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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

NOTES

1   European Parliament Press Release  16.3.11 DHA in baby food: Environment Committee opposes health claim     

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

On 6th Dec 2010 the EU Standing Committee on Food Chain and Animal Health (SCoFCAH)  which meets in private, approved the health claim  "DHA has a structural and functional role in the retina and DHA intake contributes to the visual development of infants up to 12 months of age."   for use on follow-on formulas  and baby foods. At the same meeting SCoFCAH rejected three claims suggesting that products "contribute to the optimal brain development of infants and young children." 

DHA (docosahexanenoic acid) is a Long-Chain-Polyunsaturated Fatty Acid (LCPUFA) found in human milk. The synthesised DHA, made from fish or algae, that is added to formulas is in a different biological environment to breastmilk, which is a species-specific, living substance. Formula contains no co-enzymes or co-factors to enable the fats to work optimally.  

 The  Draft COMMISSION REGULATION on the authorisation  and refusal of authorisation of certain health claims made on foods and referring to children's development and health  is available here: http://info.babymilkaction.org/news/policyblog/dhabriefing)

The MEP's Resolution objecting to the Draft  Regulation is here: http://www.europarl.europa.eu/meetdocs/2009_2014/documents/envi/re/858/858750/858750en.pdf

The summary record of the December 6th SCoFCAH meeting is published here: http://ec.europa.eu/food/committees/regulatory/scfcah/general_food/sum_06122010_en.pdf

Because the meeting is closed, the Summary Record does not state the positions of national delegations. However it is clear that several Member States  abstained or voted against the approval of  the vision claim.  The Danish opinion is that  this specific claim may mislead the consumer due to the high focus on omega-3  and that it is very important  that the consumer is not misled to believe that follow-on formulae has a health advantage in favour of breastfeeding or infant formulae.  

Follow-on formulas are breastmilk substitutes for babies over 6 months and according the WHO/UNICEF International Code of Marketing of Breast-milk Substitutes and subsequent WHA Resolutions, should not be promoted at all.  Follow-on formulas are not necessary because babies not breastfed can be fed infant formula after 6 months and for as long as necessary.  Follow-on formulas were invented by the baby food industry to get round advertising restrictions.   In countries that allow unrestricted advertising of infant formula  - such as the US and Canada - infant formulas are marketed from 0-12 months.  The EU  Infant Formula and Follow-on Formulae Directive (141/2006/EC) has some restrictions on the promotion of infant  formulas but no restrictions on follow-on formula promotion.  

2 The 2007 Systematic Review of the Cochrane Library concluded:  “This review found that feeding term infants with milk formula enriched with LCPUFA had no proven benefit regarding vision, cognition or physical growth.” Simmer K, Patole S, Rao SC. Longchain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No CD000376.DOI: 10.1002/14651858.CD000376.pub2  www2.cochrane.org/reviews/en/ab000376.html 

The 2010 IPD Meta-Analysis of 4 Large Clinical Trials by Beyerlein et al, Infant Formula Supplementation With Long-chain Polyunsaturated Fatty Acids Has No Effect on Bayley Developmental Scores at 18 Months of Age.  J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):79-84  concluded that "LCPUFA supplementation of infant formula does not have a clinically meaningful effect on the neurodevelopment as assessed by Bayley scores at 18 months...except possibly for very low-birth weight babies." www.ncbi.nlm.nih.gov/pubmed/19881391 

Comment in the Archives of Diseases in Childhood responding to a critique by Martek (the manufacturer of the synthesised DHA):   

http://adc.bmj.com/content/95/8/588/reply#archdischild_el_8934   "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."

3  Letter from the European Food Safety Authority (EFSA) to the Commission clarifying its position in relation to follow-on milks and baby foods. 3.9.09 http://ec.europa.eu/food/efsa/comments/efsa_reply_q_2008_211.pdf

When evaluating claims, EFSA is not required to look at 'risk' (either of the ingredient itself - or the effect of a claim)  nor at anything other than the dossiers supplied by industry - parts of which can be commercially confidential.  All three EFSA opinions state that EFSA could not have reached its conclusion, "without considering the studies claimed by the applicant as proprietary."   There is a known bias against the publication of trials with negative outcomes, and such evidence is rarely included in industry dossiers.  

