. 2023 Feb 15:380:e071075.

doi: 10.1136/bmj-2022-071075.

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

Ka Yan Cheung¹, Loukia Petrou¹, Bartosz Helfer^{2

3

4}, Erika Porubayeva⁵, Elena Dolgikh⁵, Sana Ali⁶, Insaf Ali⁷, Lindsay Archibald-Durham⁸, Meredith Merilee Brockway⁹, Polina Bugaeva¹⁰, Rishma Chooniedass¹¹, Pasquale Comberiati¹², Erika Cortés-Macías¹³, Sofia D'Elios¹², Gavriela Feketea^{14

15}, Peter Hsu¹⁶, Musa Abubakar Kana¹⁷, Tatiana Kriulina¹⁸, Yuzuka Kunii¹⁹, Comfort Madaki²⁰, Rihab Omer²¹, Diego Peroni¹², Jana Prokofiev²², Melanie Rae Simpson^{23

24}, Naoki Shimojo¹⁹, Linda P Siziba²¹, Jon Genuneit²¹, Sohini Thakor¹, Marium Waris², Quan Yuan¹⁶, Sadia Zaman¹, Bridget E Young²⁵, Brighid Bugos²⁵, Matthew Greenhawt²⁶, Michael E Levin²⁷, Jonathan Zheng²⁸, Robert J Boyle², Daniel Munblit^{29

5}

Affiliations

¹ Faculty of Medicine, Imperial College London, London, UK.
² National Heart and Lung Institute, Imperial College London, London W2 1PG, UK.
³ Institute of Psychology, University of Wroclaw, Wroclaw, Poland.
⁴ Meta Research Centre, University of Wroclaw, Wroclaw, Poland.
⁵ Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child's Health, I.M. Sechenov First Moscow State Medical University, Sechenov University, Moscow, Russia.
⁶ Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
⁷ College of Medicine, King Faisal University, Kingdom Saudi Arabia.
⁸ Wits Donald Gordon Medical Centre, School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
⁹ University of Manitoba, Department of Pediatrics and Child Health, MB, Canada.
¹⁰ Julius-Maximilians-Universität Würzburg, Würzburg, Germany.
¹¹ School of Nursing, Faculty of Health and Social Development, University of British Columbia, Kelowna, Winnipeg, BC, Canada.
¹² Department of Clinical and Experimental Medicine, Section of Paediatrics, University of Pisa, Pisa, Italy.
¹³ Institute of Agrochemistry and Food Technology (IATA-CSIC), National Research Council, 46980 Valencia, Spain.
¹⁴ Department of Pediatrics, Pediatric Allergy Outpatient Clinic, "Karamandaneio," Children Hospital, Patras, Greece.
¹⁵ Department of Pharmacology, "luliu Hatieganu" University of Medicine and Pharmacy, 400337, Cluj-Napoca, Romania.
¹⁶ Department of Allergy and Immunology, The Children's Hospital at Westmead, Sydney, NSW, Australia.
¹⁷ Department of Community Medicine, College of Medicine, Kaduna State University, Kaduna, Nigeria.
¹⁸ Department of Paediatrics and Paediatric Rheumatology, Institute of Child's Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
¹⁹ Centre for Preventive Medical Sciences, Chiba University, Chiba, Japan.
²⁰ Kaduna Infant Development (KID) Birth Cohort Study Project, Kaduna, Nigeria.
²¹ Pediatric Epidemiology, Department of Pediatrics, Medical Faculty, Leipzig University, Leipzig, Germany.
²² Tel HaShomer Medical Centre, Ramat Gan, Israel.
²³ Department of Public Health and General Practice, NTNU - Norwegian University of Science and Technology, Trondheim, Norway.
²⁴ Clinic of Laboratory Medicine, St Olavs Hospital, Trondheim, Norway.
²⁵ Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
²⁶ Department of Pediatrics, Section of Allergy/Immunology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, USA.
²⁷ Division of Paediatric Allergy, Department of Paediatrics, University of Cape Town, Cape Town, South Africa.
²⁸ Department of Electrical and Electronic Engineering, Imperial College London, London, UK.
²⁹ National Heart and Lung Institute, Imperial College London, London W2 1PG, UK daniel.munblit08@imperial.ac.uk.

PMID: 36792145
PMCID: PMC9930154
DOI: 10.1136/bmj-2022-071075

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

Ka Yan Cheung et al. BMJ. 2023.

. 2023 Feb 15:380:e071075.

doi: 10.1136/bmj-2022-071075.

