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FDA’s food program restructuring plan fails to address fundamental problems that have undermined agency’s effectiveness

CR and coalition of groups had urged the FDA to appoint a deputy commissioner with authority over all aspects of the agency’s food program

WASHINGTON, D.C. – The FDA’s proposal to restructure its human foods program fails to address the fundamental problems at the agency that contributed to the infant formula crisis and continue to hamper its ability to ensure our food is safe, according to Consumer Reports.  FDA Commissioner Robert Califf released new details today about its plans in response to an external review by the Reagan-Udall Foundation, which concluded that the agency’s culture, organizational structure and governance model have undermined its effectiveness.

The Foundation recommended that FDA Commissioner Robert Califf appoint a fully empowered, expert deputy commissioner with direct line authority over all key units of the foods program. Consumer Reports and an unprecedented coalition of organizations representing consumers, food industry leaders, and state regulators have been calling on the FDA to adopt such an approach for the past year.  Despite broad support for the report’s central recommendation, Commissioner Califf’s plan fails to unify the entire foods program under a single leader.

“It’s very disappointing that Commissioner Califf has rejected one of the key recommendations of the Reagan-Udall report,” said Brian Ronholm, director of food policy for Consumer Reports.  “The FDA’s matrix management plan will simply perpetuate the dysfunctional structure at the agency that has failed miserably in the past and led to its botched response to the infant formula crisis and other food safety issues.”

Ronholm continued, “The Reagan Udall recommendation has widespread support among lawmakers in Congress, consumer groups, industry leaders, and state regulators. Everything has essentially been gift-wrapped for the FDA to adopt, but they continue to stubbornly cling to a fragmented organizational structure that has stood in the way of real progress on food safety.”

The FDA’s plan includes the creation of a new deputy commissioner position with authority over Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Regulatory Affairs (ORA) state partnership offices. However, ORA’s core food inspection, laboratory, compliance, and import oversight would remain in a separate ORA organization led by an Associate Commissioner for Regulatory Affairs (ACRA), presumably reporting to the FDA Commissioner.

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