Is The FDA Doing Enough To Keep Problematic Personal Care Products Off Shelves?

When you slather that trendy beauty lip balm on or try a new shampoo for the first time, perhaps you’re under the impression that the federal government has a process in place that ensures that cosmetic or personal care product is safe before it touches your body. But the reality is that cosmetics manufacturers don’t have to obtain premarket approval before selling most new products — and whether or not they report adverse events related to those items is pretty much up to them. Some in the industry think it’s time for this to change.

In a research letter published today in JAMA Internal Medicine, researchers analyzed every single adverse event report included in the Food and Drug Administration’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CFSAN) submitted from 2004 to 2016.

They found that there were a total of 5,144 adverse events in that time, with an average of 396 events per year.

But in 2015 and 2016, reports specifically involving hair care products increased to 706 events and 1,591, respectively. The most commonly implicated products included hair care, skin care, and tattoos.

What this all comes down to is a need for “better cosmetic surveillance” from the FDA, researchers suggest: Not only is there no requirement for manufacturers to obtain premarket approval, no regulatory body currently has to evaluate claims about the safety or effectiveness. And these adverse event reports are just what consumers are submitting directly to the FDA — manufacturers don’t have to pass along any such complaints they receive if they don’t want to.

To that end, the “FDA’s role with regard to cosmetics is thus similar to that of police, who can act only if they become aware of something that gives them ‘probable cause’ to investigate,” a group of doctors note in an editorial discussing the research letter.

For example: The FDA announced in 2016 that it would investigate hair loss claims linked to Wen by Chaz Dean haircare products, but only after the agency received 127 adverse event reports. The company itself received 21,000 complaints directly from customers.

“The lack of high-quality data leads to reactionary responses by the FDA subject to consumer pressure as evidenced by the WEN conditioners controversy,” the researchers note, adding that better cosmetic surveillance of cosmetic products “is needed given their ubiquity and lack of a premarket approval pathway.”

The first step to improve cosmetic safety is broader reporting, researchers note, especially from manufacturers. Greater coordination with other databases like the National Poison Data System could yield useful collateral information.

In the editorial related to the research letter, doctors also suggest that Congress should also give the FDA “an adequate budget to fulfill its existing responsibilities, which it mandates,” noting that the agency is “vastly underresourced for even the very limited responsibilities it currently has for the safety of cosmetics.”

To that end, with a tiny $13 million budget, the Office of Cosmetics and Colors within CFAN is “chronically underfunded, even considering its limited responsibilities and scope of authority,” write the doctors — especially when compared to the $265 billion the global cosmetics industry is expected to rake in this year.

Congress should also require manufacturers to register marketed products: While the FDA has a voluntary registration system, the lack of a mandatory system means the agency “has no way to determine the universe of products to which consumers are exposed.”

“Absent such data, the FDA’s task of discerning important safety signals with passive surveillance alone is prohibitively difficult,” the doctors note.

Some lawmakers are already trying to change how such products are regulated: This year, Senators Dianne Feinsetein (CA) and Susan Collins (Maine) introduced the Personal Care Products Safety Act [PDF], which aims to create uniform safety rules for companies by strengthening the FDA’s authority to regulate the ingredients in personal care products.