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Research Letter
June 26, 2017

Adverse Events Reported to the US Food and Drug Administration for Cosmetics and Personal Care Products

Author Affiliations
  • 1Northwestern University Feinberg School of Medicine, Chicago, Illinois
  • 2Division of Biostatistics, Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois
  • 3Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois
JAMA Intern Med. Published online June 26, 2017. doi:10.1001/jamainternmed.2017.2762

The US Food and Drug Administration (FDA) defines cosmetics as articles for beautification, cleansing, or altering physical appearance. There have been multiple public health controversies surrounding cosmetics involving lip balms,1 lipsticks,2 and eyelash makeups adulterated with prostaglandins.3 In 2014, the FDA began investigating WEN by Chaz Dean Cleansing Conditioners after directly receiving 127 consumer reports. The FDA later learned the manufacturer had already received 21 000 complaints of alopecia and scalp irritation.4 The product remains on the market with the FDA currently soliciting additional consumer reports. To encourage greater transparency and more reporting, the FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CFSAN), a repository of adverse events related to foods, dietary supplements, and cosmetics, was made publically available in 2016. Our objective was to examine adverse events in CFSAN to inform future policymaking.

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