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EU Directives - Health Protection Double Speak

by Helen Fullerton(more info)

listed in nutrition, originally published in issue 89 - June 2003

The EU is forcing through three Directives in the guise of consumer protection: the Food Supplements Directive which became law in July 2002; the Traditional Herbal Medicinal Products Directive, voted for at first reading by the European Parliament on the 21 November 2002; and the Proposed Amendments to the Medicines Directive.

The Directive on Food Supplements 2002/46/EC stipulates (a) that the allowable upper limits should be standardised across the EU. These have yet to be determined. And (b) that the only minerals and vitamins permitted and their only allowable formulations will be those restricted to the "positive lists" (Annex 1 and 2).

The Directive is to be incorporated into UK law by means of a Statutory Instrument in 2003. Since the public must be consulted, the Food Standards Agency (FSA) published the draft of the Government's proposed Food Supplements Regulation together with a Regulatory Impact Assessment (RIA).[1] Deadlines to respond were February 11 and 17 for England and Wales respectively.

The RIA sets out the Government's view of the Directive's benefits and disbenefits to manufactureres, retailers and consumers. It accepts the intrusion of the Directive into the freedom of UK consumers and intends without demur to "fulfil our Community obligation". It has nothing to say on the UK position on maximum dose levels, nor any criticism of the restrictive positive lists, including the likely exclusion also of non-mineral/ vitamin nutrients. Food supplements not on the positive lists would continue to be sold as permitted in Article 4 until 31 December 2009, but a safety dossier must be submitted to the EU Commission before July 12 2005 for each and every several hundred substances: a deadline many specialist manufacturers may not have the resources to meet. Finally there is no mention of the proposed Amendments to the Medicines Directive whose definition of medicinal could nullify any negotiated agreement on maximum limits and the positive lists.

The objective of the proposed Regulations was "to ensure adequate protection of public health yet reduce the negative impact on industry". This phrase suggests that in the Government's view lower dose levels and fewer supplements would be better for public health but unfortunate for the trade.

The Food Standard Agency's view of the nutritional benefits of food supplements

According to the RIA, the only disbenefit the Regulations would impose on the public would not be inadequate health protection but "a restriction in consumer choice". What alarms the consumer is that the proposed restrictions will put their health in jeopardy and give them no choice whatsoever except resort to drugs.

In the western world, we are besieged with degenerative diseases induced by nutritional deficiencies, due to vitamin/mineral depleted soils (inadequate intake), malabsorption (inadequate uptake), insufficient antioxidants and inefficient detoxification systems to deal with environmental toxicities.

The RIA admits that an estimated 40.9% of the population consume food supplements. It ignores the fact that millions depend on the extra nutrition to protect them from the diseases they most fear: cancers, heart disease, strokes, arthritis, diabetes type II, macular degeneration, dementias ... and the side effects of drugs.

In this they are unsupported by the medical profession, who are largely ignorant of nutritional science, despite research published since the mid-sixties and contemporary advances in molecular biochemistry and genomics that illuminate the role of antioxidants, trace element and vitamin co-factors and essential fatty acids in preventing inflammatory, carcinogenic and degenerative disease.

Nutrition is still virtually excluded from the medical curriculum, whose content, apart from surgery, is determined by the belief that every condition can best be treated by a drug. Furthermore researchers, consultants and advisory experts are unwilling to put their careers, grants and livelihoods at risk by offending a pharmaceutical industry on which they have almost exclusively depended since Margaret Thatcher privatized research institutes and forced universities to rely on corporate funding.

Trade rules

The over-riding objective of the Directive is to facilitate trade. The RIA spells it out succinctly: "Foods containing concentrated sources of nutrients have, up to now, been regulated by different national rules that have resulted in different levels of consumer choice, impeded free movement of food supplements, created unequal conditions of competition and have had a direct effect on the functioning of the internal market." These impediments prevented the creation of a vast, uniform market across Europe which could then be flooded with low cost supplements, mass produced by the multinational companies. The Directive, the RIA explains, "lays down a framework for Community rules on food supplements in order to promote the free movement of goods" and "ensure a high level of consumer protection". The two are incompatible. The so-called protection of human health is nothing more than a cover-up to ensure that the internal market is not distorted by the unfair competition of therapeutic supplements which most EU countries are not allowed to market.

If, in the interests of harmonization and free trade, doses are restricted to some uniform 'perceived need', as is the case in most EU countries, rather than to a 'safe upper level', as is the case in UK; and if supplements are restricted to arbitrary positive lists that exclude valuable health products; or if health products are banned as 'medicinal', then there will be a collapse of public health, overflowing doctors' surgeries, misery from the side effects of drugs and betrayal of the consumer.

The Food Standards Agency (FSA) was set up to protect the consumer, not to further trade. Its first remit was to ensure food safety. Its second to promote nutrition. The framers of the Regulations would do well to heed the wise counsel of Professor Philip James: "The impact of poor nutrition usually emerges over a longer period and in less dramatic form than the still rare E.coli-induced form of kidney disease or possible cases of the new variant CJD. Any new body will need to look further than the old-fashioned definition of food safety. There are other inter-related aspects of food policy such as labelling and education which are crucial."[2]

This advice would appear to suggest a policy similar to that adopted by US in their Dietary Supplement Health and Education Act 1994.

