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.

December 8, 2010

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."

Even more amazing, even after heating human breast milk properly to kill pathogens, it still retains 50 to 70 percent of IgA antibodies, the protectors that coat the mucous membranes (eyes, nose, ears, eyes, digestive tract, vagina) from outside pathogens. They are key in keeping babies healthy. Because of IgA and other beneficial components of breast milk, the list of breastfeeding's benefits is long and well documented, which makes it worth the effort of many mothers to find donor milk. Breastfed babies are much healthier and less likely to become overweight in adolescence, and they are less prone to develop mental disorders, certain autoimmune diseases, and possibly even ailments like diabetes, ulcerative colitis, and Crohn's disease later in life.

Beyond that, there have been plenty of concerns over formula, including the beetles recall and the fact that virtually all soy-based formulas are made from genetically engineered ingredients that have never been proven safe. (Organic certification bans the use of genetically engineered ingredients.) "The immediate and long-term health benefits of breast-milk-feeding outweigh the known risks associated with formula-feeding," says certified nurse midwife Heather Swanson, spokeswoman for the American College of Nurse-Midwives. "Human milk is species-specific—no other species creates milk that is immunologically and nutritionally designed to optimally develop and protect a human baby. Likewise, soy-based formulas lack the immunological and nutritional components found in human milk."

Giving babies soy formula or cow's milk also increases the risk of allergies or elevated rates of infection in babies. "But if that's your only choice, you have to feed the baby," adds Hale.

Here's how to feed your baby if you're having challenges providing breast milk.

• Be sure you can't make your own milk. A number of mothers who can't breastfeed, such as an adoptive mother or a woman who has undergone a mastectomy, are seeking milk from other nursing mothers, given all the benefits of breastfeeding. But some other mothers give up or avoid giving breastfeeding a try because they don't receive enough support from hospital staff or they run into roadblocks once at home. If this happens, look to the La Leche League, an international breastfeeding support group, for tips and forums to discuss boosting your changes of successfully breastfeeding.

While the benefits of breastfeeding are unequivocal, if you're unable to produce enough milk or obtain it from a milk bank, don't feel guilty about giving your baby formula. After all, your number one job is to make sure your baby gets enough calories and nutrients to stay healthy, whether through your breast milk, someone else's, or from formula.

• Bank on safe breast milk. "If you're going to use milk from another mother, it should be pasteurized. That's the number one takeaway, or the baby could be put at risk," says Hale, who notes that licensed milk banks pasteurize breast milk under Human Milk Banking Association guidelines and are regarded as very safe. Viruses and virtually all harmful bacteria are eliminated when the milk is kept at 62.5 degrees Celsius (144.5 degrees Fahrenheit) for 30 minutes. "The safest form of donor human milk is pasteurized," he adds.

• Network with moms, weigh the risks with benefits. Certainly, screened, pasteurized breast milk from another mother is safe, says Hale. But trading with mothers without proper pasteurization does carry risks. For more information about the risks and benefits of breast-milk-sharing, or to find out how to donate your own, visit La Leche League's site.