With AE Reporting Push, FDA Emphasizes Importance Of Cosmetic Safety
This article was originally published in The Rose Sheet
Executive SummaryFDA hopes a campaign promoting its adverse event reporting program for cosmetics will lead to increased consumer participation, which could put further pressure on industry to ensure the safety of their products.
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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.
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.
The number of adverse events associated with cosmetics reported to FDA rose by nearly 100 between fiscal 2011 and 2012. The rise follows a push by the agency to increase awareness of the reporting program, but FDA cautions that may not solely be responsible for the higher numbers.