Following criticism, FDA proposes redesign of its human food program | CNN


The head of the US Food and Drug Administration on Tuesday proposed sweeping changes to the agency’s food safety programs in order to protect the US food supply and promote better nutrition.

FDA Commissioner Dr. Robert Califf proposed new structures for the Human Food Program, saying it will be led by a single director who would oversee food safety, policy and some regulatory duties, and report to the head of the agency. The changes would reform human food programs and the FDA’s Office of Regulatory Affairs, which handles inspections, laboratory testing, import and investigative operations.

“The proposed structures for both groups will have clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment,” Califf said in a statement.

The new structure would include a new center focused on nutrition, and an office responsible for coordination with state and local authorities, to “ensure greater collaboration and support of state-level inspectional activities.” The changes would also create a Human Foods Advisory Committee made up of external experts of food safety, nutrition and technology.

The announcement follows months of scrutiny of the agency’s handling of a lengthy US infant formula shortage, and past critiques that the agency was too slow to handle other nutrition and food safety issues. Last year, Califf commissioned an internal review of the FDA’s handling of infant formula regulation, and an external review from the Reagan-Udall Foundation of its human food program.

The external review acknowledged the food system in the US is generally recognized as safe, but was highly critical of the FDA’s operations, noting a “lack of a single, clearly identified person” to lead the food program and “constant turmoil” that led to “indecisiveness and inaction.” Earlier this month, the FDA’s deputy commissioner for food policy and response, Frank Yiannas, announced he would resign from the agency later in February. He said the FDA’s decentralized structure “significantly impaired FDA’s ability to operate as an integrated food team and protect the public.”

Califf said details of the proposed restructure are still in development, and more details will be provided at the end of February.

Mitzi Baum, CEO of the advocacy group STOP Foodborne Illness, said in a statement the revamp would mark “significant cultural changes” that could lead to accelerated decision-making and better communication, but noted “many details have yet to be determined,” including who would lead this change.

Brian Ronholm, director of food policy at Consumer Reports, said the FDA’s plan fell short of what’s needed, and “essentially cements the current dysfunctional structure at the FDA that led to the infant formula crisis and contributed to other longstanding problems that have plagued the agency.”

“The FDA’s plan fails to ensure that all of the agency’s food program staff will work together seamlessly with a common strategic direction, clear priorities, sound resource management, and internal accountability,” Ronholm said in a statement. “We’ll continue to urge Commissioner Califf to strengthen leadership and accountability at the FDA to modernize its food program, emphasize prevention and enable it to better protect the public when problems arise.”

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