Excerpt from Global Compliance News Article, Published on Nov 14, 2023

Amidst the rollout of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA has announced a significant extension in compliance deadlines, aiming to alleviate concerns over implementation challenges. With a looming set of regulatory requirements, the FDA’s recent move seeks to provide relief to entities grappling with the complexities of adhering to the new framework.

The FDA’s latest guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing,” unveiled on November 8, 2023, outlines a six-month enforcement discretion extension. This extension aims to offer the industry additional time to fulfill the mandatory facility registration and product listing mandates under MoCRA. Notably, the compliance deadline shift acknowledges the current unavailability of the FDA’s facility registration and product listing submissions, hinting at potential delays in the original timeline.

In tandem with the extension, the FDA is actively developing an electronic submission portal, Cosmetics Direct, geared to streamline the submission process for necessary information. Emphasizing the push towards electronic submissions, the agency is concurrently working on alternative paper forms, namely FDA Forms 5066 and 5067, for submission convenience. Moreover, the FDA plans to conduct a pilot program to test the functionality and usability of the electronic submission portal.

Expected to be operational in early December 2023, the electronic submission portal, technical assistance documents, and paper submission forms will equip the industry with diverse avenues for compliance. This strategic approach aims to ensure accessibility and facilitate a smoother transition for entities navigating the complex landscape of MoCRA regulations. As the industry braces for change, the FDA’s proactive measures aim to foster a more seamless integration of the new cosmetic regulatory framework.

To delve deeper into this topic, please read the full article on Global Compliance News