DeLauro Leads Bicameral, Bipartisan Letter Urging FDA Action On Preterm Infant Formula Fortifiers

WASHINGTON -Today, US Representative Rosa DeLauro released a letter to the Secretary of Health and Human Services, along with Senator Martin Heinrich, Senator Roger Marshall, Senator Jeff Merkley, Representative Madeleine Dean, Representative Riley Moore, and Representative Jeff Van Drew, urging action 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 (NEC), associated with the use of non-human milk-derived fortifiers:

"These lawsuits raise serious questions about the use of non-human milk preterm infant formulas for very low birthweight infants said Congresswoman DeLauro. "NEC is a deadly disease for our infants, with one baby dying each day in NICUs. I will never support blanket liability protections for major companies because protecting our youngest and most vulnerable infants should be our highest priority. We must take action to stabilize the preterm infant formula market based on the overwhelming scientific consensus that human milk is the best source of infant nutrition. That is why the FDA should quickly implement the actions outlined in this bipartisan, bicameral letter to increase the availability of human milk-based fortifiers and provide better information and potentially better options to parents, who should not be forced to guess what product is best for their child."

"New and expecting moms deserve access to the best possible resources and information to care for their newborns," said Senator Merkley. "As necrotizing enterocolitis (NEC) continues to harm infants, with one baby per day dying of this disease, the FDA must take action to ensure parents aren't left wondering about the formula they choose. Reforms are necessary to ensure peace of mind for the millions of parents in Oregon and across the nation."

"It is the duty of Congress to protect our most vulnerable - including our precious newborns. And as a mother and grandmother, I am deeply concerned by the more than 1,000 lawsuits against preterm infant formula manufacturers whose job it is to nourish them," Rep. Dean said. "I join my colleagues, led by Congresswoman DeLauro, in urging the FDA to take action to help parents better access human milk-based fortifiers and better educate families who are caring for their newest members."

"For too long, there has been a lack of transparency between infant formula companies and the public on the nature of Necrotizing Enterocolitis (NEC) and human-derived infant formula fortifiers," said Congressman Riley Moore. "Parents deserve to know what is in the formula they are giving their children. We must continue to ensure transparency for parents of premature infants to protect children from deadly and highly preventable NEC."

"When you have more than a thousand lawsuits from parents who all say the same thing, that tells me there is a real problem," said Congressman Van Drew. "If the evidence shows certain non-human milk fortifiers carry a higher risk of NEC in very small infants, then the FDA has a responsibility to act. I am proud to join this bipartisan effort to make sure parents have clear information and safer options."

The text of the letter is available here.