The Scary FDA Loophole That Allows Cosmetics With Reported Side Effects to Remain on Shelves

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Consumer complaints for side effects caused by ingredients in cosmetic products have more than doubled from last year according to a new study published in JAMA Internal Medicine. Northwestern University researchers analyzed all complaints submitted to the Food and Drug Administration’s Applied Nutrition’s Adverse Event Reporting System between 2004 and 2016. Researchers found that the majority of complaints filed were in reference to hair care and skin care products.

In 2015, there were 706 complaints reported to the FDA; in 2016 that number more than doubled to 1,591. When analyzing the number of reports filed over the 12-year span, researchers found there was a 78 percent increase in 2015 and a 300 percent increase in 2016.

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Lead study author and resident physician in the department of dermatology at Northwestern University’s Feinberg School of Medicine, Dr. Steve Xu, spoke with Fortune about the recent findings and says they demonstrate why the FDA should adopt stricter standards to ensure potentially harmful products don’t stay on the market. “Cosmetic products don’t need FDA approval; they’re largely self-regulated,” said Dr. Xu. “I think people understand that a soap brand doesn’t require FDA-approval before getting on the market. But [what is perhaps less understood] is, let’s say a soap caused you to experience an irritation or skin problem, and you tell the company—the company is under no obligation to forward your complaint to the FDA, and the FDA has no legal authority to recall the product.”

To highlight the dangers of the current system, Dr. Xu cites the case of Wen Hair Care, which is currently under investigation with the FDA in response to 127 consumer complaints, which allege that using Wen products resulted in side effects such as skin irritation and hair loss. “Two and a half years later, we still don’t know what is causing the complaints, and the products are still on market,” said Dr. Xu. “I’m not advocating we need clinical trials for every moisturizer…I’m not an alarmist. The message isn’t, ‘cosmetics are unsafe, throw away your shampoos and conditioners.’ But our system is very reactionary. This is problematic, especially for new product classes, such as cell therapy or skin lightening creams, which don’t need approval before entering the market.”

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