You walk over to the counter and ask the assistant-who has always been helpful in the past-for the best herbal preparation to treat your migraine. He informs you that, under the new EU law, he is not allowed to make health claims for any product in the shop.
You wonder if your migraine is the result of a vitamin deficiency, so you consider trying some of the higher-dose vitamins that you've used in the past for therapeutic purposes. Where are they, you ask? The shop assistant tells you that the manufacturers have stopped making them, again because of EU limitations on potency. The pharma-ceutical companies or their sub-sidiaries now make most of the standard-dose vitamins.
If self-medication is difficult, perhaps you could see a practitioner. You ask to see his directory of alternative practitioners who work locally. It's suddenly become a slender volume, as there are now only two practitioners using any type of herbal medicine where once there were pages of them, working in the Chinese, traditional and Ayurvedic disciplines.
What's happened to all the herbal practitioners, you ask? Most have ceased to practise because they could no longer get hold of the herbs they needed to treat their patients, the shop assistant says.
The homeopathic hospitals will soon be closing down too, he says, because NHS funding has dried up. And where are the homeopathic remedies in the shop? They can all be found under the section marked 'Placebos', says the assistant.
Exasperated, you ask the assistant what your options are for treating the migraine. Go to see your local doctor, he advises, and he'll give you a prescription drug.
This bleak picture could materialize within two years if the current and proposed laws come into effect without any modifications. Natural medicine will be legislated out of existence, and it will cease to be a genuine therapeutic alternative to orthodox medicine.
On the face of it, most of these restrictions are being applied in the name of consumer safety and to create a standardized marketplace across the European Union. Never-theless, the influence of the pharma-ceutical industry is apparent, as it seeks to control all of medicine, and eliminate the lucrative alternative medicines market that is a challenge to its profit line. The pharmaceutical industry has already sponsored one move that will ban all vitamins and minerals that have any preventative or therapeutic value, and will also reclassify vitamins as drugs.
The result of this sustained assault will be a lack of consumer choice; if you want healthcare, it will have to be the sort offered by the pharmaceutical industry and the doctor.
Other governments and health authorities around the world are watching the introduction of these draconian controls with great interest, as they see the EU regulatory framework as the model to adopt in their own countries.
EU regulators have been working closely with the Codex Alimentarius Commission, a group that seeks to establish standards and controls for all food groups-including vitamins and nutritional supplements-around the world (see box, page 13). The Codex itself will be providing the blueprint, based on the EU regulatory framework, for other nations to introduce and follow.
One concern of the EU watchers has been the level of resistance from consumers, health groups and the alternative-medicine industry-which, thus far, has been minimal and containable. In the UK, consu-mer groups such as the Alliance for Natural Health (ANH) and Consumers for Health Choice have been mounting legal and political challenges, respectively. Although funding for their campaigns has come in part from the healthcare industry, no manufacturer or supplier has directly challenged the legislation.
Returning to our future customer in the health shop, these are the reasons why his visit was so frustrating.
o Health claims. By 2012, it will
be illegal for a manufacturer or supplier of any health product to make general claims of any beneficial effects. Even though there may be good research to demonstrate that omega-3 fish oils help to alleviate depression, for example, a manufacturer of omega-3 capsules will not be permitted to make any such claims for his product. If the manufacturer wants to make a general claim of health benefits, he will have to put his case to the European Food Safety Authority (EFSA), based in Parma, Italy. The EFSA will then give its 'scientific opinion' of the manufacturer's application, although it will then be up to the unelected European Commission to enforce the law, should the manufacturer act against the opinion.
Thus far, the EFSA has given around a thousand opinions-mainly on plant-derived nutrients and phytochemicals-and has found against the manufacturer in almost every case. Glucosamine and probiotics have already fallen foul of the EFSA's scientific opinions. It will soon be illegal for manufacturers of glucosamine, the shellfish-derived polysaccha-ride, to claim that their products help maintain joint health, despite the mountain of properly conducted research that has demonstrated that it has such positive effects. Similarly, the makers of probiotics are not allowed to claim that their products can in any way improve intestinal health, yet another decision that flies in the face of the scientific evidence to date.
