F.D.A. Report Faults Agency’s Food Unit for Leaderless Dysfunction

The Food and Drug Administration’s food division has no clear leadership, avoids bold policy or enforcement actions, and fosters a culture that doesn’t adequately protect public health, according to a report issued on Tuesday by an agency-related group.

Experts with the group, the Reagan-Udall Foundation, which was asked to examine the food division after widespread criticism stemming from the infant formula crisis, concluded in the report that the division’s management structure and mission should be overhauled.

Dr. Robert Califf, the agency commissioner, released a statement Tuesday saying he would form a group to advise him on the findings and on how to put the recommendations in place. The infant formula crisis was the first major challenge that Dr. Califf confronted this year as commissioner, although the agency has also faced criticism over the regulation of vaping and tobacco products, which prompted a similar review of its tobacco division.

“I expect this leadership group to be bold and focused on the transformative opportunities ahead for the F.D.A.’s food program,” Dr. Califf said. “I will be fully engaged to ensure that the program comes out of this transition with the resources, tools and visibility it warrants given how critical its work is to every American.”

Congressional lawmakers and others have long called for strengthening the authority and influence of the agency’s food division, given the effects of foods like added sugar and salt on deadly chronic diseases and the toll of food-borne illnesses that account for an estimated 128,000 U.S. hospitalizations and 3,000 deaths each year.

The report followed years of complaints that the food unit was toothless, a criticism that was amplified by what critics viewed as the agency’s plodding and disorganized response to reports of infant illness and death and unsanitary conditions at the Abbott Nutrition infant formula plant in Michigan. The agency’s shutdown of the factory in February aggravated an infant formula shortage that left parents scrambling to feed their babies for months earlier this year.

A New York Times review found that the F.D.A. had fielded a complaint in September 2021 about a Minnesota infant hospitalized with the deadly Cronobactor sakazakii bacteria, reportedly after consuming formula from the plant. Yet even though agency inspectors inspected the plant in Sturgis, Mich., at the time, it was not until February that the authorities swabbed the plant and discovered the bacteria near production areas. Abbott has said that genetic sequencing did not connect bacteria found in the plant to the deaths of infants infected with Cronobactor.

Representative Rosa DeLauro, Democrat of Connecticut and chairwoman of the House Appropriations Committee, which oversees the agency, said in a statement that she was “pleasantly surprised by the formal acknowledgment of the issues that plague the F.D.A. foods program.”

“I look forward to working with the F.D.A. on how they intend to implement the positive reforms in this report,” Ms. DeLauro said.

Food safety advocates who have been harsh critics of the agency said the report appeared detailed and strong enough to pave the way for needed change.

“It’s very significant and encouraging from that standpoint, because for them to outline the findings that they did is important, because it’s a critical acknowledgement that things definitely need to change,” Brian Ronholm, director of food policy for Consumer Reports, said. “Now it comes down to: How does F.D.A. process this report and the information contained in it, and how does that translate to meaningful reform?”

Some critics, however, pointed to the relationship the report’s authors have with the agency. The Reagan-Udall Foundation is funded by the F.D.A. and major corporations like Pfizer, AbbVie and Nestle USA, which makes infant formula. The foundation sought the views of food safety and nutrition experts and collated the comments of agency staff members, but has since removed the feedback from its website.

The staff comments, reviewed by The Times, showed some discontent with how the division was run. Some employees repeatedly complained that division managers stopped short of enforcing food-safety laws out of fear of complaints or lawsuits. Others said that input from industry consultants and special advisers from industry added little value. And some others chafed about a lack of clear priorities, or personality politics and favoritism that trumped a focus on protecting the nation’s food supply.

Four former F.D.A. food center directors submitted a statement calling for the division to be better protected from budget cuts and for giving its officials more control over food facility inspections.

The report underscores that concern about lack of leadership, noting that three food division officials have competing levels of authority. The report recommends a structural change, laying out several options that would make leadership more centralized. It also recommended more funding to enhance the division’s operations, although congressional approval for budgetary increases might prove difficult now that inflation and the economy may force cutbacks.

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