Child formulation provide nonetheless in danger: ex-FDA official tells Congress
Frank Yiannas, former Deputy Commissioner of the Office of Nutrition Policy and Response at the Food and Drug Administration (FDA), speaks during a House Oversight and Accountability Subcommittee hearing Tuesday, March 28, 2023 in Washington, DC.
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The US infant formula supply is still vulnerable to safety issues and supply disruptions, more than a year after a nationwide shortage left parents scrambling to feed their children, a former Food and Drug Administration official told US lawmakers on Tuesday .
“In my opinion, the state of the infant formula industry today isn’t much different than it was then,” Frank Yiannas, the agency’s former deputy commissioner for food policy, said during a hearing before a subcommittee of the House Oversight Committee. Yiannas helped guide the FDA’s response to the shortage before resigning earlier this year.
“In other words, the nation remains one outbreak, tornado, flood or cyberattack from finding itself in a place similar to February 17, 2022,” he added.
The FDA announced a nationwide recall that day Abbott nutrition‘s popular Similac, Alimentum and EleCare baby formulas that sparked the nationwide shortage. The infant formula was recalled after several infants contracted bacterial infections and two died.
He said the agency was slow to act when these concerns about contamination surfaced at Abbott’s formula manufacturing facility in Sturgis, Michigan. The plant was closed for months, severely reducing the supply of infant formula in the United States. Prior to the recall, Abbott controlled an estimated 40% of the nation’s infant formula market.
Yiannas underscored the dysfunction within the FDA, which he believes has exacerbated the shortage. He pointed to structural and cultural problems within the agency, a failure in oversight of the food supply chain, and inadequate public health surveillance of the deadly bacterium Cronobacter sakazakii, which contaminated Abbott’s formula.
However, he also highlighted the ongoing threats to the infant formula supply that need to be addressed to prevent a similar crisis in the future, such as: B. production facilities in need of renovation and strong consolidation in the industry.
Shelves normally dedicated to baby food stand almost empty at a store in downtown Washington, DC on May 22, 2022.
Samuel Korum | AFP | Getty Images
The FDA first received a whistleblower complaint about contamination at Abbott’s formula plant on Oct. 26, 2021, he said. But Yiannas said he only became aware of the complaint four months later, on February 10, 2022, prompting him and his team to take action to mitigate the shortage at the time.
Yiannas said the FDA previously blamed “mail problems” for the delay, but noted that multiple agency officials received both printed and electronic copies of the complaint.
Instead, he pointed to decentralized agency offices and centers that were slow to share the critical information, he noted.
“I wish the communication silos didn’t exist and I would have been notified earlier so I could have taken those steps sooner,” Yiannas said during the hearing. “I also believe that if we had taken these steps and acted sooner, the recall might have been less.”
Yiannas said an “important lesson” he learned from the crisis is that the FDA needs to update infant formula guidelines to strengthen prevention.
He noted that Abbott’s Sturgis facility is not the only one having problems with the Cronobacrer sakazakii bacterium. The FDA needs to update its infant formula rule that includes testing requirements for these bacteria, Yiannas said.
Only about 300 grams of the formula is usually tested for these bacteria, although some plants produce up to 50,000 to 60,000 pounds at a time, he noted. These testing requirements should be updated because, according to Yiannas, they currently make the chances of detecting Cronobacrer sakazakii “much lower than they should be.”
He recommended that the FDA and CDC designate Cronobacrer sakazakii as a nationally reportable disease, which would require states to report data and other information about the bacterium to the government. The Centers for Disease Control and Prevention says only two to four cases of infection are reported to the agency each year because Minnesota and Michigan are the only states that require reporting.
Yiannas acknowledged that making a disease nationally notifiable is a complicated process that requires the advice and vote of the Council of State and Territory Epidemiologists. The FDA has been working to put it on the agenda for the upcoming June council meeting, he said.
The FDA also needs to work with the baby food industry to ensure production facilities are up to date, Yiannas said, adding that some equipment at Abbott’s Sturgis plant “predates me.”
“We should no longer make infant formula with equipment that reveals their age and increases the risk of potential problems,” he told lawmakers.
New FDA strategy
Yiannas’ comments 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 improving inspections of infant formula manufacturers, encouraging industry to develop and implementing risk management plans, and accelerating the review of new infant formulas to avoid future shortages.
When asked about the FDA’s new plan during the hearing, Yiannas called it “well intentioned.” But he noted that it was described as a vision and strategy that is “quite 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 does not go as far as the actions taken by previous FDA deputy commissioners.
Rep. Lisa McClain, R-Mich., the subcommittee chair, acknowledged that Abbott and the broader infant formula industry share some of the blame and must be held accountable for any negligence.
But she said the FDA is “just as guilty.”
“What was reported today by the witnesses was most remarkable. The FDA must be held accountable to Congress and the American people for its lack of transparency,” McClain said. She added, “I hope we can make the necessary changes for the American people, especially for parents out there with newborns.”
Since the recalls, both Abbott and the FDA — as well as the broader infant formula industry — have come under close scrutiny.
The company said in January the Justice Department was investigating behavior at its Michigan infant formula plant. Last May, the Federal Trade Commission launched an investigation into whether mergers in the baby food industry contributed to the current shortage. Multiple congressional oversight hearings have also scrutinized key officials that lawmakers believe could have done more to prevent the shortage, such as: B. FDA Commissioner Dr. Robert Califf.
The Biden administration has taken steps to alleviate the shortage. The president invoked the Defense Production Act in May to increase formula manufacturing. The White House also announced last year that the US would ship bottles of baby formula from abroad by air.