Food and Drug Administration Expert Panel on Infant Formula "Operation Stork Speed" June 2025: Part 3, Marketing of Infant Formulas, Breastfeeding Support, Hypoallergenic Formulas, and Nutrition for Preterm Infants.
Academic Article
Overview
abstract
The United States formula industry uses aggressive marketing strategies that exploit parental anxieties, undermine breastfeeding, and violate ethical international standards, all of which contribute to early formula introduction and disparities in breastfeeding. In addition, misleading or complex labeling contributes to caregiver and provider confusion regarding the content of formulas. A centralized, Food and Drug Administration-maintained database of infant formulas could support caregivers and healthcare professionals in countering misinformation and making evidence-based decisions. Human milk remains the reference standard for infant nutrition, with strong evidence supporting its role in reducing morbidity and mortality, especially in the neonatal intensive care unit (NICU). Despite this, disparities persist in breastfeeding rates, particularly among Black and Hispanic mothers. These are driven by structural barriers, including lack of paid parental leave and inadequate lactation support. Donor human milk (DHM) is the recommended alternative for high-risk infants in the NICU when the mother's own milk is unavailable. However, due to lack of federal funding and oversight, high cost and inconsistent insurance coverage, the use of DHM is limited, especially in safety-net hospitals. Specialized hypoallergenic and metabolic formulas are essential for managing medical conditions including cow's milk-protein allergy and inborn errors of metabolism. These are regulated as exempt formulas but must meet rigorous clinical standards. In the NICU, adequate early nutrition for preterm infants is crucial to reduce morbidity and mortality and improve long-term neurodevelopmental outcomes. Human milk fortifiers are composed of similar ingredients to infant formula and are used to improve the nutritional content of feedings given in the NICU and postdischarge. The use of live biotherapeutic products or probiotics as additives to preterm infants has been demonstrated in multiple studies to reduce the incidence of necrotizing enterocolitis, late-onset sepsis, and all-cause mortality.
