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Following China, Hong Kong criminalizes CBD under harsh penalties

Following China, Hong Kong criminalizes CBD under harsh penalties
Hong Kong has banned CBD, adopting harsh criminal punishment aligned with China’s zero-tolerance policy which led to a ban on the mainland last year. The new policy, approved last October …

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February 7, 2023 10:39 am

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!

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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

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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
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#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

Curaleaf Controversies

Curaleaf Controversies

Curaleaf, the world’s largest cannabis company, is mired in scandals involving Russian oligarch money, product safety violations, and unfair labor practices.

#CBD #Hemp https://www.projectcbd.org/curaleaf-controversies February 6, 2023 9:31 am

More than 400 CBD products are now barred from sale in UK

More than 400 CBD products are now barred from sale in UK
More than 400 CBD products have now been stricken from a public list by UK food safety officials, and may not be sold to consumers. The UK’s Food Standards Agency …

More than 400 CBD products are now barred from sale in UK Read More »


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https://hemptoday.net/more-than-400-cbd-products-must-be-removed-from-uk-market/
February 2, 2023 11:53 am

French and Polish hemp varieties stand out in Australian trials

French and Polish hemp varieties stand out in Australian trials
French and Polish hemp varieties stood out in initial hemp cultivation trials in Australia, according to development corporation Agri-Futures Australia. Reports are coming in from hemp trials now ongoing in …

French and Polish hemp varieties stand out in Australian trials Read More »


#CBD #Hemp
https://hemptoday.net/french-and-polish-hemp-varieties-stand-out-in-australian-trials/
February 1, 2023 6:26 am

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

USDA weekly hemp reports aim to add much-needed market insight

USDA weekly hemp reports aim to add much-needed market insight
The U.S. Department of Agriculture’s (USDA) has added a bit more clarity to the hemp markets with a weekly report covering prices and imports. The reports, to be issued each …

USDA weekly hemp reports aim to add much-needed market insight Read More »


#CBD #Hemp
https://hemptoday.net/usda-weekly-hemp-reports-aim-to-add-much-needed-market-insight/
January 31, 2023 1:21 pm

CBD Confounds FDA, Torn Between “Do The Right Thing” and “Working for Big Pharma”

If FDA really wanted to hurt CBD, it could do it tomorrow using the Exclusionary Rule. All of it, save Epidiolex. Food too.

Instead, the medicine experts are punting the issue to a clueless, impotent, and paralyzed Congress, obviously in order to get new legislation.

But what will that legislation look like, with a zillion lobbyists descending on them? And is this our chance to fix hemp, let alone CBD? Or will the states take the 10A initiative and regulate CBD, like so many already have that and marijuana?

Read more at: https://hemptoday.net/fda-says-it-cant-manage-regulation-of-cbd-calls-on-congress-to-act/

Argentina launches agency to guide hemp, medical cannabis

Argentina launches agency to guide hemp, medical cannabis
Argentina has officially launched an agency in support of industrial hemp and medical cannabis, the latest in a string of key moves that show the government is serious about developing …

Argentina launches agency to guide hemp, medical cannabis Read More »


#CBD #Hemp
https://hemptoday.net/argentina-launches-agency-to-guide-hemp-medical-cannabis/
January 30, 2023 12:42 pm

PubMed: Investigation of microorganisms in cannabis after heating in a commercial vaporizer

PubMed: Investigation of microorganisms in cannabis after heating in a commercial vaporizer

Front Cell Infect Microbiol. 2023 Jan 13;12:1051272. doi: 10.3389/fcimb.2022.1051272. eCollection 2022.

ABSTRACT

INTRODUCTION: There are concerns about microorganisms present on cannabis materials used in clinical settings by individuals whose health status is already compromised and are likely more susceptible to opportunistic infections from microbial populations present on the materials. Most concerning is administration by inhalation where cannabis plant material is heated in a vaporizer, aerosolized, and inhaled to receive the bioactive ingredients. Heating to high temperatures is known to kill microorganisms including bacteria and fungi; however, microbial death is dependent upon exposure time and temperature. It is unknown whether the heating of cannabis at temperatures and times designated by a commercial vaporizer utilized in clinical settings will significantly decrease the microbial loads in cannabis plant material.

METHODS: To assess this question, bulk cannabis plant material supplied by National Institute on Drug Abuse (NIDA) was used to assess the impact of heating by a commercial vaporizer. Initial method development studies using a cannabis placebo spiked with Escherichia coli were performed to optimize culture and recovery parameters. Subsequent studies were carried out using the cannabis placebo, low delta-9 tetrahydrocannabinol (THC) potency and high THC potency cannabis materials exposed to either no heat or heating for 30 or 70 seconds at 190°C. Phosphate-buffered saline was added to the samples and the samples agitated to suspend the microorganism. Microbial growth after no heat or heating was evaluated by plating on growth media and determining the total aerobic microbial counts and total yeast and mold counts.

RESULTS AND DISCUSSION: Overall, while there were trends of reductions in microbial counts with heating, these reductions were not statistically significant, indicating that heating using standard vaporization parameters of 70 seconds at 190°C may not eliminate the existing microbial bioburden, including any opportunistic pathogens. When cultured organisms were identified by DNA sequence analyses, several fungal and bacterial taxa were detected in the different products that have been associated with opportunistic infections or allergic reactions including Enterobacteriaceae, Staphylococcus, Pseudomonas, and Aspergillus.

PMID:36710966 | PMC:PMC9880168 | DOI:10.3389/fcimb.2022.1051272

https://pubmed.ncbi.nlm.nih.gov/36710966/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230130152044&v=2.17.9.post6+86293ac January 30, 2023 11:00 am

PubMed: Sex differences in adolescent cannabis vapor self-administration mediate enduring effects on behavioral flexibility and prefrontal microglia activation in rats

PubMed: Sex differences in adolescent cannabis vapor self-administration mediate enduring effects on behavioral flexibility and prefrontal microglia activation in rats

bioRxiv. 2023 Jan 22:2023.01.21.524468. doi: 10.1101/2023.01.21.524468. Preprint.

ABSTRACT

Cannabis is the most used illicit drug in the United States. With many states passing legislation to permit its recreational use, there is concern that cannabis use among adolescents could increase dramatically in the coming years. Historically, it has been difficult to model real-world cannabis use to investigate the causal relationship between cannabis use in adolescence and behavioral and neurobiological effects in adulthood. To this end, we used a novel volitional vapor administration model to investigate long-term effects of cannabis use during adolescence on the medial prefrontal cortex (mPFC) and mPFC-dependent behaviors in male and female rats. Adolescent (35-55 day old) female rats had significantly higher rates of responding for vaporized Δ 9 -tetrahydrocannabinol (THC)-dominant cannabis extract (CAN THC ) compared to adolescent males. In adulthood (70-110 day old), female, but not male, CAN THC rats also took more trials to reach criterion and made more regressive errors in an automated attentional set-shifting task compared to vehicle rats. Similar set-shifting deficits were observed in males when they were exposed to a non-contingent CAN THC vapor dosing regimen that approximated CAN THC self-administration rates in females. No differences were observed in effort-based decision making in either sex. In the mPFC, female (but not male) CAN THC rats displayed more reactive microglia with no significant changes in myelin basic protein expression or dendritic spine density. Together, these data reveal important sex differences in rates of cannabis vapor self-administration in adolescence that confer enduring alterations to mPFC structure and function. Importantly, female-specific deficits in behavioral flexibility appear to be driven by elevated rates of CAN THC self-administration as opposed to a sex difference in the effects of CAN THC vapor per se .

PMID:36711651 | PMC:PMC9882275 | DOI:10.1101/2023.01.21.524468

https://pubmed.ncbi.nlm.nih.gov/36711651/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230130152044&v=2.17.9.post6+86293ac January 30, 2023 11:00 am

PubMed: Delta-8 tetrahydrocannabinol: A Scoping Review and Commentary

PubMed: Delta-8 tetrahydrocannabinol: A Scoping Review and Commentary

Addiction. 2023 Jan 29. doi: 10.1111/add.16142. Online ahead of print.