Maximum limits

Article 5 recognises that, in UK and the Netherlands maximum levels are derived from the upper safe limit, but despite assurances that this would be the criterion, the levels adopted are expected to be much lower. They will be whittled down by including intakes from food, and from fortified foods, possibly a big contribution since the food industry is keen to give its high sugar, additive-laden junk a healthy image. Together with an additional safety factor, these devices could bring the levels closer to the 1-3 x RDA levels demanded by the majority of EU countries.

RDAs (recommended daily allowance, now referred to as the RNI or reference nutrient intake) were formulated some 50 years ago to ensure against acute deficiency diseases such as pellagra and scurvy. Permitted levels of some small multiple of the RDA enforced across the EU would be totally inappropriate for UK consumers. They take no account of subclinical deficiencies due to:

(i) Variability of diet : Fast food consumers will be particularly deficient. Fortified carbohydrates supply some of the nutrients removed in processed foods, but not the bioflavonoids to be found in fruit and vegetables. Vegetarians, and vegans especially, may be deficient in zinc and vitamin B12. The entire UK population is deficient in selenium. And all northern Europeans have lower intakes of the anti-oxidative phytonutrients compared to those in Mediterranean countries where these are plentiful in grapes, wine and citrus fruits – and affordable, but too expensive for those on low incomes in the north.

(ii) Malabsorption/utilisation of nutrients : malabsorption, particularly of magnesium, zinc, selenium, chromium and the B vitamins, can be caused by low stomach acidity (affecting an estimated one third of the elderly); pancreatic enzyme under-activity; invasion of the gut microflora by alien bacteria causing dysbiosis; leaky gut allowing toxic molecules to invade the bloodstream; and by over-population of the gut with Candida albicans, a yeast that, besides displacing the symbiotic microflora, also secretes acetaldehyde. The acetaldehyde competes with the aldehyde of pyridoxal-5-phosphate, the active form of vitamin B6, blocking it from the enzymes it co-factors and inducing B6 functional deficiency.

Zinc, in addition to being malabsorbed, may be lost via excretion from a body under stress. Zinc is essential to the activation of over 300 known enzymes, and for numerous known and unknown functions. T-lymphocyte and macrophage activity, healing, thyroid action, healthy eyes, respiration control, DNA synthesis, and the cell membrane stability required for inter- and intra-cell communication all depend on zinc.

Magnesium levels are low in many people. This causes inadequate gluconeogenesis (glucose supply) resulting in exhaustion and muscle weakness. Magnesium is the calming element, controlling raised levels of intra-cellular calcium. Its deficiency can cause diarrhoea, hypertension, heart attacks, mitochondrial energy collapse and neuro-degenerative disease.

Chromium potentiates insulin and its transport of glucose into the cells. Its deficiency induces both low blood sugar (hypoglycaemia), expressed in depressed physical and metabolic energy, dizziness, concentration difficulty, palpitations; and high blood sugar (hyperglycaemia), expressed in non insulin-dependent diabetes.

For some human beings, a physiological function can be restored, corrected and maintained at the level of food. For others, due to some genetic defect or suppressed gene expression, medical history, stress, age, pollutant exposure or economic malnutrition, higher intakes are required.

We are not clones. Inequalities of need cut across populations. Biochemically we are all individuals. This is even the case with inbred, same-strain experimental animals.

(iii) Mineral and vitamin depletion in soils and foods: The accelerated decline in micro-nutrient levels is a global problem in industrially farmed soils, caused by their extraction in intensive farming, by reduced levels of organic matter and of the microfloral activity that makes nutrients more available and by failure to restore what is removed. If they are deficient in our soils they are deficient in our grazing animals, in our crops and in flour, meat, milk and dairy products. Moreover, plant breeding in favour of high yields has bred out the phyto-nutrients present in traditional varieties and wild plants.

Mineral and vitamin depletion in food has been documented in the US from Department of Agriculture reports[3], and in the UK from McCance and Widdowson's 1940, 1978 and 1991 'Chemical Composition of Food' commissioned by the Medical Research Council. Between 1940 and 1991, our vegetables lost an average of 27% of their iron and 76% of their copper. Between 1978 and 1991 the magnesium content of vegetables fell by 33% and zinc by 59%. The magnesium in fruit fell 16% and zinc 21%. Meat lost 10% magnesium, 54% iron and 24% copper. Milk 21% magnesium and 38% iron. In 1991, McCance and Widdowson added manganese, selenium and iodine to the assays and are currently compiling a fourth report where further falls can be expected.[4]

Selenium is deficient in most northern European soils, but in the UK has been rendered acutely so due to intensive farming and leaching by acid rain. Levels should be 0.8-1.2 ppm[5] and are seldom more than 3ppm[6]. These levels are reflected in the frequent Vet Record reports of selenium deficiency disease in farm animals. A survey of the human population by MAFF in 1995 found intakes of 29-39 mcg/day[7] where the RNI is 60mcg and 75mcg for women and men respectively.[8] It is obvious that every UK citizen should take a selenium supplement of 50mcg/d to bring them only to the level of the RNI. Up to 200mcg or more is required for health protection. MAFF were not alarmed at the results of their survey, and the Department of Health (COMA) called for "more research because there was uncertainty of outcomes".

