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Life Extension Magazine

LE Magazine July 2003

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Europe Threatening To Ban Dietary Supplements
International Assistance Needed To
Stop Draconian EU Vitamin Laws

By John C. Hammell, President
International Advocates for Health Freedom
http://www.iahf.com

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Poster for the Health Freedom Movement

Currently under consideration in Europe is legislation that will severely limit a consumer’s right to choose and use supplements. This restrictive legislation is the first major step towards the adoption of global standards for the regulation of dietary supplements, as is being worked on at the UN’s Codex Alimentarius Commission. Since the U.S. is part of this process and is a member of the World Trade Organization, the U.S. could be forced to harmonize its vitamin laws with these new, highly restrictive international standards.

In an effort to stop this punitive legislation, the Alliance for Natural Health (ANH), an organization based in England, is planning to file an emergency lawsuit on behalf of consumers, vitamin companies and health food stores to overturn the European Union (EU) Food Supplements Directive, which became law on June 10, 2002. The Food Supplements Directive (FDS), currently concerns itself only with vitamins and minerals. However, by the year 2007 the European Union (EU) will be obliged to provide detailed proposals to expand the law to cover all other types of nutrients. Eventually this will force vitamin companies to reformulate their most important supplements. Although the 13 key vitamins would be permitted, the Directive excludes the most bioavailable forms of vitamin complexes. For example, The Food Supplement Directive bans any chelated or other organically complexed mineral forms such as selenomethionine. Additionally, it will only allow the alpha-tocopherols of Vitamin E but excludes the complete tocopherol range as found in nature (including the gamma-tocopherols), which are far more effective as antioxidants than the simpler alpha-tocopherol group. Research has proven that many vitamins and minerals are most bioavailable when in the forms found in nature. Unless the current Directive is overturned, many Life Extension products will be banned, and the Foundation will be forced to either cease selling particular products in Europe or will be forced to reformulate their scientifically-balanced products.

Replacing them would be vitamins that are less bio-available, potentially more toxic and better suited to the pharmaceutical industry affiliated supplement companies. In other cases, entire minerals such as boron, sulphur and vandadium would have to be removed as they would not be allowed under the new EU law. If this law is not overturned in July 2003 then it will become the national law of all European Union member states including England, Ireland, Netherlands and Sweden, which currently have liberal vitamin laws similar to those of the United States. Along with the Food Supplements Directive, is the additional threat of the Traditional Herbal Medicinal Products Directive which would impose medicinal law on herbs and other so-called borderline supplements. Both of these Directives would severely limit any chance for individuals to oversee their heath as they so choose.

TAKING IT TO THE STREETS

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Veteran health freedom advocate Clinton Ray Miller (left) and Bonnie Miller advise ANH Attorney David Hinde on defending vitamin access world wide.

On June 15th, the UK-based Health Freedom Movement (HFM) (http://www.healthfreedommovement.com), a consortium of more than 700 health freedom organizations, will be holding a street march and health freedom rally in central London in opposition to England harmonizing their vitamin law to the Food Supplements Directive. The march will go from Hyde Park to Trafalgar Square. Lynne McTaggart of HFM told me in an interview that she hopes to carry a message to the government and to the EU that the FSD is totally unacceptable. She also hopes to generate donations for the Alliance for Natural Health, a non-profit organization seeking ways to change, reshape or revoke laws affecting dietary supplement consumers, practitioners and manufacturers in Europe. As publisher of What Doctors Don’t Tell You, the UK’s leading alternative medical newsletter, McTaggart, who is in constant contact with alternative practitioners, supplement manufacturers and consumers, is painfully aware of what is at stake with this pending legislation. She wants American vitamin companies and consumers to be aware that, “will we, along with future generations be deprived of access to the most innovative dietary supplements currently on the market including many of the Life Extension Foundation’s products? Will the Foundation be forced to reformulate Life Extension Mix by removing all the most bio-available, effective and natural-state nutrients? Will the Foundation be blocked from selling life-saving products due to future harmonization to a grossly restrictive international standard? We stand at a crossroad—the fate of this global industry is literally in all of our hands right now. We sink, or swim, together. This is the battle for The Dietary Supplement Health and Education Act (DSHEA) all over again, but this time on a world stage.” We can be negatively impacted here via the mechanisms of globalization unless we actively assist our international allies. Those who think DSHEA posed the ultimate bulwark against the Pharma Cartel are sadly mistaken.

Summary of key European legislation affecting dietary supplements

 

Food Supplements Directive (FSD)

Pharmaceuticals Directive (PD)

Traditional Herbal Medicinal Products Directive (THMPD)

Status

Passed into EU law 10 June 2002

First Reading 23 October 2002

First Reading 21 November 2002

Impact

Limits ingredients (nutrient sources) and maximum dosages.
Framework structure; only applies to vitamins and minerals at present, will cover other nutrients in future. Full impact will not be felt until 2005 - 2009. Is likely to omit 285 nutrient sources that are currently used in Europe. Improved prospects for trade between European countries.

All dietary supplements that are not controlled under FSD will be controlled under PD. A drugs regime would therefore apply and this would not be affordable for many non-pharmaceutical-owned supplement manufacturers.

A derogation of PD which allows fast-track legislation for eligible herbal products. The number of products caught will ultimately depend on PD definition of a medicine. Allows for improved labelling and quality control of medicinal herbs.

Potential for improvements to Directive

Can affect implementation in EU member states through national authorities.
Can influence maximum permitted levels of nutrients. Consider challenging entire legality of directive.

Can alter the definition of a medicine, as well as scope of directive, to ensure that most dietary supplements cannot fall under PD.
Can positively exclude non-medicinal food supplements, herbs and cosmetics.

First Reading amendments allow for combinations of herbs and nutrients, but make ineligible herbs that have less than 10 years use in EU.
Can promote amendments for Second Reading which allow traditional (e.g. 30-year) use from outside the EU with evidence from a competent authority.

Summary of ANH achievements in 2002

Mounted Brussels and UK-based campaign which helped to almost block FSD's passage through Second (final) Reading in EU Parliament.

Lobbied to ensure tabling of critical amendments on definition of a medicine, scope of directive and exclusions. All amendments successfully voted for at First Reading.

Lobbied to help ensure major amendments were supported. Key amendment on non-EU traditional use was lost in pre-First Reading vote but successfully re-tabled by European Liberal Democrats at First Reading plenary. Although it again failed, it can be re-tabled at Second Reading.

Source: Alliance for Natural Health Newsletter, March 2003.

Recently I spoke at the Vitality Vitamin Trade Show in England before a group of alternative medical practitioners and consumers who form the backbone of the growing European health freedom movement. My concern is that these latest directives threaten to force the creation of a draconian vitamin standard at the UN’s Codex Alimentarius Commission. What is especially troubling is that due to America’s membership in the Word Trade Organizatoin, the United States could be forced to harmonize its vitamin laws to this emerging restrictive international standard.

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