FDA Cosmetic Adverse Event Data Beg Question: Mandatory Reporting?
This article was originally published in The Tan Sheet
Legislation to update cosmetics oversight would require companies to report serious adverse events, which could propel numbers upward while providing FDA with greater insight to the marketplace. According to FDA data, cosmetic-related AERs in 2015 more than tripled from 2009, with consumers doing most reporting.
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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.
During a March 1 press call, the Environmental Working Group highlighted findings from an 800-person survey indicating that 68% of men and women likely to vote this fall support increased government oversight of cosmetic chemicals. Senator Dianne Feinstein touted her proposed Personal Care Products Safety Act as the answer to consumer concerns, hopeful that a Senate committee hearing will be held in the spring.
FDA says cosmetic-related adverse events were down in fiscal 2013, but suggests the decline may be due to a falloff in agency outreach and lower consumer awareness. The agency is focused on trace contaminants, with guidance in the works on lipstick lead, and aims to release its final guidance on cosmetic nanomaterials in the coming months, according to Linda Katz, director of FDA’s cosmetics office.