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Healthy Insider Podcast 49: Claims substantiation complexities

In the United States, claims for supplement products are governed by two federal agencies – FDA and FTC – but they want different things. To add to the confusion, a study may satisfy FTC's demands, but may not be able to support a claim in FDA's eyes.

In the United States, claims for supplement products are governed by two federal agencies—FDA and FTC—but they want different things. FDA polices claims to ensure they are fit for the product that carries the claim. FTC isn’t concerned with product type, but enforces that claims are truthful (not misleading). To add to the confusion, a study may satisfy FTC’s demands, but may not be able to support a claim in FDA’s eyes.

To help sort out claims substantiation, attorney Justin Prochnow, shareholder, Greenberg Traurig LLP, discusses these complexities with Sandy Almendarez, editor in chief, Natural Products Insider, at Natural Products Expo West 2017. In this episode, they discuss:

  • FTC, FDA and NAD: who they are and what they “govern” regarding claims
  • The substantiation standard of “competent and reliable scientific evidence,” and how health and nutrition brands can meet this standard
  • The type of studies that will most likely substantiate claims (like real estate, location matters!)
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