Infant formula

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 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.

Poster advertisement for Nestle’s Milk by Thophile Alexandre Steinlen, 1895

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 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 Nestle’s Milk.

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. 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.

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. 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.

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 (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 attempt to make infant formulas that more closely matched its composition. 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.”

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 hospitals and pediatricians. 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.

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. Organized protests, the most famous of which was the Nestl boycott of 1977, called for an end to unethical marketing. This boycott is ongoing, as the current coordinators maintain that Nestl 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 in the United States are required to adhere to the U.S. Food and Drug Administration (FDA) guidelines.

The Mayo Clinic said, s 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.21]

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.

Follow-on and toddler formulas

In the 1980s and 1990s, formula was introduced for older children, up to the age of 2 years, under such terms as “follow-on formula” and “toddler formula”. This was done partly because the market for infant formula (strictly speaking, up to age 6 months, when infants typically exclusively breastfeed) was saturated in developed countries, as discussed in industry, below, 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 advertising for similarly packaged and branded follow-on formula is often interpreted as advertising for infant formula targeted at under 6 month-olds.

An early example of follow-on formula was introduced by Wyeth in the Philippines in 1987, following the introduction in this country of regulations on infant formula advertising, which regulations did not address follow-on formula, which did not exist at the time of their drafting.

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. 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 312 months.

Leading health organizations (e.g. US CDC, WHO, US HHS) are attempting to increase the prevalence of breastfeeding through public awareness campaigns. The goals of these programs vary by organization, with recommended breastfeeding ages ranging between birth and 24 months. 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.

Reasons to use infant formula

There are few medical reasons to use infant formula “The vast majority of mothers can and should breastfeed, just as the vast majority of infants can and should be breastfed,” and “Only under exceptional circumstances can a mother’s milk be considered unsuitable for her infant.” Alternatives to breast-feeding include:

expressed breast milk from an infant own mother,

breast milk from a healthy wet nurse,

breast milk from a human-milk bank,

as well as infant formula. Among these, the WHO states that “the choice of the best alternative … depends on individual circumstances.”

Reasons to not breastfeed or it is not possible to breastfeed include:

The mother’s health: The mother is infected with HIV or tuberculosis. She is malnourished or has had certain kinds of breast surgery. She is taking any kind of drug that could harm the baby, 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.

a couple is practicing natural family plan: Breastfeeding acts as a natural contraception for the first 6 months after birth.

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.

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.

Social discomfort: The mother may feel uncomfortable breastfeeding around other people.

Personal beliefs: The mother may choose to not breastfeed for varied personal reasons for instance, she may feel that breasts are too sexual for a baby.

Lack of training: The mother is not trained sufficiently to breastfeed without pain and to produce enough milk.

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.

Reasons to supplement by alternatives, in addition to breastfeeding, include:

Social structure or discomfort: The mother may be able to breastfeed at some hours, but not at others, for reasons cited above.

Lactation insufficiency: The mother is unable to produce sufficient milk, which affects around 2 to 5% of women.

Reasons to use infant formula specifically, as opposed to the alternatives of expressed milk, wet nurses, and milk banks, include:

Lack of education: The mother, her doctor, or family may believes that her breast milk is of low quality or in low supply, or that breastfeeding will decrease her energy, health, or attractiveness, and be unaware of other alternatives. Nursing by a relative or paid wet-nurse may be believed to be unhygienic.

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.

Personal beliefs: The mother may choose to use formula for varied personal beliefs.

Lack of alternatives:

Lack of refrigeration: Expressed breast milk requires refrigeration if not immediately consumed, and sanitary preparation conditions this latter requirement is shared with infant formula.

Lack of wet nurses: Wet nursing is illegal and stigmatized in some countries, and may not be available. It may also be socially unsupported or expensive, and safe use of wet nurses requires health screening of the nurses.

Lack of milk banks: Human-milk banks may not be available; relatively few exist, and they require screening and refrigeration.

