Baby formula shortage reveals gaps in regulation and reporting

Riley San Miguel said her son, Kru, was barely a month old when he started crying all the time, not wanting to eat. When he developed a fever, he was quickly admitted to an intensive care unit. His spinal fluid was infected with bacteria, and it was spreading to his brain. The doctors believed it had probably come from his infant formula.

“Initially, doctors were worried Kru wasn’t going to make it,” said San Miguel, 23, who lives in Sonora, Texas. The baby underwent the first of several operations on his brain to control escalating seizures and swelling, and when he could no longer breathe on his own, they put him on a ventilator for 21 days. Eventually, most of the right side of his brain had to be removed.

Her son, she learnt, had been exposed to Cronobacter sakazakii, a deadly bacterium that is often linked to babies who consume powdered formula and can cause serious brain damage, developmental disabilities and death. Health officials analysed two open cans of formula from San Miguel’s home; one tested negative and the other did not have enough product left to test.

Kru fell ill in August 2019, more than two years before similar infections in four babies — two of them fatal — triggered a voluntary recall at an Abbott Nutrition plant in Sturgis, Michigan, that manufactured formula consumed by the latest sickened babies.

The recall helped lead the way to a nationwide shortage of infant formula that has left parents struggling to feed their children; the Biden administration has responded by working with Abbott to restart production and flying in additional supplies from Europe.

As with Kru’s illness, no link was established between infections in the four recent sick babies and production at any Abbott Nutrition plant. But while most of the attention has been focused on fixing the dire supply shortfall, regulators are confronting deeper issues of safety that persist in the manufacturing of powdered infant formula.

There is no comprehensive mechanism for detecting or investigating Cronobacter infections, and only one state, Minnesota, requires doctors and laboratories to report cases to the authorities. Manufacturers are left to conduct tests themselves on a relatively small sample of their production, with less than 1% of the Abbott plant’s total output required to be tested. The combination of blind spots makes it difficult to trace infections to their source and could leave families at risk of future shutdowns and infant fatalities.

In October, a whistleblower complaint from a former Sturgis quality assurance worker landed with the Food and Drug Administration. He claimed that, in 2019, the plant did not destroy an entire batch of formula where problematic microorganisms had been found because “senior management was under significant pressure to meet its ‘numbers’”; and that the company was “sanitising” files before providing them to FDA auditors, failing to disclose details about microorganisms it found.

Abbott has said that no Cronobacter samples from the four sick babies matched ones found at the Sturgis plant. An opened container of formula consumed by one of the babies had tested positive for two strains of Cronobacter, the company said, but those strains also did not match any that were found at the plant, and one matched a sample found on a water bottle that had been used to mix the formula.

“The formula from this plant did not cause these infant illnesses,” the company said.

Kru San Miguel, who was exposed to a deadly bacteria that doctors believe probably came from his infant formula, with his parents, Noah and Riley San Miguel, in Sonora, Texas, May 18, 2022. Matthew Busch/The New York Times

The company said it expected to be able to address all of the FDA’s concerns by the time it reopens the Sturgis plant within the next two weeks. A consent decree the company signed with the government provides a series of new safeguards, including hiring a qualified expert to oversee improvements at the plant and notifying the FDA if it finds any contamination.

The lack of testing and public reporting makes it difficult to know how many people are infected with Cronobacter. One study estimated about 18 cases per year in US infants, according to Dr Julia Haston, an official with the federal Centers for Disease Control and Prevention. Outcomes are usually severe, she said, and up to 40% of infants who go on to get bacterial meningitis, a frequent complication, die from the infection.

The relatively low rate of testing makes it difficult to provide a positive link between illnesses and contamination at a particular plant. The fact that there was not a genetic match between the bacteria found in a sick infant and bacteria found at a plant might be because the contamination occurred in the home, in a batch that was not tested or in a portion of a sample that was not analysed.

It was an inspection last September that uncovered serious process problems that would set in motion the most recent product recall.

On Sept 16, the FDA called the Sturgis plant to sort out COVID-19 procedures before the inspection. This was the plant’s first FDA visit since the beginning of the coronavirus pandemic.

On the same day, officials in Minnesota reported to the CDC that an infant had been hospitalised with a Cronobacter infection after consuming formula from the Sturgis plant.

When FDA officials arrived in Sturgis, agency records show, they found water pooled on the floor in three areas, a situation that could create a growth environment for bacteria.

The FDA also discovered that the plant had found Cronobacter in a finished powdered formula lot in June 2020. But the agency’s inspectors did not swab for the bacterium in or near production areas on this September visit, it confirmed.

The FDA concluded in a report that Abbott had not maintained the building “in a clean and sanitary condition.”

Bill Marler, a Seattle lawyer who sues food companies on behalf of consumers, said he had “very seldom” seen such a blunt assessment. “I’ve been in a lot of dirty plants,” said Marler, who has not filed a case over the formula issue, “and I’ve seen a lot of inspection reports. And you never see that kind of language.”

By October, the CDC found Cronobacter in the Minnesota infant’s open formula can, according to the agency. Yet five months passed before the FDA took samples in the Sturgis plant that were compared with the bacteria from the formula, according to the CDC. (During some of those months, the FDA again held back inspectors amid the omicron surge.)

They were not a genetic match. That could have meant that the formula was contaminated from something in the baby’s home. Or it could have meant that formula in the Sturgis plant that might have been contaminated was not tested.

In January, a health department in Texas examined the only other sample that emerged from the four infant illnesses that resulted in the Sturgis recall. That baby’s formula had no bacteria and the baby’s strain of the virus did not match the Minnesota baby’s.

Still, FDA inspectors who returned at the end of the month found more standing water. This time they swabbed around the production area and found Cronobacter, agency records show. They discovered that the company’s own testing from Feb 6 through 20 found the bacterium 20 times in the plant, including in critical areas, according to the inspection report.

By Feb 17, the company issued a major voluntary recall and halted production. The FDA is now seeking authority to require formula-makers to do more testing and to ensure that details about the Cronobacter they find is entered into a national database.

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