Benefits of Donor Breast Milk Highlighted Amid NEC Baby Formula Lawsuits
With an ever-increasing number of NEC lawsuits being filed against baby formula manufacturers, health officials have spoken out publicly on the need to protect premature babies by emphasizing the benefits of breast milk, especially in light of the risks linked to cow’s milk-based formulas.
Necrotizing enterocolitis (NEC) is a severe and sometimes fatal intestinal condition that primarily affects premature babies. Families allege that baby formula companies were aware of the increased risk of NEC associated with cow’s milk-based formulas but failed to warn doctors and parents.
As NEC baby formula lawsuits progress, discussions among doctors, researchers, and lawmakers are highlighting the need to increase the availability of donor breast milk for premature infants. Breast milk has been shown to reduce the risk of NEC compared to formula.
Congresswoman Takes Action about Infant NEC
Rep. Rosa DeLauro (D-CT), co-chair of the Baby Caucus and the Food Safety Caucus in Congress, is urging the FDA to prioritize educating parents and healthcare providers about the benefits of donor breast milk and the risks of cow’s milk-based formulas. In a letter to FDA Deputy Commissioner for Human Foods Jim Jones, she stressed the importance of public awareness about NEC and access to human milk-based nutrition.
DeLauro’s letter follows a September NEC working group report by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which found that premature birth is the primary risk factor for NEC. The NICHD report confirmed that human milk is protective against the condition.
In October, the FDA, CDC, and NIH issued a joint statement emphasizing the benefits of breast milk but noted the need for more research and public education.
For DeLauro, although the consensus statement serves as reassurance “for parents about the safety of nutrition that is regularly offered in the Neonatal Intensive Care Units,” it also makes it clear there is more to be done, including more education for the public as well as creating more access to donated human breast milk when a baby’s mother is unable to provide her own.
The American Academy of Pediatrics reports fewer than 20 donor milk banks nationwide. When donor milk is unavailable, premature infants often rely on formula, which may increase their risk of developing NEC. DeLauro has called on the FDA to promote greater access to donor milk and ensure parents and healthcare providers are informed about the latest research on premature infants and the prevention of NEC.
The congresswoman ended the letter stressing that it is “important that FDA be proactive on this issue, not reactive.” She included four questions for the FDA that she would like answers to by mid-December.
- What actions are the FDA taking, alone or in collaboration with the NEC Working Group of Council, to disseminate the evidence and information that “a diet containing human breastmilk appears to be protective against the development of NEC” and “the use of human milk-based fortifier in the infant’s diet, rather than bovine-based fortifier, may be useful in reducing the development of NEC?” Has the FDA communicated its findings to any outside stakeholders? If so, which ones?
- What steps can the FDA take, in collaboration with the CDC and NIH, to promote greater access to healthy and safe donor human milk and donor human milk-derived fortifiers, especially for VLBW infants?
- How is FDA supporting parent education both before delivery and in the NICU about feeding practices, nutritional products, and limits of products for infants with specific conditions, including the limits that cow-derived preterm infant formulas and fortifiers can have on VLBW premature babies?
- How is the FDA ensuring that parents and medical providers are adequately aware of the risks of NEC and how to avoid potentially increasing the chances for a preterm infant to develop NEC?
NEC Lawsuits Gain Momentum
The work being done by DeLauro and other health officials at the national level comes after a landmark $495 million verdict in Missouri recently held Abbott Laboratories responsible for a premature infant developing NEC after consuming their specialized formula. Hundreds of similar cases are pending across the country, with grieving parents seeking justice and accountability.
Parents whose babies developed NEC after consuming cow’s milk-based formulas are helping raise awareness and push for change by pursuing legal action. Consulting an NEC baby formula lawyer can help families explore their options and advocate for safer nutrition for all infants.
