European Parliamentarians oppose bogus health claim

16th March – Brussels

Members of the European Parliament have moved to block a baby food company from using a health claim on labels of follow-on formula.

The European Parliament’s committee on Environment, Public Health and Food Safety  Committee (ENVI) today voted to stop the claim that DHA, a long-chain fatty acid found in breastmilk, when added to  follow-on formulas and baby foods improves babies’ vision. A Resolution will now go to the full Plenary in Strasbourg in April and if it is passed there, the claim will not be allowed in EU countries from 2012, or on exports from the EU. (1)  Baby Milk Action is lodging an official complaint about misinformation put out by the European Commission in trying to influence the votes of MEPs.

 

This is first time since the 2006 European Health and Nutrition Claims Regulations came into effect that  MEPS have used their right to block a claim and the news was greeted with huge relief by thousands of health professionals and public health  campaigners both in the EU and globally who have been fighting to protect parents rights to truly independent information about infant feeding.

 

Socialist MEP Glenis Willmott, Co-Chair of the Health Working Group, who led the  MEPs veto said: “The European Parliament delegated the power to make  decisions about infant feeding to the Commission and a specialist committee, which meets behind closed doors.  However MEPs have an important role to play in scrutinising these decisions as this claim shows.  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. As the scientific evidence is still inconclusive, we cannot allow parents to be misled. Babies’ health is too important to be left in the hands of a multinational company’s marketing department.”

Dr Antonyia Parvonova, of the Alliance of Liberals and Democrats for Europe group (ALDE) said: “I supported this important Resolution along with my Liberal Democrat colleagues on the Committee.  The  Resolution is  not deciding whether the ingredient should be permitted but whether there are implications or risks in making such a promotional claim on baby formulas and baby foods.  I think we all agree that if an ingredient is proven to provide a benefit without an unacceptable risk it should be an essential ingredient required by EU law in ALL formulas, and not a marketing tool promoted with a claim.” 

 

Elisabetta Gardini, from the European People’s Party (EPP)  said: “Today`s vote is in line with the spirit of the international standards on marketing and mothers` milk substitutes developed by the World Health Organization, which aim to ensure that there is no form of advertising or promotional material for substitute products of mother`s milk.  Furthermore, according to these standards the labelling of these products must not in any way discourage breastfeeding and must say that the product would only be used with a prescription and under medical supervision.”

 

Carl Schlyter, Green Group, European Free Alliance (EFA), Vice Chair of ENVI Committee said: “Health claims on food products are there to help consumers to do healthier choices, not to mislead. If a substance is useful it should be a required ingredient of infant formula if not then obviously no health claims can be made” added .

 

Kartika Liotard,  of the Nordic Green Left Group (GUE/NGL) said: “We must be very careful with authorizing health claims, especially with claims on  baby food. There should be no risk of consumers being misled for commercial interests. The DHA claim is far too controversial to allow it being on baby food.” 

 

The debate revolved around the lack of consistent peer-reviewed, independent evidence of any causal relationship between DHA fortified-formulas and better eyesight in term babies. The two independent systematic reviews  of the evidence (one in 2007 and another in 2010) found no proven benefit  for the formulas – except possibly for pre-term babies.(2)

 

Also key was an ‘AIDE Memoire’, issued by   European Commission  to MEPs before the vote, that failed to make the key point that the European Food Safety Authority (the body tasked with evaluating the claim) had seen no evidence of any benefit from adding the ingredient to follow-on formulas. In reality, EFSA had told the Commission in a letter:  “The evidence, however, does not establish that starting DHA supplementation at 4-6 months in infants who had received a control (DHA-free) formula in the first months of life would have an effect on the visual development of those children…… There are no data from specific randomised control trials supporting a benefit of DHA supplementation starting at 6 months of life in infants fed a DHA-free formula in the first 6 months of life……” (3)

 

The Aide Memoire also incorrectly stated that ” During the period in which the public may comment on the scientific advice of EFSA, no comments were made by stakeholders/scientists contesting EFSA’s conclusions or indicating a risk for infants.”

