This month, the FDA has announced several updates regarding the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), including the final guidance for industry on Registration and Listing of Cosmetic Product Facilities and Products, an electronic submission portal Cosmetics Direct for facility registration, an updated Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, and updated instructions for Serious Adverse Event Reporting for Cosmetic Products.
FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products
Yesterday, December 18, 2023, FDA released a final guidance for industry, specific to cosmetic product facility registrations and product listings as stipulated in MoCRA requirements, which “assists stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, when to submit, and certain exemptions to the registration and listing requirements,” as described in FDA’s announcement.
The guidance explains how FDA will be utilizing “the FDA Establishment Identifier (FEI) as the required facility registration number” for cosmetic product facility registrations. As detailed in the guidance, the FEI number must be obtained before submission of facility registration by the facility’s designated responsible person “for each facility where their cosmetic products are manufactured or processed.”
The FEI Search Portal is available for responsible persons to confirm if a facility already has an FEI number assigned and also hosts resources to assist in obtaining an FEI number if needed.
The guidance also includes a new draft guidance section entitled Appendix B, which is “for comment purposes only,” and “describes frequently asked questions and answers about cosmetic product facility registrations and product listing submissions.” For more information on how to submit commentary, visit the Federal Register Notice here.
FDA Announces Launch of Cosmetics Direct for Electronic Registration and Listing of Cosmetic Product Facilities and Products
Also, on December 18, 2023, FDA made its Cosmetics Direct electronic submission portal available for the industry. As detailed in the announcement, the portal is “dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA” as mandated by MoCRA and offers “user-friendly data entry forms that create, validates, saves, submits, processes, and automatically transmits the Structured Product Labeling (SPL) submission to FDA.”
As explained by FDA, SPL submissions are “a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information,” and include “Registration and Listing of Cosmetic Product Facilities and Products.” FDA’s Electronic Submissions Gateway (ESG) also accepts SPL submissions.
While FDA “strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency,” paper forms are also in development as an alternative submission tool and, per FDA, will be offered soon.
FDA Publishes Structured Product Labeling (SPL) Implementation Guide with Validation Procedures for Cosmetic Product Facility Registrations and Product Listings
Originally published on October 13 of this year, FDA’s Structured Product Labeling (SPL) Implementation Guide with Validation Procedures was updated on December 14, 2023. This latest version includes “updates to the cosmetics product facility registrations and product listings included within the SPL framework,” per FDA’s announcement.
FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products
Also, on December 14, 2023, FDA updated instructions regarding Serious Adverse Event Reporting for Cosmetic Products as required in MoCRA’s mandate. In November of this year, FDA recommended “that industry responsible persons submit serious adverse event reports for cosmetics” using MedWatch Form 3500A, which is to be submitted electronically via email or paper copy mailed to FDA CDER Mail Center, Attn: Cosmetics MedWatch reports, White Oak Campus, Building 22, G0207, 10903 New Hampshire Ave., Silver Spring, MD 20993.
In this latest update, FDA released instructions intended to “make it easier for the industry responsible person to complete the form to report a serious adverse event for a cosmetic product,” which can be reviewed here. For more information on how to report a cosmetic-related complaint, visit the FDA website here.
