This week the U.S. Food and Drug Administration (FDA) issued warning letters to 15 companies for illegally selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act. The FDA also published a revised consumer update detailing safety concerns about CBD and indicated that, based on the lack of scientific information supporting the safety of CBD in food, it cannot conclude that CBD is generally recognized as safe. It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.
The revised FDA consumer update outlines specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness and a variety of other side effects. At this point, the FDA has approved only one CBD product, a prescription drug product to treat two rare, severe forms of epilepsy.
As outlined in this week’s warning letter, the receiving companies are using product websites, 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 animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.
This is not the first the FDA has issued warning letters to CBD companies. In the previous three years, the FDA has issued over 25 warning letters to CBD producers. Most notably, in July 2019, the FDA issued a warning letter to Curaleaf, alleging that the company was illegally selling unapproved products containing CBD with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among others.
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An example of the warning letter:KOI CBD LLC – 593391 – 11_22_2019 _ FDA
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