The one sign of hope has come from the US, where the District of Columbia's US District Court has struck a blow for common sense. In May of this year, the Court overturned a decision by America's drugs regulator, the Food and Drug Administration (FDA), which had barred manu-facturers of selenium supple-ments from claiming that the mineral helped to reduce the risk of cancer.
District Court judge Ellen Huvelle ruled that "qualified health claims" are protected by the First Amendment, which allows free speech. She stated that the First Amendment also protects any claim that is an accurate reflection of the state of science. Her verdict was that the FDA's bar was, therefore, unconstitutional.
The FDA had introduced the ban in June of 2009. It had been supplied with conclusive and credible evidence to support the claim that selenium protects against cancer, which it clearly dismissed. The plaintiffs, led by the Alliance for Natural Health USA, had argued that the ban prevented manufacturers from communicating truthful health information to the public.
After the verdict, Dr Robert Verkerk, director of ANH Inter-national, commented, "The verdict against the FDA should send shockwaves across the Atlantic to the EFSA." Although that may be overly optimistic, the ruling does put a dent in the Codex Alimentarius' ambitions to create global-and uniform-controls over the supply and sale of vitamins and nutritional sup-plements. The FDA is expected to appeal the verdict.
o Vitamin levels. Consumers in the so-called 'liberal' countries, such as the UK, Sweden and the Netherlands, can currently buy high-dose vitamins for therapeutic purposes from their local stores. These products contain dose levels that are far above the RDA (recommended daily allowance), the minimum amount that the government agencies calculate is needed for the body to maintain good health.
By 2011, high-dose supple-ments will disappear from shelves throughout the EU. Also, although the 'maximum permitted levels' (MPLs) are still being debated, the future looks grim for the therapeutic nutri-tional market. The head of the food law unit of the European Commission, Basil Mathioudakis, has already stated that he wishes to outlaw the use of nutrients in clinical nutrition, functional medicine and nutritional therapy. In other words, vitamins and minerals are a food and not a medicine, and should not be used therapeutically. Mr Mathioudakis is also the European representa-tive on the Codex Alimentarius Commission.
Even now, high-dose vitamins sold in the UK already must include a warning that the dosage could be dangerous, and have done so since 2004, after the UK Expert Group on Vitamins and Minerals published its own con-clusions on safe upper limits.
However, the MPL proposals currently being discussed by the European Commission contain a number of anomalies and absurdities. The proposed safe level for beta-carotene supple-ments, for example, is equivalent to what you would get from eating one-and-a-half carrots, while the proposed level for selenium is similar to eating two Brazil nuts.
Campaigners such as the ANH fear that the MPLs are being used to create a false distinction between food and medicine.
"Just because a particular meal or food supplement is healthy and has beneficial effects on the body does not mean it should be classified as medicinal. Setting low borderlines between foods and medicines is clearly a political, not scientific, agenda," argues Verkerk-and it's also a commer-cial one. When the safe upper limits are set, high-dose vitamins and supplements will become a medicine and will then be only available on prescription. As it's unlikely that doctors will be reaching for their prescription pads to write out a script for a vitamin, the therapeutic supple-ments market will effectively die.
At present, the high-dose market represents around 15 per cent of the total vitamin market in the UK, and has annual revenues of around lb33 million (Food Survey Information Sheet 12/06. Survey to assess the market for high dose vitamin and mineral supplements in the UK and to determine the use of voluntary advisory statements; www.food.gov.uk/ science/surveillance/fsisbranch2006/ fsis1206).
Instead, consumers will have access to only standard-dose vitamins, the majority of which are manufactured by pharma-ceutical companies or their subsidiaries. While the high-dose products may be available on the Internet, this source will also dry up as the Codex Alimentarius sets safe limits similar to the EU's that will kill the therapeutic vitamins market worldwide.
o Natural herbs. Simple herbal remedies that have been around for years will still be available after the EU legislation comes into force next year on 1 April. This is because they are protected by the 30-year rule, which is included in the Traditional Herbal Medicinal Products Directive.
The rule singles out all herbal products that have been used safely for 30 years, including 15 years in Europe. However, the rule clearly discriminates against non-European herbal products, such as those that belong to the Ayurvedic, Traditional Chinese Medicine (TCM) and other traditions, that have not been used for 15 years in Europe, even though they may have been used in their own cultures for hundreds-if not thousands-of years. As a result, thousands of herbal products will also disappear from the shelves.
