The U.S. Food and Drug Administration has provided updates on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). These decisions are intended to enhance coordination, prevention and response activities across the FDA, and were identified by a cross-cutting working group of agency officials with expertise in different functional and operational areas.

The agency has provided high-level organization charts to reflect the changes that are being proposed as part of the unified HFP and new ORA model. To enhance clarity around the proposed core mission of ORA, the FDA is also considering a renaming effort for this office to more appropriately align its title to the structure and functional duties of the agency's field operations.

FDA is proposing a number of changes to ORA, including moving several of the office's laboratories and merging its current compliance functions into those of the new HFP and other agency product centers. Based on recommendations from the working group and from the external evaluation conducted by the Reagan-Udall Foundation, FDA is proposing the following additional changes:

  • Establishing ORA's core mission as conducting investigations, inspections, and imports for all FDA-regulated products, with assignments planned in partnership with the HFP and other product programs or centers. The new Deputy Commissioner for Human Foods will have oversight of all budget and resource allocations for the entire HFP, including ORA resources.
  • Merging compliance functions currently managed within ORA into the HFP and the product centers' existing compliance functions to streamline operations and expedite decision-making.
  • Realigning the eight Human and Animal Food laboratories that are currently managed by ORA into the HFP. These eight labs will team up with the four labs in FDA's current Center for Food Safety and Applied Nutrition (CFSAN) to form a unified food laboratory enterprise under the HFP. The labs will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods, who will work closely with the Chief Scientist and the Center for Veterinary Medicine (CVM) director to coordinate on research priorities. These labs will remain open and in the same geographic location under the proposal.
  • Transitioning certain functions under the Office of Security and Emergency Management, currently in the Office of Operations, to ORA. This includes the Office of Emergency Management, which activates Incident Management Groups with augmented staffing from relevant Centers and Offices to monitor and manage coordinated responses to emergency situations, such as emergencies involving regulated products like recalls, hurricanes, fires, floods, and other incidents.
  • As previously shared, unifying state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP. This office will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods who will closely collaborate with the CVM director to advance a truly integrated food safety system.
  • Reviewing support functions across ORA and proposing realignment of certain resources and personnel to support these changes. This includes staff and resources in ORA's Office of Regulatory Management Operations, Office of Information Systems Management, Office of Training, and Office of Communications and Project Management.
  • Prioritizing recruitment, retention and training opportunities for field-based employees with the availability of Title 21 hiring authority to support the agency's ongoing efforts to increase its inspectional activities domestically and internationally.

These proposed changes align with many of the recommendations from the Reagan-Udall Foundation evaluation as well as a separate internal review of the agency's infant formula response completed last year. They also empower the Deputy Commissioner for Human Foods to have full authority over, and set the strategic direction of, all foods-related resources.

Stakeholder groups such as the Consumer Brands Association are praising the new ORA model, stating, “We are pleased FDA is taking bolder action to make meaningful and lasting change by answering informed industry and stakeholder calls to unite and elevate HFP and fully authorize the deputy commissioner with control over its strategic direction... We are also encouraged that FDA plans to address areas of duplication and refocus ORA on its core business, inspections and investigations.”

FDA recently began a recruitment effort to fill the position of Associate Commissioner for Regulatory Affairs who will lead ORA through the proposed changes and assist the organizational evolution as envisioned in this proposal if approved. FDA is in the final stages of the recruitment process for the Deputy Commissioner for Human Foods and will be providing an update in the near future. FDA remains on target to finalize its reorganization proposal, for both ORA and the unified HFP, this fall.