Between the end of 2025 and the start of 2026, the U.S. Food and Drug Administration (FDA) released two documents with a significant impact on the cosmetics industry.
The federal agency closed 2025 by releasing its long-anticipated report on PFAS in cosmetic products. Three weeks later, it followed with a draft guidance detailing its newly expanded authority to access cosmetic industry records. Both publications stem directly from MoCRA – one from a statutory deadline, the other from a regulatory shift already in motion.
FDA findings on PFAS in cosmetic products
The PFAS report, submitted to Congress on 29 December 2025, draws from the first wave of product listing data filed under MoCRA. In it, the FDA identifies 51 PFAS compounds intentionally added to cosmetics, present in 1,744 product formulations. From this set, the agency prioritised 25 substances for toxicological review.
Data gaps remain, as for most of these substances FDA found that toxicological data were insufficient to determine safety. Five PFAS were deemed to present a low safety concern under current use conditions. One ingredient flagged: the agency identified one PFAS (perfluorohexylethyl triethoxysilane) as a potential concern when used in body lotions, although further data are needed.
Currently, there are no restrictions on PFAS at federal level. The agency stated it would continue to monitor the science and consider additional steps if concerns arise.
FDA Draft guidance on records access
On 21 January 2026, FDA published a draft guidance explaining how the FDA will implement its new inspection powers under MoCRA Sections 605 and 610. During routine inspections, the FDA can access all adverse event records, whether or not they were classified as serious and reported to the agency. These must be retained for six years (or three for small businesses).
In cases where the FDA has a reasonable belief that a product may cause serious adverse health consequences or death, it may request broader documentationunder Section 610. This includes safety substantiation files, test results, manufacturing records, raw ingredient and finished product analytical results, distribution lists, and related internal materials.
The FDA cannot request recipes of cosmetics, pricing data, or unrelated personnel records. However, refusal to provide required records is considered a prohibited act under the law. The guidance is currently in draft form and open for public comment.
Do you have questions on compliance of cosmetics in the EU, UK, USA, and Canada? Contact us here or at coslaw@obelis.net.
References
U.S. Food and Drug Administration. (2025). FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products. Retrieved on 6 February 2026.
U.S. Food and Drug Administration. (2026). FDA Issues Draft Guidance for Industry: FDA Records Access Authority for Cosmetics Products. Retrieved on 6 February 2026.
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