The rule has other limitations, too. It protects only individual herbs or simple combinations that have been in use for at least 30 years. This means that any innovative product that is made up of a novel combination of herbs will not be allowed, but will have to pass through stringent and expensive licensing tests.
As with the safe upper limits on vitamins, herbal regulations attack the therapeutic end of the market, where herbs are seen as a genuine alternative to pharmaceutical drugs. Complex or newer herbal products will be available either directly to consumers-but only if they pass a rigorous and expensive licensing process, which most manufacturers cannot afford to undertake-or indirectly by pres-cription. However, again, it is unlikely that doctors will be writing out many prescriptions for herbal medicines, while herbal practi-tioners will be unable to do so, as the UK government has resisted moves to regulate the herbal practitioner. Without these proper regulatory controls, the herbal practitioner will be reduced to using only simple herbal concoc-tions that are not available by prescription (see box, page 12).
o Health foods. The EU regulators view vitamins and minerals as food supplements-they are a further source of nutrients over and above the typical diet-but only as long as the dose is low, beneath a level that is considered therapeutic (see 'Vitamin levels', page 12). Vitamins and minerals can also be added to foods. However, only those vitamins that are on the EU's 'positive list' can be used as either supplements or food enhancers. The positive list was finalized last January and includes 181 'safe' supplements. However, it has outlawed a number of nutrients and vitamins that were previously allowed in the UK and other liberal countries. Food supplements containing vanadium, silver or sulphur have all been banned. The ban on sulphur also explains why supplements such as MSM (methyl-sulphonyl-methane), which were taken to support healthy joints, skin and nails, have already been removed from UK shelves.
o Homeopathic remedies. Homeop-athy has been left relatively unscathed by EU regulations-
no doubt thanks to its pivotal position in the German medical system. However, it's under attack in the UK (see box, page 14). As Cristal Sumner, chief executive of the British Homeopathic Asso-ciation, says, "There are plenty of products on the pharmacy shelves that are not evidence-based. In fact, there is a great deal of evidence to demonstrate that homeopathy does work, but doctors continue to ignore it. On the other hand, around half of all medical practices have absolutely no evidence that they work."
The end for alternatives
The thrust of the EU legislation-which, if successful, will be introduced worldwide with the help of the Codex Alimentarius-is to kill off natural medicine as a viable alternative to conventional medi-cine. Alternative and complemen-tary medicine will be reduced to offering simple, relatively anodyne, remedies for minor ailments. People who self-medicate will find that many of their choices will have disappeared over the next 24 months.
By the end of those two years, manufacturers will be barred from making any general health claims about their products, no matter how much it flies in the face of common sense. Higher-dose and therapeutic vitamins and minerals will be removed from the shelves, as will the more complex and innovative herbal remedies, along with many products from the Ayurvedic and Chinese medicine traditions.
The EU legislation is very much the test case for the rest of the world: if it's successfully introduced and met with the minimum of resistance, it will be used as the model for the Codex Alimentarius, which will help other governments to introduce similar regulations in their own countries. Moves to restrict natural medicine are already quickening in the US.
In the UK, herbal medicine faces yet another, separate threat. The UK government is walking away from its commitment to regulate the profession and, instead, wants to introduce a 'light-touch' regulatory framework. Without such proper regulation, herbal practitioners will be unable to prescribe the complex herbal concoctions that are their stock in trade (see box, page 12). Although homeopathy faces its own challenges, they are not as serious as those threatening herbal medicine, and they are mainly related to the lb4 million annual funding that the four homeopathic hospitals in the UK receive from the NHS (see box, on the right).
What can you do?
The UK, Sweden and the Netherlands-the member states within the EU that operate liberal health regimes-will be the most affected by the new EU legislation. Other countries, such as Germany and France, already control, for example, the dosage levels of vitamins and minerals, which are available only at very low levels.
