September 14, 2023

After infant formula crisis, lawmakers look to donor milk

Bill aims to increase access to pasteurized donor milk for infants and push the FDA to regulate the practice

Source: Roll Call


An infant formula shortage last year that left store shelves empty and parents panicked spurred lawmakers to scramble for solutions.

One year later, some think they’ve found one: Donor breast milk.

On Thursday, a bipartisan group of lawmakers led by Sen. Tammy Duckworth, D-Ill., will introduce a bill that aims to increase access to pasteurized donor milk for infants and push the FDA to regulate the practice.

It’s the latest move aimed at solving a problem that dominated headlines last year. Initially, Congress passed legislation to ease imports of baby formula and the Food and Drug Administration created a Human Foods Program to oversee food safety and nutrition. 

But one year later, there still is not easy access to a formula alternative for parents who cannot nurse — and Duckworth and other lawmakers argue that donor breast milk could be a solution, with lead Republican co-sponsor Marco Rubio of Florida arguing that donor milk is a “safe and effective alternative to formula.”

The proposal is not without critics: Donor breast milk is typically recommended for use in an inpatient hospital setting, and it’s more difficult to access outside of a neonatal intensive care unit. It’s also expensive, with pasteurized donor milk running as much as $5 per ounce from a milk bank. And unless the highest standards are met, the practice of using donated breast milk could pose potential health risks.

Pasteurized donor breast milk is a rare resource usually reserved for extremely premature babies in the neonatal intensive care unit. But Duckworth said parents of babies who come out of the NICU relying on donor milk may want to continue using donor milk when they get home, particularly if their mothers aren’t producing enough milk.

Interest in donor breast milk increased during the infant formula crisis, said Christie del Castillo-Hegyi, an emergency medicine pediatrician and co-founder of the nutrition advocacy group Fed is Best. But she said she advises families that despite the “breast is best” mantra often repeated to new mothers, there is little scientific evidence suggesting differences in health outcomes between formula-fed and breast milk-fed babies. The difference often comes when socioeconomic and household factors are considered, according to sibling studies of breastfed and formula fed babies, she said.

“If there’s a child and you’re considering donor milk versus formula because those are the only options, then … you should not be spending your money on something that is so expensive that it might impair your ability to afford your child’s entire nutritional requirements,” Castillo-Hegyi said. 

Duckworth’s bill seeks to increase access to and awareness of donor milk as an additional resource for parents. It would provide $3 million in emergency funding to support sudden increases in demand, establish a donor milk awareness program within the Health Resources and Services Administration and require the FDA to examine potential federal regulation of donor breast milk.

This marks the second Congress in which Duckworth has tried to push access to donor breast milk. But this year, Duckworth has pulled in Rubio as a co-sponsor. Her House co-lead, Rep. Chrissy Houlahan, D-Pa., has two Republican co-sponsors: Stephanie Bice of Oklahoma and Maria Elvira Salazar of Florida.

“Part of what’s moved this forward has been that the formula crisis with Abbott recall really woke everybody up to ‘Oh, wait, there’s this other resource out there,’” Duckworth said, referring to the February 2022 recalls of three infant formulas produced at an Abbott plant in Sturgis, Mich., over concerns about potential bacterial contamination. The Sturgis plant reopened in August 2022.

A Rare Resource
Donor breast milk, or pasteurized donor human milk as physicians refer to it, is the standard protocol of care for premature babies in the neonatal intensive care unit with very low birth weight — roughly 3.3 lbs or less. Donor breast milk allows premature infants to take in more nutrients faster than cow’s milk-based formula, and it allows the babies to grow. Sometimes, donor milk can also help hospitalized infants with severe intestinal disorders, according to the American Academy of Pediatrics. 

Much of this milk comes from nonprofit donor milk banks. There are only 32 certified pasteurized donor human milk banks in the United States and Canada that are members of the Human Milk Banking Association of North America, though some hospitals have their own milk banks to supply their neonatal intensive care units.

Shetal Shah, a neonatologist in New York and a member of the American Academy of Pediatrics, compared donor breast milk to “liquid gold” — a rare resource that doctors must allocate to those most in need.

Physicians say they already have to be judicious about deciding when to use donor breast milk for preemie babies. Putting more strain on the donor milk supply, they say, could backfire.

Last year’s version of Duckworth’s bill included language aimed at getting donor breast milk covered by the Special Supplemental Nutrition Program for Women and Children, commonly known as WIC. But that provision faced pushback from already strained milk banks, Duckworth said.

Instead, this year’s bill does not push for WIC coverage of donor breast milk. Instead, it empowers SNAP and WIC to use excess funds to purchase coolers to collect and store donor breast milk. 

“If you wind up having a lot more babies who are otherwise healthy, who are taking donor milk, you’re going to start potentially removing donor milk from those special populations,” Shah said.  

While donor milk is technically accessible in an outpatient setting without a prescription, it still can be difficult to bring home. Medicaid covers donor breast milk in inpatient settings but not outpatient. Without insurance, donor breast milk can run from $3 to $5 an ounce. 

“It’s not within most people’s budget. I mean, the formula itself is hard to afford,” Castillo-Hegyi said.

Stranger danger
During the formula shortage last year, Shah saw a “huge surge” in interest in donor breast milk, but not a lot of knowledge around the subject. 

The FDA and leading medical organizations all strongly discourage peer-to-peer milk sharing or buying donor milk from someone you don’t know on the internet. 

Not-for-profit human milk banks screen, pasteurize and test donated breast milk to make sure it is free of diseases or chemicals that could hurt the baby. That’s not the case when picking up some excess frozen milk a local mom posted about on Craigslist or through a milk share Facebook group.

Right now, the FDA classifies donor milk as a food and does not differentiate between cow milk or human milk with its pasteurization standards. But the FDA website does urge parents to only use milk from a source that has screened its milk donors and taken other precautions to ensure the safety of the milk.

The American Academy of Pediatrics and other pediatric health organizations have called for more federal and state guidelines around donor milk pasteurization, handling, transfer and storage. 

Houlahan, meanwhile, said her office is talking with the FDA’s new Human Foods Program to brainstorm ways to better regulate human milk. 


The upcoming farm bill, which both the House and Senate are currently drafting, could be a vehicle for the legislation, Duckworth said, but the sponsors also believe that the legislation could pass as a stand-alone. The current farm bill expires Sept. 30.

Houlahan says she’s optimistic that more Republicans will support the legislation this year as Republicans look to support “pro-families bills” in the wake of the Supreme Court’s decision to overturn the federal right to an abortion. She’s hoping to get the bill introduced in the Energy and Commerce Committee in the House.

“I do believe there’s some pressure on the Republican Party to be more forward-leaning on family issues, for evident reasons,” Houlahan said. 

By:  Ariel Cohen