The health risks associated with the use of infant formula were first brought to the world’s attention in 1939 when Dr. Cicely Williams spoke on Milk and Murder, railing against the dangers of using the product in low-income countries . Challenges against infant formula rose to a high level in 1974 with the publication of The Baby Killer [26,27].
In the past, campaigns against the use of the infant formula focused on its frequently being used in unsafe ways, and on the risks of its contamination, especially in low-income countries. There have been significant improvements in the quality of infant formula, and a great deal has been done to ensure that it is prepared safely. Nevertheless, it remains true that many health outcomes are worse for formula-fed infants than for breastfed infants, including in high-income countries [28-32]. They are not as bad as the health outcomes in low-income countries, but they are bad and require attention. Apart from special conditions such as infants with certain disorders, at the population level every type of infant formula produces worse health outcomes than breastfeeding, no matter how carefully it is handled.
Many people have the impression that in high-income countries, where contamination and mishandling of infant formula is not a major issue, there is no problem with using the product. This is a serious error. There is a need to give attention not only to whether infant formula is safe, but also to whether it is effective in doing what it is supposed to do, its functionality. Saying that a food won’t make you sick right away is not the same as saying that it meets your needs. The studies cited in the preceding paragraph show that in all sorts of conditions, outcomes with formula feeding are consistently inferior to those obtained with breastfeeding. In some cases the outcomes may be only slightly inferior and in others greatly inferior, but I know of no credible studies that show formula feeding to be equal to or superior to breastfeeding in any general population. This is the pattern even when there are no safety issues. This means that infant formula is nutritionally inadequate when compared with breastfeeding. Of course, infant formula can play an important role in sub-populations with specific problems.
While the death and disease associated with unsafe use of infant formula usually shows up quickly, the harm to health that results from nutritional inadequacy usually is more subtle and slow to appear. A study that follows children only up to age seven , for example, will miss important long-term impacts, such as overweight, cognitive impairment, and susceptibility to various diseases throughout the lifespan. The failure of infant formula feeding to produce good results on these long-term impacts usually are not described as safety issues. This is why attention needs to be given to not only to the safety but also the nutritional adequacy of infant formula.
The common understanding is that food safety is about whether disease or death is likely to result from consuming the food product in the short term. This conforms with the United States government’s definition: “safe” means “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use”, as specified in the U.S. Code of Federal Regulations at 21 CFR 170.3(i). Often, concerns about safety are triggered by a record of “adverse reactions” to consumption of the product.
Food safety is about harms that are likely to make consumers worse off than they would have been if they had not consumed the food . However, concerns about health benefits focus on whether consumers are better off as a result of consuming the food. When evaluating food products it is important to give attention not only to harms but also to benefits. Obviously, infant formula should do no immediate harm. It should also provide the benefits it is supposed to provide. If benefits are expected but not obtained, that too is a kind of harm.
Some studies describe the absence of anticipated health benefits as a safety issue, but it makes sense to distinguish the two as different types of quality issues. Failure of infants who use a particular type of infant formula to achieve anticipated weight gains, for example, usually would be regarded as a failure to achieve an anticipated health benefit, not as a safety issue. Similarly, overweight usually is not viewed as a food safety issue.
The tendency toward being overweight often begins in childhood . As many people’s first processed food, infant formula might be a significant factor leading to overweight in childhood and throughout the lifespan [36,37]. Studies on being overweight have given little attention to its possible relationship to infant feeding methods.
Worldwide, there are many regulations relating to food safety, but foods are not regulated in relation to their effectiveness. Their producers generally do not make explicit claims regarding their effectiveness, and proof of effectiveness is not required before they are marketed. This is understandable because most foods are components in diverse diets, and it is difficult to isolate the benefits associated with any single type of food. Unfortunately, governments have taken this approach to the regulation of infant formula, so the manufacturers are not required to demonstrate that infant formula is nutritionally adequate in the sense of ensuring intellectual development, vision, and immune system development comparable to that obtained with breastfeeding .
