FDA 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

The U.S. formula industry utilizes aggressive marketing strategies which exploit parental anxieties, undermine breastfeeding, violate ethical international standards, all of which contribute to early formula introduction and disparities in breastfeeding. Additionally, misleading or complex labeling contribute to caregiver and provider confusion regarding the content of formulas. A centralized, Food and Drug Administration (FDA)-maintained database of infant formulas could support caregivers and healthcare professionals in countering misinformation and making evidence-based decisions. Human milk remains the gold 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 mother’s own milk (MOM) is unavailable. However, due to lack of federal funding and oversight, high cost and inconsistent insurance coverage, the use of DHM use 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 (HMFs) are composed of similar ingredients as infant formula and are used to improve the nutritional content feedings given in the NICU and post-discharge. The use of live biotherapeutic products (LBPs) or probiotics as additives to preterm infants have been demonstrated in multiple studies to reduce the incidence of NEC, late-onset sepsis, and all-cause mortality.