New Year, Same MoCRA: FDA Cosmetic Requirements as of January 1, 2025

As you know, MoCRA was passed just over two years ago on December 29, 2022, and imposed extensive new requirements related to cosmetic products. We have covered those provisions at length across various alerts, which we have hyperlinked below.

Now that it is officially 2025, we wanted to recap which MoCRA requirements have gone into effect and which are still yet to come. With that in mind, we have compiled below a comprehensive list of MoCRA requirements and their effective dates:

• Exemption for Small Businesses: December 29, 2022
  • Alerts available here, here, here, here, and here.
• Exemption for Certain Products and Facilities: December 29, 2022
  • Alerts available here, here, here, here, and here.
• Record Keeping Requirements: December 29, 2023
  • Alerts available here and here.
• Safety Substantiation Requirements: December 29, 2023
  • Alerts available here and here.
• FDA Mandatory Recall Authority: December 29, 2023
  • Alerts available here and here.
• Adverse Event Reporting Requirements: December 29, 2023
  • Alerts available here, here, here, and here.
• FDA Enforcement Authority: December 29, 2023
  • Alert available here.
• Professional Use Labeling Requirement: December 29, 2023
  • Alert available here.
• General Labeling Requirement: December 29, 2024
  • Alert available here.
• Facility Registration Requirements: July 1, 2024
  • Alerts available here, here, here, here, here, here, here, and here.
• Product Listing Requirements: July 1, 2024
  • Alerts available here, here, here, here, here, here, here, and here.
• Talc-Containing Cosmetic Requirements: To Be Determined
  • This requirement will go into effect after the FDA has undergone the rulemaking process and promulgated new regulations. Note that on December 26, 2024, the FDA published a proposed rule regarding these requirements.
  • Alerts available here and here.
• Good Manufacturing Practice (GMP) Requirements: To Be Determined
  • This requirement will go into effect after the FDA has undergone the rulemaking process and promulgated new regulations.
  • Alert available here.
• Fragrance Allergen Labeling: To Be Determined
  • This requirement will go into effect after the FDA has undergone the rulemaking process and promulgated new regulations.
  • Alert available here.

ArentFox Schiff will continue to closely monitor additional updates on MoCRA compliance and is especially keeping an eye out for anything regarding the GMP requirements and fragrance allergen labeling rules.

If you are interested in more information about MoCRA or would like guidance on complying with these requirements, please contact ArentFox Schiff’s Food, Drug, Medical Device & Cosmetic group.