20 December 2023
The FDA releases final guidance and updates on registration, listing, and adverse event reporting for cosmetic products under the Modernization of Cosmetics Regulation Act.
The FDA has recently made significant strides in implementing the Modernization of Cosmetics Regulation Act (MoCRA). This month, the agency announced a series of updates, including the final guidance for industry on Registration and Listing of Cosmetic Product Facilities and Products. Additionally, the FDA introduced an electronic submission portal called Cosmetics Direct for facility registration, an updated Structured Product Labeling (SPL) Implementation Guide, and revised instructions for Serious Adverse Event Reporting for Cosmetic Products. These developments aim to streamline processes, enhance transparency, and ensure the safety of cosmetic products in the market.
Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products
The FDA released a comprehensive final guidance for industry on cosmetic product facility registrations and product listings. This guidance provides clear instructions on who is responsible for submitting registrations and listings, the required information, submission methods, deadlines, and exemptions. The guidance emphasizes the use of the FDA Establishment Identifier (FEI) as the facility registration number. Responsible persons must obtain an FEI number before submitting facility registrations. The FEI Search Portal is available for confirmation of assigned FEI numbers and provides resources for obtaining an FEI number if needed. The guidance also includes an appendix with frequently asked questions and answers to further assist stakeholders.
of Cosmetics Direct Electronic Submission Portal
To streamline the registration and listing process, the FDA has launched the Cosmetics Direct electronic submission portal. This portal is exclusively dedicated to cosmetic product facility registration and listing submissions. It offers user-friendly data entry forms that create, validate, save, submit, process, and transmit Structured Product Labeling (SPL) submissions to the FDA. SPL submissions, which follow the document markup standard approved by Health Level Seven (HL7), facilitate the exchange of product and facility information. The FDA’s Electronic Submissions Gateway (ESG) also accepts SPL submissions. While electronic submissions are strongly encouraged for efficiency, the FDA is developing paper forms as an alternative submission tool.
Updated Structured Product Labeling (SPL) Implementation Guide
The FDA recently updated its Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. This updated version incorporates changes related to cosmetic product facility registrations and product listings within the SPL framework. The guide provides detailed instructions on how to create and validate SPL submissions, ensuring accurate and standardized information exchange between stakeholders.
Revised Instructions for Serious Adverse Event Reporting for Cosmetic Products
In compliance with MoCRA’s mandate, the FDA has updated instructions for reporting serious adverse events related to cosmetic products. Previously, the agency recommended using MedWatch Form 3500A for electronic or paper submissions. In the latest update, the FDA has made improvements to simplify the reporting process for industry responsible persons. The revised instructions aim to facilitate the completion of the form for reporting a serious adverse event for a cosmetic product. The FDA website provides further information on how to report a cosmetic-related complaint.
Conclusion:
The FDA’s recent updates regarding the implementation of the Modernization of Cosmetics Regulation Act (MoCRA) demonstrate the agency’s commitment to enhancing transparency, efficiency, and safety in the cosmetic industry. The final guidance on registration and listing, the of the Cosmetics Direct electronic submission portal, the updated Structured Product Labeling (SPL) Implementation Guide, and the revised instructions for serious adverse event reporting all contribute to a more streamlined and standardized regulatory framework. These developments will not only benefit industry stakeholders but also ensure consumer confidence in the safety and quality of cosmetic products.
