The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”)

by | Jan 30, 2023 | Cosmetics, FDA, U.S. Regulatory, Uncategorized

On December 29, 2022, President Joe Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This new cosmetic legislation establishes federal standards for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, recalls, and more.

New Requirements for Cosmetics:

  1. Adverse Event Record keeping and Serious Adverse Event Reporting:
  • Must report to FDA no more than 15 business days of event awareness
  • Must maintain all related records
  • Cosmetic product labels must list contact information for consumers to report side effects
  1. Mandatory Facility Registration and Product and Ingredient Listing:
  • Facility Registration by December 29, 2023 – All existing facilities (domestic and foreign) that engage in the manufacturing or processing of a cosmetic product for distribution in the United States must register with the FDA
  • Must be renewed every 2 years
  • Product Listing must be submitted within 120 days of market launch and it must be renewed annually
  1. Cosmetic Safety Substantiation
  • Adequate substantiation of safety is required for all cosmetics
  1. Cosmetic Labeling and Fragrance Allergen Transparency
  • Product labels must be updated to include fragrance allergens
  • June 29, 2024 – List of allergens to be declared will be proposed by FDA and finalized within 180 days of the comment period ending
  • Labeling must be updated by December 29, 2025
  1. Current Good Manufacturing Practices:
  • Manufacturers must meet GMP by 2025
  • FDA is expected to publish a proposed regulation before December 29, 2024 and finalize it by December 29, 2025
  1. Talc rule:
  • FDA to publish a proposed test protocol for asbestos in Talc by December 29, 2023
  • To be finalized 180 days after comment period ends
  1. PFAS Report:
  • FDA to assess the use of per- and polyfluoralkyl substances (“PFAS”) in cosmetic products and the scientific evidence regarding the safety of their use in cosmetics products
  • FDA will publish the results of this assessment in a public report no later than December 29, 2025
  1. Animal testing
  • No requirements specific to testing involving animals, but animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances

MoCRA EXEMPTIONS:

  • Small business exemptions apply – average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000 AND
  • Do not engage in the manufacturing or processing of the cosmetic products listed below:
    • Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
    • Cosmetic products that are injected.
    • Cosmetic products that are intended for internal use.
    • Cosmetic products that are intended to alter appearance for more than 24 hours.

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