AS many as nine children have died since early 2021 due to baby formula possibly contaminated at a factory in Michigan, according to new documents.
The Food and Drug Administration has investigated these claims, previously stating that only two children had died and two others were sickened after consuming the formula from the Sturgis plant.
However, the agency said on Friday that more reports were received of more children that either died or became sick after drinking the formula that allegedly contained the bacterium cronobacter sakazakii.
The FDA was unable to determine the source of the infection in all nine fatalities as, in some cases, there wasn't enough formula leftover to test.
For the babies who died of infections from the bacteria, test results showed different strains than what was found at the Sturgis plant during an inspection.
Now questions are being raised how Abbott Nutrition's maintenance of the plant, which makes a large share of the nation's powdered formula supply.
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There are also doubts about how the FDA handled the complaints against the Sturgis factory, which has been shut down for five months from safety concerns – resulting in the nationwide shortage of baby formula.
About four million 8-ounce bottle equivalents of infant formula will be sent to the US by June 19th to help offset the shortage.
The reports of the infant's deaths were included in a list of 128 consumer complaints collected by the FDA from the agency's consumer complaint system between December and March.
The names of the babies have not been made public and have only been identified by their case numbers.
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"The FDA takes its responsibility seriously to ensure the foods we eat are safe and meet our rigorous standards for quality and safety," said an FDA spokesperson in a statement.
"Based on FDA’s thorough review and investigation of all 128 consumer complaints reported to the agency and recently released to media in response to a FOIA request, only four complaints could be included in the case series associated with the Abbott Nutrition investigation."
Abbott Nutrition stated that no causal relationship had been established 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," said the company in a statement.
"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," 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 were sickened after drinking the formula made by Abbott.
He claimed the reports are evidence of systemic 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," he said.
The Centers for Disease Control and Prevention confirmed that the bacteria had been present at the factory and performed tests, however, the source of the infection – whether it was 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 health communication specialist for the CDC, Brian Katzowitz.
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The Sturgis plant was reopened on Saturday and investigators from the FDA were on site for several days to observe the facility.
"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 Farber, senior vice president for government affairs for the Environmental Working Group.
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