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Infant Formula

Infant formula is a manufactured food designed and marketed for feeding to babies and 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 by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk”.


The composition of infant formula is designed to be roughly based on a human mother’s milk at approximately one to three months postpartum, although there are significant differences in the nutrient content of these products. The most commonly used infant formulas contain purified cow’s milk whey and casein as a protein source, a blend of vegetable oils as a fat source, lactose as a carbohydrate source, a vitamin-mineral mix, and other ingredients depending on the manufacturer.In addition, there are infant formulas using soybean as a protein source in place of cow’s milk (mostly in the United States and Great Britain) and formulas using protein reduced (hydrolysed) into its component amino acids for infants who are allergic to other proteins. An upswing in breastfeeding in many countries has been accompanied by a deferment in the average age of introduction of baby foods (including cow’s milk), resulting in both increased breastfeeding and increased use of infant formula between the ages of 3- and 12-months.


A 2001 World Health Organization (WHO) report found that infant formula prepared in accordance with 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 infants and 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”. In particular, the use of infant formula in less economically-developed countries is linked to poorer health outcomes because of the prevalence of unsanitary preparation conditions, including lack of clean water and lack of sanitizing equipment.[6] UNICEF estimates that a formula-fed child living in unhygienic conditions is between 6 and 25 times more likely to die of diarrhea and four times more likely to die of pneumonia than a breastfed child. Rarely, use of powdered infant formula (PIF) has been associated with serious illness, and even death, due to infection with Enterobacter sakazakii and other microorganisms that can be introduced to PIF during its production. Although E. sakazakii can cause illness in all age groups, infants are believed to be at greatest risk of infection. Between 1958 and 2006, there have been several dozen reported cases of E. sakazakii infection worldwide. The WHO believes that such infections are under-reported.

The WHO, UNICEF and other national and international health agencies, with few exceptions, now recommend exclusive breastfeeding for the first six months of life. Infant formula is considered an imperfect approximation of breast milk because:

The exact chemical properties of breast milk are not fully understood.
A mother’s breast milk changes in response to the feeding habits of her baby and over time, thus adjusting to the infant’s individual growth and development.
Breast milk includes the mothers’ antibodies that help the babies avoid or fight off infections and give their immature immune systems the benefit of their mothers’ immune system that has many years of experience with the germs common in their environments.