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Identity Overlooked As Supplement Firms Bypass Basic GMP Testing

 
• By Dan Schiff

Warning letters show that the ingredient identity testing requirement in the good manufacturing practices final rule continues to trip up dietary supplement firms.

Recent FDA warning letters to Ambix Laboratories, Finemost Corp., Liquid Health Inc. and Primarch Manufacturing Inc. demonstrate that some supplement manufacturers continue to fall down on ingredient identity testing, a fundamental tenet of the good manufacturing practices final rule. Those firms all “failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use,” the agency said.

This has become the most violated provision of the regulation, according to FDA’s top dietary supplements official, Daniel Fabricant. He said recently that a lack of identity testing will be...

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