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Opinion | Tear apart the FDA after the infant formula crisis


The Food and Drug Administration has repeatedly failed to protect the nation’s babies from tainted formula last year. The infant formula fiasco was the latest in a long line of food crises that the agency has been slow to catch and manage. But the infant deaths and the desperation of parents trying to find enough food for their newborns have shocked Congress, the public and the world into realizing just how broken the US food monitoring system is.

To his credit, FDA Commissioner Robert M. Califf is promising to make major changes to the nation’s food safety system. A big announcement is expected by the end of the month. Dr. Califf should be bold, calling for the FDA to be split into a drug division and an entirely separate food agency with its own commissioner.

Read the Editorial Board’s questions and answers with FDA Commissioner Robert Califf about infant formula and food safety

FDA’s current food safety operations are underfunded and understaffed, and lack a coherent chain of leadership that can move quickly during crises. Numerous reports and officials have noted these flaws. Last year, a Politico investigation found the FDA’s food safety operations to be a “global backlog” and a “joke,” according to officials and industry experts. Journalist Helena Bottemiller Evich wrote: ‚ÄúThis is not your slow-moving Washington bureaucracy. The FDA’s food division is so slow it’s practically in a league of its own. A 2017 inspector general report found the same, warning that the food recall system was dangerously slow. The Government Accountability Office has repeatedly cited “high-stakes” issues, including the urgent need for a national food security strategy and “high-level sustained leadership.”

Dr. Califf requested another independent evaluation of the FDA’s food divisions from the Reagan-Udall Foundation in July. The report is now public, and its main finding is that the FDA’s Human Food Program lacks a single clear leader and is in “permanent confusion.” The FDA also suffered from the above whiplash. “How do you expect an agency with seven commissioners in seven years to do well?” Dr. Califf said.

Even the current organization of the FDA, which is part of the Department of Health and Human Services, is difficult to understand. Three separate teams play a major role in food oversight, but all have their own directors who report to the commissioner: the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and the Office of Regulatory Affairs.

The picture is further complicated because food control is split between the Department of Agriculture, which oversees meat, poultry and eggs, and the FDA, which now controls about 80 percent of human food as well as animal feed. It would certainly be ideal to bring all food safety under one roof, but breaking up the FDA is a first step.

FDA’s food operations should be merged into a new agency with its own leader who can work with Congress to provide the money and authority needed to protect a more complex food system. About one-third of the vegetables, more than half of the fruits, and 94 percent of the seafood consumed in the United States today are imported from other countries.

Dissolving the FDA would likely require Congress to pass legislation. Bipartisan outrage over the ongoing shortage of infant formula should prompt Congress to act. An alternative is to streamline divisions within the FDA. But it’s like a quick paint job on a damaged house with cracks in the foundation. In fact, Congress has already tested it.

The Food Safety Modernization Act went into effect in 2011. He should have reformed the FDA’s food divisions to be proactive in preventing outbreaks. This didn’t work. After the bill passed, cases of foodborne illness spiked in the years leading up to the pandemic, federal data show, including a 2018 outbreak of E. coli in lettuce that killed five Americans.

The same issues keep coming up: Different parts of food safety and control don’t communicate well. (It took four months for the FDA deputy to receive a whistleblower complaint about the Abbott infant formula factory. commissioner for food policy and response.) Computer systems need to be modernized. The budget is too low. The Reagan-Udall report noted that staffing, particularly for investigations, “has remained relatively stable since 1978.” The system still relies on in-person site visits, which collapsed during the pandemic and have yet to fully recover. According to FDA data, there were 6,829 local inspections of food and cosmetic manufacturing facilities in fiscal year 2022, down from 8,595 in 2018 and more than 10,000 in 2011.

Regulators should receive timely information updates from companies and investigations should be increased. As Congress reviews the structure of the FDA, lawmakers must also ensure that food safety efforts are adequately funded, regardless of which agency carries them out. The drug side of the FDA receives most of its funding from fees companies pay for reviews. There is a way to do something similar on the food side to help increase revenue to expand operations.

Food insecurity affects every American on a daily basis. People die when it’s not done right. The United States can watch tragedies like the infant formula crisis unfold and independent experts write reports that come to largely the same conclusions. Or the FDA commissioner and Congress may finally act decisively.

Post Appearance | About the Editorial Board

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

Members of the Editorial Board and areas of focus: Opinion Editor David Shipley; Deputy Opinion Editor Karen Tumulty; Assistant Opinion Editor Stephen Stromberg (national politics and policy, legal issues, energy, environment, health); Lee Hockstader (European affairs, based in Paris); David E. Hoffman (global public health); James Hohmann (domestic politics and electoral politics, including the White House, Congress and governors); Charles Lane (foreign affairs, national security, international economics); Heather Long (economics); Associate Editor Ruth Marcus; and Molly Roberts (technology and society).

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