FDA lacks science to declare CBD GRAS; issues warning to companies selling CBD-containing products
The U.S. Food and Drug Administration (FDA) issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating that it can’t conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.
The actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products. The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.
“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,’” said FDA Principal Deputy Commissioner Amy Abernethy. “Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety—including reports of products containing contaminants, such as pesticides and heavy metals—and there are real risks that need to be considered.”
Some of the products are foods to which CBD has been added. Under the FD&C Act, it is illegal to introduce into interstate commerce any human or animal food to which certain drug ingredients, such as CBD, have been added. In addition, the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food. There also is no food additive regulation that authorizes the use of CBD as an ingredient in human food or animal food, and the agency is not aware of any other exemption from the food additive definition that would apply to CBD. Therefore, CBD is an unapproved food additive, and its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient. Some of the products are marketed as dietary supplements. However, CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.
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