The food division of the Food and Drug Administration lacks clear leadership, avoids bold policies or enforcement actions and fosters a culture that does not adequately protect public health, according to a report released Tuesday by an agency-related group.
Experts from the group, the Reagan-Udall Foundation, which was asked to investigate the nutrition division following widespread criticism due to the infant formula crisis, concluded in the report that the division’s management structure and mission needed to be reviewed.
Dr. Robert Califf, the agency’s commissioner, released a statement on Tuesday saying he would form a group to advise him on the findings and how to implement the recommendations. The infant formula crisis was the first major challenge that Dr. Califf as commissioner this year, though the agency also faced criticism over its regulation of vaping and tobacco products, prompting a similar overhaul of its tobacco division.
“I expect this leadership group to be bold and focused on the transformative opportunities that lie ahead for the FDA’s nutrition program,” said Dr. Calif. “I will be fully committed to ensuring that the program emerges from this transition with the resources, tools and visibility it warrants, given how critical its work is to every American.”
Congressional legislators and others have long called for strengthening the authority and influence of the agency’s food division, given the effects of foods such as added sugar and salt on deadly chronic diseases and the toll of foodborne illnesses that account for an estimated 128,000 U.S. hospitalizations and 3,000 deaths annually.
The report followed years of complaints that the food unit was toothless, a criticism reinforced by what critics saw as the agency’s floundering 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 closure of the factory in February exacerbated an infant formula shortage that forced parents to feed their babies for months earlier this year.
A New York Times review found that in September 2021, the FDA filed a complaint about a Minnesota baby hospitalized with the deadly Cronobactor sakazakii bacteria, allegedly after consuming formula from the plant. But even though agency inspectors inspected the plant in Sturgis, Michigan at the time, it wasn’t until February that authorities swept the plant clean and discovered the bacteria near production areas. Abbott has said genetic sequencing did not link bacteria found in the plant to the deaths of babies infected with Cronobactor.
Representative Rosa DeLauro, a Connecticut Democrat and chair of the House Appropriations Committee, which oversees the agency, said in a statement that she was “pleasantly surprised by the formal acknowledgment of the problems plaguing the FDA’s food program.”
“I look forward to working with the FDA on how they plan 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 the necessary change.
“It’s very important and encouraging from that standpoint, because it’s important for them to outline the findings that they’ve made, because it’s a critical acknowledgment that things definitely need to change,” said Brian Ronholm, director of food policy for Consumer Reports. . “Now the bottom line is, how is the FDA processing this report and the information it contains, and how does that translate into meaningful reform?”
However, some critics pointed to the report’s authors’ relationship with the agency. The Reagan-Udall Foundation is funded by the FDA and major companies such as Pfizer, AbbVie, and Nestle USA, which make infant formulas. The foundation solicited the views of food safety and nutrition experts and collected the comments of agency employees, but has since removed the feedback from its website.
Staff comments, reviewed by The Times, revealed some dissatisfaction with the way the division was being run. Some employees repeatedly complained that divisional managers stopped enforcing food safety laws for fear of complaints or lawsuits. Others said input from industry consultants and industry special advisors added little value. And some others were chafed by a lack of clear priorities, or personality politics and favoritism that trumped the focus on protecting the nation’s food supply.
Four former FDA nutrition center directors filed a statement calling for better protection of the division from budget cuts and for its officials to have more control over food facility inspections.
The report underlines that concern about lack of leadership, noting that three food department officials have different levels of authority. The report recommends a structural change, outlining several options that would make leadership more centralized. It also recommended more funding to improve the division’s operations, though congressional approval for budget increases could prove difficult as inflation and the economy could force budget cuts.