FDA investigated more infant deaths linked to Abbott plant than previously known: report

The Food and Drug Administration (FDA) reportedly investigated seven more infant deaths due to consumption of contaminated infant formula from the Michigan Abbott Nutrition plant than previously known.

The Washington Post, citing newly released documents, said 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 became ill after consuming formula containing cronobacter sakazakii bacteria.

The newspaper said the agency acknowledged Friday that it had received such additional reports and was unable to identify the source of the infection in all cases.

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The FDA and Abbott Nutrition did not immediately respond to FOX Business’ request for comment.

The complaints were first reported by eFoodAlert and obtained in response to a Freedom of Information Act (FOIA) request.

Two of the deaths were accounted for with the four confirmed outbreak cases identified by the US Centers for Disease Control and Prevention (CDC), the website said, with two of the others seven deaths reported to the FDA about the agency’s consumer complaint system that mentions Salmonella in the description of the complaint.

Maryland Formula

Yury Navas, 29, of Laurel, Maryland, kisses her two-month-old baby, José Ismael Gálvez, at Superbest International Market in Laurel, Maryland, on Monday, May 23, 2022, while looking for formula. (AP Photo/Jacquelyn Martin/AP Newsroom)

eFoodAlert said that consumers described twenty-five (25) incidents categorized as “Life Threatening Injuries/Illnesses” and eighty (80) cases of “Non-Life Threatening Injuries/Illnesses”.

The seriousness of the complaints was not corroborated by the professionals, except in the case of death or confirmed presence of a bacterium.

The children’s identities were not made public.

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In a statement to The Washington Post, the FDA said that based on its review and investigation of the complaints published in the FOIA request, “only four complaints could be included in the series of cases associated with the Abbott Nutrition investigation.”

“Abbott performs microbiological testing on products prior to distribution and no Abbott formula is distributed to consumers tested positive for Cronobacter sakazakii or Salmonella. All retained products tested by Abbott and the FDA during the facility inspection were negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility,” Abbott Nutrition said in its own statement.

The CDC’s Brian Katzowitz reportedly said there is no pending evidence related to the investigation.

The Sturgis plant restarted production a week ago, after shutting down in February.

That closure caused a nationwide supply shortage which is expected to persist into the summer. The FDA has faced criticism for taking months to shut down the plant and FDA Commissioner Robert Califf told lawmakers their response was “too slow” with “suboptimal” decision-making.

“We will ramp up production as quickly as we can while meeting all requirements,” Abbott Nutrition 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.

Associated Press contributed to this report.

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