Audio Transcript | FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

Audio Transcript | FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds Audio Transcript | FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds Anonymous (not verified) Mon, 02/06/2023 – 12:59

Detailed Description
Audio Transcript | FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

 

Dr. Weber: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast Series.

Today’s topic: FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds. There is increasing interest in the potential utility of cannabis for a variety of medical conditions. Studies in clinical trial settings are needed to assess the safety and effectiveness of cannabis and cannabis-derived products for the treatment of any disease or condition, and FDA has an important role to play in supporting this scientific research and providing guidance.

My name is Dr. Ellicia Weber, and today we are joined by Dr. Cassandra Taylor, Chemist and FDA Cannabis Subject Matter Expert from the Botanical Review Team within FDA’s Center for Drug Evaluation and Research (or CDER) Office of Pharmaceutical Quality.

Hi Dr. Taylor, thanks for joining us today to discuss the recently finalized Guidance for Industry, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”.

Dr. Taylor: Glad to be here!

Dr. Weber: Dr. Taylor, it may be helpful to begin by clarifying the various cannabis related terms.

Dr. Taylor: Sure! There’s quite a few of them. Cannabis sativa L. is a plant that contains over 500 different naturally occurring compounds. 100 of those 500 compounds are called “cannabinoids,” and we kind of categorize them in 3 main buckets:

  • The first one is Cannabis-derived compounds, so (or call them CDPs), and those occur naturally. They are extracted directly from the plant, and some examples are cannabidiol (or CBD), delta-9-tetrahydrocannabinol (or delta-9 THC). And these CDPs, they can be used to manufacture drug products and drug substances, and they include botanical raw materials; they include extracts, highly purified substances of botanical origin.
  • The second bucket is something called Cannabis-related compounds. These are synthetic compounds that are made in a laboratory. Sometimes they are also found in nature in small quantities, but they can also be used to manufacture drug products.
  • And the third bucket is Hemp. Hemp, which is a legal term defined by the 2018 Agricultural Improvement Act (also known as the Farm Bill) and is generally defined as Cannabis sativa L. and any part of the plant with a delta-9 THC concentration of not more than 0.3% delta-9 THC on a dry weight basis.

Dr. Weber: CDPs are held to the same regulatory standards as any other botanical raw materials, botanical drug substance or botanical drug product, correct?

Dr. Taylor: Yes, that’s right. When a researcher intends to study botanical products – that includes products that contains cannabis, CDPs, or those cannabis-related synthetic compounds we just talked about – in order to determine effects of either the diagnosis, cure, mitigation, treatment, or prevention of a disease, then those products are drugs under the Federal Food, Drug, and Cosmetic Act. Researchers must meet all FDA requirements to conduct human clinical trials, regardless of their source of cannabis or any other botanical product under study in the trial. FDA has a guidance that’s available, it’s called the “Botanical Drug Development Guidance for Industry.” It’s a very helpful resource that provides FDA’s current thinking on the appropriate development plans for botanical drugs.

Dr. Weber: FDA recently finalized a guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” to provide recommendations for researchers interested in developing cannabis and CDPs for use in human drugs for clinical research. Can you describe how this final guidance differs from the previous draft guidance?

Dr. Taylor: Sure. There’s quite a few differences, but a few of the highlights include clarifying sources of cannabis for clinical research (that does include using Schedule I sources for clinical research), adding resources explaining expectations for investigational new drug applications (or INDs as we call them) throughout the various stages of drug development, and providing guidance on quality considerations for INDs. It’s important that listeners understand the guidance does not address development of cannabis-related compounds, or those synthetic ones – those are regulated just like any other synthetic drugs at FDA.

Dr. Weber: Are these products all controlled substances?

Dr. Taylor: No, they are not. The Farm Bill, which we just talked about, removed hemp from the Federal Controlled Substances Act (or the CSA). And botanical raw materials, extracts, and derivatives that contain CDPs with delta-9 THC content that’s above that 0.3 percent by dry weight – those remain Schedule I controlled substances. So that means that activities related to, you know, the growing and manufacturing these products for use as investigational drugs for research must comply with the Controlled Substances Act and the Drug Enforcement Agency (or the DEA) requirements.

DEA should be consulted regarding the control status of cannabis or cannabis-derived materials in manufacturing or investigational drugs that are under development. And even if the starting materials meet that legal definition of hemp, intermediates or drug products could be created that contain greater than 0.3 percent delta-9 THC by dry weight, and they may no longer meet that definition of hemp, and they might be considered controlled substances.

Dr. Weber: Per the guidance, in clinical research, sources of cannabis defined as hemp and those containing greater than 0.3% delta-9 THC on a dry weight basis may be used if deemed to be of adequate quality by FDA when reviewed as part of an IND. What can researchers use as a source of cannabis for their studies?

Dr. Taylor: You can use botanical sources that meet all the FDA requirements to conduct human clinical trials. The National Institute on Drug Abuse (or NIDA) has a Drug Supply Program, and they’re a source of cannabis over that 0.3 percent delta-9 THC threshold that we’ve been talking about, and those can be used. DEA also continues to update their list of authorized growers, and researchers may also use those as sources of Schedule I cannabis materials for researchers, or excuse me, for research. Researchers at each study site who are planning to conduct studies with controlled cannabis study drugs need to be registered with the DEA and comply with all applicable DEA regulations.

Dr. Weber: To gain insight into their product’s potential abuse liability and control status, researchers may find it useful to calculate the delta-9 THC content in their proposed cannabis or cannabis-derived investigational drug product early in the development process – which is also addressed in the guidance. Can you explain this further?

Dr. Taylor: Of course. FDA recommends that the calculation of total delta-9 THC percentage be based on the composition of your proposed formulation with that amount of water removed. This includes any water that might be in your excipients, and so you need to make sure that that’s also removed from your calculation. Researchers should not rely on the 0.3% delta-9 THC by dry weight threshold when they’re evaluating tetrahydrocannabinols as impurities for the purposes of quality control and commercial drug application submission. The documentation regarding the steps for the delta-9 THC calculation should be submitted in the IND.

Dr. Weber: To conduct clinical research, researchers work with the FDA to submit an IND application to CDER, which must include information from three broad areas: animal pharmacology and toxicology studies, clinical protocols and investigator information, and manufacturing information. Can you generally describe the required manufacturing information for inclusion?

Dr. Taylor: Absolutely. Researchers submitting an IND must submit sufficient information to demonstrate the identity, quality, purity, and potency or strength of the investigational drug in each phase of clinical investigation. The final guidance lists applicable United States Pharmacopeia (or USP) chapters on quality and testing, and also identifies relevant International Council for Harmonisation (or ICH) guidelines, as well as FDA guidances and considerations for devices used in combination with a drug. It also contains a listing of principles, regulations, and guidance documents that FDA recommends researchers using CDPs consider before submitting INDs to FDA for review.

Now, the manufacturing information should also include quantitative data indicating the percent delta-9 THC by dry weight in the botanical raw materials. And if the study proposes to use cannabis that contains greater than that 0.3 percent delta-9 THC on a dry weight basis, the researcher should contact NIDA or another DEA-registered source of cannabis and/or the cannabis-derived substance to obtain information on the specific cultivars that are available for research.

Dr. Weber: And regardless of the delta-9 THC content, the researcher should provide all necessary chemistry manufacturing and controls (or CMC) and botanical raw materials information in the IND, correct?

Dr. Taylor: That’s correct. Cannabis researchers are encouraged to use Drug Master Files (or DMFs) to help support their cannabis research, speed their drug development, address concerns regarding protection of proprietary information, while participating in the drug development process. If the selected hemp, or botanical raw materials, or drug substance manufacturer holds a DMF, the researcher must obtain a Letter of Authorization (often called an LOA) to reference the CMC and botanical raw material information in the DMF when they submit their IND.

Dr. Weber: Thank you again Dr. Taylor for joining us today and providing your expertise on this topic. Are there any final words you would like to share with us today?

Dr. Taylor: Thank you so much Dr. Weber. I would like to say that here at the FDA we’re really committed to supporting robust scientific research into understanding therapeutic uses and safety of cannabis and cannabis-derived products, and we offer quite a number of resources to help researchers and investigators. That includes “FDA and Cannabis: Research and Drug Approval Process” and “FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol” webpages. They’re available for everyone. The resources also provide contact information for the CDER’s Botanical Review Team (BRT), which is what I’m a part of. We serve as the expert resource on botanical issues. The agency also continues to conduct research on various cannabis quality consideration, including BRT’s recent publications on quality standards in state programs permitting cannabis for medical uses and investigation of microorganisms in cannabis after heating in a commercial vaporizer.

Dr. Weber: You can find a link to the full SBIA Chronicles article at www.fda.gov/cdersbiachronicles. Also visit www.fda.gov/cdersbia to stay connected with upcoming webinars and conferences, sign up for SBIA email updates, and follow SBIA on LinkedIn. Thanks for tuning in!

Related Information

Short Title
Cannabis and Cannabis-Derived Compounds

Source Organization

Short Description
Audio Transcript | FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

Content Owner

Publish Date
Tue, 02/07/2023 – 14:16

Review Date
Tue, 02/06/2024 – 00:00

Last Reviewed Date
Mon, 02/06/2023 – 00:00

Next Review Date
1 Year

Navigational Page
Off

Bulk Approved
Off

Display Short Description
Off

First Publish Date
Mon, 02/06/2023 – 16:13

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/drugs/cder-small-business-industry-assistance-sbia/audio-transcript-fda-regulation-and-quality-considerations-cannabis-and-cannabis-derived-compounds February 6, 2023 5:59 pm

FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds Anonymous (not verified) Mon, 02/06/2023 – 10:50

Detailed Description
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

Podcast and newsletter

Podcast   Transcript

Cassandra Taylor photo

Dr. Cassandra Taylor – Chemist and FDA Cannabis Subject Matter Expert
Botanical Review Team; Office of Pharmaceutical Quality | CDER | FDA

There is increasing interest in the potential utility of cannabis for a variety of medical conditions, as well as research on possible adverse health effects. Studies in clinical trial settings are needed to assess the safety and effectiveness of cannabis and cannabis-derived products for the treatment of any disease or condition, and FDA has an important role to play in supporting this scientific research and providing guidance. To clarify some terminology:

  • Cannabis sativa L. is a plant that contains over 100 different naturally occurring compounds called “cannabinoids.”
  • Cannabis-derived compounds are compounds occurring naturally in the plant, like cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), that are extracted directly from the plant. Cannabis-derived compounds that may be used in manufacturing human drugs include botanical raw materials (BRMs), extracts, and highly purified substances of botanical origin.
  • Cannabis-related compounds are synthetic compounds created in a laboratory and can be used to manufacture drug products. Some may also occur naturally in the plant.
  • Hemp is a legal term defined by the 2018 Agricultural Improvement Act (Farm Bill) and is generally defined as Cannabis sativa L. and any part of the plant with a delta-9 THC concentration of not more than 0.3% on a dry weight basis.

Though the Farm Bill removed hemp from the federal Controlled Substances Act (CSA), BRMs, extracts, and derivatives that contain cannabis-derived products (CDPs) with delta-9 THC content above 0.3 percent by dry weight remain Schedule I controlled substances. Thus, activities related to growing and manufacturing these products for use as an investigational drug for research must comply with the CSA and Drug Enforcement Agency (DEA) requirements.

FDA recently issued a final guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” to provide recommendations for sponsors interested in developing cannabis and CDPs for use in human drugs for clinical research. Notable changes that were made from the 2020 draft guidance include clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for investigational new drug (IND) applications in various stages of drug development, and providing guidance on quality considerations for INDs. Note that this guidance does not address development of cannabis-related compounds, which are regulated like other synthetic drugs.

Sources of Cannabis: Both sources of cannabis defined as hemp and those containing >0.3% delta-9 THC on a dry weight basis may be used for clinical research if deemed to be of adequate quality by FDA when reviewed as part of an IND. Researchers may use the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP) as a source of cannabis over the 0.3% delta-9 THC threshold, or they may use other sources authorized by DEA to provide Schedule I cannabis materials for research. The DEA webpage also contains a list of DEA-authorized growers of Schedule I cannabis and information on importation of controlled substances (21 CFR 1312).

Control Status: Sponsors and investigators may find it useful to calculate the delta-9 THC content in their proposed cannabis or cannabis-derived investigational drug product early in the development process to gain insight into their product’s potential abuse liability and control status. However, they should not rely on the 0.3% delta-9 THC by dry weight threshold when evaluating tetrahydrocannabinols as impurities for the purposes of quality control and application submission. FDA recommends that the calculation of total delta-9 THC percentage be based on the composition of the formulation with the amount of water removed, including any water that excipients may contain. The calculation of THC percentage is detailed in the final guidance document, and the documentation regarding the steps of the delta-9 THC calculation should be submitted in the IND.

The DEA should be consulted regarding the control status of cannabis or cannabis-derived materials in manufacturing or investigational drug products that are under development. Even if the starting materials meet the definition of hemp, intermediates or drug products that contain greater than 0.3% delta-9 THC by dry weight may no longer meet the definition of hemp and may be considered Schedule I controlled substances.

Regulation of botanical drug products: CDPs are held to the same regulatory standards as any other BRM, botanical drug substance or botanical drug product. When a researcher intends to study botanical products (including one that contains cannabis, CDPs, or cannabis-related compounds) to determine their effects in the diagnosis, cure, mitigation, treatment, or prevention of a disease, these products are considered to be drugs under the Food, Drug, and Cosmetic Act. Researchers must meet all FDA requirements to conduct human clinical trials, regardless of the source of cannabis or any other botanical product under study in the trial. FDA’s “Botanical Drug Development Guidance for Industry” is a helpful resource that provides FDA’s current thinking on appropriate development plans for botanical drugs and recommendations for researchers to consider.

IND submission: To conduct clinical research, including research in humans using materials from plants such as cannabis, researchers work with the FDA to submit an IND application to FDA’s Center for Drug Evaluation and Research (CDER). The IND must include information from three broad areas: animal pharmacology and toxicology studies, clinical protocols and investigator information, and manufacturing information. This includes protocols describing proposed studies, the qualifications of the investigators who will conduct the clinical studies, assurances of informed consent and protection of the rights, safety, and welfare of the human subjects, and quality control information for the drug(s) proposed for use.

IND sponsors must submit sufficient information to demonstrate the identity, quality, purity, and potency or strength of the investigational drug in each phase of clinical investigation and should take into account key considerations, including the impurity profile, selection of a container closure system, metabolic profile, and literature to support clinical development. The final guidance lists applicable United States Pharmacopeia (USP) chapters on quality testing, including the assessment of leachables from packaging and delivery systems, and identifies relevant International Council for Harmonisation guidelines, FDA guidances, and considerations for devices used in combination with a drug. It also contains a listing of principles, regulations, and guidance documents that FDA recommends that those pursuing research and/or drug development using CDPs consider before submitting INDs to FDA for review.

Manufacturing information should also include quantitative data indicating the percent delta-9 THC by dry weight in the BRM. If the study proposes to use cannabis that contains greater than 0.3% delta-9 THC on a dry weight basis, the sponsor should contact NIDA or another DEA-registered source of cannabis and/or cannabis-derived substances to obtain information on the specific cultivars available.

Regardless of the delta-9 THC content, the sponsor should provide all necessary chemistry manufacturing and controls (CMC) and BRM information in the IND. Cannabis researchers are encouraged to use Drug Master Files (DMFs) to support cannabis research, speed drug development, and address concerns regarding protection of proprietary information while participating in drug development. If the selected hemp, BRM or drug substance manufacturer holds a DMF, the sponsor must obtain a Letter of Authorization (LOA) to reference the CMC and BRM information in the DMF. To learn more, we have made available a recorded webinar, “Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations.”

Prior to submission of the IND, FDA offers an optional pre-IND meeting, which is very valuable in planning a drug development program. This meeting can provide researchers information that will assist them in preparing to submit complete IND applications and is a valuable opportunity to obtain FDA guidance on research plans and required content for IND submission.

Once the IND submission is ready, the researcher should send a copy of the IND and clinical protocol, including a LOA (if applicable), to FDA for review as highlighted on our website “IND Forms and Instructions.” The sponsor must wait 30 calendar days after submission before initiating any clinical trials. During this time, FDA reviewers assess if the study is safe to proceed or will be placed on clinical hold.

All investigators at each study site who are planning to conduct studies with cannabis study drugs need to be registered with the DEA and comply with all applicable DEA regulations, including the regulations for the use, manufacturing, handling, and storage of a Schedule I drug. Schedule I licenses from the DEA are needed prior to the initiation of a clinical study with cannabis study drugs with greater than 0.3% delta-9 THC on a dry weight basis. If the cannabis study drug is synthetic or semi-synthetic, the chemist who is synthesizing the drug should also be doing so under a Schedule I license. If a sponsor already possesses a Schedule I research registration with DEA for a specific cannabis study drug, all new protocols must be submitted to DEA as an amendment to that registration. Once the Schedule I license is granted by DEA, the sponsor should contact NIDA or another DEA-registered source to obtain the substances so they can then begin the study.

The agency is committed to supporting robust scientific research into understanding therapeutic uses and safety of cannabis and CDPs. In addition to the final guidance, our “FDA and Cannabis: Research and Drug Approval Process” and “FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabadiol” webpages provide sponsors and researchers with resources, including contact information for the CDER’s Botanical Review Team (BRT), which is serves as an expert resource on botanical issues.

Resources

  1. Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research – Guidance for Industry”
  2. FDA and Cannabis: Research and Drug Approval Process webpage
  3. FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabadiol
  4. CDER’s Botanical Review Team
  5. NIDA Drug Supply Program
  6. Investigator-Initiated INDs
  7. Pruyn SA, Wang Q, Wu CG, Taylor CL (2022) Quality standards in state programs permitting cannabis for medical uses, Cannabis and Cannabinoid Research 7:6, 728–735, DOI: 10.1089/can.2021.0164.
  8. Sopovski DS, Han J, Stevens-Riley M, Wang Q, Erickson BD, Oktem B, Vanlandingham M, Taylor CL and Foley SL (2023) Investigation of microorganisms in cannabis after heating in a commercial vaporizer. Front. Cell. Infect. Microbiol. 12:1051272. doi: 10.3389/fcimb.2022.1051272
Short Title
Cannabis and Cannabis-Derived Compounds

Source Organization

Short Description
CDER Small Business and Industry Assistance Chronicles

Content Owner

Publish Date
Tue, 02/07/2023 – 14:13

Review Date
Wed, 02/07/2024 – 00:00

Last Reviewed Date
Tue, 02/07/2023 – 00:00

Next Review Date
1 Year

Navigational Page
Off

Bulk Approved
Off

Display Short Description
On

First Publish Date
Mon, 02/06/2023 – 16:15

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/drugs/cder-small-business-industry-assistance-sbia/fda-regulation-and-quality-considerations-cannabis-and-cannabis-derived-compounds February 6, 2023 3:50 pm

Anticipating the Ebbs and Flows of Seasonal Retail Cannabis Sales

Anticipating the Ebbs and Flows of Seasonal Retail Cannabis Sales

Like any industry, cannabis can experience ups and downs, especially when it comes to a doors-open retail business. Dispensaries that operate in towns or cities that attract tourists experience this more than anyone, seeing sales spike during the busy months and reach lows during the off-season.

We spoke with the folks at Dragon Hemp, a hemp retailer based in Sag Harbor in the Hamptons. As a brand that has first-hand experience with seasonal spikes, they were able to provide more context when it comes to anticipating the ebbs and flows of seasonal retail cannabis sales.

What is the Best Way to Prepare for Post-Busy Season Retail Lulls?

In Sag Harbor, Dragon Hemp awaits a spike during the busy summer months, as well as lulls when the tourist season is down and visitors head back to New York City and beyond, many becoming loyal online customers year-round.

According to Kevin Menard, LAc, founder of Dragon Hemp, the best way to prepare for post-busy season retail lulls is to build a community of loyal customers that take your brand home with them.

“Post-busy season lulls can be very useful in setting strategies and goals for the coming year. In our case, we do a thorough inventory review and align what we have with what we need for the upcoming peak season,” says Menard. “As the season winds down, they prepare for online orders that come from the impression left on customers in the store. “We also focus on cultivating our owned channels where we can have more direct communication with our community.”

Advice on Preparing for Busy Retail Seasons

Kevin Menard, LAc, founder of Dragon Hemp

Before the busy season is even over, it’s important to start preparing for the lull in business that’s bound to set in. For Kevin Menard and his business, preparation starts with inventory. So, what’s their secret? “Make sure you have budgeted for an inventory of your most popular items and hire excellent storytellers in both your retail locations and e-commerce marketing teams.”

Keeping an eye out on inventory management can be a great way to spend the slow months. Give brands a chance to monitor sales trends and keep up with changes in consumer preferences, putting more time and effort into online retail and social media and implementing promotions and sales online and in-person. Grow the team behind the brand, keep up with all new regulations and focus on customer loyalty to maintain trustworthiness even from afar.

Turning a Seasonal Customer Into a Lifetime E-Commerce Customer

In order to turn a seasonal customer into a life-long client, it’s important to connect beyond just the sale and product. For Dragon Hemp, the most important part is personalizing the experience for their customers: “For us, it’s all about achieving personalization with each customer,” says Menard. “Typically, a seasonal retail buyer will be opportunistic about their purchase in-store, but that purchase is indicative of a longer-term need. We try to create customer profiles based on in-store buyers and craft recommendations that fit that customer’s health needs over the long term.”

