Infant formula
Encyclopedia
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
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...

 (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
Whey
Whey or Milk Serum is the liquid remaining after milk has been curdled and strained. It is a by-product of the manufacture of cheese or casein and has several commercial uses. Sweet whey is manufactured during the making of rennet types of hard cheese like cheddar or Swiss cheese...

 and casein
Casein
Casein is the name for a family of related phosphoprotein proteins . These proteins are commonly found in mammalian milk, making up 80% of the proteins in cow milk and between 60% and 65% of the proteins in human milk....

 as a protein
Protein
Proteins are biochemical compounds consisting of one or more polypeptides typically folded into a globular or fibrous form, facilitating a biological function. A polypeptide is a single linear polymer chain of amino acids bonded together by peptide bonds between the carboxyl and amino groups of...

 source, a blend of vegetable oils as a fat source, lactose
Lactose
Lactose is a disaccharide sugar that is found most notably in milk and is formed from galactose and glucose. Lactose makes up around 2~8% of milk , although the amount varies among species and individuals. It is extracted from sweet or sour whey. The name comes from or , the Latin word for milk,...

 as a carbohydrate
Carbohydrate
A carbohydrate is an organic compound with the empirical formula ; that is, consists only of carbon, hydrogen, and oxygen, with a hydrogen:oxygen atom ratio of 2:1 . However, there are exceptions to this. One common example would be deoxyribose, a component of DNA, which has the empirical...

 source, a vitamin
Vitamin
A vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on...

-mineral
Mineral
A mineral is a naturally occurring solid chemical substance formed through biogeochemical processes, having characteristic chemical composition, highly ordered atomic structure, and specific physical properties. By comparison, a rock is an aggregate of minerals and/or mineraloids and does not...

 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
Breastfeeding
Breastfeeding is the feeding of an infant or young child with breast milk directly from female human breasts rather than from a baby bottle or other container. Babies have a sucking reflex that enables them to suck and swallow milk. It is recommended that mothers breastfeed for six months or...

 in many countries has been accompanied by a deferment in the average age of introduction of baby food
Baby food
Baby food is any food, other than breastmilk or infant formula, that is made specifically for infants, roughly between the ages of four to six months to 2 years. The food comes in multiple varieties and tastes, can be produced by many manufacturers, or may be table food that the rest of the family...

s (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
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

 (WHO) report found that infant formula prepared in accordance with applicable Codex Alimentarius
Codex Alimentarius
The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. Its name derives from the Codex Alimentarius Austriacus...

 standards was a safe complementary food and a suitable breast milk substitute
Milk substitute
A milk substitute is a liquid that replaces milk in a diet or recipe. This overlaps with but is distinct from the group of milk-like liquids called "milks" because of their similarity to the liquid produced by mammary glands....

. 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. UNICEF estimates that a formula-fed child living in unhygienic conditions is between 6 and 25 times more likely to die of diarrhea
Diarrhea
Diarrhea , also spelled diarrhoea, is the condition of having three or more loose or liquid bowel movements per day. It is a common cause of death in developing countries and the second most common cause of infant deaths worldwide. The loss of fluids through diarrhea can cause dehydration and...

 and four times more likely to die of pneumonia
Pneumonia
Pneumonia is an inflammatory condition of the lung—especially affecting the microscopic air sacs —associated with fever, chest symptoms, and a lack of air space on a chest X-ray. Pneumonia is typically caused by an infection but there are a number of other causes...

 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
Enterobacter sakazakii
Enterobacter sakazakii is a Gram-negative rod-shaped pathogenic bacterium. It is a rare cause of invasive infection with historically high case fatality rates in infants.It can cause bacteraemia, meningitis and necrotising enterocolitis. E...

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.

Early infant foods

Throughout history, mothers who could not breastfeed their babies either employed a wet nurse
Wet nurse
A wet nurse is a woman who is used to breast feed and care for another's child. Wet nurses are used when the mother is unable or chooses not to nurse the child herself. Wet-nursed children may be known as "milk-siblings", and in some cultures the families are linked by a special relationship of...

 or, less frequently, prepared food for their babies, a process known as "dry nursing". Baby food composition varied according to region and economic status. In Europe and America during the early 19th century, the prevalence of wet nursing began to decrease, while the practice of feeding babies mixtures based on animal milk rose in popularity. This trend was driven by cultural changes as well as increased sanitation measures, and it continued throughout the 19th and much of the 20th century, with a notable increase after Elijah Pratt invented and patented the India-rubber nipple in 1845. As early as 1846, scientists and nutritionists noted an increase in medical problems and infant mortality was associated with dry nursing. In an attempt to improve the quality of manufactured baby foods, in 1867, Justus von Liebig
Justus von Liebig
Justus von Liebig was a German chemist who made major contributions to agricultural and biological chemistry, and worked on the organization of organic chemistry. As a professor, he devised the modern laboratory-oriented teaching method, and for such innovations, he is regarded as one of the...

 developed the world's first commercial infant formula, Liebig's Soluble Food for Babies. The success of this product quickly gave rise to competitors such as Mellin's Infant Food, Ridge's Food for Infants and Nestlé
Nestlé
Nestlé S.A. is the world's largest food and nutrition company. Founded and headquartered in Vevey, Switzerland, Nestlé originated in a 1905 merger of the Anglo-Swiss Milk Company, established in 1867 by brothers George Page and Charles Page, and Farine Lactée Henri Nestlé, founded in 1866 by Henri...

's Milk.
These findings are not supported by modern research. These studies, accompanied by the affordable price of evaporated milk and the availability of the home icebox initiated a tremendous rise in the use of evaporated milk formulas. By the late 1930s, the use of evaporated milk formulas in the United States surpassed all commercial formulas, and by 1950 over half of all babies in the United States were reared on such formulas.

Commercial formulas

In parallel with the enormous shift (in industrialized nations) away from breastfeeding to home-made formulas, nutrition scientists continued to analyze human milk and attempted to make infant formulas that more closely matched its composition. Maltose
Maltose
Maltose , or malt sugar, is a disaccharide formed from two units of glucose joined with an αbond, formed from a condensation reaction. The isomer "isomaltose" has two glucose molecules linked through an α bond. Maltose is the second member of an important biochemical series of glucose chains....

 and dextrin
Dextrin
Dextrins are a group of low-molecular-weight carbohydrates produced by the hydrolysis of starch or glycogen. Dextrins are mixtures of polymers of D-glucose units linked by α- or α- glycosidic bonds....

s were believed nutritionally important, and in 1912, the Mead Johnson
Mead Johnson
Mead Johnson & Company is a company which was majority owned by Bristol-Myers Squibb after an acquisition in 1967, but was spun off in 2009 as an independent firm. Mead Johnson is a major manufacturer of infant formula both domestically and globally with its flagship product Enfamil...

 Company released a milk additive called Dextri-Maltose. This formula was made available to mothers only by physician
Physician
A physician is a health care provider who practices the profession of medicine, which is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury and other physical and mental impairments...

s. In 1919, milkfats were replaced with a blend of animal and vegetable fats as part of the continued drive to closer simulate human milk. This formula was called SMA for "simulated milk adapted."

In the late 1920s, Alfred Bosworth released Similac (for "similar to lactation"), and Mead Johnson released Sobee. Several other formulas were released over the next few decades, but commercial formulas did not begin to seriously compete with evaporated milk formulas until the 1950s. The reformulation and concentration of Similac in 1951, and the introduction (by Mead Johnson) of Enfamil in 1959 were accompanied by marketing campaigns that provided inexpensive formula to hospital
Hospital
A hospital is a health care institution providing patient treatment by specialized staff and equipment. Hospitals often, but not always, provide for inpatient care or longer-term patient stays....

s and pediatricians. By the early 1960s, commercial formulas were more commonly used than evaporated milk formulas in the United States, which all but vanished in the 1970s. By the early 1970s, over 75% of American babies were fed on formulas, almost entirely commercially produced.

