Frank Yiannas, former deputy commissioner of the office of food policy and response on the Food and Drug Administration (FDA), speaks during a House Oversight and Accountability Subcommittee hearing in Washington, DC, on Tuesday, March 28, 2023.
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The U.S. supply of infant formula industry continues to be vulnerable to questions of safety and provide disruptions greater than a yr after a nationwide shortage that left parents scrambling to feed their children, a former Food and Drug Administration official told U.S. lawmakers on Tuesday.Â
“It’s my view that the state of the infant formula industry today is just not much different than it was then,” Frank Yiannas, the agency’s former deputy commissioner for food policy, said during testimony before a subcommittee of the House Oversight Committee. Yiannas helped lead the FDA’s response to the shortage before resigning earlier this yr.Â
“In other words, the nation stays one outbreak, tornado, flood or cyberattack away from finding itself in an identical place to that of February 17, 2022,” he added.Â
The FDA announced a nationwide recall on that day of Abbott Nutrition‘s popular Similac, Alimentum and EleCare baby formulas that sparked the nationwide shortage. The infant formula was recalled after several infants became sick with bacterial infections and two died.Â
He said the agency was slow to act when those concerns about contamination arose at Abbott’s formula manufacturing plant in Sturgis, Michigan. The plant was shuttered for months, sharply reducing formula supply across the U.S. Prior to the recall, Abbott controlled an estimated 40% of the nation’s baby formula market.Â
Yiannas underscored dysfunction inside the FDA that he believes exacerbated the shortage. He pointed to structural and cultural issues inside the agency, a failure to observe the food supply chain and inadequate public health surveillance of the fatal bacteria, Cronobacter sakazakii, that contaminated Abbott’s formula.Â
But he also highlighted ongoing threats to infant formula supply that must be addressed to stop an identical crisis in the long run, comparable to manufacturing plants in need of refurbishment and heavy consolidation within the industry.
‘Communications silos’
Shelves normally meant for baby formula sit nearly empty at a store in downtown Washington, DC, on May 22, 2022.
Samuel Corum | AFP | Getty Images
The FDA first received a whistleblower criticism concerning the contamination at Abbott’s formula plant on Oct. 26, 2021, he said. But Yiannas said he only became aware of the criticism 4 months in a while Feb. 10, 2022, which prompted him and his team to take motion to mitigate the shortage on the time.Â
Yiannas said the FDA previously blamed “mail issues” for the delay, but noted that multiple agency officials received each hard and electronic copies of the criticism.Â
He as an alternative pointed to decentralized offices and centers on the agency that were slow to pass along the critical information, he noted.Â
“I wish that the communications silos had not existed and that I’d have been notified earlier, so I could have initiated these steps sooner,” Yiannas said through the hearing. “I also consider that had we been capable of initiate these steps and act sooner, the recall can have been smaller in size.”
Latest FDA strategy
Yiannas’ remarks got here after the FDA unveiled a recent national technique to make sure the secure and adequate supply of baby formula. The agency developed the strategy under the Food and Drug Omnibus Reform Act of 2022.
The strategy includes enhancing inspections of infant formula manufacturers, pushing the industry to develop and implement risk-management plans and expediting the review of recent infant formulas to stop future shortages.
When asked concerning the FDA’s recent plan through the hearing, Yiannas called it “well intentioned.” But he noted it has been known as a vision and strategy, which is “very different” than a reorganization of the agency’s structure.
“You would like a technique first, and you wish a structure to support that strategy,” he said. Yiannas added the proposal doesn’t go so far as the actions under previous FDA deputy commissioners.
Because the recalls, each Abbott and the FDA — in addition to the broader infant formula industry — have been under high scrutiny.Â
The corporate in January said the Department of Justice was investigating conduct at its Michigan infant formula plant. Last May, the Federal Trade Commission launched an investigation into whether mergers in the child formula industry contributed to the present shortage. Several congressional oversight hearings even have grilled key officials that lawmakers consider could have done more to stop the shortage, comparable to FDA Commissioner Dr. Robert Califf.Â
The Biden administration has taken steps to ease the shortage. The president in May invoked the Defense Production Act to extend formula manufacturing. The White House also announced last yr the U.S. would airlift bottles of infant formula from abroad.
