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FSDIAHF List: The following article from the UK's Observer Magazine provides an

excellent wake up call to anyone you may know who doesn't realize the supplement

industry is under global attack.Please mass forward it, and urge everyone to

donate to the Alliance for Natural Health via

http://www.alliance-natural-health.org for the second half of their legal

campaign to overturn the EU FSD. The article quotes David Hinde from ANH. Far

too many Americans, especially, are oblivious to the dire need for consumers

world wide to support ANH's legal and lobbying efforts. Anyone who needs help

" connecting the dots " so as to understand why ANH's effort in England is so

important to Americans, (and vitamin consumers world wide) should read Greg

Ciola's interview with me in The Health Crusader Magazine at

 

http://www.thehealthcrusader.com/pgs/article-0104-ban.shtmlhttp://observer.guard\

ian.co.uk/magazine/story/0,11913,1157031,00.htmlNil by mouth For thousands of

Britons battling the debilitating effects of cancer, depression, even eczema,

diet is crucial. They view the vitamins and minerals they take as vital in their

fight against sickness. So why does the EU want to cut off their supply? Rose

Shepherd makes the case for rescuing remedies Sunday February 29, 2004The

Observer In the 21st century we live under siege. There are concerns about

pesticides, herbicides, antibiotics, GM, mobile phones, microwaves, amalgam

fillings, falling sperm counts, mad cows, MMR - even milk. Farmed salmon is a

Trojan horse for carcinogens. Obesity and diabetes are on the march. There is a

mass of documentation on all this. So what is the European Commission's big

idea? 'Let's clamp down on vitamins and minerals.'It would be funny if it

weren't so tragic. While the EU has been busy drafting legislation,

we seem to have been sleepwalking into a situation where chemists and health

stores will be purged of hundreds of nutritional supplements.I'm sorry, maybe

you are alert to this already. Maybe you have written to your MEP, marched with

the Health Freedom Movement, joined the Alliance for Natural Health or Consumers

for Health Choice. Tens of thousands of people have been railing against this

infringement of their rights, this insult to their intelligence and, not least,

this threat to their health. The psychotherapist, writer and long-time cancer

survivor Beata Bishop, author of A Time to Heal speaks for many when she says,

'I feel passionately angry about this.' I myself have been surprised, though, by

how many others seem neither to know nor to care about any of what is afoot -

and, still more, by the complaisance of some commentators.What is at issue is

couched in soothing terms in three EU directives. First, the Food Supplements

Directive (FSD), under the guise of harmonisation,

creates a restricted list of vitamins and minerals, effectively a 'positive

list' of allowable nutrients. EU member states will be mandated to market these

'harmonised' supplements, facilitating trade. However, from August 2005,

nutrients not on the list will be banned. This may be good news for states in

which the sales and dosages of supplements have hitherto been severely

restricted, but it's bad news for the UK, where our regulators have long

regarded food supplements as foods, not medicines. We face losing some 270

nutrient supplements, including 40 trace elements, most forms of the more

bioavailable organic minerals, and most food-state vitamins. And it doesn't end

with vitamins and minerals. By 2007, if not before, the directive requires the

European Commission to put forward proposals for a similar list, to apply to all

nutrient supplements.Nor does it stop at nutrients. The Traditional Herbal

Medicinal Products Directive (THMPD), now working its way through the EU

machine,

promises to provide for a 'simplified pharmaceutical registration' for 'herbal

medicines' - but only for substances that have been in safe use for 30 years, 15

of them within the EU, singly or in the same combinations. Thus, medicinal herbs

in centuries-long use outside the community cannot benefit from the fast-track

licence procedure. The THMPD is a part of the existing Pharmaceuticals

Directive, currently being amended to widen the scope of drug classification.