When birth rates in industrial nations tapered off during the 1960s, infant formula companies heightened marketing campaigns in non-industrialized countries. Unfortunately, poor sanitation led to steeply increased mortality rates
Infant mortality
Infant mortality is defined as the number of infant deaths per 1000 live births. Traditionally, the most common cause worldwide was dehydration from diarrhea. However, the spreading information about Oral Re-hydration Solution to mothers around the world has decreased the rate of children dying...

 among infants fed formula prepared with contaminated (drinking) water. Organized protests, the most famous of which was the Nestlé boycott
Nestlé boycott
The Nestlé boycott is a boycott launched on July 7, 1977, in the United States against the Swiss-based Nestlé corporation. It spread quickly throughout the United States, and expanded into Europe in the early 1980s. In Canada, the controversy lasted from 1978 to 1984...

 of 1977, called for an end to unethical marketing. This boycott is ongoing, as the current coordinators maintain that Nestlé engages in marketing practices which violate the International Code of Marketing of Breast-milk Substitutes
International Code of Marketing of Breast-milk Substitutes
The International Code of Marketing of Breastmilk Substitutes is an international health policy framework for breastfeeding promotion adopted by the World Health Assembly of the World Health Organization in 1981...

.

Generic brand formulas

In additional to commercially marketed brand
Brand
The American Marketing Association defines a brand as a "Name, term, design, symbol, or any other feature that identifies one seller's good or service as distinct from those of other sellers."...

s, generic brand
Generic brand
Generic brands of consumer products are distinguished by the absence of a brand name. It is often inaccurate to describe these products as "lacking a brand name", as they usually are branded, albeit with either the brand of the store in which they are sold or a lesser-known brand name which may...

s (or store brands) of infant formula were introduced in the United States in 1997, first by PBM Products. These private label
Private label
Private label products or services are typically those manufactured or provided by one company for offer under another company's brand. Private label goods and services are available in a wide range of industries from food to cosmetics to web hosting...

 formulas are sold by many leading food and drug retailers such as Wal-Mart
Wal-Mart
Wal-Mart Stores, Inc. , branded as Walmart since 2008 and Wal-Mart before then, is an American public multinational corporation that runs chains of large discount department stores and warehouse stores. The company is the world's 18th largest public corporation, according to the Forbes Global 2000...

, Target
Target Corporation
Target Corporation, doing business as Target, is an American retailing company headquartered in Minneapolis, Minnesota. It is the second-largest discount retailer in the United States, behind Walmart. The company is ranked at number 33 on the Fortune 500 and is a component of the Standard & Poor's...

, Kroger
Kroger
The Kroger Co. is an American supermarket chain founded by Bernard Kroger in 1883 in Cincinnati, Ohio. It reported US$ 76.7 billion in sales during fiscal year 2009. It is the country's largest grocery store chain and its second-largest grocery retailer by volume and second-place general retailer...

, Loblaws
Loblaws
Loblaws is a supermarket chain with over 70 stores in Canada, headquartered in Brampton, with stores across Ontario and Quebec. Loblaws is a division of Loblaw Companies Limited, Canada's largest food distributor...

, and Walgreens
Walgreens
Walgreen Co. , doing business as Walgreens , is the largest drugstore chain in the United States of America. As of August 31st, the company operates 8,210 locations across all 50 states, the District of Columbia and Puerto Rico. Founded in Chicago, Illinois in 1901, and has since expanded...

. All infant formula brands in the United States are required to adhere to the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 (FDA) guidelines. As reported by the Mayo Clinic
Mayo Clinic
Mayo Clinic is a not-for-profit medical practice and medical research group specializing in treating difficult patients . Patients are referred to Mayo Clinic from across the U.S. and the world, and it is known for innovative and effective treatments. Mayo Clinic is known for being at the top of...

: “as with most consumer products, brand-name infant formulas cost more than generic brands. But that doesn't mean that brand-name [Similac, Nestle, Enfamil] formulas are better. Although manufacturers may vary somewhat in their formula recipes, the FDA requires that all formulas contain the same nutrient density.”

Similarly, in Canada all infant formulas regardless of brand are required to meet standards set by Health Canada.

Follow-on and toddler formulas

In the 1980s and 1990s, some companies introduced formula versions for older children, generally marketed for use from age 12 months up to about 2 or 3 years, under such terms as "follow-on formula" and "toddler formula". This was done partly because the market for infant formula (generally up to age 6 or 12 months, when infants are typically breastfeed) was considered largely saturated, and in conjunction with regulations on infant formula advertising. Critics have argued that follow-on and toddler formulas were introduced partly to circumvent these regulations and have resulted in confusing advertising.

An early example of follow-on formula was introduced by Wyeth
Wyeth
Wyeth, formerly one of the companies owned by American Home Products Corporation , was a pharmaceutical company. The company was based in Madison, New Jersey, USA...

 in the Philippines in 1987, following the introduction in this country of regulations on infant formula advertising, but which did not address follow-on formulas (products that did not exist at the time of their drafting). Similarly, while infant formula advertising is illegal in the United Kingdom, follow-on formula advertising is legal, and the similar packaging and market results in follow-on advertisements frequently being interpreted as advertisements for formula. (See also industry and marketing, below.)

These products have also recently fallen under criticism for contributing to the childhood obesity
Childhood obesity
Childhood obesity is a condition where excess body fat negatively affects a child's health or wellbeing. As methods to determine body fat directly are difficult, the diagnosis of obesity is often based on BMI. Due to the rising prevalence of obesity in children and its many adverse health effects...

 epidemic in some developed countries due to their marketing and flavoring practices.

Usage since 1970s

Since the early 1970s, industrial countries have witnessed a resurgence in breastfeeding
Breastfeeding
Breastfeeding is the feeding of an infant or young child with breast milk directly from female human breasts rather than from a baby bottle or other container. Babies have a sucking reflex that enables them to suck and swallow milk. It is recommended that mothers breastfeed for six months or...

 among newborns and infants to 6 months of age. This upswing in breastfeeding has been accompanied by a deferment in the average age of introduction of other foods (such as cow's milk), resulting in increased use of both breastfeeding and infant formula between the ages of 3–12 months.

The global infant formula market has been estimated at $7.9 billion, with North America and Western Europe accounting for 33% of the market and considered largely saturated, and Asia representing 53% of the market. South East Asia is a particularly large fraction of the world market relative to its population. Infant formula is the largest segment of the baby food market, with the fraction given as between 40% and 70%.

Leading health organizations (e.g. WHO
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

, U.S. Center for Disease Control and Department of Health and Human Services
United States Department of Health and Human Services
The United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...

) are attempting to reduce the use of infant formula and increase the prevalence of breastfeeding from birth through 12 to 24 months of age through public health
Public health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals" . It is concerned with threats to health based on population health...

 awareness campaigns. The specific goals and approaches of these breastfeeding promotion
Breastfeeding promotion
Breastfeeding promotion refers to coordinated activities and policies to promote health among women, newborns and infants through breastfeeding....

 programs, and the policy environment surrounding their implementation, vary by country. As a policy basic framework, the International Code of Marketing of Breast-milk Substitutes
International Code of Marketing of Breast-milk Substitutes
The International Code of Marketing of Breastmilk Substitutes is an international health policy framework for breastfeeding promotion adopted by the World Health Assembly of the World Health Organization in 1981...

, adopted by the WHO's World Health Assembly
World Health Assembly
The World Health Assembly is the forum through which the World Health Organization is governed by its 194 member states. It is the world's highest health policy setting body and is composed of health ministers from member states....

 in 1981, requires infant formula companies to preface their product information with statements that breastfeeding is the best way of feeding babies and that a substitute should only be used after consultation with health professionals. The Baby Friendly Hospital Initiative
Baby Friendly Hospital Initiative
The Baby Friendly Hospital Initiative , also known as “Baby Friendly Initiative” , is a worldwide programme of the World Health Organization and UNICEF, launched in 1991 following the adoption of the Innocenti Declaration on breastfeeding promotion in 1990...

 also restricts use by hospitals of free formula or other infant care aids provided by formula companies. (See also Policy section below.)

