In January 2024, the US FDA announced the availability of SPL Xforms, a structured product label (SPL) authoring tool intended for the registration of cosmetic product facilities and the listing of cosmetic products, as required by the Modernization of Cosmetics Regulation Act (MoCRA).
The U.S. Food and Drug Administration (FDA) has published the availability of additional submission tools for cosmetic product facility registration and cosmetic product listing using the Xforms system, which is an option for creating an SPL file that includes cosmetic product facility registration and cosmetic product listing information. In addition, the FDA is accepting cosmetic product facility registrations and cosmetic product listings via electronic submission.
FDA also announced the availability of Form FDA 5066 and Form FDA 5067 as an additional submission tool for providing cosmetic product facility registration and cosmetic product listing information to FDA. These paper forms are available at Registration & Listing of Cosmetic Product Facilities and Products.
The electronic submission options:
- Cosmetics Direct, an FDA Structured Product Labeling (SPL) authoring tool and electronic submission portal at https://direct.fda.gov/
- SPL-formatted submissions through the Electronic Submissions Gateway (ESG).
- Completed paper forms can be mailed to FDA’s Registration and Listing of Cosmetic Product Facilities and Products Program.
Learn more about how to facilitate the registration of cosmetic products with the FDA:
- Cosmetics Direct: Is an electronic submissions portal for the registration & listing of cosmetic product facilities and products. It is an FDA Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing without having to use the Electronic Submissions Gateway (ESG).
- Electronic Submissions Gateway: The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting majority of electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. Refer to ESG’s Center Submission Types webpage for the list of acceptable electronic regulatory submissions via ESG.
- Structured Product Labeling Resources: The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.
- Registration & Listing of Cosmetic Product Facilities and Products: The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily.
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.