HHS' Proposed FDA Reorganization Would Drastically Alter Structure of Agency, Eliminate Product-Specific Offices
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A plan to dramatically restructure the U.S. Food and Drug Administration (FDA) has been leaked, just days after 3,500 staffers were fired from the agency as part of an overhaul of the U.S. Department of Health and Human Services (HHS). The structure of FDA already went a major, very recent overhaul that took effect in October 2024—which would be upended by the rumored proposed reorganization.
Proposed FDA Reorganization Would Eliminate Product-Specific Offices in Favor of Focus on Functions
According to Inside Health Policy, the proposed reorganization would parse FDA into five newly created offices, with all of its product review divisions merged into a single Office of Product Evaluation and Regulation. This office would serve as a “central hub for product review and regulatory decision-making across drugs, biologics, devices, tobacco, and foods,” absorbing the existing, separate offices dedicated to reviewing these products.
Additionally, an Office of Inspections, Compliance, and Enforcement would combine the compliance units from each FDA Center, including the Office of Inspections and Investigations, which replaced the Office of Regulatory Affairs as part of the FDA reorganization that took effect in October 2024. An Office of Scientific and Regulatory Policy would also be formed from the ashes of FDA’s various policy offices, which took major hits during the sweeping HHS cuts implemented in the beginning of April.
Other offices that would be established by the proposed reorganization include 1) an Office of Administrative and Shared Services that would handle human resources, budget, information technology (IT), and training, 2) an Office of Strategic Programs and Innovation that would focus on cross-cutting agency initiatives and technology modernization, and 3) a Digital Health Center of Excellence, which would focus on long-term strategic planning and technology adoption.
The leaked HHS email provided to Inside Health Policy did not include information about how finalized the proposal may be or whether there is an established timeline for its implementation. HHS did not comment on the details of its reorganization plan to Inside Health Policy, but said, “The department is now detailing the structure of each redefined division to streamline operations, enhance responsiveness to the American people, and ultimately improve the nation’s health as part of [HHS Secretary Robert F. Kennedy Jr.’s] Make America Healthy Again initiative. HHS will notify external stakeholders, including Congress, and will comply with all statutory requirements.”
FDA Human Foods Program Already Underwent a Major Reorganization in 2024
In October 2024, after two years of planning and Congressional review and approval, a major restructuring took effect at FDA, establishing a new Human Foods Program and Office of Inspections and Investigations. The reorganization was informed by an extensive, independent review conducted by the Reagan-Udall Foundation, through which an expert panel scrutinized and provided recommendations about FDA’s organizational culture, structure, resources, and authorities.
The Reagan-Udall independent expert panel was convened in July 2022 and produced its report in December 2022. The evaluation was commissioned to strengthen FDA’s food regulatory role following significant food safety and security crises that arose earlier that year, such as the much-publicized infant formula shortage precipitated by infant illnesses linked to Cronobacter-contaminated formula and a halt in production at a large Abbott Nutrition manufacturing facility.
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James (Jim) Jones was hired at FDA in September 2023 to guide the establishment of the reorganized Human Foods Program and serve as its first Deputy Commissioner. He resigned from his role in February 2025 after probationary employees across the federal government were culled, including 89 staff members within the Human Foods Program alone, who had “highly technical expertise in nutrition, infant formula, and food safety response.”
Stakeholders Voice Opposition: “Regulating Foods is Very Different Than Regulating Tobacco”
President of the Center for Science in the Public Interest (CSPI) Peter G. Lurie, M.D., M.P.H., said the proposed reorganization would “recklessly rip apart the specialized centers” and “undermine the current system designed to protect reviewers from the kinds of political interference that can damage public health.” He continued to say that the proposal would “unravel years of effort to organize FDA staff more effectively towards solving emerging problems within product categories,” including the work to establish the new Human Foods Program.
“To work effectively for Americans, FDA teams need to focus on the problems they solve, not the regulatory powers they wield. And that means teams should be focused on particular regulated products, as regulating foods is very different from regulating tobacco,” said Dr. Lurie. “The new reorganization proposal will reverse and destroy current alignment around products, breaking apart existing teams and eliminating the ability to plan and cooperate in a way that prioritizes food and medical product safety. And, unlike FDA’s thoughtful, deliberative, transparent reorganization of its Human Foods Program, the new proposed reorganization could be rushed through without adequate stakeholder input.”