Variations

Infant formulas come in powder, liquid concentrate, and ready-to-feed forms. They are designed to be prepared by the parent or caregiver in small batches and fed to the infant, usually with either a cup, as recommended by the WHO, or a baby bottle
Baby bottle
A baby bottle is a bottle with a teat to drink directly from. It is typically used by infants and young children when a mother does not breastfeed, or if someone cannot drink from a cup, for feeding oneself or being fed.In particular it is used to feed infant formula, expressed breast milk or...

.

Infant formulas also come in a variety of types:
  • Cow's milk formula is the "typical" most commonly used type (e.g.: Similac
    Similac
    Similac is a brand of infant formula that was developed by Alfred Bosworth of Tufts University and marketed by Ross Laboratories....

    , Enfamil
    Enfamil
    Enfamil is a brand of infant formula made by Mead Johnson. Since 1972, the rabbit character appearing on the packaging is Beatrix Potter's Peter Rabbit.Enfamil is a product name associated with formulas for babies.-History:...

    ).
  • Soy protein based formulas are frequently used for infants allergic to cow's milk (e.g.: Isomil, ProSobee).
  • Partially hydrolyzed formulas (e.g.: Good Start and Gentlease brands) are marketed as having improved digestibility.
  • Extensively hydrolyzed formulas (e.g.: Alimentum, Nutramigen, and Pregestimil) are considered "hypoallergenic
    Hypoallergenic
    Hypoallergenic, meaning "below normal" or "slightly" allergenic, was a term first used in a cosmetics campaign in 1953. It is used to describe items that cause or are claimed to cause fewer allergic reactions...

    ". One study reported that 90% of children with cow's milk allergies will tolerate them.
  • Amino acid based formulas (e.g.: Neocate, EleCare, and Nutramigen AA) are more expensive, but are reported least likely to cause allergic reactions.


Hypoallergenic formulas, such as those synthesized from raw amino acids, and sometimes referred to as elemental infant formula, are considered to reduce the likelihood of certain medical complications in babies with specific health problems, such as severe allergies to cow's milk and soy. Made of purely synthetic monomeric amino acids, they are often considered quite foul-tasting, and it is not uncommon for infants to reject elemental formulas after having been established on a sweeter-tasting regular formula.

Manufacturers and health officials advise it is very important to measure powders or concentrates accurately to achieve the intended final product concentration; otherwise, the child will be malnourished. It is advisable that all equipment that comes into contact with the infant formula be cleaned and sterilized before each use. Proper refrigeration
Refrigeration
Refrigeration is a process in which work is done to move heat from one location to another. This work is traditionally done by mechanical work, but can also be done by magnetism, laser or other means...

 is essential for any infant formula which is prepared in advance.

In developing countries, formula is frequently prepared improperly, resulting in high infant mortality due to malnutrition
Malnutrition
Malnutrition is the condition that results from taking an unbalanced diet in which certain nutrients are lacking, in excess , or in the wrong proportions....

 and diseases such as diarrhea
Diarrhea
Diarrhea , also spelled diarrhoea, is the condition of having three or more loose or liquid bowel movements per day. It is a common cause of death in developing countries and the second most common cause of infant deaths worldwide. The loss of fluids through diarrhea can cause dehydration and...

 and pneumonia
Pneumonia
Pneumonia is an inflammatory condition of the lung—especially affecting the microscopic air sacs —associated with fever, chest symptoms, and a lack of air space on a chest X-ray. Pneumonia is typically caused by an infection but there are a number of other causes...

. This is due to lack of clean water, lack of sterile conditions, lack of refrigeration, illiteracy (so written instructions cannot be followed), poverty (diluting formula so that it lasts longer), and lack of education of mothers by formula distributors. These problems and resulting disease and death are a key factor in opposition to the marketing and distribution of infant formula in developing countries by numerous public health
Public health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals" . It is concerned with threats to health based on population health...

 agencies and NGOs (discussed in more detail at Nestlé boycott
Nestlé boycott
The Nestlé boycott is a boycott launched on July 7, 1977, in the United States against the Swiss-based Nestlé corporation. It spread quickly throughout the United States, and expanded into Europe in the early 1980s. In Canada, the controversy lasted from 1978 to 1984...

 and International Code of Marketing of Breast-milk Substitutes
International Code of Marketing of Breast-milk Substitutes
The International Code of Marketing of Breastmilk Substitutes is an international health policy framework for breastfeeding promotion adopted by the World Health Assembly of the World Health Organization in 1981...

).

Nutritional content

Infant formula is nutritionally inferior to breast milk but superior to other substitutes, such as milk from cows. Besides breast milk, infant formula is the only other milk product which the medical
Medicine
Medicine is the science and art of healing. It encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness....

 community considers nutritionally acceptable for infants under the age of one year. Supplementing with solid food
Baby food
Baby food is any food, other than breastmilk or infant formula, that is made specifically for infants, roughly between the ages of four to six months to 2 years. The food comes in multiple varieties and tastes, can be produced by many manufacturers, or may be table food that the rest of the family...

 in addition to breast milk or formula begins during weaning
Weaning
Weaning is the process of gradually introducing a mammal infant, either human or animal, to what will be its adult diet and withdrawing the supply of its mother's milk.The process takes place only in mammals, as only mammals produce milk...

, and most babies begin supplementing about the time their first teeth appear, usually around the age of six months.

Although cow's milk is the basis of almost all infant formula, plain cow's milk is unsuited for infants because of its high casein
Casein
Casein is the name for a family of related phosphoprotein proteins . These proteins are commonly found in mammalian milk, making up 80% of the proteins in cow milk and between 60% and 65% of the proteins in human milk....

 content and low whey
Whey
Whey or Milk Serum is the liquid remaining after milk has been curdled and strained. It is a by-product of the manufacture of cheese or casein and has several commercial uses. Sweet whey is manufactured during the making of rennet types of hard cheese like cheddar or Swiss cheese...

 content, which may put a strain on an infant's immature kidney
Kidney
The kidneys, organs with several functions, serve essential regulatory roles in most animals, including vertebrates and some invertebrates. They are essential in the urinary system and also serve homeostatic functions such as the regulation of electrolytes, maintenance of acid–base balance, and...

s, and untreated cow's milk is not recommended before the age of 12 months. The infant intestine is not properly equipped to digest non-human milk, and this may often result in diarrhea, intestinal bleeding and malnutrition. To reduce the negative effect on the infant's digestive system, cow's milk used for formula undergoes processing to be made into infant formula. This includes steps to make protein more easily digestible and alter the whey
Whey
Whey or Milk Serum is the liquid remaining after milk has been curdled and strained. It is a by-product of the manufacture of cheese or casein and has several commercial uses. Sweet whey is manufactured during the making of rennet types of hard cheese like cheddar or Swiss cheese...

-to-casein
Casein
Casein is the name for a family of related phosphoprotein proteins . These proteins are commonly found in mammalian milk, making up 80% of the proteins in cow milk and between 60% and 65% of the proteins in human milk....

 protein balance to one closer to human milk, the addition of several essential ingredients (often called "fortification", see below), the partial or total replacement of dairy fat with fats of vegetable or marine origin, etc.

The nutrient content of infant formula for sale in the United States is regulated by the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 (FDA) based on recommendations by the American Academy of Pediatrics
American Academy of Pediatrics
The American Academy of Pediatrics is the major professional association of pediatricians in the United States. The AAP was founded in 1930 by 35 pediatricians to address pediatric healthcare standards. It currently has 60,000 members in primary care and sub-specialist areas...

