Infant formula can and has saved lives. In the minority of cases where a woman cannot breastfeed, where there is no mother to breastfeed, no wet nurse available and human milk cannot be obtained from any other source it may be the only alternative. But the belief that breastmilk substitutes have equal benefits and are a safe alternative to breastfeeding, which leads to mode of feeding being seen as essentially a lifestyle choice, needs to be countermanded.

Artificial feeding has real and serious health risks yet we seldom hear of them. Globally, governments spend millions on the promotion of breastfeeding but there is less alacrity when it comes to providing information on the risks, in infancy and beyond, of artificial feeding. To do so, would mean going up against the commercial interests of, and losing taxes from, the multi-billion-earning infant formula industry; one of the biggest global business sectors in existence. Moreover, the breastmilk substitutes industry also funds, from its massive profits, cash-hungry national health sectors and health research projects, which ensures that the scientific community, while vaunting the benefits of breastfeeding, rarely speaks about the disbenefits of artificial feeding.

The International Code

Low breastfeeding rates are, in large measure, due to the substitutes industry’s claim that its products are health-promoting and a safe alternative to human milk with equivalent benefits. In recognition of the harm done to infants by a lack of breastfeeding, the International Code of Marketing of Breast-Milk Substitutes was issued by WHO in 1981, which contains measures to control the promotion of artificial feeding. Unfortunately, not all WHO signatory member states have instituted the Code and breastmilk substitutes continue to be promoted around the world, though there have been successes in some locations.

●               In India, infant formula packaging must display a conspicuous health warning about artificial feeding.

●               In Iran, the government controls import and sale of breastmilk substitutes and infant formula is only available on prescription.

●               In Papua New Guinea, the sale of feeding implements (bottles, etc) is strictly controlled and there is a ban on advertising breastmilk substitutes and feeding implements.

●               In the UK, the advertising of infant formula is banned.

●               In Saudi Arabia, the government is in process of instituting an advertising ban on infant formula.

The breastmilk substitutes industry has vigorously resisted implementation of the Code. In the Philippines, for instance, legislation was passed banning the advertising of breastmilk substitutes. However, with financial help from powerful vested interests (American plastics industry – think bottles), the legislation was subsequently successfully appealed and infant formula continues to be advertised pending final outcome. The substitutes industry now pays lip service to ‘breast is best’ in some locations because it has found a way round bans by producing, and freely advertising, ‘follow-on’ milk for infants aged six months and older (all that follows applies equally to follow-on products).

Regulations and approval

Breastmilk substitutes are classified as food and are not subject to the more vigorous regulations applied to pharmaceuticals. Yet these concoctions have questionable synthesized ingredients. Most artificial milk is produced in the USA. The ultimate regulatory authority there is the Food and Drug Administration (FDA). Requirements for infant formula are contained in the Federal Food, Drug and Cosmetic Act, which states ‘all manufacturers of infant formula must begin with safe food ingredients, which are either generally recognized as safe (GRAS) or approved as food additives for use in infant formula’. The FDA has no authority over ingredients with GRAS status, though it does require further research to be conducted.


The attempt to replicate human milk has produced increasingly complex concoctions. Most formulations are based on cow’s milk, which must be modified. The protein and mineral content is reduced and carbohydrate content increased, usually by the addition of sugars such as lactose, fructose, glucose and maltodextrose. Infant formula contains high levels of sugar, yet a loophole in the law allows them to be misleadingly advertised as ‘sucrose-free’. Ingredients added to modified cow’s milk: carbohydrate (corn maltodextrin, modified corn starch, corn syrup solids), protein (casein, whey, soy protein isolate), fat (soy oil, coconut oil, corn oil, sunflower oil, palm or olein oilÆ), vitamins, folic acid, pantothenic acid, calcium, minerals, phosphorus, iodine, sodium chloride, potassium chloride and other nutrients.

The ‘other’ category includes: rice starch (added to anti-regurgitant formula), dietary fibre (added to soy formulaÆ for temporary treatment of diarrhoea) and amino acids, such as taurine, methionine and carnitine, as well as nucleotides – to ‘mimic’ the immune system growth and repair properties of breastmilk. Nucleotides have been a constituent of infant formula for about 15 years, and scientists still disagree about their efficacy in immune system development. An instance of on-going research: with contradictory research findings, the jury is still out on whether or not synthesized nucleotides play a role in controlling diarrhoea in formula-fed infants.

