Electronic 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.
The Electronic Submissions Gateway (ESG) NextGen is the FDA's modernized electronic submission system for receiving regulatory submissions. It replaced the original ESG system and supports submissions for multiple FDA-regulated product categories, including cosmetics under MoCRA.
ESG NextGen accepts submissions in SPL (Structured Product Labeling) XML format. For cosmetics, this includes facility registration submissions (initial and biennial renewal) and product listing submissions (initial, updates, and annual certification). The gateway provides automated acknowledgments and validation responses.
To use ESG NextGen, submitters must first create an ESG account and obtain credentials. Submissions can be made manually through the ESG web interface or programmatically through the ESG API, which enables integration with compliance management systems for automated bulk submissions.
Compared to the alternative Cosmetics Direct web portal, the ESG pathway offers advantages for companies with large product portfolios or those seeking to automate their FDA compliance workflows. The ESG API supports batch processing, submission status tracking, and programmatic retrieval of acknowledgments.
Related Terms
Structured 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.
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.
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.
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