Poorly substantiated health claims on infant formula

Dear Editor

The ‘4Ms (Milk, Marketing, Malnutrition and Mortality)’, ‘Actions’ and ‘Counter-Actions’ by ‘Industries’ and ‘Interest Groups’, the resultant ultimate ‘1979 UN Meeting on Infant and Young Child Feeding (UNMIYCF)’ ALL disposed the ‘Template’ for the ‘1981 Adoption of the International Code of Marketing of Breastmilk Substitutes (BMS)’ [1] to Protect, Promote and Support Breastfeeding towards achieving sustainable ‘Optimal IYCF’ for improved Child Survival, Health, Nutrition, Protection and Development. ‘The Code’ is the ‘1981 Code’ and ‘ALL Subsequent Relevant WHA Resolutions’ with their ‘Provisions’ read, interpreted and implemented together with ‘Statutory and Legal Parity’; included is the ‘WHA 69.9/ WHO Guidance of 2016’ which ‘Prohibits Sponsorships of Health Professionals/ Associations’’[2].

The WHA 58.32/ 2005 is another important ‘Resolution’ which ‘Prohibits Health and Nutrition Claims’ which concern ‘IYC Foods’ and ‘IYCF Ecosystem’. The recent ‘Communication’ [3] is, therefore, quite interesting. It is reported that several ‘Investigated Health and Nutrition Claims’ did not reveal or confirm ‘Good or Strong Evidence-base’ to ‘Substantiate’ the ‘Health and Nutrition Claims’: ‘Healthy Brain Immune System Development’, ‘Growth and Development’-‘Easy Digestibility’ among others [4-6].

The ‘IYCF Ecosystem’ from the ‘2023 Three-Paper Lancet Series’ [7-9] includes, among several others: The ‘Mother-IYC-IYC Foods-Industries’-‘Relevant Stakeholders-Healthcare Professionals-Legal Personnel-Politicians-Policy Makers’-‘Conventions-Codes-Judiciary-Litigation-Adjudication’-‘Determinants of Optimal IYCF’. The ‘Mother-Child Dyad’ is important and ‘Industries’, with the limited knowledge of mothers and the ‘Normal Immature Development and Behavioural Patterns’ of the newborns at birth and ‘Early Postnatal Period’, mount ‘Aggressive Exploitative Products Marketing’ to perpetuate their ‘Unsubstantiated Health and Nutrition Claims’ and present their ‘Products as Solutions’ to the ‘IYCF Ecosystem Difficulties’. [7-9]

‘Breastfeeding’-‘Breastmilk’-‘IYCF’ represent ‘Complex Human Biological Systems/ Processes’ with significant ‘Nutrigenetics-Nutrigenomics’ and ‘Nutritional Epigenetics’[10-12]. ‘Breastmilk’ is a ‘Complex Dynamic Living Food’ with ‘Changing Contents and Composition’ including ‘Epigenomes’ which actually makes ‘Health and Nutrition Claims Impossible’. Also, ‘Breastfeeding’ with the ‘Complex Ontologically Developed and Continuously Maturing Oral-Motor System’ presents the ‘Suckling-Sucking Dichotomy’ making ‘Breastfeeding’ and ‘Bottle-Feeding’ a ‘Yawning-Gap Apart’. The ‘Industries’ NOW ‘Aggressively Digitally Market’ their ‘Breastmilk Bottles’ and ‘Teats’ with ‘Claimed Technological Innovations’ to SIMULATE ‘Breast’-‘Breastfeeding’ with ‘Unsubstantiated Health and Nutrition Claims’. ‘Digital Marketing’ is NOW a ‘Huge Global Difficulty’ for which the 75th WHA (2022) directed a ‘Comprehensive Study’ to be formally reported to the 77th WHA (2024).

Countries that are ‘Signatories’ to ‘The Code’ are expected to domesticate same with ‘Appropriate National Legislative Enactments’ but ONLY 32 of 144 Countries with ‘Code Laws’ (Of 194 Signatories) have ‘Substantially Code-compliant National Legislations’ (WHO-UNICEF-IBFAN 2022). ‘The Code’ and its ‘Provisions’ represent the MINIMUM to be IMPLEMENTED in its ENTIRETY but most ‘National Code Legislations’ reflect ‘CAFETERIA IMPLEMENTATION’: ‘Pick and Mix’/ ‘Pick and Choose’. It is even more bothersome that ‘Industries’ exploit ‘Loopholes in National Code Legislations’ to continue their ‘Aggressive Exploitative Products Marketing’[13-16]. There is, therefore, worrisome ‘Global Systemic Systematic Code Violations’ and ‘Successful Litigations-Adjudications’ represent yet another ‘Monumental Difficulty’ as there is a clearly distinct ‘Responsibility Definition and Separation’: ‘Law Enactment’-‘Law Implementation’-‘Law Interpretation’; ‘Judicial/ Legal Personnel’ need education on the ‘Original and True Spirit and Intendment of ‘The Code’’ to undergird the ‘Appropriate Interpretation’ for ‘Successful Litigations-Adjudications’[17].

