Health and nutrition claims in infant formulas

Apr 26, 2023
Sébastien Bouley

An international cross-sectional study recently published in the British Medical Journal found that infant diet products communicated from 1 to 4 health and nutrition claims. The authors pointed out that 2/3 of the products with at least one claim did not provide any reference. When registered clinical studies were referenced, the authors noted a high risk of bias.


Study conditions:

Products for infants (≤ 12 months) born at full term were collected from April 2020 to July 2022 in 15 countries around the world of either high, middle or low income. The countries selected were Australia, Canada, Germany, India, Italy, Japan, Niger, Norway, Pakistan, Russia, Saudi Arabia, South Africa, Spain, United Kingdom and United States. Infant formulas as well as foods for special medical purposes such as extensively hydrolyzed protein formulas or amino acids were also included in this study because these products are administered to full-term infants. However, products for metabolic disorders, premature or low birth weight infants, milks for young children (1-3 years) and supplements to fortify breast milk were excluded. The health and nutrition claims for these products were identified on the packaging and on the local websites of the companies marketing the infant diet products, both on the public and professional pages, in the official local language.

What is a nutrition and health claim in this study?

A claim was defined as a statement that “asserts, suggests or implies that a food or a component of the food has, or may have, an effect on the human body”. The authors thus considered claims that link the product or a component of the product with a potential effect on the normal body functioning, growth and development, or health of the consumer. Nutrition claims relating to nutritional intake alone without reference to a potential effect on the body were excluded.

  • A total of 747 infant diet products with 1884 nutrition and health claims classified in 31 categories were collected in these 15 countries.
  • The median number of claims per product was 2 (ranging from 1 to 4 claims in Australia and the USA respectively) for both infant diet products for infants 0-6 months and 0-12 months and follow-on milks (6-12 months).
  • Of the 608 products with at least one claim, the most frequent claim types were

“helps/maintains brain and/or eye and/or nervous system development” on 53% (323) of products with 13 constituents,

“strengthens/maintains a healthy immune system” on 39% (239) of the products with 12 constituents,

“helps/maintains growth and development” on 37% (224) of products with 20 constituents.

  • Half of the claims were made without reference to a specific constituent.
  • The most frequently cited constituents in the claims were long-chain polyunsaturated fatty acids, prebiotics, probiotics, or symbiotics and hydrolyzed proteins.
  • 26% (161/608) of products with at least one claim provided a scientific reference to support their claim. The most frequently cited references were clinical studies (50%) and reviews (26%). 28% of the referenced clinical studies (n=38) were registered.
    • 58 claims were based on 32 of the registered clinical studies: 51 claims are based on a randomised controlled trial of which 46 out of the 51 claims refer to the results of registered clinical studies at high risk of bias by using the Cochrane risk of bias tool.
    • all systematic reviews cited and analyses combined were at high risk of bias by using the risk of bias tool for systematic reviews.

The authors conclude that there is a lack of transparency on the scientific basis of nutrition and health claims on infant diet products.

Comment from Orchidali:

It is a pity that the authors did not consider the regulatory requirements for the use of nutrition and health claims in the different countries. In Europe, for example, the evidence for the health effects for infants has been scientifically validated by the independent scientific authority EFSA. Authorized health claims are used without reference to clinical studies that substantiated the effect.

To know more on the results of this study.


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