FDA Says Supplement Adverse Event Under-Reporting Should Feed Growth
This article was originally published in The Tan Sheet
FDA published a how-to guide to push dietary supplement firms toward tighter compliance with the requirement to submit serious adverse event reports to the agency.
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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.
FDA’s dietary supplement program chief raised eyebrows at a botanical products conference citing low estimates on rates of compliance with the good manufacturing practices final rule and the new dietary ingredient notification requirements, as well as adverse event reporting.