
FDA Modernization Efforts for Establishing a Unified Human Foods Program launched
On Oct. 1, 2024, the U.S. Food and Drug Administration (FDA) announced that the unified Human Foods Program, a new model and name for field operations and other modernization efforts were now in effect. This was the single largest reorganization in the agency’s recent history, as it impacted more than 8,000 employees and touched almost every facet of the agency.
In January 2023, the FDA announced it would develop a reorganization proposal to create a unified Human Foods Program and restructure its field operations (formerly the Office of Regulatory Affairs and the Office of Inspections and Investigations) 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 and implemented the reorganization on Oct. 1, 2024.
The FDA restructured and renamed the field operations unit to focus on inspections, investigations and imports as its core mission. The reorganization of the Office of Inspections and Investigations or OII (previously known as the Office of Regulatory Affairs), extends beyond foods and has an impact on how the FDA oversees all FDA-regulated products. The agency has created an enterprise-wide structure to enhance collaboration between our field investigators and other subject matter experts throughout the agency.
The reorganization also contained additional improvements to modernize and strengthen the entire agency to work more cohesively and collaboratively together to accomplish its public health mission.
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Source: U.S. Food and Drug Administration
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