Last Updated on March 30, 2023 by Ithos Global Regulatory Team
The FDA has released two major updates in response to the implementation of the Modernization of Cosmetics Regulation Act (MoCRA). In this article, we will discuss the implications of these changes and the next steps that companies in the cosmetic industry should take.
MoCRA Explained: Bringing US Cosmetic Regulation into the Modern Era
FDA VCRP
What is it?
According to an FDA constituent update released March 27, 2023, the FDA will no longer accept and/or process VCRP submissions (as of January 2023) and will no longer use the VCRP system. Compliance with MoCRA requires a mandatory reporting procedure, which the FDA will need to implement without the help of the VCRP’s existing platform. This is because the VCRP system does not include the necessary fields for MoCRA compliance.
What’s the impact?
The VCRP was not obligatory and did not serve as an authorization process, hence the information received through it did not offer a comprehensive understanding of cosmetics available in the US market. However, MoCRA necessitates specific companies to register their facilities and enlist their products with FDA, and due to the high volume of submissions expected, FDA is devising a new system to manage them. It is crucial to acknowledge that the data provided through the VCRP will not be migrated to the system under development for facility registrations and product listings mandated by MoCRA.
When is it happening?
The FDA stopped accepting VCRP submissions as of March 27th, 2023. The timeline for the launch of the new reporting system has not been announced yet, but the FDA assures that it will continue to post updates its forthcoming availability.” It is important to note that the compliance date for reporting will still be December 29th, 2023. The FDA is hopeful that the new reporting system will be online soon so that companies will have several months of lead time to complete their registrations before the compliance date.
What are the next steps?
Enforcement of MoCRA will require companies to register their manufacturing facilities and list their products with the FDA. Companies should gather all necessary formulation and manufacturing documentation to facilitate both registrations. Additionally, if any products have been previously notified with the VCRP, those products will need to be registered with the new reporting system, since information from the VCRP will not be transferred to the new reporting system. Companies should keep a close eye on FDA communications to ensure that they comply with upcoming timelines and release dates for the new reporting system.
For more information about the FDA’s decision to deactivate its VCRP system, click to read the official constituent update.
FDA Office of Regulatory Affairs (ORA) Restructuring Update
What is it?
The U.S. Food and Drug Administration (FDA) announced they have begun restructuring of its Human Foods Program and Office of Regulatory Affairs (ORA). Certain functions of the Office of Regulatory Affairs (ORA) and all functions of the Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) will come together under the umbrella authority of its Human Foods Program. In addition, the FDA is announcing that this restructure will include moving cosmetics regulation and color certification functions out of the Center for Food Safety and Applied Nutrition (CFSAN) and into the Office of the Chief Scientist. The FDA notes that the “proposed move will better align the expertise” of cosmetics experts and the agency’s Chief Scientist to work together as a body focused on “research, science, and innovation.” Additionally, this shift will better leverage the FDA’s expertise as it works to implement the Modernization of Cosmetic Regulation Act of 2022 (MoCRA).
What’s the impact?
The goal of this restructure is to “enhance coordination, prevention and response activities” within these departments. The vision for the restructuring is in part to improve the agency’s overall efficiency and effectiveness and in part to assign clear roles and responsibilities to the respective authorities.
This new model of restructuring aims to “enable ORA and program personnel to function as a multidisciplinary team” empowering them to make efficient, knowledgeable decisions. Its core activities of focus will include:
- Setting the global standard in inspections
- Investigations
- Laboratory analysis
- Import operations
When is it happening?
On February 28th, 2023, the FDA announced a proposal for the restructuring. The FDA is hoping to finalize this proposal in Fall of 2023.
What are the next steps?
To finalize the proposal, a reorganization package will be created, comprising a new structure, a budget, and a staff mapping from the current to the new organization. Before sending it to Congress for a 30-day notification period, the package will be reviewed. During this time, Congress members may voice concerns that the FDA will need to address. After the notification period ends, the FDA will publish a Federal Register Notice and negotiate with affected staff unions before implementing the new proposal. Additional updates will be provided as work on this proposal continues to unfold.
For more information about the FDA’s restructuring of its Office of Regulatory Affairs, click to read the FDA’s full release.