ABSTRACT

Delta-8 tetrahydrocannabinol (THC) is a psychoactive substance from the Cannabis plant that has been rising in popularity in the United States since the 2018 U.S. Farm Bill implicitly legalized it. This study reviewed research from peer-reviewed and non-peer-reviewed (e.g., anecdotal and news) reports related to Delta-8 THC to summarize current knowledge and implications for public health and safety METHODS: A scoping review was conducted using PubMed, Scopus, Google Scholar, and Google as search engines, leading to the identification of 103 documents that were summarized. The themes that emerged were: (1) legality, (2) use (popularity, motives, psychoactivity/potency, benefits/consequences), (3) synthesis (byproducts, lab testing), and (4) retail (availability, price, packaging, youth-oriented marketing). A second author independently coded 20% of the documents, which verified the categorization of articles by these emergent themes RESULTS: Most research used animal/cell models or focused on ways to identify the chemical structure of Delta-8 THC in various products. Findings suggest that people often use Delta-8 THC as a substitute for other substances. Anecdotally, Delta-8 THC is a less potent psychoactive than Delta-9 THC; however, several negative consequences have been reported. There is no federal age restriction for purchase/possession of Delta-8 THC products. Delta-8 THC is readily accessible online, is typically less expensive than Delta-9 THC, and is often marketed in ways that would seemingly appeal to children. There are no regulations on synthesis, resulting in products being contaminated and/or yielding inconsistent effects. There have been thousands of calls to U.S. poison control centers due to accidental Delta-8 THC exposure among minors CONCLUSIONS: Most research on Delta-8 THC is largely anecdotal, not peer-reviewed, and does not involve human subjects. Future research should examine Delta-8 THC use using nationally representative samples to better understand the prevalence and consequences of use. Laws are needed to mitigate the risks of using Delta-8 THC, particularly quality control of synthesis and minimum purchase age.

PMID:36710464 | DOI:10.1111/add.16142

https://pubmed.ncbi.nlm.nih.gov/36710464/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230130152044&v=2.17.9.post6+86293ac January 30, 2023 11:00 am

PubMed: Hemp seeds: Nutritional value, associated bioactivities and the potential food applications in the Colombian context

PubMed: Hemp seeds: Nutritional value, associated bioactivities and the potential food applications in the Colombian context

Front Nutr. 2023 Jan 11;9:1039180. doi: 10.3389/fnut.2022.1039180. eCollection 2022.

ABSTRACT

For many years, Colombia was one of the countries with the largest illegal cultivation of cannabis around the world. Currently, it is going through a period of transition with a new government law that recently allows the cultivation, transformation, and commercialization of such plant species. In this sense, the identification of strategies for the valorization of products or by-products from Cannabis sativa represent a great opportunity to improve the value chain of this crop. One of these products is hemp seeds, which are exceptionally nutritious and rich in healthy lipids (with high content of three polyunsaturated fatty acids: linoleic acid, alpha-linolenic acid, and gamma-linolenic acid), good quality protein, and several minerals. In addition, hemp seeds contain THC (tetrahydrocannabinol) or CBD (cannabidiol) in traces, molecules that are responsible for the psychoactive and therapeutic properties of cannabis. These low terpenophenolic contents make it more attractive for food applications. This fact, together with the constant search for proteins of vegetable origin and natural food ingredients, have aroused an important interest in the study of this biomass. Some bioactivities of phytochemical compounds (polyphenols and terpenoids, mainly) present in hemp seeds have provided antioxidant, antimicrobial, and anti-inflammatory properties. This review summarizes and discusses the context of hemp use in Latin-American and the new opportunities for hemp seeds culture in Colombia considering the valuable nutritional value, main functional bioactivities, and recent advances in food market applications of hemp seeds.

PMID:36712539 | PMC:PMC9875026 | DOI:10.3389/fnut.2022.1039180

https://pubmed.ncbi.nlm.nih.gov/36712539/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230130152044&v=2.17.9.post6+86293ac January 30, 2023 11:00 am

PubMed: Standard operating procedures for the comprehensive and reliable analysis of cannabis terpenes

PubMed: Standard operating procedures for the comprehensive and reliable analysis of cannabis terpenes

Methods Enzymol. 2023;680:381-419. doi: 10.1016/bs.mie.2022.07.029. Epub 2022 Sep 6.

ABSTRACT

Terpenes are the primary determinants of cannabis flower aroma, and ongoing research tests their potential for impacting the overall experience. Frustratingly, despite the importance of terpenes in cannabis physiology and commercial uses, literature reports vary widely regarding the major constituents of volatile blends and the concentrations of individual terpenes. In this article, we provide detailed descriptions of complementary approaches that will allow researchers to determine the identity and quantity of cannabis terpenes unequivocally and reliably. These standard operating procedures will guide decisions about which method to employ to address specific analytical goals. We are including two application examples to illustrate the utility of different approaches for tackling the analysis of terpenes in cannabis flower samples.

PMID:36710020 | DOI:10.1016/bs.mie.2022.07.029

https://pubmed.ncbi.nlm.nih.gov/36710020/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230130152044&v=2.17.9.post6+86293ac January 29, 2023 11:00 am

PubMed: Cannabis-opioid interaction in the treatment of fibromyalgia pain: an open-label, proof of concept study with randomization between treatment groups: cannabis, oxycodone or cannabis/oxycodone combination-the SPIRAL study

PubMed: Cannabis-opioid interaction in the treatment of fibromyalgia pain: an open-label, proof of concept study with randomization between treatment groups: cannabis, oxycodone or cannabis/oxycodone combination-the SPIRAL study

Trials. 2023 Jan 27;24(1):64. doi: 10.1186/s13063-023-07078-6.

ABSTRACT

BACKGROUND: Opioids continue to be widely prescribed for chronic noncancer pain, despite the awareness that opioids provide only short-time pain relief, lead to dose accumulation, have numerous adverse effects, and are difficult to wean. As an alternative, we previously showed advantages of using pharmaceutical-grade cannabis in a population of chronic pain patients with fibromyalgia. It remains unknown whether combining an opioid with pharmaceutical-grade cannabis has advantages, such as fewer side effects from lesser opioid consumption in chronic pain.

METHODS: Trial design: a single-center, randomized, three-arm, open-label, exploratory trial. Trial population: 60 patients with fibromyalgia according to the 2010 definition of the American College of Rheumatologists.

INTERVENTION: Patients will be randomized to receive up to 4 daily 5 mg oral oxycodone sustained release (SR) tablet, up to 5 times 150 mg inhaled cannabis (Bediol®, containing 6.3% Δ9-tetrahydrocannabinol and 8% cannabidiol), or the combination of both treatments. Treatment is aimed at self-titration with the daily maximum doses given. Treatment will continue for 6 weeks, after which there is a 6-week follow-up period. Main trial endpoint: The number of side effects observed during the course of treatment using a composite adverse effect score that includes the following 10 symptoms: dizziness (when getting up), sleepiness, insomnia, headache, nausea, vomiting, constipation, drug high, hallucinations, and paranoia. Secondary and tertiary endpoints include pain relief and number of oxycodone doses and cannabis inhalations.

DISCUSSION: The trial is designed to determine whether self-titration of oxycodone and cannabis will reduce side effects in chronic pain patients with fibromyalgia. TRIAL REGISTRATION {2A AND 2B}: EU trial register 2019-001861-33, URL https://www.clinicaltrialsregister.eu , on July 17, 2019; World Health Organization International Clinical Trials Research Platform NL7902, URL https://trialsearch.who.int , on July 26, 2019.

PMID:36707893 | DOI:10.1186/s13063-023-07078-6

https://pubmed.ncbi.nlm.nih.gov/36707893/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230129152256&v=2.17.9.post6+86293ac January 28, 2023 11:00 am

FDA says it can’t manage regulation of CBD, calls on Congress to act

FDA says it can’t manage regulation of CBD, calls on Congress to act
Saying federal safety standards are insufficient to manage the CBD industry, the U.S. Food and Drug Administration (FDA) has called on Congress to set rules for the products through legislation. …

FDA says it can’t manage regulation of CBD, calls on Congress to act Read More »


#CBD #Hemp
https://hemptoday.net/fda-says-it-cant-manage-regulation-of-cbd-calls-on-congress-to-act/
January 27, 2023 11:03 am

PubMed: Interventions for generalized anxiety disorder

PubMed: Interventions for generalized anxiety disorder

Curr Opin Psychiatry. 2023 Mar 1;36(2):134-139. doi: 10.1097/YCO.0000000000000840. Epub 2022 Dec 6.

