On May 30, 2024, FDA announced that the Secretary of Health and Human Services approved FDA’s plans to reorganize the Human Foods Program. The reorganization follows the findings and recommendations of a Reagan-Udall Foundation expert panel and is designed to enhance FDA’s ability to oversee the human food supply as well as other products the agency regulates. FDA expects to implement the reorganization fully by October 1, 2024.
FDA’s reorganization plan largely tracks the high-level proposal it announced last year. It realigns the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response, and key functions from the Office of Regulatory Affairs (ORA), including human foods compliance, Human and Animal Food Laboratories, and State Partnerships into a new organization—the Human Foods Program. Additionally, the plan will establish an external Human Foods Advisory Committee to advise FDA on issues in food safety, nutrition, and innovative food technologies; create a Center for Excellence in Nutrition intended to take action to reduce diet-related diseases; and develop an Office of Integrated Food Safety System Partnerships to strengthen FDA’s collaboration with state and local regulators. The Office of Dietary Supplement Programs will sit within a new Office of Food Chemical Safety, Dietary Supplements, and Innovation. Deputy Commissioner for Human Foods Jim Jones will lead the new Program and report directly to the FDA Commissioner.
In addition, more broadly, ORA will be renamed the Office of Inspections and Investigations (OII) to reflect its new focus on inspections, investigations, and imports as its core mission. Certain key ORA functions will be realigned to other parts of the agency: (1) ORA’s compliance functions will now be handled by individual center compliance offices, and (2) ORA’s laboratory safety functions will now be overseen by the Office of the Chief Scientist. The plan also includes a number of other organizational changes to non-food components of the agency, including realigning the Office of Cosmetics and Colors organization from CFSAN to the Office of the Chief Scientist and a number of other changes to the structure of offices within the Office of the Commissioner.
FDA’s announcement thanked Congress and the Office of Management and Budget for their support and guidance, implying that the reorganization has already undergone review by these entities. FDA has indicated that the final step before implementation will be reaching an agreement with labor unions and that negotiations are already underway. FDA expects the reorganization to be implemented by October 1, 2024.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Beverage, and Dietary Supplements or Animal Food and Drug practices.
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