Infant formula, also called baby formula, simply formula (American English), formula milk, baby milk, or infant milk (British English), is a manufactured food designed and marketed for feeding infants under 12 months of age, usually prepared for bottle-feeding or cup-feeding from powder (mixed with water) or liquid (with or without additional water). The U.S. Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants because it simulates human milk or its suitability as a complete or partial substitute for human milk". The use of infant formula has been found to be associated with health risks such as type 1 and 2 diabetes, sudden infant death syndrome (SIDS), eczema, and more when compared to infants who are breastfed. A 2001 World Health Organization (WHO) report found that infant formula prepared per applicable Codex Alimentarius standards was a safe complementary food and a suitable breast milk substitute. In 2003, the WHO and UNICEF published their Global Strategy for Infant and Young Child Feeding, which restated that "processed-food products for ... young children should, when sold or otherwise distributed, meet applicable standards recommended by the Codex Alimentarius Commission", and also warned that "lack of breastfeeding—and especially lack of exclusive breastfeeding during the first half-year of life—are important risk factors for infant and childhood morbidity and mortality". Some studies have shown that use of formulas can vary according to the parents' socio-economic status, ethnicity or other characteristics.
Usage
The use and marketing of infant formula have been subject to scrutiny. Breastfeeding, including exclusive breastfeeding for the first 6 months of life, is widely advocated as "ideal" for babies and infants, both by health authorities—and accordingly in ethical advertising of infant formula manufacturers. Despite the recommendation that babies be exclusively breastfed for the first 6 months, 48% of infants below this age are exclusively breastfed worldwide. The overwhelming majority of American babies are not exclusively breastfed for this period—in 2025 24.9% of babies were breastfed exclusively for the first 6 months, with nearly 40% of babies less than 3 months of age being supplemented with infant formula in 2022, and approximately 20% of infants having infant formula feeding within two days of birth. The use of hydrolysed cow milk baby formula versus standard milk baby formula does not appear to change the risk of allergies or autoimmune diseases.
Use of infant formula
In some cases, breastfeeding is medically contraindicated; these include:
Mother's health: The mother is infected with HIV or has active tuberculosis. She is extremely ill or has had certain kinds of breast surgery, which may have removed or disconnected all milk-producing parts of the breast. She is taking any kind of drug that could harm the baby, including both prescription drugs such as cytotoxic chemotherapy for cancer treatments, as well as illicit drugs. One of the main global risks posed by breast milk specifically is the transmission of HIV and other infectious diseases. Breastfeeding by an HIV-infected mother poses a 5–20% chance of transmitting HIV to the baby. However, if a mother has HIV, she is more likely to transmit it to her child during the pregnancy or birth than during breastfeeding. A 2012 study conducted by researchers from the University of North Carolina School of Medicine showed reduced HIV-1 transmission in humanized mice, due to components in the breast milk. Cytomegalovirus infection poses potentially dangerous consequences for pre-term babies. Other risks include mother's infection with HTLV-1 or HTLV-2 (viruses that could cause T-cell leukemia in the baby), herpes simplex when lesions are present on the breasts, and chickenpox in the newborn when the disease manifested in the mother within a few days of birth. In some cases these risks can be mitigated by using heat-treated milk and nursing for a briefer time (e.g. 6 months, rather than 18–24 months), and can be avoided by using an uninfected woman's milk, as via a wet-nurse or milk bank, or by using infant formula and/or treated milk. In balancing the risks, such as cases where the mother is infected with HIV, a decision to use infant formula versus exclusive breastfeeding may be made based on alternatives that satisfy the "AFASS" (Acceptable, Feasible, Affordable, Sustainable and Safe) principles. Baby is unable to breastfeed: The child has a birth defect or inborn error of metabolism such as galactosemia that makes breastfeeding difficult or impossible. Baby is considered at risk for malnutrition: In certain circumstances infants may be at risk for malnutrition, such as due to iron deficiency, vitamin deficiencies (e.g. vitamin D which may be less present in breast milk than needed at high latitudes where there is less sun exposure), or inadequate nutrition during transition to solid foods. Risks can often be mitigated with improved diet and education of mothers and caregivers, including availability of macro and micronutrients. For example, in Canada, marketed infant formulas are fortified with vitamin D, but Health Canada also recommends breastfed infants receive extra vitamin D in the form of a supplement. Other reasons for not breastfeeding include:
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