Authors

Affiliations

¹ Faculty of Medicine, Imperial College London, London, UK.
² National Heart and Lung Institute, Imperial College London, London W2 1PG, UK.
³ Institute of Psychology, University of Wroclaw, Wroclaw, Poland.
⁴ Meta Research Centre, University of Wroclaw, Wroclaw, Poland.
⁵ Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child's Health, I.M. Sechenov First Moscow State Medical University, Sechenov University, Moscow, Russia.
⁶ Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
⁷ College of Medicine, King Faisal University, Kingdom Saudi Arabia.
⁸ Wits Donald Gordon Medical Centre, School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
⁹ University of Manitoba, Department of Pediatrics and Child Health, MB, Canada.
¹⁰ Julius-Maximilians-Universität Würzburg, Würzburg, Germany.
¹¹ School of Nursing, Faculty of Health and Social Development, University of British Columbia, Kelowna, Winnipeg, BC, Canada.
¹² Department of Clinical and Experimental Medicine, Section of Paediatrics, University of Pisa, Pisa, Italy.
¹³ Institute of Agrochemistry and Food Technology (IATA-CSIC), National Research Council, 46980 Valencia, Spain.
¹⁴ Department of Pediatrics, Pediatric Allergy Outpatient Clinic, "Karamandaneio," Children Hospital, Patras, Greece.
¹⁵ Department of Pharmacology, "luliu Hatieganu" University of Medicine and Pharmacy, 400337, Cluj-Napoca, Romania.
¹⁶ Department of Allergy and Immunology, The Children's Hospital at Westmead, Sydney, NSW, Australia.
¹⁷ Department of Community Medicine, College of Medicine, Kaduna State University, Kaduna, Nigeria.
¹⁸ Department of Paediatrics and Paediatric Rheumatology, Institute of Child's Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
¹⁹ Centre for Preventive Medical Sciences, Chiba University, Chiba, Japan.
²⁰ Kaduna Infant Development (KID) Birth Cohort Study Project, Kaduna, Nigeria.
²¹ Pediatric Epidemiology, Department of Pediatrics, Medical Faculty, Leipzig University, Leipzig, Germany.
²² Tel HaShomer Medical Centre, Ramat Gan, Israel.
²³ Department of Public Health and General Practice, NTNU - Norwegian University of Science and Technology, Trondheim, Norway.
²⁴ Clinic of Laboratory Medicine, St Olavs Hospital, Trondheim, Norway.
²⁵ Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
²⁶ Department of Pediatrics, Section of Allergy/Immunology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, USA.
²⁷ Division of Paediatric Allergy, Department of Paediatrics, University of Cape Town, Cape Town, South Africa.
²⁸ Department of Electrical and Electronic Engineering, Imperial College London, London, UK.
²⁹ National Heart and Lung Institute, Imperial College London, London W2 1PG, UK daniel.munblit08@imperial.ac.uk.

PMID: 36792145
PMCID: PMC9930154
DOI: 10.1136/bmj-2022-071075

Abstract

Objectives: 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.

Design: International cross sectional survey.

Setting: 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.

Results: 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.

Conclusions: 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.

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: no support from any organisation for the submitted work. Outside of the submitted work: JG and LPS benefit from unrestricted research grants from Danone Nutricia Research to Leipzig University for research into human milk composition within the Ulm Birth Cohort Studies. This work is not related to the present publication. RJB declares consultancy payment from Cochrane, Wiley and the British Society for Allergy and Clinical Immunology for editorial work, and payment for expert witness work in cases involving food anaphylaxis and a disputed infant formula health claim. BEY owns Feed Baby Love, which provides educational resources to parents and providers regarding infant feeding.

Figures

**Fig 1**
Network plot of claims associated with ingredients with a frequency of ≥10. Green midpoint box represents health claims associated with a non-specified ingredient. Blue labels represent type of ingredient; different shades represent unique ingredients associated with different claims. Purple labels represent health and nutrition claims. Thickness of lines represents frequency of health claims associated with an ingredient. CMA=cow’s milk allergy; MFGM=milk fat globule membrane

**Fig 2**
Outline of main number of products, claims, ingredients, and references cited

**Fig 3**
Risk of bias assessment of clinical trials

See this image and copyright information in PMC

Comment in

Poorly substantiated health claims on infant formula.
Rollins N. Rollins N. BMJ. 2023 Feb 15;380:310. doi: 10.1136/bmj.p310. BMJ. 2023. PMID: 36792116 No abstract available.

References

1. Lessen R, Kavanagh K. Position of the academy of nutrition and dietetics: promoting and supporting breastfeeding. J Acad Nutr Diet 2015;115:444-9. 10.1016/j.jand.2014.12.014 - DOI - PubMed
1. Rollins NC, Bhandari N, Hajeebhoy N, et al. Lancet Breastfeeding Series Group . Why invest, and what it will take to improve breastfeeding practices? Lancet 2016;387:491-504. 10.1016/S0140-6736(15)01044-2 - DOI - PubMed
1. Victora CG, Bahl R, Barros AJD, et al. Lancet Breastfeeding Series Group . Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet 2016;387:475-90. 10.1016/S0140-6736(15)01024-7 - DOI - PubMed
1. Allen J, Hector D. Benefits of breastfeeding. N S W Public Health Bull 2005;16:42-6. 10.1071/NB05011 - DOI - PubMed
1. Gartner LM, Morton J, Lawrence RA, et al. American Academy of Pediatrics Section on Breastfeeding . Breastfeeding and the use of human milk. Pediatrics 2005;115:496-506. 10.1542/peds.2004-2491 - DOI - PubMed

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

LinkOut - more resources

Full Text Sources
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Comment in

References

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical