FDA Will Crack Down On GMP Ingredient, Contaminant Spec Requirements
This article was originally published in The Tan Sheet
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.
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American Pure Whey says on its website, "we are temporarily discontinuing the sale of products. Please check back in 7 days and you will be able to order our products." But firm previously warned by FDA about GMP deficiencies might want to recalculate how long sales will be stopped due to 41-count indictment on criminal charges.
FDA is seeing supplements spiked with Rx ingredients indicated for pain management and diabetes treatment, and needs industry help identifying violators, CFSAN head Michael Landa says.
FDA supplement programs director Dan Fabricant and food and drug law attorney Marc Ullman reflect on the ongoing struggles of many supplement firms to meet good manufacturing practice standards. “‘I don’t have the resources to comply’ is not an excuse. Then get out of the business,” Ullman says.