Study Tallies Adverse Events Reported to FDA for Cosmetics

Monday, June 26, 2017 | FDA Approval/Clearance , Skin Care , Research and Publications


There were 5,144 adverse events reported to the US Food and Drug Administration (FDA) for cosmetics and personal care products from 2004 to 2016, an average of 396 events per year, according to a new research letter published by JAMA Internal Medicine.

From 2015 (706 events) to 2016 (1,591 events), there was an increase in adverse events, specifically involving hair care products, compared with the average. The three most commonly reported products were hair care, skin care and tattoos. Those classes of products with higher than average reports of serious health outcomes were: baby, unclassified product classes, personal cleanliness, hair care and hair coloring products,  the study showed.

Shuai Xu, M.D., M.Sc., of the Northwestern University Feinberg School of Medicine, Chicago, and colleagues, culled the entire FDA Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CFSAN) data file (2004 to 2016), which included voluntary submissions by consumers and health care professionals.

Limitations of the study include that causality of adverse events cannot be determined from the data, health outcomes are self-reported and reports from consumers vs. health care professionals cannot be distinguished.

“Unlike devices, pharmaceuticals and dietary supplements, cosmetic manufacturers have no legal obligation to forward adverse events to the FDA; CFSAN reflects only a small proportion of all events. The data suggest that consumers attribute a significant proportion of serious health outcomes to cosmetics,” the article concludes. "The first step to improve cosmetic safety is broader reporting, especially from manufacturers. Greater coordination with other databases (eg, National Poison Data System) may yield useful collateral information."

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