1 July 2024 marked the enforcement date of the new US cosmetics law – The Modernization of Cosmetic Regulations Act of 2022 (MoCRA).  Now it is in force, US retailers have started issuing letters to their cosmetics suppliers requiring them to comply with the new regulations.  Failure to do so risks them being removed from their stores.

If you’re exporting to the US, it is crucial that you adhere to the MoCRA requirements that are now in force:

• Product Listing and Mandatory Facility Registration: This involves submitting cosmetic registration and listing data electronically, on the FDA’s new submissions portal, ‘Cosmetics Direct’.
• 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. Therefore, companies should have systems in place to receive and respond to adverse events. Labelling should also include contact details for adverse events.
• Safety Substantiation: A responsible person is required to ensure and maintain records supporting adequate safety substantiation for their products. Now MoCRA is in force, safety substantiation documentation must be available.

More regulations are set to be introduced for:

• Fragrance allergen labelling, which will take effect at the end of 2024.
• Good Manufacturing Practice (GMP). This will align US GMP with international standards and is expected to be completed in 2025.
• 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.

With our extensive experience in working with US cosmetics and personal care product manufacturers – and supported by our new US corporation, MSL Regulatory Solutions Inc., we can help you stay compliant.

Our services include acting as US agent; facility registrations; product listings; FDA and state regulatory compliance checks on formulations; ingredient safety support; development of Product Information Files (PIFs); artwork checks; record keeping and collection of adverse events; creation of adverse event Standard Operating Procedures (SOPs); accelerated stability studies; preservative efficacy (challenge) testing.

For further information about our MoCRA services, check out our dedicated MoCRA support page here USA – MOCRA – MSL or get in touch at info@msl.io.