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FAQs - Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 MoCRA

The Modernization of Cosmetics Regulation Act 2022 (MoCRA) was signed into law at the end of 2022, and it brings the first major changes to cosmetics business regulations since 1938’s Federal Food, Drug and Cosmetic Act (FDCA). Here are some frequently asked questions (FAQ s) related to MoCRA:




Why Is This New Law So Significant?

It’s not just that it’s been more than 80 years since the passing of the FDCA, but also the fact that it only provided general guidance outside of one requirement, that being that finished products be safe when used in accordance with labeling. Modernization Cosmetics Regulation Act 2022 MoCRA aims to achieve that.


How Do I Know if Modernization of Cosmetics Regulation Act 2022 Applies to My Business?

The criteria for exemption from MoCRA is fairly straightforward. Generally, the requirements apply to all cosmetics manufacturers, packers, importers and distributors in the U.S., as well as those outside the country that market their products in the U.S.


What are the new authorities provided to FDA by MoCRA?

Modernization Cosmetics Regulation Act 2022 provides new authorities to FDA including: Records Access, Mandatory Recall Authority.


  • Adverse Event Reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product1. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days.


  • Mandatory Facility and Product Registration: MoCRA mandates that cosmetics manufacturers and processors must register their facilities and products.


Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), there are several key details regarding Mandatory Facility and Product Registration:

  • Facility Registration: Owners and operators of U.S. and foreign-based facilities that manufacture and process cosmetics distributed in the U.S. are required to register their facilities with the FDA. The registration should include:

    • The name of the owner/operator of the facility.

    • The facility’s physical address and information for a contact person.

    • The FDA Establishment Identifier (FEI) as the required facility registration number.


  • Product Listing: Manufacturers, packers, and distributors of cosmetics in the U.S. are required to submit listings of their cosmetics products (and ingredients) to the agency. The listing should include:

-A list of all brand names of the cosmetic products manufactured or processed at the facility.

-The responsible person for each cosmetic product.

-The product category or categories into which each product falls (based on the options listed in the Appendix A to the Final Guidance).

The FDA has developed a draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067) to facilitate the registration and listing process. The agency strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management. However, respondents that prefer to submit paper registrations and listings will still have the option to do so.


  • Adherence to Cosmetics Good Manufacturing Practices (GMPs).

  • Safety Substantiation: The Act includes new requirements such as documentation for safety substantiation.

  • Labeling Changes: The Act also includes new requirements for labeling changes.


These new requirements aim to ensure the safety of cosmetic products that many consumers use daily using the Modernization Cosmetics Regulation Act 2022 MoCRA.


For more detailed information, you may want to refer to the official FDA resources or consult with Artixio expert

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