EU laws on sale of vitamins 'valid'
July 12 2005
Controversial new European laws which could outlaw thousands of vitamin and mineral supplements were upheld by European Court judgesy.
The European Court of Justice rejected British health food industry claims that the proposed Food Supplements Directive, coming into force on August 1, breaches EU rules.
The surprise decision goes against an opinion delivered by the same court's advocate-general in April, advising that the rules should be scrapped because they contravene basic EU principles of "legal protection, legal certainty and sound administration".
The judges countered that the proposed arrangements, designed to tighten controls on the growing market in products sold under the health food heading, can go ahead as planned.
Health food companies have to submit natural remedies, vitamin supplements and mineral plant extracts - many of them in long-established regular use in a £300 million-a-year market in the UK - for approval and inclusion on a list of recognised food supplements.
The judges backed the move saying: "A 'positive list' system is appropriate
for securing the free movement of food supplements and ensuring the protection
of human health."
Find this story at http://www.thisislondon.co.uk/news/articles/PA_NEWA69691121104201A0000?version=1
©2005 Associated New Media
Action Alert:CAFTA & Codex
July 13, 2005
Will the Central America Free Trade Agreement (CAFTA) finally force
a doctor's prescription just to buy vitamin C, or E, or other dietary
currently pick up "over the counter" in America? Powerful special
banking on it.
Since 1995, Big Medicine has spent billions of dollars trying to get
regulate your dietary supplements just as European governments do. So
effort has failed in America. But you may lose the battle for health
freedom if CAFTA
entangles the U.S. in Europe's infamous Codex Alimentarius (Codex).
And if you think CAFTA -- the bogus "free trade" agreement -- really
do with limiting the manufacture and distribution of dietary
supplements, then why
does it specifically mention Codex?
CAFTA, chapter 6, article 6.3.6(d) states: "The Committee [Committee
and Phytosanitary Matters] shall provide a forum for consulting on
and agendas for meetings of the WTO SPS Committee, the various Codex
committees (including the Codex Alimentarius Commission), the
Protection Convention, the International Office of Epizootics, and other
and regional fora and food safety and human, animal, and plant health."
On top of this, CAFTA is being shoved down Congress' throat under
"fast track" trade-negotiation authority. That way, Congress isn't
allowed to change
even one word it. That means Congress must either accept the Codex
reject all of CAFTA. The special interests love it -- they are betting
have the courage to dump CAFTA.
You see, CAFTA, like NAFTA, isn't really about free trade. It's
where government gets to pick the winners and losers. In this case, major
pharmaceuticals win, and you, the consumer, lose. The pharmaceutical
want government to "manage" the dietary supplement industry under Codex
to drive out competitors so only they can manufacture and distribute
vitamin C and
other dietary supplements. If that happens, as it already has in
supplements you now take will be available only by prescription and at a
cost -- if they are available at all.
We will fight CAFTA, NAFTA, WTO and the like because they subjugate
sovereignty to the "rulings" of global institutions and the whims of the
bureaucrats-for-life who run them. As this web of global governance
freedom to choose shrinks -- and health freedom is just one example.
You can't afford to stay out of this fight.
Read "Your dietary supplements: Under attack again" by Henry Lamb,
"Controversial EU vitamin ban to go ahead" by Sam Knight.
View the powerful documentary "We Become Silent" narrated by British
Dame Judi Dench. This film features Congressman Ron Paul.
Then, call your U.S. representative. Urge him or her to vote against
to dump --
CAFTA. The U.S. House will likely vote on CAFTA next week.
This vote will be very close. They are keeping score on Capitol
and your effort
"Your dietary supplements: Under attack again"
"Controversial EU vitamin ban to go ahead"
"We Become Silent"
The U.S. House is likely to vote on CAFTA next week. Please, take
action today --
and spread the word.
The Liberty Committee
Health supplements: R.I.P.
