The Washington PostDemocracy Dies in Darkness

Opinion For the nation’s health, break up the Food and Drug Administration

A sign notifying customers about the shortage of baby formula at a grocery store on May 10, 2022, in Salt Lake City. (Rick Bowmer/AP)
5 min

The Food and Drug Administration last year failed repeatedly to keep the nation’s babies safe from tainted formula. The baby formula fiasco was the latest in a long line of food crises that the agency was slow to catch and handle. 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 into realizing just how broken the U.S. food-monitoring system had become.

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

Read the Editorial Board's Q&A with FDA Commissioner Robert Califf on baby formula, food safety

The FDA’s current food-safety operations are underfunded and understaffed, and they lack a coherent leadership chain that can act swiftly in crises. Multiple reports and officials have pointed out these flaws. A Politico investigation last year found the FDA’s food-safety operations are a “global laggard” and a “joke,” according to officials and industry professionals. Reporter Helena Bottemiller Evich wrote: “This is not your run-of-the-mill slow-churning Washington bureaucracy. The FDA’s food division is so slow, it’s practically in its own league.” A 2017 inspector general report found much the same, warning that the food recall system is dangerously sluggish. The Government Accountability Office has repeatedly called out “high risk” problems, including an urgent need for a national food-safety strategy and “high-level sustained leadership.”

Dr. Califf requested another independent assessment of the FDA’s food divisions in July from the Reagan-Udall Foundation. The report is now public, and its key finding is that the FDA’s Human Foods Program lacks a single clear leader and is in “constant turmoil.” The FDA has also suffered from whiplash at the top. “How do you expect an agency to do well when it’s had seven commissioners in seven years?” Dr. Califf said.

It’s difficult to even make sense of the current organization of the FDA, which is part of the Department of Health and Human Services. Three separate teams play big roles in food oversight, yet they 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.

This picture is even more complex because food oversight is divided between the Agriculture Department, which oversees meat, poultry and eggs, and the FDA, which currently handles about 80 percent of the human food supply, as well as animal feed. Arguably, it would be ideal to house all food safety under one roof, but breaking up the FDA is a first step.

The FDA’s food operations should be consolidated into a new agency with its own leader who can work with Congress to secure the money and authority needed to protect a food system that has grown far more complex. Today, nearly one-third of vegetables, over half of fruits and 94 percent of seafood consumed in the United States is imported from other countries.

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Breaking up the FDA would probably require Congress to pass legislation. The bipartisan outrage over the baby formula shortage — which is still ongoing — should motivate Congress to act. An alternative is to streamline divisions within the FDA. But that would be akin to doing a quick paint job on a damaged house with cracks in the foundation. In fact, Congress has already tried this.

The Food Safety Modernization Act took effect in 2011. It was supposed to reform the FDA’s food divisions to be proactive at preventing outbreaks. It didn’t work. Foodborne outbreaks increased in the pre-pandemic years after the bill passed, federal data shows, including the scary E. coli outbreak in lettuce that caused the deaths of five Americans in 2018.

The same issues keep coming up: Different parts of food safety and oversight aren’t communicating well. (It took four months for a whistleblower complaint about an Abbott infant formula factory to reach the FDA’s deputy commissioner for food policy and response.) The computer systems need modernizing. The budget is too small. Staffing, especially for investigations, has “remained relatively flat since 1978,” the Reagan-Udall report notes. The system still relies heavily on in-person site visits, which fell apart during the pandemic and still have not fully rebounded. There were 6,829 domestic inspections of food and cosmetic production facilities in fiscal year 2022, according to FDA data, down from 8,595 in 2018 and more than 10,000 in 2011.

Regulators should get timely data updates from companies, and investigations need to increase. As Congress reviews the FDA’s structure, lawmakers should also ensure food-safety efforts, whichever agency is conducting them, are properly funded. The drug side of the FDA gets the majority of its funding from fees that companies pay for reviews. There’s likely a way to do something similar on the food side to help grow revenue to expand operations.

Food safety affects every American on a daily basis. When it’s not done properly, people die. The United States can keep watching tragedies such as the baby formula crisis happen and having independent experts write reports that come to largely the same conclusions. Or the FDA commissioner and Congress can finally act decisively.

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