Vitamins, Minerals and European Directive

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