There are four main ways to fight the new regulations.
o Public action. This has been the least utilized, possibly because it requires a central organizer, and a great deal of time and energy. WDDTY organized a protest march through the streets of London six years ago, culminating in speeches by Tory MP John Redwood, Euro MP Daniel Hannan and WDDTY editor Lynne McTaggart in Trafalgar Square. Around 10,000 people marched and, yet, it warranted just one paragraph in the following day's national newspapers. The Daily Mirror quipped that it was surprised that a pretty girl like Billie Piper, the celebrity who joined the march, could find nothing better to do with her Sundays than protest when she could be out shopping.
Consumer protest could include a protest strike over certain prescription medications, and there could be a refusal to take any novel prescription drugs. New drugs-products that have been licensed for less than five years-are the lifeblood of the pharmaceutical industry, and the consumers' refusal to take them would hit them hard. Also, from a safety perspective, such drugs are the most dangerous, as there are less practical data collected about them.
o Political action. In the UK, the Consumers for Health Choice (CHC) have been lobbying UK MPs for years, but with limited success. Although Tony Blair had agreed to use the UK's influence within the EU to maintain high dosage levels of vitamins and minerals while prime minister, his successor was less committed.
Nevertheless, most MPs have been lobbied to urge the UK's various health ministers to "redouble their efforts" to safe-guard alternative healthcare in the UK. Lately, the CHC has focosed its attention on the European Commission and its health commissioner John Dalli, urging consumers to write directly to him in protest against the proposed lowering of vitamin doses. You can also write to your local MP and MEP (Member of the European Parliament) to express your concerns.
o Legal action. The Alliance for Natural Health (ANH) believes the best hope lies in a legal challenge to the legislation. So far, the
ANH has mounted challenges to the Food Supplements Directive, which seeks to restrict the vitamins and minerals that are available, and to reduce their upper safe limits, while its inter-national arm has overturned an FDA ban on a general health claim in the US.
o Donate. At this time-and in the absence of collective consumer action-our best hopes in the UK rest with the CHC and ANH. Both these groups desperately need funds to allow them to continue their fight.
o Contact information
v Alliance for Natural Health, The Atrium, Curtis Road, Dorking, Surrey RH4 1XA; tel: 01306 646 600; website: www.anhcampaign. org
v Alliance for Natural Health USA, 1350 Connecticut Avenue NW, 5th floor, Washington, DC 20036; tel: (1) 800 230 2762; website: www.anh-usa.org
v Consumers for Health Choice, Southbank House, Black Prince Road, London SE1 7SJ; tel: 020 7643 0690; website: www. consumersforhealthchoice.com
v European Commission, DG Health & Consumer Protection,
B-1049, Brussels, Belgium.
Four directives and regulations determine the future viability of natural health in the UK and Europe. Fundamentally, they change the category of vitamins and minerals from foods to drugs if they contain higher doses. Herbal treatments that are new, or have not been used in Europe for at least 15 years, will also be treated as medicines and, as such, controlled.
o Food Supplements Directive (Directive 2002/46/EC). This directive determines both the positive list-the vitamins and minerals that can be used as supplements and in foods-and their maximum permitted levels (MPLs). MPLs will determine at what dose vitamins and minerals become medicines and no longer foods. As medicines, they will be restricted and available only by prescription. In reality, the MPLs will signal the death of the therapeutic vitamin market. Also, EU observers fear that the MPL will be set at a very low level. While UK representatives, including the Food Standards Agency, are bidding for relatively high levels, the Germans and French are likely to win the day.
o Nutrition and Health Claims Regulation (EC No. 1924/2006). This will severely restrict the health claims that can be made about any product. Two types of claims are allowed: generic, a general claim based on good scientific data; and preventative. The European Food Safety Authority assesses all generic claims, while preventative claims will have to pass onerous-and expensive-tests. These will include human clinical trials that are beyond the scope and budgets of most manufacturers.
o Human Medicinal Products Directive (Directive 2001/83/EC, an amendment to Directive 2004/27/EC). This legislation has the most potential to do harm, as it's currently very wide-ranging, according to the ANH's legal representatives. This directive imposes tight regulations on drugs, but its definition of a drug is loose enough to include anything that may make you feel better. This could be extended to include foods and drinks, for example, even though they are currently excluded from the legislation.
o Traditional Herbal Medicinal Products Directive (amending Directive 2004/24/EC). This is a subdirective of the HMPD (see above) that allows traditional and herbal remedies to continue to be sold in the EU without control provided they have been used safely for 30 years, of which 15 years must be within the EU. Medical claims are permissible only for minor ailments. The directive bars many herbal preparations from the Chinese and Ayurvedic traditions in particular, as well as newer herbal remedies that cannot pass the 30-year test.
