FDA has made good on its promise to continue enforcing against companies selling CBD products that violate the Federal Food, Drug, and Cosmetic Act (FDCA). FDA issued 15 warning letters against companies in CA, TX, OK, CO, OR, NY, NC, AZ, KY, and FL, showing that it is scrutinizing companies across the country. As before, FDA issued the warning letters for products to which food has been added and products marketed as dietary supplements, as neither type of product is permissible in interstate commerce under the FDCA. New in this batch of warning letters are products targeted for infants and children (a vulnerable population) and products taken by food-producing animals (for which there is a lack of data establishing safe levels). The claims made on the product for food-producing animals were far less egregious than the typical cancer/diabetes/Alzheimer's-fighting claims consistently targeted by FDA; in this case, the claims focused on management of aches and pains and anxiety.
While FDA has previously designated as GRAS (Generally Recognized as Safe) three hemp derivatives - hemp seed oil, hulled hemp seed, and hemp seed protein, FDA explicitly stated today that it would not issue the GRAS designation to CBD recognizing it to be safe for use in human or animal food.
Importantly, FDA acknowledged that it is continuing to explore ways for various types of CBD products to be lawfully marketed. However, the agency notes that many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. In response, FDA issued a Consumer Update that discusses potential side effects from CBD products.
We will continue to monitor FDA's progress. For now, companies deciding whether to place into interstate commerce foods, dietary supplements, or unapproved drugs containing CBD should contemplate receiving an FDA Warning Letter when conducting internal risk/benefit analyses.