In order to turn a one-time buyer from out of state or city into a lifelong loyal customer, there are a few things to consider that can make this connection happen. First and foremost, building a relationship by maintaining impeccable customer service and personalizing the experience.

Focusing on online retail is also important in order to maintain the connection with clients. Making sure the website is in perfect shape and offer loyalty programs, incentives, promotions, sales, discounts or rewards to returning customers.

Marketing and publicity are other essentials, as you want to target those who have a long-time need that needs to be filled. Allowing for a fuss-free online shopping experience, targeting people who fall in line with the brand’s products and values, being creative and innovative when promoting the website and keeping in touch with active social media and newsletters.

How to Project Goals In Places That Swell Seasonally

It can be difficult to project year-on-year retail goals when the geographic location has a tendency to swell seasonally and have off-seasons but preparing and knowing what to expect can help with reaching those goals (and even surpassing them).

According to Menard, the secret to projecting their goals starts with their first location: “Since our first retail location in Sag Harbor, NY has been open only a year, our projections are still a work in progress! We’re using 2022 data to budget for this year, accounting for marketing efforts, increased awareness, and seasonality. We have some sensitivities built into this model based on different growth scenarios.”

The instabilities and fluctuations that come with a business that works on a seasonal tempo can be challenging when it comes to reaching and achieving specific goals, but there are things that can be done to make the whole process more seamless, and hopefully, more successful.

Looking back at previous years can be helpful in pinpointing tendencies and habits that can be observed in the consumer, and the lower sales allow space for the time that can be used in innovating and creating new products that are based on what the client base wants.

Researching not only the immediate region, but the regions that people often visit is another handy trick. Knowing who is coming, why they’re coming, and what they’re looking for can help set objectives that can be brought to reality throughout the off-season and the busy season, even experiencing more foot traffic in town. Moreover, making the most of the local events, occasions, changes and circumstances like holidays and local events can keep the brand connected to its roots and primary clients.

The off-season is a great time to set up a budget or specific monetary goals to reach, and off-season fluctuations can be added in to give a more complete idea of what the year might look like. Keeping an eye on the market by monitoring it and using forecasting models to predict results can also help set the stage for changes in the year-to-year goals.

Expanding From a Cannabis Retailer to a National E-Commerce Brand

Dragon Hemp didn’t start off with a bang, but they sure have achieved it over time. Dragon Hemp products were conceived by renowned alternative health practitioner and founder, Kevin Menard. Using hemp oil, Chinese herbs and native botanicals, they have managed to create a variety of beneficial and natural products.

“Our apothecary in Sag Harbor has been a great success, but the most rewarding aspect of the location has been the ability to have direct conversations with customers and get a deep understanding of how we can support their journey to better health,” says Menard. “We’re excited to expand our mission of helping people feel like themselves again by using next-generation natural botanicals and time-honored herbal remedies.”

Final Thoughts

As the country continues toward legal and accessible cannabis, new businesses are learning the ropes and those that have been there all along have been leading the way.

Having ups and downs in any business is to be expected, but just like any industry, knowing what to expect and what to do can make these challenges seem like less of a hassle. Building an online presence that clients connect to, developing e-commerce strategies, expanding product lines, building a loyal customer base and staying up-to-date with the latest regulations are surefire ways to stay on top of the cannabis business.

The post Anticipating the Ebbs and Flows of Seasonal Retail Cannabis Sales appeared first on Cannabis Industry Journal.


#CBD #Hemp

Anticipating the Ebbs and Flows of Seasonal Retail Cannabis Sales


January 31, 2023 9:33 pm

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward Anonymous (not verified) Thu, 01/26/2023 – 08:55

Short Title
FDA Statement on Cannabidiol

FDA Statement
No

Statement Author

Leadership Role
Principal Deputy Commissioner – Office of the Commissioner

Janet Woodcock M.D.

Press Release Date
January 26, 2023

Detailed Description
The FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter.

Short Description
A new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.

Audience

Body

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.  

The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant. 

A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.

The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive. 

The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency. Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods. 

CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.

The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.

Content Owner

Contributing Office

Publish Date
Thu, 01/26/2023 – 10:12

Review Date
Fri, 01/26/2024 – 09:00

Last Reviewed Date
Thu, 01/26/2023 – 09:00

Site Structure

Next Review Date
1 Year

Source Organization

Bulk Approved
Off

Hide main image
hide

Display Short Description
Off

Language

Media Contact
Media Contact Name
Courtney Rhodes

Media Contact Phone
202-281-5237

Media Contact Email

First Publish Date
Thu, 01/26/2023 – 10:12

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 Statement

#CBD #Hemp http://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol January 26, 2023 1:55 pm

FDA Roundup: January 24, 2023

FDA Roundup: January 24, 2023 FDA Roundup: January 24, 2023 Anonymous (not verified) Tue, 01/24/2023 – 12:35

Short Title
FDA Roundup: January 24, 2023

FDA Statement
No

Press Release Date
January 24, 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: January 24, 2023

Body

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

  • On Monday, the FDA issued a final guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry.” This guidance provides the FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds. The agency is committed to supporting robust scientific research into understanding therapeutic uses and safety of cannabis products. The FDA believes the drug development and approval process represents the best way to ensure safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.
  • On Monday, the FDA reopened the comment period for 45 days for the proposed rule entitled Color Additive Certification; Increase in Fees for Certification Services that appeared in the Federal Register on November 2, 2022. The FDA is reopening the comment period in response to a recent request from stakeholders to allow additional time for interested persons to develop and submit comments. 
  • On Monday, the FDA cleared for marketing the Tidepool Loop, a mobile application intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons six years of age and older. The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired.  The Tidepool app is a prescription-only device for single patient use that works with integrated continuous glucose monitors (iCGMs) and alternate controller enabled pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose (sugar) values. The app can also recommend, and with the user’s confirmation, control the delivery of correction insulin amounts when glucose values are predicted to exceed user configurable thresholds. Tidepool Loop’s algorithm technology is designed to be compatible with other individual interoperable devices that meet pre-specified acceptance criteria set forth in a validation and integration plan provided by the sponsor and cleared by the FDA as part of the premarket submission. 
  • COVID-19 testing updates: 
    • As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and one diagnostic breath test. There are 79 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
    • The FDA has authorized 44 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1217 revisions to EUA authorizations.
       
Incident ID

Content Owner

Contributing Office

Publish Date
Tue, 01/24/2023 – 13:37

Review Date
Wed, 01/24/2024 – 13:00

Last Reviewed Date
Tue, 01/24/2023 – 13:00

Site Structure

Next Review Date
1 Year

Source Organization

Bulk Approved
Off

Hide main image
hide

Display Short Description
Off

Language

Media Contact
Media Contact Name
FDA Office of Media Affairs

Media Contact Phone
888-INFO-FDA

Media Contact Email

First Publish Date
Tue, 01/24/2023 – 13:37

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-january-24-2023 January 24, 2023 5:35 pm

A Modest Proposal: Let’s Regulate Alcohol Like Marijuana

A Modest Proposal: Let’s Regulate Alcohol Like Marijuana

          Amendment 64 was Colorado’s “Regulate Marijuana Like Alcohol” initiative, which passed with 55% of the vote in 2012, getting 60,038 more votes than Obama. Part of the measure reads “effectively regulating cannabis in a manner similar to alcohol.”

          However, seven months into it, Regulating Marijuana Like Alcohol has been anything but like regulating marijuana like alcohol.

          Here’s what it would look like in Colorado today if instead, Alcohol were regulated like recreational Marijuana:

          No Bars or Taverns or Drinking in Restaurants. The biggest change to the Alcohol landscape will be the total lack of someplace to go and drink. Bars and Taverns are now completely illegal, as is drinking in a restaurant, per the Denver PD. Not even hotel rooms (private rules), private unadvertised members-only clubs, VFW, or Elks Lodges.

          Tax Rate. Hold on to your hat. Currently, the Colorado Liquor Excise Tax is $0.045 per six-pack, but the Retail Marijuana State Sales Tax is 10%, plus a 15% Retail Marijuana Excise Tax, which goes to Colorado public school construction. So that $9.00 six-pack is now $11.25!

          No Liquor Stores Within 1,000 Feet. The Cole Memo said all marijuana operations must be at least 1,000 feet from any school, park, or church. That means Oscar Blues and Lumber Liquors in Lyons has to close, as does Mountain Sun in Boulder. And none can open pretty much anywhere in downtown Lyons. No more wine in church, back to the grape juice again.

          Hours. It’s 7:30pm. Bummer, all the liquor stores are closed. Only open 11 to 7. Go home and burn one instead.

          Drunk Last Night = DUI Tomorrow. Did you get hammered last night? Three days later you could still get a DUI. Regardless of lack of impairment.

          Drink 3 Weeks Ago = Fail Drug Test. Have to pee in a cup for a job or a PO? If you drank in the last 3 weeks, you’re gonna fail the drug test. Zero tolerance and all.

          Can’t Buy Alcohol in Many Cities and Counties. There are entire counties, cities, and towns where you can’t buy any Alcohol. Period. Dry as a bone. No Alcohol of any kind in grocery stores. And no liquor stores at all, so deal with it.

          No Drinking in Public. Used to drinking in a park? On a patio on Pearl St Mall? At the Boulder Creek Fest? CU football games? Not any more.

          Child-resistant Containers. All Alcohol must be in a child-resistant package. Have you ever tried to open a child-resistant container after 5 beers?

          No Delivery. No more party delivery by Liquor Mart. What will frat houses do?

          Maximum Purchase Size. Having a party? Plan on making many trips to the liquor store instead of one. Maximum purchase size is 2 cases.

          Taking Alcohol to Another State. It’s a felony to buy Alcohol in Colorado and take it to any other state. And try not to leave it in the rental car when you return it. And if you travel out of state, expect to illegally get pulled over by cops looking for Colorado Alcohol.

          Only In-state Suppliers. The liquor store has to make 70% of what they sell. Somewhere, somehow. That means 70% of all the beer, wine, and spirits they sell. No state-wide brands, no more Leopold Brothers or Stranahan’s. And the other 30% has to be in-state as well.

          No Alcohol in Your Suitcase. It’s illegal to have your bottle of Alcohol anywhere on DIA property. Including your suitcase. If confiscated, you could be detained. There are “Amnesty Boxes” for you to put your bottle in at the airport.

          Or Anywhere in Any Airport. Every airport in the state is off-limits to Alcohol. No drinking in the airport before the flight, no buying booze at the duty-free shop, no drinking at all until they serve you at 30,000 feet.

          CCTV. Smile! You’re on camera. 100% of the store must be visible on camera, which is fed in realtime to the state liquor board.

          No QA or Tests Required. No tests are required on the Alcohol sold in liquor stores. Not ABV, not microbiological, not adulterants or contaminants, not nothin’.

          Only Two Customers. After you waited 15 minutes to get in, you see why: no more than 2 customers can be in the store at a time. Take a number and get in line.

          ID to Enter Regardless of Age. Are you clearly north of 90? Bring your ID anyway, since 100% of liquor store patrons are carded. Period.

          No More Loyalty and Rewards. All those loyalty and rewards programs are out the window.

          Spirits In Small Quantities. Spirits only come in pint bottles, no more quarts, fifths, or magnums. On the plus side, you can buy the same quantity of spirits that you can of beer, so you can buy two cases of pint bottles of vodka. A quirk in the law.

          Unknown ABV. Want to know how much Alcohol is in that bottle? Then you’ll have to guess, because there is no requirement to tell you.

          Threat to Ban Spirits. From time to time the state will threaten to ban spirits like vodka, whiskey, and tequila.

          Employees. The guy waiting on you has been fingerprinted, has had a background check done, and state-mandated training. Just to get minimum wage selling you a sixer.

          Ownership. Good to know, only Colorado residents for one year can own a liquor store. Plus the mandatory fingerprints and background check. And sometimes an investigation. All for a liquor store.

          Armed Regulators. The guy from the state who checks on the store? He’s armed and has a badge.

          Health Inspections. Although they don’t prepare food, the local Health Department will still inspect liquor stores, just as if they were a restaurant.

          No Credit Cards Because No Banks. Forgot cash, so you need to use your card? Too bad. Since they can’t use banks, they can’t take credit cards.

          No IRS Deductions. So it’s April 15 and the liquor store owner wants to deduct costs of doing business, like every other business in America. Except the IRS will not allow even one single deduction! Not for labor, not for rent, not for insurance, not for anything. And since you have no bank account, you have to pay your payroll and income taxes in cash, which is another 10% penalty.

          SBA. You want to apply for an SBA loan for your liquor store? Don’t bother, they will reject it instantly. Same with commercial banks. Your liquor store is not considered legal enough for them.

          3 Years to Get License. So despite all this you still want to open a liquor store? Expect to open and then wait 3 years to finally get your state license, operating on a conditional one the whole time.

          This is the reality of regulating Alcohol like Marijuana. It’s inherently unfair to Marijuana buyers and vendors, and contrary to the letter and the spirit of Amendment 64.

          Beer drinkers should count their blessings.

By Richard Rose

Richard Rose has a long history with the hemp food industry in North America, with his involvement starting in 1994. Richard is the founder of Hemp Food Association, past Treasurer and Food Committee Chair of the Hemp Industries Association, and co-author of “The HempNut Cookbook” (see Facebook.com/TheHempNut).

#  #  #  #  #

Copyright 2014 Richard Rose, all rights reserved.

Originally posted at http://www.ladybud.com/2014/08/13/a-modest-proposal-lets-regulate-alcohol-like-marijuana/. It was taken down by Ladybud after I called out their promoting this BS from HIA, trying to hurt CBD like HIA did hempseed for birdseed and hemp food years earlier.

Photo Credit: Geralt under public domain via Pixabay

Reduce THC Dysphoria With Citicoline

THC dysphoria (too uncomfortably high) is a common problem for those using edibles or oil. I’ve used Citicoline (CDP Choline) to substantially reduce the high in 20 minutes for those obviously way too baked.

If state marijuana regulators actually cared, they would mandate giving two pills for every edible sold. Citicoline could also be used for risk management at Cannabis lounges; dab all night then be fit to drive in minutes.

A challenge for Democrats

A challenge for Democrats

My friend and fellow Democrat Thomas Mills predicts:

“I . . . think the legislature will pass some form of medical marijuana bill. The momentum is moving too quickly in favor of legalization. With Virginia heading that way in 2024 and maybe sooner, North Carolina stands to lose millions of dollars in tax revenue if they keep prohibition in place. Enough states have legalized it without seeing any devastating consequences to move forward and I think that will happen this year.”  https://www.politicsnc.com/maybe-im-wrong/

Medical in 2023?

Who gets the money (and first dibs on the recreational money)?  If lobbying works, SB711 aims to give licenses to outfits funded by Matt Gaetz’s wild and crazy crowd, so Ds should object, and by Russian money, so most everyone should be nervous.

We can do better.  If Democrats can’t figure out how to share this not-even-in-existence wealth, count on us for something other than equity.


#CBD #Hemp
A challenge for Democrats
January 4, 2023 10:35 pm

Holding up marijuana legalization?

Holding up marijuana legalization?

The U.S. cannabis industry is not a monolith.  Some players have reason to say that marijuana legalization is best left to the states

Here it is: Federal legalization of cannabis will hurt producers. 

Today, foreign imports don’t come in, but once we legalize, existing trade treaties will automatically oblige us to allow imports. U.S. producers will say, “Ouch.”

Retailers and distributors and to some extent Multi-State Operators don’t join producers in this fear of legalization.


#CBD #Hemp
Holding up marijuana legalization?
December 18, 2022 3:21 am

Phasing out of marijuana tax policy

Phasing out of marijuana tax policy

Starting in late 2009, I tried to be the world’s expert on cannabis tax policy, but now, at 75, I haven’t needed to try for a while, because first-rate tax policy scholars have been looking at and writing about marijuana revenue.  They cheer me up.  Here are writings, roughly in reverse chronological order, showing why I have been easing up.

Richard Auxier of the Tax Policy Center, https://www.taxpolicycenter.org/publications/pros-and-cons-cannabis-taxes (with Nikhita Airi).

Ben Leff of American University Law School, https://www.bu.edu/bulawreview/files/2021/07/LEFF.pdf.

Carl Davis of the Institute on Taxation and Economic Policy, https://itep.org/?s=cannabis#gsc.tab=0&gsc.q=cannabis&gsc.page=1 (Richard Phillips and Misha Hill contributed to some of this work.)  Start with https://itep.org/taxing-cannabis/.

Ulrik Boesen, when he was at the Tax Foundation, https://taxfoundation.org/individual-and-consumption-taxes/excise-taxes/marijuana-taxes/.  Start with https://taxfoundation.org/recreational-marijuana-tax/.

Jane Gravelle and Sean Lowry from the Congressional Research Service way back in 2014, https://newtax.files.wordpress.com/2015/01/fed-mj-tax-r43785.pdf.

Lots of drug policy scholars look at cannabis revenue policy too, and plenty of interested industry people do, but my own background in tax leads me to appreciate especially the tax policy specialists who have taken up this work. There’s plenty still to do, and our wide variety of state experiments will help Congress figure out what to do eventually.

A greater need now for me is to follow not just licensing revenue but the whole licensing process, where policymakers are flailing.  Nothing works – on the merits, lotteries, social equity – all end with arguable unfairness and time-consuming appeals.

In my state, North Carolina, the State Senate has passed, with negligible debate, a huge medical cannabis bill, SB711, licensing only 10 vertically integrated marijuana sellers, who will be well-heeled investors.  We can do better.  So watch this space.


#CBD #Hemp
Phasing out of marijuana tax policy
November 28, 2022 3:50 pm

FDA Roundup: November 22, 2022

FDA Roundup: November 22, 2022 FDA Roundup: November 22, 2022 Anonymous (not verified) Tue, 11/22/2022 – 16:26

Short Title
FDA Roundup: November 22, 2022

FDA Statement
No

Press Release Date
November 22, 2022

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

Body

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

  • Today, the FDA issued an emergency use authorization (EUA) for the Lucira COVID-19 and Flu Test for use in a point-of-care (POC) setting, following collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). “This authorization demonstrates our continued commitment to expand the availability of multiplex tests for COVID-19 and flu and provide a streamlined approach to developers to increase the availability of these types of tests,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We will continue to work with developers and our government colleagues to ensure the public has access to appropriately accurate and reliable tests they can count on and we stand ready to authorize additional multi-analyte tests, including at-home tests, to meet current public health testing needs.” The Lucira COVID-19 and Flu Test is a single use molecular test intended for detection of both the SARS-CoV-2 virus and influenza (A or B) if a patient is suspected of respiratory viral infection consistent with COVID-19. The test can be used in persons aged two years or older and is collected by nasal swab by a health care provider in a POC setting. Negative test results should be confirmed with another FDA-authorized molecular test. Negative test results must be combined with clinical observations, patient history and epidemiological information.
  • Today, the FDA provided updated information about medical device reports received from Aug. 1 to Oct. 31, 2022, that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Since April 2021, the FDA has received more than 90,000 medical device reports, including 260 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. The FDA will continue to update the public about the status of the Philips Respironics’ recall announced in June 2021.
  • On Monday, the FDA posted warning letters to five companies for illegally selling products containing cannabidiol (CBD). These companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.
  • On Monday, the FDA authorized the Fastep COVID-19 Antigen Home Test (manufactured by Azure Biotech Inc.), an over-the counter (OTC) COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used as a serial test for people within the first five days of symptom onset or for people who do not have symptoms. The Fastep test was validated with data that was gathered through the FDA’s collaboration with the NIH ITAP.
  • On Monday, the FDA authorized the CorDx COVID-19 Antigen Test (manufactured by CorDx, Inc.), an OTC COVID-19 antigen diagnostic test that shows results in 10 minutes. The test can be used as a serial test for people within the first seven days of symptom onset or for people who do not have symptoms.
  • On Friday, the FDA announced it will hold a public meeting on Dec. 7, 2022, to offer opportunity for comment on the proposed recommendations for reauthorization of the Animal Drug User Fee Act (ADUFA). Interested parties can share their comments at the meeting or by submitting them to the public docket. ADUFA gives the FDA the authority to collect user fees that provide supplemental funding to support the new animal drug review process. The FDA’s responsibility is to ensure these drugs are safe and effective and ADUFA program resources enhance the timeliness and predictability of application review for animal drugs needed by various animal populations. Reauthorization of this program includes an annual revenue of at least $32 million in user fees, supplementing budget authority funding for the new animal drug program. The current user fee program expires Sept. 30, 2023. To attend or provide comment at the meeting, please register here.
  • On Friday, the FDA issued an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products that appear on the FDA’s drug shortage list by a licensed pharmacist in a state-licensed pharmacy or federal facility. The guidance describes steps to reduce the risk of cross-contamination between these and other products. Beta-lactam drugs can cause life-threatening allergic reactions in some patients.

    Amoxicillin is widely used for the treatment of bacterial infections in children, among other uses. Antibiotics like amoxicillin treat many different infections caused by bacteria, but they are not effective against viral infections like the common cold, most sore throats, and the flu.