Nutritional content

Infant formula is nutritionally inferior to breast milk, and superior to other substitutes such as animal milk. 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 note that solid food is nutritionally acceptable in addition to breast milk or formula during weaning.

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, 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[citation needed]. 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[citation needed]. The nutrient content of infant formula for sale in the United States 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

Carbohydrates

Carbohydrates are an important source of energy for growing infants as it accounts for 35 to 42% of their daily energy intake. In most cow’s based formulas, lactose 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 like sucrose and glucose, natural and modified starches, monosacchardies and indigestible carbohydrates. Lactose is not only a good course of energy, it also aids in the absorption of various minerals like magnesium, calcium, zinc and iron.

Nucleotides

Nucleotides are compounds found naturally in human breast milk. They are involved in many different critical metabolic processes in the body like 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 nucleotides like uridine, inosine, and cytidine. Therefore, several companies that produce infant formula have added nucleotides to their infant formulas.

Other Ingredients

Emulsifiers and stabilizers

Emulsifiers and stabilizers are raw materials that are added to prevent the separation of the oil and water-soluble component in the infant formula. Some commonly used emulsifiers include mono, di-glycerides, and gums.

Diluent

The ingredient helps create the liquid bulkiness in infant formula. Skim milk is commonly used as the primary diluent in milk-based formulation. In contrast, purified water is the most commonly used diluent in milk-free formulations.

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.

Recently the market has been segmented by age into:

infant formula, up to 6 months,

follow-on formula, from 6 months to 12 months,

toddler formula, from 12 months on.

These categories and formulations may overlap, and there is substantial consumer confusion about these categories.

These all provide inferior nutrition to breast milk, nor are they recommended by health authorities as a supplement to breast milk[citation needed] recommendations are to breastfeed exclusively for 6 months, then to continue to breast feed to 12 or 24 months (depending on authority), supplementing with solid food and eventually weaning. Cow’s milk should not be introduced before 12 months follow-on formula is superior to cow’s milk for 6 to 12 month olds, but inferior to breast milk.

These were introduced and developed partly to address the saturation of the infant formula market (up to 6 months) in developed countries, as discussed in industry, below, and partly due to regulations on infant formula, which often did not cover milk substitutes for children older than 6 months; an early example is Wyeth’s introduction of follow-on formula in the Philippines in 1987, following introduction of regulations on infant formula marketing. They have also result in confusing advertising in the United Kingdom infant formula advertising is illegal, but follow-on formula advertising is legal, and the similar packaging and market results in follow-on advertisements frequently being interpreted as adverts for formula.

Preparation

Infant formula should be prepared by the caregiver or parent in small batches and fed to the infant, usually with either a cup, as recommended by the WHO, or a baby bottle.

It is very important to measure powders or concentrates accurately to achieve the intended final product, 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 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 and diseases such as diarrhea and pneumonia. 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 NGOs these groups do not consider infant formula appropriate technology for developing countries.

Controversy and science

The use and marketing of infant formula has come under scrutiny; as discussed at breastfeeding, breast milk is considered the “ideal food” for babies, and the “ideal addition” to other foods, and exclusive breast feeding for the first 6 months of a baby’s life is advocated by health authorities and accordingly by infant formula manufactures.

Use

Despite the recommendation that babies be exclusively breastfed for the first 6 months of life, 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 infant having infant formula feeding within two days of birth.

Ethnicity

According to a research conducted in Vancouver, Canada, 1998, at birth, 82.9 % of mothers breastfeed their babies, but this number differs between Caucasians(91.6%) and Non-Caucasians(56.8%).

Nutritional value

The WHO considers infant formula that is safely prepared and formulated in accord with the Codex Alimentarius a nutritionally adequate and safe complementary food.

Toxins

Infant formula contains significantly higher levels of manganese than breast milk 80 times as much in soy-derived, and 30 times as much in animal milk-derived. This level of manganese and its presence in infant formula has been implicated in learning disabilities such as ADHD.

Health effects

Use of infant formula is cited in numerous health risks. 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.

