An infant in Minnesota was hospitalized with a rare and lethal bacterial infection known as Cronobacter Sakazakii after consuming infant formula manufactured by Abbott. The public learned of the infant’s death after Abbott issued a recall of its infant formula in February 2022 due to potential bacterial contamination in various products, including Similac, Alimentum, and EleCare formulas. Four illnesses and one death have been reported in connection with bacterial contagion and other cases are expected to develop since the affected formula has been distributed worldwide.

Abbott Deceptively Marketed Formula as Safe

A recent class action lawsuit by a plaintiff in South Carolina claims that Abbott used deceptive tactics to market Similac, Alimentum and EleCare infant formulas as a safe food product. The affected formulas were found to contain a bacterium that can cause serious infections and gastrointestinal illness. The bacteria may also have contributed to the death of one of the infants. Yet, Abbott failed to take necessary steps to warn the public about possible contamination and continued to advertise its formula as safe for infants. Several months passed between inspection of the facility and the company’s recall, suggesting that Abbott turned a blind eye to these serious safety concerns.

FDA Failed to Timely Address Health Risks Related to Abbot Products

The FDA had several missteps in its handling of the Abbott recall. To start, the FDA’s inspection in September 2021 failed to mention that Abbott had previously destroyed products due to contamination by the cronobacter bacteria, as reported by the company in June 2020. The FDA could have recalled any affected products at that time based on testing records if it determined that the formula created a safety risk. Moreover, the FDA could have warned consumers about contamination when it inspected the Michigan facility in September. Tests at the facility revealed widespread violations of regulations implemented to avoid contamination of infant formula. However, Abbott’s voluntary recall did not occur until February 17, 2022. The FDA failed to take immediate action even though its inspection of the Abbott facility raised concerns about contamination. For example, the FDA noted several violations, including failure by personnel to wash their hands prior to handling infant formula.

Infant Formulas Subject to Higher Standards of Regulation

FDA regulations govern the manufacturing of infant formula to prevent incidents of contagion or adulteration. Infant formulas, unlike other food products, are inspected annually by the FDA. Infant formula companies are required to test for contamination, including the presence of cronobacter and salmonella in infant formulas, especially because these bacteria have been known to taint infant powdered formulas. Infant formula contamination incidents are generally easier to identify since infants only consume formula or breast milk. In this case, given the rarity of cronobacter infection and its high correlation to infant formula, the initial illness in Minnesota should have prompted the FDA and Abbott to take immediate action. However, it was not until three additional serious injuries were reported that the FDA and Abbott issued warnings and recalls related to contaminated formula.