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FDA’s dysfunctional food safety program undermines agency’s ability to protect public

CR calls for strengthened leadership and accountability for FDA’s food safety program at Senate Appropriations Agriculture Subcommittee hearing 

WASHINGTON, D.C. – Brian Ronholm, director of food policy at Consumer Reports, will highlight how FDA’s fragmented structure and leadership is hurting its ability to ensure our food is safe in testimony today at a hearing before the Senate Appropriations Submcommittee on Agriculture. Ronholm will call on lawmakers to support more focused leadership and accountability at the FDA and to investigate how the agency allocates food program funding during his testimony.

The hearing will be livestreamed beginning at 10am ET and is taking place one day after FDA Commissioner Robert Califf ordered an external review of the agency’s offices on food safety and tobacco regulation.

“The FDA’s botched response to the infant formula crisis and recent recalls are just the latest signs of longstanding problems at the agency that undermine its effectiveness,” said Ronholm.  “Unfortunately, the FDA has failed to implement a culture of prevention and move quickly on proposed rules and initiatives to improve its ability to protect the public. We need a full-time, fully empowered expert leader at the FDA to oversee its food safety program who can be held accountable for taking action when problems like the infant formula crisis arise.”

In April, CR joined an unprecedented coalition of 30 organizations representing consumers, industry leaders, and local regulators, which called on the agency to unify the food program under a deputy commissioner for foods. This position would have accountability to the commissioner and direct line authority over the Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), and the food-related components of the Office of Regulatory Affairs (ORA).

Ronholm’s testimony points out that the current fragmentation of the food program and lack of a single, fully empowered leader has caused delays in the implementation of the Food Safety Modernization Act, which aimed to shift FDA’s culture from one that reacted to food safety issues to one focused on prevention. This is most critically needed in the Office of Regulatory Affairs, which is responsible for inspection and compliance, and receives approximately 70 percent of all FDA food program funding. But despite funding increases by Congress, ORA’s domestic food inspections declined in the years after FSMA was enacted and before the pandemic shutdown.

Ronholm’s testimony notes that most FDA commissioners in recent decades have been medical specialists who naturally focus on the programs impacting medical products. There is intense competition for the commissioner’s time and support, and focus on the food program has typically suffered under this dynamic.

“It is virtually impossible for an FDA commissioner to have the bandwidth needed to provide strategic leadership and management accountability to such a large set of offices that regulate 80 percent of our food supply,” said Ronholm.  “We need to restructure FDA’s food safety program with an expert leader empowered to take action to protect the public and ensure our food is safe.”

Michael McCauley, michael.mccauley@consumer.org, 415-902-9537