 Committee on Nutrition. The following must be included in all formulas produced in the U.S.:
  • Protein
    Protein
    Proteins are biochemical compounds consisting of one or more polypeptides typically folded into a globular or fibrous form, facilitating a biological function. A polypeptide is a single linear polymer chain of amino acids bonded together by peptide bonds between the carboxyl and amino groups of...

  • Fat
    Fat
    Fats consist of a wide group of compounds that are generally soluble in organic solvents and generally insoluble in water. Chemically, fats are triglycerides, triesters of glycerol and any of several fatty acids. Fats may be either solid or liquid at room temperature, depending on their structure...

  • Linoleic acid
    Linoleic acid
    Linoleic acid is an unsaturated n-6 fatty acid. It is a colorless liquid at room temperature. In physiological literature, it has a lipid number of 18:2...

  • Vitamin
    Vitamin
    A vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on...

    s: A
    Vitamin A
    Vitamin A is a vitamin that is needed by the retina of the eye in the form of a specific metabolite, the light-absorbing molecule retinal, that is necessary for both low-light and color vision...

    , C
    Vitamin C
    Vitamin C or L-ascorbic acid or L-ascorbate is an essential nutrient for humans and certain other animal species. In living organisms ascorbate acts as an antioxidant by protecting the body against oxidative stress...

    , D
    Vitamin D
    Vitamin D is a group of fat-soluble secosteroids. In humans, vitamin D is unique both because it functions as a prohormone and because the body can synthesize it when sun exposure is adequate ....

    , E
    Vitamin E
    Vitamin E is used to refer to a group of fat-soluble compounds that include both tocopherols and tocotrienols. There are many different forms of vitamin E, of which γ-tocopherol is the most common in the North American diet. γ-Tocopherol can be found in corn oil, soybean oil, margarine and dressings...

    , K
    Vitamin K
    Vitamin K is a group of structurally similar, fat soluble vitamins that are needed for the posttranslational modification of certain proteins required for blood coagulation and in metabolic pathways in bone and other tissue. They are 2-methyl-1,4-naphthoquinone derivatives...

    , thiamin (B1), riboflavin
    Riboflavin
    Riboflavin, also known as vitamin B2 or additive E101, is an easily absorbed micronutrient with a key role in maintaining health in humans and animals. It is the central component of the cofactors FAD and FMN, and is therefore required by all flavoproteins. As such, vitamin B2 is required for a...

     (B2), B6
    Vitamin B6
    Vitamin B6 is a water-soluble vitamin and is part of the vitamin B complex group. Several forms of the vitamin are known, but pyridoxal phosphate is the active form and is a cofactor in many reactions of amino acid metabolism, including transamination, deamination, and decarboxylation...

    , B12
    Vitamin B12
    Vitamin B12, vitamin B12 or vitamin B-12, also called cobalamin, is a water-soluble vitamin with a key role in the normal functioning of the brain and nervous system, and for the formation of blood. It is one of the eight B vitamins...

  • Niacin
    Niacin
    "Niacin" redirects here. For the neo-fusion band, see Niacin .Niacin is an organic compound with the formula and, depending on the definition used, one of the forty to eighty essential human nutrients.Niacin is one of five vitamins associated with a pandemic deficiency disease: niacin deficiency...

  • Folic acid
    Folic acid
    Folic acid and folate , as well as pteroyl-L-glutamic acid, pteroyl-L-glutamate, and pteroylmonoglutamic acid are forms of the water-soluble vitamin B9...

  • Pantothenic acid
    Pantothenic acid
    Pantothenic acid, also called pantothenate or vitamin B5 , is a water-soluble vitamin. For many animals, pantothenic acid is an essential nutrient. Animals require pantothenic acid to synthesize coenzyme-A , as well as to synthesize and metabolize proteins, carbohydrates, and fats.Pantothenic acid...

  • Calcium
    Calcium
    Calcium is the chemical element with the symbol Ca and atomic number 20. It has an atomic mass of 40.078 amu. Calcium is a soft gray alkaline earth metal, and is the fifth-most-abundant element by mass in the Earth's crust...

  • Minerals: magnesium
    Magnesium
    Magnesium is a chemical element with the symbol Mg, atomic number 12, and common oxidation number +2. It is an alkaline earth metal and the eighth most abundant element in the Earth's crust and ninth in the known universe as a whole...

    , iron
    Iron
    Iron is a chemical element with the symbol Fe and atomic number 26. It is a metal in the first transition series. It is the most common element forming the planet Earth as a whole, forming much of Earth's outer and inner core. It is the fourth most common element in the Earth's crust...

    , zinc
    Zinc
    Zinc , or spelter , is a metallic chemical element; it has the symbol Zn and atomic number 30. It is the first element in group 12 of the periodic table. Zinc is, in some respects, chemically similar to magnesium, because its ion is of similar size and its only common oxidation state is +2...

    , manganese
    Manganese
    Manganese is a chemical element, designated by the symbol Mn. It has the atomic number 25. It is found as a free element in nature , and in many minerals...

    , copper
    Copper
    Copper is a chemical element with the symbol Cu and atomic number 29. It is a ductile metal with very high thermal and electrical conductivity. Pure copper is soft and malleable; an exposed surface has a reddish-orange tarnish...

  • Phosphorus
    Phosphorus
    Phosphorus is the chemical element that has the symbol P and atomic number 15. A multivalent nonmetal of the nitrogen group, phosphorus as a mineral is almost always present in its maximally oxidized state, as inorganic phosphate rocks...

  • Iodine
    Iodine
    Iodine is a chemical element with the symbol I and atomic number 53. The name is pronounced , , or . The name is from the , meaning violet or purple, due to the color of elemental iodine vapor....

  • Sodium chloride
    Sodium chloride
    Sodium chloride, also known as salt, common salt, table salt or halite, is an inorganic compound with the formula NaCl. Sodium chloride is the salt most responsible for the salinity of the ocean and of the extracellular fluid of many multicellular organisms...

  • Potassium chloride
    Potassium chloride
    The chemical compound potassium chloride is a metal halide salt composed of potassium and chlorine. In its pure state, it is odorless and has a white or colorless vitreous crystal appearance, with a crystal structure that cleaves easily in three directions. Potassium chloride crystals are...

  • Carbohydrates
    • Carbohydrates are an important source of energy for growing infants, as they account for 35 to 42% of their daily energy intake. In most cow's milk-based formulas, lactose
      Lactose
      Lactose is a disaccharide sugar that is found most notably in milk and is formed from galactose and glucose. Lactose makes up around 2~8% of milk , although the amount varies among species and individuals. It is extracted from sweet or sour whey. The name comes from or , the Latin word for milk,...

       is the main source of carbohydrates present, but lactose is not present in cow's milk-based lactose-free formulas nor specialized non-milk protein formulas or hydrolyzed protein formulas for infants with milk protein sensitivity. Lactose is also not present in soy-based formulas. Therefore, those formulas without lactose will use other sources of carbohydrates, such as sucrose and glucose
      Glucose
      Glucose is a simple sugar and an important carbohydrate in biology. Cells use it as the primary source of energy and a metabolic intermediate...

      , dextrins, and natural and modified starch
      Starch
      Starch or amylum is a carbohydrate consisting of a large number of glucose units joined together by glycosidic bonds. This polysaccharide is produced by all green plants as an energy store...

      es. Lactose is not only a good source of energy, it also aids in the absorption of the minerals magnesium, calcium, zinc and iron.
  • Nucleotides
    • Nucleotides are compounds found naturally in human breast milk. They are involved in critical metabolic processes, such as energy metabolism and enzymatic reactions. Also, as the building blocks of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), they are essential for normal body functions. Compared to human breast milk, cow's milk has lower levels of the nucleotides uridine, inosine, and cytidine. Therefore, several companies that produce infant formula have added nucleotides to their infant formulas.