According to the amendment, anything that 'restores, corrects or modifies

physiological function' in the body will be deemed a drug. The directive will

have power to take precedence over both the FSD and THMPD, even though they may

all be applicable to the same natural food supplement. Public safety is cited as

the motivating force behind these directives. Their combined effect, however,

could be to drive out, degrade or drive underground many of the herbs and

nutrients to which some people swear they owe their health. For

the 40.9 per cent of us who use supplements to boost nutrition, this is no

trivial matter, while to those using herbs and supplements to manage chronic

pain or life-threatening disease, it must seem like sabotage. Sceptics dismiss

such individuals' experience as 'anecdotal', but when you are your own anecdote,

it's hard not to be convinced. Beata Bishop's book - now, sadly, out of print -

is a testament to the value of a nutrient-rich diet, boosted by supplements. As

she wrote in 1985: 'I should have died of malignant melanoma... around June

1981. When my secondary cancer was diagnosed in late 1980, I was suffering from

diabetes, incipient osteoarthritis, frequent knockout migraines and dental

abscesses.' Today, she is free of these and attributes her recovery to Gerson

Therapy, the radical regime under which the body is detoxified and activated

with ionised minerals and organic fruit and vegetables, whereupon, it is hoped,

the natural healing process kicks in. I don't want to be

glib or simplistic about cancer. I know it comes in many guises and has

multiple causes. Having lost two grandparents, my father and my partner to it, I

am in mortal terror of it. Like most people, irrationally, I fear it more than I

do the cardiovascular disease that took my other two grandparents and my mother.

I should find it hard to refuse the slash-and-burn approaches to it. But when I

try to think of it as being, like heart disease, a degenerative process, I see

the wisdom of Gerson. 'I have been described as disgustingly healthy,' Beata

Bishop tells me, 'but when I was very, very ill, without those supplements I

wouldn't have got well. I believe it's totally wrong to interfere in people's

attempts to maintain their health. I'm willing to fight at the barricades if it

comes to that, because if it ain't broke, don't fix it.'Or, you might say, if it

ain't broke, don't break it. Despite occasional scare stories, the risk of death

from food supplements is less than that of being

struck by lightning, and significantly less than that of dying of penicillin

allergy. Should the EU plans prevail, however, consumers may in future have to

resort to the internet, to order products from unregulated sources, with no

guarantee of quality or authenticity. It sounds fanciful, but observers are

predicting a black market. After next August, if someone sidles up to you and

asks if you want to buy some 'E', think mixed tocopherols and tocotrienols,

since almost the whole spectrum of naturally occurring vitamin E is off the

positive list.'In my opinion,' says OM columnist Dr John Briffa, 'the proposal

to restrict public access to nutritional supplements represents one giant

retrograde step for the health of the nation. There is good evidence that the

nutritional content of our diet has declined substantially over the past few

decades. At the same time, studies exist that show that long-term nutrient

supplementation has the potential to prevent a range of conditions,

including heart disease, cataracts and certain forms of cancer.''We, as a

nation, have a huge problem in looking after our people,' says Sue Croft, a

director of Consumers for Health Choice, 'and those of us who take the trouble

to keep ourselves well should be encouraged. Yet the very tools we need to do so

are being taken away from us by Brussels, and our government is standing by and

doing nothing.''It's disgraceful,' agrees shadow health minister Earl Howe.

'Traditionally, in this country, we've adopted a safety-based approach to

licensing products for sale. There's never been any suggestion that our vetting

procedures are inadequate in that respect. To have a harmonisation measure

foisted upon us for no good reason is a very retrograde step indeed, and

consumers will suffer.' And so we will, one way or another. Consider HRT,

associated with an increased breast cancer risk. For this and other reasons,

women are turning, in preference, to alternative remedies, at the very time

when these remedies seem threatened with extinction. 'The mineral boron is very

useful,' says Dr Marilyn Glenville, a specialist in women's health and prolific

author. 'There are good clinical trials on its effect on bone health. If you get

a good multivitamin that's designed around the menopause, boron will be in

there.' But boron is off the positive list, guilty until proved innocent, under

European Napoleonic law.Boron could even now be reprieved. The European Food

Safety Authority, a faceless organ of the European Commission, will consider

dossiers submitted on banned nutrients. With a deadline of 12 July 2005,

however, and with compiling costs of anything from £80,000 to £250,000 per

substance, the race will be to the swift and to the rich. Some big manufacturers

are working on dossiers. But with no guarantee they will be accepted and no

possibility of a patent on the nutrients they champion, there can be scant

incentive to do so. Hence, a kind of nutritional dumbing down is

underway, with manufacturers reformulating products.So much for boron. How

about the herbal supplements black cohosh and dong quai? Both can be effective

against hot flushes, but their future looks uncertain under the THMPD and

amended Pharmaceuticals Directive. The THMPD is, in some ways, the most

Eurocentric directive. In his 1997 King's Fund lecture on integrated healthcare,

the Prince of Wales said: 'No knowledge, experience or wisdom from different

traditions should be overlooked in efforts to help the suffering.' This

directive could scarcely be less in that spirit. We plunder the world's larder,

the world's table, yet set our face against the herbal medical traditions on

which two-thirds of the world relies, when they could have much to give us.