The differences in impacts of different feeding methods should be assessed on many different dimensions. One breastfeeding advocacy group documents 21 Dangers of Infant Formula . Apart from the usual health oriented concerns listed there, feeding methods also affect children’s development on other dimensions, such as their lifelong immune functions and their visual acuity. Further, the choice of feeding methods also has implications relating to economic costs, environmental impact, convenience, and the mother’s self-image. There are many considerations that must be taken into account if we are to understand the choices parents make regarding how they feed their children.
A distinction should be made between impacts that are readily detected and those that can only be estimated based on statistical analyses of population data. One study estimated, “If 90% of US families could comply with medical recommendations to breastfeed exclusively for 6 months, the United States would . . . prevent an excess 911 deaths, nearly all of which would be in infants. . .  p. e1048” When this estimate was published it got little attention in U.S. or world media. In contrast, when the deliberate contamination of infant formula with melamine was reported to have led to six infant deaths in China, it aroused huge alarm in China and the world. The alarm has continued on for years, even though that particular cause of infant death is no longer in place.
Nutritional adequacy can be estimated only on the basis of population-based studies, conducted over time by expert researchers. Parents need to be informed of the scientific findings in ways that are fair and meaningful for them.
It is especially difficult to assess the impacts on child health of shifts from lower to higher levels of income. Overall, there is a clear trend of improvements in child health as families and countries move to higher income levels. However, increasing use of infant formula as incomes increase in emerging economies is likely to mean that the improvement in health associated with increased wealth is lower than it would have been if these families had instead practiced optimum breastfeeding. In terms of population-level trends, the positive health impact of the increase in wealth might mask the harm to health due to the shift from breastfeeding to infant formula.
Infant formula is regulated under weak national rules in some countries and not at all in other countries. One way to change that would be to have national law treat infant formula as a pharmaceutical, and not just as a food. This would be important because pharmaceuticals are assessed and regulated not only in terms of their safety but also their effectiveness. For infant formula, effectiveness would be equivalent to its nutritional adequacy.
Section 2.1.1 of the standards set out by the Codex Alimentarius Commission in 1981 said:
Infant formula means a breast-milk substitute specially manufactured to satisfy, by itself, the nutritional requirements of infants during the first months of life up to the introduction of appropriate complementary feeding  p. 1.
This means that infant formula should be viewed as nutritionally adequate only if it is proven to be as good for children as breastfeeding.
Most manufacturers do not claim that feeding with infant formula is as good as or better than breastfeeding for infants’ health. However, they do not provide the users of the product with systematic information about its nutritional inadequacies. Some parents believe infant formula is as good as or better than breastfeeding. Some reasonably objective agency should provide the information that is needed so that not only parents but also health workers and governments can make well-informed decisions about how to feed infants and young children.
Reclassifying infant formula as a pharmaceutical might not be politically feasible, but even so it would be interesting to know how it would be assessed if it were viewed as a pharmaceutical rather than as an ordinary food. Guidance for conducting such an analysis is available from the United States’ Institute of Medicine .
In the United States and some other countries, people who purchase pharmaceuticals must be told about the risks and side effects that might be involved in using them. What would be said if infant formula were to be categorized as a pharmaceutical? Whether or not the legal system treats infant formula as a pharmaceutical, it is important for parents, health workers, and governments to know not only about the safety but also the nutritional adequacy of the product.
The situation in China illustrates the importance of being attentive to the issue of nutritional adequacy. There are still strong feelings in the country about the infant formula contamination episode of 2008. As a result, the government has issued strong regulations to protect itself from similar scandals in the future [42,43]. Unfortunately, these regulations focus on food safety and fail to question the nutritional adequacy of the product. Apparently there is an unexamined assumption that if infant formula is safe, it will be good for the infants. This assumption places infants in China and everywhere else at risk. China and other countries that anticipate large increases in the use of infant formula among their people should consider monitoring the long-term health impact of these increases.
Some government agencies give useful advice on how to prepare and use infant formula safely . Several promote breastfeeding in various ways. However, I have not been able to find any agency that provides systematic evidence-based information to guide parents’ choice between breastfeeding and feeding with formula. While there is much discussion about safety, there is practically no discussion about nutritional adequacy. There is a clear need for better management of the information needed by both parents and governments regarding the choice of infant feeding methods.