Other commonly used ingredients:
  • Emulsifiers and stabilizers
    Stabilizers
    The Stabilizers were an American pop/rock duo founded in the early 1980s by musicians Dave Christenson and Rich Nevens. With Christenson on lead vocals and Nevens on guitars and occasional keyboards, they spent the first few years touring the Pennsylvania area and recording original compositions on...

    : Ingredients added to prevent the separation of the oil from the water (and its soluble components) in the infant formula. Some commonly used emulsifiers include monoglycerides, diglycerides, and gums.
  • Diluent
    Diluent
    A diluent is a diluting agent.Certain fluids are too viscous to be pumped easily or too dense to flow from one particular point to the other. This can be problematic, because it might not be economically feasible to transport such fluids in this state.To ease this restricted movement, diluents...

    s: Skim milk is commonly used as the primary diluent in milk-based liquid formula to provide the bulk of the volume. In contrast, purified water is the most commonly used diluent in milk-free formulations.


In addition, formulas not made with cow's milk include biotin
Biotin
Biotin, also known as Vitamin H or Coenzyme R, is a water-soluble B-complex vitamin discovered by Bateman in 1916. It is composed of a ureido ring fused with a tetrahydrothiophene ring. A valeric acid substituent is attached to one of the carbon atoms of the tetrahydrothiophene ring...

, choline
Choline
Choline is a water-soluble essential nutrient. It is usually grouped within the B-complex vitamins. Choline generally refers to the various quaternary ammonium salts containing the N,N,N-trimethylethanolammonium cation....

, and inositol
Inositol
Inositol or cyclohexane-1,2,3,4,5,6-hexol is a chemical compound with formula 6126 or 6, a sixfold alcohol of cyclohexane. It exists in nine possible stereoisomers, of which the most prominent form, widely occurring in nature, is cis-1,2,3,5-trans-4,6-cyclohexanehexol, or myo-inositol...

.

Uses, risks and controversies

The use and marketing of infant formula has come under scrutiny. Breastfeeding
Breastfeeding
Breastfeeding is the feeding of an infant or young child with breast milk directly from female human breasts rather than from a baby bottle or other container. Babies have a sucking reflex that enables them to suck and swallow milk. It is recommended that mothers breastfeed for six months or...

, 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, less than 40% of infants less than this age are exclusively breastfed worldwide. The overwhelming majority of American babies are not exclusively breastfed for this period – in 2005 under 12% of babies were breastfed exclusively for the first 6 months, with over 60% of babies of 2 months of age being fed formula, and approximately one in four breastfed infants having infant formula feeding within two days of birth.

Some studies have shown that use of formula can vary according to the parents' socio-economic status, ethnicity or other characteristics. For example, according to a research conducted in Vancouver, Canada, 82.9% of mothers breastfeed their babies at birth, but the number differed between Caucasians (91.6%) and non-Caucasians (56.8%), with the difference essentially attributed to marital status, education and family income. In the United States, mothers of lower socio-economic status have been found less likely to breastfeed, although this may be partly related to adverse effects of government nutrition supplementation programs that provide subsidies for infant formula.

Use of infant formula

There are few medical reasons to use infant formula; breastfeeding is suitable for most mothers and babies. Infant formula is the most common alternative to breastfeeding. Other options include bottle-feeding the mother's expressed breast milk, breast milk from a healthy wet nurse
Wet nurse
A wet nurse is a woman who is used to breast feed and care for another's child. Wet nurses are used when the mother is unable or chooses not to nurse the child herself. Wet-nursed children may be known as "milk-siblings", and in some cultures the families are linked by a special relationship of...

, and bottle-feeding breast milk from another woman collected through a human-milk bank
Human-milk bank
A human milk bank is a service which collects, screens, processes, and dispenses by prescription human milk donated by nursing mothers who are not biologically related to the recipient infant.See also: Human milk banking in North America...

.

Some mothers are unable to breastfeed, and others choose not to breastfeed, or choose to combine breastfeeding with use of infant formula. Reasons for using formula may include:
  • The mother's health: The mother is infected with HIV
    HIV
    Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...

     or has active tuberculosis
    Tuberculosis
    Tuberculosis, MTB, or TB is a common, and in many cases lethal, infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. Tuberculosis usually attacks the lungs but can also affect other parts of the body...

    . She is malnourished, extremely ill or has had certain kinds of breast surgery
    Breast surgery
    Breast surgery is a form of surgery performed on the breast.Types include:*Breast reduction surgery*Augmentation mammoplasty*Mastectomy*Lumpectomy*Breast-conserving surgery, a less radical cancer surgery than mastectomy...

    . She is taking any kind of drug
    Drug
    A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...

     that could harm the baby, or drinks unsafe levels of alcohol.
    • One of the main global risks posed by breastmilk specifically is the transmission of HIV
      HIV
      Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...

       and other infectious diseases. Breastfeeding by an HIV-infected mother poses a 5–20% chance of transmitting HIV to the baby. Cytomegalovirus
      Cytomegalovirus
      Cytomegalovirus is a viral genus of the viral group known as Herpesviridae or herpesviruses. It is typically abbreviated as CMV: The species that infects humans is commonly known as human CMV or human herpesvirus-5 , and is the most studied of all cytomegaloviruses...

       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
      T-cell leukemia
      T-cell leukemia describes several different types of lymphoid leukemia which affect T cells.Types include:* Large granular lymphocytic leukemia* Adult T-cell leukemia/lymphoma* T-cell prolymphocytic leukemia...

       in the baby), herpes simplex
      Herpes simplex
      Herpes simplex is a viral disease caused by both Herpes simplex virus type 1 and type 2 . Infection with the herpes virus is categorized into one of several distinct disorders based on the site of infection. Oral herpes, the visible symptoms of which are colloquially called cold sores or fever...

       when lesions are present on the breasts, and chickenpox
      Chickenpox
      Chickenpox or chicken pox is a highly contagious illness caused by primary infection with varicella zoster virus . It usually starts with vesicular skin rash mainly on the body and head rather than at the periphery and becomes itchy, raw pockmarks, which mostly heal without scarring...

       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.
  • The baby is unable to breastfeed: The child has a birth defect or inborn error of metabolism
    Inborn error of metabolism
    Inborn errors of metabolism comprise a large class of genetic diseases involving disorders of metabolism. The majority are due to defects of single genes that code for enzymes that facilitate conversion of various substances into others...

     such as galactosemia
    Galactosemia
    Galactosemia is a rare genetic metabolic disorder that affects an individual's ability to metabolize the sugar galactose properly. Although the sugar lactose can metabolize to galactose, galactosemia is not related to and should not be confused with lactose intolerance...

     that makes breastfeeding difficult or impossible.
  • The 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
    Hypovitaminosis D
    Hypovitaminosis D is a deficiency of Vitamin D. It can result from: inadequate nutritional intake of vitamin D coupled with inadequate sunlight exposure , disorders that limit vitamin D absorption, and conditions that impair the conversion of vitamin D into active metabolites including certain...

     which may be less present in breastmilk than needed at high latitudes where there is less sun exposure), or inadequate nutrition during transition to solid foods. However these 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
    Health Canada
    Health Canada is the department of the government of Canada with responsibility for national public health.The current Minister of Health is Leona Aglukkaq, a Conservative Member of Parliament appointed to the position by Prime Minister Stephen Harper.-Branches, regions and agencies:Health Canada...

     also recommends breastfed infants receive extra vitamin D in the form of a supplement.
  • Personal preferences and beliefs: The mother may dislike breast-feeding or think it inconvenient. She may feel that breasts are too sexual for a baby, or that bottle-feeding will increase the father's role in parenting his child.
  • Absence of the mother: The child is adopted, orphan
    Orphan
    An orphan is a child permanently bereaved of or abandoned by his or her parents. In common usage, only a child who has lost both parents is called an orphan...

