Recently, the Food and Drug Administration  (FDA) released its “Report on the Use of PFAS in Cosmetic Products and Associated Risks”, evaluating per- and polyfluoroalkyl substances (PFAS)  and their use in cosmetic products.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) – the most significant expansion of the FDA’s authority to regulate cosmetics in over 80 years – required that this report be issued by December 29, 2025, of which it was. This report is significant because it is the federal government’s first examination of PFAS as used in cosmetic products.

The scope of the report is limited to PFAS that are “intentionally added to cosmetic products as an ingredient and does not include PFAS that may be present in the final product as contaminants.” According to the report, PFAS have been widely used in cosmetic products because they are water- and oil-resistant, and are long-lasting, but their use has raised “significant health and environmental concerns due to their persistence and potential toxicity, leading to tightened global regulatory oversight including bans and restrictions by a growing number of states in the United States.”

Certain PFAS are intentionally added as ingredients to some cosmetic products, such as lipsticks, eyeshadows, moisturizers, nail polish and enamel, and cleansers. The report explains that PFAS are used in cosmetic products to “condition and smoothen skin and hair, making them appear shiny, or to modify product consistency and texture.”

According to the report, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetic ingredients or products do not require FDA approval before they go on the market, with the exception of color additives which are subject to FDA approval before use. Otherwise, the report explains that “manufacturers are generally allowed to use any ingredient in the formulation of a cosmetic product, as long as the ingredient and the finished product are safe, the product is appropriately labeled, and the use of the ingredient does not render the cosmetic product adulterated or misbranded under FDA’s laws.”

The report explains that there are currently no federal regulations that specifically address the use of PFAS in cosmetic products in the United States; PFAS that are “intentionally added to cosmetic products as an ingredient are not currently prohibited and do not, based on presence alone, render the cosmetic product adulterated or misbranded.”

However, there are a number of states that have passed legislation to prohibit the use of intentionally added PFAS in cosmetics. They include California, Colorado, Connecticut, Maine, Minnesota, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, and Washington

There are also a number of other states – Georgia, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, and Tennessee – which have proposed laws to ban or limit the use of PFAS in cosmetic products.

The report’s analysis found that according to cosmetic product listing data submitted as required by MoCRA, “51 PFAS are intentionally added as ingredients in a total of 1,744 cosmetic product formulations sold in the U.S. (as of August 30, 2024).”  According to the report, “eye shadows, face and neck products (leave-on), eyeliners, face powders, and foundations were the top five product categories and constitute approximately 56% of PFAS-containing cosmetic products.”

The FDA’s cosmetic product listing data alleges that polytetrafluoroethylene (PTFE) is the most frequently used PFAS in cosmetic products in the United States, appearing in 490 products and accounting for 28.1 percent of all PFAS-containing cosmetic products. PTFE is followed by perfluorononyl dimethicone, trifluoroacetyl tripeptide-2, tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate, perfluorohexylethyl triethoxysilane, methyl perfluorobutyl ether, and methyl perfluoroisobutyl ether – used in 232 (13.3 percent), 164 (9.4 percent), 156 (8.9 percent), 124 (7.1 percent), 114 (6.5 percent) and 108 (6.2 percent) cosmetic products, respectively.

According to the report, the safety of most (N=19 or 76 percent) of the reviewed PFAS could not be definitively determined due to the lack of critical toxicological data. Five PFAS (PTFE, perfluorodecalin, HC Yellow No. 13, perfluorohexane, and tetrafluoropropene) were considered to pose low safety concerns in cosmetic products under intended use conditions. One PFAS, namely perfluorohexylethyl triethoxysilane, was identified as having a potential safety concern when used in body lotion at the highest use level (i.e., the concentration of an ingredient in a final product). However, the report explains that its assessment is “subject to significant uncertainties, including limited data on use level, lack of dermal and oral absorption data, and mechanistic information, as well as the absence of dermal toxicity data.”

As further data becomes available for these PFAS ingredients, the report states that assessments could be refined to provide a more accurate evaluation of the safety and potential risks associated with their use in cosmetic products. The report also explains that it “underscores significant data gaps for PFAS used in cosmetic products,” and that the FDA will continue to monitor emerging data on PFAS to ensure the continued safety of cosmetic products.