Are infant formula claims substantiated by evidence?


Despite several health and nutrition claims on breast milk substitutes and infant formula products, little to no evidence supported these claims in a multicountry study published in BMJ.

Are infant formula claims substantiated by evidence? | Image Credit: © 279photo - © 279photo -

Are infant formula claims substantiated by evidence? | Image Credit: © 279photo - © 279photo -

After conducting an international, multi-country, cross sectional survey, investigators found that a majority of infant formula products reviewed had at least 1 nutrition and health claim, but most products did not provide references supporting such claims. Further, some claims that did include references were not supported by “robust” clinical trial evidence, authors noted in a BMJ study.

Though evidence consistently supports multiple short- and long-term benefits of human breast milk, infant feeding decisions can be influenced in multiple ways. One aspect of decision making for parents is in the form of marketing from formula companies and the industry. The study authors reference multinational research from the World Health Organization (WHO) and United Nations International Children’s Emergency Fund (UNICEF), which noted that infant formula marketing can be “pervasive, personalized and powerful.” Since infant formula can enhance perceived benefits compared to breastfeeding, nutrition and health claims can be controversial and undermine breastfeeding.

To substantiate available nutrition and health claims related to infant formula products, study investigators reviewed the websites of public facing and health care professional facing, or company managed formula industries, that provided product information marketed for healthy infants delivered at full term. The cross-sectional survey included 15 countries: Australia, Canada, Germany, India, Italy, Japan, Nigeria, Norway, Pakistan, Russia, Saudi Arabia, South Africa, Spain, the United Kingdom, and the United States in 2020 to 2022, according to the study.

Infant formula was defined as “any formula suitable for infants aged 12 months or younger that serves as a breast milk substitute,” by the study authors. Products subdivided by stage of development or age were counted as separate products because country regulation of claims could vary by age of the infants and product indication. Claims that were repeated for health care professional facing and public facing websites were tallied as 1 claim for that specific product. A claim was defined as “states, suggests or implies that a food or component of the food has, or may have, an effect on the human body.”

In all, 757 infant formula products, paired with 1884 health and nutrition claims were identified and categorized into 31 claim types. For each product, the median number of claims was 2 (IQR, 1-4), which was similar for products designated as “infant formula (0-6 months and 0-12 months), follow-on formula (6- 12 months), and food for special medical purposes.” The most common claim types were: “helps/supports development of brain and/or eyes and/or nervous system” (323 products [53%], 13 ingredients), “strengthens/supports a healthy immune system” (239 products [39%], 12 ingredients), “helps/supports growth and development (224 products [37%], 20 ingredients), “easy to digest” (182 products [30%] 14 ingredients), and “dietary management of allergy including cow’s milk allergy (CMA) (96 products [16%] 4 ingredients).

In all, there were 41 ingredients associated with 1 or more claim. Of those, the most common were polyunsaturated fatty acids (278 products [46%], 9 different claims); probiotics, prebiotics, or synbiotics (225 products [37%], 19 claims); and hydrolyzed protein (120 products [20%], 9 claims). Of 608 products with 1 or more claims, 161 (26%) included a scientific reference supporting the claim. For these 161 products, there were 266 unique references cited for 24 different claims. Clinical trials (50%) and reviews (20%) were the most frequently cited references. Of the 134 clinical trials referenced, 38 (28%) were registered. A total of 58 claims referenced 32 registered clinical trials, of which 51 claims were related to a randomized comparison. According to results of the study, “46 of 51 claims (90%) referenced registered clinical trial outcomes at high risk of bias, and all cited systematic reviews and pooled analyses, carried a high risk of bias.”

Thirty-eight publications were referenced by 58 claims, all arising from 32 registered clinical trials. Of these registered trials, 28 (88%) received formula industry funding and/or included formula industry-affiliated authors, according to results. Four trials (8 claims) did not have industry funding or “relevant” conflicts of interests from the author(s).

Through this cross-sectional, international survey, investigators found a high prevalence of infant formula claims, “that seem to have little or no scientific substantiation,” they concluded. The findings support regulatory framework revision for breast milk substitutes, to better protect consumers from aggressive marketing strategies of these products and their respective companies or industries.


Cheung KY, Petrou L, Helfer B, et al. Health and nutrition claims for infant formula: international cross sectional survey. BMJ. 2023;380:e071075. Published 2023 Feb 15. doi:10.1136/bmj-2022-071075

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