Infant Formula Crisis Could Recur, Former FDA Official Tells Congress

WASHINGTON — U.S. lawmakers on Tuesday debated if enough has changed to prevent a repeat of the infant formula shortage, more than a year after a nationwide crisis began. 

The U.S. House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services heard from two experts that while the U.S. Food and Drug Administration has made some structural changes, infant formula manufacturers are still not required to notify the FDA if they detect certain types of bacteria at their facilities. 

“The state of the infant formula industry today is not much different than it was then — the public health surveillance system for this pathogen remains insufficient, the necessary safeguards have not been advanced at an adequate pace to prevent future illnesses and the infant formula supply chain continues to lack serious resilience,” said Frank Yiannas, former deputy commissioner of the FDA Office of Food Policy & Response from 2018 to 2023.

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

Subcommittee Chairwoman Lisa McClain, a Michigan Republican, criticized the FDA for its response to the 2022 infant formula crisis, saying it “underscores a major problem with the FDA.”

“The FDA is responsible for 78% of the U.S. food supply, but the FDA is not prioritizing food safety,” McClain said. 

McClain rebuked FDA leadership for holding onto a whistleblower complaint about unsafe and unsanitary conditions at Abbott Nutrition’s infant formula facility in Sturgis, Michigan for about four months before it inspected the site. 

In a hearing last year, the head of the FDA, Robert Califf, told Congress he found no evidence of intentional delay or malfeasance within the agency — though it took months to act on the whistleblower report of what he called “egregiously unsanitary” conditions at the Sturgis plant. No current FDA official testified at Tuesday’s hearing.

California Democratic Rep. Katie Porter, the ranking member on the panel, questioned if such a delay would happen now if another whistleblower report made its way to the FDA. She also asked if the infant formula supply chain within the United States has diversified enough to handle one plant shutting down. 

“This is partially an FDA problem, but it is also partially a big business problem. And Republicans and Democrats can’t pick and choose who to hold accountable,” she said. 

Porter said while she expected many lawmakers to bash the FDA during the hearing, “discrediting an agency without figuring out what went wrong and how to fix it is simply malpractice.”

“I’m not afraid to say that the FDA has a lot of work to do, no matter who that offends. At the same time, I’m not afraid to say that Congress is part of the problem. We have to empower the FDA for it to succeed,” Porter said. 

Abbott Nutrition and other food suppliers, Porter added, are ultimately “responsible for producing safe products.”

Porter charged that Congress must “stop turning a blind eye to consolidation in our food markets,” noting that “Abbott is one of three companies that control 90% of the formula market.”

“They have very few incentives to self regulate when they are so powerful, but that doesn’t mean we can let Abbott off the hook for its negligent behavior,” Porter said. 

Peter Lurie, president and executive director for the Center for Science in the Public Interest, said that if lawmakers were looking for a spot to place blame, “the best place to start is at the Abbott Nutrition plant that produced the formula.”

“It was there that infant formula with Cronobacter was destroyed years before the outbreak without FDA being notified,” Lurie said, noting the whistleblower report detailed lax cleaning, falsified records, and relevant information hidden from FDA inspectors.

Preventing and managing future food crises, Lurie said, would require changes to the FDA’s authority, funding and organizational structure.   

“No mother, no father, should ever again face a desperate store-by-store search for a product, simply to nourish their infants.”

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