ABSTRACT

PURPOSE OF REVIEW: To provide an overview of recently published work on anxiety, focusing on generalized anxiety disorder (GAD) and its treatment.

RECENT FINDINGS: Self-reported anxiety symptoms were highly prevalent during the COVID-19 global pandemic in both the general population and in selected groups. There remains divided opinion about whether internet-based cognitive behavioural therapy (CBT) is noninferior to face-to-face CBT for GAD. A systematic review of drug treatment for GAD showed efficacy for selective serotonin reuptake inhibitors (SNRIs), agomelatine, and quetiapine. There may be a place for repetitive transcranial magnetic stimulation in the treatment of GAD. There was some evidence of efficacy for complementary therapies, including physical exercise, yoga, acupuncture, and Withania somnifera (ashwagandha). However, a systematic review of cannabidiol and tetrahydrocannabinol found insufficient evidence of efficacy in anxiety disorders.

SUMMARY: Antidepressants and quetiapine show efficacy in the treatment of GAD. Internet-based psychological interventions have a place in the treatment of GAD when face-to-face treatment is inaccessible. There is increasing evidence for the use of physical exercise in the management of GAD. Some other complementary therapies, including cannabinoids, require further, methodologically sound, research.

PMID:36705012 | DOI:10.1097/YCO.0000000000000840

https://pubmed.ncbi.nlm.nih.gov/36705012/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230127152308&v=2.17.9.post6+86293ac January 27, 2023 11:00 am

PubMed: Contemplating cannabis? The complex relationship between cannabinoids and hepatic metabolism resulting in the potential for drug-drug interactions

PubMed: Contemplating cannabis? The complex relationship between cannabinoids and hepatic metabolism resulting in the potential for drug-drug interactions

Front Psychiatry. 2023 Jan 10;13:1055481. doi: 10.3389/fpsyt.2022.1055481. eCollection 2022.

ABSTRACT

The majority of states have fully legalized the use of medical cannabis (MC), and nearly all other states allow limited access to cannabidiol (CBD), a non-intoxicating constituent of cannabis often touted for a range of therapeutic indications. Further, the Agricultural Improvement Act of 2018 legalized hemp-derived products in all 50 states; typically high in CBD, these products are derived from cannabis varieties containing ≤0.3% delta-9-tetrahydrocannabinol (THC) by weight. The recent “green rush” has resulted in a striking increase in cannabis use among patients and consumers who often use a wide variety of novel product types, each with a unique blend of cannabinoid constituents. Importantly, however, several cannabinoids have the potential to cause drug-drug interactions (DDI) with other medications, primarily due to their involvement with the hepatic cytochrome P450 (CYP450) system. This article examines the potential for individual cannabinoids, particularly CBD, to interact with the hepatic metabolic system, which is concerning given its involvement in the metabolism of commonly-prescribed medications. CBD and other cannabinoids are metabolized extensively by the CYP450 system, and also inhibit many of these enzymes, potentially leading to variable serum levels of other medications, as well as variable levels of cannabinoids when other medications modify the system. As access and interest in cannabinoid-based products continues to increase, critical questions remain unanswered regarding their safety. The complex relationship between cannabinoids and the hepatic metabolic system, including common potential DDI resulting from cannabinoid exposure, are explored along with the clinical significance of these potential interactions and monitoring or mitigation strategies.

PMID:36704740 | PMC:PMC9871609 | DOI:10.3389/fpsyt.2022.1055481

https://pubmed.ncbi.nlm.nih.gov/36704740/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230127152308&v=2.17.9.post6+86293ac January 27, 2023 11:00 am

PubMed: Beneficial metabolic transformations and prebiotic potential of hemp bran and its alcalase hydrolysate, after colonic fermentation in a gut model

PubMed: Beneficial metabolic transformations and prebiotic potential of hemp bran and its alcalase hydrolysate, after colonic fermentation in a gut model

Sci Rep. 2023 Jan 27;13(1):1552. doi: 10.1038/s41598-023-27726-w.

ABSTRACT

Hemp seed bran (HB) is an industrial food byproduct that is generally discarded. Knowledge on the functional capabilities of HB is limited and it is not known the impact of HB on human colon microbiota, where vegetable fibers are metabolized. In this work, we investigated in depth the prebiotic potential of HB and HB protein extract hydrolyzed by alcalase (HBPA) in comparison to fructooligosaccharides (FOS) after human distal colonic fermentation using MICODE (multi-unit in vitro colon gut model). During the 24 h of fermentation, metabolomics (SPME GC/MS) and microbiomics (MiSeq and qPCR) analyses were performed. The results indicated that HBPA on a colonic fermentation had a higher prebiotic index than HB (p < 0.05), and slightly lower to that of FOS (p > 0.05). This feature was described and explained as HBPA colonic fermentation produces beneficial organic fatty acids (e.g. Pentanoic and Hexanoic acids); reduces detrimental phenol derivates (e.g. p-Cresol); produces bioactives VOCs (e.g. Acetophenone or 4-Terpineol); increases beneficial bacteria (e.g. 1.76 fold and 2.07 fold more of Bifidobacterium bifidum and Bacteroides fragilis, respectively) and limits opportunistic bacteria (e.g. 3.04 fold and 2.07 fold less of Bilophila wadsworthia and Desulfovibrio, respectively). Our study evidenced the prebiotic role of HB and HBPA, and within the principles of OneHealth it valorizes a byproduct from the queen plant of sustainable crops as a food supplement.

PMID:36707683 | DOI:10.1038/s41598-023-27726-w

https://pubmed.ncbi.nlm.nih.gov/36707683/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230128152309&v=2.17.9.post6+86293ac January 27, 2023 11:00 am

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

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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.

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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.

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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.

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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.

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#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 recommendations on cannabis could signal progress for CBD

FDA recommendations on cannabis could signal progress for CBD
The U.S. Food and Drug Administration (FDA) says it is only months away from finalizing recommendations for how cannabis should best be regulated and whether additional legislation from Congress is …

FDA recommendations on cannabis could signal progress for CBD Read More »


#CBD #Hemp
https://hemptoday.net/fda-recommendations-on-cannabis-could-signal-progress-for-cbd/
January 26, 2023 12:17 pm

PubMed: The effect of tetrahydrocannabinol:cannabidiol oromucosal spray on cognition: a systematic review

PubMed: The effect of tetrahydrocannabinol:cannabidiol oromucosal spray on cognition: a systematic review

Eur J Clin Pharmacol. 2023 Jan 26. doi: 10.1007/s00228-023-03454-y. Online ahead of print.

ABSTRACT

PURPOSE: Previous studies have shown that tetrahydrocannabinol (THC), the main psychoactive component of cannabis, can impair cognitive abilities. There is also some evidence that cannabidiol (CBD), the most abundant non-intoxicating constituent of cannabis, can attenuate these effects. The purpose of this study was to investigate the effects of THC:CBD oromucosal spray (with equal parts THC and CBD) on cognition compared with control conditions in human studies.

METHODS: A systematic literature search was performed on four major bibliographic databases. Studies were included in the present review if they evaluated the cognitive effects of THC:CBD oromucosal spray compared with a control condition.

RESULTS: Ten studies were identified (7 on patients with multiple sclerosis, 1 on those with Huntington, and 2 on healthy volunteers) with 510 participants in total. There was considerable heterogeneity among the studies in terms of dose and duration of administration. All studies have used an equal or nearly equal dose of THC and CBD.

CONCLUSIONS: Although the results across studies were somewhat inconsistent, most evidence revealed that there is no significant difference between THC:CBD oromucosal spray and control treatments in terms of cognitive outcomes. However, more trials are needed with longer follow-up periods, and dose considerations, particularly comparing lower and higher doses of the spray.

PMID:36700997 | DOI:10.1007/s00228-023-03454-y

https://pubmed.ncbi.nlm.nih.gov/36700997/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230126152141&v=2.17.9.post6+86293ac January 26, 2023 11:00 am

PubMed: Evidence of the Ability of Microsatellite Method to Distinguish <em>Cannabis</em> Strains with High Cannabinoid Content

PubMed: Evidence of the Ability of Microsatellite Method to Distinguish <em>Cannabis</em> Strains with High Cannabinoid Content

Cannabis Cannabinoid Res. 2023 Jan 24. doi: 10.1089/can.2022.0272. Online ahead of print.

