Positive Health Online

EU Supplement Directive Court Challenge

The Alliance for Natural Health today presented its oral submission to the European Court of Justice in Luxembourg in its landmark case challenging the ban in the EU Food Supplements Directive on 75% of
vitamin and mineral forms currently sold in the EU market.

Opposing oral submissions were made by the European Commission, the Council of Ministers, the European Parliament and only one EU Member State, Greece.

The UK Government does not present its objections to the challenge.

Interestingly, neither the UK government nor Portugal attended to present oral arguments despite having filed Written Observations in the case. This means that none of the major EU countries felt the need to oppose the ANH’s application for a declaration that the ban in the Directive was unlawful.

David Hinde Solicitor and ANH Legal Director said: “Given the vigour with which the UK government resisted this application at the Judicial Review stage, it was extraordinary it did not now think the issue sufficiently important to warrant being represented at the ECJ to make oral submissions. The question inevitably arises whether this signifies a change of attitude on their part and a retreat from their previously bullish position about the legality of the Directive.” Paul Lasok QC, a world leading expert on EU law, representing the ANH opened the proceedings and systematically undermined the legal and scientific basis of the Directive, highlighting contradictions between various arguments put forward by the key bodies involved in developing the Directive, namely the European Commission, the Council of Ministers and the European Parliament.

If the ban on vitamins and minerals is implemented there is much at stake: Over 5000 products will disappear from the shelves of UK health stores as a result of the ban removing access to over 300 vitamin and mineral ingredients (out of a total of 420). These include amongst others the main natural forms of Vitamin E, many forms of vitamin C and MSM and minerals such as vanadium, silicon and boron, all being products which millions of consumers choose to take as part of their regular health regime and have done so without any ill effects for many years.

An individual’s freedom of choice to take safe natural health products will be removed – 40% of the UK’s population take vitamins and minerals. Products are to be banned with absolutely no scientific justification. Many of the world’s leading scientific and medical experts in nutrition support this.

When asked by Judge Lenaerts as to the origin of the positive list which appeared to have been derived from an old list produced by the European Commission, and so omitted a vast array of nutrients that can normally be found in food, Mr Lasok responded: “The list was put together without adding, without subtracting and without thinking.” Advocate General Geelhoed, the senior judge at today’s hearing, appeared to be baffled by the procedure for adding nutrients to the positive list, which he described: “As transparent as a black box.”

Dr Robert Verkerk, executive director of the ANH said after the hearing: “It was remarkable that the vast majority of points that we had gone to great length to show the Court were not countered in any effective way by the opposing parties. The Commission, the Council and the Parliament were not able to give any adequate scientific explanations for why so many forms of vitamins and minerals that naturally occur in foods could be banned across the EU.” Final judgement is expected in June 2005.

The Advocate General announced that he would deliver his opinion on 5 April 2005, while the Court is expected to give its judgement in June, shortly before the ban would otherwise be set to come into effect on 1 August 2005.

Further information

Alliance for Natural Health  www.alliance-natural-health.org
David C. Hinde, Solicitor, Legal Director Tel: 020-7738 1640; Mob: 07958 548 186
davidh@alliance-natural-health.org
Dr Robert Verkerk, Executive Director Tel: 01252 371 275; Mob: 0771 484 7225
robv@alliance-natural-health.org
IKON Associates (PR for the Alliance for Natural Health)
Adrian Shaw Tel: 01483 535102; Mob: 0797 9900733
adrian@ikonassociates.com

Response to Johns Hopkins article on Vitamin E by Neil Levin
Is Vitamin E Dangerous in High Doses?

In some circumstances, it may be. But these are limited conditions and there are certainly some easy ways to get around them.

