What Every Parent Should Know About Infant Formula by Katie Allison Granju

By now, every doctor and parent in America has heard the news: breastfeeding is best for babies. What's not-so-old news is the growing body of evidence demonstrating that commercial infant formulas are simply not good enough. While commercial infant formulas are commonly perceived to be the medically recommended second-choice infant food after breastfeeding, the World Health Organization (WHO) actually states: "The second choice is the mother's own milk expressed and given to the infant in some way. The third choice is the milk of another human mother. The fourth and last choice is artificial baby milk." 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 breast milk at all. Fewer than twenty-two percent of American babies are still breastfed at five 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.

Minority and disadvantaged children are most likely to be fed a diet of artificial breast milk substitutes. The United States government's food program for Women, Infants and Children (WIC) serves the nutritional needs of low-income women and children, and is the single greatest purchaser of commercial infant formula. WIC provides free infant formula to thirty-seven percent of all infants born in the United States at a cost of almost $600 million annually.

With so many American babies--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 breast milk 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 synthetic infant nutrition will cause bottle-feeding mothers to feel guilty for not breastfeeding. In fact, this unwillingness to explore the safety and nutritional competency of infant formulas retards consumer pressure for better quality product. Marsha Walker, R.N., International Board Certified Lactation Consultant, and recognized expert on infant-nutrition, wrote in a September, 1993 issue of THE JOURNAL OF HUMAN LACTATION, "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 . . . "

Formula manufacturers aggressively promote the idea that today's "highly-scientific" breast milk substitutes have been "specially formulated" to be "like breast milk." 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 breast milk. 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."

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 closer in composition to our own. Indeed, some researchers are asking why infant formula cannot be prepared on a base of 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 commercial synthetic milk. Content and quantities of nutrients vary 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 particular baby--advice implying that each baby'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." 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 experimentation on infant consumers. Today's breast milk 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) states: "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 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." Studies are now underway to determine how much iron should be included in a can of infant formula. Meanwhile, commercial formulas can offer no real assurances that bottle-fed babies are receiving the proper amount of this vital nutrient. The late Dr. Derrick Jelliffe 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 breast milk, leading to optimal neurologic development. Several peer-reviewed medical studies have now revealed that formula feeding is 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 significantly lower test scores on several measures of cognitive ability, including the Denver Development Screening Test, and the Bayley Mental Development Index. One 1994 study reported in DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY showed some aspects of intellectual attainment at five and ten years of age to be inferior among children who were formula-fed compared with those who were exclusively breastfed for at least three months. In another 1988 study, test scores were directly correlated with duration of breastfeeding; the more months a child was breastfed, the higher she scored on the test.

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 significant 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 the U.S. Congress passed in reaction to a formula-manufacturing error that flooded the market with chloride-deficient formula. Today, manufacturers are required simply to include an insignificant number of mandated ingredients and to list 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 often the well-publicized Nestle Boycott of the 1970s and '80s. Many Americans recall seeing the photos of severely malnourished "bottle babies" from various third-world nations as consumer-advocacy groups alerted citizens for the first time to the marketing practices being employed in the third world by major infant-formula corporations.

Physicians and other health-care providers in the developing world were influenced 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 breast milk 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 breast milk substitutes in the Third World. At the time, the acting World Health Director stated, "In my opinion, the campaign against bottle-feed advertising is unbelievably more important than the fight against smoking advertisements."

WHO subsequently drafted the International Code on the Marketing of Breast Milk Substitutes. The Code's main points called for no sales promotion to the public of products used as breast milk 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 withheld 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 irrelevant 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 breast milk substitute is a modern, commercially available product, regulated by the government and prepared in a sanitary fashion. Although it is estimated that the risk of death from diarrhea in less-developed nations is twenty-five times greater for bottle-fed infants than for breastfed ones, artificial feeding methods still carry significant health risks in the United States. Naomi Baumslag, M.D., 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 significantly 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."

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 bottle-fed 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 in 1993, 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- eight-fold risk of developing lymphomas 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 (or 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.

Not surprisingly, in light of health risks associated with formula, is the 1995 study by Kaiser-Permanente Health Maintenance Organization in North Carolina finding that these babies' annual health costs averaged over $1400 more per infant than their breastfed counterparts. 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 1,000 infants born in this country each year, four will die because they were artificially fed. In another study, Dr. Miriam Labbock, a nutrition expert at Georgetown University, says 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.

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 car seat 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 as a group, these infants' risk for negative health outcomes is increased by a statistically significant 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 breast milk 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. 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 totaling hundreds of thousands of dollars annually.

Individual medical students and doctors receive loans, grants, and "gifts" from the pharmaceutical companies which produce infant formula, and a 1991 study found that the U.S. pharmaceutical 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 accommodates 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 Breast Milk 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, the government, or the formula manufacturers themselves to effect change in favor of better quality commercial 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 ninety to ninety-five percent of new mothers--remains the safest, least expensive, and most healthful choice in infant feeding.