Witness Carctol. At the inaugural conference of the British Society of

Integrated Medicine last November, Dr Rosy Daniel introduced four cancer

patients, all doing well on a dairy-free, vegetarian diet and this Ayurvedic

preparation.

'We have a traditional remedy that has been brought from India,' says Daniel,

founder of Health Creation, which offers holistic healthcare stuff and support.

'But because three of the eight herbs in Carctol are classed as medicine, they

are prohibited from putting out any information about it, as this is construed

as advertising.' The law is spacious enough to allow doctors to prescribe an

unlicensed medicine if they believe it may be effective. Patients have to be

told that the medicine is unlicensed, and to sign a consent form. What doctors

cannot tell patients is what they think the stuff will do, since this would be

to make a medicinal claim. Importers Cankut Herbs are similarly constrained.

'It's a bizarre paradox, isn't it,' says Daniel, 'that when something actually

does work, and has some medical activities, nobody can talk about it?'Well,

Gillian Gill, at least, can talk. When she was diagnosed with an inoperable

ovarian tumour, she was offered radiotherapy but, having made

her own risk-benefit assessment, declined. A combination of meditation, Reiki

healing and a non-dairy, vegetarian diet effected some improvement. Then, when

progress stalled, with some trepidation she went on Carctol. 'It was,' she

recalls, 'like a splint to my brain. Suddenly the panics, the awful thoughts and

feelings didn't come any more, and there was no looking back. With each six

months I had more energy. I feel fitter now than I did before I had cancer.

Eighteen months ago my oncologist gave me the best present I could have. She

said, " Gillian, I'm seeing something I've never seen before. " My tumour had been

so big they said they'd never seen anything like it. Now it's about the size of

an orange, and it seems to have transformed into a cyst with fluid.'In the

course of her recovery, Gill wrote and published a book, Where's the Meat?

Acid-free Vegetarian Dishes. It is available from Health Creation and costs £6.

Hospital dieticians still tell cancer patients to combat

cachexia, or wasting, with high-calorie cakes, pork pies and burgers. However,

pioneers of integrated medicine, such as Dr Julian Kenyon at the Dove Clinic,

near Winchester, propose a wholefood regime free of meat, dairy products and

sugar, designed to push the acid/alkaline balance of the body towards an

alkaline environment, in which, they say, tumours cannot thrive. Derek Ritchie

is a Dove Clinic patient. He has mesothelioma, an asbestos-related cancer of the

lung lining. It is slow-growing, but the prognosis was depressing: two years at

best. Yet six-and-a-half years later, here he is, about to fly to Spain,

sustained by a regime that has included high-dose vitamins, herbal remedies and

food supplements. He admits he's 'lost a bit of weight and one thing and

another', but says, 'Quality of life is not bad. And all I know is, if I hadn't

been taking these things from the very beginning, I wouldn't be here.' Kenyon

prescribes the remedies that he favours, always with an eye to

quality and emerging research, on an informed consent basis. 'I am aware of

impending legislation,' he says, 'and I am making every effort to comply

completely with all regulatory issues.' But such remedies will disappear if

their manufacturers go to the wall once the shop shelves are stripped.How can

such ostensibly benign and well-intentioned legislation be so onerous? To

understand, look first at which products are berthed in the safe harbour of the

FSD positive list, and which cast adrift. The positive list overwhelmingly

excludes natural, organic substances, which, say campaigners, are the most

innovative and most readily absorbed. But, then, the list has not, as you'd

imagine, been drawn up on the basis of scrupulous research into the safety and

efficacy of available supplements. The permitted substances are those listed

under the Directive on Foods for Particular Nutritional Use (Parnuts) which

determines what may be added for nutritional purposes to adult dietetic foods.

The

list is literally one they made earlier, and is inappropriate to the

consideration of food supplementation. Critics point to the fact that it

sanctions the use of sodium and potassium hydroxides, powerful caustic agents

that no one would want to supplement ('If swallowed,' runs the safety advice for

the former, 'drink plenty of water and call for immediate medical help.') At the

same time, highly valuable nutrients are absent. Take selenium, a mineral in

which the British diet is known to be deficient. Inorganic selenite and selenate

are on the list, but two organic forms, selenomethionine and selenium yeast, are

not. This despite the fact that selenomethionine (the primary form, in foods

such as Brazil nuts) and selenium yeast are safer and more bioavailable. 'With

cancer,' says Ralph Pike, director of the National Association of Health Stores

(NAHS), 'selenium is the most important mineral. There is a big company in the

process of compiling a dossier on selenium yeast. It's cost

them far in excess of £250,000. They've just completed a two-year rat study.

