After baby formula scandal, FDA announces new unit focused on food safety

Stung by recent food safety scandals—most notably last year’s infant formula shortage—the U.S. Food and Drug Administration announced Tuesday that it is creating a new unit devoted to food safety.

“We’re proposing the creation of a unified, newly envisioned organization, called the Human Foods Program, that elevates key focus areas, removes redundancies, and consolidates activities under a single leader, a deputy commissioner for human foods,” FDA Commissioner Robert Califf, M.D., said during a media briefing announcing the change, adding that the deputy commissioner “will have clear decision-making authority and oversight of priorities to ensure a safe and nutritious U.S. food supply.”

The sweeping move comes after a scathing report in early December from the Reagan-Udall Foundation, which found that the FDA food program is in a state of “constant turmoil” and requires stronger leadership.

That report was commissioned by Califf once the agency conducted its own review after facing serious criticism for its handling of the infant formula shortage. That shortage, which dragged on for months, was prompted in part by a recall of potentially contaminated infant formula at the Abbott Labs Michigan-based infant formula production facility.

One of the Reagan-Udall panel’s big recommendations was to create a separate food agency with wide-ranging powers within the U.S. Department of Health and Human Services (HHS). The new Human Foods Program should function in that way, assuming under one umbrella the functions of some existing programs within HHS—the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and certain functions of the Office of Regulatory Affairs (ORA), the FDA field-based operations unit.

ORA itself is poised for an overhaul: According to the FDA, ORA will sharpen its focus on its “core mission”: food inspections, lab testing, imports oversight, and investigations. The goal is to spot threats to public health in the food supply early and prevent outbreaks before they start.

Besides improving the safety of the foods Americans consume, the FDA also plans to keep consumers better informed about the nutrition of everyday food products with the creation of a new Center for Excellence in Nutrition. The agency will also create an Office of Critical Foods within this center. The entire restructuring underway at the FDA is also meant to foster and reinforce cooperation between the FDA and food safety organizations within various states. A new Office of Integrated Food Safety System Partnerships will help direct that effort, the FDA said.

Finally, to help keep the agency on an evidence-based path to better food safety, the FDA plans to appoint experts to its new Human Foods Advisory Committee. Their advice to the agency should help guide the activities of the Human Foods Program going forward.

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