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The ongoing formula crisis demands FDA regulation of donor milk

(AP Photo/Michael Conroy, File)
FILE – Baby formula are displayed on the mostly-empty shelves of a grocery store in Carmel, Ind. on May 10, 2022. On Wednesday, Jan. 25, 2023, Frank Yiannas, the federal Food and Drug Administration’s top food safety official, resigned, citing concerns about the agency’s oversight structure and the infant formula crisis that led to a nationwide shortage.

The infant formula crisis has been a nightmare for parents and caregivers. Families continue to struggle with supply shortages, high price tags and the fear that our country is one recall away from a panic of food shortages for our most vulnerable populations.  

The U.S. Food and Drug Administration (FDA) is at the forefront of this disaster and has been pressed by lawmakers and the public to take steps to prevent another infant formula shortage. As we wait to hear how they will course correct, the FDA must also enact meaningful reforms to solve another pressing issue facing preemies and infants: improving safety standards for donor human milk.

The donor human milk industry has exploded in recent years. The Human Milk Banking Association of North America reported 7.4 million distributed ounces in 2019, and 9.2 million ounces were distributed in 2021. This growth is wonderful news for babies, particularly premature infants. Here’s why donor milk is so important: Breast milk donated by women to milk banks and hospitals is often the only available human food source for premature infants, born as young as 22 weeks old. Fortified human milk is one of the only products their fragile systems can process, providing key nutrients for development. Unfortunately, most mothers of premature infants are unable to produce breast milk on their own. But this growing market represents a remarkable movement among mothers supporting other mothers in need. 

This is a positive development, but it brings a responsibility for federal regulators to ensure this lifeline food source is safe for infants. 

Parents and health care providers would be shocked to learn that human donor milk banks are not properly or consistently regulated by the FDA for safety standards. Some milk banks claim their protocols fill this void, but they are voluntary, inconsistent and self-regulated within their organizations. Indeed, on their website, the FDA declares they “have not been involved in establishing these voluntary guidelines or state standards” for approving the safety of human donor milk from milk banks.

There were two recent developments in Washington that paved the way for improving donor human milk safety standards. First, President Biden signed an omnibus spending bill with a directive for the FDA to regulate donor human milk banks and products. We join the National Coalition for Infant Health in applauding this success and urge the FDA to take swift action. Second, a recent independent report from the Reagan-Udall Foundation calls on the FDA to provide details that will directly impact oversight of infant formula. This gives the FDA another opportunity to add the same oversight for donor human milk, ensuring the safety standards for infant formula are matched for donor human milk.

To be sure, parents deserve more access to options for taking care of their children. The memory of last spring’s infant formula that wiped shelves clear across the nation and drove out-of-stock rates up to 74 percent is still top of mind. But more supply must be coupled with assurances that vital nutrients provided to infants and premature babies are safe for consumption. 

At the National Black Nurses Association, where I am president and CEO, our nurses are on the frontlines in NICUs across the country and we believe all babies deserve access to nutritious and properly regulated food. A vast majority of donor milk is distributed in NICUs which support babies born around three pounds. The Centers for Disease Control and Prevention refers to this population as very low birthweight births (VLBW), and these babies are disproportionately Black in the U.S. According to 2020 data, Black babies were 190 percent more likely to be VLBW than white babies, underscoring the need to support this vulnerable population in every zip code.  

While most of the world may think we are out of the woods on the infant formula crisis, there are many young families still concerned about shortages and recalls. It’s time for the FDA to step up to address the pressing issue of safety for human donor milk to provide some peace of mind for a basic human need.

Martha Dawson is a Doctor of Nursing Practice and the president/CEO of the National Black Nurses Association

Tags Baby formula shortage FDA approval Food and Drug Administration Politics of the United States

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