ABSTRACT

Introduction: Cannabis is a plant with high potential for use in several sectors of the industry; however, it is also a controversial crop due to its tetrahydrocannabinol (THC) content. Moreover, the plant has a rather unclarified classification. Traditionally, two types of Cannabis have been distinguished, hemp as a source of fiber and low THC content, and marijuana with high THC levels, which is used as a drug. With the increasing use of CBD strains and wide range of commercially used THC strains, it is becoming paramount to be able to develop an easy and reliable method for Cannabis strain differentiation. The use of simple sequence repeat markers, or microsatellites, seems to be an applicable choice. Materials and Methods: In this study, 52 strains of Cannabis with variable cannabinoid content were collected from growers from different geographical regions and analyzed using 17 different microsatellite markers. For more precise differentiation, five strains were selected and a higher number of individuals of each were analyzed. Results: Fragment analysis and cluster analysis showed that when one to three individual plants per strain were analyzed, the method was able to classify these samples into distinguishable groups with similar gene structure. They also revealed that when a larger sample set was used (10 individual plants per strain), highly specific strain clusters could be fully discriminated. Conclusion: Our study involved the highest number of cannabinoid-rich strains up to now and showed that the microsatellite method can be used to reliably differentiate Cannabis strains and show their relationships.

PMID:36695671 | DOI:10.1089/can.2022.0272

https://pubmed.ncbi.nlm.nih.gov/36695671/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230125152210&v=2.17.9.post6+86293ac January 25, 2023 11:00 am

PubMed: Tetrahydrocannabinols: potential cannabimimetic agents for cancer therapy

PubMed: Tetrahydrocannabinols: potential cannabimimetic agents for cancer therapy

Cancer Metastasis Rev. 2023 Jan 25. doi: 10.1007/s10555-023-10078-2. Online ahead of print.

ABSTRACT

Tetrahydrocannabinols (THCs) antagonize the CB1 and CB2 cannabinoid receptors, whose signaling to the endocannabinoid system is essential for controlling cell survival and proliferation as well as psychoactive effects. Most tumor cells express a much higher level of CB1 and CB2; THCs have been investigated as potential cancer therapeutic due to their cannabimimetic properties. To date, THCs have been prescribed as palliative medicine to cancer patients but not as an anticancer modality. Growing evidence of preclinical research demonstrates that THCs reduce tumor progression by stimulating apoptosis and autophagy and inhibiting two significant hallmarks of cancer pathogenesis: metastasis and angiogenesis. However, the degree of their anticancer effects depends on the origin of the tumor site, the expression of cannabinoid receptors on tumor cells, and the dosages and types of THC. This review summarizes the current state of knowledge on the molecular processes that THCs target for their anticancer effects. It also emphasizes the substantial knowledge gaps that should be of concern in future studies. We also discuss the therapeutic effects of THCs and the problems that will need to be addressed in the future. Clarifying unanswered queries is a prerequisite to translating the THCs into an effective anticancer regime.

PMID:36696005 | DOI:10.1007/s10555-023-10078-2

https://pubmed.ncbi.nlm.nih.gov/36696005/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230125152210&v=2.17.9.post6+86293ac January 25, 2023 11:00 am

PubMed: Composition and functional properties of hemp seed protein isolates from various hemp cultivars

PubMed: Composition and functional properties of hemp seed protein isolates from various hemp cultivars

J Food Sci. 2023 Jan 24. doi: 10.1111/1750-3841.16467. Online ahead of print.

ABSTRACT

Hemp seed protein isolates (HPI) were extracted from seven commercial hemp cultivars, a Cornell breeding line, and a commercial hemp heart product, and their composition and functional properties were investigated. HPI contained different ratios of edestin, vicilin, and albumin proteins, which affected protein solubility and functionality. Higher protein solubility was associated with cultivars that contained more vicilin and albumin, which influenced the subsequent functional properties of HPI. Significant differences in water holding capacity (0.83-1.05 g water/g protein isolate), oil holding capacity (1.28-1.81 g oil/g protein isolate), foam capacity (52.9%-84.9%), and foam stability (68.1%-89.4%) were observed across HPI. The Cornell hemp breeding line exhibited the highest protein solubility at pH 7.0 and was uniquely capable of forming an emulsion. The relationship identified between hemp seed protein composition and functionality, in conjunction with the demonstration of an on-going hemp breeding line, suggest that continued, targeted development of hemp cultivars can improve its seed protein functional properties for ingredient utilization in plant-based foods.

PMID:36694405 | DOI:10.1111/1750-3841.16467

https://pubmed.ncbi.nlm.nih.gov/36694405/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230125152210&v=2.17.9.post6+86293ac January 25, 2023 11:00 am

PubMed: Parkin Mediates Cannabidiol Prevention of Amyloid-Beta-Induced Senescence in Human Astrocytes

PubMed: Parkin Mediates Cannabidiol Prevention of Amyloid-Beta-Induced Senescence in Human Astrocytes

Cannabis Cannabinoid Res. 2023 Jan 24. doi: 10.1089/can.2022.0186. Online ahead of print.

ABSTRACT

Introduction: As aging is the leading risk factor for Alzheimer’s disease (AD), ablation of senescent cells is a promising therapeutic approach to prevent AD. It is known that astrocytes lose their ability to maintain a healthy brain environment when aging. Studies have recently shown that cannabidiol (CBD) provides a promising therapeutic avenue for AD; however, if or how CBD prevents astrocyte aging is not known. Materials and Methods: In this study, human astrocytes were employed to measure amyloid-beta (Aβ)-induced senescence features, including senescence-associated β-galactosidase (SA-β-gal), p16INK4A, p21WAF1, and p53. The effects of CBD on the production of mitochondrial dysfunction and mitophagy pathway were measured by Western blot and fluorescence assay. Caenorhabditis elegans was used as in vivo AD model to investigate the effects of CBD on life span and health span. All experimental procedures were approved by the Human Research Ethics Committee, University of Wollongong, Australia. Results: In human astrocytes, we show that treatment with Aβ, an endogenous pathogenic agent of AD, results in an increase in the percentage of SA-β-gal-positive cells and induces mitochondrial reactive oxygen species (ROS). However, CBD treatment protects from Aβ-induced senescence. Furthermore, the anti-senescence and anti-apoptotic activities of CBD were observed to be mediated through the protective effect of Parkin-dependent mitophagy. In C. elegans, we used the transgenic GRU102 strain, which expresses the human Aβ peptide, and found that CBD treatment extended life span, improved pumping rate, and decreased mitochondrial ROS. Conclusion and Significance: Our results demonstrate that CBD prevents the human astrocyte senescence induced by Aβ by a mechanism involving the Parkin-mediated mitophagy pathway. Our findings support the new therapeutic avenues of CBD for the treatment of AD patients.

PMID:36695672 | DOI:10.1089/can.2022.0186

https://pubmed.ncbi.nlm.nih.gov/36695672/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230125152210&v=2.17.9.post6+86293ac January 25, 2023 11:00 am

PubMed: Surface engineering of zinc phthalocyanine organic thin-film transistors results in part-per-billion sensitivity towards cannabinoid vapor

PubMed: Surface engineering of zinc phthalocyanine organic thin-film transistors results in part-per-billion sensitivity towards cannabinoid vapor

Commun Chem. 2022 Dec 24;5(1):178. doi: 10.1038/s42004-022-00797-y.

ABSTRACT

Phthalocyanine-based organic thin-film transistors (OTFTs) have been demonstrated as sensors for a range of analytes, including cannabinoids, in both liquid and gas phases. Detection of the primary cannabinoids, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), is necessary for quality control and regulation, however, current techniques are often not readily available for consumers, industry, and law-enforcement. The OTFT characteristics, X-ray diffraction (XRD) spectra, and grazing incident wide angle x-ray scattering (GIWAXS) spectra of two copper and three zinc phthalocyanines, with varying degrees of peripheral fluorination, were screened to determine sensitivity to THC vapor. Unsubstituted ZnPc was found to be the most sensitive material and, by tuning thin-film morphology, crystal polymorphs, and thickness through altered physical vapor deposition conditions, we increased the sensitivity to THC by 100x. Here we demonstrate that deposition conditions, and the resulting physical film characteristics, play a significant role in device sensitization.

