The cannabis industry received a wake-up call when the news emerged that the Food and Drug Administration (“FDA”) had issued a warning letter (“Warning Letter”) to Curaleaf, Inc. (“Curaleaf”) for selling products containing cannabidiol (CBD) with unsubstantiated claims. While the FDA has issued warning letters in the past, the Warning Letter marks a milestone because it may be the biggest distributor that the FDA has targeted till date. Curaleaf recently touted its partnership with CVS Health Corp. (“CVS”) to distribute CBD products through CVS’S retail stores – a decision that may be impacted by the Warning Letter. Curaleaf has fifteen days in which to respond to the Warning Letter, and its response will be closely watched by the industry.
In general, the FDA has taken the position that CBD cannot be marketed through interstate commerce as a food additive or dietary supplement because of the “IND preclusion” provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act). CBD has been approved as a drug, Epidiolex®, which triggered the preclusion provision. However, despite the lack of approval of any CBD-containing product other than Epidiolex®, enforcement actions by FDA have the FDA have been relatively sparse. In that respect, this Warning Letter provides several important insights into FDA’s regulatory priorities.
First, the scope of the claims the matter. The broader the claims, the increased likelihood of scrutiny. This is consistent with the public statements from the Commissioners. For example, in public remarks in December 2018, Commissioner Gottlieb stated, “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider ‘over-the-line claims.” In May 2019, Dr. Sharpless also commented, “Selling unapproved drug products with unsubstantiated therapeutic claims is a violation of the law, and puts patients at risk.”
In its Warning Letter, the FDA highlighted claims directed at a range of conditions with widely different pathophysiology including ADHD, depression, anxiety, PTSD, chronic pain, slipped spinal discs, eating disorders, addiction, neurodegenerative disorders, breast cancer, Parkinson’s, Alzheimer’s disease, schizophrenia, and other conditions. The FDA listed the different categories of evidence, including website and social media postings, relied upon to reach the conclusion that Curaleaf intended that its products were intended to be used as drugs in the treatment of the above conditions, including statements made on its website and social media accounts. The FDA’s detailed listing the broad range of disease categories shows its sensitivity to the breadth and nature of the claims made by Curaleaf – the claims included life threatening conditions such as cancer and chronic conditions, such as pain, which are both difficult to treat and detrimental to the quality of life.
Second, claims for different categories should be considered in conjunction with the specific regulatory requirements. For example, dietary supplements, vape pens, cosmetics, and topically administered products are subject to different regulatory requirements. Each product must be assessed in the context of the specific regulatory requirements and the risk tolerances assessed accordingly. This is well illustrated in the Warning Letter where the FDA has highlighted that Curaleaf appears to improperly present its “CBD Lotion,” “CBD Pain-Relief Patch,” and “CBD Disposable Vape Pen” as dietary supplements. As the FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) as products that is “intended for ingestion,” these products cannot, by definition be supplements. This is in addition to making claims with regards to these products which suggests they are also misbranded as drug delivery devices.
Third, the Warning Letter indicates that claims with regards to animal health products is not exempt from its scrutiny. Veterinary care is in some respects is highly species specific, and regulatory approval may be in narrower categories than in humans. Thus, overbroad claims can trigger greater enforcement oversight and it is important to be aware of the regulatory requirement when making labeling claims.
Takeaways: The most important takeaway is that the FDA will not hesitate to enforce its authority, including against large companies selling through major outlets. While better regulatory guidance with regards to the use of CBD in food & beverages, dietary supplements, cosmetics, and animal products would be greatly welcomed by the industry, the Warning Letter provides substantive insight into FDA’s enforcement priorities. First, be careful about the scope of claims. The FDA’s distaste for cure-all claims is well established. The broader the claims, the greater the likelihood of enforcement actions. Second, know the appropriate regulations for the class of products. The regulations of a drug, a dietary supplement, a topical ointment, and a cosmetic impose different requirements and risk tolerances and must be assessed accordingly. Finally, human and animal products are assessed differently – and claims with regards to animal products must be assessed with regards to the specific regulatory requirements.