McCaskill Not Sold On Retailer Exemption From Supplement AER Filing

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.

Retailers are not required to compile customers’ reports on adverse events about dietary supplements, but Sen. Claire McCaskill suggests in letters to 15 major consumer products businesses that they should be part of the supplement adverse event reporting network.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 mandates that firms marketing supplements and OTC monograph drugs...