Agency issued 15 warning letters to CBD companies
The U.S. Food and Drug Administration (FDA) issued a press release on November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain CBD. The warning letters follow FDA’s trend of focusing its CBD product enforcement on unapproved drug claims. The regulatory decision stated in the press release concerns FDA’s decision that CBD is not generally recognized as safe (GRAS) for use as a food additive.
The 15 warning letters, each dated November 22, were issued to companies marketing various CBD products. The products identified in the letters spanned conventional foods, dietary supplements and animal products, and the FDA made specific mention in several warning letters about statements regarding the use of CBD products in infants and children.
The press release also stated that the agency cannot conclude that CBD is GRAS among qualified experts for use in human or animal food. Based on this conclusion, the FDA updated information on its website about cannabis and cannabis-derived compounds to provide additional information about safety concerns. Regarding these changes and its decision on CBD’s use in food, the FDA states: “Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. The revised consumer update outlines specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.”
Apart from the press release and consumer update, it does not appear that the FDA has provided any other documentation on its GRAS decision, such as in a formal report or white paper. Such documentation will be valuable to establish what data and information needs to be gathered to determine the safety of CBD.
The warning letters highlight the FDA’s continued concerns related to the use of CBD. Common to most warning letters are unapproved human drug claims associated with serious diseases, including cancer, autism, opioid addiction, post-traumatic stress disorder, diabetes and Alzheimer’s disease, among others. The one exception appears to be the warning letter issued to Apex Hemp Oil LLC, of Redmond, Oregon, which cites only limited claims such as “helps cells regenerate,” “the answer for sore muscle aches” and “balances the mind and body by promoting natural healing through the endocannabinoid system.” The warning letter to Apex also addresses a number of animal health claims, including one for treatment of “arthritis & joint discomfort.” It is not known if this warning letter is an outlier or if it suggests the agency will increase its focus on CBD veterinary claims or human structure/function claims.
Along with these issues, the FDA raised concerns with the use of CBD in:
– Animal food, especially when it is intended for consumption by food-producing animals as there is a lack of data establishing safe CBD residue levels;
– Conventional food, as CBD is not GRAS and there is no food additive regulation that authorizes the use of CBD as an ingredient in human food;
– Dietary supplements, as CBD products do not meet the definition of dietary supplement; and
– Products marketed for infants and children as they may be at greater risk for adverse reactions due to differences in the ability to absorb, metabolize, distribute or excrete CBD.
Over the last several years, the FDA has sent warning letters to other companies that sell products containing CBD that claim to prevent, diagnose, mitigate, treat or cure diseases, such as cancer and Alzheimer’s. This most recent action makes it clear that the FDA will take action against products that make claims that could result in consumers avoiding important medical care due to the unsubstantiated claims. Additionally, this action underscores the FDA’s need for additional data to establish safety for the use of CBD in human and animal food and dietary supplements.
Steven Levine is a partner in Husch Blackwell’s Denver office, where he leads the firm’s national cannabis practice.
Seth Mailhot is a Washington, D.C.-based partner with Husch Blackwell. He leads the firm’s food safety and regulation group and is an active member of the cannabis practice.
Emily Lyons, an attorney in Husch Blackwell’s Washington, D.C. office, is active within the firm’s food and agribusiness and cannabis practices.