Following criticism, FDA proposes redesign of its human food program

By Jamie Gumbrecht, CNN

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

FDA Commissioner Dr. Robert Califf proposed new structures for the Human Foods 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.

“As I look at the 10-year horizon, I see threats from climate change, supply chain disruption and international strife. All these factors threaten our ability to provide Americans with safe, plentiful and nutritious food,” Califf said at a news conference Tuesday, adding that the proposed changes to the program could turn that around.

The new plan would also “elevate the importance of nutrition, given declining life expectancy in the US due in large part to chronic diseases with a basis in nutrition,” he said.

The announcement follows months of scrutiny of the agency’s handling of a lengthy US infant formula shortage and critiques that it 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 Foods Program.

FDA Principal Deputy Commissioner Dr. Janet Woodcock said the internal review found that the infant formula crisis was a “systems problem, not an individual problem.”

“We’ve already made changes in leadership, as you know, as things evolve in the program, but the short answer is, no one is going to be reassigned or fired because of the infant formula situation,” Califf said.

The external review acknowledged that 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.”

The FDA’s deputy commissioner for food policy and response, Frank Yiannas, announced this month that he would resign 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 he would be “directly responsible” for some of the duties related to the Human Foods Program.

“Of course, we’ll miss Frank. He was certainly an expert in how the foods industry works. But it’s also the case that, as we’re making these changes, we are really going to consolidate these functions, and we’re going to recruit a new leader who will be in charge,” he said. “In the interim, I’ll be directly responsible for the efforts in the commissioner’s office related to the Human Foods Program, so I think we’ve got it covered.”

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

Mitzi Baum, CEO of the advocacy group STOP Foodborne Illness, said in a statement that the revamp would mark “significant cultural changes” that could lead to accelerated decision-making and better communication, but she noted that “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,” he 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.”

Califf said Tuesday that the number of issues with the FDA’s food safety programs “had reached the point where something needed to be done.”

Reports that examined agency operations showed “ample documentation of issues that needed to be addressed and improved in the Human Foods Program and, you know, almost none of it has to do with the people,” he said. “We’ve got really hard-working, good people who have basically kept the food supply safe compared to any other country, and our knowledge of nutrition has advanced greatly due to their work, but the organization was impeding the work that needed to be done.”

Woodcock said that evolving and adapting FDA programs as science and technology develops is critical and said the agency has begun taking steps toward executing the new program.

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CNN’s Carma Hassan contributed to this report.