The Washington Post
Powdered formula’s ‘burden’ on parents
Onus of preventing rare but grave infections often falls to families
Jeanine Kunkel had been the healthy twin, the one who came home from the hospital that day in 2008 while her brother James stayed a few nights in intensive care. But within days of arriving, she spiked a fever that sent her back to the hospital.
The newborn had developed an infection — caused, her doctors said, by ingesting formula tainted with the bacteria Cronobacter sakazakii. The infection led to a severe case of meningitis that caused irreparable brain damage. Jeanine’s family sued the formula maker, Abbott Laboratories, arguing the company was responsible for her illness, but a jury found the company not liable. The company’s lawyers dredged up incidents from the family’s past and argued that the bacteria could have come from
anywhere, including the family kitchen.
Jeanine’s situation is rare, but not isolated. Federal regulators and food safety experts have long been troubled by powdered formula’s ability to harbor cronobacter — a bacteria that is harmless for most but can be debilitating or deadly for newborns and others with weak immune systems. The Food and Drug Administration requires formula makers to inspect for cronobacter and have urged neonatal intensive care units to avoid powdered formula.
But information about the risk of cronobacter infections is not trickling down to parents of healthy, full-term babies, who remain vulnerable to infection until about 2 or 3 months, according to experts. New parents are often sent home from the hospital with free samples of powdered formula — and they are rarely urged toward what food safety experts say is a safer and widely available alternative: sterile, ready-to-drink formula sealed at the factory.
“The FDA, CDC and companies know the [powdered] product is not sterile, but moms and dads do not,” said Bill Marler, an attorney who specializes in foodborne illness outbreaks. They “are putting the burden of making this product safe on the consumer before it is fed to their baby.”
In the meantime, an unknown number of babies keep getting sick. The latest cronobacter outbreak occurred last year, when the Food and Drug Administration said four babies fell ill, including two who died, after drinking powdered formula manufactured at an Abbott plant in Michigan. Investigators were not able to identify the source of the bacteria, but the company recalled 5 million units of powdered formula and shuttered the plant for five months to address problems identified by the FDA, sparking a nationwide shortage.
After the incident, the Centers for Disease Control and Prevention changed its website to warn in conspicuous blue highlighting that “powdered formula is not sterile and might have germs in it.
Powdered infant formula can be contaminated in homes or in processing facilities that make it.” The agency said in a statement the adjustment was made in part “to emphasize to parents and caregivers the risks associated with powdered infant formula. We also wanted to raise awareness of the different ways powdered infant formula can become contaminated, and reinforce that infants at highest risk of cronobacter infection might benefit from receiving liquid formula, which is sterile.”
In statements to The Washington Post, the three main U.S. formula makers said they rigorously test for cronobacter before their products leave the factory, often exceeding FDA regulations. The companies — Abbott Nutrition, Reckitt’s Mead Johnson and Nestlé’s Gerber, which together control the majority of the market — voluntarily add warnings to cans of powdered formula noting the product is not sterile and urging guidance from a doctor.
The world has moved on, but time has stood still for Jeanine Kunkel, who remains like a newborn, helpless and bedridden.
“My life is her. I was pushed into that life,” her mother, Megan Surber, said in an interview from her home in Sioux City, Iowa.
Surber said she is sometimes haunted by the suggestion that her daughter’s illness was a result of the lack of cleanliness in her kitchen, or neglect in safely preparing the formula.
“It completely changed me to where I question everything now. Am I good enough? Is this right? Is this wrong?" she said. “I know I did right. I know I did everything. I fed my daughter like I was supposed to. I made it the way I was supposed to.”
Rare but dangerous
Asked about the Kunkel case and that of Slade Sisk, who was also sickened by formula as an infant in 2004, Abbott said it sympathized with the families. “We know that cronobacter is ubiquitous in the environment, including in peoples’ homes,” spokesman John Koval said in a statement. “In both of these cases, after a complete trial in which evidence related to those unfortunate instances was heard, these juries found us not responsible — and they did so based on the facts: that the pathogen came from some other source that wasn’t our product.”
