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Health Supplements ALERT
August 3, 2004

Is your government doing enough to protect you from! the dangers of vitamin supplements? The absurdity of that question would be comical if it weren't the basis of an international drive to severely limit our access to dietary supplements.

In yesterday's e-Alert I gave you some background on the "European Union Directive on Dietary Supplements" that will become law in August of 2005. Among the 25 European Union (EU) nations (representing more than 450 million people), this directive reclassifies vitamin supplements as "medical drugs," mandates low dosage levels, and outlaws many supplement ingredients that are currently widely available. Created to "protect" consumers, the directive will do exactly the opposite by denying consumers access to natural therapeutic supplements.

But don't think you're off the hook if you live outside the EU. Plans are already underway to bring these extreme regulations to the U.S. and many other countries.

Trying to stay positive

Under the EU directive, a "positive list" has been created to mandate which dietary supplements will be allowed for sale. The list does not include about 350 supplement ingredients, such as boron, a mineral that helps manage symptoms of menopause.

So if you're a supplement manufacturer in an EU country, and you produce a supplement that contains boron, you'll be required to remove it from the supplement by August 2005. But there is another option. You can submit a "technical dossier" to argue the case that a particular ingredient (such as boron) should be included on the positive list. Ah, but there's a catch: The European Commission has made this process so expensive and time consuming that many manufacturers simply can't afford the costs involved. As a result, many safe formulas and nutrients that have been on the ! market for decades will soon be banned.

But wait... it gets worse

The positive list isn't really as positive as it sounds.

For instance: Vitamin E made it on the positive list. Sort of. As HSI Panelist Allan Spreen, M.D., has made clear in several e- Alerts, there are a number of different vitamin E forms, and the synthetic form should be avoided for internal use. But according to Euromonitor International, the ONLY form of vitamin E on the positive list is the synthetic form.

And then there's selenium. Besides the fact that selenium has excellent antioxidant properties that have been shown to help increase insulin efficiency, selenium also enhances the effect of vitamin E, making it a perfect match for any vitamin E regimen. But the only two forms of selenium that made the positive list are - yep - synthetic forms.

Wondering why the positive list emphasizes synthetics? I'll answer that question with another question: What sort of company specializes in manufacturing synthetic forms of natural treatments?

You already saw it coming, didn't you? The answer: pharmaceutical companies. Large drug companies can easily produce synthetic ingredients at low cost. So the positive list will certainly be positive for drug companies, while many small manufacturers of natural supplements will be forced out of business.

Decoding Codex

The outlook for the future of dietary supplements in Europe is decidedly gloomy. But if you're a U.S. citizen you might be wondering how all of this will affect you. In fact, the 2005 implementation of the EU directive won't directly affect consumers outside the EU. But the U.S. and the EU are both members of a much larger club.

The U.S. is one of the 165 member countries of the Codex Alimentarius Commission - an international food standards program created by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). One of the purposes of the Codex Commission is to "harmonize" international food trade. And here are a few key elements of that harmonizing:

* WHO regards all dietary supplements as "drugs" * The Codex Commission has made it clear that it wants to limit over-the-counter sales of dietary supplements while reclassifying others as pharmaceuticals, available only through a pharmacist

* The U.S. has one vote on the Codex Commission. The European Union represents 27 votes on the commission: the 25 votes of its member countries and 2 votes of the 2 EU candidate countries

* Under World Trade! Organization (WTO) rules, Codex decisions override decisio ns of individual countries

* Member countries (including the U.S.) that refuse to "harmonize" with WTO directives may be subject to restrictive trade sanctions

* The European Union is the United States' largest trade and investment partner, with a yearly two-way trade in goods and services that is estimated to be nearly $600 billion

"Harmony" never sounded so awful.

Securing the Homeland

The remarkably harsh restrictions of the EU directive on Dietary Supplements have met with an enormous protest from people who correctly see this process as an infringement on their right to make their own health care choices. This past February, the High Court in London ruled that a case challenging the directive should be referred to the European Court - the only court with the authority to challenge EU directives. Exactly when that court will hand down a ruling is not known. What is known is that the decision will have a profound effect on the availability of dietary supplements in Europe and beyond.

Meanwhile, back on the other side of the Atlantic, many congressmen and pro pharmaceutical organizations have been calling for more restrictive regulations of supplements. So there's no time to waste in letting our legislators know that we don't want to see any form of the EU directive taking effect in the U.S.

A complete list of government e-mail and postal addresses is available at a web site called

Send a message to your congressmen and let them know that we want no part of international "harmonizing" that restricts our access to supplements. And most importantly, tell them that you don't need any government or international organizations to "protect" you from your personal health care choices.

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