Legal, clinical, and scientific perspectives on formula use and NEC risk in preterm infants.

Garg, Parvesh Mohan; Rodriguez, Ricardo J; Shenberger, Jeffrey S · Pediatr Res · 2026

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Abstract

Recent legal verdicts implicate cow’s milk-based infant formulas, notably Similac and Enfamil, as contributing to the causation of select cases of necrotizing enterocolitis (NEC) in preterm infants. These rulings have intensified debate regarding the safety of formula use in neonatal care, leading to increased scrutiny of clinical practices and calls for clearer scientific evidence. This brief commentary reviews the current legal landscape, examines available research on NEC risk factors, and highlights the clinical implications of ongoing litigation. The report also argues for the importance of evidence-based standards for both legal and medical decision-making.