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Back door laws against natural health

MagazineApril 2009 (Vol. 20 Issue 1)Back door laws against natural health

There's a build-up of pressure on many natural-health fronts worldwide, as Big Pharma and Big Food, together with their affiliates in regulatory agencies, unleash their most "vicious attack yet" on natural health, says Dr Robert Verkerk, the executive and scientific director of the Alliance for Natural Health (ANH)

There's a build-up of pressure on many natural-health fronts worldwide, as Big Pharma and Big Food, together with their affiliates in regulatory agencies, unleash their most "vicious attack yet" on natural health, says Dr Robert Verkerk, the executive and scientific director of the Alliance for Natural Health (ANH). "We're at an extremely critical stage at the moment," he says.

New food-claims legislation

On 1 July this year, the Nutrition and Health Claims Regulation-which will govern any health claims made about foods or supplements-comes into force throughout Europe. It's billed by the European Commission (EC) and Big Food as a major step forward in consumer protection. "Consumers can no longer be duped by false or confusing assertions on food labels," claims EU Health Commissioner Markos Kyprianou.

Health claims for food will be allowed, but only if backed by "gen-erally accepted scientific data", the "killer phrase", says Verkerk, that's laced throughout the regulation.

It will prevent most claims of bene-fit other than the most generic or bland statements about a food, ingred-ient or supplement used by every manufacturer, thereby eliminating any information to help consumers make a choice. "All of these products will look the same," says Verkerk. "None will be able to claim any use thera-peutically for disease risk reduction, and the cheap and least effective ones will inevitably win out."

Although the EU is still mulling over the kind of scientific data that companies must offer to satisfy claims that a product reduces disease, it appears likely that it will request randomized controlled trials-the so-called 'gold standard' of orthodox science-as evidence.

However, only the larger food manufacturers have the financial ability to provide the necessary scientifically acceptable substantia-tion that a particular food or supplement can reduce the risk of a particular disease. Such claims require scientific trials that typically cost hundreds of thousands of pounds or dollars.

Case histories from medical doctors with decades of experience using natural products, or even epidemio-logical evidence involving certain populations, cannot be used as proof of effectiveness. So, even if 20 studies of magnesium have shown that it can successfully combat heart disease, these findings cannot be used by a supplement manufacturer to make any disease-risk-reduction claims for its own product-unless a trial using its own specific product is carried out.

In practice, this means that the Big Food players will be able to make more health claims than small players for what may be essentially inferior products. Unilever, for example, which has carried out its own scientific trials, will be able to make specific health claims for its phytosterol-containing Flora Pro-activ margarine, while smaller producers of possibly healthier spreads entirely made of, say, olive oil, won't be able to.

According to EU rules, no national government can question the regula-tion once it has become law.

Food Supplements Directive

Two years ago, the European Court of Justice handed down a judgment on the case led by the ANH that upheld the controversial Food Supplements Directive. This piece of regulation proposes not only to limit which nutrients can be used, but also to restrict levels to only very low doses. The Directive also acts as a barrier against natural, food-derived vitamins.

Again, the legislation was consider-ed a nod to Big Pharma, as most pharmaceutical companies are easily able to produce low-dose, synthetic products that can be produced cheaply and sold throughout Europe.

Nevertheless, the lawyers funded by the ANH and the healthfood industry challenged the law through the European Court of Justice, and the Court's final ruling on the law changed its wording in a variety of important ways. The Court's interpretation indi-cates that naturally derived vitamins are outside the scope of the Directive, as they are simply considered food, not supplements. Most of the market's innovative products, created by small supplements manufacturers, are thus exempt. More important, the Court ruled that a supplement is considered safe until proven guilty-it would only be rejected if the European Commission could show that it posed a risk to the general public. The onus of proof of a supplement's safety or risk is there-fore firmly on the shoulders of the regulators. Nevertheless, the EC seems to be blatantly ignoring this ruling and going after a number of products. Recently, in Germany, teams of enforcement officers stormed into a company making a natural cancer treatment and seized the products, claiming they were unlicensed products. A similar raid took place in the oncology department of a hospital in the UK. However, legal challenges sponsored by the ANH have been able to show that all of the substances in question are foods or supplements and, thus, not subject to the Direc-tive's legislation.

