After a baby formula crisis and a scathing critique of the FDA’s disjointed structure, Commissioner Robert Califf said on Tuesday he would reorganize the agency to put food safety offices under the control of a powerful deputy commissioner. Consumer groups generally applauded Califf’s plan as a step forward, although some critics called for more sweeping reforms, such as the creation of a separate agency for food safety.
“Today, I am announcing a new, transformative vision for the FDA Human Foods Program,” said Califf. “Creating a Human Foods Program under a single leader who reports directly to the Commissioner unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way.”
The revamped foods program would absorb the functions of Center for Food Safety and Applied Nutrition and the Office of Food Policy and Response, as well as some of the work of the Office of Regulatory Affairs. The Center for Veterinary Medicine (CVM) would continue as a separate office; “the relevant food safety activities will be closely coordinated” between the CVM director and the deputy commissioner for human foods, said Califf.
The FDA has jurisdiction over 78 percent of the U.S. food supply, including fruits, vegetables and most prepared foods. Yet, its work on food and nutrition is often over-shadowed by its role in overseeing drugs and medical devices. “It is imperative that the Human Foods Program become more prominent,” said a panel of experts on Dec 6.
“Changing the current organizational structure will assist the agency in advancing its mission,” said the panel, chaired by former FDA commissioner Jane Henney and operating under the aegis of the Reagan-Udall Foundation. The panel said food safety responsibilities were divided among FDA offices and a reliance on consensus resulted in an agency “with an aversion to risk that undercuts its public health mandate.” An internal FDA review cited organizational flaws in the agency’s slow response to reports of contaminated baby formula in late 2020. The country spent months coping with a formula shortage after the FDA warned consumers against using some of the formula produced at a factory in Michigan.
Under Califf’s proposal, the deputy commissioner for food “will have decision-making authority over policy, strategy and regulatory program activities within the Human Foods Program, as well as resource allocation and risk prioritization.” An advisory committee of outside experts would look at “challenging and emerging issues in food safety, nutrition and innovative food technologies.”
Principal deputy commissioner Janet Woodcock said an “implementation and change” group of FDA managers already was laying the groundwork to make the reorganization a reality. “We look forward to sharing further details next month and in the future on our progress,” she said.
The deputy commissioner will be named by spring, Califf told the Associated Press.
“Overall, this is a positive step toward improving the ability of the FDA’s human food program to respond to a rapidly changing environment,” said the Association of Food and Drug Officials, speaking for state and local food regulators.
The Consumer Federation of America and the Center for Science in the Public Interest said the reorganization should better protect consumers. “The reorganization plan is not perfect,” said the CFA . It noted the Center on Veterinary Medicine (CVM) would be outside of the ambit of the new deputy commissioner “even though its regulation of areas like animal antibiotics impacts the food system.”
Food safety lawyer Bill Marler, who advocates splitting the FDA into two agencies, said Califf’s plan “re-arranges the deck chairs on the USS FDA — food safety iceberg be damned.” The group Nourish Science said, “It’s time to move the ‘F’ in FDA to a Department of Food and Agriculture that would elevate food and nutrition policy to the cabinet level where it needs to be.”
There was “ample documentation” of organizational shortcomings at FDA in the Reagan-Udall report and internal reviews, Califf said, during a news conference. “It had reached the point where something needed to be done.”
Asked why the CVM was left out of the reorganization, he said, “The majority of Center of Veterinary Medicine work are animal drugs and devices … I wouldn’t want the deputy commissioner for foods to be making decisions about therapeutic antibodies for cats or devices for animals.” When CVM activities impinge on food, the deputy commissioner “will have primary authority for resources and priorities.”
With the reorganization, the FDA will be quicker on its feet and “much more pre-emptive … so that we catch these things earlier,” Califf said in response to a question if there could be shortages in the future of baby formula or other critical foods. “We’ll do everything we can but it could happen again,” said Woodcock, without a resilient food processing system or if production relies on a few large factories.