On June 27, 2023, the U.S. Food and Drug Administration (FDA) is providing an update on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). The main updates are as follows:

-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 the FDA’s current Center for Food Safety and Applied Nutrition 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 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, etc. 

-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.