    ed, abandoned, or in the sole custody
    Child custody
    Child custody and guardianship are legal terms which are used to describe the legal and practical relationship between a parent and his or her child, such as the right of the parent to make decisions for the child, and the parent's duty to care for the child.Following ratification of the United...

     of a man. The mother is separated from her child by being in prison
    Prison
    A prison is a place in which people are physically confined and, usually, deprived of a range of personal freedoms. Imprisonment or incarceration is a legal penalty that may be imposed by the state for the commission of a crime...

     or a mental hospital
    Mental Hospital
    Mental hospital may refer to:*Psychiatric hospital*hospital in Nepal named 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.
  • Societal structure: Breastfeeding may be forbidden 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 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.
  • Lack of training: The mother is not trained sufficiently to breastfeed without pain and to produce enough milk.
  • Lactation insufficiency: The mother is unable to produce sufficient milk. In studies that do not account for lactation failure with obvious causes (such as use of formula and/or breast pumps), this affects around 2 to 5% of women. 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.
  • 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' breastmilk.
    • 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. It has also been reported that "adverse effects on learning and behavior are strongly associated with fetal exposure to persistent pollutants, not with breast milk exposure".
    • In developing countries, environmental contaminants associated with increased health risks from use of infant formula, particularly diarrhea 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 breastmilk:
    • 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 bank
      Human-milk bank
      A human milk bank is a service which collects, screens, processes, and dispenses by prescription human milk donated by nursing mothers who are not biologically related to the recipient infant.See also: Human milk banking in North America...

      s may not be available, as few exist, and many countries cannot provide the necessary screening for diseases and refrigeration.

Health risks

Use of infant formula has been cited for numerous increased health risks. Studies have found infants in developed countries who consume formula are at increased risk for acute otitis media
Otitis media
Otitis media is inflammation of the middle ear, or a middle ear infection.It occurs in the area between the tympanic membrane and the inner ear, including a duct known as the eustachian tube. It is one of the two categories of ear inflammation that can underlie what is commonly called an earache,...

, gastroenteritis
Gastroenteritis
Gastroenteritis is marked by severe inflammation of the gastrointestinal tract involving both the stomach and small intestine resulting in acute diarrhea and vomiting. It can be transferred by contact with contaminated food and water...

, severe lower respiratory tract infections, atopic dermatitis
Dermatitis
-Etymology:Dermatitis derives from Greek derma "skin" + -itis "inflammation" and genetic disorder.-Terminology:There are several different types of dermatitis. The different kinds usually have in common an allergic reaction to specific allergens. The term may describe eczema, which is also called...

, asthma
Asthma
Asthma is the common chronic inflammatory disease of the airways characterized by variable and recurring symptoms, reversible airflow obstruction, and bronchospasm. Symptoms include wheezing, coughing, chest tightness, and shortness of breath...

, obesity
Obesity
Obesity is a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health, leading to reduced life expectancy and/or increased health problems...

, type 1 and 2 diabetes, sudden infant death syndrome
Sudden infant death syndrome
Sudden infant death syndrome is marked by the sudden death of an infant that is unexpected by medical history, and remains unexplained after a thorough forensic autopsy and a detailed death scene investigation. An infant is at the highest risk for SIDS during sleep, which is why it is sometimes...

 (SIDS), eczema
Eczema
Eczema is a form of dermatitis, or inflammation of the epidermis . In England, an estimated 5.7 million or about one in every nine people have been diagnosed with the disease by a clinician at some point in their lives.The term eczema is broadly applied to a range of persistent skin conditions...

, necrotizing enterocolitis
Necrotizing enterocolitis
Necrotizing enterocolitis is a medical condition primarily seen in premature infants, where portions of the bowel undergo necrosis .-Signs and symptoms:...

 and autism
Autism
Autism is a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior. These signs all begin before a child is three years old. Autism affects information processing in the brain by altering how nerve cells and their...

 when compared to infants who are breastfed. Some studies have found an association between infant formula and lower cognitive development
Cognitive development
Cognitive development is a field of study in neuroscience and psychology focusing on a child's development in terms of information processing, conceptual resources, perceptual skill, language learning, and other aspects of brain development and cognitive psychology compared to an adult's point of...

, including iron supplementation in baby formula being linked to lowered I.Q. and other neurodevelopmental delays; however other studies have found no correlation.

In addition, mothers who forego breastfeeding in favour of formula feeding are reported more likely to develop certain types of cancer.

Melamine contamination

Health officials around the world have been on alert for melamine
Melamine
Melamine is an organic base and a trimer of cyanamide, with a 1,3,5-triazine skeleton. Like cyanamide, it contains 66% nitrogen by mass and, if mixed with resins, has fire retardant properties due to its release of nitrogen gas when burned or charred, and has several other industrial uses....

 contamination in infant formula since the 2008 discovery of a massive case of melamine poisoning in China
People's Republic of China
China , officially the People's Republic of China , is the most populous country in the world, with over 1.3 billion citizens. Located in East Asia, the country covers approximately 9.6 million square kilometres...

, where milk was deliberately adulterated with the chemical, leading to illnesses in more than 300,000 infants, including cases of acute kidney failure, and blamed for the deaths of at least six babies. Large quantities of melamine were added to watered-down milk to give it the appearance of having adequate protein levels.

In November 2008, traces of melamine were reported to have been found by the U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 in infant formula sold in the United States made by the three main American firms — Abbott Laboratories
Abbott Laboratories
Abbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr....

, Nestle
Nestlé
Nestlé S.A. is the world's largest food and nutrition company. Founded and headquartered in Vevey, Switzerland, Nestlé originated in a 1905 merger of the Anglo-Swiss Milk Company, established in 1867 by brothers George Page and Charles Page, and Farine Lactée Henri Nestlé, founded in 1866 by Henri...

 and Mead Johnson
Mead Johnson
Mead Johnson & Company is a company which was majority owned by Bristol-Myers Squibb after an acquisition in 1967, but was spun off in 2009 as an independent firm. Mead Johnson is a major manufacturer of infant formula both domestically and globally with its flagship product Enfamil...

 — responsible for 90-99% of the infant formula market in that country. The levels were much less than those reported in China, where levels of melamine contamination had reached as much as 2,500 parts per million, about 10,000 times higher than the recorded US levels. The material safety data sheet
Material safety data sheet
A Material Safety Data Sheet is a form with data regarding the properties of a particular substance....

 for melamine (CAS registry number
CAS registry number
CAS Registry Numbersare unique numerical identifiers assigned by the "Chemical Abstracts Service" toevery chemical described in the...

 108-78-1; C3-H6-N6) recorded the acute oral toxicity (median lethal dose) at 3161 mg/kg (3161 ppm) for a rat.

Health Canada
Health Canada
Health Canada is the department of the government of Canada with responsibility for national public health.The current Minister of Health is Leona Aglukkaq, a Conservative Member of Parliament appointed to the position by Prime Minister Stephen Harper.-Branches, regions and agencies:Health Canada...

 conducted a separate test and also detected traces of melamine in infant formula available in Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...

. The melamine levels were well below Health Canada's safety limits, although concerns remain about the safety of manufactured food for infants and monitoring of potentially dangerous substances.

Other health controversies

  • In 1985, Syntex
    Syntex
    Laboratorios Syntex SA was a pharmaceutical company formed in Mexico City in 1944 by Russell Marker to manufacture therapeutic steroids from the Mexican yam....

     was ordered to pay $27 million in compensation for the deaths of two American infants who suffered brain damage after drinking the company's baby formula, called Neo-mull-soy. Formulas produced by Syntex had previously been subject to a major recall as they were found to have insufficient chloride to support normal infant growth and development.
  • In 2010, Abbott Laboratories
    Abbott Laboratories
    Abbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr....

     issued a voluntary recall of about five million Similac brand powder infant formulas that were sold in the United States, Guam, Puerto Rico and some Caribbean countries. The recall was issued after the presence of a 'small common beetle
    Beetle
    Coleoptera is an order of insects commonly called beetles. The word "coleoptera" is from the Greek , koleos, "sheath"; and , pteron, "wing", thus "sheathed wing". Coleoptera contains more species than any other order, constituting almost 25% of all known life-forms...

