McCaskill Not Sold On Retailer Exemption From Supplement AER Filing
This article was originally published in The Tan Sheet
Executive Summary
FDA regulations exempt retailers from compiling supplement adverse event reports, even for products that bear a store brand. Private label firms or contract manufacturers are required to receive AERs linked to those products and to forward reports of serious events to FDA within 15 days.
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Cognitive Claims Stir Senators To Question FDA Supplement Regulation
Senator McCaskill says FDA might “lack a systematic approach to preventing adulterated, mislabeled and fraudulent products from entering the market.” She and Senator Susan Collins ask FDA for a “detailed description” of the agency’s evaluation of medical and nutritional claims for supplements on the market.”
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