FDA Finalizes Guidance on Cannabis Clinical Research and Drug Development

Marijuana Moment reports that the Food and Drug Administration (FDA) has now issued its final guidance on developing cannabis-based drugs, which covers key topics such as sourcing cannabis, recommendations for sponsors conducting clinical research and quality considerations.

The Breakdown

• The guidance details how the agency regulates drugs in general but also its requirements for THC-containing products more specifically and is intended to address the legal definitions and regulatory controls related to cannabis, and certain questions raised about drugs containing cannabis.”
• Cannabis-based drugs will no longer be to the limited number of National Institute on Drug Abuse- (NIDA) contracted suppliers as long as they are “deemed to be of adequate quality by FDA.
• The guidance also details basic standards for clinical studies, how combustible drug products differ om oral preparations, storage requirements for researchers and more.

Our Perspective

Although considered by some to be a small step, it’s certainly one in the right direction. The reason for the guidance primarily relates to the passage of the 2018 Farm Bill, that made the drug development protocol different for cannabis containing less than 0.3%. One not One notable difference between the draft guidance released in 2020 relates to methodology for calculating the percentage of delta-9 THC. Although FDA suggests this method is for clinical research purposes only, it’s possible other regulators and/or legislators will take note and incorporate these concepts into policies they are developing. Unfortunately, this guidance will not impact CBD policy by the FDA, as they just announced it will not develop rules to allow marketing of CBD products as dietary supplements or food items citing that existing regulatory pathways don’t allow for it, and it will be up to Congress to enact rules for the industry.

Health Canada Issues Warning to Producers of Edible Cannabis Extract’s

Some licensed producers have started receiving letters from Health Canada asking them to stop selling certain ingestible cannabis products the regulatory agency says are incorrectly classified and labeled as “extracts” rather than “edibles, reports MJBiz Daily.

The Breakdown

• One letter sent by from Anika Stella Chasse, acting director general of the Compliance Directorate in Health Canada’s Controlled Substances and Cannabis Branch. requested the company (who wished to remain anonymous) to halt the sale of the flagged products.
• Health Canada did not however order the company to recall the products, which have been on store shelves and available to consumers for several months now.
• The letter states that “Health Canada has determined that (the products in question) are consumed in the same manner as food, and therefore fit the definition of edible cannabis.”

Our Perspective

This recent development has raised several concerns for the industry, given the enormous cost producers that are selling these types of products would face if they were deemed non-compliant and removed from the market. With that said, this edible extract format, which we have discussed previously here on The Rotation, has always been described as a loophole and therefore it was only a matter of time before Health Canada took notice. An important point here is that Health Canada does not formally approve any new cannabis products but rather companies are required to submit a notification of a new product to the agency. Moving forward, Health Canada may eventually change the Cannabis Regulations to include oligiofructose as a prohibited substance in extracts. Regardless, this will certainly be an issue to watch closely but from our perspective, the much easier option would be to just raise the edible limits. Although this may have been needed at the start of legalization, now that several years have passed, this has become an anchor on the industry and prevented some consumers from transitioning to the legal market.

New Research Highlights Aroma of Cannabis as Main Factor for Quality Cannabis

The research paper, published in Psychoactives, used cannabis samples from Oregon’s regulated supply chain, taken from a state cannabis competition known as The Cultivation Classic, determined that High-THC as well as terpene content were less of a determining factor in “pleasant subjective effects” than the aroma of cannabis, reports StratCann.

The Breakdown

• Volunteers were provided with a kit containing from the cannabis competition in their kit and given a month to consume the samples.
• Volunteers were then asked to complete a 15-item questionnaire about the subjective effects and desirability of each cannabis sample in their kit.
• Based on the results, the strongest contribution to positive responses from the volunteer judges was related to “pleasant subjective aroma.” Surprisingly, THC as well as levels of terpenes were not directly correlated to “experiential appeal.”
• Interestingly, flower samples with higher total terpene content, based on lab results, were not considered by participating volunteer judges to be more subjectively appealing.

Our Perspective

This is fascinating new research that points to the fact that “contrary to both market dynamics and consumer perception, neither THC potency nor THC dose had an impact on subjective appeal…In other words, high-THC cannabis may cause people to feel high, but high-THC cannabis is not always enjoyable.” This is particularly important given the 20% threshold that companies feel obligated to meet to be listed by provincial buyers. We would also argue that aroma, taste, and flavor has been lacking in the regulated supply chain and hopefully research like this will lead to companies focusing more on these attributes to appeal to consumers.