 

Baby Milk Action’s Policy Director, Patti Rundall, OBE, is lodging a complaint of maladministration with the EU Ombudsman  following the Commission’s failure to issue a correction before the crucial ENVI vote. The comments objecting to the claim by the International Baby Food Action Network and the Baby Feeding Law Group (BFLG)  are on the Commission website, but having been told that none were submitted few MEPs will have looked for them.    The BFLG represents the views of 23  leading health professional and lay organisations in the UK, including the Royal College of Paediatrics and Child Health, The Royal College of Midwives and the Royal College of Nursing. (4)

 

Commenting on today’s vote  Patti Rundall, said:  “This vote is a really significant development in public health policy setting.   It has been a long time since MEPs have had an input into the marketing of breastmilk substitutes because their right to do so was taken away  in 1989 with the adoption of the PARNUTs Directive. This Directive  passed all the power to the European Commission, which is,  in this particular case,  protecting the interests of the baby food industry.  It is high time that the PARNUTs Directive is changed or scrapped, and it is already on the Agenda of the Council meeting in June. If the legislation controlling baby food marketing was more transparent and democratic,  people would soon realise that such highly promotional claims on baby formulas and foods are totally inappropriate and harmful to child health. “

 

As the UK Scientific Advisory Committee on Nutrition (SACN)  said in 2007: “We find the case for labelling infant formula or follow on formula with health or nutrition claims entirely unsupportable. If an ingredient is unequivocally beneficial as demonstrated by independent review of scientific data it would be unethical to withhold it for commercial reasons. Rather it should be made a required ingredient of infant formula in order to reduce existing risks associated with artificial feeding.”

 

At the centre of the debate are two US companies –  Mead Johnson  and Martek Biosciences Corporation – who have been in hot water elsewhere in their eagerness to promote their products.  In the US and Canada  there have been Private legal actions and investigations by the  US Food and Drug Administration, the Federal Trades Commission over their claims, described variously as ‘repeated flagrant violation of the US industry self-regulation adjudications  and as “unsubstantiated, unacceptable, misleading and unauthorized.”  (5)

 

The FDA also has serious safety concerns. In a letter to Martek FDA said: “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 authorisation for DHA was not an assurance of safety and was given on condition that the industry  conducted regular  post-market surveillance of  the safety of DHA/ARA, none of which have been done.  (6)  It was revealed in 2007 that the FDA itself had already recorded 98 reports of  adverse reactions to DHA fortified formulas.

 

Following all the investigations Mead Johnson has toned down its vision and brain claims in the US.  The  FDA is now proposing an investigation of 10,000 women to see how such claims influence parents perceptions. (7)

 

The MEPs concerns are shared by several Member States, and a wide range of medical and public health bodies, including the Standing Committee of European Doctors (CPME) COFACE (the Confederation of Family Organisations in the European Union),  EPHA (the European Public Health Association)  BEUC (the European Consumers Association), and in the UK the Royal College of Paediatrics and Child Health, Sustain’s Childrens Food Campaign,  the National Childbirth Trust,  the Baby Feeding Law Group and the International Baby Food Action Network – which objected to the claim in 2009 – and many others from around the world.

In his letter to ENVI members, Dr K Weerasuriya,  Former Professor of Pharmacology, Sri Lanka explained how this decision would affect health in the developing world: “Often the examples of legislation and regulation  from the developed world are taken as the starting point in the developing world. While it is argued that developing world countries would use their expertise to make decisions, many have insufficient expertise and trust that the developed countries placed health as the first priority. The legislation then often is a “copy and paste” … In this globalised interconnected world, what a committee does in Brussels can (and will) have an effect in nutrition of infants in the developing world – a butterfly flapping it’s wings in one area of the world, can cause a tornado in another part of the world.”

–  END –

For more information contact: Patti Rundall: 07786 523493

 

For the Press release of the European Public Health Alliance:

http://www.epha.org/a/4465

For the European Parliament press release see this link:

http://www.europarl.europa.eu/en/pressroom/content/20110314IPR15477/html/DHA-in-baby-food-Environment-Committee-opposes-health-claim