This month, the FDA released several updates regarding the implementation of the Cosmetic Modernization Regulatory Act (MoCRA). This includes final guidance for the industry on the registration and listing of cosmetic facilities and products, an electronic filing portal for facility registration Cosmetics Direct, an updated Structured Product Labeling (SPL) implementation guide with verification procedures, and a Serious Hazards Guide for Cosmetics. Latest instructions regarding incident reporting.
FDA issues final guidance on registration and listing of cosmetic facilities and products
Yesterday, December 18, 2023, the FDA Final guidance for industrySpecific to the Cosmetic Facility Registration and Product Listing specified in MoCRA requirements,Register a cosmetic facility and submit a product listing to the FDA by explaining who is responsible for registration and listing submissions, what information to include, how to submit, when to submit, and certain exemptions to registration and listing requirements. We will support those involved.” explained in the FDA announcement.
This guidance states that FDA “FDA Facility Identifier (FEI) as required facility registration numberFor information on registering a cosmetic facility, see . As detailed in the guidance, the facility’s designated responsible person must obtain her FEI number before submitting the facility registration.For each facility where cosmetics are manufactured or processed”
of FEI Search PortalThe Director will be available to confirm whether your facility has already been assigned an FEI number and will also provide resources to assist you in obtaining an FEI number if needed.
This guidance also includes a new draft guidance section titled Appendix B.For comment purposes only,”,”Find answers to frequently asked questions about registering a cosmetics facility and submitting a product listing.” For more information on how to submit comments, please see the Federal Register Notice. here.
FDA Announces Launch of Cosmetics Direct for Electronic Registration and Listing of Cosmetic Facilities and Products
Also, on December 18, 2023, the FDA cosmetics directAn electronic submission portal available to the industry. As detailed in the announcement, the portal “We specialize exclusively in cosmetic facility registration and electronic submission of cosmetic listings to the FDA.As required by MoCRA, we provide “.User-friendly data entry form. Structured Product Label (SPL) Submission to FDA”
According to the FDA, the SPL application “Document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information”, and “”Registration and listing of cosmetics facilities and cosmetics” F.D.A. Electronic Submission Gateway (ESG)also accepts SPL submissions.
On the other hand, the FDAElectronic submission is strongly encouraged to promote efficiency and timeliness of agency data submission and management.Paper forms are also being developed as an alternative submission tool and will be available soon, according to the FDA.
FDA issues Structured Product Labeling (SPL) Implementation Guide with Steps to Register Cosmetic Facilities and Verify Product Listings
First announced on October 13th of this year, the F.D.A. Structured Product Labeling (SPL) Implementation Guide with Validation Stepswas updated on December 14, 2023. This latest version includes:Cosmetic product facility registration and product list updates included in the SPL framework” according to an FDA statement.
FDA issues updated instructions for reporting serious adverse events for cosmetics
Additionally, on December 14, 2023, FDA updated its instructions regarding the reporting of serious adverse events for cosmetics as required by MoCRA mandates. In November of this year, the FDAIndustry leaders must submit serious adverse event reports regarding cosmetics.using Medwatch Form 3500AYou must submit by email or mail a paper copy to the FDA CDER Mail Center. Attn: Cosmetics MedWatch reports, White Oak Campus, Building 22, G0207, 10903 New Hampshire Ave., Silver Spring, MD 20993.
With this latest update, FDA has released instructions to:Make it easier for industry managers to fill out a form to report serious adverse cosmetic events‘ can be reviewed. here. For more information on how to report cosmetic complaints, please visit the FDA website. here.
