An infant being fed from a baby bottle.

A 2001 WHO report finds that infant formula prepared in accord with applicable Codex Alimentarius standards is a nutritionally adequate and safe complementary food and a suitable breast milk substitute. Nonetheless, with few exceptions the WHO report recommends exclusive breastfeeding for the first 6 months of life.^[3]

Infant formula is necessarily an imperfect approximation of breast milk because:

• The exact chemical properties of breast milk are still unknown.^[4]
• 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.^[5]
• Breast milk includes a mother's antibodies that help the baby avoid or fight off infections and give his immature immune system the benefit of his mother's immune system that has many years of experience with the germs common in their environment.

History of formula

Early infant foods

Throughout history, mothers who could not (or chose not to) breastfeed their babies either employed the use of a wet nurse^[6] or, less frequently, prepared food for their babies, a process known as "dry nursing."^[7][6] Baby food composition varied according to region and economic status.^[7] 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.^[8][9]

Poster advertisement for Nestle's Milk by Théophile Alexandre Steinlen, 1895

Raw milk formulas

As physicians became increasingly concerned about the quality of such foods, medical recommendations such as Thomas Morgan Rotch's "percentage method" (published in 1890) began to be distributed, and gained widespread popularity by 1907.^[6] These complex formulas recommended that parents mix cow's milk, water, cream, and sugar or honey in specific ratios to achieve the nutritional balance believed to approximate human milk reformulated in such a way as to accommodate the believed digestive capability of the infant.^[1]

At the dawn of the 20th century in the United States, most infants were breastfed, although many received some formula feeding as well. Home-made "percentage method" formulas were more commonly used than commercial formulas in both Europe and the United States.^[15] They were less expensive and were widely believed to be healthier. However, formula-fed babies exhibited more diet-associated medical problems, such as scurvy, rickets and bacterial infections than breastfed babies. By 1920, the incidence of scurvy and rickets in formula-fed babies had greatly decreased through the addition of orange juice and cod liver oil to home-made formulas. Bacterial infections associated with formula remained a problem more prevalent in the United States than in Europe, where milk was usually boiled prior to use in formulas.^[15]

Evaporated milk formulas

In the 1920s and 1930s, evaporated milk began to be widely commercially available at low prices, and several clinical studies suggested that babies fed evaporated milk formula thrive as well as breastfed babies^[6][16] (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.^[1] 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.^[6]

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 attempt to make infant formulas that more closely matched its composition.^[1] Maltose and dextrins were believed nutritionally important, and in 1912, the Mead Johnson Company released a milk additive called Dextri-Maltose. This formula was made available to mothers only by physicians. 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."^[6]

In the late 1920s, Alfred Bosworth released Similac (for "similar to lactation"), and Mead Johnson released Sobee.^[6] 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 hospitals and pediatricians.^[6] By the early 1960s, commercial formulas were more commonly used than evaporated milk formulas, which all but vanished in the 1970s. By the early 1970s, over 75% of babies in the United States were fed on formulas, almost entirely commercially produced.^[1]

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 among infants fed formula prepared with contaminated (drinking) water.^[17] Organized protests, the most famous of which was the Nestlé boycott 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.

Store Brand (Generic) Infant formulas

Store brand infant formula was first introduced in the United States in 1997 by PBM Products. All infant formula brands adhere to Food and Drug Administration (FDA) guidelines.

The Mayo Clinic stated in a November 2007 publication: ?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.?

Private label infant formulas have allowed the leading food and drug retailers to provide formula to customers that is labeled under the store brands of companies such as Wal-Mart, Target, Kroger, Loblaws, and Walgreens.

Usage since 1970s

Since the early 1970s, industrial countries have witnessed a dramatic resurgence in breastfeeding among children from newborn to 6 months of age.^[2] However, 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.^[1][2]

Leading health organizations (e.g. US CDC, WHO, US HHS) are attempting to increase the prevalence of breastfeeding through public awareness campaigns.^[18][19][20] The goals of these programs vary by organization, with recommended breastfeeding ages ranging between birth and 24 months.^[21] Additionally, regulatory initiatives also encourage breastfeeding. For example, the International Code of Marketing of Breast-milk Substitutes 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.^[22]

Choosing to use infant formula

Reasons for using infant formula include:

