FDA Cosmetics Update: 2013 AE Reports Tallied, 2014 Research Targeted
This article was originally published in The Rose Sheet
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.
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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.
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.
According to FDA’s Office of Cosmetics and Colors, the number of cosmetic adverse events reported to the agency reached 491 in fiscal 2014, a 56% increase over fiscal 2013. FDA reps say the agency’s data can be deceptive and the total number likely would be higher if cosmetic adverse-event reporting were mandatory.