FDA Delays Enforcement of MoCRA Facility Registration and Product Listing Requirements
Client Alert | 1 min read | 11.09.23
On November 8, 2023, the U.S. Food and Drug Administration (FDA) issued guidance on its intent to delay enforcement of the facility registration and product listing requirements set forth in in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for an additional six months (until July 1, 2024) to allow cosmetics companies enough time to submit facility registration and product listing information.
Absent exemption, MoCRA requires that:
-
-
- owners and operators of U.S. and foreign-based facilities that manufacture and process cosmetics distributed in the U.S. register their facilities with the FDA, and
- manufacturers, packers, and distributors of cosmetics in the U.S. submit listings of their cosmetics products (and ingredients) to the agency.
-
In August, the FDA issued draft guidance, which provides recommendations and instructions to assist with facility registration and product listing compliance. In September, FDA announced its newly developed draft electronic submission portal—Cosmetics Direct. The comment period closed on October 18, and FDA is now in the process of obtaining approval from the Office of Management and Budget. Screenshots released by the FDA for commenting on Cosmetics Direct, provide helpful, step-by-step guidance for how to submit required information to the FDA through the new system.
Contacts
Insights
Client Alert | 5 min read | 07.25.25
The Changing Face of UK Defence and Security
On 2 June 2025, the UK Government unveiled its 2025 Strategic Defence Review titled the “Plan for Change for Defence” (the “2025 SDR”), heralding it as the dawn of a new era in British defence and security. Hailed as a landmark by the Prime Minister, the 2025 SDR underscores the urgent need to address daily cyber threats and embrace the rapid evolution of technology that is reshaping the battlefield. It also emphasises both the necessity of and the opportunities that this approach affords to create a new partnership with industry and radically reform procurement, leading to the creation of a “defence dividend” of jobs, wealth and opportunity throughout the UK.
Client Alert | 1 min read | 07.24.25
Commission In Limbo: SCOTUS Puts CPSC Commissioners Back Out of Action
Client Alert | 3 min read | 07.24.25
UK Government's take on ransomware: Insights from the recent consultation
Client Alert | 4 min read | 07.24.25