Infant formula giants Abbott and Mead Johnson have never reported a single infant death linked to necrotizing enterocolitis (NEC) to the FDA — despite receiving hundreds of complaints. A KFF Health News investigation reveals that federal rules leave the reporting decision largely to manufacturers, and that companies routinely closed files without escalating concerns. Massive jury verdicts against both companies are now shining a light on the regulatory gap.
A KFF Health News investigation has uncovered a striking regulatory blind spot: infant formula manufacturers Abbott Laboratories and Mead Johnson have never once reported a baby's death to the FDA under rules requiring notification when there is a "reasonable possibility" that formula caused the death. This includes hundreds of complaints involving necrotizing enterocolitis (NEC), a devastating and often fatal intestinal condition disproportionately affecting premature infants.
Under current federal rules, companies are only required to notify the FDA within 15 days if they themselves determine a "reasonable possibility" of a causal link — a standard that, in practice, companies have consistently declined to meet. Internal documents and court testimony reveal that both Abbott and Mead Johnson repeatedly dismissed NEC complaints, citing lack of causation, even as their own internal research acknowledged cow's milk-based formula as a primary NEC risk factor.
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Why it matters: The investigation exposes a self-policing system where manufacturers decide whether to report infant deaths — with no public database, no mandatory disclosure, and limited FDA oversight. As litigation mounts and appeals courts call Abbott's conduct "significantly reprehensible," calls for stronger federal reporting requirements are likely to intensify.
