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FDA Consumer magazine
May-June 2003
Table of Contents
By Carol Lewis
Two decades of scientific research, and years of proactive measures by health experts and others, are beginning to pay off. Attitudes and behaviors toward breast-feeding in the United States are changing.
During the last 15 years, the importance of breast-feeding has been recognized as one of the most valuable medical contributors to infant health. In 1990, the United States signed a formal declaration on the protection, promotion, and support of breast-feeding adopted by the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF). At the same time, the Department of Health and Human Services (HHS), through a national health promotion and disease prevention initiative called Healthy People 2000, and subsequently Healthy People 2010, established breast-feeding objectives for the first year of an infant's life.
Recognition of the benefits of breast-feeding has already spread to many health and professional organizations, such as the American Academy of Family Physicians, the American Dietetic Association, and the American College of Obstetricians and Gynecologists. Moreover, the American Academy of Pediatrics considers breast-feeding to be "the ideal method of feeding and nurturing infants."
To further these efforts, the HHS Office on Women's Health (OWH), in cooperation with other federal agencies and health care professional organizations, developed a comprehensive national breast-feeding policy, called the HHS Blueprint for Action on Breastfeeding.
The OWH has been given funds to translate the recommendations of the Blueprint into the National Breastfeeding Awareness Campaign to promote breast-feeding among first-time parents. The overall goal of both the Blueprint and the campaign is to increase the number of mothers who breast-feed their babies in the early period following their birth (postpartum) to 75 percent and to raise to 50 percent those who are breast-feeding at 6 months postpartum by the year 2010.
The Blueprint introduces an action plan for breast-feeding that reaffirms its superiority for most newborns. The plan is based on education, training, awareness, support, and science, and includes key recommendations of the HHS Subcommittee on Breastfeeding.
"The Blueprint has been widely circulated and the number of requests for the document has been unprecedented," says Suzanne G. Haynes, Ph.D., chairwoman of the HHS Subcommittee on Breastfeeding and senior science advisor at the OWH. "It is being used in teaching settings, in hospitals, and in communities," she adds, noting that the U.S. Department of Agriculture is using the document to promote breast-feeding in nine state projects.
As part of the National Breastfeeding Campaign, a comprehensive three-year media campaign will be launched in the summer of 2003. The campaign will be marketed in partnership with selected organizations and will get the message out through public service announcements, bus-stop posters, billboards, articles in community newspapers, parenting and women's magazines, Web sites, and educational pamphlets.
In addition, 18 community-based demonstration projects throughout the United States will work with the OWH and the Advertising Council to implement the National Breastfeeding Awareness Campaign on a local level. The projects will attempt to educate women about the benefits of breast-feeding, encourage them to choose to breast-feed, and create awareness that breast-feeding is normal, desirable, and achievable.
Legislative support of breast-feeding is growing. As of 1999, 33 states had enacted laws relating to a wide range of issues involving various aspects of breast-feeding, such as redefining indecent exposure rules, allowing breast-feeding in public places, jury duty postponement due to breast-feeding, and promotion of breast-feeding programs. Hawaii, for example, prohibits employers from discriminating against a mother who breast-feeds or expresses milk with a pump at the workplace.
In addition, several health plans are working to make women aware of the many health benefits breast-feeding holds for their newborns and for themselves. "We have the support of the leading policy groups for health plans," says Haynes. According to the American Association of Health Plans (AAHP), health plans have a vital role to play in increasing the number of women who successfully breast-feed their babies.
Health plans can influence both families and health care providers through targeted educational interventions promoting breast-feeding, and breast-feeding support services, provided before, during, and after birth. Additionally, health plans can support breast-feeding mothers during the critical first days and weeks postpartum by offering all mothers access to special services provided by trained physicians, nurses, lactation specialists (breast-feeding coaches), and peer counselors or other trained health care providers.
