE DECISION MADE: 30-AUG-23 South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NovoFine® Plus Novo Nordisk Inc.                 510(k) NO: K231255(Special) ATTN: Hiral Palkhiwala Shah       PHONE NO : 609 7877603  P.O Box 846                       SE DECISION MADE: 25-AUG-23 Plainsboro NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pangea Utility Plating System, Pangea Platform Stryker GmbH                      510(k) NO: K231257(Traditional) ATTN: Danese  Joiner-Fox          PHONE NO : 475 3334452  325 Corporate Drive               SE DECISION MADE: 18-AUG-23 Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System Stryker GmbH                      510(k) NO: K231262(Traditional) ATTN: Danese  Joiner-Fox          PHONE NO : 475 3334452  325 Corporate Drive               SE DECISION MADE: 18-AUG-23 Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pediatric Nailing Platform | Tibia OrthoPediatrics Corp.             510(k) NO: K231266(Traditional) ATTN: Yan  Li                     PHONE NO : 574 2670864  2850 Frontier Drive               SE DECISION MADE: 21-AUG-23 Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Natural Cycles Natural Cycles Nordic AB          510(k) NO: K231274(Traditional) ATTN: Raoul  Scherwitzl, PhD      PHONE NO : 46 707 174866____  St Eriksgatan 63b                 SE DECISION MADE: 24-AUG-23 Stockholm  SE 112 34              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SmartCardia 7L Platform SmartCardia SA                    510(k) NO: K231276(Traditional) ATTN: Srinivasan  Murali          PHONE NO : 41 788 750864  EPFL Innovation Park Building C   SE DECISION MADE: 30-AUG-23 Lausanne  CH 1015                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Knotless Suture Anchor Riverpoint Medical, LLC           510(k) NO: K231278(Traditional) ATTN: Bianca Silva de Sousa       PHONE NO : 503 5178001  815 NE 25th Ave                   SE DECISION MADE: 01-AUG-23 Portland OR  97232                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Chemfort® Catheter Adaptor Simplivia Healthcare LTD.         510(k) NO: K231286(Traditional) ATTN: Shay  Shaham                PHONE NO : 97 246 908826  North Industrial Zone             SE DECISION MADE: 02-AUG-23 Kiryat Shmona  IL 1101801         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: S-Patch Ex Wearable ECG Patch Wellysis Corp.                    510(k) NO: K231289(Traditional) ATTN: DoGyun  Im                  PHONE NO : 82 109 1408475  8F, 425 Teheran-ro, Gangnam-gu    SE DECISION MADE: 30-AUG-23 Seoul  KR 06159                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Vscan Air GE Medical Systems Ultrasound and 510(k) NO: K231301(Traditional) ATTN: Bush  Lee                   PHONE NO : 262 3099429  9900 W. Innovation Drive          SE DECISION MADE: 15-AUG-23 Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ancora-SB Aspero Medical, Inc.              510(k) NO: K231323(Traditional) ATTN: Mark  Rentschler            PHONE NO : 303 8347885  320 E. Vine Drive, Suite 101      SE DECISION MADE: 31-AUG-23 Fort Collins CO  80524            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LUX-Dx II (M302); LUX-Dx II+ (M312) Boston Scientific Corp            510(k) NO: K231328(Traditional) ATTN: Melissa  Klamerus           PHONE NO : 651 5826771  4100 Hamline Ave North            SE DECISION MADE: 19-AUG-23 St. Paul MN  55112                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: STRETTO™ Cable System Globus Medical Inc.               510(k) NO: K231333(Traditional) ATTN: Jennifer  Antonacci         PHONE NO : 610 9301800  2560 General Armistead Ave.       SE DECISION MADE: 04-AUG-23 Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Organic cotton tampon, Viscose tampon Zhejiang Tianqing Manufacturing Te510(k) NO: K231341(Traditional) ATTN: Roy  Du                     PHONE NO : 86 138 17862379  Lianshi Industrial Park, Nanxun DiSE DECISION MADE: 14-AUG-23 Huzhou  CN 313013                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ActivSight Intraoperative Imaging System Activ Surgical Inc.               510(k) NO: K231344(Traditional) ATTN: Nicholas  Child             PHONE NO : 857 4494840  30 Thomson Place                  SE DECISION MADE: 02-AUG-23 Boston MA  02110                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Dewin Blastocyst Medium (with HSA and without HSA) DonneVie Medical Technology (Shang510(k) NO: K231370(Traditional) ATTN: Hannah Hang Yin             PHONE NO :  Suite 201, Bld 1, 138 Xinjun Ring SE DECISION MADE: 04-AUG-23 Shanghai  CN 201114               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) Smith & Nephew Inc.               510(k) NO: K231376(Traditional) ATTN: Pragnya  Bakka              PHONE NO : 512 3913900  150 Minuteman Road                SE DECISION MADE: 09-AUG-23 Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AirLife DuoTherm™ Humidification System Vyaire Medical, Inc.              510(k) NO: K231380(Traditional) ATTN: Megan  Walsh                PHONE NO : 872 2063142  26125 N. Riverwoods Blvd.         SE DECISION MADE: 10-AUG-23 Mettawa IL  60045                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Harvest Dental HD Gum Strip Harvest Dental Products, LLC      510(k) NO: K231389(Traditional) ATTN: Colleen  Boswell            PHONE NO : 714 5853431  905 Columbia Street               SE DECISION MADE: 16-AUG-23 Brea CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Intense Pulsed Light System Smedtrum Medical Technology Co., L510(k) NO: K231394(Traditional) ATTN: Crimson  Wu                 PHONE NO : 88 622 2989578 301 1F., No. 8, Ln. 97, Wugong Rd.,   SE DECISION MADE: 09-AUG-23 New Taipei City  TW 248016        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Bladeless Trocar – Artemis Lap Cannula T.A.G. Medical Products Corporatio510(k) NO: K231400(Special) ATTN: Shlomi  Dines               PHONE NO : 972 4 9858400  T.A.G. Medical Products CorporatioSE DECISION MADE: 04-AUG-23 Gaaton  IL 2513000                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button Healthium Medtech Limited         510(k) NO: K231404(Traditional) ATTN: Pankaj  Dawar               PHONE NO : 91 988 6529934  472-D, 13th Cross, 4th Phase, PeenSE DECISION MADE: 04-AUG-23 Bangalore  IN 560058              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: StarFin Premium Medical Technology LLC    510(k) NO: K231407(Traditional) ATTN: Kuowei  Chang               PHONE NO : 781 8914201  1377 Main Street 2nd Floor        SE DECISION MADE: 29-AUG-23 Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile Shandong Intco Medical Products Co510(k) NO: K231408(Traditional) ATTN: Max  Li                     PHONE NO : 86 189 18364816  No. 9888 Qiwang Road, Naoshan InduSE DECISION MADE: 11-AUG-23 Qingzhou  CN 2625000              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Erchonia FX-405 Erchonia Corporation              510(k) NO: K231409(Traditional) ATTN: Travis  Sammons             PHONE NO : 888 2420571  650 Atlantis Road                 SE DECISION MADE: 11-AUG-23 Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EnSite™ X EP System Abbott Medical                    510(k) NO: K231415(Traditional) ATTN: Alyssa  Timmers             PHONE NO : 651 7563706  One St. Jude Medical Drive        SE DECISION MADE: 10-AUG-23 St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ENDOGATOR™ Hybrid Irrigation Tubing Medivators                        510(k) NO: K231418(Traditional) ATTN: Disha  Kabrawala            PHONE NO : 732 3197766  14605 28th Avenue North           SE DECISION MADE: 14-AUG-23 Minneapolis MN  55447             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Aura 10 PET/CT XEOS Medical                      510(k) NO: K231420(Traditional) ATTN: Bjorn  Delbeecke            PHONE NO : 0032 09 2777794  Ottergemsesteenweg-Zuid 808 Bus 35SE DECISION MADE: 10-AUG-23 Gent  BE 9000                     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Precision GI Limaca Medical Ltd                510(k) NO: K231422(Traditional) ATTN: Assaf  Klein                PHONE NO : 972 54 2299572  3 Ha'Rimon street Mevo-Carmel ScieSE DECISION MADE: 28-AUG-23 En Ha'Emeq  IL 1925000            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL Thermo Fisher Scientific          510(k) NO: K231433(Traditional) ATTN: Cynthia  Knapp              PHONE NO : 800 87189093 224117 1 Thermo Fisher Way               SE DECISION MADE: 31-AUG-23 Oakwood Village OH  44146         510(k) STATEMENT                                                       DEVICE: DESS Dental Smart Solutions Terrats Medical SL                510(k) NO: K231434(Traditional) ATTN: Roger  Terrats              PHONE NO : 34 935 646006  Carrer Mogoda 75-99               SE DECISION MADE: 14-AUG-23 Barbera del Valles  ES 08210      510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid Kimberly-Clark Corporation        510(k) NO: K231435(Traditional) ATTN: Kimberly  Tempas            PHONE NO : 920 7214084  1400 Holcomb Bridge Road          SE DECISION MADE: 28-AUG-23 Roswell GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Powder Free White, Black, and Purple Nitrile Examination Glove S&S Glove Corporation             510(k) NO: K231439(Traditional) ATTN: Poppy Farrah Rossa          PHONE NO : 84 283 8725999  Lot 4, D6 Road, Dat Do I IndustriaSE DECISION MADE: 11-AUG-23 Ba Ria-Vung Tau  VN VN790000      510(k) STATEMENT                                                       DEVICE: Implant-One System Implant Logistics, Inc.           510(k) NO: K231455(Traditional) ATTN: Thomas  Arendt              PHONE NO : 1 608 4984855  711 Spartan Drive                 SE DECISION MADE: 15-AUG-23 Sparta WI  54656                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SPARK Scan SPARK Neuro Inc.                  510(k) NO: K231457(Traditional) ATTN: Marinela  Gombosev          PHONE NO : 949 5847331  212 West 18th Street, Unit 17A    SE DECISION MADE: 18-AUG-23 New York NY  10011                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Extremity Staple restor3d                          510(k) NO: K231458(Traditional) ATTN: Anika  Moorjani             PHONE NO : 501 2403476  311 West Corporation Street       SE DECISION MADE: 03-AUG-23 Durham NC  27701                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Xpert Xpress CoV-2/Flu/RSV plus Cepheid®                          510(k) NO: K231481(Traditional) ATTN: Suzette  Chance             PHONE NO : 262 6231775  904 Caribbean Drive               SE DECISION MADE: 17-AUG-23 Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Celerity™ HP Chemical Indicator;  Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape STERIS                            510(k) NO: K231488(Traditional) ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437  5960 Heisley Rd                   SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator STERIS Corporation                510(k) NO: K231490(Traditional) ATTN: Gregory  Land               PHONE NO : 440 3927424  5960 Heisley Rd                   SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TA™ Stapler and Loading Unit with DST Series™ Technology Covidien                          510(k) NO: K231491(Traditional) ATTN: Emily  Jacobs               PHONE NO : 860 9336557  60 Middletown Ave.                SE DECISION MADE: 16-AUG-23 North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NITINEX Memory Compression Staple Vilex, LLC                        510(k) NO: K231493(Traditional) ATTN: Brock  Johnson              PHONE NO : 801 9164157  111 Moffitt Street                SE DECISION MADE: 11-AUG-23 McMinnville TN  37110             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TITAN 3-D Wedge System Paragon 28 Inc                    510(k) NO: K231496(Traditional) ATTN: Haylie  Hertz               PHONE NO : 303 7200017  14445 Grasslands Drive            SE DECISION MADE: 22-AUG-23 Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Vis-U-All Low Temperature Sterilization Pouches Steris Corporation                510(k) NO: K231500(Traditional) ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458  5960 Heisley Road                 SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: PRO-LITE Sterilization Tray STERIS Corporation                510(k) NO: K231501(Traditional) ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458  5960 Heisley Road                 SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CUPTIMIZE™ Advanced DePuy Orthopaedics, Inc           510(k) NO: K231503(Traditional) ATTN: Sierra  Robinson            PHONE NO : 850 2519921  700 Orthopaedic Dr                SE DECISION MADE: 22-AUG-23 Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Current Health System Current Health Ltd                510(k) NO: K231506(Special) ATTN: Giovanni  Maggi             PHONE NO : 44 131 2858101  The Stamp Office, Level 3, 10 WateSE DECISION MADE: 24-AUG-23 Edinburgh  GB EH1 3EG             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) Xiantao Zhibo Non-Woven Products C510(k) NO: K231510(Traditional) ATTN: Fen  Peng                   PHONE NO : 86 188 72609993  No. 8 Hefeng Industrial Park, PengSE DECISION MADE: 22-AUG-23 Xiantao  CN                       510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VITROS Immunodiagnostic Products CEA Reagent Pack Ortho Clinical Diagnostics        510(k) NO: K231517(Traditional) ATTN: Rebecca  Lewis              PHONE NO : 440 7917 427649  Felindre Meadows Pencoed          SE DECISION MADE: 23-AUG-23 Bridgend  GB CF35 5PZ             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack Ortho Clinical Diagnostics        510(k) NO: K231525(Traditional) ATTN: Declan  Hynes               PHONE NO : 44 0750 5370257  Felindre Meadows Pencoed          SE DECISION MADE: 09-AUG-23 Bridgend  GB CF35 5PZ             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SofWave System Sofwave Medical Ltd.              510(k) NO: K231537(Traditional) ATTN: Ruthie  Amir, MD            PHONE NO : 97 254 3003164  1 Ha-Otsma St.                    SE DECISION MADE: 28-AUG-23 Yokneam Ilit  IL 2069200          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Meical Diode Laser, Model S1Pro Wuhan Pioon Technology Co., Ltd.  510(k) NO: K231548(Traditional) ATTN: Feng  Zhang                 PHONE NO : 86 180 62448535  7th Floor, A21 of Sino Pharm BuildSE DECISION MADE: 03-AUG-23 Wuhan  CN 430075                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ZENEX FreeMilling & CCM Cast Abutment Izenimplant Co., Ltd.             510(k) NO: K231557(Traditional) ATTN: Ji-Hwan  Jeong              PHONE NO : 82 31 6620657  1, 2Dong, 26-32, Suworam 4-Gil, SeSE DECISION MADE: 24-AUG-23 Pyeongtaek-Si  KR 17703           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) Medtronic Xomed, Inc.             510(k) NO: K231580(Traditional) ATTN: Alexandra  Oliver           PHONE NO : 904 3328936  6743 Southpoint Drive North       SE DECISION MADE: 30-AUG-23 Jacksonville FL  32216            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Route 92 Medical Full Length 054 Access System Route 92 Medical, Inc.            510(k) NO: K231583(Special) ATTN: Kirsten  Valley             PHONE NO : 650 2798427  155 Bovet Road, Suite 100         SE DECISION MADE: 15-AUG-23 San Mateo CA  94402               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sapphire X3 Anterior Cervical Plate System Spinal Elements, Inc              510(k) NO: K231593(Traditional) ATTN: Julie  Lamothe              PHONE NO : 760 6071816  3115 Melrose Dr., Suite 200       SE DECISION MADE: 02-AUG-23 Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Stryker MP, Mandible, HMMF and MMF AXS Screws Stryker Leibinger GmbH & Co. KG   510(k) NO: K231599(Traditional) ATTN: Amelia  Kesti               PHONE NO : 269 3305919  Boetzinger Strasse 41             SE DECISION MADE: 24-AUG-23 Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing GA Health Company Limited         510(k) NO: K231602(Traditional) ATTN: Cindy  Ye                   PHONE NO : 852 28339010  Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 01-AUG-23 Hong Kong  HK                     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Instrument Case Cochlear Americas                 510(k) NO: K231604(Special) ATTN: Whitney  Alexander          PHONE NO : 719 3378620  10350 Park Meadows Drive          SE DECISION MADE: 24-AUG-23 Lone Tree CO  80124               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: HOLO Portal™ Surgical Guidance System Surgalign Spine Technologies      510(k) NO: K231611(Traditional) ATTN: Jeremy  Markovich           PHONE NO : 760 5224378  520 Lake Cook Road Suite 315      SE DECISION MADE: 31-AUG-23 Deerfield IL  60015               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ZEUS IFA(TM) nDNA Test System, ZEUS dIFine ZEUS Scientific                   510(k) NO: K231616(Traditional) ATTN: Mark  Kopnitsky             PHONE NO : 908 5263744  200 Evans Way                     SE DECISION MADE: 31-AUG-23 Branchburg NJ  08876              510(k) STATEMENT                                                       DEVICE: Nuubo Smart Smart Solutions Technologies SL   510(k) NO: K231620(Traditional) ATTN: Borja Gonzal Vez            PHONE NO :  Paseo de la Castellena 200        SE DECISION MADE: 01-AUG-23 Madrid  ES 28046                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Distal Elbow Plating System Skeletal Dynamics Inc             510(k) NO: K231623(Traditional) ATTN: Alexandra  Rodriguez Rojas  PHONE NO : 305 5967585  7300 North Kendall Drive          SE DECISION MADE: 28-AUG-23 Miami FL  33156                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: OSPREY Closed IV Catheter System (OspreyV2) SkyDance Vascular, Inc.           510(k) NO: K231626(Traditional) ATTN: Scott  Pease                PHONE NO : 678 6898010  3058 Millcreek Road               SE DECISION MADE: 31-AUG-23 Pleasant Grove UT  84062          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NorthStar OCT System SeaSpine Inc.                     510(k) NO: K231654(Traditional) ATTN: Jesse  Albright             PHONE NO : 815 3422428  5770 Armada Dr.                   SE DECISION MADE: 03-AUG-23 Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Brainomix 360 e-MRI Brainomix Limited                 510(k) NO: K231656(Traditional) ATTN: Zsolt  Szrnka               PHONE NO : 0044 79 49013914  First Floor Seacourt Tower West WaSE DECISION MADE: 30-AUG-23 Oxford  GB OX2 0JJ                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: P200TE (A10700) Optos Plc                         510(k) NO: K231673(Traditional) ATTN: Rachel  Reay                PHONE NO : 00 441 383843300  Queensferry House, Carnegie CampusSE DECISION MADE: 18-AUG-23 Dunfermline  GB KY11 8GR          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CALLISTO eye Carl Zeiss Meditec AG             510(k) NO: K231676(Traditional) ATTN: Hans-Joachim  Miesner       PHONE NO : 49 3641 220362  Goeschwitzer Strasse 51-52        SE DECISION MADE: 28-AUG-23 Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AccelFix Lumbar Expandable Cage System L&K BioMed Co., Ltd.              510(k) NO: K231680(Special) ATTN: Katherine  Kim              PHONE NO : 82 10 54770325  #101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 24-AUG-23 Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal Prevest Denpro Limited            510(k) NO: K231696(Traditional) ATTN: Atul  Modi                  PHONE NO : 941___ 9194280  Unit II, Export Promotion IndustriSE DECISION MADE: 11-AUG-23 Bari Brahmana  IN 181133          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Holmium Medical Laser Allengers Global Healthcare Privat510(k) NO: K231718(Traditional) ATTN: Harpreet  Singh             PHONE NO : 91 1762 272600  Room No.5, Khasra no. 79, BhankarpSE DECISION MADE: 18-AUG-23 Derabassi, District- Mohali  IN 14510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 McGovern Medical School           510(k) NO: K231731(Traditional) ATTN: K. Lance  Gould             PHONE NO : 713 5006611  6431 Fannin Street, MSB 4.256     SE DECISION MADE: 21-AUG-23 Houston TX  77030                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MA012 Aluminum wheelchair, MS019 steel wheelchair Sichuan AST Medical Equipment Co.,510(k) NO: K231750(Traditional) ATTN: Mae  Tse                    PHONE NO : 86 830 8130333  No.58 JinPeng Road, Area C, West ISE DECISION MADE: 15-AUG-23 Luzhou City  CN 646100            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Stable-C Interbody System Nexus Spine, LLC                  510(k) NO: K231763(Traditional) ATTN: Jared  Crocker              PHONE NO : 801 7028592  2825 East Cottonwood Parkway SuiteSE DECISION MADE: 21-AUG-23 Salt Lake City UT  84121          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) Olympus Winter & Ibe GmbH         510(k) NO: K231777(Traditional) ATTN: Ian  Pericevic              PHONE NO : 49 40 669660  Kuehnstrasse 61                   SE DECISION MADE: 18-AUG-23 Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: primaLOK™ SP Interspinous Fusion System Wenzel Spine, Inc.                510(k) NO: K231807(Traditional) ATTN: William  Wilson             PHONE NO : 512 4690600  1130 Rutherford Lane, Suite 200   SE DECISION MADE: 15-AUG-23 Austin TX  78753                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Zavation Connector System Zavation Medical Products, LLC    510(k) NO: K231811(Traditional) ATTN: Noah  Slack                 PHONE NO : 601 9191119  3670 Flowood Dr.                  SE DECISION MADE: 22-AUG-23 Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NOxBOXi Nitric Oxide Delivery System Linde Gas & Equipment Inc.        510(k) NO: K231823(Special) ATTN: Dave  Loflin                PHONE NO : 412 8743315  208 W Main St.                    SE DECISION MADE: 11-AUG-23 Livingston TN  38570              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Xenix Medical Sacroiliac Fixation System HT Medical d.b.a. Xenix Medical   510(k) NO: K231829(Traditional) ATTN: Teresa  Cherry              PHONE NO : 888 5948633  111 W Jefferson St., Suite 100    SE DECISION MADE: 15-AUG-23 Orlando FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TiLink-L Joint Fusion System SurGenTec                         510(k) NO: K231831(Special) ATTN: Andrew  Shoup               PHONE NO : 561 9907882  911 Clint Moore Rd                SE DECISION MADE: 03-AUG-23 Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: RxSight® Insertion Device (63002) RxSight, Inc.                     510(k) NO: K231838(Traditional) ATTN: Maureen  OConnell           PHONE NO : 978 2071245___  100 Columbia                      SE DECISION MADE: 15-AUG-23 Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Arthrex TightRope II Arthrex Inc.                      510(k) NO: K231857(Traditional) ATTN: Kristi  Frisch              PHONE NO : 1 239 5984302 73849 1370 Creekside Boulevard          SE DECISION MADE: 08-AUG-23 Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Grappler Suture Anchor System Paragon 28, Inc.                  510(k) NO: K231867(Traditional) ATTN: Edward  Wells-Spicer        PHONE NO : 585 4552810  14445 Grasslands Dr               SE DECISION MADE: 21-AUG-23 Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) Kirwan Surgical Products LLC      510(k) NO: K231872(Traditional) ATTN: Matthew  Prario             PHONE NO : 781 8349500  180 Enterprise Drive              SE DECISION MADE: 25-AUG-23 Marshfield MA  02050              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Medline UNITE® REFLEX® Nitinol Staple System Medline Industries, LP            510(k) NO: K231885(Traditional) ATTN: Jennifer  Mason             PHONE NO : 847 6433652  Three Lakes Drive                 SE DECISION MADE: 09-AUG-23 Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Montage-QS Settable, Resorbable Bone Putty Orthocon, Inc.                    510(k) NO: K231903(Traditional) ATTN: Aniq  Darr                  PHONE NO : 855 4759175  700 Fairfield Avenue- Suite 1     SE DECISION MADE: 25-AUG-23 Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Electro-Spec Steri-Caps Electro-Spec, Inc                 510(k) NO: K231905(Traditional) ATTN: Jeff  Smith                 PHONE NO : 1 317 7390924  1800 Commerce Parkway             SE DECISION MADE: 14-AUG-23 Franklin IN  46131                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Mineral Collagen Composite Bioactive Extra Moldable Collagen Matrix, Inc.             510(k) NO: K231942(Special) ATTN: Victoria  Augustine         PHONE NO : 646 2229564  15 Thornton Rd.                   SE DECISION MADE: 02-AUG-23 Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CATAMARAN SI Joint Fusion System Tenon Medical, Inc.               510(k) NO: K231944(Traditional) ATTN: Susan  Noreiga              PHONE NO : 650 7931966  104 Cooper Court                  SE DECISION MADE: 24-AUG-23 Los Gatos CA  95032               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Aristotle 18 Guidewire; Aristotle 24 Guidewire Scientia Vascular, Inc.           510(k) NO: K231954(Special) ATTN: Bailey  Johannsen           PHONE NO : 888 3859016  2460 S 3270 W                     SE DECISION MADE: 01-AUG-23 West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EXPD 4357; EXPD 4357P DRTECH Corporation                510(k) NO: K231959(Special) ATTN: Lee  Youna                  PHONE NO : 82 31 7797710  Suite No.1, 2 Floor/Suite No. 2, 3SE DECISION MADE: 01-AUG-23 Seongnam-si  KR 13216             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NIBPCuff Shenzhen SINO-K Medical Technology510(k) NO: K231961(Traditional) ATTN: Lao  Chengxin               PHONE NO : 86 137 15333326  Room401,Bldg2,Veteran Ind.city,GonSE DECISION MADE: 30-AUG-23 Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: REAL INTELLIGENCE™ CORI™ Blue Belt Technologies, Inc.      510(k) NO: K231963(Special) ATTN: Corrine  Herlinger          PHONE NO : 412 5526428  2875 Railroad Street              SE DECISION MADE: 01-AUG-23 Pittsburgh PA  15222              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 VivaChek Biotech (Hangzhou) Co., L510(k) NO: K231978(Traditional) ATTN: Jessica  Chen               PHONE NO : 86 182 57349413  Floor 2, Block 2, 146 East ChaofenSE DECISION MADE: 31-AUG-23 Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml Thermo Fisher Scientific          510(k) NO: K231988(Traditional) ATTN: Joel  Mathew                PHONE NO : 978 9074417  One Thermo Fisher Way             SE DECISION MADE: 30-AUG-23 Oakwood Village OH  44146         510(k) STATEMENT                                                       DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL Thermo Fisher Scientific          510(k) NO: K231994(Traditional) ATTN: Cynthia  Knapp              PHONE NO : 1 216 2122844  One Thermo Fisher Way             SE DECISION MADE: 25-AUG-23 Oakwood Village OH  44146         510(k) STATEMENT                                                       DEVICE: HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) Smith & Nephew, Inc.              510(k) NO: K232005(Special) ATTN: Camille  Fleischer          PHONE NO : 978 7491057  150 Minuteman Road                SE DECISION MADE: 04-AUG-23 Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LEGACY®  IPC IG Technology Ltd                 510(k) NO: K232006(Third Party - Traditional) ATTN: Ivan  Green                 PHONE NO : 440 7770 386797  Wylcut House, 316 Petre St        SE DECISION MADE: 04-AUG-23 Sheffield  GB S33 0AW             510(k) STATEMENT                                   THIRD PARTY REVIEW  DEVICE: Disposable Medical Examination Nitrile Gloves Raxwell Industrial LLC            510(k) NO: K232008(Third Party - Traditional) ATTN: Xianda  Yao                 PHONE NO : 1 765 4300178___  20323 Bristol Bluff Ln            SE DECISION MADE: 08-AUG-23 Richmond TX  77407                510(k) SUMMARY AVAILABLE FROM FDA                                   THIRD PARTY REVIEW  DEVICE: iTEMPSHIELD AION Biosystems Inc.              510(k) NO: K232010(Third Party - Traditional) ATTN: Joseph  Azary               PHONE NO : 203 2426670  12 Plymouth Road                  SE DECISION MADE: 04-AUG-23 Darien CT  06820                  510(k) SUMMARY AVAILABLE FROM FDA                                   THIRD PARTY REVIEW  DEVICE: ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) ATMOS MedizinTechnik GmbH & Co. KG510(k) NO: K232015(Traditional) ATTN: Reinhold  Storch            PHONE NO : 49 7653 689647  Ludwig-Kegel-Str. 16              SE DECISION MADE: 03-AUG-23 Lenzkirch  DE 79853               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ingenia Elition R5.7.1 SP4 MR Systems Philips Medical Systems Nederland 510(k) NO: K232030(Special) ATTN: Ioana  Ulea                 PHONE NO : 31 618 345875  Veenpluis 6                       SE DECISION MADE: 02-AUG-23 Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Grand Work Plastic Products Co., L510(k) NO: K232039(Special) ATTN: Wu  Yuli                    PHONE NO : 86 311 66179668  Donggao Industrial Zone           SE DECISION MADE: 09-AUG-23 Zanhuang  CN 050000               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ceribell Instant EEG Headband Ceribell, Inc.                    510(k) NO: K232052(Special) ATTN: Raymond  Woo                PHONE NO : 650 5564349  360 North Pastoria Avenue         SE DECISION MADE: 08-AUG-23 Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: YosemiteView 4343W/YosemiteView 3643W CareRay Digital Medical Technology510(k) NO: K232058(Special) ATTN: Xu  Wei                     PHONE NO : 86 512 86860288  A2-201/B3-501, Biobay,218 Xinghu SSE DECISION MADE: 03-AUG-23 Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Efai Pacs Picture Archiving and Communication System Pro Ever Fortune.AI Co., Ltd.         510(k) NO: K232100(Special) ATTN: Joseph  Chang               PHONE NO : 866 4 23226363  8 F., No. 573, Sec. 2, Taiwan BlvdSE DECISION MADE: 08-AUG-23 Taichung City  TW 403020          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CoreLink Navigation Instruments CoreLink, LLC                     510(k) NO: K232116(Special) ATTN: Steven  Mounts              PHONE NO : 888 3497808___  2072 Fenton Logistics Park        SE DECISION MADE: 16-AUG-23 St. Louis MO  63026               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil Covidien                          510(k) NO: K232126(Special) ATTN: Helen  Chen                 PHONE NO : 86 21 33230135  Room 501, 502, 601, 602, No. 3 BuiSE DECISION MADE: 16-AUG-23 Min Hang District, Shanghai  CN 20510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 21HQ513D, 32HL512D, 31HN713D, 32HQ713D LG Electronics Inc.               510(k) NO: K232127(Special) ATTN: Daseul  An                  PHONE NO : 82 31 80665641  168, Suchul-daero                 SE DECISION MADE: 15-AUG-23 Gumi-si  KR 39368                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LifeSPARC System CardiacAssist, Inc.               510(k) NO: K232132(Special) ATTN: Arielle  Drummond           PHONE NO : 412 8899021  620 Alpha Drive                   SE DECISION MADE: 03-AUG-23 Pittsburgh PA  15238              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) Medtronic Sofamor Danek USA, Inc. 510(k) NO: K232141(Special) ATTN: Kelly  McDonnell            PHONE NO : 1 651 2699806  1800 Pyramid Place                SE DECISION MADE: 16-AUG-23 Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Products of the APTUS System Medartis AG                       510(k) NO: K232144(Special) ATTN: Claudia  De Santis          PHONE NO : 41 61 6333434  Hochbergerstrasse 60E             SE DECISION MADE: 18-AUG-23 Basel  CH 4057                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ZSFab Cervical Interbody System ZSFab Inc.                        510(k) NO: K232150(Special) ATTN: Xuewei  Ma                  PHONE NO : 617 4688665  96 Clematis Ave, Suite 2F         SE DECISION MADE: 18-AUG-23 Walthan MA  02453                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Avéli Revelle Aesthetics, Inc.          510(k) NO: K232153(Special) ATTN: Melissa  Viotti             PHONE NO : 650 3365985  2570 W El Camino Real, Suite 310  SE DECISION MADE: 18-AUG-23 Mountain View CA  94040           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control Stryker Corporation               510(k) NO: K232157(Special) ATTN: Janki  Bhatt                PHONE NO : 669 2153045  5900 Optical Ct                   SE DECISION MADE: 18-AUG-23 San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome Boston Scientific Corporation     510(k) NO: K232162(Special) ATTN: Stephanie  Gorman           PHONE NO : 508 3820441  100 Boston Scientific Way         SE DECISION MADE: 14-AUG-23 Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SM-IV Sedecal SA                        510(k) NO: K232185(Special) ATTN: Mª Luisa Gómez  de Agüero   PHONE NO : 34 91 6280544  C/ Pelaya, 9 - 13 Pol. Ind. Río DeSE DECISION MADE: 21-AUG-23 Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter Medtronic Vascular                510(k) NO: K232190(Special) ATTN: Colleen  Gentile            PHONE NO : 1 508 8436178  37A Cherry Hill Drive             SE DECISION MADE: 22-AUG-23 Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: OMNI Surgical System Sight Sciences Inc.,              510(k) NO: K232214(Special) ATTN: Ranjani  Madhavan           PHONE NO : 737 2470998  4040 Campbell Ave, Suite 100      SE DECISION MADE: 25-AUG-23 Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Quantra Hemostasis Analyzer HemoSonics, LLC                   510(k) NO: K232215(Special) ATTN: Debbie  Winegar             PHONE NO : 919 2446990  4020 Stirrup Creek Drive, Suite 10SE DECISION MADE: 24-AUG-23 Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Zenius™ Spinal System Medyssey USA, Inc.                510(k) NO: K232218(Special) ATTN: Youngsu  Jang               PHONE NO : 847 4270200  43176 Business Park Dr Ste 107    SE DECISION MADE: 24-AUG-23 Temecula CA  92590                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ARROW Off-Centred Humeral Insert FH Industrie                      510(k) NO: K232226(Special) ATTN: Naoual  Rahimi              PHONE NO : 33 02 56102046  6 rue Nobel, Zi De Kernevez       SE DECISION MADE: 29-AUG-23 Quimper  FR 29000                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EVO 700 series high speed handpiece Ttbio Corp.                       510(k) NO: K232243(Special) ATTN: Sheng-Chieh  Su             PHONE NO : 886 4 23595958  2F., No.7, 6th Road Industry Park SE DECISION MADE: 23-AUG-23 Taichung  CN 40755                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: RAYSCAN a-Expert3D Ray Co., Ltd.                     510(k) NO: K232287(Special) ATTN: Sooji  Huh                  PHONE NO : 82 605 1000  1F~3F, 4F(Part), 5F, 265, Daeji-RoSE DECISION MADE: 31-AUG-23 Yongin-si  KR 16882               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Essenz HLM, Essenz ILBM LivaNova Deutschland GmbH         510(k) NO: K232291(Special) ATTN: Florian  Goetz              PHONE NO : 49 89 32301236  Lindberghstr. 25                  SE DECISION MADE: 24-AUG-23 Munich  DE 80939                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LAA Exclusion System Syntheon, LLC                     510(k) NO: K232295(Special) ATTN: Toygar  Unal                PHONE NO : 973 9978532  13755 SW 119 Avenue               SE DECISION MADE: 30-AUG-23 Miami FL  33186                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System L&K Biomed Co., Ltd.              510(k) NO: K232311(Special) ATTN: Katherine  Kim              PHONE NO : 82 10 54770325  #101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 14-AUG-23 Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) Ethicon Endo Surgery, LLC.        510(k) NO: K232313(Special) ATTN: Lakrisha  Tinner            PHONE NO : 517 3377475  475 Calle C                       SE DECISION MADE: 29-AUG-23 Guaynabo  PR 00969                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: StealthFix Intraosseous Fixation System Medartis Inc.                     510(k) NO: K232324(Special) ATTN: Chelsea  Kozior             PHONE NO : 610 7318650  1195 Polk Drive                   SE DECISION MADE: 30-AUG-23 Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AC3™ Series IABP Arrow International, LLC          510(k) NO: K232343(Special) ATTN: Sheila  Payzant             PHONE NO : 763 6564290  3015 Carrington Mill Blvd         SE DECISION MADE: 30-AUG-23 Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Powder Free Nitrile Examination Gloves (Black) Shanxi Hongjin Plastic Technology 510(k) NO: K232353(Special) ATTN: Wu  Zhigang                 PHONE NO : 86 311 66179668  Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 31-AUG-23 Linfen  CN 042300                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Treace Medical Concepts (TMC) Compression Implant System Treace Medical Concepts           510(k) NO: K232387(Special) ATTN: Brittany  Grochala          PHONE NO : 515 8650494  100 Palmetto Park Place           SE DECISION MADE: 28-AUG-23 Ponte Vedra FL  32081             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio Ultradent Product, Inc.           510(k) NO: K232498(Third Party - Traditional) ATTN: Ruth  Gardner               PHONE NO : 801 5534431  505 West Ultradent Drive (10200 SoSE DECISION MADE: 18-AUG-23 South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA                                   THIRD PARTY REVIEW                 TOTAL 510(k)s THIS PERIOD   310                                                     TOTAL WITH SUMMARIES        289                                                     TOTAL WITH STATEMENTS        21                                        

Short Title
August 2023 510(K) Clearances

Source Organization

Short Description
August 2023 510(K) Clearances

Publish Date
Wed, 09/06/2023 – 10:58

Review Date
Fri, 09/06/2024 – 00:00

Last Reviewed Date
Wed, 09/06/2023 – 00:00

Site Structure

Next Review Date
1 Year

Navigational Page
Off

Bulk Approved
Off

Display Short Description
Off

First Publish Date
Wed, 09/06/2023 – 10:00

Generic Boolean
Off

Language

Number of Related Information to Display
3

Add Subscription Box
Off

Display Short Title
Off

#CBD #Hemp http://www.fda.gov/medical-devices/510k-clearances/august-2023-510k-clearances September 6, 2023 2:00 pm

Marijuana or Cannabis

Marijuana or Cannabis

What do we call the drug?

