Guidance for the Conduct and Reporting of Clinical Trials of Breast Milk Substitutes

Another important paper has been published in JAMA using the output from a global Delphi project which aims to protect breastfeeding when clinical trials of BMS are undertaken and provide criteria against which BMS trials can be judged.
JAMA Pediatr. doi:10.1001/jamapediatrics.2020.0578    May 11, 2020.

BMJ 2020; 369 doi: (Published 06 May 2020) Cite this as: BMJ 2020;369:m875

Author affiliations

  1. Correspondence to: R J Boyle
  1. Daniel Munblit, associate professor of paediatrics12,
  2. Helen Crawley, director3,
  3. Richard Hyde, professor of law4,
  4. Robert J Boyle, reader in paediatric allergy25

Marketing claims for infant formula should be banned, argue Daniel Munblit and colleagues

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.

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