The three EFSA opinions on Vision:

http://www.efsa.europa.eu/en/efsajournal/doc/941.pdf

http://www.efsa.europa.eu/en/efsajournal/doc/1003.pdf

http://www.efsa.europa.eu/en/efsajournal/doc/1004.pdf

4  http://ec.europa.eu/food/food/labellingnutrition/claims/comments_efsa_en.htm

5  In 2009 a Private Action taken by a supermarket in Alabama about Mead Johnson's comparative claims concluded that the company was in 'repeated flagrant violation of the US industry self-regulation adjudications'. The ruling of the National Advertising Division (NAD) of the Council of Better Business Bureaus on the Private Action said "The self-regulatory process cannot function properly when advertisers state, on the one hand, that they MEAD JOHNSON NUTRITIONALS Enfamil LIPIL   respect the process and will comply with NAD’s decision, and then do the opposite. Accordingly, NAD has no choice but to refer this matter to the appropriate government agency for possible law enforcement action pursuant to section 4.1(B) of the NAD/NARB Procedures". (#4822 AMU, closed 02/12/2009)

http://jimedwardsnrx.files.wordpress.com/2009/02/nad-enfamil-decision.pdf

http://www.courthousenews.com/2010/05/06/Lipil.pdf

In 2004 an investigation by Health Canada concluded that Mead Johnson's claims were “unsubstantiated, unacceptable, misleading and unauthorized” and called on them to stop immediately. (5)

http://www.infactcanada.ca/INFACT%20Summer+Fall%202004%20Pgs%201-5.pdf

6 The FDA evidence shows that there  seems to be a subset of babies who cannot tolerate these formulas and studies that look more broadly than neurodevelopment indicate that there may be long-term problems too. The 10-year follow-up of a randomised trial of DHA-supplemented formula, published in December 2010,  found that girls were heavier and had higher blood pressure.

10-year follow-up of a randomised trial of longchain polyunsaturated fatty acid supplementation in preterm infants: effects on 

growth and blood pressure. Arch Dis Child 2010;95:588–595. 588 doi:10.1136/adc.2009.167270  

FDA Q&A:  www.fda.gov/Food/FoodSafety/Product-SpecificInformation/InfantFormula/ConsumerInformationAboutInfantFormula/ucm108079.htm        

Replacing mother - Imitating Breast Milk in the Laboratory.  www.cornucopia.org  The Food and Drug Administration senior scientists recommended convening a panel of independent scientists to review the safety of these additives.  The Institute of Medicine's Food and Nutrition Board also pointed to problems with Martek's safety tests. Federal Trades Commission's closing letter to Martek Biosciences Corporation  (File No 0223238)  http://www.ftc.gov/os/closings/staff/050711martek.pdf

Obama administration bans two additives used in organic baby food 

www.washingtonpost.com/wp-dyn/content/article/2010/04/27/AR2010042704500.html

7 FDA call for comments on a proposal to study of  10,000 women's understanding of health claims such as “supports brain 

and eye development."  OMB Control Number 0910–NEW - http://www.regulations.gov     Refer to Docket No. FDA–2011–N–0098))  http://edocket.access.gpo.gov/2011/2011-4740.htm

www.theatlantic.com/life/archive/2011/03/omega-3-fatty-acids-in-formula-time-for-a-close-look/72238/

9 Breaking the Rules - Stretching the Rules 2010.  IBFAN's  independent monitoring report from over 46 countries shows how the baby food industry uses claims that mislead parents to increase sales of breastmilk substitutes and baby foods. www.ibfan.org/icdc/

More information follow this link: 

http://info.babymilkaction.org/news/policyblog/dhabriefing

Patti Rundall,  OBE, Policy Director, Baby Milk Action

for my latest news see Policy Blog: http://info.babymilkaction.org/news/policyblog

Secretariat of  the Baby Feeding Law Group

C/o Baby Milk Action, 34 Trumpington St,   Cambridge   CB2 1QY    

Work Tel: 01223 464420, Mobile: 07786 523493, Fax: 01223 464417

prundall@babymilkaction.org  www.babymilkaction.org

www.babyfeedinglawgroup.org.uk

The Baby Feeding law Group is a coalition of 24 leading health professional and lay organisations working to bring UK and EU legislation into line with International Code of Marketing of Breast-milk Substitutes and subsequent relevant World Health Assembly Resolutions. 

BFLG Member organisations: Association of Breastfeeding Mothers - Association for Improvements in the Maternity Services - Association of Radical Midwives - Baby Milk Action - Best Beginnings – Breastfeeding Community - Breastfeeding Network - Caroline Walker Trust - Community Practitioners and Health Visitors’ Association - Food Commission - Heart of Mersey - Lactation Consultants of Great Britain - La Leche League (GB) - Little Angels - Midwives Information and Resource Service - National Childbirth Trust - Royal College of Midwives - Royal College of Nursing   - Royal College of Paediatrics and Child Health - The Baby Café - UK Association for Milk Banking - Unicef UK Baby Friendly Initiative - UNISON - Women’s Environmental Network.

The Baby Feeding Law Group is also a member of the Breastfeeding Manifesto Coalition which is calling for action in 7 areas to protect, promote and support breastfeeding.  Baby Milk Action takes the lead on Objective 7. 

http://www.breastfeedingmanifesto.org.uk