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Justice Department opens investigation into Abbott over baby formula

Nearly a year after the FDA closed a Michigan manufacturing plant for safety violations, American families still struggle to find enough formula for their infants

A can of Similac infant formula. (Ting Shen/Bloomberg News)

The Justice Department has opened a criminal investigation into the Abbott Laboratories plant at the heart of last year’s baby formula shortage, a company spokesperson confirmed late Friday.

The Sturgis, Mich., facility closed for more than four months after Food and Drug Administration inspectors detected Cronobacter sakazakii, a deadly bacteria for newborns and immunocompromised infants, in the plant along with a rash of safety violations, according to inspection records.

The closure of that plant worsened a nationwide shortage that left parents unsure where they would find more baby formula. It came four months after a whistleblower had submitted a report to the FDA alleging unsanitary conditions at the Sturgis plant.

At least four babies fell ill from a bacterial infection after drinking powdered formula manufactured there, according to the FDA. Two of the babies died. FDA investigators were not able to identify the source of the bacteria, and it subsequently investigated reports that as many as nine children have died since early 2021 after consuming baby formula produced at the Michigan plant.

Abbott recalled its Similac formula and other powdered formula products that were made at the plant and later entered into a consent decree with the FDA to restart its production lines at the Michigan facility under stricter scrutiny.

FDA comes to agreement with baby formula factory to resume production

Abbott spokesman Scott E. Stoffel told The Washington Post late Friday that the Justice Department had informed the company of its investigation “and we’re cooperating fully.” Those comments came after the Wall Street Journal first reported the existence of the Justice Department investigation.

A DOJ representative declined to comment. The scope of the department’s investigation is unclear.

Abbott is one of four major companies that control some 90 percent of the infant formula supply in the United States. That market concentration, experts said, contributed to severe shortages that continue to affect families.

The White House in May invoked the Defense Production Act to help formula manufacturers obtain necessary ingredients and launched Operation Fly Formula, importing product from around the world to stock store shelves. Those efforts offered some help, but there were still widespread shortages on grocery shelves, market research firm IRI reported.

A separate report by Reckitt Benckiser, the maker of Enfamil, indicated that shortages will likely persist until at least this spring.

The bacterial risk in powdered infant formula — which is not sterile, unlike liquid formula — has been well known among formula producers, food safety scientists and federal regulators for years.

While cronobacter is harmless to most, it can be debilitating or deadly for newborns and others with weak immune systems, where it can cause fatal courses of meningitis.

The fight to keep little-known bacteria out of powdered baby formula

The bacteria survives especially well in dry environments like milk powder. It is difficult to eradicate because it can be introduced in any stage of formula preparation — from points on a factory floor to a hospital nursery to a parent’s kitchen.

It is also difficult to detect, especially after a child has taken ill. The bacteria are known to clump together in tight bunches, scientists have found. Serving a scoop of tainted formula can itself destroy evidence of contamination.

Families of sickened children have sued formula makers, arguing that the companies had a duty to notify consumers of the pathogenic risks, but with little success.

“I have to say it’s about time,” Steve Rathke, a retired attorney who tried civil cases against the formula companies on behalf of families, said of the Justice Department investigation. “I wish they’d done it 10 years ago.”

Abbott said last summer that no causal relationship had been established between its products and any of the reported deaths.

“Abbott conducts microbiological testing on products before distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella. All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility,” Abbott said in a statement at the time.

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But federal food safety scientists met as early as 2003 with representatives of the major formula companies to discuss cronobacter risk. An Abbott representative acknowledged to the FDA and Center for Disease Control and Prevention 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.

After representatives of all three major companies said there was no way to sterilize the powder, the FDA issued a requirement that every batch of powdered infant formula be tested for cronobacter and salmonella, an FDA spokeswoman said.

In 2012, after another formula-related cronobacter outbreak, federal officials discussed the risk to newborns whose families were enrolled in the federal food assistance program known as WIC.

At the time, most parents who took part in WIC could buy only powdered formula rather than the sterile liquid. Agency scientists proposed that WIC expand its benefits to allow the purchase of sterile liquid formula. But the proposal did not advance, largely because liquid formula is more expensive and the costs would rise for state WIC programs and families, according to one of the scientists involved.

Whistleblower report on baby formula didn’t reach top FDA food safety official

Then in October 2021, a whistleblower sent a 34-page report to the FDA alleging a host of unsanitary conditions at Abbott’s Sturgis facility, months before the first baby became sick with bacterial infections after ingesting formula made at the plant.

The former employee pointed to instances of falsification of records and safety violations, including the release of batches of formula after the discovery of microorganisms. The whistleblower claimed there were active efforts to keep FDA inspectors from learning about the microorganisms in the formula and that Abbott employees “even celebrated during and after the 2019 FDA audit.” The complainant also alleged that in 2020 there were significant problems with the seams on cans of Similac, which left the contents vulnerable to pathogens.

But that complaint didn’t reach the appropriate FDA officials for four months. By that time, one infant had already died and two others were hospitalized due to bacterial infections related to powdered formula.

Food safety advocates and parents have asked regulators for years to require companies to include warning labels on their powdered formula about the risks to newborns. Infants that young, doctors say, lack the sophisticated immune system required to fight off cronobacter infections.

“If you can’t get rid of the bacteria, then why not put a warning on their labels that says, ‘Do not feed powdered infant formula to a baby under 30 days of age? Use our sterile liquid formula instead,’” Rathke said.

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