Heinrich, Colleagues Urge FDA Action on Preterm Infant Formula Fortifiers

WASHINGTON - U.S. Senator Martin Heinrich (D-N.M.) sent a letter to U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. demanding action from the U.S. Food and Drug Administration (FDA) on preterm infant formula. Heinrich's demand comes in the wake of over 1,000 lawsuits against preterm infant formula manufacturers in the United States, stemming from failures to warn parents of the increased risk of a serious gastrointestinal illness, necrotizing enterocolitis, associated with the use of non-human milk-derived fortifiers.

Heinrich sent the letter alongside U.S. Senators Roger Marshall (R- Kan.) and Jeff Merkley (D-Ore.), and U.S. Representatives Rosa DeLauro (D-Conn.), Madeleine Dean (D-Pa.), Riley Moore (R-W.Va.), and Jeff Van Drew (R-N.J.).

"Protecting our youngest, most vulnerable infants should be our highest priority. We request your attention to nutritional products that feed very low birthweight infants," the lawmakers wrote to Secretary Kennedy. "Necrotizing enterocolitis is among the most fatal diseases in the neonatal intensive care unit, with one baby a day dying of this debilitating disease. Over 1,000 lawsuits threaten the stability of the infant formula industry and endanger our most vulnerable."

"Human milk-derived formulas and fortifiers are proven to have a 77 percent reduction in the development of necrotizing enterocolitis, among other devastating complications of prematurity. Human milk has proven beyond doubt to be the best source of infant nutrition, and we urge the Department of Health and Human Services to investigate other preterm infant fortifiers and their potential impact on the gut health of premature infants," the lawmakers continued.

The lawmakers conclude their letter by emphasizing the need for HHS to thoroughly explore how very low birthweight babies are impacted by the components of the fortifiers and recommending HHS take the following steps:

The text of the letter is here and below:

Dear Secretary Kennedy:

Protecting our youngest, most vulnerable infants should be our highest priority. We request your attention to nutritional products that feed very low birthweight (VLBW) infants, particularly those born weighing 1,250 grams (2.75 lbs.) or less.

There has been a recent deluge of lawsuits against preterm infant formula manufacturers in the United States because of a failure to warn of the increased risk of a serious gastrointestinal illness, necrotizing enterocolitis (NEC), with the use of non-human milk-derived fortifiers. NEC is among the most fatal diseases in the neonatal intensive care unit (NICU), with one baby a day dying of this debilitating disease. Over 1,000 lawsuits threaten the stability of the infant formula industry and endanger our most vulnerable. We propose multiple actions that this Administration could take right now to address health concerns while ensuring the fragile preterm formula market remains stable.

One factor that has been proven to reduce the development of NEC in VLBW infants is the use of human milk. Human milk-derived formulas and fortifiers are proven to have a 77 percent reduction in the development of NEC, among other devastating complications of prematurity. Human milk has proven beyond doubt to be the best source of infant nutrition, and we urge the Department of Health and Human Services (HHS) to investigate other preterm infant fortifiers and their potential impact on the gut health of premature infants.

The October 2024 Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH) consensus statement identified the absence of human milk as being associated with an increased risk of NEC. There are nearly two decades of studies consistently showing that an exclusively human milk diet (mom's own milk or pasteurized human donor milk and human milk-derived fortifier) is the best source of nutrition for VLBW babies. Of the 22 studies comparing human milk-based fortifiers to non-human milk based fortifiers that have reported on NEC as an outcome, all 22 studies have shown lower rates of NEC in the babies fortified with human milk-based fortifiers.

As you further investigate this concerning connection, one thing is clear, human milk reduces the incidence of NEC. Additionally, a study released in 2024 showed that VLBW babies fed human milk-derived human milk fortifiers also experienced shorter NICU stays, with savings ranging from $307,916 to $2,520,000 per institution annually. We emphasize the need for HHS to thoroughly explore how VLBW babies are impacted by the components of the fortifiers.

We recommend taking the steps below:

1) Ensure that the FDA has received all adverse event reports from infant formula manufacturers related to the feeding of non-human milk derived fortifiers in this population. Without this information, HHS cannot evaluate all data needed to determine the best nutritional sources for preemies.

2) Instruct the FDA to explore ways to make pasteurized donor human milk (PDHM) safer and more accessible. Given the overwhelming evidence supporting the use of PDHM for premature infants, the Department should solidify proper oversight of PDHM, ensuring milk banks adhere to consistent minimum safety standards. This oversight will ensure better coverage of, and access to, safe and affordable PDHM.