Millions of Britons take herbal vitamin and mineral
supplements, either as a preventative measure or to
treat specific ailments. But we may not be able to for
Saturday September 14, 2002
You feel shivery, your back aches, the glands in your throat
resemble golfballs; it's only a matter of time until your nose
starts streaming. What do you do? You could visit your doctor's
surgery and brave a waiting room full of people who are in as bad
a state as you, or worse, and wait patiently for a five-minute
consultation with your pressured GP - only to be told that it's
probably viral and you should go home to bed, or be given
antibiotics that you most likely don't need. Alternatively, you
used to be able to head for your local healthfood shop where, at
no cost to the creaking, over-burdened NHS, you could get free,
and often lengthy, advice from a helpful member of staff who
would recommend an affordable combination of vitamin C,
echinacea and zinc, a safe, over-the-counter supplement found
to be effective by millions of users.
If you're one of those who find such remedies useful, however,
you'd better start stockpiling now. A raft of EU legislation looks
set to nip the natural medicine market in the bud: soon, that
popular vitamin C, echinacea and zinc combination may not be
allowed on the shelves. A shadow looms large over the
alternative health sector. Estimates of the impact of this new
legislation vary, but hundreds of vitamin and mineral
supplements could be banned outright, while an as yet
incalculable number of common herbal remedies will disappear
unless consumers challenge it. The National Association of
Health Food Stores claims that as many as three-quarters of its
members could go out of business. The writing is on the wall for
small British supplement companies, which will be forced to
reformulate entire ranges and invest massively in applying for
new product licences.
It's a scenario that is hard to take in. In recent years, so many
more consumers have been turning to the health store in
preference to the doctor's surgery that it had begun to seem a
permanent fixture in modern life. Though there may still be the
odd simple soul who believes that eating a clove of garlic can
cure cancer, all sorts of perfectly sensible people who want to
take greater personal responsibility for their health are finding
solutions, or partial ones, at least, in natural remedies. Arthritis
sufferers tired of conventional anti-inflammatory drugs that upset
the stomach are looking to alternatives such as glucosamine
sulphate and chondroitin. People prone to anxiety are choosing
kava kava over Valium. Those who feel depressed are going for
St John's wort in preference to conventional anti-depressants
such as Prozac. Menopausal women are seeing black cohosh
as an attractive alternative to hormone replacement therapy. The
hungover take high doses of vitamins B and C (eg, in the popular
Berocca tablets). This surge is reflected in the media.
Conventional "doctor knows best" columns have been eclipsed
by alternative practitioners with a proactive attitude to health and
a range of natural, nonpharmaceutical suggestions for the
treatment of everything from cold sores to migraine.
All this interest is despite the fact that evidence of how - and,
indeed, if - these remedies work is open to interpretation and
incomplete. Some supplements are relatively well researched -
two major epidemiological studies have shown that vitamin E
supplements, for example, can reduce the incidence of heart
disease by about 40%, while a substantial body of research
suggests that antioxidant vitamins protect against certain
For other more obscure supplements, however, relatively little
conventional medical research has been carried out, so evidence
of efficacy relies more heavily on traditional usage. Much of the
scientific work into rhodiola rosa, for example - a herb that is
thought to make the body more resistant to stress - has been
carried out in Russia, and a lot more research is needed to
confirm the benefits that are claimed for it. Even so, it seems
that growing sections of the public can live with this sort of
uncertainty. More people are voting with their feet and
concluding that alternative remedies work as well, or even better,
than conventional drugs, with fewer, if any, side effects. But that
option could be taken away altogether if the new EU legislation
goes ahead unchecked.
The attack comes from four different pieces of legislation, one of
which is already in force, another approved in principle. All are
couched in the now familiar EU language of consumer safety
and free trade. Currently, the UK, the Netherlands and Ireland
have a far more permissive attitude towards supplements than
other member states, and make available a wider range of
higher-dose remedies. This approach is in line with those in the
US, Australia, New Zealand and Canada. But those days are
numbered. The idea behind the new regulations is that,
irrespective of whether you are a healthy Cretan, living on fish,
multiple fruit and vegetables and monounsaturated olive oil, or a
typically sun-starved Brit, existing on nutritionally impoverished
processed food, you should have the same range and strength
of supplements at your disposal.
