The number of consumer complaints sent to the Food and Drug Administration (FDA) regarding cosmetics and personal care products jumped more than twofold from 2015 to 2016, according to a study published online Monday in JAMA Internal Medicine.
That year’s huge leap in complaints was mostly due to hair care products, particularly one line of products: WEN by Chaz Dean Cleansing Conditioners (for hair). In 2014, after receiving 127 complaints about WEN conditioners causing brittle hair, bald patches, itchy scalp and rashes, the FDA contacted the products’ manufacturer for a response. It was only then that the agency discovered that the manufacturer had itself received 21,000 consumer complaints.
The FDA launched an investigation, and consumers then became aware that they could send their complaints about WEN conditioners to the agency as well as to the company. Many did — and thus the jump in overall complaints to the FDA.
But this new study isn’t just about one line of hair products. Instead, it offers a cautionary tale to all consumers who mistakenly believe that cosmetic products — the items they use for beautification, cleansing or altering their physical appearance (which is how the FDA defines such items) — have to receive some kind of safety preapproval from government regulators before going on the market.
Nor are cosmetic manufacturers under any legal requirement to forward reports from consumers — or health professionals — about adverse health events related to their products to the FDA.
“The FDA has much less authority to recall cosmetics from the market in stark contrast to drugs or medical devices,” said Dr. Steve Xu, a corresponding author of the study and a dermatologist at Northwestern University Feinberg School of Medicine, in a released statement. “It’s harder for the FDA to get harmful cosmetics off the shelves.”
Until recently, it was also difficult to obtain information about complaints sent to the FDA about cosmetic products. But last fall, to encourage greater transparency, the FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CFSAN), which collects adverse health reports related to foods, dietary supplements and cosmetics, opened up its files to the public.
Xu and his colleagues decided to take a look at the reports about cosmetics — all 13 years of them (2004-2016). They found that 5,144 adverse health events were reported over that period, an average of 396 per year.
Almost two-thirds of the complaints were for hair care products (1,805), skincare products (1,148) and tattoos (388). The types of products with the highest proportion of reports of serious adverse health outcomes — such as serious allergic reactions and even, in rare cases, death — were baby products, personal cleanliness products, hair care products and hair coloring products.
Those numbers, however, likely represent only a fraction of such events — as evidenced by the difference in the number of original complaints received by the FDA regarding WEN by Chaz Dean Cleansing Conditioners (127) and the number received by the product’s manufacturer (21,000).
“This is a $430 billion-a-year global industry with millions of products on the market,” Xu said. “But we are only getting, on average, between 200 and 400 adverse events per year. That represents significant under-reporting.”
“If we want more public safety and to keep dangerous products off the market, the first step is to make sure we have reasonably good data,” he added. “The key point of our results is we don’t have it.”
‘A wake-up call’
Xu and his colleagues point out in their study that Sen. Diane Feinstein (D-Calif.) has introduced the Personal Care Products Safety Act, which would, among other things, require cosmetic companies to report adverse events and allow the FDA to recall unsafe cosmetics.
That legislation “is a first step in the right direction to protect consumers,” they write.
The researchers also say they are particularly concerned about the relatively recent appearance of a new branch of cosmetics — “cosmeceuticals” — which are often advertised as having an “active ingredient.”
“Although not explicitly studied, this cosmetic product class is becoming a growing problem,” said Xu. “Many of these products are really making drug-like claims but are skirting the FDA approval pathway by presenting themselves as a cosmetic. At the very best, these products are making unsubstantiated marketing claims for products that may or may not work. At the very worst, there are actual drug components in these products that can cause real harm.”
Xu urges everybody — consumers and healthcare providers alike — to report suspected cosmetic-related adverse events directly to the FDA as well as to the product’s manufacturer.
“This is really a wake-up call,” he said, referring to his study. “The point of the paper is to broaden the awareness of [the FDA] database and the need for everyone to participate in reporting adverse events from cosmetics.”
NOTE: While the FDA conducts its investigation, WEN by Chaz Dean Cleansing Conditioners remain on the market. Guthy-Renker, the marketing company behind the products, released the following statement to National Public Radio: “We welcome legislative and regulatory efforts to further enhance consumer safety across the cosmetic products industry. However, there is no credible evidence to support the false and misleading claim that WEN products cause hair loss.”