Breast may be best but don’t block omega-3 infant formula claims, says practitioner

By Shane Starling

- Last updated on GMT

Related tags Breastfeeding Infant formula European food safety authority

All those in favour say "Eye". MEPs are set to vote on DHA baby milk claims in April
All those in favour say "Eye". MEPs are set to vote on DHA baby milk claims in April
The late move by a European Parliament committee to block the addition of DHA omega-3 claims to baby milk products across the EU bloc, would be a triumph of politics over science, a medical practitioner in the area has written.

Writing in the Annals of Nutrition and Metabolism, Berthold Koletzko PhD, MD, from the Division of Metabolic and Nutritional Medicine at the University of Munich Medical Centre in Germany, said blocking the EFSA-approved claim would be detrimental to the health of infants and babies.

“Preventing communication of scientifically assured benefits of optimised products bears the risk that it may slow or even stop the significant quality improvements of foods for infants that has occurred over the last decades in numerous single steps, and which has led to large benefits for child health,”​ Dr Koletzko wrote.

“Therefore, it is truly important that science and not lobbying prevails in this matter.”

The long-running issue revolves around a 2009 Mead Johnson European Food Safety Authority (EFSA) health claim approval for its Enfamil Lipl product that read: “DHA intake contributes to the visual development of infants up to 12 months of age.”

The final claim related to infant formulas and follow-on formulas that contained 0.3 per cent DHA of total fatty acids.

The claim was approved at European Commission level but this month a European Parliament committee voted 30 votes to 28 that the Parliament should not authorise it. The full Parliament is due to vote on the claim in its April 4-7 session next month.

Dr Koletzko said the influential breast milk lobby group, Baby Milk Action, had effectively lobbied MEPs with what he called “pseudo-scientific” ​arguments.

He pointed to the fact that EFSA’s health claims panel had evaluated 43 scientific studies including 13 randomised clinical trials in handing in its opinion.

“It is very surprising and disturbing that the members of the European Parliament find such a profound scientific evaluation by an independent body less convincing than the arguments of a loud-mouthed lobbying group,”​ he wrote.

Breast is best?

He said safety concerns highlighted by the parliamentarians were not supported in the scientific literature and noted the support for DHA fortification from groups including the World Health Organization, the Child Health Foundation, the European Association of Perinatal Medicine, the European Society for Clinical Nutrition and Metabolism, the European Society for Paediatrics and the French Food Safety Authority.

“Perhaps one might question whether there should be any health claims made for infant food products, since breastfeeding is clearly considered the optimal form of infant feeding which therefore must be strongly protected, promoted and supported.

However, not all infants are fully breastfed during the first half year of life and partially breastfed thereafter. For these infants, safe infant formulae of the highest possible quality are required, and health care professionals and families should be able to receive appropriate information on their characteristics.”


MEPs including the British Labour MEP Glenis Willmott have disputed the EFSA opinion, believing there is not enough scientific consensus on the effect DHA (docosahexaenoic acid)-fortified baby milk has on infants.

“The European Commission has authorised this health claim, but independent studies say there is no proven link between artificially added DHA and eyesight, and some studies have found possible negative effects of DHA supplementation,” ​Willmott said.

“If an ingredient is genuinely found to be beneficial and risk free then it should be obligatory in all formula milk, and not be used as a marketing ploy by a specific brand.”

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Response to comments posted

Posted by Prof. Berthold Koletzko,,

In response to the comments posted, I could not agree more that decisions on health policy should be based on scientific evidence. Indeed, this is the key message I tried to convey ín the commentary published in Annals of Nutrition and Metabolism 2011;58(1):79-81, from which single statements have been cited by this website. I confirm that I am an independant academic researcher at the University of Munich employed as a public servant by the State of Bavaria. I follow the policy established by the University of Munich Medical Centre for its academic staff to provide full transparency declarations on any support provided by public or private stakeholders. In addition, I follow the policy of disclosure of potential conflicts of interests as established by the International Committee of Medical Journal Editors, as exemplified by the publication cited in the comment where financial support received contributing to the cost of a scientific workshop was transparently reported. With regards to the cited commentary in Annals of Nutrition and Metabolism, there were no conflicts of interest to be declared. For completeness, I should like to add that I did not participate „in the Nestle Symposium in India about DHA in formulas“ as suggested by Ms. Rundall; in fact I have never heard about that symposium before.
Prof. Berthold Koletzko, Univ. of Munich Medical Centre

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Are incentives to industry more important than child health?

