As required under a December 2019 appropriations bill, the FDA recently provided Congress with a report on its progress in the evaluation of pathways for FDA-regulated products containing or derived from cannabis, including cannbidiol (CBD).
The report addressed a number of product areas, including human drugs, animal drugs, dietary supplements, foods, cosmetics, and vape products, and is based on data collected through public hearings, data requests, and findings published in scientific literature.
For purposes of this alert and its audience, the most important takeaways are:
- Dietary Supplements. FDA continues to take a proactive approach to analyzing relevant safety questions related to the presence of CBD in dietary supplements and how best to regulate and conduct essential oversight. Next steps in assessing the safety of CBD-containing dietary supplements includes the creation of a process for the submission of proprietary information regarding specific products (with appropriate protection for trade secrets) that will assist FDA in assessing appropriate regulatory steps. Processors and manufacturers are reminded that while this process takes place, CBD products cannot lawfully be sold as dietary supplements.
- Human Drugs. The regulatory pathway for the development of human drugs containing CBD is controlled via the FD&C Act. The report directs those interested in CBD drug development to contact the Center for Drug Evaluation and Research (CDER) and CDER’s Botanical Review Team (BRT) for assistance on drug development programs for cannabis-derived or CBD-containing drug products.
- Enforcement. FDA continues to monitor the CBD market for violative products, with a particular emphasis on those products that are marketed with claims of therapeutic benefit, including efficacy for the treatment of serious diseases such as cancer and Alzheimer’s. FDA is also closely monitoring CBD products for contaminants (heavy metals and high levels of THC, in particular) and those marketed with false claims regarding ingredients or the amount of CBD contained in the product. Enforcement actions will ensue against those products that pose a threat of harm to the public.
The FisherBroyles Pharmacy and Health Care Law team is pleased to keep those in the industry updated on topics of interest. Questions regarding the subject matter of this alert may be directed to any of the following attorneys.