The U.S. Food and Drug Administration warned five companies on Tuesday to stop selling CBD products the agency said violate the Federal Food, Drug, and Cosmetic Act.
The regulatory body issued warning letters to Bee Delightful; G&L Wellness (C Better Daily); New Leaf Pharmaceuticals; NextL3vel Services Group, LLC, doing business as This Stuff Is Good For You; and Wellness BioSciences.
None of the products addressed in the letters underwent its drug approval process, the FDA said.
The concerns are raised around the route of the product’s administration, as well as the using CBD as a food additive and marketing CBD products as dietary supplements.
The FDA highlighted that Epidiolex is the only drug approved for treating seizures related to tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome.
“The first priority is to protect the health and safety of Americans,” FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. said in a statement.
“Many questions remain regarding the science, safety, effectiveness, and quality of products containing CBD,” she said, adding that the FDA will “remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety.”
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