After baby formula disaster, the FDA’S proposed reforms are inadequate

The Food and Drug Administration vowed to make big changes to its food safety teams after the 2022 infant formula crisis exposed deep flaws in the agency’s culture, technology and structure. On Tuesday, the FDA finally revealed its fix: creating a new deputy commissioner for human foods. This is a major disappointment.

The new deputy commissioner position would not even have authority over all food safety and nutrition. Confusingly, there will still be a separate Office of Regulatory Affairs at the FDA that handles food safety investigations. On a call with reporters, FDA Commissioner Robert Califf and Principal Deputy Commissioner Janet Woodcock spent 45 minutes trying to explain which powers this new deputy would have and which authorities the Office of Regulatory Affairs’ leader would exercise. The purpose of this reorganization is to create a clear leader overseeing human food safety and a streamlined reporting process. It needs to be simple. This proposed change does not achieve that.

In fact, the FDA has already tried this before. There was a deputy commissioner of food. The position was eliminated in the early years of the Trump administration. Even in the unlikely event that reestablishing the job spurs broad improvement, there is no guarantee it will endure under future FDA commissioners.

It’s important to remember why the FDA — a massive agency that handles drug and the bulk of food safety oversight — needs overhauling. During the baby formula disaster, the FDA was too slow to react to tragic infant deaths and a whistleblower report outlining safety failures at an Abbott baby formula plant in Michigan. It was unclear who was in charge at key moments. But the baby formula crisis wasn’t an isolated incident. Several independent reviews of the FDA’S food operations found years of “constant turmoil” and slow responses to food emergencies. Congress passed the 2011 Food Safety Modernization Act after a series of distressing foodborne outbreaks. A decade later, similar problems persist.

It does not help that for years the agency’s food program has been an afterthought compared to the FDA’S drug side. An independent report released in December recommended splitting the FDA into a food agency and a separate drug agency to finally give food safety the attention, funding and clear leadership it deserves. This is a good idea that Mr. Califf should have endorsed on Tuesday.

He told us that splitting up the FDA “deserves some due consideration.” Specifically, Congress would have to make such a big change (lawmakers introduced a bill last year to do this) and it would have to adequately fund the federal government’s food safety programs, too. This sweeping reform would better reflect the scale of the FDA’S problems than the modest reorganization the agency announced this week. How many more crises — and infant deaths — will it take for lawmakers to accept that modest reform is not enough?