ISIS Report 13/01/2003
Hands Off Vitamins and Herbs
source ISIS

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 600 million people have protested against these Directives (see box) by signing the largest on-line global petition ever (www.vitamins-for-all.org), 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

First 300 key vitamins and minerals axed, now 5 000 supplements banned by "insane" EU Directive. Sam Burcher reports on the right to freedom for the £1.6 billion alternative health industry.

The Alliance of Natural Health (ANH) is set to legally challenge the contentious EU Directive on Food Supplements (FSD). The FSD passed into European law in July 2002 and effectively brings about a ban on 300 nutrients included in 5 000 health products, most of which are in dietary supplements closest to food forms.

In July this year, the House of Commons Standing Committee for FSD Regulations met and voted the Food Supplement Directive through into English, Scottish and Welsh law. Dr Robert Verkerk, executive director of London-based ANH hopes a successful challenge would result in the FSD being overturned by all EU states.

The ANH represent the interests of a number of organisations including the British Association of Complimentary Medicine and the British Society for Allergy Environmental and Nutritional Medicine as well as a number of independent manufactures, suppliers and distributors of vitamins and minerals. Together they suggest the existing Directive be replaced with a revised FSD that allows for high quality, effective supplements across the whole of Europe. This would effectively harmonise to good standards, not bad ones.

Three other Directives concerning Herbal Medicine, Novel Foods and EU Medicines are under consideration, but have not yet been ratified into UK law. The appropriation of traditional products is likely to increase with food supplements, food substances and food/beverages (health drinks and fruit juices) suppressed by EU Directives repackaged as "Nutraceuticals" and sold by pharmaceutical companies. (See box 1) 

Two Labour MPs have voiced concerns about the way the Regulations were voted through by the Standing Committee. Kate Hoey MP (Vauxhall) revealed what happened: "I was a member of this committee until I said, very honestly, that I would vote against the regulations." She was, together with five other MPs, "unceremoniously removed" from the committee the night before the vote took place and replaced with MPs who voted in favour of the FSD.

According to Kate Hoey, this gives a clear message that the government cares more for the pharmaceutical industry that it does about ordinary people. Her views are shared by Jeremy Corbyn MP (Islington), he said: "The FSD is a product of ruthless lobbying tactics by the pharmaceutical industry which is not keen on the diversity of supply of vitamin supplements available in health food shops." He backs the ANH move to legally challenge the Directive. 

Legal challenges are seldom made to the 40 000 EU Directives implemented since the UK joined the Common Market in 1972, ostensibly to share in the Common Agricultural Policy (CAP). But Conservative MP Daniel Hannan complained to the Daily Telegraph last September 3, that, "whenever you see an apparently insane Brussels Directive, someone, somewhere stands to gain." And in his view, the Directives affecting natural remedies resulted because of lobbying by the large pharmaceutical companies. (See box 2)

MEP, Nigel Farrage said that on one occasion, MEPs were required to vote on Directives 450 times in one 80-minute session. He freely admitted that it was a farce and he voted as he was told. 

To simply question the validity of food supplementation is no longer enough when it is generally acknowledged that modern food production methods and deterioration of soil due to intensive farming are affecting vitamins and mineral content in food. For example, levels of the mineral selenium (Se) declined 50% between 1974-1991 and the UK population selenium levels are lower than many other European countries. Scientific studies show selenium is an essential nutrient associated with the function of major metabolic pathways, and taken up rapidly by the body when given as a dietary supplement. Also well established is the fact that dietary selenium is important for a healthy immune response, and the effects of its deficiency can include decreased T-cell counts and impaired lymphocyte proliferation. Fourteen forms of selenium, including the organic forms, selenium yeast and selenomethionine are forbidden on ‘The Positive List’ 

In fact vulnerable groups such as the elderly, pregnant and those coping with chronic diseases such as arthritis can all benefit from food supplements. But, in essence, the FSD is another blow to the individual’s freedom to choose how to look after their health, be it in conjunction with a good diet, or simply as a preventative against developing a chronic disease. Increasing visits to GPs to obtain the correct supplements, as the Directive would have us do will not suit the overburdened Health Service at all, but it might just serve the big corporations.
Box 1 
Some of the 300 vitamins and mineral excluded from the FSD positive list 
Substance
Benefit
Boron (All forms) 
Required for absorption of calcium
Vitamin E (naturally occurring tocopherols and toctotrienols)
Antioxidants, which protect against damage by free radicals, associated with cancer and other degenerative diseases.
Calcium (23 food forms)
For bones, teeth and cell function
Chromium (17 forms)
For balancing blood sugar levels, widely used by diabetics
Magnesium (30 forms)
Healthy bones and teeth 
Potassium (21 forms)
Maintains blood pressure and heart beat rhythm
Silica (All forms)
Works in conjunction with boron, calcium, and other minerals to support bones, arteries, connective tissue, hair, skin and nails
Selenium (14 forms)
Antioxidant, important for heart function. Contributes to healthy immune response.

The dietary supplement Glucosamine, a combination of minerals,vitamins and fatty acids bought by millions of arthritis suffers to ease their painful symptoms has been banned as a food supplement by the Medicines Agency in Denmark and Sweden. Instead it is has been allowed on to the shelves as an over the counter medicine produced by Recip Glucosine and Pharma Nord - two pharmaceutical companies.

Box 2 
The Food Supplements Directive covers two fundamental areas: 
1. The types of vitamins and minerals that may be legally sold from mid-2005. 
2. The maximum doses at which they may be supplied from 2006. 

The EU Commission has designated a list of permissible nutrients called 'The Positive List.' Specialist vitamin manufactures have expressed concern that their products containing organic ingredients, excluded from the 'List', are being compromised by synthetic or inorganic equivalents that are on the 'List.' All attempts to include a number of organic vitamins and minerals have been refused. Not only that, but to register their high quality products for sale could cost up to £250,00 per nutrient plus evidence of their safety. All nutrients must be paid for and registered by August