FDA Warning Letters to CBD Companies: Unapproved Drug & Misbranding Violations

— Written By and last updated by

3/23/2021 – Since the 2018 Farm Bill was signed into law, the Food and Drug Administration (FDA) has said that it has authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to regulate food products and dietary supplements that contain CBD, as well as other products that contain CBD that make health claims. Earlier this week the FDA issued warning letters to two companies that used CBD in a way that was not in compliance with the FD&C Act.

The following is from the FDA’s news release:

“Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.”

Read more on the FDA’s website.