Study Released Regarding FDA Overseeing of Food Programs

In July, Robert M. Califf the commissioner of the FDA, authorized an external evaluation of the U.S. Food and Drug Administration’s Human Foods Program, including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA).  The external evaluation, conducted by an expert panel facilitated by the Reagan-Udall Foundation, was asked to assess the processes and procedures, resourcing, and organizational structure for the Foods Program. GCCA and food industry partners met with Commissioner Califf earlier this year and expressed support for the FDA evaluating how it administers food programs.

On December 6, 2022, the Independent Expert Panel for Foods submitted its report on the Operational Evaluation of FDA’s Human Foods Program to FDA Commissioner Dr. Robert Califf. The evaluation of FDA’s Human Foods Program launched on September 8, 2022. The evaluation focused on structure/leadership, authorities, resources, and culture, expecting to provide recommendations that would equip FDA to carry out its regulatory responsibilities, strengthen its relationships with state and local governments, and secure the nation’s food supply for the future.

• • Culture – The Panel found that while the staff are dedicated to protecting public health, the current culture, structure, and governance model detract from the HFP’s effectiveness.
  • Structure – Related to their recommendations regarding the culture, the Panel found the HFP lacked a clear leader or decision-maker, outside of the Commissioner.
  • Resources – The Panel found that the HFP is significantly under-resourced and additional resources, in conjunction to other changes, are critical to future success.
  • Authorities – The HFP is challenged in keeping up with the innovations in food and regulatory science.

In a press release about the report, Commissioner Califf stated that he will be “making final decisions regarding the future of the FDA Human Foods Program after reviewing the report and consulting with stakeholders both externally and internally.” The Commissioner intends to form a group of agency leaders to determine how best to implement and operationalize the Panel’s findings.