Hands Off Vitamins and Herbs

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http://www.i-sis.org.uk/vitamins.phpISIS Report 13/01/2003Hands 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 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 set by

the UK Council for Responsible Nutrition (CRN) and the European Health Product

Manufactures. 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 in 3 women and 1 in 12 men at some point in their lifetime. Key

minerals, boron and sulphur, are among those targeted by the Directives.

According to the UK National Osteoporosis Society, 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 " will be tested and reassessed 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

 

MATERIAL ON THIS SITE MAY BE REPRODUCED IN ANY FORM WITHOUT PERMISSION, ON

CONDITION THAT IT IS ACCREDITED ACCORDINGLY AND CONTAINS A LINK TO

http://www.i-sis.org.uk/

 

 

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