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The recently issued Spring 2025 Unified Agenda of Federal Regulatory and Deregulatory Actions outlines the U.S. Food and Drug Administration’s (FDA) priorities for the year ahead. For the cosmetics sector, the Spring 2025 Unified Agenda reflects the ongoing implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and other federal initiatives that will shape product safety, transparency, and compliance requirements.
The document provides an early signal of the Administration’s regulatory focus, with several developments that could have significant impact on cosmetics manufacturers, ingredient suppliers, and distributors.
What’s New and Significant
Formaldehyde in Hair Smoothing Products
FDA plans to publish a proposed rule prohibiting or restricting formaldehyde and formaldehyde-releasing chemicals in hair smoothing and straightening products. This initiative reflects long-standing safety concerns and MoCRA’s mandate to regulate high-risk cosmetic ingredients. Originally scheduled for March 2025, the proposal is now expected in December 2025.
Fragrance Allergen Disclosure
In line with MoCRA and the EU’s established requirements, FDA is preparing a proposed rule to mandate the disclosure of specific fragrance allergens on cosmetic product labels. This step will increase transparency for consumers and bring the U.S. market closer to global alignment. The proposal is projected for May 2026.
Good Manufacturing Practices (GMPs)
FDA continues its work on a proposed rule to establish GMP standards for cosmetic facilities. Although required under MoCRA, the Agency has moved this rulemaking to the “long-term actions” list, suggesting delays in publication. By law, FDA was expected to issue proposed GMP regulations by December 29, 2024, and finalize them by December 29, 2025. Missing these deadlines may leave FDA vulnerable to legal challenges.
Asbestos in Talc-Containing Products
The Spring 2025 Unified Agenda also includes FDA’s ongoing work to standardize testing methods for asbestos in talc-containing cosmetics. A proposed rule was issued in December 2024, and the final rule is targeted for March 2026.
Overhaul of the GRAS Framework
A new proposed rule would make the filing of “Generally Recognized as Safe” (GRAS) notices mandatory for human and animal food uses. This change would effectively remove the long-standing practice of private GRAS self-affirmation, creating new hurdles for companies introducing novel food-derived ingredients or continuing to use substances not previously disclosed to FDA. The proposal is expected in October 2025.
Implications for Industry Stakeholders
Cosmetics companies should prepare for stricter U.S. requirements under MoCRA, particularly regarding:
- The removal of formaldehyde/formaldehyde releasers in hair products.
- Talc impurity testing and asbestos detection.
- Fragrance allergen labelling obligations.
R&D, formulation, and supply chain strategies may need early adjustments. In addition, while FDA advances federal regulations, state-level initiatives are expected to continue, potentially leading to divergent requirements across jurisdictions.
What’s Next in FDA Compliance
MoCRA implementation remains the focal point of FDA’s cosmetics agenda, with significant regulatory milestones approaching in 2025–2026. Companies manufacturing, importing, or distributing cosmetics in the U.S. should closely monitor these developments and plan for compliance.
How Cosmeservice Can Help
Exploring the evolving U.S. cosmetics regulatory landscape requires expertise and foresight. At Cosmeservice, we support companies in adapting to new FDA requirements under MoCRA, from ingredient compliance checks to label reviews and GMP readiness.
Our team helps manufacturers, importers, and suppliers ensure that their products meet U.S. regulatory standards, avoiding delays and minimizing compliance risks.
Contact Cosmeservice to learn how we can help you anticipate regulatory changes and prepare your business for success in the U.S. market.
References
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions
- FDA Proposed Rule: Formaldehyde in Hair Smoothing Products (RIN 0910-AI83, 2025)
- Disclosure of Fragrance Allergens in Cosmetic Labeling (RIN 0910-AI90, 2025)
- Good Manufacturing Practice for Cosmetic Product Facilities (RIN 0910-AJ00, 2025)
- Sun & UV Exposure: Safety of Sunscreens” (RIN 0910-AI82, 2025)
- Substances Generally Recognized as Safe (GRAS) (RIN 0910-AJ02, 2025)
