FDA Cracks Down on CBD

CBD-FDA[Image: Kimzy Nanney/Unsplash]The U.S. Food and Drug Administration (FDA) has issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. These actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.

Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. The FDA Consumer Update includes concerns about CBD relating to potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.

CBD is marketed in a variety of product types, including topical lotions and creams used in the spa setting. The companies that received warning letters from the FDA are:

The FDA has previously sent warning letters to other companies illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act. Some of these products were in further violation because CBD was added to food, and some of the products were also marketed as dietary supplements despite products which contain CBD not meeting the definition of a dietary supplement.

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