Cosmetics Industry Regulatory Challenges Accelerate

The past three years have marked the most significant expansion of cosmetic industry oversight since 1938. The updates below outline key provisions of the Modernization of Cosmetics Regulation Act of 2022 ("MoCRA") and proliferating state bans, many of which are effective in 2026.

FDA Implements MoCRA: Expanding Oversight Across the Cosmetics Supply Chain

The U.S. Food and Drug Administration ("FDA") continues to implement the Modernization of Cosmetics Regulation Act of 2022 ("MoCRA"), enacted under the Consolidated Appropriations Act of 2023. MoCRA establishes new requirements for the cosmetics sector, including mandatory facility registration, product listing, safety substantiation, and adverse event reporting.

Under MoCRA:

• Serious adverse event reporting is required within 15 business days, with additional reporting if new medical information arises within one year.
• Facility registration is now mandatory for all domestic and foreign manufacturing or processing facilities distributing cosmetic products in the U.S., with biennial renewal.
• Product listings must be filed and updated annually, detailing ingredients for each marketed product.
• Safety substantiation records must be maintained demonstrating that products are safe for intended use.

MoCRA also authorizes FDA to suspend a facility's registration if products may cause serious health consequences and expands FDA's inspection and enforcement powers. Additionally, FDA must publish a PFAS report assessing the use and risks of these substances in cosmetics.

Pending FDA Rulemaking Actions

FDA has initiated multiple rulemaking actions required by MoCRA, including:

• Formaldehyde Ban in Hair Smoothing Products – proposes prohibiting formaldehyde and formaldehyde-releasing agents.
• Asbestos Testing in Talc-Based Cosmetics – establishes standardized methods for asbestos detection.
• Fragrance Allergen Disclosure – mandates label disclosure of specific fragrance allergens.
• Good Manufacturing Practice ("GMP") for Cosmetic Facilities – provides GMP requirements; nonbinding guidance.

State Cosmetic-Specific PFAS and Chemical Restrictions Accelerate Nationwide

By late 2025, nearly 20 states have enacted or proposed legislation restricting PFAS, formaldehyde, lead, and other substances in cosmetics. Notable examples include:

• California: PFAS-Free Cosmetics Act (effective 2025) and expanded Toxic-Free Cosmetics Act banning multiple classes of toxic chemicals.
• Colorado and Maryland: Comprehensive bans on intentionally added PFAS in cosmetics (effective 2025).
• Connecticut: Bans intentionally added PFAS in cosmetics, unless the product is accompanied with a PFAS disclosure (effective 2026). After January 1, 2028, bans all intentionally added PFAS, with limited exceptions.
• Maine and Vermont: Phased PFAS prohibitions in cosmetics and menstrual products with limited exemptions for unavoidable use (effective 2026–2032).
• Minnesota: Phased PFAS prohibitions in cosmetics and menstrual products with limited exemptions for unavoidable use (effective 2025 - 2032); Requires disclosures to agency when PFAS is intentionally added (effective 2026).
• Washington: Restricts certain chemicals and chemical classes from cosmetic products manufactured, distributed, or sold in the state (effective 2025); in-state retailers may exhaust existing stock through sales until 2026.

State momentum suggests a trend toward uniform PFAS phaseouts by 2032, despite the absence of a federal ban.

Conclusion

These overlapping developments are rapidly reshaping the federal and state compliance landscape for the cosmetics industry. They create a complex compliance matrix spanning FDA and state environmental and health agencies.

Baker Botts Environmental, Safety & Incident Response Team continues to monitor these developments and assist clients with compliance strategies, advocacy, and rulemaking engagement.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.