Attack number one comes in the form of the Food Supplements
Directive, which will set maximum levels for vitamins and
minerals. Currently, consumers in the UK can buy high-strength
vitamins in dosages that are way above what's known as the
recommended daily allowance (RDA). Far from being a formula
for good health, however, the RDA is simply the minimum dose
you need to prevent nutritional deficiency. RDAs were developed
during the second world war, to ensure that soldiers did not get
sick. Now, modern research into the positive health properties of
vitamins and minerals is focused on safe upper levels, or
"suggested optimal nutrient allowances" (SONAs), much larger
doses that actively promote health, rather than simply prevent
disease. The difference between the two is vast. The RDA for
vitamin B5, for example, is just 6mg, but consumers in the UK
can currently buy it in 550mg doses; and arthritis sufferers take
it in doses as high as 1g-2g, and find it efficacious. Meanwhile,
in most other European countries, a much more restrictive range
of vitamin and minerals, based on the RDA, is available. A likely
EU consensus might set limits at only two or three times the
RDA, representing a liberalisation for most European countries,
but decimating the choice available to the British consumer.
This "framework" directive has already been approved in principle
by MEPs, most of whom were effectively voting as if writing a
blank cheque; now that the full implications of the directive are
emerging, however, many of those same MEPS are reported to
be "flabbergasted". The all-important detail - the setting of new
upper limits and an agreed "positive list" of nutrients - will be
decided next spring. So far, some 300 popular nutrient forms
from which thousands of supplements are derived are not listed.
"This will wipe the most popular and effective higher-dose
vitamins and minerals off the shelves," says Sue Croft of
Consumers For Health Choice, the group that successfully
campaigned between 1997 and 1998 against the proposed ban
on higher-dose vitamin B6. "Millions of people will have their
choices restricted or taken away."
The second attack takes the form of the Traditional Herbal
Medicinal Products Directive, which says that herbal remedies
can only be licensed if they can be shown to be safe and
produced to high standards. That sounds reasonable enough -
until you learn that herbal remedies will be licensed in the same
way as drugs. A company making garlic capsules, for example,
will have to go through many of the same regulatory hoops as a
company producing a new pharmaceutical drug. Estimates for
the cost of getting these herbal licences vary from £10,000 to
several million pounds a product. This would almost certainly
deter all but the largest companies from producing remedies
such as St John's wort, kava kava, gingko biloba, red clover,
rhodiola, evening primrose oil and ginger. There is no prospect of
several manufacturers pooling resources to get an ingredient
licensed, because each company's formulation will be treated as
Furthermore, to get a licence, a specific product must have been
on the market for 30 years, 15 of which must have been in
Europe. The effects of that time bar are dramatic. Black cohosh,
for example, an oestrogenic herb traditionally used by native
Americans, has demonstrated results superior to hormone
replacement therapy in the treatment of menopausal symptoms,
with women who take the herb reporting fewer adverse events,
even than those taking a placebo.
But black cohosh has only been available here for around five
years, so, like any product introduced since 1973 - in other
words, the most cutting-edge herbal products - it will become
illegal. As yet unknown herbal remedies might never even see
the light of day in Europe. "This is highly restrictive and racist,"
says Patrick Holford, founder of the Institute for Optimum
Nutrition. "It could wipe out hundreds of really useful herbs, not
on the basis of consumer protection or science, but on the basis
of geography - herbs that have been used safely for hundreds of
years in the Americas, Africa, India and China." In addition, any
combination of herbal and vitamin/mineral products that natural
medicine practitioners believe work better in synergy than apart,
such as vitamin B6 with evening primrose oil, will be banned.
There's a third prong to the attack, in the form of the Novel
Foods Directive, which is already in force. This was originally
designed to control genetically modified foods and new,
so-called "functional" foods, such as fish oil-enriched bread, but
is now being applied to absolutely everything that is sold under
food law. Any food product (which includes supplements) that
was not on the EU market before May 15 1997 can only be
granted approval after submission of a dossier containing huge
amounts of technical and safety data. So far, a herbal sweetener
and an immune system-boosting tonic have already been forced
off the shelves as a result, and next in the line of fire is MSM, an
increasingly popular organic sulphur that has been found to be
effective in the treatment of joint problems. What makes these
developments even more worrying is that there is no appeals
process under this directive.
