FDA restructuring proposal would shift cosmetic regulation function from CFSAN to OCS

08-Mar-2023 - Last updated on 08-Mar-2023 at 20:08 GMT

The proposed move is intended to “better align the expertise of the agency’s cosmetics subject matter experts with the Chief Scientist…and will leverage the FDA’s areas of expertise across the agency as it works to implement the Modernization of Cosmetics Regulation Act of 2022 (MoCRA),” the FDA news release explained. © hapabapa Getty Images

With MoCRA coming into force at the end of this year, the FDA has proposed that the Office of the Chief Scientist assume primary responsibility for color certification and cosmetic regulation oversight and enforcement.

At the end of last month, the U.S. Food and Drug Administration (FDA) published a news release that detailed its proposal for significant internal restructuring of the agency’s Human Foods Program and its Office of Regulatory Affairs (ORA). This proposal includes shifting the responsibilities of cosmetics regulation and color certification functions away from the Center for Food Safety and Applied Nutrition (CFSAN) and into the Office of the Chief Scientist (OCS).

As detailed on the FDA website, “the OCS supports the research foundation, science, and innovation that underpins FDA’s regulatory mission.” Further, the OSC functions “through a broad framework that encompasses scientific collaborations, laboratory safety, the transfer of FDA inventions to the private sector, scientific integrity in FDA policy- and decision-making, the professional development of regulatory scientists, and its core research component—FDA’s National Center for Toxicological Research—which generates the vital data FDA requires for its regulatory decision-making and development of sound regulatory policy.”

Proposal background

In a statement issued with the release, FDA Commissioner Robert M. Califf, M.D. added that “we’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed and there’s too much duplication.” Therefore, he concluded, the proposed plan is intended “to fix this and strengthen both the regulatory programs and field force.”

If approved, the plan is for the OCS to work closely with the “FDA’s Human Foods Program, Center for Drug Evaluation and Research, Office of Minority Health and Health Equity and Office of Women’s Health” on all matters relating to cosmetics regulation and color certification functions including enforcement as outlined in MoCRA.

As previously reported in CosmeticsDesign earlier this year, MoCRA signifies the first significant change to cosmetic industry regulations in 85 years and comes into force at the end of this year. The Act will provide a more unified legal framework that includes the FDA assuming mandatory recall authority, allergen labeling for cosmetic products, current good manufacturing practice regulations, cosmetic manufacturing and processing facility registration, product listing requirements, adverse event reporting, and safety substantiation.

Next steps

The FDA hopes to finalize its proposal this Fall, following outlined procedural steps, which include “the development of a reorganization package that contains the newly designed structure, an established budget, and a detailed mapping and crosswalk of staff from the current to new organization” as outlined in the FDA news release.

The proposal will be presented for a thirty-day Congressional notification period following a comprehensive review process. It will be subject to any member concerns, which the FDA must address directly before advancement. Finally, the FDA will “issue a Federal Register Notice, provide notification to and engage, as needed, in negotiations with the Unions for impacted staff, prior to initiation of the new proposal.” Stakeholders will remain engaged with the FDA throughout the process.