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FDA Proposes Significant Reorganization to Enhance Oversight of Human Food Supply

- by Maryann Pugh
Food and Drug Administration

The U.S. Food and Drug Administration (FDA) has recently shared an important update regarding its efforts to establish a unified Human Foods Program (HFP) and remodel the Office of Regulatory Affairs (ORA). The proposed reorganization aims to bolster the FDA’s ability to oversee and safeguard the human food supply and other regulated products.

Currently under review by the U.S. Department of Health and Human Services (HHS), the proposal marks a significant step in the process, following over a year of work after recommendations from the Reagan-Udall Foundation and other inputs. The FDA expects to implement these changes in 2024, subject to several remaining crucial steps.

Here are the key aspects of the proposed reorganization:

  • The FDA’s HFP and product Centers will solely handle consumer and whistleblower complaints, improving the detection of issues.
  • The ORA is set to be renamed as the Office of Inspections and Investigations (OII), reinforcing its role in field-based inspection, investigation, and import operations.
  • An Office of the Chief Medical Officer (OCMO) will be established within the Office of the Commissioner to coordinate cross-agency medical issues, including those concerning people with rare diseases and children.
  • The Office of Counterterrorism and Emerging Threats and the Office of Regulatory Science and Innovation are proposed to merge to form the Office of Regulatory and Emerging Science, enhancing regulatory science and preparedness research efforts.
  • A new Office of Enterprise Transformation is proposed to drive high-priority, cross-cutting business process improvement efforts across the FDA.

These proposals have been developed in tandem with the FDA’s efforts to enhance its response processes for infant formula, following the Abbott infant formula recall in February 2022. Last year, an Internal Evaluation of the FDA’s Infant Formula Response was conducted to identify areas for improvement.

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Before implementation, the proposed reorganization will be subject to review by the Office of Management and Budget, a 30-day notification period for Congress, a Federal Register notice issue, and necessary negotiations with Unions representing impacted staff.

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