Food and Drug Administration

An increase in adverse events, specifically related to hair care products, was recorded by the Food and Drug Administration from 2015 – 2016.  The authors of this study identify a need for further regulation of cosmetic products to ensure their safety.

The Food and Drug Administration (FDA) defines cosmetics as products used for the beautification, cleansing, or alteration of physical appearance. Currently, cosmetics are not held to the same standards for pre-market testing as medications or medical devices.  In addition, adverse events (serious or otherwise) do not have to be reported to the FDA.  Health-related concerns following the use of lip balms, lipsticks and eyelash makeups adulterated with prostaglandins have resulted in encouraging better reporting and greater transparency.

The public availability of the Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CFSAN) in 2016 enabled Michael Kwa and colleagues at Northwestern University to extract data submitted by volunteers and healthcare professionals from 2004 – 2016. Self-reported adverse health outcomes, serious injury, disability, congenital defects, or death were recorded for each product class.

Whereas serious health outcomes averaged around 35%, product classes higher than the average included products used on babies (51.8%), unclassified (50.2%), personal cleanliness (47.15), hair care (43.9%) and hair coloring products (40.5%). Cosmetic manufacturers are not legally obligated to report adverse events, and even though cosmetics are ubiquitous they lack the premarket approval that is necessary for medical drugs, dietary supplements, and medical devices.

In a research letter published in the Journal of the American Medical Association (JAMA) Internal Medicine, the authors encourage broader reporting from manufacturers and coordination with databases such as National Poison Data System. The introduction of the Personal Care Products Safety Act by Senator Diane Feinstein now allows the FDA to recall unsafe cosmetics, requires mandatory reporting of adverse events and the safety review of ingredients with a suggestion to consider premarket approval.  The authors note that the Personal Care Products Safety Act is a step in the right direction.

Written by Joseph M. Antony, PhD


Kwa M, Welty LJ, Xu S. Adverse Events Reported to the US Food and Drug Administration for Cosmetics and Personal Care Products. JAMA Intern Med. 2017 Aug 1;177(8):1202-1204.

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