  • COVID-19 testing updates:
    • As of today, 439 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 53 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 21 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
    • The FDA has authorized 37 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1162 revisions to EUA authorizations 

Content Owner

Contributing Office

Publish Date
Tue, 11/22/2022 – 17:04

Review Date
Wed, 11/22/2023 – 00:00

Last Reviewed Date
Tue, 11/22/2022 – 00:00

Site Structure

Next Review Date
1 Year

Source Organization

Bulk Approved
Off

Hide main image
hide

Display Short Description
Off

Language

Media Contact
Media Contact Name
FDA Office of Media Affairs

Media Contact Phone
888-INFO-FDA

Media Contact Email

First Publish Date
Tue, 11/22/2022 – 16:35

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-22-2022 November 22, 2022 9:26 pm

Phil’s Power Pancake Issues Allergy Alert on Undeclared Wheat in Phil’s Power Pancake

Phil’s Power Pancake Issues Allergy Alert on Undeclared Wheat in Phil’s Power Pancake Phil’s Power Pancake Issues Allergy Alert on Undeclared Wheat in Phil’s Power Pancake Anonymous (not verified) Fri, 11/18/2022 – 13:15

Recall Type
Company Announcement

Brand Name(s)
Phil’s Power Pancake

Recall Reason
Food & Beverage Safety,Potential or Undeclared Allergen,Wheat

Company or Government Agency Name

Short Title
11-17-2022 Phil’s Power Pancake

Body

Phil’s Power Pancake of Costa Mesa, CA is recalling its 5 oz. packages of individually wrapped Power Pancakes in all 5 varieties (Mango, Raspberry, Cranberry, Dates, and Chocolate Chip Hempseed) because they may contain undeclared wheat. People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

Phil’s Power Pancakes are distributed locally in Orange County & Los Angeles, CA at various gyms and markets in refrigerated cases.

Pancakes are individually wrapped in clear 5 oz. plastic packages labeled with UPC Code 8 37654 48372 5. All product currently on the market is subject to recall.

All 5 varieties of pancakes contain rye flour that contains 1% wheat. Labels on the product distributed state “wheat free” and new labels will read “99% wheat free”.

No illnesses have been reported to date in connection with this product.

This recall is being made with the knowledge of the U.S. Food and Drug Administration

Consumers who have purchased 5 oz. packages of Phil’s Power Pancakes are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 949-637-2253.

 

Publish Date
Fri, 11/18/2022 – 13:38

Review Date
Sat, 11/18/2023 – 00:00

Source Organization

Last Reviewed Date
November 18, 2022

Company Announcement Date
November 17, 2022

Consumer Contact Name
Phil’s Power Pancake

Consumer Contact Phone
949-637-2253

Detailed Description
Phil’s Power Pancake of Costa Mesa, CA is recalling its 5 oz. packages of individually wrapped Power Pancakes in all 5 varieties (Mango, Raspberry, Cranberry, Dates, and Chocolate Chip Hempseed) because they may contain undeclared wheat. People who have an allergy or severe sensitivity to wheat run

Next Review Date
1 Year

Product Description
Pancakes in 5 varieties (mango, raspberry, cranberry, dates, chocolate chip hempseed

Bulk Approved
Off

Problem

Display Short Description
Off

Product Type(s)*

Language

Recall Reason Description
Undeclared wheat

Add Subscription Box
Off

Terminated Recall
Off

#CBD #Hemp http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/phils-power-pancake-issues-allergy-alert-undeclared-wheat-phils-power-pancake November 18, 2022 6:15 pm

Public Calendar: October 30 – November 5, 2022

Public Calendar: October 30 – November 5, 2022 Public Calendar: October 30 – November 5, 2022 Anonymous (not verified) Tue, 11/15/2022 – 11:28

Detailed Description
Significant meetings held by FDA officials with persons outside of the executive branch of the federal government, October 30 – November 5, 2022

This public calendar is issued by the Food and Drug Administration. It lists significant meetings held by designated FDA policy makers with persons outside the executive branch of the federal government.

Official Name: Robert M. Califf, M.D., MACC, Commissioner of Food and Drugs

Event Date: 10/31/2022
Location: Virtual
Subject: Vaccine Hesitancy and Misinformiaton
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members of public health advocacy groups

Event Date: 11/01/2022
Location: Virtual
Subject: Infant Formula Update
FDA Participant/Group: TRISTAN COLONIUS; MARK RAZA;
Non FDA Participant/Group: Eugenia Pierson, Kevin O’Neill (Arnold & Porter); Kyle Hanson, Murray Kessler (Perrigo);

Event Date: 11/01/2022
Location: Virtual
Subject: Vaccine Hesitancy and Misinformation
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members of public health advocacy groups

Event Date: 11/01/2022
Location: Washington, DC
Subject: Dinner in Honor of Sir Patrick Vallance, UK Government Chief Scientific Advisor
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, academia, and other invited guests

Event Date: 11/02/2022
Location: Washington, DC
Subject: Clinical and Translational Science Award Program Annual Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, academia, and other registered attendees

Event Date: 11/03/2022
Location: Virtual
Subject: Annual Cocaine, Meth and Stimulant Summit
FDA Participant/Group: MICHELLE ADAMS;
Non FDA Participant/Group: Government, academia, media, industry, and other registered attendees

Event Date: 11/03/2022
Location: Virtual
Subject: Virginia Tech Maury Strauss Distinguished Public Lecture: The Role of Translational Science in Addressing the Decline in Health Status in the U.S.: A Perspective from FDA
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, academia, industry, media, and other registered attendees

Event Date: 11/04/2022
Location: Chicago, IL
Subject: American Heart Association Scientific Sessions
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, academia, industry, media, and other registered attendees

Official Name: Janet Woodcock, M.D., Principal Deputy Commissioner

Event Date: 11/01/2022
Location: Virtual
Subject: Regulatory Pathways for Hemp Products, Including Cannabidiol (CBD)
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives from the Office of the Secretary and Executive Office of the President

Official Name: Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response

Event Date: 11/01/2022
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several leaders and staff from the Canadian Food Inspection Agency and Health Canada

Event Date: 11/02/2022
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: LARRY MORRIS;
Non FDA Participant/Group: Brian Olney, Danny Wegman, Dave Corsi, Kathleen O’Donnell, Martha Hilton (Wegmans Food Markets, Inc.);

Event Date: 11/04/2022
Location: Virtual
Subject: Infant Formula Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members of industry, trade, and retail associations

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

No Significant Event

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Erica Jefferson, Associate Commissioner for External Affairs

No Significant Event

Official Name: Namandjé N. Bumpus, Ph.D., Chief Scientist

No Significant Event

Official Name: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research

Event Date: 11/04/2022
Location: Virtual
Subject: C-Path / FDA 2022 Annual Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Bri Sullivan, Cecile Ollivier, Graham Higson, Huong Huynh, Julie Strzyzewski, Karen Stamm, Kevin B. Perkins, Klaus Romero, Kristen Swingle, Rebecca Yuan, Richard Liwski, Stephen Joel Coons, Sudhir Sivakumaran, Wain Fishburn (Critical Path (C-Path) Institute);

Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

Event Date: 10/31/2022
Location: Virtual
Subject: In Vivo Gene Therapy and Genome Editing Summit; FDA Efforts to Advance Gene Therapy
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, research, and academia stakeholders

Event Date: 11/02/2022
Location: Virtual
Subject: International Society for Pharmaceutical Engineering; Regulatory Keynote: The Potential Impact of Global Convergence on the Availability of Cell and Gene Therapy
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, government, research, and academia stakeholders

Event Date: 11/02/2022
Location: Virtual
Subject: International Society for Pharmaceutical Engineering; Global Regulatory Town Hall
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, government, research, and academia stakeholders

Event Date: 11/03/2022
Location: Virtual
Subject: Perinatal Stem Cell Society; Advancing the Development of Safe and Effective Regenerative Medicine Products
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, research, and academia stakeholders

Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

Event Date: 10/31/2022
Location: Virtual
Subject: Real World Evidence Data Collection
FDA Participant/Group: WILLIAM MAISEL; ANGELA KRUEGER; MARY RITCHEY; BRENDAN O’LEARY; DANIEL CANOS; SONJA FULMER;
Non FDA Participant/Group: Ladd Wiley, Sam Butler, Stirling Martin, Sumit Rana (Epic Systems Corporation);

Event Date: 11/04/2022
Location: Virtual
Subject: Diabetes Technology Meeting; Keynote
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of government, industry, technology developers, and users

Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

Event Date: 10/31/2022
Location: Virtual
Subject: Health and Chemicals Coalition Meeting; Food Chemical Safety Work Including Chemical Contaminants and Toxic Elements
FDA Participant/Group: DOUGLAS STEARN; KRISTI MULDOON JACOBS; CONRAD CHOINIERE; PAUL SOUTH; STEVEN MUSSER; STEVE HERMANSKY; REBECCA BUCKNER;
Non FDA Participant/Group: Lisette Van Vliet (Breast Cancer Prevention Partners); Jose Jensen, Sarah Sorscher, Thomas Galligan (Center for Science in the Public Interest); Jaydee Hanson (Center for Food Safety);

Official Name: Brian King, Ph.D., Director, Center for Tobacco Products

Event Date: 11/01/2022
Location: Virtual
Subject: Update on Premarket Tobacco Product Applications (PMTA) and Non-Tobacco Nicotine (NTN) Enforcement
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Katlin Backfield (US Senate, Health, Education, Labor and Pension (HELP) Staff); Jacquelyn Bolen (US House of Representatives, Energy and Commerce (E&C) Staff);

Event Date: 11/01/2022
Location: Virtual
Subject: American Association for Cancer Research (AACR) Introductory Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several Representatives from the American Association for Cancer Research (AACR)

Event Date: 11/03/2022
Location: Virtual
Subject: Public Health Law Center (PHLC) Webinar; Future Priorities for Federal Commercial Tobacco Regulation: A Conversation with Dr. Brian King
FDA Participant/Group: N/A
Non FDA Participant/Group: Several Representatives from the Public Health Law Center (PHLC)

Official Name: Steven Solomon, Director, Center for Veterinary Medicine

No Significant Event

Official Name: Tucker Patterson, Ph.D., Acting Director, National Center for Toxicological Research

No Significant Event

Official Name: Mark Raza, J.D., Chief Counsel

No Significant Event

 

Short Title
Public Calendar: October 30 – November 5, 2022

Source Organization

Short Description
Significant meetings held by FDA officials with persons outside of the executive branch of the federal government, October 30 – November 5, 2022

Publish Date
Tue, 11/15/2022 – 12:09

Review Date
Wed, 11/15/2023 – 11:00

Last Reviewed Date
Tue, 11/15/2022 – 11:00

Next Review Date
1 Year

Navigational Page
Off

Bulk Approved
Off

Display Short Description
Off

First Publish Date
Tue, 11/15/2022 – 12:08

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/news-events/public-calendar-meetings-fda-officials/public-calendar-october-30-november-5-2022 November 15, 2022 4:28 pm

Public Calendar: October 23-29, 2022

Public Calendar: October 23-29, 2022 Public Calendar: October 23-29, 2022 Anonymous (not verified) Fri, 11/04/2022 – 10:44

Detailed Description
Significant meetings held by FDA officials with persons outside of the executive branch of the federal government, October 23-29, 2022

This public calendar is issued by the Food and Drug Administration. It lists significant meetings held by designated FDA policy makers with persons outside the executive branch of the federal government.

Official Name: Robert M. Califf, M.D., MACC, Commissioner of Food and Drugs

Event Date: 10/24/2022
Location: Virtual
Subject: Food Industry Issues
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members of the Food and Beverage Issue Alliance

Event Date: 10/24/2022
Location: Virtual
Subject: Diagnostic Testing Issues
FDA Participant/Group: JEFFREY SHUREN;
Non FDA Participant/Group: Stakeholders from several academic medical centers

Event Date: 10/25/2022
Location: Washington, DC
Subject: Friends of Cancer Research 26th Annual Cancer Leadership Awards Reception
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members of the Friends of Cancer Research, industry, academia, government and other invited guests

Event Date: 10/25/2022
Location: Boston, MA
Subject: Vision for the FDA
FDA Participant/Group: JEFFREY SHUREN; MICHAEL FELBERBAUM;
Non FDA Participant/Group: Several members of the Advanced Medical Technology Association Board

Event Date: 10/25/2022
Location: Boston, MA
Subject: The MedTech Conference; Fireside Chat
FDA Participant/Group: MICHAEL FELBERBAUM; JEFFREY SHUREN;
Non FDA Participant/Group: Government, academia, industry, media and other registered attendees

Event Date: 10/26/2022
Location: Plano, TX
Subject: Vision for the FDA
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members of the American Heart Association Board of Directors, staff and other invited guests

Event Date: 10/27/2022
Location: New York, NY
Subject: 2022 Galien Forum; Speaker: Keynote Address
FDA Participant/Group: N/A
Non FDA Participant/Group: Government, academia, industry, media, and other registered attendees

Event Date: 10/28/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: JULIA TIERNEY; MARK RAZA; SUSAN MAYNE; TRISTAN COLONIUS; FRANK YIANNAS;
Non FDA Participant/Group: Allen Hubert, Monica Wilkins, Robert Ford (Abbott Laboratories);

Official Name: Janet Woodcock, M.D., Principal Deputy Commissioner

Event Date: 10/25/2022
Location: Virtual
Subject: Data Standardization
FDA Participant/Group: RAM IYER; VIDYUT DESAI; JAMES MULHOLLAND; THOMAS BEACH; MEREDITH CHUK; MOHAMMED CHAUDHRY;
Non FDA Participant/Group: Jessica Wasserman (WassermanRowe); Kari Finch (General Mills); Alycia Sohn (American Association of Exporters and Importers (AAEI));

Event Date: 10/27/2022
Location: Virtual
Subject: Council for Federal Cannabis Regulation (CFCR) | FDA Webinar
FDA Participant/Group: N/A
Non FDA Participant/Group: CFCR members, industry, and other stakeholders

Official Name: Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response

Event Date: 10/24/2022
Location: Salinas, CA
Subject: Leafy Greens and Food Safety Issues of Mutual Interest
FDA Participant/Group: JEFFREY FARRAR; KAREN MEISTER;
Non FDA Participant/Group: Representative Jimmy Panetta (D-CA) and staff, Representative Zoe Lofgren (D-CA) and staff, representatives from the California Leafy Green Products Handling Marketing Agreement, representatives from the California Department of Food and Agriculture, farmers, and food manufacturers

Event Date: 10/28/2022
Location: Virtual
Subject: Food Safety Culture
FDA Participant/Group: N/A
Non FDA Participant/Group: Anju Rao (Starbucks);

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

Event Date: 10/26/2022
Location: Virtual
Subject: Introductory Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Jigar Raval (Indian Embassy);

Event Date: 10/27/2022
Location: Virtual
Subject: 11th Meeting of the WHO Member State Mechanism on Substandard and Falsified Medicines
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of the Pan American Health Organization

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Erica Jefferson, Associate Commissioner for External Affairs

No Significant Event

Official Name: Namandjé N. Bumpus, Ph.D., Chief Scientist

No Significant Event

Official Name: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research

Event Date: 10/25/2022
Location: Virtual
Subject: 2022 C-Path Neuroscience Annual Meeting
FDA Participant/Group: JACQUELINE CORRIGAN CURAY;
Non FDA Participant/Group: Industry, academia, regulatory agencies, and other stakeholders

Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

Event Date: 10/24/2022
Location: Boston, MA
Subject: Massachusetts Consortium on Pathogen Readiness Symposium – Illuminating Our Path Forward: Lessons from an Evolving Pandemic; Facilitating the Development and Availability of COVID-19 Vaccines
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Massachusetts Consortium on Pathogen Readiness Symposium

Event Date: 10/26/2022
Location: Virtual
Subject: Pharmaceutical Executive Summit; Gene Therapy – Unlocking the Promise
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Pharmaceutical Executive Summit

Event Date: 10/27/2022
Location: New York, NY
Subject: Galien Forum 2022; Panelist: COVID Pandemic Science 2022: Current Vaccines and Treatments and the Future Outlook
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Galien Forum 2022

Event Date: 10/28/2022
Location: Virtual
Subject: Alliance for Regenerative Medicine/FDA Liaison Meeting
FDA Participant/Group: SHERYL LARD WHITEFORD; ANITA RICHARDSON; WILSON BRYAN; RACHAEL ANATOL; CHRISTOPHER JONECKIS; MELISSA MENDOZA;
Non FDA Participant/Group: Representatives from the Alliance for Regenerative Medicine

Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

Event Date: 10/26/2022
Location: Boston, MA
Subject: The MedTech Conference; CDRH Town Hall
FDA Participant/Group: ELI TOMAR; WILLIAM MAISEL; DOUGLAS KELLY; SUZANNE SCHWARTZ; MICHELLE TARVER;
Non FDA Participant/Group: Government, academia, industry, media and other registered attendees

Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

No Significant Event

Official Name: Brian King, Ph.D., Director, Center for Tobacco Products

Event Date: 10/24/2022
Location: Bethesda, MD
Subject: Tobacco Centers of Regulatory Science (TCORS) Fall Conference; Speaker
FDA Participant/Group: BRIAN KING;
Non FDA Participant/Group: Several representatives from the Tobacco Centers of Regulatory Science (TCORS)

Event Date: 10/26/2022
Location: Washington, DC
Subject: Update on FDA Product Standards
FDA Participant/Group: BRIAN KING;
Non FDA Participant/Group: Several representatives from the Council on Foreign Relations

Event Date: 10/26/2022
Location: Virtual
Subject: American Thoracic Society (ATS) Introductory Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives from the American Thoracic Society (ATS)

Event Date: 10/26/2022
Location: Virtual
Subject: Health Canada Introductory Meeting
FDA Participant/Group: ESHAEL JOHNSON; PRISCILLA LYON; BRIAN KING; MEGAN HICKS;
Non FDA Participant/Group: Several representatives from Health Canada

Event Date: 10/27/2022
Location: Virtual
Subject: American Society for Clinical Oncology (ASCO) Introductory Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives from American Society for Clinical Oncology (ASCO)

Official Name: Steven Solomon, Director, Center for Veterinary Medicine

Event Date: 10/27/2022
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives of the Generic Animal Drug Alliance (GADA)

Official Name: Tucker Patterson, Ph.D., Acting Director, National Center for Toxicological Research

No Significant Event

Official Name: Mark Raza, J.D., Chief Counsel

No Significant Event

Short Title
Public Calendar: October 23-29, 2022

Source Organization

Short Description
Significant meetings held by FDA officials with persons outside of the executive branch of the federal government, October 23-29, 2022

Publish Date
Fri, 11/04/2022 – 11:54

Review Date
Sat, 11/04/2023 – 10:00

Last Reviewed Date
Fri, 11/04/2022 – 10:00

Next Review Date
1 Year

Navigational Page
Off

Bulk Approved
Off

Display Short Description
Off

First Publish Date
Fri, 11/04/2022 – 11:54

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/news-events/public-calendar-meetings-fda-officials/public-calendar-october-23-29-2022 November 4, 2022 2:44 pm

Public Calendar: October 16-22, 2022

Public Calendar: October 16-22, 2022 Public Calendar: October 16-22, 2022 Anonymous (not verified) Fri, 10/28/2022 – 15:23

Detailed Description
Significant meetings held by FDA officials with persons outside of the executive branch of the federal government, October 16-22, 2022

This public calendar is issued by the Food and Drug Administration. It lists significant meetings held by designated FDA policy makers with persons outside the executive branch of the federal government.