There is no uncertainty about the outcomes. Selenium deficiency contributes to the incidence of cancer, heart disease and Parkinsonism, to the virulency of flu[9], to immuno-suppression, to interference with thyroid function[10] and to infertility in men, and in women to conception failures.[11]

In a randomised double-blind 10 year clinical trial to investigate selenium deficiency effects on cancer incidence and mortality, 1,312 patients were recruited and given either 200mcg/d or a placebo, comprising a total intake of 300mcg/d when food intakes in eastern USA were included. After eight years, the trial was unblinded because there was a 51% reduction in cancer deaths in those taking selenium compared to gender-matched controls, with biggest reductions in prostate (69%), colorectal (64%) and lung (46%) cancers[12], and to continue the placebos was considered unethical.

A trial is now in progress to verify these results with the participation of 5 northern European countries including the UK and the US. 52,500 volunteers are receiving daily supplements of 300mcg, 100mcg of selenium or placebo for 5 years.[13]

Zinc intakes in UK are also low. Soil levels are often as low 3ppm where they should be 12-15ppm in available zinc.6 In 1990, the Dietary and Nutritional Survey of British adults reported mean intakes of 11.4 and 8.4mg/d for men and women respectively. This might be considered acceptable: COMA (1991) set the RNIs at 9.0 for men and 7.0 for women.8 But many criticise that these RNIs are too low and conceal the UK's deficiency. The US and others set the zinc RNI at 15mg/d.

The evidence indicates we can no longer get adequate nutrition from our food. In a recent issue of JAMA, the American Medical Association recommended that all US citizens, including the healthy, should take supplements – a complete somersault from their previously entrenched position. Similar advice was given by medical nutritionists at the Harvard School of Public Health in a rewrite of the US Department of Agriculture's 1992 dietary guide.[14] One fears that when the EU Commission publishes its maximum limits for supplements, these will be out of step with what are known to be required for health protection.

There appears to be an obligation to conceal the facts. The EU Directive stipulates: "No person shall sell any food supplements the labelling, presentation or advertising of which includes any mention expressed or implied, that a balanced and varied diet cannot provide appropriate quantities of vitamins and minerals in general." This clause is incorporated into the proposed Statutory Instrument (para 6. 4). So much for "openness and transparency".

Our health is to be sacrificed on the altar of free trade. This is not confined to the EU. In a globalised economy free trade rules all, over-riding every consideration of food security and health protection. Until the misdirected powers of the World Trade Organisation (WTO) are curtailed, we shall be at the mercy of regulations to restrict the free availability of food supplements not only in Europe but worldwide, engineered by commercial interests via their manipulation of CODEX[15] where they have an overwhelming presence.

Positive lists

The positive lists (annex 1 and 2) of Directive 2002/46/EC were drawn up by the Scientific Committee for Food (SCF) on the basis of continental Napoleonic law where everything is forbidden unless expressly permitted, in contrast to British common law where everything is permitted unless expressly forbidden. Hence it is important that the lists should be as comprehensive as possible, compiled by nutritionists on the basis of up to date nutritional science.

Instead, an existing legislation has been used which specifies what may be added for a specific nutritional purpose (Parnuts), mainly for baby milk or the fortification of cereals and other processed foods from which the vitamins and minerals have been removed. The fortifying ingredients are selected by the manufacturers, often on the basis of their cheapness.

To underline this point, the Commission recently published their proposed regulation "on the addition of vitamins and minerals to foods". The lists of substances permitted for fortifying foods are identical to those permitted in food supplements, despite their very different purpose.[16] As a result, important nutrients are omitted from annex 1, notably boron, which is involved in bone maintenance and development and relied upon by the middle-aged and elderly to relieve their arthritis and protect against osteoporosis.[17] Some 350 formulations are missing from annex 2, mainly organic forms such as ascorbate, malate and amino chelates. which are more available and better absorbed than the inorganic forms permitted. Selenium-methionine and selenium-cysteine are excluded, the very forms in which selenium is transported in the body; also selenium yeast, which is used in the European/US cancer trial above, while selenium-methionine was chosen for a similar trial by the US National Cancer Institute. Chromium-nicotinate and chromium-glucose tolerance factor are excluded, as are numerous organic forms of calcium, magnesium and zinc, all in favour of less desirable inorganic forms.

The RIA makes no reference to the crucially important group of non-vitamin/mineral supplements for which a positive list has yet to be declared, and which the Parnuts scheme would certainly ignore. It includes :

(a) the amino acids.

(b) phytonutrient antioxidants, such as resveratrol (high in grapes), a phenolic that prevents clot formation and heart disease; and lutein (high in oranges), which protects the eyes from macular degeneration.

