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DeLauro, Schrier, Advocates Introduce Donor Milk Safety Act

April 1, 2022

WASHINGTON, DC — Today, House Appropriations Committee Chair Rosa DeLauro (CT-03) and Representative Kim Schrier, M.D. (WA-08) introduced the Donor Milk Safety Act, legislation that will require the U.S. Food and Drug Administration (FDA) to ensure that donor breast milk consumed by vulnerable infants meets uniform minimum safety standards – just as the Agency does for blood, plasma, other human tissue, biological products, and infant nutrition under the FDA's jurisdiction.

"It is unacceptable that babies continue to be put at risk by FDA's failure to ensure the safety and quality of donor human milk, especially as many parents switch to donor milk following Abbott's deadly infant formula recall," said Congresswoman DeLauro. "Despite the unprecedented growth of the industry, no federal oversight exists of human milk banks and the products they produce. Despite my years of urging the FDA to regulate donor milk similarly to other biologics like blood and human tissue, the Agency has failed to act. That is why Congress must pass the Donor Milk Safety Act and ensure the safety of the donor milk supply for all the vulnerable infants who rely upon it."

"No parent should have to worry about the safety of the milk they are providing for their newborn," said Congresswoman Schrier. "As a pediatrician, I know that donor milk can help boost the health and development of premature and high-risk infants. But right now there are no uniform safety standards. By giving the FDA the power to appropriately regulate donor milk, this bill will give new parents the peace of mind that the milk nourishing their baby is safe."

Following the Abbott recall of large swaths of infant formula products, several media reports have highlighted the fact that concerned parents are switching to donor human milk to avoid possibly contaminated infant formula or infant formula shortages. However, many of these parents would be shocked to know that FDA fails to properly and consistently regulate the donor human milk sector to ensure quality and safety.

The bill would require the FDA to correctly classify any donor human milk that undergoes bioburden reduction – pasteurization or otherwise – as an exempt infant formula. This recognizes the important distinction and associated risk between a mother's own milk, and milk that has been collected, combined, and processed before being sold to a hospital or other setting. This classification will allow the FDA to appropriately regulate donor milk under the systems that exist for its intended use as a complete or partial substitute for a mother's own milk.

The Donor Milk Safety Act is supported by a number of children's health groups including, the National Black Nurses Association, Mended Hearts, Preemie World, Alliance for Black NICU Families, and The Tiny Miracles Foundation.

"The National Black Nurses Association (NBNA) commends Congresswoman DeLauro and Schrier on the introduction of the Donor Milk Safety Act, legislation that would require the FDA to apply exempt infant formula regulations to human donor milk," said NBNA President Dr. Martha Dawson. "Recent events have led us all to realize how important oversight is in the safety of the nutrition we provide our infants, and human donor milk is no exception. We commend the Congresswomen on taking the initiative to ensure the nutrition our most vulnerable infants receive is as safe as possible."