Summary of The Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

MoCRA FDA Regulations Easy Overview blog post image. Comply with Amazon small business cosmetics certificate requirements.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a significant update to U.S. cosmetics regulations, strengthening the FDA’s oversight of cosmetic products and ensuring consumer safety. Signed into law as part of the Consolidated Appropriations Act of 2023, MoCRA represents the most substantial reform of the Federal Food, Drug, and Cosmetic Act (FDCA) regarding cosmetics since 1938.

MoCRA Key Provisions:

Facility Registration & Product Listing

  • Cosmetic manufacturers and processors must register their facilities with the FDA.
  • Companies must list each marketed cosmetic product with the FDA, including ingredients.

Good Manufacturing Practices (GMPs)

  • The FDA will establish regulations for cosmetic Good Manufacturing Practices (GMPs) to ensure product quality and safety.

Adverse Event Reporting

  • Companies must report serious adverse events (e.g., infections, allergic reactions) to the FDA within 15 business days.

Safety Substantiation

  • Companies must ensure and maintain records demonstrating that their products are safe for use under labeled or customary conditions.

Labeling Requirements

  • Products containing fragrance allergens must disclose them on the label.
  • Professional-use products must include clear usage directions.

Mandatory Recall Authority

  • The FDA now has the authority to recall cosmetic products if they pose a risk to public health.

Talc and PFAS Regulation

  • The FDA will assess the safety of talc-containing products and study the use of PFAS (per- and polyfluoroalkyl substances) in cosmetics.

Exemptions for Small Businesses

  • Small businesses (except those dealing with high-risk products like injectable cosmetics or those posing significant risks) may be exempt from certain requirements.

MoCRA Key Terms

  • FDA (Food and Drug Administration) – The regulatory agency overseeing MoCRA implementation.
  • Good Manufacturing Practices (GMPs) – Standards ensuring cosmetic products are produced consistently and safely.
  • Serious Adverse Event – Health-related reactions requiring medical attention (e.g., hospitalizations).
  • Product Listing – Submission of product details, including ingredients, to the FDA.
  • Mandatory Recall – The FDA’s power to force product recalls when public health is at risk.
  • PFAS – Synthetic chemicals under scrutiny for potential health risks in cosmetics.

Impact of MoCRA

MoCRA shifts cosmetics regulation from a voluntary compliance system to a more structured, FDA-supervised framework, ensuring greater accountability, transparency, and consumer safety. The law places the U.S. closer in line with global cosmetic regulatory standards, such as those in the EU.

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