(c) endogonous antioxidants, such as coenzyme Q10 and lipoic acid that protect against free radical disruption of the mitochondrial production of ATP. Their supplementation lifts the energies of those suffering post viral fatigue, ME and MS and protects against neuro-degeneration.[18]

(d) The essential fatty acids. These are comprised of the omega-6 and omega-3 series. Omega-6 include arachidonic acid, a constituent of brain tissue, and the anti-inflammatory dihomolinolenic acid concentrated in evening primrose and borage oil. The omega-3 precursor alpha-linolenic acid is converted to dicosahexaenoic acid (DHA) a crucial structural component of cell membranes, synapses and brain tissue, and eicosapentaenoic acid (EPA) that activates the anti-inflammatory prostaglandins PG1 and PG3.[19] The best sources of DHA and EPA are oily fish, but the chlorinated hydrocarbons concentrated there from our polluted oceans cannot be tolerated by those whose occupation has sensitised them to these chemicals. Flaxseed oil is another source, but their conversion from alpha-linolenic acid requires adequate B6, magnesium and zinc as co-factors for the activity of delta-6-desaturase in the enzyme pathway – three nutrients commonly deficient.

(e) the 'mending' molecules, such as glucosamine sulphate, which is taken to help repair of cartilage, and glutamine to heal a leaky gut. A leaky gut allows toxins to enter the circulation and suppresses gut lymphocytes which, seldom realized, comprise the bulk of the immune system.

We have every reason to predict that these nutrients will be excluded from the positive lists and have to be fought for by a beleaguered public.

The positive list (annex 2) is even more horrendous for the ingredients it allows. Ferrous sulphate, a form avoided by nutritionists because it irritates the bowel and many anaemic patients cannot tolerate it, is considered 'safe'. It is doubly ill-advised as a source of free radicals that destroy vitamin E. But there is worse. The list includes sodium hydroxide and potassium hydroxide, caustic chemicals that will rip the skin off your fingers and the lining from the throat. It includes sodium and potassium carbonate. Have none of the Scientific Commttee for Food used soda crystals to scour the sink? Are they and the FSA going to sanction the marketing of a potassium supplement as potassium hydroxide?

The SCF have forgotten their own definition of a supplement as a concentrated source of nutrients. This is very different to adding the same ingredient to a food where the caustic alkalinity will be well diluted. It is obvious we are not safe in the hands of the experts, although it is, of course, unlikely that any manufacturer would be so stupid as to market potassium hydroxide as a supplement. But by sanctioning it the SCF and the FSA could be sued for legalising bioterrorism.

Risks and benefits in food supplements and in drugs

The risks of too great an intake in mineral/vitamin supplements are small.[20] The only deaths recorded for a supplement have been due to toxic contamination as in the case of the amino acid tryptophan. Nobody has died of a vitamin overdose. Certainly upper safe levels particularly of selenium, manganese and chromium should not be exceeded.

Undeterred by the long history of safe supplement use, the RIA notes, "there is no UK system for recording adverse reactions to dietary supplements ... no conclusions can be drawn about the actual incidence of adverse reactions ... there is a general absence of evidence on whether or not older people are at risk from high levels of supplements".

The RIA is biased in its failure to note the overwhelming evidence of the opposite: the risks of mineral/vitamin sub-clinical deficiency, and that older people are at greater risk and have a greater need for supplementation.

Why does the RIA so studiously avoid mention of the benefits? Why is there no comparison to the pharmaceutical risks, the inevitable 'adverse drug reactions' (ADRs) many of them severe and life-threatening? Iatrogenic diseases are now the fourth cause of death in the US.[21] In the UK, 10-20% of hospital patients suffer from ADRs - many of them fatal.[22] Drug after drug is withdrawn when the side effects are found to be insupportable and worse than the disease they are treating. The risks, we are told, have to be balanced against the claimed benefits. Yet the least suspicion of non-safety on the flimsiest of evidence invokes a threat of illegality for a supplement. Why the disproportionate treatment?

Nutrient intake risks are assessed by toxicologists, as if the nutrient was a poison, in contravention of the WHO recommendations that they must be differently treated.[23] Pharmaceutical risks are assessed from the information supplied by the manufacturers, and risk : benefit ratios largely derived from the unsafe business of extrapolating from animal experiments. If toxicologists were in charge of pharmaceutical licencing and used the same risk:benefit criteria they apply to supplements, few if any drugs would get a licence.

The effects of deficiency on society

Mineral and vitamin deficiencies affect the health and happiness of the individual. They may also have far-reaching effects on society.

(i) They are a burden on the NHS, already short staffed and overloaded. Those who take responsibility for their own health have less occasion to visit their GP and occupy hospital beds.

(ii) Evidence indicates that nutrient deficiencies contribute to the violence and aggression whose rising levels make our streets and housing estates unsafe for the majority. In the US, trials demonstrated the effect of subclinical deficiences on prison violence, whose incidence fell in a number of prisons if the inmates' diet was supplemented.[24] In the UK, the charity Natural Justice, in a search for the causes of unsocial behaviour, conducted a nine month double-blind trial at a young offenders institution in Aylesbury. Inmates were given a supplement containing 28 minerals, vitamins and essential fatty acids at levels close to the RNI for most of them, or a placebo. Those taking the supplements committed 37% fewer violent offences than those on placebo. Levels of violence quickly returned to normal when the trial was finished.[25] The Government has so far refused to fund a follow up of these results. Perhaps if our children suffered less from nutrient deficiencies our schools would be happier places and fewer demoralized teachers quitting.

