FDA Takes Action Against Curaleaf for Misbranded CBD Products
Health & Life Sciences Alert 07/25/19 Theodore M. Sullivan
On July 23, 2019, the Food and Drug Administration (FDA) issued a regulatory Warning Letter to Curaleaf, Inc. of Wakefield, MA for its cannabidiol (CBD) containing topical and ingestible products. The Agency claims that the Curaleaf products represent unapproved human and veterinary drug products. This Warning Letter represents the FDA's first real enforcement action against CBD products in approximately six months.
CBD is a non-psychoactive component of the cannabis plant. Prior to the 2018 Farm Bill, CBD was considered a Schedule I controlled substance. The Farm Bill descheduled CBD that is derived from hemp products (defined as cannabis containing less than 0.3 percent THC), but the ingredient is still subject to the requirements of the Food, Drug, and Cosmetic Act (FDCA) when used in FDA regulated products.
Curaleaf appears to have been marketing its CBD-containing products as dietary supplements and cosmetic products; however, for a variety of reasons, the FDA considered these products to be unapproved drugs. The FDA notes that Curaleaf's website and products make claims that CBD can treat or cure a number of diseases or medical conditions, including cancer, chronic pain, ADHD, anxiety, depression, post-traumatic stress disorders, schizophrenia, and addiction. These claims are considered to be drug claims, and not appropriate for cosmetic products or dietary supplements. Additionally, the FDA states that CBD cannot legally be used as a dietary supplement ingredient. Under the FDCA, an ingredient cannot be used as a dietary ingredient in a supplement product if that ingredient is first used in an approved drug product. The FDA has determined that CBD was used in the approved drug Epidiolex prior to any valid supplement use.
Curaleaf also marketed some of its CBD products for veterinary use. The FDA considers such products to be unapproved veterinary drugs. As with the human products, these products make a number of disease or condition treatment claims that make the products drugs.
Since the passage of the Farm Bill, the Agency has been taking a somewhat hands-off approach to regulating CBD products. The FDA has stated that CBD containing food and supplement products are not legal, but has not been actively enforcing against companies marketing these products. This action against Curaleaf may represent a signal that the FDA is ready to step up enforcement action against CBD-containing products, at least where the companies marketing the products make disease treatment claims. It is not clear if the FDA might only pursue those companies that make serious disease claims for CBD products, or if it may take action against products making softer claims, or those that simply use CBD as an ingredient in dietary supplements.
The FDA Warning Letter to Curaleaf, Inc. can be found here.
If you have any questions about how this might affect your business, please contact your Quarles & Brady attorney or:
- Ted Sullivan: (202) 372-9533 / [email protected]