Science has proved that breast-fed babies have a healthier start in life. Human milk contains a balance of nutrients that closely matches infant requirements for brain development, growth and a healthy immune system. Human milk also contains immunologic agents and other compounds that act against viruses, bacteria, and parasites. Since an infant's immune system is not fully developed until age 2, human milk provides a distinct advantage over formula.
Because breast milk provides protection against germs that a baby or mother may carry, studies in infant feeding have found lower rates of several chronic childhood diseases, including respiratory infections and ear infections, as well as symptoms such as diarrhea, among children who were breast-fed.
Research also suggests that breast-fed infants gain less weight and tend to be leaner at 1 year of age than formula-fed infants. This early indicator may influence later growth patterns, resulting in fewer overweight and obese children.
But infants aren't the only ones who benefit from breast-feeding. Mothers, too, are the recipients of many positive hormonal and physical effects. Breast-feeding releases a hormone in a woman's body that causes her uterus to return to its normal size and shape more quickly and reduces blood loss after delivery. In addition, according to the Blueprint, studies have shown that breast-feeding for longer periods of time (up to 2 years) and among younger mothers may reduce the risk of premenopausal and possibly postmenopausal breast cancer. Also, the risk of ovarian cancer may be lower among women who have breast-fed their children.
Haynes says intriguing new developments indicate that breast milk may even have another role in the battle against cancer. In particular, breast-feeding may reduce the risk of childhood cancer.
Researchers have identified a protein in human milk--human alpha-lactalbumin made lethal to tumors (HAMLET)--that induces apoptosis, or programmed cell death, in which cells, responding to environmental signals, self-destruct. Apoptosis, a relatively new study in biology, is the natural mechanism the body uses to recycle material that is not needed for functioning. When apoptosis is initiated, the cell's genetic material becomes shredded so that the cell cannot replicate itself. With cancer cells, apoptosis is inhibited, allowing rapid growth of dysfunctional cells. Haynes says that the isolation of HAMLET as a trigger for apoptosis in cancer cells could give further weight to evidence linking breast milk to reduced incidences of some cancers.
From a budget standpoint, breast-feeding can save a family hundreds of dollars a year, even with the added cost of breast pumps, devices regulated by the Food and Drug Administration that allow mothers to express milk when they are away from their babies or when they want to save extra milk to be given to the baby at other times. According to the Blueprint, breast-feeding also saves money for insurers and employers by cutting down on doctor visits and sick days.
Why, then, with all these benefits, don't more mothers breast-feed?
Breast-feeding requires a substantial commitment from a mother. Some mothers feel tied down by the constant demands of a nursing newborn. Others feel embarrassed or concerned about breast-feeding, especially in public places.
"That's just the type of image we're trying to change," says Haynes. "We're trying to normalize breast-feeding so that people won't blink an eye when they see it." Haynes says removing these kinds of barriers is a major challenge of the campaign.
But she also emphasizes that breast-feeding is not the end of a woman's independence. Women can use pumps to express milk when they are going to be away from their babies so that others can bottle feed them, allowing mothers to keep up their milk supply. She adds that women can return to full-time work with careful planning and a discussion with employers about a private and sanitary area to express milk.
Carol Huotari manages the Center for Breastfeeding Information at the Schaumburg, Ill., headquarters of La Leche League, an international breast-feeding support and educational organization. She says, "It's not uncommon for mothers to face difficulties." While the ability to breast-feed is not necessarily inherent in a mother, Huotari says with the proper information and support, the experience of breast-feeding is more often than not successful, and when it is successful it can be profoundly fulfilling. "It's more than just the benefits to the baby--it's about the benefits to the mother, too." While obstacles can sometimes hinder success, Huotari says that most can be overcome.
Because diabetes and allergies run prevalent on both sides of Amy Finnerty's family, the 29-year-old Huntley, Ill., resident especially wanted to breast-feed her baby. But obstacles, like her baby's inability to latch on to her breast properly as the result of a stressful birth experience and the temporary pain she experienced early on, nearly convinced Finnerty that, for her, breast-feeding just wasn't meant to be.
