FDA Plans to Redesign the Human Foods Program

FDA Plans to Redesign the Human Foods Program

February 1, 2023, Covington Alert

On January 31, 2023, FDA Commissioner Robert M. Califf announced a proposed redesign of the human foods program at FDA. The proposal follows the findings and recommendations of a Reagan-Udall Foundation expert panel that Dr. Califf had charged with evaluating the agency’s existing human foods program. Commissioner Califf called the redesign “transformative” and believes the proposed structures will have clear priorities to protect and promote a safe and nutritious food supply in the current and evolving environment.

In the high-level proposal, FDA intends to unify various functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), and Office of Regulatory Affairs (ORA) under an organization called the Human Foods Program. A Deputy Commissioner for Human Foods will lead that program and 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 Human Foods Program will have a larger executive team with clearly defined lines of authority to ensure decisive leadership. This will include a Principal Associate Commissioner reporting to the Deputy Commissioner. Based on the organizational chart provided in the proposal, the Deputy Commissioner for Human Foods appears to be on the same level as the Director of the Center for Veterinary Medicine (CVM).

In addition, a Human Foods Advisory Committee of external experts will be formed to advise FDA on issues in food safety, nutrition, and innovative food technologies.

FDA also plans to create a Center for Excellence in Nutrition within the Human Foods Program, that will work with industry to offer healthier, more nutritious foods. The Center is intended to elevate and empower action on nutrition science, policy, and initiatives to reduce diet-related chronic diseases and improve health equity. The Center will include an Office of Critical Foods responsible for the regulation of infant formula and medical foods, presumably also to help ensure a robust supply of such critical products.

FDA intends to establish an Office of Integrated Food Safety System Partnerships to prioritize and unify FDA’s work with state and local regulators. The aim is to ensure greater collaboration and support to state-level inspectional activities. The changes to ORA mentioned below will strengthen the goals in the New Era of Smarter Food Safety.

The proposal also reimagines ORA. The new model will focus on setting the global gold standard in inspections, investigations, laboratory analysis, and import operations. ORA will support the Human Foods Program and other regulatory programs by focusing on critical activities. As a result, ORA will take a more prevention-based approach to food safety inspections. It will also will modernize and increase its specialization alongside the regulatory programs. Certain ORA functions such as state and local food safety partnership functions will be realigned into the Human Foods Program to streamline the agency’s oversight over foods.

FDA proposes to create an Office of Animal Biotechnology Innovation within CVM, which will work on advancing FDA’s regulation of animal biotechnology. The office will collaborate with the Human Foods Program on agricultural biotechnology innovation. The CVM Director’s role will be expanded to include duties as Chief Veterinary Officer (CVO) to reinforce CVM’s One Health mission; where the Director is not a veterinarian, the duties will be held by a senior veterinarian within CVM. 

Commissioner Califf will next turn this high level proposal into a concrete reorganization plan. To do so, the Commissioner will engage with internal and external stakeholders on this proposal, and will provide an additional update on FDA’s progress on reorganization and timeline by the end of February.

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If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements or Animal Food and Drug practices.