U.S. baby formula supply is still vulnerable, former FDA official tells lawmakers

The U.S. supply of infant formula industry is still vulnerable to safety issues and supply disruptions more than a year 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. 

“It is my view that the state of the infant formula industry today is 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 year. 

“In other words, the nation remains one outbreak, tornado, flood, or cyber-attack away from finding itself in a similar place to that of February 17, 2022,” he added. 

The FDA announced a nationwide recall 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. 

He said the agency was slow to act when those concerns about contamination arose at Abbott’s formula manufacturing plant in Sturgis, Mich. 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. 

Yiannas underscored dysfunction within the FDA that he believes exacerbated the shortage. He pointed to structural and cultural issues within the agency, a failure to monitor the food supply chain and inadequate public health surveillance of the fatal bacteria, Cronobacrer sakazakii, that contaminated Abbott’s formula. 

But he also highlighted ongoing threats to infant formula supply that need to be addressed to prevent a similar crisis in the future, such as manufacturing plants in need of refurbishment and heavy consolidation in the industry.

Yiannas’ remarks came after the FDA unveiled a new national strategy to ensure the safe 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 new infant formulas to prevent future shortages.

When asked about the FDA’s new plan during the hearing, Yiannas called it “well-intentioned.” But Yiannas noted it’s been referred to as a vision and strategy, which is “very different” than a reorganization of the agency’s structure.

“You need a strategy first, and you need a structure to support that strategy,” he said. Yiannas added that the proposal doesn’t go as far as the actions of previous FDA deputy commissioners.

Since the recalls, both Abbott and the FDA – as well as the broader infant formula industry – have been under high scrutiny. 

The company 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 baby formula industry contributed to the current shortage. Several Congressional oversight hearings have also grilled key officials that lawmakers believe could have done more to prevent the shortage, such as FDA Commissioner Dr. Robert Califf. 

The Biden administration has taken steps to ease the shortage. The president in May invoked the Defense Production Act to increase formula manufacturing. The White House also announced last year the U.S. would airlift bottles of infant formula from abroad.