The Food and Drug Administration has issued warning letters to 15 companies for illegally selling cannabidiol (CBD) products in ways that violate the Federal Food, Drug, and Cosmetic Act. The health agency has also advised consumers that it cannot conclude that CBD is generally recognized as safe for use in human or animal food.
“The FDA has approved only one CBD product, a prescription drug product to treat two rare, severe forms of epilepsy,” the FDA said in a revised Consumer Update, posted Monday. “It is currently illegal to market CBD by adding it to food or labeling it as a dietary supplement. The FDA has only seen limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.”
The Consumer Update also warned that some products are being marketed with “unproven medical claims” and are “of unknown quality,” adding that potential risks in using such products include liver injury, drug interference, risk of drowsiness when mixed with alcohol or other depressants, gastrointestinal distress and changes in mood.
“Consumers should be aware of the potential risks associated with using CBD products,” the update said, adding consumers should discuss using CBD-containing products with a health care provider before trying it.
Six of the companies sent warning letters by the FDA are located in California, while the others are scattered across Oklahoma, Texas, Colorado, Oregon, New York, Florida, North Carolina, Arizona and Kentucky.
The agency said it is evaluating regulatory frameworks that “apply to certain cannabis-derived products that are intended for non-drug users, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate.”
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns," Amy Abernethy, M.D., Ph.D., FDA principal deputy commissioner said, in a news release.