The final attack seems on the surface to be an innocuous
tidying-up of the EU Medicines Directive. But, in fact, it will
mean that anything with a physiological action can be
reclassified as a medicine - and under EU definitions, that
means that any product sold in a health store, even herbal tea,
could be deemed to be medicines, while items such as coffee
and grapefruit juice (which also have proven physiological
effects, but which are sold in food shops), will not be affected.
So much for Hippocrates, who said, "Let food be your
medicine." The new EU laws will say that a product must be
either one or the other.
The authority in the UK charged with drawing this line is the
Medicines Control Agency (MCA), yet it has a direct interest in
classifying supplements as medicines - it earns 95% of its
budget from licensing the latter. MCA committees are filled with
doctors whose experience lies in conventional medicine. Many
of them are either employees of pharmaceutical companies or
are beholden to them for research grants. By contrast, the New
Zealand government recently decided that its equivalent of the
MCA is not qualified to consider natural reme-dies, while in
Australia the Traditional Medicines Evaluation Committee made
up of natural medicine practitioners, suppliers and scientists and
applies different criteria to supplements than those it applies to
Faced with this onslaught of hos-tile legislation, the UK natural
health industry is smarting at what it sees as the breathtaking
injustice of it all. A key principle of natural medicine is the
Hippocratic requirement primum no nocere , or "first, do no
harm". At the moment, supplements are sold under food law,
which means they have to be as safe as a loaf of bread. The
MCA already has the power to remove from the market any
supplement it considers to be dangerous. Conventional
pharmaceutical drugs, on the other hand, are sold on a costs
versus benefits basis, the thinking being that the beneficial
effects of the drug should be balanced against its risks. Side
effects are simply an accepted part of the pharmaceutical
"There has never been a death due to vitamin and minerals in
the UK," says Holford, "but thousands have been caused by
conventional drugs. The risks are completely different." Or, as
John McKee, who runs Hanover Health Foods in Edinburgh, puts
it: "You can go to any petrol station and buy enough
paracetamol to kill yourself. It's very hard to commit suicide in a
Yet EU commissioner David Byrne insists that the aim of the
legislation is to "assure consumers that these products are safe
and that doses available are not excessive and potentially
dangerous". This echoes the long-running demonisation by the
orthodox medical establishment of natural health practitioners
as a bunch of cranks and charlatans, hawking useless and
potentially deadly products to a gullible public.
If you believed recent headlines, then fears over kava kava, the
traditional Polynesian remedy for anxiety, seem to lend weight
to that viewpoint. "Shyness remedy ruins your liver!" screamed
the London free paper Metro last December, and throughout the
media reports appeared that kava kava had been linked to 30
cases of liver failure and death in Germany. The MCA put
pressure on health stores not to stock it, and it was promptly
voluntarily withdrawn; it has been off the shelves ever since.
Kava kava's future is now in the hands of the MCA and the Food
Standards Agency (which has gone as far as issuing it with a
health hazard warning), and a proposed permanent ban is out for
consultation. The MCA claims that there is "significant existing
evidence of hepatoxicity".
But delving into the details of those so-called casualties, the
case against kava kava is deeply unconvincing. Most of the
victims were already taking pharmaceutical drugs known to be
toxic to the liver, and many were elderly heavy drinkers who had
already abused their livers. "The vast majority of these cases
involved hepatoxic drugs or alcohol," says Holford. "Of the
remaining nine, five have spurious relevance to a safety
assessment of kava kava for one reason or another, and four do
not provide enough data to know if it was kava kava causing the
problem." Holford, along with Dr Hyla Cass, associate professor
at the University of California's school of medicine, has carried
out a detailed review, which is consistent with the longest
running study of kava kava to date, reported in 1997 in the
journal Pharmacopsychiatry, which concluded that, "in contrast
to both benzodiazepines and antidepressants, kava kava
possesses an excellent side-effect profile".
