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Most baby formula health claims not science-backed – global analysis

Researchers have urged manufacturers to market baby formula in plain packaging, saying that after their survey into health claims made for 608 products on the websites of baby formula companies in 15 countries, most were unsupported by rigorous scientific evidence.

The study came shortly after a group of doctors and scientists called for a regulatory crackdown on the $55bn formula industry for “predatory” marketing, which, they said, exploited the fears of new parents to convince them not to breastfeed, reports AFP.

Breastfeeding is widely recognised to have huge health benefits for babies. The World Health Organisation and the US CDC recommend breastfeeding exclusively during the first six months of a newborn’s life.

However, that recommendation is followed for less than half of infants globally, according to the WHO.

Daniel Munblit, an honorary senior lecturer at Imperial College London and an author of the latest study, said researchers were not on a “crusade” against baby formula, which should remain an option for mothers who cannot or choose not to breastfeed.

“But we are very much against inappropriate infant formula marketing, which provides misleading claims not backed up by solid evidence,” Munblit told AFP.

Munblit and an international team of researchers looked at the health claims made for 608 products on the websites of infant formula companies in 15 countries, including the United States, India, Britain and Nigeria.

The most common claims were that formula supports brain development, strengthens immune systems and more broadly, helps growth.

Half of the products did not link the claimed health benefit to a specific ingredient, according to the study published in the BMJ. Three quarters did not refer to scientific evidence supporting their claims.

Of those that provided a scientific reference, more than half pointed to reviews, opinion pieces or research on animals.

Just 14% of the products referred to registered clinical trials on humans.

However, 90% of those trials carried a high risk of bias, including missing data or the finding not supporting the claim, the study said.

And nearly 90% of the clinical trials had authors who received funding from or had ties to the formula industry, it added.


The most commonly cited ingredient was polyunsaturated fatty acids, which is in breast milk and is considered important for brain development.

However, there is no evidence of any added benefit when the ingredient is added to baby formula, according to a Cochrane systematic review.

Munblit said the health claims were mostly used to advertise premium formula products, which could be “distressing” for parents who are misled into believing the ingredients are essential but cannot afford them.

When asked what he thinks needs to be done to address the problem, Munblit was concise. “Plain packaging,” he said.

The study comes after a series of papers were published in The Lancet journal this month calling for global policy makers to end exploitative formula marketing, as reported in MedicalBrief.

WHO infant health specialist Nigel Rollins, an author of one of the Lancet papers, said busy parents “lack the time to properly scrutinise claims” about infant formula.

The new study showed that “governments and regulatory authorities must commit the necessary time and attention to review the claims of formula milk products”, Rollins said in a linked BMJ editorial.

Study details

Health and nutrition claims for infant formula: international cross sectional survey

Ka Yan Cheung, Loukia Petrou, Bartosz Helfer,  Erika Porubayeva,  Elena Dolgikh, Michael Levin, professor,  Jonathan Zheng, Robert Boyle,  Daniel Munblit et al.

Published in BMJ on 15 February 2023


To review available health and nutrition claims for infant formula products in multiple countries and to evaluate the validity of the evidence used for substantiation of claims.

Public facing and healthcare professional facing company owned or company managed formula industry websites providing information about products marketed for healthy infants delivered at full term in 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 2020-22.

Main outcome measures
Number and type of claims made for each product and ingredient. References cited were reviewed and risk of bias was assessed for registered clinical trials using the Cochrane risk of bias tool, and for systematic reviews using the Risk Of Bias in Systematic reviews tool.

A total of 757 infant formula products were identified, each with a median of two claims (range from 1 (Australia) to 4 (US)), and 31 types of claims across all products. Of 608 products with ≥1 claims, the most common claim types were “helps/supports development of brain and/or eyes and/or nervous system” (323 (53%) products, 13 ingredients), “strengthens/supports a healthy immune system” (239 (39%) products, 12 ingredients), and “helps/supports growth and development” (224 (37%) products, 20 ingredients). 41 groups of ingredients were associated with ≥1claims, but many claims were made without reference to a specific ingredient (307 (50%) products). The most common groups of ingredients cited in claims were long chain polyunsaturated fatty acids (278 (46%) products, 9 different claims); prebiotics, probiotics, or synbiotics (225 (37%) products, 19 claims); and hydrolysed protein (120 (20%) products, 9 claims). 161/608 (26%) products with ≥1 claims provided a scientific reference to support the claim—266 unique references were cited for 24 different claim types for 161 products. The reference types most frequently cited were clinical trials (50%, 134/266) and reviews (20%, 52/266). 28% (38/134) of referenced clinical trials were registered, 14% (19/134) prospectively. 58 claims referred to 32 registered clinical trials, of which 51 claims (27 trials) related to a randomised comparison. 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.

Most infant formula products had at least one health and nutrition claim. Multiple ingredients were claimed to achieve similar health or nutrition effects, multiple claims were made for the same ingredient type, most products did not provide scientific references to support claims, and referenced claims were not supported by robust clinical trial evidence.

tactics of formula milk industry


BMJ article – Health and nutrition claims for infant formula: international cross sectional survey (Open access)


BMJ editorial article – Poorly substantiated health claims on infant formula (Open access)


BMJ linked article – Harnessing local jurist networks across South Asia to protect breastfeeding (Open access)


The Lancet article – Marketing of commercial milk formula: a system to capture parents, communities, science, and policy (Open access)


The Lancet article – Breastfeeding: crucially important, but increasingly challenged in a market-driven world (Open access)


The Lancet article – The political economy of infant and young child feeding: confronting corporate power, overcoming structural barriers, and accelerating progress (Open access)


France24 article – Most baby formula health claims not backed by science: study (Open access)


See more from MedicalBrief archives:


US federal probe into baby formula company


Reports by experts slam ‘underhand, exploitative’ milk formula marketing


Breastfeeding improves cognitive skills for children of poorer mothers – UK study


Formula feeding linked to 70% higher antibiotic-resistance genes in babies


Health professionals targeted by formula milk companies to push products






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