FDA Gives Update on Human Foods Program Restructuring, Announces Search for Deputy Commissioner; Stakeholders Express Concern

On February 28, 2023, the U.S. Food and Drug Administration announced a national search for a new Deputy Commissioner for Human Foods and provided an update on the recently proposed restructuring of the agency's Human Foods Program and Office of Regulatory Affairs (ORA). Following the announcement, organizations representing consumers, industry, and state and local regulators expressed their concerns.

The coalition of stakeholder organizations—including Consumer Reports, Consumer Brands Association (CBA), the Association of Food and Drug Officials (AFDO), Stop Foodborne Illness, the International Fresh Produce Association (IFPA), the Environmental Working Group, and the American Frozen Food Institute (AFFI)—has been asking FDA to strengthen leadership at the agency by appointing a fully empowered Deputy Commissioner for foods, with direct line authority over all key elements of the Foods Program, as recommended in the independent evaluation of FDA conducted by the Reagan-Udall Foundation.

FDA’s proposal for restructuring its foods program is intended to address issues identified by the Reagan-Udall Foundation, as well as by an internal evaluation of the agency’s response to the infant formula crisis. However, the February 28 update from FDA Commissioner Robert Califf, M.D. on the agency’s plans to execute organizational transformation has left the stakeholder coalition with several worries.

FDA is seeking to finalize its proposal by autumn 2023, including the newly designed structure, an established budget, and a detailed mapping and crosswalk of staff from the current to new organization.

FDA’s Search for a Deputy Commissioner for Human Foods

Dr. Califf’s update includes the announcement that the search for a new Deputy Commissioner for Human Foods is underway, and is open to both external and internal candidates under the agency's expanded Title 21 hiring authority for a foods-related position.

The description for the Deputy Commissioner position defines the role as “the principal advisor to the Commissioner of Food and Drugs in matters relating to policy initiatives that involve human food, including safety, innovation, and nutrition programs,” with oversight regarding foods activities in CFSAN, ORA, and the Office of Food Policy and Response (OFPR). Part of the duties and responsibilities of the new Deputy Commissioner will be to drive the unification and cultural transformation of the Human Foods program.

FDA Transformation Efforts

The update states that work on agency-wide transformation of how programs and field functions are organized and operate is underway, to achieve the goal of better integrating ORA’s expertise in field-based operations with product subject matter experts across FDA’s programs. The Deputy Commissioner for Human Foods and other program leads will be charged with setting strategic direction for food inspections and have authority over program resource allocation.

Steps FDA has taken to achieve the new vision for the agency include:

Assessing specific functions of ORA, CFSAN, and OFPR to be unified into a new Office of Integrated Food Safety Systems Partnerships that will engage with state, local, tribal, and territorial food safety regulatory partners, taking into consideration how best to enhance connectivity with international food safety partnership programs
Analyzing inspection and compliance functions that sit within both ORA and program offices across the agency to determine opportunities to streamline operations and clarify decision-making authority at each step of the inspection process, as well as to integrate new automation and information technology (IT) support
Determining how best to empower the Deputy Commissioner for Human Foods and leaders of other programs, along with the Associate Commissioner for Regulatory Affairs, to oversee program and field resource allocation, including publicly mapping the budget to functional activities to provide clarity on resource allocation
Ensuring coordination across FDA and state-operated food laboratory operations by evaluating the foods laboratory programs, including the relationships, roles, and responsibilities among CFSAN, CVM, ORA, and state-operated laboratories
Improving FDA's ability to conduct risk prioritization by performing an evaluation of how the Human Foods Program accomplishes risk management, particularly risk prioritization, given the multitude of demands and the scarce resources, and how this can be used to guide dynamic work planning and resource allocation
Planning for greater enterprise transformation of certain ORA IT functions, which will be coordinated with the FDA's Office of Digital Transformation (ODT), building on an existing project to create an enterprise-wide platform for managing inspections and compliance activities
Evaluating training programs, including for FDA investigators, to see how they can best serve the needs of FDA, regulatory partners, and industry.

FDA also announced that cosmetics regulation and color certification functions will be moved out of CFSAN and into the Office of the Chief Scientist.

Stakeholder Organizations’ Concerns

The coalition of stakeholder organizations believe that FDA’s plan rejects the Reagan-Udall Foundation’s recommendation that the agency appoint an empowered, single leader of the Human Foods program. Instead, according to Consumer Reports’ Director of Food Policy Brian Ronholm, FDA is opting to employ “matrix management,” which is a form of organizational structure in which personnel report to multiple supervisors across functions and projects. Representatives from the organizations express that matrix management is ineffective, especially for a government organization, and has been unsuccessful at FDA in the past.

Roberta Wagner, Vice President of Regulatory and Technical Affairs at CBA, previously worked at FDA for over 20 years. She stated that she has seen matrix management stunt successful food safety implementation at FDA, and that the currently proposed structural changes represent “business as usual” rather than the transformational changes that are needed. Steve Mandernach, Executive Director at AFDO, added that matrix management prevents accountability and will deter potential candidates for the Deputy Commissioner of Human Foods role. He also highlighted the slow pace of FDA’s execution of organizational restructuring, estimating that, based on FDA’s fall projection for finalizing its proposal this autumn, change will not be effected for another two years.

Additionally, FDA’s vision for its restructuring does not seem to address the insularity of ORA nor the associated cultural issues, according to Mitzi Baum, CEO of Stop Foodborne Illness. Jennifer McEntire, Ph.D., Chief Food Safety and Regulatory Officer at IFPA, also questioned Dr. Califf’s statement that FDA is “determining how best to empower the Deputy Commissioner for Human Foods and leaders of other programs, along with the Associate Commissioner for Regulatory Affairs, to oversee program and field resource allocation, including publicly mapping the budget to functional activities to provide clarity on resource allocation.” Jennifer believes that this suggests that authority will be divided, and it is unclear how decision-making will be streamlined. Finally, Donna Garren, Ph.D., Executive Vice President of Science and Policy at AFFI, added her belief that the proposed structure, as well as the fact that decisions made by committee will continue, will set the future Deputy Commissioner up to fail.

Overall, the stakeholder representatives expressed that they have not felt included in effective dialogue about the restructuring at FDA thus far. When asked what the next steps are for the stakeholder groups, Roberta Wagner stated that they will have “no choice but to go to congress,” where they believe there is bipartisan support to enact meaningful changes to FDA’s Human Foods program.