The U.S. Food and Drug Administration (FDA) has announced updates to its proposal for a unified Human Foods Program (HFP) and a new model for the Office of Regulatory Affairs (ORA). The changes aim to enhance coordination, prevention, and response activities across the FDA and improve the agency’s ability to support public health goals. The FDA Commissioner, Robert M. Califf, stated that the evolving human food landscape requires a stronger HFP and ORA to address increasing complexity and the growing demands of public health.
A working group of FDA officials has been working to identify opportunities to strengthen operations within the new HFP and ORA. The proposed changes include establishing ORA’s core mission as investigations, inspections, and imports for all FDA-regulated products. The new Deputy Commissioner for Human Foods will have oversight of the entire HFP’s budget and resource allocations, including ORA resources.
Compliance functions currently managed within ORA will be merged into the HFP and the product Centers’ existing compliance functions to streamline operations and expedite decision-making. The eight Human and Animal Food laboratories managed by ORA will be realigned into the HFP, forming a unified food laboratory enterprise with the four labs in the FDA’s current Center for Food Safety and Applied Nutrition. These labs will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods.
Certain functions of the Office of Security and Emergency Management will be transitioned to ORA, including the Office of Emergency Management. The proposal also includes the establishment of an Office of Integrated Food Safety System Partnerships in the HFP to unify state and local food safety partnership functions and certain aspects of international food safety partnerships.
Support functions across ORA will be reviewed, and resources and personnel will be realigned to support the proposed changes. Recruitment, retention, and training opportunities will be prioritized for field-based employees to increase inspectional activities domestically and internationally.
The proposed changes align with recommendations from the Reagan-Udall Foundation evaluation and an internal review of the FDA’s infant formula response. The proposed changes empower the Deputy Commissioner for Human Foods to have full authority over all foods-related resources and set the strategic direction.
The FDA is considering renaming ORA to align its title with the agency’s field operations. The agency is currently in the recruitment process for the Associate Commissioner for Regulatory Affairs and the Deputy Commissioner for Human Foods. The FDA aims to finalize its reorganization proposal for both ORA and the unified HFP in the fall.
The FDA is an agency within the U.S. Department of Health and Human Services responsible for assuring the safety, effectiveness, and security of drugs, vaccines, medical devices, food, cosmetics, dietary supplements, products that emit electronic radiation, and tobacco products.
Overall, the proposed changes to the FDA’s HFP and ORA aim to strengthen its ability to regulate and ensure the safety of human foods. With a rapidly evolving food landscape, increased complexity, and growing public health needs, these changes will enhance coordination, prevention, and response activities across the FDA, ultimately better supporting its mission to protect public health.
