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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.


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copyright, 1997, 1998, Katie Allison Granju.
Breastfeeding.com would like to express our thanks to Katie for allowing her fine article to be reprinted here.