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The quality of infant formula is of paramount importance in the United States --where, despite the American Academy of Pediatrics' endorsement of breastfeeding for a minimum of twelve months and WHO's recommendations to breastfeed for at least two years, only slightly more than half of all mothers offer their newborns any breastmilk at all. Fewer than twenty-two percent of American babies are still breastfed at six months of age, and this figure drops to under ten percent by twelve months.These statistics mean that the vast majority of American babies rely solely on the synthetic infant nutrition known as infant formula for their critical first year of life. 

With so many American babies -- and particularly those at socioeconomic risk -- relying on this single food source for their growth and nutritional well-being, it is incumbent upon those concerned with infant-maternal health issues to examine breastmilk substitutes carefully and critically. Unfortunately, many health-care professionals and public-health officials avoid scrutinizing the production and marketing of commercial infant formula in the United States under the mistaken assumption that providing consumers with all the facts on artificial breastmilk substitutes willcausebottle-feeding mothers to feel guilty for not breastfeeding. In fact, this unwillingness to explore the safety and nutritional competency of infant formulas only succeeds in retarding consumer pressure for better quality. As Marsha Walker, RN, IBCLC, and a recognized expert on infant nutrition writes: "This paternalistic view seeks to protect women from making 'poor' choices for themselves and their infant, and robs parents of the right to informed decision making. Withholding information generates more anger than guilt in parents..."("A Fresh Look At The Risks of Artificial Infant Feeding", J Hum Lact 9(3), 1993).

Formula manufacturers aggressively promote the idea that today's 
"highly-scientific" breastmilk substitutes have been "specially formulated" to be "like breastmilk." One leading manufacturer's advertising campaign even equates its product to a "miracle." Yet, common commercial representations fail to reveal the rest of the story: researchers are increasingly convinced that despite advances, infant formulas cannot now or ever accurately imitate human breastmilk. According to the Food and Drug Administration (FDA), pediatric-nutrition researchers at Abbott Laboratories, one of the largest manufacturers of commercial infant formula, recently conceded that creating infant formula to parallel human milk is "impossible." These scientists, writing in the March, 1994 issue of Endocrine Regulations, state, "[It is] increasingly apparent that infant formula can never duplicate human milk. Human milk contains living cells, hormones, active enzymes, immunoglobulins and compounds with unique structures that cannot be replicated in infant formula." (Stehlin, Isadora. FDA Consumer Magazine, June, 1996)

Some infant-health advocates advise a move away from formulas based on ingredients such as cow's milk and soybeans -- undoubtedly chosen for their agricultural abundance and low cost -- and call for the development of formulas based on milk compositionally closer to our own. Indeed, some researchers are asking why infant formula cannot be prepared on a base of donated human milk.

In the meantime, commercial infant formulas are not only distant in composition from human milk, but various brands of synthetic milks aren't even comparable to one another. Contrary to what the name implies, there is no fixed "formula" for artificial baby milk Content and quantities of nutrients varies widely between brands and types of formula (soy, cow's milk, and meat-based). According to formula manufacturers, a pediatrician should recommend an appropriate brand and type of formula for each bottlefed baby -- advice implying that each child's nutritional needs are unique and that physicians can recognize these special needs upon examination and select a formula accordingly. This is, of course, neither accurate nor possible. 

Compositional variance between formulas persists because manufacturers must attempt to simulate a product for which they do not have the recipe -- a fact FDA officials recognize in their recent statement that "....the exact chemical makeup of breast milk is still unknown." (Stehlin) As Marsha Walker notes, "Formula-fed infants depend on products which can be quite different from each other, but which are continually being found deficient in essential nutrients...These nutrients are then added, usually after damage has occurred in infants or overwhelming market pressure forces the issue." 