"I remember thinking, 'I'm not going to be a good mom,'" she says. "I didn't think I could take the pain anymore." But the support she received both from the local La Leche League group and her husband clinched it for Finnerty. "Meeting with women who shared my common interest of breast-feeding certainly helped bolster my commitment to nursing," she says. "And Bill would encourage me each time to get through one more feeding, even though I was feeding several times a day. Eventually he was right. I stayed with it and it just clicked." Finnerty is today happily and successfully nursing her daughter, Veronica.
Huotari says that professional and family support can influence a mother's breast-feeding choice and practices. "It's important to begin sharing positive information on breast-feeding to both boys and girls in school," she says. And health care providers can promote breast-feeding during pregnancy check-ups. "We know that decisions made to breast-feed are often made well before the baby arrives, yet some others do decide that they will breast-feed when their newborn is in their arms for the first time."
Even the childbirth experience can make a great impact on the way breast-feeding begins and continues, says Huotari. "Amy did a lot of preparation for birth beforehand," she says, "and despite the fact that Veronica's birth didn't go the way she planned, Amy is now a well-established breast-feeding mom."
The La Leche League has chapter meetings throughout the country where expectant and new mothers can learn about breast-feeding, nutrition, and other aspects of child care. (See "For More Information" for the number to call for local chapters.)
Despite the benefits, not every mother is able to breast-feed or chooses to do so. In rare cases, a mother's health may prevent her from breast-feeding. Women who test positive for HIV and AIDS or who have human T-cell leukemia virus type 1 (HTLV-1) should not breast-feed or provide their breast milk for the nutrition of their own or other infants because of the risk of transmission to the child.
Under certain conditions, a case-by-case assessment should be made about whether or not breast-feeding is advisable or should be temporarily stopped. According to the Blueprint, some of these conditions include:
Mothers should always ask their physicians before continuing or taking new medications while nursing.
The American Academy of Pediatrics (AAP) first issued a statement on the transfer of drugs and chemicals into human milk in 1983, revising its lists in 1989 and 1994. Information continues to become available. The current statement, which can be found on the AAP's Web site (www.aap.org/policy/0063.html), is intended to assist physicians in counseling a nursing mother regarding breast-feeding when the mother has a condition for which a drug is medically indicated.
Susan F. Wood, Ph.D., director of the FDA's Office of Women's Health (OWH) says, "The FDA's Center for Drug Evaluation and Research and the OWH are working to improve the current label on products so that it is more helpful to both mothers and prescribing physicians. However, more research is needed in order for good information to show up in the label, and FDA is also working to encourage such research."
For women who are unable to breast-feed, the FDA recommends using only commercially prepared formulas as an alternative to breast milk. These formulas contain the complex combination of proteins, sugars, fats, minerals, and vitamins needed to support growth in infants. The composition of commercial formulas is carefully controlled, and the FDA requires that these products meet very strict standards.
The safety of commercially prepared formula is ensured by the agency's nutrient requirements and by strict manufacturing quality control procedures. These procedures require manufacturers to analyze each batch of formula for required nutrients, test samples for stability during the shelf life of the product, code containers to identify the batch, and make all records available to FDA investigators.
But, while formulas try to imitate the ingredients in human milk, the exact composition of breast milk cannot be duplicated. Human milk contains living cells, hormones, active enzymes, and immunoglobulins that cannot be replicated in infant formula. It also has carbohydrates, easily digestible proteins, and fat, plus antibodies that can protect the baby from infection. Therefore, performance of infant formulas is measured by the infant's growth, absorption of nutrients, and gastrointestinal tolerance.
As of 200l, the year for which the most recent statistics are available, almost 70 percent of all mothers breast-fed in the early postpartum period, and about 32 percent of all mothers breast-fed at 6 months postpartum. Comparing rates in 2001 to 1996, increases in initiating breast-feeding and continued breast-feeding to 6 months were greater among groups that have been historically less likely to breast-feed: black women, women younger than 20 years old, no more than high school educated, working women, and others.
