What is mocra?
Modernization of Cosmetics Regulation Act
MoCRA is the broadest change in cosmetic regulations since the original FD&C Act of 1938. All companies that manufacture or market cosmetics in the US, with very few exceptions will be required to comply with the many new requirements described below.
Registration of Manufacturing Facilities & Processors
All facilities manufacturing, filling and processing cosmetics are required to be registered with the FDA by July 1, 2024.
Listing of all cosmetics sold in the United States
All cosmetics sold in the United States must be listed with the FDA by July 1, 2024, with very few exceptions. Listing can be done with FDA via structured product labeling forms (SPL). FDA's Listing system opened in December 2023, allowing 6 months to submit and comply.
Prior entry in the Voluntary Cosmetic Registration Program (VCRP) portal will not count toward this requirement.
New Labeling Requirements for Cosmetics
MoCRA also added the requirement for cosmetic product labels to include contact information (US address, US phone number, or electronic contact information that may include a website) through which the responsible person can receive adverse event reports. FDA must issue a proposed rule for fragrance allergen labeling considering EU and other international requirements by June 2025 and a final rule 180 days after the close of public comment. We can help by reviewing your packaging for compliance.
Mandatory GMPs
FDA must establish good manufacturing practice (GMP) regulations consistent with national and international standards. FDA will issue a proposed rule by December 2025 and a final rule no later than December 2026.
Mandatory Adverse Event Reporting
Responsible persons (companies that manufacture or market cosmetics in the US) must:
· maintain records of any health-related adverse events associated with the use of their products for six years (or three years for some small businesses)
· disclose to FDA any serious adverse events within 15 business days of initial report. A responsible person is also required to provide to FDA any new and material medical information related to the serious adverse event for one year following the initial submission.
Cosmetic Safety Substantiation
Responsible persons (companies that manufacture or market cosmetics in the US) must maintain records that support and substantiate the safety of their cosmetic products.
FDA is required to issue standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics.