On May 13, 2024, the FDA’s Office of the Commissioner announced the approval of an agency-wide reorganization, the biggest restructuring of FDA in 70 years. The reorganization took into account the 2022 findings and recommendations proposed by the Reagan-Udall Foundation that studied FDA’s functions, culture, efficiencies, and capabilities to protect
the public health.
Additionally, an internal review of FDA's infant formula response and feedback from external and internal stakeholders provided impetus for a restructured agency that will allow FDA to elevate the importance of a smarter era of food safety, advance nutrition to help reduce diet-related diseases, strengthen state partnerships, and embrace innovative food and agricultural technologies to more effectively regulate the U.S. food supply.
The reorganization creates a unified Human Foods Program (HFP) by realigning the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, as well as key functions from the Office of Regulatory Affairs (ORA) under one program. Additionally, the FDA is changing the name of ORA to the Office of Inspections and Investigations (OII). The intent is to better convey the office’s role as the frontline of the FDA, which provides real-time insights and science-based evidence necessary to ensure the safety and quality of products. The restructuring of ORA is intended to enable this field operations unit to focus on inspections, investigations, and imports as its core mission.
The organizational changes impact other products that FDA regulates, such as medical products and cosmetics, by promoting more streamlined, efficient decision-making, and strengthening the enterprise wide structure to enhance collaboration across FDA.
A full list of the changes made in FDA’s structure can be found in the Federal Register notice.