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FDA Warns Companies over Illegal Sales of CBD Products

Monday, December 02, 2019
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued warning letters to 15 companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. The agency states that it cannot conclude that CBD is generally recognized as safe (GRAS) for use in human or animal food based on the lack of scientific information supporting such a determination.

According to the FDA, CBD is marketed in a variety of product types such as oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams. The companies receiving the warning letters are ostensibly using product webpages, online stores, and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. Other violations, according to the FDA, include marketing CBD products as dietary supplements and adding CBD to human and animal foods.

The FDA states that these actions come as the agency continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products while maintaining the agency’s rigorous public health standards. Current FDA safety concerns regarding CBD include potential liver injury, interactions with other drugs, drowsiness, diarrhea, and mood changes.

For more information, please contact customs and trade attorney Lenny Feldman at (305) 894-1011.

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