The dangerous bacteria that sparked powdered formula recalls and shortages last year has infected two babies this year, killing a Kentucky child and causing brain damage in a Missouri infant.
Federal health officials confirmed Thursday that two cases of invasive infections caused by cronobacter sakazakii have been reported in 2023, both in infants who consumed powdered infant formula made by Abbott Nutrition, the company at the center of the 2022 crisis.
Food and Drug Administration officials said there was no evidence that the infections were linked to manufacturing and no reason to issue new recalls. The bacteria are found naturally in the environment and also can make their way into infant formula after the packaging is opened.
"There is no indication of a broader public health concern related to this product at this time," the FDA said in a statement.
Kentucky health officials notified the Centers for Disease Control and Prevention on Nov. 15 that a child who consumed Similac Total Care powdered formula died after being infected with cronobacter sakazakii.
In Missouri, 6-week-old Mira White, of Sikeston, was diagnosed in early March with a brain infection caused by the bacteria, which was detected in an open container of Similac NeoSure formula in her home.
The same type of bacteria led federal investigators to shut down an Abbott formula plant in Sturgis, Michigan, last year when inspections sparked by four infant illnesses, including two deaths, showed widespread contamination in the plant.
Since falling ill, Mira has suffered nearly constant seizures and inconsolable bouts of crying, said her 33-year-old mother, Asian Davis. Brain scans showed neurological damage and missing tissue caused by the infection.
"It affected her brain real bad," Davis said. "She'll grow, but it will be a slow progress."
FDA investigators said they "did not identify a causal link" between Mira's infection and the Casa Grande, Arizona, factory that made the formula marketed for premature babies. Abbott officials said they found no cronobacter in batches of formula at the plant. The bacteria also weren't found in unopened cans of Similac NeoSure formula from Mira's home.
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In Kentucky, the FDA said it "has not found evidence" of contamination after a Nov. 21 inspection at an Abbott plant. Officials did not identify the child or the location of the plant.
Abbott officials said there is no evidence that conditions at the company's manufacturing plants or contamination in sealed products caused the illnesses.
Frank Yiannas, a former FDA official in charge of food safety response, cautioned that a negative test does not guarantee there's no contamination.
"A positive test result means a lot. A negative test result doesn't mean anything," he said.
Food safety advocates say the tragic cases underscore the overlooked risk of powdered formula, particularly for babies born prematurely, as Mira was. And it highlights the need for better education for parents and caregivers about how to prepare and use the crucial food.
Many people don't understand that powdered infant formula isn't sterile, said Mitzi Baum, chief executive of the nonprofit group STOP Foodborne Illness.
The powder itself can harbor potentially dangerous germs — and it is easily contaminated by sources in the home. Cronobacter sakazakii bacteria are common in soil and surface water, as well as dry foods.
Very young babies and those born prematurely are vulnerable to illnesses caused by the germ because their immune systems aren't developed enough to fight it off.
Earlier this year, the CDC warned parents to wash their hands and to sterilize equipment and the environment before feeding newborns. The warning followed the 2022 death of a baby from a cronobacter sakazakii infection tied to a contaminated breast pump.
The CDC typically receives two to four reports per year of invasive disease caused by cronobacter, though officials believe that's an undercount. Starting Jan. 1, the agency will begin formally tracking illnesses from the germ. Powdered infant formula is the most common cause of cronobacter infections in babies, the agency said.
Asian Davis said she had never heard of cronobacter sakazakii before Mira got sick.
The girl was hospitalized for weeks after her premature birth in January, but was developing normally when she went home in February. In March, within days of feeding Mira the formula, Davis noticed a difference.
"She stopped eating and sucking," Davis recalled. "That mother instinct came in and I said, 'Something's wrong with my baby.'"
After a battery of tests, doctors diagnosed Mira with bacterial meningitis caused by cronobacter sakazakii found in her spinal fluid and blood.
On Monday, lawyers representing Davis and her daughter moved to sue Abbott, claiming the company sold a defective product and that it should have warned parents of premature babies that powdered formula can cause serious disease. Officials at the Illinois court where the lawsuit was sent said civil claims can take days to process and that the case was not yet in its system.
The pending lawsuit also includes the family of a second child — Ryker Brown, of DeKalb, Illinois — who developed bacterial meningitis and brain damage in 2021 caused by a cronobacter infection after consuming Similac NeoSure formula. It's not clear how he became infected.
The Abbott plant in Michigan is still being monitored under a legal agreement with the FDA.
The agency, which came under fire for a slow response to previous cronobacter illnesses, warned three other U.S. formula makers in August to step up efforts to prevent contamination at manufacturing plants.
Davis, a single mother with four older children, has been unable to work at her job as a certified nursing assistant because of Mira's severe needs. She said she joined the lawsuit to raise awareness about the dangers of the rare bacteria — and to provide financially for Mira's future care.
"She will need surgeries, she might need a wheelchair," Davis said. "She might need that stuff for the rest of her life."