Here’s the first jurisdiction to tax our subject:

British Indian colonizers used “hemp drugs” generally, ganja and bhang and more for different products, cannabis rarely, and only for the plant (marijuana not at all): 

https://digital.nls.uk/indiapapers/browse/archive/74574106

https://nida.nih.gov/publications/drugfacts/cannabis-marijuana:

Marijuana refers to the dried leaves, flowers, stems, and seeds from the Cannabis sativa or Cannabis indica plant.

https://www.dea.gov/sites/default/files/2020-06/Marijuana-Cannabis-2020_0.pdf:

Marijuana is a mind-altering (psychoactive)
drug, produced by the Cannabis sativa plant. 

Beyond official federal sources, there are lots of opinions.  I googled marijuana or cannabis – and I may slant what I found toward marijuana.

https://www.theguardian.com/society/2018/jan/29/marijuana-name-cannabis-racism:

Harborside, which is among the oldest and largest dispensaries in California, says on its website: “‘Marijuana’ has come to be associated with the idea that cannabis is a dangerous and addictive intoxicant, not a holistic, herbal medicine … This stigma has played a big part in stymying cannabis legalization efforts throughout the US.”

It’s clear why a business like Harborside would prefer the more scientific word for branding purposes, but does that mean everyone should follow along?

https://www.leafly.com/news/politics/is-the-word-marijuana-racist:

(I know the author, who is at the top of hemp drug journalism — I recommend the whold article)

Queen Adesuyi, senior national policy manager for the Drug Policy Alliance, brought up another aspect of marijuana usage. That is: Labeling marijuana as racist or offensive may alienate many of the people most connected to the plant—and those disproportionately targeted by the War on Drugs.

“The word cannabis is very disconnected to most communities,” she said. “Your average person does not refer to the plant as cannabis.”

“As we’re working to advance legalization across the country, what we don’t want is a complete whitewashing of the history of marijuana criminalization and the impact that’s had on people of color,” Adesuyi added. “This is something we’re seeing the industry do. There’s an active attempt to revamp what the plant means, and who it represents.”

“When you think about ‘the new face of cannabis’” presented by some companies, she said, “it oftentimes is not in alignment with [those most affected by] the stigmatized and criminalized history of the plant.”

There’s also the question of political focus and wasted resources. “It’s important to lead the public discussion about the terms we use,” said Calvin Stovall, Leafly’s East Coast editor, “but I don’t think it’s productive to police how consumers or other members of the industry use the word marijuana.

“I’d rather see us direct our collective energy at the institutional level—to change the laws that are racist and offensive. Forcing people to take a political stance by only saying cannabis and never marijuana creates a dynamic where the legalization community gets caught up arguing among ourselves about terminology.”

Decision time in Word Court

After weeks of conversation and rumination, I find myself disagreeing with Rep. Melanie Morgan.

Let me say it clearly: Marijuana is not pejorative or racist.

The impulse that drove Morgan to change the language of Washington State law wasn’t unfounded, though. It’s time to update the legal conversation to cannabis. But Morgan’s diagnosis was imprecise and too simplistic. Marijuana is a problematic, complicated word with a problematic, complicated history. In the year 2022 it exists in a state of flux, loathed by some while used without malice by many.

Thriving in the cannabis world requires flexibility and quick adaptive reflexes. The language we use reflects that. We’re constantly reading the room to determine the appropriate verbiage. Mostly it’s cannabis or marijuana, but now and then it’s weed and sometimes it’s pot. Sometimes it can feel like living in a Key & Peele code-switch sketch.

That’s my answer today. Stay tuned. It’ll probably change, because language never stops evolving and neither should we.

https://www.kuow.org/stories/stop-using-the-word-marijuana-some-lawmakers-think-so:

Stop saying ‘marijuana’? Lawmakers say it’s racist

David Hyde

March 31, 2022 / 11:55 am

caption: Chelsea Stenson trims marijuana buds before packaging  on Wednesday, July 18, 2018, at House of Cultivar in Seattle.

Chelsea Stenson trims marijuana buds before packaging on Wednesday, July 18, 2018, at House of Cultivar in Seattle. 

KUOW Photo/Megan Farmer

PLAYING5 MINS LEFT

Gov. Jay Inslee recently signed a bill striking the word “marijuana” from the text of all state law. The measure says to use the word “cannabis” instead.

The effort in Washington is part of a national movement to retire the word.

Washington Democrat Melanie Morgan, who sponsored the bill in the state House, calls the word marijuana “pejorative and racist.” Morgan said replacing it is merely one way to create change.

Some cannabis retailers and industry trade groups have stopped using the word. Earlier this year, Maine and Virginia also introduced bills about striking the word marijuana from their laws.

Recreational weed is now legal in these states. But lawmakers are seeking to address the ways that decades of anti-drug policies continue to affect communities of color. For instance, arrests and incarceration for drug crimes have hit Black and Latino communities hardest. Arrests can make it harder to find a job, buy a home and build generational wealth.

“This is just another layer, of peeling off the systemic racism that’s built in our system,” Morgan said of the effort to retire the word marijuana.

But some historians are raising concerns about this effort. They say those who support it are leaning too heavily on a version of cannabis history that’s seeped into popular culture. They say that Morgan and other reformers who point to racist usage of the word have based that assessment on an incomplete reading of cannabis history.

The marijuana story

Historians note that “marijuana” was the word most people in Mexico used for the drug cannabis by the 19th century. Here in the U.S., by the 1920s and ’30s, anti-drug crusaders spread false claims about the effects of smoking marijuana. The 1936 movie “Reefer Madness” famously repeated this misinformation, claiming weed-smoking led to murder, suicide and insanity.

 Anti-drug activists often used the word marijuana in a negative way, and the media and government officials also turned it against people of color, including Mexican immigrants and jazz musicians. Then, in 1937, the federal government outlawed the drug.

That popularized narrative is part of why many now say the word marijuana should be retired. But historians KUOW spoke with believe the popular version of cannabis history is incomplete, and ultimately inaccurate.

“The idea that the word marijuana is racist, I just think it’s nonsense. Marijuana is just the Mexican word for drug cannabis,” said Isaac Campos, a professor of Latin American history who has studied the story of weed.

The making of a myth

Campos said stories about smoking marijuana leading to madness and violence didn’t originate in the U.S. They were first printed in Mexican newspapers, and it was the Mexican government that ended up outlawing the drug first — nearly 20 years before the U.S. did.

U.S. media reprinted anti-weed stories from the Mexican press. And as immigrants moved north, many carried negative stories about marijuana with them.

According to Campos, the more complete story of the word marijuana is a story about the influence of Mexican culture. He believes banning the word would erase that history.

Campos doesn’t deny that racists have sometimes used the word marijuana in a pejorative way. But he argues many other words, such as “salsa,” have also been used in racist ways without anyone calling for their retirement.

“The way we use the word marijuana in the United States is not unlike the way we use the word salsa in the United States. Salsa in Mexico just means ‘sauce.’ It’s any kind of sauce — it could be a Hollandaise sauce — it’s not necessarily what we call salsa in this country. 

“But the fact that we use it for a certain kind of Mexican sauce that goes on tacos just shows that Mexican cuisine has had a huge influence in this country,” Campos said.

Another cannabis historian, Adam Rathge, said something else is missing from pop-culture histories of weed. Long before anyone in the U.S. linked Mexican immigrants with the word marijuana, doctors and lawmakers in America were raising concerns about consuming cannabis.

“If you read 19th century medical journals or if you go look at laws that are passed in the 19th century, at the state level, there’s immediate concern by American physicians about the potential negative effects of cannabis,” Rathge said.

But that story was forgotten. In its place, by the 1980s, the cannabis legalization movement instead preferred a partially made-up narrative, based largely on an influential book written by a pot legalization activist named Jack Herer, who claimed America had a simple love affair with hemp and cannabis before racist prohibition began.

The film “Dazed and Confused” satirized this version of history, with tales of George Washington smoking weed with Martha Washington’s assistance, back when the “whole country” was supposedly “getting high.”

 For her part, Rep. Melanie Morgan stands by the new measure nixing the word marijuana from state law. But she also said she welcomes more information and debate about the linguistic history of the word.

“I’m glad that this is causing conversations, because what this is doing is actually opening the door to bigger issues,” Morgan said.

Morgan pointed to other bills to address structural racism that did not pass this legislative session, including an attempt to increase the number of cannabis businesses licenses that go to communities most affected by the war on drugs, and a bill she sponsored to address racial, economic and social disparities.

The measure striking the word marijuana from Washington state law starts to go into effect this coming June.


#CBD #Hemp

Marijuana or Cannabis


August 28, 2023 10:58 pm

The CBD Regulatory Environment in Europe: Part 2

The CBD Regulatory Environment in Europe: Part 2

This is Part Two of a four-part series discussing European cannabis regulations. Click here for Part One. Part Two analyzes the differences between the UK, the EU and the US. Part Three, coming next week, dives into dosage, approvals and more. Stay tuned for more.


EU Regulatory Environment

We Europeans look with envy at the American market and wonder, why can’t we be more like that? The differences between the American market, the UK and the EU economic zone couldn’t be more different, but changes seem to be on the horizon. While both the UK and the EU apply the Novel Food law, implementation varies significantly.

In the EU, applications are submitted to the EU Commission, and approval can take up to nine months – just for approval of the application – not the testing that will follow. And while the application carries no fee, collecting the required data just to make the application can be expensive, and can run into six figures or higher. Once the application is approved, there may still be data gaps and uncertainties, with toxicology testing that can take years to complete, and ultimately must be approved and validated by EFSA (European Food Safety Authority). The required toxicology testing is where things get really expensive, with both the EIHA (European Industrial Hemp Association) and EFSA estimating costs around €3.5 million.

The EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) has received 19 applications thus far for CBD as a novel food, with more in the pipeline. According to their website, NDA chair Prof. Dominique Turck reported that they “have identified several hazards related to CBD intake” and that many data gaps need filling before evaluations can go ahead. However, she concluded, “It is important to stress that we have not concluded that CBD is unsafe as food.”

As always, with food and drug reviews, it is up to the applicant to prove that a product is safe for human consumption. And for the EU Commission, EFSA is conclusive. And while initial testing is with animals, it also includes human testing, which helps explain the high cost.

At present, the EFSA has been unconvinced by the applications submitted so far, and seeks more data regarding the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being, as well as the impact on human reproduction.

Thus, in 2019, the EIHA formed a German corporation, the “EIHA projects GmbH”, formed for the purpose of pooling partners money to pay for the application and toxicity testing. The Novel Food applications (NFAs) for CBD isolate and synthetic CBD were submitted on November 4, 2022 and full spectrum will follow in April/May of 2023. It should be noted that the application for synthetic CBD has been completely dropped as no testing was ever preformed.

The applications must be reinforced by a series of tox studies under the auspices of the EFSA and for the UK, the FSA. The EFSA will start the risk assessment as soon as the suitability check is performed. The suitability check is a process performed by EFSA to make sure that they have enough data to perform the risk assessment. According to their webpage, the risk assessment can take nine months.

In the case of the application put forth by the EIHA projects GmbH, the CBD isolate dossier will be submitted to the EFSA in September and enter the risk assessment phase. In this phase, the EFSA will go over the data and can ask for more data, should they feel it necessary. They are allowed 9 months to complete this task and submit their recommendations to the EU commission for a 27-member vote, whereby the EIHA projects GmbH application will be valid and legally binding. The EIHA projects GmbH is expecting a validation during the course of 2024. This is a huge game changer!

The application for Full Spectrum distillate should be readied by the end of 2023, whereby the EFSA should be finished with the risk assessment near the end 2024. As Full Spectrum takes into account minor cannabinoid as well as limited THC, it is more complex. It should be noted, that testing full spectrum distillate with a 0.2% THC limit, tests the limit for how much THC can be ingested by humans without side effects. This study is unprecedented and might well have an enormous impact on the issue of THC and its possible future legalization. It is also costing a further one million euros to bring to fruition.

The UK Regulatory Approach

The UK Novel Food approach differs greatly from the EU’s, which has both strengths and weaknesses. What makes the UK CBD market so robust is that the FSA allows products to be sold as long as they were on the market prior to February 13, 2020 and are linked to applications submitted before March 31, 2021. As a result, the FSA was flooded with applications – many later denied on technical grounds, in great part because they didn’t meet these terms. Currently, some 11,000 products worth a projected 1 billion GBP in revenue remain on the FSA list, having passed pre-validation while the FSA awaits the final toxicology report. Only 400 CBD products have been culled from the list, but to date, not a single application has yet been approved. Pre-validation status is incumbent upon a toxicology report, and it remains to be seen how many companies are able to produce such a report.

Important to note is that due to Brexit, a UK validation when it does come, will not be valid in the EU, but products with an EU application accepted on the Union list will be valid in the UK.

UKflagStill with a projected 1 billion GBP at stake, it is easy to why UK CBD manufacturers work to appease the FSA despite the regulatory hurdles. By keeping the door open, the UK has managed to keep investors interested in the CBD market and the public safe from unmonitored products.

This is certainly not the case in the EU, where despite a smattering of products still ducking the authorities, the EU market remains thin by comparison. Their approach has stymied growth compared to the UK where robust Novel Food regulation is in place, but approached differently.

At present, a market comparison of the EU to the UK or North America seems bleak, at least for now, but following approval, future EU-wide distribution could be highly profitable. As we inch closer to a Novel Food listing, the European market may yet prove to be one of the largest markets for the safest CBD products in the world.

The American Market

Still, it is the American market that makes our mouth water; where oils, tinctures, candies, cakes, and drinks with every cannabinoid from CBD to Delta 9, Delta 8, and HHC are available and producers are on their way to becoming millionaires. With a market currently estimated at $6 billion, forecasts reach upwards of $16 billion by 2026.

FDAlogoAnd the health-related concerns, the testing requirements? Are these limited to the UK and the EU? Let’s take a closer look! A mood of caution is emerging in the American cannabis market, that includes producers and lawmakers alike, who are pushing for stricter laws and enforcement.

In America, the FDA (Food and Drug Administration) has alerted the public to CBD’s potential harmful side effects on their website and hope to force congress to deal with the issue.

Many of their concerns validate those of the FSA and the EFSA. For example: on their website the FDA makes a reference to only one CBD product that has been approved: a medicine called Epidiolex. The FDA cites the review of the Epidiolex’s application in 2018 when they identified certain safety risks, including potential for liver damage. The EFSA requires testing on the same issue.

The post The CBD Regulatory Environment in Europe: Part 2 appeared first on Cannabis Industry Journal.


#CBD #Hemp

The CBD Regulatory Environment in Europe: Part 2


August 28, 2023 7:03 pm

The CBD Regulatory Environment in Europe: Part 1

The CBD Regulatory Environment in Europe: Part 1

This is Part One of a four-part series discussing European cannabis regulations. Part One serves as an introduction. Part Two, coming next week, will analyze the differences between the UK, the EU and the US. Stay tuned for more.


As I walk through any European cannabis expo – events like Cultiva Hanfexpo, Cannafest Prague or Spannabis – it is easy to be struck by the differences to those in the U.S. First, there are no THC products, nor are there any CBD food products such as drinks or confectionaries. This is because of the EU Novel Food regulations: “which applies to any food stuffs not commonly used for human consumption before 15 May, 1997.”

As a result, American CBD manufacturers – with virtually no regulation of cannabinoid infused products – have an enormous advantage. In the EU, any “novel food” must be tested and proven to be safe for human consumption.

Still, hemp was not always considered “novel.” In 1997, hemp plant products were considered outside the scope of the regulations EC 258/97.” And more specifically, “that hemp flowers … are considered to be food ingredients” (e. g. used for the production of beer-like beverages). Hence, not ‘novel.’

european union statesSo, right until the end of 2018, nature more or less aligned with the legal establishment, and many products made it safely to market because extracts of cannabidiol (CBD) were considered ‘novel’ only if the levels of CBD were “higher than the CBD levels in the source of the plant itself: Cannabis sativa L.”

However, in January 2019, the catalogue entries for “Cannabis sativa L.” were updated, such that even a naturally occurring level of cannabinoids are now excluded. For the industry, this was a frustrating turn of events, affecting any and all food products to which CBD might be added – confectioneries such as gummies, brownies or cakes, but also includes oils and tinctures containing CBD extracts and other cannabinoids.

Technically, all products on the EU market containing natural CBD or an isolate or distillate are illegal. So, the industry has been playing a cat and mouse game, where consumer labels display vague information or simply state ‘not for human consumption’. The result is a well-developed gray market, that hinges on benign authorities in your jurisdiction.

Sometimes, a producer is able to convince authorities that their product is allowed under Article 4 submission, whereby the producer claims that any CBD content in the food is naturally occurring and a traditional food.

Article 4 is a provision of the Novel Food Regulation (EU) 2015/2283 that allows an operator to check with the national authority on the status of a particular food before bringing the product to market. In the framework of this EU regulation, the operator checks whether the food is traditional or novel. If the food is considered traditional, then the food can be placed on the market immediately. But, if it is novel, it requires a Novel Food authorization.

Good news emerged on June 2, 2023, where in the EU, it has been agreed that once again, hemp leaves are considered a traditional food and are no longer considered Novel. Hemp leaves and tea can be marketed in the EU without further hurdles, but this does not include extracts.

In the case of extracts, CBD isolate and distillate are Novel, not traditional, and a firm must provide toxicology reporting. Both EU and UK law provides that any product containing a CBD extract placed on the market falls under the Novel Food regulations. Ultimately, tests must verify with a high degree of certainty whether CBD is safe to ingest in any amount. And how much is safe before changes occur to internal organs such as the liver or reproductive systems. The FSA will verify results in the UK, while the EFSA is responsible for the EU. 

In the EU, the EFSA will send their final recommendation to the EU commission for approval, where after a 27-member vote, the item will be added to the Novel Food Catalogue. Approval at the individual state level, is next to impossible to acquire, for example, Austrian law states: “Oils/extracts containing cannabinoids placed on the market as such or in foods are considered novel foods and must be authorized in the EU.” No such approval is currently available. Placing it on the market is therefore not permitted.

No ambiguity there!

Some EU countries, such as Greece for example, appear more lenient and others not, but it is retail that is first in line for fines if an investigative authority walks in the door. The situation is certainly nerve-wracking, and having suffered through several of these AGES investigations, I closed my store as a result. Others have had similar experiences. One large retail chain owner reported that he fears the check by the authorities, as each one leads to a fine of some sort, or the demand to remove products. Without notice, he says, the health authorities could decide on even harsher punishments such as larger fines or even removing his business license. Then what, he wonders?

The post The CBD Regulatory Environment in Europe: Part 1 appeared first on Cannabis Industry Journal.


#CBD #Hemp

The CBD Regulatory Environment in Europe: Part 1


August 21, 2023 6:04 pm

Who should get a license to sell cannabis? 

Who should get a license to sell cannabis? 

Here’s a list of cannabis supply architecture models that say what private sellers can get licenses.  Maybe others have been used.  (Jurisdictions listed are just examples, not exhaustive.)

All comers (Oklahoma with $2,500 fee)

All comers with significant fees (Doesn’t some state do that?)

All comers at the state level with local license needed (Colorado, California)

First-come first-served (Los Angeles for retail; no state starts with this, but moratoria in Oklahoma and Oregon transmute “All comers” into FCFS when licensing stops)

Grandfather existing medical marijuana sellers (lots of states)

Lottery for all applicants who meet certain criteria (Washington, https://www.pbs.org/newshour/health/medical-marijuana-licensing-states))

Lottery for all comers (“Arizona doesn’t analyze business proposals the way other states do.  https://www.pbs.org/newshour/health/medical-marijuana-licensing-states)

Lottery for social equity applicants with post-drawing verification of status (Illinois, https://www.illinois.gov/news/press-release.26715.html; Connecticut, https://portal.ct.gov/cannabis/knowledge-base/articles/how-does-the-lottery-work?language=en_US)

Lottery for social equity applicants with pre-drawing verification of status (Maryland, I think, https://www.cannabisindustrylawyer.com/maryland-social-equity-cannabis-lottery-licenses/)

On the merits – competitive licensing (Georgia, Florida)

On the merits — social equity licensing (New York)

Auctions (British India) 


#CBD #Hemp

Who should get a license to sell cannabis? 


August 20, 2023 9:42 pm

In North Carolina, the Left and the Right oppose casinos and medical marijuana cartels.

In North Carolina, the Left and the Right oppose casinos and medical marijuana cartels.

They also oppose having some state body in charge of somehow choosing a handful of medical marijuana sellers that will cartelize the market.

https://reason.org/commentary/north-carolina-house-medical-marijuana-bill/


#CBD #Hemp

In North Carolina, the Left and the Right oppose casinos and medical marijuana cartels.


August 11, 2023 3:05 pm

Cannabis Legalization at UVA Law School

Cannabis Legalization at UVA Law School

University of Virginia Law School Professor Kim Krawiec, who had me talk to her class at when she taught at Duke, asked me to help her teach a class on cannabis legalization this fall.  I was delighted to sign up to in person in Charlottesville for four Fridays.

https://www.law.virginia.edu/courses/cannabis-legalization-sc-123820664

Cannabis Legalization (SC)

LAW7724

Section 1, Fall 23

Krawiec, Kimberly D. 

Oglesby, Pat 

SCHEDULE INFORMATION

Enrollment: 16/16

Credits: 1

Days Date Time Room
Fri 09/08/2023 0900-1200 WB127
Fri 09/29/2023 0900-1200 WB127
Fri 10/20/2023 0900-1200 WB127
Fri 11/10/2023 0900-1200 WB127

COURSE DESCRIPTION

This short course will examine various cannabis legalization regimes, both domestically and internationally, with a focus on the market and financial aspects of legalization. Specifically, we will consider license allocation methods, taxation, racial equity, reparative justice for casualties of the war on drugs, and the continuing existence of illegal transactions after commercial legalization.

COURSE REQUIREMENTS

WRITTEN WORK PRODUCT

Students will be required to upload a final paper to EXPO by noon on Nov 24th. 2500 words maximum. That’s about five single-spaced or ten double-spaced pages. You’ll be able to choose among a variety of topics on implementation and regulation of cannabis commerce

OTHER COURSE DETAILS

Prerequisites: None Concurrencies: None

Exclusive With: None

Laptops Allowed: Yes

First Day Attendance Required: Yes

Course Resources: To be announced.

GRADUATION REQUIREMENTS

Satisfies Understanding Bias/Racism/Cross-Cultural Competency requirement: Yes

Satisfies Writing Requirement: No

Credits For Prof. Skills Requirement: No

Satisfies Professional Ethics: No

ADDITIONAL COURSE INFORMATION

Schedule No.: 123820664

Modified Type: ABA Seminar

Cross Listed: No

Concentrations: Health Law  , Public Policy and Regulation  , Tax Law

Evaluation Portal Via LawWeb Opens: Thursday, November 02, 08:01 PM

Evaluation Portal Via LawWeb Closes: Sunday, November 12, 11:59 PM


#CBD #Hemp

Cannabis Legalization at UVA Law School


August 8, 2023 2:38 pm

La FDA y la FTC advierten a seis compañías por vender ilegalmente imitaciones de productos alimenticios que contienen Delta-8 THC

La FDA y la FTC advierten a seis compañías por vender ilegalmente imitaciones de productos alimenticios que contienen Delta-8 THC La FDA y la FTC advierten a seis compañías por vender ilegalmente imitaciones de productos alimenticios que contienen Delta-8 THC Anonymous (not verified) Thu, 07/06/2023 – 10:08

Short Title
La FDA y la FTC advierten a las compañías por vender ilegalmente imita

FDA Statement
No

Press Release Date
July 05, 2023

Detailed Description
La FDA y la FTC emitieron cartas de advertencia a seis compañías por vender ilegalmente imitaciones de productos alimenticios que contienen Delta-8 THC en violación de la Ley Federal de Alimentos, Medicamentos y Cosméticos (FD&C Act, por sus siglas en inglés).

Short Description
La FDA y la FTC emitieron cartas de advertencia a seis compañías por vender ilegalmente imitaciones de productos alimenticios

Body

English

Hoy, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) y la Comisión Federal de Comercio (FTC, por sus siglas en inglés) emitieron cartas de advertencia a seis compañías por vender ilegalmente imitaciones de productos alimenticios que contienen tetrahidrocannabinol Delta-8, también conocido como Delta-8 THC. Estos productos pueden confundirse fácilmente con alimentos tradicionales como papas fritas, galletas, dulces, gomitas u otros refrigerios. A la FDA le preocupa que los consumidores, incluidos los niños, puedan ingerir accidentalmente estos productos o que los tomen en dosis superiores a las previstas. Las cartas de advertencia se emitieron a: Delta Munchies, Dr. Smoke LLC (también conocida como Dr. S LLC), Exclusive Hemp Farms/Oshipt, Nikte’s Wholesale LLC, North Carolina Hemp Exchange LLC y The Haunted Vapor Room.

“Los niños son más vulnerables que los adultos a los efectos del THC, y muchos de ellos se han enfermo e incluso han sido hospitalizados después de comer “productos comestibles” que lo contienen. Es por eso que emitimos advertencias a varias compañías que venden imitaciones de productos alimenticios que contienen Delta-8 THC, que pueden confundirse fácilmente con alimentos populares que son atractivos para los niños y pueden hacer que un niño pequeño lo ingiera en dosis muy altas sin darse cuenta”, declaró la Comisionada Principal Adjunta de la FDA, Dra. Janet Woodcock, “Los productos contra los que advertimos imitan de manera intencional marcas conocidas de refrigerios al usar nombres de marcas, logotipos o imágenes similares en el envase, que los consumidores, especialmente los niños, pueden confundir con refrigerios tradicionales. También nos preocupa que los adultos puedan consumirlos de manera involuntaria o consumir una dosis más alta de la prevista y sufrir consecuencias graves. Este riesgo es especialmente peligroso para aquellas personas que conducen, trabajan o tienen otras responsabilidades. La FDA mantiene su compromiso de tomar medidas contra cualquier compañía que venda de manera ilegal productos regulados que puedan representar un riesgo para la salud pública”.

Delta-8 THC es una sustancia que se encuentra en la planta de Cannabis sativa, de la cual la marihuana y el cáñamo son dos variedades. Tiene efectos psicoactivos e intoxicantes que pueden ser peligrosos para los consumidores y no ha sido evaluado ni aprobado por la FDA para su uso seguro en ningún contexto, incluso cuando se agrega a los alimentos. La FDA ha recibido informes de efectos adversos graves experimentados por personas que han consumido estos productos, como alucinaciones, vómitos, temblores, ansiedad, mareos, confusión y pérdida del conocimiento. A la FDA también le preocupa que las compañías estén produciendo Delta-8 THC de maneras que podrían resultar en productos con contaminantes dañinos. 

“La comercialización de productos comestibles con THC que los niños pueden confundir fácilmente con alimentos regulares es imprudente e ilegal”, declaró Samuel Levine, Director de la Oficina de Protección al Consumidor de la FTC. “Las compañías deben asegurarse de que sus productos se comercialicen de manera segura y responsable, especialmente cuando se trata de proteger el bienestar de los niños”.

En junio de 2022, la FDA advirtió a los consumidores sobre el consumo de productos alimenticios que contenían Delta-8 THC. Como se indicó en la advertencia, la agencia recibió más de 125 reportes sobre efectos adversos desde el 1 de enero de 2021 hasta el 31 de mayo de 2022, relacionados con niños y adultos que consumieron productos comestibles que contenían Delta-8 THC. Diez de los informes mencionan específicamente que el producto comestible es una imitación de los refrigerios populares.

Si un consumidor cree que un producto podría haber provocado una reacción o una enfermedad, debe dejar de usar el producto de inmediato y comunicarse con su proveedor de atención médica. La FDA también alienta a los proveedores de atención médica y a los consumidores a informar las reacciones adversas asociadas con los productos regulados por la FDA a la agencia mediante MedWatch o el Portal de informes de seguridad.

Estas cartas de advertencia describen violaciones de la Ley Federal de Alimentos, Medicamentos y Cosméticos relacionadas con la adición de Delta-8 THC a los alimentos convencionales. La FDA ha solicitado respuestas por escrito de las seis compañías que recibieron cartas de advertencia en un plazo de 15 días hábiles en las que se indica cómo abordarán estas violaciones y evitarán que vuelvan a ocurrir. Si no se abordan de inmediato las violaciones, se pueden iniciar acciones legales, incluidas incautaciones de productos y/o medidas cautelares.

Content Owner

Publish Date
Thu, 07/06/2023 – 10:20

Review Date
Sat, 07/06/2024 – 10:00

Last Reviewed Date
Thu, 07/06/2023 – 10:00

Site Structure

Next Review Date
1 Year

Source Organization

Bulk Approved
Off

Hide main image
hide

Display Short Description
Off

Regulated Product*

Language

Media Contact
Media Contact Name
Gloria Sánchez-Contreras

Media Contact Phone
301-796-7686

Media Contact Email

First Publish Date
Thu, 07/06/2023 – 10:10

Add Subscription Box
Off

Boilerplate
La FDA, una dependencia del Departamento de Salud y Servicios Sociales de los Estados Unidos, protege la salud pública asegurando la protección, eficacia y seguridad de los medicamentos tanto veterinarios como para los seres humanos, las vacunas y otros productos biológicos destinados al uso en seres humanos, así como de los dispositivos médicos. La dependencia también es responsable de la protección y seguridad de nuestro suministro nacional de alimentos, los cosméticos, los suplementos dietéticos, los productos que emiten radiación electrónica, así como de la regulación de los productos de tabaco.

Quote Attribution

Announcement Type
FDA News Release

#CBD #Hemp http://www.fda.gov/news-events/press-announcements/la-fda-y-la-ftc-advierten-seis-companias-por-vender-ilegalmente-imitaciones-de-productos July 6, 2023 2:08 pm

Medical marijuana in North Carolina op-ed

Medical marijuana in North Carolina op-ed

The Raleigh, Durham, and Charlotte papers put this op-ed below in online and print editions, https://www.newsobserver.com/opinion/article272626684.html#storylink=hpdigest_opinion; it’s been mentioned favorably by Thomas Mills’s PoliticsNC, https://www.politicsnc.com/a-week-of-bipartisan-progress-for-nc/, and featured in depth by a NC Policy Watch, https://ncpolicywatch.com/2023/03/21/north-carolina-should-learn-from-other-places-and-try-to-do-marijuana-right/ (no paywalls).

Excerpts:

The Compassionate Care Act (Senate Bill 3) would unleash the profit motive on millions of dollars’ worth of medical marijuana commerce in our state. But it’s likely to let well-funded out-of-state corporations grab the lion’s share of that money. They would then want to legalize lucrative recreational use quickly and be first in line to sell it.

While state commerce violates free market principles, SB 3’s 10 permanent licenses make for oligopoly, not market freedom. Sure, state delivery and eventually stores would take time and money to set up, but awarding licenses to private sellers “on the merits” or by lottery, SB-3-style, is a recipe for delays and litigation. Four years elapsed between the passage of a medical marijuana law and the first legal sale of medicine in West Virginia and Delaware.


#CBD #Hemp
Medical marijuana in North Carolina op-ed
March 22, 2023 2:04 pm

Social equity and state cannabis sales

Social equity and state cannabis sales

Excerpts from panel appearance of Shaleen Title of the Parabola Center for the North Carolina Department of Justice webinar in 2022.  https://www.youtube.com/watch?v=ehlLi6hlWRE, 21-minute mark:

We need to make “evidence-based decisions that are not based on fear or stigma but rather the reality of data that we have in front of us.  I also want to say you don’t have to use the same models that other states have used. You can think about fairness and equity and one thing that’s brought up a lot is the idea of potentially state regulated storesI think we are long overdue for a state to try that model. I think from a public health perspective and equity perspective it makes sense to see if they try that so I hope that is considered strongly.”

25-minute mark:

“I hope you’ll consider being the first state potentially to look at a state-run model . . . especially because we don’t have a state yet that has a successful equitable for profit model.  Maybe we will soon.  I think New York is an exciting one to look at, but we don’t have that yet.”

Here’s the Parabola Center’s story:

“Our team was the first in the nation to devise a clear path for small businesses and historically disenfranchised groups to enter the market. We are here to help create polices that reflect the needs of the millions of people who continue to form the legal cannabis movement.”


#CBD #Hemp
Social equity and state cannabis sales
March 15, 2023 4:48 pm

CTP-Supported Tobacco Regulatory Research Projects (3-1-23 TEST)

CTP-Supported Tobacco Regulatory Research Projects (3-1-23 TEST) CTP-Supported Tobacco Regulatory Research Projects (3-1-23 TEST) Anonymous (not verified) Wed, 03/01/2023 – 10:17

Detailed Description
CTP-Supported Tobacco Regulatory Research Projects (3-1-23 TEST)

Research supported by FDA’s Center for Tobacco Products (CTP) informs regulatory and public education efforts aimed at improving the overall health of the public and may also provide data about the impact of these efforts.

Award
Date
Title /
Description
Principal
Investigator(s)
Info
04/15/2022

Systematic Identification of Cardiotoxic E-Cigarette Flavorants

The goal of this study is to examine how individual flavorants in e-cigarettes modify the effects of e-cigarette aerosol exposures on the electrical activities of the heart (i.e., cardiac electrophysiology), leading to heart arrhythmias and functional remodeling. Researchers will identify short-term and long-term effects of flavorant exposure on cardiac electrophysiology in mice by using various state-of-the-art analytical approaches. Study aims are: (1) to identify the short-term effects of flavored e-cigarette aerosol inhalation on cardiac electrophysiology; (2) to examine the direct impact of flavorants on cardiac electrophysiology by examining cardiac myocyte function; and (3) to clarify the impacts of individual flavorants on the short- and long-term impacts of e-cigarette aerosol exposures on cardiac electrophysiology, structure, and function. This study will provide new data on the cardiac toxicity of e-cigarette flavorants.

