The FDA and Breastfeeding

by Food and Drug Administration (FDA)

(Page 4 of 4)

Increasing the Rates

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.

The FDA and Breast-Feeding

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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.