New additives

The contents of the ‘other’ category of ingredients fluidly shift in response to research findings on the properties and beneficial effects of breastfeeding, and the substitutes industry’s ever-watchful drive to replicate. The most recent innovation also highlights inadequacies in regulation.

Following research that showed the positive cognitive effects of the long chain polyunsaturated fatty acids (LC-PUFAs) docosahexaeonic acid (DHA) and arachidonic acid (ARA) found in breastmilk, nutrition-scientists came up with the latest novel ingredient: LC-PUFAs manufactured from plant sources. These LC-PUFAs contain triglycerides not found in human milk and are thus structurally different to the LC-PUFAs in human milk. The DHA in infant formula is extracted from fermented microalgae, Cryptecodiunium cohnii, and ARA is extracted from soil fungus, Mortierelle alpina.[i] Cryptecodiunium cohnii and Mortierelle alpina are new to the food chain – therefore any long-term effects cannot yet be fully known. Moreover, the manufacturing process of these LC-PUFAs causes concern. The solvent used to extract the oil is hexane, a petroleum-refining by-product and a known neurotoxin and air pollutant.[ii] Scientists have tested for hexane residues in other oils and residues were found in some samples.[iii]

Scientific concerns

In the development process of LC-PUFAs, side effects were observed in animal studies, including increased liver weight, underdeveloped renal papilla,    lipid peroxidation and disruption of the anti-oxidant system. Scientists in the field had concerns:

●               ‘At present there is little evidence from randomized trials of LC-PUFA supplementation to support the hypothesis that LC-PUFA supplementation confers a benefit for visual or general development of term infants.’[iv]

Nevertheless, LC-PUFAs were granted GRAS status in 2001. On the basis of limited trials using only small samples of infants, these new formulations, touted by the manufacturers as ‘the closest to breastmilk’, appeared, with a premium price tag, on the market in 2002/2003. These LC-PUFAs are also in ‘follow-on’ concoctions, also at a premium price. Parents are willing to pay, up to as much as 30% more, believing their children will benefit.

However, troubling issues have continued to be raised ever since:

●               A 2002 research study raised concerns of a link between ARA in infant formula and obesity.[v]

●               ‘A panel of independent scientists convened by the Institute of Medicine concluded that safety tests for DHA and ARA were inadequate. Too few safety tests were performed. Some tests were performed only on rats, when tests on nonhuman primates should also have conducted. Chronic toxicity or chronic carcinogenicity studies were not performed, not even on rats. “Long-term” tests lasted for a mere 90 days.’[vi]

In March 2004, the Report Briefing of the Institute of Medicine of the National Academies stated that the existing guidelines and regulations for safety evaluation

●               ‘…are not sufficient to address the diversity of potential new ingredients proposed by manufacturers to develop formulas that mimic human milk and do not adequately address the uniqueness of infants and infant nutrition’.

In 2006, a paper presented at a forum of the International Society for the Study of Fatty Acids and Lipids (ISSFAL) stated:

●               ‘There is insufficient evidence to make robust conclusions regarding the effect of LC-PUFAs on diseases associated with prematurity.’[vii]

In 2008 two studies emerged which show that

●               ‘LC-PUFAs added to infant formula do not improve the physical, neurodevelopmental, or visual outcomes in either term or pre-term infants.’[viii]

Side effects

Adverse reactions in infants to these formulations have now been reported – including diarrhoea, vomiting, bloating, gastrointestinal discomfort, rashes and seizures – justifying the Cornucopia Institute statement that a ‘more comprehensive testing protocol is currently taking place – on our nation’s unsuspecting children’.[ix]


●               In 2008, the National Alliance for Breastfeeding Advocacy and the Cornucopia Institute filed a petition with the FDA urging the requirement of a label, warning of side effects, on all infant food products containing LC-PUFAs.

●               In 2008, the Cornucopia Institute subsequently filed a complaint with US Dept of Agriculture about the use of LC-PUFAs in organic infant formula, and other products targeted toward children, because of the use of hexane and genetically engineered fungi.

