DeLauro Calls on FDA to Prioritize Reducing Risk of Infant Formula for Vulnerable Infants

Today, Congresswoman Rosa DeLauro (CT-03) sent a letter to the Food and Drug Administration’s Deputy Commissioner for Human Foods Jim Jones urging him to increase public awareness of the benefits of human donor milk and potential benefits of human milk-derived human milk fortifier for Very Low Birth Weight infants. Specifically, the lawmaker noted the increase in the litigation connecting traditional cow’s milk-derived fortifier and necrotizing enterocolitis (NEC) in certain infant formula brands.

“FDA is responsible for ensuring the quality and safety of infant formula products. Fortifiers for premature infants are regulated by the FDA as ‘Exempt Infant Formulas,’ and explicitly manufactured and marketed for this population,” DeLauro wrote. “Therefore, FDA must be more actively working to inform medical providers and parents about the suspected limitations of cow’s milk-based infant formula and fortifiers for premature infants in comparison with other feeding options, including donor human milk and human milk-derived human milk fortifiers.”

NEC is a severe gastrointestinal disease primarily affecting premature and very low birth weight (VLBW) infants. It can cause inflammation and bacterial invasion of the intestine, leading to tissue death and, in severe cases, can be fatal. Studies show that premature infants fed cow's milk-based formula are at significantly higher risk of developing NEC compared to those fed human milk or human milk-derived fortifiers.

An exempt infant formula is an infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems

You can read DeLauro’s letter here.