DeLauro Statement on Additional Infant Deaths and Hospitalizations Reported to FDA during Abbott Nutrition Investigation

Congresswoman Rosa DeLauro today issued a statement in response to a report that the Food and Drug Administration (FDA) received nine reports of infant deaths and additional illnesses among babies who were fed powdered infant formula manufactured by Abbott Nutrition in Sturgis, MI:

"We now know that contrary to initial reports, nine babies who were fed Abbott powdered infant formula manufactured in their Sturgis, Michigan facility have died," said Congresswoman DeLauro. This is heartbreaking and shameful. Many of these deaths could have likely been prevented if Abbott Nutrition and the FDA did not drag their feet to investigate credible allegations of substandard food safety practices at the plant. And what is deeply disturbing is the timeline in which these events unfolded.

"In February 2021, an entire year before the voluntary recall, Abbott and the FDA were alerted to allegations concerning problems at the Sturgis, Michigan manufacturing facility through a complaint filed by an employee. The problems included failing equipment in need of repair and formula released without adequate evidence that it was safe for consumption. Abbott confirmed receipt and submitted a formal response to the complaint two months later.

"Despite knowing this information, it was not until September 2021 that the FDA conducted a routine inspection of the facility and learned of the potential link between a specific rare and deadly foodborne pathogen and powdered infant formula manufactured by Abbott. At the same time, an infant in Minnesota given formula manufactured in Abbott's Sturgis, Michigan facility was diagnosed with Cronobacter sakazakii. This was the first case reported.

According to a new report, between December 1, 2021 and March 3, 2022, the FDA received nine reports of infant deaths and over 100 health-related complaints among babies who were fed powdered infant formula manufactured by the Abbott Nutrition facility in Sturgis, Michigan.

In addition to the nine deaths, consumers described over 100 life-threatening and non-life-threatening incidents suffered by infants. The documented symptoms include fever (31 babies), vomiting (42 babies), diarrhea (47 babies), and blood in stool (6). Most babies suffered from multiple symptoms. Other reported symptoms included loss of appetite, rash, lethargy, dehydration, irritability, weight loss, and difficulty breathing.

"While these infants suffered from different symptoms, there remains one constant: The sick babies were fed an Abbott powdered formula," DeLauro continued. "Each new revelation begs more questions.

"Why did FDA not immediately investigate the causes of these deaths linked to powdered infant formula? Why was a whistleblowers report outlining credible allegations of wrongdoing not immediately escalated both times the FDA received it? And why did Abbott wait months after reports of infant deaths and hospitalizations to finally recall their contaminated product? I expect Abbott and the FDA to answer to these questions.

"I extend my condolences to the families and parents who lost their babies, and I vow I will not stop fighting to uncover what went wrong. Once we get to the bottom of what went wrong, I expect the individuals responsible for this crisis to be held accountable."

Chair DeLauro has been closely tracking this issue since Abbott Nutrition first announced the formula recall which has driven the nationwide shortage. She examined the recall at a hearing and submitted for the record a report acquired from a whistleblower who worked at the Abbott facility which produces infant formula recalled by the Food and Drug Administration (FDA) in February. She has also requested an investigation into the FDA's handling of the Abbott powdered formula recall, which the Health and Human Services Office of Inspector General recently announced they would investigate. She also has requested an additional investigation into the FDA's recent enforcement discretion process to ensure that imported infant formula is safe and being tested and monitored.

DeLauro has also introduced legislation to ensure that an infant formula shortage caused in part by lax food safety practices cannot potentially happen again, and would make Cronobacter sakazakii a reportable disease so that it can be monitored and responded to.