Seyfarth Synopsis: In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products containing CBD. In addition to the letters, the FDA published a revised Consumer Update detailing safety concerns about CBD products more broadly. Notably, the FDA commented that it “plans to provide an update on its progress regarding the agency’s approach to these [CBD] products in the coming weeks.”
Previously, the FDA had indicated it would generate a report by this Fall. Finally, the FDA reiterated that “[i]t is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.” Unlike hemp derivatives– hulled hemp seed, hemp seed protein powder, and hemp seed oil–which were added to the FDA’s Generally Recognized as Safe (GRAS) inventory, the FDA also confirmed that, at this time, CBD is not generally recognized as safe for use in human or animal food.
The latest series of letters signal that while the FDA is continuing its work to develop a regulatory framework, it is still regularly monitoring the market. As FDA Principal Deputy Commissioner Amy Abernathy remarked, the FDA will “take action as needed against companies that violate the law in ways that raise a variety of public health concerns.” Of critical concern to the FDA, “[m]isleading, unproven, or false claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care.” In the warning letters, the FDA makes familiar scolding that the recipient cannot make claims about CBD’s ability to cure or treat a disease on product labels, company websites, Facebook, Instagram, and YouTube. The letters also explain that because CBD is an active ingredient in the epilepsy drug, Epidiolex, products containing CBD are therefore outside the definition of a dietary supplement and cannot be added to food products.
Implicated in the letters is an array of CBD products, including oils, tinctures, balms, gummies, lotions, roll-on gels, caramels, soaps, face masks, pet products, water, sprays and creams. While a majority of the letter recipients reside in California, other companies in Texas, Oklahoma, Colorado, Oregon, New York, Florida, North Carolina, Arizona, and Kentucky also received warning letters, demonstrating that the unauthorized sale of CBD products is a growing national problem. The FDA has requested responses from the warning letter recipients within 15 working days stating how they plan to correct these violations, with serious legal ramifications on the line should they fail to comply.
The FDA also highlighted the issue it has proclaimed since May 2019, when the CBD Policy Working Group held a public hearing–“many unanswered questions and data gaps about CBD toxicity” remain. Dr. Abernathy cautioned, “[a]side 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.” In the revised Consumer Update, the FDA seeks to eliminate the concept that CBD “can’t hurt.” To combat that misconception, the FDA outlines a number of known concerns with CBD, including liver injury, drug interactions, male reproductive toxicity, and side effects. As to areas that the FDA is “actively working to learn more about”, those include: cumulative exposure, effects on special populations, and CBD use with animals.
Importantly, the FDA’s latest update reminds companies that it is illegal under federal law to market food products that contain CBD or label CBD as a dietary supplement. With an emphasis on the safety concerns posed by CBD use–both known and unknown–the FDA’s enforcement efforts and consumer publications serve as a plea to manufacturers to exercise patience and let the FDA continue to assess the outstanding safety issues of potential uses of CBD, and develop a sufficient regulatory framework for non-drug uses accordingly. Until the FDA issues its much-anticipated CBD policy, we can expect the FDA to continue sending warning letters to manufactures that simply are not listening to regulators and instead heeding consumer demand.
Additionally, class actions continue to populate the federal docket based on third-party testing revealing that CBD supplements are not as advertised, only bolstering the FDA’s safety concerns. See, e.g., Gaddis v. Just Brands USA Inc., et al., Case No. 0:19-cv-62067-RS, in the U.S. District Court Southern District of Florida; Darrow v. Just Brands USA Inc., et al., Case No. 1:19-cv-07079, in the U.S. District Court Northern District of Illinois; Kathryn Potter v. PotNetwork Holdings Inc. et al., case number 1:19-cv-24017, in the U.S. District Court for the Southern District of Florida.