The threat to herbal medicine
Herbal medicine, which has been practised in the UK for many centuries, is now under serious threat. EU legislation, combined with the recalcitrance of the UK government, could prevent herbalists from practising by April 2011. If that happens, herbal medicine will cease to be a genuine alternative to conventional medicine and will be reduced to offering simple off-the-shelf remedies for minor ailments.
Under the Traditional Herbal Medicinal Products Directive, complex herbal remedies used by herbalists will be accessible to the public only through 'authorized health professionals'.
However, because herbalists in the UK are not regulated, they are not deemed to be professional-although not for want of trying. For the past
10 years, the European Herbal & Traditional Medicine Practitioners Association (EHTPA) has been lobbying to have the profession properly regulated; since then, three Parliamentary working groups have confirmed that full regulation is the best way forward.
However, one of the last acts of outgoing health minister Andy Burnham was, instead, to opt for so-called 'light-touch' regulation, presumably because of costs. However, this means that herbal practitioners-as well as acupuncturists-will not be properly regulated to the requirements of EU legislation.
Michael McIntyre, a fellow of the EHTPA, says: "We have until next April to get fully regulated, which is when the herbals directive comes into being. If we are not regulated by then, I reckon this will deprive around 80 per cent of Chinese and Western herbalists from practising as they won't be able to have access to the herbs they need."
At the time of writing, Mr McIntyre has heard neither from the new coalition government nor anything of its stance on herbal regulation, even though both parties were opposed to the light-touch approach when they were in the opposition.
The Codex Alimentarius
The Codex Alimentarius-or 'Food Code'-was created in 1963 by the World Health Organization (WHO) and the Food and Agriculture Organiza-tion (FAO) of the United Nations with the objective of setting guidelines and standards to ensure 'fair-trade practices' and consumer protection in the global foods marketplace.
Controversially, it has extended its remit to include vitamin and mineral supplements. In 1996, a German delegation put forward the proposal that no herb, vitamin or mineral should be used for preventative or therapeutic purposes, and that supplements should be reclassified as drugs. The move had been sponsored by the pharmaceutical industry. Although the proposal was passed, public protests stopped it from being implemented.
By 2013 at the latest, the Codex Alimentarius' own framework for the control of natural healthcare products will be completed. Not surprisingly, it copies almost word for word the EU regulations. This act may finally close the door to freer markets in which European citizens can still obtain high-dose vitamins via the Internet, for example.
The future of homeopathy
Rumours of the death of homeopathy may have been exaggerated, but it has taken a terrible and sustained battering from scientists, self-appointed 'quackbusters' and, more recently, UK doctors. At its annual conference in June, the British Medical Association-the doctors' trade union-called for all NHS funding of homeopathy to be stopped, as it claims that the therapy is no better than a placebo. The doctors also want homeopathic remedies sold in pharmacies and health shops under a section marked 'Placebos'.
These bully-boy tactics, which have been waged for some years already, have had some effect. Fewer PCTs (primary care trusts) within the NHS are offering homeopathy, and homeopathic training schools are seeing recruit-ment levels fall, possibly because potential students fear they could be wasting years of training for a therapy that may not have a future.
However, not all doctors are happy with their union. Around 200 of the BMA's membership are qualified homeopaths, and urologist David Ship-stone reminded his colleagues at the BMA meeting that they were happy to use other procedures that were also not proven. "What is valid scientific evidence? Academics can argue about it all day," he told his fellow delegates.
Cristal Sumner, chief executive of the British Homeopathic Association, believes that the motions are "flippant" and "a joke", and that the govern-ment won't take them seriously. But just to make sure, Tory MP David Tredinnick has put forward Early Day Motions to defend homeopathy within the NHS, and to resist the BMA's call.
The NHS currently spends lb4 million each year on homeopathy, mainly on four homeopathic hospitals that treat around 55,000 patients every year. This represents only 0.001 per cent of the total annual NHS budget.
WDDTY VOL. 21 ISSUE 5