The U.S. Food and Drug Administration (FDA) has approved reorganization, including the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations, and other significant modernization efforts. The agency plans to implement the reorganization Oct. 1 to enhance its ability to oversee and protect the human food supply and other products.
The changes made within the FDA come about in large part as a reaction to its handling of the infant formula safety and shortage issues in 2022. In July 2022, Robert Califf, FDA’s commissioner, ordered an external review of the agency’s office of food safety. The report issued later that year by the Reagan Udall Foundation concluded that the agency’s culture, organizational structure, and governance model undermined its effectiveness.
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The reorganization that the FDA is taking now will enable it to be more efficient, nimble and prepared for the ever-changing and complex industries it regulates, new food and medical product technologies, as well as the impacts of globalization, climate change, according to a statement from the agency.
“This is a distinctive moment for the FDA. I’m very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the agency, we are a step closer to seeing the largest reorganization of the agency in recent history come to life this fall,” Califf says. “This reorganization has been a major undertaking for the FDA, and I am proud of what we will be able to accomplish more efficiently and collaboratively to better meet our public health mandate.”
A reaction from Consumer Reports
Consumer Reports praises the steps that Califf took to lead to the changes, as well as the creation of the Human Foods Program itself—pointing to the need for the agency to more effectively protect public health from foodborne illness outbreaks and other food safety risks.
“Consumers depend on the FDA to be effectively organized and governed to ensure our food is safe,” says Brian Ronholm, director of food policy at Consumer Reports. “Today’s announcement is a major step forward and much credit goes to Commissioner Califf for facilitating the process to get to this point.”
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The creation of a unified HFP is expected to help the FDA realize the preventive vision laid out in the Food Safety Modernization Act (FSMA). It is also expected to strengthen local, state and international partnerships, and better position the FDA to regulate innovative food and agricultural products.
Pointing to the 2022 infant formula crisis specifically, the agency notes that the reorganization should help it better protect the nation’s food supply and respond to such food-related emergencies in the future.
“We recognize that a significant amount of work remains to be done because a meaningful change in culture does not happen overnight,” Consumer Reports’ Ronholm adds. “We look forward to working with the FDA to ensure this plan is effectively implemented so that it can carry out its critical mission to protect the public from food safety risks.”
More about the restructuring
To establish the HFP, the agency realigned the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, as well as key functions from the Office of Regulatory Affairs (ORA) under one program.
“The restructuring of ORA will enable our field operations unit to focus on inspections, investigations, and imports as its core mission,” the FDA notes in its statement. “The FDA is changing the name of ORA to the Office of Inspections and Investigations (OII) to better convey the organization’s role as the frontline of the FDA, which provides real-time insights and science-based evidence necessary to ensure the safety and quality of products Americans depend on.”
Goals of the reorganization include optimizing resources to help meet the agency’s public health mission, providing employees with clearer priorities, and complying with the recently enacted Food and Drug Omnibus Reform Act of 2022.
A full list of the changes can be found in the Federal Register notice.