"The MCA's double standards are abhorrent," says Holford. "A
large number of published safety and toxicity studies clearly
indicate that kava kava is far safer than conventional
pharmaceutical anti-anxiety and antidepressant prescription
The MCA's cautious approach to kava kava contrasts with its
attitude to the commonly prescribed family of drugs called
Selective Serotonin Reuptake Inhibitors (SSRIs), of which
Prozac is the best-known example. These have been blamed for
suicides, murders and even mass murders in the US, and are
the subject of ongoing litigation. In the UK, however, the MCA
has resisted putting a warning on them. "The MCA liaises with
pharmaceutical companies to decide what warnings might be
appropriate," says Dr David Healy of the North Wales
department of psychological medicine, who has been petitioning
the MCA to issue some form of general warning. The drug firms,
however, argue that patients on SSRIs are already high suicide
risks, and that the warnings that accompany the medication are
sufficient. "These are big players with tremendous incentives to
defend their product," says Healy. "Small companies fighting off
restrictions on herbs are at a disadvantage. They are small, they
don't have exclusive ownership of the herbs, so they have less
reason to do so, and they don't bite back."
Speculation is rife in the natural medicine world about the extent
to which pharmaceutical interests are orchestrating legislation.
Back in 1987, the Campaign Against Health Fraud
(Healthwatch) waged an aggressive public campaign against
natural remedies, financed initially by medical insurance and
drug companies. Similar campaigns were waged in the US and
Canada. And in the 1990s, there was a series of well-publicised
attacks on food supplements. Now, there's a persistent rumour
that PR agencies working for drug firms are spinning stories to
the media, casting doubt on the safety and efficacy of natural
Drug companies have a proven track record in trying to legislate
the natural health business out of existence. In 1996, for
example, the Ecologist magazine revealed that, when the Codex
Alimentarius (the World Trade Organisation body that sets
international standards for drugs, food, supplements, etc) met,
the German delegation put forward a proposal, sponsored by
three German pharmaceutical firms, that no herb, vitamin or
mineral should be sold for preventive or therapeutic reasons, and
that supplements should be reclassified as drugs. The proposal
was agreed, but protests halted its implementation.
That same lobby now seems to be powering EU legislation.
According to the UK department of health, the impetus for the
Traditional and Herbal Medicinal Products Directive came from
the European commission's pharmaceutical committee. "No one
is saying that the natural health industry does not need
regulation," says Holford. "It has grown from a small niche to a
major market sector. But this legislation is draconian. UK
consumers now have experience of many years of safe and
effective usage. They don't want supplements forced off the
shelves or available only in ludicrously low doses."
And if consumers can no longer buy that helpful supplement in
the health store, they may simply source them from unregulated
internet suppliers. It might lead, say, to a new variant on the
clothes shopping trip to New York: UK consumers who can
afford it might go on supplements trips to stock up on remedies
that are freely available in the US, but banned or unavailable
Surprisingly, in the 1980s the policy of the US Food and Drugs
Administration was to reclassify supplements as medicines.
This even led to a farcical situation in which armed FDA officers
would raid clinics looking for illegal caches of vitamins. But
public protest forced a change, and since 1994 the US has had
a statute that guarantees both free availability of supplements
and information about how they work. Similarly, in Canada,
doctors in the 1990s were being struck off for prescribing
vitamins and the government reclassified hundreds of herbal
remedies as medicines. Following public outcry, however, they
were all later declassified.
In the UK, when the government tried to withdraw higher-dose
vitamin B6, it met with a similar reaction. Many MPs were
staggered by the sheer volume of well-informed mail, and B6
was saved - at least until now. And the natural health sector
hopes that it can play the same card again, with the same
results: "There is still time to force changes to this ruinous
legislation," says Croft.
To that end, healthfood stores are tooling up with Save Our
Supplements petitions and leaflets, while celebrities such as
Elton John, Cliff Richard and Paul McCartney have weighed in
with support. The ranks of regular health store users are being
mobilised. As consumers begin to realise the extent of the
attack on natural remedies, the hope is that they will simply not
stand for it. And heaven help any politicians who try to come
between articulate OAPs and their glucosamine sulphate or
angry hormonal women deprived of vitamin B6 and evening
Consumers For Health Choice can be contacted by email
Breaking News:Judge Overrules Brussels Ban on Vitamins
EU Supplements Directive
Sept 7 2005
A controversial EU directive that could ban thousands of popular vitamin and mineral supplements has been declared illegal by a European Advocate.
