On July 21^st, the FDA issued new draft guidance on the use of cannabis and cannabis-derived compounds in clinical research. This draft guidance is non-binding and narrow in that it only applies to the use of cannabis in clinical trials for the development of human drug products. 

Prior to 2018, any cannabis to be used for clinical research related to the development of human drug products, regardless of THC concentration, had to be obtained from a single source – the National Institute on Drug Abuse Drug Supply Program. (NIDA DSP). After the passage of the 2018 Farm Bill, and the descheduling of hemp, cannabis and cannabis-derived compounds containing not more than 0.3% THC by dry weight may be sourced outside of the NIDA DSP. 

BIG TAKEAWAYS FOR CANNABIS INDUSTRY 

1. FDA will not regulate or give guidance on the use of cannabis containing a THC concentration above 0.3%. DEA and the CSA maintain the regulatory authority over that material and sponsors or applicants hoping to use botanical material or a derived compound from that category need to contact the DEA for further guidance.

2. Affirms/clarifies that cannabis and cannabis-derived compounds at 0.3% THC concentration or below will be treated the same as all other botanical materials used in clinical trials for human drug products.

3. FDA proposes methods for testing and dosing of human drug products.

If you’re a glass-half-full kind of person, this FDA draft guidance may appear as a significant step in the direction of clear regulations and federal standardization of the cannabis industry.

If you’re a glass-half-empty kind of person, this guidance looks like a nod to the pharmaceutical industry and the beginning of a very difficult regulatory road. Is this the standard that the industry wants to be held to? While suggested protocols may feel more comfortable in comparison to the lack of standards, how long will it be before this collar starts to chaff?

Either way, right now, this guidance is non-binding and only applicable to cannabis or cannabis-derived human drug products. But, if administrative and enforcement agencies use these “suggestions” as a starting point to extend such guidance into the rest of the cannabis industry, the burden may prove too high for many producers.