FDA Weighs in on Breast Milk Sharing

As breast milk sharing becomes increasingly popular, the FDA deliberates safety.

December 6, 2010, 5:57 PM

Dec. 6, 2010— -- Kimberlee Bookhart, a 38-year-old Kansas City mother, is convinced that donated breast milk played an important part in saving her baby's life.

Born three months premature and weighing 1 pound, 1 ounce, Bookhart's baby, Zahra, could fit into the palm of her father's hand.

Because Zahra was born so prematurely, Bookhart had difficulty producing enough breast milk to nourish her, so doctors fed Zahra a special formula while in the hospital. But Zahra soon experienced serious health problems, including necrotizing enterocolitis in which portions of the bowel die, a medical condition often seen in premature infants.

Bookhart thinks the formula partly contributed to Zahra's failing health. Believing in the powerful benefits of breast milk, Bookhart contacted the Mothers' Milk Bank in Colorado. She now receives regular shipments of donated breast milk. Zahra, now 7 months old, is still in the hospital, but doctors say she is going to be fine.

"Milk banks have been a lifesaver in our case," said Bookhart.

Although milk banks have become increasingly popular for mothers and fathers, there is no federal regulation governing the donating and distributing of human milk. The only state-regulated milk banks are in California and New York, where donor milk banks must be licensed tissue banks and are regulated by the state Health Department.

To address the regulatory situation, the Food and Drug Administration held an informational session Dec. 6, where advisers weighed in on the safety, risks and needed regulation for the collection, screening, processing and distribution of human milk.

The meeting came on the heels of an FDA warning issued last week about what it believes are the risks -- including contamination and the spread of illness -- of feeding a baby breast milk from a source other than its mother.

For many donors, though, the act of giving milk has become a moral imperative.

Giving Breast Milk to Others Right Thing to Do

Two months after Theresa Giarratano gave birth to her son, she donated her breast milk to Mothers' Milk Bank at the Rocky Mountain Children's Health Foundation at Presbyterian St. Luke's Medical Center, the same bank that ships milk to Bookhart in Kansas City.

"Once I knew that I had plenty of milk for my little guy and enough to share, I became a donor," said Giarratano, a 29-year-old high school science teacher from Littleton, Colo.

Now, once Giarratano finishes breastfeeding her 5-month-old son, Lucca, she tries to pump a little extra and tosses it in the freezer. A Mothers' Milk Bank representative picks it up and brings it to the milk bank, where it is processed and shipped off to a baby in need.

"If I'm able to help a baby who needs breast milk. I can't imagine not helping when it's so easy," said Giarratano. "I plan on continuing to donate for a year, or the duration of my breastfeeding."

Health organizations have long encouraged mothers to breastfeed their newborn babies. Breast milk provides antibodies against pathogens, and has been associated with reduced morbidity and mortality from gastrointestinal, respiratory and other diseases.

But what if a child is adopted? Or the baby is born premature and the mother cannot produce enough milk? Or has had a mastectomy?

In cases like these, human milk banks have been a godsend for women.

"Milk banks are important in the way that blood banks are important," said Karla Shepard Rubinger, executive director of the Academy of Breastfeeding Medicine. "Blood banks need oversight and regulations. You ask most people about milk banks and they go 'yucky.' Ask them how they feel about blood banks, and they'll say we need to support them."

According to the Human Milk Banking Association of North America, milk banks dispensed a total of 409,077 ounces of milk in 2000. In 2005, that number increased by 45 percent. And demand continues to grow.

Standards for Breast Milk Donation

The Human Milk Banking Association was established in 1985 and currently acts as the umbrella association for nonprofit North American milk banks. The organization sets standards and develops guidelines that include donor screening and pasteurization.

While many milk banks voluntarily follow the milk banking association's guidelines, the FDA has recently become aware of for-profit milk banks like Prolacta Bioscience, a large-scale human milk company, and the donation and selling of breast milk through the Internet.

"We need doctors and regulators to become more informed, because we need them to regulate this -- not to prevent it but to support it happening in a way that protects mothers and babies," Rubinger said.

Some of that support could be financial. At $3.50 an ounce, the continuous need for breast milk can add up to a significant amount of money each month, but Mothers' Milk Bank does not require immediate payment if parents cannot afford it.

"Insurance companies say the breast milk is not a necessity, so right now, we're fighting with the insurance company to cover it," said Bookhart.

Online Milk Sharing

High costs and high demand have caused some women to turn to Internet-based organizations, such as Eats on Feets, a global initiative that connects milk donors with women who need milk. Women can now post their breast milk needs on Eats on Feets Facebook pages.

"We have an online space for families in need and women who have a surplus," said Emma Kwasnica, a 32-year-old mother of three from Montreal and co-founder of Eats on Feets. "We're putting it back in the hands of the mothers."

Breast Milk and Contamination

While many pediatricians consider breast milk the perfect food for babies, human milk can be contaminated with bacteria and viruses, such as HIV, and can be a source of infection among nursing infants. The risks could be easily identified and controlled in the proper setting, but the FDA fears that, without screening, donors could inadvertently spread serious illness to the nursing babies.

Rubinger, of the Academy of Breastfeeding Medicine, said it's a matter of overcoming certain technicalities, drawing again on the blood bank analogy.

"There are a lot of issues with milk in milk banks, just as there are with blood in blood banks," she said. "This is not insurmountable information, though. That's why we have the scientists to deal with that."

Because Eats on Feets only provides a space for milk donors and recipients to connect, it requires no formal blood tests or screenings, although it encourages recipients to ask potential donors about their lifestyles and medications. But it's up to them to reach an agreement on blood tests and who will cover the costs.

"Milk sharing is community-based, so, while it's possible that a woman might receive milk from an absolute stranger, there are usually not too many degrees between the recipient and donor," said Shell Walker, the other co-founder of Eats on Feets and a 43-year-old Phoenix midwife and mother of four.

"I'm not saying we need to discount possible concerns because they are real and legitimate," said Walker. "But women are smart enough to figure these things out."

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