Will FDA’s Proposed Restructure Work?

As FDA continues its mission to develop food safety into a separate agency, some vested organizations have doubts about the success of the proposed restructure.

On January 31, Robert M. Califf, MD, FDA’s Commissioner of Food and Drugs, announced a plan that calls for the functions of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA) to be unified into a newly envisioned organization called the Human Foods Program. According to an FDA press release, the new program will be run by a single leader who reports directly to the commissioner. The agency says that this will unify and elevate the program while removing redundancies, enabling it to oversee human food more effectively and efficiently.

Critics of the plan say that it doesn’t follow the advice of a report conducted by the Reagan-Udall Foundation, an independent group of experts that Dr. Califf commissioned in 2022 to review the Human Foods Program following the powdered infant formula crisis; the report called for an overhaul and reform of the entire agency. “While we were first pleased by Dr. Califf’s announcement to advance an agency restructure, the details released on February 28, 2023, fall short of what is needed,” says Donna Garren, PhD, executive vice president of science and policy at the American Frozen Food Institute. “The plan fails to implement recommendations from the Reagan-Udall Foundation, including making bold structural changes to mitigate systemic cultural challenges within the organization.” She adds that FDA has indicated that it will continue to allow a divided and siloed organizational and leadership approach, which she says will ultimately impact the agency’s ability to set mission priorities and allow for quick and effective decision making regarding food safety.

Mitzi D. Baum, MSc, CEO of Stop Foodborne Illness, a nonprofit public health organization based in Chicago, also has concerns about the proposed restructuring. “The commissioner’s proposed incremental changes don’t get to the root of deeply embedded cultural issues,” she says. “The insularity of the ORA is of specific concern because it operates separately from science and policy areas. The plan will allow ORA to continue to have a culture of reaction rather than shifting to a proactive approach as mandated in FSMA.”

Specific Concerns of the Proposed Restructure

In particular, Baum says that the proposed changes don’t go far enough to provide consumers with the confidence that FDA leadership is doing everything possible to fix the fractured leadership and prevent another disaster like the powdered infant formula crisis. “Moreover, it’s essential to focus on the broader issue of food safety and prevention in today’s modern food system,” she adds. “It seems the commissioner chose the items and issues of least resistance to create this plan. He has ignored the experts he enlisted to provide recommendations and has continually dismissed the calls for change from external stakeholders. It’s a half measure that will not lead to safer food for consumers.”

Emily Moyer, PhD, vice president of regulatory compliance and global food safety standards at the International Fresh Produce Association in Washington, D.C., says that it’s unclear which functions of the ORA will become part of the Human Foods Program. ORA is the compliance arm that houses FDA’s inspectors and those who handle import safety, and it also oversees regulatory laboratories. “If they remain separate from the Human Foods Program, with different leadership, FDA would remain siloed, which would prevent FDA from fully embracing and achieving the preventive vision of FSMA,” she adds.

If the deputy commissioner’s role is to be truly empowered, this person needs to have a direct line of authority over the entirety of the Human Foods Program, Dr. Moyer says. Dr. Califf stated in a February 28 press release that the newly created deputy commissioner would set the strategic direction for food inspections and have budget authority, while also acknowledging that he is still “determining how to best empower the deputy commissioner, leaders of other programs, and the associate commissioner for regulatory affairs.”