Alex Carll and Matthew Nystoriak Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01HL163818-01
Institution: University of Louisville
03/30/2022

Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-Cigarettes Among Current Menthol Smokers

The goal of this study is to model the impact of different menthol regulatory scenarios on real-world smoking behavior. Study aims are: (1) to examine the impact of banning menthol flavor in cigarettes and e-cigarettes on smoking behavior and (2) to investigate whether outcomes differ by race to understand the impact of menthol ban policies on Black (vs. non-Black) individuals, given high rates of menthol cigarette use in this population. Researchers will recruit 150 adults (ages 21+) who currently smoke menthol cigarettes and will provide them with cigarette and e-cigarette products to use for 8 weeks; subjects will be randomized to one of three study conditions in which they will receive products as follows: (1) no menthol ban (menthol cigarettes and menthol flavored e-cigarettes), (2) menthol ban on cigarettes only (non-menthol cigarettes and menthol flavored e-cigarettes), or (3) menthol ban on both cigarettes and e-cigarettes (non-menthol cigarettes and tobacco flavored e-cigarettes). A follow-up survey at 12 weeks will assess changes in the number of cigarettes smoked per day (the primary study outcome) as well as percent days smoke-free, changes in nicotine dependence, and motivation, confidence, and intention to quit smoking. Findings may inform regulatory activities related to menthol.

Krysten Bold Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01DA054993-01A1
Institution: Yale University
03/28/2022

Novel “Tobacco-Free” Oral Nicotine Pouches: The Impact of Product Features and Marketing Influences on Abuse Liability, Perceptions, and Use Behavior in Smokers and Non-Nicotine Users

A novel class of oral nicotine pouches that contain a nicotine powder instead of tobacco leaves has recently emerged; these pouches often contain non-tobacco flavors (e.g., fruit) with known appeal to youth. The goal of this study is to describe nicotine pouch product features and marketing tactics that may drive initiation and continued use among smokers and non-nicotine users, including youth. Study aims are: (1) to examine how pouch flavors and nicotine doses impact pharmacokinetics (PK), or how nicotine moves through the body, and pharmacodynamics (PD), or the effects a person feels after using a drug, in cigarette smokers; (2) to characterize nicotine pouch marketing tactics in advertisements and examine the influence of these tactics on cigarette smokers’ and youth non-nicotine users’ product perceptions; and (3) to examine how a common marketing tactic (e.g., “tobacco-free” descriptors) impacts use behaviors and PK/PD effects in cigarette smokers and non-nicotine users. To achieve Aim 1, 28 smokers (ages 21+) will use pouches of different flavors (tobacco, mint, fruit) and nicotine doses (low, high), and their own brand of cigarettes over seven laboratory sessions, and PK and PD effects (e.g., subjective abuse liability, tobacco withdrawal) will be assessed. In Aim 2, researchers will review nicotine pouch advertisements over 5 years to identify/monitor marketing tactics and examine, via web-based experiments, how common tactics influence product perceptions (i.e., perceived harm, addictiveness, appeal) and use intentions among 2,500 adult (ages 21+) cigarette smokers and 2,500 youth (ages 13-20) non-nicotine users. In Aim 3, researchers will conduct a second laboratory study with 60 smokers and 60 non-nicotine users (ages 21+) to determine how a common marketing tactic identified from the Aim 2 marketing analysis (“tobacco-free” descriptors) impacts pouch use behaviors and PK/PD effects. Findings may inform future regulatory activities related to novel oral nicotine pouches.

Tory Spindle and Meghan Moran Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01DA055962-01
Institution: Johns Hopkins University
03/22/2022

The Effect of Menthol on ENDS Users’ Dependence, Respiratory, and Toxicants Emission Outcomes

The goal of this study is to clarify how menthol affects electronic nicotine delivery system (ENDS) users’ experience and puffing patterns, which in turn affect dependence, exposure to toxicants, and clinical outcomes. In this study, 200 current/past month closed-system ENDS users (ages 21-35) will attend two laboratory sessions and use their ENDS once with menthol flavor and once with tobacco flavor. Study aims are: (1) to test the effects of menthol vs. tobacco flavor on subjective, puffing, and respiratory outcomes including pre-post-use assessment of craving, withdrawal, satisfaction, harm perception, intention to quit or use, respiratory functions, and symptoms (e.g., dry mouth, irritation, cough, palpitation, nausea); and (2) to use a smoking robot to measure the effects of menthol vs. tobacco flavor on ENDS emissions of 14 aldehydes. Findings may inform future regulatory activities related to the use of menthol flavor in ENDS.

Wasim Maziak Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01DA055937-01
Institution: Florida International University
03/18/2022

The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

More information about the impact of menthol-flavored e-cigarettes in enabling menthol cigarette smokers to switch to e-cigarettes would be useful. The goal of this study is to compare the efficacy of menthol-flavored versus tobacco-flavored e-cigarettes in facilitating switching from combustible cigarettes to e-cigarettes among adult menthol smokers. Researchers will randomize 800 menthol smokers (≥ age 21) into a 12-week trial comparing menthol-flavored and tobacco-flavored e-cigarettes, with follow-up at week 26. Study aims are: (1) to compare the effectiveness of menthol versus tobacco e-cigarettes at facilitating switching (measured by cigarette and e-cigarette use patterns) at week 12; (2) to compare tobacco harm reduction of menthol versus tobacco e-cigarettes (measured by self-reported health-related quality of life, expired carbon monoxide, respiratory measures, and blood pressure) at week 12; (3) to compare the acceptability of menthol versus tobacco e-cigarettes (measured by product use; effects on withdrawal, craving, and dependence; and subjective and sensory effects) at week 12; and (4) to examine the long-term use of menthol versus tobacco e-cigarettes at week 26. Findings may inform future regulatory activities related to menthol flavoring in e-cigarettes.

Nicole Nollen Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01DA055999-01
Institution: University of Kansas Medical Center
10/31/2021

Nicotine Flux, A Potentially Powerful Tool for Regulating Nicotine Delivery from Electronic Cigarettes: Significance of Nicotine Flux to the Rate of Nicotine Delivery and Subjective Effects

The rate at which electronic nicotine delivery systems (ENDS) emit nicotine (“nicotine flux”) can be predicted based on knowledge of a few device design and operating variables. The goal of this study is to provide empirical evidence demonstrating the relationship between nicotine flux and nicotine delivery and between nicotine flux and the physiological and subjective effects that support nicotine dependence. Study aims are: (1) to examine the relationship between nicotine flux, nicotine form, and the rate and dose of nicotine delivery, and (2) to assess the relationship between nicotine flux, nicotine form, and subjective effects. To achieve Aim 1, participants will puff on ENDS devices under conditions that differ by flux and form while arterial blood is sampled for nicotine levels; the outcome will indicate the degree to which nicotine flux and form determine the speed and dose of ENDS nicotine delivery, and thus, abuse liability. To achieve Aim 2, participants will use ENDS devices with varying nicotine fluxes and forms, and dependency measures such as urge to smoke, craving, and abstinence will be assessed; the outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and toxicant exposure. Findings may provide evidence for using nicotine flux to inform possible regulatory activities.

Soha Talih Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01DA052565-01A1
Institution: American University of Beirut
10/15/2021

CTP Supplement to Parent Grant: Chronic Hookah (Waterpipe) Smoking, Vascular Dysfunction, Inflammation and Oxidative Stress

As a supplement to a parent grant, this study will further examine the long-term health effects of hookah smoking by evaluating autonomic nervous system regulations of the heart and identifying additional biomarkers of harm that could be used to evaluate and monitor the effects of chronic hookah smoking on cardiovascular health. In a group of generally 34 healthy chronic hookah smokers ages 21-49 who do not smoke cigarettes — matched with 34 cigarette smokers and 34 nonsmokers — researchers will examine: (1) cardiac sympathetic nerve activity measured by heart rate variability; and (2) biological markers of inflammation and oxidative stress, including: (a) interleukin-6 and tumor necrosis factor-a; (b) free polyunsaturated fatty acids and oxidized metabolites, assessed by mass spectrometry; and (c) concentrations of glutathione, bilirubin, heme oxygenase-1, and functional activity of paraoxonase1, determined by colorimetric and enzymatic assays. Findings will provide new information about the cardiovascular effects of hookah smoking.

Mary Rezk-Hanna Funding Mechanism: National Institutes of Health – Grant
ID Number: 3R01HL152435-02S1
Institution: University of California, Los Angeles
10/12/2021

Determinants and Health Effects of Dynamic Changes in E-Cigarette use Before, During, and After Pregnancy

The goal of this secondary data analysis is to examine changes in maternal e-cigarette use before, during, and after pregnancy, determinants of these changes, and their effects on maternal and infant health. Study aims are: (1) to examine determinants of changes in e-cigarette use before, during, and after pregnancy; and (2) to assess health outcomes associated with changes in e-cigarette use (discontinuing, switching, and relapsing) before, during, and after pregnancy. Researchers will analyze data from two large U.S. national studies: the Pregnancy Risk Assessment Monitoring System (PRAMS) with N=153,336 existing mothers during 2016-2019 plus new mothers in 2020-2021, and the Population Assessment of Tobacco and Health (PATH) Study with N=4,392 existing pregnancies in waves 1-4 during 2013-2017 plus new pregnancies in wave 5 during 2018-2019 and the adult telephone survey in 2020. Potential determinants of e-cigarette use changes to be evaluated will include socio-demographics, pregnancy intention and characteristics, baseline e-cigarette use and product features, risk perception of e-cigarette use, concurrent substance use, and time of survey. Prenatal outcomes will include gestational weight gain and gestational duration. Neonatal outcomes will include small-for-gestational-age birth, mode of delivery, and length of infant hospital stay. Postpartum outcomes will include breastfeeding and postpartum depression. Findings will provide new information about changes in e-cigarette use and its effects on maternal and child health.

Xiaozhong Wen Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21DA053638-01A1
Institution: State University of New York at Buffalo
09/30/2021

Can Machine Generated Nicotine Yield Predict Human Nicotine Exposure from ENDS?

The goal of this study is to examine whether machine-generated nicotine yield from electronic nicotine delivery systems (ENDS) can predict human exposure to nicotine. Study aims are: (1) to determine whether nicotine yields generated from machine-vaped ENDS are associated with human nicotine exposure following prescribed or ad libitum ENDS use, and (2) to determine which machine-vaping regimes (e.g., CORESTA, intense, playback of human puff topography), if any, are most effective for estimating human exposure to nicotine. Researchers will also investigate how changes in ENDS nicotine yield may affect nicotine pharmacokinetics, pharmacodynamics, non-nicotine HPHC exposure, subjective effects, and puff topography. In this randomized study, 32 current ENDS users (ages 21-65) will complete four experimental visits during which they will use an ENDS containing one of four e-liquid nicotine concentrations (i.e., very low, low, medium, high) under prescribed and ad libitum use conditions; researchers will then measure nicotine pharmacokinetic parameters (e.g., maximum plasma nicotine concentration) to determine nicotine exposure and compare it to machine-generated yields. Results will help determine whether nicotine yield data can be used to estimate human exposure to nicotine from ENDS, whether these data can be used to draw inferences regarding ENDS abuse liability, and whether certain machine-puffing regimens are most suitable for estimating human nicotine exposure from ENDS.

Wallace Pickworth (CTP Contact: Marzena Hiler and Arit Harvanko) Funding Mechanism: Research Contract
ID Number: HHSF22320170040I
Institution: Battelle
09/23/2021

Strengthening Cigar Warnings to Prevent Adolescent Use

In 2016, the Food and Drug Administration (FDA) mandated six rotating text-only warning statements to be placed on little cigar and cigarillo (LCC) packaging. The goal of this study is to advance the science on LCC warnings that are effective for youth ages 15-20 who currently use, have ever used, or are susceptible to using LCCs, especially Black/African American youth. Study aims are: (1) to identify the most effective images to pair with FDA-mandated LCC text-only warning statements using a youth advisory board and a quantitative online survey delivered to 500 youth; (2) to examine whether LCC warning size (30% vs 50% on the LCC package principle display panels) and type (text-only vs. text+image) affect perceived message effectiveness of LCC warnings among an online sample of 500 youth; and (3) to conduct a randomized controlled trial with 900 youth to test whether the most effective LCC warnings from Aim 2 reduce willingness to use LCCs (compared to the text-only 30% size FDA-mandated LCC warnings and a control condition). Findings may inform regulatory activities related to LCC warnings.

Leah Ranney and Jennifer Cornacchione Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01CA260822-01A1
Institution: University of North Carolina at Chapel Hill
09/23/2021

Effect of Tobacco Use Patterns on Toxicant Exposure and Successful Cessation: A Longitudinal Study among US Adult Cigarette Smokers

Researchers will analyze data from Waves 1-5 of the Population Assessment of Tobacco and Health (PATH) Study to identify groups of adult smokers defined by their toxicant exposure and investigate how levels of nicotine dependence and patterns of tobacco use could impact adults’ ability to achieve successful smoking cessation (smoking abstinence ≥3 months). Study aims are: (1) to analyze data on biomarkers of exposure to tobacco chemicals (i.e., nicotine, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, volatile organic compounds) in 8,000 adult current cigarette smokers and group those smokers based on toxicant concentrations detected in urine; researchers will examine whether groups differ by personal characteristics, smoking behaviors (e.g., menthol vs. non-menthol smoking; cigarette smoking only or polytobacco use), and level of nicotine dependence; and (2) to describe trends in nicotine dependence and smoking behaviors to identify characteristics and behaviors of adults who achieved successful smoking cessation. Findings may inform regulatory and research activities that address tobacco-related toxicant exposure and will shed light on barriers and facilitators to achieving successful smoking cessation in adults.

Ban Majeed Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21CA267932-01
Institution: Augusta University
09/23/2021

Development of Biomarkers of Exposure and Effects for Electronic Cigarette vs. Combustible Cigarette Use

E-cigarette use has been associated with a variety of diseases, including cancer. The goal of this study is to detect genetic and epigenetic (i.e., behavioral, environmental) alterations in key genes in the oral and blood cells of 45 healthy adult vapers and 45 healthy adult smokers in comparison to a control group (45 nonsmokers/non-vapers) matched for age, sex, and race. Study aims are: (1) to screen for the deregulation (i.e., functional impairment) of disease-related genes in oral and blood cells of vapers and smokers as compared to controls; (2) after identifying the deregulated genes, to employ targeted next-generation sequencing (a method of analyzing DNA) to detect genetic changes in the deregulated genes; and (3) to employ targeted next-generation sequencing to detect epigenetic modifications to the deregulated genes. As a secondary goal, researchers will identify correlations between the identified genetic changes and subjects’ tobacco product use patterns and product characteristics (e.g., e-cigarette device features; e-liquid content; cigarette brand, type, and chemical constituents); this will clarify the impact of vaping/smoking dose and product characteristics on the biological effects of e-cigarette use vs. cigarette smoking. Study findings will identify gene changes that can serve as biomarkers to differentiate among vapers, smokers, and nonsmokers/non-vapers, thereby indicating the health risks and/or potential benefits of e-cigarette use relative to smoking.

Ahmad Besaratinia Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21CA268197-01
Institution: University of Southern California
09/21/2021

Pulmonary Toxicological Evaluation and Chemical Interactions of Menthol, Mint, and Tobacco Flavored E-Cigarette Products

Menthol/mint and tobacco flavors contain harmful chemicals that can cause adverse cellular and molecular changes in lung tissue. The goal of this study is to identify constituents of menthol/cooling and tobacco flavors and their pulmonary toxicity and to determine potential biomarkers of disease. Study aims are: (1) to identify the chemistry of menthol, menthol-like (cooling), and tobacco flavors, including flavoring chemicals and secondary products formed upon aerosolization; (2) to determine the in vitro and in vivo toxicity and health effects of menthol, menthol-like, and tobacco-flavored electronic nicotine delivery systems (ENDS) in EpiAirway 3D tissues (tissues constructed of human tracheal/bronchial epithelial cells) and in mice under normal and pre-existing respiratory conditions (chronic obstructive pulmonary disease and asthma) (3) to determine in vitro and in vivo toxicity and health effects of exposure to responsible flavoring chemicals identified in Aim1 using EpiAirway 3D tissues and mice under normal and pre-existing respiratory conditions. Findings will provide new information about lung toxicity caused by menthol and tobacco flavored e-cigs, identify disease processes of asthma and COPD upon switching to menthol and tobacco flavors from combustible cigarettes, and identify the culprits in these flavored e-cigs causing lung disease and exacerbations, thus, providing critical information for regulation of constituents of these ENDS.

Thivanka Muthumalage Funding Mechanism: National Institutes of Health – Grant
ID Number: 1K99ES033835-01
Institution: University of Rochester
09/21/2021

Impact Analysis of Flavor Restrictions and Tobacco 21 Policies on Youth Tobacco Use

Sixteen states and the District of Columbia enacted state-wide tobacco 21 (T21) policies prior to passage of the federal T21 law in December 2019, and seven states have recently enacted bans on flavored tobacco products. The goal of this study is to examine the impact of state flavor restrictions and state and federal T21 policies on disparities in tobacco use among youth and young adults aged 14-24 years. Researchers will analyze data from two surveys: the Behavior Risk Factor Surveillance System (BRFSS), an annual national phone-based survey of health-related behaviors among adults aged 18+; and the Youth Risk Behavior Survey (YRBS), a biennial school-based survey of health-related behaviors in 44 states. Study aims are: (1) to evaluate the impact of flavor restrictions and T21 policies on tobacco use (cigarettes, ENDS, smokeless tobacco) across age (18-20 vs. 21-24) and examine the impact of both policies on tobacco use across socio-demographic strata, using BRFSS data; (2) to evaluate the impact of flavor restrictions and T21 policies on tobacco use (cigarettes, ENDS, smokeless tobacco, cigars) across age (14-17 vs. 18) and examine the impact of both policies on tobacco use across socio-demographic strata, using YRBS data; and (3) to examine the impact of Covid-19 state closures and re-openings on tobacco use overall, by age, and across sociodemographic strata, using data from both surveys. Findings may inform future regulatory activities related to youth and young adult tobacco use.

Summer Hawkins Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21CA268199-01
Institution: Boston College
09/21/2021

Countering E-cigarette Marketing in the Retail Environment among Adolescents and Young Adults

Many adolescents and young adults directly purchase e-cigarettes from brick-and mortar retail stores. The goal of this study is to identify appealing and influential characteristics of e-cigarette marketing in the retail environment that impact adolescent (ages 11-18) and young adult (ages 19-21) e-cigarette purchase and use. Study aims are: (1) to examine adolescent and young adult descriptions of e-cigarette marketing in the retail environment and its influence on their e-cigarette purchase and use behavior; (2) to identify the most appealing characteristics of e-cigarette retail marketing that influence purchase and use; and (3) to develop and evaluate the effectiveness of an e-cigarette counter-marketing lesson to reduce adolescents’ intent to use and actual use of e-cigarettes. To achieve Aim 1, researchers will conduct focus group discussions with adolescents and young adults who have either never used e-cigarettes or have ever used or currently use e-cigarettes; the study will include a separate focus group for youth peer advocates working on e-cigarette prevention (total participants = 72). To achieve Aim 2, researchers will survey 2,250 adolescents and young adults to identify how and which e-cigarette marketing characteristics influence e-cigarette purchase and use; the survey will include a discrete choice experiment. Aim 3 will involve a randomized controlled trial that will assign 950 adolescents to one of two conditions: (1) a newly-developed online counter-marketing lesson about e-cigarette marketing in the retail environment, or (2) an existing online e-cigarette overview lesson to assess influence on intent to use and actual use of e-cigarettes. Findings may inform future educational and regulatory activities related to e-cigarette retail marketing.

Shivani Gaiha Funding Mechanism: National Institutes of Health – Grant
ID Number: 1K99CA267477-01
Institution: Stanford University
09/20/2021

Personal Factors, Product Characteristics, and Changes in Biomarkers of Exposure among Cigarette Smokers Who Switch to Noncombustible Tobacco Products

The goal of this study is to evaluate the factors associated with transitioning from cigarettes to noncombustible tobacco products (e.g., smokeless tobacco, e-cigarettes) and assess the potential of noncombustibles as a harm reduction strategy. Researchers will evaluate four possible trajectories — continued smoking (least optimal outcome), complete cessation (most optimal outcome), exclusive noncombustible use (possible harm reduction) or dual/poly tobacco use (unlikely harm reduction) — through an analysis of Population Assessment of Tobacco and Health Study data. Study aims are: (1) to identify personal characteristics (e.g., sociodemographic characteristics, smoking history, harm perceptions, exposure to messaging) associated with switching from cigarettes to noncombustibles; (2) to describe product characteristics (e.g., cigarette characteristics, noncombustible characteristics such as flavor and nicotine content) associated with switching; and (3) to examine health outcomes and exposure biomarkers in smokers who have switched. Findings will provide new information related to switching from cigarettes to noncombustible tobacco products.

Nicholas Felicione Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21CA268198-01
Institution: Roswell Park Cancer Institute Corporation
09/14/2021

Modeling the Impact of Tobacco Regulations on US Future Trends of Chronic Obstructive Pulmonary Disease

The objective of this research project is to build a chronic obstructive pulmonary disease (COPD) model based on individual cigarette smoking histories that will be used to predict the long-term population impact of two FDA tobacco regulatory scenarios on COPD disease burden. Study aims are: (1) to analyze data from a database of US adults with COPD (the COPDGene Study) to determine the impact of smoking behavior changes on lung function decline and COPD mortality; (2) to develop a COPD simulation that estimates future COPD incidence, prevalence and COPD-associated respiratory and lung cancer deaths based on individual smoking histories; and (3) to predict possible future trends in COPD morbidity and mortality under two FDA tobacco regulatory scenarios: cigarette pack and advertisement graphic health warnings (implementation of a Final Rule) and a menthol cigarette ban (planned). Findings will provide new information about the impact of tobacco control policies on COPD trends.

Luz Maria Sanchez-Romero Funding Mechanism: National Institutes of Health – Grant
ID Number: 1K01CA260378-01A1
Institution: Georgetown University
08/20/2021

CTP Supplement to Parent Grant: Impact of Flavor on Youth & Young Adults Use Intention, Abuse Liability and Perceptions of Cigarillos

The goal of this project supplement to the parent grant is to determine how the removal of flavors from cigarillos could impact co-use of cigarillos and cannabis, and whether that impact is related to perceptions of appeal or harm. Specific aims are: (1) to analyze parent study data on 361 young adult (ages 21-28) cigarillo users to determine the relationship between use of flavored cigarillos and co-use with cannabis (including blunts), and (2) to conduct one-on-one interviews with a subset of 38 participants to expand findings from the parent study, including understanding flavor appeal, perceived harm, and product substitution, and to assess these factors in the context of co-use with cannabis. Findings will provide new information about the influence of flavor on young adult co-use of cannabis and cigarillos.

Erika Trapl Funding Mechanism: National Institutes of Health – Grant
ID Number: 3R01DA048529-03S1
Institution: Case Western Reserve University
08/18/2021

Evaluation and Comparison of Impacts of Flavored Waterpipe Tobacco and Electronic Waterpipe E-Liquid Formulation Variations on Toxicant Yields and Particle Size Distribution in Mainstream Emissions

The popularity of flavored waterpipe (WP) smoking has expanded in recent years to flavored tobacco-free alternatives, including electronic WP (EWP). EWP replaces the traditional WP bowl and heat source with an electronic head filled with flavored, nicotine-containing liquid (e-liquid), turning the WP into an electronic nicotine delivery system (ENDS). The goal of this study is to compare the impact of variations in flavor profiles, humectants, sugar levels, and heating temperature in a variety of commercially available WP tobaccos and EWP e-liquids on hazardous and potentially hazardous constituents (HPHCs) and other toxicant yields as well as particle size distribution in mainstream WP emissions. Specific aims are: (1) to characterize variations in formulations of a variety of commercially available WP tobaccos and EWP e-liquids by determining the flavor profiles and humectant and sugar content; (2) to determine HPHC and other toxicant yields and particle size distribution in mainstream emissions generated by machine-smoking the WPTs using a research-grade electric heater operating at a high and low temperature; and (3) to determine HPHC and other toxicant yields and particle size distribution in mainstream emissions generated by machine smoking the e-liquids at a high and low EWP power setting. To achieve Aim 1, nine WP tobaccos and nine e-liquid flavors within popular flavor categories will be selected and chemically analyzed using established methods. To achieve Aim 2, WP tobaccos selected in Aim 1 will be machine-smoked using a human-derived smoking regimen; mainstream emissions will be analyzed for volatile and semivolatile HPHCs, particle size distribution, and other toxicants. The heater and tobacco temperature will be monitored and recorded. To achieve Aim 3, EWP e-liquids selected in Aim 1 will be machine-smoked as in Aim 2 but using an EWP head with variable power. Findings may inform future regulatory actions related to WP and EWP.

Stephanie Buehler Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01ES033016-01
Institution: Battelle Centers Public Health Research and Evaluation
07/22/2021

Survey of Risk Factors of Lithium Ion Batteries Used in ENDS

Electronic nicotine delivery system (ENDS) lithium-ion battery-related overheat, fire, and explosion (O/F/E) incidents have increased in recent years, but limited information is available about ENDS-related O/F/E risk factors. Efforts to understand causes of ENDS-related O/F/E incidents suggest that specific products and certain user practices may increase the risk of ENDS-related O/F/E incidents. The goals of this project are to collect data from a representative sample of 6,000 U.S. adult ENDS users via an online survey to identify user practices, ENDS devices, and batteries that may increase the risk of ENDS-related O/F/E incidents, and to estimate the prevalence of O/F/E incidents. Findings may inform future regulatory activities related to ENDS.

Jessica Pepper (CTP Contact: Azieb Kidanu) Funding Mechanism: Research Contract
ID Number: 75F40120A00017
Institution: Research Triangle Institute (RTI) International
06/30/2021

Multi-Parameter Investigation of Factors Controlling Carbonyl Emissions from Electronic Cigarettes

Carbonyl compounds, such as formaldehyde, a known human carcinogen, are among the hazardous and potentially hazardous constituents (HPHCs) found in e-cigarette aerosols. Researchers have reported numerous factors that influence e-cigarette carbonyl production (e.g., e-cigarette type, power, coil material, e-cigarette liquid (e-liquid) composition, topography), but differences in sampling methodology and testing protocols and a limited number of parameters investigated in individual studies have contributed to controversy regarding carbonyl levels in e-cigarette aerosols and the role individual factors play in their production. The goal of this study is to resolve some of the outstanding questions regarding e-cigarette carbonyl emissions by performing comprehensive testing of popular devices that are representative of three e-cigarette types (a cig-a-like, a sub-Ohm “mod”, and a “pod” type) under a variety of use patterns. Study aims are: (1) to test different carbonyl collection methods using a NIST-traceable formaldehyde standard and e-cigarette aerosols containing different amounts of liquid particulates, and select the best method for subsequent tests; (2) to investigate interactions between the main flavoring compound classes with e-cigarettes that have fresh and aged coils at different temperatures and e-liquid formulations; and (3) to investigate how different combinations of power, puff topography, and e-liquid viscosity affect carbonyl emissions of the e-cigarette types. Findings will help determine the optimal sampling methodology for carbonyls in e-cigarette aerosols and may inform future regulatory activities related to e-cigarettes.

Andrey Khylstov Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01ES033390-01
Institution: Desert Research Institute
06/15/2021

Receipt and Use of Prohibited Free Samples of Tobacco Products Among Adult Cigarette, Cigar, and/or Smokeless Tobacco Users, 2020

On March 19, 2010, FDA finalized regulations restricting the distribution of free samples of cigarettes, roll-your-own cigarette products, and smokeless tobacco in the U.S. (excepting free samples of smokeless tobacco distributed in “qualified adult-only facilities”). This ban was extended to cover all tobacco products, including e-cigarettes and cigars, when the Deeming Rule went into effect on August 8, 2016. More information about tobacco product free samples distribution since the regulations went into effect would be useful. Using data from the National Panel of Tobacco Consumer Studies (TCS Panel), which includes approximately 4,000 U.S. adult current cigarette, cigar, and/or smokeless tobacco users, this study will report on free samples receipt and use behavior for cigarettes, cigars, smokeless, and e-cigarette products; locations where free samples are received; top brands received; and demographic and behavioral characteristics of recipients. If sample sizes are large enough, the following may also be examined: how and/or where tobacco users receive free samples, including vouchers to exchange for free samples; types of products and top brands received; how often tobacco users received free samples; whether recipients used the free samples; whether users of the free samples like and consider purchasing products that they received as free samples; and significant predictors or factors associated with receipt. Findings will provide new information on outcomes related to the tobacco free samples ban.

Brett Loomis (CTP Contact: Naa Inyang) Funding Mechanism: Research Contract
ID Number: HHSF223201510002B-HHSF22317005
Institution: Research Triangle Institute (RTI) International
06/15/2021

Predicting Effects of ENDS Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability among African American Menthol Smokers

More research would be useful regarding how electronic nicotine delivery system (ENDS) uptake affects tobacco use and associated toxicity among African American (AA) cigarette smokers, particularly those who smoke menthol cigarettes. The goal of this study is to evaluate how future ENDS flavor regulations may impact African American menthol smokers. The study will evaluate whether ENDS menthol flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers (N=210, ages ≥21) by performing a six-week clinical trial of ENDS provision with follow-up to 30 days. Specific aims are: (1) to compare the effect of ENDS flavor availability on patterns of tobacco use behavior; (2) to quantify the effect of ENDS flavor availability on biomarkers of cigarette/ENDS exposure (expired air carbon monoxide, urine cotinine/NNAL, and urine propylene glycol; and (3) to test the effect of ENDS flavor availability on addiction/abuse liability using validated behavioral economic instruments at multiple time points during the trial. Researchers will provide subjects with JUUL devices with compatible cartridges at 5% nicotine and will randomize them to one of three groups that differ by potential FDA regulations related to ENDS flavor availability: (1) the current market where only menthol- and tobacco-flavored ENDS cartridges are available; (2) a market where only tobacco-flavored ENDS are available, and (3) a market where only unflavored cartridges are available. Study visits will occur weekly beginning one week prior to randomization with daily tobacco use monitoring throughout and biomarker/self-report data collection at each in-person visit. Study results may clarify the impact on AA menthol smokers of moving from the current regulatory market where menthol/tobacco-flavored ENDS cartridges are available, to one where only tobacco or unflavored cartridges are available.

Andrew Barnes and Caroline Cobb Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01DA050996-01A1
Institution: Virginia Commonwealth University
05/28/2021

The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults

Data on the impact of sweet flavoring on combustible cigarillo use is important for understanding their health impact among young adults. The study aim is to determine whether the subjective rewarding value, the relative reinforcing value, and the absolute reinforcing value of sweet-flavored cigarillos are greater than that of non-flavored cigarillos among young adults. Researchers will investigate these aims in three separate laboratory visits among 86 young adults (ages 18-24 years) who have smoked at least 10 cigarillos in their lifetime. Participants will complete various validated scale measurements, a behavioral choice task, and an ad-libitum smoking procedure. Researchers will examine whether indices of abuse liability remain significant while controlling for other factors that may underlie the preference for flavoring. Results may inform future regulatory activities related to cigarillos.

Janet Audrain-McGovern Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21DA050789-01A1
Institution: University of Pennsylvania
05/27/2021

The Effects of IQOS Use on Cigarette Smoking Behavior

In 2019, the Food and Drug Administration (FDA) authorized the sale of IQOS, and more data on the impact of IQOS use on cigarette smoking behaviors would be useful. This study addresses two aims: (1) to evaluate the effects of IQOS use on cigarette smoking behaviors; and (2) to examine which subjective and objective effects of IQOS predict cigarette smoking. Researchers will recruit 100 combustible cigarette smokers ages (18-65) to a 21-day study. Baseline smoking rate will be established during days 1-5. After overnight cigarette smoking abstinence, laboratory visits on days 6 and 7 will assess IQOS-associated craving relief, withdrawal relief, risk perceptions, subjective reward, and the reinforcing value of IQOS relative to combustible cigarettes. Participants will switch from cigarette smoking to IQOS use for the following 14 days (days 8-21). Participants will collect their spent cigarette filters and their used IQOS HeatSticks daily to enable researchers to assess consumption of cigarettes and tobacco sticks per day. The primary outcome is the daily count of cigarettes from baseline to day 21, and the secondary outcome is changes in motivation to quit smoking from baseline to day 21. Findings may inform future regulatory activities related to heated tobacco products.

Janet Audrain-McGovern Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01CA260448-01
Institution: University of Pennsylvania
05/24/2021

The Impact of Cigarillo Warnings on Purchasing and Smoking Behaviors Among Young Adult Cigarillo Users

This study will assess the effectiveness of cigarillo warnings by extending previous research in which the researchers developed pictorial warnings for cigarillos. Study aims are: (1) to examine the impact of a pictorial cigarillo warning policy on young adult cigarillo smokers’ purchasing behaviors using a behavioral economics framework; and (2) to examine the impact of repeated exposure to pictorial versus text cigarillo warnings on cigarillo smoking intentions and behaviors. Participants will be young adult frequent cigarillo users ages 21-34. An estimated 1,282 subjects (635 Black/African American and 647 White) will complete an online shopping task using the Experimental Tobacco Marketplace; researchers will then examine the impact of different cigarillo warning manipulations (pictorial, FDA text-only, Surgeon General text-only) on cigarillo purchasing, cigarillo demand, and substitution of other tobacco products. Researchers will then recruit another sample of 600 young adult frequent cigarillo users (300 Black/African American and 300 White) to participate in a 6-week randomized control trial where they will be exposed to cigarillo warnings weekly to examine the impact of the warnings on intentions to continue cigarillo smoking and cigarillo smoking behaviors. Study results may reveal how to effectively communicate the risks of cigarillo smoking to young adults, including Black/African Americans, and may inform regulatory decision-making related to cigarillo warnings.

Jennifer Cornacchione (Ross) Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01CA260460-01
Institution: Wake Forest University Health Sciences
05/18/2021

Exosomal Epigenetic Biomarkers Associated with Flavored Electronic Cigarette Use in Adults

More information about the health risks, especially long-term health risks, of flavored e-cigarette use would be useful. The goal of this study is to identify exosomal epigenetic biomarkers (including microRNAs and long non-coding RNAs) associated with flavored e-cigarettes. Study aims are: (1) to examine blood and urinary exosomal epigenetic biomarkers and associated biological pathways related to flavored (such as fruit-flavored) e-cigarette use; and (2) to evaluate within-subject alterations in exosomal epigenetic biomarkers and associated biological pathways during e-cigarette initiation and cessation. Researchers will analyze blood and urine specimens from the Population Assessment of Tobacco and Health (PATH) Study biorepositories. After identifying key biomarkers, researchers will expose them to primary human bronchial epithelial cells and small airway epithelial cells from non-smoker adults to determine their toxicity/inflammatory response. Findings may inform future regulatory activities related to flavored e-cigarettes.

