The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks the most significant update to U.S. cosmetic regulations since 1938. Enacted by the FDA, MoCRA introduces new mandatory requirements for cosmetic manufacturers, packers, and distributors selling products in the United States. Compliance is no longer optional companies must adapt to these rules to avoid enforcement actions, detentions, and penalties.

One of the biggest changes under MoCRA is the requirement for facility registration and product listing. Every domestic and foreign cosmetic facility that manufactures or processes products for the U.S. market must register with the FDA. Likewise, companies must list each marketed product, including its ingredients and responsible party information.

Another major provision is adverse event reporting. Companies are now required to maintain records and report any serious adverse events associated with their cosmetic products. This step increases transparency and consumer safety, allowing the FDA to take swift action if public health risks arise.

MoCRA also places emphasis on safety substantiation. Cosmetic manufacturers must be able to provide adequate evidence that their products are safe for intended use. This includes toxicological reviews, ingredient compliance checks, and documented safety assessments—especially for innovative or imported formulations.

At XPRO America, we provide complete MoCRA compliance support for global cosmetic businesses. Our services include:

• FDA Facility Registration & Product Listing – End-to-end filing and renewal support.
• Adverse Event Reporting Systems – Setting up reporting processes and FDA-ready documentation.
• Safety Substantiation & Toxicology Reviews – Ensuring scientific evidence supports product safety.
• Ongoing Compliance Monitoring – Staying updated with FDA’s evolving cosmetic regulations.

With MoCRA reshaping the regulatory landscape, cosmetic brands must act quickly to align with these requirements. XPRO America helps companies minimize risks, avoid costly delays, and achieve smooth FDA compliance for U.S. market entry.

XPRO America offers full MoCRA 2022 FDA compliance services, including facility registration, product listing, adverse event reporting, and safety substantiation.