In all nine deaths, the agency was unable to identify the source of the infection. In some cases, there were not enough residues of the formula to test. Of the babies who died from Cronobacter infections, genomic sequencing showed strains other than those discovered at the Sturgis facility during an inspection this spring.
But the revelation deepens the questions about Abbott’s maintenance of the plant, which makes up a large part of the country’s powder formula supply. There are also further doubts about the FDA’s handling of complaints related to the Sturgis factory, which was closed for five months due to food safety problems, which contributed to a nationwide shortage of baby substitutes.
The complaints were first reported by eFoodAlert and food safety expert Phyllis Entis, who obtained them through a Freedom of Information Act request.
The recently 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. The identities of the dead children were not made public and identified only by case number.
“The FDA takes its responsibility seriously to ensure that the food we eat is safe and meets our strict standards of quality and safety,” an FDA spokesman said in a statement. “Based on the FDA’s thorough review and investigation of all 128 consumer complaints reported to the agency and recently released to the media in response to a FOIA request, only four complaints could be included in the case series related to the Abbott Nutrition investigation.”
In a statement on Friday, Abbott Nutrition said no causal link had been established between Abbott’s products and any of the reported deaths.
“Abbott performs microbiological tests on products before 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 plant came back negative for Cronobacter sakazakii and / or Salmonella. No Salmonella was found at the Sturgis plant, it is stated in Abbott’s statement.
“There does not appear to be any sense of urgency in the FDA to deal with a deteriorating situation in a manufacturing facility that in many cases was the sole source of food for a vulnerable population,” Entis told The Washington Post in a statement.
Sam Geisler, a lawyer representing more than two dozen families who say their children became ill after consuming formula made by Abbott, said the reports are evidence of systemic problems at the Sturgis plant.
“With each development, it becomes clearer and clearer that the babies were the latest assessment from regulators and the company,” Geisler said.
In congressional testimony, FDA Commissioner Robert M. Califf described the conditions at the facility as “appalling.” But Califf’s agency has also been criticized 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 cases of “non-life-threatening illness / injury”. The severity of the complaints was not confirmed by medical professionals, except in the case of death or confirmed presence of a bacterium such as salmonella or cronobacter.
The Centers for Disease Control and Prevention confirmed the presence of the bacteria and performed genome sequencing in the four previously revealed cases, although the source of the infection – either formula or something else – could not be confirmed.
“The CDC has not been notified of any further cases received through the Consumer Complaints System at this time, and there are no pending tests associated with this investigation,” said Brian Katzowitz, CDC Health Communications Specialist.
The Sturgis facility 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 paralyzed parents’ ability to find the formula they need to feed their babies could have been avoided if the FDA had the resources and leadership structure to make food safety a priority,” said Scott Faber, senior vice president of government affairs for the Working Group on environment.
Califf said in hearings at Capitol Hill last month that once the baby replacement crisis was resolved, the agency would focus on reorganizing the FDA’s food safety leadership.