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).
SPL, an established document sanctioned by health level seven (HL7) for the exchange of product and facility-related information, serves as a foundational reference for regulatory guidance documents and product labeling content exchange. It enforces control over crucial product information, resulting in a standard for product labeling. The FDA has adopted SPL to enhance patient/customer safety and product usability within its consumer base. In 2005, the FDA mandated the use of XML compliant with the SPL standard for electronic submissions. This standard defines the content and structure of product labeling required for submission to the FDA. Consistent structure and standard terminology are employed to enhance the accuracy and reliability of product information. For additional information, see the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures.
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- Registration & Listing of Cosmetic Product Facilities and Products
- Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
- Cosmetic Product Categories and Codes
- 12/18/2023 - FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products
- 12/18/2023 - FDA Announces Launch of Cosmetics Direct for Electronic Registration and Listing of Cosmetic Product Facilities and Products