Skip to content
Infant formula clinical trials lack seriousness, study finds


Infant milks, sold to young parents to replace breastfeeding, are generally poorly tested and therefore risk being accompanied by misleading claims in terms of nutrition, warns a study published in the British Medical Journal on Thursday.

These substitutes, for example made from cow’s milk proteins, represent a growing market in the world. They promise to provide the infant with food equivalent to its mother’s milk.

Producers of infant milk must therefore systematically conduct clinical trials aimed at proving that their product nourishes the baby well enough. But “(these) trials are unreliable,” conclude the authors of a study published in the BMJ.

Producers too closely involved in the studies

It examined the conduct of 125 trials conducted since 2015. For four-fifths of them, there are enough gaps to doubt their conclusions. For example, multiple trials do not specify before they take place what needs to be evaluated. To be credible, a good clinical trial must, on the contrary, be clear from the start about its objective, otherwise the researcher may be tempted to retain only what suits him.

Another problem is that some trials arbitrarily exclude infants from the test group. This raises concerns about a distorted comparison. In the end, “the conclusions are almost always favorable,” stress the authors, who believe that producers are too closely involved in the studies, at the risk of a lack of independence.

They also believe that the trials lack safeguards to ensure that tested infants are not at risk, including undernutrition. It is necessary “to change in a consequent way the way in which the tests (…) are carried out and are then the subject of publications, so (…) that consumers do not suffer from misleading information”, concludes the study.