Iron fortification serves as a startling example of this ongoing marketplace experimentation on infant consumers. Today's commercially available breastmilk substitutes are designated as either iron-fortified or low-iron. However, William J. Klish, M.D., chairman of the American Academy of Pediatrics Committee on Nutrition (the body which recommends

formula-nutrient requirements to the FDA) has stated: "There should not be a low-iron formula on the market for the average child because a low-iron formula is nutritionally deficient." The Food and Drug Administration, which allows the mass marketing of these low-iron formulas, states that "researchers continue to try to determine the best amount of iron for infant formula. While low iron formulas don't supply enough iron, the best amount of iron for formulas has not been established." Dr. Klish verifies that the medical community "did not have much data at the time the regulations [which are still in effect today] were written for different intake levels of iron." (Stehlin). Studies are now underway to determine how much iron should be included in a can of infant formula. Meanwhile, commercial formulas are unable to offer any 

legitimate assurance that bottle-fed babies are receiving the proper amount of this vital nutrient. The late Dr. Derrick Jelliffe, prominent infant nutrition researcher, was quoted in a 1980 interview with the Wall Street Journal as saying, "Hindsight shows the story of  formula production to be a succession of errors. Each stumble is dealt with and heralded as yet another breakthrough, leading to further imbalances and then more modifications."

Yet another contentious issue in the manufacture of infant formula involves the omission of docosahexaenoic acid (DHA). Although most formula sold in the United States still lacks this ingredient, many other nations have now mandated that DHA be added to all commercial infant formula. DHA was recently discovered to be an important component in human breastmilk, leading to optimal neurologic development (Brody, Jane, New York Times, Wednesday, November 6, 1996). Several peer-reviewed medical studies have now revealed that formula feeding is
clearly and consistently associated with learning deficiencies later in 
childhood. Researchers have demonstrated that, even after adjusting for socioeconomic and educational differences among parents, children who were not breastfed as infants experience signifigantly lower test scores on several measures of cognitive ability. In one study, test scores were directly correlated with duration of breastfeeding; the more months a child was breastfed, the higher she scored on the test (See footnotes).

One of the least publicized risks of infant formula is inescapably inherent in the consumption of any commercially prepared and mass-marketed food product: between 1982 and 1994 alone, there were twenty-two signifigant recalls of infant formula in the United States due to health and safety problems. At least seven of these recalls were classified by the FDA as "Class I", meaning the problem could be life threatening. In several instances, random lots of lab-tested infant formula have been found to contain bacterial and elemental contaminants that, while a risk to infant health, do not rise to the level of threat considered appropriate for a widespread recall by the FDA. In February of 1995, FDA special agents uncovered a successful criminal scheme in California in which
thousands of cans of substandard infant formula had been improperly labeled for resale. No one knows how many infants received this counterfeit product in their bottles.

Many consumers are under the mistaken impression that the FDA closely
and carefully monitors infant formula, perhaps more scrupulously than other foods, since infant-consumers are particularly vulnerable by virtue of their age and total dependence on this one product. In fact, the FDA sets forth only minimal standards regarding the production and sale of synthetic milks. The mandated nutrient requirements for formula are contained in the outdated Infant Formula Act of 1980, which was passed by the U.S. Congress in reaction to a formula-manufacturing error that flooded the market with chloride-deficient formula. Today, manufacturers are required simply to include a relatively short list of ingredients and to record them on the package.

News of any real health risks associated with modern formulas surprises most Americans, whose only point of reference on the subject is generally
the well-publicized Nestle Boycott of the 1970s and '80s. Many Americans recall seeing the photos of severely malnourished "bottlebabies" from various third-world nations, as consumer-advocacy groups alerted citizens for the first time to the marketing practices being employed abroad by major infant-formula corporations. 

Physicians and other health-care providers in the developing world were
bribed by formula manufacturers to steer patients away from breastfeeding and toward a particular brand of synthetic infant nutrition. Age-old cultural norms of exclusive and extended breastfeeding were disrupted as huge advertising campaigns convinced women that commercial infant formula was the "modern, sterile, western" way to feed babies. New mothers were lured into giving birth in hospitals funded by infant formula manufacturers. There, these women were encouraged to offer bottles of artificial breastmilk substitutes -- a practice proven to disrupt breastfeeding.

