U.S. FDA MoCRA Requirements Enforcement Delayed by 6 Months

By Percefoni Doufou-Shafiq, Ph.D., Regulatory Affairs Lead, Supply Chain Team, UL Solutions

The U.S. Food and Drug Administration (FDA) announced on Nov. 8, 2023, that it will delay, by 6 months, enforcement of the requirements for product facility registration and cosmetic product listing as mandated by the Modernization of Cosmetics Regulation Act (MoCRA). The delay of enforcement applies to both existing and new facilities and products.

When MoCRA was signed into law on Dec. 29, 2022, it was not clear how the registration and product listing would proceed, and it was speculated that the FDA may use the existing Voluntary Cosmetic Registration Program (VCRP) platform. The VCRP was the platform that companies used up to that point for voluntarily registering their facilities and listing their products. However, on March 27, 2023, the FDA announced that it will no longer accept submissions to the VCRP because it was creating a new platform for the compulsory registration and product listing.

On Aug. 8, 2023, the Office of Cosmetics and Colors (OCAC) and the Office of the Chief Scientist (OCS) in the FDA solicited applications from members of the cosmetic product industry for participation in a voluntary pilot program to evaluate a potential electronic submissions portal for the registration and product listing. It also issued a Draft Guidance on cosmetics registration and product listing under MoCRA.

In Sept. 2023, the Administration sought comments on the draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067).  As another alternative, users can transmit SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG), before Cosmetics Direct becomes fully functional. Information on SPL-formatted submissions is found in the document Structured Product Labeling (SPL) Implementation guide with Validation Procedures published on Nov. 14, 2023. Eventually, as per the FDA plan, the Cosmetics Direct portal will be the exclusive portal for electronic cosmetic facility registration and product listing, using the same SPL authoring tools and format for submissions without going through ESG.

The FDA mentions in its Nov. 2023 document, Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing, that it anticipates electronic (strongly recommended) and paper form submissions to be available in early December 2023, and encourages companies to do their registration/product listing if they have all the necessary information ready. It acknowledges, however, industry concerns regarding readiness to follow ongoing developments and meeting requirements in a timely manner. The industry has stated, among others, needing additional time to gather required information, obtain Facility Establishment Numbers (FEI) before registering/product listing, and gain access to the electronic submissions database. In light of these concerns, the FDA has decided to delay enforcement of the requirements under section 607 of the FD&C Act (facility registration/product listing) for an additional 6 months for both existing and new facilities:

• July 1, 2024, instead of Dec. 29, 2023, for registration of existing facilities/product listing.
• July 1, 2024, for facilities that first engaged in manufacturing/processing a cosmetic product after Dec. 29, 2022, or product listing for cosmetic products marketed after Dec. 29, 2022.

For a quick summary of the specific requirements under MoCRA please refer to the article ‘’Newly Passed Law Tightens U.S. Cosmetics Regulations’’ which was previously published by UL Solutions.

Sources

Modernization of Cosmetics Regulation Act of 2022

FDA - Cosmetics

Registration & Listing of Cosmetic Product Facilities and Products