The Biden administration should restructure the FDA to give more prominence to federal regulation of the food supply, with steps that could include appointing a deputy commissioner for food or even splitting the FDA into two entities, one dealing with drugs and the other overseeing food, said a panel of experts on Tuesday. “The current organizational structure lacks a clear leader and decision-maker,” said the panel’s report.
FDA Commissioner Robert Califf, who requested the review after the agency bumbled its response to contaminated infant formula early this year, said the report “will help to inform a new vision for the FDA Human Foods Program,” with public updates to be made within weeks, in January and February. “I will be making final decisions…after reviewing the report and consulting with stakeholders both externally and internally.”
The FDA has jurisdiction over 78 percent of the U.S. food supply, including fruits, vegetables and most prepared foods. Yet its work in food safety and nutrition is often overshadowed by the agency’s role overseeing drugs and medical devices, leading to grim jokes that the “F” in FDA is silent. “Food is not a high priority at the Food and Drug Administration,” concluded a Politico investigation in April.
A panel of experts, operating under the auspices of the Reagen-Udall Foundation and chaired by former FDA commissioner Jane Henney, said repeatedly that food regulation was hindered by diffuse leadership and duties scattered among four agencies.
“Changing the current organizational structure will assist the agency is advancing its mission,” said the panel. “It is imperative that the Human Foods Program become more prominent. When compared to the medical products program within FDA, the Human Foods Program continously struggles for visibility and prominence.”
Five options to remodel FDA were proposed by the panel. One was to split the FDA into a drug administration and a food administration within the Health and Human Services Department. Another was to name an FDA deputy commissioner to hold the food portfolio. A third was to split FDA activities between a deputy commission for food and a deputy commissioner for medical products and tobacco. Others would put the director of the Center for Food Safety and Applied Nutrition in charge of all food programs or would put the FDA commissioner personally in charge of food programs.
Congressional approval would be needed to create a Federal Food Administration. The other options could be implemented by the FDA on its own.
“Now the question is will Congress and the FDA commissioner take the report to heart?” said food safety lawyer Bill Marler in a blog that commended the panel for seeking cultural, structural and financial change at the agency. Marler said his preference was splitting FDA into two agencies, one devoted to food and the other to drugs.
Members of several consumer and food industry groups spoke in favor of FDA deputy commissioner of food during a video news conference. There are policy difference among organizations, said Roberta Wagner of Consumer Brands Association, but “we all agree there needs to be a deputy commissioner of food.”
Brian Ronholm of Consumer Reports said the report was “an important first step toward reform” and would compel FDA to act.
The expert panel also said a reliance on consensus among FDA staff “has significant drawbacks” in deciding on regulatory action and resulted in an agency “with an aversion to risk that undercuts its public health mandate.” Among steps to change the mind-set within the agency, the panel said FDA should “identify, communicate, embrace and promote a clear and compelling vision, mission and value statement for the Human Foods Program.”
The Reagan-Udall Foundation report is available here.