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Mandatory AE Reporting In Supplement Space Offers Glimpse Of Possible Cosmetic Future

 
• By Ryan Nelson

Reports of serious adverse events in the dietary supplement industry have increased exponentially since reporting was made mandatory in 2008, and FDA warning letters citing 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 the cosmetics industry under proposed bills in the US House and Senate.

If mandatory reporting of serious adverse events is in the cosmetics industry's future, the dietary supplement industry's experience in recent years offers a preview of what companies could be in for.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 made serious adverse-event reporting mandatory for supplement makers (and...

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