PMID:36697684 | PMC:PMC9814745 | DOI:10.1038/s42004-022-00797-y

https://pubmed.ncbi.nlm.nih.gov/36697684/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230126152141&v=2.17.9.post6+86293ac January 25, 2023 11:00 am

PubMed: Origins of <em>Cannabis sativa</em> in Ireland and the Concept of Celtic Hemp: An Interdisciplinary Review

PubMed: Origins of <em>Cannabis sativa</em> in Ireland and the Concept of Celtic Hemp: An Interdisciplinary Review

Cannabis Cannabinoid Res. 2023 Jan 23. doi: 10.1089/can.2022.0263. Online ahead of print.

ABSTRACT

Introduction: Ireland’s agriculture has been shaped by Celts, Romano-British Christians, Norse-Vikings, Anglo-Normans, and subsequent migrants. Who introduced hemp (Cannabis sativa) to Hibernia? We addressed this question using historical linguistics, fossil pollen studies (FPSs), archaeological data, and written records. Methods: Data gathering utilized digital resources coupled with citation tracking. Linguistic methods separated cognates (words with shared etymological origins) from loanwords (borrowed from other languages). Cannabis pollen in FPSs was identified using the “ecological proxy” method. Archaeological reports were ranked on a “robustness” scale. Results: Words for “hemp” in Celtic languages are loanwords, not cognates. The Irish word cnáib is first attested in texts written 1060 and 1127-1134 CE. Old Breton coarcholion, corrected to coarch, is attested in a text from the 9th century. Pollen consistent with cultivated Cannabis appears in the Middle Ages, ca. 700 CE, at sites in the vicinity of monasteries. Archaeological finds (hemp seeds and fiber) date to later Norse-Viking and Anglo-Norman sites. Discussion: People of the Hallstatt Culture in Central Europe have long been considered speakers of the “Proto-Celtic” language. The lack of “hemp” cognates means a Proto-Celtic word cannot be reconstructed, which implies that Hallstatt people (with robust archaeological evidence of hemp) did not speak Proto-Celtic. Cnáib is absent in Old Irish glossaries, epics, and mythologies (600-900 CE). FPS data suggest that the onset of hemp cultivation correlated-chronologically and spatially-with the founding of Romano-British monasteries. Irish cnáib was likely borrowed from Clerical Latin canapis or canabus.

PMID:36695660 | DOI:10.1089/can.2022.0263

https://pubmed.ncbi.nlm.nih.gov/36695660/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230125152210&v=2.17.9.post6+86293ac January 25, 2023 11:00 am

FDA Roundup: January 24, 2023

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

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FDA Roundup: January 24, 2023

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January 24, 2023

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

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FDA Roundup: January 24, 2023

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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.
       
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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.

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#CBD #Hemp http://www.fda.gov/news-events/press-announcements/fda-roundup-january-24-2023 January 24, 2023 5:35 pm

South Dakota was No. 2 grower in 2022, state hemp association says

South Dakota was No. 2 grower in 2022, state hemp association says
South Dakota has leaped into second place as a grower of industrial hemp, increasing plantings while most states across the U.S. trimmed their fields last year, according to analysis by …

South Dakota was No. 2 grower in 2022, state hemp association says Read More »


#CBD #Hemp
https://hemptoday.net/south-dakota-was-no-2-grower-in-2022-state-hemp-association-says/
January 24, 2023 1:57 pm

PubMed: Real world data on cannabidiol treatment of various epilepsy subtypes: a retrospective, multicenter study

PubMed: Real world data on cannabidiol treatment of various epilepsy subtypes: a retrospective, multicenter study

Epilepsia Open. 2023 Jan 24. doi: 10.1002/epi4.12699. Online ahead of print.

ABSTRACT

OBJECTIVE: Cannabidiol (CBD) is approved for treatment of Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC). Several studies suggest anti-seizure effects also beyond these three epilepsy syndromes.

METHODS: In a retrospective multi-center study, we analyzed the efficacy and tolerability of CBD in patients with epilepsy at 16 epilepsy centers.

RESULTS: The study cohort comprised 311 patients with epilepsy with a median age of 11.3 (0-72) years (235 children and adolescents, 76 adults). Therapy with CBD was off-label in 91.3% of cases due to age, epilepsy subtype, lack of adjunct therapy with clobazam, and/or higher dose applied. CBD titration regimens were slower than recommended, with good tolerability of higher doses particularly in children. Of all patients, 36.9% experienced a reduction in seizure frequency of >50%, independent of their epilepsy subtype or clobazam co-medication. The median observation period was 15.8 months. About one third of all patients discontinued therapy within the observation period due to adverse effects or lack of efficacy. Adverse effects were reported frequently (46.9%).

SIGNIFICANCE: Our study highlights that CBD has an anti-seizure effect comparable to other anti-seizure medications with a positive safety profile independent of the epilepsy subtype. Comedication with clobazam was not associated with a better outcome. Higher doses to achieve seizure frequency reduction were safe, particularly in children. These findings call for further trials for an extended approval of CBD for other epilepsy subtypes and for children < 2 years of age.

PMID:36693811 | DOI:10.1002/epi4.12699

https://pubmed.ncbi.nlm.nih.gov/36693811/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230125152210&v=2.17.9.post6+86293ac January 24, 2023 11:00 am

PubMed: Enantioselective Total Synthesis of Cannabinoids via a Tandem Conjugate Addition/Enolate Alkylation Annulation with Ambiphilic Organoboronates

PubMed: Enantioselective Total Synthesis of Cannabinoids via a Tandem Conjugate Addition/Enolate Alkylation Annulation with Ambiphilic Organoboronates

Org Lett. 2023 Jan 24. doi: 10.1021/acs.orglett.3c00090. Online ahead of print.

ABSTRACT

Cannabinoid research depends on synthesizing derivatives for structure-activity relationship studies. (-)-Δ9-Tetrahydrocannabinol and cannabidiol were synthesized via a tandem enantioselective conjugate addition/enolate alkylation annulation with a novel ambiphilic trifluoroborate in seven steps. A new class of alkenyl and aryl ambiphilic trifluoroborates were synthesized and showed great compatibility with various functional groups, high yields, and excellent enantio- and diastereoselectivity. A novel benzo-fused cannabinoid analogue and tandem quaternary stereocenter-containing reaction products were synthesized with good to excellent enantioselectivity.

PMID:36693245 | DOI:10.1021/acs.orglett.3c00090

https://pubmed.ncbi.nlm.nih.gov/36693245/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230125152210&v=2.17.9.post6+86293ac January 24, 2023 11:00 am

PubMed: Molecular insights into the interaction of eighteen different variants of SARS-CoV-2 spike proteins with sixteen therapeutically important phytocompounds: in silico approach

PubMed: Molecular insights into the interaction of eighteen different variants of SARS-CoV-2 spike proteins with sixteen therapeutically important phytocompounds: in silico approach

J Biomol Struct Dyn. 2023 Jan 23:1-28. doi: 10.1080/07391102.2023.2169761. Online ahead of print.

ABSTRACT

SARS-CoV-2 has mutated many times among different populations. We analyzed wild-type spike protein and 18 different variants of SARS-CoV-2 spike protein known until the beginning of 2022 (alpha, beta, B.1.429, B.1.616, B.1.620, B.1.617.3, C.1.2, delta, epsilon, eta, gamma, iota, kappa, lambda, mu, omicron, theta, and zeta) for their interaction with 16 phytocompounds and remdesivir, resulting into 425 combinations. The largest number of mutations has been reported in the omicron followed by delta variant. However, the virulence of the delta variant has been reported higher as compared to omicron. Mutations at a few locations (D215G, K417N, E484K, N501Y, D614G, and P681H) were common in most of the variants. 3 D structures of all the 18 spike proteins were created using SWISS-MODEL to test the binding affinities with caffeine theophylline, emodin, vitexin, berberine, curcumin, piperine, quercetin, artemisinin, carvacrol, capsaicin, tetrahydrocannabinol, cannabidiol, α- pinene, β- pinene and gingerol. Phytocompounds and mutant variants were prepared using AutoDock 4.2.6 software. Binding affinities of the selected phytocompounds with the different mutant spike proteins were achieved using AutoDock Vina. Out of all combinations investigated, the best binding affinities were observed with 3 variants of SAR-CoV-2 with 5 phytocompounds along with remdesivir. The range of best binding energies varied from -9.1 to -8.0 kcal/mol. Further, MD simulation was done for selected 9 phytocompound-spike mutant complexes for analyzing the stability of interactions for 100 ns. ADMET studies via ProTox-II and SwissADME displayed that phytocompounds are safe and less toxic in comparison to remdesivir.Communicated by Ramaswamy H. Sarma.