People will find it abhorrent that the only way that selenium yeast can stay on

the market is by killing untold rats. They've actually told us animal studies

are not necessary. This is one of the myths surrounding the directive. Every

time you talk to the Commission, they say " absolutely not necessary " , but if

you're going to show how selenium yeast goes through the body and where it ends

up in tissues, you've got to start doing histology, and autopsies, and tissue

samples.' 'The science simply does not add up,' says David Hinde, legal director

of the Alliance for Natural Health. The Alliance has mounted one of two separate

legal challenges to the FSD (alongside the NAHS and the Health Food

Manufacturers' Association), which were heard in the high court on 31 January,

when Mr Justice Richards was persuaded that both had 'an arguable case' and

agreed that both should be referred to the European Court as soon

as possible. 'At the heart of the challenge is, first, the contention that the

alleged legal basis for the directive under Article 95 is invalid under EU law,'

Hinde continues. 'The European Union doesn't have the right to legislate just

any old way. It's subject to very strict rules. Then there is the principle of

subsidiarity. That means that decisions should always be taken as close to the

rock-face as possible, so if a member state is capable of regulating its own

food supplements, they shouldn't be regulated by the EU unless there is a very

good reason.'In court, the government was put in the invidious position of

defending the directive proposed by the European Commission in Brussels. When

asked why there was this prohibition, says Hinde, 'They were reduced to saying,

" Well, because of safety. " That's a bit like saying we are incapable of

regulating our supplements as food in this country, even though we've done so

for many years.'The judge, most helpfully, wants to push

things along. It normally takes 18 months to two years to get a decision, but

the ANH is hopeful we'll get one before the ban is set to come in on 1 August

2005.Hinde is not just a professional but a personal advocate of

supplementation, having made the engagingly boyish mental leap from internal

combustion engine to human organism. 'I was your typical male. I'd whack a Lean

Cuisine in the microwave, take some salad, and think I was doing a good job for

myself.' He then discovered that if he put clean, high-octane petrol in his car

it went better, and he saw the light. 'I started taking supplements, and

couldn't believe the increase in energy. I thought, " These things work! " Then I

began to look into this whole area, and discovered the fundamental thesis that

is missing from our health paradigm is the link between micro-nutrition

deficiency and illness. Your body is remarkably resilient. If you're missing key

nutrients, it gets by, but eventually things begin to go wrong.'That was

the way Dr Max Gerson's thoughts were running in the 1920s, in a far less toxic

world. And it is how Dr Robert Verkerk's thoughts are running now. Previously a

research fellow at Imperial College, Dr Robert Verkerk left to set up the ANH.

Researching sustainable agriculture, he had seen how impoverished our soil, and

hence our food supply, was becoming. 'There are few drugs that can demonstrate

the cancer-defying properties of natural substances,' he says. 'Why on earth is

the EU wanting to ban them? How many leading cancer research institutes, still

besotted by chemical and radiation treatments, have put together the poor

nutrition, plus poor lifestyle, plus toxic chemical puzzle?''Let food be thy

medicine,' said Hippocrates, yet precious few of the doctors who have sworn the

Hippocratic oath, or one of its revisionist versions, have embraced this tenet.

In his Editor's Choice column in the BMJ of 24 January, Richard Smith wrote:

'Although many patients are convinced of the

importance of food in both causing and relieving their problems, many doctors'

knowledge of nutrition is rudimentary. Most feel much more comfortable with

drugs than foods, and the " food as medicine " philosophy of Hippocrates has been

largely neglected.' Smith goes on to make the 'unadventurous prediction' that we

will be hearing much more about the science, medicine and politics of food, and

concludes, 'Hippocrates would be pleased.' Not with the FSD, he wouldn't. The

idea of setting safe maximum limits on supplements is also highly questionable.

