The U.S. Food and Drug Administration has sent warning letters to five companies for selling food and beverage products that contain cannabidiol (CBD).
The U.S. Food and Drug Administration (FDA) has sent warning letters to five companies for selling food and beverage products that contain cannabidiol (CBD). According to the warning letters, these products are considered adulterated under “section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce…into interstate commerce under sections 301(ll) and 301(a) of the FD&C Act, 21 U.S.C. 331(ll) and 331(a).”
According to FDA, the use of CBD in the food and beverage products is an unapproved food additive. An ingredient is not a food additive, and does not require premarket approval if it is generally recognized as safe (GRAS) by “qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.” While some brands have made self-determinations of GRAS, the agency states that it is not “aware of any basis to conclude that CBD is GRAS for use in conventional foods,” nor does it “know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Therefore, FDA concludes that these products violate 301(a) by introducing adulterated foods into interstate commerce. FDA also states that the companies violated section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll) by introducing into interstate commerce food that contains a drug approved under 505 of the FD&C Act. Currently, CBD is approved as a drug to treat epilepsy, called Epidiolex.
The Agency also cites safety concerns regarding accidental or overconsumption of CBD, as well as drug interactions. Here, the agency claims that it has received numerous adverse reports pertaining to CBD-containing products. Of particular concern to FDA are dosage formats that appeal to children such as gummies, hard candies, and cookies. With regard to interactions, FDA cites the presence of caffeine-containing teas in CBD-containing products sold by 11-11-11 Brands. “Evidence suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects,” states FDA in its warning letter.
The companies have 15 days to respond to FDA, explaining how they will address the issues raised in the letters. Failure to address the violations may results in legal action, including product seizure and/or injunction.