Part One: A storm is brewing…
The future of each nation’s natural health industry, nutritional innovation and each individual’s personal freedom of choice regarding access to a wide range of vitamin supplements, amino acids, herbs and ancient and modern traditional medicines, appears with little doubt to be at genuine risk in the not-too-distant future. One can later speculate and even try to reason the intentions and motivations that have brought about this situation; however, it is certain that the situation exists and is no accident of circumstances.
This article will attempt to explain, document, and clarify the actual situation by separating the facts from numerous assertions, biased interpretations, and short-sighted solutions being attempted.
The situation we face is primarily the result of a series of apparently unrelated, but in fact, well-coordinated and complex events; executed slowly over time in incremental steps. It is a situation driven by vested interests, implemented by cooperating foreign and national governmental representatives, agencies, and legislative bodies, and fully upheld by a number of international trade agreements signed by heads of state.
While much confusion, conflicting opinion, and even heated argument exist as to the legal relevance and potential influence of “Codex Alimentarius” (Codex) to the future of vitamin supplements, herbs, amino acids, and many widely accepted forms of traditional medicines, the story does not begin in the Americas.
It began in the European Union
In Europe, the European Food Supplement’s Directive was legislated and brought into law in 2002. The EU Food Supplements Directive was then upheld in the European Court of Justice despite fierce legal challenges by watchdog organizations within the natural health community in 2005.
These unnecessary and severely restrictive pieces of European legislation are now in various stages of clarification, finalization, and implementation throughout the European Union.
In summary, the EU Food Supplements Directive will:
(a) Eliminate (completely ban) almost two-in-every-three currently available vitamin substances, amino acids, herbs; and traditional medicines;
(b) Dramatically reduce dosage levels to newly established Maximum Permitted Levels (MPLs), based on a severely flawed procedure for assessing risk (no consideration is even given to existing benefits) and directly influenced by pharmaceutical industry participants;
(c) Reclassify the remaining “allowable” vitamin substances as medicine;
(d) Severely censor what the industry itself or any practitioner can promote, publish, or say about their mental or physiological influence.
Amino acids, herbs, Ayurvedic and other long-accepted, traditional health remedies are also under the EU Food Supplements Directive’s legislative control.
Natural products and vitamin substances that have not been approved, or those of manufacturers who fail to provide adequate and fully documented dossiers to the authorized governing bodies, will begin to be removed from the shelves in shops and websites throughout Europe in the months to come.
It is important to note that we are not reporting on a few “snake oil” or “miracle water” bottles. This is really not a massive attempt to protect consumers against the few undesirable “con artists” in this industry. No, we’re actually reporting on the fact that nearly 2/3rds of currently available and perfectly valid natural products have been unequivocally banned by the EU Food Supplements Directive and will soon be pulled from the shelves throughout Europe.
· Nearly the entire spectrum of natural vitamin E, including gamma tocopherols and tocotrienols
· Mixed, natural spectrum of carotenoids
· All forms of Boron
· 14 different forms of Selenium, including selenium yeast products
· 23 different food forms of Calcium
· Colloidal or ionic trace elements derived from natural sources
· 21 food forms of Iron including iron-based yeast
· 30 different forms of Magnesium
· 21 different forms of Potassium
· Molybdenum – 15 forms of amino acid chelate
… and many other natural substances already proven to be effective.
In fact, a detailed list of the remaining allowable vitamin substances, known as the Approved List” should leave many food supplement manufacturers, health practitioners and consumers quite distressed over the obvious and severe limitations and impact it will have on viable and beneficial existing products – let alone its impact on continued research and innovation.
High Dose Supplements
While food-based (normally low-dose) products appear to have been spared from outright banning by the EU Food Supplements Directive, there are three important points to think about;
1. The EU Food Supplements Directive will eliminate High-dose supplements through the establishment of (upper safe) Maximum Permitted Levels (MPLs). Based on faulty risk-assessment evaluation, the “MPLs” will dramatically reduce legal dosage levels to nearly placebo levels.
2. Even the low-dose, food-based supplementation, herbs, and other (natural) nutritional substances are targeted to be re-classified as medicine by the EU FOOD SUPPLEMENTS DIRECTIVE’s Human Medicinal Products Directive.
This Directive asserts that any product, even a food or food supplement, which has a physiological effect on the body, can be classified as a drug by the regulators.
3. The Nutrition and Health Claims Regulation, an integral part of the EU Food Supplement’s Directive, will severely censor what can actually be said, promoted or advertised about mental or physiological benefits of nutritional supplements.
What about “Sovereign” nations?
The EU FOOD SUPPLEMENTS DIRECTIVE may very well be the law now, but it certainly will only affect Europe. And while other countries might sympathize with the fate of the European natural health industry, it doesn’t really have anything to do with the U.S. or other countries outside of Europe.
…or does it?
Note: Links to all documentation available at the http://WINHS.ORG web site