Ocular Adverse Effects of Over-the-Counter Cosmetics and Personal Care Products Reported to the Food and Drug Administration.

Abstract

Purpose: Personal care and cosmetic products can cause periocular and ocular adverse effects (AEs), for example, ocular surface disease, trauma, and hypersensitivity. The publicly available Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) database includes AE reports by consumers, healthcare practitioners, and manufacturers. The purpose of this study was to characterize ophthalmic AE associated with cosmetics and personal care products reported by the FDA CAERS database.

Methods: AE related to the eye or ocular adnexa from cosmetics submitted by consumers, healthcare practitioners, and manufacturers from January 2004 to June 2022 were identified after filtering using the Medical Dictionary for Regulatory Activities coding system. Demographic information, case outcome, and categories of product and AE were included. Chi-square analysis, with statistical significance at a = 0.05, was performed to ascertain variation in ocular, periocular, and general outcomes by product category.

Results: Reports of ophthalmic AEs related to cosmetics per year increased from 2006 to 2018, reaching a maximum of 161 reports in 2018, then decreased from 2018 to 2021. In total, 959 and 1382 unique periocular and ocular AEs were reported. There were 1711 total incidences of reported periocular AEs and 2485 ocular AEs. The most reported periocular AEs were inflammation (770/1711) and hypersensitivity (331/1711). The most reported ocular effects were discomfort (946/2485) and inflammation (709/2485). Ocular, periocular, and general outcomes significantly varied by product category.

Conclusions: Consumers, healthcare practitioners, and manufacturers should be made aware of potential ophthalmic AE and outcomes associated with cosmetics and personal care products.