• The mother's health: The mother is infected with HIV^[23] or tuberculosis.^[23] She is malnourished or has had certain kinds of breast surgery. She is taking any kind of drug that could harm the baby,^[23] or drinks unsafe levels of alcohol. The mother is extremely ill.
• The baby is unable to breastfeed: The child has a birth defect or inborn error of metabolism such as galactosemia that makes breastfeeding difficult or impossible.
• Absence of the mother: The child is adopted, orphaned, or in the sole custody of a man. The mother is separated from her child by being in prison or a mental hospital. The mother has left the child in the care of another person for an extended period of time, such as while traveling or working abroad. The mother has abandoned the child.
• Family pressures: Family members, such as mother's husband or boyfriend encourage use of infant formula.
• Lack of education: The mother believes that her breast milk is of low quality or in low supply, or that breastfeeding will decrease her energy, health, or attractiveness. The mother is not trained sufficiently to breastfeed without pain and to produce enough milk.
• Financial pressures: Maternity leave is unpaid, insufficient, or lacking. The mother's employment interferes with breastfeeding.
• Societal structure: Breastfeeding is difficult or forbidden at the mother's job, school, place of worship or while commuting. The mother feels infant formula is socially preferable.
• Personal beliefs: The mother feels that breasts are too sexual for a baby or feels uncomfortable breastfeeding around other people. Nursing by a relative or paid wet-nurse is socially unsupported, believed to be unhygienic, or too expensive. Also, the mother does not want to breastfeed or prefers to use both breast milk and infant formula.
• Dietary concerns: The contents of breastmilk are influenced by the dietary habits of the mother. If the mother consumes a food that contains an allergen breastfeeding may, for a brief period after consumption, provoke an allergic reaction in the infant.

Nutritional content

Besides breast milk, infant formula is the only other milk product which the medical community considers nutritionally acceptable for infants under the age of one year. Although cow's milk is the basis of almost all infant formula, plain cow's milk is unsuited for infants because of its high protein and electrolyte (salt) content which may put a strain on an infant's immature kidneys. The infant intestine is not properly equipped to digest non-human milk and this may often result in diarrhea, intestinal bleeding and malnutrition. Evaporated milk, although perhaps easier to digest due to the processing of the protein, is still nutritionally inadequate. To reduce the negative effect on the infants digestive system, cows milk used for formula undergoes processing in order to be made into infant formula. This includes steps in order to make protein more easily digestible and alter the whey-to-casein protein balance to a ratio 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.

Most of the world's supply of infant formula is produced in the United States. The nutrient content is regulated by the American Food and Drug Administration (FDA) based on recommendations by the American Academy of Pediatrics Committee on Nutrition. The following must be included in all formulas produced in the U.S.:

• Protein
• Fat
• Linoleic acid
• Vitamins: A, C, D, E, K, thiamin (B1), riboflavin (B2), B6, B12
• Niacin
• Folic acid
• Pantothenic acid
• Calcium
• Metals: magnesium, iron, zinc, manganese, copper
• Phosphorus
• Iodine
• Sodium chloride
• Potassium chloride

In addition, formulas not made with cow's milk must include biotin, choline, and inositol.

Hypoallergenic formulas reduce the likelihood of certain medical complications in babies with specific health problems. Baby formula can be synthesized from raw amino acids. This kind of formula is sometimes referred to as elemental infant formula or as medical food because of its specialized nature. While quite expensive, such formula is hypoallergenic and is sometimes used for babies with severe allergies to cow's milk and soy. Some commercial brands are Neocate and Peptamen. Being purely synthetic monomeric amino acids, it is also quite foul-tasting to adults, and it is not uncommon for infants to reject elemental formulas after having been established on a sweeter tasting, non-elemental formula.

Variations

Infant formula is available in powder, liquid concentrate and ready-to-feed forms, which are prepared by the caregiver or parent in small batches and fed to the infant, usually with either a baby bottle or cup. It is very important to measure powders or concentrates accurately to achieve the intended final product. It is advisable that all equipment that comes into contact with the infant formula be cleaned and sterilized before each use. Proper refrigeration is essential for any infant formula which is prepared in advance.

Controversy and science

The use of infant formula has come under scrutiny. Health authorities recommend breastfeeding for newborns through 12 months of age, and some through 24 months due to the infant's need for Omega 3, a nutrient that is ordinarily found in breast milk but not in formula.^[21] Today, however, DHA (docosahexaenoic acid) Omega-3 and ARA (arachidonic acid) are found in over 97% of U.S. infant formulas. Studies have found infants in developed countries who consume formula are at increased risk for acute otitis media, non-specific gastroenteritis, severe lower respiratory tract infections, atopic dermatitis, asthma, obesity, type 1 and 2 diabetes, sudden infant death syndrome (SIDS), eczema, necrotizing enterocolitis and autism when compared to infants who are breastfed.^{[24][25][26][27]}

Although some early studies have found an association between infant formular and lower cognitive development,^[28] other studies have found no correlation.^[24] However recently more questions have arisen. It has been discovered that iron supplementation in baby formula is linked to lowered I.Q. and other neurodevelopmental delays.^[29]

Melamine contamination

On November 25, 2008, an Associated Press article entitled, "FDA finds traces of melamine in US infant formula," explains infant formula made by the main three firms has tested positive for melamine contamination.^[30] These three main firms are responsible for 90% of infant formula in the US, "Abbott Laboratories, Nestle and Mead Johnson."^[31]

The MSDS for Melamine (CAS NO 108-78-1; C3-H6-N6) records the acute oral toxicity (LD50) at 3161 mg/kg (3161 ppm) for a rat. The highest levels previously reported in China reached approximately 2500 ppm. The article mentioned above indicated that the US testing found 10,000 times less than the China levels or 0.25 ppm.

