Health Claims Substantiation Dossier

We review and evaluate marketing claims in light of FTC and FDA regulations. We also review the intended use of your product to ensure the efficacy and safety of its dietary ingredients as per standards of evidence outlined in the Federal Act.

Health Claims Substantiation on a Dietary Supplement

You might have heard a claim like “this particular product will make you look 5 years younger!” The question is whether such a product actually performs its claims. National Advertising Division (NAD), The Federal Trade Commission (FTC), Food and Drug Administration (FDA) and other government agencies (OGAs) take it upon themselves to ensure that these “too good to be true” claims are not misleading users.

Dietary Supplements in the US do not undergo a licensing or approval process by the FDA.  It is very important for any company to ensure that any structure-function claim made on a dietary supplement label is truthful, not be misleading, and that the manufacturers 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)).

health claims substantiation dossier

What Is a Health Claim?

A claim is any description, representation made about a particular product. Unlike a label, a claim can be made anywhere that the product is marketed, on a website, a label, a flyer, a radio talk show, a marketing event, commercial ads. In general, there is no limit to how or where this representation can be asserted.

fda health claims

Evidence Source to Support Dietary Supplement Health Claims

Claim substantiation is based on the quality and totality of the evidence that is needed and is directly related to the claim that is being made. Common sources of evidence to support health claims:

  • Peer-reviewed published studies 
  • Intervention studies
  • Observational studies
  • Animal studies
  • In vitro studies
  • Testimonials and anecdotal evidence
  • Review articles, letters to editors
  • Meta-analysis, product monographs

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

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