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A Reprieve for EU Vitamins and Minerals
First-round win against Codex
May 25, 2005 - A lawsuit brought by the Alliance of Natural Health (ANH) contesting the ban of over three hundred vitamin and mineral ingredients used in food supplements began in the High Courts of Justice in London in 2004. The case was referred to the European Courts of Justice in Luxembourg, where more than a year later, the Advocate General and senior advisor to all the European Court judges ruled in favor of the ANH.
Judge Geelhoeds' opinion is that the FSD is illegal under EU law. The FSD infringes the principle of proportionality, because basic principles of community law such as the requirements of legal protection and sound administration were not taken into account. In other words, the FSD's "Positive List" of permissible vitamins and minerals that excludes natural substances contained in five thousand products is perceived as too narrow, restrictive, and based on flawed science.
Dr. Robert Verkerk, executive director of the ANH, is delighted. "All that the ANH is campaigning and working cooperatively for is the right of consumers to have access to safe, natural healthcare and for legislation to be based on good science and good law." He said, "This is a great day for the tens of millions of people who believe passionately in the benefits of natural preventative healthcare." Verkerk believes overturning the FSD will set a precedent across Europe that assures the availability of food supplements and prevents their reclassification as drugs.
The European Court delivers its final judgment on the FSD in August 2005. The Advocate General's recommendations are generally adopted by the residual European Court Judges. If the ANH wins, this will scupper the long-term agenda of the Codex Alimentarius Commission to set legal standards for vitamins and minerals at very low doses across its 163 member countries. The Codex Alimentarius Commission is the body that draws up international food standards in conjunction with the Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO). Although these standards are supposed to be voluntary, they are nevertheless adopted by the World Trade Organisation (WTO), which levies draconian fines and sanctions on countries failing to comply with the rules.
"Harmonizing" standards of vitamins and minerals hands control of many traditional remedies over to the pharmaceutical companies and, in turn, to the supermarkets and big pharmacies. This would prevent independent companies and practitioners from supplying appropriate supplements for nutritional purposes to patients and consumers. Under the Human Medicinal Product Directive (HMPD), and the Traditional Medicinal Products Directive (TMPD) (a subset of the Pharmaceutical Directive), health claims made on dietary products will be outlawed.
Restrictions on natural products are widely seen as an encroachment on civil liberties and threaten some of the oldest traditional healthcare practices in the world, such as African, Ayurvedic, Chinese, Tibetan, and South American medicine, on which some eighty percent of the world's population are dependent. Codex guidelines for vitamin and mineral food supplements destroy effective remedies and give regulators the power to choose whichever product they want and call it a drug. Further proposals restricting amino acids, essential fatty acids, enzymes, plant extracts, and probiotics are planned for an expanded FSD scheduled for 2007.
The ANH points out that most of the natural forms of vitamins and minerals such as mixed carotenoids, vitamin E, folic acid, and selenium, along with the most digestible and safest forms of vitamin C and magnesium are excluded from the "Positive List." Conversely, some of the few vitamin and mineral forms associated with adverse effects are allowed; for example, iron in the form of ferrous sulphate that can cause stomach cramps and bowel problems. There is also concern that a ban on natural nutrients will encourage the use of synthetic alternatives and genetically modified (GM) substances in food supplements. Pharmaceutical giants have been buying up small vitamin and mineral companies recently. For example, Merck has acquired Lamberts, and Wyeth, a global pharmaceutical and biotechnology company, has bought Solgar.
In fact the drug companies have gained control of natural products altogether, through PharmaPrinting, the result of collaborations between PharmaPrint Inc. and the University of Miami. PharmaPrinting is a technology that isolates and measures the bioactivity of the active compounds of any plant or natural remedy and replicates it in the laboratory. These compounds are standardized as a pharmaceutical for government approval. Patents are currently pending on pharmaceutical versions of some of the most useful and widely available herbal remedies such as St John’s Wort (depression), Echinacea (immune function), ginkgo biloba (brain booster), saw palmetto (prostate function), and mistletoe (alternative cancer treatment). Even the dietary herb ginger is under patent for use as a treatment for motion sickness.
Under Good Manufacturing Practice (GMP), PharmaPrinting involves clinical trials costing up to $6.5 million per product and patent protection costing $0.5 million, which takes five years to complete. Investors are reluctant to commit to such costs unless market exclusivity is assured. One way of creating an exclusive market is to ban or invalidate natural remedies. The existing U.S. healthcare market, including health foods and drinks, is estimated to be worth $1.5 trillion. This staggering amount makes it a market worth manipulating. Synthetic supplements also provide a royalty to drug companies each time a patented product is purchased.
The Health Protection Branch (Canada's equivalent of the U.S.. FDA) has called for any product registered as a "natural therapeutic" to be registered as a drug. Fish oils (lubricating joints), cranberry capsules
(treating urinary problems), and hawthorn berries (for the heart) have all been issued with a DIN, a "Drug Identification Number," which costs $720. Without a DIN, natural products cannot be sold, and doing so is an offence under Canadian law. DIN entails still further costs: an annual licensing fee, GMP annual inspection, yearly assessment fees, foreign assessment fees, an analysis fee, and Health Protection Branch inspection fees.
Strict controls and fees are unwarranted for natural products with no record of adverse health effects in Canada. In contrast, conventional drugs kill six hundred hospital patients in Ontario alone, while prescription drugs are responsible for ten thousand deaths every year.
"Food as drugs" guidelines laid out by Codex were adopted by Australia, Denmark, Germany, and Norway, and many products have been co-opted by the pharmaceutical companies and repackaged as drugs. (See "European Directive against vitamins and minerals"). India has resisted Codex, so has Japan, Un the U.S., Congressman Ron Paul has put forward the Health Freedom Bill (HR 4004), which prevents the Federal Government from restricting the distribution of a dietary supplement or other nutritional food because the manufacturer makes health claims unapproved by the Food and Drug Administration (FDA).
The South African government also opposes Codex and highlights the role of vitamins and minerals in accordance with the World Health Organisation report, "Diet, Nutrition, and Prevention of Chronic Diseases" (2003). Codex rejects the report, despite its close links to the WHO. Dr. Manto Tshabalala-Msimang, South African health minister, told her department, "I would like to avoid the pitfall of putting such products in the same regulatory environment as pharmaceutical drugs, whose testing and control is very different." She allocated six million rand into testing the safety and quality of traditional medicines used as immune boosters by people living with "Nutritionally Acquired Immune Deficiency Syndrome (NAIDS)," usually referred to as HIV/AIDS.
Recent action by the WHO, UNICEF, and an AIDS activist group promoting drug therapy in South Africa attack vitamin therapy that exceeds Recommended Daily Allowance (RDA).
In Unravelling AIDS, a new book from ISIS published later this year, we examine how numerous essential nutrients are effective in preventing and treating NAIDS, HIV/AIDS, and other chronic diseases. The WHO and the United Nations (UNICEF) appear to be backing the sole use of drug therapy at a time when drug-resistant strains of HIV are on the increase.
ISIS opposes the Codex agenda of restricting access to natural products by treating them as pharmaceutical drugs. It takes away our rights to food and health-promoting nutrition, and allows the pharmaceutical corporations to profit from pirating and expropriating herbal remedies that have been the mainstay of traditional healthcare systems for millennia.
The Institute of Science in Society, PO Box 32097, London, England NW1 OXR. This article can be found on the I-SIS website.
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