●               In 2008, the National Alliance for Breastfeeding Advocacy and the Cornucopia Institute petitioned the Federal Trade Commission to investigate the use of misleading advertising claims – equivalence to breastmilk, superior cognitive, development, vision and immune system outcomes (they remain unproven).

●               In 2009, the California Women, Infant and Children (WIC) Association called for stricter regulation of additives in infant formula and a limit on marketing.

Yet more ingredients

There are other disturbing ingredients in breastmilk substitutes. Marsha Walker, an executive director of NABA (National Association of Breastfeeding Advocacy) USA, has produced a fully referenced compilation[x] of research studies that reveal a cocktail of chemicals in infant formula. Those listed below are derived from Walker’s list unless stated otherwise.

●               Aluminium: interferes with cellular metabolic processes and information transfer from DNA.

●               Silicon: effect of large amounts on infants unknown.

●               Cadmium: a highly toxic metal; can cause kidney damage in large amounts; neurotoxic effects, such as psychomotor disturbances; behavioural and cognitive disorders noted in animals with low-dosage exposure.

●               MSG, highest levels found in hypoallergenic infant formulas: a known neurotoxin; no studies undertaken, effect unknown.

●               Phytoestrogens in soy formulas: endocrine disrupters – can influence gonadal function and give rise to thelarche (breast development in infants and girls under eight); also acts on thyroid gland – children with autoimmune thyroid disease three times more likely to have been fed soy formula in infancy.

●               Genetically engineered soybeans. According to Infact Canada, the daily exposure of infants to Isoflavones in soy infant formulas is 6–11 fold higher on a body-weight basis, than the dose that has hormonal effects in adults that consume soy foods. Effect unknown.

●               Phosphate. According to the Breastfeeding Taskforce for Los Angeles, formula-fed infants face a 30-fold risk of neonatal hypocalcemic tetany (convulsions, seizures, twitching) during the first 10 days of life.[xi]

●               Phthalates and Bisphenol-A, a plasticiser and lacquer respectively, endocrine-disrupting industrial chemicals that leach into infant formula from metal packaging and feeding bottles.

Water contamination

The most basic ingredient added locally to infant formula is water. WHO estimates that – where water is contaminated by micro-organisms (parasites such as cryptosporidium and giardia, and bacteria such as E. coli) – a bottlefed child is up to 25 times more likely to die as a result of diarrhoea, than is a breastfed child.

Water contamination is not just an issue in the developing world. The New York based Natural Resources Defense Council (NRDC) states:

Even in developed countries, contamination of water supplies by parasites (cryptosporidium and giardia) and bacteria (such as e coli) can be very dangerous for an infant whose undeveloped immune system cannot tolerate exposure to these disease-causing invaders.

According to NRDC, chlorine by-products, as well as arsenic, solvents, insecticides and weed killers, are other common water contaminants. Other findings are:

●               One research study found that the European Union drinking water maximum admissible standard for aluminium and barium, and the US EPA standard for thallium, were violated in some infant formula brands.[xii]

●               In rural areas, water contamination by nitrate runoff from fertilizers is common. When added to infant formula powder and ingested, nitrates are converted to nitrites and haemoglobin is converted to methemoglobin, which cannot bind molecular oxygen. The result is reduced oxygen-carrying capacity in blood, which can lead to the sometimes fatal ‘blue baby syndrome’.

●               In cities and towns with the worst Atrazine (known to cause mammary and uterine cancer in rats[xiii]) tap-water contamination, babies fed with reconstituted formula, would receive a lifetime dose of this chemical in the first four months of their lives.

●               Although measures have been taken to reduce lead in recent years, and is now only present in relatively small quantities when introduced into water systems, it is nevertheless commonly found in tap water (leaching from pipes), which can result in a 6 point drop in IQ for every 10μg increase in blood lead levels.

The manufacturing process

Bacterial contamination can also occur in the manufacturing process and many instances have been documented. Clusters of infections and deaths of newborns fed infant formula have been reported worldwide since 1961. Infant formula is not produced in sterile conditions. Infant formula is not sterile the powder provides an excellent medium for the growth of bacteria and fungi.

●               SMA products were recalled in 2001 because of contamination by the bacterium Clostridium botulinum Type B, which causes botulism.

●               According to the NRDC, cancer-causing Aflatoxin has been detected in infant formulas.

