Abbott Restarts Baby Formula Plant: Crisis-Inducing

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In what will come as welcome news to anxious parents across the country, Abbott Nutrition announced it restarted production of infant formula at its Sturgis, Michigan plant on Saturday. The company is prioritizing EleCare and other specialty and metabolic formulas, with product expected to start reaching consumers June 20.

Abbott closed the plant in February as the Food and Drug Administration investigated the deaths of two infants who succumbed to bacterial infections. Each had consumed powdered formula from the Sturgis facility, as did two other infants who were hospitalized but recovered.

The shutdown turned a preexisting shortage—fueled by supply chain problems and hoarding—into an all-out empty-shelf crisis, prompting the waiving of import regulations and restrictions, and a military airlift of formula from Europe. As of May 22, 73% of baby formula products were out of stock.

However, a detailed look at the FDA investigation suggests the three-month shutdown was unnecessary, as the FDA investigation failed to produce any evidence linking Abbott's Sturgis facility or its formula to the illnesses and deaths.

The four infected infants consumed four different types of Abbott formula made over the course of almost a year; the illnesses took place over several months in three different states.

The bacteria that sickened the infants, Cronobacter sakazakii, is a commonly-occurring microbe found naturally in the environment; illnesses are rare, but can be deadly for infants. Though the FDA found the bacteria in areas of the plant that do not have product contact, none was found in the testing of finished product, says Abbott.

What's more, genetic sequencing of the bacteria samples from the available samples of two sick infants did not match the strains found at the plant. They didn't even match each other.

"In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative," according to a summary of the case Abbott posted on May 11.

Open containers were tested in three of the cases. One tested positive for two strains, one of which matched a strain found in a bottle of distilled water the family used to mix the formula.