What would happen in the United States if there were no cow milk-based preterm infant nutritional products: historical perspective and evaluation of nutrient-related challenges

Authors: ABRAMS, STEVEN - University Of Texas At Austin; SHULMAN, ROBERT - Children'S Nutrition Research Center (CNRC)

Submitted to: The American Journal of Clinical Nutrition
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 8/28/2024
Publication Date: 8/30/2024
Citation: Abrams, S.A., Shulman, R.J. 2024. What would happen in the United States if there were no cow milk-based preterm infant nutritional products: historical perspective and evaluation of nutrient-related challenges. The American Journal of Clinical Nutrition. 120(4):781-784. https://doi.org/10.1016/j.ajcnut.2024.08.028.
DOI: https://doi.org/10.1016/j.ajcnut.2024.08.028

Interpretive Summary: Recently, there has been a number of lawsuits filed purporting that cow milk-based formulas specifically designed for premature infants and shown to be nutritionally beneficial for premature infants might be harmful to some infants. In this article we review the history of why special formulas designed for premature infants needed to be developed; for example, neither unfortified human milk nor formulas designed for full term infants provide adequate nutrition for a premature infant, resulting in poor growth, bone disease, and nutrient deficiencies. We describe how limited availability and cost currently do not allow the use of an all-human-milk diet for premature infants. Concocting a formula from different nutritional components carries a number of risks such as errors in mixing and not providing adequate nutrition. For the foreseeable future, the continued availability of cow milk-based formulas designed for premature infants is critical for the nutritional health of premature infants.

Technical Abstract: Recent litigation has led to a situation where preterm cow milk-based infant nutritional products (PCMBPs) may soon have limited or no availability in the United States. Given their limited availability, similar products based only on human milk are unlikely to meet the needs of most preterm infants requiring such products, especially those born >1500 g or very preterm infants born at <1500 g after they reach 34-35 wk postmenstrual age. Alternative nutritional strategies, used before the introduction of specialized preterm products, would require modular nutrient additions to a formula designed for full-term infants and donor or maternal milk. The addition of modular products would require careful calibration to provide needed macro and micronutrients which would expose infants to risks of contamination, poor growth, and limited bioavailability of some of these modulars. Substantial risks of metabolic derangements, and ultimately, poor outcomes would occur. In the long-term greater availability and support for the use of human milk-based products is needed. However, policymakers cannot assume that PCMBPs will not be critically needed and should identify strategies for their continued marketplace availability.