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ISIS Report 13/01/2003

Hands Off Vitamins and Herbs

Visits to Complementary Alternative Medicine practitioners throughout Europe outnumber those to doctors by two to one. Government figures show UK citizens spend £70 million per year on nutritional supplements and about 20% of the population use vitamins and minerals in their diets. But European Parliament Directives passed in March 2002 will ban food supplements, in a bid to re-classify them as medical drugs. Sam Burcher reports.

The complete document with references, is available in the ISIS members site. Full details here

Criticism is mounting for what is seen as an "over the top" move by pharmaceutical companies to take firmer control of the lucrative health promotion and disease prevention markets. More than 6 million people have protested against these Directives (see box) by signing the largest on-line global petition ever (, demanding continued freedom to access natural remedies.

Fears that high-strength multivitamins and minerals will only be available on prescription are not unfounded. A spokesperson from the Alliance for Natural Health (ANH) said, "the freedom of consumers to make their own informed choices is massively reduced."

Present regulations governing high-dose vitamins for long-term use are governed in the UK by the Department of Health and advised by Council for Responsible Nutrition (CRN) and the Expert Panel on Vitamins and Minerals. Long-term use is essential for many needing extra vitamins and minerals, as in the case of osteoporosis, a debilitating bone disease that affects 1-3 women and 1-12 men at some point in their lifetime. Key minerals boron and sulphur are amongst those targeted by the Directives. Boron boosts vitamin D production and is combined with calcium for bone maintenance, while sulphur eases joint stiffness and arthritic pain.

A total of 300 "over the counter pills" are likely to be axed by the EU Science Commission for Foods, a body of scientists unaccountable to any government or parliament. They have already greatly limited the amount of vitamins and minerals available and will be seeking to set the absolute minimum Recommended Daily Allowance (RDA)

Dr Mark Atkinson of the Complementary Medical Association believes the stricter proposals will discourage people from managing their own health. He is also concerned that lowering levels of RDA for vitamins such as B6 to below 25mg per day will render them "useless".

The EU Directives Targeting Vitamins & Drugs

Food Supplements Directive: Sets maximum RDA for vitamins and minerals. This standard (dating from World War II) states the minimum dose needed to prevent malnutrition. Up-to-date research focuses on much larger doses that actively promote health rather than just prevent disease. These are known as SONAs or Suggested Optimal Nutritional Allowances. The difference between the two is significant. A person who has a disease such as osteoarthritis (painful swelling of joints) could benefit from up to 100mg of vitamin B6 per day, while the RDA is 6mg.

Traditional Medicinal Products Directive: Herbal remedies can only be licensed once shown to be safe and produced to high standards. This puts them through the same regulatory tests as pharmaceutical drugs, at estimated costs for licenses ranging from £10,000 to millions of pounds. It would deter all but the largest companies from producing well-used herbal remedies such as St Johns Wort, Ginkgo Biloba, Red Clover and Oil of Evening Primrose. To qualify, products must have been on the global market since 1973 and in Europe for 15 years, thus discriminating against development of any new herbal discoveries. At a time when our search for alternatives to antibiotic-resistant pathogens is likely to focus on natural anti-microbials, restrictions on traditional medicine could prove hazardous.

Novel Foods Directive: Already in force and originally designed to regulate genetically modified foods, it now applies to everything sold under food law, including supplements. Foods that were not on the EU market before May 1997 cannot now be granted approval without submitting a vast dossier of technical and safety data. Manufacturers unable to do so will have products taken off the market.

EU Medicines Directive: Under EU definitions, products sold in a health store, including herbal teas, could be re-classified as drugs, whilst other items with physiological effects e.g. fruit juices and coffee for sale elsewhere are unaffected. The new law states that a product must be either food or drugs. Currently, the UK Medicines Control Agency adjudicates over which is which and earns 95% of its budget from licensing supplements.

