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Cosmetic Reactions Are Getting More Common, According to New Study of FDA Reports

According to a new study, the FDA is getting more complaints about personal care products than ever

Macaela Mackenzie, Allure, Jun 28, 2017

The world of personal care products is tricky. On one hand, we get cool, cutting edge formulations at lightning speed. On the other, they're not actually regulated by the FDA, which means cosmetic reactions can't always be kept in check. And according to a new study, the FDA is getting more complaints about personal care products than ever.

According to current laws, the FDA doesn't have a lot of enforcement power when it comes to pulling products that have caused cosmetic reactions off the shelves (Congress is currently working on new regulations that would give the FDA more power to keep baddies out of your beauty bag, but it's still a ways away from approval). For example, if your new foundation gives you a rash and you report it to the company, they are not required to disclose that to the FDA. And even if they do, the FDA can't actually make them do anything about it. The most famous example of this issue is the Wen hair care lawsuit involving over 6 million unhappy customers, which blew up last year.

"Adverse events to cosmetics matter to patients mostly because nearly everyone uses a cosmetic or personal care product every single day," senior study author Shuai Xu, M.D., told Reuters. "Unlike drugs and medical devices, cosmetics permeate daily life. We're exposed to hundreds of chemicals a day from these products."

Reuters also notes that limitations of the study include the lack of data on what caused side effects with researchers unable to distinguish between reports from consumers and from health professionals. Since reporting isn't mandatory, it's also possible that the study underestimates the total number of adverse events or the number of serious side effects. Making things even trickier, companies and manufacturers are not required to share complaints they receive with the FDA, according to the Reuters article.

Xu and his team of researchers at Northwestern University looked into product complaints filed with the FDA over the past 12 years, peering into the records of everything from makeup, to hair products, to sunscreen. In a total of 5,144 "adverse event" reports, they found that the complaints had more than doubled between 2015 and 2016 (from 706 complaints up to 1591). According to their findings published in JAMA Internal Medicine, the increase was especially pronounced when it came to hair care products - overall, that category was the most likely to pop up on the FDA's radar, along with skin care products and tattoos. The products with "significantly higher than average reports of serious health outcomes" included personal cleanliness products, hair-care products, hair-coloring products, and even baby products. Yikes.

The issue is that since companies aren't required to disclose info to the FDA, they don't always know what ingredients might be to blame for the complaints filed by users and health care professionals. Further, the authors suggest the FDA data is likely only a small number of all adverse reactions out there. "The first step to improve cosmetic safety is broader reporting, especially from manufacturers," they wrote in their research paper.

"I'm not advocating we need clinical trials for every moisturizer... I'm not an alarmist," Xu said in an interview with Fortune. "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."

The bottom line, read labels and use caution when trying out a new product. And if you do have an adverse reaction, report it to the FDA.

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