The judgment is a victory for health food manufacturers and retailers who appealed to the European Court of Justice to overturn the proposed law.
The new rules governing vitamins and minerals are due to come into effect on 1 August and are designed to improve the safety and efficacy of products sold by the industry, worth millions of pounds. Only named ingredients with proven scientific benefits have been included on an EU "positive" list of approved substances that would be allowed in health supplements.
More than 300 different vitamins and minerals are not on the positive list, meaning that 5,000 supplements will be banned if the proposals become law, according to campaigners, who have been led by Carole Caplin, Cherie Blair's former lifestyle adviser. Popular supplements that will be outlawed include certain vitamin C brands, some calcium capsules and copper tablets.
The legal case against the directive was brought by the Alliance for Natural Health (ANH), a Europe-wide association of more than 300 manufacturers, retailers, consumers and doctors opposed to the legislation.
The advocate general at the European Court of Justice (ECJ) gave an advisory opinion that the directive, as it stands, infringes basic EU principles.
He said that the current proposals lacked clear rules for the European Commission to follow when deciding whether or not to include an ingredient on the positive list. The advocate general's opinion that the directive is "invalid" is not binding, and the full ECJ will rule on the case in July, but the court normally follows his opinion.
More than 20 million people in the UK spend £335m a year on vitamins and supplements in the belief that they bolster health and well-being. One in three women and one in four men takes supplements, and campaigners said the legislation would lead to inferior ingredients being used because more beneficial ones had been left off the positive list.
David Hinde, legal director at the ANH, said: "This is a very significant opinion in a landmark case. What we want to see in the EU is the food supplements directive doing the job for which it was created, which is to provide a 'safe harbour' for food supplements so that they are not classified as drugs, and to promote their availability across the EU. We are optimistic the ECJ will adopt the recommendations of the advocate general."
Under the directive, manufacturers could apply for products to be added to the "positive" list by submitting scientific evidence about the benefits of the supplements. But the high cost of producing such dossiers - up to £250,000 - would have meant that smaller manufacturers and health stores were most at risk from the new rules.
Sara Novakovic, the owner of Oliver's Wholefood Store in Richmond, south-west London, welcomed yesterday's ruling. She said: "At last it is now highly likely that we can continue to offer the products that our customers ask for and want, rather than have to remove them all from the shelves for no good reason and supply them with inferior quality alternatives."
However, the industry faces a continuing fight against EU legislation over health supplements and vitamins. The advocate general upheld the concept of EU legislation on health supplements, saying that the proposals needed to be reworked rather than scrapped.
Further directives on the maximum doses of vitamins and rules governing herbal remedies are due to be brought in over the next two years.
A mineral found naturally in nuts, raisins and leafy green vegetables, and included in supplements such as Boots A-Z multivitamins. It is needed for the absorption of calcium, and deficiency is linked to osteoarthritis and osteoporosis.
An antioxidant that can protect against free radicals associated with degenerative disease. Naturally occurring versions of the compounds that make up vitamin E would be banned.
Antioxidant that can help boost immune response and improve heart function, and is linked to sperm function. Certain types are on the positive list, but yeast form is said to be the most easily absorbed.
Vital for the production of haemoglobin, the pigment in red blood cells that transports oxygen around the body. Organic forms of iron that are easily absorbed by the body would be banned.
A mineral that balances blood sugar levels and is widely used by diabetics to help control their condition. Chromium picolinate supplement, which is not on the "positive list", is seen by health professionals as a safe and effective nutritional supplement for people with insulin resistance and those at risk of diabetes.
"Bio" forms of calcium that are the most easily absorbed by the body would be banned. Calcium works with vitamin D and is needed to build bones and teeth, and can help regulate heartbeat.
A diet low in potassium can be a factor in high blood pressure, and supplements can help with fluid balance, heart rhythm and nerve impulses. More than 20 forms would be outlawed.
All forms would be banned, yet it can help maintain flexible joints, supple skin and strong nails and hair. Silica levels in the body deplete with age, and many elderly people take supplements.
© Copyright 2005 by 1stvitality.com