On Monday, July 22, the U.S. Food and Drug Administration (FDA) took a rare and significant step in issuing a warning letter to Curaleaf Holdings, Inc. (Curaleaf), one of the country’s larger producers of CBD-based products, regarding Curaleaf’s marketing of its CBD-based products for the treatment of diseases and other health concerns. The FDA has generally taken a passive approach to enforcement of industrial hemp-derived CBD products, which have flooded the market since the passage of the Agricultural Improvement Act of 2018 (also known as the 2018 Farm Bill) in December 2018—making hemp-derived CBD production and interstate commerce explicitly lawful under federal law as long as compliant with the requirements thereunder. In fact, this marks only the fourth warning letter issued by the FDA to a CBD products manufacturer and the only such warning letter issued by the FDA since October 31, 2017.
The letter notes that certain Curaleaf products are unapproved “drugs” within the meaning of the Federal Food, Drug, and Cosmetic Act, because the products are intended for use in the “diagnosis, cure, mitigation, treatment, or prevention or disease and/or intended to affect the structure or any function of the body.” In making this determination, the FDA took issue with the following health claims:
- Claims that CBD can be used for chronic pain
- Claims that CBD can be used to address the symptoms of anxiety and depression
- Claims that CBD can be used to treat cancer
- Claims that CBD can be used to address the symptoms of ADHD
- Claims that CBD has been linked to effective treatment of Parkinson’s disease and Alzheimer’s disease
According to the warning letter, the majority of these statements were pulled from Curaleaf’s website and social media pages.
Although the Curaleaf warning letter did not go so far as to say that retailers carrying Curaleaf products should cease doing so until Curaleaf meets the FDA requirements, one of the country’s largest retail and drugstore chains responded by immediately removing all Curaleaf products from its shelves—including lotions and transdermal patches which fell outside the FDA warning. Such a move by the chain signals its desire to partner only with fully legally compliant suppliers.
The FDA warning letter to Curaleaf underscores the need for all those in the industrial hemp supply chain—from cultivation to manufacturing to packaging and marketing to distribution to retailers—to understand the laws applicable to CBD commercial operations and to implement robust compliance programs that meet those laws.
Current federal law expressly permits hemp-derived CBD products that are compliant with the federal restrictions for THC content (0.3%), subject to state law restrictions. However, such products are still subject to other federal laws, including the Federal Food, Drug, and Cosmetic Act. The act requires that any product designed for use as a drug be subjected to the FDA’s drug approval process before the product may be distributed. In addition, FDA has taken the position that CBD may not be used in products designed for human or animal consumption, or in dietary supplements, prior to FDA approval for such use.
However, to date, enforcement of this policy has been inconsistent. In addition, some states have adopted legislation directly contradicting the federal prohibition of CBD use in food and dietary supplements, further muddying the legal framework for CBD products.
Until the FDA adopts a different policy, CBD product manufacturers, marketers, distributers and retailers engaging in interstate commercial activities should refrain from selling hemp-derived CBD food products or dietary supplements (including food and supplements for animals) or any CBD product that makes a health claim.
The FDA’s letter is available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curaleaf-inc-579289-07222019