Thank you so much to everyone who has contacted their representatives in the European Parliament asking them to vote in favour of a Resolution to protect the rights of parents and carers to accurate information on infant formula. We know it is having an impact because those defending the rights of the baby food industry to put misleading claims onto formula are becoming more active and Mead Johnson has apparently hired an expensive Public Relations firm, to lobby politicians. We need the voices of the public to counter this offensive. Click here if you have not yet sent a message to your representatives in the European Parliament yet or to spread the word if you have. If you want to know the detail of what is taking place, read on.
The European Commission has just written to all Members of the European Parliament (MEPs) supporting authorisation of a claim about DHA and eye development and attacking the Resolution adopted by the European Parliament Environment, Public Health and Food Safety (ENVI) Committee that would prevent this and lead to improvements in the authorisation process. The arguments the Commission presents show even more clearly that the evidence has not been adequately scrutinised, as will be explained. We have also seen a Professor wading into the debate and calling Baby Milk Action a 'loud-mouthed lobbying organisation' - while failing to reveal his relationship with the company that produces the DHA additives added to formula and the company that has applied for the right to use the health claim. More than ever, we need voters to send messages to their representatives asking them to put the scientific evidence and the well-being of infants before the vested interests of the formula industry and unelected European Commission officials who seem intent on providing a boost to the formula industry regardless of the evidence - click here.
UNICEF gives its strong support to the Resolution
On the side of mothers and babies, we see that UNICEF has responded to a request from MEPs for an opinion indicating its strong support for the Resolution opposing the claim. And from the responses sent to our supporters its clear that many MEPs are determined to back the Resolution. But when the vote goes to the full Parliament on the 5th or 6th of April we will need 369 of the 736 MEPs on side - even if only 400 are in the room at the time. We are trying to directly contact those who say they are intending to vote against the resolution (and FOR the claim) to find out their reasons for doing so. There seems to be some confusion that prohibiting the claim will stop DHA being added to formula, which is incorrect. DHA is a permitted ingredient, though it is not a required ingredient, because it has no proven benefit.
MEPs opposing the Resolution use an argument that makes support more sensible
The argument put by some MEPs explaining their opposition to the Resolution actually makes more sense as a reason for voting in favour. We have seen several state: "If an ingredient is proven to be safe and important for baby health, then it should be included." That is the position of those supporting the Resolution: if an ingredient is proven safe and beneficial it should be a requirement in all formulas and added to the list of essential ingredients in the EU Infant Formula and Follow-on Formula Directive. Nobody who really cares about infant health would want an inferior formula on the market, it is too important a product.
DHA is not a required ingredient because it has no proven benefit
When the composition requirements were updated in 2006, DHA was not included on the list of required ingredient because of the lack of evidence of benefit. Those opposing the Resolution are opposing the principle that safe and important ingredients should be included and if successful will allow an unproven ingredient to be added and promoted to mothers with an unsubstantiated claim. The image on the left shows how Mead Johnson promotes its formula as if it will transform a child's eyesight.
The Commission has written to MEPs attempting to defend the scientific basis of the claim, including a letter from the European Food Safety Authority (EFSA). However, the arguments prove the point that consideration of the evidence of benefits and risks is incomplete.
Cochrane Library review attacked
EFSA's letter suggests that the independent, systematic Cochrane Library review, which found 'no proven benefit' from adding DHA to formula, did not separately consider DHA supplementation at the levels specified by Mead Johnson, which filed the original claim of benefit for the ingredient. Yet Cochrane explicitely refers to the Birch study used as justification and would surely have mentioned the evidence of benefit at higher levels had the evidence been convincing. It states: "Only one group of researchers have shown some beneficial effects on VEP [visually evoked potential] acuity.... Further research is needed to see if the beneficial effects demonstrated by Dallas 2005 trial of Birch et al can be replicated in different settings."
Kathy Kennedy, Professor Alan Lucas and Mary Fewtrell, authors of a study (see below) that has found possible negative health impacts of DHA-supplemented formula, pointed out in defending their study from industry attack in the Archive of Diseases in Childhood: "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." [emphasis added]
Evidence of risks ignored in EFSA letter
The EFSA letter dismisses the need for further research on possible risks from DHA supplementation, rejecting a study by Kennedy et al published in the Archive of Disease on Childhood as having 'considerable weaknesses (e.g. a very low number of subjects)' - in fact a study group of 105. The Kennedy paper itself states that further research is needed to see if the evidence of high blood pressure etc. found in the 10-year follow-up is replicated. Significantly EFSA seems to ignore the evidence we raised in our submission about the evidence held by the US Food and Drug Administration (FDA) of parents and carers reporting adverse reactions to formulas supplemented with Long Chain Polyunsaturated Fatty Acids (such as DHA). The FDA noted in its response to a filing from Martek Biosciences, manufacturer of the DHA additive, for Generally Recognised As Safe approval (click here):
"Some studies have reported unexpected deaths among infants who consumed formula supplemented with long-chain polyunsaturated fatty acids. These unexpected deaths were attributed to Sudden Infant Death Syndrome (SIDS), sepsis or necrotizing enterocolitis. Also, some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice, and apnea in infants fed long-chain polyunsaturated fatty acids."
The FDA requires formula companies to do post market surveillance - yet in the 9 years since this stipulation no industry reports appear to have been made, while the FDA had recorded 98 cases of parents and carers reporting adverse reactions by 2007.