Official Name: Robert M. Califf, M.D., MACC, Commissioner of Food and Drugs

Event Date: 10/16/2022
Location: Washington, DC
Subject: National Academy of Medicine 50th Anniversary Celebration
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members of the National Academy of Medicine, academia, industry, government, and other invited guests

Event Date: 10/17/2022
Location: Virtual
Subject: The Organization for Professionals in Regulatory Affairs (TOPRA) 2022 Human Medicines Symposium: Lessons Learned and Strategic Priorities
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, government, media, and other invited attendees

Event Date: 10/17/2022
Location: Washington, DC
Subject: National Organization for Rare Disorders, Rare Diseases, and Orphan Products Breakthrough Summit
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, government, media, and other registered attendees

Event Date: 10/17/2022
Location: Virtual
Subject: Great Plains IDeA-CTR Annual Scientific Meeting: Biomedical Research & Healthcare Informatics Conference
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, government, media, and other invited attendees

Event Date: 10/18/2022
Location: Virtual
Subject: Infant Formula Issues
FDA Participant/Group: TRISTAN COLONIUS;
Non FDA Participant/Group: Robert Ford (Abbott Laboratories);

Event Date: 10/19/2022
Location: Virtual
Subject: Foundation for the National Institutes of Health Awards Ceremony
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members of the Foundation for the National Institutes of Health, industry, academia, government, and other invited attendees

Event Date: 10/19/2022
Location: Virtual
Subject: Continued Transformation of the Health Research Enterprise
FDA Participant/Group: N/A
Non FDA Participant/Group: Lisa Simpson (AcademyHealth); Lucas Tramontozzi (SCI Solution);

Event Date: 10/19/2022
Location: Virtual
Subject: 12th Annual Conference of Global Summit on Regulatory Science
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, academia, industry, and other registered attendees

Event Date: 10/20/2022
Location: Virtual
Subject: Reagan Udall Foundation COVID-19 Evidence Accelerator Public Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, academia, industry, media, and other registered attendees

Event Date: 10/20/2022
Location: Virtual
Subject: Foundation for the National Institutes of Health (FNIH) Board of Directors Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Several members of the FNIH Board of Directors and staff

Event Date: 10/20/2022
Location: Virtual
Subject: Biosimilars Forum Board of Directors Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several board members of the Biosimilars Forum

Official Name: Janet Woodcock, M.D., Principal Deputy Commissioner

Event Date: 10/17/2022
Location: Virtual
Subject: Foods Program Funding Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Jennifer McEntire (Fresh Produce Association); Donna Garren (American Frozen Food Institute); Mitzi Baum (Stop Foodborne Illness); Brian Ronholm (Consumer Reports); Scott Faber (Environmental Working Group (EWG)); De Ann Davis (Western Growers); Roberta Wagner (Consumer Brands Association);

Event Date: 10/17/2022
Location: Virtual
Subject: Milken Institute FasterCures Virtual Roundtable – Community-Based Infrastructure for Inclusive Research; Speaker: Opening Remarks
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, regulatory organizations, and other stakeholders

Event Date: 10/18/2022
Location: Virtual
Subject: People for the Ethical Treatment of Animals (PETA) Science Consortium International (SCI) Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: April Naab, Jeffrey Brown (People for the Ethical Treatment of Animals (PETA));

Event Date: 10/19/2022
Location: Virtual
Subject: Tobacco Expert Panel Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Charlene Frizzera (CF Health Advisors); Jane Axelrad, Lauren Silvis, Susan Winckler (Reagan-Udall Foundation);

Event Date: 10/19/2022
Location: Virtual
Subject: Cannabis Product Regulation
FDA Participant/Group: N/A
Non FDA Participant/Group: Brian Miller (Miller Research Group);

Official Name: Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response

No Significant Event

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

Event Date: 10/17/2022
Location: Geneva, Switzerland
Subject: Substandard and Falsified Medical Products Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Paul Huleatt (World Health Organization Substandard and Falsified Medical Products Steering Committee);

Event Date: 10/17/2022
Location: Geneva, Switzerland
Subject: World Health Organization Substandard and Falsified Medical Products Projects Update
FDA Participant/Group: LEIGH VERBOIS, RUSSELL CAMPBELL
Non FDA Participant/Group: Rutendo Kuwana (World Health Organization);

Event Date: 10/17/2022
Location: Geneva, Switzerland
Subject: Substandard and Falsified Medical Products Meeting
FDA Participant/Group: LEIGH VERBOIS, RUSSELL CAMPBELL
Non FDA Participant/Group: Rogerio Gaspar (World Health Organization);

Event Date: 10/19/2022
Location: Virtual
Subject: European Medicines Agency (EMA) – FDA Collaboration with African Medicines Agency Meeting
FDA Participant/Group: RAVI BHARWANI, ANNA FERUS, DOUGLAS SHAFFER, SEMA HASHEMI, DANIJELA STOJANOVIC
Non FDA Participant/Group: Martin Harvey (European Medicines Agency);

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Erica Jefferson, Associate Commissioner for External Affairs

No Significant Event

Official Name: Namandjé N. Bumpus, Ph.D., Chief Scientist

No Significant Event

Official Name: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research

Event Date: 10/18/2022
Location: Washington, DC
Subject: National Organization for Rare Disorders, Rare Diseases, and Orphan Products Breakthrough Summit; Panelist: Fireside Chat Session with FDA Center Directors
FDA Participant/Group: PETER MARKS; JEFFREY SHUREN;
Non FDA Participant/Group: Industry, patient advocacy organizations, academia, and other stakeholders

Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

Event Date: 10/19/2022
Location: Silver Spring, MD
Subject: American Society of Gene and Cell Therapy and Alliance for Regenerative Medicine Public Meeting; Potency Assays for Cell and Gene Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, research, and academia stakeholders

Event Date: 10/21/2022
Location: Washington, DC
Subject: ID (Infectious Disease) Week; Moderator: COVID-19 Late Breaking Abstracts
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, research, and academia stakeholders

Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

No Significant Event

Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

No Significant Event

Official Name: Brian King, Ph.D., Director, Center for Tobacco Products

Event Date: 10/19/2022
Location: Virtual
Subject: Introductory Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives from the National Association of Tobacco Outlets (NATO)

Event Date: 10/20/2022
Location: Washington, DC
Subject: Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference; Keynote Address: Programmatic Updates
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, government, and other stakeholders

Event Date: 10/21/2022
Location: Virtual
Subject: Introductory Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Representative Raja Krishnamoorthi (D-IL)

Official Name: Steven Solomon, Director, Center for Veterinary Medicine

Event Date: 10/17/2022
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: TRACEY FORFA; PATRICK MCDERMOTT; ANTONIA MONIQUE SENNETT; CHARLOTTE CONWAY; TIMOTHY SCHELL; JEANETTE MURPHY; SIOBHAN DELANCEY; ANNE NORRIS; JENNIFER ERICKSON; DAVID EDWARDS; WILLIAM FLYNN;
Non FDA Participant/Group: Representatives of the Pet Food Institute (PFI)

Official Name: Tucker Patterson, Ph.D., Acting Director, National Center for Toxicological Research

No Significant Event

Official Name: Mark Raza, J.D., Chief Counsel

No Significant Event

 

Short Title
Public Calendar: October 16-22, 2022

Source Organization

Short Description
Significant meetings held by FDA officials with persons outside of the executive branch of the federal government, October 16-22, 2022

Publish Date
Fri, 10/28/2022 – 15:28

Review Date
Sat, 10/28/2023 – 15:00

Last Reviewed Date
Fri, 10/28/2022 – 15:00

Next Review Date
1 Year

Navigational Page
Off

Bulk Approved
Off

Display Short Description
Off

First Publish Date
Fri, 10/28/2022 – 15:28

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/news-events/public-calendar-meetings-fda-officials/public-calendar-october-16-22-2022 October 28, 2022 7:23 pm

Advancing Knowledge and Expertise in the Cannabis Testing Industry

Advancing Knowledge and Expertise in the Cannabis Testing Industry

The cannabis laboratory testing market has undergone a lot of changes in the past ten years. With those growing pains so common in such a new industry, come plenty of challenges driven by market dynamics, new regulations and scientific advancements.

Julie Kowalski, a cannabis testing consultant at JA Kowalski Science Support, has seen these changes firsthand. For twelve years, she worked at Restek as a senior chemist, helping to provide expertise and develop analytical solutions for their cannabis testing partners. She also worked as chief scientific officer for Trace Analytics, a cannabis testing lab in Spokane, Washington. Between being an advisor, consultant, trainer and accreditation assessor, she wears many different hats in the space. We sat down with Kowalski to learn more about the evolution of the marketplace, the importance of product safety and some of the common challenges that labs face.

Greg Kozadjian: Tell us a little about yourself and how you came to be working as a consultant in the cannabis and hemp testing industry?

Julie Kowalski, Owner of JA Kowalski Science Support

Julie Kowalski: I began working on gas chromatographs when I was about 20 years old, added liquid chromatography to my repertoire in my early 20’s, and have been in the lab nearly every day since then.

My consulting business launched in early 2020 after I received numerous requests from my network for help and advice regarding cannabis testing. I am passionate about helping people, talking science, and promoting growth and innovation in the cannabis industry.

Speaking with individuals and businesses who potentially received conflicting advice or felt somewhat overwhelmed by the complex and rapidly evolving cannabis industry, I realized I could help. So, I decided to utilize my experience and knowledge to promote trust and expertise within the cannabis industry and champion science over profit.


Kozadjian: Why do you think it’s crucial to test cannabis and hemp-based products in today’s market?

Kowalski: The way I look at it is that cannabis and hemp-based products are like any other product in that the consumer has the right to have some assurance that these products are safe, and that the labeling information is accurate.

Then, there are the increasing number of people seeking to use cannabis for medicinal reasons. Again, the industry should be able to assure them that the products they are using are safe to help them with their health issue.

Kozadjian: How has the market evolved over the last five years to meet the current testing regulations, and which of those regulations focus more on the safety of cannabis and hemp-based products?

Kowalski: In the past five years, more states have been coming online domestically. So, we are dealing with a regulatory environment where different states may have different regulations, a situation that will continue to exist for the foreseeable future. There have been efforts on the regulatory side, if not to coordinate efforts directly, to at least connect and communicate, and hopefully, out of those communications comes increased coordination.

I am hopeful that scientists, myself included, can do our part and provide additional data and information about testing that works, testing that doesn’t work, and that the regulators will consider and incorporate much of that information into changes in current and future regulations.

It is important to note that many state agencies were put in the position of creating a regulatory system that they were perhaps not familiar with, or accustomed to doing, particularly from the testing standpoint. There are no federal programs to model against, so programs are being developed from scratch and need to address all aspects of the market. It is a complicated task. It made sense to borrow from similar existing markets, but there is now the opportunity to use what we have learned to improve regulations.

For example, adopting certain criteria and practices from environmental, food, and agricultural testing was a great place to start. Now, we better understand some of the unique challenges associated with cannabis testing, it is time to set our fit-for-purpose best practices.

I hope that we, as an industry, can increasingly provide more data to help guide the regulators so that their goals are achieved and based on a growing body of data. I am optimistic that there will be much more interaction and coordination between regulators and scientists. This would greatly help with some of the struggles some cannabis labs are feeling in the current market.

Kozadjian: What are some of the challenges that testing labs face?

Kowalski: The cannabis and hemp-based products market is competitive with multiple sources of pressure. A definite challenge has been the gold rush mentality. Folks want to enter the cannabis business, and establishing a testing lab is attractive and perhaps perceived as more comfortable because it is not directly growing or producing a product.

There is a burden to set up a lab and open as quickly as possible because while the lab is being set up no money is being made. It can be stressful, and sometimes shortcuts are taken while developing technical programs. These shortcuts can ultimately cause disruption, stress, and risk. I saw this ten years ago, I saw this five years ago, and I am still seeing it now. I am still waiting for people to come into the industry with more realistic expectations of what it takes to establish functional technical programs and laboratories.“There are fundamental knowledge gaps that this market as a whole needs to address.”

Inadequate technical programs resulting from poorly vetted and insufficiently validated methods do not function well in the real world, changing regulations, as well as changing matrices, can result in chaos in the lab. A lab will fight fires daily if it does not plan for and build well-vetted, robust methods. Unfortunately, I have seen many new testing labs rush through development, and then when they open their doors for business, they realize their methods do not function properly.

Daily, they may be faced with deciding whether they should pass a sample batch because technically, it did not meet the criteria, but the client is waiting. Or labs constantly needing to retest may lose confidence in their ability. This is a high-stress situation, and quite a few labs are probably operating in this mode in the market right now. Substandard testing is becoming riskier as we see scrutiny, mainly due to test lab shopping increasing. I do want to make it clear and be fair to point out that the economics of cannabis testing is challenging. Pricing in most markets is too low to allow high-quality testing.

Kozadjian: How do you think this testing era will evolve in the next five years?

Kowalski: I think we will start to see more involvement and recognition of standards organizations like the AOAC, USP, ASTM. They have existed and have been working for at least a few years, and now are publishing methods, guidance documents, and providing education. That will be very helpful, and I invite testing labs to join in and participate in these efforts. Your voice is critical. We need more knowledge in the market, whether it is knowledgeable people entering the market, or people currently in the market who are willing to invest the time to learn analytical chemistry, for example. There are fundamental knowledge gaps that this market as a whole needs to address.

The post Advancing Knowledge and Expertise in the Cannabis Testing Industry appeared first on Cannabis Industry Journal.


#CBD #Hemp

Advancing Knowledge and Expertise in the Cannabis Testing Industry


October 26, 2022 5:18 pm

Oversight and onward

Oversight and onward

After spending weeks writing an article warning of the dangers of interstate commerce or federal legalization for states that tax marijuana by weight (Alaska, California, Colorado, Maine, and Nevada) or collect pre-processing (Canada; Alaska, California, Colorado, Illinois, Maine, and Nevada) and publishing it in Tax Notes, I remembered that New Jersey did both.

I’ve made lots of mistakes before; and list some here:  https://newrevenue.org/2015/01/28/3-errors-in-laws-to-tax/.  And for this recent article, I skipped the step, so useful in earlier writing, of soliciting comments before publication, like in 2011:

Still, overlooking New Jersey at age 75 is kind of embarrassing. But it may mean I can slow down, maybe to the point of being a critic or second set of eyes, and take comfort from some tax policy scholars who have been looking at and writing about cannabis revenue:

Carl Davis of the Institute on Taxation and Economic Policy, https://itep.org/?s=cannabis#gsc.tab=0&gsc.q=cannabis&gsc.page=1(Richard Phillips and Misha Hill contributed to some of this work.

Ulrik Boesen, when he was at the Tax Foundation, https://taxfoundation.org/individual-and-consumption-taxes/excise-taxes/marijuana-taxes/

Richard Auxier of the Tax Policy Center, https://www.taxpolicycenter.org/publications/pros-and-cons-cannabis-taxes (with Nikhita Airi)

Ben Leff of American University Law School, https://www.bu.edu/bulawreview/files/2021/07/LEFF.pdf

Jane Gravelle and Sean Lowry from the Congressional Research Service way back in 2014, https://newtax.files.wordpress.com/2015/01/fed-mj-tax-r43785.pdf

Lots of drug policy scholars look at cannabis revenue policy too, but my own background in tax leads me to appreciate these tax policy people who have taken up this work especially.


#CBD #Hemp
Oversight and onward
October 25, 2022 2:56 pm

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

CTP Supplement to Parent Grant: Impact of Flavor on Youth & Young Adults Use Intention, Abuse Liability and Perceptions of Cigarillos CTP Supplement to Parent Grant: Impact of Flavor on Youth & Young Adults Use Intention, Abuse Liability and Perceptions of Cigarillos Anonymous (not verified) Tue, 10/18/2022 – 08:55

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

Principal Investigator: Erika Trapl
Funding Mechanism: National Institutes of Health – Grant
ID Number: 3R01DA048529-03S1
Award Date: 8/20/2021
Institution: Case Western Reserve University 


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.

Short Title
CTP Supplement to Parent Grant: Impact of Flavor on Youth & Young Adul

Source Organization

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

Publish Date
Tue, 10/18/2022 – 08:57

Review Date
Wed, 10/18/2023 – 00:00

Last Reviewed Date
Tue, 10/18/2022 – 00:00

Site Structure

Next Review Date
1 Year

Navigational Page
Off

Bulk Approved
Off

Display Short Description
Off

First Publish Date
Tue, 10/18/2022 – 08:57

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/tobacco-products/research/ctp-supplement-parent-grant-impact-flavor-youth-young-adults-use-intention-abuse-liability-and October 18, 2022 12:55 pm

ASTM Debuts New Standards for Cannabis

ASTM Debuts New Standards for Cannabis

Earlier this month, ASTM International announced that the D37 cannabis committee has approved four new standards for the cannabis industry. Just a few days ago, the same organization announced the development of a new standard that will be published soon.

According to a press release, the four new standards that are already approved will help those working in the cannabis space, as well as regulators and consumers. The four new approved standards are as follows:

  • D8375: This standard provides a method to establish cannabinoid content in cannabis and hemp samples. ASTM member Garnet McRae says, “the standard will help ensure products are labeled properly in jurisdictions where they are legally produced and sold.”
  • D8399: This standard “will aid laboratories in analyzing cannabis and hemp samples to establish pesticide concentration levels – or lack thereof – to ensure products meet regulatory requirements within appropriate jurisdictions,” reads the press release.
  • D8442: This standard aids stakeholders in the cannabis supply chain with quality control measurements. It provides a method for testing terpenes and cannabinoid levels using gas chromatography.
  • D8469: This one provides a new metals testing method for cannabis using inductively coupled plasma mass spectrometry (ICP-MS).

David Vaillencourt will be discussing standards and more at the Cannabis Quality Conference on October 17. The fifth standard that ASTM International announced this week is D8439. This one is designed “to support sound and reproducible research” by providing specifications for medicinal-use cannabis flower. ASTM member David Vaillencourt says it will help establish consistent testing for safety and quality. “With a fragmented cannabis industry marketplace, there is no common set of requirements around reporting cannabinoids and terpenes, which are the primary constituents that are linked to therapeutic benefits,” says Vaillencourt. “This lack of consistency harms public health and prevents evaluation of product safety and efficacy across jurisdictions. This standard provides a solution to this problem.”

The post ASTM Debuts New Standards for Cannabis appeared first on Cannabis Industry Journal.


#CBD #Hemp

ASTM Debuts New Standards for Cannabis


October 12, 2022 5:38 pm

Partial abandonment of hope on DCC and marijuana

Partial abandonment of hope on DCC and marijuana

Yesterday, I posted a hope that the Dormant Commerce Doctrine does not apply to federally illegal cannabis.

My friend Rob Mikos, a law professor at Vanderbilt and probably the leading expert on marijuana federalism, graciously responded to an email copying that post, writing, “I agree with the policy argument, but not the legal one.”

He points out that the Dormant Commerce Doctrine is old and settled law, operating in the face of the 10thAmendment for centuries.  He’s the expert, so I’ll back off from any hope that as a practical matter the 10th Amendment will come to the rescue of state freedom here.

He says, “There’s a recognized solution to the policy problems the DCC is going to cause for cannabis – it’s to have Congress pass legislation suspending the Dormant Commerce Clause,” and links to this piece with Scott Bloomberg: https://digitalcommons.pepperdineedu/plr/vol49/iss4/2/.

I’m afraid Congress is too dysfunctional to get this right, so I’m wishfully hoping the courts can find a way. 


#CBD #Hemp
Partial abandonment of hope on DCC and marijuana
October 7, 2022 3:27 pm

The Dormant Commerce Clause and Marijuana

The Dormant Commerce Clause and Marijuana

The Dormant Commerce Clause cases that force states to accept out of state owners for local cannabis licenses strike me as wrongly decided.  

Congress’s faint, implied, “dormant” display of intention to open markets in an illegal substance to all comers seems dwarfed by the 10th Amendment’s express and overriding reservation of power to the states to do whatever the heck they want.  “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” The Constitution doesn’t prohibit states from regulating commerce – Congress can allow them to regulate commerce, though it rarely does.

From a policy perspective, too, discarding the Dormant Commerce Clause argument is helpful.  Congress doesn’t know how to do legalize cannabis.  In my field of tax, states are experimenting with all kinds of approaches, and there’s no consensus about which is best.  Some experiments haven’t even gotten underway.  But tax is just a small piece of the cannabis legalization puzzle:  There are tricky problems like testing and packaging where states are experimenting in many ways.  And states are experimenting with ways to share this new cannabis wealth, and to allow ownership for deserving parties.

So Congress is shrewdly waiting to figure out how to legalize before legalizing.   The freer the rein the states have, the more evidence Congress can examine.  Artificially restricting state experiments will not help the process.

Plus, when the profit motive is involved with sales of a problematic and federally illegal drug, isn’t it rational to think that local people might have more of a community spirit than outsiders?  Local people seem more likely to balance the profit motive with a spirit of looking after the good of the community in which they (but not outside investors) live.  

The DCC and cannabis are discussed here: https://ylpr.yale.edu/inter_alia/sleeping-giant-how-dormant-commerce-clause-looms-over-cannabis-marketplace#_ftn37


#CBD #Hemp
The Dormant Commerce Clause and Marijuana
October 6, 2022 2:16 pm

Ask the Experts: Ensuring the Validity of Cannabis Lab Testing

Ask the Experts: Ensuring the Validity of Cannabis Lab Testing

Cannabis testing laboratories are one of the major players in the industry for protecting public health. Ensuring that laboratory test results are reliable and valid requires a multipronged approach involving method validation, proficiency testing and performing frequent reviews of equipment and processes.

Cannabis testing laboratories often use a variety of different methods to conduct proficiency testing. Laboratories can either participate in programs run by ISO/IEC 17043-accedited proficiency testing providers or through intralaboratory comparison. Comparing different instruments, methods, technologies against pre-defined criteria is a must when validating methods for a specific type of test and ensuring the competence of the laboratory.

Beyond proficiency testing, there are a number of other stopgaps at a laboratory’s disposal for ensuring valid results, like using accredited certified reference materials, performing checks on measuring equipment frequently, reviewing reported results and retesting retained items. All of that and more is outlined in the ISO/IEC 17025:2017 standard, section 7.7.

labsphoto
What good is a test result if you cannot attest to its validity?

There’s a lot that goes into making sure laboratories provide valid results, much of which is detailed in the accreditation process. For more information, we sit down with Keith Klemm, senior accreditation manager for ANSI National Accreditation Board to learn about laboratory accreditation, method validation and other certifications and credentialing available in the cannabis industry.

Q: Why is method validation important for cannabis test methods? 

Keith Klemm: Because cannabis production, testing, and sales is regulated by each individual state, there are very few standard methods for testing cannabis and cannabis-derived products. Non-standard methods or methods developed by the laboratory must be validated to ensure the methods are fit for their intended purpose. What good is a test result if you cannot attest to its validity? There would be no confidence that the results are accurate. Additionally, while organizations such as ISO, AOAC and ASTM are developing standard methods for use in the laboratory, the wide range of products and matrices being tested require modifications to standard methods. Standard methods used outside their intended scope must also be validated, again to ensure the method remains fit for the intended purpose.

Q: We’re pretty familiar with laboratory accreditation. What other accreditations are available in the cannabis industry?

Klemm: Accreditation programs are available for product certification and personnel credentialing, in addition to laboratory accreditation. ANAB’s product certification program was launched in 2020 and is based on the requirements of ISO/IEC 17065. The program combines the requirements of this standard with specific scheme requirements to attest to the competency of certification bodies who then certify products within the scheme. Two schemes are in development specific to the cannabis industry: Cannabis Safety and Quality (CSQ) and PurityIQ. For personnel credentialing, a new Cannabis Certificate Accreditation Program (C-CAP) was developed and is based on ASTM D8403, Standard Practice for Certificate Programs within the Cannabis and Hemp Industries. It also includes any additional state Responsible Vendor Training requirements.

Q: What are the steps to becoming an accredited cannabis testing laboratory, product certification body, or C-CAP organization?

