Supplements' Mandatory Adverse Event Reporting Portends Cosmetics' Potential Future

Supplement firms' reports of serious adverse events jump since becoming mandatory in 2008 and FDA warnings on failures to report have been on the rise as companies labor to keep up with investigations and reporting duties. Similar challenges could lie ahead for cosmetics firms under House and Senate bills.

The dietary supplement industry's experience could offer a preview of the cosmetics industry's future under legislation to require manufacturers to report serious adverse events to FDA within 15 business days of receiving the information.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 made serious adverse-event reporting mandatory for supplement makers, and monograph OTC drugs, and AERs linked to supplement products more...

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