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IFC Statement of Facts Concerning Disease Claims Related to Infant Feeding

The International Formula Council (IFC)* and each of its members support breastfeeding and the American Academy of Pediatrics’ (AAP) position that breastfeeding is best, and that it offers specific child and maternal benefits. There is some evidence that breastfeeding is associated with a reduction in common acute childhood illnesses; however, it is not conclusive that breast milk is a direct cause of this reduction. Additionally, given the data available, it is not scientifically correct to conclude that lack of breastfeeding plays a causative role in the development of chronic diseases. Breast milk supplies the proper balance of nutrients required for the term infant’s growth and development, minimizing the likelihood of excesses or deficiencies. Parents should be aware, however, that if the decision is made not to breastfeed for whatever reason, iron-fortified infant formula is the safest, most nutritious and only recommended alternative.

Statements that breastfeeding prevents disease or that formula feeding increases the risk of disease are misleading and lack support; the scientific data in many cases are inconclusive. Claims regarding potential detrimental health effects due to the absence of breast milk (and, by implication, the use of infant formula) are likely to cause unjustified worry among mothers who may formula-feed their infants. In most cases, a mother’s decision about how to feed her baby is a personal one and is influenced by many factors, including her personal support system, her access to lactation information and services, her return to the work place, the need for childcare, and the type of childcare used. Moreover, breastfeeding is not an option for all women or all infants. Maternal health conditions, such as human immunodeficiency virus infection, as well as infant health conditions, such as inherited metabolic disorders, can preclude a woman from breastfeeding her infant.

A review of the scientific literature finds support for the benefits of breast milk, especially regarding the possible effects in reducing the incidence of acute pediatric infections (e.g., diarrhea, respiratory or ear infections). However, for chronic illnesses such as cardiovascular disease, diabetes and obesity, environmental and genetic factors play a significant role in disease development. Additionally it should be recognized that studies showing differences in health outcomes between breastfed and non-breastfed infants have an inherent selection bias, as subjects are not randomly assigned to feeding groups. The decision to breastfeed is associated with other lifestyle variables that may themselves influence disease risk. Studies using sibling comparison are a useful tool for controlling unobserved but relevant environmental and genetic sources of variation.

Parents should receive accurate information about all appropriate infant feeding options to help ensure their child’s optimal nutrition and overall wellbeing, regardless of whether they choose to breastfeed or formula-feed their infant.

Infant Formula Only Recommended Alternative to Breast Milk
The infant formula industry agrees with the World Health Organization (WHO) and the American Academy of Pediatrics (AAP) that breastfeeding is the ideal method of feeding and nurturing infants and that breastfeeding offers specific child and maternal health benefits. The infant formula industry fully supports positive, accurate promotion of breastfeeding including additional efforts to foster increased breastfeeding rates.

Mothers who cannot or choose not to breastfeed should know that the U.S. Food and Drug Administration (FDA), the AAP, the United States’ special supplemental food program for Women, Infants, and Children (WIC), the American Dietetic Association (ADA) and other leading health professional organizations recognize that infant formula is the safest, most nutritious, and only recommended feeding alternative for babies who are not breastfed. Each of these entities thoroughly reviewed the science behind infant formula in reaching this conclusion.

Discussion of Specific Illness and Disease Claims: Acute Illnesses
There is some medical evidence that breastfeeding is associated with a reduction in common childhood illnesses like diarrhea, respiratory and ear infections. However, it is not conclusive that breast milk is the direct cause of the reduction. It is important to note that these common conditions are associated with a combination of factors, including daycare attendance, exposure to a smoke-filled environment, the feeding position of a baby, and diet. There is no credible conclusive scientific evidence to suggest that lack of breastfeeding alone is the root cause of any of these conditions.

Diarrhea: Evidence suggests that diarrhea occurs less frequently in breastfed infants.  Protection from diarrhea may be conferred both by exclusive and partial breastfeeding. The protective effect of breastfeeding is thought to be partially mediated through maternal antibodies against rotavirus, which are thought to be present in breast milk, and partly through the specific inhibitory activity of human milk nonantibody glycoconjugates. Several factors can predispose an infant to the development of diarrhea. These factors include the following: daycare attendance, exposure to other children with diarrhea, number of siblings of elementary school age, household crowding, poor sanitation, paternal social class, maternal age, and passive tobacco smoke exposure.

Respiratory Disease: Breastfeeding may confer modest protection against developing respiratory diseases; however, many studies have shown this effect is not statistically significant. Additionally, respiratory disease includes many different illnesses with complex etiologies further confounding the existing data and the true extent of the reported protective effect. It remains unclear whether the protection conferred by breastfeeding is due to contents of the breast milk itself or due to other maternal characteristics, such as education,  smoking  habits, socioeconomic status, caregiver environment, or technical aspects of feeding, such as nipple flow and cleanliness of equipment. The complex etiology of asthma makes it difficult to ascertain whether breastfeeding is indeed protective, and it is likely that any relationship between breastfeeding and asthma is modest at best.

Ear Infections (Otitis Media): The data available suggest that the modest protective effect of breastfeeding on ear infections is present both with exclusive and partial breastfeeding. However, the confounding variables for the development of otitis media are numerous, and the risk for otitis media is not solely dependent upon the presence or absence of exclusive breastfeeding. Recent data demonstrate that participation in daycare is a far more powerful predictor of ear infections than the presence or absence of exclusive breastfeeding.

