FDA Warns 5 Companies Illegally Selling CBD

Agency highlights potential risks of products
CBD products
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration sent warning letters to five companies illegally selling cannabidiol (CBD) products.

Brands sent warning letters were 11-11-11 Brands, Naturally Infused LLC, Newhere Inc. (doing business as CBDFX), Infusionz LLC and CBD American Shaman LLC, according to the FDA. These companies are selling CBD-containing products that people may confuse for traditional food or beverages, the agency said, adding that CBD products in forms appealing to children are concerning.

The warning letters also outlined additional violations of the Food, Drug and Cosmetics Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases. The companies have 15 working days to respond to the warning letters, or they face legal action.

The FDA said it has not found adequate information showing how much CBD—a chemical compound found in the cannabis plant—can be consumed, and for how long, before causing harm—especially for vulnerable people like children and those who are pregnant. Risks include liver injury, harm to the male reproductive system and changes in alertness, among other symptoms, the FDA said. More information can be found on the agency’s website.  

While the 2018 Farm Bill made hemp federally legal under the Controlled Substances Act, it is unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, among other restrictions. 

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