FDA sets a date for public meeting on CBD, and other steps to evaluate potential regulatory pathway

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U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced several steps the agency is taking to evaluate potential regulatory pathways for supplements and foods containing hemp-derived CBD. In February, Gottlieb stated that FDA would hold a public meeting on the issue, and now, in this most recent statement, the Commissioner announced that the meeting will take place on May 31, 2019 from 8 a.m. to 6 p.m. Request to make oral presentations and comments at the meeting should be submitted by May 10, 2019, though electronic and written comments will be accepted by FDA until July 2, 2019.

The Commissioner also announced the formation of a high-level internal agency working group exploring potential regulatory pathways for hemp-derived CBD products, which will be co-chaired by principal deputy commissioner Amy Abernethy, MD, PhD, and principal associate commissioner for policy Lowell Schiller. The working group will consider FDA’s options under its current authority as well as potential legislative options. There have also been updates to the agency's webpage containing answers to frequently asked questions on the topic of cannabis and cannabis-derived products.

Coinciding with this announcement, FDA also announced it has issued multiple warning letters to companies marketing CBD with unsubstantiated claims, sending the message that the agency is serious about enforcing its authority over CBD products.

There are still many unanswered questions regarding the long-term safety of CBD, said Gottlieb, citing potential for liver injury from using Epidiolex, the CBD drug FDA approved for treating epilepsy, as well as unknowns about the cumulative exposure to CBD if people have access to it across a range of consumer products.

“It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA’s regulatory oversight of these products – especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods,” says Gottlieb. “As I stated in December, the FDA would only consider this path if the agency were able to determine that all other requirements in the FD&C Act [Federal Food, Drug, and Cosmetic Act] are met, including those required for food additives or new dietary ingredients.”