Klemm: The process begins with a request for quote. The organization prepares for the initial assessment by implementing the requirements of the applicable standards, regulatory requirements, and scheme requirements. ANAB believes in a partnership approach to accreditation with a focus on customer needs while ensuring accreditation requirements are met. Once the organization is ready, an initial document review is performed. The accreditation assessment is then performed on-site by technically skilled and knowledgeable assessors. If any nonconformities are encountered, the organization provides a response with cause and corrective actions. Once all nonconformities are resolved and technical review is completed, a scope of accreditation and certificate are provided to the organization. The technical review may vary depending on the accreditation that is being sought, but the general process of accreditation is the same. After accreditation is achieved, the organization moves into a cycle of surveillance and reassessment as defined by the accreditation program and any scheme requirements.

About Keith Klemm

Keith Klemm is a graduate of Manchester University with a B.S. in Biology.  Keith is an experience laboratory director and operations manager with 30 years’ experience in the laboratory environment and has worked as a senior accreditation manager for ANSI National Accreditation Board for the past five years.

Keith’s areas of expertise include:

  • Microbiological assays for food, medical device, and environmental test matrixes.
  • Environmental chemistry of water and wastewater.
  • Biocompatibility testing of medical devices.
  • ISO/IEC 17025:2017
  • AOAC International – guidelines for food laboratories program requirements
  • 21 CFR Part 58, GLP program requirements
  • EPA NLLAP program requirements
  • AAFCO program requirements
  • FDA ASCA Pilot program for Biocompatibility
  • Michigan Cannabis Regulatory Agency program requirements
  • ISO 20387 Biobanking

The post Ask the Experts: Ensuring the Validity of Cannabis Lab Testing appeared first on Cannabis Industry Journal.


#CBD #Hemp

Ask the Experts: Ensuring the Validity of Cannabis Lab Testing


September 30, 2022 3:15 pm

Unanswered questions about cannabis taxation

Unanswered questions about cannabis taxation

Tax THC with a CBD offset? Maybe not so fast.

Studies [the link is to an article with an impressive number of authors] have shown that the THC:CBD ratio also influences the level of psychoactivity experienced by cannabis consumers. For infrequent cannabis consumers, when CBD is present at much higher levels than THC, intoxication is reduced compared to THC alone. Conversely, consumption of THC (8 mg) together with half as much CBD (4 mg) enhances the intoxicating effect, but only for infrequent consumers. In people who frequently consume cannabis, the intoxicating effects of THC don’t change much when combined with CBD. This indicates that the psychoactive effects of cannabis can change based on the THC:CBD ratio in a way that depends on your level of consumption experience.”

That’s from  https://www.leafly.com/news/science-tech/the-entourage-effect-does-it-really-exist (which I don’t vouch for or criticize).

Leave aside CBD offsets. Even for a THC tax, I have a lot of questions.

In trying to assign a tax burden, in dollars and cents, to the sale of a particular product, is “intoxication” the negative externality or phenomenon we want to target and burden?  “Psychoactivity”?  If so, can we measure the phenomenon targeted?  That is, can we assign numbers to such a phenomenon?   

Maybe not, but even if we can assign numbers to negative externalities, how might those numbers correspond to consumption of the product sold?  (This is your tax person looking for an answer in dollars and cents.  For tobacco, the externalities seem understandable enough that our weight-based $1.01 per pack federal tax on cigarettes seems to make some sense. Cannabis is trickier.)  Is there some level of cannabis intoxication or psychoactivity that’s mostly harmless?  (For alcohol use, there seems to be a relatively harmless level of intake for a given day – if it stops there.)  What if different consumers, as the article suggests, react differently to different products?

What if instead of “intoxication” or “psychoactivity” we want to burden “impairment”?  So far, is there any kind of quantifiable road-side alcohol test analog for cannabis driving impairment that is satisfactory enough to put to rest the use of blood and urine tests – whose main virtue is that they give precise numbers?  (Today’s Wall Street Journal goes into detection of impairment by law enforcement.  https://www.wsj.com/articles/welcome-to-the-worlds-oddest-pot-party-thrown-by-the-local-police-11663597103?page=1 shows police considering subjects walking in a line, focusing on a close object, counting to 20 (one subject who drank alcohol too skipped from 16 to 19), and using a driving simulator.)

Beyond current impairment (or whatever), how about other problems, like youth use?  Tax-targeting sales of products that appeal to youth might look at marketing or something unrelated to THC, but other than the 280E denial of deductions for advertising and marketing expenses, there’s no way to target youth use so far, or is there?  

Do certain products (like high-THC products) lead (more than others) to cannabis hyperemesis syndrome?

Do certain products lead (more than others) to substance use disorder in the long run?  Can we assign a dollar-and-cent tax burden to sale of a product on the basis of its potential to create negative externalities that may take years to develop?  Are high-THC products especially dangerous on this score?

Do certain products lead (more than others) to whatever caused former California Governor Jerry Brown to worry, “how many people can get stoned and still have a great state or a great nation?”? 

Do sales of some products deserve a tax break because the products inherently tend to be medical rather than recreational?

What about components beyond delta-9 THC, like delta-8 and THC-O?

+++

Enough questions.  Even if we tax alcoholic beverages on the basis of pure ethanol (like the federal tax on spirits), then each milliliter of ethanol bears an identical tax, but doesn’t create identical negative externalities – or even necessarily similar blood alcohol content. If people somewhere are forced, Orwell-style, to have chips inserted in their bodies, maybe some tax authority will try to collect tax on drivers (as a safety measure) or consumers (as a standard sumptuary tax) on the basis of blood alcohol content.  But even that science fiction scenario wouldn’t solve the problems with cannabis.  I don’t know what we might want to measure, and I don’t know how to measure anything we might want to measure.


#CBD #Hemp
Unanswered questions about cannabis taxation
September 20, 2022 5:31 pm

Revenue policy to share cannabis wealth and allow home grows

Revenue policy to share cannabis wealth and allow home grows

An increasing per-plant or per-square foot fee — as the only marijuana revenue government gets — is still possible in newly legalizing states.

The lack of legal interstate commerce in cannabis in the United States offers opportunities for states to experiment.  Some say courts will use the Dormant Commerce Clause to open up interstate commerce without Congressional action.  That would bring an end to many state tax experiments.  https://newtax.files.wordpress.com/2022/05/federal-shake-up-2022-april-4-tax-notes-oglesby.pdf

With imports and exports illegal,  a closed loop jurisdiction is in place.  In a closed loop jurisdiction, taxes can be imposed anywhere in the supply chain, from the farm or “grow” to the retail cashier – it doesn’t matter where.

For instance, this method of sharing cannabis wealth and allowing home marijuana grows will work only in a closed loop jurisdiction: 

Everyone 21+ can have a grow license.

There are no taxes, and there is only one fee.

Per plant fee:
$1x for the 1st plant
$2x for the 2nd
$4x for the 3rd
$8x for the 4th
$16x for the 5th
& so on.

x=1? 5? 10? . . .

Doubling is easy to understand, but rather than doubling for each plant, the ratio could be smaller:  1.5 instead of 2?  1.2 instead?

And rather than number of plants, the fee could work off grow area, with exponentially increasing rates as grow area expanded.

And we’d need enforced anti-aggregation rules, which the Tax Code has developed well, to prevent people from disguising true ownership.

This kind of fee is realistic only in states that have not legalized commerce yet.  Or in nations that won’t allow imports.  (Who knows?  With narcotics treaties still in place, maybe the United States won’t allow imports after legalization.)

But if you favor wealth sharing and home growing, interstate commerce would kill this kind of revenue plan, as imported products wouldn’t be grown in the state at all.  Courts looking at interstate commerce in commerce should understand that it would end all kinds of state experiments, experiments that the federal government should be encouraging, and that federal prohibition indirectly encourages thanks to the existence of closed loop jurisdictions.


#CBD #Hemp
Revenue policy to share cannabis wealth and allow home grows
September 16, 2022 12:11 pm

Fly By Night: Do Your Gummies Take the Red-Eye?

Fly By Night: Do Your Gummies Take the Red-Eye?

The global vitamin supplement market is projected to grow at 6.2% compound annual growth rate (CAGR) to $71.37 billion by 2028 with the most rapid growth now occurring in the gummy vitamin segment. Gummy supplements are expected to have the fastest CAGR at 12.6% to exceed $33 billion by 2028. Initially developed for youths, gummies are now preferred by all age segments as an alternative to tablets, capsules and pills.

As one might expect, cannabidiol (CBD) gummies are also projected to grow rapidly at a 30.7% CAGR to $13.9 billion by 2028. In terms of actual number of CBD gummies produced last year, a rough estimate would be at least 1.7 billion. For perspective that equates to 53 gummies produced every second, 24 hours a day, 365 days per year. One might reasonably ask, “So where do all these gummies come from?” and “Who makes them and under what conditions and quality assurance standards?

There is no short answer to these questions nor confidence that all cannabinoid gummies are manufactured with adherence to a minimum set of safety and quality standards. Gummy recipes and ingredients are readily available online and there is no shortage of hobbyists who make small batches for family, friends and to sell at retail pop-ups and farmers’ markets. There are a number of well-known brands that started out in home kitchens and garages. In terms of production scale, on the other end of the spectrum are companies like Bloomios, Inc. (OTCQB: BLMS), that operates a 51,000-square-foot Current Good Manufacturing Practices (cGMP) compliant facility in Florida.

The Hobbyists

A variety of CBD products on the market today

For the hobbyist producer, they often begin to scale out of their home kitchen and take over part of their garage or basement and while the entrepreneurial spirit is admirable, most consumers wouldn’t be comfortable with their pharmaceuticals, supplements or even grocery items being manufactured under these conditions which often lack:

  • Rigorous sanitary practices
  • Measures to mitigate contaminants entering the production areas
  • Quarantine, chain-of-custody audit and testing of active ingredients used in production
  • Standardized and rigorous quality assurance testing of finished product
  • Certificate of Analysis (COA) for active ingredients in finished product for certainty of dosage levels
  • Labeling and packaging standards to ensure product information and volumes are correct
  • Batch record data collection, retention and audit procedures.

However, the hobbyists constitute only a very small fraction of gummy production today, and they typically take great pride in their work and show a high degree of care in production practices. Thus, when demand begins to outpace the artisanal home production capacity, many growing brands turn to contract manufacturers to assist with scaling the production side while the brand focuses on the sales, marketing and distribution side of the business. This is an ideal solution as high quality product can be produced at volume in cGMP facilities which enhances the consumer experience, confidence in the product and further grows brand value. This is a best-case scenario of small emerging brands that care deeply about their reputations and their customers’ experience scaling production and growing responsibly.

The Opportunists

The real underbelly of commercial gummy production is characterized by the pure profit seeking producers that set up semi-permanent production lines in flex-industrial spaces not suitable for food handling, with limited buildout for isolation of each production stage. This process includes: materials storage, weight/measures prep, ingredient mixing, molding, dehydration, coating, sorting and filling, labeling and finish packaging. Lacking cGMP compliant facilities and practices, they neglect or fail entirely to maintain batch records, COAs or chain-of-custody practices and have limited ability to address defective product once in the stream of commerce. Let’s refer to these manufacturers as the “Opportunists.

Opportunists see the current cannabinoid gummy market for what it is. It is an emerging market really taking form only since the 2018 Farm Bill legalized hemp derived cannabinoids. As such it is very much in its “gold rush” phase with many of the participants having just entered the sector. Many participants have adopted ad hoc practices with no standardization and no explicit federal oversight because the FDA has yet to acknowledge any cannabinoids under its generally regarded as safe (GRAS) standard.

FDAlogoIn addition, the FDA has excluded CBD products from the dietary supplement definition of the Food, Drug and Cosmetics (FD&C) Act. Under the FD&C Act, if a substance is an active ingredient in a drug product that has been approved or has been authorized for investigation as a new drug, then products containing said substance are excluded from the definition of dietary supplement. So far cannabinoid gummy demand has continually outstripped supply supporting attractive margins and with little oversight. The Opportunist mindset has focused on maximizing profits while they can before regulation increases costs, compresses margins and reduces profits.

The Opportunists have more cover to seek profit maximization as opposed to incurring the cost of setting up cGMP facilities and adhering to rigorous standards due to the fact that the brands consumers recognize are often manufactured by one or more third-party contract manufacturers. Some brands also want to maximize near-term profits and manufacturers with a lower cost structure can more effectively compete on price as opposed to quality.

As demand surges, some brands will supplement their third-party cGMP produced product with additional product sourced from Opportunists and “recycle” the valid COAs from their cGMP product without the cGMP manufacturer or consumers even knowing. With lax regulatory oversight, these brands are inclined to look the other way on their contract manufacturer’s production practices so long as the large volume orders are delivered on time and at lower cost.

GMPFor gummies produced by Opportunists, if there are product defect issues, the consumers likely won’t be able to rely on the batch record data and purported COAs linked to/from QR codes on the container, many of these COAs have been recycled from legitimate batches or simply doctored up and reproduced rather than generated on a per batch basis. There is limited to no audit trail and recalls are unlikely to be effective, if even initiated. A refund is the most likely solution a consumer has which leaves perhaps a much larger run of defective product in the market still unaddressed. Moreover, brands that suffer reputational harm due to quality issues can simply launch a substitute brand with a similar look through its same distribution channels and maintain much of its market share.

Best Practices

If today’s CBD gold rush sounds much like the Wild West, you would be correct. However, as more consumers become aware of cannabinoids’ health and wellness benefits in addition to the recreational uses, this larger and more diverse consumer base is raising the bar and demanding more transparency and certainty on manufacturing practices than ever before.

americana dummies
A roughly estimated 1.7 billion CBD dummies were produced last year

How are the leading cannabinoid nutraceutical manufacturers proactively addressing consumers’ desire for high quality, rigorously tested products manufactured in accordance with standards already imposed on mainstream nutritional supplement and prepared food manufacturers? Although the answer may be simple, the implementation and ongoing compliance is not.

The answer is voluntary adoption and compliance with the same regulations applicable to non-cannabinoid dietary supplement manufacturers. Given that the FDA has not recognized cannabinoids as dietary supplements quite yet, certain aspects of dietary supplement regulation can’t be adhered to such as notifying the FDA of structure/function claims as new products are brought to market or notice of new dietary ingredients. On the other hand, many of the regulations can and should be adhered to by cannabinoid nutraceutical manufacturers to ensure its safe, transparent orderly growth.

Chief among the FDA requirements that Bloomios and other leading manufacturers adhere to are:

  • Register with the FDA as a food handling and production facility.
  • Adopt Current Good Manufacturing Practices for dietary supplements which establishes uniform standards needed to ensure quality throughout the manufacturing process and verification of the identity, purity, strength and composition of their products.
  • Undertake at least annually an independent third-party cGMP audit of their facility and procedures.
  • Comply with Code of Federal Regulations (21 CFR 101.36) supplement label requirements to ensure that the ingredients list is accurate, and the content matches the amount declared on the label among other disclosures.

The most significant challenge in adopting all of the above best practices is cGMP facility qualification and ongoing compliance. The cGMP standards require specific facility build-out features, equipment, and of course standard operating procedures. There are significant additional costs to bring a cGMP facility on-line, additional time and required experienced personnel that can implement the operating procedures and recertification every time a production line’s configuration is changed or augmented with additional equipment.

Bloomios annual cGMP audit was conducted in August and over 130 specific requirements were evaluated and graded. While Bloomios passed the audit and evaluation, what is of far greater significance is that cGMP practices become part of a company’s culture so that these high standards are maintained year-round and not rushed into practice just for the audit.

The post Fly By Night: Do Your Gummies Take the Red-Eye? appeared first on Cannabis Industry Journal.


#CBD #Hemp

Fly By Night: Do Your Gummies Take the Red-Eye?


August 31, 2022 3:46 pm

Intimate Care Products with Cannabinoids Need More Safety Data

Intimate Care Products with Cannabinoids Need More Safety Data

Cannabinoid products for intimate care use are now being sold in the unregulated cannabidiol (CBD) marketplace without proper evaluation of their impact on the vaginal microbiota or women’s health. Cannabinoids can exhibit complex and at times contra intuitive actions. The addition of CBD to these products is presumably for its anti-inflammatory pain-relieving qualities even though little is understood with regards to dosing and formulating. Moreover, in states where cannabis is legal, tetrahydrocannabinol (THC) along with other minor cannabinoids are also being added to intimate care products without purview of any federal agency. In general, the impact of vaginal products on vaginal microbiota is poorly understood. Ten years ago, Jespers et al. (2012) proposed to monitor lactobacilli indicator species of the vaginal microbiota in safety trials of intimate care products. Yet today, human safety data are not required prior to commercialization of intimate care products which are currently regulated like cosmetics except for lubricants which do require a 510K filing with the FDA.

The vaginal microbiota (VMB) of healthy women is dominated by Lactobacillus species, which exert important health-promoting effects to their host through the production of antimicrobial compounds, including hydrogen peroxide and lactic acid, to prevent invasive microbes from establishing in the vaginal epithelial mucosa (Pino et al. 2019). It was established almost 40 years ago by Speigel et al. (1983), that changes to the dominant Lactobacillus species, a process called dysbiosis, and overgrowth by diverse anaerobes can result in symptomatic conditions including bacterial vaginosis (BV), vaginal candidiasis, pelvic inflammation, and endometriosis (Taylor et al. 2013). The conditions resulting from dysbiosis are also linked to fertility problems, poor pregnancy outcomes, spontaneous miscarriages and preterm birth (Laniewski et al 2020).

An example of an infused intimate care product, the Foria Awaken Arousal Oil with CBD

Complications from dysbiosis of the reproductive tract can be serious in women wanting to become pregnant and in already pregnant women, including preterm premature rupture of membranes, spontaneous preterm labor and preterm birth (Ventolini et al. 2022). Reproductive tract microbiomes from idiopathic infertile women differ from fertile women’s VMB (Tomaiulol et al. 2020; Wee et al. 2018). Numerous studies have documented the vaginal community type microbiota associated with occurrence of BV around the world showing that HIV load is inversely proportional to lactobacilli species but positively correlated with BV (Sha et al 2005) as well as endometrial and ovarian cancer development (Walther- Antonio et al. 2016; Zhou et al. 2019).

Sexual lubricants often contain antimicrobial preservatives that have been shown to directly impact lactobacilli species in the cervicovaginal microbiome. The deterioration or absence of the lactobacilli-dominated vaginal mucosal biome through exposure to over-the-counter lubricants has been linked to increased incidence of BV (Brotman et al. 2010) and release of IL-8, a proinflammatory innate immunity mediator, produced by human epithelial cells to recruit leukocytes in response to infection, initiating an inflammatory response (Fashemietal.2013). The addition of under-researched cannabinoids to these products introduces the potential for further biological activity. Cannabinoids are widely reported to exhibit anti-microbial activity in vitro. The mechanism of CBD’s anti-microbial activity is thought to be due to its ability to intercalate into cytoplasmic membranes (Guard et al. 2022) and thereby modulate membrane vesicle (MV) release from bacterial cells which is associated with cell-to-cell communications (Kosgodage et al. 2019). Treatment of the gram-negative bacteria, E. coli, with CBD inhibited MV release and resulted in higher susceptibility to antibiotics but had minimal impact on gram- positive bacterial MV release. And CBD has recently been documented to inhibit the common human fungal pathogen, Candida albicans, from forming biofilms due to increased membrane permeability, reduced ATP levels, and modified cell walls (Feldman et al 2021).

In other reporting, the in vitro antimicrobial properties of CBD were demonstrated to have selective activity across a wide range of gram-positive bacteria, including several antibiotic resistant and anaerobic strains, with minimum inhibitory concentrations (MIC) in the low ppm range (Blaskovich et al. 2021). The conditions of a study impacted the observation of inhibition; for example, if human sera were present in the assay media, the antibacterial activity was drastically reduced. This has been attributed to CBD’s propensity to bind to non-specifically to proteins and thereby become unavailable (Tayo et al. 2018). Surprisingly, CBD does not exhibit broad antibacterial activity against Gram-negative species except against the human pathogens: Neisseria gonorrhoeae, N. meningitides, Moraxella catarrhalis, and Legionella pneumophila (Blaskovich et al. 2021). Bacteria do not develop resistance to CBD, but CBD is also non-systemic because of its high serum binding activity (Tayo et al. 2018).

The active ingredients in intimate care products can impact beneficial microorganisms but also deleterious ones. CBD has become a widespread, understudied active ingredient for women’s health. Today the molecular screening tools exist to conduct large scale epidemiological studies to further understanding of the consequences of dysbiosis and document the adverse effects on women’s reproductive health outcomes. Preventative treatments to reestablish dominant lactobacilli, in particular L. crispatus could have big impacts on not only women’s health but public health (Borgdorff et al. 2014).

As Ley R (2022) recently opined on the human microbiome, “there is much left to do.” Microbiomes are essential to the proper functioning of our bodies affecting social engagement, mental health, obesity, and disease states, and little is known about differences in microbiota across different groups of humans. More research is needed on the biological activity of cannabinoids as well as regulatory oversight to protect the health and safety of consumers.


