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.
Speaking of marketplace data, the crisis was compounded by the concentration of the U.S. baby formula market, where just two companies—Abbott and Mead Johnson—comprise about 80% of it.
As we explained a few weeks ago, that concentration is largely the result of government policies that include 17.5% tariff-rate quotas and Trump’s USMCA trade agreement that restricts Canadian imports.
While those trade limitations are important, the welfare state is the biggest driver of market concentration. Via the Women, Infants and Children (WIC) program, the federal government buys about half of all infant formula used in America—and, in administering the program, each state contracts with just one producer.
If federal legislators really want to prevent future shortages, the answer is less government, not more.