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CBD Again Rejected as a Dietary Supplement

While many marketers of CBD products label such products as “dietary supplements,” the FDA has made clear that it rejects the designation under the current regulatory standards.  The FDA’s recent pronouncement is consistent with its previously stated position that such products may not be marketed as dietary supplements because of a drug approval for the ingredient.

By letter dated July 23, 2021, the FDA responded to an application by Charlotte’s Web, Inc. to designate its CBD as a new dietary ingredient (NDI) to be used in a dietary supplement tincture known as “Charlotte’s Web Full Spectrum Hemp Extract.”  The FDA stated that CBD could not be marketed as a dietary supplement or as an NDI because of an existing drug approval for Epidiolex, and thus is subject to the exclusion from the definition of dietary supplement. Because CBD is the active ingredient in the approved drug product, the CBD product could not be marketed as or in a dietary supplement.   The FDA added that it “has concerns about the adequacy of safety evidence” that the company submitted relating to potential liver and reproductive toxicity.

Takeaway: Marketers of CBD products need to take into account the current regulatory status of the ingredient.  With the FDA again rejecting characterization of CBD as a dietary supplement ingredient, caution is urged in making traditional structure/function claims for such products.

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