Posted by Patti Rundall, OBE, Policy Director, Baby Milk Action,

I am really surprised and saddened by this response from Prof Koletzko. Is he really saying that the Cochrane Library systematic review of the research on LCPs in formulas which found that they provided "no proven benefit regarding vision, cognition or physical growth" is “pseudo-scientific”? Or EFSA's clarifying letter to the European Commission which stated that EFSA had no sound evidence to support the claim on follow-on formulas or baby foods?

This said there is NOTHING in the Resolution that would prevent the addition of DHA to follow on formulas - it is a legally permissable ingredient - or the continuation of good research to improve formulas. The Resolution is merely opposing the highly promotional and misleading claim. And why oh why can no one answer the obvious question. If this ingredient is so marvellous as to deserve a claim why is it not in all formulas?

Is it not because so many scientists are really not sure about either the benefits or the risks of DHA fortified formulas. Prof Alan Lucas, who conducted the study that identified some of the possible long-term health risks stated: "It is worth noting here that, although the vast majority of infant formulas now contain LCPUFA, the scientific evidence base for their addition is recognised by most investigators and Key Opinion Leaders in the field to be weak; the most recent update of the Cochrane systematic reviews on LCPUFA supplementation of formulas for both preterm and term infants (encompassing 29 trials) concluded that there is no evidence for outcome benefits of the intervention, at least up to 18 months of age......Indeed, Birch's study, which may have been one of the most influential trials driving the addition of LCPUFA to US formulas, was based on an incomplete follow up where only 19 subjects remained in the relevant intervention group, providing inadequate power to provide any realistic estimation of the treatment effect."

In attacking Baby Milk Action so fiercely Prof Koletzko is surely trying to divert attention from such evidence, which fortunately the MEPs on the ENVI committee took the trouble to scrutinise. We hope that next week MEPs will do the same rather than uncritically accepting the views of those who seek to benefit from the claim and who incidentally seem to be the only ones to find the evidence compelling. We acknowledge that Prof Koletzko has carried out much important work on infant feeding, but I hope in future he will be more open about his own personal conflicts of interest, for example his lead authorship of a paper recommending the addition of DHA additives, that was funded by Martek Biosciences, the manufacturer of the DHA used by most of the formula industry, or his role last year in the Nestle Symposium in India about DHA in formulas. Perhaps then this article can be seen in its correct context. The Resolution seeks to protect child health and ensure that the EU processes are thorough - not provide incentives to industry - who already have a responsibility to ensure their products are as safe and nutritious as possible.

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Declarations of conflicts of interest please

Posted by Mike Brady,

Baby Milk Action believes that it is important the conflicts of interest are declared.

We note, for instance, that Professor Berthold Koletzko was lead author of a 2008 paper recommending DHA be added to formula. We also note the declaration included in that paper: "The scientific workshop held at Barcelona was financially supported by Martek Biosciences Corporation. BK is the recipient of a Freedom to Discover Award of the Bristol Myers Squibb Foundation, New York, NY, USA."

Martek Biosciences manufactures the DHA additives used by the majority of formula companies. Until recently (December 2009), Bristol Myers Squibb owned Mead Johnson, the company that filed the application to use the DHA claim which Prof. Koletzko is seeking to defend by labelling Baby Milk Action as a 'load-mouthed lobbying group'.

We believe the decision should be based on the evidence, that it is important to include evidence free from commercial influences and those that seek to influence policy should declare their interests.

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