Nonmonograph OTC ingredients may re-emerge with structure/function claims, FDAer says.
This article was originally published in The Tan Sheet
STRUCTURE/FUNCTION CLAIMS MAY BE USED AS AVENUE BACK TO MARKET FOR BANNED OTCs, FDA Drug Labeling Compliance Division Director Bradford Williams predicted at the National Nutritional Food Association symposium on statements of nutritional support Feb. 29. Williams cited the potential impact of the Dietary Supplement Health and Education Act's structure/function claims provisions on FDA's "negative" monographs as one of his chief concerns about the implementation of the bill.
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