ISIS Report 31/08/05

Compromise on EU Vitamins and Minerals

A legal challenge to overturn the EU’s controversial Food Supplements Directive is over, but the corporate takeover of herbal medicine and natural remedies continues. Sam Burcher

A fully referenced version of this article is posted on ISIS members’ website. Details here

EU Directive upheld with key provisions

The European Court’s final judgment on the European Food Standard Directive (FSD) was delivered in July 2005.  The Alliance of Natural Health (ANH) and many thousands of their supporters had hoped the opinion of the Advocate General given a few months previously, would be upheld by the rest of the European Court judges [1].  It was his opinion that the FSD is invalid under EU law and as “transparent as a black box”. The European court judges usually follow the Advocate General’s advice, but not in this case.

The ANH is a pan-European and international organisation of supplement manufacturers, retailers, practitioners and consumers. They began their landmark challenge of the EU Directive at the High Court in London in 2004.  Two hearings at The European Courts of Justice followed; the first ruled in their favour and the second against them.  The ANH are now satisfied, nevertheless, that their main concerns have been addressed without invalidating the Directive; and that this has been achieved through a process of legislation, which has provided a win-win situation.

The ANH chief executive, Dr Robert Verkerk said, “The Court has made clear some key provisions of the Directive (see Box 1), which massively reduce the difficulty of getting onto the once-feared ‘Positive List’” [2]. The Positive List excludes many natural and organic forms of selenium, vitamin C, vitamin E, and boron and calcium that strengthen bones. (See “European Directive Against Vitamins and Minerals” http://www.i-sis.org.uk/vitamins2.php or SIS 20) [3]. Verkerk is confident that the simplified requirements for getting onto the ‘Positive List’ will no longer constitute a barrier for those ingredients allowed in food supplements.

Thousands of health products saved from European ban

Had the Court not accepted the legal challenge and the key arguments against the Directive, seventy five percent of supplementary vitamin and mineral ingredients found in five thousand natural health products would have been banned on 1 August 2005.

The Health Food Manufacturers Association (HFMA), the National Association of Health Stores (NAHS) and Consumers for Health Choice (CHC) felt, however, that the legal challenge did not go far enough. Together they began a process of “national derogation” (a ‘subsidiarity’ in legal parlance), which will allow ingredients used in food supplements prior to 2003 to continue until at least 31 December 2009. The Directive and the Food Standards Agency have accepted the derogation dossiers. Now the HFMA hopes to protect the interests of the UK food supplements industry by enlisting the support of ministers and PM Tony Blair while he holds the six-month rotating EU Presidency [4].

The fight is by no means over; it has moved to the international arena of the Codex Alimentarius Commission.

Europe holds the decisive vote in Codex

The Codex Alimentarius Commission is the body set up in 1963 to set international food standards in conjunction with the Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO) [5]. Codex Alimentarius means “food code” and the Commission covers other important aspects of food trade such as GMOs, and pesticides and hormone residues in food. Although these standards are supposed to be voluntary, they are nevertheless adopted by the World Trade Organisation (WTO), which levies draconian fines and sanctions to countries failing to comply with their rules, which are anything but fair.

Codex international standards for vitamins and mineral do not override national legislation, but do provide national governments with a blueprint for domestic vitamin and mineral regulation more restrictive the American dietary supplement law.  The guidelines are fraught with risks for consumers and producers alike.  As nations begin to adopt laws that embrace the guidelines, in order to avoid losing international trade disputes, there is risk that the world market in supplements will level off at a relatively few, low potency products.

If markets shrink then pressure will bear on the US supplements industry advocates to adjust its laws to international standards.  And critics fear that Industry will have little commercial incentive to keep resisting Codex. [6].

Consumers for Health Choice (CHC) cite the EU as the single most important influence on Codex decision-making [7].  Basil Mathioudakis, who drafted the EU Directive on behalf of Codex, also heads the EU Commission delegation at the Codex meetings on Nutrition and Foods for Special Dietary Uses. In May 2004, ten new candidate countries joined the EU, and Mathioudakis represents all twenty five-member states at the Codex meetings.  When he votes, the other twenty-five member states are unable to do so.  Essentially, the European block vote covered almost fifty percent of attending countries. The 28^th meeting of the Codex Alimentarius Commission met in Rome just one week before the European Court judges gave their final decision on the EU Directive, and voted to accept the Codex restrictive guidelines on vitamins and minerals.

