Adverse Events From Cosmetics Increase, Prompting Calls for More Regulation

Adverse Events From Cosmetics Increase, Prompting Calls for More Regulation

Nearly 1,600 reports of adverse events related to cosmetics and personal care products were reported to the FDA last year. Since cosmetics manufacturers are not required to disclose adverse events to the FDA, and the industry doesn’t have the kind of regulations for approval that drugs do, researchers say some kind of premarket approval for certain products may be necessary.

For the first time, the FDA last year made available data from its Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System. The database contains adverse events — reported mostly by consumers and healthcare professionals — related to cosmetics, as well as dietary supplements and foods. The first reports to the database came in 2004.

An analysis of the database conducted by researchers found that there were 5,144 adverse events related to cosmetics and personal care products between 2004 and 2016, according to a research letter published in JAMA. Between 2015 and 2016, there was a significant increase in reports, especially with hair care products. Overall, hair care, skin care and tattoos accounted for the most events.

Adverse events ranged from nonserious injury to some reports of disability, congenital defects and even death after using certain products.

Because the adverse events are self-reported, the true number is likely much, much higher. For example, in 2014, the FDA began to look at hair conditioners from WEN by Chaz Dean following more than 100 reports of people’s hair falling out after using the product. When the agency contacted the company, however, they found it had received more than 21,000 complaints of hair loss and scalp problems.

“The first step to improve cosmetic safety is broader reporting, especially from manufacturers,” the authors write. “For products blurring the line between drug and cosmetic (cosmeceuticals), a form of premarket approval should be considered.”

They also call for the passage of the Personal Care Products Safety Act, which was introduced by Sen. Dianne Feinstein (D-Calif.). The bill would give the FDA authority to recall unsafe cosmetics and mandate that manufacturers report adverse events.

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