Mothers and babies were then sent home with a small "free" supply
of infant formula. By the time the supply ran out, baby was refusing the breast, mother's own milk supply was diminished, and the typical, impoverished family was unable to pay for any more infant formula. These practices, combined with an unsanitary water supply, lack of sterilization and refrigeration facilities, and poor access to medical care, conspired to kill millions of third-world babies each year, according to the World Health Organization (WHO). 

That is why, in 1977, a world-wide boycott was launched against Nestle
Corporation, determined to be the most egregiously unethical actor in
this sad drama. Consumers all over the world stopped purchasing Nestle
products, and WHO convened a meeting to discuss what could be done to influence corporations marketing breastmilk substitutes in the third world. At the time, the acting World Health Director stated that, "In my opinion, the campaign against bottle-feed advertising is unbelievably more important than the fight against smoking advertisement." 

WHO subsequently drafted the International Code on the Marketing of Breastmilk Substitutes. The Code's main points called for no sales promotion to the public of products used as breastmilk substitutes, and distribution of factual, ethical information to parents by health care workers. While the rest of the world signed onto the Code in the early 1980s, the United States witheld its support until the Clinton administration voiced its approval in 1994. Public-health and consumer activists have charged that Nestle and other corporations continue to violate the Code. According to WHO and UNICEF, between one and two million infants around the world still lose their lives each year due to artificial feeding. That is why, after a brief hiatus, the Nestle Boycott was relaunched in 1988 and continues to this day.

While American parents of the '90s may find information about bottle-feeding in the third-world interesting, most consider it irrrelevant to their own infant-feeding choices, and believe that differing health outcomes between breastfed and artificially fed infants are minimized, if not negated, when the artificial breastmilk substitute is a modern, commercially available product, regulated by the government and prepared in a sanitary fashion. Although it is true that the risk of death from diarrhea in less-developed nations is twenty-five times greater for bottle-fed infants than for breastfed ones (Robbins, John. "May All Be Fed" Avon Books. New York, 1992),artificial feeding methods still carry signifigant health risks in the United States. Naomi Baumslag, MD, MPH, and Dia Michels note in their book, Milk, Money and Madness (Bergin and Garvey, 1995): "Even where bacterial contamination can be minimized, the risks of bottle-feeding are not inconsequential. Bottle-fed infants raised by educated women in clean environments, to this day, have signifigantly greater rates of illness and even death... In a study that analyzed hospitalization patterns for a homogeneous, middle-class, white American population, bottle-fed infants were fourteen times more likely to be hospitalized than breastfed infants." Another researcher concluded that, for every every 1000 bottlefed infants, 77 hospital admissions would result. The comparable figure for breastfed infants was determined to be five hospital admissions (Salisbury L, Blackwell AG: Petition to Alleviate Domestic Infant Formula Misuse and Provide An Informed Infant Feeding Choice. San Francisco:Public Advocates, Inc., 1981, p. 45).

According to Diane Weissinger, International Board Certified Lactation
Consultant and nationally-known speaker on the topic of infant nutrition, "The only advantage that American women who formula-feed tend to have over third world women is better sanitation and medical care -- and that's far from a culture-wide advantage. That in no way alters the long list of ailments to which their bottlefed babies are prone."

The Texas Department of Health's Bureau of Nutrition Services says that
artificially-fed infants in the United States are three to four times more likely to suffer from diarrheal diseases (the number-one killer of
infants worldwide), four times more likely to suffer from meningitis, and
have an eighty percent increase in the risk of lower respiratory infections. 
Marsha Walker, in her article, "A Fresh Look at The Risks of Artificial Feeding" published in the Journal of Human Lactation, refers 
to research demonstrating that artificially-fed babies see their risk for 
moderate to severe rotavirus gastroenteritis increase by five-fold. "Formula feeding is consistently associated with immune system disorders," she states. "Formula feeding accelerates the development of celiac disease, is a risk factor for Crohn's Disease and ulcerative colitis in adulthood, accounts for two to twenty-six percent of childhood-onset insulin dependent diabetes mellitus (and) imposes a five to eight fold risk of developing lymphomas (cancer) in children under fifteen if they were formula-fed.or breastfed for less than six months."