References

  1. Blaskovich MAT, Kavanagh AM, Elliott AG, Zhang B, Ramu S, Amado M, Lowe GJ, Hinton AO, Thu Pham DM, Zuegg J, Beare N, Quach D, Sharp MD, Pogliano J, Rogers AP, Lyras D, Tan L, West NP, Crawford DW, Peterson ML, Callahan M, Thurn M (2021) The antimicrobial potential of cannabidiol. Commun Biol 4:7
  2. Borgdorff J, Tsivtsivadze E, Verhelst R, Marzorati M, Jurrrians S, Ndayisaba GF, Schuren FH, van de Wijgert J HHM (2014) Lactobacillus-dominateed cervicovaginal microbiota associated with reduced HIV/STI prevalence and genital HIV viral load in African women. The ISME J 8:1781-1793.
  3. Brotman RM, Ravel J, Cone RA, Zenilman JM. (2010) Rapid fluctuation of the vaginal microbiota measured by Gram stain analysis. Sex Transm Infect 86(4):297-302.
  4. Fashemi B, Delaney MA, Onderdonk AB, Fichorova RN (2013) Effects of feminine hygiene products on the vaginal mucosal biome. Microbial Eco in Health & Disease 24:19703-08.
  5. Feldman M, Sionov RV, Mechoulam R, Steinberg D (2021) Anti-biofilm activity of cannabidiol against Candida albicans. Microorganisms 9:441-457.
  6. Ilha EC, Scariot MC, Treml D, Pereira TP, Sant’Anna ES, Prudencio ES, Arisi ACM (2015) Comparison of real-time PCR assay and plate count for Lactobacillus paracasei enumeration in yoghurt. Ann Microbiol 66:597-606.
  7. Jespers V, Menten J, Smet H, Poradosu S, Abdellati S, Verhelst R, Hardy L, Buve A, Crucitti T (2012) Quantification of bacterial species of the vaginal microbiome in different groups of women, using nucleic acid amplification tests. BMC Microbiol 12:83.
  8. Kosgodage U et al. (2019) Cannabidiol is a novel modulato of bacterial membrane vesicles. http://doi.org/10.3389/fcimb.2019.00324.
  9. Laniewski P, Ilhan ZE, Herbst-Kralovetz MM (2020) The microbiome and gynaecological cancer development, prevention, and therapy. Nat Rev Urol 17(4):232-250.
  10. Laniewski P, Owen KA, Khnanisho M, Brotman RM, Herbst-Kralovetz MM (2021) Clinical and personal lubricants impact growth of vaginal Lactobacillus species and colonization of vaginal epithelial cells: an in vitro study. Sex Transm Dis 48(1):63-70.
  11. Ley R (2022) The human microbiome: there is much left to do. Nature p. 435
    Pino A, Bartolo E, Caggia C, Cianci A, Randazzo CL (2019) Detection of vaginal lactobacilli as probiotic
  12. candidates. Sci Rep 9:3355
  13. Sha BE, Zariffard MR, Wang QJ, Chen HY, Bremer J, Cohen MH, Spear GT (2005) Female genital-tract HIV load correlates inversely with Lactobacillus species but positively with bacterial vaginosis and Mycoplasma hominis. J Infect Dis 191:25-32.
  14. Spiegel CA, Davick P, Totten PA, Chen KC, Eschenbach DA, Amsel R, Holmes KK (1983) Gardnerella vaginalis and anaerobic bacteria in the etioloty of bacterial (nonspeecific) vaginosis. Scand J Infect Dis Suppl 40:41- 46.
  15. Taylor BDP, Darville T, Haggerty CL (2013) Does bacterial vaginosis cause pelvic inflammatory disease? Sex Transm Dis 40:117-122.
  16. Tayo B. (2018) Exploration of the potential for plasma protein binding displacement and drug-drug interactions of valproate in combination with cannabidiol [abstract] Amer Epilepsy Soc Ann Mtg. New Orleans LA.
  17. Ventolini G, Vieira-Baptista P, DeSeta F, Verstraelen H, Lonneee-Hoffmann R, Leeev-Sagie A (2022) The vaginal microbiome: IV. The role of vaginal microbiome in reproduction and in gynecologic cancers. J Lower Genital Tract Dis 26(1):93-98.
  18. Walther-Antonio MRS, Chen J, Multinu F et al. (2016) Potential contribution of the uterine microbiome in the development of endometrial cancer. Genome Med 8:1-15.
  19. Zhou B, Sun C, Huang J et al. (2019) The biodiversity composition of microbiome in ovarian carcinoma patients. Sci Rep 9:1691.

The post Intimate Care Products with Cannabinoids Need More Safety Data appeared first on Cannabis Industry Journal.


#CBD #Hemp

Intimate Care Products with Cannabinoids Need More Safety Data


August 22, 2022 5:25 pm

ASTM Approves New Cannabis Standards

ASTM Approves New Cannabis Standards

According to a press release sent out today, ASTM International’s D37 cannabis committee has approved three new standards for environmental conditions during packaging, shipping and storing cannabis and hemp flower. The three new standards are:

  • Standard Specification for Environmental Conditions for Post Packaged Storage and Retail Merchandising of Cannabis/Hemp Flower (soon to be published as D8423);
  • Standard Specification for Environmental Conditions While In-Transit for Packaged Cannabis/Hemp Flower (soon to be published as D8432); and
  • Standard Specification for Environmental Conditions While Packaging Cannabis/Hemp Flower (D8450).

ASTM members will be presenting at the Cannabis Quality Conference & Expo, October 17-19 in New Jersey. Click here for more information. Jonathan DeVries, a member of ASTM, says these standards are designed for the entire cannabis supply chain, from cultivation, manufacturing and transportation all the way to the end consumers. “These standards are designed to support the safety and quality of packaged cannabis and hemp flower as it moves through the supply chain,” says DeVries. “This includes the activities following curing and drying, namely packaging, transit, and storage, until it reaches the final end user.”

The ASTM D37 committee is working on a number of other standards related to these and they invite anyone interested to share their feedback.

The post ASTM Approves New Cannabis Standards appeared first on Cannabis Industry Journal.


#CBD #Hemp

ASTM Approves New Cannabis Standards


August 9, 2022 4:04 pm

FluxxLab LLC – 637158 – 08/04/2022

FluxxLab LLC – 637158 – 08/04/2022 FluxxLab LLC – 637158 – 08/04/2022 Anonymous (not verified) Thu, 08/04/2022 – 13:05

Company Name

FEIN

Short Title
FluxxLab LLC

WARNING LETTER

RE: 637158

Date: August 4, 2022

TO: 
Arend John Kuijvenhoven
FluxxLab LLC
Arendis, LLC
6124 County Road 5
Ridgeway, CO 81432

RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

This is to advise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address https://fluxxlab.com/ on July 12, 2022, and August 1, 2022, respectively. The FDA has observed that your website offers the Covid-19 Immune Support Tincture and the CBDA+CBD Oil Tincture products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.2 In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.3 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

Some examples of the claims on your website that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:

 “CBD+CBDa
Immune Support
Special Formulation
In a recent study, CBDa was examined to determine how cannabinoids interact with Covid-19.
Researchers discovered that cannabidiolic acid, also known as CBDA, binds to the spike protein of SARS-CoV-2, the virus that causes Covid-19.
As the compounds bind to the spike protein, they prevent the virus from infecting cells and causing infection, opening up new avenues for the prevention and treatment of the disease.” [From your webpage https://fluxxlab.com/product-category/cbda/]

 “Special
Immune Support Formulation
See Covid-19 Research”

“Researchers have very recently discovered that CBDa, and CBGa bind to the spike protein of SARS-CoV-2, the virus that causes Covid-19.
As the compounds bind to the spike protein, they can prevent the virus from infecting cells and causing infection.”

The product name: “Covid-19 Immune Support” [From your webpage https://fluxxlab.com/product/cbda-cbga-immune-support-special-formulation/]

You should take immediate action to address the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA’s implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act. Within 48 hours, please send an email to [email protected] describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction.

FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products. Once you have taken actions to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.

This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. 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 are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.

Please direct any inquiries to FDA at [email protected]

FTC Cease and Desist Demand: In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the products identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction and an order may require that you pay back money to consumers. In addition, pursuant to the COVID-19 Consumer Protection Act, Section 1401, Division FF, of the Consolidated Appropriations Act, 2021, P.L. 116-260, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of COVID-19 are subject to a civil penalty of up to $46,517 per violation and may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b). Within 48 hours, please send an email to Richard Cleland, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at [email protected] certifying that you have ceased making unsubstantiated claims for the products identified above. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088.

Sincerely,
/S/

Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

Sincerely,
/S/

Serena Viswanathan
Associate Director
Division of Advertising Practices
Federal Trade Commission

_____________

1 As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).

2 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.

3 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.

Fri, 08/05/2022 – 10:00
Review Date
Sat, 08/05/2023 – 10:00

Source Organization

Recipient Name
Arend John Kuijvenhoven

Last Reviewed Date
Fri, 08/05/2022 – 10:00

Site Structure

Letter Issue Date
August 04, 2022

Federal Trade Commission
Issuing Office Building Name
Center for Drug Evaluation and Research | CDER

Next Review Date
1 Year

Detailed Description
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

[email protected]
MARCS CMS ID

Bulk Approved
Off

Address

United States

Display Short Description
Off

Regulated Product*

Sender Address

United States

Recipient Address

1681 Niagara Rd.
Montrose, CO 81401
United States

Language

Address

United States

Add Subscription Box
Off

#CBD #Hemp http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fluxxlab-llc-637158-08042022 August 4, 2022 5:05 pm

Transportation & Supply Issues in Cannabis Staffing: How to Get Unstuck

Transportation & Supply Issues in Cannabis Staffing: How to Get Unstuck

Anyone in cannabis will tell you that complex transportation and supply issues are stalling industry growth and impacting employers’ ability to hire teams for the critical roles that keep product moving on schedule.

Since the onset of COVID-19 in March 2020, global and domestic supply chains have suffered bottlenecks caused by ever-changing public health policies and ongoing materials and labor shortages. While the status of transportation as an essential business kept other essential sectors, such as cannabis and grocery, chugging along, the current situation is still challenging.

Transportation remains the biggest supply-side problem, with the American Trucking Association reporting a shortage of an estimated 80,000 truckers in October 2021. The Bureau of Labor Statistics also continues to report high numbers of job openings across supply-chain jobs such as warehousing and transportation.

Cannabis businesses, from multistate operators to distributors to delivery service startups, are hardly immune to these issues. In fact, they face the additional hurdle of restrictive federal regulations, including the illegality of transporting cannabis across state borders. For example, this stipulation means that the over-saturation of flower in California cannot be addressed in a naturally symbiotic manner by shipping to states whose markets demand more flower, such as Arizona and New Mexico.

In the aggregate, these challenges impact employers’ operational and logistics goals and diminish candidates’ interest to work in a highly scrutinized industry. Many trucking companies have found it a challenge to attract drivers. Low pay, grueling schedules, and zero-tolerance cannabis testing for drivers despite legalization have led to an exodus of truckers in the U.S. and Canada.

Despite these obstacles, cannabis employers can still embrace smart strategies to attract quality employees and create much-needed stability to thrive in the rapidly changing marketplace.

Cannabis, COVID & the Great Resignation

In recent months, when it seemed America was finally emerging from COVID’s long shadow, the Great Resignation dampened business optimism. Employee turnover hit cannabis hard—especially in California, where other challenges like a thriving illicit market, high taxes and wholesale price compression have impacted companies’ ability to operate smoothly. Transportation and supply issues compound the problems.

For example, even transporting federally legal hemp in California and elsewhere has its headaches. Our company’s trimmer certification course uses hemp for training purposes. We ship the hemp directly to students’ homes so they can participate in virtual training sessions. Although our company has certified that the course packet contains only hemp, the U.S. Postal Service (USPS) will not ship it, regardless of whether the delivery location is in or out of state. We therefore must rely on a private carrier to transport the course packets to class participants, which is more time consuming and costly

Staffing Strategies for Transportation & Supply Jobs

Cannabis employers have several traditional and non-traditional tools at their disposal to address transportation and supply-related staffing.

While standard ecommerce jobs are synonymous with turnover, here lies an opportunity for cannabis operators to differentiate themselves. This is the cannabis industry, after all, and plenty of individuals who might not normally be interested in the transportation or supply aspect of ecommerce, might be far more open to those types of roles if they know the jobs involve cannabis.

What can employers do to attract these more receptive candidates to their organizations? Hone in on workers who have a passion for the plant. In job descriptions, position cannabis messaging front and center and conduct outreach through LinkedIn groups and other social media platforms to groups and individuals that have a cannabis focus.

Salary and Benefits

These days, a competitive salary simply is not enough to entice the right employees. A solid benefits package goes a long way to establishing trust between employers and employees and provides employees with a level of comfort and reassurance that they are supported during these tumultuous times. For example, companies must prioritize healthcare benefits and consider including coverage for part-time workers on the supply side of the cannabis industry.

Bonuses

Bonuses are another great way to catch the eye of potential employees, but bonuses must be developed within a framework designed for retention. Cannabis employers who establish performance bonuses and loyalty bonuses also increase that ever-important aspect of trust within their companies.

Safety

A transparent and robust HR plan that addresses safety concerns—COVID and beyond—can affect employees’ comfort for certain supply or transport positions that may involve increased public exposure or enhanced personal safety risks. Be clear with employees about the system that’s in place to support them in the event of unforeseen emergencies or injuries.

Procedures

Cannabis employers should also be aware of the importance of having compliance-focused internal transportation standard operating procedures and protections for employees. These policies can be a key factor in attracting both drivers and additional transport and supply experts from other regulated transport industries such as food, agriculture and pharmaceuticals. Candidates without a cannabis background will be more drawn to companies that provide a well-developed and safe infrastructure.

Smart Cannabis Staffing Solutions: The Time is Now

Federal cannabis legalization is coming, and with that nationwide sea change other issues in cannabis supply and transport will emerge. How will cannabis transport consolidate? Will the nation’s top carriers simply take over?

Regardless of what those answers might be, the need to embrace smart staffing solutions now is imperative. Providing a solid base wage with health benefits, and making it clear to current employees and job candidates that there’s an internal infrastructure of support—from HR to loyalty bonuses—is the best way to tackle the transportation and supply issues to position your company for future success.

The post Transportation & Supply Issues in Cannabis Staffing: How to Get Unstuck appeared first on Cannabis Industry Journal.


#CBD #Hemp

Transportation & Supply Issues in Cannabis Staffing: How to Get Unstuck


July 28, 2022 4:34 pm

Senators Introduce Cannabis Administration and Opportunity Act

Senators Introduce Cannabis Administration and Opportunity Act

Senate Majority Leader Chuck Shumer (D-NY), Sen. Cory Booker (D-NJ) and Sen. Ron Wyden (D-OR) introduced the Cannabis Administration and Opportunity Act (CAOA), a bill that seeks to decriminalize cannabis and end prohibition as we know it. About a year ago, the same lawmakers held a press conference where they unveiled their first draft of the CAOA, calling on the public for comments and input.

In that press conference last year, Sen. Booker emphasized the need to address social equity and restorative justice, laying out the foundation for what would soon be called the most comprehensive piece of cannabis legislation so far.

Sen. Schumer unveiling the Cannabis Administration and Opportunity Act last year.

According to the Minority Cannabis Business Association (MCBA), the bill succeeds in doing that, offering a number of provisions that would help those most impacted by cannabis prohibition, offer funding for equity programs, support for minorities in the cannabis market and more. “The CAO Act represents a giant leap forward in federal cannabis policy by outlining the most meaningful solutions to address issues facing minority cannabis businesses we’ve seen in a federal legalization bill to-date,” says Kaliko Castille, president of MCBA.

Notable provisions in the bill also include:

  • Removes cannabis from the Controlled Substances Act scheduling entirely.
  • Allows states to implement their own policies without the federal government interfering.
  • Allows cannabis businesses access to financial services, removes the threat of 280E tax code impacting normal business deductions.
  • Regulatory responsibility would fall under the authority of the Alcohol and Tobacco Tax and Trade Bureau (TTB), the Food and Drug Administration (FDA).
  • Immediate expungement for prior cannabis convictions and cancellation of any sentencing for those incarcerated for cannabis.
  • Raise allowable THC content in hemp from 0.3% to 0.7%.
  • Sets up a pilot program with the Small Business Administration (SBA) for minority-owned and economically disadvantaged cannabis businesses.
  • High taxes: Up to a 25% federal excise tax on top of state cannabis taxes.

The post Senators Introduce Cannabis Administration and Opportunity Act appeared first on Cannabis Industry Journal.


#CBD #Hemp

Senators Introduce Cannabis Administration and Opportunity Act


July 21, 2022 6:12 pm

The Dormant Commerce Clause and Marijuana 

The Dormant Commerce Clause and Marijuana 

Whatever we think of judge-made law attempting to read Congress’s unexpressed mind, allowing states to restrict commerce in something the federal government expressly refrains from legalizing (because it doesn’t know how ) helps the goal of allowing states to run experiments, even bad ones, with all the freedom we can muster , as we try to figure out how to legalize federally.  Let the Labs of Democracy percolate.

And wouldn’t Congress opposed to marijuana applaud any restrictions states might put on?


#CBD #Hemp
The Dormant Commerce Clause and Marijuana 
July 12, 2022 9:55 pm

The Man Behind MXXN: An Interview with CEO and Founder Darnell Smith

The Man Behind MXXN: An Interview with CEO and Founder Darnell Smith

Hangovers are one of the aftereffects often experienced with spirits. Who doesn’t love a good martini or a refreshing margarita? One company is on a mission bring the flavor profile and buzz of spirited drinks without the negative consequences.

Like this article and want to see more? Subscribe to our free newsletter hereMXXN is a California-based cannabis infused beverage manufacturer specializing in 1:1 non-alcoholic replacements for everyone’s favorite spirits, enhanced with a touch of cannabis. By combining new technology in cannabis oil nano emulsions and alt-alcohol, MXXN is able to create flavor matching spirits sold by the 750 mL bottle. MXXN recently launched with three product SKUs including London Dry (gin), Jalisco Agave (tequila) and Kentucky Oak (bourbon) with a rum replacement due to launch soon.

We caught up with Darnell Smith, founder & CEO of MXXN, to ask about the technology going into infused non-alcoholic spirits, regulatory challenges and more. Prior to MXXN, Darnell was a spirits industry veteran, having worked with companies including Diageo, Pernod-Ricard and Bacardi.

Aaron Green: Darnell, nice to meet you. How did you get involved in the cannabis industry?

Darnell Smith: For me, it wasn’t something that was premeditated, in a sense. I had always been a cannabis user in my adult life. I played Division I sports. Cannabis replaced a lot of painkillers and medications that I probably would have had to take just to cope with athletic injuries. That’s how I got introduced to cannabis. And there is the recreational use of it as well.

Darnell Smith, Founder & CEO of MXXN

To get to the origin story of MXXN, I spent a large part of my career working in spirits, namely, on the innovation and commercialization side of bringing new products to market under very well-known trademarks for large multinational companies. A few years into it, my liver was kind of at a point where it was like, “It’s gonna be you or me here, buddy.” So, I made the decision to start making – this is 15 years ago, in New York – a tincture where I would just heat up flower and decarb it and soak it in a high proof spirit. I would cover it for 30 days then strain it and have my tincture.

I’d be the guy in the bar, that would say “Hey, can I get a tonic and lime?” and I would put three drops of my tincture in there, and I would session cocktails along with everyone else. Next day at work, I’m the guy that’s bright-eyed and bushy-tailed and everyone else is kind of feeling a little bit weathered by that alcohol.

Innovation is usually born out of a personal need and that’s the same way here. So, fast forward 15 years and the technology has finally caught up. The rise of non-alcoholic spirits, the rise of cannabis and water-soluble emulsification, those two things combined really made the light bulb go off and say now is the time to offer this product. I feel like MXXN has a very specific place in our consumption of beverages and can fill a unique need that I think is rising.

Green: I’m interested in learning about the technology and the product. We can start with the technology that went into the product development process. I’ll go on to product next.

Smith: From a technical standpoint, up until a few years ago, the way that edibles were made was basically like raw extraction. There was very little ability to be precise about dosage. It was like trying to throw softballs through a chain-link fence. Non-uniformity made it very hard to say, “Here’s how this is going to affect you.” Fast forward and companies like Vertosa and Source have perfected this kind of nano-emulsion technology, which is basically water-suspended cannabis that can uniformly be used in food, beverage and cosmetic applications. And it’s akin to trying to throw sand through a chain-link fence. It’s just much smaller. It can remain more uniform, and thereby be more predictable in terms of dosage and effect.

The MXXN London Dry

So, that technology made it possible for us to then combine it with another wave that’s happening, which in the spirits industry is called alt-alcohol. What we do is distill all the flavor essences of well-known spirits and skip the alcohol. We then add the emulsified cannabis in place of the alcohol. And so with that, we offer a new kind of experience which is basically all the buzz but none of the booze. That’s really where technology-wise things have evolved. The rise of the non-alcoholic spirits and then the rise of being able to do water-soluble compatible cannabinoid emulsions.

Green: Are you selling this then as packaged goods or are you selling it as bladders similar to Coca-Cola in a bar setting?

Smith: This is a CPG packaged product and it really is analogous to a 750 ML spirits bottle similar to Tito’s or Grey Goose. The form factor is the same as spirits bottles, same 750 ML bottle. It doses just like a spirit would. Standard spirit pour is an ounce and a half. For us, an ounce and a half shot has six milligrams of THC.

For the average consumer, you can session cocktails and we give you the option to dose between two and six milligrams between a half ounce and an ounce and a half pour. So, it’s very analogous to what people are experienced in when it comes to spirits from the bottle to the dosage and to the actual recipes. We pride ourselves on being able to demystify something that has been a little bit complex in terms of making cannabis-infused cocktails. We are sticking close to what people are familiar with. People have a lot of experience with tequila or gin or bourbon and so we wanted to stay very familiar but also give people a chance to make the same recipes but sans alcohol.

Green: What kind of flavor profiles are you launching with?

