Writing in the BMJ, experts from Imperial College London, believe current regulations do not effectively prevent potentially misleading claims that may carry health risks for a vulnerable population.
“Infant formula is an important food product, often consumed in high volumes in relation to an infant’s body size,” says Dr Robert Boyle, study author and specialist in child allergy at Imperial's National Heart and Lung Institute.
“Yet when we look at claims made about the nutritional or health effects of formula products we find little supportive evidence.”
However, Danone, makers of the popular Aptamil follow-on milk, responded to the publication’s comments saying, “Our infant formulas are based on scientific research, and we stand behind the nutritional value of these products.
“We do believe breast milk is the best source of nutrition for babies, and we make this very clear on our website and all our communications,” the spokesperson adds.
“But there needs to be options for women who can’t or who choose not to breast feed, and are searching for safe, nutritious alternatives for their babies.
“The information we provide helps parents choose the formula that is right for their baby’s needs and we don’t agree that it’s misleading.
“Infant formula is highly regulated, and all our formulas and communications must meet strict legal standards to ensure they are safe and the information we provide is factual and accurate. Furthermore, we ensure all our products and claims meet strict European and local regulations.”
Current policies governing infant formula claims are regulated in a similar way to other food products, with some additional information requirements.
Regulatory processes for claims on foods is considered less demanding than for medicines, and premarket approval by regulators is often not required for health and nutrition claims.
According to the article, issues of clinical trial transparency and publication of complete study reports or datasets, have yet to be fully addressed for food claims leading to a widespread presence of poorly substantiated claims for infant formula.
WHO code
Additionally, the World Health Organization International Code of Marketing of Breastmilk Substitutes advises against promoting infant formula to the public and states that information for healthcare professionals should be “scientific and factual”.
However, as the team point out this code is not legally binding, and few countries have fully endorsed its recommendations into law.
As a result, the promotion of infant formula to the public, including use of health and nutrition claims, is still permitted in most countries.
Further food standards relevant to infant formula includes the UN’s Codex Alimentarius, which while influence national and regional regulations are not legally binding.
Codex provides a list of compositional requirements for infant formula and allows optional ingredients such as Docosahexaenoic Acid (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.
‘Change should be made mandatory’
“When a change to infant formula composition is proven to reduce the risks associated with formula feeding, then that change should be made mandatory across infant formula so that all formula fed infants can benefit,” says Daniel Munblit , the article’s co-author based at Sechenov University in Moscow.
“Using the new ingredient as a health claim before assessment and inclusion in the mandatory Codex standards should be banned, they say, to “avoid misleading consumers and undermining breastfeeding.”
Suggesting an alternative approach to regulating claims, On the manufacturing side, the team adds that adequate incentives for manufacturers to develop new or improved products should be introduced.
“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.”
The team also proposes that any changes to the composition of infant formula should require premarket approval.
They say the bar for scientific substantiation needs to be significantly higher than that currently used by manufacturers to justify their claims.
“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,” they add.
“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.”
ISDI response
Commenting on the publication, the International Special Dietary Foods Industries (ISDI), an international expert association on special dietary foods, says “The priority of the infant and young child nutrition industry is to provide safe and high quality foods based on rigorous scientific processes, for babies of parents who are unable to or choose not to breastfeed.
“Infant formula is a rigorously controlled food category and all communications of the industry to both consumers and healthcare professionals are highly regulated. Health and nutrition claims are evidence-based, authorised by competent authorities and fully compliant with relevant local, national and international regulations.”
The Association adds that applicable Codex Alimentarius standards prohibit the use of nutrition and health claims for foods for infants and young children except where specifically provided for in relevant Codex Standards or national legislation.
Practically, claims can be authorised in national legislation. In Europe, for example, the applicable regulations on nutrition and health claims have stringent rules in terms of infant formula. The European Union does not allow nutrition and health claims for infant formula.
“It is crucial that parents and caregivers are able to make appropriate and informed choices about feeding their infants. Statements about the nutrients and ingredients in the product provide valuable information that helps consumers make these choices.
“The WHO Global Strategy for Infant and Young Child Feeding states, “The expert consultation recognised that some mothers will be unable to, or choose not to, follow this recommendation (to breastfeed); they should be supported to optimise their infants’ nutrition.”
“ISDI takes the view that nutrition claims on infant formulas are an effective means of educating about optimised nutrition for infants who are not breast-fed.”
Danone’s spokesperson adds, “Clinical research is at the core of our innovation process, allowing us to investigate the safety, tolerability and efficacy of our products.
“We conduct clinical studies in collaboration with independent investigators in various healthcare settings, and all research that we undertake is peer-reviewed.
“As part of this validation, manuscripts are prepared for submission to peer-reviewed journals, and the abstracts on our research, which are submitted to scientific conferences, are also peer-reviewed.”