One of the most startling discoveries concerning artificial feeding is that it appears to increase an infant's risk for Sudden Infant Death Syndrome. The U.S. Centers for Disease Control's Morbidity and Mortality Weekly Review reported in 1996 that lack of breastfeeding (artificial feeding), along with exposure to tobacco smoke and a prone sleeping position, is now recognized as one of the only known modifiable risk factors for SIDS. (MMWR 45 (RR-10);1-6).

Not surprising, in light of health risks associated with formula, is the 1995 study by Kaiser-Permanente Health Maintenance Organization in North Carolina finding that,as a group, bottlefed babies' annual health costs averaged over $1400 more per infant than their breastfed counterparts (www.greatstar.com/lois/bfh.html).Unfortunately, even with the excellent medical care available to most American infants who become ill with 
formula-related maladies, the infant mortality rate has repeatedly been shown to be higher for U.S. infants who are fed infant formula . Research conducted by the U.S. National Institute of Environmental Health Sciences estimated that, for every 1000 infants born in this country each year, four will die because they were artificially fed (Rogan WJ: Cancer From PCBs in Breastmilk? A risk benefit analysis. (Abstract No. 612) Pediatr Res 25:105A, 1989). In another study, physicians determined that universal breastfeeding in the United States during the first twelve weeks of life could lower the overall U.S. infant-mortality rate by almost five percent (Labbock, Miriam, MD,MPH. "Costs of Not Breastfeeding in the U.S." Newsletter of the Academy of Breastfeeding Medicine, 1(1):7, 1995).

Many Americans respond to the recent explosion of research into the hazards of artificial feeding by pointing out that most bottle-fed infants appear to be "just fine." Infant- health advocates counter that the vast majority of infants who ride without a carseat or who are placed to sleep in a face-down position will also be "just fine," yet concerned caregivers take the precaution of buckling children up and placing them to sleep in the medically recommended position in order to lessen risks to their health. The same is true for artificial feeding. While not every bottle-fed infant will become ill, a large and convincing body of information now demonstrates that these infants' risk for negative health outcomes is increased by a statistically signifigant margin.

Still, many parents simply cannot believe that their own doctor or hospital would take a neutral or even pro-formula stance if it posed such a threat to their babies' health. It would, indeed, be puzzling why physicians have continued to ignore the ever-growing mountain of evidence warning against routine artificial feeding for infants -- if it were not for the close ties between formula companies and the medical establishment. The manufacture and sale of artificial breastmilk substitutes is a hugely profitable venture. The average bottle-feeding family in the United States spends $1500 to $2000 per year on infant formula. According to the Attorney General of Florida, for each dollar charged for infant formula, the manufacturer spends only sixteen cents on production and delivery (Baumslag and Michels). This renders an astounding profit margin for the manufacturers. With such a lucrative product to promote, corporations have wisely enlisted the assistance of new parents' most trusted advisors -- health care providers -- in order to retain and increase their markets. 

According to Baumslag and Michels in Milk, Money and Madness, the infant-formula industry contributes $1 million annually to the American Academy of Pediatrics (AAP) and provided at least $3 million toward the cost of building the AAP's headquarters. Formula manufacturers routinely host lavish parties and receptions for pediatricians at AAP functions. Other medical groups such as the American College of Obstetricians and Gynecologists, the American Medical Association, the Association of Women's Health, Obstetric and Neonatal Nurses and the American Dietetic Association receive cash grants and advertisements for their publications totalling hundreds of thousands of dollars annually. Individual medical students and doctors receive loans, grants and "gifts" from the pharmeceutical companies which produce infant formula, and a 1991 study found that the U.S. pharmeceutical industry spends $6,000 to $8,000 per doctor per year in promotion. Increasing amounts of medical research into infant health and nutrition is being underwritten by the infant formula industry. Physicians and nurses who choose to formula-feed their own infants frequently receive a year's free supply of formula. With all of this financial support, it's no wonder the U.S. medical community accomodates infant-formula manufacturers' distribution of advertising and "free samples" to parents in doctors'offices and hospitals, a practice which has been proven to discourage breastfeeding and which is in clear violation of the WHO Code on the Marketing of Breastmilk Substitutes. The infant-formula industry needn't worry, however, since health care providers are the group ethically responsible for reporting Code violations in the first place. 