●               Enterobacter sakazakii, a bacterium that causes sepsis (overwhelming bacterial infection in the bloodstream), necrotizing enterocolitis (severe infection and inflammation of the small intestine and colon) and meningitis, with fatality rates as high as 50%, has been centrally implicated in outbreaks of infection and death.

●               Sparked by the death of a premature infant in April 2001, and traces of E. sakazakii found in four formula processing plants in 2004, there were numerous product recallsÆ from several manufacturers in subsequent years involving millions of cans.

●               The FAO (Food and Agriculture Organization of the UN) and WHO jointly convened an expert meeting in February 2004[xiv] on E. sakazakii and other micro-organisms in tins of infant formula. After reviewing the available scientific information, the meeting concluded that ‘intrinsic contamination of powdered infant formula with E. Sakazakii and Salmonella has been a cause of infection and illness in infants, including severe disease which can lead to serious developmental sequelae [health consequences] and death’.

●               In May 2005 the fifty-eighth World Health Assembly (WHA 58.32) urged member states to urgently establish microbiological criteria and standards related to E. sakazakii, to provide guidance on safe handling and on product packaging, to take the lead in supporting research into E. sakazakii and to explore means of reducing its level in powdered infant formula.

●               In 2006, researchers in the field concluded that E. sakazakii: ‘now represents a serious challenge to all those involved in the manufacture of infant formula products’.[xv]

Human Error

Because manufacture is prone to human error, infant formula can be a serious risk to health and life in other ways.


Foreign objects, including broken glass and fragments of metal are frequently found, necessitating product recalls:

●               In 2006, both Nestlé and Mead Johnson recalled infant formulas because of contamination with metal fragments. If ingested, these particles present a serious risk to a baby’s respiratory system and throat.

Vital ingredients can also be added to excess, or even left out. Instances include:

●               Carnation Follow-up formula was recalled in 2001 as a result of excess magnesium (can give rise to low blood pressure and irregular heartbeat).

●               In 2003 a soy-based formula lacking vitamin B1 entered the marketplace – many infants suffered severe central nervous system damage; several suffered irreparable damage and two died. Seventeen families sued two German companies, Remedia and Humana. Former executives, along with health ministry officials, were charged with negligent sabotage, fraud, conspiracy, misleading the public, obstruction of justice, actions that may spread disease, and involuntary manslaughter.[xvi]

●               Ross Products recalled two products in 2006, involving hundreds of thousands of units, which were deficient in vitamin C (infant deficiency would result if consumed for 2–4 weeks), and in 2007 recalled products deficient in iron (infant-anaemia would result if consumed for a month).[xvii]


Labelling can also be a source of risk. Cans with wrong labels, or misprinted labels (ingredients not listed, with a possibility of infant allergic reaction), were recalled by several manufacturers, involving millions of product units, throughout 2000 and 2001.

●               Mead Johnson’s Nutramigen products labelled with incorrect preparation instructions (with potential to cause seizure, irregular heartbeat and even death) were widely distributed in the Dominican Republic, Guam, Puerto Rico and the US. When the error was discovered, the products were allowed to remain on the shelves, with correct instructions available as tear-off sheets to be noticed (or not) by the consumer.

Criminal actions

Scurrilous practices in pursuit of profits also endangers lives.

●               The practice of re-labelling formula, to alter the sell by date or to disguise contents, caused the FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements, to issue a warning to parents in 2002.

●               In 2004, dozens of babies in China died as a result of being fed counterfeit formula, which contained as little as one-sixth of the nutrients required for proper development.

●               In 2008, 300,000 Chinese infants suffered acute kidney failure and six died, as a result of a toxic industrial chemical, melamine, being added to formula to make it appear higher in protein – the death sentence was subsequently handed out to three of the people involved and two others were imprisoned for life.

But even when infant formula is perfectly produced, free from contaminants and honestly marketed there is still danger.

