Press release 2023/029 from

Most health and nutrition claims on food products for infants, i.e. substitutes for breast milk, are hardly or not at all supported by high-quality scientific evidence. This is the conclusion of an international study from 15 countries in which scientists from Leipzig University Hospital took part. The data was recently published in the prestigious journal “The BMJ”.

Health and nutrition claims on food products for infants are controversial because they emphasise supposed benefits over breastfeeding. However, there is little data on the prevalence of the claims and their scientific basis. This is why an international team of researchers studied health claims on breast milk substitute product packaging and accompanying websites in 15 countries on different continents between 2020 and 2022.

“Our findings reveal the widespread yet poorly scientifically supported health-related marketing claims on breast milk substitutes. Stronger regulation, in addition to the existing World Health Organisation code on the marketing of such products, accompanied by consistent sanctions for non-compliance with this code, appears necessary,” says Jon Genuneit, co-author of the study and Professor of Paediatric Epidemiology at Leipzig University. He and his team conduct research at the Faculty of Medicine on topics including breastfeeding behaviour and breast milk.

Health claims scientifically substantiated in only 26 per cent of breast milk substitutes

The current study covered all health and nutrition claims linking the product or one of its ingredients to a potential positive effect on the consumer’s growth, development or health. For 608 products, the most common claims were that the product: helped/supported brain and/or eye and/or nervous system development (53 per cent); strengthened/supported a healthy immune system (39 per cent); and helped/supported growth and development (37 per cent).

Across all countries, only 161 out of 608 breast milk substitutes included a scientific reference to support the claims. Where scientific evidence was referenced, 14 per cent of these references were registered clinical trials. Some 84 per cent of these studies were conducted by authors who were either funded by or directly affiliated with the food industry. In 74 per cent of products that made specific health claims, there was no scientific reference.

Separation of ingredients and health benefits unclear

“Most infant formula products made at least one claim in their advertising. Often the same or similar health benefits were attributed to several ingredients and at the same time individual ingredients were associated with multiple health benefits. This lack of specificity could indicate that the links between ingredient and health benefit are not causal or are named very superficially, which allows for many false conclusions on the part of the consumer,” explains Professor Genuneit.

The most common ingredient groups mentioned in the claims of breast milk substitutes were unsaturated fatty acids, at 46 per cent. As of February 2022, the unsaturated fatty acid docosahexaenoic acid (DHA), with proven, recognised health effects on the development of the child's nervous system, must be included in breast milk substitutes in the EU. From February 2025, explicit advertising of this ingredient will be banned in the EU. Other common ingredients are prebiotics, probiotics or synbiotics in 37 per cent of infant formula and hydrolysed protein in 20 per cent.

One special thing about the study is that it did not receive any separate research funding, but was prepared by an international medical network on its own initiative. This is a highly relevant topic: as recently as the beginning of February 2023, three articles were published in the prestigious medical journal The Lancet on the highly effective marketing strategies of the manufacturers of breast milk substitutes. Here, health experts called for a crackdown on corporate marketing practices and more support for mothers who breastfeed. In their paper in The BMJ, the researchers come to the following joint conclusion: “These findings support calls for a revised regulatory framework for breast milk substitutes to better protect consumers and avoid the harms associated with aggressive marketing of such products.”

Original publication in The BMJ:
Health and nutrition claims for infant formula: international cross sectional survey doi: https://doi.org/10.1136/bmj.p310