In a pivotal moment for cosmetic regulation, the Modernization of Cosmetics Regulations Act of 2022 (MoCRA) has significantly enhanced the authority of the U.S. Food and Drug Administration (FDA) to oversee cosmetic products. This legislative change marks the most substantial regulatory shift since the Federal Food, Drug, and Cosmetic Act of 1938, specifically focusing on the safety issues surrounding per- and polyfluoroalkyl substances (PFAS) in cosmetics.
Findings from the FDA Report
The FDA’s long-anticipated report, “Report on the Use of PFAS in Cosmetic Products and Associated Risks,” was released on December 29, 2025. This comprehensive study highlights the agency’s findings regarding the prevalence of PFAS in cosmetics and the associated safety risks.
In its analysis, the FDA prioritized a selection of the top 25 PFAS compounds, which collectively account for over 96 percent of the PFAS used in cosmetics available in the U.S. Notably, polytetrafluoroethylene (PTFE) emerged as the most frequently detected PFAS, present in approximately 28 percent of all PFAS-containing cosmetic products.
Legislative Landscape and State Actions
Despite the FDA’s findings, efforts to further update MoCRA through additional legislation, such as the Safer Beauty Bill Package proposed by Rep. Jan Schakowsky, have stalled in Congress. This legislative stagnation, coupled with increasing international regulatory pressure from entities like the European Union and Canada, has created a regulatory gap within the U.S. cosmetics industry.
In response, several states have begun enacting their own restrictions on PFAS, leading to a fragmented compliance environment. With each state taking different approaches, companies in the cosmetics sector face challenges in navigating this complex regulatory landscape. As states introduce new PFAS bans and reporting requirements in the upcoming legislative year, businesses must stay vigilant to ensure compliance.
The Need for Consistency in Regulations
The current patchwork regulation of cosmetic ingredients underscores the pressing need for cohesive federal guidelines. Without comprehensive congressional action, the cosmetics industry will continue to encounter an array of state regulations that vary significantly in their scope and enforcement. This inconsistency complicates compliance efforts and increases the risk of non-compliance for companies operating across state lines.
Anticipated Regulatory Developments
Looking ahead, regulatory scrutiny in the cosmetics sector is expected to intensify in 2026. FDA Commissioner Dr. Martin Makary has indicated that the agency will persist in its efforts to enhance PFAS regulations, aligning with the Make America Healthy Again initiative. The FDA plans to collaborate with the Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA) to refine recommendations regarding PFAS across various regulated industries.
Industry Response and Proactive Compliance
In light of these developments, it is imperative for companies in the cosmetics sector to proactively adapt to evolving regulatory standards. The FDA’s report signals a shift toward greater oversight and accountability, making it essential for businesses to monitor both federal and state regulations closely.
Key stakeholders, including Holland & Knight’s Healthcare and Life Sciences teams, are committed to tracking these changes and offering guidance to the industry.
Takeaways
- The FDA’s report indicates a significant presence of PFAS in cosmetics, particularly PTFE.
- Legislative efforts to expand MoCRA face challenges, leaving states to implement their own regulations.
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Companies need to navigate a complex patchwork of state laws regarding PFAS in cosmetics.
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Regulatory scrutiny is projected to increase in 2026, prompting the industry to adapt proactively.
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Collaboration between the FDA, CDC, and EPA will shape future PFAS recommendations.
In conclusion, the FDA’s thorough examination of PFAS in cosmetics represents a crucial step toward enhancing consumer safety and regulatory clarity. As the landscape continues to evolve, companies must be proactive in their compliance efforts to navigate the complexities of both federal and state regulations effectively.
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