The Food and Drug Administration investigated complaints that as many as nine children died after drinking baby formula produced at an Abbott Nutrition plant in Michigan since early 2021 – seven more than previously confirmed by the FDA.
 
The FDA earlier stated that two children died and two others became ill after drinking formula containing the bacterium cronobacter sakazakii from the Sturgis facility. However, the agency admitted on Friday that it has received new allegations of children dying or becoming ill after allegedly drinking formula prepared in the country.

The government was unable to determine the source of the virus in any of the nine fatalities. There was not enough leftover formula to test in certain circumstances. The genetic sequencing of the babies who died from cronobacter illnesses revealed different strains from what was detected at the Sturgis factory during an inspection this spring.

Abbott Nutrition mismanagement 

However, the revelation raises new concerns about Abbott's management of the factory, which produces a significant portion of the nation's powdered formula supply. It also casts further questions on the FDA's handling of complaints concerning the Sturgis factory, which was closed for five months due to food safety issues, contributing to a statewide scarcity of baby formula.

eFoodAlert and food safety expert Phyllis Entis first reported the concerns, which she got through a Freedom of Information Act request.

Newborn deaths 

The newly reported newborn deaths were among 128 customer complaints received by the FDA through its consumer complaint system between December and March. The identities of the deceased children were not made public, and they were only known by case number.
 
“The FDA takes its responsibility seriously to ensure the foods we eat are safe and meet our rigorous standards for quality and safety,” an FDA spokesman said in a statement.

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Abbott Nutrition said in a statement Friday that no causal association has been found between Abbott's products and any of the reported deaths.

“Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella. All retained products tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility,” Abbott’s statement said.

“There appears to have been no sense of urgency within the FDA to address a deteriorating situation in a production facility that was, in many cases, the sole source of nourishment to a vulnerable population," Entis told The Washington Post in a statement.

According to Sam Geisler, an attorney who represents more than two dozen families who claim their children became ill after drinking Abbott formula, the claims are proof of widespread problems at the Sturgis facility.

“With every development, it becomes clearer and clearer that the babies were the last consideration on the part of regulators and the company,” Geisler said.

FDA Commissioner Robert M. Califf described the plant's circumstances as "egregious" in congressional testimony. However, Califf's office has also come under fire for failing to respond fast to concerns about its operations.
 
In addition to the nine deaths, consumers who filed complaints described 25 cases as "life-threatening illness/injury" and 80 incidents as "non-life-threatening illness/injury." Medical specialists did not validate the severity of the complaints, except in the case of death or the detection of a bacteria such as salmonella or cronobacter.

Confirmed bacteria 

In the four previously publicized cases, the Centers for Disease Control and Prevention confirmed the existence of the bacteria and performed genome sequencing, but the source of the infection — whether the formula or something else — could not be determined.

“The CDC has not been notified of additional cases received via the consumer complaint system at this time and there is no pending testing related to this investigation," said Brian Katzowitz, health communication specialist for the CDC.
 
On Saturday, the Sturgis factory reopened. The FDA has investigators on site for several days to observe facility upgrades as one of several prerequisites for reopening.

“The crisis that has crippled the ability of parents across the country to find the formula they need to feed their babies could have been avoided if the FDA had the necessary resources and leadership structure to make food safety a priority,” said Scott Faber, senior vice president for government affairs for the Environmental Working Group.

During congressional hearings last month, Califf stated that once the baby formula crisis was resolved, the FDA would focus on reforming its food safety leadership.

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