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Cosmetic surveillance needs improvement

Because cosmetic manufacturers are not legally obligated to report adverse events to the FDA, people may experience serious health outcomes related to cosmetics; therefore, a type of premarket approval may be necessary, according to a letter published in JAMA Internal Medicine.

“There have been multiple public health controversies surrounding cosmetics involving lip balms, lipsticks and eyelash makeups adulterated with prostaglandins,” Shuai Xu, MD, MSc, from the department of dermatology at Northwestern University Feinberg School of Medicine, and colleagues wrote. “To encourage greater transparency and more reporting, the FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CFSAN), a repository of adverse events related to foods, dietary supplements, and cosmetics, was made publicly available in 2016.”

To determine adverse events in CFSAM that could inform future policymaking, the researchers extracted the entire file, with data from 2004 to 2016 and all voluntary submissions by consumers and health care professionals, for examination. Categorizing all cosmetic-related adverse events by FDA-designated product class, they collected self-reported adverse health outcomes for each event. Adverse health outcomes included nonserious injury, serious injury, disability, congenital defects and death. Using logistic regression model, they compared the proportion of serious adverse health outcomes reported for each product class with the global average.

In total, 5,144 adverse events were submitted from 2004 to 2016. The investigators observed an increase in events from 706 in 2015 to 1,591 in 2016, particularly involving hair care products, compared with the global average. Analysis showed that hair care (n = 1,805), skin care (n = 1,148) and tattoos (n = 388) produced the most commonly reported adverse events. Product classes with higher than average reports of serious health outcomes included baby (51.8%; 95% CI, 44.2-59.3), unclassified (50.2%; 95% CI, 44.1-56.3), personal cleanliness (47.1%; 95% CI, 41.2-53.2), hair care (43.9%; 95% CI, 41.7-46.2), and hair coloring products (40.5%; 95% CI, 35-46.1).

“Better cosmetic surveillance is needed given their ubiquity and lack of a premarket approval pathway… The first step to improve cosmetic safety is broader reporting, especially from manufacturers,” Xu and colleagues wrote. “For products blurring the line between drug and cosmetic (cosmeceuticals), a form of premarket approval should be considered.”

In a related editorial, former FDA Commissioner Robert M. Califf, MD, from the division of cardiology in the department of medicine at Duke University School of Medicine, and colleagues offered some suggestions for the FDA to improve the regulation of cosmetics.

“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,” Califf wrote. “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.” – by Savannah Demko

Disclosures: Xu reports an advisory role with Logical Images Inc and owns an equity interest in a consumer-oriented online health resource that has no financial relationships with manufacturers. Please see the full study for a complete list of all other authors’ relevant financial disclosures. Califf served as Commissioner of the FDA and currently receives consulting payments from Merck. Please see the full study for a complete list of all other relevant financial disclosures.