Reviews | After the infant formula crisis, break up the FDA


Last year, the Food and Drug Administration repeatedly failed to protect the country’s babies from contaminated formula. The infant formula fiasco was the latest in a long line of food crises that the agency has been slow to catch and deal with. But the deaths of babies and the desperation of parents trying to find enough food for their newborns shocked Congress, the public and the world with the realization of how broken America’s food surveillance system had become.

To his credit, FDA Commissioner Robert M. Califf has pledged to make substantial changes to the nation’s food safety system. A major announcement is expected by the end of the month. Dr. Califf should be bold, calling for splitting the FDA into an entirely separate pharmaceutical and food administration division with its own commissioner.

Read the Editorial Board’s Q&A with FDA Commissioner Robert Califf on infant formula and food safety

Current FDA food safety operations are underfunded and understaffed, and they lack a cohesive chain of leadership that can act quickly in a crisis. Several reports and officials have pointed to these flaws. A Politico investigation last year found that the FDA’s food safety operations are a “global retard” and a “joke”, according to officials and industry professionals. Journalist Helena Bottemiller Evich wrote, “This is not your mundane, slow bureaucracy in Washington. The Food Division of the FDA is so slow it’s practically in its own league. A 2017 Inspector General report found much the same thing, warning that the food recall system is dangerously slow. The Government Accountability Office has repeatedly denounced “high-risk” issues, including the urgent need for a national food security strategy and “sustained high-level leadership”.

Dr. Califf commissioned another independent assessment of the FDA’s food divisions in July from the Reagan-Udall Foundation. The report is now public, and its main finding is that the FDA’s Human Foods program has no clear leader and is in “constant turmoil.” The FDA also suffered whiplash at the top. “How do you expect an agency to succeed when it has had seven commissioners in seven years?” said Dr. Califf.

It is even difficult to make sense of the current organization of the FDA, which is part of the Department of Health and Human Services. Three separate teams play an important role in food oversight, but they all have their own directors who report to the Commissioner: the Center for Food Security and Applied Nutrition, the Office of Food Policy and Response, and the Office of Regulatory Affairs.

This picture is even more complex because food oversight is divided between the Department of Agriculture, which oversees meat, poultry and eggs, and the FDA, which currently manages about 80% of the human food supply, as well than animal feed. Arguably, having all food safety under one roof would be ideal, but dismantling the FDA is a first step.

FDA food operations should be consolidated into a new agency with its own head that can work with Congress to get the money and authority needed to protect a food system that has become far more complex. Today, almost a third of the vegetables, more than half of the fruits and 94% of the seafood consumed in the United States are imported from other countries.

Breaking the FDA would likely force Congress to pass legislation. Bipartisan outrage over the infant formula shortage — which is still ongoing — should motivate Congress to act. An alternative is to streamline divisions within the FDA. But that would be like doing a quick paint job on a damaged house with cracks in the foundation. In fact, Congress has already tried that.

The Food Safety Modernization Act took effect in 2011. It was supposed to reform FDA food divisions to be proactive in preventing outbreaks. It did not work. Foodborne outbreaks increased in pre-pandemic years after the bill passed, according to federal data, including the frightening outbreak of E. coli in lettuce that killed five Americans in 2018.

The same issues keep coming back: different parts of food safety and monitoring don’t communicate well. (It took four months for a whistleblower complaint about an Abbott infant formula factory to reach the FDA Deputy Commissioner for Food Policy and Response.) IT systems need to be upgraded. The budget is too small. Staffing, particularly for investigations, has “remained relatively stable since 1978,” the Reagan-Udall report notes. The system still relies heavily on in-person site visits, which crashed during the pandemic and still haven’t fully rebounded. According to FDA data, there were 6,829 nationwide inspections of food and cosmetics production facilities in fiscal year 2022, compared to 8,595 in 2018 and more than 10,000 in 2011.

Regulators should get timely data updates from companies, and investigations need to be stepped up. As Congress reviews the structure of the FDA, lawmakers should also ensure that food safety efforts, regardless of which agency leads them, are properly funded. The drug side of the FDA derives the majority of its funding from the fees companies pay for reviews. There is probably a way to do something similar on the food side to help increase revenue to expand operations.

Food security affects every American every day. When it’s not done properly, people die. The United States can continue to watch tragedies such as the infant formula crisis and have independent experts write reports that come to much of the same conclusions. Or the FDA commissioner and Congress can finally act decisively.

The post’s point of view | About the Editorial Board

Editorials represent the opinions of The Post as an institution, as determined by debate among members of the Editorial Board, based in the Opinions section and separate from the newsroom.

Members of the editorial board and areas of intervention: Opinion Editor David Shipley; associate editor Karen Tumulty; Associate Opinion Editor Stephen Stromberg (National Politics and Policy, Legal Affairs, Energy, Environment, Healthcare); Lee Hockstader (European Affairs, based in Paris); David E. Hoffman (global public health); James Hohmann (domestic and electoral politics, including White House, Congress, and governors); Charles Lane (foreign affairs, national security, international economy); Heather Long (economics); Associate Editor Ruth Marcus; and Molly Roberts (technology and society).

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