Developing world should not be complacent

Those who believe that it is only in the developing world that infant mortality is linked to the consumption of infant formula should think again. Health and childhood expert, Dr Linda Folden Palmer, author of Baby Matters, has examined research studies and compared several countries’ infant mortality rates of formula-fed and breastfed babies. In a pioneering, fully referenced, article she reveals the increased relative risk of death and illness that stem from formula feeding ( Below are a few elements of her report.[xviii]

●               Necrotizing enterocolitis affects around 4% of low birth-weight babies and 1% of full-term infants; about one-third of low-birth weight infants and 20% of full-term infants die. Necrotizing enterocolitis is reported to be responsible for about 1.4% of all infant deaths, and likely to be higher. A 1990 UK study, found that confirmed cases of necrotizing enterocolitis occurred in three times as many infants who received no breast milk, as in those who received both breast milk and formula; and occurred six to ten times more often in wholly formula-fed infants. For infants who were exclusively breastfed, it occurred six to ten times less often than among wholly formula fed infants.

●               Sudden Infant Death Syndrome (SIDS) accounts for 10% of US infant deaths. Several studies in the US and other industrialized nations reveal increased risks of SIDS among formula fed infants. A 2003 US study found a five-fold risk factor for formula fed infants over breastfed infants. A 1997 German study found a 7.7 fold risk and a 2002 Scandinavian study found a risk range from 1.6 to 5.1.

●               Research into infant deaths from heart, circulatory and respiratory failure, discovered that higher blood pressure is associated with formula-fed infants in Scotland.

●               In the US, formula results in longer hospital stays, inferior body temperature regulation, apnea and many episodes of oxygen de-saturation (none among breastfed infants).

●               A WHO study reports a risk of diarrhoea for formula-fed babies in developing nations averaging more than six times that of breastfed infants and an average triple risk in the developed world. In the US, four studies indicate a doubled risk of illness or death from diarrhoea for formula fed infants, compared to those breastfed. One study revealed five times the risk in Scotland and another found three times the risk in Italy, while a study in Canada indicated almost twice the risk.

Studies cited by Folden Palmer, demonstrate not only higher rates of illness in formula fed infants, but also illnesses of greater severity and duration, which result in proportionately more deaths.

●               In Brazil, a death rate of 14 times more for formula-fed infants over those breastfed; in India six times; in the Philippines, nine times; in Italy, three times; in Mexico, 4 to 6.3 times more.

●               A joint US Canadian 2002 study on neuroblastoma, a common childhood cancer, revealed a double risk of contracting the disease for children who did not receive breastmilk for more than one year.

●               A 2002 French study found a two-fold risk for leukemia and a Chinese 1995 study found a 1.5 risk.

●               16% of infant deaths in the US are attributed to premature birth and low birth weight. US studies reveal that the rate of illness and death in formula-fed pre-term infants is two to six times greater than for those fed with human milk.

●               Studies in India found that premature infants developed twice as many infections as those who received some human milk. One study on high-risk newborns found that those receiving human milk plus formula suffered twice the infection rate of those receiving only pasteurized human milk and triple the rate of those receiving only raw human milk.

In an impressive statistical analysis, Folden Palmer calculates that, of the 28,000 infant deaths in the US in 1999, the lives of 9,335 infants could have been saved if they had been breastfed. Interestingly, her analysis also reveals that, contrary to popular opinion, illness and death as a result of being fed infant formula occurs irrespective of socioeconomic status or level of parental education.

One bottle won’t hurt – will it?

Some breastfeeding mothers give their babies the occasional bottle of formula to ‘give myself a break’, or so someone else can feed the child. ‘It’s only one bottle, from time to time, it won’t harm’. However, according to Walker, it might well. Her fully referenced piece, Supplementation of the Breastfed Baby,[xix] makes sobering reading. Here are a few points:

●               Breastfed and formula fed infants have different gut flora.

●               Breastfed babies have a lower gut pH (acidic environment), 5.1 to 5.4, and gut flora is dominated by beneficial bifidobacteria (47%), with a low level of ‘pathogenic (disease causing) microbes’, such as E. coli, Bacteroides, Clostridia and streptococci.

●               Formula-fed babies have a high gut pH, 5.9 to 7.3, only 15% bifidobacteria, with a variety of putrefactive bacterial species, including enterococci.

●               Relatively small amounts of formula supplementation (one supplement per 24 hours) will result in shifts from a breastfed to a formula-fed gut flora pattern. Once dietary supplementation begins, the dominance of bifidobacteria is lost, and the development of obligate anaerobic bacterial populations occur.