Discussion of Specific Illness and Disease Claims: Chronic Illnesses/Diseases
Based on the data available, there is insufficient scientific evidence to conclude that lack of exclusive breastfeeding plays a causative role in the development of obesity, diabetes, cardiovascular disease or leukemia.

Obesity: Formula-fed infants tend to be heavier than breastfed infants; however, the impact of breastfeeding on obesity in later childhood, if any, is unknown and is difficult to determine because children are exposed to environmental factors during their later development that more significantly contribute to obesity. Additionally, many studies on infant feeding practices and incidence of obesity or overweight later in life fail to account for confounding variables that also influence obesity. Sibling pair analysis is a useful tool to evaluate family genetic and environmental confounding variables.  A recent pair analysis of 850 sibling pairs in which one was fed formula and one was breast-fed found no effect on overweight.  Further, another study included 2,750 sibling pairs one fed formula and one breast-fed. This study shows no difference in BMI, overweight, asthma, allergy, or diabetes between breast-fed and formula fed infants.

It is important to note that the most recent study of more than 300 five-year-old children (March 2006 American Journal of Clinical Nutrition) has found that whether infants are breastfed or formula-fed does not seem to influence their risk of becoming overweight kids. The study author, Dr. Hillary Burdette, of the University of Pennsylvania School of Medicine commented, "Our findings do not suggest that any changes be made in the current recommendations about infant feeding."  For mothers who are unable to breastfeed, however, "our results should be viewed as good news," added Burdette, who is also a nutrition specialist at The Children's Hospital of Philadelphia. "We found no evidence that children who were formula-fed were fatter at age 5 than those who were breastfed. Although breastfeeding provides positive benefits to both mother and child, families should be given balanced information about the likelihood that breastfeeding will protect their children from obesity," Burdette told Reuters Health.

Diabetes: Like many chronic diseases, there are several factors that can impact whether a child develops diabetes. Investigators have hypothesized that early exposure to solid foods, cereal, cow’s milk, or cow’s milk protein may predispose an infant to developing Type 1 diabetes. The data are inconclusive and in fact, more recent studies suggest that other factors in the infant’s diet may be involved in the development of type 1 diabetes. There is little if any evidence available to support enhanced risk of development of Type 1 diabetes with formula feeding in infants who have not been identified as having a high risk of developing Type 1 diabetes (e.g., family history). The small single study supporting a protective effect of breastfeeding against Type 2 diabetes was conducted in a population in which the baseline prevalence of Type 2 diabetes is high. In the general population, any role of breastfeeding in protection against Type 2 diabetes must be carefully considered in the context of other significant genetic and environmental factors, such as obesity and dietary practices other than breastfeeding.

Cardiovascular disease: Results from studies assessing the indirect and direct effect of type of infant feeding method on cardiovascular disease (CVD) are inconsistent, reporting both no effect and beneficial effects of breastfeeding. Although evidence does exist to indicate that type of infant feeding may affect the risk of CVD and its indicators, there is no evidence to support the claims stating that the presence of infant formula or absence of breast milk directly increases the risk of CVD. Two studies directly assess the impact of breastfeeding on CVD disease and the results are contradictory. Investigations of the effect of infant feeding method on cholesterol levels do not consistently report increases in cholesterol and the results are highly dependent on the age of the subject at the time of assessment. Studies that suggested a mean decrease in blood pressure during childhood in association with breastfeeding, were either small in size or did not specifically address exclusive breastfeeding. In larger studies, the effect on blood pressure later in life because of early breastfeeding, including exclusive breastfeeding, was small and of limited clinical significance. The risk of CVD, including hypertension and high cholesterol, is influenced by many factors, such as birth weight, genetics, and diet.

Leukemia: Leukemia is the most common form of cancer in children.  The specific etiology of childhood acute lymphoblastic leukemia remains unknown for over 95% of patients who lack a pre-existing genetic disorder. The data suggesting an association between breastfeeding and childhood leukemia remains unclear. A large meta-analysis of 14 case-control studies with over 8,000 subjects reported a significant, negative association between short-term breastfeeding (six months or less) and acute lymphoblastic leukemia, but not acute myeloblastic leukemia. Caveats to this study include a potential systematic bias in the most influential, case-control studies arising from differential participation rates for case and control samples that differed in socioeconomic status. Two large cohort studies, which were not subject to these biases, did not find a statistically significant association between breastfeeding and acute lymphoblastic leukemia.

A recent meta-analysis reported that both long-term (greater than 6 months) and short-term (6 months or less) breastfeeding were associated with a decreased risk of acute lymphoblastic leukemia, but only long-term breastfeeding was associated with a decreased risk of acute myeloblastic leukemia. However, the authors provided a number of alternative explanations, including potential systematic bias, to consider with regards to the data, indicating that breastfeeding was not the only factor likely to affect the risk of leukemia in these infants. Importantly, the statistically significant association between breastfeeding and acute lymphoblastic leukemia was not seen in most independent case-control or cohort studies. Together, these data indicate that although infant feeding is one of a number of risk factors that have been investigated for childhood leukemia, there is no conclusive evidence of any relationship between breastfeeding and decreased risk of leukemia.

Note: Please download the Microsoft Word format version of this article for complete footnotes and works cited.

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*IFC is an international association of manufacturers and marketers of formulated nutrition products (e.g., infant formulas and adult nutritionals) whose members are predominantly based in North America. IFC members include all major U.S. manufacturers: Mead Johnson Nutritionals; Nestle USA, Inc., Nutrition Division; Ross Products Division, Abbott Laboratories; Solus Products; and Wyeth Nutrition.

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