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EU Supplement Legislation Update: The Next Battlefronts

by Dr Robert Verkerk(more info)

listed in brexit and eu directives, originally published in issue 107 - January 2005

The Alliance for Natural Health (ANH) have been leading a pan-European effort to demonstrate why a positive list-based system for food supplement regulation in Europe would be devastating to leading-edge, innovative companies and would prevent access by consumers and patients to some of the safest and most effective ingredients in food supplements.

The ANH has won the first stage of a legal challenge in the High Court in London and awaits a hearing date for the next phase of the action in the European Court of Justice in Luxembourg. The hearing is likely to occur some time in the first quarter of 2005.

Could Therapeutic Doses of Food Supplements be Made Illegal?

While this fate is decided, there are a range of other battlefronts that are as important as the legal challenge to the bans implicit in the Food Supplements Directive. Pivotal will be Article 5 of the same Directive, which seeks to place maximum limits on allowed dosages of nutrients. The ANH is deeply concerned that dosages that are therapeutic and have real health benefits for consumers and patients will be disallowed. Products with higher dosages would only be available if companies saw fit to pay the very considerable costs required to gain market authorizations as drugs.

The ANH, along with scientists and doctors in Europe and the USA, is developing a nutrient-focused risk management model which it believes is a major step forward compared with the risk assessment model that is currently gaining favour with the likes of the European Food Safety Authority and Codex Alimentarius. The ANH believes that the existing risk assessment models that are being canvassed by organisations such as the International Alliance for Dietary Supplement Associations (IADSA) do not go far enough and risk unfairly preventing use of supplements at dosages that are beneficial (and therapeutic) for very large numbers of people.

Combating Media Assaults Against CAM

Another critical battlefront is public awareness via the media. Although reports in the media which are critical of Complementary and Alternative Medicine (CAM) have long been present, they appear to have gathered momentum in recent weeks. The recent Horizon programme (16 September 2004) and BBC Watchdog (5 October 2004) which attacked Gerson therapy and coffee enemas are but two examples. In both cases the reports were extremely unbalanced and unfair; the ANH is in the process of making formal complaints to OfCOM.

The ANH is seeking to commission a top public relations firm to help put a fair and balanced picture of the importance and role of CAM to the media. Such a campaign needs to be both proactive and reactive. The ANH is working on developing media campaigns both in the UK and other parts of the EU.

Nutrition and Health Claims Regulations – Another nightmare?

A further critical battlefront is the EU's proposed Nutrition and Health Claims Regulations. Unlike European Directives, which need to be transposed into national laws, European Regulations become law in all 25 European Member States once they have successfully passed through the European Commission, Council of Ministers and Parliament.

In brief, the Regulations will ban all health claims, including implied health claims given as product trade names (e.g. Slim ****, Cardio ****, Joint ***) unless they are specifically allowed. In principle, this would not be such a burden if approvals of health claims were within reach of a wide range of companies. Sadly, this is not the case, just as the tortuous dossiers which theoretically allow derogation of non-positive list ingredients in the Food Supplements Directive have acted as a major obstacle to smaller, innovative companies. The procedure for provision of scientific substantiation of health claims is extremely onerous. Large transnational companies who are looking to make health claims for ingredients like phytosterols in their margarine products will almost certainly have no problem in providing the necessary data, but smaller companies – often the key innovators in the health field – will simply not have the financial capacity to meet the data requirements.

Bizarrely, under Article 11 of the proposed Regulations, no claims of any sort for any weight loss product would be allowed, and any claims implying psychological or behavioural effects would also be disallowed. This seems completely out of step with the nature of the current healthcare crisis, in which obesity and psychological disorders, both of which have been shown to be in many cases strongly associated with nutritional status, are major and ever-increasing health concerns.

The good news is that there is a lot to play for. The Regulations have already been thrown out by the European Parliament earlier this year given the huge controversy they created, and they return for a 'second coming' this Autumn. We suggest that you express your concerns about these regulations to your local MEP and you can find plenty of information about this important issue on the ANH website (www.alliance-natural-health.org).

We Need Your Help

The ANH is now fundraising to support our legal challenge, media campaigns and lobbying on the Nutrition and Health Claims Regulations. You can make your donations securely via Worldpay via the homepage on our website or alternatively you can send a cheque payable to Alliance for Natural Health to, Mount Manor House, Guildford, Surrey GU2 4HS. We are doing this work to help develop a more sustainable future for healthcare – and we need YOUR support. Thank you.

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About Dr Robert Verkerk

Robert Verkerk BSc MSc DIC PhD FACN Founder, Executive & Scientific Director of Alliance for Natural Health. For over three decades, Rob Verkerk has developed an intimate relationship with the tightropes that span between science and law, between academia and industry, between government and the people — and not least — between humanity’s internal and external environments. He has Masters and Doctorate degrees from Imperial College London, where he also worked as a postdoctoral research fellow for 7 years. In 2002, Dr Verkerk founded the Alliance for Natural Health International (ANH-Intl) and has acted as its executive and scientific director since this time. He has directed legal actions to protect the right to natural health and campaigned against drinking water fluoridation and genetically modified crops. He has also been instrumental in exposing the limitations of classical risk analysis as applied by government authorities to foods and natural health products and he is a recognised pioneer in the development of novel, scientifically rational risk/benefit analysis approaches. He is also the scientific director of ANH-USA. Dr Verkerk has authored some 60 papers in scientific journals and conference proceedings and contributes regularly to magazines and other popular media. He is an accomplished and inspirational speaker and communicator on a wide range of issues relating to sustainability in healthcare, agriculture, food quality and related fields. Dr Verkerk may be contacted on Tel: 01483 362200; info@anhinternational.org or www.anhinternational.org/

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