At present, concerned parents clearly cannot rely upon the medical community, government or formula manufacturers themselves to effect change in favor of better quality commercial synthetic infant nutrition. It will require a consumer movement in the United states approaching the scale and intensity of the Nestle Boycott to bring about reforms. In the meantime, breastfeeding, an option available to an estimated 90-95 % of new mothers, remains the safest, least expensive and most healthful choice in infant feeding. 

Selected Medical References:

Borgnolo G, et al. A case-control study of Salmonella gastrointestinal infection in Italian children. Acta Paediatr 85:804-8 (1996) [Not breastfeeding was the single most important factor associated with a 5-fold increased risk of Salmonella infection.] 

Beaudry M, et al. Relation between infant feeding and infections during the first six months of life. J Pediatr 126:191-7 (1995) [Not breastfeeding substantially increased risk of respiratory and gastrointestinal infections in first six months of life.] 

Aniansson, G et al. A prospective cohort study on breastfeeding and otitis media in Swedish Infants.Pediatr Infect Dis. J. 13:183-88 (1994) [Acute otitis media frequency was significantly higher in the non-breastfed children in each age group (2,6, and 10 months of age); the frequency of upper respiratory infections was also increased in those children, but reduced in the breastfed group.] 

Lerman, Y. et al. Epidemiology of acute diarrheal diseases in children in a high standard of living rural settlement in Israel. Pediatr. Infect. Dis. J. 13(2):116-22 (1994) [Children less than 12 months of age had a higher incidence of acute diarrheal diseases during the months they were being formula-fed than children who were breastfed during the same period.] 

Pisacane A; Graziano L; Zona G; Granata G; Dolezalova H; Cafiero M; Coppola A; Scarpellino B; Ummarino M; Mazzarella G; Breast feeding and acute lower respiratory infection. 83 Acta Paediatr 714-18 (1994) [not breastfeeding is a strong risk factor for acute lower respiratory infection (i0.e., pneumonia and bronchitis) in industrialized countries] 

Harabuchi, Y. et al. Human Milk secretory IgA antibody to nontypeable Haemophilus influenzae: possible protective effects against nasopharyngeal colonization. J. Pediatr. 124:193-98 (1994) [Formula lacks specific secretory IgA antibody present in breastmilk, suggests a mechanism by which formula-fed infants have higher incidence of infection.] 

Howie PW, et al. Protective effect of breastfeeding against infection. BMJ 300:11-16, 1990. [The added risk of formula-feeding can account for 7% of all infants hospitalized for respiratory infections.] 

Duffy LC, et al. The effects of infant feeding on rotavirus-induced gastroenteritis: a prospective study. Am J Pub Health 76:259-263 (1986). [In industrialized nations, formula-fed infants have a 3-4 fold risk of diarrheal illness. Moderate to severe rotavirus gastroenteritis is five times more common in formula-fed infants.] 

Cochi SL, et al. Primary invasive Haemophilus influenza b disease: a population based assessment of risk factors. J. Pediatr. 108:887-896 (1986). [A 4-16 fold higher risk exists for H influenzae bacteremia and meningitis in North American formula-fed babies.] 

Children who were formula-fed score lower on indices of neurological development than do children who were breastfed. Wang YS, Wu SY. The effect of exclusive breastfeeding on development and incidence of infection in infants. J Hum Lact 12:27-30 (1996) [Normal fullterm infants studied during the first year after birth. Those exclusively breastfed for the first four months differed significantly from those not exclusively breastfed: at one year, the artificially-fed group showed less advanced. Personal-Social and gross motor development on the Denver Developmental Screening Test, and higher cumulative incidence of infectious diseases.] 

Pollock, J.I. Long-term associations with infant feeding in a clinically advantaged population of babies. Dev. Med. Child Neurol. 36(5);429-40 (1994) [Some aspects of intellectual attainment at five and ten years of age can be demonstrated to be inferior among children who were formula-fed compared with those that were exclusively breastfed for at least three months.] 

