US FDA questions safety of sunscreens, again


Agency requests safety, efficacy data for a dozen common chemical UV filters

The US Food and Drug Administration is reverting back to a 2019 proposal that requires sunscreen manufacturers to demonstrate that their active ingredients are generally recognized as safe and effective (GRASE). The agency announced its decision Sept. 24 in a proposed order that is intended to replace an order attached to the 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act.

The CARES Act overhauled the FDA’s over-the-counter drug approval process and deemed several sunscreen ingredients as GRASE. The FDA had requested safety and efficacy data for 12 of those sunscreens in 2019, but under the CARES Act such data were no longer necessary. Now, the agency is once again asking for the data to demonstrate the substances are GRASE.

The sunscreen ingredients in question are avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O, and sulisobenzone. Zinc oxide and titanium dioxide would maintain their GRASE status without additional data.

The FDA is seeking safety data for the 12 chemicals because new research shows that some of them are absorbed through the skin (JAMA 2020, DOI: 10.1001/jama.2019.20747). The Environmental Working Group (EWG), an advocacy organization, claims that some of the chemicals are potential endocrine disruptors.

“Sunscreen chemicals like oxybenzone pose significant health concerns, but the sunscreen industry continues to bury its head in the sand,” Scott Faber, the EWG’s senior vice president for government affairs, says in a statement. “We’re grateful the FDA continues to demand basic data on the health effects of these chemicals.”

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~sChemical & Engineering News, 27 September 2021