Infant formula made by Abbott Nutrition is linked to at least two deaths. It has tested positive for a deadly bacteria at least twice since 2019. The FDA cited newly released records last month while announcing a recall of products Abbott made.
Abbott issued the recall over concerns of bacterial contamination in several products that include certain Similac, Alimentum, and EleCare brands which are linked to the deaths of at least two infants, as well as multiple illnesses. The risk stems from a rare and deadly bacteria called Cronobacter sakazakii.
However, Abbott told Consumer Reports that it shared those test results with the FDA during an inspection in September 2021, just as the first death from the rare bacteria was reported.
The revelations should raise concerns among lawmakers and tax payers that the FDA could have acted sooner to pull infant formula from the market.
Lawmakers and citizens have reasonably questioned whether the FDA had a chance to catch the problem sooner. The agency said it first learned in September 2021 about a possible link between Abbott’s powdered infant formula and cronobacter, a rare and deadly infection. However, FDA didn’t issue the recall until four months later, following reports that at least two infants had died and others were hospitalized after consuming formula. The FDA and the CDC say they are investigating the reports.
FOIA Requests reveal FDA Inspection Reports
The new records, released earlier this month in response to Consumer Reports’ and other news organizations’ FOIA requests, include agency inspection reports in 2019, 2021, and 2022. The reports show that the FDA had documented serious and ongoing safety concerns at Abbott’s plant just as the outbreak emerged this month.
However, the FDA did not appear to make the company’s testing records a concern until additional reports of death and illness emerged.
A spokesperson for Abbott said the company is taking the situation “very seriously and working closely with the FDA to implement corrective actions.”
“We have already begun implementing corrective actions and enhancements at the facility,” said the spokesperson, “leveraging new technology and strengthening our processes, to give parents and customers renewed confidence in the quality of manufacturing at our Sturgis plant when we restart operations there.”
Genetic Makeup Dispute
The spokesperson also said no infant formula comes into direct contact with areas in the Sturgis factory where Cronobacter was found, and that its testing did not detect that bacteria or salmonella in any of the products it distributed to consumers. The Abbott spokesperson also said the genetic makeup of the Cronobacter sakazakii microbes found in nonproduct areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases.
Director of food safety and research at Consumer Reports, Dr. James E. Rogers, said cronobacter may still have been present in other untested samples of product distributed to consumers. He also said Abbott’s statement on the genetic makeup of cronobacter strains found at the company’s facility and in sick infants is puzzling.
“I am not sure why Abbott would emphasize this fact because plants can contain multiple strains of a pathogen,” said Dr. Rogers. “Just because the patient strains and those isolated so far don’t match does not mean that the patients were not, or could not be, sickened by cronobacter from infant formula.”
Questions for FDA
When the FDA announced the recall, the agency said that several samples it took at Abbott’s lab last month revealed cronobacter in several locations. FDA said the company’s own records showed that infant formula was previously destroyed because of bacterial contamination.
But questions have continued to rankle about what the FDA knew as the first reports of bacterial infections emerged.