FDA to revamp food safety program in wake of infant formula crisis

The Food and Drug Administration (FDA) is launching an overhaul of its food safety and nutrition division in the wake of a series of crises including the recent baby formula shortage, the agency announced Tuesday.

As part of the move, Commissioner Robert Califf said the FDA will combine two separate divisions to create a new human foods program, which will be led by a single deputy commissioner. The deputy commissioner will have decisionmaking authority over policy, strategy and regulatory program activities within the Human Foods Program as well as resource allocation and risk prioritization.

“Creating a Human Foods Program under a single leader who reports directly to the Commissioner unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way,” Califf said in a statement.  

The FDA has long faced criticism that it doesn’t give enough resources to its food safety program. Those shortcomings were exposed last year as an infant formula shortage left parents scrambling.

The formula crisis, which persists, resulted in congressional hearings, investigations, and calls to separate the food program from the rest of the agency that focuses on drugs and medical devices. The FDA oversees about 80 percent of the nation’s food supply.

The change announced Tuesday comes on the heels of a scathing report from the Reagan-Udall Foundation that found the food program was too slow and risk-averse, which “compromises the agency’s willingness to act in enforcement or policy development.”

The food program is led by officials with overlapping jurisdictions, and the independent report recommended establishing either a food safety agency that would be separate from the Federal Drug Administration or better, clearer lines of command within the existing agency.

As part of the change, the revamped foods program will include a dedicated office to manage the regulation of infant formula and medical foods. There will also be a separate office to coordinate state efforts to identify and prevent foodborne illness outbreaks.

“Consumers can be confident in the safety of the food they eat each day in part thanks to the work of the FDA’s dedicated workforce,” Califf said. “Our ability to continue our work means consistently evolving and adapting with the constantly changing, complex industries we regulate and the emergence of new technologies.”