Can dietary supplement products still be marketed with structure/function claims such as “supports the natural release of adult stem cells”?
Yes – The Draft Guidance has no impact on legal structure/function claims for foods or dietary supplements, and does not change how products making such claims will be regulated. Q: If individual distributors or the manufacturer make oral or written claims for a dietary supplement that the product will help prevent or treat a disease, how will the product be regulated according to the Draft Guidance? A: As an illegal drug — Disease prevention or treatment claims, such as curing or preventing cancer, diabetes, arthritis or other disease, would cause FDA to regulate the dietary supplement as an illegal drug, with the exception that if there is an FDA-approved health claim, disease prevention claims might be legal. Disease treatment claims for dietary supplements were illegal before the issuance of the Draft Guidance and continue to be illegal. Claims to decrease risk or prevent disease should not be made in the context of the sale of dietary supplements without first confirming that suc
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