The RIA reports that the main users of supplements are those in the A,B and C1 socio-economic groups. This does not only reflect the fact that these groups are better informed as to what supplements can do for them. It also reflects the inability of those with lower incomes to afford them - despite a poorer diet and greater need. The answer would be to obtain them on prescription. But this is forbidden. Food supplements are on the so-called 'black list' published monthly in the Drug Tariff, and may not be prescribed on the NHS[26], presumably because that would classify them as 'administered' and define them as a medicine.

The proposed EU Medicines Directive, like a grim reaper, will get rid of this undemocratic anomaly by removing the consumers' right to obtain the supplements they need, whether they can afford them or not.

History of food supplement denigration

The Food Supplements Directive is the culmination of a sustained attack on dietary supplements by commercial interests. An attempt to harmonize the marketing of supplements throughout the EU was initiated in 1991. It was driven (a) by multinational companies, particularly those operating in the UK who foresaw a lucrative market for low level supplements, untramelled by national restrictions of maximum limits; and (b) by the pharmaceutical industry, who feared that if consumers turned to nutritional solutions for health protection, the profitability of drugs would be severely eroded. Working through organistions such as the Campaign Against Health Fraud (Health Watch) and via their hold on researchers following the privatisation of medical research, pharmaceutical interests were able to vilify food supplements.[27] First they were condemned as useless, peddled by quacks to rip off the gullible, including those who 'believed' themselves to be ill with ME, MCS (multiple chemical sensitivity) and food intolerance. Such accusations still persist.[28] Next, supplements were condemned as toxic at raised levels. Flawed research in 1994 accused vitamin C of causing kidney stones, which, if confirmed, could have restricted its dosage to one of no therapeutic value. Two large trials have scuppered the accusation. In 1997, an attempt was made on the advice of COT and the Food Advisory Committee to ban vitamin B6 at levels greater than 10mg on the erroneous grounds that higher levels taken over a period caused sensory neuropathy.[29]

Several million depend on B6 to protect them from premenstrual syndrome and the many other ill-effects of B6 deficiency. The outcry led the Government to back off temporarily, by setting up the Expert Committee on Vitamins and Minerals (EVM) to advise on all vitamin/mineral upper safe limits. In 2002, the EVM resurrected the toxicity charge using the same flawed evidence as COT, and again set the level at 10mg[30], despite that in the US this evidence was rejected and upper safe levels set at 100mg.[31] The SCF restricts B6 levels to 25mg, but the EVM's intervention may get it reduced to 10mg.

The charge that dietary supplements were unsafe inspired the first demand for a Directive. This came, not from Europe as generally supposed, but from a MAFF/Department of Health Working Group chaired by Sir Howard Denner which recommended low maximum strengths for most mineral and vitamin supplements.[32] It was severely criticized as inaccurate, but nevertheless used by the EU Commission in drawing up the proposed 1992 Directive. An unprecedented campaign in Britain to stop the Directive persuaded UK to vote that nutritional need was a matter for the consumer (Brussels, March 1992) and the Council of Ministers (Edinburgh, May 1992) decided to restrict Community legislation to what was strictly needed and apply where necessary the principle of mutual recognition.

The agitation for harmonization continued however, both in the EU and at CODEX meetings. Lest this proved ineffective there was a more potent weapon. Food supplements could be crushed out of existence on the grounds they were medicinal. The authority for this was Article 1 of Directive 65/65/EEC which defines a medicinal product as :

(i) Any substance or combination of substances presented for treating or preventing disease in human beings or animals.

(ii) Any substance or combination of substances which may be administered to human beings or animals with a view to making a diagnosis or to restoring, correcting or modifying physiological functions.

To comply with this Directive, the UK replaced the relevant section in the Medicines Act 1968 by Statutory Instrument (SI) 1994/3144. Draconian criteria as to what constituted medicinal by function were given in the Medicines Control Agency (MCA) leaflet guidelines MAL8. Claims that a supplement could treat any adverse condition constituted a medicinal claim.[33] Alleviate, maintain, calm, detoxify were among the words constituting a claim.

A storm of protest was only quelled when the MCA, in reply to a Parliamentary question by Peter Hain MP (October 31 1995), softened the criteria by introducing a fudge that allowed 'discretionary interpretations'.

When the European Court of Justice ruled it was for national authorities to determine, subject to review by the Courts, whether or not a product should be controlled as medicinal, the relevant authority was the MCA, a body staffed by those responsive to the demands of the pharmaceutical industry and deriving its income from the granting of licences (Market Authorisations). The MCA was now determined to put classification on a statutory basis, and proposed November 6 1998 in a Consultation Letter MLX 249, that the classification procedure would be an MCA notice that it is minded to determine a product "a medicinal product".[34] This would mean:

(a) It was only available on prescription.

(b) It would require a licence. Thus it would have to prove efficacy by means of animal experiments and controlled trials as if it were a drug. The estimated cost was £80,000 per nutrient – a cost so prohibitive for the specialist manufacturer that the supplement might not even be available on prescription.

