In all nine deaths, the agency was unable to identify the source of infection. In some cases, there was not enough formula left to test. Among the babies who died of cronobacter infections, genomic sequencing revealed strains different from those discovered at the Sturgis plant during an inspection this spring.
But the disclosure digs deeper into questions about how Abbott maintains the plant, which accounts for much of the country’s powdered formula supply. It also raises new doubts about the FDA’s handling of complaints related to the Sturgis plant, which was shut down for five months over food safety concerns, contributing to a nationwide formula shortage.
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 through the agency’s consumer complaints system between December and March. The identities of the deceased children have not been made public and identified only by case number.
“The FDA takes seriously its responsibility to ensure that the foods we eat are safe and meet our rigorous quality and safety standards,” an FDA spokesperson said in a statement. “Based on the FDA’s thorough review and investigation of the 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 associated with the Abbott Nutrition investigation.”
In a statement Friday, Abbott Nutrition said no causal relationship has been established between Abbott’s products and any of the reported deaths.
“Abbott performs microbiological testing of products prior to distribution and no Abbott formula distributed to consumers has tested positive for Cronobacter sakazakii or Salmonella. All retained products tested by Abbott and the FDA during the facility inspection have tested negative for Cronobacter sakazakii and/or Salmonella. No salmonella was found at the Sturgis plant,” Abbott’s statement read.
“There appears to have been no sense of urgency within the FDA to deal with the deteriorating situation at a production facility that was, in many cases, the only source of food for 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 fell ill after consuming formula milk made by Abbott, said the reports are evidence of systemic problems at the Sturgis facility.
“With each development, it becomes increasingly clear that babies were the last consideration for regulators and the company,” Geisler said.
In testimony to Congress, FDA Commissioner Robert M. Califf described the conditions at the plant as “egregious.” But Califf’s agency has also been criticized for not responding quickly to complaints about operations there.
In addition to the nine fatalities, consumers who filed complaints described 25 incidents reported by complainants as “fatal illness/injury” and 80 as “non-fatal illness/injury”. The seriousness of the complaints has not been substantiated by medical professionals, except in cases of death or confirmed presence of bacteria such as salmonella or cronobacter.
The Centers for Disease Control and Prevention has confirmed the bacteria’s presence and performed genome sequencing in all four previously disclosed cases, though the source of infection – whether formula or otherwise – could not be identified. be confirmed.
“The CDC has not been notified of any additional cases received through the consumer complaints system at this time and there are no pending tests related to this investigation,” said Brian Katzowitz, communication specialist on the health for the CDC.
The Sturgis plant reopened on Saturday. The FDA had investigators on site for several days to observe the 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 averted if the FDA had the resources and leadership structure to make food safety a priority. “said Scott Faber, senior vice president for government affairs for the environmental task force.
Califf said in hearings on Capitol Hill last month that once the infant formula crisis is resolved, the agency will focus on revamping the food safety directorate at the FDA.