Cosmetics Direct Portal Now Open

Cosmetic facility registrations and product listings required under the Modernization of Cosmetics Regulation Act (MoCRA) may now be submitted to the United States Food and Drug Administration (FDA) using the Cosmetics Direct portal.

The FDA has also published the final guidance document, Registration and Listing of Cosmetic Product Facilities and Products, to assist the facility registration and product listing submission process. The final version includes an appendix with frequently asked questions and answers.

The FDA also published an updated version of the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures for Cosmetic Product Facility Registrations and Product Listings.

Reminder: The FDA has extended the compliance date from December 29, 2023 to July 1, 2024.

Link to the Cosmetics Direct portal: https://direct.fda.gov/

Link to the final guidance document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products

Link to the updated SPL guidance: https://www.fda.gov/cosmetics/cosmetics-news-events/fda-publishes-structured-product-labeling-spl-implementation-guide-validation-procedures-cosmetic

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