FDA and FTC Warn CBD Marketers

April 8, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals

On March 28, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent joint Warning Letters to three marketers of products represented as cannabidiol (popularly known as CBD) dietary supplements. According to the letters, the products are being marketed with questionable claims indicating that they can be used to treat a variety of diseases, including cancer, Alzheimer’s disease, fibromyalgia, and “neuropsychiatric disorders.” One of the companies also represented that “CBD has anti-emetic, anti-convulsive, anti-inflammatory and analgesic properties,” and that “CBD is a viable option for minimizing these effects within the brain.”

The joint letters advised each company that the claims in question would make its product an unapproved new drug under the Federal Food, Drug, and Cosmetic Act, as well as create liability for making unsubstantiated advertising under the Federal Trade Commission Act. New drugs require extensive premarket testing for safety and efficacy and FDA approval, and advertising claims must be supported by “competent and reliable scientific evidence.”

The letters instruct the companies to notify the FTC within 15 days of the specific actions they take to address the agency’s concerns. Similarly, the FDA expects to receive responses to Warning Letters, describing all corrective actions taken, within 15 business days.

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