EFSA 'unaware' of other factors in breastmilk relevant to DHA effect
EFSA also dismisses the point that DHA is in a different environment in formula than in breastmilk, yet the FDA stated in its response to Martek:
"In addition, CFSAN [Center for Food Safety and Applied Nutrition] noted that your notice had not accounted for the fact that the bioactive fatty acids ARA and DHA when consumed in mature human milk are part of a complex matrix that includes, for example, linoleic acid, alpha-linolenic acid, and other polyunsaturated fatty acids and that important physiologic considerations relative to the matrix are not accounted for by the simple addition of LCPUFAs to infant formula."
"We are unaware of any factor in breast milk which is needed for DHA to exert its 'optimal' effect."
This raises questions about gaps in the scientific basis for EFSA's position.
EFSA dismisses the call for further research by pointing out:
"DHA levels in formula as proposed for the claim are in the normal range of DHA content naturally present in mother's milk."
It is over-simplistic simply to look at breastmilk as a template in setting levels; health outcomes need to be properly considered. Even when there is benefit from adding an ingredient to formula, it may be required at different levels to those in breastmilk. It should be remembered, for example, that the iron levels in formula are around 5 times that in breastmilk because a child absorbs it differently from the different environment - if formula simply followed the levels in breastmilk, children fed on formula would not absorb enough iron.
Professor with links to Martek and Mead Johnson attacks Baby Milk Action
Wading into the issue in extended comments in Nutraingredients is Professor Berthold Koletzko, calling the EFSA investigation a "profound scientific evaluation", ignoring the shortcomings mentioned above and the findings of independent scientists.
Professor Koletzko attacks Baby Milk Action for 'pseudo-scientific' arguments and is entitled to his opinion, but it is relevant to examine his conflicts of interest, which were not declared in the article. Professor Koletzko was lead author of a 2008 paper recommending DHA be added to formula. The declaration included in that paper states:
"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'.
The need for objectivity
We believe that policy should be based on objective evidence. This is even more important for foods for infants and young children, which is a multi-billion pound industry. There is a need to ensure that research free from commercial influence forms the main basis for policy setting and that the totality of the evidence is independently reviewed. It is impossible to know with industry funded research how much inconvenient data has been hidden.
We agree that if an ingredient is of proven benefit and safe then it should be included in formula. No claims should be made about these ingredients; claims only have the purpose of boosting sales. Inferior formula should not be on the market and parents and carers have a right to accurate information.
The wider harm that will be caused by opposing the Resolution
As UNICEF points out: "There can be little doubt that the use of such health claims can mislead parents into thinking that the formulas are as good as, if not better than breastmilk."
We saw in the Philippines how claims about DHA led some parents and carers to believe it was better to use formula rather than breastfeed. You can watch a UNICEF film about this online by clicking here.
Even in the UK, where companies get away with many health claims, access to midwives, health visitors and others is not enough to correct the misleading impression given by baby food industry promotion. According to a Department of Health survey a third of mothers incorrectly believe that infant formula is the same or almost the same as breastfeeding. See Myths stop mothers giving their babies the best start in life.
Protecting babies fed on formula
There is an argument that allowing companies to make health claims encourages investment on new ingredients that may be of health benefit. Professor Berthold Koletzko sent a statement dated 28 February to all MEPs attacking the Resolution as the German Society for Paediatrics and Adolescent Medicine. There is no declaration of Prof. Koletzko's links with the baby food industry, as described above. Prof. Koletzko states:
Preventing the communication of scientifically assured benefits of optimised products bears the risk that it may slow or stop the significant quality improvements of foods for infants has occurred over the last years and decades in numerous single steps, and which has led to large benefits for child health. In the future, manufacturers might not be willing to invest major financial resources into the development, clinical evaluation and implementation of further improvements, if there is no chance to communicate such improvements.
There are several issues with this argument.
Firstly, while it is true that the possibility of making claims about some new ingredient encourages investment, this is not necessarily going to lead to benefits for infant health. In the case of DHA, investment advisors Hambrecht & Quist suggested investing in Martek Bio-sciences Corporation in 1996, saying:
"Even if Formulaide (DHA/AHA) had no benefit we think that it would be widely incorporated into most formulas as a marketing tool and to allow companies to promote their formula as ‘closest to human milk’."
They understood the value comes from health claims as a marketing tool, not from any health benefit from the ingredient. This approach advocated by Prof. Koletzko also drives a search for something to make a claim about - and we have seen this result in unnecessary and even potentially harmful products such as so-called Goodnight milks (click here for analysis by the UK Scientific Advisory Committee on Nutrition of Goodnight milks and associated claims).
Secondly, the US Food and Drug Administration requires companies there to record evidence on ill effects and keeps its own record (see above). Effectively, an uncontrolled mass trial is taking place amongst those who use formula, based on parents self-selecting whether to buy formula with DHA or not. If this was a scientific study, participants would have the right to free and informed consent. Health claims not only negate that principle, they turn it on its head.
Thirdly, science IS conducted in the public interest on new ingredients.
Fourthly, if an ingredient is of benefit, should it be denied to babies by allowing inferior formula to be marketed? Note that in this case, Martek does not produce formula itself. If DHA had been accepted as beneficial and added to the list of required ingredients when this was discussed when the EU Directive was updated in 2006, it would have found an even larger market. Pre-approval would not prevent development, it would simply require the benefit and safety of new ingredients to be proven through experiments with proper informed consent, preferably with a significant level of independent studies.
To ensure that formula is as safe and as beneficial as it can be and that information about it is accurate, we need the Resolution to be supported by the European Parliament at the beginning of April.
So please do keep sending messages. Our multilingual campaign page tells you how to do so quickly and easily - click here. If you have already sent your own messages, use the tools on that page to ask friends and colleagues to do the same.