Cronobacter infections are rare, and the vast majority of exposed children will never become ill. Since 2002, the CDC has received 76 reports of cronobacter cases in infants, the agency said. This is likely an undercount, food safety experts say, because health-care providers aren’t required to report cases to the government, as they are with salmonella.
“Because cronobacter is not a nationally notifiable disease, the number of cronobacter infections in the U.S. is not fully known,” said Robert Tauxe, director the CDC’S foodborne, waterborne and environmental diseases division.
But the outcomes can be disastrous for premature infants, newborns and those with compromised immune systems. A 2020 study found that 1 in 5 infants in the United States who developed meningitis or bloodstream infections as a result of cronobacter infections later died. Those who survive can suffer lasting complications.
While federal regulators have enacted policies aimed at protecting preemies and other babies in intensive care, less is done to warn parents of other newborns.
All babies under 2 months are at risk because of their underdeveloped immune systems, said Russell Merritt, director of the intestinal rehabilitation program at Children’s Hospital Los Angeles and a former Abbott Nutrition medical director.
“Infants are born with an immature immune system,” he said. “In the first couple of months of life, we’re still looking at a baby who does not have a totally competent immune system.”
Eradicating cronobacter entirely from factories is difficult, experts say. The pathogen survives especially well in dry environments like powdered formula, unlike other bacteria, said Justin Wiertzema, a microbiologist and senior scientist at Post Consumer Brands who researched cronobacter at the University of Minnesota.
“They are very good or even excellent at surviving at low water activity,” he said.
The bacteria can also make its way into formula at any point of preparation, including in home and day care kitchens, which makes it difficult to track the source or hold people or companies accountable for outbreaks.
U.S. officials began to reconsider the safety of powdered formula after the United States’ first known cronobacter outbreak, in 2001, when eight babies were sickened and another died at a Tennessee hospital after being fed formula prepared from a powder made by Mead Johnson, according to the CDC. Infant formula producers were not checking for the bacteria in their factories at the time, the FDA said. A subsequent FDA investigation found that nearly a quarter of the powdered formulas available on American store shelves and in health-care settings contained cronobacter.
During a 2003 meeting at U.S. Department of Agriculture offices in Riverdale, Md., an Abbott representative acknowledged to FDA and CDC officials that cronobacter had proven to be “a little bit more ubiquitous” in the powdered formula production process than previously thought, according to a transcript obtained by The Post. Representatives of all three major companies said there was no way to sterilize the powder. The discussion led to an FDA requirement that every batch of powdered infant formula be tested for cronobacter and salmonella, an FDA spokeswoman said.
The bacteria again sparked concern in 2011, when four babies in four states were sickened by cronobacter after drinking different brands of powdered formula. An interagency meeting was convened in 2012, federal employees with knowledge of the meeting told The Post, this time focused on mothers in the federal food assistance program known as WIC.
At the time, most mothers were permitted by their states to buy only powdered formula, rather than the sterile liquid. Agency scientists proposed that the federal WIC program expand the number of “neonates,” or newborns, allowed to use benefits to purchase sterile liquid formula. But the proposal did not advance, largely because liquid formula is more expensive and it would drive up the cost for state WIC programs and families, said one scientist present.
“Everyone was concerned about infants’ safety, but the cost was a real factor. There was also a little concern about the potential stigmatization of powdered formula,” the scientist recently told The Post on the condition of anonymity because the person was not authorized to speak publicly on the subject.
Many parents don’t know to ask for sterile liquid formula, the scientist said, because medical professionals don’t push it.
“I’m a pediatrician and in medical school got extremely little education about formula and how to prepare it and the risks and benefits,” the scientist said. “I believe there is a very large gap across pediatric and obstetric education, and in talking to mothers about how to feed their infants.”
WIC recipients purchase the majority of the nation’s supply of baby formula, according to USDA estimates. The program had 6.2 million women and children in the program last year, including 1.5 million infants. Many state WIC programs require a doctor’s note or special permission from a WIC agent to get sterile liquid formula.
The United States is one of the few nations that has not signed on to the World Health Organization’s Code of Marketing BreastMilk Substitutes. The code calls for a prohibition of free formula samples at hospitals, among other marketing limits.
