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Dietary Ingredient Identity Testing Exemptions Remain A Puzzle

This article was originally published in The Tan Sheet

Executive Summary

The trade groups ask FDA to keep open the door for supplement firms to petition for 100% identity testing exemptions under an IFR published in 2007. AHPA and NPA say supplement manufacturers have insufficient guidance on information the agency expects in petitions for identity testing waivers.

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A N.Y. investigation showed GNC, Target, Walgreens and Walmart products “either could not be verified to contain the labeled substance” or contained ingredients not listed on labels. FDA says it does not use the testing method employed in the investigation, and trade groups criticize it as inappropriate to analyze herbal ingredients.

FDA Does Not Use Testing Behind New York ‘Cease And Desist’ On Major Retailers’ Herbals

A N.Y. investigation showed GNC, Target, Walgreens and Walmart products “either could not be verified to contain the labeled substance” or contained ingredients not listed on labels. FDA says it does not use the testing method employed in the investigation, and trade groups criticize it as inappropriate to analyze herbal ingredients.

Dietary Supplement GMP Warning Letters

NYSW Beverage Brands responds to FDA that some ingredients are provided with specification sheets from suppliers. The agency advises the firm is “still responsible for establishing specifications” and that “reliance on the specification sheets provided by your supplier is insufficient to meet” GMP requirements.

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