Second Shot Across the Bow: FDA Issues Warning Letters to 15 CBD Companies
Health & Life Sciences Alert 12/02/19 Roger Morris, Ted Sullivan, Nicholas H. Meza
The Food and Drug Administration (FDA) intends to hold the cannabidiol (CBD) industry accountable for alleged violations of the Food, Drug, and Cosmetic Act (FDCA), as indicated by a press release, a new consumer update on CBD, and 15 warning letters to CBD companies issued on Monday, November 25, 2019.
In a press release, the FDA explained that it cannot currently conclude that CBD is “generally recognized as safe” (a designation often abbreviated as “GRAS”). In practical terms, withholding the GRAS designation means that CBD cannot be used as a food ingredient without passing through the FDA review process. The FDA explained that the basis of this decision is a lack of scientific support indicating that CBD is safe to use in food.
The FDA also issued 15 warning letters to CBD companies for allegedly selling CBD in violation of the FDCA. These warning letters, which form the second issuance of FDA warning letters involving CBD this year, generally address the marketing of CBD products through social media or online stores as a means to treat disease, or as having certain therapeutic uses. The FDA explained that this intent triggers scrutiny, because products intended for medicinal use will be treated as drugs under the FDCA. At this point in time, the FDA has only approved one CBD drug product—a prescription drug called Epidiolex, which is used to treat certain pediatric epilepsy disorders.
Additional concerns cited by the FDA in its warning letters include the marketing of CBD products to vulnerable populations, including infants and children; the marketing of products, which fail to meet the FDCA definition of “dietary supplement,” as dietary supplements; and the production of certain CBD products for food-producing animals, as this may affect the safety of the resulting food products intended for human consumption.
In a consumer update, the FDA detailed its current observations relating to the safety of CBD products, citing liver damage, adverse effects resulting from drug interactions, and male reproductive toxicity as potential risks associated with using CBD products without the guidance of a health care provider.
The FDA is planning to provide a progress update on its CBD position in the coming weeks, as there is significant public interest in CBD. However, as it now stands, the FDA clearly intends to closely monitor the CBD industry and is prepared to take enforcement action. Entities considering manufacturing or selling CBD products must be cognizant that this area remains unsettled, and that until the FDA provides further guidance, sales may be considered a violation of the FDCA.
For more information, please contact your Quarles & Brady attorney or: