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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.”

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.”

FDA Needs To Track Actions Built On Supplement AERs – GAO Report

A GAO report says FDA “may be able to expand” its use of supplement adverse event reports if it can track its use of the data to support actions it takes to protect consumers. The report makes five key recommendations for the agency to improve its approach to AERs.

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