USA – MOCRA

The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) is the first major update to the US Food and Drug Administration’s (FDA) authority over cosmetic products since 1938.

By 1st July 2024, cosmetic brands and manufacturers will need to ensure that their practices comply with the new law. While the industry waits for FDA to finalise instructions and guidance, we can help brands and manufacturers prepare for this now to ensure you stay compliant when the law comes into force. Our range of services include:

  • Acting as US agent
  • Facilities registration
  • Product listing
  • FDA and state regulatory compliance checks on formulations
  • Artwork checks (both State and FDA)
  • Safety substantiation
  • Accelerated stability studies
  • Preservative efficacy (challenge) testing

More about MoCRA

The MoCRA requirements now in force from 1 July 2024 include:

  • Mandatory Facility Registration: Cosmetic brands and manufacturers must register their facilities with the FDA and renew their registration every two years.
  • Product Listing: A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, place of manufacture, product listing number, and provide any updates annually. This registration must be complete before December 2023 for existing products on the market and 120 days for new products.
  • Adverse event reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the US to the FDA within 15 business days after receiving the report and certain additional information, such as new medical information, within one year of the initial report. The FDA will also have access to adverse event reports during an inspection.
  • Safety Substantiation: A responsible person is required to ensure and maintain records supporting adequate safety substantiation for their products.

As part of MoCRA, the FDA will also be establishing regulations for:

  • Good Manufacturing Practice (GMP): This will align US GMP with international standards and is expected to be completed in 2025.
  • Fragrance allergen labelling: Cosmetic labels will be required to identify every fragrance allergen in a product. This requirement will take effect at the end of 2024.
  • Talc: The FDA will be issuing regulations to establish and require standardised testing methods for detecting and identifying asbestos in talc-containing cosmetic products.
  • Perfluoralkyl and polyfluoralky substances (PFAs): The FDA is required to issue a public report, no later than three years after MoCRA is enacted, to assess the use of PFAs in cosmetic products.

For small businesses, there are exemptions from GMP, registration, and product listing requirements. More guidance will be issued in the coming months.