Cosmetics 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.
Cosmetics Direct is the FDA's online portal designed specifically for cosmetic facility registration and product listing as required by MoCRA. It provides a web-based form interface as a user-friendly alternative to the more technical SPL XML/ESG NextGen submission pathway.
Through Cosmetics Direct, responsible persons and facility operators can register manufacturing and processing facilities (including obtaining or linking FDA Establishment Identifier numbers), submit product listings with ingredient information, update existing registrations and listings, and complete biennial registration renewals.
The portal is free to use and accessible through the FDA's website. It is well-suited for companies with a small number of products who prefer manual data entry over automated submissions. However, for companies with large product portfolios, the ESG NextGen API pathway is typically more efficient.
Cosmetics Direct internally generates SPL XML from the data entered through its web forms, so the underlying data format is the same regardless of which submission pathway is used. Both pathways result in the same FDA registration and listing records.
Related Terms
Food 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.
RegulationModernization 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.
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.
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.
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