    ' was found in the product.
  • In Canada, New Zealand and elsewhere, public concerns have been raised over the continued sale and marketing of soy-based formulae potentially containing high levels of phytoestrogens
    Phytoestrogens
    Phytoestrogens are plant-derived xenoestrogens functioning as the primary female sex hormone not generated within the endocrine system but consumed by eating phytoestrogonic plants...

    , linked to abnormal child development including damage to babies' thyroid glands.

Policy, industry and marketing

The policy, regulatory and industry environments surrounding the infant formula market vary tremendously between countries.

International

The International Code of Marketing of Breast-milk Substitutes
International Code of Marketing of Breast-milk Substitutes
The International Code of Marketing of Breastmilk Substitutes is an international health policy framework for breastfeeding promotion adopted by the World Health Assembly of the World Health Organization in 1981...

 is an international health policy framework adopted by the World Health Assembly
World Health Assembly
The World Health Assembly is the forum through which the World Health Organization is governed by its 194 member states. It is the world's highest health policy setting body and is composed of health ministers from member states....

 of the WHO
Who
Who may refer to:* Who , an English-language pronoun* who , a Unix command* Who?, one of the Five Ws in journalism- Art and entertainment :* Who? , a 1958 novel by Algis Budrys...

 in 1981 regarding infant formula marketing, including strict restrictions on advertising. Its implementation depends on the laws of different countries and the behavior of infant formula manufacturers – the code has no power itself. Legislation and corporate behavior vary significantly between countries: at least 65 countries have enacted national legislation implementing all or many of the provisions of the Code; whereas elsewhere neither the Code nor its principles are followed by governments or formula manufacturers.

Practices that are banned in the Code include most advertising, claiming health benefits for formula, and giving free samples to women able to breastfeed – this latter practice is particularly criticized because it can interfere with lactation, creating dependence on formula. In many countries free samples of infant formula have been provided to hospitals for decades; infant formula is often the only product routinely provided free of charge to hospitals. The Baby Friendly Hospital Initiative
Baby Friendly Hospital Initiative
The Baby Friendly Hospital Initiative , also known as “Baby Friendly Initiative” , is a worldwide programme of the World Health Organization and UNICEF, launched in 1991 following the adoption of the Innocenti Declaration on breastfeeding promotion in 1990...

 aims to reduce and eliminate this controversial practice.

Philippines

Infant formula is one of the top three consumer commodities in the Philippines, and among the most imported products. Annual sales amount to some US$469 million annually. US$88 million is spent on advertising the product.

Infant formula marketing has been regulated since the 1987 Executive Order 51 or "Milk Code", which regulated, but did not ban, practices such as advertising and providing free samples. Shortly after it was enacted, Wyeth
Wyeth
Wyeth, formerly one of the companies owned by American Home Products Corporation , was a pharmaceutical company. The company was based in Madison, New Jersey, USA...

 introduced "follow-on formula", which was not in the purview of the Milk Code which predated its market entry.

In 2006, the Department of Health
Department of Health (Philippines)
The Philippines’ Department of Health is the principal health agency in the Philippines. It is the executive department of the Philippine Government responsible for ensuring access to basic public health services to all Filipinos through the provision of quality health care and the regulation of...

 banned the advertising of infant formula and the practice of providing free samples, regardless of intended age group (in the Revised Implementing Rules and Regulations of Executive Order 51, or RIRR). The new regulation was challenged by the infant formula industry in the Supreme Court. Initially the challenge was dismissed, but this decision was reversed following industry pressure and a controversial letter by American business leader Thomas Donahue, then President and CEO of the US Chamber of Commerce
Chamber of commerce
A chamber of commerce is a form of business network, e.g., a local organization of businesses whose goal is to further the interests of businesses. Business owners in towns and cities form these local societies to advocate on behalf of the business community...

, resulting in the regulation being suspended and advertising continuing.

United Kingdom

In the United Kingdom, infant formula advertising has been illegal since 1995, but advertising for "follow-on formula" is legal, which has been cited as a loophole allowing advertising of similarly-packaged formula.

United States

In the United States, infant formula is both heavily marketed – the country has not adopted the Code
International Code of Marketing of Breast-milk Substitutes
The International Code of Marketing of Breastmilk Substitutes is an international health policy framework for breastfeeding promotion adopted by the World Health Assembly of the World Health Organization in 1981...

, nor is it being systematically implemented by manufacturers for domestic marketing – and even heavily subsidized
Subsidy
A subsidy is an assistance paid to a business or economic sector. Most subsidies are made by the government to producers or distributors in an industry to prevent the decline of that industry or an increase in the prices of its products or simply to encourage it to hire more labor A subsidy (also...

 by the government: at least one third of the American market is supported by the government, with over half of infant formula sold in the country provided through the Special Supplemental Nutrition Program for Women, Infants and Children
Special Supplemental Nutrition Program for Women, Infants and Children
The Special Supplemental Nutrition Program for Women, Infants and Children is a Federal assistance program of the Food and Nutrition Service of the United States Department of Agriculture for healthcare and nutrition of low-income pregnant women, breastfeeding women, and infants and children...

 (known as WIC
WIC
The abbreviation WIC can mean:*Walta Information Center, a news agency based in Ethiopia.*Dutch West India Company, a former trading cooperation that led to the establishment of some Dutch colonies....

)..

According to surveys, over 70% of large U.S. hospitals dispense infant formula to all infants, a practice opposed by the American Academy of Pediatrics
American Academy of Pediatrics
The American Academy of Pediatrics is the major professional association of pediatricians in the United States. The AAP was founded in 1930 by 35 pediatricians to address pediatric healthcare standards. It currently has 60,000 members in primary care and sub-specialist areas...

 and in violation of the Code. The Gerber Products Company
Gerber Products Company
Gerber Products Company is a purveyor of baby food and baby products. A former American-owned company, Gerber is now a subsidiary of Nestlé, and is currently located in Fremont, Michigan, USA.-History:...

 began marketing its brand of infant formula directly to the public in October 1989, while the Carnation Company began marketing Good Start infant formula directly to the public in January 1991.

Infant formula costs are a significant fraction of the WIC program costs: 21% post-rebate and 46% pre-rebate. Formula manufacturers are granted a WIC monopoly
Monopoly
A monopoly exists when a specific person or enterprise is the only supplier of a particular commodity...

 in individual states. Meanwhile breastfeeding rates are substantially lower for WIC recipients; this is partly attributed to formula being free of charge to mothers in the WIC program, who are of lower socio-economic status. Violations of federal policy have also been found in terms of infant formula company advertising using the WIC trademark, to reach both WIC and non-WIC participants. In recent years WIC has been expanding its breastfeeding promotion
Breastfeeding promotion
Breastfeeding promotion refers to coordinated activities and policies to promote health among women, newborns and infants through breastfeeding....

 strategies, including providing subsidies for clients who use milk banks.

