Health and nutrition claims for infant formula are poorly substantiated and potentially harmful
BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m875 (Published 06 May 2020) Cite this as: BMJ 2020;369:m875
- Daniel Munblit, associate professor of paediatrics12,
- Helen Crawley, director3,
- Richard Hyde, professor of law4,
- Robert J Boyle, reader in paediatric allergy25
- 1Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child’s Health, Sechenov First Moscow State Medical University, Moscow, Russian Federation
- 2Section of Inflammation, Repair and Development, National Heart and Lung Institute, Faculty of Medicine, Imperial College London, London, UK
- 3First Steps Nutrition Trust, London, UK
- 4School of Law, University of Nottingham, University Park, Nottingham, UK
- 5Centre of Evidence-based Dermatology, University of Nottingham, Nottingham, UK
- Correspondence to: R J Boyle r.boyle{at}imperial.ac.uk
Despite improvements in infant formula over its 150 year history, it is still associated with health risks for mother and infant compared with breastfeeding. Manufacturers try to limit these risks through changes to formula composition, which are often accompanied by health or nutrition claims that aid product differentiation or increase market value. Academics and regulators have raised concerns, however, that these claims are often unfounded and may undermine efforts to support breastfeeding.123456 The current regulatory environment allows claims to be made for food products with low levels of evidence, but the potential harms associated with claims are higher for infant formula than for other foods. How can we prevent the harms associated with infant formula claims while ensuring formula fed infants can benefit from improvements in formula composition?
Potential harms of health and nutrition claims
Health and nutrition claims are commonly made for a wide variety of food products, and the level of evidence supporting such claims is variable. However, special consideration is needed for claims related to infant formula products, which we define as breastmilk substitutes for use in the first year of life, including follow-on formula and foods for special medical purposes. Infant formula is consumed by a substantial proportion of the world’s infants, often in large volumes in relation to their body weight—typically 150-200 mL/kg/day for a young infant fed solely on formula milk, the equivalent of 11-14 L/day for a 70 kg adult. The developmental status of infants means that any potential harms associated with infant formula claims may have a high cumulative impact over their life.7
Mothers are also vulnerable during the period when they make infant feeding choices, with up to 20% experiencing a mental illness during pregnancy or the first year of their infant’s life.8 Aggressive promotion of infant formula can influence decisions to use formula milk in place of breast milk,9 and health and nutrition claims are likely to contribute to this process by narrowing the perceived benefits of breast milk over formula.
Box 1 lists some of the established risks of using infant formula in place of breast milk for infant and mother. The potential for an adverse effect on breastfeeding means that claims for infant formula can cause more harm than those for most other food products. Even if the claims are scientifically well substantiated, there is a problem of inequity. Given the unique role of early nutritional influences on health and development, limiting access to improved infant formula products to those who pay a premium is difficult to justify. Any compositional changes that are supported by good evidence should be included in all relevant products. Poorly substantiated claims may also cause inappropriate price inflation for consumers or healthcare providers. If these claims imply effective treatment of problems such as colic, gastro-oesophageal reflux, cow’s milk allergy, or poor weight gain, they may cause harm by delaying appropriate investigations or treatments for underlying medical problems.
Some known risks of using infant formula in place of breast milk
Increased gastrointestinal diseases, including necrotising enterocolitis1011
Increased infectious diseases, including respiratory tract infection4
Altered adiposity and intellectual development4
Increased maternal breast cancer through reduced duration of breastfeeding4
Adverse effects related to formula contamination or reconstitution problems—eg, bacterial infection or burn injury
Increased cost of purchasing milk
Scientific evidence behind claims
Several groups have suggested that the scientific basis of claims made to consumers and healthcare professionals for infant formula is weak.123456 Concerns include the risk of bias in scientific evidence underlying such claims and selective use of data to support claims. Evidence used to support claims often includes conference abstracts rather than peer reviewed papers, and post hoc analyses or selective data rather than prespecified analyses or comprehensive evidence syntheses.2Table 1 gives some examples of poorly substantiated claims as illustration. Our first example is partially hydrolysed whey protein dominant formula, which has carried claims of reduced eczema or milk allergy in many regions for many years based on selected data from individual trials and two industry funded systematic reviews in 2010.1920 However, two rigorous and independent systematic reviews subsequently found no evidence to support this claim, and in 2016 the UK Food Standards Agency’s committee on toxicity concluded there is “no evidence that hydrolysed formula prevents eczema or milk allergy.”13
Examples of recent poorly substantiated health or nutrition claims for infant formula
One of the most common claims made in the United States is that polyunsaturated fatty acids in infant formula improve cognitive development. This claim is based on evaluation of a subset of outcome measures in fewer than 150 participants in one trial. In contrast a 2017 Cochrane review that found a lack of clear or consistent benefit included 11 trials with more than 1000 participants.1721
Claims to reduce crying, colic, or other signs of infant distress are made for many products in different regions, often without citing specific scientific evidence. Limited evidence from individual trials supports dietary interventions to treat colic, but as summarised in a 2018 Cochrane review the evidence is sparse and has a high risk of bias, leaving the Cochrane authors “unable to recommend any intervention.”18
Regulation of infant formula claims
Health and nutrition claims for infant formula are regulated in a similar way to other food products, with some additional information requirements.22232425 The regulatory framework for claims on foods is less demanding than for medicines, and premarket approval by regulators is often not required for health and nutrition claims. The issues of clinical trial transparency and publication of complete study reports or datasets, which are beginning to gain traction in drug development, have not yet been fully addressed for food claims.26 This lack of regulatory oversight explains the widespread presence of poorly substantiated claims for infant formula.