Dongmei Li and Ifran Rahman Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21ES032159-01A1
Institution: University of Rochester
05/10/2021

Impact of E-Cigarette Characteristics and Marketing on Tobacco Use and Health: A Longitudinal Study Among U.S. Youth and Adults

More information about the impact of e-cigarette characteristics and marketing on tobacco use among youth and adults would be useful. Researchers will analyze longitudinal data (Waves 1-4) from the Population Assessment of Tobacco and Health (PATH) Study to accomplish three study aims: (1) to identify the impact of e-cigarette flavors (non-tobacco and non-menthol flavors vs. tobacco and menthol flavors) and types (open vs. closed system) on e-cigarette use among youth (12-17 years), young adults (18-34 years), and older adults (35 years and older); (2) to determine the impact of e-cigarette advertising exposure on e-cigarette initiation, use frequency, and susceptibility, as well as the mediating effect of harm and addiction perceptions; and (3) to identify the effect of e-cigarette use on cardiovascular, respiratory, and periodontal health, and compare the effects among different types of tobacco users (e.g., exclusive e-cigarette users, never cigarette smokers, exclusive e-cigarette users, former cigarette smokers, dual users, cigarette-only smokers). Findings may impact future regulatory activities related to e-cigarettes.

Nan Jiang Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21CA260423-01
Institution: New York University School of Medicine
04/28/2021

The Effects of Branded and Influencer Social Media Promotion of Flavored Tobacco Products (FTP) on FTP Use Among Youth and Young Adults

This study will examine the impact of exposure to social media marketing of flavored tobacco products (FTPs). Study aims are: (1) to identify and characterize social media message content related to FTPs by source (e.g., brand, influencer/community, regular consumer) and major themes (e.g., new-user targeting, health risks, flavor-type); (2) to examine the impact of exposure to commercial and influencer FTP content on product sales and on youth and young adult awareness, risk perceptions, intentions to use, initiation, and patterns of use of FTP products; and (3) to study whether/to what extent FTP regulatory policies modify the impact of exposure to social media content on FTP product sales and youth and young adult awareness, risk perceptions, intentions to use, initiation, and patterns of use of FTP products. These aims will be accomplished by analyzing social media data from Twitter and Instagram; individual-level data on exposure to tobacco marketing, tobacco attitudes, and tobacco use from the Population Assessment of Tobacco and Health (PATH) Study; FTP sales volume data from Nielsen store scanner data; and state/local FTP policy data collected by the National Opinion Research Center. Findings from this study may inform future regulatory activities related to social media marketing of FTPs.

Sherry Emery and Ganna Kostygina Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01DA051000-01A1
Institution: National Opinion Research Center
04/20/2021

Racial Disparities in Biomarkers, Tobacco Cessation, and Smoking Relapse in Association with Electronic Cigarette Use

Biomarkers can play an important role in assessing the potential health effects of tobacco products. However, evidence on the racial disparities related to biomarker outcomes of e-cigarette use is scarce. The goal of this study is to examine the racial disparities in biomarkers of exposure and toxicants in association with e-cigarette use by analyzing Population Assessment of Tobacco and Health (PATH) Wave 1-4 biomarker data. Study aims are: (1) to assess racial disparities in biomarkers of tobacco exposure and toxicants; and (2) to develop a bio-socio-psycho risk score in prediction of cessation, relapse, and health outcomes. To achieve Aim 1, researchers will link the biomarker data with the PATH adult surveys to identify the between-person and within-person differences in biomarkers by use of different vaping products, flavors, and transitions between e-cigarettes and combustible cigarettes across different waves. To achieve Aim 2, researchers will then use machine learning algorithms to develop a composite bio(biomarker)-socio(socio-demographics)-psycho(psychosocial factors) risk index score for each racial/ethnic group to predict subsequent abstinence from cigarette smoking and relapse to cigarette smoking. Study findings will provide new information related to racial disparities in e-cigarette health effects.

Hongying Dai Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21DA054818-01
Institution: University of Nebraska Medical Center
04/20/2021

Electronic Cigarette Use During Pregnancy and the Impact on Newborn Metabolic Profile and Perinatal Health Outcomes

More information about the effects of e-cigarette use by pregnant women would be useful. The goal of this study is to evaluate the potential adverse effects of e-cigarettes on pregnant women and their developing fetuses. Specific study aims are: (1) to determine the pattern of women’s smoking from preconception to the perinatal period; (2) to determine the pattern of women’s smoking from 2016 to 2018; (3) to determine whether pregnancy e-cigarette use is associated with pregnancy, perinatal, and infant-related adverse outcomes; and (4) to determine whether pregnancy e-cigarette use is associated with an imbalanced metabolic profile in infants measured at birth. Researchers will conduct a surveillance study of women who had live births between 2016-2018 and participated in the Pregnancy Risk Assessment Monitoring System (PRAMS) survey. Data analyzed will include detailed smoking information, including conventional cigarette and e-cigarette use during preconception, third trimester of pregnancy, and post-delivery; researchers will also link PRAMS subjects from Tennessee and Iowa to newborn metabolic screening data to identify and validate metabolic profiles measured at birth that are associated with secondhand in utero e-cigarette and conventional cigarette exposure. Study findings may inform future regulatory activities that impact pregnant e-cigarette users.

Pingsheng Wu Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21DA052026-01A1
Institution: Vanderbilt University Medical Center
04/20/2021

Assessing the Impacts of the Four 2019/2020 US Federal-Level Tobacco Control Actions: Flavors, Youth Marketing, Youth Access, and Tobacco 21

Four key federal-level tobacco control actions were taken in the U.S. in December 2019/January 2020 to reduce electronic nicotine delivery system (ENDS)/tobacco use appeal and access, particularly among young people. These four actions were: (1) ENDS Flavors/Device Guidance, in which FDA prioritized enforcement against “any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product),” (2) ENDS Marketing Guidance, in which FDA prioritized enforcement against “any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors,” (3) ENDS Access Guidance, in which FDA prioritized enforcement against “all other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access,” and (4) Federal T21, in which the federal minimum age of sale of tobacco products was raised from 18 to 21 years. Around the same time, two national public health events occurred that likely also contributed to population-level changes in ENDS/tobacco use behaviors: an outbreak of ENDS/vaping-associated lung injury (EVALI) was identified by CDC in August 2019, and the spread of a novel coronavirus in the US in January 2020 (COVID19). The shared historical timing of these actions and events requires innovative methods to assess the specific impacts of each federal action. Researchers will use a theoretically grounded mediational model to disentangle overall impacts into action-specific impacts. They will conduct secondary data analyses using the following sources: two complementary nationally-representative data sources, which each assess key measures of appeal and access and together include over 61,000 participants; the Population Assessment of Tobacco and Health (PATH) Study youth and adult surveys (2017-2021); and the U.S. arm of the International Tobacco Control (ITC) Project youth and adult surveys (2018-2021). Study findings will contribute to an understanding of the impacts of each action on Americans’ ENDS/tobacco use behaviors.

Karin Kasza Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R21DA053614-01
Institution: Roswell Park Cancer Institute Corporation
04/16/2021

Testing the Effect of Anti-Tobacco Message Framing on Polytobacco Use in Lesbian, Gay, Bisexual, and Transgender Young Adults

Polytobacco use, defined as concurrent use of more than one tobacco product including electronic nicotine delivery systems (ENDS), is rising in lesbian, gay, bisexual, and transgender (LGBT) young adults. More information about how to effectively frame polytobacco risk communications for this population would be useful. The goal of this study is to test the effect of polytobacco message framing on risk perceptions and polytobacco use in LGBT young adults. Study aims are: (1) to identify polytobacco risk messages that effectively communicate absolute and relative risks to young adults; (2) to determine the effects of cultural targeting on LGBT young adult polytobacco users’ attention to messages and perceived effectiveness; (3a) to assess the feasibility of polytobacco risk messages developed in Aims 1 and 2 to LGBT young adults via text; and (3b) to estimate the effect sizes of exposure to messages on risk perceptions and tobacco use over time. Researchers will develop 48 messages and will conduct an online survey study with 2400 young adults (ages 18-35, estimated 50% LGBT) in which each participant will view and rate eight polytobacco education messages. Researchers will also conduct an in-laboratory study and focus groups (108 and 24-32 participants, respectively) and a Phase I randomized controlled trial (300 participants) to determine the message framing and targeting most effective for LGBT young adults. Findings may inform future tobacco education campaigns targeted to LGBT young adults.

Joanne G. Patterson Funding Mechanism: National Institutes of Health – Grant
ID Number: 1K99CA260718-01
Institution: The Ohio State University
01/26/2021

Pharmacokinetic Bridging Study for the Inhalation of Nicotine in Saline in Male Sprague-Dawley Rats

Additional information on nicotine pharmacokinetics (PK) following inhalation will be useful in accurately predicting its PK across species (i.e., rodents, non-human primates, and humans). The CTP-NCTR InhaleCore Group has recently completed studies evaluating nicotine PK profiles in rats following a single dose administration by inhalation, oral gavage, and intravenous injection (E07607.01 and E07716.01). In these studies, the dose formulations for inhalation exposure consisted of nicotine in propylene glycol and water. Due to possible unknown inhalation toxicities of propylene glycol and its potential to impact the lungs, propylene glycol is probably not an appropriate vehicle for investigating nicotine inhalation toxicity in planned subacute and subchronic inhalation toxicology studies. In this study, the InhaleCore Group will assess the applicability of the previously collected PK data (nicotine in propylene glycol and water) to the PK profiles for new nicotine formulations (nicotine in saline) that will be used in the planned studies. Results from these studies will provide useful information for the development of physiologically-based pharmacokinetic (PBPK) modeling to characterize the PK of nicotine and its metabolites (cotinine and 3-hydroxycotinine) in rodents across different routes of exposure.

Qiangen Wu (CTP Contact: Prabha Kc) Funding Mechanism: FDA Internal
ID Number: E07763.01
Institution: National Center for Toxicological Research (NCTR)
12/22/2020

Uptake and Patterns of Use of the IQOS Heated Tobacco System by US Smokers

More information about the U.S. population health impact of IQOS, a heated tobacco system, would be useful. The goal of this project is to provide postmarket data evaluating the sociodemographic and tobacco use patterns of IQOS initiators, including the extent to which adult smokers are completely stopping use of all tobacco products, switching to exclusive IQOS use, dual-using cigarettes and IQOS, or rejecting IQOS and continuing smoking, as well as differing perceptions and use of IQOS by sociodemographic variables relevant to tobacco disparities. Study aims are: (1) to examine the sociodemographic and tobacco use characteristics, decision-making processes, and marketing exposure among adult initiators of IQOS; and (2) to examine the longitudinal determinants of long-term tobacco use outcomes among adult cigarette smokers who purchased and initiated use of IQOS. The study will involve an initial survey of 1000 adult (ages ≥18) IQOS initial purchasers and follow-up surveys of 600 cigarette smokers initially surveyed; follow-up will occur at 1 month, 6 months, and 12 months. A subsequent focus group study of 20 survey participants who had either switched to exclusive IQOS use or were dual-using IQOS and cigarettes will be conducted to obtain a deeper understanding of the quantitative findings. Findings will reveal important information about heated tobacco product use in the U.S.

Scott Weaver Funding Mechanism: National Institutes of Health – Grant
ID Number: 1R01DA051002-01A1
Institution: Georgia State University
12/01/2020

Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Product

A single standardized smoking machine adaptor for cigars, ENDS, and heated tobacco products does not exist, making it difficult to accurately quantify the aerosol and smoke physical properties and hazardous and potentially hazardous constituent (HPHC) levels produced by these products. This design project has four aims: (1) to develop a single universal adaptor, or standardized family of adaptors, for the attachment of ENDS, cigars, and heated tobacco products to existing smoking machines originally designed for use with cigarettes; (2) to ensure that the adaptor(s) have high repeatability and reproducibility; (3) to coordinate and administer a study that tests repeatability and device validation while comparing the newly designed adaptor(s) to currently available adaptors; and (4) to provide tobacco product stakeholders with continued adaptor product support and improvement. A well-validated standardized smoking machine adaptor will ensure that accurate data are being used by stakeholders in their efforts to protect the public from tobacco-related death and disease.

Marielle Brinkman (CTP Contact: Raymond Williamson) Funding Mechanism: Research Contract
ID Number: 1UC2FD007229-01
Institution: The Ohio State University
09/15/2020

Waterpipe Tobacco Additives and Their Effect on Human Puffing Behavior, Toxicant Exposures, Pulmonary Function and Appeal

Sweetened waterpipe (WP) tobacco may increase WP smoking appeal for first-time users; furthermore, high levels of sweet additives produce harmful and potentially harmful constituents (HPHCs) in WP smoke. The goal of this study is to define the effects of WP tobacco’s primary chemical additives with respect to sweet perception, appeal, toxicant exposure, addictiveness, harm and health risk perceptions, and lung function. Study aims are: (1) to characterize the HPHC and sugar content of four WP tobaccos (one brand prepared four different ways to vary glycerol and sugars); (2) to characterize the HPHC and sugar yields in mainstream smoke generated from machine smoking the four WP tobacco preparations using a research-grade waterpipe and a standardized WP puffing regimen; (3) to determine how WP tobacco content impacts puffing behaviors, a carbon monoxide biomarker, pulmonary function, nicotine uptake, and perceived sensory attributes and appeal of WP smoking, based on data gathered from 50 experienced WP smokers (ages 21-50) who will smoke the four different WP tobacco preparations in four different laboratory sessions; and (4) to determine the HPHC exposure ranges from the average puffing behaviors measured under Aim 2 for each WP tobacco preparation. Findings will provide new information about the impact of chemical additives in WP tobacco.

Marielle Brinkman and Theodore Lee Wagener Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01CA255563-01
Institution: Ohio State University
09/10/2020

Understanding Uncontrolled Vaping Among Vulnerable Populations

E-cigarettes differ from combustible cigarettes in ways that may make it harder to control vaping. For example, e-cigarettes lack many of the same stopping cues as cigarettes, indoor bans are less common, and discreet use is easy. The goal of this study is to understand uncontrolled vaping and vaping restraint strategies. Study aims are: (1) to develop measures of uncontrolled vaping and restraint strategies; (2) to assess prevalence of and factors related to both uncontrolled vaping and restraint strategies; and (3) to establish the long-term impact of vaping restraint on uncontrolled vaping. To achieve Aim 1, researchers will conduct phone interviews with 8 adolescent (ages 13-17), 8 young adult (ages 18-25), and 8 adult (ages 26 and older) current e-cigarette users to understand how they describe uncontrolled use and vaping restraint and will then develop survey measures. To achieve Aim 2, researchers will survey 1,050 current e-cigarette users (300 adolescents, 300 young adults, and 450 adults) and evaluate the usefulness of the new measures. Researchers will then estimate uncontrolled use and vaping restraint strategies for the nation and examine whether these outcomes are more common among vulnerable populations, certain device type users, and dual users. To achieve Aim 3, researchers will conduct a follow-up online survey with approximately 700 e-cigarette users from the Aim 2 sample to examine how baseline vaping restraint related to uncontrolled vaping and smoking behavior one year later. Findings may inform regulatory activities related to e-cigarettes.

Noel Todd Brewer Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01CA246606-01A1
Institution: University of North Carolina
09/10/2020

The Impact of Cigar Pack Quantity on Tobacco Use Behaviors

The goal of the proposed analyses is to clarify the relationship between cigar pack quantity and tobacco use behaviors. Study aims are: (1) to determine whether cigar pack quantity is associated with between- or within-person changes in cigar use and assess whether changes vary by sociodemographic characteristics (age, sex, race, ethnicity, income, and educational attainment); (2) to evaluate the impact of minimum cigar pack quantity laws on tobacco use and assess whether the impact of these laws varies by sociodemographic characteristics; (3) to evaluate the impact of minimum cigar pack quantity laws on cigar sales and assess whether the impact of these laws varies by county characteristics; and (4) to characterize differences in implementation and enforcement of minimum cigar pack quantity laws through qualitative interviews with key implementation personnel. The researcher will analyze data from national datasets, including the Population Assessment of Tobacco and Health (PATH) Study, the Tobacco Use Supplement to the Current Population Survey (TUS-CPS), the Youth Risk Behavior Surveillance System (YRBSS), and Nielsen retail scanner data. Study findings may inform future regulatory activities related to cigar pack quantity.

Jessica Lynn King Funding Mechanism: National Institutes of Health – Grant
ID number: 1K01CA253235-01
Institution: University of Utah
09/09/2020

Designing and Evaluating Communication for Dual Users of E-cigarettes and Combustible Cigarettes

People who use both cigarettes and e-cigarettes (“dual users”) may not be adequately informed of their continued risk from smoking combustible cigarettes as well as the known harms of e-cigarettes. The goal of this project is to develop communication campaign messages for dual users that increase their knowledge of the high health risk of dual use and increase their intent to quit combustible cigarettes and ultimately e-cigarettes. Study aims are: (1) to develop effective campaign messages by investigating how dual users think about their identity, motivations for tobacco product use, and the barriers to quitting combustible cigarettes; (2) to determine whether campaign ads are more engaging if they focus on quitting combustible cigarettes only, sequentially quitting cigarettes and e-cigarettes, or simultaneously quitting cigarettes and e-cigarettes; and (3) to pilot test the effectiveness of texted campaign ads in changing real-world combustible cigarette and e-cigarette quit intention among dual users. To achieve Aim 1, the research team will conduct six focus groups (8-10 adult dual users ages 18+ per group) to better understand dual use and gather concepts for messages, draft 50-75 potential campaign messages for dual users to encourage them to quit, and conduct a national survey with 1,008 adult dual users to select the most promising campaign message themes. To achieve Aim 2, the team will create visual ads for the messages from Aim 1 and use an eye-tracking experiment to determine how the different conditions affect attention among dual users. To achieve Aim 3, the team will conduct a five-week experiment with 90 adult dual users randomized to receive the most effective ads from Aim 2 or control ads in order to determine subsequent quit intentions and behaviors. Study findings may inform the development of communication campaign messages specifically for dual cigarette and e-cigarette users.

M. Justin Byron Funding Mechanism: National Institutes of Health – Grant
ID number: 1K01CA253234-01
Institution: University of North Carolina
09/16/2020

Patterns of Use and Health Effects of “Premium Cigars” and Priority Research

Patterns of use can vary widely across cigar subtypes both by frequency of use and the population subgroups most likely to use them. Some research indicates that “premium” cigar smokers (versus smokers of other cigar subtypes) are significantly less likely to use cigars regularly (daily or monthly) or report current cigarette smoking. Still, all cigars pose serious negative health risks and premium cigars are used by youth and young adults. The goal of this study is to conduct an in-depth evaluation of the public health issues related to premium cigars (defined in this study as large cigars that contain tightly rolled tobacco wrapped in a tobacco leaf) as well as the health effects of premium cigars compared to other cigars and other tobacco products. This study will involve a comprehensive and systematic review and assessment of the scientific literature related to premium cigars. Topics evaluated will include patterns of use of premium cigars; how use patterns differ among cigar subtypes and other tobacco products and among different populations (types of tobacco users, age groups, and other demographics); and the short- and long-term health effects of premium cigar use. Findings may inform future regulatory activities related to premium cigars.

Stuart Nightingale and Caroline Hagedorn (CTP Contact: Lisa Lagasse) Funding Mechanism: Research Contract
ID Number: 75F40120S90019
Institution: National Academics of Sciences, Engineering, and Medicine (NASEM)
09/14/2020

Chronic Hookah (Waterpipe) Smoking, Vascular Dysfunction, Inflammation and Oxidative Stress

The goal of this research is to clarify the long-term health effects of hookah (waterpipe) smoking on endothelial (artery lining) and vascular (blood vessel) function and identify biomarkers of harm that are associated with the effects of chronic hookah smoking on vascular health. Study aims are: (1) to evaluate the chronic effects of hookah smoking on peripheral endothelial function; (2) to study the chronic effects of hookah smoking on central artery stiffness; and (3) to evaluate the chronic effects of hookah smoking on biological markers of oxidative stress and inflammation. In 34 healthy chronic hookah smokers (ages 21-49 years) who never smoked cigarettes, matched for age and sex with 34 cigarette smokers and 34 non/never-smokers, researchers will measure: (a) endothelial function (measured by brachial artery flow-mediated dilation); and (b) vascular stiffness (measured by carotid-femoral pulse wave velocity and aortic augmentation index). Biological markers of inflammation (high sensitivity C-reactive protein, 8-iso-prostaglandin F2a, fibrinogen) and oxidative stress (pro-oxidant high density lipoprotein oxidant index and total antioxidant capacity) will be collected. Findings will provide new information about the chronic effects of hookah smoking and provide a foundation for future long-term studies of the effects of hookah smoking.

Mary Rezk-Hanna Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01HL152435-01A1
Institution: UCLA
09/10/2020

The Effect of Switching on or off Menthol Use on Cigarette Consumption, Dependence, Nicotine Exposure and Quitting Success

More information about menthol use among subpopulations would be useful. Researchers will analyze data from the adult (ages 18+) sample of cigarette smokers in Waves 1-4 of the Population Assessment of Tobacco and Health (PATH) Study using a technique called propensity score matching. They will study two groups of adult smokers: smokers who switched from menthol to non-menthol cigarettes and later attempted to quit smoking, and smokers who switched from non-menthol to menthol cigarettes and later attempted to quit smoking. Study aims are: (1) to compare quitting success between quit attempters who switched from menthol to non-menthol cigarettes and those who switched from non-menthol to menthol cigarettes; (2) to compare consumption, nicotine exposure, and dependence between adult smokers who did not successfully quit after either switching from menthol to non-menthol cigarettes or switching from non-menthol to menthol cigarettes; and (3) to assess whether race, sex or age modify the effect of switching from menthol to non-menthol cigarettes or from non-menthol to menthol cigarettes on 30-day cigarette abstinence, 12-month cigarette abstinence, consumption, dependence, and nicotine exposure. Study findings may inform future regulatory activities related to menthol.

Eric Leas Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051356-01
Institution: University of California, San Diego
09/01/2020

Distinguishing Exposure to Secondhand and Thirdhand Tobacco Smoke and Electronic Cigarettes among U.S. Children Based on Multiple Biomarker Profiles

Currently, tobacco smoke exposure biomarkers that differentiate exposure to thirdhand smoke (THS) from exposure to secondhand smoke (SHS) or e-cigarette aerosol exposure are lacking. The goal of this project is to examine existing tobacco-specific and nonspecific biomarkers to assess children’s exposure to diverse tobacco/nicotine products. Researchers will analyze National Health and Nutrition Examination Survey (NHANES) 2013-2016 data to examine the prevalence and health risks of exposure to SHS and THS among children presumed to be unexposed to any tobacco smoke and among children exposed to e-cigarette aerosol only. This project has three study aims. Aim 1 is to compare tobacco-specific biomarkers of exposure (e.g., cotinine, total nicotine equivalents, tobacco-specific nitrosamines) with self-reported smoking and tobacco smoke exposure to categorize children into one of four groups: (a) mixed SHS and THS group (MEG): lives with nonsmokers or smokers of combustible products only, reported SHS; (b) THS group (TEG): lives with nonsmokers or smokers, no reported SHS; (c) e-cigarette group (ECG): lives with e-cigarette only users, reported e-cigarette aerosol exposure; and (d) no/minimal exposure group (NEG): lives with nonsmokers, no reported SHS. Aim 2 is to examine multiple tobacco-nonspecific (i.e., polyaromatic hydrocarbons, volatile organic compounds) and tobacco-specific biomarkers and biomarker ratios (e.g., NNAL/cotinine, 2-hydroxyfluorene/cotinine) to assess which combination of biomarker profiles further differentiates children by exposure type. Aim 3 is to examine the associations between exposure type and demographics, exposure-related symptoms, diagnoses, and healthcare utilization patterns in the MEG, TEG, and ECG compared with the NEG. Study findings will provide insight into the different health effects children experience depending on type of tobacco product exposure.

Ashley Merianos Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21ES032161-01
Institution: University of Cincinnati
08/24/2020

CTP Supplement to Parent Grant: Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine, and Other Constituents (YCSTP) (TCORS 2.0)

This supplement project will measure the effects of e-cigarette use and abstinence on the adolescent brain and behavior by testing biomarkers to assess short- and long-term e-cigarette effects. This project will add neuroimaging and neurocognitive testing to an existing clinical trial of an e-cigarette cessation intervention in adolescents (Yale’s Adolescent Brain Cognitive Development [ABCD] study); it will use ABCD neuroimaging and neurocognitive testing protocols to investigate how critical domains of function (i.e., reward processing, impulsivity and impulse control, working memory, emotion regulation) differ among adolescent e-cigarette users and change with abstinence. All youth in the trial (N=100; ages 13-20) will complete the ABCD neurocognitive battery, and 30 youth in the trial and 30 age/sex-matched controls will complete the ABCD neuroimaging protocol. Specific aims are: (1) to test for baseline brain and behavioral differences in critical domains of function between youth e-cigarette users and non-users; (2) to compare changes in brain and behavioral measures of critical domains of function between youth e-cigarette users and non-users; and (3) to test the relationship between changes in critical domains of function and e-cigarette abstinence among youth users. Findings will provide some of the first measures of the impact of e-cigarette use and abstinence on brain and behavior biomarkers of addiction among adolescents.

Stephanie O’Malley and Suchitra Krishnan-Sarin Principal Investigator:
Funding Mechanism: National Institutes of Health – Grant
ID Number: 3U54DA036151-08S3
Institution: Yale University
08/21/2020

Center for the Study of Tobacco Products: Respiratory Effects of THC and Nicotine E-Cigarettes: A Prospective Study

E-cigarette/vaping-associated lung injury (EVALI) is a new disease that is not well-understood, in part because of the differences among e-cigarette devices and liquids used; however, it has been linked to tetrahydrocannabinol (THC) liquid use and vitamin E acetate inhalation. Importantly, computed tomography (CT) scans of the lungs of EVALI patients uniformly reveal “ground-glass opacities” (GGOs), which indicates partial displacement of air within the lung; the appearance of GGOs in e-cigarette users is a potential EVALI biomarker. Researchers at the Center for the Study of Tobacco Products (CSTP) will perform CT scans and pulmonary function tests and analyze the devices and liquids from healthy e-cigarette users aged 18-45 years. They will track participants’ respiratory health for two years and then conduct a second set of CTs and pulmonary function tests. Study aims are: (1) to perform CT scans and pulmonary function tests at baseline and after two years on 45 exclusive nicotine e-cigarette users, 45 exclusive THC e-cigarette users, and 45 nicotine+THC e-cigarette users, as well as an additional 45 non-e-cigarette users as controls; (2) to identify e-cigarette devices and analyze e-cigarette liquids used by each participant; and (3) to track respiratory health over two years using quarterly online surveys assessing respiratory and gastrointestinal symptoms. Study findings may provide more information about EVALI and may inform future regulatory activities related to e-cigarettes.

Thomas Eissenberg Funding Mechanism: National Institutes of Health – Grant
ID number: 3U54DA036105-08S1
Institution: Virginia Commonwealth University
08/20/2020

Pilot Study to Determine Health Effects of E-cigarettes in Healthy Young Adults

In this CTP supplement to a parent grant (Integrated Translational Health Research Institute of Virginia (iThriv): Using Data to Improve Health), researchers will conduct studies to assess early changes in human lungs due to e-cigarette use. This study will use a new magnetic resonance imaging technique called 3-dimensional hyperpolarized xenon-129 MRI. It is anticipated that this new MRI technique will help detect possible early changes in the lungs of healthy young people who use e-cigarettes. Study aims are: (1) to determine effects of e-cigarette use on healthy young adults (ages 21-30) who have never smoked cigarettes, and (2) to develop research methods to perform a larger clinical trial to determine whether e-cigarettes cause lung disease, and if so, what kind. To achieve the first aim, researchers will study ten e-cigarette users with normal lung function tests and ten healthy non-users. Researchers will perform MRI tests and collect exhaled breath, blood, and urine for testing. To achieve the second aim, researchers will develop study methods for performing MRIs at two locations, the University of Virginia and Duke University, in preparation for a multi-center clinical trial to conclusively determine if there are harmful health effects of e-cigarettes. Study results will provide new knowledge on the impact of e-cigarettes on human lung health.

Karen Johnston Funding Mechanism: National Institutes of Health – Grant
ID number: 5UL1TR003015-02S4
Institution: University of Virginia
08/19/2020

Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine and Other Constituents

To reduce the risk of e-cigarette/vaping acute lung injury (EVALI), several states have banned flavored e-cigarette sales and one temporarily banned all vaping product sales. In this CTP supplement to a parent grant (Yale Center for the Study of Tobacco Product Use and Addiction), researchers will use new data from e-cigarette/vaping acute lung injury (EVALI) case reports by state and by month to estimate how smoking and vaping rates shifted in response to these policies as well as to the EVALI outbreak itself. Study aims are: (1) to clarify how state variation in behaviors and policies may have contributed to EVALI’s geographic distribution; (2) to quantify changes in vaping and smoking rates in response to the EVALI outbreak; and (3) to estimate how states’ policy responses to EVALI affected vaping and smoking. To address Aim 1, researchers will conduct analyses to characterize states’ 2019 EVALI prevalence by their pre-outbreak rates of vaping and marijuana use as well as marijuana legalization policies. To address Aim 2, researchers will analyze how adults’ smoking and vaping behavior shifted following changes in their state’s reported EVALI prevalence. To address Aim 3, researchers will estimate how banning flavored e-cigarette sales and all vaping product sales affected smoking and vaping rates (before and after policy implementation and compared to states that did not adopt policies). Study findings may inform state regulatory activities related to e-cigarettes.

Suchitra Krishnan-Sarin Funding Mechanism: National Institutes of Health – Grant
ID number: 3U54DA036151-08S2
Institution: Yale University
08/14/2020

Secondhand E-cigarette Exposure and Lung Function in Children

In this CTP Supplement to a parent grant about how lifetime environmental exposures impact health (the HERCULES Exposome Research Center), researchers will describe secondhand e-cigarette aerosol exposure and measures of lung function in children (ages 6-12) who reside with daily vapers. Study aims are: (1) to examine associations between secondhand e-cigarette aerosol chemical exposures and salivary metabolic profiles and pathways, and (2) to examine associations of secondhand e-cigarette chemical exposure and salivary metabolic profiles with markers of lung function. To achieve Aim 1, researchers will measure nicotine, benzene, and toluene exposure in 30 children of daily vapers and 30 children of non-vapers/non-smokers who will wear wristband air samplers for 120 hours (5 days). Researchers will collect saliva samples and analyze them to identify altered metabolic profiles and pathways; they will also examine associations of nicotine, benzene, and toluene with salivary metabolic profiles. To achieve Aim 2, researchers will examine associations between nicotine, benzene, and toluene exposure data and metabolomics data (from Aim 1) and lung function measures including fractional exhaled nitric oxide (FeNO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC), mid-expiration forced expiratory flow rate (FEF 25-75%), and parent report of recurrent/chronic respiratory symptoms. Study findings may inform future regulatory activities related to e-cigarettes.

Carmen Marsit Funding Mechanism: National Institutes of Health – Grant
ID number: 3P30ES019776-08S1
Institution: Emory University
08/11/2020

Understanding the Influence of E-cigarette Advertisement Features

The goal of this study is to examine the influence of four e-cigarette advertisement features (flavors, models, marketing claims, and price promotions) on young adult (ages 18-29) non-tobacco users who are susceptible to e-cigarette use. Study aims are: (1) to identify key features of e-cigarette advertisements that lead to greater attention; (2) to examine the associations between key features of e-cigarette advertisements and positive neurocognitive responses; and (3) to determine whether edited advertisements without key features lead to reduced positive e-cigarette perceptions and behavioral intentions compared to original advertisements. To address Aim 1, researchers will use eye-tracking technology to identify key e-cigarette advertisement features that receive attention (gaze duration and fixation frequency) in 70 young adults. To address Aim 2, researchers will use electroencephalogram (EEG) technology to evaluate the associations between key e-cigarette advertisement features and sustained cognitive processing and emotional arousal in 120 young adults. To address Aim 3, researchers will conduct a randomized comparative study among 900 young adults to determine whether an intervention group that receives e-cigarette advertisements without key features has lower levels of positive e-cigarette perceptions and behavioral intentions than a control group that receives original unaltered advertisements. Findings will provide information about the potential impact of specific e-cigarette advertising characteristics on the initiation and progression of e-cigarette use among young adults.

Julia Cen Chen-Sankey Funding Mechanism: National Institutes of Health – Grant
ID number: 1K99CA242589-01A1
Institution: National Institute on Minority Health and Health Disparities
08/07/2020

The Relationship Between Nicotine Metabolism and Nicotine Concentrations in E-cigarettes on Smoking Behavior and Toxicant Exposure in African American and White Smokers

African Americans are particularly vulnerable to smoking-related diseases and are less successful at smoking cessation. The goal of this study is to investigate the use of e-cigarettes for smoking reduction in African American and White smokers. Study aims are: (1) to investigate the impact of nicotine metabolism on nicotine pharmacokinetics and the subjective effects of nicotine concentrations in e-cigarettes, and (2) to elucidate the relationship between nicotine metabolism and nicotine concentrations in e-cigarettes and the impact on smoking behavior and toxicant exposure. To address Aim 1, 56 smokers (28 African American subjects and 28 White subjects ages 18 and older) will receive e-cigarettes with their preferred flavor (menthol or tobacco) and 10mg/ml and 50mg/ml of nicotine during two sessions (one concentration per session). To address Aim 2, one week after the completion of Aim 1, subjects will receive preferred-flavor e-cigarettes with 10mg/ml or 50mg/ml of nicotine to take home for two weeks. Outcomes (and associated race differences) for these study aims will include nicotine metabolite rate, plasma nicotine levels, carbon monoxide, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), cigarette craving, nicotine withdrawal, nicotine dependence, cardiovascular and lung function, volatile organic compounds, self-reports of combustible tobacco product use, e-cigarette use, and amount of e-liquid used. Study findings will help elucidate the relationship between nicotine metabolism and e-cigarette nicotine concentration and its impact on smoking behavior and toxicant exposure in African American and White smokers.

Asti Jackson Funding Mechanism: National Institutes of Health – Grant
ID number: 1K01DA051882-01
Institution: Yale University
08/05/2020

Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Use Escalation Among Young Adult Electronic Nicotine Delivery Systems Users

The goal of this study is to identify neurobehavioral markers of nicotine use escalation and cigarette smoking initiation among young adult electronic nicotine delivery systems (ENDS) users. Study aims are: (1) to identify neural and behavioral markers of ENDS escalation and smoking initiation; (2) to determine whether neural markers add predictive utility beyond traditional measures; and (3) to determine the efficacy of public service announcements (PSAs) and identify neural predictors of PSA efficacy. At baseline, the researcher will measure traditional behavioral and novel brain responses using functional MRI in 180 non-smoking young adult (age 18-20) ENDS users to identify salient predictors of nicotine use escalation and smoking initiation; the researcher will quantify responses to smoking stimuli, vaping stimuli, and associated food stimuli in brain systems associated with cognitive control, emotion, and salience. Responses in the same brain networks will be assessed in response to existing tobacco control education PSAs and PSAs addressing ENDS flavors. Over the following six months, participants will receive weekly PSAs and bi-weekly PSA evaluations via emails and texts. In addition to evaluating the PSAs, participants will report all tobacco product use during the past two weeks. In-person visits at 3, 6, 9 and 12 months will include breath carbon monoxide and urine cotinine tests. Outcomes will include cigarettes smoked, exhaled carbon monoxide levels, urine cotinine levels, and ENDS and tobacco use outcomes. Study findings may inform future regulatory activities related to ENDS.

