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The FDA is focused on transforming the agency to be more efficient, nimble and ready for the future with the ever-changing and complex industries we regulate, including the emergence of new food technologies, the impacts of globalization, climate change and other factors that require the FDA to quickly adapt to an evolving world. 

In January 2023, the FDA announced it would develop a reorganization proposal to create a unified Human Foods Program and restructure its field operations (Office of Regulatory Affairs) after carefully reviewing the findings and recommendations of a Reagan-Udall Foundation evaluation, an internal review of the agency’s infant formula response, and feedback from external and internal stakeholders. 

The FDA completed its proposed reorganization package in December 2023. After undergoing a formal external review process required for all federal reorganizations, the FDA received approval of the reorganization package in May 2024. The reorganization is considered final, and the FDA is planning to implement the reorganization on October 1, 2024. 

The changes in the reorganization will allow the agency to:

• More effectively realize the preventive vision laid out in the FDA Food Safety Modernization Act. 
• Elevate the importance of nutrition to help reduce diet-related diseases.
• Strengthen state partnerships and embrace innovative food and agricultural technologies that will position the agency to more effectively regulate and uphold safety of the nation’s food supply. 

The FDA also has changes that will impact other products we regulate, such as medical products and cosmetics, by creating an enterprise-wide structure that will enhance collaboration between its field investigators and subject matter experts throughout the entire agency. The reorganization includes additional improvements to modernize and strengthen the entire agency to work more cohesively and collaboratively together to accomplish its public health mission.

Announcements

• FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations (July 2022)
• FDA Provides Update on External Evaluation to Strengthen Agency’s Human Foods Program (December 2022)
• FDA Proposes Redesign of Human Foods Program (January 2023)
• Media Call: New Vision for Human Foods Program (January 2023)
• Fact Sheet: Vision for a Reimagined FDA Human Foods Program (January 2023)
• FDA Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring (February 2023)
• FDA Provides Update on Proposal for Unified Human Foods Program, including New Model for the Office of Regulatory Affairs (June 2023)
• Stakeholder Call: Update on Proposal for Unified Human Foods Program Stakeholder Call (July 2023)
• FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program (August 2023)
• FDA Advances Reorganization Proposal for Unified Human Foods Program, Field Operations and Additional Modernization Efforts (December 2023)
• FDA’s Reorganization Approved for Establishing Unified Human Foods Program, New Model for Field Operations and Other Modernization Efforts (May 2024)
• Federal Register Notice (May 2024)

Approved Organizational Structures

• Approved FDA Organization Chart
• Approved HFP Organization Chart
• Approved OII Organization Chart

Background 

• FDA Evaluation of Infant Formula Response (September 2022)
• Reagan-Udall Foundation: Evaluation of FDA’s Human Foods Program (December 2022)
• FDA Modernization Efforts: Milestones 2022 - 2024 (May 2024)

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