Supplement AER Compliance Costs Exceed FDA Estimates – Industry
This article was originally published in The Tan Sheet
FDA’s estimate of supplement AER costs does not consider that firms must thoroughly investigate and evaluate all reports to determine whether they are serious and maintain records of reports, industry trade groups say.
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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.
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