I am writing this in response to an article to be published this week in Annals of Internal Medicine. Researchers at Johns Hopkins have subjected some Vitamin E studies to a meta-analysis, which is where previously published studies are re-examined and compared in order to try to mine more information out of them. These meta-analyses are often highly speculative, because the protocol for each study is different enough that it becomes a stretch to link the results and imply a common thread runs through them despite the different variables. For example, the supplement tested may be given in different forms or doses, the patient group may have significant differences, the length of time taking the supplement may vary considerably or may even include previous users, and new users, etc. There are also differences between natural and synthetic Vitamin E, with most studies using only the synthetic forms that are composed of different-shaped molecules and only half as effective as natural Vitamin E. Natural Vitamin E is called d-alpha tocopherol and synthetic Vitamin E is called dl-alpha tocopherol.

Official US dietary guidelines set an upper tolerable intake limit of up to 1,500 IU per day, based on the scientific record.

While these meta-analyses are academically useful to point to potential new problems or solutions, by no means are they definitive proof of anything, due to the lack of uniform protocols and patient groups. But that won’t stop the medical lobby from trying to use these results to limit potencies of vitamins to everyone ‘for our own good’. The doctors and researchers may be well-meaning, but results of this kind of preliminary study can be publicized and take on a life of their own, with a new role as ‘proof’ of the dangers of taking vitamins.

One thing that many of the patients in this analysis of previous studies had in common was being elderly and sick. So the first caution issued by the report’s authors is that their speculative findings would not even apply to healthy or younger people. That’s one BIG argument against using this analysis to set general restrictions on Vitamin E dosages. We already have some evidence that taking one antioxidant, rather than antioxidant formulas or multiple vitamins, may increase the cancer risks for aged smokers. This may be because antioxidants need to recharge and support each other or else some can actually transform into pro-oxidants that can increase the damage.

I always caution against taking mega-doses of one nutrient without considering potential side effects. Taking only one antioxidant may seem to deplete others because of the way they interact, with one antioxidant chemically supporting others. A surplus of one nutrient may increase a person’s need for one or more other nutrients, creating an apparent functional deficiency.

There is a recent example that illustrates my point. Some years ago an antioxidant study in Finland was halted early, with a widely reported increase in cancer rates among male smokers taking beta-carotene. Headlines associated vitamins with cancer risk. Despite objections that the study was flawed, vitamin use dropped.

Fast-forward to this year. A new analysis published in July takes another look at that same Finnish smokers’ study, but now takes into account their total antioxidant intake, and clears up that whole controversy. Their risk of getting lung cancer was closely associated with total antioxidants in the diet, with more antioxidants meaning less cancer.

A composite antioxidant index was generated for each of the 27,000 men over 14 years. The calculated amounts of carotenoids, flavonoids, Vitamin E, selenium and Vitamin C were compared to actual lung cancer rates, with a clear result: a combination of antioxidants lowers lung cancer risk in male smokers.

What does this all mean? I think we are in for another round of attacks on vitamins based on this crude analysis of Vitamin E, with some medical experts calling for restrictions on vitamin potency. That would be a mistake, both scientifically and from a public health viewpoint. The message should be that people should not try to take a high dose of one supplement without considering that it may increase our need for other nutrients. Elderly, sick people need a more holistic approach rather than using a single nutrient in high doses, as if it were a drug. Nutrients just don’t work well in isolation from each other. Vitamins are essential to health and life, but the average American gets only 1/3 of the recommended daily intake of Vitamin E that would prevent serious illnesses. Most people would benefit from taking a multiple vitamin and a Vitamin E supplement, and it would be safer than just the Vitamin E alone.

That shouldn’t be hard for the smart folks at Johns Hopkins to understand.

References

American Journal of Epidemiology. July 2004.
Poster session abstract: High-dose vitamin E supplementation may increase all-cause mortality, a dose response meta-analysis of randomized trials; Ernest N Morial Convention Center, Exhibit Hall 1-2.) TO BE PUBLISHED: Annals of Internal Medicine. Nov. 10, 2004. By Neil E. Levin, CCN, DANLA
Source: Elwood Richard,
President Now Foods elwood.richard@nowfoods.com