As many as nine children have died from potentially contaminated baby formula at a Michigan factory since early 2021, according to new documents.
The Food and Drug Administration has investigated these claims and previously found that only two children died and two others were sick after consuming the formula made from the Sturgis plant.
However, the agency said on Friday that more reports had come in of more children either dying or becoming ill after drinking the formula, which allegedly contained the bacterium Cronobacter sakazakii.
The FDA was unable to determine the source of infection in all nine deaths because, in some cases, there wasn’t enough formula left for testing.
For the babies who died from infections caused by the bacteria, test results showed different strains than those found during an inspection at the Sturgis plant.
Now questions are being raised about how Abbott Nutrition maintains the facility, which accounts for a large portion of the country’s powdered formula supply.
There are also doubts about how the FDA has handled complaints against the Sturgis factory, which was closed for five months over safety concerns – leading to a nationwide baby formula shortage.
The reports of the infant’s death were added to a list of 128 consumer complaints the FDA collected from the agency’s consumer complaint system between December and March.
The babies’ names were not released and were identified only by their case numbers.
“The FDA takes seriously its responsibility to ensure that the foods we eat are safe and meet our strict quality and safety standards,” an FDA spokesman said in a statement.
“Based on the thorough review and investigation of all 128 consumer complaints reported to the agency and recently released in response to a FOIA request from the FDA, only four complaints were included in the case series related to Abbott Nutrition’s investigation.”
Abbott Nutrition stated that no causal relationship between Abbott’s products and any of the reported deaths had been established.
“Abbott performs microbiological testing on products prior to distribution, and no Abbott formula distributed to consumers has tested positive for Cronobacter sakazakii or Salmonella. All retained product tested by Abbott and the FDA during the facility inspection was negative for Cronobacter sakazakii and/or Salmonella. No salmonella was found at the Sturgis facility,” the company said in a statement.
“There appears to have been no sense of urgency within the FDA to address a worsening situation at a manufacturing facility that in many instances was the sole source of food for a vulnerable population,” said Phyllis Entis, a food safety expert who first reported the complaints.
Attorney Sam Geisler is representing over two dozen families who said their children became ill after drinking the formula made by Abbott.
He claimed the reports were evidence of systemic issues at the Sturgis facility.
“With every development, it’s becoming clearer and clearer that the babies were the final consideration on the part of regulators and the company,” he said.
The Centers for Disease Control and Prevention confirmed the bacteria was present at the factory and ran tests, but the source of the infection – whether it was the formula or something else – could not be determined.
“The CDC has not been notified at this time of any additional cases received through the consumer complaint system and there are no pending tests related to this investigation,” said Brian Katzowitz, the CDC’s health communications specialist.
The Sturgis facility reopened Saturday and FDA investigators were on site for several days to monitor the facility.
“The crisis that has impacted 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 resources and governance necessary to make food safety a… priority,” said Scott Farber, senior vice president for government affairs for the Environmental Working Group.
https://www.the-sun.com/news/5555127/baby-deaths-contaminated-formula-sturgis-michigan-factory/ Nine children are dead and dozens more sick after eating baby food made at a contaminated factory