Although some early studies have found an association between infant formula and lower cognitive development, other studies have found no correlation. 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.

Melamine contamination

Main article: 2008 Chinese milk scandal

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. These three main firms are responsible for 90% of infant formula in the US, “Abbott Laboratories, Nestle and Mead Johnson.”

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.

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.

Other controversies

In 1985 Syntex was ordered to pay $27 million for the death of two infants who were given the Syntex baby formula, called Neo-mull-soy, when they were infants. In 1978, Syntex had eliminated salt from the formula.

Risks decreased

Some risks are cited as being decreased when using alternatives to breastfeeding by the mother generally, or by using formula specifically.

Decreased by alternative to breastfeeding by the mother

Infectious diseases transmitted from the breastfeeder

The main risk posed by the mother’s milk specifically is the transmission of infectious diseases such as HIV. In some cases these can be mitigated by using heat-treated milk and nursing for a briefer time (6 months, rather than 1824 months), and can be avoid by using an uninfected woman’s milk, as via a wet-nurse or milk bank, or by using formula, or treated animal milk.

HIV infection

Breastfeeding by an HIV-infected mother poses a 520% chance of transmitting HIV to the baby, assuming

CMV infection, with potentially dangerous consequences in pre-term babies

HTLV-1 infection

HTLV-2 infection

Tuberculosis in the context of tuberculosis mastitis

Herpes simplex when lesions are present on the breasts

Chickenpox in the newborn, when the disease manifested in the mother within a few days of birth

Risks decreased by formula-feeding specifically

Some risks are present in all breast milk, and are only mitigated by the use of infant formula.

Environmental contaminants

Exposure to polybrominated diphenyl ethers (PBDEs)

Exposure to polychlorinated biphenyls

Malnutrition

While in general breast milk is the “ideal food” for babies, in certain circumstances or respects infants may be at risk for malnutrition.

Iron deficiency

Vitamin deficiencies

Particularly vitamin D in babies at high latitudes who lack sun exposure

Inadequate nutrition during transition to solid foods

Balancing risks

Weighing the risks, health authorities generally on balance judge breastfeeding the healthiest, least risky option, as follows:

In cases where the mother has an infectious diseases such as HIV, exclusive breastfeeding is suggested until alternatives that satisfy the AFASS (Acceptable Feasible Affordable Sustainable and Safe) principles are available; such alternatives include breast milk from other women, infant formula, and treated animal milk. In developing countries, risks from other sources of infant mortality such as diarrhea, particularly due to unclean water and lack of sterile conditions both prerequisites to the safe use of formula often outweigh risks from breastfeeding.

The risks from pollution are not seen to outweigh the benefits of breastfeeding, and “adverse effects on learning and behavior are strongly associated with fetal exposure to persistent pollutants, not with breast milk exposure”.

The WHO finds that neurological benefits of breast milk remain, regardless of the dioxin exposure from milk, and other researchers conclude that the benefits of breastfeeding outweigh the danger posed by these toxins.

Industry

This section requires expansion.

Manufacturers

The US infant formula industry is highly concentrated: it is an oligopoly with 3 companies accounting for 99% of the market in 2000:

Mead Johnson: 52%, owned by Bristol-Myers Squibb, makes Enfamil, Pregestimil, Nutramigen, and Nutramigen AA

Abbott Laboratories: 35%, Ross division makes Similac, Isomil, Alimentum, and EleCare

Nestl: 12%, the largest producer of formula in the world, makes Good Start; owns Gerber Products Company

Other infant formula manufacturers include:

Danone recently acquired Royal Numico, Dumex, Milupa

Earth’s Best owned by Hain Celestial

Natures One – privately held Ohio based company producing mostly organic formula for toddlers

Nutricia – maker of Neocate

Wyeth Nutrition: Market leader in the Philippines

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

Market size

This section requires expansion.

Infant formula is the largest segment of the baby food market, with the fraction given as between 40% and 70%.

