The U.S. Food and Drug Administration’s (“FDA”) May 31 public hearing on cannabis and cannabis-derived compounds (including hemp-derived CBD) reflected and confirmed the confusion many in the space have been experiencing and underscored the importance of entrants to this new industry proceeding cautiously. In the all-day meeting, public comments from academia, agriculture (governmental and non-governmental organizations), consumers, health professionals and patients, public safety, manufacturers, and retailers/distributors, covered wide-ranging and divergent opinions about the benefits and drawbacks of cannabis and hemp-derived CBD, whether and how the FDA should regulate these products, and the need for more research, among other issues.
In opening remarks, the FDA provided background on its role in oversight of cannabis, cannabis-derived compounds, and hemp-derived CBD and again articulated the FDA’s position on these products (which has not changed):
- Marijuana and its derivatives remain Schedule 1 drugs under the Controlled Substances Act (“CSA”).
- Hemp and its derivatives, including hemp-derived CBD, are no longer controlled substances scheduled under the CSA (as a result of the 2018 Farm Bill).
- The FDA has always had and continues to have oversight into substances that are added to foods and dietary supplements, which now includes hemp-derived CBD.
- The FDA’s position remains that cannabis and cannabis-derived compounds (e.g., CBD and THC, regardless of source) may not be added to foods or dietary supplements.
- To date, the FDA has focused its enforcement efforts on CBD products that make health and drug claims (i.e., claims that CBD can prevent, diagnose, mitigate, treat, or cure diseases or other health-related conditions). This remains the FDA’s most significant area of concern.
- The FDA is also concerned about the lack of research into cannabis- and hemp-derived compounds (e.g., dosage issues related to how much can be safely consumed; whether dosages are different for various types of products; how dosages may be affected by other drugs; potential side effects; whether and how cannabis- and hemp-derived compounds can/should be used for children, etc.). Such research is needed to assist the FDA in evaluating its potential pathways for regulating cannabis- and hemp-derived compounds.
Here are a few of our takeaways and comments from the rest of the public hearing:
- This hearing comes just at the beginning of the FDA’s process of exploring how it will regulate cannabis. The FDA is still accepting written comments until July 2, 2019, especially scientific studies and hard data, on these preliminary information-gathering questions. There will likely be future opportunities to comment (e.g., on a proposed rule) but this initial comment period will help shape the FDA’s next steps in its evaluation of cannabis regulation. As of the day this advisory was written, more than 1,100 comments have been submitted to the FDA on this subject.
- Commenters appeared to conflate issues related to hemp/CBD with issues related to marijuana – although the FDA’s position is the same on the two categories of cannabis, there are some important differences. This illustrates the amount of confusion present in society around these issues.
- Some commenters expressed concern over the glut of hemp-derived CBD products in the market in the absence of a federal regulatory framework. For example, commenters noted that tests results of certain hemp-derived CBD products on the market indicated that the products do not contain as much CBD as claimed.
- The FDA expressed interest in understanding more about whether and how cannabis and cannabis-derived compounds used in drugs (e.g., CBD in Epidiolex) can coexist with cannabis- and hemp-derived compounds used in foods and dietary supplements.
The FDA highlighted the issue of different age groups having access to the products, and whether to regulate the products differently if intended for use by “children” (also to-be-defined).
Our bottom line is that the FDA’s position on cannabis, cannabis-derived compounds, and hemp-derived CBD has not changed, and there remains regulatory uncertainty and risk around developing and selling products that contain those substances. Industry members interested in developing and selling products that contain cannabis- and/or hemp-derived CBD should proceed with caution and consult with their attorneys to understand the current risks associated with such activity.