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Healthy Insider Podcast 49: Claims substantiation complexitiesHealthy 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.

Sandy Almendarez

April 5, 2017

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!)

About the Author(s)

Sandy Almendarez

editor in chief, Informa

Sandy Almendarez entered the natural products industry in 2009 when she joined Virgo Publishing (now Informa Exhibitions) as an assistant editor. Since then, she's worked her way up to editor in chief where she writes, edits and manages content for INSIDER. Under Sandy’s direction, INSIDER has won editorial awards from Folio: every year since 2014, including B2B Editorial Team of the Year in 2015.

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