The global infant formula market is estimated at $7.9 billion. North America and Western Europe are 33% of the market and saturated, while Asia is 53% of the market. South East Asia is a particularly large fraction of the world market relative to its population.

Government subsidies

United States

In the United States, infant formula is heavily subsidized by the government: at least one third of the US market is supported by the government, with over half of infant formula in the US provided through WIC WIC is the US food aid program, not a medical program, which is Medicaid. Breastfeeding rates are substantially lower for WIC recipients; this is partly attributed to formula being free of charge to WIC mothers, and partly to WIC recipients being poor and uneducated, hence less likely to breastfeed. Further, some promotional materials use the WIC trademark, in violation of federal policy. Infant formula costs are a significant fraction of WIC costs: 21% post-rebate, and 46% pre-rebate. Formula manufacturers are granted a WIC monopoly in individual states only one brand of formula will be eligible for WIC.

WIC also pays for milk banks.

Marketing

This section requires expansion.

Marketing of infant formula and the regulation thereof varies between countries.

The International Code of Marketing of Breast-milk Substitutes is a statement of principles 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: in some countries the code is implemented in law and followed by formula manufacturers, while in others it is not.

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.

Free samples of infant formula have been provided to hospitals since the 1930s, which practice has been criticized continuously since then; further, infant formula is the only product routinely provided free of charge to hospitals.

United States

In the United States, infant formula is heavily marketed both in advertising to mothers and doctors and via free samples in violation of the principles in the code, which has not been adopted or implemented by manufacturers in the US for US marketing.

In surveys, over 70% of large hospitals dispense infant formula to all infants, which is opposed by the AAP and in violation of the code.

The American Academy of Pediatrics opposes marketing of infant formula directly to the public.

The Gerber Products Company began marketing Gerber Baby 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.

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, and is confusing to mothers.

By country

This section requires expansion.

Philippines

Infant formula is a major product in the Philippines it is one of the top three consumer commodities, and among the most imported products.

Infant formula marketing has been regulated since the 1987 Executive Order 51 or “Milk Code”. This regulated but did not ban practices such as advertising and providing free samples. Shortly after it was enacted, Wyeth introduced follow-on formula, which was not in the purview of the Milk Code, follow-on formula not having existed at the time of the writing of the Milk Code.

In 2006, the Department of Health banned the advertising of infant formula and the practice of providing free samples, regardless of intended age group (in regulation RIRR), which regulation was challenged by the infant formula industry in the Supreme Court. Initially the challenge was dismissed, but this decision was immediately reversed, following a letter by American business leader Thomas Donahue, then President and CEO of the United States Chamber of Commerce, resulting in the regulation being suspended and advertising continuing.

In the Philippines annual sales amount to some US$469 million annually. US$88 million is spent on advertising the product.

Canada

Vitamin D deficiency is a health concern in Canada. Infant formulas marketed in Canada are fortified with Vitamin D. Health Canada recommends that breastfed infants also receive extra vitamin D in the form of a supplement. With the exception of vitamin D, vitamin and mineral supplementation of breastfed term infants in the first 6 months is not recommended unless a mother is a vegan. Infant formulas marketed in Canada have not been tested for the presence of phthalates, a chemical used in the production of plastics, though concerns have been raised by Great Britain. Unlike other countries (e.g. New Zealand, UK) who have banned the general use of soy-based infant formula, it is still allowed in Canada. It is estimated that 20% of infants in Canada are fed soy beased infant formula and thus exposed to levels of phytoestrogen up to 22000 times higher than those normally found in breast milk, which gives the potential to damage a baby’s thyroid.

Infant Formula Processing

History of Infant Formula Development

Dates

Events

1867

Formula contains wheat flour, cow milk, malt flour, and potassium bicarbonate

1915

Powder form of infant formula was introduced. Formula contained cow milk, lactose, oleo oils, and vegetable oils

1929

Soy formula was introduced

1935

Protein was introduced into the infant formula. Protein was added because it was believed that cow-milk protein content was lower than human-milk protein content. 3.34.0 g/100 kcal of proteins were added.