Health Canada conducted a separate test and also detected traces of melamine in infant formula available in Canada. The melamine levels were well below Health Canada's safety limits, although some public health advocates are critical of the industry and regulators for allowing any residues of a potentially dangerous substance in food for infants.^[32]

Health officials have been on alert for the chemical since the discovery this year of a massive case of melamine poisoning in China, where milk was deliberately adulterated with the chemical, leading to illnesses in more than 50,000 children, including cases of acute kidney failure. In China, large quantities of melamine were deliberately added to watered-down milk to give it the appearance of having adequate protein levels.^[33]

Risks increased

In studies, formula-feeding is associated with increased likelihood of the following conditions in infants: Digestive/gastrointestinal issues

• Appendicitis^[34]
• Constipation and Anal fissures^[35]
• Diarrhea^{[36][37][38][39][40]}
• Esophogeal and Gastrid Lesions^[41]
• Gastroenteritis^[42]
• Gastroesophogeal Reflux^[43]
• Necrotizing Enterocolitis^[44][45]
• Salmonellosis^[46]
• Ulcerative Colitis^[47]

Respiratory issues

• Allergies^[48][49]
• Asthma^[50]
• Respiratory Infections^[51]
• Respiratory Syncytial Virus^[52]
• Wheezing^[53][54][55]

Autoimmune disorders

• Autoimmune Thyroid Disease^[56]
• Celiac Disease^[57][58]
• Crohn's Disease^[59]
• Diabetes Mellitus^[26][60]
• Juvenile Rheumatoid Arthritis^[61]
• Multiple Sclerosis^[62]

Other infectious diseases

• Candidiasis^[63]
• Ear Infection^[38][64]
• Haemophilus influenzae^[65][66][67]
• Streptococcus pneumoniae^[68]
• Tonsillitis^[69]
• Urinary Tract Infections^[70]

Cardiovascular issues

• High Blood Pressure^[71]
• High Cholesterol^[72][73]

Mental/Psychological issues

• Delayed Speech and Language Development^[74][75]
• Lower IQ^[76][77]
• Schizophrenia^[78]

Other issues

• Anemia and Iron Deficiency^[79][80]
• Cancer^{[81][82][83][84][85][86]}
• Cryptorchidism^[87]
• Eczema^[88]
• Inguinal Hernia^[89]
• Lower Visual Acuity^[90]
• Lower Bone Mass^[91]
• Morbidity and Mortality^{[92][93][94][95][96][97]}
• Obesity^{[98][99][100][101]}
• Sudden Infant Death Syndrome (SIDS)^{[102][103][104][105]}

Risks decreased

Infectious diseases transmitted from the breastfeeder

• HIV infection^[106][107]
• CMV infection,^[106] with potentially dangerous consequences in pre-term babies^[108]
• HTLV-1 infection^[106][107]
• HTLV-2 infection^[107]
• Tuberculosis in the context of tuberculosis mastitis
• Herpes simplex when lesions are present on the breasts^[107]
• Chickenpox in the newborn, when the disease manifested in the mother within a few days of birth^[107]

Environmental contaminants

• Exposure to polybrominated diphenyl ethers (PBDEs)
• Exposure to polychlorinated biphenyls^[109]

Malnutrition

• Iron deficiency
• Vitamin deficiencies
• Inadequate nutrition during transition to solid foods^[110]

Manufacturers

Major infant formula manufacturers include:

• Mead Johnson: owned by Bristol-Myers Squibb, makes Enfamil
• Nestlé: the largest producer of formula in the world, makes Good Start
• Abbott Laboratories: makes Similac, Isomil, and Alimentum
• Wyeth Nutrition: Market leader in the Philippines
• PBM Products: Makers of store brand formula in the U.S.

S-26 Gold, Promil Gold, Progress Gold, S-26, Promil, Promil Kid, Bonna, Bonamil, Bonakid 1+, Bonakid 3+, Nursoy,Parent's Choice/Bright Beginnings

• Gerber Products Company
• Earth's Best owned by Hain Celestial

• Danone recently acquired Royal Numino, Dumex, Milupa

See also

• Child development
• Baby food
• Baby bottle
• Breastfeeding
• Breast milk

References

^[111]

External links

• U.S. FDA Infant Formula: Second Best but Good Enough
• Infant Formula Frequently Asked Questions Center for Food Safety and Applied Nutrition/Food and Drug Administration
• "Breast-feeding and Guilt: Interview with a Mayo Clinic Specialist"

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