On Monday, the FDA announced the long-awaited launch of its Cosmetic Direct electronic submission portal for registration and listing of cosmetic product facilities and products, as required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
Now available, the Cosmetics Direct portal is specifically designed for cosmetic product facility registration and cosmetic product listing electronic submissions to FDA and is intended to be a shiny new streamlined process to meet the new MoCRA registration and listing requirements. Cosmetics Direct can be accessed at https://direct.fda.gov.
As described in FDA’s earlier Draft Guidance, Cosmetics Direct is an FDA Structured Product Labeling (SPL) tool with user-friendly data entry forms that creates, validates, saves, submits, processes and automatically transmits the SPL submission to FDA for internal processing, and bypasses using FDA’s Electronic Submissions Gateway (ESG) system.
FDA clarified that it is also accepting cosmetic product facility registration and cosmetic product listing submissions via SPL-formatted submissions through the ESG. Additionally, FDA is developed SPL-X forms that the Agency anticipates will be available soon. While electronic submissions remain the most efficient mechanism for data submission and FDA management, for those that prefer old fashioned paper forms, FDA is in the process of developing paper forms for cosmetic product registration and cosmetic product listing as an alternative submission tool that it anticipates will be available soon.
As a reminder, and as reported earlier here, FDA does not intend to enforce the requirements related to cosmetic facility registration and cosmetic product listing until July 1, 2024 (an additional 6 months after the December 29, 2023 statutory deadline) to ensure industry has sufficient time for submissions. This deadline also includes owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022.
So bottom line, you do not necessarily need to change sparkly holiday plans to get that registration in before year end…but we recommend collecting all required information (as reported previously here) and ensuring you submit timely at the start of the New Year!
For any questions on U.S. FDA compliance of cosmetics and personal care products including registration, labeling, substantiation and GMP compliance, or FDA enforcement matters including import detentions, FDA inspection preparedness, FDA 483 or Warning Letter responses, or FDA recalls, please contact info@garg-law.com.
