Will the EU ban natural supplements?
Currently under consideration in Europe is legislation that will severely limit a consumer's right to choose and use supplements. The "European Union Directive on Dietary Supplements" is poised to become law in August 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.

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 currently in use. This follows the "European Union (EU) Food Supplements Directive", which became law on June 10, 2002. The Food Supplements Directive (FDS) 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, rather than a synthetic form.

Unless the Directive is overturned, many current natural products will be banned, and companies will be forced to either cease selling particular products in Europe or will be forced to reformulate scientifically-balanced products.

An example is boron, a mineral that helps prevent and treat osteoporosis. Since boron is not on the "positive list", it will be banned. Furthermore, any products that contain boron along with other ingredients will need to be reformulated, unless a company wants to embark on an expensive and time consuming process to convince the European Commission of the benefits and safety of boron. Because boron is a natural chemical, the companies that currently produce it do not have any patent protection, like the big pharmaceutical companies have on their prescription drugs, allowing them to have a monopoly on the drug and charge high prices for it. This makes it unlikely that producers of natural supplements would have the financial means to prove undergo the drug-approval process.

A similar process is occurring in the United States. In 2003 the U.S.Food and Drug Administration (FDA) contracted the National Academy of Science to prepare a report and draft "safety monographs" for several of the top selling, most effective dietary supplements: saw palmetto, chaparral, chromium picolinate, melatonin, DHEA and shark cartilage. This analysis will eventually be applied to all dietary supplement nutrients under a three-stage process, which in its final stage is very similar to the stringent evaluation process for pharmaceuticals referred to as a "critical safety evaluation." In time, the FDA wants all supplement ingredients to go through this third, most onerous route, as well as any new ingredients, regardless of how closely related it is to other well-known, safe ingredients.

It is clear that pharmaceutical companies in the United States and Europe want to limit the public's access to natural supplements. And this is a movement that is occurring in other places in the world.

In July 2003 over 1300 dietary supplement product lines were banned by the Australian TGA (Therapeutic Goods Administration) due to a recall under highly suspicious circumstances. This caused 80% of the stock of Australian health food stores to be pulled from the shelves while the media advised consumers to stop taking their dietary supplements.

World government control of natural supplements

The restrictive EU 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. The Codex Alimentarius Commission is the international body charged with setting global food standards, and is jointly sponsored by the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex Alimentarius literally means "food code", and the Commission was set up in 1963 to protect the health of consumers, ensure fair practices in international food trade and to co-ordinate all international food standards work.

Codex is attempting to pass a variation on the EU Food Supplements Directive as the blueprint for the global regulation of food supplements. Member countries that refuse to "harmonize" with WTO directives may be subject to restrictive trade sanctions.

Of the 48 countries that attended the previous meeting of the "Codex Committee on Nutrition and Foods for Special Dietary Uses" in November 2003, only one of them, South Africa, is actively opposing these restrictive proposals for the world-wide availability of vitamins and mineral supplements.

The EU, with its soon-to-be population of 450 million people, is allowed 25 votes at Codex. The United States, with its population of over 280 million people, should proportionately be given at least 15 votes. Under the Codex voting system, however, the United States is only allowed one vote.

The "positive list" of "admissible" vitamins and minerals is being challenged in the European Court of Justice by the Alliance for Natural Health, a pan European group of concerned dietary supplement consumers, manufacturers, and alternative practitioners who have widespread international support for their work. They hope to overturn EU Directive 2002/46/EC on the grounds that it violates European law by arbitrarily, and without any scientific justification, blocking the sale of nearly 300 safe ingredients which have been in use in dietary supplements for decades in Britain and around the world. They contend that the European Food Supplement Directive is supposed to expand the sale of dietary supplements, when in reality, the so called "Positive" list actually has the opposite effect--- of arbitrarily and capriciously redicing the number, kinds, and potencies of products allowed to be sold, and wholly without just cause based on sound science.

The UK High Court has referred this and another case challenging the legality of the ban to the European Court of Justice in Luxembourg.

A meeting was scheduled in Bonn, Germany on November 1, 2004 to possibly finalize the Codex vitamin and mineral restrictions. Even if the legal challenges to the EU Food Supplements Directive are successful the Codex proposals could still be implemented as the global standard, thus effectively overruling any short-term victory for health freedom in the EU. As such, a finalized Codex text would have the ability to override the dietary supplement laws of all countries, including the United States.

I have attempted to find out what occurred at the November 1 meeting, and it appears that the Codex vitamin standard was passed along with a framework that intends to "fill in the blanks" on allowable potency levels for vitamins later. A "working group on Risk Analysis" is being chaired by Australia for that purpose.

In September 2004, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) announced a "joint nutrient risk assessment project" intended to define a scientifically-based and internationally applicable approach for "nutrient risk assessment". The work will provide scientific advice on the principles and methodologies to be used in conducting risk assessments for nutrients and related substances. A key component of the project is the development of an interdisciplinary technical workshop tasked with (i) identifying an international general approach for nutrient risk assessment as well as (ii) demonstrating the application of the approach through the development of upper levels for selected vitamins and minerals. It is anticipated that the workshop will be scheduled for May 2005. For more information see http://www.who.int/ipcs/highlights/...ntraproject/en/.

I have tried to get more updated information on this topic but found it difficult. The best source I could find is International Advocates for Health Freedom at www.iahf.com. I was disappointed to find the information on this website rather disorganized and unclear, and interspersed with activist sensationalism that I shy away from. However, there are some links to additional information, such as a very interesting article by Alan Gaby, M.D. that was published in the Journal of Orthomoleculalr Medicine Vol 18, 3rd and 4th quarters 2003, No. 3 & 4, titled, "Safe Upper Levels for Nutritional Supplements: One Giant Step Backward." You can find this article at http://www.iahf.com/20040127.html (it starts in the middle of the page). The author points out the scientific error in defining an "upper limit" of a nutrient based on safety without regard to benefit, and how this will impact the ability of the public to receive health benefits from natural supplements

http://www.theidealdiet.com/newslet...04WWZ/Nov04.htm