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.
FDA regulations prohibit making drug claims for dietary supplement products even if such claims are supported by scientific evidence. A recent FDA enforcement action involving dietary supplement products promoted to address high cholesterol, hypertension, diabetes, depression and muscle pain claims show that the agency is prepared to take significant steps where manufacturers continue to make drug claims for dietary supplement products, particularly where the facility fails to meet CGMP requirements.