(c) Efficacy could be impossible to prove. A drug treats a condition. A supplement makes good a deficiency. The deficiency might cause a range of conditions depending on individual biochemistry, and be compounded with more than one deficiency. Its efficacy cannot be determined by the approved method of double-blind, controlled trials.

Only the trade were consulted. The consumer who would be most affected was ignored. Additionally, it should be noted that even if the supplement was licenced and requested by the patient, there is no obligation on the GP to prescribe it. Even if he was willing, he might be deterred by the fact that he could be penalized or even struck off the list by the British Medical Council for failing to use 'best practice' – drug therapy.

Again public protests forced the MCA to back down with the assurance that "the proposals would not change the status of products which are correctly classified now as nutritional supplements." (Letter from Paul Brittain, Border Line Senior Policy Adviser, MCA to the writer, 17 May 1999). Minister of Health, Frank Dobson, in a letter to MPs explained: "It is common ground that the Directive 65/65 EEC does not apply to foods and that foods can have an effect on physiological function." (Letter to Rt. Hon Dr. Alan Williams, MP, 27 May 1999).

It is clear that the MCA's intention was not to ban supplements themselves, but supplements that exceeded an arbitrary maximum level, now increasingly sought by a public grown wary of drugs.

The get-out phrase is 'correctly classified'. Jeff Rooker, Minister of State for Food, in his evidence to the House of Commons Agriculture Committee's Inquiry into Vitamin B6, having retreated from the untenable position that B6 levels greater than 10mg should be banned because they were toxic, in reply to questioning shifted the goal-posts: they should be banned because medicinal claims were made for them – no, not by manufacturers, but "in journals"[35], presumably including peer-reviewed researches.

Jeff Rooker's intervention that a lack of manufacturers' claims was irrelevant to the definition of medicinal appears to anticipate the proposed Amendments to the Medicines Directive which shift the emphasis defining a medicine from the way it is administered to the function of its ingredients. The Amendments would enable the MCA, and comparable bodies in member states, to define as a medicinal product and regulate its use, anything intended to restore, correct or modify a physiological function. It would include products already regulated under other sectoral legislation (such as homeopathic medicines) or not regulated (such as desensitisation vaccines against chemical and food intolerance).

To the Government's credit, Philip Hunt, Undersecretary of Health, wrote to Alex Salmond MP (June 2002): "The Government sees no justification for this proposal and will contiue to resist it, enlisting the support of member states." Glenys Kinnock, MEP, wrote to the writer September 9 2002: "Labour MEPs and the UK Government will seek to amend this proposal."

Foods as medicines : labelling and health claims

Knowledge of the nutrient content of our foods is an expanding subject. In addition to their vitamin-mineral content, fruit and vegetables contain a multitude of phytonutrients that protect the plant from its pests and pathogens and, in most cases, the animal consumer from the free radicals and toxins that induce degenerative diseases. Those with strong antioxidant acivity include garlic, soybeans, cabbage and umbelliferous vegetables, such as carrot and celery. Limonene in grapefruit and orange juice stimulates the gene expression of glutathione-S-transferase, a liver enzyme that promotes detoxification and elimination of carcinogens, as do the indoles of cruciferous vegetables, broccoli, brussel sprouts and cauliflower. Garlic and onions are medicinal for their allyl sulphides antioxidant and detoxifying activity. There is alpha-carotene in carrots and tomatoes, and some 200 carotenoids in oranges, including lutein, augmenting that present in the eye to protect the elderly against blindness. 1000 bioflavonoids have been found in foods. These are gene-response modifiers, antioxidant and anti-inflammatory. In one trial, dietary flavonoids protected against stroke.

Numerous phytonutrients, the B vitamins and zinc modulate gene expression. As research on nutrients and their control of gene expression advances, the distinction between a food and a drug is being blurred.[36]

Foods are medicines. Animals know that. They self-medicate themselves.[37] Cattle eat down dandelions to the knuckles and even unpalatable young docks to get at the selenium these deep rooters bring up from the subsoil. They select yarrow for its zinc, chickweed for its magnesium, search the hedgerows for the minerals and phytonutrients their depleted genetically-eroded pastures can't supply. They plaster their faces with soil from the banks to be licked off as a mineral supplement. A sick cow will nip off dozens of ragwort heads for its poisonous pyrrolizidine in an attempt to kill the pathogen afflicting her.

Nutritional medicine is the preventive/curative medicine that will rescue us from the hazards of chemotherapy, heart surgery, transplantation, in vitro fertilisation and the iatrogenic effects of drugs. By their definition of a medicinal product as capable of restoring, correcting or modifying a physiological function, the impending Amendments to the Medicines Directive would logically classify foods as medicinal products. The EU Directives, agreed and impending, have tied up the EU Commission, the Department of Health and the Food Standards Agency into knots of inconsistency and led them up a blind alley of outmoded policies. Their regulations fetter the science of health and abuse the citizens' rights to resources that should protect them in pregnancy, in childbirth, in old age and in their occupations from disease and a polluted world. The EU definition of a medicine is a contrived one, emanating from an all-powerful pharmaceutical industry for whom reclassification of therapeutic supplements as medicinal is now an urgent issue. The simplest way to eliminate the unwelcome competition is to have them made illegal.

