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Health Claims Substantiation Dossier

Dietary Supplements in the United States do not undergo the licensing or review process by the FDA as they do for approval to sell  in Canada and some other countries.  However, the expectation is that any structure-function claim made on a dietary supplement label be truthful, not be misleading and that the manufacturer have evidence to support these claims.  This is clearly stated in the regulations in section 403(r)(6) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 343 (r) (6)).  

The substantiation is based on the quality and totality of the evidence.  Peer reviewed published studies including intervention studies, observational studies, are common sources of evidence to support dietary supplement health claims.   Animal studies, in vitro studies, testimonials and anecdotal revidence, review articles, letters to editors, meta-analysis, product monographs, though acceptable background information, would not be sufficient to substantiate a claim.

Quality Smart Solutions has extensive experience in preparing dossiers to support safety and efficacy of dietary ingredients based on the standards of evidence as outlined in the Federal Act.