WHO recommendations
The World Health Organization International Code of Marketing of Breastmilk Substitutes and subsequent World Health Assembly resolutions recommend against promoting infant formula to the public and state that information for healthcare professionals should be “scientific and factual” (box 2). This is not legally binding, and few countries have fully enacted its recommendations into law. Promotion of infant formula to the public, including use of health and nutrition claims, is still permitted in most countries.6
WHO code on marketing of breastmilk substitutes
Informational and educational materials intended to reach pregnant women and mothers of infants and young children should not use any pictures or text which may idealise the use of breastmilk substitutes
Information provided by manufacturers and distributors to health professionals should be restricted to scientific and factual matters, and not imply or create a belief that bottle feeding is equivalent or superior to breastfeeding
Neither the container nor the label should have pictures of infants; nor should they have other pictures or text which may idealise the use of infant formula
There should be no advertising or other form of promotion to the general public of products within the scope of the code
Nutrition and health claims should not be permitted for breastmilk substitutes, except where specifically provided for in national legislation
Codex food standards
Codex Alimentarius is a set of food standards established under the United Nations Food and Agriculture Organization and WHO. These influence national and regional regulations but are not legally binding. Codex provides a list of compositional requirements for infant formula.27 It allows optional ingredients such as DHA to be added to infant formula if they are ordinarily present in human milk and have adequate safety testing. Codex does not recommend premarket approval of health and nutrition claims associated with these optional ingredients.
National and regional regulations
Most regions allow some claims about infant formula without regulatory review of the evidence and allow promotion of formula to the public and healthcare professionals. In the US most labels on food for infants carry at least one claim about the function of an ingredient (table 2).21 These do not need premarket authorisation or need to meet the “significant scientific standard” and are protected by the First Amendment right to free speech, provided that they are truthful and not misleading.28 However, the Food and Drug Administration may investigate claims to ensure they are not misleading.24
US approach to classifying health and nutrition claims for foods
The European Union banned health and nutrition claims for infant formula from 22 February 2020 (table 3),22 but there are several exceptions. These include “contains DHA,” “reduced lactose,” and potentially protein hydrolysates for preventing cow’s milk allergy), and the prohibition does not apply to follow-on formula. Foods for special medical purposes are regulated separately—they carry statements such as “for the dietary management of colic and constipation” and branding as “comfort milks,” which some consumers may view as health claims but do not require premarket authorisation and are sometimes poorly substantiated.1829 This failure of regulation and associated potential for harm suggests the need for a new approach.
EU approach to classifying health and nutrition claims for foods
New approach to regulating claims
Current regulations do not effectively prevent potentially misleading claims that may carry health risks for a vulnerable population.30 Even when the claims for infant formula have strong scientific support, their use may be inappropriate since they still risk undermining breastfeeding and limit access to improvements in these important nutritional products to those able to pay a premium price.
We propose that any changes to the composition of infant formula should require premarket approval, and the bar for scientific substantiation needs to be significantly higher than that currently used by manufacturers to justify their claims.31 When a change in infant formula composition has been shown to have a beneficial health effect, that change should be added to Codex standards so that all formula fed infants can benefit. Moreover, using the new ingredient as a health claim before assessment and inclusion in the mandatory Codex standards should be banned. This will avoid misleading consumers and undermining breastfeeding.
Restrictions on use of health and nutrition claims for infant formula should be balanced by adequate incentives for manufacturers to develop new or improved products. For example, if a new ingredient or formulation became part of the Codex compositional requirements, manufacturers could license the new technology, knowhow, or product to other manufacturers rather than limit its use to their own products. This would require a change in culture across the industry, with a focus on scientifically validated improvements in formula composition rather than on generating data which meet a bare minimum standard of evidence in order to support a poorly substantiated claim to aid product differentiation or pricing.
Infants and their carers are not being adequately protected from adverse consequences of claims about infant formula. The current regulatory environment is permissive and associated with poorly substantiated and potentially harmful claims. Global action is needed to break the current cycle of weak scientific evidence and unreliable claims and move to a new era where carers of infants are given accurate information about infant formula products in a manner that does not undermine breastfeeding.
Key messages
Infant formula health and nutrition claims are regulated in a similar way to other food claims
Infant formula claims carry a higher risk of harm than most other food claims because of the developmental vulnerability of infants and the potential to undermine breastfeeding
Infant formula claims are poorly substantiated, suggesting that current legal protections for infants and their carers are inadequate
Health and nutrition claims should not be permitted on infant formula
Any scientifically proved compositional improvements in infant formula should be made mandatory for all relevant products
Acknowledgments
We thank Patti Rundall and the International Baby Food Action Network for access to Breaking the Rules, Stretching the Rules 2017 and Merve Akillioğlu and Yana Gustom for technical help. We thank Barbara Schneeman and Julian Savulescu for helpful comments on an earlier draft.
Footnotes
Contributors and sources: The authors have experience and research interests in breastfeeding research, clinical trials, law, policy development, and implementation. The initial draft was prepared by DM and RJB. RH provided expertise on legal aspects of the reviewed topic. HC contributed to regulatory aspects of the reviewed topic. The final draft of the manuscript was critically reviewed and approved by all the authors. All authors provided substantive intellectual contributions. RJB is the guarantor.
Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following interests: DM and RJB have received consultancy payment from Dairy Goat Co-Operative (NZ) for designing a clinical trial of an infant formula. RJB is senior editor for the children and families network of Cochrane Review Groups, has acted as an expert witness in a class action relating to an infant formula health claim, and previously led a Food Standards Agency commissioned systematic review of the evidence for hydrolysed formula preventing allergic conditions. RJB’s employer, Imperial College London, has a formal research and innovation partnership with Nestlé, who manufacture and market infant formula products and sponsor infant formula research.
Provenance and peer review: Not commissioned; externally peer reviewed.
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