●               The neonatal GI tract matures and undergoes rapid growth and change following birth. It takes weeks for junctions of the infant’s GI mucosa to mature and close the gut to whole proteins and pathogens. Open junctions and immaturity play a role in the acquisition of necrotizing enterocolitis diarrhoea and allergy (eg cow’s milk sensitization). This state of gut permeability decreases faster in breastfed babies than in formula fed infants.

●               Infant formula should not be given to a breastfed baby before gut closure occurs.

For those interested in the science of infant gut biology and the growth of the immune system, Lars Hanson’s rendering is extraordinarily accessible without compromising one jot on technicality. [REF: L A Hanson, MD, ‘Immunobiology of Human Milk: How Breastfeeding Protects Babies]

After babyhood

Nor do the disbenefits of infant formula stop at infancy. Drawing again on Folden Palmer:

●               Studies show a sizeable increase in illnesses throughout the whole of childhood for those who were never breastfed or prematurely weaned (studies: Scotland and Sweden 1998 and 1999).

●               An increased risk of death throughout life has been documented for people who were formula-fed.

●               Higher blood pressure, more heart disease, obesity, diabetes and artery disease, a nearly doubled rate of Crohn’s disease and tripled rates of celiac disease have all been associated with early formula feeding (studies: Scotland, UK, USA, Germany, New Zealand, Brazil, Canada, Finland, Italy, New York, 1992–2001).

Informed choice

In all likelihood, many mothers who chose to feed their children with infant formula were unaware of the full implications. Mothers are not in a position to make an informed choice, because information about risk factors is not made readily available. As Folder Palmer says:

Parenting is all about making choices and weighing risks and benefits. Many parents need to make the riskier choice of formula feeding in order to balance other factors that benefit the family. Yet, some parents who have lost their children, possibly based on paediatric advice condoning or encouraging formula-feeding, would surely wish that they had been informed of the very real risks related to using formula.

Profits are put before people, in this case the most vulnerable. Revenue and budget deficits are put before newborns and infants, and research-driven career interests are skewed toward producing the results the breastmilk substitutes industry wants and away from revealing information that would jeopardize its interests.

Governments, however, have a duty of care to its citizens. By not making information about issues surrounding breastmilk substitutes (from which revenue is earned) as readily available as information about breastfeeding (from which nothing is earned), governments are in dereliction of their civil duty. It’s only a matter of time before an enraged parent decides to sue.

Æ Inevitably, oils are largely sourced from genetically altered organisms.

Æ Soy infant formula is now strongly discouraged and effectively banned in Australia, New Zealand, Israel and UK.

Æ Details of recalls going back some 20 years are posted on NABA’s website. www.

[i] NABA Newsletter, Winter 2003,

[ii] EPA, Technology Transfer Network, Air Toxics,

[iii] Joint Campaign Basel City and Country, Vegetable Oils/Fatty Acid Composition, Hexane Residues, Declaration, Pesticides,

[iv] A review of research by the Cochrane Library, 2001

[v] F Massiéra et al, ‘Arachidonic acid and prostacyclin signalling promote adipose tissue development: a human health concern’, J Lipid Res, doi:10.1194

[vi] Cornucopia Institute, Replacing Mother: Imitating Human Breast Milk in the Laboratory, Jan 2008

[vii] Clinical Events After LCPUFA Supplementation of Infant Formula for Preterm Infants: A Meta Analysis, ISSFAL 2006

[viii] K Simmer et al, ‘Longchain polyunsaturated fatty acid supplementation in infants born at term’, Cochrane Database Syst Rev, Jan 2008, 23(1): CD000376, and K Simmer et al, ‘Longchain polyunsaturated fatty acid supplementation in preterm infants’, Cochrane Database Syst Rev, Jan 2008, 23(1): CD000375

[ix] Cornucopia Institute, Questions and Answers About DHA/ARA and Infant Formula



[xii] Abkua Iem et al, ‘Levels of 26 elements in infant formula from USA, UK and Nigeria by microwave digestion and ICP-OES’, Science Direct, Food Chemistry, Volume 77, Issue 4, June 2002, Pages 439-447



[xv] N R Mullane et al, ‘Enterobacter sakazakii: biological properties and significance in dried infant milk formula powder’, International Journal of Dairy Technology, May 2006, 59(2), Blackwell Publishing






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