Today, Dec. 18, 2023, the U.S. Food and Drug Administration (FDA) announced the launch of its Cosmetics Direct electronic submission portal for the registration and listing of cosmetic product facilities and products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
See related: FDA Releases Update to Ongoing Activities Related to Serious Adverse Event Reporting for MoCRA
Cosmetics Direct is an FDA Structured Product Labeling (SPL) authoring tool that, according to the FDA, features user-friendly data entry forms and creates, validates, saves, submits, processes and automatically transmits the SPL submission to the FDA for internal processing — without the need to use the Electronic Submissions Gateway (ESG). However, the agency is also accepting SPL-formatted facility registration and product listing submissions through the ESG. In addition, the FDA reports it is developing SPL-X forms that are anticipated to be available soon.
While the FDA is also developing paper forms as an alternative submission tool (available soon), the agency strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.
As a reminder, as previously reported, the FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing until July 1, 2024, to provide regulated industry additional time to comply with these requirements. This deadline includes owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product, and/or products first marketed after Dec. 29, 2022.