Complementary and Alternative Medicine (CAM) practitioners were not consulted by the European Commission about nutritional supplements and were also unable to make statements to Parliament on the impact the Directives would have on their work or the availability of therapy. Products must be re-labelled with warnings of possible side effects and mandatory dose instructions to standardize supplements across Europe by 2005. CAM producers will be hardest hit with big financial outlays to register products, thus threatening small to medium businesses.

The battle to keep vitamins "free" was won in the US when the Dietary Supplement Health and Education Act (DSHEA) 1994 was passed. However, two years later the UN Codex Alimentarius Commission sought to outlaw vitamins on a worldwide scale, but was defeated by mass protest. Meanwhile, the US Food and Drug Administration (FDA) weakened the DSHEA by redefining certain structure and function regulations, suppressing information on supplements, classifying vitamins as "drugs" and insisting on "drug approval". Registration of such "drugs" would cost $100 million per product.

The Consumer Health Free Speech Act was reintroduced to prevent supplements from being removed from the market unless there was "significant or unreasonable risk of illness or injury." In 1999, the Circuit Court of Appeals in Washington ruled that the FDA’s suppression of health claims for nutritional supplements was unlawful and unconstitutional.

In Europe, the Directives are likely to affect higher dose multi-vitamins, most containing some vitamin C, easily destroyed in the cooking process. Vitamin C strengthens the immune system, assists in wound healing, and is an essential cofactor for enzymes involved in synthesis of collagen, the primary structural protein in connectives tissues such as bones, cartilage and skin.

Vitamin C at higher than RDA levels (60mg) from foods and/or supplements has been shown to reduce risk of cancers and cataracts. The safety of higher than RDA intakes is confirmed in eight placebo-controlled, double blind studies and six non-placebo clinical trials where up to 10,000mg of vitamin C was consumed daily for up to three years without adverse effect. Moreover, higher than RDA intakes of vitamin C have been associated with lowered cardiovascular disease, blood pressure and cardiovascular mortality.

After Dr Linus Pauling (twice Nobel Prize winner) published his book on vitamin C in the 1970's, mortality from heart disease in the US decreased from 741,000 deaths per year to less than 500,000 deaths by 1986.

At Arizona University, the Panel on Dietary Antioxidant and Related Compounds of the Food and Nutrition Board of the Institute of Medicine analysed evidence of high-dose vitamin C intake and concluded that very high intakes of vitamin C, e.g. 2-4g/day, are well tolerated in healthy mammalian systems.

Numerous scientific studies over the past thirty years have proved vitamin C’s positive effects on health. But last year, Science published a paper suggesting that vitamin C has carcinogenic properties. The ex-vivo study added ascorbic acid to solutions of food-derived fatty acids found in human blood, which may be converted into genotoxins that may in turn damage DNA, but admits "it is far from conclusive that this is cancer-causing".

A study in 2000 measured the effects of 260mg per day of vitamin C and vitamin C plus iron in humans, and concluded that there was "no compelling evidence for a pro-oxidant effect of ascorbate supplementation, in the presence or absence of iron on DNA base damage".

Vitamins are often recommended in the use of toxic conventional medicines to give the body a fighting chance against overload. A patient receiving chemotherapy is given a combination of vitamins, allowing the two health systems to work in tandem. Use of vitamins in conventional medicine is known as orthomolecular medicine.

To date, not one death from supplements has ever been reported in the UK. This is in stark contrast to the hundreds of thousands maimed and killed by adverse reactions to conventional drugs worldwide every year.

Health promotion and prevention against disease using natural remedies inevitably leads to losses for the pharmaceutical companies, the largest profit industry of all time.

The restrictions on vitamins and herbs in Europe through the EU Directives contravene guidelines set out by the WHO Global Strategy for Traditional Medicine 2002-2005 by "limiting availability of TM and CAM including essential herbal medicine". Instead of suppressing health supplements, a better direction would have been to make drugs affordable and available to those in dire need and for nature’s harvest to be un-patented and free.

The complete document with references, is available in the ISIS members site. Full details here

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