PMID:36690609 | DOI:10.1080/07391102.2023.2169761

https://pubmed.ncbi.nlm.nih.gov/36690609/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230124152241&v=2.17.9.post6+86293ac January 23, 2023 11:00 am

Epidiolex maker files suit in U.S. to protect its patents

Epidiolex maker files suit in U.S. to protect its patents
The maker of CBD prescription drug Epidiolex has filed a lawsuit in the USA alleging patent infringement. GW Research Ltd, a subsidiary of Ireland-based Jazz Pharmaceuticals, claims that more than …

Epidiolex maker files suit in U.S. to protect its patents Read More »


#CBD #Hemp
https://hemptoday.net/epidiolex-maker-files-suit-in-u-s-to-protect-its-patents/
January 23, 2023 7:16 am

PubMed: Health value and keeping quality of chevon from goats fed finisher diets containing hemp (Cannabis sativa L.) seed cake

PubMed: Health value and keeping quality of chevon from goats fed finisher diets containing hemp (Cannabis sativa L.) seed cake

Meat Sci. 2023 Jan 14;198:109114. doi: 10.1016/j.meatsci.2023.109114. Online ahead of print.

ABSTRACT

Wether goats (n = 7) were fed finishing diets containing either 0, 25, 50, 75 or 100 g/kg DM of hempseed cake (HSC) substituting soybean meal to evaluate chevon fatty acid, volatile and oxidative profiles. Feeding HSC diets linearly decreased (P < 0.05) chevon c9-16:1, 16:0, total saturated FA (SFA) and protein oxidation but linearly increased (P < 0.05) t9-18:1, t11-18:1, conjugated linoleic acids, n-3 polyunsaturated FA (PUFA), individual long-chain n-6 PUFA and antioxidant activity. On day 1 and 7 of retail display, diets containing 75 and 100 g/kg DM HSC had greater (P < 0.05) TBARS than the other diet × day interactions. Addition of HSC to the diet increased (P < 0.05) and preserved (P < 0.05) chevon contents of hexanal and methyl caprate throughout the retail display period. Overall, feeding HSC up to 100 g/kg DM enhances chevon profiles of healthful PUFA, desirable flavor volatiles and protein shelf-stability.

PMID:36682284 | DOI:10.1016/j.meatsci.2023.109114

https://pubmed.ncbi.nlm.nih.gov/36682284/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230123152108&v=2.17.9.post6+86293ac January 22, 2023 11:00 am

PubMed: The effects of cannabidiol on immune function and health parameters in senior horses

PubMed: The effects of cannabidiol on immune function and health parameters in senior horses

Vet Immunol Immunopathol. 2023 Jan 19;257:110549. doi: 10.1016/j.vetimm.2023.110549. Online ahead of print.

ABSTRACT

Cannabidiol (CBD) has potential to reduce pain and inflammation in humans leading to the interest of use in equine. The purpose of this study was to determine the effects of CBD on immune function by measuring inflammatory cytokines and antibody responses to vaccination, as well as other health parameters in senior horses. Horses were orally-dosed with CBD (2 mg/kg: 13 horses) or control (soy oil: 14 horses) daily for 90 days, from July 2021 to November 2021. Peripheral blood samples were collected on days 0, 30, 60, and 90 before administering treatments. On day 90 all horses were kept on treatment and vaccinated with an equine influenza vaccine and blood samples were collected post-vaccination on days 14 and 21. For all time points, plasma samples were analyzed for determination of CBD and metabolites, 7-OH CBD and 7-COOH CBD, using tandem mass spectrometry. For time points 0, 30, 60 and 90, blood samples were analyzed for CBC and chemistry. Additionally, peripheral blood mononuclear cells (PBMC) were isolated, stimulated with phorbol 12-myristate 13-acetate (PMA) and ionomycin, stained intracellularly for interferon gamma (IFN-γ) and tumor necrosis factor alpha (TNF-α) then analyzed via flow cytometry. Real-time PCR (RT-PCR) analyzed both stimulated PBMCs and whole blood for cytokine gene expression. Inflammatory proteins C-reactive protein, interleukin 1 receptor agonist, and prostaglandin E2 were measured with equine-specific enzyme linked immunosorbent assays. Thyrotropin-releasing hormone stimulation test and oral sugar test were performed on all horses before and after the study to analyze metabolic function. Hemagglutination inhibition (HI) titers were measured for immune responses pre- and post-vaccination. All data were analyzed using either a paired t-test or a two-way repeated measures analysis of variance (significance P < 0.05). Plasma concentrations of CBD and metabolites were determined with 7-COOH CBD, the most significant metabolite, in CBD treated horses compared to control treated horses. A significant decrease was determined for whole blood inflammatory cytokine expression of IFN-γ at day 60, and for IL6 at day 60 and 90 for CBD-treated horses when compared to control horses. CBD did not significantly affect any other immune factors, HI titers, or health parameters. This study demonstrated that treatment with CBD reduced some inflammatory cytokine production with no negative side effects as measured by CBC or chemistry profiles. This study reveals the initial understanding of CBD in the horse, however more in-depth research is needed to fully understand its efficacy on the health of the horse.

PMID:36682327 | DOI:10.1016/j.vetimm.2023.110549

https://pubmed.ncbi.nlm.nih.gov/36682327/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230123152108&v=2.17.9.post6+86293ac January 22, 2023 11:00 am

PubMed: Screening System of <em>Cannabis&amp;amp;nbsp;sativa</em> Extracts Based on Their Mitochondrial Safety Profile Using Cytochrome c Oxidase Activity as a Biomarker

PubMed: Screening System of <em>Cannabis&amp;amp;nbsp;sativa</em> Extracts Based on Their Mitochondrial Safety Profile Using Cytochrome c Oxidase Activity as a Biomarker

Int J Mol Sci. 2023 Jan 10;24(2):1315. doi: 10.3390/ijms24021315.

ABSTRACT

The development of Cannabis sativa strains with high cannabidiol (CBD) and low tetrahydrocannabinol (THC) content is a growing field of research, both for medical and recreational use. However, the mechanisms behind clinical actions of cannabinoids are still under investigation, although there is growing evidence that mitochondria play an important role in many of them. Numerous studies have described that cannabinoids modulate mitochondrial activity both through activation of mitochondrial cannabinoid receptors and through direct action on other proteins such as mitochondrial complexes involved in cellular respiration. Thus, the aim of this study was to determine the actions of a panel of extracts, isolated from high-CBD varieties of Cannabis sativa, on the activity of the mitochondrial electron transport chain complex IV, cytochrome c oxidase (CCO), in order to select those with a safer profile. After demonstrating that Cannabis sativa strains could be identified by cannabinoids content, concentration-response curves were performed with a collection of extracts from strains with high-CBD and low-THC content using bovine CCO. The CCO rate was clearly modified by specific extracts of Cannabis sativa plants compared to others. Half maximal inhibitory concentrations (IC50) of extracts and the inhibitory effects evoked at 1 × 10-4 g/mL displayed a significant correlation with the THC. Therefore, the screening of extracts based on CCO activity provides a powerful and rapid methodology to identify those plants with higher mitochondrial toxicity or even mito-protective actions.

PMID:36674832 | DOI:10.3390/ijms24021315

https://pubmed.ncbi.nlm.nih.gov/36674832/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Comparison of the Cannabinoid and Terpene Profiles in Commercial Cannabis from Natural and Artificial Cultivation

PubMed: Comparison of the Cannabinoid and Terpene Profiles in Commercial Cannabis from Natural and Artificial Cultivation

Molecules. 2023 Jan 13;28(2):833. doi: 10.3390/molecules28020833.

