The Food and Drug Administration investigated reports that as many as nine children have died since early 2021 after consuming baby formula produced at an Abbott Nutrition plant in Michigan — seven more than previously acknowledged by the FDA, according to newly released documents.
In all nine fatalities, the agency was unable to identify the source of the infection. In some cases, there was not enough leftover formula to test. Of the babies who died of infections from cronobacter, genomic sequencing turned up different strains than what was discovered at the Sturgis plant during an inspection this spring.
But the disclosure deepens questions about Abbott’s maintenance of the plant, which makes a large share of the nation’s powdered formula supply. It also raises further doubts about the FDA’s handling of complaints related to the Sturgis factory, which was shuttered for five months over food safety concerns, contributing to a nationwide shortage of baby formula.
The complaints were first reported by eFoodAlert and food safety expert Phyllis Entis, who obtained them through a Freedom of Information Act request.
The newly reported infant deaths were included in a list of 128 consumer complaints collected by the FDA via the agency’s consumer complaint system between December and March. Identities of the dead children were not made public and identified only by case number.
“The FDA takes its responsibility seriously to ensure the foods we eat are safe and meet our rigorous standards for quality and safety,” an FDA spokesman said 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.”
In a statement Friday, Abbott Nutrition said 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 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,” Abbott’s statement said.
“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," Entis told The Washington Post in a statement.
Sam Geisler, an attorney representing more than two dozen families who say their children were sickened after consuming formula made by Abbott, said 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,” Geisler said.
In congressional testimony, FDA Commissioner Robert M. Califf described conditions at the plant as “egregious.” But Califf’s agency has also come under fire for not acting quickly on complaints about operations there.
In addition to the nine deaths, consumers who submitted complaints described 25 incidents reported by the complainants as “life-threatening illness/injury” and 80 instances of “non-life-threatening illness/injury.” The severity of the complaints were not corroborated by medical professionals, except in the case of death or confirmed presence of a bacteria like salmonella or cronobacter.
The Centers for Disease Control and Prevention confirmed the presence of the bacteria and performed genome sequencing in the four previously disclosed cases, though the source of the infection — whether the formula or something else — could not be confirmed.
“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 Brian Katzowitz, health communication specialist for the CDC.
The Sturgis plant reopened on Saturday. The FDA has had investigators on site for several days to observe improvements made to the facility as one of several conditions for the reopening.
“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 Faber, senior vice president for government affairs for the Environmental Working Group.
Califf said in hearings on Capitol Hill last month that once the baby formula crisis was resolved, the agency would focus on reorganizing the food safety leadership at the FDA.