Supplements' Mandatory Adverse Event Reporting Portends Cosmetics' Potential Future
This article was originally published in The Tan Sheet
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.
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Despite repeated stakeholder assertions of being “closer than ever” to modernizing cosmetics regulations, the 115th Congress ended with reform legislation stranded in committee. The Personal Care Products says midterm elections diverted lawmakers’ attention from unresolved issues, likely including possible preemption terms to put a lid on growing state and local requirements.
Committee members' current priorities do not include authorizing user fee programs for the OTC monograph process or supplement GMP inspections, but proposals could get traction. "We think it is a happy medium of getting FDA the resources it needs," says Tiffany Guarascio, minority chief of staff.
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.