1959

Iron fortification was introduced because a large amount of iron (~80%) will be 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

Whey : Casein ratio was made similar to human milk because producers were aware that human milk contain a higher content of whey protein and cow milk contain a higher content of casein.

1984

Taurine fortification introduced because new born infants lack the enzymes needed to convert and form taurine.

Late 1990

Nucleotide fortification was introduced into infant formula because nucleotide can act as growth factors and may enhance the immune system in infant body.

Early 2000

Polyunsaturated fatty-acid fortification was introduced. Polyunsaturated fatty-acids, such as Docosahexaenoic acid (DHA) and Arachidonic acid (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 60C.Then, fats, oils and emulsifiers are added next. Additional heating and mixing may be required to get proper consistency. Next, minerals, vitamins, stabilizing gums are added at various points depending on their sensitivity to heat. This 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 85-94C 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 filled into metal cans w/ lids crimped into place.

Heat Treatment/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 an additional spray drying would be required after this. Retort sterilization is a traditional retort sterilization method that uses 10-15mins treatment at 118C. Ultrahigh-temperature (UHT) is a method that uses a brief (23 seconds) treatment at 142C. Because of the short time used, there is little protein denaturation but still ensures sterility of the final product.

Recent and future potential new ingredients

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 this far suggests that probiotics are generally safe. Therefore, the study suggested that 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 nondigestable carbohydrates that promote the growth of probiotic bacteria in the gut. Human milk contains a variety of oligosaccharides that are 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 in favor of beneficial effects of prebiotics in dietary products.

Lysozyme and Lactoferrin

Lysozyme is an enzyme that is responsible for protecting the body by damaging bacterial cell walls. Lactoferrin is a globular, multifunctional protein that has antimicrobial activity. Comparing with human milk, cow 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

Baby food

Baby bottle

Breastfeeding

Breast milk

References

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^ Mayo Clinic, November 2007

^ a b c d [The Philippine Milk Code: A timeline http://www.pcij.org/blog/?p=1789]

^ “Promotion & Support of Breastfeeding and Obesity Prevention”. Centers for Disease Control and Prevention. May 22, 2007. http://www.cdc.gov/breastfeeding/promotion/index.htm. Retrieved 2008-05-24. 

^ United States Department of Health and Human Services (June 4, 2006). “Public Service Campaign to Promote Breastfeeding Awareness Launched”. Press release. http://www.hhs.gov/news/press/2004pres/20040604.html. Retrieved 2008-05-22. 

^ “Promoting proper feeding for infants and young children”. World Health Organization. http://www.who.int/nutrition/topics/infantfeeding/en/index.html. Retrieved 2008-05-24. 

^ a b c “Breastfeeding Frequently Asked Questions”. Centers for Disease Control and Prevention. May 22, 2007. http://www.cdc.gov/breastfeeding/faq/index.htm. Retrieved 2008-05-24. 

^ International Code of Marketing of Breast-Milk Substitutes. World Health Organization. 1981. ISBN 9789241541602. http://www.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&codcol=15&codcch=94. 

^ Emphasis added.

^ a b c “When should a mother avoid breastfeeding?”. Centers for Disease Control and Prevention. 2006-08-26. http://www.cdc.gov/breastfeeding/disease/contraindicators.htm. Retrieved 2007-02-25. 

^ http://www.womens-health.co.uk/breast.asp

^

^ “Breast-feeding and Guilt: Interview with a Mayo Clinic Specialist”

^ Guardian Unlimited: Not your mother’s milk

^ a b c d e f g h i Blachford, Ed. Cengage, G. aby Formula, eNotes.com, November 03, 2009

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^ GEA Processing Engineering Inc.”Production of Powdered Baby Food”, 1992

^ a b c Legal loophole allows banned formula advertising to mothers

^ Discussed in detail at Nestl boycott and references thereof.

^ Nestl FAQ Should all mothers be encouraged to breastfeed exclusively for the first 6 months?

