FDA Warning Letter Declares Delta-8 and CBD Gummies ‘Adulterated Foods’

December 12, 2023

On Dec. 6, 2023, the U.S. Food and Drug Administration (FDA) sent a warning letter to the owners of online hemp, tetrahydrocannabinol (THC) and cannabidiol (CBD) retailer Hemp-xr.com for introducing adulterated foods into interstate commerce. FDA took issue with certain cookies, edibles, gummies and honey containing delta-8 THC and CBD because they “bear or contain an unsafe food additive.”

What’s unusual about this warning letter is that FDA has, in the past, focused on companies that market their products containing THC or CBD as products that can treat, cure, prevent or mitigate diseases, which renders the products unapproved drugs. This warning letter instead shifts focus to the fact that FDA considers neither delta-8 THC nor CBD to be “generally recognized as safe” (GRAS) food additives. FDA goes so far as to declare that products containing delta-8 THC “may pose a serious health risk to consumers.”

On Nov. 21, 2023, FDA sent a series of five warning letters to companies selling food products containing CBD, though some of those warnings focused on claims that the CBD products treat or cure disease. FDA followed up with a series of 15 more warning letters to companies selling products containing CBD, many of which again focused on offering CBD as an unapproved new drug, as well as declaring certain pet products adulterated animal foods. Is the FDA’s recent activity an indication that it’s ready to start enforcing its long-held position that CBD is not safe for consumption?

On July 5, 2023, FDA and the Federal Trade Commission initiated a joint crackdown on the sale of products containing delta-8 THC. The agencies collectively issued cease-and-desist letters to six companies for selling edible products containing the substance, though some of the concern surrounded marketing and packaging that appeared directed toward children. FDA previously warned in 2022 that it believes delta-8 THC, the hemp-derived psychoactive THC (which some argue is legal because it is derived from hemp, not cannabis), “has serious health risks” and “may be marketed in a way that put[s] the public health at risk.” It appears, with this latest warning letter, FDA is prepared to continue pushing back against the burgeoning cannabis and marijuana industries.

McGuireWoods attorneys are experienced in handling complex cannabis, marijuana, CBD and legal issues. For more information on how the latest FDA warning letter could impact your business, contact one of the authors of this client alert.