It also says the water used to reconstitute powdered formula should be heated to 158 degrees Fahrenheit (70 degrees Celsius), about the temperature of very hot coffee, to kill pathogens like cronobacter.
The FDA requires powdered U.S. formula labels to contain warning language such as “the health of your infant depends on carefully following the directions for preparation and use,” though most manufacturers go further than that.
“Many manufacturers’ labels voluntarily note that infant formula is not sterile and should not be used by premature infants or infants suffering from immune problems unless directed to do so by a physician,” the Infant Nutrition Council of America, a formula industry lobbying group, said in a statement.
But U.S. formula makers do not recommend using water heated to 158 degrees because of the risk of burns and because the heat could kill nutrients or cause the formula to clump, the organization said.
Minnesota is the only state where cronobacter is a reportable pathogen — meaning when it is identified by doctors or laboratories, it must be reported to the state, which must then notify the CDC. Minnesota officials discovered the first infection of the 2021 cluster and reported it to the FDA. That led the CDC, clinicians and state and local health departments to exchange information to turn up other cases in Texas and Ohio.
Since Minnesota started keeping track in 2003, the state has logged one to three cronobacter cases per year, compared with about 800 cases of salmonella, according to the state Department of Health — a relatively tiny number that Wiertzema of Post Consumer Brands said has dampened efforts in other states to require reporting.
“More and more we’re now seeing these little outbreaks, and you shouldn’t even say little outbreaks,” he said. “Food scientists, microbiologists, we don’t even want one death.”
A disease or pathogen becomes “nationally notifiable” when CDC, state officials and the Council of State and Territorial Epidemiologists, a nonprofit organization, jointly determine it should be added to the list of roughly 120 others. The CSTE said it is not considering any formal proposals to make cronobacter reportable, despite a push by advocacy groups including Stop Foodborne Illness, Consumer Reports and Environmental Working Group.
“We need to do a better job on the easy part — warning consumers what could make them sick,” said Teresa Murray, consumer watchdog director for the Public Interest Research Group.
Gerber and Mead Johnson did not respond to questions about whether they support cronobacter reportability. In a statement, Abbott said, depending on the details of the proposal, “we support increased awareness around cronobacter as a notifiable disease.”
Food safety experts say frequent testing of powdered formula is needed because bacterial particles can lurk in shelf-stable formula for long stretches of time and can be unevenly distributed in formula powder, meaning that one scoop of formula could contain the organism and the next may not.
The elusive quality of the bacteria can also make it difficult to pin down the source of an infection, leaving families to bear the blame for their children’s illnesses in court.
In 2012, Abbott lawyers deposed Megan Surber for seven hours, asking how she prepared Jeanine’s formula and about the cleanliness of her kitchen. They also asked about a past shoplifting offense and outstanding debt. And they asked her husband about his past substance abuse and his arrest record from a troubled youth.
“I was so tired,” Surber recalled of her deposition. “The questions kept coming and coming, and it didn’t have nothing to do with [my daughter]. And every question was twisted into the same question over and over again, waiting for me to change my story, waiting for me to screw up.”
After Abbott won the case, Abbott’s attorney sought $28,468.88 in attorneys’ fees and trial costs from Surber and her family. The judge ordered Abbott to pay its own expenses.
Other families have had similar experiences.
Kimberly Sisk’s 18-year-old son Slade contracted spinal meningitis from cronobacter when he was 3 weeks old, leaving him with spastic quadriplegia, a severe type of cerebral palsy, and epilepsy. Sisk sued Abbott for negligence in 2014 in federal court in Asheville, N.C.
“On the stand they asked me all kinds of questions: Did I live near a farm? Had anyone in my household had the flu? Did I clean my bottles well enough?” Sisk said.
The jury found for Abbott, concluding that it was not negligent in the manufacture of the infant formula Slade consumed. But to this day, Sisk is convinced the pathogen wasn’t introduced in her home.
“I have OCD. I clean houses for a living,” she said. “I was meticulous about preparing those bottles.”