Adverse Events Reported to the US Food and Drug Administration for Cosmetics and Personal Care Products

Abstract

This study examines adverse events for cosmetics in the FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System to inform future policymaking to protect consumers.

Figure 1.. Adverse Event Reports for Cosmetics and Personal Care Products From 2004 to 2016

The US Food and Drug Administration (FDA) provides definitions for all product classes. Briefly, skin care products constitute a broad range of items, including cleansing lotions and creams, depilatories, sprays, moisturizers, and anti-wrinkle products. Personal cleanliness products included bath soaps, deodorants, and douches. Baby products included shampoos, lotions, oils, creams, and powders marketed toward newborns and infants. Hair care products, which include shampoos (noncoloring), rinses (noncoloring), hair spray, and hair straighteners, constituted 35% (n = 1805) of all adverse health reports. Skin care products were the next most common source of complaints at 22% (n = 1148). Five percent of products (n = 257) were not classifiable based on the available data. The data label for each year indicates the total number of adverse events reported. On average, 396 cosmetic-related adverse events were sent to the FDA every year. There was a 78% increase in 2015 and a 300% increase in 2016 for adverse event reports compared with the mean across the entire time period (2004-2016). This increase was largely driven by the hair care products class, specifically the WEN product line by Chaz Dean.

Figure 2.. Adverse Events Leading to Serious Adverse Health Outcome, a Nonserious Adverse Health Outcome, or a Health System Visit for Cosmetic and Personal Care Product Classes

A “serious” adverse health outcome was counted whenever a reporter attributed a specific adverse event with any of the following: serious injury, disability, congenital anomaly, or death. We collapsed 5 product types that had 20 or fewer adverse outcomes, which included bath preparation products, shaving products, cosmetic raw materials, cosmetic devices, and multiple category products into the “other” category. The dashed vertical line illustrates the average percentage of reported adverse events across the 14 product types for each of the adverse health outcomes. An orange dot signifies a higher-than-average percentage compared with the mean (P < .05). A purple dot signifies a lower-than-average percentage compared with the mean (P < .05). A black dot signifies no significant difference compared with the average. Error bars indicate 95% CIs. As expected, products with high percentages of serious adverse events also had lower percentages of nonserious adverse events.