Health and nutrition claims for infant formula are poorly substantiated and potentially harmfulBMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m875 (Published 06 May 2020) Cite this as: BMJ 2020;369:m875
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BSNA members believe that all parents should feel respected and supported in their decision on how to feed their baby. We strongly disagree with the suggestion by the authors that formula milks are risky and health and nutrition claims are poorly substantiated. We find the article misleading and unhelpful for parents, carers and healthcare professionals.
Breastfeeding is the best way to feed an infant and is important for both mother and baby’s health and well-being. However, when parents are unable to or choose not to breastfeed, the only food recognised by the World Health Organization (WHO) as a suitable and safe alternative to breastmilk is a scientifically developed infant formula. The nutritional composition, labelling and marketing of infant formula, follow-on formula and foods for special medical purposes (FSMP) is strictly regulated in Europe and the UK. The regulations are in place to ensure formula milks are safe and suitable for infants before products are brought to market and are labelled to ensure parents, carers and healthcare professionals receive useful information to make informed decisions.
Article 3 of EU Regulation No 2016/127 governing the composition and information requirements for infant formula and follow-on formula (1) places a legal obligation on the food business operator to demonstrate the suitability of ingredients through a systematic review of the available data relating to the expected benefits and safety considerations and, where necessary, appropriate studies. Article 12 requires notification of the product to the competent authority of the country where the product will be marketed. At this stage, the competent authority e.g the DHSC in the UK, sees the product labelling and can request to see all or any supporting data. Similar provisions are in place for FSMP via EU Regulation No 2016/1282.
FSMP, such as products for cow’s milk allergy, are mandatorily required by EU Regulation No 2016/128 to carry the statement ‘For the dietary management of …’ where the blank shall be filled in with the disease, disorder or medical condition for which the product is intended (2). We strongly disagree with the suggestion by the authors that this statement could be interpreted as a health claim. A claim is defined as a message or representation on a label which is not mandatory (3). Since FSMP must be used under medical supervision, the involvement of the health professional in recommending or prescribing the product should mean that proper investigations or treatments for underlying health conditions are not delayed. Health and nutrition claims are evidence-based, assessed by the European Food Standards Agency (EFSA) and approved for use by the European Commission. Such claims can only be made on formula milks if they are compliant with the strict legislation. Since February 2020, the use of nutrition and health claims is no longer permitted on the labelling of infant formula or FSMPs due to the full application of the EU Regulations stated above.
It is crucial that parents and caregivers are able to make appropriate and informed choices about the feeding of infants and statements about the nutrients and ingredients in formula products provide valuable information that help make these choices.
Director General, British Specialist Nutrition Association (BSNA)
1. U Delegated Regulation 2016/127 (Infant formula and Follow-On Formula) http://data.europa.eu/eli/reg_del/2016/127/oj
2. EU Delegated Regulation 2016/128 (Food for special medical purposes) http://data.europa.eu/eli/reg_del/2016/128/oj
3. Regulation No 1924/2006 Nutrition & Health Claims, Article 2.2(1) http://www.legislation.gov.uk/eur/2006/1924/article/2
Competing interests: No competing interests
As a lactation consultant (IBCLC), I am distressed by the use of risk-based language to describe infant formula use. For many parents, avoiding formula is not an option, due to persistently low milk supply, employment restrictions, or mental health concerns. In those cases, being told to avoid of formula due to “risks” could have profoundly negative consequences. Infants whose mothers have low milk supply are at risk of insufficient growth, and mothers with intractable breastfeeding problems are more prone to postpartum depression.
Breastfeeding promotion, protection, and support are important; but formula does not need to be presented as risky or suboptimal in order to do that. Formula was created using human milk as a model, to provide excellent nutrition to infants, and it does that to the best of scientific and economic feasibility. Whether babies are breastfed, formula fed or combination fed, support should be the foundation of health care for women and infants.
Lynnette Hafken, MA, IBCLC
Competing interests: No competing interests
As parents, we share Munblit and colleagues’ concerns1 about misleading formula marketing and welcome attempts to hold companies to account. However, we are frustrated to see this framed primarily as an obstacle to breastfeeding promotion, rather than as an issue of misinformation in its own right.
We were alarmed by the implication that vulnerability and mental illness make mothers susceptible to harmful decision-making in response to advertising. Advertising’s influence on breastfeeding rates is subject to debate2. We assure the authors that our decisions were based on a range of personal, medical and social circumstances and made in our families’ best interests.
Yet, we faced multiple barriers to informed decision-making. Current guidelines meant we received no information about formula if we intended to breastfeed, and information about bottle feeding was not on general display3. Consequently, the most accessible information was from industry.
Our healthcare providers made many claims about breastfeeding’s health benefits without indicating the scale of these benefits. Neither did they acknowledge uncertainty about causality in associations between breastfeeding and better outcomes. As some clinicians have cautioned4, 5, parents cannot weigh up benefits and costs and make autonomous decisions on this basis.
