FDA Issues Warning Letter to Curaleaf Over Its CBD Products

Last week, the Food and Drug Administration (FDA) sent a regulatory ‘Warning Letter‘ to Curaleaf, Inc. (Curaleaf) regarding its cannabidiol (CBD) containing products.

CBD and tetrahydrocannabinol (THC) are two natural compounds found in cannabis or marijuana plants. CBD is a non-psychoactive compound, meaning that it doesn’t produce the high or sense of euphoria associated with THC.

According to the FDA, Curaleaf has been marketing its CBD-containing products as supplements and cosmetic products, which the FDA considers to be unapproved drugs, and making unsubstantiated drug claims that these CBD-containing products can treat or cure diseases or medical conditions such as cancer, chronic pain, ADHD, anxiety depression and addiction.

The FDA’s Warning Letter is significant because it represents the first real enforcement action against CBD-containing products since the passage of the 2018 Farm Bill (Farm Bill). Prior to the Farm Bill, CBD was considered a Schedule I Controlled Substance. The Farm Bill, however, descheduled CBD that is derived from hemp products (i.e. cannabis containing less than 0.3% THC) but still subjects CBD-containing products to the requirements of the Food, Drug and Cosmetic Act (FDCA) when used in FDA regulated products.

Under the FDCA, an ingredient cannot be used as a dietary ingredient in a supplement if the ingredient is first used in an approved drug product. The mid-2018, the FDA approved Epidiolex (cannabidiol), the first drug comprised of an active ingredient derived from marijuana, and determined that CBD was used in Epidiolex prior to any valid supplement use (i.e. after the passage of the Farm Bill in late 2018).

The Warning Letter to Curaleaf may be a sign that the FDA is prepared to take action against companies marketing and selling CBD-containing products when the companies claim such products  treat diseases or medical conditions.

Curaleaf, in response to the FDA’s Warning Letter, promptly removed its blog, deleted social media posts and articles on its website saying its products can be used to treat diseases and medical conditions to become compliant.