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FDA New Cosmetic Regulation : Modernization of Cosmetics Regulation Act

January 25 2023




On December 29, 2022, The president signed into law: The modernization of Cosmetics Regulation Act of 2022 (MOCRA) which amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The MOCRA is not immediately changing and FDA will issue related guidance and final rules on specific compliance dates.


Under the new FDA Cosmetic Regulations required labeling, warning statements for products, and included prohibitions on the use of a few ingredients and sections on the voluntary registration of cosmetic facilities and voluntary filing of cosmetic ingredient statements.

Regulatory Requirement

Effective Date

Serious Adverse Event Reporting

December 29, 2023

Good Manufacturing Practices

December 29, 2025

Facility Registration

December 29, 2023

Product Listing

December 29, 2023

Safety Substantiation

December 29, 2023

Labeling to include a way to report adverse events

December 29, 2024

Labeling of Fragrance Allergens

Rules must be finalized 180 days after the public comment period ends.

Mandatory Recall Authority

December 29, 2023



Requirements for Cosmetic


- Mandatory Facility Registration and Product Listing: The new regulations will include the listing of ingredients.

- Safety Substantiation: Compliance will likely be difficult for many companies.

- Labeling: A domestic address, domestic phone number, or electronic contact information, for reporting a cosmetic adverse event must be on the product label.

- Adverse Event Reporting and Recordkeeping


FDA Enforcement Authorities


- GMP(Good Manufacturing Practices): The new regulations will require to maintain records of any health-related adverse events for 3 years of using products.

- Recalls/Exemptions: FDA will also issue recalls for unsafe products.

Small businesses with less than one million dollars in sales over the previous three years are exempt from the regulations unless they manufacture:

  • Cosmetic products that regularly come into contact with the mucus membrane of the eye under customary or usual use.

  • Cosmetic products that are injected.

  • Cosmetic products that are intended for internal use.

  • Cosmetic products that are intended to alter the appearance for more than 24 hours do not require the consumer to remove them under usual and customary conditions of use.

Others


- Talc and PFAS: The FDA will issue a standardized test method for detecting asbestos in talc-containing products.

- Animal Testing: FDA will not adopt specific requirements for animal testing. However, Animal testing should not be used for the purpose of safety testing on cosmetic products.





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