We suggest three ways to rectify this unsatisfactory situation:
1. Healthcare providers recognise that their ethical duty to patient autonomy comes before a public health agenda to promote breastfeeding.
2. Healthcare providers give a science-based perspective on the health effects of feeding methods, including absolute benefits and risks.
3. Healthcare providers assume responsibility for ensuring information about all feeding methods is offered to parents, equipping us to make confident, informed decisions.
As parents who breastfed, formula-fed and mixed-fed, we make a united plea to healthcare policy-makers and providers: please stop pitting breastfeeding against formula. It is time to refocus attention on the needs of the families you serve.
1. Munblit D, Crawley H, Hyde R, Boyle R. Health and nutrition claims for infant formula are poorly substantiated and potentially harmful. BMJ 2020;369:m875. doi:10.1136/bmj.m875 pmid: 32376671
2. World Health Organization. Infant formula and related trade issues in the context of the international code. Geneva, Switzerland. 2001. https://www.who.int/nutrition/publications/infantfeeding/infant_formula_...
3. UNICEF UK. Guidelines on providing information for parents about formula feeding. 2014. https://www.unicef.org.uk/babyfriendly/wp-content/uploads/sites/2/2018/0...
4. Mathew R. Infant feeding, informed choice, and shared decisions. BMJ 2019;365:l4061. doi:10.1136/bmj.l4061 pmid: 31197023
5. Wilson J, Wilson B. Is the “breast is best mantra” an over-simplification? Journal of Family Practice 2018;67(6):E1-E pmid: 29879244
Competing interests: Competing interests: all authors are part of Infant Feeding Alliance, a UK based parent-led movement campaigning for compassion, autonomy and safety in infant feeding. Neither Infant Feeding Alliance nor any of the authors receive funding from any organisation linked with infant feeding.
We refer to the article ‘Health and nutrition claims for infant formula are poorly substantiated and potentially harmful’ by Munblit et al.. We agree that research into all areas of infant feeding should be scientific and factual and, given that infant feeding research is often heavily confounded leaving room for interpretation, this should be more widely acknowledged and discussed across the board. We also note that the neonatal period currently sees "up to 20% [of mothers] experiencing a mental illness during pregnancy or the first year of their infant’s life" (1). Thus, we were disappointed by the adoption of ‘risk language’ throughout the paper.
Risk language reframes the ‘benefits of breastfeeding’ as ‘risks of formula feeding’. It was recommended to encourage the view that "artificial feeding" is "incomplete and inferior" and to foster belief for formula feeding families that their home life is "sub-normal" and meals "deficient" on the grounds that "you may not expect to be far above normal, but you certainly don’t want to be below it" (2). Furthermore, risk language is damaging; audiences find their trust in public health messaging eroded and are likely to turn away from those using it (3). Prominent breastfeeding advocates have noted that there is a lack of evidence-base for the adoption of risk based language in breastfeeding advocacy (4) and the current approach to breastfeeding support in the UK has been shown to foster "negative emotional experiences" (5). There are a number of examples of how we can communicate risk accurately, effectively, and with compassion (6,7).
We suggest that the presentation of unbiased and robust research using palatable language is the best way to support parents to make informed decisions about infant feeding in a way that protects maternal mental health. It is difficult to give the important points raised by Munblit et al. the discussion it deserves when the piece uses such draconian language as to alienate the very people that it seeks to help. We urge writers and editors to consider these points for future research and publications.
01. Bauer A, Parsonage M, Knapp M, Lemmi V and Adelaja B. Costs of Perinatal Mental Health Problems. Centre for Mental Health and London School of Economics, 2014.
02. Wiessinger D. Watch Your Language!. Journal of Human Lactation 1996; (2)1-4. doi 10.1177/089033449601200102
03. Ebert Wallace L and Taylor EN. Running a Risk: Expectant Mothers Respond to ‘Risk’ Language in Breastfeeding Promotion, Women’s Reproductive Health 2016; 3, (1): 16–29. doi 10.1080/23293691.2016.1150133
04. Might There Be Risks of Risk-Based Language? Breastfeeding Medicine (blog), April 13, 2016, https://bfmed.wordpress.com/2016/04/13/might-there-be-risks-of-risk-base....
05. Fallon VM, Alison Harrold JA and Chisholm A. The Impact of the UK Baby Friendly Initiative on Maternal and Infant Health Outcomes: A Mixed-Methods Systematic Review, Maternal & Child Nutrition 2019; 15(3): e12778. doi 10.1111/mcn.12778
06. Gigerenzer G and Kolpatzik K. How New Fact Boxes Are Explaining Medical Risk to Millions, BMJ 2017. doi 10.1136/bmj.j2460
07. Absolute versus Relative Risk – Making Sense of Media Stories, Cancer Research UK - Science blog, accessed May 12, 2020, https://scienceblog.cancerresearchuk.org/2013/03/15/absolute-versus-rela....
Competing interests: No competing interests