Most health claims on infant formula are not scientifically proven

Most of the industry claims about the health and nutrition benefits of infant formula are not supported by robust clinical trial evidence.

Maria Zavialova

Infant formula manufacturers often talk about the incredible nutritional benefits of their products. However, most of these claims are not backed by high-quality scientific evidence. This is evidenced by the results of an international study published on February 15, 2023, in The BMJ*.

The threat of unreasonable advertising of infant formula

Common claims that products contribute to the development of the brain, immunity, and growth of babies do not convince researchers. According to them, “transparency is still lacking,” which poses a potential threat to infants.

The health and nutrition claims on infant formula are controversial because they may reinforce the perception that formula is superior to breastfeeding (BF). In this way, they may persuade mothers to interrupt breastfeeding or add formula to their diets unnecessarily.

At the same time, all these claims usually lack scientific evidence.

Research method

The researchers analyzed claims about the benefits and nutritional content of infant formula in a group of high, middle, and low-income countries. They then assessed the credibility of the evidence used to support these claims.

They researched the websites of infant formula companies, examined packaging, and documented claims. The complaints concerned products for healthy full-term infants in 15 countries. Among them are Australia, Canada, Germany, India, Italy, Japan, Nigeria, Norway, Pakistan, Saudi Arabia, South Africa, Spain, the United Kingdom, and the United States in 2020-22.

All health and nutrition claims that linked a product or its ingredient to a potentially beneficial effect on function, growth and development, or health were analyzed.

The researchers identified 757 infant food products, each associated with an average of two claims and 31 types of claims across all formulas.

Of the 608 products with one or more claims, the most common were:

  • “Helps/supports brain and/or eye and/or nervous system development” (53% of products, 13 ingredients);
  • “Strengthens/maintains a healthy immune system” (39% of products, 12 ingredients);
  • “Helps/supports growth and development” (37% of products, 20 ingredients).

In all, 41 ingredient groups were identified with one or more claims. At the same time, many claims did not contain a reference to a specific ingredient (307 or 50% of products).

The most common ingredient groups mentioned in claims were:

  • Long-chain polyunsaturated fatty acids (46% of products, 9 different formulas);
  • Prebiotics, probiotics or synbiotics (37% of products, 19 formulas);
  • Hydrolyzed protein (20% of products, 9 formulas).

What evidence did formula manufacturers provide?

Across all countries, only 161 of the 608 (26%) products with at least one claim provided a scientific reference to support the claim. For the majority (74%) of products with specific health claims, no scientific evidence was provided.

Moreover, among these references, only 56% reported the results of clinical trials. The rest were reviews, commentaries, or other types of research, including animal studies. Only 14% of references to clinical trials were prospectively registered. Overall, 90% of the statements that referred to registered clinical trials had a high risk of bias.

What’s more, 88% of the registered studies had authors who received funding from the pharmaceutical industry or were directly related to it.

Conclusions of the researchers

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.

Authors of the study

In a linked editorial, Nigel Rollins at the World Health Organization agrees that authorities should protect infants and parents from commercial interests.

He recognizes that in today’s world, healthcare professionals and families do not have the time to properly scrutinize claims.

Self-regulation has not worked, and responsible, ethical marketing by the formula industry seems unlikely. Regulatory authorities must therefore decide whether the use of such apparently misleading evidence is acceptable or hold the formula industry to higher standards, require better products based on high quality evidence, and review standards.

Dr. Nigel Rollins, Department of Maternal, Newborn, Child and Adolescent Health at WHO

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*The BMJ (British Medical Journal) is one of the world’s oldest general medical journals. The British edition was founded in 1840.

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