The FSA should be aware that transposition of the EU Directives overrides the Guiding Principles enshrined in law when it was set up:[38]

1. Protection of health in relation to food. Restrictions on food supplements are an attack on health protection.

2. Assessments to be unbiased and based on the best available scientific advice. MCA members have no professional training or experience in nutrition, and the EVM recommendations are flawed. Links with the pharmaceutical industry may prejudice judgement.

3. Avoidance of over-regulation. An over-regulated 'nanny' state is proposed.

4. The general public must be allowed to make informed choices. This right is taken away.

5. Decision making processes to be open, transparent and consultative. Complaints against MCA decisions are reviewed by an MCA tribunal and difficult to be challenged by the public

6. Consultation to include representatives of those affected. The interests of those affected is disregarded.

The FSA and the Department of Health should make it their business to inform the public and allow manufacturers to inform their consumers, via the label and accompanying literature, as to what an antioxidant, an enzyme co-factor, an essential fatty acid is. What it does. Where in food it can be found. How it can be supplemented. The information must be scientifically validated. No claims for cure can be made, for this is unpredictable: We are biochemically and genetically individual and there are no panaceas. But to suppress information that may help to heal is more heinous than making a dishonest claim.

Out of the impasse

In America in the 1980s, the outlawing of food supplements was the policy of the Food and Drug Administration (FDA). FDA officers raided health practitioners clinics looking for 'illegal' B vitamins, continuing a policy of repression against those who had promoted, sold or treated with vitamins ever since the 1940s. In response to public pressure, the Nutrition Labelling and Education Act (NLEA 1990) permitted medicinal claims to be made for dietary supplements where these were scientifically validated, but there was frustration when the FDA repeatedly disallowed them.

By 1990, some 50% of Americans were taking food supplements and the FDA, riddled with pharmaceutical interests, threatened their reclassification as medicines.

Congress responded to an enraged public by passing with an overwhelming vote the Dietary Supplement Health and Education Act (DSHEA) in 1994, with the support of President Clinton.

The Act safeguarded the free availability of dietary supplements as nutritional supports for maintaining health; recognised there was a link between the ingestion of certain nutrients and the prevention of chronic diseases such as cancer, heart disease and osteoporosis; and stipulated the public's right to be properly informed of the nutrient's physiological function on the label.[39]

While the EU and UK legislation is generated by a bureaucratic definition as to what is medicinal, the US legislation is generated by an understanding of the role of supplements in health protection and the part played by deficiency in undermining it.

The Government should examine the NLEA and the DSHEA together with its 'Commission on Dietary Supplements Final Report' on claims and labelling (November 24 1997), with a view to protecting in law the UK public's right to health foods, and right to be informed as to their function.

The RIA put forward four options for the transposition of the Food Supplement Directive. They rejected option 1 – "do nothing and fail to implement the Directive" – on the grounds that this would "fail to deliver improved consumer protection, particularly in the elderly". Again, the ambiguous phrase indicates that the FSA views the expected lower maximum limits and restricted positive lists as protective of human health. In view of the therapeutic benefit and safety of food supplements from clinical evidence and contemporary nutritional research, this bare-faced assertion on the part of the FSA is breath-taking.

It is obvious that a refusal to implement Directive 2002/46/EC is the only one that safeguards human and animal health and stands up for our democratic rights. But we should not "do nothing". The least we must do is:

(i) claim subsidiarity, irrespective of trade rules, and protect dietary supplements and health foods in law.
(ii) Remove dietary supplements together with herbal medicines from the jurisdiction of the MCA.
(iii) Insist the FSA carries out its legal obligation to promote nutritional health protection.

More than this, we should join forces with like-minded countries such as the Netherlands and Sweden to transform EU health policies, and ensure that the interests of those pressing for harmonization and free trade, whether via CODEX or EU Directives, are overridden.

We must develop nutritional science, fund its research, and induce the Medical Profession to become versed in nutrition, where they are now totally dependent on drugs.

The science of nutrition is rooted like pharmaceutical science in molecular biochemistry, genomics, proteinomics and the complexities of gene expression, but it does not manipulate nature and distort outcomes. It should be welcomed as the safest form of medicine.