The pervading effects of the ‘Unsubstantiated Health and Nutrition Claims’ is the reportedly ‘Negatively Altered IYCF Ecosystem’ with poor compliance with ‘WHO IYCF Recommendations’ [18,19] and some recently disposed ‘IYCF Data’ [7-9]: ‘Less than 50% of children are fed according to WHO Recommendations’, [18,19] ‘Less than 50% of babies are breastfed within 1Hr’, ‘45% receive formula within 6 months’, and ‘One-third prematurely stopped Breastfeeding’; a major ‘Determinant’ was ‘Self-Reported Insufficient Milk (SRIM)’. There is an urgent imperative to address this unacceptable ‘Negatively Altered IYCF Ecosystem’ to harvest the limitless ‘Mother-Child Benefits’ of ‘Optimal IYCF Practices’.

REFERENCES
1. World Health Organization. International Code of Marketing of Breast-milk Substitutes. World Health Organization. Geneva. 1981
2. World Health Organization. Guidance on ending the inappropriate promotion of foods for infants and young children. World Health Organization. Geneva. 2016
3. Rollins N. Poorly substantiated health claims on infant formula: Authorities should move to protect infants and parents from commercial interests. BMJ 2023; 380:p310
4. 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; 387:504
5. Cheung KY, Petrou L, Helfer B. Health and nutrition claims for infant formula: international cross-sectional survey. BMJ 2023; 380:e071075
6. Munblit D, Crawley H, Hyde R, Boyle RJ. Health and nutrition claims for infant formula are poorly substantiated and potentially harmful. BMJ 2020; 369:doi:10.1136/bmj.m875 pmid:32376671
7. Perez-Escamilla R, Tomori C, Hernandez-Cordero S et al. Breastfeeding: crucially important, but increasingly challenged in a market-driven world. Lancet 2023; 401:472-485
8. Rollins N, Piwoz E, Baker P et al. Marketing of commercial milk formula: a system to capture parents, communities, science and policy. Lancet 2023; 401:486-502
9. Baker P, Smith J, Garde A et al. The political economy of infant and young child feeding: confronting corporate power, overcoming structural barriers, and accelerating progress. Lancet 2023; 401:503-524
10. Verduci E, Barderali G, Barberi S et al. Epigenetic effects of Human Breast Milk. Nutrients 2014; 6:1711-1724
11. Genna CW. Epigenetics, Methylation, and Breastfeeding. Clinical Lactation 2018; 9:144-147
12. Briollais L, Rustand D, Allard C et al. DNA methylation mediates the association between breastfeeding and early-life growth trajectories. Clinical Epigenetics2021; 13:https://doi.org/10.1186/s13148-021-01209-z. Accessed 27th February 2023
13. Infant milks marketed as foods for medical purposes. Baby Feeding Law Group UK. Dec 2022. https://www.bflg.uk.org.
14. Wise J. Formula milk companies are exploiting legal loopholes, say campaigners. BMJ 2022; 379:o2926
15. World Health Organization, Pan American Health Organization. How the marketing of formula milk influences our decisions on infant feeding. Feb 2022. https://www.paho.org/en/events/how-marketing-formula-milk-influences-our....
16. Eregie CO. Formula milk companies are exploiting loopholes in national laws that are not even ‘substantially code-compliant’ or strictly enforced. https://bmj.com/content/379/bmj.o2926/rr of 2nd January 2023
17. Mendoza RL. Breast Milk Versus Formula. Courts, Health Marketing, and Asymmetric Information. Infants 2010:DOI:10.1177/1941406409358564-4.pdf Accessed 1st March 2023
18. World Health Organization. Infant and young child feeding. World Health Organization. Geneva. 2021
19. UNICEF. Infant and young child feeding. UNICEF. New York. 2021

Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education), FAMedS, FIPMD
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria.
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria.
UNICEF-Trained BFHI Master Trainer,
ICDC-Trained in Code Implementation,
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria,
*No Competing Interests.