^ Infant Feeding Practices Study II > Results

^ Breastfeeding Among U.S. Children Born 19992005, CDC National Immunization Survey

^ Williams, PL; Innis, SM; Vogel, AM;, (1998), Breastfeeding and weaning practices in Vancouver http://www.ncbi.nlm.nih.gov/pubmed/8870300

^ a b Environmental Working Group Mother’s Milk Mother’s Milk: Sidebar: Breast Milk Is Still Best

^ Collipp PJ. Manganese in infant formula and learning disability. Ann Nutr Metab 27:488-494. 1983.

^ Van Scoy, H. Soy-based formulas may be linked to ADHD: elevated levels of manganese the suspected culprit. Health Scout News Reporter. October 8, 2002.

^ a b Breastfeeding and Maternal and Infant Health Outcomes in Developed Countries. Tufts-New England Medical Center Evidence-Based Practice Center. April 2007. http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1b.chapter.106732. Retrieved 2008-05-22. 

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^ Sadauskaite-Kuehne V, Ludvigsson J, Padaiga Z, Jasinskiene E, Samuelsson U (2004). “Longer breastfeeding is an independent protective factor against development of type 1 diabetes mellitus in childhood”. Diabetes Metab. Res. Rev. 20 (2): 1507. doi:10.1002/dmrr.425. PMID 15037991. 

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^ McCann JC, Ames BN (2005). “Is docosahexaenoic acid, an n-3 long-chain polyunsaturated fatty acid, required for development of normal brain function? An overview of evidence from cognitive and behavioral tests in humans and animals”. Am. J. Clin. Nutr. 82 (2): 28195. PMID 16087970. 

^ Kerr, Martha; Dsire Lie (2008). “Neurodevelopmental Delays Associated With Iron-Fortified Formula for Healthy Infants”. Medscape Psychiatry and Mental Health. http://www.medscape.com/viewarticle/574363. Retrieved 2008-08-04. 

^ (dead link)

^ FDA Finds Traces Of Melamine In US Infant Formula, by Martha Mendoza and Justin Pritchard, November 25, 2008, Huffington Post

^ a b (The Globe and Mail Article), registration required

^ “$27 Million for 2 Victims”. Chicago Tribune. March 1, 1985. http://pqasb.pqarchiver.com/chicagotribune/access/25099431.html?dids=25099431:25099431&FMT=ABS&FMTS=ABS:FT&date=Mar+01,+1985&author=Charles+Mount&pub=Chicago+Tribune+(pre-1997+Fulltext)&desc=$27+MILLION+FOR+2+VICTIMS+OF+BABY+FORMULA&pqatl=google. Retrieved 2009-04-23. “were given the baby formula, called Neo-mull-soy, when they were infants … In 1978, Syntex eliminated salt from the formula, a move that Hayes said caused …” 

^ a b Infant Feeding Options in the Context of HIV

^ a b c Lawrence RM, Lawrence RA (2004). “Breast milk and infection”. Clin Perinatol 31 (3): 50128. doi:10.1016/j.clp.2004.03.019. PMID 15325535. http://linkinghub.elsevier.com/retrieve/pii/S009551080400020X. 

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^ WHO, UNICEF, UNFPA, UNAIDS. HIV transmission through breastfeeding: A review of available evidence. Geneva: World Health Organization, 2004.

^ Schleiss MR (2006). “Acquisition of human cytomegalovirus infection in infants via breast milk: natural immunization or cause for concern?”. Rev. Med. Virol. 16 (2): 7382. doi:10.1002/rmv.484. PMID 16287195. 

^ Przyrembel H, Heinrich-Hirsch B, Vieth B (2000). “Exposition to and health effects of residues in human milk.”. Adv. Exp. Med. Biol. 478: 30725. doi:10.1007/0-306-46830-1_27. PMID 11065082. 

^ Mamiro PS, Kolsteren P, Roberfroid D, Tatala S, Opsomer AS, Van Camp JH (2005). “Feeding practices and factors contributing to wasting, stunting, and iron-deficiency anaemia among 3-23-month old children in Kilosa district, rural Tanzania.”. J Health Popul Nutr 23 (3): 22230. PMID 16262018. 

