FDA investigated more baby deaths related to Abbott plant than previously known: report
FDA, Abbott Nutrition say there’s no evidence formula caused the deaths
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The Food and Drug Administration (FDA) reportedly investigated seven more child deaths due to the consumption of contaminated baby formula from the Michigan Abbott Nutrition plant than was previously known.
The Washington Post, citing newly released documents, said that the agency investigated reports that as many as nine children had died since March 2021.
Previously, the FDA said two children had died and two were sickened after consuming formula that contained the bacterium cronobacter sakazakii.
The paper said the agency acknowledged Friday that it had received such additional reports, being unable to identify the source of the infection in all cases.
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Abbott told FOX Business in a statement that "there is no causal relationship between Abbott’s products and 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," the company said. "All retained product 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."
The complaints were first reported by eFoodAlert, and obtained in response to a Freedom of Information Act (FOIA) request.
An FDA spokesperson told FOX Business that the agency takes its responsibility seriously to ensure the foods the U.S. eats are safe and meet rigorous quality and safety standards.
"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," the agency said.
Two of the deaths were tallied with the four confirmed outbreak cases identified by the U.S. Centers for Disease Control and Prevention (CDC), the website said, with two of the other seven deaths reported to the FDA on the agency's consumer complaint system mentioning salmonella in the complaint description.
Yury Navas, 29, of Laurel, Md., kisses her two-month-old baby Jose Ismael Gálvez, at Superbest International Market in Laurel, Md., Monday, May 23, 2022, while looking for formula. (AP Photo/Jacquelyn Martin / AP Newsroom)
EFoodAlert said consumers described 25 incidents categorized as "Life Threatening Illness/Injury" and 80 instances of "Non-Life Threatening Illness/Injury."
The severity of the complaints was not corroborated by professionals, except in the case of death or the confirmed presence of a bacteria.
The FDA spokesperson said that two of the nine deaths were previously reported as part of the investigation and – based on whole-genome sequencing of cronobacter – that it was unable to definitively demonstrate the deaths were attributable to the consumption of an Abbott product.
"There is no scientific evidence linking the other seven deaths with the evidence from those case complaints and our investigation of the Abbott Nutrition Sturgis plant, including extensive product testing, which is why these additional complaints were not previously made public in connection with the Abbott investigation," an FDA spokesperson said.
The identities of the children were not made public.
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CDC spokesperson Brian Katzowitz allegedly said there is no pending testing related to the investigation.
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The Sturgis plant restarted production a week ago, after shutting down in February.
That shutdown led to a nationwide supply shortage that is expected to persist into the summer. The FDA has faced criticism for taking months to close the plant and FDA Commissioner Robert Califf told lawmakers that its response was "too slow" with "suboptimal" decision-making.
"We will ramp production as quickly as we can while meeting all requirements," Abbott said in a statement.
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Abbott Vice President Christopher Calamari apologized to parents for the shortage.
"We’re going to learn from this. We’re going to get better as a result of this," he said.
The Associated Press contributed to this report.
This story has been updated to include comments from Abbott Nutrition and the Food and Drug Administration