http://www.i-sis.org.uk/vitamins.php
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 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".
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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.
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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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