References

1. Food Standards Agency (FSA). Transposition of Directive 2002/46/EC on food supplements. Oct 2002.
2. James P. An interim proposal. Food Standards Agency (FSA). April 1997.
3. Bergner P. The Healing Power of Minerals, Special Nutrients and Trace Elements. Prima pub. Rocklin CA. 1997.
4. Thomas D. A study on the mineral depletion of foods available to us as a nation over the period 1940-1991. Trace Minerals (UK) Ltd. Forest Row. Jan 2000.
5. Wells N. Selenium in horizons of soil profiles. New Zealand J Soil Sci. 10: 142-153. 1967.
6. Goodwin-Jones D. Unpublished Farm Reports 1983-2002. Trace Element Services. Carmarthen.
7. Dietary intakes of selenium. Food Surveillance Information Sheet. No. 126. MAFF. Oct 1997.
8. Dietary Reference Values for Food Energy and Nutrients for the UK. Committee on Medical Aspects of Food and Nutrition Policy (COMA) Dept of Health. HMSO. 1991.
9. Beck MA et al. Benign human enterovirus becomes virulent in selenium-deficient mice. J Medic Virol 43: 166-170. 1994.
10. Arthur J R. The role of selenium in thyroid metabolism. Canad J Physiol Pharm 69: 1648-1652. 1991.
11. Rayman MP. Dietary seleniuim: time to act. Br Med J 314: 387-388. 1997.
12. Clark LC. et al. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. J Am Med Assoc 276:1957-1963. 1996.
13. Clark LC. Prevention of cancer with selenium in Europe and America : a randomised cancer prevention trial. Bulletin Selenium-Tellurium Development Assoc. Oct 1998
14. Willett M and Stamfer M J. Rebuilding the food pyramid. Scientific American 288: 52-59. 2003.
15. Downing D. Codex Alimentarius. J Nutr Env Med 7: 75-77. 1997.
16. SANCO/329/2003 Preliminary draft proposal for a regulation of the European Parliament and of the Council on the addition of vitamins and minerals and certain other substances to foods.
17. Newnham RE. Arthritis without Drugs. The Natural Answer. Business Communications SA. Lausanne, Switzerland. 1997.
18. Beal M F. Aging, energy and oxidative stress in neuro-degenerative diseases. Am Neurol Assoc 38:357-366. 1995.
19. Erasmus U. Fats that Heal Fats that Kill. Alive Books. BC, Canada. 1993.
20. Penharic L. et al. Toxicological problems resulting from exposure to traditional remedies and food supplements. Drug Safety 11: 284-294. 1994.
21. Lazarou J. et al. Incidence of adverse drug reactions in hospitalised patients. J Am Med Assoc 279: 1200-1205. 1998.
22. Pirmohamed M et al. Br Med Assoc 316: (25.4) 294. 1998.
23. International Programme in Chemical Safety: Environmental Health Criteria 70. World Health Organisation. Geneva. 1987.
24. Schoenthaler SJ and Bier ID. The effect of vitamin and mineral supplementation on juvenile delinquency among American school children : a randomized double-blind, placebo-controlled trial. J Alt Comp Med 6: (1) 7-17. 2000.
25. New Scientist pp38-41. Nov 16 2002.
26. National Health Service. Drug Tariff. Compiled monthly on behalf of the Dept of Health by the Prescription Pricing Authority NHS England and Wales.
27. Walker M.J. Dirty Medicine. Slingshot Pubs. London. 1994.
28. Meah J and Cade J. Why do women use health foods and supplements ? Psychological and social influences. MAFF Research and Development Final Project Report. 30 April 1998.
29. Committee on Toxicity and Chemicals in Food, Consumer Products and the Environment (COT). Statement on vitamin B6 (pyridoxine) toxicity. Annex A. Dept of Health. June 1997.
301. Expert Group on Vitamins and Minerals (EVM). Safe upper limits for vitamins and minerals. Draft for Consultation. Vitamin B6. pp77-87. Aug 2002.
31. US National Academy of Sciences (NAS). Dietary Reference Intakes. Report on the B vitamins. Tolerable safe upper limits of vitamin B6. pp7.22 - 7.24. April 1998.
32. Report of the Working Group on Dietary Supplements and Health Foods. The Denner Report. MAFF publications. London. March 1991.
33. Medicines Control Agency (MCA). Medicines Act Leaflet (MAL 8). A set of guidelines as to what is a medicinal product as defined by the Medicines for Human Use (Market Authorisations Regulations) Statutory Instrument 3144. 1994.
34. MCA Consultation Document MLX 249. Proposed amendments to the Medicines for Human Use (Marketing Authorisations) 1994. 1998.
35. Jeff Rooker MP Minister of State for Food. House of Commons Agriculture Committee Iquiry into Vitamin B6. 5th Report of Proceedings, Session 1997-1998. Minutes of Evidence. Paras 266, 282, 314-325 19 May 1998. Stationery Office. 1998.
36. Bland J.S. and Benum S. Genetic Nutritioneering. Keats Pub. Los Angeles. 1998.
37. Engels C. Wild Health. Phoenix. London. 2003.
38. Food Standards Agency. A Force for Change. White Paper. Stationery Office. Jan 1998.
39. DSHEA: Congressional Findings. 1994.

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About Helen Fullerton

Helen Fullerton BSc. MSc. PhD campaigns on nutritional, animal welfare issues and others such as organo-phosphate poisoning, challenging flawed and corrupted science. She Learned homeopathy and the importance of trace element nutrition from my dairy cows, calves and sucklers. She urges unresponsive bodies such as MAFF (Defra) that our farm animals could resist TB and other diseases if trace elements were restored to our depleted soils. Her academic qualifications include a BSc in chemistry, PhD in agricultural chemistry. She has lectured on Soil Science at Glasgow University for 12 years. She can be reached on Tel: 01269 831 752; hf1000000@hotmail.com

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