^ Healthy Milk, Healthy Baby Chemical Pollution and Mother’s Milk Chemicals: Dioxins and Furans

^ a b Rogan, W.J., et al. Should the Presence of Carcinogens in Breast Milk Discourage Breast Feeding?, Regulatory Toxicology and Pharmacology 1991; 13: p. 228-240. cited in NRDC

^ Brouwer, A., et al. Report of the WHO Working Group on the Assessment of Health Risks for Human Infants from Exposure to PCDDs, PCDFs and PCBs, Chemosphere 1998; 37(9-12): p. 1627-1643. cited in NDRC

^ a b c d e f Sharing the Economic Burden: Who Pays for WIC Infant Formula?, USDA

^ a b c d Ingredients for the World Infant Formula Market, UBIC consulting

^ a b Google Answers: Infant Formula Sales/Market/Statistics

^ a b c A Growing Boost for Baby Formula, by Markos Kaminis, BusinessWeek, January 11, 2005

^ a b Breastfeeding: Some Strategies Used to Market Infant Formula May Discourage Breastfeeding; State Contracts Should Better Protect against Misuse of WIC Name, GAO

^ Indiana Mother’s Milk Bank to Open Third Location

^ Banking on Breastmilk

^ Counseling the nursing mother, By Judith Lauwers, Anna Swisher, p. 597

^ a b c Periodic Survey of Fellows: Survey shows most AAP members support formula advertising policy, AAP

^ Statutory Instrument 1995 No. 77: The Infant Formula and Follow-on Formula Regulations 1995

^ a b Milk wars in the Philippines: Breastmilk versus Infant Formula, and links thereof

^ Letter by Thomas Donahue

^ Breast or bottle: The final showdown

^ Cher S Jimenez, “Spilled corporate milk in the Philippines”, Asia Times Online, 25 July 2007, retr 22Dec 2008

^ a b http://www.hc-sc.gc.ca/fn-an/pubs/infant-nourrisson/nut_infant_nourrisson_term_3-eng.php

^ Canadian Health Coalition(1999), Health Canada exposing babies to serious risks, http://www.healthcoalition.ca/soy-babies.html

^ a b c d e f g h i j Institute of Medicine (U.S.) (2004). Defining Safety for Infants. In nfant Formula: Evaluating the Safety of New Ingredients,The National Academic Press. p. 22-42., Retrieved on November 15, 2009.

^ American Academy of Pediatrics. Committee on Nutrition. (1999). Iron fortification of infant formulas. Pediatrics, 104(1), 119-123.

^ Heird, W.C. (2004). Taurine in neonatal nutrition – revisited. Arch Dis Child Fetal Neonatal Ed, 89, 473-474.}}

^ a b c Lonnerdal, B. and Hernell, O. (1998). Effects of feeding ultrahigh-temperature (UHT)-treated infant formula with different protein concentrations or powdered formula, as compared with breast-feeding, on plasma amino acids, hematology, and trace element status. Am. J. Clin. Nutr., 68, 350-6.

^ a b c d e f Carvalho, R.S., Michail, S., Ashai-Khan, F., Mezoff, A.G. (2008). An Update on Pediatric Gastroenterology and Nutrition: A Review of Some Recent Advances. Curr Probl Pediatr Adolesc Health Care, 204-228.

^ a b c International Assosication of Infant Food Manufacturers,rebiotics in Infant Nutrition, November 09, 2009

External links

Isadora B. Stehlin. “Infant Formula: Second Best but Good Enough”. Archived from the original on 2007-12-26. http://web.archive.org/web/20071226072202/http://www.fda.gov/fdac/features/596_baby.html. 

Baby Formula Feed

FDA 101: Infant Formula

“Breast-feeding and Guilt: Interview with a Mayo Clinic Specialist”

Infant and Toddler Nutrition

Breastfeeding VS Formula Feeding

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