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GMP Interim Final Rule Sets Bar High For 100% Testing Exemption – Experts

This article was originally published in The Tan Sheet

Executive Summary

Firms "rarely" will meet the scientific rationale FDA included in an interim final rule to substantiate petitions for exemption from 100 percent ingredient identity testing required in the dietary supplement good manufacturing practices, according to food and drug law expert Scott Bass

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Dietary Ingredient Identity Testing Exemptions Remain A Puzzle

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.

Dietary Ingredient Identity Testing Exemptions Remain A Puzzle

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.

Supplement Firms Confounded By Identity Testing Waiver Process

FDA says it has not received any petitions to request an exemption from the 100% supplement ingredient identity testing requirement. Food and drug attorneys say the hassle of preparing a petition for a waiver outweighs the potential benefits

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