Positive Health Online

Most of us take for granted that we live in a democratic society in which the rules and regulations are carefully constructed by experts in their respective fields. Having been working closely with EU legislation affecting natural healthcare for more than two years now, I know differently.

I believe that a combination of factors at work at the present provide the perfect recipe for disastrous legislation. Legislation so disastrous that it seems the entire future of healthcare, especially self-care, is now at risk.

If we wish to protect it, we need to do three things more or less immediately:

1. We must continue to intercept, alter or positively shape the laws or guidelines working their way through the EU and UN;

2. We must show people that the law-making process is neither democratic nor is it proposed by those who are fully expert in the required fields;

3. We must demonstrate that self-care and complementary therapies, based around sound nutrition and integrated systems of healthcare, provide the only viable, cost effective and sustainable solution to healthcare.

It is also vitally important to support the ANH legal challenge to the Food Supplements Directive.

European and International Regulations and Guidelines

There is increasing evidence that EU Directives, EU Regulations and international guidelines to be instigated through the United Nations instrument, Codex Alimentarius, in 2004 and 2005 will determine our future ability to manage our health with the support of natural products. This means if we want to protect the future availability of natural healthcare we must act now. There is no time for complacency. All of these regulatory processes need to be intercepted or challenged while they pass through the legislative pipeline. Anyone waking up to these problems in 2006 might have to accept that it might then be too late too to have any appreciable impact on the regulatory process.

EU Food Supplements Directive

The Food Supplements Directive (FSD) is the first of several EU Directives affecting natural healthcare products to have been passed into EU law. The European Commission tell us they are not proposing to ban 300 out of 420 vitamin and mineral forms on the UK market; they are simply asking companies to supply data to ensure that these substances are safe.

But when the data requirements, in some cases, require extensive studies and even animal testing (an ethical no-no for many companies in the natural products field), this requirement for safety dossiers places a major obstacle in the way of innovative food supplement producers, particularly the smaller ones. On its face, this seems like a reasonable approach, but when you consider that toxic substances like sodium fluoride and sodium selenite are allowed through with no data requirements, yet calcium hydroxyapatite, selenomethionine, mixed tocopherols and tocotrienols all require safety dossiers (which might cost more than £250,000 each to prepare), we begin to see how things are stacked against the smaller innovators.

Many people buy Vitamin E because they know it is an antioxidant vitamin, yet key antioxidant components, gamma-tocopherol[1] and the spectrum of tocotrienols, could well be banned by 1 August 2005. Gamma-tocopherol is the primary food form, plasma levels of which have long been known to be reduced by alpha-tocopherols.[2] There are more than another 250 vitamin and mineral forms omitted from the FSD's positive list – most with similar stories demonstrating, at the very least, illogic in the minds of the legislators.

On 13 October 2003 ANH filed its legal challenge against this Directive, to demonstrate that it was invalid under European law. The ANH is arguing that the European Commission does not have the power to effectively ban large numbers of nutrients across Europe, unless of course there had been strong health grounds for such a ban. The Directive has been issued under Article 95 of the European Treaty which sets out the basis for "the establishment and functioning of the internal market" across the EU. Given the weight of EU membership, including pressure from the governments of Germany and France that are opposed to making therapeutic food supplements available to the general market, it is no surprise that the FSD has followed a course to satisfy the 'lowest common denominator countries'. But if there is no legal or scientific basis for these countries' restrictions, why should those of us in countries with a more liberal approach to natural healthcare suffer?

On 30 January 2004, the English High Court found, following consideration of both the ANH's case and that of two UK industry associations, the National Association of Health Stores and the Health Food Manufacturers Association (HFMA), that the cases should be referred to the European Court of Justice in Luxembourg. In this court, probably in 2005, one of the most important decisions influencing health freedom will be decided. We are urging practitioners and consumers who support natural healthcare to contribute financially to support the ANH's case – as a large sector of the industry appears to be sitting on the fence on this issue. The HFMA has even indicated that their challenge is conditional, and may be dropped if the European Commission adds some more vitamins and minerals to the list.[3]

It is the view of the ANH that a positive list system, if maintained as the sole basis for authorization of food supplements, could wreak havoc with future aspects of the Directive in relation to amino acids, essential fatty acids, phytonutrients, fibre and other non-vitamin and mineral nutrients. The challenge is therefore crucial – and if successful in its second stage in Luxembourg – will set a precedent and have a huge positive impact not only on this Directive but also on future directives affecting natural products.

Other Concerns

The Codex Alimentarius Commission appears intent on finalizing guidelines on maximum levels of vitamins and minerals as early as this November. The EU Commission is pushing through Nutrition and Health Claims Regulations which could make it very difficult for consumers and patients to receive adequate information about natural products. The Commission is also doing its best to ensure that food supplements, in strict legal terms, fall under European medicines legislation. Adding insult to injury, the Commission is now also starting to focus on the bioenergy medicine field and are proposing that some devices might have to be removed from the market until further trials, often prohibitively expensive for smaller companies, have been conducted. The ANH, with its partners around Europe, is working on all these fronts. Please support us so we can help to safeguard the future of natural healthcare.

References

1. Cooney RV Franke AA Harwood PJ et al. Gamma-tocopherol detoxification of nitrogen dioxide: superiority to alpha-tocopherol. Proc Natl Acad Sci USA. 90: 1771-1775. 1993.
2. Handelman GJ Machlin L J Fitch K et al. Oral alpha-tocopherol supplements decrease plasma gamma-tocopherol levels in humans. J Nutr. 115: 807-813.1985.
3. HFMA website: www.hfma.co.uk/news.htm; and comments made by Peter Aldis, HFMA Chairman at Natural Trade Show, Brighton, 15 March 2004.

Further Information

The ANH can be contacted on Tel: 01252 371 275;
info@alliance-natural-health.org www.alliance-natural-health.org*

*Please Join the Alliance to receive campaign updates by email. Donations can be made via a secure server, or better still on a monthly basis by completing a standing order form downloadable from the site.