However, racial and ethnic disparities in breast-feeding rates remain significant and, according to HHS, black women breast-feed at alarmingly low rates.
HHS believes that the nation needs to address these low rates as a public health challenge and put in place national, culturally appropriate strategies to promote breast-feeding.
There are many reasons for the low breast-feeding rates in the black community, but they are reversible. For one thing, breast-feeding is thought to be painful. Most people do not realize that, although there can be some initial discomfort, if done properly, breast-feeding should not cause pain.
Another reason is that the attitude toward breast-feeding in the black community has not been positive. Experts say the message that breast-feeding is superior to formula-feeding has not been heard. Black women also say it is difficult for them to receive information and education about breast-feeding, to have breast-feeding initiated in the hospital, to continue breast-feeding in the early days in the home setting, and to continue breast-feeding for an extended period.
The Baltimore-based African-American Breastfeeding Alliance, Inc. (AABA) seeks to make breast-feeding a family affair, since black communities often are based on kinship. The decision to breast-feed is frequently directly related to influence from peers, husbands, boyfriends, and other family members. In other words, a woman is more likely to breast-feed if members of her family--primarily spouses--support it.
"It is often taken for granted that African-American women will not breast-feed so they generally don't receive good breast-feeding education and support," says Katherine Barber, founder and Executive Director of AABA. According to AABA, breast-feeding education should be an essential component during prenatal care.
Increasing the rates of breast-feeding is a compelling public health goal, particularly among the racial and ethnic groups who are less likely to initiate and sustain breast-feeding throughout the infant's first year. According to the Blueprint, this goal can only be met when breast-feeding is supported in the family, community, workplace, health care sector, and society.
Overall, the Blueprint speaks to federal, state, and local governments, families, and the medical community--especially hospitals, where staff can be re-educated, consultants hired, and peer counselors made available to promote breast-feeding. Recognizing that breast-feeding rates are influenced by various factors, the document suggests an approach in which all interested people and organizations come together to forge a partnership to promote and encourage breast-feeding in the United States.
Center for Food Safety and Applied Nutrition
(HFS-555)
Food and Drug Administration
5100 Paint Branch Parkway, College Park, MD 20740-3835
Office of Women's Health
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
Office on Women's Health
Department of Health and Human Services
8550 Arlington Blvd., Suite 300 Fairfax, VA 22031
1-800-994-WOMAN (1-800-994-9662); TDD: 1-800-220-5446
La Leche League International
1400 N. Meacham Road, Schaumburg, IL 60173-4808
1-800-525-3243 (for information and local chapter numbers)
Two of the FDA's regulatory centers have a responsible role with regard to breast-feeding.
The FDA's Center for Devices and Radiological Health (CDRH) is responsible for ensuring that devices such as breast pumps are safe and effective for nursing moms. Breast pumps are classified as either powered or non-powered devices. All powered breast pumps are subject to premarket review and clearance prior to marketing in the United States. Non-powered breast pumps do not require any premarket review unless the manufacturer makes a fundamental change in the technology of the device. Both types of breast pumps are, however, subject to other regulatory controls, such as good manufacturing practices and record keeping.
To report an adverse experience by telephone, or to register a complaint about breast pumps, contact the FDA's Office of Emergency Operations at 1-888-463-6332.
The FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the safety and nutritional adequacy of commercially prepared infant formulas.
In the rare circumstances when breast-feeding is not possible or recommended, or for various reasons a mother may choose not to breast-feed, commercially prepared infant formula can be used as an alternative form of feeding. Infant formulas are liquids or reconstituted powders fed to infants and young children. They have a special role to play, because often they are the only source of nutrients for infants during a very vulnerable period of rapid growth and development.
Current laws require that infant formula manufacturers must provide the FDA assurance of the nutritional quality of each formulation before marketing. The FDA has provisions that include requirements for certain labeling, nutrient content and manufacturers' quality control procedures (to assure the nutrient content), as well as for company records and reports.
More information on commercially prepared infant formulas is available on CFSAN's Web site.