In many EU countries, they are limited to three times the recommended daily

amount, and this could be imposed across the board. But, with RDAs, you need to

think bog standard, not gold standard. 'I call them the Ridiculous Dietary

Arbitraries,' says Patrick Holford, founder of the Institute for Optimum

Nutrition (ION), and author of The Optimum Nutrition Bible. 'The RDA is not a

scientifically robust score for a nutrient. It's the level

that prevents overt deficiency, and if you take the case of vitamin C, it

started at 30mg, then went to 45mg, then 60mg, while in America it's 85mg. Now,

30mg does prevent scurvy, but scientists on the panels who decide RDAs are

gradually thinking that more might be better. We [the ION] work from what is

arguably the most scientific position, which is to ask, " What is the optimal

intake of a nutrient? " What level of, say, vitamin C confers maximum protection

against infections? And we know that it is around 1,000mg.'The official EU

classification of a drug, meanwhile, throws up some priceless anomalies. There

are two parts to the definition of a drug. One is the 'presentation' limb, that

anything that claims to treat, prevent or cure a disease is a medicine. 'So, if

you say, " An apple a day keeps the doctor away, " and you're selling the apple,'

says Holford, 'you've just contravened the Medicines Act.' The other is the

so-called 'function' test: ie, if something 'restores, corrects

or modifies physical function' in the body, it can be classified as a drug

(that apple, again). Does this mean that, to reverse the logic, if anything

remains on the positive list and is not reclassified as a medicine, we can

assume it does not restore, correct or modify physical function? If so, who is

going to rush out to buy supplements that can claim, at best, to have no

effect?This is not to say that there are no concerns about the use of herbs and

supplements, and in particular about how they interact with prescription drugs.

Dong quai, feverfew, St John's wort and ginkgo, for instance, are

contraindicated with warfarin. But, then, so is cranberry juice. Warfarin is the

sodium salt form of rat poison. Cranberry juice is rich in antioxidants and

potent against cystitis. Anyone on warfarin should be advised to avoid it, but

it would be a strange inversion of reality to say that cranberry juice is

dangerous. In the matter of St John's wort, if we apply the same risk-benefit

criteria as are used in the licensing of medicines, we may well find in favour

of an antidepressant herb that has far fewer side effects than its chemical

counterparts. In February 1992, the consumer research body Social Audit

reported, on the basis of four studies between 1981 and 1988, that more than

10,000 hospital beds are taken up at any one time by people suffering adverse

reactions (ADR) to prescription drugs. While the side effects of drugs is a

recognised problem, it is one with which we are prepared to live, much as we are

prepared to live with the car, for all the hazards it poses.While we know that

cars kill, however, we are less conscious that drugs are a major cause of

mortality in the Western world. In May 1998, The Journal of the American Medical

Association reported that 'each year, prescription drugs injure approximately

1.5m people so severely that they require hospitalisation, and 100,000 die.'

That puts the health concerns over herbs into perspective. Not that

we want a free-for-all. There are some horrible products out there, but if you

use a legislative purse-seine net to trap the fishiest ones, you inevitably get

a huge and unacceptable by-catch.'Herbs are powerful,' acknowledges actress

Jenny Seagrove, a stalwart of Consumers for Health Choice, 'which is why they

work when used properly, and why they can cause problems when used incorrectly.

However, they're not as powerful as the synthetic versions, which are

prescription drugs. I believe there should be some kind of regulation, but not

the kind they're suggesting. I think they should have spot checks of every

manufacturer's products each year, and people who sell herbs should have to do

some kind of training. Products should be labelled with health warnings, then

people could make educated choices.'Not the least depressing aspect of this

whole debate is the orgy of vivisection it could unleash. Animal rights

campaigners, who point out that ADRs are rife in medicines that have passed

animal tests, must be feeling nauseated at this point.The Alliance for Natural

Health at least has the green light to make its case to the European Court. 'The

doors are closing,' says Robert Verkerk, 'but our recent court success tells us

that the EU may have overstretched its powers. We believe that bringing this

case to the European Court of Justice might elicit the paradigm shift needed by

our healthcare system, currently splitting at the sides.'The fight doesn't end

there. Today Europe, tomorrow the world. Similarities have been noted between

the EU's Food Supplements Directive and the Codex Alimentarius Draft Guidelines

for Vitamin and Mineral Supplements. Codex is about harmonisation on a global

scale. US health freedom campaigners are watching nervously, mindful that the US

will have one vote, compared with the expanded EU's 25-strong block vote. If the

legal challenges succeed, it will pose a potent obstacle to the plan to impose

Codex worldwide. If they fail... Well,

ultimately you have to ask yourself, cui bono?This is what the Americans term a

wake-up call. I prefer the English word 'alarm'. Be alarmed. Be very alarmed.·

Alliance for Natural Health 01252 371 275; Consumers for Health Choice 020 7222

4182; Health Creation helpline 0845 009 3366 Observer sections

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