Smith: We’re launching with three SKUs. Our first is London Dry, which is our take on a gin and that one has cucumber, juniper, coriander, and a nice peppery finish. We have Jalisco Agave, which is our take on a tequila or Mezcal. You have notes of agave, flint, salt, oak, and vanilla. And then the last one is Kentucky Oak, which is our version of a bourbon or whiskey. There you have charred oak, vanilla, and other flavor components that make up what bourbon is.

The MXXN Kentucky Oak

Now we have a rum in development that’s nearing the end of a robust R&D pipeline. We have some other options like ready-to-drink cocktails made with MXXN to more high-dose products for what we consider the “legacy consumer” who is maybe more medically inclined in the hopes of being able to give people more options when it comes to consumption of flavored spirits.

Green: On the cannabis side, with the infusions that you’re doing, is it pure THC or are you doing full spectrum?

Smith: Yes, full-spectrum cannabinoid. You’ll notice some beverage brands have what we consider a hybrid, some THC and some CBD. For us, and for the effects that we wanted to have the product to have we stuck with a THC-forward blend. There is a trace of CBD in there, but we don’t even claim it. It’s not something that we go forward with. Our emulsion is THC-based.

Green: Where are you at today in terms of the launch and presence?

Smith: We just finished a pilot test here in California. We started late-January, early-February and we’ve been selling direct-to-consumer. Just order and you can have it at your door in 24 hours for about 85% of the state. We’ve blown through our entire pilot run. Now we are entering into what we consider our launch phase which will be available in select retailers late-July. We are gearing up for our next big production run here in mid-July. We are basically all systems go.

At the same time, we’re exploring multi-state expansion. We have a lot of interest in states like Colorado, Nevada, Arizona and we’re having constant conversations with partners in those states to help bring the product to market.

Green: Have you looked at lounges?

Smith: Lounges have been our biggest traction as we start the retail rollout. We literally just started the dispensary piece of what we’re doing last month. And this is by design. First, we wanted to go direct-to-consumers for proof of concept to make sure we weren’t, you know, saying the story to ourselves. I think just by the performance of the pilot run and direct-to-consumer sales, we proved okay, this is a viable concept.

MXXN’s Jalisco Agave

So as we go out, our number one targets are obviously establishments that also are connected to or have connections with a consumption lounge. There aren’t a ton at this point. They’re still kind of proliferating. But I will tell you the moment we walk into one of these accounts is like a no-brainer because it allows this account to offer a whole new experience. When it comes to consumption lounges in terms of great cocktails you already know: gin and tonics, margaritas, paloma, with no real education required on the part of who’s ever going to be serving. We basically take 20 retailers a month in chunks and so far of the 15-20 that we’ve done, four or five of them have consumption lounges and you’ll see it in those very soon.

Green: Are there any challenges there with dosing in a lounge where the onus is on the operator to dose? How do the regulations work there?

Smith: It’s similar to alcohol, right? As an establishment, you have a responsibility to kind of pay attention to what’s happening as the consumer is consuming. Typically, most of the legislation that was written is for an inhaled consumption lounge. Ingestibles weren’t necessarily considered heavily when it came to legislation. What we tell folks is you have the same responsibilities you would if you were a bartender. Our recommended pour in consumption lounges is a lighter dose. This way, the customer has a chance to start low and go slow, and really recognize how it’s going to affect them.

Legally, there is no firm guidance on what overconsumption looks like for the typical consumer. So, we tell folks you have to kind of get a feel for who the consumer is. If they’re curious person who doesn’t have a lot of experience with cannabis, we typically recommend not to exceed a five-milligram serve per sitting until you figure out how it’s going to affect them. However, if you have very high dose legacy consumers, who buy and drink these 100-milligram single-serve bottles it’s a different story. You kind of need to gauge that from consumer to consumer, and what their tolerance level is. A lot of onus is on the consumption lounge. And I think that’s why they’ve kind of been slow to really roll out how they deal with beverages, because it’s just a different beast. It’s absorbed differently by the body from inhalable products

Green: What trends are you looking at in the industry?

Smith: I love seeing more food-based options. Edibles to this point have been mostly candies and gummies and I see the trend going to more high-end, curated food selections. I think that’s super interesting. The condiments that go into cooking is a category that I’m keeping an eye on. I came across a THC and CBD-infused Siracha sauce the other day and I was like, “wow, this is fantastic!”

MXXN logo

In the beverage space, there continues to be innovation, which we are on the forefront of. There’s a point of saturation that’s going to come for how many seltzers can exist in the market at the same time. And I think we’re kind of reaching that point. So, it’s going to be incumbent upon the beverage space to continue to innovate.

I’m also watching where things go with hemp-derived THC, the Delta-8s and those things and how is that going to be dealt with when it comes to the legal market. I think you see varying ways that it’s being dealt with across states. That’s a trend I’m certainly keeping an eye on as things continue to roll out across the country.

Green: What, in your personal life or in cannabis are you most interested in learning about?

Smith: Given where the world is today, I feel like we all live in this “OR” mindset. It’s either you OR me, it’s either this OR that. And I think you can see with some of the more recent political things that have happened, it’s this ideology of like, trying to force your beliefs on someone else. For me, it’s more about like, how can we learn to live more in the “AND” right? You can have this AND this and they can coexist, and they don’t have to be in competition. In my personal life, that’s where a lot of my energy is going. How do I spread that thought of getting out of this living in OR. We must move to this kind of mindset of AND. How can we be accommodating for a bunch of different beliefs, a bunch of different approaches? It causes so much friction when we try to impose beliefs on others that may not share the same beliefs.

I am thinking about how I can apply that to the cannabis industry as well. In terms of federal legalization versus state, where can we find that the happy ground? If we think about going across state lines, that’s effectively building a whole other business in the state, and in virtually no other industry does that exist. I can tell you economically this country could use infusion of cannabis to be more freely available. So those are the types of things that keep me moving these days. I’ve had a lot of success in my past and so for me, it’s less about financial achievements, and it’s more about how we can help move folks to this is AND mentality and not everything has to be OR.

Green: Great. That concludes the interview.

The post The Man Behind MXXN: An Interview with CEO and Founder Darnell Smith appeared first on Cannabis Industry Journal.


#CBD #Hemp

The Man Behind MXXN: An Interview with CEO and Founder Darnell Smith


July 11, 2022 3:20 pm

CBD Safety in Edibles: What Regulators are Thinking

CBD Safety in Edibles: What Regulators are Thinking

Despite the popularity of cannabidiol (CBD) infused edibles among consumers there are storm clouds on the horizon for this market. The potential threat stems from continuing uncertainty about the regulatory status of CBD in the United States (US) and the European Union (EU). Recent statements by government agencies in both areas are reminders that regulators could make decisions or take actions that would suddenly end the viability of this market. Any company that sells, or is planning to sell, CBD infused edibles such as bakery items, candy and beverages needs to understand what the regulators are thinking now and what might happen in the future.

in the US, the 2018 Farm Bill created a category of products called hemp that are derived from the Cannabis sativaplant and contain less than 0.3% tetrahydrocannabinol (THC). This law also explicitly confirmed the authority of the US Food and Drug Administration (FDA) to regulate the safety of hemp-derived infused edibles. This means CBD needs to navigate the New Dietary Ingredient pathway for dietary supplements, and either the food additive petition process or the Generally Recognized as Safe (GRAS) pathway for foods before it can be used as an ingredient in a food. All three of these processes require that someone (an individual, a company or a group) acting as a petitioner or notifier must submit safety data to the agency or arrange for a safety evaluation by independent experts.

Just some of the many hemp-derived CBD products on the market today

In the EU, CBD is regulated as a Novel Food in a process that is triggered by a submission to the European Commission. The submission must include safety data that is evaluated by the European Food Safety Authority (EFSA). In England and Scotland, CBD products are also novel foods and are evaluated using a process like that in the EU. As in the US, it is the responsibility of an applicant to provide the safety data.

The standard used by the FDA to judge the safety of new food substances in all three pathways is that there should be a “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” The standard used by EFSA for novel foods is, “the food does not, on the basis of the scientific evidence available, pose a safety risk to human health.”

It is important to realize that both in the US and the EU the safety standard for evaluating new food substances only considers the safety of that substance. The laws or regulations that define agency authority do not allow for consideration of any potential benefits. Approval (or rejection) must be based solely on the safety of the substance. Further, safety is evaluated in the context of the intended use of the substance, the planned level of use and the resulting consumer exposure to that substance.

What do we know about FDA’s and EFSA’s current thinking about CBD safety? 

Unfortunately, both the FDA and EFSA have made it abundantly clear that they believe the available scientific data does not meet the required safety standards. FDA has issued multiple warning letters to companies that sell CBD products and has rejected two NDI notifications for CBD. Although these actions were primarily based on non-safety issues (illegal health claims and the drug exclusion provision in the FD&C Act, respectively), in each case the FDA also raised safety concerns. This was done by saying that the agency is not aware of any data that would support a GRAS determination or that the products raise “concerns about the adequacy of the safety evidence.” This doubt echoes statements from the agency in public meetings and advisories. These doubts were expressed as recently as June 2022 during a meeting of the FDA Science Advisory Board.

Similarly, EFSA has stated that they feel that there are critical gaps in the existing CBD safety data. In April 2022, they published a statement with a detailed analysis of the relevant scientific literature and explicitly identified critical data gaps. EFSA said that these data gaps prevented them from evaluating CBD as a novel food.

What do the regulators see as data gaps?

Although the details of each of the data gaps are technically complex, for both the FDA and EFSA they fall into few broad categories.

FDAlogoThe first is that the agencies feel that they need better information on how CBD behaves in the human body. This is described as understanding the absorption, distribution, metabolism and excretion (ADMA) of CBD. The agencies also would like to see data on whether repeated use of CBD might cause damage to specific organs that does not occur from single exposures.

The second need is for more data related to the negative effects that have been observed in some previous work. This includes effects on the liver and reproductive system.  In particular, the agencies would like to know whether it is possible to identify a level of exposure that is low enough to not cause any negative effects. This is termed the No Observed Adverse Effect Level (NOAEL). In an ingredient safety assessment, the NOAEL is used to establish a safe intake level, called the Acceptable Daily Intake (ADI). Comparing the ADI to the expected exposure for the intended use allows the regulators to assess overall safety for a substance.  If the expected exposure is below the ADI, the substance is considered safe. Both agencies feel that the existing data do not allow them to identify a NOAEL for CBD.

The third data need relates to the composition of the CBD products used in safety studies. Food safety determinations are based on the total composition of an ingredient that is produced using a fully defined process. Even if the potential ingredient is 95% or 99% pure, a safety evaluation needs to know what is in that other 5% or 1%, and that this is the same from batch to batch. For example, the presence or absence of residual processing chemicals (such as extraction solvents) and the nature and concentration of substances such as other cannabinoids and terpenes will differ between manufacturers and processes. These differences could affect the overall safety profile for each CBD product. Therefore, it is considered important that studies supporting a safety determination for a new substance be carried out with the actual article of commerce.

Unfortunately, many different CBD preparations have been used in past studies, and in most cases these preparations were poorly characterized. This makes it difficult or impossible to combine the safety data obtained using one product with data obtained with a different product. For example, data obtained using CBD isolates from two different sources cannot be combined unless it can be shown that they were made using the same process and have the same overall composition.

What does this mean for the future?

Neither the FDA nor EFSA is likely to take any positive action on CBD until they receive safety data that fill the gaps that they have identified.

Given these data problems, it is likely that there will be little or no movement on regulatory approvals for CBD in edibles (or dietary supplements in the US) for at least several years. In the US, these products will remain in legal limbo, with state regulations playing the leading role in determining what is allowed on the market. Products with health claims will continue to be particularly vulnerable to FDA action.  The situation in the EU will be at least as confusing because, in the absence of action from EFSA, the regulatory and market status of CBD edibles will be determined by each member country independently.

In view of this uncertainty and business confusion, that are three ways that companies making CBD and CBD edibles can respond. First, in the short term, they can develop and implement manufacturing processes that ensure that their products are consistent from batch to batch and that they have the intended dose of CBD per serving or per product unit. This includes working with the analytical community and organizations such as AOAC and ASTM to ensure that there are validated testing methods available for the CBD and for the final edible products.

In the medium term, business risk management plans for companies that make CBD and CBD infused edibles should consider the possibility that new scientific data will push food safety authorities to actively conclude the CBD does not meet the current regulatory safety standards. In that case, the regulators might start to act against all CBD-containing products.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Businesses should also be aware that the agencies could make a positive safety determination but that they would use the available data to establish a low maximum allowed dose per serving or set very low limits on the presence of specific contaminants such as other cannabinoids.

In the longer term, the CBD industry as a whole might consider advocating for legislative changes. The best statutory fix is likely to be one that that regulates all cannabis-derived products in a system or agency that is separate from the food safety system. This approach is being used in Canada under the Cannabis Act. It is also similar to the way that alcoholic beverages are regulated in the US. This approach, if appropriately designed, could avoid the need for safety determinations but might also limit market access. While this approach could bring clarity and certainty to the market, it is important to remember that it will take time and effort to create a functionally system under this scenario.

There are many market reports that forecast on-going high rates of growth for the CBD market.  However, the regulatory and scientific developments that are likely to occur of the next couple of years will determine whether those projections can become reality.

Companies making these products need to monitor changes and prepare to respond to either positive or negative events.

These companies should also remember that edible products are mostly made from food ingredients using standard food product processes. It is critical that these products be made under a system that prevents food-borne hazards.

The post CBD Safety in Edibles: What Regulators are Thinking appeared first on Cannabis Industry Journal.


#CBD #Hemp

CBD Safety in Edibles: What Regulators are Thinking


July 6, 2022 4:49 pm

SC Labs Continues National Expansion

SC Labs Continues National Expansion

According to a press release published last week, SC Labs is in the midst of a multi-state expansion under new leadership. The company hired Jeff Journey as their new CEO, coming from a VP position at Thermo Fisher Scientific.

Jeff Journey, the new CEO of SC Labs

Last year, in what seemed like an initial move to establish the lab on a coast-to-coast level, SC Labs developed a hemp testing panel that covers a number of contaminants on a national regulatory level. The hemp testing panel they developed purportedly meets testing standards in states that require contaminant levels below a certain action limit.

Then in February of this year, the company announced a partnership with Colorado-based Agricor and Botanacor Laboratories, with the goal of establishing a national testing network, offering comprehensive cannabis and hemp lab testing. All three of those organizations are certified by the Colorado Department of Public Health and Environment (CDPHE) for compliance testing required for hemp products.

In the press release that was published last week, they hinted at another announcement coming soon: a new partnership with Michigan-based Can-Lab. This, coupled with hints at further expansion and their current presence in California, Colorado and Oregon, means Journey will have his hands full and his sights set on nationwide cannabis testing.

“We’re looking forward to partnering with cannabis and hemp brands at every stage of the supply chain to share our innovative and forward-thinking scientific expertise so they can deliver safe products to the marketplace,” says Journey. “As cannabis legalization expands across the country, the testing industry is rapidly shifting and scaling to meet both market and regulatory demands.”

The leadership team will still have a few familiar faces, such as Jeff Gray as chief innovation officer and Josh Wurzer as chief operating officer. “The most important assets we can offer as a multi-state operator are scientific expertise, financial stability, and unquestionable integrity, the principles on which SC Labs has long stood for and will continue to provide to our valued customers,” says Journey.

The post SC Labs Continues National Expansion appeared first on Cannabis Industry Journal.


#CBD #Hemp

SC Labs Continues National Expansion


July 5, 2022 6:14 pm

A book I won’t read

A book I won’t read

In a Time magazine interview, an author of a new book, Can Legal Weed Win?: The Blunt Realities of Cannabis Economics, says this:

“Legal weed producers and sellers in Washington and Colorado have a better chance at capturing market share than they do in other states. That’s not just because of lower taxes and regulations. It’s also because those two states have been open for recreational and adult use the longest.”

The casual reader would think that cannabis taxes in Washington are low, but they are the highest in the world.  

When I look at cannabis writing, I search for the tax part to judge the whole thing.   Since the authors are off-base on what little I’ve seen from them on taxes, I won’t bother reading this book.


#CBD #Hemp
A book I won’t read
July 2, 2022 2:04 pm

CDPHE Certifies More Labs for Hemp Testing

CDPHE Certifies More Labs for Hemp Testing

Aurum Labs, a cannabis testing laboratory based in Durango, Colorado, announced last week that they have become certified by the Colorado Department of Public Health and Environment (CDPHE) for all of the compliance testing required for hemp products. The press release says they are the first independent lab that is actually based in the state to receive the CDPHE certification for every compliance test.

Last year, Colorado rolled out hemp testing regulations that are some of the most comprehensive in the world. The required pesticide screening includes testing for more than 100 different types of pesticides. The new rules, along with the certification requirement, make it difficult for labs to enter the market, with only eleven total labs certified by the CDPHE for various hemp compliance panels and only five certified for every type of test, according to the department’s website.

Most of the companies on that list certified to conduct hemp compliance testing are familiar labs with large footprints, such as Eurofins, Kaycha Labs, Columbia Labs, SC Labs, InfiniteCAL and ACS Labs. Most of these labs are out of state and by the looks of it, only three independent, Colorado-based labs are certified so far: Aurum Labs, Gobi Analytical and Minova Labs. Gobi and Minova, however, are not yet certified for pesticide testing, while Aurum appears to be certified for all compliance testing.

“It’s difficult to compete with these large, private-equity-funded labs, but Aurum is passionate about serving the evolving hemp industry” Liz Mason, director of operations at Aurum Labs, said in a press release. “We are committed to staying on the scientific forefront to give the most comprehensive services to our clients.”

The post CDPHE Certifies More Labs for Hemp Testing appeared first on Cannabis Industry Journal.


#CBD #Hemp

CDPHE Certifies More Labs for Hemp Testing


June 22, 2022 8:59 pm

Slides for Chief Judge Foley’s class

Slides for Chief Judge Foley’s class

My old friend Maurice Foley from Senate Finance staff days has risen to become Chief Judge of the U.S. Tax Court, and is teaching a class at the University of San Diego Law School. I’m to make a remote guest appearance June 21 on marijuana taxation.; here are the slides for that appearance.


#CBD #Hemp
Slides for Chief Judge Foley’s class
June 20, 2022 9:16 pm

New Non-Profit Seeks to Provide Medical Education

New Non-Profit Seeks to Provide Medical Education

The Center for Scientific Cannabinoid Information (CSCI) announced their launch on June 14. In a press release announcing their launch, the non-profit organization says they want to serve as a resource for healthcare professionals, psychologists, doctors, athletic trainers and others looking for information on the safety and efficacy of cannabinoids. The organization is focused on providing current, research-based information on cannabis.

The advisory board for the CSCI includes: Margaret Roche, a dietitian; Dr. Steven Salzman, a surgeon; Dr. George Gavrilos, a pharmacist; Joseph Cachey, an attorney and former hemp executive; Dr. David Kushner, a hospitalist; Dr. Bonni Goldstein, a physician; Dr. Kylie O’Brien, an integrative medicine specialist; and Dr. Jason Canner, an oncologist.

According to Dr. Steven Salzman, who is named as CSCI Chief Medical Officer, their organization will help fill the knowledge void in the healthcare space. “As a physician and practitioner working with cannabinoids, I’ve heard from many other practitioners who have been searching for reliable, evidence-based information on cannabinoids, and realized there was a void,” Says Dr. Salzman. “The CSCI fills this void by serving as a valuable resource where practitioners can access accurate, up-to-date information on CBD and other cannabinoids to help them gain a better understanding of this emerging field.”

The press release says that the organization will compile the latest research and clinical best practices for cannabinoid treatments and share the information with their community. The CSCI invites folks interested in medical cannabinoid research to check out their website and join their community to receive up-to-date scientific information.

The post New Non-Profit Seeks to Provide Medical Education appeared first on Cannabis Industry Journal.


#CBD #Hemp

New Non-Profit Seeks to Provide Medical Education


June 14, 2022 9:47 pm

Federal legalization of cannabis in connection with taxes, pricing, and illegal markets

Federal legalization of cannabis in connection with taxes, pricing, and illegal markets

I’m having to miss a conference in Seattle starting tomorrow on federal legalization of cannabis in connection with taxes, pricing, and illegal markets.  Here are notes for what I hoped to say.

States fall into 4 categories:

  1. 7 states with weight-based taxes or producer taxes that will be eviscerated by interstate commerce in products like imported edibles:  Alaska, Colorado, Illinois, Maine, New Jersey, and Nevada – and California, unless its Legislature acts.  [Those states could use a separate small session.]
  2. 2 states, New York and Connecticut, whose potency taxes may be tested locally by imports that haven’t been tested in-state.  
  3. States with other taxes on the books.
  4. States without taxes yet, like my state of North Carolina, where state monopoly retailing seems a better choice for revenue and public health, and legally avoids the federal 280E selling expense tax. (https://digitalcommons.wcl.american.edu/facsch_lawrev/410/)

For any state with taxes, federal legalization brings problems and maybe opportunities:

Federal legalization and elimination of the federal prohibition premium would probably make pre-tax prices lower, leaving more room for state taxes, but new federal taxes might crowd out state taxes. 

Federal taxes might bring standardization of measurement and piggybacking opportunities – like tobacco taxes today, where the federal government’s blessing of the weight of a pack of cigarettes means states don’t have to weigh packs independently.  Federal weight or potency standards could make state weight or potency taxes just peel off.

