Formula milk companies are exploiting legal loopholes, say campaigners
BMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o2926 (Published 07 December 2022) Cite this as: BMJ 2022;379:o2926
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Dear Editor
It is bothersome that Formula Milk Companies are reportedly regularly exploiting the ‘Legal Loopholes’ in various ‘National Code Legislative Instruments’ to directly market their ‘Products’ to parents and without the required ‘Prescriptions’/ ‘Medical Supervision’ for ‘Foods for Special Medical Purposes (FSMPs)’[1,2]. Some of these ‘Products’ are supposedly ‘Foods for Special Medical Purposes (FSMPs)’ and the UK ‘Baby Feeding Law Group (BFLG)’ reportedly indicates ‘Lack of Legal Oversight in the commercial Marketing of these ‘Infant Foods for Special Medical Purposes (iFSMPs)’’[1]. For instance, some Lactose-free Milks and Anti-reflux Formulas are freely marketed to parents without ‘Prescriptions’/ ‘Medical Supervision’ with implications for the consumers of the ‘Products’.
Some of the Baby Foods Companies reportedly use iFSMPs to market their ‘Products’ with ‘Misleading Health Claims’2. The ‘International Code of Marketing of Breastmilk Substitutes’ adopted in 1981 is read and implemented in conjunction with ‘ALL Subsequent Relevant World Health Assembly (WHA) Resolutions’ sharing ‘Statutory Parity’ with the ‘Provisions of the Original Code’ and, together, they are referred to as ‘The Code’. The Subsequent WHA Resolution 63.23 of 2010 does NOT ‘Permit Nutrition and Health Claims’ on the ‘Foods for Infants and Young Children’ covered by the Code.
It is also reported that 2 ‘Lactose-free Milks’ (Aptamil Lactose Free and SMA Lactose Free) and a ‘Soya-based Infant Milk’ (SMA Soya) are ‘Marketed as Infant and Follow-on Formula’ under ‘Promulgated Regulations’[2]. Again, the Subsequent WHA Resolution 39.28 of 1986 clearly declared that ‘Follow-up Milks’ are ‘NOT Necessary’. The ‘Follow-up Milks’ are also referred to as ‘Follow-on Milks’ and ‘Follow-through Milks’. For ‘National Code Legislations’ to be ‘Substantially Code-compliant’, they MUST NOT ‘Permit the Marketing’ of these ‘Products’: Follow-up Milks, Follow-on Milks and Follow-through Milks. The ‘Products’ are ‘Marketed’ through Supermarkets, Pharmacies and ‘Online Sites’[2]. The Article 5 of the 1981 Adopted Code does NOT ‘Permit Direct Marketing of Products’ to ‘Mothers and the General Public’. The 75th WHA, 28th May 2022, focused on ‘Digital Marketing Practices’ and directed Member States to provide for ‘Monitoring Digital Marketing Practices’ for ‘Reporting to the 77th WHA in 2024; the use of ‘Company Carelines’ and ‘Company Websites’ are NOT ‘Permitted for Marketing these Products’.
Replacement of ‘Lactose’ with ‘Glucose and Maltodextrins’ reportedly predisposes the consumers to Dental Caries and Excessive Weight Gain and possible Obesity[2]. For SMA Soya, the contained ‘Phyto-oestrogen’ may affect ‘Reproductive Development’ and also predispose to Allergy for those at risk of Atopy. The SMA Soya is also reportedly ‘Marketed for Use from Birth’ against the ‘Recommended Use from 6 Months’[2].
The ’Partly Hydrolyzed Milks’ are reportedly ‘Marketed’ as ‘Comfort Milks’ and ‘Anti-colic Milks’ and as iFSMPs to Healthcare Professionals[2]. The WHO and UNICEF from a ‘Commissioned Report’ early in 2022 reportedly observed ‘Manipulative Marketing Tactics’ by Formula Milk Companies with the resultant undermining of Breastfeeding[3]. The BMJ in 2019 adopted a ‘Corporate Policy’ NOT to ‘Publish Advertisements for Breastmilk Substitutes’ to check ‘Product Information Communication through Peer-reviewed Reputable Biomedical Journal’[4] and was promptly commended for the ‘Courageous Visionary Envisioned Impactful Policy’ in previous ‘Communications’[5-7].
Currently, only 34 out of 196 Countries have enacted ‘National Code Legislative Instruments’ with ‘Substantial Code Provisions’ (WHO 2020). The ‘1981 Adopted Code’(WHA Resolution 34.22 of 1981) and ‘ALL Subsequent Relevant WHA Resolutions’ MUST remain the MINIMUM to be implemented in their ENTIRETY for the desired Protection, Promotion and Support for Breastfeeding to assure Protection and Promotion of Optimal Infant and Young Child Feeding for Optimal Child Survival, Health, Growth, Protection and Development. The ‘Code Legislations’ MUST also be ENFORCED to check these ‘Unacceptable Manipulative Marketing Tactics’ by Formula Milk Companies.