Jiaying Liu Funding Mechanism: National Institutes of Health – Grant
ID number: 1K01DA049292-01A1
Institution: University of Georgia
08/01/2020

Novel Methods for Evaluating the Association of Electronic Cigarette Use with Cardiovascular Health

The goal of this study is to provide population-based evidence on the cardiovascular (CV) effects of e-cigarette use, including particular e-cigarette aerosol components that may be responsible for CV harm. Study aims are: (1) to examine the effects of e-cigarette use and cigarette/e-cigarette transitions on CV events; (2) to estimate associations of e-cigarette use with risk factors and preclinical biomarkers of CV injury, and to analyze biomarkers of exposure as potential mediators; and (3) to identify unique biomarker signatures of e-cigarette exposure and to associate clusters with preclinical biomarkers of CV injury. To achieve Aim 1, the researcher will use data from the Population Assessment of Tobacco and Health (PATH) Study Waves 1-4 (2013-2017) to investigate to what extent e-cigarette use is associated with CV events including myocardial infarction, stroke, and heart failure. To achieve Aim 2, the researcher will assess the effects of e-cigarette use on CV risk factors (blood pressure, triglycerides, and cholesterol) using data from the National Health and Nutrition Examination Survey (NHANES, 2013-2016) and on preclinical biomarkers of CV injury (inflammation, thrombosis, and oxidative stress) using data from PATH Wave 1 (2013-2014). To identify specific e-cigarette aerosol components that mediate CV risk, the researcher will analyze urinary exposure biomarkers for product constituents (nicotine, tobacco-specific nitrosamines [TSNAs], volatile organic compounds [VOCs], polycyclic aromatic hydrocarbons [PAHs], and metals). To achieve Aim 3, the researcher will use data from PATH Wave 1 to define clusters of e-cigarette use based on shared urinary exposure biomarker profiles related to use behaviors (frequency, other tobacco products, and reasons for use) and product characteristics (type and flavors), and associate each with preclinical biomarkers of CV injury. Study findings may inform regulatory activities related to e-cigarettes.

Andrew Stokes Funding Mechanism: National Institutes of Health – Grant
ID number: 1K01HL154130-01
Institution: Boston University Medical Campus
07/30/2020

Development of Early Warning System for Toxins Related to EVALI and Vaping

In this CTP supplement to a parent grant (Co-Abuse of Cannabis and Tobacco), researchers will lay the foundation for developing an early warning system that identifies and evaluates emerging chemical threats posed by e-liquids that may lead to acute illnesses such as e-cigarette/vaping-associated acute lung injury (EVALI). The goal is to detect emerging trends in the composition of vaping liquids and would allow identification and evaluation of possible hazards before their use becomes widespread. Study aims are: (1) to mine social media data to identify emerging vaping products and potential hazardous constituents used in vape liquids; and (2) to analyze the aerosol properties and chemical composition of aerosolized vitamin E acetate (i.e., a chemical already suspected to be hazardous) and other potential hazardous constituents identified from social media monitoring in Aim 1 to determine their effects in lung tissue. Findings may inform future regulatory activities related to e-cigarettes.

Jenny Wiley Funding Mechanism: National Institutes of Health – Grant
ID number: 3R33DA044377-04S1
Institution: Research Triangle Institute (RTI) International
07/27/2020

Hispanic and Latino Youth and Tobacco Use: Foundational Research

The goal of this research effort is to guide CTP audience segmentation and communications strategies to inform evidence-based decisions about communications activities designed to prevent initiation of tobacco use among Hispanic/Latino youth and young adults. The research includes three tasks: (1) a comprehensive literature review and environmental scan, (2) secondary data analysis and audience segmentation, and (3) primary data collection among high-risk audiences. The scope and approach of the primary data collection will be informed by the first two phases and will include at least one round of qualitative data collection (e.g., focus group discussions) and may also include quantitative data collection/survey research; the number of subjects and age ranges have yet to be determined. This research will inform future CTP communications activities that are targeted toward Hispanic/Latino youth.

Everly Marcario and Emily Sanders Funding Mechanism: Contract
ID number: 75F40120A00002
Institution: IQ Solutions
07/27/2020

Respiratory Health and Cigar and Pipe Use in the NHLBI Pooled Cohorts Study

Cigarette smoking is the major risk factor for chronic lower respiratory disease (CLRD), which includes chronic obstructive pulmonary disease (COPD) and asthma. The goal of this study is to test whether cigar and pipe use is associated with accelerated lung function decline and CLRD-related hospitalizations and mortality. Researchers will analyze data from the National Heart, Lung, and Blood Institute (NHLBI) Pooled Cohorts Study, which collected lung function data (including spirometry exam data) from nine US general population-based cohorts that included 65,251 American Indian, Asian, Black, Hispanic and White adult men and women. Study aims are: (1) to harmonize self-reported interview questions on cigar and pipe use across the study cohorts in order to characterize cigar/pipe use; (2) to assess associations between cigar/pipe use and lung function changes over time, including rates of forced expiratory volume in one second (FEV1) decline, forced vital capacity (FVC) decline, FEV1/FVC, and airflow obstruction; and (3) to assess the association between cigar/pipe use and CLRD-related hospitalizations and mortality. Study findings may inform future regulatory activities related to cigar and pipe tobacco products.

Elizabeth Oelsner Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21HL153700-01
Institution: Columbia University Health Sciences
07/25/2020

Respiratory Effects of Exposure to Metals from Electronic Cigarettes (RE-EMIT)

Several metals, including lead and nickel, are known lung toxicants and have been found in e-cigarette aerosols. In this CTP supplement to a parent grant (The Exposure to Metals from E-Cigarettes (EMIT) Study), researchers will study how patterns of “pod” e-cigarette device use impact exposure to metals among young adults (ages 18-24) and how these metal exposures may be associated with pulmonary health effects. Study aims are: (1) to evaluate the contribution of pod devices to metal exposure; (2) to measure pod users’ pulmonary health outcomes and evaluate their association with pod use; and (3) to assess the role of metals in pod-related pulmonary health outcomes. To achieve Aim 1, researchers will assess metal concentrations in pod aerosol (collected from each participant’s device) and assess their association with use patterns (from a questionnaire) as well as established biomarkers of metal exposure in blood (lead, cadmium, manganese and zinc) and urine (nickel, arsenic, chromium, antimony, and tungsten); they will also measure chromium and arsenic in the aerosol. To achieve Aim 2, researchers will characterize differences in pulmonary outcomes between pod users and non-users at 0 and 6 months; among users, researchers will evaluate differences by age, sex, and pod type. To achieve Aim 3, researchers will assess the association of metals in pods and in biomarkers of exposure (e.g., urine nickel) with measures of lung effects by evaluating which patients fall below the lower limit of normal for pulmonary function tests. Researchers will add pulmonary outcome measures to 25 pod users and 25 control participants from the parent study, and will recruit an additional 25 pod users and 25 non-users (ages 18-24) to characterize pulmonary outcomes (reductions in the forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing capacity of carbon monoxide (DLCO)), measures of metals in device aerosols, and measures of exposure to metals in urine and blood at 0 and 6 months. Study findings may inform future regulatory activities related to e-cigarettes.

Ana Maria Rule Funding Mechanism: National Institutes of Health – Grant
ID number: 3R01ES030025-03S1
Institution: Johns Hopkins University
07/22/2020

Modeling Tyrosine Kinase Inhibitor-Induced Vascular Dysfunction Using Human iPSCs

Additional information about the pulmonary health effects of e-cigarettes would be useful, particularly given the growing number of e-cigarette or vaping use-associated lung injury (EVALI) cases. In this CTP Supplement to a parent grant (Modeling Tyrosine Kinase Inhibitor-Induced Vascular Dysfunction Using Human iPSCs), researchers will use a human induced pluripotent stem cell (iPSC)-based in vitro pulmonary toxicity screen to investigate the cellular, molecular, and genomic effects of six common e-cigarette components on lung tissue. Study aims are: (1) to generate iPSC-derived lung cells (i.e., alveolar epithelial cells, fibroblasts, smooth muscle cells, endothelial cells) from 12 existing healthy iPSC lines (6 male/6 female); and (2) to investigate the effects of e-cigarette components implicated in EVALI, including vitamin E acetate, tetrahydrocannabinol (THC), nicotine, propylene glycol, vegetable glycerin, and cannabidiol (CBD). Study findings may lead to new biomarkers and may inform future regulatory activities related to e-cigarettes.

Joseph Wu and Thomas Quertermous Funding Mechanism: National Institutes of Health – Grant
ID number: 3R01HL141851-02S1
Institution: Stanford University
07/20/2020

Cigarette Smoking as a Risk Factor for Greater Psychiatric Symptom Severity Across Serious Mental Illnesses: A Secondary Analysis of Three Nationally-Representative NIH Datasets

People with serious mental illnesses (SMIs) such as bipolar disorder (BD), schizophrenia (SCZ), and major depressive disorder (MDD) comprise a population that is especially vulnerable to tobacco use; people with SMIs are twice as likely to smoke as people without SMIs. However, a federal tobacco education campaign targeted to the SMI subpopulation has not yet been developed. The goal of this study is to provide scientific evidence that could be used to develop such a campaign. Specific aims are: (1) to determine whether smoking is a risk factor for increased time in illness episodes (mood episodes in BD smokers; psychotic episodes in SCZ smokers; and depressive episodes in MDD smokers) in people with SMIs; (2) to determine whether smoking is a risk factor for increased time in depression across SMIs; and (3) to determine predictors of within-person changes in smoking behavior (initiating, quitting, relapsing). To achieve these aims, researchers will analyze data from three large National Institutes of Health datasets (BD: STEP-BD study, N=4361; SCZ: CATIE study, N=1460; and MDD: STAR*D study, N=2248). Study findings will provide scientific evidence that may be used to inform the development of a tobacco education campaign targeted to people with SMIs.

David Bond Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051538-01
Institution: University of Minnesota
07/20/2020

Predicting Longitudinal Patterns of Change in Adolescent Polytobacco Use: A Socio-Ecological Framework

More information about how patterns of single and polytobacco use change from early adolescence into emerging adulthood would be useful. The goal of this project is to examine patterns of change and associated predictive factors over an extended time period. Study aims are: (1) to examine trajectories and related predictors of single tobacco product use from early adolescence (age 12) to emerging adulthood (age 23); (2) to examine transitions into and out of polytobacco use classes, as well as predictors of these classes, from early adolescence (age 12) to emerging adulthood (age 23), and (3) to examine interactions among individual (e.g., motives for use, sensation seeking), interpersonal (e.g., parent modeling, rules), and contextual (e.g., geographic location) factors in predicting trajectories of single tobacco product use and transitions in polytobacco use. Researchers will analyze Population Assessment of Tobacco and Health (PATH) Study data (total of 52,731 respondents) from study waves 1 (2013-2014), 2 (2014-2015), 3 (2015-2016) and 4 (2016-2018) to examine the changes over time in use of tobacco products (cigarettes, cigars, waterpipes, smokeless tobacco, electronic cigarettes) individually and in combination. Study findings may inform regulatory activities related to youth and young adult use of tobacco products.

Melissa Blank Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051628-01
Institution: West Virginia University
07/20/2020

Measuring Anatalline and Nicotelline to Differentiate Non-combusted Tobacco Use Using the PATH Study

Biomarkers that can distinguish between types of tobacco product use can be used to help track associated health effects. The goal of this study is to measure nicotelline, a minor tobacco alkaloid associated with tobacco smoke particulate matter, in urine biospecimens gathered during Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study. Previous research has shown that, when expressed as a ratio with its parent compound (anatalline), nicotelline may distinguish smokeless tobacco use from combusted tobacco use. Study Aim 1 will validate the anatalline/nicotelline ratio cut-points (as well as nicotelline in combination with other tobacco exposure biomarkers) that distinguish exclusive cigarette use, exclusive smokeless tobacco use, and dual smokeless plus cigarette use (140 adults each). In Study Aim 2, researchers will use the same participant groups defined in Study Aim 1 to explore whether nicotelline and ratios of nicotelline-to-traditional tobacco biomarkers (i.e., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL]) can differentiate e-cigarette use from exclusive cigarette use using data from exclusive e-cigarette users and dual e-cigarette plus cigarette users. Study findings may confirm nicotelline’s usefulness as a biomarker to discriminate among tobacco products and to identify patterns of polytobacco use.

Kathryn Edwards and Gideon St. Helen Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051491-01
Institution: Westat
07/20/2020

Tobacco Use Trajectories and Disparities Among Sexual Minorities in U.S Adolescents and Adults

Sexual minority individuals comprise a population that is particularly vulnerable to tobacco use. The goal of this project is to analyze tobacco use across time in sexual minorities and resulting tobacco-related health disparities using Population Assessment of Tobacco and Health (PATH) Study data. Of PATH respondents with valid self-reported sexual identity (gay/lesbian, bisexual, something else, or straight) at all four study waves (N=26,696, ages 12+years), 2,520 reported sexual minority identity at one wave or more; 1,474 reported sexual minority identify at wave 1; and 905 reported sexual minority identity at all four waves. Study aims are: (1) to examine tobacco product initiation and use trajectories by sexual orientation and their associations with regular tobacco use and tobacco use disorder symptoms; (2) to identify tobacco use trajectories by sexual orientation and different associations with self-reported and biological health outcomes; and (3) to examine the role of biological and psychological stress on tobacco use trajectories, tobacco cessation, and tobacco-related health outcomes among adults and how these measures differ by sexual orientation. Researchers will assess tobacco use trajectories, including tobacco use initiation; progression in the number of products used, with a focus on e-cigarette use/non-use; and increase and decrease in use frequency. Aims 2 and 3 will involve analysis of survey self-report measures of stress (psychological distress) and health outcomes (respiratory illness, cancer, cardiovascular disease) alongside biological markers of stress (e.g. C-reactive protein, interleukin-6) and tobacco-specific markers linked to cancer risk (NNAL, NNN, TNE2). Researchers will also examine important moderators including age, sex, race and ethnicity throughout in all analyses. This project will provide new data that may inform regulatory activities to address the health burden of tobacco use among sexual minorities.

Rebecca Evans-Polce Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051388-01
Institution: University of Michigan
07/20/2020

Do E-Cigarette Users Airways Have an Altered Lipid Content?

In this study, researchers will use previously-collected serum, saliva, sputum, and bronchoalveolar lavage fluid (BALF) from healthy never-smokers, tobacco smokers or vapers to determine whether the airways of e-cigarette users have an altered lipid (fat) content that may cause acute lung injury. Study aims are: (1) to determine the concentrations of lipid-associated surfactant proteins in samples of BALF, sputum and saliva from non-smokers, smokers and vapers; (2) to measure lung cell lipid content and stain alveolar macrophages (a type of white blood cell in the lung) with Oil Red O to look for altered lipid content in vapers’ alveolar macrophages and airway secretions; and (3) to study metabolites on samples of BALF, sputum and saliva from non-smokers, smokers and vapers. To achieve Aim 1, researchers will use western blotting techniques to determine the amounts of lipid-associated surfactant proteins in vapers’ airway secretions. To achieve Aim 2, researchers will use mass spectrometry as well as standard histological techniques to better understand the impact of lipid accumulation on vapers’ lungs. To achieve Aim 3, researchers will use mass spectrometry to determine levels of nicotine, cotinine, tetrahydrocannabinol (THC), and metabolites that are associated with lung injury in vapers’, non-smokers’, and smokers’ lungs. Findings may inform future regulatory activities related to e-cigarettes.

Robert Tarran Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21HL153698-01
Institution: University of North Carolina, Chapel Hill
07/20/2020

Do E-cigarette Design Features Impact Cigarette Initiation, Cessation & Relapse?

More information about how e-cigarette characteristics impact transitions to and from cigarette smoking would be useful. This project will evaluate the independent effects of four e-cigarette design features (flavors, device type, nicotine content, and nicotine formulation) on later cigarette smoking initiation, cessation, and relapse among youth (ages 12-17), young adults (ages 18-24) and adults (ages 25 and older) in the U.S. Researchers will analyze data from the Population Assessment of Tobacco and Health (PATH) Study, the U.S. arm of the International Tobacco Control (ITC) Youth Tobacco and E-cigarette Survey, and the U.S. arm of the ITC Four Country Smoking and Vaping Survey. Study aims are: (1) to examine e-cigarette use and cigarette initiation among non-smoking youth and young adults, particularly whether and how e-cigarette design features predict future cigarette smoking initiation, including progression to regular cigarette smoking; (2) to examine e-cigarette use and cigarette cessation among youth and adult cigarette smokers, specifically whether and how e-cigarette design features impact later cigarette smoking cessation, considering both the potential reach and effectiveness of design features; and (3) to examine e-cigarette use and cigarette relapse among adult former cigarette smokers, specifically whether and how e-cigarette design features impact later cigarette smoking relapse. These findings may inform FDA regulatory activities related to e-cigarettes.

Karin Kasza Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051446-01
Institution: Roswell Park Cancer Institute Corporation
07/17/2020

Derivation of Lung Epithelia from iPS cells for Advanced Disease Modeling

The goal of this CTP supplement to a parent grant (which funds the study of alveolar epithelial type 2 cells [AEC2s], a type of lung cell) is to determine the effects of e-cigarette vapor exposure on the human alveolar epithelium (the internal surface area of the lung). Researchers will use newly-developed protocols to generate human AEC2s from induced pluripotent stem cells (iPSCs). They will culture the AEC2s using an air-liquid interface method and then expose them to (1) e-cigarette vapor containing nicotine, (2) e-cigarette vapor containing vitamin E-acetate (implicated in e-cigarette/vaping acute lung injury, or EVALI), (3) cigarette smoke, or (4) air (a control condition). Researchers will then measure the effects of these exposures on the RNA molecules, proteins, and metabolites in the AEC2s and generate a dataset. Study findings will describe e-cigarette vapor injury to this key lung cell type.

Darrell Kotton Funding Mechanism: National Institutes of Health – Grant
ID number: 3R01HL095993-11S1
Institution: Boston University Medical Campus
07/17/2020

CTP Supplement to Parent Grant: The Role of Histone Deacetylase 9 in Vascular Calcification

In this CTP Supplement to a parent grant studying the role of histone deacetylase 9 (HDAC9, an essential regulator of vascular function), researchers will investigate whether toxic metals from vaping products prompt HDAC9-dependent dysregulation of vascular cell function and increased inflammation. Study aims are: (1) to analyze the heavy metal profiles of aerosol vapor generated by different open-system vaping devices, and (2) to determine the effects of toxic heavy metals in vaping aerosols and e-fluids on vascular cell function in vitro and cardiovascular and pulmonary function in vivo. To achieve Aim 1, researchers will use mass spectrometry to profile metals (by element and concentration) in aerosol vapor from six different open-system vaping devices (three refillable cartridges and three tank devices) and identify the origin (e-fluid, reservoir, heating coil) of each metal. To achieve Aim 2, researchers will use cell culture-based assays to determine how vaping aerosols, e-fluids, and metal constituents identified in Aim 1 affect gene and protein expression patterns and cellular function. They will also use wild-type and HDAC9-deficient mice to study the effects of chronic (1 month) vaping aerosol exposure on cardiovascular function (echocardiography), blood pressure, endothelial function, vascular reactivity, pulmonary function, and inflammation profile. Study findings may inform regulatory activities related to e-cigarettes.

Rajeev Malhotra Funding Mechanism: National Institutes of Health – Grant
ID number: 3R01HL142809-03S1
Institution: Massachusetts General Hospital
07/17/2020

A Mouse Model of Vaping Vitamin E Acetate: Effects on Lung Function and Pathology

In this CTP supplement to a parent grant (Effects of E-cigarette Exposure during Pregnancy on Offspring Lung Function and Disease: Characterization of Pulmonary, Intergenerational, and Epigenetic Effects), researchers will study the effects of inhaling vitamin E acetate (VEA) compared to aerosolized nicotine in propylene glycol/vegetable glycerol (PG/VG), which is linked to e-cigarette/vaping-associated lung injury (EVALI), on lung function and pathology in a mouse model. Study aims are: (1) to characterize the acute effects of vaping with increasing e-liquid percentage of VEA; and (2) to characterize the chronic effects of vaping VEA on lung function and pathology. To achieve Aim 1, researchers will expose mice that have not previously been exposed to vaping (naïve mice) and mice that have been exposed to house dust mite antigen (sensitized mice) or to aerosolized nicotine in PG/VG to increasing percentages (0, 10, 20, 40, or 80%) of VEA in PG/VG (1:1) e-liquid; researchers will determine VEA effects on pulse oximetry, bronchial lavage composition, and lung pathology compared to nicotine. At the optimal condition found to induce EVALI-like changes, researchers will determine the effects of modifying voltage. To achieve Aim 2, researchers will determine the chronic pulmonary effects of vaping (measured at 2 and 4 weeks) using a complete battery of pulmonary function tests, pulse oximetry, heart rate, bronchial lavage and lung pathology on naïve and sensitized mice. Study findings may inform the understanding of the link of pre-disposing factors, such as prior ENDS use, and pre-existing respiratory conditions, such as asthma, on the incidence of EVALI.

Eliot Spindel Funding Mechanism: National Institutes of Health – Grant
ID number: 3R01HL144384-02S1
Institution: Oregon Health & Science University
07/09/2020

Impact of E-cigarette Prevention Messages on Adolescents

Additional research to inform effective communications related to e-cigarette prevention among adolescents would be useful. The goal of this project is to identify e-cigarette prevention messages that will reduce adolescents’ (ages 13-17) willingness to use e-cigarettes. Study aims are: (1) to identify promising ways to communicate with adolescents to prevent e-cigarette use; (2) to develop a set of e-cigarette prevention messages that discourage adolescents from wanting to use e-cigarettes; and (3) to evaluate whether prevention messages reduce at-risk adolescents’ willingness to use e-cigarettes and e-cigarette use behavior in a randomized controlled trial (RCT). To achieve Aim 1, researchers will: identify promising prevention message themes (e.g., health effects, social norms, addiction) targeted to adolescents based on the empirical literature; vet these themes with the study team, expert consultants, and a teen advisory panel; work with an advertising agency to develop creative concepts for the most prominent themes; and conduct six focus groups with about 60 adolescents to examine their responses to the creative concepts. To achieve Aim 2, researchers will: develop 10 e-cigarette prevention messages based on the chosen concepts from Aim 1; conduct 30 cognitive interviews with 10 tobacco-using, 10 tobacco-susceptible, and 10 non-susceptible non-user adolescents to refine the messages; and conduct an online study of 1,600 adolescents to examine the perceived effectiveness of the messages in discouraging e-cigarette use. To achieve Aim 3, researchers will select a set of the most promising messages from Aim 2 to test in an RCT with 506 adolescents who will receive daily text messages for 20 days; one group will receive one of the five e-cigarette prevention messages in a randomized order, while the other group will receive a control message such as “This study will help others in the future. Thanks for taking part!”. Researchers will examine the impact of messages on willingness to use e-cigarettes (primary outcome) and e-cigarette use, cognitive elaboration, negative affect, e-cigarette beliefs, and social interactions (secondary outcomes) with a brief daily assessment, 3 weekly surveys, and a survey at 3 months. Study findings may inform e-cigarette prevention messages and campaigns for adolescents.

Seth M. Noar Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01DA049155-01A1
Institution: University of North Carolina at Chapel Hill
06/12/2020

Translational Studies on Electronic Cigarette-Derived Oxidants and Their Long-term Pulmonary Effects

Oxidative stress and damage resulting from exposure to oxidants such as free radicals and aldehydes play critical roles in the development and progression of most tobacco-caused diseases, including chronic obstructive pulmonary disease (COPD). The goal of this project is to evaluate toxicities caused by exposure to e-cigarette-derived free radicals and aldehydes and their role in the development of COPD. Study aims are: (1) to investigate the long-term pulmonary effects of e-cigarette exposure from products delivering high vs. low oxidant levels in a COPD mouse model; (2) to determine the impact of switching from cigarettes to e-cigarettes; and (3) to conduct a pilot single arm trial to determine the impact of switching from cigarettes to e-cigarettes on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting COPD. To address Aim 1, researchers will conduct 3-month exposure studies to compare high vs. low oxidant e-cigarette products (Mod vs. Juul, respectively). To address Aim 2, researchers will pre-expose mice for 1.5 months to cigarette smoke prior to switching them to filtered air, e-cigarette aerosol, or 50/50 e-cigarette aerosol/cigarette smoke for the remaining 1.5 months to mimic the harm from “real world” e-cigarette use patterns in smokers (smoking cessation, switching to e-cigarettes, and dual use). The primary outcomes of Aims 1 and 2 will be development of a COPD phenotype (including changes in lung function and histology) and assessment of systemic and lung-specific biomarkers of oxidative stress/damage and inflammation. To address Aim 3, researchers will provide e-cigarettes to 30 smokers (ages 18-65) with mild/moderate COPD and ask them to use these products exclusively for a year; e-cigarette and cigarette usage will be monitored along with assessments of COPD-related clinical symptoms, spirometric lung function, and biomarkers of oxidative stress and inflammation. These studies will provide new information about the toxicological impact of oxidant exposure from specific e-cigarette devices.

John P. Richie Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01HL152436-01
Institution: Pennsylvania State University
05/22/2020

Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

The public health impact of FDA’s proposed nicotine reduction policy hinges on the extent to which tobacco users and non-users understand the harms of nicotine in specific products (e.g., e-cigarettes, nicotine replacement therapy (NRT), reduced nicotine content (RNC) cigarettes) and how this understanding influences decisions made by non-users to try a product and by users regarding cessation, product switching, or continued use. Research has highlighted widespread public misperceptions of the health risks of nicotine. A brief nicotine corrective messaging intervention may correct misperceptions of nicotine, NRT, e-cigarettes, and RNC cigarettes. The goal of this study is to examine the effect of multiple exposures to a nicotine corrective messaging (NCM) intervention (compared to a delayed intervention control) on nicotine beliefs and intention/use of tobacco and nicotine products in U.S. adults (age 18 and older). Study aims are: (1) to test the impact of NCM on nicotine beliefs and the subsequent impact on intention and use of tobacco and nicotine products in a national sample of 715 adult smokers and non-smokers followed for 12 weeks; and (2) to test the impact of NCM (messaging vs. control) and nicotine content of study cigarettes (normal vs. reduced) on nicotine beliefs and subsequent use of tobacco and nicotine products using a 2 x 2 factorial design in a sample of 160 adult current smokers followed for 4 weeks (participants will be explicitly told which product they have been given). In both studies, participants will complete online surveys at scheduled intervals throughout the study period in which they will be exposed to up to six corrective messages and subsequently complete survey questions. Study findings will provide information about the potential of NCM communication efforts on tobacco use behavior in the general population and in adult smokers affected by a reduced nicotine content standard in combustible cigarettes.

Andrea Villanti and Andrew Strasser Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01DA051001-01
Institution: University of Vermont and State Agricultural College
05/22/2020

Modified Use of E-Cigarettes and Marketing on YouTube

The goal of this study is to understand ways in which youth modify e-cigarettes, their motivations for doing so, and marketing sources. Study aims are: (1) to identify and characterize modified uses of e-cigarettes and associated marketing sources on youth-accessible YouTube videos, and (2) to examine modified uses and marketing exposure among an online sample of 500 adolescent (ages 13-17) and 500 young adult (ages 18-25) e-cigarette users. To address Aim 1, researchers will identify modified uses of e-cigarettes and marketing using fictitious youth YouTube viewer profiles to search for e-cigarettes using a browser plug-in and custom scripted web-crawling; then they will use machine-learning to automatically code the videos to identify e-cigarette modifications, motivations for modification, marketing sources, and appeal (number of views, number of likes). Subject matter experts in tobacco regulatory science, social media, youth tobacco use, toxicology, communications, and tobacco marketing will assess the potential impact of identified modified uses on e-cigarette appeal, addiction, and health effects. To address Aim 2, researchers will conduct an online survey with 1000 adolescent and young adult e-cigarette users to examine the prevalence, appeal, motivations, risk perceptions, and marketing exposure related to these modified uses and their predictors (i.e., demographic variables, past-month e-cigarette use frequency, e-cigarette dependence, other tobacco/substance use, interpersonal and intrapersonal risk factors). Findings may inform regulatory activities related to e-cigarettes.

Grace Kong Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01DA049878-01A1
Institution: Yale University
05/22/2020

Greenwashing Cigarettes: Perceptual and Behavioral Evidence of Inaccurate Modified Risk Advertising

“Greenwashing” is an increasingly common tobacco marketing strategy in which products are portrayed as eco-friendly and/or natural. Greenwashing tactics may inaccurately convey modified product risk to consumers. The goal of this project is to describe how cigarette companies use greenwashing to market their products and test the effect of these tactics on young adult (ages 18-29) risk perceptions in an online sample and actual smoking behavior in a controlled laboratory study. Study aims are: (1) to identify specific greenwashing tactics used in cigarette ads, determine their prevalence across brands and sub-brands, and determine changes in these tactics over time; (2) to test the extent to which the greenwashing tactics identified in Aim 1 contribute to inaccurate modified risk perception in 1,500 young adults using an online survey; and (3) to test the effect of greenwashing on behavioral economic demand and smoking topography in a laboratory-controlled cigarette self-administration study of 35 young adults. Findings will provide new information about the connection of greenwashing strategies to product risk perceptions and actual smoking behavior and may inform future regulatory activities.

Meghan B. Moran and Matthew Johnson Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01DA049814-01A1
Institution: Johns Hopkins University
05/21/2020

Shrinking the Size of the Tobacco Powerwall and Restricting the Number of Tobacco Products Displayed to Reduce Adolescent Tobacco Use

The most prominent source of retail point-of-sale (POS) tobacco advertising comes from the tobacco power wall, the large, expansive display of hundreds of different tobacco products typically located behind the cashier in full view of consumers. Adolescents are frequent visitors to retail stores and thus are at significant risk for having repeated exposures to the tobacco power wall. The goal of this project is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents. Study aims are: (1) to evaluate the extent to which reducing the size of the power wall and number of units of each tobacco product displayed on the power wall influences tobacco use risk; (2) to model the mediational pathways through which these reductions initiatives have their effects; and (3) to examine whether gender and/or tobacco use experience moderate adolescents’ reactions to the power wall regulatory options under investigation. This study will take place in the RAND StoreLab (RSL), a life-sized replica of a convenience store developed to evaluate how altering aspects of POS promotion influences tobacco use risk during simulated shopping experiences. A total of 750 adolescents (ages 11-20) will be randomly assigned to shop in the RSL under one of three conditions (250 per condition): (1) large power wall/ multiple product units displayed; (2) small power wall/multiple product units displayed; and (3) small power wall/single product units displayed. Researchers will consider the effect of these power wall alterations on risk of use of four classes of tobacco products: cigarettes, electronic nicotine delivery devices, cigarillos, and smokeless tobacco. Tobacco use risk will be indexed by: attention to the tobacco power wall, perceived tobacco use norms, perceived availability of tobacco products, and tobacco use intentions. Findings may inform future regulatory activities related to POS tobacco advertising.

William G. Shadel Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01DA050972-01
Institution: RAND Corporation
05/19/2020

Assessing Toxicant Properties and Health Effects of Cigarillo and Hookah Tobacco Aerosols in Rats

The goal of this project is to evaluate whether cigarillo and hookah tobacco aerosols exhibit differences in toxicants associated with five health outcomes (cancer, transcriptional reprogramming, lung function and inflammation, cardiovascular effects and serum circulatory inflammation) compared to cigarette smoke using a rat model. Study aims are: (1) to evaluate 14-day nose-only dose response exposures to aerosols generated from cigarettes, cigarillos, and hookah products; and (2) to evaluate the effect of these exposures on biomarkers of cardiopulmonary health effects. To address Aim 1, researchers will expose a total of 360 rats (10/sex/group) for one hour per day for 14 days to one of three exposure groups (250, 500, or 750 mg total particulate matter (TPM)/m3) and one of six tobacco products (two major consumer brands each of cigarettes, cigarillos, or hookah tobacco, selected based on their in vitro toxicant properties); an air exposure group of 20 rats will be included as a control group. The exposure atmosphere will be characterized for hazardous chemical substances including (but not limited to) carbon monoxide, tobacco-specific nitrosamines, nicotine, volatile carbonyls, and tar. To address Aim 2, researchers will use biospecimens collected following the exposures to assess and compare effects across the five health outcomes listed above. Researchers will obtain quantitative readouts of cardiopulmonary biomarkers to enable comparisons across products and to evaluate dose effects; biomarkers will include specific DNA adducts, lipid peroxidation, cytokine panels, global assessment of lung transcriptional reprogramming, gene expression changes in the heart and aorta, and gene expression changes predictive of circulatory inflammation. Findings may inform regulatory activities related to cigarillos and hookah tobacco.

Steven A. Belinsky and Carmen Tellez Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01ES031787-01
Institution: Lovelace Biomedical and Environmental Research Institute (LBERI)
05/15/2020

Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

Sugars are present naturally in some tobacco types and are also added to cigarette tobacco filler. Data suggest that sugars in tobacco filler may contribute to the harmful properties of cigarettes by enhancing smoke palatability and appeal and, as precursors to aldehydes and furans in smoke, by increasing smoke toxicity and carcinogenicity and potentially addictiveness. The goal of this study is to provide additional quantitative data on the relationship between tobacco sugar content and relevant toxicant yields in U.S. commercial cigarettes, and associated user exposures, behaviors, and cigarette appeal. Study aims are: (1) to characterize the impact of sugars in the filler of U.S. cigarettes on the chemical profile of cigarette smoke; (2) to investigate the impact of sugar content in cigarette tobacco on toxicant and carcinogen intake in U.S. smokers; and (3) to investigate the impact of sugar content in cigarette tobacco on cigarette abuse liability and appeal. To address Aim 1, researchers will add stable isotope-labeled sugars to a commercial cigarette that is low in sugars and will analyze the dose-dependent formation of corresponding pyrolysis products in the smoke of this cigarette; they will also analyze the impact of sugar content on the levels of nicotine and tobacco-specific nitrosamines (TSNAs) in the smoke. To address Aim 2, researchers will analyze sugars in U.S. commercial cigarettes and use Population Assessment of Tobacco and Heath (PATH) Study biomarker data to investigate the impact of sugar content in cigarette tobacco on toxicant and carcinogen intake in U.S. smokers. To address Aim 3, researchers will investigate the impact of sugar content on cigarette abuse liability and appeal by conducting a laboratory study in which 30 smokers (aged 18 and older) will assess study cigarettes with different sugar levels. Findings may inform future regulatory measures related to sugar levels in tobacco products.

