Use of Donor Human Milk
The benefits of breastfeeding are well-established (See Resources from Other Agencies below); however, in some situations when a mother’s own milk may be unavailable or insufficient, parents may look for alternative sources of human breast milk to feed their babies.
Consult a healthcare provider first
The choice to feed a baby human milk from a source other than the baby’s mother should be made in consultation with the baby’s healthcare provider, because the nutritional needs of each baby depend on many factors including the baby’s age and health.
FDA recommends that if, after consultation with a healthcare provider, you decide to feed a baby with human milk from a source other than the baby’s mother, you should only use milk from a source that has screened its milk donors and taken other precautions to ensure the safety of its milk.
There are human milk banks that have established standards to screen milk donors and safely collect, handle, process, test, and store the milk. A few states have also established specific safety requirements for such milk banks.
You can contact your state’s department of health to find out if it has information on human milk banks in your area. Another source of information is the Human Milk Banking Association of North America (HMBANA), a nonprofit accrediting organization that sets safety standards and accredits its member milk banks in the U.S. and Canada (http://www.hmbana.org/).
FDA does not recommend feeding your baby breast milk acquired directly from individuals or through the Internet
When human milk is obtained directly from individuals (such as peer-to-peer sharing groups) or through the Internet, the donor is unlikely to have been adequately screened for infectious disease, medication and substance use, environmental exposures, or other contamination risks. In addition, it is not likely that the milk was collected, handled, processed, tested, or stored in a way that adequately protected your baby from possible safety risks.
Consider the possible safety risks
If you are considering feeding a baby with human milk from a source other than the baby’s mother, you should know that there are possible health and safety risks for the baby. If the donor has not been adequately screened, the donated milk may expose the baby to various infectious diseases (e.g., Hepatitis B, Hepatitis C, HIV) or harmful residues (e.g., from illegal/recreational drugs, some prescription drugs, or some over-the-counter medications). In addition, if proper practices are not followed during pumping, handling, storage, or preparation of human milk, then it could become contaminated and unsafe to drink.
For Industry
How FDA regulates Human Donor Milk
FDA regulates donor human milk under FDA’s regulatory authority for foods. FDA inspects donor human milk banks against the applicable requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117). Certain products containing human milk in which the milk is modified, for example, by increasing the protein content or by adding vitamins or minerals, could be considered exempt infant formulas subject to exempt infant formula requirements in addition to 21 CFR part 117. As with all food products, FDA is primarily concerned with safeguarding public health and ensuring that food is safe.
Resources from other agencies
Breastfeeding is strongly recommended by healthcare professionals and the U.S. Department of Health and Human Services. Information on breastfeeding can be found at: