The study was published on June 26, in JAMA Internal Medicine, and the mainstream consumer media has been running stories on the topic.
According to the study, consumer complaints more than doubled for cosmetic products from 2015 to 2016, with hair care products being the biggest offender. But, the study says consumers remain at risk because the industry receives little regulatory scrutiny and does not require pre-approval from the FDA.
"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.”
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 as many events are not reported by consumers or doctors, according to Xu.
According to Xu, 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. According to study, the number of overall adverse events jumped from 706 in 2015 to 1,591 in 2016, with hair care products seeing the largest increase. 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, according to the study.
Xu said the research highlights the need for better data.
“This is a $430 billion-a-year global industry with millions of products on the market,” Xu said in a quote from a Northwestern University newsletter. “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.”
Xu cited the Wen situation, specifically.
“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.
Wen/Guthy-Renker provided HAPPI with this statement in regards to the Northwestern study:
"The WEN family cares deeply about our customers, and we have a long track record of going above and beyond current industry standards. 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. Millions of bottles have been sold over the last 16 years, which is a testament to the quality of this product."
What concerns Xu the most are products that contain cosmeceuticals, which market themselves as cosmetic products but with an “active ingredient.”
Xu called Sen. Feinstein’s (D-CA) Personal Care Products Safety Act a first step forward. He 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.”