Mandatory AE Reporting In Supplement Space Offers Glimpse Of Possible Cosmetic Future
This article was originally published in The Rose Sheet
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.
You may also be interested in...
Greenberg Traurig and Hogan Lovells attorneys provide first breakdowns of the game-changing Modernization of Cosmetic Regulations Act, including the potential for new lawsuits and plaintiff tactics.
Under current cosmetics regulations FDA does not have the authority to order product recalls, as it does in the dietary supplement space, for example. Voluntary cosmetic recalls have been typically light in recent months, most often citing microbiological issues.
CFSAN publishes data on more than 55,000 AERs received from January 2004 through September 2016 for dietary supplements, food – including food additives and color additives –and cosmetics. Quarterly updates begin in February with information from reports submitted during the 2016 fourth quarter.