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Pulse News | The HinduBusinessLine

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Data gap hinders FDA’s safety review of cosmetics
2026-01-11 · via Pulse News | The HinduBusinessLine

The United States Food and Drug Administration’s evaluation of the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products “did not reach definitive safety determinations” and underscored “significant uncertainty due to gaps in existing data on PFAS exposure through cosmetics”, the regulatory agency said. The congressionally mandated report reviewed available scientific evidence on potential safety concerns.

FDA Commissioner Marty Makary said, “Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety. This lack of reliable data demands further research.”

Based on mandatory cosmetic product listing data submitted to the FDA, 51 PFAS are used in 1,744 cosmetic formulations. To assess safety, the FDA evaluated the 25 most frequently used PFAS, which represent approximately 96 per cent of PFAS intentionally added to cosmetic products. The agency found that “toxicological data for a majority of these PFAS are incomplete or unavailable”, limiting its ability to fully assess risk. Most of the toxicology data is not publicly available, it said.

The report focuses on PFAS intentionally added to cosmetic products as ingredients, rather than PFAS that may be present as contaminants. PFAS are synthetic chemicals used for properties such as water resistance, durability, and texture modification, but their persistence and potential toxicity have raised health and environmental concerns and prompted increasing regulatory scrutiny at the State, federal, and global levels, it said.

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