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The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a landmark U.S. law that significantly strengthens the regulation of cosmetic products. Enacted on December 29, 2022, as part of the Consolidated Appropriations Act of 2023, MoCRA is the most significant expansion of the FDA’s authority to regulate Cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938, with the passage of the act, the FDA has new authorities to help ensure the safety of cosmetic products that many consumers use daily.

Why MoCRA Matters

Before MoCRA, the FDA’s oversight of Cosmetics was limited. Cosmetic manufacturers were not required to register facilities, report adverse events, or provide safety data, and product recalls were largely voluntary.

MoCRA addresses these gaps by creating a modern, enforceable Regulatory framework that ensures cosmetic products used daily, such as skincare, makeup, and personal care items, are safer for consumers.

Key Objectives of MoCRA

The primary goal of MoCRA is to enhance consumer safety and transparency while aligning FDA cosmetic regulations more closely with global standards. It achieves this by introducing mandatory compliance requirements and granting the FDA stronger enforcement powers.

Key Provisions of MoCRA

MoCRA introduces several critical Regulatory requirements for cosmetic manufacturers, distributors, and brand owners:

  • Facility Registration: All facilities that manufacture or process Cosmetics for distribution in the United States must register with the FDA Cosmetics Direct portal, subject to certain exemptions.
  • Product Listing: A responsible person must submit a product listing to the FDA, including details such as ingredients and manufacturer details, etc., subject to certain exemptions
  • Safety Substantiation: Companies and individuals who manufacture or market Cosmetics are required to maintain evidence and ensure that their products are safe for consumer use.
  • Adverse Event Reporting: Serious adverse events associated with cosmetic products must be reported to the FDA within a specified timeframe, improving post-market surveillance.
  • Good Manufacturing Practices (GMP): MoCRA directs the FDA to establish mandatory Good Manufacturing Practices, ensuring consistent product quality and safety.
  • Recall Authority and Records Access: For the first time, the FDA has authority to mandate recalls of unsafe cosmetic products and access safety records during inspections.

Who Must Comply?

MoCRA applies broadly across the Cosmetics supply chain, including:

  • Manufacturers and processors
  • Responsible person
  • Importers of cosmetic products into the U.S.

These entities must ensure compliance with facility registration, listing, and safety requirements, etc., to legally market products.

Impact on the Cosmetics Industry

MoCRA marks a shift from a largely voluntary compliance system to a mandatory, enforceable one. It enhances transparency, strengthens consumer protections, and increases accountability across the industry.

For businesses, this means integrating Regulatory compliance into product development, manufacturing, and post-market monitoring processes. For consumers, it offers greater assurance of product safety and quality.

Conclusion

MoCRA is a transformative regulation that modernizes the governance of Cosmetics in the United States. By expanding FDA authority and introducing comprehensive compliance requirements, the law ensures that cosmetic products meet higher safety standards. As implementation continues, MoCRA will play a crucial role in shaping a more transparent, accountable, and consumer-focused Cosmetics industry.