Background
Last year’s infant formula recall and subsequent supply shortage led to considerable external scrutiny and criticism of FDA’s Human Foods Program (the Program). That criticism intensified in the wake of news articles reporting agency infighting and severe resource shortfalls. In response, FDA Commissioner Robert Califf asked the Reagan-Udall Foundation for the FDA (RUF) to conduct an independent evaluation of the Program, culminating in a report released on December 6, 2022.1 The RUF’s report identified a number of opportunities to strengthen the Program, which the agency reviewed in connection with Commissioner Califf’s announcement of this “new, transformative vision” for the Program.”2 The elements of this proposed reorganization are summarized below.
Summary of Proposed Restructuring
Human Foods Program
The new vision for the Program calls for combining the functions of CFSAN, OFPR, and certain portions of ORA into a single organization with “clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment.” The Program will be overseen by a Deputy Commissioner for Human Foods who will have decision-making authority over policy, strategy, and regulatory program activities, as well as resource allocation and risk-prioritization. The Deputy Commissioner will report directly to the FDA Commissioner.
The vision also includes creation of the following new elements of the Human Foods Program:
- Creation of a Human Foods Advisory Committee: This proposed committee composed of external experts will be established to “advise on challenging and emerging issues in food safety, nutrition and innovative food technologies.”
- Creation of a Center for Excellence in Nutrition: This proposed center will “elevate and empower action on nutrition science, policy, and initiatives to reduce diet-related chronic diseases and improve health equity.” As directed by the 2023 Consolidated Appropriations Act, this center will include an Office of Critical Foods to manage infant formula and medical foods.
- Creation of an Office of Integrated Food Safety Partnerships: This proposed office will be tasked with coordinating and integrating FDA food safety response activities with state and local agencies.
Other Proposed Structural Changes
The new vision also calls for changes to the Center of Veterinary Medicine (CVM) and ORA. Although CVM will continue to operate as a stand-alone center, FDA promises that “the relevant food safety activities will be closely coordinated” between the CVM Center Director and the Deputy Commissioner for Foods. In addition, the role of the CVM Director will expand to include the duties of Chief Veterinary Officer (in instances when this individual is a veterinarian) and an Office of Animal Biotechnology Innovation will be created. ORA will be “transformed into an enterprise-wide organization” that supports all regulatory programs, including foods, through a focus on core activities (e.g., inspections, investigations, laboratory analysis, and import operations). The agency plans to “better integrate” ORA with all FDA programs through 1) improving the risk prioritization and public health impact of FDA’s field activities, 2) modernizing those field activities, and 3) creating operational efficiencies.
Next Steps
FDA will conduct a nationwide search to identify the new Deputy Commissioner for Human Foods and provide another public update on its overall progress on the new vision by the end of February 2023. We will continue to monitor the agency’s reorganization plans. In the meantime, please contact us if you have any questions.