Irina Stepanov and Dorothy Hatsukami Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01DA051005-01
Institution: University of Minnesota
04/28/2020

Impact of a Reduced Nicotine Standard on Young Adult Appeal for Menthol and Non-Menthol Cigarettes

The goal of this study is to examine response to smoking menthol and non-menthol very low nicotine cigarettes (VLNCs) in 100 young adult (ages 18-24) menthol smokers. Study aims are: (1) to determine the influence of menthol flavoring on smoking reinforcement in the context of a reduced nicotine standard in the laboratory; (2) to determine the influence of menthol flavoring on smoking reinforcement in the context of a reduced nicotine standard in the natural environment; and (3) to examine the impact reinforcement on tobacco product purchasing. To achieve Aim 1, abstinent smokers (>12 hours) will attend three laboratory visits where they will smoke a cigarette. During Visit 1, smokers will smoke their usual brand cigarette ad libitum; researchers will measure subjective response (satisfaction, craving reduction, psychological reward, sensory effects like throat hit), smoking exposure (carbon monoxide [CO] boost), and behavior (number of puffs, puff volume). Next, after 7 days of usual brand smoking, participants will undergo two experimental conditions at home: (1) 7 days smoking menthol VLNCs; and (2) 7 days smoking non-menthol VLNCs. For each condition, participants will be instructed to switch their usual cigarette for the assigned research cigarette but may use other tobacco products. (Each experimental condition will be separated by a 7-day wash-out period.) On the last day of each condition, participants will smoke the assigned research cigarette in the laboratory, and researchers will collect data on subjective response, smoking exposure, and behavior to compare craving reduction, positive subjective response, and CO boost among menthol VLNCs, non-menthol VLNCs, and usual brand. To address Aim 2, during each 7-day period, participants will complete twice-daily assessments of cigarette and other tobacco use, withdrawal, and subjective response; data will allow researchers to compare cigarettes per day, craving reduction, and positive subjective response for menthol VLNCs, non-menthol VLNCs, and usual brand. To address Aim 3, in a fourth visit participants will complete two tasks in the laboratory to indicate the impact of menthol and nicotine content on cigarette purchasing behavior in the context of all tobacco products currently on the market. Findings will provide new information about the abuse liability of menthol VLNCs.

Amy M. Cohn Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01DA050990-01
Institution: University of Oklahoma Health Sciences Center
03/31/2020

A Measurement Burst Study of Vaping in a National Sample of Young Adults

In this supplement to the Monitoring the Future (MTF) parent grant (Monitoring the Future: Drug Use and Lifestyles of American Youth), researchers will conduct a new longitudinal study of approximately 1100 individuals who participated in MTF as 12th graders in 2019 and will be modal age 19 in 2020, with an oversample of those who reported vaping and other substance use in high school. Approximately 570 respondents who report current vaping at age 19 will be invited to complete a one-time web-based survey (30 minutes) followed by 14 consecutive daily web-based surveys (5-7 minutes) to capture real-time fluctuation in vaping use patterns, consequences, and co-use with other substances. Study aims are to examine: (1) vaping frequency, products, devices, patterns, and contexts with daily data over two weeks, (2) signs of vaping addiction, craving, quit attempts, and physical consequences in real time, (3) co-use of vaping and other substances including alcohol, cigarettes, marijuana, and non-prescription drugs, and (4) recent exposure to nicotine through collection of biometric samples. Findings will provide new information about vaping behaviors and consequences among young adults that may inform future regulatory activities.

Richard Miech and Megan Patrick Funding Mechanism: National Institutes of Health – Grant
ID number: 5R01DA001411-46S1
Institution: University of Michigan
03/26/2020

Identification of Free Radical Induced Biomarkers of Exposure to Electronic Cigarette Aerosol

E-cigarette aerosol contains highly reactive free radicals that can cause oxidative damage, which can contribute to the progression of cancers and other diseases. The goal of this study is to identify these free radicals and use their unique structures to develop an e-cigarette-specific biomarker of exposure. Study aims are: (1) to determine the structures of the free radicals produced by propylene glycol and glycerin in e-cigarettes; and (2) to determine the primary targets of radical adduct formation in the tissue of e-cigarette-exposed mice and identify metabolites formed from radical adducts in the serum. To address Aim 1, researchers will use free radical spin trapping, electron paramagnetic resonance spectroscopy techniques, and mass spectroscopy to identify and analyze the unique structural features of free radicals in e-cigarette aerosol produced from a popular temperature-controlled e-cigarette device. To address Aim 2, 120 mice will be exposed to e-cigarette aerosols and either pre- or post-exposed to 5,5-dimethyl-1-pyrroline noxide (DMPO) spin traps via nose-only exposures. Using an anti-DMPO antibody, the areas of free radical exposure will be observed in the pre-DMPO exposures and targets of radical damage will be observed in the post-DMPO exposures. Radical adducts formed in the post-DMPO exposures will be identified via mass spectroscopy and metabolites of these adducts will be identified in the serum to find viable e-cigarette-specific biomarkers of exposure. Findings may inform future regulatory activities related to e-cigarettes.

Zachary T. Bitzer Funding Mechanism: National Institutes of Health – Grant
ID number: 1K99HL147346-01A1
Institution: Pennsylvania State University
03/12/2020

Cardiopulmonary Effects Induced by Electronic Cigarette and JUUL Aerosols in Both In Vivo and In Vitro Models

Although clinical evidence demonstrates declines in lung function and increases in heart attack risk in healthy dual-users of e-cigarettes and cigarettes, more evidence regarding the cardiopulmonary effects of chronic inhalation of electronic nicotine delivery system (ENDS) aerosols would be useful. The goal of this study is to evaluate how two ENDS products — open system e-cigarette devices and closed system JUUL-type devices — impact individual or combinations of aerosol constituents and their toxicity using innovative cell culture systems and mouse models. Study aims are: (1) to examine the roles that e-liquid constituents (i.e., propylene glycol/vegetable glycerin, flavors, nicotine) play in the chemical profiles and lung toxicity of ENDS aerosols using in vitro models; (2) to define a panel of biomarkers for cardiopulmonary effects following exposures to e-cigarette aerosols, JUUL aerosols, and dual use of cigarettes and e-cigarettes in juvenile mice; and (3) to compare pulmonary toxicity induced by e-cigarette or JUUL aerosols in mice. Findings may clarify the cardiopulmonary effects caused by prolonged use of ENDS and inform regulatory activities.

Alexandra Noël Funding Mechanism: NIH Grant
ID number: 1K01HL149053-01
Institution: Louisiana State University A&M College Baton Rouge
03/06/2020

Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine and Other Constituents (YCSTP) (TCORS 2.0)

Systematic data collection can provide more information about e-cigarette or vaping product use-associated lung injury (EVALI), particularly regarding number of cases and specific products involved. In this supplement to the Yale University TCORS 2.0 parent grant, researchers will develop a robust surveillance system that will prospectively identify hospitalized patients with acute lung injury who vape or smoke. Study aims are: (1) to develop a robust surveillance system to prospectively identify admitted patients with acute lung injury who vape or smoke; (2) to perform toxicology analyses of e-liquids and device contents that are associated with EVALI; and (3) to build a biorepository of patient blood and urine samples among patients with acute lung injury who vape or smoke to investigate disease mechanisms. This project will enable research into disease mechanisms and elucidate risk factors associated with EVALI.

Suchitra Krishnan-Sarin and Stephanie O’Malley Funding Mechanism: National Institutes of Health – Grant
ID number: 3U54DA036151-07S1
Institution: Yale University
03/02/2020

Center for the Study of Tobacco Products – Electronic Cigarette Use and Alveolar Macrophages: A Preliminary Study

Data from animal studies suggest that e-cigarette users may be at risk for a potentially debilitating condition called lipoid pneumonia. In this supplement to the Virginia Commonwealth University TCORS 2.0 parent grant, this supplement will collect pilot data relevant to the generalizability of lipoid pneumonia-related animal study data to humans. Study aims are: (1) to investigate lipid-laden macrophages in e-cigarette users, and (2) to characterize other disease biomarkers in e-cigarette users’ bronchoalveolar lavage (BAL) fluid. To address Aim 1, researchers will recruit 10 high-wattage (i.e., >20 W) e-cigarette users (ages 21-55) with over one year of experience exclusively using nicotine-containing e-cigarettes as well as an additional 10 never-e-cigarette-using, never-smoking controls. Using well-established methods, all 20 participants will undergo bronchoscopy and BAL to enable the collection of alveolar macrophages. Researchers will then compare the incidence of lipid-laden macrophages between groups. To satisfy Aim 2, researchers will determine the alveolar fluid composition differences in miRNA expression, extra-vesicle-miRNA, and microbiome profiles between the e-cigarette users and the control group. Findings may inform regulatory activities related to e-cigarette liquid constituents that have the potential to cause lung disease.

Thomas Eissenberg and Alison Breland Funding Mechanism: National Institutes of Health – Grant
ID number: 3U54DA036105-07S1
Institution: Virginia Commonwealth University
01/31/2020

FDA CTP This is Our Watch Retailer Feedback Study

FDA’s Center for Tobacco Products (CTP) Office of Health Communication and Education has created and maintains retailer education materials, referred to as This Is Our Watch (TIOW), designed to give retailers the tools they need to comply with tobacco regulations. As a result of the Tobacco 21 legislation raising the federal minimum age for the sale of tobacco products from 18 to 21, FDA CTP is required to update TIOW retailer education materials. The goal of this study is to obtain feedback from retailers about their awareness, preferences and experiences related to the TIOW materials. Researchers will conduct 32 in-depth interviews (22 English, 10 Spanish) that will each last up to 60 minutes. Participants will include clerks, managers, and owners of tobacco retail establishments identified through government contacts, such as the State Synar Program managed by the Substance Abuse and Mental Health Services Administration (SAMHSA). Study aims are: (1) to identify T21 knowledge gaps and educational opportunities among tobacco retailers, and (2) to understand retailers’ sentiments, needs and challenges related to minimum legal purchase age compliance. Findings will allow FDA to understand what additional messages, information, and material format would complement the current TIOW education materials.

Alessandra Raimondi (CTP Contacts: Megan Wall, Matthew Walker, Emily Sanders) Funding Mechanism: Research Contract
ID Number: 75F40120A00002-75F40120F19001
Institution: Fors Marsh Group
09/30/2019

The Human Dose-Response Effects of Methyl Salicylate in Smokeless Tobacco

The goals of this project are to determine how changes in the methyl salicylate content of smokeless tobacco may affect HPHC exposure and nicotine pharmacokinetics (the body’s effects on nicotine), as well as to determine how changes in methyl salicylate content affect nicotine pharmacodynamics (nicotine’s effects on the body) and abuse liability. First, researchers will amend commercially available smokeless tobacco to create four investigational smokeless tobacco products (no methyl salicylate and low, medium, and high methyl salicylate content ranging from 0.3-30 mg/g). Next, researchers will administer each of the four products to 56 adult smokeless tobacco users (aged 21-65) under specific use conditions. Researchers will measure heart rate, blood pressure, pharmacokinetics, exposure to harmful and potentially harmfully constituents (HPHCs), and abuse liability (measures of liking, craving, and withdrawal) before and after product use. Findings may inform future regulatory activities related to smokeless tobacco products.

Bortosz Koszowski and Mollie Miller Funding Mechanism: Research Contract
ID number: HHSF223201710040I
Institution: Battelle
09/27/2019

Study of E-Cigarette Aerosol Toxicity in In Vivo Nonclinical Models

Few peer-reviewed studies have compared the toxicity associated with inhaling aerosol from different types of e-cigarettes; therefore, a thorough comparison of the chemical constituent levels, pharmacokinetics (PK), and toxicity from different e-cigarettes would be informative for future toxicological assessments. Researchers will perform a 28-day study with PK assessment, a 90-day nose-only inhalation study with 45-day recovery groups, and a 6-month nose-only inhalation study; all studies will be conducted in male and female Sprague Dawley rats. The 28-day study will evaluate the toxicity of two e-cigarettes and will provide PK data (results will be used to inform dose selection in the 90-day and 6-month studies). The objective of the 90-day and 6-month studies is to perform longer-term comprehensive studies of four top-market-share e-cigarette products in the U.S. Researchers will gather data including e-liquid and aerosol concentration measurements; measurements in animals such as body weight and food/water consumption; clinical observations; and biomarkers of exposure. Findings will provide new information about the potential toxicological effects of e-cigarette use.

Jake McDonald, Gladys V. Erives, and Cissy Li Funding Mechanism: Research Contract
ID number: 75F40119C10161
Institution: Lovelace Biomedical and Environmental Research Institute (LBERI)
09/19/2019

Smokers’ Decision-Making about Tobacco Use: The Interplay of Affective and Cognitive Factors with Product Characteristics

Misperceptions about the health risks and benefits of electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP), as well as consumer dissatisfaction with product characteristics, may limit initiation and complete substitution for cigarettes. This project will investigate how price, indoor-air policies, and ENDS and HTP product characteristics (type/design, flavors, ability to reduce cravings to smoke) interact with risk/benefit perceptions to affect smokers’ decisions to reject ENDS, to substitute them for only a few cigarettes, to switch exclusively to ENDS, or to use ENDS to completely quit using tobacco products. Study aims are: (1) to examine how cognitive, affective, and contextual factors (e.g., whether products can be used where smoking is prohibited) moderate the influence of ENDS/HTP product characteristics on product choice and tobacco use patterns and trajectories; and (2) to examine how the effects of specific ENDS/HTP product characteristics on product use patterns are moderated by risk/benefit perceptions. Aim 1 will involve qualitative focus group interviews with 120 current and former adult smokers (aged 18+) and an intensive one-year (12 weekly, then 3 quarterly) assessment with 300 current smokers who recently initiated ENDS use to examine how ENDS/HTP product characteristics influence smokers’ decisions to initiate, dual use with, or substitute for combustible product use. Aim 2 involves two experiments and a randomized clinical trial. A discrete-choice experiment (DCE) will be embedded in a survey of 300 current adult smokers to examine the relative importance of ENDS/HTP product characteristics on risk/benefit perceptions, product preferences, and use intentions, and evaluate the predictive validity of these preferences on future tobacco use. A second DCE will examine the interaction of product characteristics, risk/benefit perceptions, and contextual factors on product preferences among 2,400 adult current smokers who currently, formerly, or never used ENDS/HTP products. These results will inform the design of a randomized clinical trial with 1,800 adult smokers involving a hypothetical purchase task that will manipulate risk/benefit perceptions of ENDS/HTP products to estimate the effect on smokers’ consumption of cigarettes, ENDS, and HTP, including the substitutability or complementarity of ENDS and HTP for each other and for cigarettes. Findings may inform regulatory activities related to cigarettes, ENDS and HTP products.

Terry Frank Pechacek and Scott R. Weaver Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA235719-01A1
Institution: Georgia State University
09/18/2019

Assessing IQOS Marketing Influences and Consumer Behavior in Israel: Implications for the US

Developing an understanding of how heated tobacco products (HTPs) are marketed would be useful. IQOS, the global HTP leader, has a presence in several markets, including Israel. Israel is unique in that it represents three distinct regulatory contexts for IQOS: (1) during IQOS’s initial emergence in Israel, it was not categorized as a tobacco product (Dec 2016-Apr 2017); (2) IQOS was classified as a tobacco product in a relatively weak regulatory context (Apr 2017- December 2019); and (3) IQOS will be regulated as a tobacco product within new progressive legislation (study period starting January 2020). The goal of this study is to examine IQOS marketing strategies used in Israel during these three regulatory periods and assess their impact on segments of the Israeli and U.S. populations. Study aims are: (1) to examine IQOS marketing strategies in Israel from its emergence in the Israeli market and begin surveillance as IQOS is launched in the US; and (2) to examine market segments of Israeli and U.S. adults (users and nonusers aged 18-45) in relation to IQOS use and/or likelihood of future use. The researchers will study marketing content and consumer reactions in both Israel and the U.S. via examination of marketing channels (including point-of-sale audits), content analysis of advertising messaging strategies, interviews with IQOS retailers, online surveys of 1,000 Israeli and 1,000 U.S. adults, and interviews with 40 Israeli and 40 U.S. adults. Among the panel of Israeli and U.S. adults, the researchers will conduct market segmentation research on consumer characteristics; four specific market segments defined by the IQOS website will be examined: business and current events; art, culture and fashion; nature and hiking; and innovation and technology. By examining IQOS marketing strategies used in the three different regulatory periods in Israel and understanding the impact of these strategies on different consumer segments and the extent to which they generalize to U.S. consumers, findings will provide information to better estimate the potential impact of IQOS and its marketing in the U.S.

Carla J. Berg and Hagai Levine Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA239178-01A1
Institution: Emory University
09/18/2019

Assessing the Effects of Smokeless Tobacco Influencer Marketing in the Rapidly Changing Media Environment

Social media marketing remains an understudied area in tobacco control, particularly related to smokeless tobacco. The goal of this project is to examine the effects of exposure to smokeless tobacco-related social media content. Study aims are: (1) to conduct a content analysis to identify and characterize social media messages related to smokeless tobacco by source and major themes (e.g., new user targeting, health risks, flavors); (2) to assess the impact of social media content exposure on smokeless tobacco use, attitudes, harm perceptions, perceived prevalence of use, initiation, and use intentions) using data from the Truth Longitudinal Cohort Survey on Tobacco-Related Attitudes, Beliefs and Behavior (13,892 youth and young adults aged 15-21 at baseline [April 2014]); and (3) to study whether/to what extent tobacco control policies moderate the relationship between exposure to smokeless tobacco-related social media content and smokeless tobacco use. Investigators will apply various research and analytic methods to a unique combination of data sets, including social media data from Twitter, Instagram and Facebook and survey data on tobacco-related outcomes. Findings will provide policy-relevant scientific evidence on the impact of social media marketing of smokeless tobacco products.

Ganna Kostygina Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA234082-01A1
Institution: National Opinion Research Center
09/18/2019

The E-Cigarette Population Paradox: Testing Effects of Youth-Targeted Population Warnings for E-Cigarettes among Two Key Populations

Warnings on e-cigarette advertisements and packaging should communicate the risks of e-cigarettes to youth and non-smokers while also protecting perceptions of the potential benefits of switching completely to e-cigarettes among combustible cigarette smokers. The goal of this study is to identify effective e-cigarette ad warnings given this complex population paradox. Study aims are: (1) to develop and test a set of proposed warning messages to maximize desirable outcomes among both nonsmoking youth and adult smokers; (2) to evaluate e-cigarette ad warnings that maximize favorable effects on youth as the critical at-risk population; and (3) to test for unintended effects of e-cigarette ad warnings among adult cigarette smokers who may be discouraged from switching to e-cigarettes when exposed to some types of warnings. To address Aim 1, researchers will conduct a series of 16 focus groups (30 youth aged 14-18 and 30 adults aged 19+) to identify warnings that are likely to discourage non-smoking youth from using the product but do not discourage cigarette smokers from wanting to switch completely. To address Aim 2, researchers will use a mobile lab outfitted with computing and eye-tracking technology to test the effects of promising warnings from Aim 1 in a randomized experiment with 400 youth aged 14-18 to identify warnings that increase visual attention to the warnings, decrease attention to ad appeals, increase risk beliefs, and reduce use intentions. To address Aim 3, using the same mobile lab, researchers will randomize 400 adults aged 19+ to test whether the most effective warnings among youth that emerge in Aim 2 have any unintended consequences among adult smokers; specifically, they will test whether youth-effective warnings influence visual attention, comparative risks between combustible and e-cigarettes, and intentions to use both products (switching completely to e-cigarettes, dual use, or continued smoking of combustible cigarettes) among adults. Findings may inform regulatory activities related to e-cigarette ad warnings.

Sahara Byrne and Jeff Niederdeppe Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA246605-01
Institution: Cornell University
09/17/2019

Advancing Perceived Message Effectiveness: A New Measure for Youth Prevention Media Campaigns

Among other tools, the FDA uses the perceived message effectiveness (PME) scale to select ads for The Real Cost campaign. However, this scale has some limitations, including: (1) it was developed with adult smokers; (2) it was developed before the advent of e-cigarettes and vaping; and (3) it assesses message PME (beliefs about the message; i.e., “This ad is informative”), while a growing body of literature suggests that effects PME (beliefs about the message’s impact; i.e., “This ad gives me good reasons not to smoke”) better predicts the impact of ads on intention and behavior change. The goals of this project are to develop and validate an effects PME scale for adolescent (aged 13-17) tobacco prevention and to compare the performance of this new scale to the FDA’s current message PME scale. Study aims are: (1) to develop a youth effects PME scale for vetting cigarette and e-cigarette prevention ads; (2) to establish whether effects and message PME prospectively predict the impact of smoking prevention ads on intentions to smoke cigarettes; and (3) to examine whether effects and message PME predict the impact of vaping prevention ads on intentions to vape. To achieve Aim 1, researchers will develop a youth effects PME scale for vetting cigarette and e-cigarette prevention ads. They will develop and refine an item pool, cognitively test items with 48 adolescents, and conduct a scale development study with a national sample of 800 adolescents. To achieve Aim 2, researchers will randomize 1,280 adolescents at risk of cigarette smoking to one of three The Real Cost cigarette prevention ad conditions or to a control ad condition; participants will view a set of ads each week and complete a final assessment at week 3, and the researchers will examine whether PME predicts the impact of ads on intentions to smoke, risk beliefs about smoking, and smoking behavior. To achieve Aim 3, researchers will randomize 1,024 adolescents to view three The Real Cost e-cigarette ads or to a control ad condition and examine whether PME predicts the impact of e-cigarette ads on intentions to vape and risk beliefs. Findings may help campaign designers select more effective ads, thereby increasing the impact of tobacco education campaigns targeted to youth.

Seth Michael Noar Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA246600-01
Institution: University of North Carolina at Chapel Hill
09/16/2019

Communicating about Nicotine and Differential Risks of Tobacco Products

The goal of this project is to study a communication strategy that combines messages about reduced nicotine in combusted cigarettes with messages about relative risks of other tobacco products (i.e., potential “modified risk claims”). Study aims are: (1) to develop preliminary messages about reduced nicotine in combusted tobacco products; (2) to quantify the relative importance of different types of information in communications about reduced nicotine; and (3) to test the impact of messages about reduced nicotine in combusted tobacco products in the context of potential modified risk statements for novel tobacco products in a randomized clinical trial. To achieve Aim 1, researchers will conduct focus groups with 36 adult (aged 18+) current exclusive smokers, 36 adult dual users of cigarettes and ENDS, 36 adult former smokers, and 36 young adult non-smokers (aged 18-29). To achieve Aim 2, researchers will assess the relative effects of various message attributes (e.g., specific numbers for reduction, mention of addiction and health effects, source) on affect, perceived risk, and intentions to quit (for smokers) or to try reduced nicotine cigarettes (for non-smokers) in a discrete choice experiment; participants will be adult current exclusive smokers, adult dual users, adult former smokers, and young adult non-smokers (450 from each group). To achieve Aim 3, researchers will conduct a randomized clinical trial with 900 adult current exclusive smokers, 450 adult dual users, and 450 young adult non-smokers to compare effects of reduced nicotine and potential modified risk messages (executed as full-color ads) alone and in combination; outcomes will include risk perceptions, affect, behavioral intentions and recall and behavioral outcomes. Findings may inform regulatory activities related to communication strategies involving low nicotine tobacco products.

Lyudmila Popova and James Thrasher Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA239308-01A1
Institution: Georgia State University
09/16/2019

Impact of Adding Tobacco Constituents Nornicotine and Anatabine on Self-Administered Nicotine

Because most electronic cigarettes contain nicotine, users may be at greater risk of transitioning to other tobacco products given the addictive nature of nicotine. More information about the interactions between nicotine and other tobacco constituent compounds in the context of this addictive risk would be useful. The objective of this research is to assess the impact of the addition of other tobacco constituent compounds to nicotine in an intravenous self-administration model in male and female adult and adolescent rats. Study aims are: (1) to assess the impact of adding nornicotine and anatabine to self-administered nicotine on the motivational value of nicotine in rats that began their nicotine consumption as adults; and (2) to assess the impact of adding those constituents to self-administered nicotine on the motivational value of nicotine in rats that began their nicotine consumption as adolescents. Findings on the impact of adding tobacco constituent compounds to ongoing nicotine self-administration may inform future regulatory activities.

Jennifer E. Murray Funding Mechanism: NIH Grant
ID number: 1R03DA045740-01A1
Institution: University of Guelph
09/16/2019

The Role of Humectants and Flavor on Microbial Growth in Waterpipe Tobacco

More information regarding how additives like humectants and flavors alter microorganisms in waterpipe tobacco would be useful. The goal of this study is to assess the impact of humectants (humidifying ingredients) and flavor additives on microbial growth in waterpipe tobacco. Study aims are: (1) to evaluate the effect of flavor and humectant content on microbial growth in waterpipe tobacco; and (2) to assess the relationship between tobacco-specific nitrosamine (TSNA) production and microbial activity in waterpipe tobacco. To address Aim 1, researchers will use an unflavored, low-humectant commercially available waterpipe tobacco as a control and prepare it several different ways to determine the individual and cumulative effects of additives (glycerin, propylene glycol, and vanillin) on microbial growth; flavor and humectants will be added at quantities comparable to those in commercially available waterpipe tobacco. Researchers will quantify microbial composition using whole genome sequencing analysis, and will use shotgun proteomic analysis to characterize proteins expressed by organisms colonizing tobacco. To achieve Aim 2, two TSNAs (Nʹ-nitrosonornicotine [NNN] and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK]) will be quantified in each tobacco preparation after 1 and 6 months of incubation and compared to levels found in the control. Study findings will provide new information about how humectants and flavors influence toxic exposures associated with waterpipe tobacco.

Anna Marie Adetona Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R21CA244305-01
Institution: Battelle Centers/Public Health Research & Evaluation
09/16/2019

E-Cigarettes and Youth: Tests of Strategies to Prevent Recreational Use

Use of e-cigarettes by non-smoking youth has increased dramatically in recent years. The goal of this study is to test how variations in modified risk statements, novelty flavors, and flavor representation (pictorial images vs. plain-text flavor names) influence middle school youth (aged 11-14) e-cigarette perceptions and use susceptibility. Study aims are: (1) to determine how modified risk statements and the specificity of the health risks addressed by them influence middle school students’ perceptions of e-cigarettes and the FDA’s warning label; (2) to determine how flavor category influences middle school students’ perceptions of e-cigarettes and the FDA’s warning label; and (3) to determine how flavor representation influences middle school students’ perceptions of e-cigarettes and the FDA’s warning label. Two randomized experiments will be conducted on a sample of middle school students. The first, with 150 participants, will vary whether participants view a modified risk statement alongside the FDA warning on e-cigarette packages, as well as the type of modified risk statement (abstract health consequence vs. specific health consequence). The second experiment, with 550 participants, will vary whether participants view e-liquid vials with tobacco flavor or a novelty flavor (menthol, fruit, candy, goth). Outcome measures include risk perceptions, message comprehension, harm minimizing beliefs, susceptibility, and behavioral intentions toward e-cigarette uptake. Findings may inform communication strategies that minimize uptake of e-cigarettes by middle school youth.

Sherri Jean Katz Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R21CA246602-01
Institution: University of Minnesota
09/16/2019

Evaluating the Impact of Waterpipe Tobacco Marketing Claims on Young Adults

Specific evidence related to waterpipe tobacco packaging and marketing to identify claims and determine their influence on consumer harm misperceptions would be useful. The goal of this study is to document claims on waterpipe tobacco packaging and in digital marketing (websites and social media) and evaluate how such claims influence consumer perceptions and willingness to try waterpipe tobacco. Study aims are: (1) to identify waterpipe tobacco product packaging and digital marketing; (2) to analyze waterpipe tobacco product packaging and digital marketing to determine whether they contain health claims; and (3) to evaluate the impact of health claims on young adults’ willingness to try the product, product appeal, and perceptions of harm. To achieve Aim 1, researchers will we will select a random sample of 30 waterpipe tobacco manufacturers and purchase five flavors from each manufacturer to document claims made on product packaging (150 packages). Researchers will also randomly select 30 U.S. retailers (i.e., waterpipe cafés, bars, lounges). For each of the 30 manufacturers and 30 retailers identified, researchers will capture content from their websites, as well as capture the 20 most recent Instagram (n=1,200) and Facebook (n=1,200) posts. To achieve Aim 2, researchers will content analyze all the packaging and digital marketing content captured in Aim 1. They will then use an expert panel to determine whether claims found on packaging and in digital marketing are health claims. To achieve Aim 3, researchers will conduct a randomized online experiment with 1,500 young adults (aged 18-29), including waterpipe users or those susceptible to future use, to evaluate the impact of the health claims on willingness to try the product, perceptions of harm, and product appeal. Findings will provide new information about which claims consumers perceive as health claims and may inform related regulatory activities.

Erin L. Sutfin Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA239192-01A1
Institution: Wake Forest University Health Sciences
09/16/2019

Analysis of ENDS Products

The goal of this project is to identify which of the 93 harmful and potentially harmful constituents (HPHCs) identified by the FDA are present in electronic nicotine delivery system (ENDS) products. Using validated testing methods, researchers will analyze ENDS e-liquids (33 e-liquids and four disposable devices containing e-liquid cartridges) and ENDS aerosols (aerosols of the 33 e-liquids produced from 21 different ENDS devices). In addition, researchers will provide relevant information (when available) about the products’ physical attributes and design characteristics, including e-liquid volume or weight, labelled nicotine concentration, power output, resistance, heating coil temperature, and battery capacity.

Karen Carter and Tianrong Cheng Funding Mechanism: Research Contract
ID number: 75F40119D10003
Institution: Enthalpy Analytical
09/13/2019

CTP Supplement to Parent Grant: Center for the Assessment of the Public Health Impact of Tobacco Regulations – Diversity Supplement for Project 3 (TCORS 2.0)

This is a supplement to an existing study titled “Modeling the Impact of Tobacco Control Policies on Polytobacco Use and Associated Health Disparities.” The aims of the supplemental research study are: (1) to evaluate the relationship between perceived discrimination and individual tobacco product use by race/ethnicity and gender; and (2) to evaluate the relationship between perceived discrimination and polytobacco use by race/ethnicity and gender. Using nationally representative data of adults aged 18 years and older, the study will examine the role of perceived discrimination on the use of cigarettes, cigars, pipe, smokeless tobacco, and e-cigarettes, individually and in combination. Importantly, differences by race/ethnicity (i.e., non-Hispanic White, non-Hispanic Black, Hispanic, and other races) and gender will be examined. Findings may lead to a better understanding of the complex interplay between social determinants and tobacco-related health disparities of polytobacco use among racial/ethnic minorities.

Rafael Meza and David Levy Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 3U54CA229974-02S1
Institution: University of Michigan at Ann Arbor
09/13/2019

Modeling the Public Health Impact of a National Menthol Cigarette Ban

The goal of this project is to use microsimulation modeling to estimate the impact of a national menthol cigarette ban on tobacco use and tobacco-related disease, specifically cardiovascular disease (CVD) and tobacco-related cancers. Study aims are: (1) to identify trajectories of cigarette use over time among youth and adults using longitudinal, nationally representative survey data; (2) to conduct a review of studies examining the effects of a menthol cigarette ban on product use; and (3) to build a model of smoking and tobacco-related disease to estimate the impact of a national menthol cigarette ban on smoking, CVD, and tobacco-related cancers. To achieve Aim 1, the researcher will compute transition probabilities of tobacco use behavior (frequency, intensity, flavor preference) over time using Population Assessment on Tobacco and Health (PATH) Study data. To achieve Aim 2, the researcher will synthesize the literature on the impact of a menthol cigarette ban and conduct a meta-analysis to pool data from individual studies, generating critical information for simulation modeling. To achieve Aim 3, the researcher will build a microsimulation model of tobacco use and tobacco-related diseases, incorporate the effect of a national menthol cigarette ban on cigarette use, and estimate changes in smoking, CVD, and tobacco-related cancers that would occur in the total population and in specific socioeconomic and racial/ethnic groups if a ban were implemented. Findings may inform potential regulatory activities on menthol cigarettes.

Sarah D. Mills Funding Mechanism: NIH Grant
ID number: 1K01CA242530-01
Institution: University of North Carolina, Chapel Hill
09/13/2019

Prospective Health Outcomes and Inflammatory Biomarkers Associated with e-Cigarette Use

The goal of this project is to identify validated biomarkers for use in the assessment of electronic nicotine delivery systems (ENDS). By analyzing data from two studies (the COPDGene and UCSD ENDS studies), researchers propose to identify ENDS-related inflammatory biomarkers in ENDS-only and dual (ENDS + cigarette) users and relate these biomarkers to five-year lung health outcomes. COPDGene is an ongoing longitudinal study of >6,000 current and former cigarette smokers; the study is identifying factors that increase chronic obstructive pulmonary disease (COPD) risk and includes detailed longitudinal lung phenotyping data (including chest computed tomography [CT]), genome-wide blood RNA-sequencing, and proteomic data. The UCSD ENDS Study is a study of young ENDS-only users and controls involving detailed assessment of inflammatory biomarkers in the oropharynx, airways and blood. Study aims are: (1) to identify and validate inflammatory transcriptomic and proteomic biomarkers of ENDS exposure in ENDS-only and dual users from the COPDGene five-year study visit; biomarkers will be validated in two independent sets of subjects from the COPDGene ten-year visit and the UCSD ENDS Study; (2) to identify antibody-specific adaptive immune response biomarkers of ENDS exposure in ENDS-only and dual users using adaptive immune receptor repertoire sequencing; and (3) to relate ENDS use and biomarker panels to five-year lung health outcomes using spirometry, chest CT, and questionnaire data from COPDGene. Findings may inform future regulatory activities related to ENDS.

Peter Castaldi Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01HL147326-01A1
Institution: Brigham and Women’s Hospital
09/13/2019

Using PET to Measure Pulmonary Oxidative Stress in E-cigarette Users

Inducible nitric oxide synthase (iNOS) is an enzyme that is expressed in lung epithelium and causes inflammation, a common pathway for many types of lung disease. Researchers will measure lung inflammation using positron emission tomography (PET) imaging with [18F]-6-(1/2)(2-fluoro-propyl)-4-methylpyridin-2-amine ([18F]NOS), a new PET radiotracer that targets iNOS. The goal of the study is to use this technique to compare lung inflammation in adult (aged 18+) electronic nicotine delivery system (ENDS) users, cigarette smokers, and nonsmokers. Study aims are: (1) to quantify and localize the effects of ENDS use, cigarette smoking, and nonsmoking on lung inflammation, and (2) to examine the effect of ENDS use, cigarette smoking, and nonsmoking on biomarkers of airway and lung inflammation and lung function. To accomplish these aims, 60 subjects (three groups of 20: ENDS users, traditional cigarette smokers who report having smoked ≥10 cigarettes per day for the past year with no history of ENDS use or cannabis smoking, and nonsmoking controls) will complete self-report measures, undergo a one-hour [18F]NOS PET/CT (computed tomography) scan of the chest, provide a breath and blood sample for measurement of biomarkers of airway and lung inflammation, and complete lung function tests using spirometry. Researchers will compare biomarkers of airway (fractional exhaled nitric oxide (FeNO)) and lung inflammation (proinflammatory cytokines TNF-α, IL-1β, and IL-8) and lung function (forced expiratory volume (FEV), forced vital capacity (FVC)). Findings may inform regulatory activities related to ENDS.

