THE FDA has announced that it was notified of another baby formula-related infant death, bringing the total casualties to ten, new documents show.
This comes after an increasing number of infants have died since early 2021 due to the formula possibly being contaminated at a Michigan factory.
Abbott began a recall of its formula product in February and closed the Michigan plant.
The FDA previously reported that two children had died and two were sick due to the formula, but the number continues to grow.
Over a week ago, the FDA said more reports were received of several children who had died or become sick after drinking the formula that allegedly has a dangerous bacteria.
The formula from the Sturgis plant has contained the bacterium cronobacter sakazakii, experts believe.
The agency 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.
This continues to affect the ongoing issue of the baby formula shortage.
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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.
"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.
Phyllis Entis, a food safety expert who first reported the complaints, slammed the FDA's "lack of urgency."
"[There's] 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 Entis.
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.
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.