The U.S. Food and Drug Administration (FDA) has provided 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). These additions to the FDA commissioner’s proposal, announced earlier this year, will further enhance coordination, prevention, and response activities throughout the FDA, allowing the agency to better support its public health mission.
An interdisciplinary task force consisting of agency officials with expertise in different functional and operational areas has been working over the past few months to identify additional opportunities to strengthen operations within the new HFP and ORA. The FDA Commissioner, Dr. Robert M. Califf, stated that the agency must build a stronger Human Foods Program and Office of Regulatory Affairs in order to address the evolving human food landscape, consumer preferences, and increasing public health needs.
Based on the task force recommendations and an external evaluation conducted by the Reagan-Udall Foundation, the FDA is proposing several additional changes. These changes include establishing ORA’s central mission to conduct investigations, inspections, and imports for all FDA-regulated products, with planned allocations in partnership with HFP and other program or product centers. The new Deputy Commissioner for Human Foods will oversee all budget and resource allocations for the entire HFP, including ORA resources.
The proposal also includes combining compliance functions currently managed within ORA into the HFP and existing compliance functions of product centers to streamline operations and expedite decision-making. Additionally, the proposal suggests realigning the eight animal and human food laboratories currently managed by ORA into the HFP. These laboratories will be associated with the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) to form a unified food laboratory enterprise under the HFP. The laboratories 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 director of the Center for Veterinary Medicine to coordinate research priorities.
Other proposed changes include transitioning certain functions under the Office of Safety and Emergency Management, currently under the Office of Operations, to ORA. This includes the Office of Emergency Management, which activates Incident Management Groups with expanded staff from relevant centers and offices to monitor and manage coordinated responses to emergency situations involving regulated products such as market withdrawals, hurricanes, fires, floods, etc.
The proposal also aims to unify state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety Systems Partnerships within the HFP. This office will be supervised by a member of the executive leadership team under the Deputy Commissioner for Human Foods, who will collaborate closely with the director of the Center for Veterinary Medicine to promote a truly integrated food safety system.
To support these changes, the proposal suggests reviewing support functions within ORA and realigning certain resources and staff. It also prioritizes recruitment, retention, and training opportunities for field employees to increase the agency’s national and international inspection activities.
These proposed changes align with the recommendations of the Reagan-Udall Foundation evaluation and a separate internal review of the agency’s infant formula response completed last year. They empower the Deputy Commissioner for Human Foods to have full authority over all food-related resources and establish strategic direction for these resources. The FDA is currently providing high-level organizational charts to reflect the proposed changes within the unified HFP and the new ORA model.
The FDA has expressed gratitude to employees and stakeholders who provided feedback on the proposal through comments and internal listening sessions. The proposed changes for the Office of Regulatory Affairs have taken these comments and recommendations into careful consideration.
Dr. Califf believes that these proposed changes will result in a more agile structure that is better equipped to prevent and respond to emergencies, such as market withdrawals, and improve the agency’s ability to align inspection resources with the priorities of the program centers, while supporting employees and the public. The FDA will continue to evaluate and make adjustments as they work closely with experts across the agency to renew and enhance their field operations.
The FDA is currently in the final stages of recruiting for the position of Associate Commissioner for Regulatory Affairs, who will lead ORA through the proposed changes and assist with the organizational evolution. The recruitment process for the Deputy Commissioner for Human Foods is also underway.
The FDA is on track to finalize its reorganization proposal for both ORA and the unified HFP this autumn.
