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CR testifies on how dysfunction at the FDA hindered its infant formula response at House Appropriations Agriculture Subcommittee hearing

CR calls for strengthened leadership and accountability for FDA’s food safety program

WASHINGTON, D.C. – Brian Ronholm, director of food policy at Consumer Reports, will highlight how FDA’s dysfunctional food safety program undermined its response to the infant formula crisis and will call for more focused leadership and accountability at the agency in testimony today at a House Appropriations Subcommittee on Agriculture hearing. The hearing will be livestreamed beginning at 2pm ET and can be accessed here.

“The FDA was too slow to act, failed to take this issue seriously, and didn’t provide parents and caregivers the information they needed to prepare for the infant formula shortage,” said Ronholm. “This crisis has exposed a fundamental problem with the FDA’s organizational structure and culture that has hampered its ability to ensure our food is safe. The FDA needs a single, full-time, fully empowered expert leader to oversee its food safety program who can be held accountable for taking action to protect the public when problems like this arise.”

CR led an unprecedented coalition of 30 organizations representing consumers, industry leaders, and local regulators in April, 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 will urge the Subcommittee to investigate how FDA’s fragmented structure and leadership affected its response to reports of contamination at the Abbott infant formula plant that triggered an eventual recall. His testimony includes a detailed timeline that points out how officials at the FDA waited two months before interviewing a whistleblower who contacted the agency last October outlining allegations of wrongdoing at Abbott’s Sturgis facility, including falsification of records, releasing untested infant formula, hiding information from the FDA, and lax sanitation practices.  

While the whistleblower report was sent to some food safety leaders within the FDA, it was not shared with the deputy commissioner responsible for food policy and response until four months after it was received. It wasn’t until the end of January 2022 that the FDA began an extensive inspection of the Sturgis facility, four months after it had received the whistleblower complaint.  The agency’s delayed response to the whistleblower report is even more troubling since it had detected Cronobacter contamination in the Sturgis plant and found that the company failed to comply with a Salmonella testing requirement during a previous inspection in September 2019. 

The current fragmentation of the food program and lack of a single, fully empowered full-time expert 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 points out 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. 

FDA Commisioner Dr. Robert Califf recently announced the appointment of Dr. Janet Woodcock, the agency’s principal deputy commissioner, to oversee and provide strategic counsel to seven parts of the FDA, including major food program offices – CFSN, CVM, and ORA.  Dr. Woodcock’s extensive FDA career has focused on policies impacting medical products but she has no significant food policy credentials or standing in the food policy community.  

“Appointing someone with a medical products background to oversee the food program demonstrates the insular and dismissive approach that FDA too often takes toward the food program and virtually ensures that it will continue to have second class status at the agency,” said Ronholm. 

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