ABSTRACT

Interest in cultivating cannabis for medical and recreational purposes is increasing due to a dramatic shift in cannabis legislation worldwide. Therefore, a comprehensive understanding of the composition of secondary metabolites, cannabinoids, and terpenes grown in different environmental conditions is of primary importance for the medical and recreational use of cannabis. We compared the terpene and cannabinoid profiles using gas/liquid chromatography and mass spectrometry for commercial cannabis from genetically identical plants grown indoors using artificial light and artificially grown media or outdoors grown in living soil and natural sunlight. By analyzing the cannabinoids, we found significant variations in the metabolomic profile of cannabis for the different environments. Overall, for both cultivars, there were significantly greater oxidized and degraded cannabinoids in the indoor-grown samples. Moreover, the outdoor-grown samples had significantly more unusual cannabinoids, such as C4- and C6-THCA. There were also significant differences in the terpene profiles between indoor- and outdoor-grown cannabis. The outdoor samples had a greater preponderance of sesquiterpenes including β-caryophyllene, α-humulene, α-bergamotene, α-guaiene, and germacrene B relative to the indoor samples.

PMID:36677891 | DOI:10.3390/molecules28020833

https://pubmed.ncbi.nlm.nih.gov/36677891/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Structural Investigation of Beta-Cyclodextrin Complexes with Cannabidiol and Delta-9-Tetrahydrocannabinol in 1:1 and 2:1 Host-Guest Stoichiometry: Molecular Docking and Density Functional Calculations

PubMed: Structural Investigation of Beta-Cyclodextrin Complexes with Cannabidiol and Delta-9-Tetrahydrocannabinol in 1:1 and 2:1 Host-Guest Stoichiometry: Molecular Docking and Density Functional Calculations

Int J Mol Sci. 2023 Jan 12;24(2):1525. doi: 10.3390/ijms24021525.

ABSTRACT

The complexation of β-cyclodextrin (β-CD) with cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) was investigated using molecular docking and M062X/6-31G(d,p) calculations. The calculations suggested two possible complex formations of 1:1 and 2:1 host-guest molecular ratio of β-CD with CBD and THC. The preferred orientation of all complexes in this study exhibited the hydrogen bonding between hydroxy-substituted benzene ring of CBD and THC with the β-CD’s secondary hydroxy groups at the wide rim. The calculated complexation energies indicate that formation of the 2:1 complexes (-83.53 to -135.36 kcal/mol) was more energetically favorable and chemically stable than the 1:1 complexes (-30.00 to -34.92 kcal/mol). However, the deformation energies of the host and the guest components in the 2:1 complexes (37.47-96.91 kcal/mol) are much higher than those in the 1:1 complexes (3.49-8.69 kcal/mol), which means the formation processes of the 2:1 complexes are more difficult due to the rigidity of the dimeric β-CDs. Therefore, the inclusion complexes of β-CD with CBD and THC are more likely to be in 1:1 host-guest ratio than in 2:1 molecular ratio. The results of this study supported the experimental results that the complexation constant of 1:1 β-CD/CBD (Ks = 300 M-1) is greater than that of 2:1 β-CDs/CBD (Kss = 0.833 M-1). Altogether, this study introduced the fitting parameters that could indicate the stability of the molecular fits in complex formation of each stoichiometry host-guest ratio, which are important for the assessment of the inclusion mechanisms as well as the relationships of reactants and products in chemical reactions.

PMID:36675035 | DOI:10.3390/ijms24021525

https://pubmed.ncbi.nlm.nih.gov/36675035/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Cannabidiol Rescues TNF-α-Inhibited Proliferation, Migration, and Osteogenic/Odontogenic Differentiation of Dental Pulp Stem Cells

PubMed: Cannabidiol Rescues TNF-α-Inhibited Proliferation, Migration, and Osteogenic/Odontogenic Differentiation of Dental Pulp Stem Cells

Biomolecules. 2023 Jan 6;13(1):118. doi: 10.3390/biom13010118.

ABSTRACT

Strategies to promote dental pulp stem cells (DPSCs) functions including proliferation, migration, pro-angiogenic effects, and odontogenic/osteogenic differentiation are in urgent need to restore pulpitis-damaged dentin/pulp regeneration and DPSCs-based bone tissue engineering applications. Cannabidiol (CBD), an active component of Cannabis sativa has shown anti-inflammation, chemotactic, anti-microbial, and tissue regenerative potentials. Based on these facts, this study aimed to analyze the effect of CBD on DPSCs proliferation, migration, and osteogenic/odontogenic differentiation in basal and inflammatory conditions. Highly pure DPSCs with characteristics of mesenchymal stem cells (MSCs) were successfully isolated, as indicated by the results of flowcytometry and multi-lineage (osteogenic, adipogenic, and chondrogenic) differentiation potentials. Among the concentration tested (0.1-12.5 µM), CBD (2.5 μM) showed the highest anabolic effect on the proliferation and osteogenic/odontogenic differentiation of DPSCs. Pro-angiogenic growth factor VEGF mRNA expression was robustly higher in CBD-treated DPSCs. CBD also prompted the migration of DPSCs and CBD receptor CB1 and CB2 expression in DPSCs. TNF-α inhibited the viability, migration, and osteogenic/odontogenic differentiation of DPSCs and CBD reversed these effects. CBD alleviated the TNF-α-upregulated expression of pro-inflammatory cytokines TNF-α, interleukin (IL)-1β, and IL-6 in DPSCs. In conclusion, our results indicate the possible application of CBD on DPSCs-based dentin/pulp and bone regeneration.

PMID:36671503 | DOI:10.3390/biom13010118

https://pubmed.ncbi.nlm.nih.gov/36671503/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Cannabinoid Biosynthesis Using Noncanonical Cannabinoid Synthases

PubMed: Cannabinoid Biosynthesis Using Noncanonical Cannabinoid Synthases

Int J Mol Sci. 2023 Jan 9;24(2):1259. doi: 10.3390/ijms24021259.

ABSTRACT

We report enzymes from the berberine bridge enzyme (BBE) superfamily that catalyze the oxidative cyclization of the monoterpene moiety in cannabigerolic acid (CBGA) to form cannabielsoin (CBE). The enzymes are from a variety of organisms and are previously uncharacterized. Out of 232 homologues chosen from the enzyme superfamily, four orthologues were shown to accept CBGA as a substrate and catalyze the biosynthesis of CBE. The four enzymes discovered in this study were recombinantly expressed and purified in Pichia pastoris. These enzymes are the first report of heterologous expression of BBEs that did not originate from the Cannabis plant that catalyze the production of cannabinoids using CBGA as substrate. This study details a new avenue for discovering and producing natural and unnatural cannabinoids.

PMID:36674774 | DOI:10.3390/ijms24021259

https://pubmed.ncbi.nlm.nih.gov/36674774/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Behavior of the Flexural Strength of Hemp/Polypropylene Composites: Evaluation of the Intrinsic Flexural Strength of Untreated Hemp Strands

PubMed: Behavior of the Flexural Strength of Hemp/Polypropylene Composites: Evaluation of the Intrinsic Flexural Strength of Untreated Hemp Strands

Polymers (Basel). 2023 Jan 10;15(2):371. doi: 10.3390/polym15020371.

ABSTRACT

The growing demand for plant fiber-reinforced composites offers new opportunities to compete against glass fiber (GF)-reinforced composites, but their performance must be assessed, revised, and improved as much as possible. This work reports on the production and the flexural strength of composites from polypropylene (PP) and hemp strands (20-50 wt.%), using maleic anhydride-grafted PP (MAPP) as a compatibilizer. A computational assessment of the reaction between cellulose and MAPP suggested the formation of only one ester bond per maleic anhydride unit as the most stable product. We determined the most favorable MAPP dosage to be 0.06 g per gram of fiber. The maximum enhancement in flexural strength that was attained with this proportion of MAPP was 148%, corresponding to the maximum fiber load. The modified rule of mixtures and the assumption of similar coupling factors for tensile and flexural strength allowed us to estimate the intrinsic flexural strength of hemp strands as 953 ± 116 MPa. While falling short of the values for sized GF (2415 MPa), the reinforcement efficiency parameter of the natural fibers (0.209) was found to be higher than that of GF (0.045).

PMID:36679252 | DOI:10.3390/polym15020371

https://pubmed.ncbi.nlm.nih.gov/36679252/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Hemp Protein Hydrolysates Modulate Inflammasome-Related Genes in Microglial Cells

PubMed: Hemp Protein Hydrolysates Modulate Inflammasome-Related Genes in Microglial Cells

Biology (Basel). 2022 Dec 27;12(1):49. doi: 10.3390/biology12010049.