To counter Codex’s restrictive guidelines on the supplements market in the US, Congressperson 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 on the grounds that the manufacturer makes health claims unapproved by the Food and Drug Administration (FDA).

Natural medicines under threat

“Harmonising” standards of vitamins and minerals internationally effectively hands control of many traditional remedies over to the pharmaceutical companies and, in turn, to supermarkets and pharmacies [8]. This would prevent independent companies and practitioners 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 EU Pharmaceutical Directive) due to come into force later this year, health claims made on dietary products will be outlawed.

Restrictions on natural products are widely seen as an encroachment on civil liberties and ultimately threaten some of the oldest traditional health practices in the world, such as Ayurveda, Tibetan, Chinese and tribal medicines, on which some eighty percent of the worlds’ population depend [9]. Codex guidelines on maximum dosages for vitamins and mineral food supplements destroy effective remedies and give regulators the power to choose which product they want to call a drug.  Further proposals restricting amino acids, essential fatty acids, enzymes, plant extracts and probiotics are planned for an expanded EU FSD scheduled for 2007.

Corporate feudalism fuelled by patents and fees

A further concern is that restricting natural forms of nutrients will encourage the use of synthetic alternatives and genetically modified (GM) substances in food supplements. Pharmaceutical giants have been buying up vitamin and mineral companies recently.  For example Merck has acquired Lamberts, while Wyeth, a global pharmaceutical and biotechnology company, has bought Solgar.

In fact, the drug companies have gained control of food supplements through PharmaPrinting, the result of collaboration between PharmaPrint Inc and the University of Miami [10]. Pharmaprinting is a technology that isolates and measures the bioactivity of an active compound of any plant or natural remedy and replicates it in a laboratory. These compounds are standardised as a pharmaceutical for government approval.  Patents are currently pending on pharmaceutical versions of some of the most useful herbal remedies such as St Johns Wort, (depression) Echinacea, (immune function) Ginkgo biloba, (brain booster) Saw Palmetto (prostate function) and Mistletoe (alternative cancer treatment).

Under Good Manufacturing Practice in the US, Pharmaprinting carries out clinical trials costing up to $6.5 million per product and patent protection costing $0.5million that 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 remove natural remedies. The existing US healthcare market including health foods and drinks is estimated to be worth $1.5 trillion. This staggering amount makes it a market worth manipulating.  Patented food supplements would also provide a royalty to drug companies each time a patented product is purchased.

Foods are not drugs

 “Food as drugs” guidelines laid out by Codex were adopted by Australia, Denmark, Germany and Norway and many products have been co-opted by pharmaceutical companies and repackaged as drugs.  The Health Protection Branch (Canada’s equivalent to the US FDA) has already registered “natural therapeutic” food products as drugs.  Fish oil (lubricating joints), cranberry capsules (for urinary problems) and hawthorn berries (for the heart) have all been issued with a “Drug Identification Number” (DIN), at a cost of $720 per product, plus annual fees [11]. This is a thoroughly disproportionate degree of “protection” costs imposed on what are in effect harmless food items, especially when conventional drugs kill six hundred hospital patients in Ontario every year, with a further ten thousand deaths attributable to prescription drugs [12].

The South African government is actively opposing Codex guidelines. They highlight the role of vitamins and minerals in accordance with the World Health Organisation, “Diet, Nutrition, and Prevention of Chronic Diseases” (2003).  Dr Manto Tshabalala-Msimang, South African Health Minister has recently allocated Rand 6 million to 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 [12].

New paradigm needed for health

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 [13]. 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, and the toxicity of these drugs are becoming more and more evident.

Jim Turner, the general counsel to The Weston A. Price Foundation, a charity that disseminates knowledge on nutrition [14], believes that Codex and the EU Directive on food supplements derive from the same basic reductionist model of western science that argues that pharmaceuticals are the only answer to health problems.  World food experts refute this model by stating that natural vitamin A supplements can offer developing countries thirty times as much social improvement as one dollar of development aid.

Turner recommends that vitamin and mineral guidelines should be evaluated by nutritional science rather than the toxicological science used to evaluate toxins. Codex categorically states that nutrients should be treated as toxins and that foods and nutrients are not useful in treating disease and therefore supplements are of little value. 

Dr Robert Verkerk of the ANH agrees with Turners views [15]. He believes that a new paradigm for safety/benefit analysis is needed specifically for nutrients and has commissioned the Netherlands-based HAN Foundation to come up with a new framework that could be used in the EU and internationally through Codex.

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