Reagan R. Wetherill Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R21HL144673-01A1
Institution: University of Pennsylvania
09/13/2019

The Impact of E-cigarette Marketing Features on Youths’ E-cigarette Perceptions and Use Intentions

The goal of this study is to determine the impact of branded e-cigarette marketing features – such as color, use of people in images, and language specifically targeting smokers – on e-cigarette perceptions and use intentions among youth. Study aims are: (1) to examine the e-cigarette marketing context surrounding youth over time; (2) to assess the impact of e-cigarette marketing features on youth’s e-cigarette perceptions and use intentions; and (3) to explore the impact of branded e-cigarette marketing features on youths’ attention using eye tracking. Studies will be conducted with non-current users of e-cigarettes who are aged 13-17. To achieve Aim 1, the researcher will conduct a longitudinal content analysis over five years, as well as yearly, of print, online, and point-of-sale marketing materials for five brands of e-cigarettes to monitor the potential for youth exposure and to identify e-cigarette marketing trends. To achieve Aim 2, the researcher will first conduct four online focus groups (each with 8-12 youth) to understand their perceptions about e-cigarettes and e-cigarette marketing; the researcher will then conduct an online survey experiment with 600 youth to test the effects of use of color, use of people in images, and language specifically targeting smokers on e-cigarette perceptions and use intentions. To achieve Aim 3, the researcher will use eye tracking technology to objectively measure attention (e.g., dwell time, gaze patterns) among 60 youth exposed to e-cigarette marketing materials. Findings may inform future regulatory activities related to e-cigarette marketing, packaging, and labeling.

Michelle Jeong Funding Mechanism: NIH Grant
ID number: 1K01CA242591-01
Institution: Rutgers University, RBHS-School of Public Health
09/12/2019

CTP Supplement to Parent Grant: Graphic and Text-Based Waterpipe Warning Labels to Combat Harm Misperceptions

This study is a supplement to a parent study that investigated the impact of the placement of text-only or graphic-and-text health warning labels on waterpipes on smoking behavior and toxicant exposure. The supplemental study will investigate warning label placement and whether changes in participants’ waterpipe smoking behavior due to warning labels result in measurable changes in biomarkers of potential harm and puffing behavior. The parent study aims are: (1) to determine the optimal message and placement of the health warning label on a waterpipe to attract user attention; (2) determine the effect of the presence of the optimal text vs. text/graphic vs. no health warning label on a carbon monoxide biomarker, waterpipe puffing behavior, and other behaviors, including perceptions of risk as measured by the social interaction among participants during the waterpipe smoking session; and (3) to explore the impact of the presence of a health warning label (text vs. text/graphic) on smoking behavior at 3 and 6 months post-experiment. For Aim 1, researchers will determine the optimal placement of heath warning labels on different waterpipes using focus group methods (n = up to 36) and eye tracking research (n=72) in samples of young adults ages 18-29 years. For Aim 2, researchers will randomize 246 young adults (ages 21-29 years) to view text-only labels, text/graphic labels, or no health warning label on waterpipes that they smoke ad libitum in a controlled laboratory setting; outcomes will include waterpipe puffing topography measures; subjective ratings of nicotine dependence, craving, and liking/disliking; exhaled carbon monoxide; and conversation topics related to fear, health risks, and the health warning label. For Aim 3, researchers will measure changes in smoking behavior at 3 and 6 months after the experiment. The supplement will add spirometry and genotoxicity measures to the laboratory experiment and the 3-month assessment in order to study lung function and biomarkers of harm, respectively. This study will provide new information about waterpipe health warning labels that may inform regulatory activities.

Amy K. Ferketich and Marielle C. Brinkman Funding Mechanism: NIH Grant
ID number: 3R01CA229306-02S2(Suppl)
Institution: Ohio State University
09/12/2019

A State-of-Art NMR Technique to Investigate Biologicals Effects of Electronic Nicotine Delivery Systems

More information regarding the molecular structures of electronic nicotine delivery system (ENDS) aerosols and their biological consequences would be useful. The goal of this study is to determine whether ENDS use at different temperatures alters aerosol constituents and/or molecular structure and toxicity by identifying and using metabolic signatures. Specific aims are: (1) to investigate the formation of ENDS aerosols at different temperatures using a magic angle spinning (MAS) technique, and (2) to apply a non-destructive slow-MAS nuclear magnetic resonance (NMR) metabolomics platform to define the dynamic response of lung organotypic cultures to ENDS aerosols. To address Aim 1, researchers will use their recently developed in situ MAS technique, which generates high resolution NMR spectra on samples containing a mixture of gases, liquids, and solids at significantly elevated temperature and pressure. To address Aim 2, researchers will use their lung organotypic culture platform, which enables the investigation of single cell populations (e.g., normal vs. cancer cells) as well as mixed cell populations (e.g., normal/cancer cell co-cultures) to define the baseline metabolome of normal human lung epithelial cells, lung cancer cells, and their mixture as cultures, as well as changes induced by ENDS aerosols generated at different temperatures. Findings may inform regulatory activities related to ENDS.

Jian Zhi Hu Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R21ES029778-01A1
Institution: Battelle Pacific Northwest Laboratories
09/11/2019

Early Phase Pharmacokinetic Analysis of Nicotine in Sprague-Dawley Rats

Nicotine is a naturally occurring alkaloid that is found in many nightshade plants, with most human exposure occurring through exposure to tobacco. The CTP-NCTR InhaleCore Group has recently completed studies evaluating nicotine pharmacokinetics (PK) profiles in rats following a single dose administration by inhalation, oral gavage, and intravenous injection (E07607.01). In these studies, the dose formulations for inhalation exposure consisted of nicotine in propylene glycol and water. PK samples were collected at 10 different timepoints ranging from 3 minutes to 48 hours post-dose exposure. Early PK timepoints (< 15 minutes post-dose) were collected using venous blood via the tail vein (i.e., peripheral source), whereas later PK timepoints were collected using arterial blood via terminal cardiac puncture (i.e., systemic source). For the venous blood to reflect the PK sample of the arterial blood, a minimum of 15 minutes is needed post-dose exposure. In this study, early PK timepoints will be collected using arterial blood via cardiac puncture to obtain a more accurate assessment of nicotine levels post-dose exposure. Two timepoints (5 and 10 minutes) to replace the timepoints from the previous study data collection via the tail vein and one additional 30-minute timepoint will be included, to provide an overlapping datapoint with the previous study data collection via cardiac puncture. Results will provide useful information to characterize nicotine kinetics across different routes of exposure, which is critical for the development of the physiologically-based PK model for nicotine and its metabolites (cotinine and 3-hydroxycotinine) in rodents across different routes of exposure. This scientific data may be used to identify and assess potential public health concerns related to nicotine inhalation exposure and may inform potential nicotine product standards.

Yunan Tang (CTP Contact: Prabha Kc) Funding Mechanism: FDA Internal
ID Number: E07716.01
Institution: National Center for Toxicological Research (NCTR)
09/02/2019

Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease

Few studies have examined the effectiveness of currently mandated little cigar and cigarillo (LCC) warnings. The goal of this study is to clarify which LCC warning characteristics (i.e., content, format, size) are most influential in reducing LCC use and how an additional LCC policy, the removal of flavor descriptors on packaging, could influence LCC warning impact. Study aims are: (1) to develop a comprehensive set of effective LCC warning statements and images; (2) to determine whether effective LCC warnings increase LCC quit intentions; and (3) to determine how removal of LCC flavor descriptors on packaging further impacts attention and affective responses to LCC warnings. To address Aim 1, researchers will use existing research and expert review to develop new LCC warnings (text plus images) and test them using online experiments with 500 adult (aged 18-65) LCC users to identify warnings that subjects perceive to be the most effective. To address Aim 2, researchers will conduct a national, web-based randomized controlled trial with 900 adult LCC users to examine whether the most effective warnings identified in Aim 1 encourage quitting compared to the currently mandated warnings and a control condition. To address Aim 3, researchers will conduct an in-person laboratory study with 100 adult LCC users using objective measures of attention (eye tracking), affect (facial electromyography), and arousal (electrodermal activity) to determine how flavor descriptors influence the effectiveness of new warnings compared to currently mandated warnings. Findings may inform regulatory activities related to LCC warnings.

Adam O. Goldstein Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA240732-01
Institution: University of North Carolina at Chapel Hill
09/01/2019

Using Social Media for Tobacco Regulatory Intelligence

This research involves two projects that will use artificial intelligence (Al) methods to analyze social media posts and comments. Researchers will apply Al models to messages collected from Twitter and Reddit; these models will enable the timely identification, organization, and analysis of millions of social media posts and comments. Separate models will be developed for Twitter and Reddit, which will allow researchers to compare and contrast findings from the two social media platforms. Project 1 will detect and identify tobacco brands and products from a list of previously established brands and products. Project 2 will identify the mentions of tobacco product-related adverse events (e.g., burns from e-cigarettes, vaping lung illnesses) and the perceived health benefits and harms of tobacco products. Project findings will provide new information that may inform FDA regulatory activities and communications.

Mark Dredze (CTP contact: Mario Navarro) Funding Mechanism: Centers of Excellence in Regulatory Science and Innovation Grant (CERSI)
ID number: 3U01FD005942-04S1
Institution: Johns Hopkins University
09/01/2019

Understanding How Flavors and Nicotine are Used in Electronic Nicotine Delivery Systems Advertising (Phase 2)

This work represents an extension of earlier CERSI-funded analysis of the content of electronic nicotine delivery systems (ENDS) advertising. The goal of Phase 2 of this research is to understand how ENDS design features including flavors are presented in advertising content, as well as how nicotine and its concentration/volume/mass and type (nicotine or nicotine salts, for example) are depicted/communicated in ads. Researchers will purchase ENDS advertisements and their associated spend data (i.e., cost per ad) for 2018-2020 from a media tracking service. The sample will include ENDS ads from magazines (consumer and business-to-business), newspapers, radio, television, out-of-home (e.g., billboards, point-of-sale), and electronic media (e.g., direct-to-consumer emails, online displays, banner ads). Researchers will then content-code the ads for features, focusing on how flavors and nicotine are presented, including written and visual content; ads will also be coded for the prevalence and content of health warnings. Results across all ad years of the Phase 1 and Phase 2 study periods (2015-2020) will be combined. Researchers will analyze the depiction of flavor and nicotine content by advertisement medium over time, the depiction of flavor and nicotine content by medium audience, and marketing investments by manufacturer, brand, advertising medium, and products (including flavor and nicotine features). Researchers will also assess the presence and content of health warnings now required in ENDS advertisements. Findings of this study may be used to inform future regulatory activities related to ENDS marketing.

Ryan Kennedy (CTP contact: Dannielle Kelley) Funding Mechanism: Centers of Excellence in Regulatory Science and Innovation Grant (CERSI)
ID number: 3U01FD005942-03S1
Institution: Johns Hopkins University
08/30/2019

CTP Supplement to Parent Grant: Assessing the Intended and Unintended Consequences of E-cigarette TV Advertising

This proposed administrative supplement will build upon the parent project, titled “Assessing the Intended and Unintended Consequences of E-cigarette TV Advertising”, to leverage resources and infrastructure to investigate how a newly authorized heated tobacco product, IQOS, will be marketed in Atlanta, GA, the first test market for IQOS in the U.S. Study aims are: (1) to monitor and conduct surveillance of IQOS marketing in retail stores and public events in Atlanta, and IQOS marketing on social media, print media, and via direct mail/email; and (2) to analyze the content of IQOS marketing to determine whether it may target or appeal to tobacco disparity populations defined by gender, age, race/ethnicity, sexual orientation and socioeconomic status. Findings may inform regulatory activities related to heated tobacco products, particularly those related to youth and other priority populations.

Jidong Huang Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 3R01CA194681-05S1
Institution: Georgia State University
08/29/2019

CTP Supplement to Parent Grant: The Impact of Design Characteristics on the Modification Potential of Electronic Nicotine Delivery Systems

The goal of this project is to study early adopters of the IQOS heated tobacco product in Atlanta, Georgia by assessing their knowledge, risk perceptions, exposure to marketing, tobacco use history, and reasons for using IQOS; studying their IQOS use experience and behaviors, including dual or poly use with other tobacco products; and investigating their sociodemographics to understand the characteristics of early IQOS adopters. Study aims are: (1) to examine reasons for purchase, use intentions, risk/harm and benefit perceptions, knowledge about tobacco products, marketing exposure, tobacco use history, and sociodemographics among early adopters of IQOS in the greater Atlanta area, and (2) to conduct an in-depth examination of the IQOS retail experience, marketing exposure, and product use behaviors among IQOS early adopters, including experience with using IQOS, patterns of use, and dual or poly use with other tobacco products. To achieve Aim 1, researchers will conduct 400 intercept surveys within the first six months of product release among a convenience sample of adult (aged 18+) consumers who purchase IQOS at the IQOS store at Lenox Square and other Atlanta area retail stores that sell lQOS products. To achieve Aim 2, researchers will conduct six focus groups among IQOS early adopters (three among 20 young adults aged 18-29 and three among 20 adults aged 30+). Findings will provide information about early IQOS adopters.

Lyudmila Popova Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 3R01DA047397-02S1
Institution: Georgia State University
08/23/2019

CTP Supplement to Parent Grant: Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E-cigarettes Among Daily and Non-Daily Smokers on Abuse Liability

In this supplement to an existing study titled “Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E­cigarettes Among Daily and Non-Daily Smokers on Abuse Liability,” researchers will add a third arm to the study: one that exposes 80 adult daily cigarette smokers (aged 21 and older) to high and low nicotine dose JUUL e-cigarettes, along with very low nicotine content cigarettes (VLNCCs). Parent study aims are: (1) to characterize the effects of dual use of VLNCC and e-cigarettes on abuse liability, nicotine compensation, and product use, liking, and relative reinforcing efficacy among 80 adult daily smokers; (2) to characterize the effects of dual use of VLNCC and e-cigarettes on abuse liability, nicotine compensation, and product use, liking, and relative reinforcing efficacy among 80 adult intermittent smokers; and (3) to characterize the effects of dual product use on abuse liability as measured by retrospective measures, smartphone daily diary, and real-time measures captured via smartphone ecological momentary assessment. The study is obtaining information about the effects of dual use of VLNCCs and e-cigarettes with differing levels of nicotine on nicotine abuse liability, as measured by nicotine compensation, product use and liking, relative reinforcing efficacy, and assessments of withdrawal, craving, affect and satisfaction. In the parent study, smokers are provided with eGo-T e-cigarettes, which are second-generation devices; given the growth in market share of JUUL, researchers will add a third study arm that will use the same design and measures as existing study arms but will expose smokers to JUUL e-cigarettes rather than the eGo-T product. Findings may inform regulatory activities related to JUUL products.

Paul Cinciripini and Jason Robinson Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 3R01DA042526-03S1
Institution: University of Texas, M.D. Anderson Cancer Center
08/19/2019

Tobacco Longitudinal Mortality Study

The Tobacco Longitudinal Mortality Study (TLMS) will examine tobacco use and associated mortality in a large national sample of American households. Researchers will create a TUMS database using data from the Current Population Survey (CPS) Tobacco Use Supplements (TUS) (which includes 3 million individuals), the National Death Index (NDI), the Centers for Medicare and Medicaid Services (CMS), and other health agencies and researchers. Researchers will then link and analyze this data to estimate all-cause and cause-specific mortality outcomes including cardiovascular disease, stroke, heart attack, and respiratory disease (including chronic obstructive pulmonary disease (COPD)) associated with the use of cigarettes, cigars, pipes, hookah, and smokeless tobacco products. Finally, researchers will incorporate data from the National Cancer Institute to assess risks of lung, colorectal and breast cancer. Researchers will assess the mortality and cancer risk of common dual and poly-use patterns and may also examine the influence of tobacco cessation on total mortality, cause-specific mortality and cancer incidence. Findings will provide new information about the link between tobacco use and mortality.

Norman Johnson and Carol Christensen Funding Mechanism: Research Contract
ID number: 75F40119S90002
Institution: US Census Bureau
08/15/2019

Impact of Flavor on Youth & Young Adults use Intention, Abuse Liability and Perceptions of Cigarillos

The goal of this study is to examine the impact of characterizing flavors in cigarillos on product appeal, attention to marketing, product perceptions, abuse liability, and subsequent use behavior among youth (ages 14-20) and young adults (ages 21-28). Study aims are: (1) to evaluate perceptions of flavors on appeal, purchasing and risk perceptions of cigarillo products among young adult and adolescent cigarillo users; (2) to examine differences in visual attention and risk perceptions of flavored and unflavored cigarillo advertisements among young adult cigarillo users and nonusers; and (3) to evaluate, in an experimental tobacco marketplace, the abuse liability/addictive potential of flavored versus unflavored cigarillos while simultaneously evaluating the substitutability of flavored versus unflavored JUUL e-cigarettes. To achieve Aim 1, researchers will ask 392 youth and young adult cigarillo smokers to quantitatively rate the role of flavor and report perceptions of product appeal, health risk, advertising exposure and use intentions; participants will also complete purchase and substitution tasks. To achieve Aim 2, researchers will use eye tracking equipment to compare visual attention across a set of flavored only, unflavored only, or mixed advertisements for cigarillo products and JUUL in a randomized experiment involving 150 young adult and adolescent users and non-users; participants will provide absolute and relative risk perception ratings immediately and one week after advertisement exposure. To achieve Aim 3, researchers will randomly assign 162 young adult cigarillo users to one of four conditions in an experimental online store with different products available: (1) flavored cigarillos and fruit-flavored JUUL devices, (2) unflavored cigarillos and fruit-flavored JUUL devices, (3) flavored cigarillos and tobacco-flavored JUUL devices, or (4) unflavored cigarillos and tobacco-flavored JUUL devices; researchers will then evaluate purchasing behavior, price sensitivity, product substitutability, and motivation to quit. Findings may inform regulatory activities related to cigarillos.

Erika Trapl Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01DA048529-01A1
Institution: Case Western Reserve University
08/15/2019

Blood and Brain Based Biomarkers of Injury to Assess the Cerebrovascular Impact of Emerging Alternatives to Classic Cigarette Products

While traditional measures exist for assessing cardiovascular and respiratory health in response to the short- and long-term effects of tobacco smoking and, to a lesser extent, e-cigarette use, more data concerning the cerebrovascular toxicity of these products would be useful. The goals of this study are to investigate the impact of cigarette smoking vs. e-cigarette use on the brain microvascular environment; validate selected biomarkers associated with pro-thrombotic alteration of blood hemostasis (increased risk of stroke) and severity of post-ischemic brain injury in response to chronic exposure to tobacco smoking and/or e-cigarette use; and evaluate the relevance of selected biomarkers in assessing e-cigarette vs. tobacco smoking harm with respect to blood-brain barrier viability, neurovascular inflammation, onset of stroke, and stroke outcome. Study aims are: (1) to assess the cerebrovascular impact of e-cigarette vaping and JUULing vs. tobacco smoking in mice and develop potential biomarkers to determine harm/toxicity; and (2) to evaluate and validate the impact of chronic exposure to e-cigarettes and JUUL vs. tobacco smoking on the risk of stroke, secondary brain damage, and post-ischemic neurological impairments in mice. To address Aim 1, researchers will compare the harm/toxicity of vaping/JUULing vs. tobacco smoking on the blood-brain barrier and will evaluate potential biomarkers of harm. To address Aim 2, researchers will compare the impact of tobacco smoking and vaping/JUULing on brain vascular damage, focusing specifically on the impact on stroke risk and outcomes using brain and blood-based biomarkers specific to inflammation, hemostasis and antioxidative response that were evaluated in Aim 1. Findings may inform regulatory activities related to cigarettes, e-cigarettes, and JUUL.

Luca Cucullo and Thomas Abbruscato Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01DA049737-01
Institution: Texas Tech University Health Science Center
08/14/2019

Physical and Chemical Characterization of Aerosols Produced by Nicotine Salt Based E-Liquids

E-liquids containing nicotine salts of volatile organic acids can deliver nicotine more rapidly and efficiently than traditional free-base nicotine formulations. Manufacturers have incorporated this formulation into electronic nicotine delivery systems (ENDS) production, and nicotine salt-based products (led by JUUL) now have a major share of the U.S. ENDS market. More information regarding the chemical and physical characteristics of nicotine salt-based ENDS would be useful, specifically related to how nicotine salt aerosols differ from those produced by other nicotine formulations, which characteristics may influence nicotine delivery, and whether nicotine salt aerosols have a different profile of harmful and potentially harmful constituents (HPHCs). The goal of this project is to provide comparative data on the aerosol characteristics and HPHC profiles of nicotine salt and free-base nicotine ENDS. Researchers will develop and validate a set of analytical methods that will physically and chemically characterize nicotine salt e-liquids and the aerosols produced by both nicotine salt and free-base nicotine e-liquids. Findings will provide information about how nicotine formulation affects nicotine delivery and HPHC emissions.

Karen Carter and Margaret Schmierer Funding Mechanism: Research Contract
ID number: 75F40119D10003
Institution: Enthalpy Analytical
08/13/2019

Respiratory Effects of E-Cigarette Use Among Youth: A Prospective, Longitudinal Investigation

More information about the acute and chronic pulmonary and respiratory effects of e-cigarettes would be useful. The goal of this study is to investigate pulmonary functioning and respiratory effects among 150 youth aged 15-17 years, 100 of whom are exclusive-e-cigarette users and 50 of whom are never-users. Study aims are: (1) to compare changes over one year in pulmonary functioning and respiratory health between exclusive e-cigarette users and never-users in repeated laboratory sessions; and (2) to identify a dose-response relationship between quantity/frequency of e-cigarette use (via daily self-monitoring on a mobile phone app) and acute changes in pulmonary functioning (via same-day, home-based spirometry measurements). To achieve Aim 1, subjects will complete one baseline and four subsequent laboratory assessments over one year to provide a comprehensive assessment of respiratory health (e.g., airway reactivity, airway inflammation, pulmonary functioning). To achieve Aim 2, subjects will track their e-cigarette use by using a mobile phone app and take home-based spirometry measurements daily for four two-week periods (one prior to each laboratory assessment) so that the immediate acute effects of e-cigarette use on respiratory markers can be tracked. Findings may inform regulatory activities related to e-cigarettes.

Alayna Pauline Tackett Funding Mechanism: NIH Grant
ID number: 1K01HL148907-01
Institution: University of Oklahoma, Health Sciences Center
08/09/2019

Modeling the Impact of Flavor Bans Among Young Adult Tobacco Users Using Discrete Choice Experiments and Agent-Based Modeling

The goal of this study is to examine the impact of two flavor ban alternatives on young adults (aged 18-34) who are recent (past 30-day) users of tobacco products including electronic nicotine delivery systems (ENDS). Products studied will include menthol cigarettes; flavored cigars, cigarillos, and little cigars; and menthol and non-menthol flavored ENDS. Study aims are: (1) to assess product switching after implementation of a flavor ban and examine related determinants; (2) to estimate consumer response to hypothetical flavor bans using discrete choice experiments; and (3) to examine the impact of flavor ban policies using agent-based models. To address Aim 1, researchers will conduct an online survey among 600 young adult tobacco/ENDS users to assess product switching behavior after implementation of a flavor ban in San Francisco; researchers will evaluate flavor ban compliance enforcement, examine switching patterns, and analyze the determinants of changes in product use. To address Aim 2, researchers will conduct online discrete choice experiments with 600 young adults to estimate the impact of hypothetical flavor bans on product demand. They will examine multiple flavor ban policies related to menthol cigarette and flavored ENDS and will estimate the effects of product, flavor, price, nicotine content, and perceived harmfulness on smoker/user behavior. To address Aim 3, researchers will develop simulation models that capture the key determinants of switching behaviors and use the models to examine the impact of various flavor ban policies on switching behaviors as well as conversations between tobacco retailers and consumers. Researchers will also examine additional intervention strategies (price/tax policy, mass media campaign, smoking cessation program) that may work in concert with flavor ban policies. Findings will provide new information about the effects of tobacco product flavor bans on young adult use behavior.

Yong Yang Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R03DA048460-01A1
Institution: University of Memphis
07/30/2019

Randomized Trial of Low Nicotine Cigarettes Plus Electronic Cigarettes in Smokers with a Mental Health Condition

Individuals with mental health conditions are particularly vulnerable to tobacco use. The goal of this project is to determine the likely health effects of use of very low nicotine content (VLNC) cigarettes, in conjunction with availability of nicotine-containing e-cigarettes, in adult smokers (aged 18-65) with mental health conditions. Study aims are: (1) to determine whether smokers with mental health conditions have lower levels of markers of harm (e.g. urine NNAL, carbon monoxide [CO]), measures of mental health, and cigarette addiction when switched to VLNC cigarettes for 16 weeks, as compared with normal nicotine content cigarettes (NNCs); (2) to determine whether smokers with mental health conditions have lower levels of markers of harm and cigarette addiction when provided with nicotine-containing (15mg/ml) versus zero nicotine e-cigarettes in order to switch to e-cigarettes or lower their cigarette consumption; and (3) to determine whether use of VLNCs increases the proportion of smokers who completely switch away from combustible tobacco use, as assessed four weeks after the end of the randomized phase of the trial. Researchers will randomize 240 smokers with mental health conditions to one of four groups: (1) NNCs (11mg nicotine/cigarette) and 15 mg/mL nicotine e-cigarettes; (2) NNCs and zero mg/mL nicotine e-cigarettes; (3) VLNCs (0.2 mg nicotine/cigarette) and 15mg/mL nicotine e-cigarettes; and (4) VLNCs and zero mg/mL nicotine e-cigarettes. Subjects will be followed for 16 weeks on study products and then another four weeks thereafter. At the end of the 16-week phase, participants will attend their last visit, receive encouragement to quit all tobacco products, and notified of community resources where they can receive smoking cessation counseling. Participants will be asked to provide information about their intentions for ongoing tobacco product use or cessation and will be followed for four weeks to assess these outcomes; those claiming to be no longer using combustible tobacco products will be visited to verify with a measure of exhaled CO. Study findings may inform regulatory activities related to VLNCs.

Jonathan Foulds Funding Mechanism: NIH Grant
ID number: 1R01DA048428-01
Institution: Pennsylvania State University
06/28/2019

SmartVape: Real-Time Assessment of ECIG Device Characteristics using a Smartphone App

Most e-cigarettes use an electrically-powered heater to aerosolize a liquid that usually contains nicotine, a solvent (i.e., propylene glycol and/or vegetable glycerin), and flavorants. The power of the e-cigarette device, which is based on the device’s operating voltage and heater resistance, varies across devices and is a major determinant of how much nicotine and other toxicants are aerosolized. The goal of this study is to develop a tool to assess e-cigarette power objectively in real-world settings. Study aims are: (1) to standardize methods for e-cigarette and e-liquid image capture; (2) to develop the SmartVape app and supporting software; and (3) to test the app’s usability and data quality in real-world conditions. Researchers will develop a smartphone app (SmartVape) designed for e-cigarette users to capture images of their devices and e-liquid. On a back-end server, an operator will be able to compare these images to an image-based product registry with known data on device characteristics and e-liquid nicotine content. The result will be the ability to assess accurately the device used and the amount of liquids consumed over a discrete time period. With this information, researchers will be able to estimate nicotine intake from e-cigarettes more accurately in real-world settings. To address Aim 1, researchers will recruit 200 adult (aged 18+) e-cigarette users who will bring all of their e-cigarette devices and e-liquids to a laboratory, where the devices will be measured and photographed. To address Aim 2, researchers will develop the app and the image-based product registry. To address Aim 3, 50 adult e-cigarette users will use the app to record the devices and liquids they use over a 14-day period. The tool will provide a feasible and objective method for assessing e-cigarette device and e-liquid characteristics in surveillance research.

Bernard Fuemmeler and Thomas Eissenberg Funding Mechanism: NIH Grant
ID number: 1R21CA239188-01
Institution: Virginia Commonwealth University
06/26/2019

Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes

In July 2017, FDA announced a comprehensive approach to tobacco and nicotine regulation that includes moving toward a very low nicotine content (VLNC) standard for cigarettes. The goal of this study is to reduce unintended consequences of a VLNC policy by developing campaign messages that address the common public misperception that VLNC cigarettes are safer to smoke than normal nicotine content cigarettes (a misperception that could potentially lead to lower quit rates). Study aims are: (1) to develop communication campaign messages that address the misperception that VLNC cigarettes are less likely to cause cancer than current cigarettes; and (2) to determine whether selected campaign messages reduce this misperception. Researchers will first develop 24 potential campaign messages and will obtain feedback from a panel of communication experts to refine the messages. Next, they will conduct an online experiment in 1,000 adult (ages 18 and older) smokers to identify the six most effective messages; conduct six focus groups, each with 8-10 adult smokers, to obtain feedback about the six messages; and work with the expert panel to select three messages for evaluation. They will then conduct an online experiment with a nationally representative sample of 1,096 adult smokers to understand the extent to which the three campaign messages reduce VLNC misperceptions and increase motivation to quit if a VLNC standard is enacted. Study findings may inform communication campaigns about VLNC cigarettes.

M. Justin Byron Funding Mechanism: NIH Grant
ID number: 1R21CA234968-01A1
Institution: University of North Carolina at Chapel Hill
06/21/2019

Investigation into Waterpipe Physical Design Parameters’ Effects on HPHC yields in Smoke and Charcoal Emissions (Phase II)

The goal of this project is to investigate the relationship between waterpipe physical parameters and harmful and potentially harmful constituent (HPHC) yields. Researchers will methodically isolate and alter individual waterpipe physical parameters (e.g., hose length; stem length, stem depth in water) and determine how these parameters affect yields of HPHCs such as quantities of aldehydes, metals, nicotine, tobacco-specific nitrosamines (TSNAs), and volatile organic compound (VOC) levels in waterpipe tobacco smoke. Phase II of this project seeks to determine how waterpipe dimensions affect waterpipe tobacco smoke chemistry and explores the need for a standardized testing waterpipe. Findings may provide new information about a standard waterpipe design for waterpipe tobacco product testing.

Timothy Fennell and Megan Mekoli Funding Mechanism: Contract
ID number: 75F40119P10251
Institution: RTI
06/15/2019

Impact of Flavors on Nicotine Perception and Self-Administration via E-cigarettes

Mechanisms by which flavors impact the initiation and maintenance of tobacco use are not well understood. Existing evidence suggests that flavors may enhance the appeal of and facilitate the development of addiction to tobacco products by influencing nicotine’s reinforcing or aversive actions. The goal of this study is to examine whether menthol and fruit flavors impact e-cigarette use through specific behavioral mechanisms and exert different effects across nicotine concentrations. Study aims are to assess the impacts of nicotine and flavor (and their interactions) on participants’ subjective ratings of different e-liquids and the cumulative amounts of self-administered e-liquids. Fifty young adults (ages 18-30 years) will be asked to attend four test sessions each. Each test session will consist of two components. During the first component, subjects will use five different e-cigarettes and will be directed to take two 4-second puffs at 15-second intervals for each e-cigarette, with a 5-minute break between each e-cigarette. Subjects will be asked to self-administer a total of 12 puffs of the e-cigarette across approximately half an hour. They will be asked to report subjective effects for each e-cigarette during the 5-minute breaks using the Drug Effects Questionnaire (DEQ). In the second component, subjects will be given access to the same five e-cigarettes and be allowed to use them as they choose for 45 minutes in total; researchers will track number of puffs. The sessions will be identical except that the e-liquids in the e-cigarettes will differ between sessions. The subjects will use 20 e-liquid types across the entire study (4 test sessions x 5 e-liquid conditions per session) and the e-liquids will vary by flavor (unflavored, menthol, menthol mint, green apple, watermelon) and nicotine level (0, 6, 12, 24 mg/ml nicotine). The order of flavors and nicotine levels will be randomly assigned to each subject and neither the subject nor the researcher will be told the order. This study will provide new information about the impact of flavors on e-cigarette use.

Elise DeVito Funding Mechanism: NIH Grant
ID number: 1R01DA046360-01A1
Institution: Yale University
06/12/2019

Impact of Cigar Flavor on Tobacco Use Behaviors and Addiction in Dual Users

The rapid increase in dual use of flavored little cigars/cigarillos (LCCs) with cigarettes among U.S. young adults has significant implications for their health, addiction, and cessation. The goal of this study is to determine the addiction potential of flavored and unflavored LCCs compared with cigarettes, and if addiction potential varies by flavor and sex, among young adult (ages 18-34) dual users. Study aims are: (1) to characterize the addiction potential of LCCs compared with cigarettes; (2) to determine the extent to which the addiction potential of LCCs varies by flavor and sex of user; and (3) to determine the extent to which flavoring affects LCC use in the natural environment. The study will be conducted over three weeks with 145 young adult dual users of cigarettes and LCCs. Participants will be asked to substitute preferred flavor LCCs for one week and unflavored LCCs for one week in place of their normal LCCs. The study will include survey-based measures and ecological momentary assessments (EMAs) of addiction potential, dependence, and tobacco use, and biomarkers of exposure (exhaled carbon monoxide and urinary cotinine). Addiction potential of cigarettes and LCCs will be characterized by behavioral economic indices of demand (such as hypothetical consumption at escalating prices) and other standardized measures to address Aims 1 and 2. Participants will record their tobacco use, craving, mood, and setting using EMA on their mobile phones to address Aim 3. This study will provide new information about LCCs that may inform regulatory activities.

Erin Mead Funding Mechanism: NIH Grant
ID number: 1K01DA048494-01
Institution: University of Connecticut School of Medicine
05/24/2019

Understanding the Association Between Electronic Cigarette Aerosol Emissions, Tobacco Product Characteristics and User Topography and Consumption Behavior

There is a lack of consensus regarding appropriate metrics for reporting e-cigarette emissions. The total particulate mass concentration, CTPM, of whole aerosol emissions is dependent upon both user topography behavior and e-cigarette/e-liquid product characteristics; the mass ratio of harmful and potentially harmful constituents (HPHC) (fHPHC) and nicotine (fNic) present in aerosol emissions are different functions of topography behavior and product characteristics. The researchers propose a theoretical framework that defines the product of the two terms as HPHC mass concentration: CHPHC [mg/mL] = fHPHC [mg/mg] x CTPM [mg/mL]; similarly, for nicotine, CNic [mg/mL] = fNic [mg/mg] x CTPM [mg/mL];. The goals of this study are to use this framework to develop a standardized test protocol for e-cigarettes and e-liquids, propose standardized emissions outcome measures, and inform the development of criteria to distinguish low- and high-dose ENDS. Study aims are: (1) to conduct screening studies of 24 e-cigarette products and 8 e-liquid compositions to inform the creation of a formal, standardized e-cigarette emissions test protocol; (2) to evaluate total particulate mass concentration as a function of product characteristics and user topography behavior; and (3) to evaluate HPHC and nicotine mass ratio of emissions present in whole aerosol as a function of product characteristics and user behavior characteristics. Findings may inform standardized testing processes for e-cigarette emissions.