ABSTRACT

A prolonged inflammatory response can lead to the development of neurodegenerative diseases such as Alzheimer’s disease. Enzymatic hydrolysis is a sustainable way to increase the value of protein sources by obtaining peptides that can exert bioactivity. Hemp (Cannabis sativa L.) protein hydrolysates have been proven to exert anti-inflammatory activity. In this study, two hemp protein hydrolysate (HPHs), obtained with Alcalase as sole catalyst, or with Alcalase followed by Flavourzyme, were evaluated as inflammatory mediators (TNFα, IL-1β, IL-6, and IL-10), microglial polarization markers (Ccr7, iNos, Arg1, and Ym1), and genes related to inflammasome activation (Nlrp3, Asc, Casp1, and Il18), employing the lipopolysaccharide (LPS)-induced neuroinflammation model in murine BV-2 microglial cells. A significant decrease of the expression of proinflammatory genes (e.g., Tnfα, Ccr7, inos, and Nlrp3, among others) and increase of the expression anti-inflammatory cytokines in microglial cells was observed after treatment with the test HPHs. This result in the cell model suggests a polarization toward an anti-inflammatory M2 phenotype. Our results show that the evaluated HPHs show potential neuroprotective activity in microglial cells via the inflammasome.

PMID:36671742 | DOI:10.3390/biology12010049

https://pubmed.ncbi.nlm.nih.gov/36671742/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Effect of the Bleaching Process on Changes in the Fatty Acid Profile of Raw Hemp Seed Oil (Cannabis sativa)

PubMed: Effect of the Bleaching Process on Changes in the Fatty Acid Profile of Raw Hemp Seed Oil (<em>Cannabis sativa</em>)

Molecules. 2023 Jan 12;28(2):769. doi: 10.3390/molecules28020769.

ABSTRACT

Many refined oils from soybean, rapeseed, and sunflower, among others, are available on the food market, except olive oil. Refining, on the small production scale of niche oils, is not used due to the high cost of the refining process. Unrefined oils are characterized by intense taste, odor, color, and undesirable nutrients. The problem to be solved is determining the effects of incomplete refining of niche oils on their composition. One process, which does not require the use of complex apparatus, is the bleaching process. The results presented in this article relate to the research stage, in which the aim is to evaluate the changes occurring in the oil due to the low-temperature bleaching process with different process parameters. The presented research results provide evidence of the absence of adverse changes in the fatty acid profile of hemp oil of the varieties ‘Finola’, ‘Earlina 8FC’, and ‘Secuieni Jubileu’. Seven different types of bleaching earth were used to bleach the oil in amounts of 2.5 and 5 g/100 g of vegetable oil. The fatty acid profile was obtained by gas chromatography (GC-FID). The obtained chromatograms were subjected to statistical analysis and principal component analysis (PCA). The results show that there was no effect of the type of bleaching earth and its amount on the change in the fatty acid profile of bleached oils. Only real differences between the types of hemp oils were observed. However, an overall positive effect of the bleaching process on hemp oil was found. The amount of saturated fatty acid (SFA) was reduced by 17.1% compared with the initial value, resulting in an increase in the proportion of polyunsaturated fatty acids (PUFA) by 4.4%, resulting in an unsaturated fatty acid (UFA) proportion of 90%. There was a significant improvement in the SFA/PUFA ratio by 26% over the baseline, and the omega-6/omega-3 ratio by 8.9% to a value of 3.1:1. The new knowledge from this study is evidence of the positive effect of the low-temperature bleaching process on the fatty acid profile. In contrast, the parameters of the bleaching process itself are not significant.

PMID:36677827 | DOI:10.3390/molecules28020769

https://pubmed.ncbi.nlm.nih.gov/36677827/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Maximizing Quality of Life in Children with Epilepsy

PubMed: Maximizing Quality of Life in Children with Epilepsy

Children (Basel). 2022 Dec 28;10(1):65. doi: 10.3390/children10010065.

ABSTRACT

Arguably significant progress and improvement in the medical and surgical treatments of seizures and epilepsy in children have occurred; however, there have been relatively fewer efforts in optimizing the care of lifestyle complications related to the disease state. Many patients have significant behavioral and mental health comorbidities, including ADHD (attention deficit hyperactivity disorder), which should be treated. After epilepsy surgery, only seizure freedom results in improved quality of life (QOL). Improved compliance leads to better seizure control and ensuring that caregivers have a rescue treatment helps empower patients. Education and improving seizure illness perception is beneficial. Cannabidiol may have benefits other than seizure control. The majority of children are mainly concerned about the stigma attached to having epilepsy. Driving affecting older children is discussed. Restrictions on these children should be minimized and enabling regular activities maximized.

PMID:36670616 | DOI:10.3390/children10010065

https://pubmed.ncbi.nlm.nih.gov/36670616/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Evaluation of an Oral Supplemental Cannabidiol Product for Acceptability and Performance in Mature Horses

PubMed: Evaluation of an Oral Supplemental Cannabidiol Product for Acceptability and Performance in Mature Horses

Animals (Basel). 2023 Jan 10;13(2):245. doi: 10.3390/ani13020245.

ABSTRACT

Thirty stock type geldings (15 ± 3 years; 556 ± 63 kg BW) were used in a randomized complete design over 28 days to determine the influence of cannabidiol (CBD) oil supplementation levels on body weight, body condition, and blood chemistry. Horses were randomly assigned to one of three dietary treatments (n = 10 per treatment) formulated with canola oil to provide 1.50 mg CBD/kg BW (TRTA), 0.75 mg CBD/kg BW (TRTB), or 0.00 mg CBD/kg BW (canola oil; CTRL). Treatments were top-dressed onto concentrate and individually administered twice daily. Horses were maintained in adjacent dry lots and received coastal bermudagrass hay ad libitum. Body weight and body condition scores (BCS) were obtained every 14 days. On day 0 and 28, blood was collected via jugular venipuncture and serum was harvested to perform a blood chemistry panel and drugs of abuse screening at the Texas Veterinary Medical Diagnostic Laboratory. Data were analyzed using PROC MIXED of SAS (v9.4), and the model included treatment, time, and the treatment × time interaction, and linear and quadratic orthogonal polynomial contrasts to partition sum of squares. Analysis of composited treatment samples revealed lower CBD concentrations than indicated from initial testing by the manufacturer (0.13 mg CBD/kg in TRTA; 0.12 mg CBD/kg in TRTB). At this level of supplementation, canola-based CBD oil was well-accepted by mature horses, banned substances were not detectable in blood, and blood chemistry parameters were not adversely affected as a result of supplementation. More research is warranted to describe the discrepancy between formulated levels compared to tested levels of CBD in the canola-based supplement.

PMID:36670785 | DOI:10.3390/ani13020245

https://pubmed.ncbi.nlm.nih.gov/36670785/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230121152727&v=2.17.9.post6+86293ac January 21, 2023 11:00 am

PubMed: Effect of Cannabis on Memory Consolidation, Learning and Retrieval and Its Current Legal Status in India: A Review

PubMed: Effect of Cannabis on Memory Consolidation, Learning and Retrieval and Its Current Legal Status in India: A Review

Biomolecules. 2023 Jan 12;13(1):162. doi: 10.3390/biom13010162.

ABSTRACT

Cannabis is one of the oldest crops grown, traditionally held religious attachments in various cultures for its medicinal use much before its introduction to Western medicine. Multiple preclinical and clinical investigations have explored the beneficial effects of cannabis in various neurocognitive and neurodegenerative diseases affecting the cognitive domains. Tetrahydrocannabinol (THC), the major psychoactive component, is responsible for cognition-related deficits, while cannabidiol (CBD), a non-psychoactive phytocannabinoid, has been shown to elicit neuroprotective activity. In the present integrative review, the authors focus on the effects of cannabis on the different cognitive domains, including learning, consolidation, and retrieval. The present study is the first attempt in which significant focus has been imparted on all three aspects of cognition, thus linking to its usage. Furthermore, the investigators have also depicted the current legal position of cannabis in India and the requirement for reforms.

PMID:36671547 | DOI:10.3390/biom13010162