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BABY INFANT FORMULA
Infant formula is a manufactured food designed and marketed for feeding to babies and infants under 12 months of age, usually prepared for bottle-feeding or cup-feeding from powder (mixed with water) or liquid (with or without additional water). The U.S. Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk".
Manufacturers state that the composition of infant formula is designed to be roughly based on a human mother's milk at approximately one to three months postpartum; however, there are significant differences in the nutrient content of these products. The most commonly used infant formulas contain purified cow's milk whey and casein as a protein source, a blend of vegetable oils as a fat source, lactose as a carbohydrate source, a vitamin-mineral mix, and other ingredients depending on the manufacturer. In addition, there are infant formulas using soybean as a protein source in place of cow's milk (mostly in the United States and Great Britain) and formulas using protein hydrolysed into its component amino acids for infants who are allergic to other proteins. An upswing in breastfeeding in many countries has been accompanied by a deferment in the average age of introduction of baby foods (including cow's milk), resulting in both increased breastfeeding and increased use of infant formula between the ages of 3- and 12-months.
A 2001 World Health Organization (WHO) report found that infant formula prepared in accordance with applicable Codex Alimentarius standards was a safe complementary food and a suitable breast milk substitute. In 2003, the WHO and UNICEF published their Global Strategy for Infant and Young Child Feeding, which restated that "processed-food products for infants and young children should, when sold or otherwise distributed, meet applicable standards recommended by the Codex Alimentarius Commission", and also warned that "lack of breastfeeding—and especially lack of exclusive breastfeeding during the first half-year of life—are important risk factors for infant and childhood morbidity and mortality". In particular, the use of infant formula in less economically developed countries is linked to poorer health outcomes because of the prevalence of unsanitary preparation conditions, including lack of clean water and lack of sanitizing equipment. UNICEF estimates that a formula-fed child living in unhygienic conditions is between 6 and 25 times more likely to die of diarrhea and four times more likely to die of pneumonia than a breastfed child. Rarely, use of powdered infant formula (PIF) has been associated with serious illness, and even death, due to infection with Enterobacter sakazakii and other microorganisms that can be introduced to PIF during its production. Although E. sakazakii can cause illness in all age groups, infants are believed to be at greatest risk of infection. Between 1958 and 2006, there have been several dozen reported cases of E. sakazakii infection worldwide. The WHO believes that such infections are under-reported.
HISTORY OF FORMULA
Early infant foods
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 Nestlé's Milk.
Raw milk formulas
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
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.
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 (for "infant meal") in 1959 were accompanied by marketing campaigns that provided inexpensive formula to hospitals and paediatricians. 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 among infants fed formula prepared with contaminated (drinking) water. 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.
Generic brand formulas
Similarly, in Canada all infant formulas regardless of brand are required to meet standards set by Health Canada.
Follow-on and toddler formulas
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, 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.
These products have also recently fallen under criticism for contributing to the childhood obesity epidemic in some developed countries due to their marketing and flavoring practices.
Usage since 1970s
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, U.S. Centers for Disease Control and Department of Health and Human Services) 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 awareness campaigns. The specific goals and approaches of these breastfeeding promotion 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, adopted by the WHO's World Health Assembly 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 also restricts use by hospitals of free formula or other infant care aids provided by formula companies.
PREPARATION AND CONTENT
Infant formulas also come in a variety of types:
Hypoallergenic formulas, such as those containing free individual 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 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 public health agencies and NGOs.
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 content and low whey 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 diarrhoea, 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-to-casein 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 (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.:
Other commonly used ingredients:
In addition, formulas not made with cow's milk include biotin, choline, and inositol.
USES, RISKS AND CONTROVERSIES
The use and marketing of infant formula has come under scrutiny. Breastfeeding, including exclusive breastfeeding for the first 6 months of life, is widely advocated as "ideal" for babies and infants, both by health authorities - and accordingly in ethical advertising of infant formula manufacturers.
Despite the recommendation that babies be exclusively breastfed for the first 6 months, less than 40% of infants below 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
The mother's health: The mother is infected with HIV or has active tuberculosis. She is extremely ill or has had certain kinds of breast surgery. She is taking any kind of drug that could harm the baby, or drinks unsafe levels of alcohol.
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.
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 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. Risks can often be mitigated with improved diet and education of mothers and caregivers, including availability of macro and micronutrients. For example in Canada, marketed infant formulas are fortified with vitamin D, but Health Canada also recommends breastfed infants receive extra vitamin D in the form of a supplement.
Personal preferences, beliefs, and experiences: The mother may dislike breast-feeding or think it inconvenient. In addition, breastfeeding can be difficult for victims of rape or sexual abuse; for example, it may be a trigger for posttraumatic stress disorder. Many families bottle feed to increase the father's role in parenting his child.
Absence of the mother: The child is adopted, orphaned, abandoned, or in the sole custody of a man or male same-sex couple. The mother is separated from her child by being in prison or a mental hospital. The mother has left the child in the care of another person for an extended period of time, such as while travelling 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.
Lack of other sources of breastmilk:
In November 2008, traces of melamine were reported to have been found by the U.S. Food and Drug Administration in infant formula sold in the United States made by the three main American firms — Abbott Laboratories, Nestle and Mead Johnson — 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 for melamine (CAS registry number 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 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 concerns remain about the safety of manufactured food for infants and monitoring of potentially dangerous substances.
Other health controversies
POLICY, INDUSTRY AND MARKETING
The policy, regulatory and industry environments surrounding the infant formula market vary tremendously between countries.
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 aims to reduce and eliminate this controversial practice.
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 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 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, resulting in the regulation being suspended and advertising continuing.
According to surveys, over 70% of large U.S. hospitals dispense infant formula to all infants, a practice opposed by the American Academy of Paediatrics and in violation of the Code. The Gerber Products Company 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 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 strategies, including providing subsidies for clients who use milk banks.
INFANT FORMULA PROCESSING
Heat treatment or sterilization
Recent and future potential new ingredients
The European Society of Paediatric 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 bifido bacteria. 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
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