History of Infant Formula Development

Dates Events
1867 A formula containing wheat flour, cow's milk, malt flour, and potassium bicarbonate was developed.
1915 A powder form of infant formula was introduced, containing cow's milk, lactose, oleo oils, and vegetable oils.
1929 Soy formula was introduced.
1935 Protein was added because it was believed cow's milk protein content was lower than human milk protein content; protein at 3.3–4.0 g/100 kcal was added.
1959 Iron
Iron
Iron is a chemical element with the symbol Fe and atomic number 26. It is a metal in the first transition series. It is the most common element forming the planet Earth as a whole, forming much of Earth's outer and inner core. It is the fourth most common element in the Earth's crust...

 fortification was introduced because a large amount of iron (~80%) is used to expand the red blood cell mass in a growing infant. Infants with birth weights between 1500 and 2500g require 2 mg/kg of iron per day. Infants with weights of less than 1500g require 4 mg/kg per day.
1962 The whey
Whey
Whey or Milk Serum is the liquid remaining after milk has been curdled and strained. It is a by-product of the manufacture of cheese or casein and has several commercial uses. Sweet whey is manufactured during the making of rennet types of hard cheese like cheddar or Swiss cheese...

:casein
Casein
Casein is the name for a family of related phosphoprotein proteins . These proteins are commonly found in mammalian milk, making up 80% of the proteins in cow milk and between 60% and 65% of the proteins in human milk....

 ratio was made similar to human milk because producers were aware that human milk contains a higher ratio of whey protein, and cow's milk contains a higher ratio of casein.
1984 Taurine fortification was introduced because newborn infants lack the enzymes needed to convert and form taurine.
Late 1990 Nucleotide fortification was introduced into infant formula because nucleotides can act as growth factors and may enhance the infant immune system.
Early 2000 Polyunsaturated fatty acid fortification was introduced. Polyunsaturated fatty acids, such as docosahexaenoic acid
Docosahexaenoic acid
Docosahexaenoic acid is an omega-3 fatty acid that is a primary structural component of the human brain and retina. In chemical structure, DHA is a carboxylic acid with a 22-carbon chain and six cis double bonds; the first double bond is located at the third carbon from the omega end...

 (DHA) and arachidonic acid
Arachidonic acid
Arachidonic acid is a polyunsaturated omega-6 fatty acid 20:4.It is the counterpart to the saturated arachidic acid found in peanut oil, Arachidonic acid (AA, sometimes ARA) is a polyunsaturated omega-6 fatty acid 20:4(ω-6).It is the counterpart to the saturated arachidic acid found in peanut oil,...

 (ARA), were added because those fatty acids play an important role in infant brain development.

Current general procedure for infant formula processing

The manufacturing process may differ for different types of formula made; therefore the following is the general procedure for liquid-milk based formulas:

Mixing ingredients

Primary ingredients are blended in large stainless steel tanks and skim milk is added and adjusted to 60°C. Then, fats, oils and emulsifiers are added. Additional heating and mixing may be required to get proper consistency. Next, minerals, vitamins, and stabilizing gums are added at various points, depending on their sensitivity to heat. The batch is temporarily stored and then transported by pipelines to pasteurization equipment when mixing is complete.

Pasteurization

This is a process that protects against spoilage by eliminating bacteria, yeasts and molds.
It involves quickly heating and then cooling of the product under controlled conditions which micro-organisms cannot survive. The batch is held at around 85-94°C for approximately 30 seconds which is necessary to adequately reduce micro-organisms and prepare the formula for filling.

Homogenization

This is a process which increases emulsion uniformity and stability by reducing size of fat and oil particles in the formula. It is done with a variety of mixing equipment that applies shear to the product and this mixing breaks fat and oil particles into very small droplets.

Standardization

Standardization is used to ensure that the key parameters like pH, fat concentration and vitamins and mineral content are correct. If insufficient levels of these are found, the batch is reworked to achieve appropriate levels. After this step, the batch is ready to be packaged.

Packaging

Packaging depends on manufacturer and type of equipment used, but in general, liquid formula is filled into metal cans with lids crimped into place.

Heat treatment or sterilization

Finally, infant formulas are heat treated to maintain the bacteriologic quality of the product. This can be done traditionally by either retort sterilization or high-temperature short-time (HTST) treatment. Recently, ultrahigh-temperature treated formula has become more commonly used. If powdered formula is made, then spray drying
Spray drying
Spray drying is a method of producing a dry powder from a liquid or slurry by rapidly drying with a hot gas. This is the preferred method of drying of many thermally-sensitive materials such as foods and pharmaceuticals. A consistent particle size distribution is a reason for spray drying some...

 would be required in addition. Retort sterilization is a traditional retort sterilization method that uses 10-15mins treatment at 118°C. Ultrahigh-temperature (UHT) is a method that uses a brief (2–3 seconds) treatment at 142°C. Because of the short time used, there is little protein denaturation, but the process still ensures sterility of the final product.

Probiotics

Recently, probiotics have become a new ingredient in many of our foods, and studies have been completed regarding the use of probiotics in infant formula Several randomized, controlled trials completed recently have shown limited and short term clinical benefits for the use of probiotics in infants’ diet The safety of probiotics in general and in infants, especially preterm infants, has been investigated in a limited number of controlled trials. The findings thus far suggest probiotics are generally safe. Therefore, the study suggested more scientific research is necessary before a conclusion can be made about probiotic supplementation in infant formula, since the research is still quite preliminary.

Prebiotics

Prebiotics are undigestible carbohydrates that promote the growth of probiotic bacteria in the gut. Human milk contains a variety of oligosaccharides believed to be an important factor in the pattern of microflora colonization of breastfed infants. Because of variety, variability, complexity and polymorphism of the oligosaccharide composition and structure, it is currently not feasible to reproduce the oligosaccharide components of human milk in a strictly structural fashion.

The European Society of Pediatric Gastroenterology, Hepatology, and Nutrition Committee on Nutrition found evidence to support short term effects of ingesting prebiotics on stool microflora of infants with increased in the number of bifidobacteria. Babies can be at risk of dehydration with the induction of softer stools, if they have the kidney immaturity and/or a poor ability to concentrate urine. A reduction of pathogens has been associated with the consumption of prebiotics. However, there was no evidence to support major clinical or long-term benefits. Therefore, there is little evidence of beneficial effects of prebiotics in dietary products.

Lysozyme and lactoferrin

Lysozyme
Lysozyme
Lysozyme, also known as muramidase or N-acetylmuramide glycanhydrolase, are glycoside hydrolases, enzymes that damage bacterial cell walls by catalyzing hydrolysis of 1,4-beta-linkages between N-acetylmuramic acid and N-acetyl-D-glucosamine residues in a peptidoglycan and between...

 is an enzyme that is responsible for protecting the body by damaging bacterial cell walls. Lactoferrin
Lactoferrin
Lactoferrin , also known as lactotransferrin , is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears, and nasal secretions...

 is a globular, multifunctional protein that has antimicrobial activity. Compared to human milk, cow’s milk has a signifactly lower levels of lysozyme and lactoferrin; therefore, the industry has an increasing interest in adding them into infant formulas.

See also

  • Child development
    Child development
    Child development stages describe theoretical milestones of child development. Many stage models of development have been proposed, used as working concepts and in some cases asserted as nativist theories....

  • Baby food
    Baby food
    Baby food is any food, other than breastmilk or infant formula, that is made specifically for infants, roughly between the ages of four to six months to 2 years. The food comes in multiple varieties and tastes, can be produced by many manufacturers, or may be table food that the rest of the family...

  • Baby bottle
    Baby bottle
    A baby bottle is a bottle with a teat to drink directly from. It is typically used by infants and young children when a mother does not breastfeed, or if someone cannot drink from a cup, for feeding oneself or being fed.In particular it is used to feed infant formula, expressed breast milk or...

  • Breastfeeding
    Breastfeeding
    Breastfeeding is the feeding of an infant or young child with breast milk directly from female human breasts rather than from a baby bottle or other container. Babies have a sucking reflex that enables them to suck and swallow milk. It is recommended that mothers breastfeed for six months or...

  • Breast milk
    Breast milk
    Breast milk, more specifically human milk, is the milk produced by the breasts of a human female for her infant offspring...


External links

The source of this article is wikipedia, the free encyclopedia.  The text of this article is licensed under the GFDL.
 
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