Adverse Events Dramatically Up for Cosmetics & Personal Care Products

A new JAMA Internal Medicine study is placing cosmetics and personal care products under the microscope. A significant number of active ingredients marketed to soften, clean, sooth, plump, lengthen and boost are causing serious injury or worse, according to a study from Northwestern Medicine.  The study authors are calling for both doctors and consumers to report all related adverse events to the FDA.

Consumer complaints for cosmetics and personal care products have doubled in a one-year period. However, these reports are falling on deaf ears because the industry is under minimal scrutiny and manufacturers are not required to gain pre-approval from the Food and Drug Administration (FDA). One product had more than 21,000 adverse reports sent directly to the manufacturer but only 127 of those made it to FDA. Worse yet, the product is still on the market (see more below).

The Northwestern study reports consumer complaints more than doubled for cosmetic products from 2015 to 2016, with hair care products being the biggest offender. Baby products, unclassifiable products, personal cleanliness products, hair care products and hair coloring products had the highest proportion of self-reports of a serious adverse health outcome, such as serious injury, death, disability.

The FDA has much less authority to recall cosmetics from the market in stark contrast to drugs or medical devices,” said corresponding author Dr. Steve Xu, a resident physician in dermatology at Northwestern University Feinberg School of Medicine. “It’s harder for the FDA to get harmful cosmetics off the shelves.”

Why Cosmetics and Personal Care Products Need Stronger Oversight

Since cosmetic manufacturers are not required to submit adverse health events to the FDA, the current data sources to track product safety are significantly limited. Even though there were more than 5,000 events reported to the FDA from 2004 to 2016, it’s likely only the tip of the iceberg, Xu said. He suspects many events are not reported by consumers or doctors.

This is really a wake-up call,” Xu said. “The point of the paper is to broaden the awareness of this database and the need for everyone to participate in reporting adverse events from cosmetics.”

The most common complaints in the database were for hair care products, skincare products or tattoos, the study found. The number of overall adverse events jumped from 706 in 2015 to 1,591 in 2016, with hair care products seeing the largest increase.

“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 the make sure we have reasonably good data. The key point of our results is we don’t have it.”

 An ongoing investigation

In 2014, the FDA sent letters to manufacturers Chaz Dean and Guthy Renker LLC in response to 127 consumer complaints of hair and scalp problems related to the WEN by Chaz Dean Cleansing Conditioners. Only then did the FDA discover that the manufacturers had already received 21,000 consumer complaints of scalp irritation and alopecia.

If this was a drug, the story would be much different in regards to regulatory action,” Xu said. “Three or four people can be wrong, but it’s hard to ignore 21,000. It’s concerning when 21,000 people complained to the manufacturer, and the FDA received only 127 of those due to poor reporting from the manufacturer.”

The FDA’s investigation on WEN by Chaz Dean Cleansing Conditioner products is ongoing, and the products are still available, Xu said.

The problem with cosmeceuticals 

What concerns Xu the most are products that contain cosmeceuticals, which market themselves as cosmetic products but with an “active ingredient.”

“Although not explicitly studied, this cosmetic product class is becoming a growing problem,” Xu said. “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.”

In 2016, Sen.Dianne Feinstein’s (D-CA) presented the Personal Care Products Safety Act, which aims to tighten cosmetic regulation. Xu said he hopes the study’s findings raise awareness in support of the bill. “Feinstein’s bill is a first step forward in the right direction,” Xu said. “I would have liked an explicit push towards cosmeceutical regulation. Overall, the FDA should have the power to order recalls and mandate that manufacturers declare their products’ ingredients and report every adverse consumer health event to the FDA.”

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. Published online June 26, 2017. doi:10.1001/jamainternmed.2017.2762

For more on Sen. Feinstein’s Personal Care Products Safety Act CLICK HERE.