Edward Hensel Funding Mechanism: NIH Grant
ID number: 1R21ES029984-01A1
Institution: Rochester Institute of Technology
05/21/2019

Differences in Inflammation, Cardiovascular Risk Factors and Respiratory Health with Use of Menthol Cigarettes: Informing the Regulation of Tobacco Flavorings to Protect Public Health

There is limited information regarding potential differences in cardiovascular risk factors or respiratory health with menthol cigarette use. The goal of this project is to evaluate differences in systemic inflammation, cardiovascular risk factors, and respiratory health with use of menthol cigarettes among US smokers. Researchers will use interview, physical examination, and biological specimen data from 9,880 adult current smokers who participated in the National Health and Nutrition Examination Survey (NHANES), a series of nationally-representative surveys of the US population, from 1999 through 2016. Study aims are to evaluate the associations between menthol compared to nonmenthol cigarette use by analyzing: (1) markers of systemic inflammation (C-reactive protein, fibrinogen, white blood cell count, and homocysteine); (2) cardiovascular risk factors (hypertension, diabetes, and reduced kidney function); and (3) respiratory health outcomes (fractional exhaled nitric oxide levels, spirometry-defined pulmonary impairment, past year wheeze, and frequent cough and frequent phlegm). Findings may inform regulatory activities related to menthol cigarettes.

Miranda Jones Funding Mechanism: NIH Grant
ID number: 1R03HL147318-01
Institution: Johns Hopkins University
05/21/2019

Mitochondrial Genetic Alterations: A Clinical Trial of a Standardized Research E-cigarette

E-cigarettes may have the potential to reduce harm for current smokers, but additional research on target organ toxicity (e.g., the respiratory tract) would be useful. This study will focus on the effects of e-cigarette use on mitochondrial DNA (mtDNA) in the lung and nasal tract. Researchers will use bronchoscopy to evaluate the lungs of smokers who are switched to e-cigarettes, namely the National Institute on Drug Abuse (NIDA) Standardized Research E-cigarette (SREC). In this study, 96 smokers aged 21-45, following baseline bronchial and nasal brushings, will be randomized to continue smoking their usual brand (control group), completely switch to the SREC, or receive nicotine replacement therapy (NRT). A follow-up bronchial and nasal brushing will be done after two months of use. Study aims are: (1) to assess changes in mtDNA genetic features (mutations and copy numbers) in the bronchial and nasal epithelium of smokers randomized to continued smoking, exclusive e-cigarette, or NRT use; (2) to investigate whether changes in mtDNA alterations are associated with lung inflammation and gene expression; and (3) to compare mtDNA alterations between bronchial and nasal samples. This study will determine the extent to which mtDNA alterations as a biomarker of harm are reduced following the use of e-cigarettes and provide evidence for the use of nasal epithelium for noninvasive biomarkers of harm.

Min-Ae Song Funding Mechanism: NIH Grant
ID number: 1R21HL147401-01
Institution: The Ohio State University
05/21/2019

Electronic Cigarette Cardiotoxicity Varies by Flavorings: What Can We Learn from Mice?

More information about the potential pulmonary toxicity of e-cigarette flavorings would be useful. The goal of this study is to evaluate whether long-term (three-month) inhalation exposure of adolescent mice to flavored e-cigarette aerosols leads to changes in pulmonary blood vessels (vasculature) — such as inflammation, pulmonary remodeling, artery thickening, and increase in right ventricular systolic pressure — that predispose adult male and female mice to pulmonary hypertension. Researchers selected flavors (vanilla, cinnamon, menthol, double apple hookah, and peach schnapps) based on human usage and published diacetyl levels. The study aim (with multiple sub-aims) is: (1A) to determine whether three-month inhalation exposure of adolescent mice to e-cigarette aerosols (with or without flavorings) produces changes in pulmonary vasculature; (1B) to investigate the time course of effects by examining changes associated with the development of pulmonary hypertension and/or emphysema on days 30, 60, and 90; and (1C) to determine persistent effects 90 days after cessation of the three-month exposure. Study findings may inform regulatory activities related to flavored e-cigarettes.

Judith Zelikoff Funding Mechanism: NIH Grant
ID number: 1R21HL142507-01A1
Institution: New York University School of Medicine
05/21/2019

Oxidant Exposure and Related Harm from Tobacco Smoke

Oxidants are a major class of toxicant in tobacco smoke and likely play a critical role in the development of tobacco-related diseases including chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD), and cancer by causing oxidative stress/damage and inflammation. However, the specific oxidants most responsible remain unclear. The goals of this project are to identify specific oxidants responsible for tobacco-related harm and determine the impact of oxidant reduction on tobacco-related toxicity endpoints. Study aims are: (1): to determine the levels and identity of free radicals and other oxidants delivered by different combustible tobacco products/brands using advanced electron paramagnetic resonance (EPR) spectroscopy and liquid chromatography-tandem mass spectrometry (LC-MS/MS) methodologies; (2) to determine the impact of tobacco smoke oxidants on lung damage and inflammation, comparing effects of high vs. low oxidant brands and tobacco varieties, in mice; and (3) to determine the impact of charcoal filtration of cigarette smoke on oxidant-induced lung damage in mice. Findings will reveal new information on the toxicological importance of oxidant exposure.

John Richie Funding Mechanism: NIH Grant
ID number: 1R01HL147344-01
Institution: Pennsylvania State University
05/20/2019

Impact of New Standards for Tobacco Products among Dual E-cigarette/Combusted Cigarette Users

Dual users of e-cigarettes and combusted cigarettes comprise 40% of multiple tobacco product users. The goal of this research is to evaluate the potential effects of limiting e-cigarette/e-liquid flavors to tobacco-only on preference for combusted cigarettes. In this study, 280 adult dual users (aged 18 and older) will undergo preference sessions during which they will make choices between an e-cigarette and a combusted cigarette. Study aims are to evaluate users’ self-reported anticipated choices if e-liquid flavors would be limited to tobacco only on: (1) choices for usual brand cigarettes; (2) choices for menthol and non-menthol cigarettes (among menthol-preferring participants); and (3) choices for cigarettes with normal nicotine content versus very low nicotine content. Findings may inform regulatory activities related to product standards.

Francis McClernon Funding Mechanism: NIH Grant
ID number: 1R01DA048454-01
Institution: Duke University
05/20/2019

The Role of E-cigarette Characteristics and Constituents in Cardiac Dysfunction

The acute and chronic health effects of e-cigarettes are mostly unknown. The goal of this project is to identify specific e-cigarette device characteristics and constituents associated with cardiac toxicity. Researchers will conduct electrocardiogram (ECG) and programmed stimulus electrophysiology (EP) studies in mice to test the hypothesis that e-cigarettes induce electrical disturbances in the heart that are related to e-cigarette characteristics and constituents. Study aims are: (1) to determine how device characteristics influence the acute electrophysiologic effects of e-cigarettes in mice, and (2) to assess the impacts of chronic e-cigarette exposure on cardiac electrophysiology and hemodynamics. Real-time cardiac physiology will be monitored during and after acute exposures to aerosols of e-cigarettes with various characteristics (device type, user settings, nicotine levels) to determine how they affect both harmful and potentially harmful constituent (HPHC) production and ECG measures of cardiac dysfunction. The device characteristics with the greatest and smallest acute cardiac effects will be selected for chronic exposure studies that will comprehensively assess cardiac EP and hemodynamics. E-cigarette exposure groups will be simultaneously compared to cigarette smoke and filtered-air exposure groups. This study will present new data regarding the relative cardiac toxicity of different e-cigarette devices, constituents, and settings, particularly with regard to their potential to cause cardiac arrhythmia.

Alex Carll Funding Mechanism: NIH Grant
ID number: 1R01HL147343-01
Institution: University of Louisville
05/17/2019

Impact of Novel Heat-not-Burn Cigarettes on Pulmonary Inflammation and Immunity

More information about the impact of heat-not-burn (HnB) aerosols generated from a product called IQOS on pulmonary inflammation and immunity to pathogens that cause respiratory diseases would be useful. The goal of this project is to determine whether HnB aerosol inhalation results in pulmonary damage and suppresses the immune response to respiratory infection and vaccination. Researchers will compare the potential effects of HnB aerosol inhalation exposure to effects caused by cigarette smoke and e-cigarette aerosols in both male and female mice. Study aims are: (1) to evaluate whether chronic inhalation exposure to HnB aerosol has the potential to cause lung inflammation and prompt changes in inflammatory cell numbers and cytokine levels in the lung, thereby altering the innate immune response; (2) to evaluate whether chronic inhalation of HnB aerosol creates an environment in the lungs that has the potential to impair adaptive immune responses to a vaccine and reduce the ability to overcome infection in the lung; and (3) to evaluate whether transition to HnB use following tobacco smoke exposure hinders the reduction in pulmonary inflammation and immune suppression that could be achieved by true cessation. Findings will provide new insights on the health risks of HnB products.

Yasmin Thanavala Funding Mechanism: NIH Grant
ID number: 1R01HL142511-01A1
Institution: Roswell Park Cancer Institute Corp
05/17/2019

The Impact of E-Cigarette Advertising and Warning Labels on E-Cigarette Use Behavior in Adolescents

Images of sweet/fruit flavors on e-cigarette advertisements may distract youth from health warnings. To better understand how these factors impact youth e-cigarette use, researchers will use functional magnetic resonance imaging (fMRI) and eye tracking to link neural responses to e-cigarette advertising and health warnings to future e-cigarette use in 80 adolescents aged 14-17 years. Participants will view e-cigarette advertisements and health warnings and complete quarterly follow-up surveys for one year. Medial prefrontal cortex (MPFC) and nucleus accumbens (NAc) activity will be measured and tested for relationships with future e-cigarette attitudes, intentions and use. Researchers will also test the specific impact of different categories of health warnings and different flavors and the interactions between these factors, including impact on memory of health warnings. Study aims are: (1) to test the hypothesis that greater MPFC activity as adolescents view e-cigarette health warnings will be related to more negative e-cigarette attitudes and intentions and lower use of e-cigarettes in the next year; (2) to test the hypothesis that greater NAc activity as adolescents view e-cigarette advertisements will be related to more positive e-cigarette attitudes and intentions and greater use of e-cigarettes in the next year; and (3) to compare the relative value of multiple measures –fMRI, eye tracking and surveys — to predict future e-cigarette use in the next year. This project will generate evidence on the impact of e-cigarette advertising and health warnings on youth e-cigarette use and may inform regulatory activities related to flavors, labeling and marketing.

Kathleen Garrison Funding Mechanism: NIH Grant
ID number: 1R01DA046334-01A1
Institution: Yale University
05/09/2019

Age of Initiation of Tobacco Products Among USA Youth and Young Adults

Estimating the age of onset of tobacco product initiation, transition or trajectories of patterns of use, and correlates of use among U.S. youth and young adults could be informative. This study involves a prospective secondary analysis of the first three waves of the Population Assessment of Tobacco and Health (PATH) Study among U.S. youth (aged 12-17 years) and young adults (aged 18-24 years) who reported never use at Wave 1. Use of the following tobacco products will be analyzed: cigarettes, e-cigarettes, cigars (traditional cigars, cigarillo, filtered cigars), hookah, and smokeless tobacco. Seven outcomes will be evaluated for each product: age to first report ever or past 30-day use, age to become susceptible to use, age to be an established user (i.e. ever use fairly regularly), age to first report dual/poly use, age to report first use of a flavored product, and age of ever combustible use. Study aims are: (1) among youth who were never users at Wave 1, to estimate their age of initiation of tobacco products and to identify the risk factors associated with age of initiation of each product; (2) among young adults who were never users at Wave 1, to estimate their age of initiation of tobacco products and to identify the risk factors associated with age of initiation of each product; and (3) among all participants, to identify trajectories and transitions in the onset of tobacco product use across time and to identify associated risk factors. Researchers will explore socio-demographic, interpersonal, intrapersonal, social, and environmental factors potentially associated with the age of initiation of the different products. This study will provide new data regarding tobacco product use trajectories among youth and young adults.

Adriana Perez Funding Mechanism: NIH Grant
ID number: 1R01CA234205-01A1
Institution: The University of Texas
05/08/2019

Understanding the Real-World Impact of the Use of Three Alternate Nicotine-Delivery Products on Combustible Cigarette Use

In this study, researchers will examine how well e-cigarettes and very low nicotine content cigarettes (VLNCs) substitute for combustible cigarettes in real-world settings and whether this is influenced by nicotine patch use. Study aims are: (1) to examine the ability of VLNCs, e-cigarettes, and no alternative product to substitute for smokers’ usual cigarettes in real-world settings and whether these effects are influenced by nicotine replacement; and (2) to examine the effects of VLNC, e-cigarette, and no alternative product use on the use of study products and the underlying mechanisms that drive such use and whether these effects are influenced by nicotine replacement. Researchers will randomly assign 180 daily smokers aged 18 and older who are not planning to quit smoking to one of three study conditions: VLNCs, Juul e-cigarettes, or no alternative product. Participants will have access to these products for four weeks. During two different weeks, participants will be asked to switch from their usual cigarettes and use only their assigned study product. They will also be asked to use either a nicotine or placebo patch. Participants will record each time they use their own cigarettes or the alternative product in real time via a smartphone, and, for some use events, answer questions about the use context (e.g., affect, smoking permitted) and possible mechanisms driving use behavior (e.g., withdrawal alleviation, taste, satisfaction). Researchers will also examine the impact of factors such as sex, dependence, psychiatric comorbidity, and risk perceptions on use behavior. Findings may inform regulatory activities regarding e-cigarettes and VLNCs.

Megan Piper Funding Mechanism: NIH Grant
ID number: 1R01CA239309-01
Institution: University of Wisconsin-Madison
02/26/2019

Investigation into Waterpipe Regimen Effects on HPHC Yields in Smoke and Project Title Charcoal Emissions (Phase l)

The goal of this project is to investigate the relationship between waterpipe smoking regimen parameters and harmful and potentially harmful constituent (HPHC) yields. Researchers will methodically isolate and alter waterpipe smoking regimen parameters (e.g., puff duration, puff volume, interpuff interval) and determine how these parameters affect yields of HPHCs such as quantities of aldehydes, metals, nicotine, tobacco-specific nitrosamines (TSNAs), and volatile organic compound (VOC) levels in waterpipe tobacco smoke. Phase I of this project focuses on the way waterpipes and waterpipe tobaccos are smoked and seeks to determine how these parameters affect waterpipe tobacco smoke chemistry. Findings may provide new information about intense and non-intense smoking regimens for waterpipe tobacco product testing.

Timothy Fennell and Megan Mekoli Funding Mechanism: Contract
ID number: HHSF223201910059P
Institution: RTI
02/14/2019

Analysis of Tobacco Filler/Matrix-Specific HPHCs

The goal of this study is to identify which of the 93 harmful and potentially harmful constituents (HPHCs) identified by the FDA are present in tobacco products currently marketed in the U.S. Researchers will use validated analytical testing methods to conduct qualitative and quantitative analyses on 27 brands of cigarette tobacco fillers, 24 brands of roll-your-own tobacco fillers, 27 brands of smokeless tobacco fillers, and 21 brands of waterpipe tobacco fillers. Findings may inform regulatory activities regarding HPHCs.

Karen Carter and Tianrong Cheng Funding Mechanism: Research Contract
ID number: HHSF2232013100381
Institution: Enthalpy Analytical
11/01/2018

Identification and Validation of a Biomarker of Electronic Cigarette Exposure

The goal of this study is to identify and confirm a biomarker specific to e-cigarette use and secondhand exposure. Study aims are: (1) to confirm that the exact oligomer compounds formed by the thermal degradation of propylene glycol (PG) and vegetable glycerin (VG) are unique to e-cigarettes and not common in other tobacco products; and (2) to determine whether these chemicals or their metabolites are found in urine and/or blood specimens of e-cigarette users and bystanders who experience secondhand exposure. Researchers will confirm the chemical structure of the VG and PG oligomers formed during e-cigarette use. This information will guide a review of the literature to identify metabolites and metabolic pathways in urine and adducts in blood specimens and to inform the selection of the most appropriate biospecimen analytical approach. Researchers will then collect and analyze blood (serum and plasma) and urine from 63 e-cigarette users, conventional cigarette smokers, and non-users (ages 18 and older) to determine whether the biomarker is unique to e-cigarette users and present at measurable concentrations in the aerosol produced from 20 e-liquids. Upon agreement from FDA that a biomarker unique to e-cigarette aerosol has been identified, researchers will proceed with additional experiments to develop an empirical model that predicts the mass of the biomarker produced per puff. This model will correlate e-cigarette use with biomarker intensity in the biospecimens collected as part of a later study of e-cigarette user exposure and secondhand exposure. Study findings may provide the identification of a unique biomarker of e-cigarette use to be used in epidemiological and clinical studies that evaluate the acute and chronic health effects from e-cigarette use and secondhand exposure.

Jonathan Thornburg (CTP Contact: Marcella Ferlito) Funding Mechanism: Research Contract
ID Number: HHSF223201810194C
Institution: Research Triangle Institute (RTI), International
10/01/2018

Developing Brand and Creative Concepts Designed to Prevent AI/AN Youth Tobacco Use

FDA Center for Tobacco Products (CTP) will conduct formative research to inform the development of messaging and creative concepts for a tobacco prevention campaign targeting American Indian/Alaska Native (AI/AN) youth. Researchers will conduct 12 focus groups with up to 16 AI/AN youth ages 13-17 per group who are either experimental cigarette users or at-risk non-triers. Participants will be recruited through community-intercept recruitment. Focus group activities will include individual surveys and discussions to gain insight into youth perceptions related to local teen culture, tobacco use trends, tobacco-related facts, and campaign brands and creative concepts to inform campaign development. Findings will inform the development of an AI/AN tobacco public education campaign.

Dana Wagner and Mario Navarro Funding Mechanism: Research Contract
ID number: HHSF223201710001G
Institution: Rescue Agency
10/01/2018

Development of a Multi-pathway Physiologically Based Pharmacokinetic (PBPK) Model for Nicotine in Humans

In this study, researchers will build a computational tool to characterize nicotine pharmacokinetics in humans. This tool will include databases, referenced literature, and a multi-pathway physiologically-based pharmacokinetic (PBPK) model. In addition, the Population Assessment of Tobacco and Health (PATH) Study human nicotine and metabolite biomarker data, and potentially behavioral and physiological response profiles established in animal models, will be included. Overall, this model will be used to evaluate the nicotine exposure-response relationship across tobacco product types and user populations. The model will also be incorporated with other existing software to predict lung deposition of nicotine via inhalation exposure from tobacco product use. This computational tool may be used to inform regulatory science efforts.

Ying Bryant Funding Mechanism: Research Contract
ID number: E07682.01
Institution: National Center for Toxicological Research
09/30/2018

Experimental Study to Test Acute Nicotine Toxicity Warnings for E-Liquids on Consumer Knowledge and Perceptions

The goal of this study is to assess the effectiveness of draft acute nicotine toxicity warnings for e-liquids in promoting consumer awareness and understanding of nicotine toxicity due to exposure to electronic nicotine delivery systems (ENDS). Specific aims of this study are to evaluate the effect of acute nicotine toxicity warnings for e-liquids on: (a) consumer knowledge of the health effects of acute toxicity from e-liquid exposure; (b) consumer knowledge of precautionary storage and handling practices for products that contain e-liquids; and (c) consumer knowledge of what to do in case of accidental contact with e-liquids. The final study sample will include approximately 5,000 current ENDS users. This study will include both young adult (aged 18-24) and adult (aged 25-65) participants from an Internet panel. Findings may inform regulatory activities related to ENDS warnings.

Anh “Bao” Zarndt Funding Mechanism: Research Contract
ID number: HHSF223201510003B
Institution: Fors Marsh Group
09/21/2018

E-Cigarettes – Relationship between Wicking Rate and Other ENDS Design Parameters

As e-cigarettes have evolved, new models have increased user control of device settings, including a variety of choices in atomizers, atomizer coils, wicks, and airflow settings. If the wicking rate is insufficient, all of these parameters combined can cause a “dry puff,” essentially burning the wick and leading to an increase in carcinogenic carbonyls and other harmful and potentially harmful constituents (HPHCs). Currently, no published studies directly measure wicking rate and isolate the effects of other ENDS design parameters (e.g., puff topography, wattage, coil configuration, preheat time, wicking material and amount) on wicking rate. The goal of this study is to understand the impact of each of these design parameters on wicking rate and eventual production of HPHCs. Findings may inform future regulatory activities related to e-cigarettes.

Karen Coyne Funding Mechanism: Research Contract
ID number: HHSF223201810047I
Institution: Research Triangle Institute International
09/19/2018

Toxicity and Carcinogenicity Profiling of Tobacco Products via Organ Microengineering and Systems Biology

The goal of this study is to advance our recently developed “Breathing-Smoking Human Lung-on-a-Chip” technology to determine the toxic effects of hookah tobacco smoke and e-cigarette emissions. In Phase 1 (18 months) of this project, we will develop a three-dimensional (3D) functional organomimetic human lung airway by combining organ-on-a-chip and 3D bioprinting technologies. The synthetic living human lung will then be validated for recreating physiological responses in vitro. In Phase 2 (6 months), we will enhance a smoking robot prototype by creating add-on modules that will generate fresh whole smoke/vapors from a diverse range of hookah tobacco and e-cigarette products; we will also use tubing with minimal adsorption properties to transfer gases and aerosols and upgrade the control software to execute e-smoking and waterpipe tobacco smoking topographies. In Phase 3 (18 months), we will integrate the lung airway with the smoking robot for system- and organ-level evaluation of tobacco products. We will expose the synthetic living human lung to freshly produced emissions of two different e-cigarette products and hookah tobacco from two commercial sources and examine pathological responses, including oxidative stress, inflammation, matrix remodeling, pH changes, nicotine absorption, and pre-neoplastic transformation at molecular, cellular, tissue and organ levels. Findings may inform future regulatory activities related to hookah and e-cigarette products.

Erica Clark Funding Mechanism: Research Contract
ID number: HHSF223201810127C
Institution: University of Colorado Denver
09/19/2018

Tracking Metals from E-cigarettes: From the Coil into Lung Tissue

E-cigarette devices may release nickel, chromium, lead, and other metals into the heated aerosol that may accumulate in lung tissue and blood. The goals of this study are to analyze the metal content of e-cigarette aerosol and to measure metal concentrations in lung tissue and blood using a mouse model of exposure. Study aims are: (1) to use Neutron Activation Analysis (NAA) to radiolabel various disassembled e-cigarette hardware components, followed by reassembly and measurement of the radiation energy spectrum of collected aerosol to identify specific sources of metal contamination; and (2) to conduct mouse exposure experiments to measure and analyze time- and dose-response relationships for nickel, chromium, and lead concentrations in lungs and blood following four-week exposure to e-cigarette aerosol. Findings will provide information about toxic metal exposures arising from e-cigarette use.

Markus Hilpert Funding Mechanism: NIH Grant
ID number: 1R21ES029777-01
Institution: Columbia University Health Sciences
09/19/2018

Emerging Chemicals of Concern in Evolving Electronic Nicotine Delivery Systems

Because electronic nicotine delivery systems (ENDS) contain plastic, glass and metal parts as well as e-liquids, they may contain a number of emerging chemicals of concern (ECCs), including phthalates, phenolic compounds, and flame retardants, that have been associated with adverse health outcomes such as asthma, endocrine disruption, reproductive and developmental abnormalities, and carcinogenic activity. The goal of this study is to characterize the types and levels of these chemicals in ENDS products, using various rigorous and reproducible analytical methods. Study aims are: (1) to characterize the contamination of e-liquids with ECCs by identifying the types and levels of ECCs in e-liquids; (2) to identify and measure the types and levels of ECCs in certain parts of ENDS, including refillable cartridge/tanks, as well as mouthpieces, which are potential ECC exposure sources; (3) to characterize thes types and levels of ECCs in ENDS aerosols; and (4) to examine and characterize the similarities and differences in types and levels of ECCs in e-liquids, extracted samples, and ENDS aerosols. Findings may inform future regulatory activities related to ENDS products.

Binnian Wei Funding Mechanism: NIH Grant
ID number: 1R21ES030028-01
Institution: Roswell Park Cancer Institute Corp
09/19/2018

The Exposure to Metals from E-Cigarettes (EMIT) Study

E-cigarettes expose users to metals, since a metal coil is used to generate aerosol and most coils are composed of nickel and chromium, which are known inhalation carcinogens. A new e-cigarette type called POD is growing in popularity with unknown potential for exposure. The goal of this study is to evaluate how e-cigarette use patterns impact exposure to toxic metals. Study aims are: (1) to understand the role of metal heating components on the transfer of metals into the aerosol, by analyzing metal concentrations in e-liquid before it is in contact with the heating coil, and in the aerosol generated; (2) to characterize patterns of e-cigarette use and other potential sources of metal exposures; and (3) to measure metals in blood, urine, saliva, and exhaled breath condensate of e-cigarette users, non-users, smokers and dual users, to evaluate how different patterns of e-cigarette and smoking use impact metal exposure. Researchers will assign 250 adults ages 18 and older to one of five groups: (1) 50 MOD e-cigarette users, (2) 50 POD users, (3) 50 cigarette smokers, (4) 50 dual users of e-cigarettes and combustible tobacco products, and (5) 50 non-users/non-smokers. All participants will answer a questionnaire on smoking history, e-cigarette use patterns, and work/hobbies that may involve metal use. Researchers will collect samples of blood, urine, saliva, and exhaled breath to measure and compare metal levels; samples of e-liquid and vapor will also be collected from e-cigarette users. Researchers will then use linear regression models to estimate the association of metals in biomarkers with e-cigarette use patterns, cotinine biomarkers, and metal concentrations in e-liquid and aerosol. Findings will provide new information about e-cigarette user exposure to metals and may inform regulatory activities related to e-cigarettes.

Ana Maria Rule Funding Mechanism: Intra-Departmental Delegation of Authority (IDDA)
ID number: 1R01ES030025-01
Institution: Johns Hopkins University
09/19/2018

Assessing Toxicant Properties of Cigarillo and Hookah Aerosols in Lung Epithelial and Cardiac Cells Through Aerosol Exposure

The goal of this study is to evaluate the toxicant properties and predicted health effects of cigarillo and hookah tobacco products compared to cigarettes. Study aims are: (1) to characterize the hazardous chemicals linked to cancer and cardiopulmonary diseases in aerosols from eight common hookah tobacco products using standardized cytotoxicity, mutagenicity, and genotoxicity assays; (2) to evaluate complete and fractionated (particles and gas only) aerosols generated from cigarettes, cigarillos, and hookah products in lung epithelial cells, cardiac cells, and endothelial cells using short-term assays and biomarkers (cytokines, DNA adducts); and (3) to evaluate the adaptive responses of lung epithelial cells in response to treatment of cells for four weeks with aerosols from one of each type of tobacco product. Findings will indicate new information about the potential respiratory and cardiac health effects associated with cigarillo and hookah use.

Stephen A. Belinsky Funding Mechanism: NIH Grant
ID number: 1R01ES029448-01A1
Institution: Lovelace Biomedical & Environmental Research Institute
09/18/2018

Characterization of Potential Harm Caused by Electronic Cigarette Flavor Chemicals and their Reaction Products

The flavor chemicals and their degradation reaction products (generated by heating) in e-cigarette aerosols may cause cell toxicity. The goals of this project are to analyze commercial e-liquids to identify and quantify flavor chemicals and their degradation reaction products and to evaluate cellular responses. The researchers will test 550 popular refill and cartomizer fluids and 100 fluids that have been anecdotally reported to cause sickness in users using gas chromatography/mass spectrometry, liquid chromatography/mass spectrometry, and other analytical methods. Study aims are: (1) to understand the identities and concentrations of dominant flavor chemicals in e-cigarette refill fluids and heat-generated reaction products in aerosols; (2) to analyze 3D lung epithelial cells at the air liquid interface to identify and characterize their response to heat-generated aerosols containing high potency flavor chemicals; and (3) to evaluate the potency and biological effects of individual flavor chemicals and reaction products in aerosols generated without heating. Study findings may inform future regulatory activities related to e-cigarettes.

Prudence Talbot Funding Mechanism: NIH Grant
ID number: 1R01ES029741-01
Institution: University of California Riverside
09/17/2018

Studies Using the Tobacco Consumer Studies Panel – Topical Study B

This study is part of a larger contract to conduct a series of studies using the Tobacco Consumer Studies (TCS) Panel to research consumer reactions to tobacco-related information/communications and perceptions of tobacco products and their association with product use, intention, and behaviors; and consumer reactions (such as purchasing behaviors) to anticipated or actual changes in tobacco product availability and in tobacco product constituents. This study focuses specifically on free samples of tobacco products and tobacco product coupons participants may have received, how they received them, and where they redeemed them for tobacco products. The full TCS panel of approximately 4,000 tobacco users will be invited to take part in this study via web or mail. Researchers will conduct analyses to assess the prevalence of coupon and free sample receipt and use as well as details surrounding the receipt and use context (e.g., demographics, product type/brands, locations). Further analyses may explore the relationships between receipt of free samples/coupons and use behaviors, quit intentions, and harm perceptions.

Caryn Nagler Funding Mechanism: Research Contract
ID number: HHSF223201510002B
Institution: Research Triangle Institute International
09/14/2018

Linking E-Cigarette Aerosol Characteristics to Mechanisms of Pulmonary Toxicity

The goal of this study is to understand how atomizer parameters and key ingredients in e-liquids contribute to undesirable aerosol characteristics and pulmonary toxicity. Study aims are: (1) to systematically vary e-cigarette device parameters (e.g., coil composition, coil resistance, applied voltage) and e-liquid components (propylene glycol, vegetable glycerin, nicotine, flavoring) to determine their impacts on aerosol physiochemical characteristics and in vitro toxicity; (2) to expose human airway epithelial cells to e-cigarette aerosols and determine toxicity signatures resulting from specific physiochemical features; and (3) to determine acute and sub-chronic lung toxicity profiles resulting from exposures to e-cigarette aerosols in mice. Findings may inform future regulatory activities related to e-cigarettes.

Yifang Zhu Funding Mechanism: NIH Grant
ID number: 1R01HL139379-01A1
Institution: University of California Los Angeles
09/14/2018

Implied Modified Risk Statements as Predictors of Flavored Little Cigar and Cigarillo Use

Several brands of flavored little cigar and cigarillos (LCCs) come in packages that use potential modified risk descriptors (e.g., “additive-free”). The goal of this study is to examine how young adults’ receptivity to flavored LCC product packaging features (e.g., text, colors, images, pack size) and price influences their smoking behavior. Study aims are: (1) to assess the impact of flavored LCC packaging descriptors in risk perceptions and future LCC smoking behaviors among young adult LCC current users and non-users; and (2) to assess the influence of flavored LCC package features on young adults’ preferences for LCCs. Researchers will conduct a 12- and 24- month online survey (1,120 young adults ages 18-34 in each wave) to examine transitions in risk perceptions and subsequent LCC smoking behavior that occur due to receptivity to flavored LCC packaging descriptions. Also, six focus groups (with 6-8 participants per group), stratified by race/ethnicity and smoking status, will be conducted after each survey wave to understand what factors influenced transitions in receptivity, risk perceptions, and LCC smoking profiles. Next, researchers will conduct a discrete choice experiment to assess the impact of packaging features such as text, color, images, and pack size, as well as price, on the product preferences on 250 ever and 250 never LCC users ages 18-34. Findings may inform future regulatory activities related to LCC packaging.

Kymberle L. Sterling Funding Mechanism: NIH Grant
ID number: 1R01CA228906-01A1
Institution: University of Texas Health Sciences Center School of Public Health
09/14/2018

Investigating the Cardiovascular Toxicity of Exposure to Electronic Hookah Smoking

Electronic hookah (e-hookah) bowls, which contain flavored e-liquid that is heated electrically but inhaled through traditional waterpipes, are increasing in popularity in the United States. The goals of this study are to compare the effects of traditional hookah smoking with e-hookah inhalation on human vascular and endothelial function, and to examine the role of inflammation and oxidative stress in hookah-related cardiovascular disease development. Study aims are: (1) to determine the acute effects of e-hookah bowl inhalation on endothelial function; (2) to determine the acute effects of e-hookah bowl inhalation on arterial stiffness; and (3) to determine the acute effects of e-hookah bowl inhalation on biomarkers of oxidative stress and inflammation. Researchers will conduct cross-over studies in 18 young adult hookah smokers (ages 21-39). Findings will provide new information about the effects of e-hookah use on human health and may inform regulatory activities related to e-hookah.

Mary Rezk-Hanna Funding Mechanism: NIH Grant
ID number: 1R21HL145002-01
Institution: University of California-Los Angeles
09/14/2018

Effects of E-Cigarette Exposure During Pregnancy on Offspring Lung Function and Disease: Characterization of Pulmonary, Intergenerational, and Epigenetic Effects

Nearly all the effects of maternal smoking during pregnancy on fetal lung development are caused by nicotine crossing the placenta to interact with nicotinic receptors in the developing lung. The goal of this study is to use a mouse model to describe the effects of perinatal e-cigarette exposure on offspring pulmonary function and disease. Study aims are: (1) to characterize the direct effect of maternal in-utero e-cigarette exposure on first-generation offspring pulmonary function, respiratory disease and epigenetic changes; (2) to characterize the intergenerational effect of grand-maternal in-utero e-cigarette exposure on second-generation offspring pulmonary function, respiratory disease and epigenetic changes; and (3) to characterize the additive, multigenerational effect of both grand-maternal and maternal in-utero e-cigarette exposure on offspring pulmonary function, respiratory disease and epigenetic changes. Researchers will expose pregnant mice to filtered air, e-cigarettes without nicotine, and e-cigarettes with nicotine from gestation day 1 to postnatal day 7 and will analyze effects on lungs at age 8 weeks; in addition, they will analyze the effects of in-utero exposures on asthma susceptibility based on sensitivity to house dust mite antigen. Researchers will conduct similar analyses on the second-generation mice to determine intergenerational effects. Findings will provide new information about the effects of e-cigarette use by pregnant women.

Eliot R. Spindel and Kent Pinkerton Funding Mechanism: NIH Grant
ID number: 1R01HL144384-01
Institution(s): Oregon Health & Science University and University of California, Davis
09/14/2018

Airway Protein Modifications caused by New and Emerging Tobacco Products as Markers of Exposure and Potential Health Risks

The use of new and emerging tobacco products (NETPs) such as hookah and e-cigarettes is increasing, particularly by the younger population in the US. The goal of this study is to examine airway protein modifications that result from NETP use. Study aims are: (1) to identify NETP-induced protein modifications in vitro of smoke/vapor-exposed human bronchial epithelial cell (HBEC) surfaces (airway epithelial cells for analysis are routinely received and subsequently maintained by the institution); and (2) to establish protein modifications as markers of NETP use and effects in vivo by conducting mass spectrometry analysis of tobacco product user sputum samples (previously collected from healthy cigarette, e-cigarette and hookah users ages 18-50). Findings will provide new information about the airway toxicity effects of tobacco product use.

Boris Reidel Funding Mechanism: NIH Grant
ID number: 1R03HL140402-01A1
Institution: University of North Carolina – Chapel Hill
09/14/2018

CRoFT TCORS: WNY Center for Research on Flavored Tobacco Products (CRoFT)

Many tobacco flavoring ingredients are labeled Generally Recognized as Safe (GRAS) as they are intended for ingestion; however, they have not been evaluated for inhalation toxicity. More data can provide understanding regarding how consumers perceive and use flavored tobacco products and whether these have implications for health. The goal of the Western New York (WNY) Center for Research on Flavored Tobacco Products (CRoFT) is to develop a novel framework and approaches for assessing the impact of tobacco product flavors and flavorings on consumer behavior, exposures, and health. Four projects will provide useful information about the toxicological, health, and behavioral impli