Interstate commerce could bring a race to the bottom on marijuana taxes, as we have today with tobacco taxes, as the Eric Garner case shows.  Now some states may want to race to the bottom, and become marijuana tax havens, but Congress could solve that problem in advance, by giving a capped rebate, or a credit against federal marijuana tax for state taxes paid.  So if the federal tax rate is $10, they could give states a credit up to say $8.  If the state tax is zero, the federal tax is $10.  If the state tax is $5, the federal tax is $5.  If the state tax is $8, the federal tax is $2.    If the state tax is $9, the federal tax is still $2, because the credit is capped at $2.  States would have no incentive to race to the bottom.  If the states get together, Congress will listen.  We’re still at the starting gate.


#CBD #Hemp
Federal legalization of cannabis in connection with taxes, pricing, and illegal markets
June 5, 2022 9:22 pm

Medical marijuana in the North Carolina Senate 

Medical marijuana in the North Carolina Senate 

Medical marijuana passed the North Carolina Senate, 35-10, after this hearing in the Rules Committee, where I speak at the 36’45” mark — mostly about how state retail sales are safer, more lucrative, and maybe faster than issuing licenses to just 10 vertically integrated corporations.

https://www.wral.com/nc-senate-committee-votes-on-legalizing-medical-marijuana/20309778/

My two-minute appearance starts this way: “Thank you, Mr. Chairman, I’m Pat Oglesby, a lawyer with the nonprofit Center for New Revenue.Marijuana is coming.  Iit makes people nervous but we’re gonna have it and the patients are gonna be getting their medicine — and I like to think about where the money goes.  And right now [under SB711] you’ve got these 10 corporations set up.  Antitrust? [Maybe] you can’t bring an antitrust action for selling a federal illegal product. But the antitrust policy of not concentrating all this economic power in these 10 companies:  It’s the same policy.”

Full transcript:

DISCLAIMER: This transcript is automatically generated and may contain spelling and grammatical errors, and mistaken words. WRAL can not guarantee the accuracy of the transcript.
Transcript:

Dwight grain dane Peterson ha Matthew lee and linda Matthews, thank you. Our pages today are john Eagle, Bessemer City sponsored by Senator Cathy Harrington uh telecheck from Saulsberry sponsored by Senator carl ford and David smith from Lexington sponsored by senator steve Jarvis. Thank you all I think you all three were here yesterday. Uh and so you’re you’re having a a good oversight of what’s going on in the Senate this week. So thank you Two bills on the agenda today. We will start with Senate Bill 774 D. O. T. Legislative changes and agency Bill, Senator Mcinnis. Good morning. You have that. Thank you. Mr Chair ladies and gentlemen, the committee. This is the annual D. O. T. Agency bill. It’s pretty self explanatory. It is non controversial. Uh We did amend the bill yesterday for uh some clarity and uh issued the bill to you for your consideration and appreciate your support. Glad to answer any questions. Thank you questions and comments. None are anyone in the audience. Anyone from the agency in the audience who cares? Okay, Senator Waddell don’t go now. Right. Oh I hope the cameras are rolling because that’s the first mr. We clarified, we clarified in regards to the fee for record request where they’re charging a dollar for somebody to uh to get the records request of a of a of a official document. And uh they they’ve been doing it and we just codified that with the amendment yesterday and make sure it was clarified nothing new. Thank you. Find bill. Well thank you any further discussion or debate. I see no one from the audience that cares to speak on a motion from so what they offer a favorable report uh for Senate Bill 774 D. O. T. Legislative changes. Agency bill all in favor. Please say I oppose no motion carried. Thank you. Thank you. Senator. Uh I’ll call this bill and ask senator heist if he will chair please because I will present along with some other Senate bill 7 11, the N. C. Compassionate Care Act and Senator lee and Senator love. And I will just get us all through this help. Mm hmm. Okay. Thank you. Lord. Thank you. Members of the committee bill before us. Senate Bill 7 11. I will recognize Senator raven to speak first on the bill. Thank you. Mr Chairman uh Members and members of the public uh public Member thank you for being here. Uh No bill in my tenure of of the Senate has gone through more committees. Uh I’ve been more open to comment and uh I’ve been adjusted and readjusted more than this bill had. Uh It’s personally very, very important to me. I want you to know that going in. Uh and I hope that I have been fair and giving everyone uh their chance to uh be for it or against it. And having said that I will give you an overview of the bill and what it does the purpose of the bill is to allow carefully regulated use of medical cannabis for the treatment of debilitating diseases. The recreational sale or use of marijuana will remain illegal under north Carolina law to receive medical cannabis patients must have at least one qualifying debilitating condition as certified in writing by bona fide physician with a patient. Uh relationship qualifying conditions Are defined in the bill. There are 15 of them. Uh we don’t need to go through all of them, but I will uh just highlight some uh cancer, hospice care, uh Ataxia, Crohn’s disease, A. L. S. Uh and other end of life diseases uh that are very debilitating, very horrible ways to die. And this is just a compassionate way to address that. Uh and and help these folks that need it. And I certainly don’t want to leave out the veterans and the PTSD that is associated with some of the problems that are veterans and first responders and other members of society have the patients And design caregivers must apply to DHHS for a registration card in order to receive cannabis from the center. Uh qualified patient caregiver may only possess 30 days. Uh 30 day supply of cannabis. We uh we realized that in the past some of the other uh Bad drugs that have been uh available in cannabis is not one of those by the way have been pretty much a free free prescription from uh physicians in 90 days, 120 days refill as you want. This is not the case and this this is very tightly regulated and designed to be used as necessary again uh in most cases uh in in in end of life hospice care uh for various things. Uh The bill establishes the medical cannabis uh production commission within the D. H. S. To develop a supply system that authorizes uh suppliers to produce cannabis and cannabis infused products uh in the production facilities and produce them uh through uh provide them through medical medical cannabis centers. The bill calls for uh 10 licenses to be issued issued stay wide, and a supplier may only sell cannabis through its own medical centers and not for resale and other centers by another supplier. Each supplier may operate uh no more than eight uh centers that will be an amendment right now. The bill as it reads as four, which will put 80 statewide Uh DHHS will charge an initial non refundable license fee of $50,000 plus $5,000 for each medical cannabis facility. Um And the licensed cannabis suppliers shall pay to DHHS a monthly fee of 10% of gross revenues from the sale of the cannabis or cannabis and Hughes products In in inhalation of cannabis. And that has been a sticking point with some folks is prohibited uh in anyone under 18. Uh it is also uh the smokable products are prohibited in uh many places that you would assume ah like all public places ah nowhere near school grounds. Uh huh. It’s it’s pretty tightly done. Uh And I think if you if you have read it and I think everyone in here, probably everyone in the room has uh good, pretty darn good thing. Closing it, what the bill does, 37 other states have already done this. Uh It is my opinion that no state has done it as well as we are attempting to do it. This is the tightest uh the best written following the models of other states and talking to other states and seeing what they did wrong. We have tried to admit those pitfalls and come up with something that will do just what the bill title does and just what the intention of this bill is. And that is give the citizens the citizens of this state who need and deserve compassionate care just that and it is nothing more than trying to help those people ah with the care that they need ah and augment their treatments as decided upon by the patient and buy a a physician uh and some very very very sad and serious situations. So I would thank you for your support. I will give you a couple of statistics Before I turn it over to the other two about this bill. And I will give you the question on this pole because it was not a push poll. This was not done for my benefit or the other sponsors benefit. This was a straight up question and the question to the voters was this quote, would you support or oppose the General Assembly legalizing medical marijuana for patients with a prescription from a doctor. The end quote, 82% of the voters supported the legislation of medical marijuana, including 57% of the voters who strongly supported the measure, 75% Republicans, 87% unaffiliated, 86%,, democrats backed the measure, At least 78% of male and female, white and black. Matted, moderate conservative voters support medical marijuana. 77% of evangelical voters support medical marijuana. It’s hard for me to say that I have ever seen a poll In my 40 years of the political spectrum one way or another, The polls, 82-77% on anything other than maybe is water wet. Those are amazing numbers. And it shows uh it shows that uh north Carolina and north Carolinian voters do have compassion for their fellow man. Ah and I think that we’re going to have overwhelming support for this measure and I appreciate everyone that has helped me work on this uh for the last five years or so, and I certainly hope that it moves forward and mr chairman, I will turn this over to my other two committee members if they would like to sara low was recognized explains. Mhm. My the reason that I have taken part with this bill is because I believe it will help north Carolinians. I think there are individuals with chronic ailments and other kinds of conditions. And cannabis will help someone and that’s why I support it. Um Other states have done it and as far as I’m concerned, there’s no reason in the world why we shouldn’t open things up so that our citizens can take part in medicine that will help them. Now. I know that a lot of times people when we look at things like this, we in our system of medicine, all kinds of things have been used. One of the things that have been used is opiates which are extremely dangerous, but they’re used and they continue to be used. And those of you that are in this room that have had operations, opiates were used in most cases. Um I think cannabis is much safer and I think that it is something that will help our citizens. So I would encourage you to support this bill as we move forward. Under the thank you mr Chairman, um Over the memorial day weekend, I was hanging out with a friend of mine who was diagnosed with cancer, had surgery about, I think it was six weeks ago, had a scar from here to here. And he was talking about, you know, Delta eight and things that you can buy in the store gummies. They’re completely unregulated to help him through um the chemo that he’s getting ready to go through and for us as a state to be able to find a way where patients can consult with their physician as opposed to their friend on something that they’re going through is incredibly important and so a lot has already been said in committee meetings and other places. But hopefully you would support the bill and to open up this access for physicians to be able to speak with their patients on the best course of treatment may not always be this particular the path that they head down, but at least it’ll be an option for a lot of those folks. Thank you. Questions or comments from members of the committee still dives. Um Thanks so much. Mr Chair I just have three questions in particular. I would like to maybe start out with today, ask your first question. Thank you. Um The first question is when I look at the list of no and I’m just trying to pull it up on my screen. Medical conditions on this is on page two on this listed. Um I’m just curious because often sometimes you know and dealing with other bills that list out conditions. Um The feel that this is an exhaustive list of david deep until they the um but debe Attila I’m gonna get it right the basilica di but I’m gonna get it, your work on me afterwards. Um Is this an exhaustive list. Um Is it a comprehensive list or is this something we’re gonna I mean I may not be here but find ourselves just coming back every session to amend. Thank you on that question. Uh I think that list is uh numerically a through oh with elm and then being halfway through the alphabet, which means that’s 15. So there’ll be 17 of both. Oh right. uh and those 17 things are things that are Mhm. Have some scientific evidence of medical cannabis having a positive effect on or Ameliorating. Ah those diseases somewhat it lists things like growing disease, A. L. S. Hospice care end of life. Uh Cancers. It’s at the uh if you go down that list and those are things that uh let’s say we know that medical cannabis can be useful for and can give some relief or completely satisfied. PTSD is a big one among that as well. Uh And and that is not the end of it all. Um Glaucoma is one that is not on that list that it has been proven that cannabis can help with. But in order for cannabis to work on glaucoma, it has to be a constant a constant infusion or profusion. And that simply can’t happen with today’s uh methodologies and and delivery methods that we have for this product. But the uh the commission. Mhm. It does have the ability to add as they see fit uh other conditions and that will be a plus when you look at the makeup of the commission. Uh It it’s not just one that you’re gonna be put on because you just want to an appointment is gonna be one, you’re gonna be put on to work and help people in north Carolina. Okay. Follow up to that question. So based on this list is currently that’s listed in the bill of debilitating. How do we do that time um conditions? Is this consistent would you say? What other states? Um I think what you’ll find is there’s kind of a hodgepodge around the United States. Although there’s a core group of those that I think are within that. And as Senator raven mentioned the advisory board which has medical professionals, pharmacists and others that will be kind of looking at the research moving forward to be able to make those determinations As two additional debilitating conditions that may qualify. Okay. And if if I actually that was some subsequent questions that they have a question specifically, I do have a question specifically about PTSD. And the question regarding the PTSD is what exactly is the purpose of um In line 43 and 40 for it says details of the Trauma shall not be required because if I understand correctly wooden a veteran in this case or military personnel go to a physician. And would this limit then that conversation with the physician. I’m just trying to understand ah what the the purpose or the intent of quote details of the trauma shall not be required. So while while the commission will be adopting rules, I think if you’ll look on the written certification, it talks about um, mm about how the physician has to outline what the debilitating condition is. And I think the intent is that it’s not required to release that information to the commission. Um, excuse me to DHHS for purposes of the written certification. So you go to a physician, you talk to them about what has given rise to the PTSD, they write your certification, the state’s PTSD, but they don’t have to go into the in depth with DHHS as to what that is. That that’s my understanding of what’s there. Okay. And then the last question then. Okay, looking at the advisory board. Um, I’m just curious and especially with the commitment the General assembly has already made in particular. Um, and I think everybody here voted for it and supported eight spot. Um, if we believe there could be some positive benefit, you know, from veterans, I’m still curious. Um, looking at the composition of the board, you know, we do have some patients that are identified to be participants of the board. Um, is there any specific reason why we would not have a veteran um, on the board? Mm hmm. Let me check back through. And I hate, I hate to air on this with without being exact, but I believe in the seven, uh, in the seven positions, uh, I’m mistaken, but appointed by the governor, that one of those, uh, either is or treats, um that specifically I think he’s human with. Yeah I think you’re I think we’re okay on that. I think you’re talking about the advisory, I’m talking about the advisable and page four you can handle that. Uh No there’s not a specific reference um There is a reference to a cardholder, a patient and then also um a parent of a minor qualified patients. Um You know, I don’t know that we we dug that deep into the advisory board. It’s not exclusive. Such that subsection f on page for uh you know that that particular patient maybe a veteran or someone suffering from PTSD, it’s not excluded but it is not specifically included at this time. Just a final comment. Final final final. Now the question that’s a comment. No, you know I put it as well, I understand what you’re attempting to do, you know? But again I would just emphasize, you know, we understand that Um the number I tend to hear 22 or so veterans, you’ll on average commit suicide a day across the nation and we have made a commitment as a general assembly, you know, just trying to do what we can to address, you know the veteran population out there. So when it’s gone um served the country, they they’ve come back and if you know we think there’s some benefit here and we’ve already made a commitment with the hyperbaric oxygen therapy treatment and we now think perhaps you know those with um debilitating conditions, medical conditions could benefit. I I would just wonder if there would be utility and if if you all would consider, you know, opening, you know, some opportunity for a veteran. So that’s just a thought for you other questions or comments from the committee. Senator Children. Mhm. Thank you. Mr Chair. Um I want to just thank the bill sponsors for the work on this and especially you Senator raben. I um no from my personal experience when I first began to serve here in the legislature. Uh some of the early meetings I had were with patients that um had used medical marijuana to deal with the conditions that they had in place and it was really eye opening to to see how cannabis can heal the pain that so many people experience. And I want to thank you for this. Um Just one a couple of questions I think related to the economics of the bill that you and I have uh chatted about. Uh I know that this is what’s called a vertically mandated um Bill, vertically integrated mandated bill in the sense that uh there will be 10 licenses that are gonna be issued for those that will go that will provide seed to sale. And um and I and I understand, I believe the argument really is that it allows for efficiency and also consumer safety um if the state were to go forward because I guess there is some concern that with the vertically integrated model that growers will be excluded manufacturers will be, were excluded. Um My question to you is, I guess the medical cannabis production commission cannot make that decision and we would have to make those changes would have to be made through state through legislative changes. Is that is that correct? So senator, Yes, it is, but we would certainly, I think those changes would cut them about upon the recommendation of that commission. Uh and and that’s what I see going forward. You know, this is uh I think it is necessary to do the uh beginning to the end the the seed to sale product to absolutely ensure quality control and to know that uh that the product that we are producing uh is safe and that the amount uh of THC in that product is going to be the same every time. And just standardization is part of it. I’m sure that if the industry grows as, I think it will grow, um changes will come. Uh but I don’t know what those are, the commission will, will have to in order to change that, Make recommendations to the legislature and this body will then decide, okay, just 1, 1 other follow up. I know that this vertically integrated model I believe exists and um the mandated model exists in florida and new Mexico. Are we aware of any and maybe literally you can answer this if if there had been any any trust challenges for the fact that a limited licenses have been issued. That that may or may not be concerned just a question. Yeah, I’m not aware of that. I mean the process and the bill provides for 20 recommendations to come out of the HHS and the commission has, you know, the ability to choose up to 10 of those from a vertical integration perspective. I don’t know that, that I’m not sure that that any other state is, has had any kind of inquiry um, with the Department of justice or whatever federal agency handles that. Thank you center. Whatever my questions were similar to what um my colleague senator charge we just mentioned, but I have something to other questions concerning that. I did visit a marijuana plant in las Vegas when I went to training and we saw how they were doing what they did from start to finish. But I’m concerned about the business aspect of it in that um, it said here that for business to get licensed, all medical marijuana companies must manage every aspect from farming to the final sale, including owning and operating storefronts and expensive barrier for entry and sometimes the majority of north Carolina farmers are not ready to do so. So is there any sense that this would be like so that the small farmer or the person who’s entering it for the first time would have an opportunity. So I think what the bill allows for is for to be able to work with those who have the expertise that’s required in the application process. Um, So I do think there are opportunities and options in that regard. However, I will say that this is an expensive operation. Um, so you want to make sure that, that the licenses have the ability to produce a product that is of of the quality that you would expect for a physician to write a recommendation for. So the requirements in the application process does not exclude anyone allows them the ability to bring in those with the expertise um, that are required in the application process. But again, it is a, an expensive venture to begin in order to hit the quality measurements that will be needed for a physician to write a recommendation. All right. Thank you. Yes, follow up. And then there’s further stated here that um, The commission will be allowed to issue 10 medical cannabis supplier license. Each supplier would be allowed to operate no more than four medical centers, one of which must be located in a tear one county. So if you’re limited 1 to 81 county. What about the others? Is there any specifications for them? So, um, I think Senator raven mentioned we’re going to increase that to eight. So double the amount of, of access points for patients. Um, the idea behind having at least one in a tier one county was so that um, the suppliers, we’re not just focused around the larger areas and so that folks in rural areas would still have access. So that was kind of the gist behind that having at least one follow up, but it does not say specifically If you have one in one tier one county that some of the others could not Be operating and then in addition to go to till one county. So there’s no limitations. I’m not sure I understand the question. You think there’s not a limitation on how many you can have it here with? There is not, there’s not. So you could put them all in a tier one county if if a licensee wanted to. The idea was that most licenses you’re gonna want to be in in where the major medical centers are because most of the debilitating conditions are those of which folks would be going to some of the major cities not just have a comment. I’m concerned because I had several constituents who approached me, they’re in business already, but not this kind of business. They know how to operate a business because they’ve been doing it that they will be not included and not have the opportunity to be included in this. And we are explicit that we are open. Even if you are running another kind of business, it does not allow you to do this. I think we should open it up and that’s my comment. Any other questions, comments center, Fitch. Look to the legal side I believe similarly responded there was they were not aware of any that’s for coming in. Any other questions or comments. I’ll hold. I’ll come back to you for the motion any other questions or comments from the committee. I don’t have a list up but any members of the public who have signed up for others to speak on this bill. Uh huh. Three. Okay, excuse me. Thank you. Mr. Chairman members of the committee. My name is jerry Royal. I’m counsel for the north Carolina Family Policy Council. Yeah, Based on current medical research and the cost of the harmful effects have been found. We strongly encourage you to oppose Senate Bill 7 11. We all want to be compassionate and to help people in need. As we look at potential health benefits of medical marijuana. We must also weigh the harms and costs to individuals, their families, their community in our state. To find the facts, we need to look to medical professionals and see what they have found so far in their research. We have provided information for you from the Food and Drug Administration, american Academy of neurology, american psychiatric association and american Medical Association. All of these groups encourage continuing research but currently do not support medicinal use of marijuana. A good overview is provided at 2021 article on the A. M. A. Website about a friend of the court brief. They have filed quote. While it is possible, there may be beneficial medicinal uses of marijuana, numerous evidence based studies demonstrate that significant deleterious effects abound. The brief tells the court going on to say without question. The public health risks are immense. Drug abuse and addiction change in brain function, lung disease, intoxication and impaired driving developmental interference, impaired cognition, psychological illness, cardiovascular abnormalities, negative social functioning effects and cancer. The A. M. A. Brief went on to say a massive amount of future systemic research and controlled trials are needed to study the safety and efficacy of cannabis for medicinal purposes. At this point in time, the research clearly shows that the harms and costs to individuals, families and the state greatly outweigh any potential benefits. We therefore encourage you to oppose Senate Bill 7 11. Thank you. Next up, I have reverend Mark Creech, thank you. Mr Chairman and members of the committee reverend Mark Creech, executive director of the christian Action League. Over recent months we’ve heard some emotional testimonies in favor of this bill but I just want to remind you that all of these testimonies are anecdotal evidence, not scientific. I believe that everything that the christian Action League has meant to say on this proposal is summed up in a statement by Dr Samuel Wilkinson and Deepak Cyril D’Souza of the Yale School of Medicine in the Journal of the American Medical Association. If marijuana is to be used for medical purposes, it should be subjected to the same evidence based review and regulatory oversight as other medications prescribed by physicians. Potentially therapeutic compounds of marijuana should be purified and tested and randomized double blind placebo and active controlled clinical trials. Towards this end, the federal government should actively support research examining marijuana’s potentially therapeutic compounds. These compounds should be approved by the F. D. A. Not by popular vote or state legislature, produced according to good manufacturing practice standards distributed by regulated pharmacies and dispensed via a conventional and safe route of administration. Otherwise, states are essentially legalizing recreational marijuana but forcing physicians to act as gatekeepers for those who