McCaskill Not Sold On Retailer Exemption From Supplement AER Filing
This article was originally published in The Tan Sheet
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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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.