On November 25, 2019, the U.S. Food & Drug Administration (FDA) announced that it had issued warning letters to 15 U.S. businesses engaged in the sale of products containing cannabidiol (CBD); that it had published a revised Consumer Update detailing safety concerns about CBD products; and that it “cannot conclude that CBD is generally recognized as safe (GRAS)” for use in human or animal food. These actions and statements by FDA cut against industrywide hopes that FDA might soon realign its enforcement policy in light of market realities.
The Warning Letters
The warning letters targeted private companies based in Arizona, California, Colorado, Florida, New York, Kentucky, Oklahoma, Oregon and Texas. One company in California, for instance, was cited by FDA for suggesting that CBD can be used to treat diseases and disorders such as PTSD, multiple sclerosis, Crohn’s disease and schizophrenia. That same company was also cited for promoting adulterated foods, a violation of the Food, Drug & Cosmetic Act (FDCA), based on the business’ marketing of CBD gummies as a human food and for marketing an unapproved new animal drug, also unlawful under the FDCA, based on its offering of CBD spray and soft chews for pets. (A number of warning letters, including one sent to a Florida CBD company, also warned of FDA’s inability to conclude, among qualified experts, that CBD is GRAS for its use in human or animal food.)
An Oregon business was advised that its “K9 oil” and dog treats were unapproved new animal drugs in violation of the FDCA and that its CBD products marketed to “help… cells regenerate” and “balance… the mind and body by promoting natural healing through the endocannabinoid system” constituted the unapproved new drugs under the FDCA. The warning letters also advised businesses that labeling CBD products “dietary supplements”—widely practiced in the industry—was a violation of the FDCA given the use of CBD in an approved drug (Epidiolex).
These warning letters are not the first of their kind: FDA has been issuing warning letters relating to CBD products since 2015. However, this recent burst of 15 warning letters appears to have just tripled the amount of warning letters issued by FDA this year, an indication that although regulatory reform may be on the horizon, FDA is not slowing down.
The Consumer Update (CBD)
Among other things, while the Consumer Update recognizes the obvious—“cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, and animal health products”—it just as quickly reminds consumers that, aside from Epidiolex, an oral solution for the treatment of certain seizures, FDA “has not approved any other CBD products.” Relatedly, the Consumer Update flags the lack of sufficient data on CBD’s effects and identifies potential risks associated with the use of CBD products, among them liver injury (identified as a potential risk during FDA’s review of the marketing application for Epidiolex), drug interactions and male reproductive toxicity (shown in male offspring of CBD-treated pregnant females in laboratory animal studies).
As FDA attempts to make clear in its Consumer Update, while many companies are selling and marketing CBD products as elixirs for ailments and diseases ranging from muscle aches to Alzheimer’s, the medical benefit claims are being overstated while the potential medical risks are being ignored or disregarded. The Consumer Update also reiterated FDA’s stance on the labeling of CBD products as dietary supplements: “We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is illegal to market CBD this way.”