FDA's Cosmetic AE Data Begs Question: What If Reporting Were Mandatory?
This article was originally published in The Rose Sheet
Infographic: According to FDA data, cosmetic-related AE reports in 2015 more than tripled what they were in 2009, but consumers still do the bulk of the reporting themselves. Proposed federal bills to update cosmetics oversight would require companies to report serious adverse events, which could propel numbers upward while providing FDA with greater insight into the marketplace.
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Momentum this year behind legislative proposals for cosmetics regulatory reform has prompted key Congress members to question FDA about the current oversight system. In a response to the Senate HELP Committee’s chairman, FDA provides a wealth of data on its enforcement activities and confirms hair loss as an adverse event it considers “serious,” if not one currently identified as such by MedWatch’s definition.
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.
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.