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The U.S. cosmetics regulatory framework is undergoing one of its most relevant transformations in decades. Throughout 2025, federal reforms linked to MoCRA and OTC sunscreen regulation, together with increasingly strict state-level chemical restrictions, are redefining how cosmetic products are placed, maintained and expanded in the U.S. market.
Below is a structured recap of the most impactful developments adopted or formally advanced this year, with a focus on what has changed, when compliance applies, and why it matters for the industry.
MoCRA implementation and expanded FDA oversight
The Modernisation of Cosmetics Regulation Act (MoCRA), enacted under the Consolidated Appropriations Act, 2023, continues to reshape U.S. cosmetic compliance in 2025 as its requirements move fully into operational and enforcement phases.
MoCRA significantly expands FDA authority over cosmetics, introducing mandatory facility registration, product listing, reinforced serious adverse event reporting, and clear expectations around safety substantiation for all cosmetic products marketed in the U.S.
While many obligations are already applicable, one of the most consequential elements of MoCRA is forward-looking. The Act authorises the FDA to establish mandatory cosmetic Good Manufacturing Practices, with rulemaking activities ongoing. For brands, this represents a structural shift from a largely voluntary system to a compliance model closer to those already established in the EU and other regulated markets.
OTC sunscreen reform and the reopening of UV filter innovation
Another regulatory landmark in 2025 is the reform of U.S. sunscreen regulation through the SAFE Sunscreen Standards Act and related FDA initiatives.
In the U.S., sunscreens are regulated as over-the-counter drugs, a framework that has historically limited innovation and prevented the approval of new UV filters for decades. The 2025 reform aims to modernise how the FDA evaluates sunscreen active ingredients by accelerating review processes, incorporating more advanced scientific methodologies and gradually moving away from outdated testing approaches.
The FDA is expected to publish updated sunscreen rules by the end of 2025, with substantive reviews of UV filters anticipated during 2026. This change directly affects ingredients already authorised outside the U.S., such as Bemotrizinol, widely used in the EU and South Korea. While approval is not automatic, the reform establishes a realistic regulatory pathway that did not previously exist.
PFAS restrictions and the rise of state-level regulation
In the absence of a comprehensive federal restriction on per- and polyfluoroalkyl substances (PFAS) in cosmetics, 2025 has seen intensified regulatory activity at state level.
Several states, including California, Washington, Colorado and Maryland, have implemented or enforced prohibitions on cosmetics containing intentionally added PFAS. In California, the sale of such products has been prohibited since 1 January 2025, while other states apply similar measures with differing scopes and enforcement timelines.
This state-driven approach has created a fragmented regulatory landscape. For cosmetic brands, federal compliance alone is no longer sufficient, and ingredient decisions increasingly need to be assessed against the most restrictive state requirements.
Toxic-free cosmetics laws beyond PFAS
Beyond PFAS, certain states are advancing broader chemical restriction frameworks. Washington State’s Toxic-Free Cosmetics Act is a key example, targeting a wider group of substances considered harmful, including formaldehyde-releasing ingredients, specific heavy metals and other chemicals of concern.
These initiatives highlight a wider trend in U.S. cosmetics regulation, where chemical safety policies are increasingly shaped at state level rather than through federal harmonisation. This adds complexity to brands operating nationwide and reinforces the need for continuous regulatory monitoring.
Talc and Asbestos, what is going on
The U.S. Food and Drug Administration (FDA) officially withdrew its proposed rule that would have required standardized testing for asbestos contamination in talc-containing cosmetic products, with a need to reconsider the best approach to achieve the same consumer protection goals, including responding to complex scientific, technical, and policy feedback received during the rulemaking process.
A new version of the rule will be published, but no new timeline for publication of a revised proposal has been announced. Asbestos testing requirements may remain in flux, and industry risk management (supplier QA, batch testing) is still recommended.
What this means for the U.S. cosmetics market
Taken together, the regulatory changes advancing in 2025 signal a clear shift in U.S. cosmetic compliance. MoCRA strengthens federal oversight, OTC sunscreen reform reopens innovation pathways, and state-level legislation continues to raise the bar on ingredient safety.
For cosmetic brands, this environment demands more than reactive compliance. Regulatory strategy, ingredient foresight and market-by-market risk assessment are becoming essential to maintain access to the U.S. market and to plan future product development.
How Cosmeservice supports U.S. cosmetic compliance
Cosmeservice supports international brands navigating U.S. cosmetic and OTC regulation, including MoCRA compliance, sunscreen regulatory strategy and state-level chemical restrictions. Our team assists with ingredient reviews, regulatory assessments, documentation alignment and ongoing monitoring, helping brands anticipate regulatory change rather than respond to it.
For tailored guidance on how these developments may affect your cosmetic portfolio in the U.S., contact us at info@cosmeservice.com.
