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FDA Won't Regulate Breast Milk…for Now

With sharing breast milk becoming more popular, the FDA is concerned that the risks could outweigh the benefits.



FDA Won't Regulate Breast Milk…for Now

Breast milk is best, but if that's not possible, some mothers turn to milk from a donor.

RODALE NEWS, EMMAUS, PA—The U.S. Food and Drug Administration (FDA) will not move to regulate breast milk banks for now, but a panel recommended in December that more research is needed to make sure the benefits of using breast milk from another mother outweigh the higher price tag and potential health risks for the child, including transmission of infectious diseases and contamination from drugs. The panel meeting took place on the heels of FDA's late-November announcement warning mothers against casually sharing unscreened breast milk. The announcement was sparked by the growing trend of mothers soliciting and sharing unscreened breast milk through social-media networks—including Eats on Feets on Facebook—connecting breast milk donors with mothers seeking milk for their infants.


"I do agree that there is an apparent increase in the use of shared milk, and that a statement isn't totally unwarranted, but I wish the FDA would publicly recognize that formula causes health concerns and is a sub-optimal means to feed infants," says Kim Updegrove, RN, CNM, MPH, executive director of Mother's Milk Bank at Austin, located in Texas. "Feeding an infant anything other than their mothers' own milk is feeding a breast milk substitute; whether it be breast milk [from another woman] or formula, there are risks association with any alternative," she says.

THE DETAILS: The FDA panel examined the costs of obtaining breast milk from milk banks, along with the potential for disease transmission. While breast milk from donor banks is considered a lifesaver for many premature babies because of its unparalleled ability to prevent pulmonary and GI-tract infection, as well as necrotizing enterocolitis (in which parts of the bowel start dying), mothers who can't produce milk, or enough of it, are also looking to milk donors to keep their babies on nature's formula. One of the problems with obtaining milk from licensed breast milk banks—which is pasteurized—is cost. The FDA's Dec. 6 Meeting on Donor Human Milk Banking estimated that donor milk costs more than $10 more per 100 milliliters when compared to formula. Which is one reason why some mothers are going the social-media route to collect milk for much cheaper rates (or even for nothing) from breast milk donors.

But using unpasteurized, unscreened breast milk opens up the door to possible life-threatening virus transmission to the baby, risking exposure to HIV, hepatitis B, and cytomegalovirus, all which can survive in breast milk. (Breast milk donor banks screen for these and other infectious diseases and will not accept milk from infected women.) A 2009 study looking at vigorous blood-screening results in potential donors found that 3 percent harbored viruses, including HIV and hepatitis B.

WHAT IT MEANS: Taking the above-mentioned risks into consideration, it's also important to understand that there's something potent about the beneficial power of breast milk. It just knows what to do. "The most beautiful part is the evolutionary process through of all of this," says Thomas Hale, RPH, PhD, executive director of the InfantRisk Center at Texas Tech University. "We may not know why it is what it is, but we know that it's right."

For instance, for years, researchers wondered why there was virtually no iron in breast milk. "Then we found out that iron causes bacteria to grow, and the milk doesn't want to stimulate that growth."

Published on: December 8, 2010
Updated on: January 25, 2011



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Donor breast milk

Please don't feel bad if you don't or can't breast feed. It is your choice. I was not able to breast feed my premature daughter, and she was fed a special formula for preemies that had extra calories in it. If we had chose donor breastmilk, she would not have been able to receive the extra calories that she needed from it! Only from me or the preemie formula would she have benefited!

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