REFERENCES
1. Infant milks marketed as foods for medical purposes. Baby Feeding Law Group UK. Dec 2022. https://www.bflg.uk.org.
2. Wise J. Formula milk companies are exploiting legal loopholes, say campaigners. BMJ 2022; 379:o2926
3. 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....
4. Godlee F, Cook S, Coombes R, El-Omar E, Brown N. Calling time on formula milk adverts. BMJ 2019; 364:doi: 10.1136/bmj.11200 pmid: 30880279
5. Eregie C.O. There is no Breastmilk Substitutes (Including Infant Formula) and Prohibition of its Advertisement is Programmatically Appropriate for Optimal Child Health. https://www.bmj.com/content/364/bmj.l1279/rr-4 of 28th March 2019
6. Eregie C.O. Still on the Superiority of Breastmilk over Breastmilk Substitutes (Including Infant Formula): Further Justification for the Programmatic Appropriateness of the Prohibition of Advertisement of Breastmilk Substitutes. https://www.bmj.com/content/364/bmj.l1279/rr-5 of 2nd April 2019
7. Eregie C.O. Breastmilk, Breastmilk Substitutes (Including Infant Formula) and Infant Microbiome: Still more Justification for the Prohibition of the Advertisement of Breastmilk Substitutes (BMS). https://www.bmj.com/content/364/bmj.l1279/rr-6 of 4th April 2019
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.
Competing interests: No competing interests
Re: Formula milk companies are exploiting legal loopholes, say campaigners
Dear Editor,
I am writing on behalf of the British Specialist Nutrition Association (BSNA) in response to the BMJ article ‘Formula milk companies are exploiting legal loopholes, say campaigners’ (7 December 2022).
BSNA members believe a number of statements within this article to be inaccurate and when taken together, run the risk of creating unnecessary doubt and confusion amongst parents who may need to feed an infant food for special medical purposes (iFSMP) to their infant.
“many baby milks marketed as iFSMPs have no established medical role…”
Art.2.2. of Regulation 2016/128 (Retained EU Law), which provides the specific compositional and information requirements for FSMPs, including iFSMPs, requires that “the formulation of FSMPs shall be based on sound medical and nutritional principles [and that] its use, in accordance with manufacturer’s instructions, shall be safe, beneficial and effective in meeting the specific nutritional requirements of the persons for whom it is intended, as demonstrated by generally accepted scientific data”, to which our members abide.
“…insufficient medical oversight of FSMP purchases”.
For both prescribed iFSMPs and over the counter products, a clear statement is displayed on pack to make it evident that they should be used under the guidance of a healthcare professional. This is in accordance with Article 5.2.(a) of Regulation 2016/128 (Retained EU Law).
“…manufacturers themselves decide which infant milks are marketed as… iFSMPs, with little legal oversight”
Article 9 of Regulation 2016/128 (Retained EU Law) requires that companies must notify the competent authority, for example, the Department of Health and Social Care (DHSC), in GB, when placing any new or reformulated product on the market, including submission of the product label. Furthermore, products placed on the market as FSMPs (including iFSMPs) must meet the definition set by Article 2.2.(g) of Regulation 609/2013 (Retained EU Law). DHSC (or the relevant competent authority) can, and do, request any other information to establish compliance with the Regulation, and thus suitability as an iFSMP. These products are based on extensive scientific research into the dietary management of infants' disease, disorders and medical conditions, supported by robust clinical trial evidence.
“The baby milk industry is misusing the iFSMP category to make misleading health or nutrition claims…”
BSNA members comply with Article 7 of Regulation 2016/128 (Retained EU Law), which prohibits the use of nutrition and health claims on all FSMPs. As per Regulation 2016/128 (Retained EU Law), Recital (14) provides that stating the properties and characteristics that make the product useful for its specific intended purpose, are a mandatory declaration; these should not be considered nutrition or health claims, which are voluntary statements. The DHSC has the authority to prohibit a product entering the market as an iFSMP if the labelling, including properties and characteristics of the product, do not meet regulatory requirements.
“[Some] lactose-free infant formula milk and soya based infant formula milk are currently marketed under the infant and follow-on formula regulations…” and “…would be more appropriately marketed as an iFSMP”
Criteria for these products are set by Regulation 2016/127 (Retained EU Law), which provides the specific compositional and information requirements for infant formula and follow-on formula. BSNA member companies comply with all relevant legislation concerning product positioning.
iFSMPs can play a vital role in safeguarding infants whose health or development may be threatened through a disease, disorder or medical conditions that may be difficult or impossible to manage through breastmilk or infant formula alone.
We are concerned that these statements remain on the BMJ website and believe this letter provides the necessary corrections.
Yours sincerely
Declan O’Brien
Competing interests: BSNA represent UK formula manufacturers.