Modernization of Cosmetics Regulation Act (MoCRA)
A US federal law (Public Law 117-328, Title XXXV) signed on December 29, 2022, that gives the FDA new authority over cosmetics including mandatory facility registration, product listing, adverse event reporting, safety substantiation, and recall authority.
MoCRA is the most significant update to US cosmetics regulation since the Federal Food, Drug, and Cosmetic Act of 1938. Enacted as Title XXXV of the Consolidated Appropriations Act, 2023, it amends the FD&C Act to grant the FDA regulatory powers it previously lacked over the cosmetics industry.
Key requirements introduced by MoCRA include mandatory facility registration and product listing through the FDA's Cosmetics Direct portal or the Electronic Submissions Gateway (ESG NextGen), mandatory reporting of serious adverse events within 15 business days, safety substantiation obligations, and GMP requirements aligned with ISO 22716.
MoCRA applies to every person or company that manufactures, processes, packs, or holds cosmetics for US distribution. A limited exemption exists for businesses with average annual gross sales under $1,000,000 over the previous three years, although even exempt businesses must comply with adverse event reporting and safety substantiation requirements.
The law also grants the FDA mandatory recall authority over cosmetics for the first time, and requires the establishment of fragrance allergen labeling rules. Facility registration and product listing deadlines began in July 2024, with GMP enforcement expected in 2026.
Related Terms
Federal Food, Drug, and Cosmetic Act (FD&C Act)
The foundational US law (21 U.S.C. ch. 9) granting the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics. MoCRA (2022) amended the FD&C Act to significantly expand FDA's cosmetics oversight.
OrganizationFood and Drug Administration (FDA)
The US federal agency within the Department of Health and Human Services responsible for regulating cosmetics, food, drugs, medical devices, and other products. Under MoCRA, the FDA has expanded authority over cosmetics including facility registration, product listing, and mandatory recall power.
DocumentCosmetics Direct
The FDA's web-based portal for cosmetic facility registration and product listing submissions under MoCRA. It provides a user-friendly interface as an alternative to the SPL/ESG submission pathway, allowing manual entry of registration and listing data.
DocumentElectronic Submissions Gateway NextGen (ESG NextGen)
The FDA's electronic gateway for receiving regulatory submissions in SPL XML format, including MoCRA cosmetic facility registrations and product listings. ESG NextGen replaced the original ESG and supports automated, API-driven submissions.
ProcessFDA Establishment Identifier (FEI)
A unique numerical identifier assigned by the FDA to each establishment (facility) involved in the manufacture, processing, packing, or holding of FDA-regulated products. Under MoCRA, an FEI number is required for cosmetic facility registration.
ProcessAdverse Event Reporting
The regulatory process of reporting harmful health effects associated with cosmetic products to authorities. Under MoCRA, US responsible persons must report serious adverse events to the FDA within 15 business days; the EU requires reporting serious undesirable effects to competent authorities.
ProcessSafety Substantiation
The regulatory requirement that cosmetic manufacturers ensure and maintain adequate evidence demonstrating their products are safe under labeled or customary conditions of use. Under MoCRA, the FDA can request access to safety substantiation records during facility inspections.
ProcessGood Manufacturing Practices (GMP)
A system of guidelines ensuring cosmetic products are consistently produced and controlled according to quality standards. MoCRA requires FDA to establish cosmetic GMP regulations; in the EU, compliance with ISO 22716 is presumed to satisfy the GMP requirement of EC 1223/2009.
DocumentStructured Product Labeling (SPL)
An XML-based document format defined by HL7 and used by the FDA for electronic submission of product information, including cosmetic facility registrations and product listings under MoCRA. SPL submissions are transmitted through the ESG NextGen gateway.
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