Infant formula


Infant formula, also called baby formula, simply formula, formula milk, baby milk, or infant milk, is a manufactured food designed and marketed for feeding babies and infants under 12 months of age, usually prepared for bottle-feeding or cup-feeding from powder or liquid. The U.S. Federal Food, Drug, and Cosmetic Act 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 lower cognitive development and numerous increased health risks such as type 1 and 2 diabetes, sudden infant death syndrome, eczema, and more when compared to infants who are breastfed.
A 2001 World Health Organization 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 formula 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, 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, 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" 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, 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:
  • Personal preferences, beliefs, and experiences: The mother may dislike breast-feeding or find it inconvenient. In addition, breastfeeding can be difficult for victims of rape or sexual abuse; for example, it may be a trigger for posttraumatic stress disorder. Many families bottle feed to increase the father's role in parenting his child.
  • Mental health: The pressure to breastfeed in many cultures can be so much that the mother's mental health may take a sharp decline. This can have physical effects such as poor latching, as well as milk depletion and a lack of connection to the child. In some cases, the child should be formula-fed so that a better bond can be made between mother and child, rather than the 'special bond' that comes from breastfeeding being tainted by negative breastfeeding experiences. The pressure to breastfeed in many cultures can increase the likelihood of postpartum depression.
  • Absence of the mother: The child is adopted, orphaned, abandoned, or in the sole custody of a man or male same-sex couple. The mother is separated from her child by being in prison or a mental hospital. The mother has left the child in the care of another person for an extended period of time, such as while traveling or working abroad.
  • Food allergies: The mother eats foods that may provoke an allergic reaction in the infant.
  • Financial pressures: Maternity leave is unpaid, insufficient, or lacking. The mother's employment interferes with breastfeeding. Mothers who breastfeed may experience a loss of earning power.
  • Societal structure: Breastfeeding may be forbidden, discouraged, or difficult at the mother's job, school, place of worship, or in other public places, or the mother may feel that breastfeeding in these places or around other people is immodest, unsanitary, or inappropriate.
  • Social pressures: Family members, such as the mother's husband or boyfriend, or friends or other members of society, may encourage the use of infant formula. For example, they may believe that breastfeeding will decrease the mother's energy, health, or attractiveness. Conversely, societal pressures to breastfeed can also lead to mental health issues. A sense of shame from not being able to or struggling to do so equalling being a failure, has a connection to Postpartum Depression
  • Lack of training and education: The mother lacks education and training from medical providers or community members.
  • Lactation insufficiency: The mother is unable to produce sufficient milk. In studies that do not account for lactation failure with obvious causes, chronic lactation insufficiency affects around 10–15% of women. For about 5–8% of women, milk coming in may not occur at all, and only drops are produced. Alternatively, despite a healthy supply, the woman or her family may incorrectly believe that her breast milk is of low quality or in low supply. These women may choose infant formula either exclusively or as a supplement to breastfeeding. New research is showing that mothers who report problems with milk production have physical markers indicating low milk production, calling into question the assumption that mothers are incorrect about the quantity of milk they are producing.
  • Fear of exposure to environmental contaminants: Certain environmental pollutants, such as polychlorinated biphenyls, can bioaccumulate in the food chain and may be found in humans, including mothers' breast milk.
  • * However, studies have shown that the greatest risk period for adverse effects from environmental exposures is prenatally. Other studies have further found that the levels of most persistent organohalogen compounds in human milk decreased significantly over the past three decades and equally did their exposure through breastfeeding.
  • *Research on risks from chemical pollution is generally inconclusive in terms of outweighing the benefits of breastfeeding. Studies supported by the WHO and others have found that neurological benefits of breast milk remain, regardless of dioxin exposure.
  • *In developing countries, environmental contaminants associated with increased health risks from use of infant formula, particularly diarrhoea due to unclean water and lack of sterile conditions – both prerequisites to the safe use of formula – often outweigh any risks from breastfeeding.
  • Lack of other sources of breast milk:
  • * Lack of wet nurses: Wet nursing is illegal and stigmatized in some countries, and may not be available. It may also be socially unsupported, expensive, or health screening of wet nurses may not be available. The mother, her doctor, or family may not know that wet nursing is possible, or may believe that nursing by a relative or paid wet-nurse is unhygienic.
  • * Lack of milk banks: Human-milk banks may not be available, as few exist, and many countries cannot provide the necessary screening for diseases and refrigeration.