FDA Data Reveal Surge in Cosmetic-Related Adverse Health Events

Besides ensuring the safety of food and drugs, the FDA also monitors adverse reactions to cosmetic products. A newly published analysis, supported by an editorial, found that the growing prevalence of such adverse events may warrant stronger regulation of these products used to alter appearance.

The research letter published in JAMA Internal Medicine analyzes data from the FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System, which tracks reports of adverse events linked to food, dietary supplements, and cosmetics. This repository of side effects, which can be submitted by consumers or clinicians, was made public in 2016.

Researchers identified 5144 adverse events that were reported between 2004 and 2016. Hair care products were the most common source of complaints, followed by skin care and tattoos. The mean percentage of adverse reactions considered serious, meaning they caused serious injury, disability, or death, was 35% across all product types. Baby products were the most likely to have serious outcomes (51.8% were serious), while personal cleanliness, hair care, and hair coloring products also had higher than average reports of serious adverse events.

The number of adverse events reported more than doubled from 706 in 2015 to 1591 in 2016, which was driven by a sharp increase in the number of hair care-related reports. The letter’s authors noted that the FDA had launched an investigation of a brand of conditioners in 2014 after receiving 127 adverse event reports. In the course of its investigation, the FDA found that more than 21,000 consumers had already complained to the manufacturer about hair loss and scalp irritation, but the company was not required to report these events.

This disparity between adverse events reported to the manufacturer and to the FDA highlights an important consumer safety issue, according to the authors. Manufacturers are not required to submit their products for approval prior to marketing nor to disclose complaints from customers, so the FDA will only begin to investigate a cosmetic’s safety after a sufficient number of consumers file a direct complaint in its database, which contains a small fraction of all events.

Highlighting the efforts of Senator Dianne Feinstein (D-California) to propose the Personal Care Products Safety Act, the letter’s authors praised the bill for requiring manufacturers to report unsafe events, allowing the FDA to recall dangerous cosmetics from the market, and instituting an annual review of the safety of 5 ingredients. While it does not allocate more funding to the National Toxicology Program to increase scientific testing, they called the act “a first step in the right direction to protect consumers.”

An accompanying editorial in the same issue highlighted the challenges the FDA faces in trying to regulate cosmetics. According to former FDA Commissioner Robert M. Califf, MD, and co-authors, these constraints include inadequate funding, a voluntary cosmetic registration system, and limited authority to surveil and regulate the safety of cosmetics. They explain that the FDA, like police, need “probable cause” to begin an investigation, which comes from voluntary consumer complaints.

In contrast, the postmarket regulatory system for drugs mandates safety reporting and strengthens oversight using a technological “ecosystem” of claims and records that allows for active surveillance. If the cosmetic regulatory system replicated these policies, the FDA would be better able to identify and intervene in cases of adverse events, the authors wrote.

“By borrowing innovations being developed for efficient, cost-effective active surveillance of drugs and devices, the oversight of cosmetics can be modernized without creating an inappropriately burdensome regulatory process,” they concluded. “Using these new tools to collect and analyze the right kinds of empirical data, we can achieve the high levels of safety people in the United States have a right to expect.”