On Monday, the U.S. Food and Drug Administration (FDA) issued warnings to two companies for selling cannabidiol (CBD) products in a manner that it claims violates the Federal Food, Drug, and Cosmetic Act. Honest Globe Inc. and Biolyte Laboratories LLC received letters from the FDA reminding them that the agency has not approved any over-the-counter (OTC) drugs containing CBD, and that none of their products may be legally marketed without an approved new drug application.
According to the FDA’s press release, the letters also note that because CBD has known pharmacological effects and demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that have not received FDA approval. The agency explains that other than one prescription treatment for seizures, it has yet to approve any CBD-containing drug products.
The FDA’s letters also take issue with the companies’ allegedly substandard manufacturing practices. In the case of Honest Globe, the FDA instructs the company to improve its practices by better evaluating product quality, exercising independent authority over manufacturing operations, and establishing procedures describing critical oversight responsibilities. The FDA has requested a response from both companies within 15 days.
Monday’s letters represent the most recent step taken by the FDA to crackdown on what it sees as the deceptive marketing of CBD products. For example, last December, the regulatory body announced the rollout of “Operation CBDeceit,” a law enforcement initiative aimed at curbing abuses, in addition to the filing of several administrative complaints.