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More GMP Warnings Likely As Botanicals Fail On Adulteration Awareness

This article was originally published in The Tan Sheet

Executive Summary

FDA supplement program official Daniel Fabricant says firms that fail to use appropriate tests for botanical ingredients are at risk of eliciting warning letters and other agency actions for violating GMPs. AHP’s Roy Upton says he sees FDA’s botanical expertise outpacing industry’s.

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FDA Will Crack Down On GMP Ingredient, Contaminant Spec Requirements

GMP inspectors will begin more aggressively enforcing requirements for ingredient and contaminant specifications, FDA’s Fabricant warns. Recalls for undeclared allergens, salmonella and other pathogens are emerging more frequently as well.

Senate Appropriators Call For Botanical Identity Testing Guidance

A Senate FDA appropriation report says the guidance would enhance the agency’s ability to inspect and assess industry practices for manufacturing botanical dietary supplements. A National Center for Natural Products Research official says most botanical ingredients lack standard identity tests.

Ephedra Back On Regulatory Radar As Supplement Adulterant

FDA acknowledges that enforcement activity on ephedra has been a lower priority than other adulterants since the agency banned ephedrine alkaloids in supplements in 2004. “The presumption was that it was banned and people were abiding by the law,” says FDA supplement official Daniel Fabricant.

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