Morley R., et al. Mother's choice to provide breastmilk and developmental outcome. Arch Dis Child 63:1382-1385 (1988). [Formula-fed preterm infants had lower Bayley Mental Develpment scores at 18 months, even after adjusting for social and demographic influence.] 

Morrow-Tlucak, M, et al., Breastfeeding and cognitive development in the first two years of life. Soc Sci Med 26:635-639 (1988). [Scores on the Bayley Mental Development Index were lower in formula-fed at 1-2 years of age, and scores were directly correlated with duration of breastfeeding.] 

Bauer G, et al. Breastfeeding and cognitive development of three-year-old children. Psychological Reports 68:1218 (1991). [Scores on the McCarthy Scales of Children's Abilities were significantly lower at three years of age as the duration of breastfeeding decreased.] 

Taylor B, et al. Breastfeeding and child development at five years. Dev Med Child Neurol 26:73-80 (1984). [Formula-fed children showed reduced performance on developmental tests at age five years.] 

Lucas, A. et al. Breast milk and subsequent intelligence quotient in children born preterm. Lancet 1992;33;261-62. [Formula-fed preterm infants had lower IQ scores at age 7-8 years than preemies fed expressed breastmilk; the association held after controlling for mother's education and social class, and regardless of whether the mother attempted to express milk and failed or never attempted to express milk.] 

Lucas, A., et al. A randomised multicentre study of human milk versus formula and later development in preterm infants. Arch. Dis. Child 70:F141-146 (1994) 

Davies, M. et al. Infant feeding and childhood lymphomas [cancer]. Lancet 2:365-368 (1988). [There was as much as an 8 fold increase in risk of developing lymphomas among children artificially fed or breastfed less than six months.] 

Schwartzbaum, J. et al. An exploratory study of environmental and medical factors potentially related to childhood cancer. Med & Pediat Oncology 19(2): 115-21 (1991). 

Freudenheim, J. et al. 1994 Exposure to breast milk in infancy and the risk of breast cancer. Epidemiology 5:324-331. [For both premenopausal and postmenopausal breast cancer, women who were breastfed as children, even if only for a short time, had a 25% lower risk of developing breast cancer than women who were bottle-fed as infants.] 

Verge CF, et al. Environmental factors in childhood IDDM. A population-based, case-control study. Diabetes Care 17:1381-9 (1994) [Study showed an increased risk of IDDM associated with early dietary exposure to cow's milk-containing formula, short duration of exclusive breast-feeding, and high intake of cow's milk protein in the recent diet] 

Virtanen SM, et al. Early introduction of dairy products associated with increased risk of IDDM in Finnish children.Diabetes 42:1786-90 (1993). [Introduction of cow's milk-based formula a significant risk factor in IDDM] 

Mayer EJ, et al. Reduced risk of insulin-dependent diabetes mellitus among breastfed children. Diabetes 37:1625-1632 (1988) [Formula feeding accounts for as much as 26% of insulin dependent diabetes mellitis in children.] 

Borch-Johnson, K., et al., Relation between breastfeeding and incidence of insulin-dependent diabetes mellitus. Lancet 2:1083-86 (1984) [It is postulated that insufficient breast-feeding of genetically susceptible newborn infants may lead to beta-cell infection and IDDM later in life] 

Rigas A, et al. Breast-feeding and maternal smoking in the etiology of Crohn's disease and ulcerative colitis in childhood. Ann Epidemiol 3:387-92 (1993) [Lack of breastfeeding was associated with higher rates of inflammatory bowel disease in children and adolescents] 

Koletzko S., et al. Role of infant feeding practices in development of Crohn's disease in childhood. Br. Med. J. 298:1617-18 (1989) 
Bergstrand O; Hellers G. Breast-feeding during infancy in patients who later develop Crohn's disease. Scand J Gastroenterol 18:903-6 (1983) [Lack of breastfeeding appears to be a risk factor in development of Crohn's disease]