Baby Formula Shortage Sparked by Pathogen Deaths

A nationwide shortage of baby formula intensified this month, leaving around 31% of stores out-of-stock and prompting the federal government to take action to accelerate production.

Abbott Laboratories — responsible for 43% of domestic baby formula production — voluntarily recalled powdered infant formulas (PIF) produced at its Sturgis, Michigan facility after four infants who consumed Similac PM 60/40 fell ill and two died.

Both infant deaths were attributed to Cronobacter sakazakii infection, a Gram-negative, coliform bacterium that thrives in dry environments and is often fatal to infants. Abbott Laboratories denied that the deaths attributed to Cronobacter were linked to formula contamination at the Sturgis manufacturing facility after an internal investigation showed that no distributed product tested positive for the bacteria.

In September of 2021, a routine FDA inspection of the same Sturgis, Michigan plant found sanitation issues and an instance where employees may have transferred contaminants from a nonsterile surface to a batch of formula. Additionally, Abbott found Cronobacter contamination among products manufactured in 2019 and 2020 that were not distributed.

Cronobacter can cause bloodstream infections and meningitis, resulting in disability or death. And one study from 2020 found that, of all cases of bloodstream infection or meningitis among infants, 79% had consumed powdered infant formula.

For mothers who do not breastfeed, the supply shortage is a crisis. CDC data from 2017 indicates that reliance on formula is very high, with 19.2% of infants receiving some type of formula within two days after birth. The same data set found that only 46.9% of babies were exclusively breastfeeding at three months after birth.

About half of all formula purchased nationwide is bought using WIC benefits (Special Supplemental Nutrition Program for Women, Infants, and Children). Traditionally, states grant a single manufacturer the exclusive right to provide the formula to all WIC beneficiaries in a state in exchange for a rebate. Currently, Abbott is the provider for more than 30 states’ WIC programs making this recall and shortage especially damaging to women who rely on WIC benefits to feed their infants.

The FDA and White House issued statements concerning the shortage, citing steps to increase production across the country. In a public statement, FDA Commissioner Robert M. Califf, MD, acknowledged the problem: “We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it.”

The White House commented that officials are currently working to supplement the domestic production of infant formula — which usually provides for 98% of national demand — with imports from trading partners like Mexico, Chile, Ireland, and the Netherlands.