Feeding Newborns Infant Formula May Increase Food Allergy Risks: Study

The findings join a growing body of evidence that has highlighted the advantages of human breast milk over infant formula.

A team of Australian researchers are calling for newborns to be fed breast milk in the first three days of life to lower the risk of food allergies.

Despite decades of claims by infant formula manufacturers suggesting their products are a safe alternative for newborns, numerous studies published in recent years have highlighted the importance of breastfeeding or using human milk products for babies. 

These studies show that human milk delivers the essential nutrients a newborn needs to thrive, provides key immunities developed by the mother, and aids in the development of the infant’s digestive tract.

A new report published in the February 2025 issue of The Journal of Allergy and Clinical Immunity now adds to these prior findings, warning that babies fed infant formula immediately after birth face more than double the risk of peanut and other food allergies.

In the study, researchers from the University of Western Australia looked at data on nearly 700 infants from the ORIGINS pregnancy cohort.

The team, which was led by Maneshwar Bhasin, focused on feeding data from the first three days of the infants’ lives, excluding preterm infants, babies born to women under the age of 18, and those who were never breastfed.

According to the findings, infants fed colostrum, which is the breast milk produced within the first three days after birth, appeared to receive significantly more protection from future food allergies than those fed infant formula.

Infants who were fed formula during that period, even if they also received breastfeeding, were 2.48 times more likely to develop food allergies within the first year, the data indicated.

The researchers highlighted that during the initial three days, colostrum contains significantly higher levels of protein, maternal immunities and microbiota. As lactation progresses, the breast milk composition shifts to become richer in fat and lactose.

Breastfeeding Benefits Over Infant Formula

While the study was small, researchers noted that enough clinical data exists to prove the benefits of breastfeeding, particularly early in life. Research has regularly shown cow’s milk-based baby formula products do not confer the same benefits as breastfeeding and may increase the risk that premature infants develop necrotizing enterocolitis (NEC), which frequently results in severe, life-long injuries or death.

A January 2022 study found that nutrients in breast milk play a critical role in helping the intestinal epithelial layer mature in preterm infants, strengthening their resistance to NEC. However, these nutrients are not present in cow’s milk-based infant formula marketed for premature babies, such as the popular Similac and Enfamil product lines.

In July 2022, the American Academy of Pediatrics (AAP) issued a policy statement calling for hospitals and the government to promote breastfeeding as the primary form of nutrition for newborns.

Another study, published last October, even found that preterm infants fed breast milk were less likely to develop asthma later in life.

Infant Formula NEC Lawsuits

Concerns over the use of cow’s milk-based formula are not limited to what it does not do for infants. They also include serious concerns that the use of infant formula, particularly in prematurely born babies, can increase the risk of NEC.

Necrotizing enterocolitis is a devastating gastrointestinal condition that occurs when harmful bacteria breach the walls of the intestines, causing portions of the tissue to become inflamed or die. It primarily affects premature babies and often results in the need for emergency surgery while the baby is still in the NICU. Many infants do not survive.

As a result of the failure of formula manufacturers to disclose the risk of NEC, hundreds of families are now pursuing Similac lawsuits and Enfamil lawsuits, claiming that their premature children could have avoided debilitating and often fatal injuries if earlier warnings had been provided for users and the medical community in recent years.

Since complaints filed throughout the federal court system each raise common questions of fact and law, an infant formula lawsuit MDL (multidistrict litigation) was established in 2022, centralizing the claims before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois, for discovery and a series of early trial dates.

As part of the coordinated management of the federal litigation, Judge Pallmeyer previously established a “bellwether” program, where a small group of representative claims are being prepared for a series of early trial dates to help evaluate the strengths and weaknesses of the cases, and promote global NEC settlement negotiations.

While the outcome of these early trials will not have any binding impact on NEC injury lawsuits being pursued by other families, the average payouts awarded by juries will likely have a substantial impact on the amount that Abbott and Mead Johnson may be required to pay in NEC injury settlements to avoid hundreds of additional claims going before juries.

If the parties fail to resolve the litigation following the federal bellwether trials, Judge Pallmeyer may start remanding dozens of individual claims back to U.S. District Courts nationwide for separate trial dates.