On May 31, the FDA will hold its first public hearing on products containing cannabis and cannabis-derived compounds. The FDA is also “forming a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.”
In a statement, FDA Commissioner Scott Gottlieb reiterated that the agency currently considers cannabis a drug, not a food. Thus, it’s “unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC as dietary supplements.” Since CBD and THC are active ingredients in FDA-approved drugs…”the only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use.”
Gottlieb identified several “open questions” that the agency is working to resolve:
- How the safety risks of CBD use (e.g., potential for liver injury) can be managed when exposure is across a broad range of consumer products
- The intended functionality of CBD in such products
- Whether some threshold of CBD could be allowed in food products “without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.”
It’s this last point that the FDA is primarily concerned with — how drug development with CBD might be impacted by widespread commercial availability of the products and what might happen if patients choose to take CBD on their own as opposed to in the doses studied for clinical purposes.
Last year’s Farm Bill legalized hemp, and many food and beverage companies took that as a green light to start selling CBD-infused products. However, the FDA recently issued a Q&A stating that the agency retains the authority to regulate products containing cannabis or cannabis-derived compounds. The Q&A also explicitly states that it’s illegal to sell any food to which CBD or THC has been added in interstate commerce.
The FDA is also cracking down on companies that make therapeutic claims related to CBD’s ability to “limit, treat, or cure” a variety of health conditions. The agency recently sent warning letters to three companies about making such claims.
Gottlieb noted in his statement that the issue is “complicated” and “could take some time to resolve fully.” The FDA expects to start sharing information from the working group with the public as early as this summer.