On Monday, December 29, notably meeting the exact statutory deadline set by Congress in MoCRA, FDA published a report on the use of PFAS in cosmetic products and any associated risks (the “PFAS Report”).
The PFAS Report identifies 51 different PFAS that are currently used as ingredients in cosmetic products in the United States, based on cosmetic product listing information submitted to FDA, and includes safety evaluations for the top 25 most used PFAS ingredients. FDA concludes that toxicological data for a majority of these PFAS are incomplete and identifies significant variability in risk profiles depending on the specific PFAS chemical at issue: 5 of the 25 PFAS evaluated have low safety concerns; however, safety conclusions cannot be reached for the majority of the PFAS (19/25) due to a lack of critical toxicological data.
FDA Commissioner Makary stated the following in a release about the PFAS Report, linking it to the administration’s broader Make America Healthy Again (MAHA) efforts and signaling potential activity in other product categories as well: “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. Consistent with the MAHA Strategy Report, the FDA will continue working with the CDC and EPA to update and strengthen recommendations on PFAS across the retail and food supply chain.”
As part of a broader legislative package aimed at modernizing FDA’s cosmetic regulatory program (see our January 2023 client alert), Congress directed FDA in section 3506 of MoCRA to issue a report on the use of PFAS in cosmetic products and the associated safety data. PFAS are a broad class of synthetic chemicals used in various cosmetic products to improve texture, impart shine, and condition and smoothen skin and hair. Due to concerns associated with the use of certain PFAS, some states have moved to restrict their use in various products, including cosmetics. But no FDA regulations specifically focus on the use of PFAS in cosmetic products, and FDA’s PFAS Report affirms that presence of PFAS alone does not render a cosmetic product adulterated or misbranded. FDA did not take any regulatory action through the PFAS Report, nor was any specific action required by Congress when directing FDA to issue the report.
To develop the PFAS Report, FDA relied on current cosmetic product listing data to understand the scope of PFAS use in cosmetic products in the United States. The PFAS Report does not consider unintentional PFAS contamination in cosmetic products.
- Scope of Use: Based on FDA’s cosmetic product listing data, 51 different PFAS are currently being used in 1,744 cosmetic product formulations in the United States, representing approximately 0.41% of all registered cosmetic products (as of August 30, 2024). Data from FDA’s now-defunct Voluntary Cosmetic Registration Program and Mintel's Global New Products Database suggest that the use of PFAS in cosmetics has declined over time.
- Safety Determinations: 5 of the 25 PFAS FDA evaluated for safety have low safety concerns under their conditions of intended use in cosmetic products. One PFAS, perfluorohexylethyl triethoxysilane, was identified as having a potential safety concern when used in body lotion at the highest concentration level. The PFAS report states that FDA could not reach conclusions about the safety of the remaining 19 PFAS substances because it did not have sufficient data.
- Looking Ahead: FDA will continue to monitor emerging information on the use and safety of PFAS in cosmetics and will devote additional resources to address data gaps. FDA commits to “supporting the Department of Health and Human Services’ Make America Healthy Again efforts to reduce PFAS across the food and consumer product supply chain through expanded testing, monitoring, and surveillance.”
If you have any questions concerning the material discussed in this client alert or any aspects of FDA’s implementation of MoCRA, please contact any members of our Cosmetic practice.
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