The ANH's EU lawyers have also decided to expose the EC's continued hard-line actions as a blatant flouting of the European Court's ruling by spotlighting it through a number of 'test cases' and through the threat of further legal action. Since February of this year, they have submitted 15 precedent-setting dossiers for certain supplements to be accepted by the EC on the 'positive list'-the list of vitamins and minerals deemed acceptable for public consumption. The ANH has made it clear that, if the dossiers are rejected, they will again take the EC to court.

It's important to keep in mind that the Directive is a 'framework' piece of law that will introduce increasingly more stringent provisions over time. Besides determining which substances are allowed to be sold, it will probably set maximum upper levels of vitamins deemed safe in 2009. But thanks to consumer lobbying, in September 2006, Britain's Food Standards Agency (FSA) advised that Britain should try to "obtain EU agreement to a two-tier system that would allow the UK to keep its high-dose vitamin supple-ments on the market, subject to advisory statements about high doses on product labels".

Verkerk prefers to fight the legis-lation with science. The EC, which still appears to prefer 'total harmoni-zation' of vitamin levels throughout Europe, bases its risk assessment on highly restrictive levels. The ANH's challenge is to refute the logic behind the assessment of risk (see Viewpoint, page 5).

US crackdowns

Up till now, US supplements have been protected by the liberal Dietary Supplement Health & Education Act (or DSHEA, pronounced 'de-shay'), passed in 1994 following the biggest demonstration of consumer concern ever unleashed onto Congress. Under DSHEA, supplements are governed by different legislation from drugs. Safety is firmly in the hands of individual manufacturers, and the Food and Drug Administration (FDA) can only step in if a product is shown to be unsafe after it is marketed.

However, this important legislation appears to be seriously under threat.

The first cloud is the Trilateral Cooperation Charter (TCC) that dates back to 2004 between the US, Canada and Mexico, and is gaining more and more traction in the States. One of its main purposes is "cooperation in combating health fraud".

Among its various provisions, it also governs the sale of "products or services" that are represented as being to "diagnose, prevent, treat or cure disease". In practice, Mexico and Canada are cooperating with America to target any alternative manufacturer as well as the hundreds of alternative clinics established outside the borders of the US precisely to avoid the draconian US health-fraud laws. But it's also a back-door means of target-ing products and services in the US itself. Already, under the TCC, there have been over 700 prosecutions-mainly of slimming products.

Another threat came last December, when the FDA flexed its muscles by issuing a 'guidance' document aimed at complementary and alternative medicine to remind its practitioners of its powers under operational laws, including DSHEA, which are, in fact, stronger than was previously recognized. The fine print of the law gives the authorities wider powers to regulate and possibly ban products.

The guidance clearly attempts to define all therapies-even those using food-as drugs. If a practitioner wants to use carrot juice in his cancer treatment, says the guidance, and "the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act".

Such a scenario could also equally and easily apply to food supplements, thereby making most alternative practitioners subject to regulation.

The third attack has come from an unexpected quarter-namely, the usually liberal Senator Ted Kennedy. In May 2007, his oddly named Food and Drug Revitalization Act was passed-despite huge consumer protest. Its laudable purpose is to "oversee drug safety", but natural-health lobby groups say that it only serves to deepen the financial ties between Big Pharma and the FDA. What's more, within the fine print of the legislation is a call for the creation of the Reagan- Udall Foundation, the purposes of which is to evaluate the safety not only of drugs, but also of foods and supplements.

Senator Kennedy claims that his bill does nothing to change the law regarding supplements. Responds Verkerk: "The tactic of Big Pharma and Big Food as always is to boil the frog slowly."

Tony Edwards and Lynne McTaggart

What you can do to help

- Make donations to the non-profit organizations that are fighting these directives in court. If you live in Europe, give to the Alliance for Natural Health (ANH; www.anhcampaign.org). This pan-European group and its lawyers continue to challenge the laws.

- In the US, donate to the Health Freedom Foundation (www.healthfreedom. net) or Citizens for Health (www.citizens.org).

- Look into the 'Support Base' on the ANH website for other groups that are helping to fight for health freedom.

- Write to your MP and MEP demanding that your levels of supplements remain safeguarded and also that the EC be held accountable for flouting the Food Supplements Directive. To find your MP, phone 020 7219 4272 or log onto www.locata.co.uk/commons. To find your MEP, phone 020 7227 4300 or log onto www.europarl.org.uk/uk.meps (choose option 2 or 3).

- Add your name to the Consumers for Health Choice petition (go to www.consumersforhealthchoice.com .

Losing weight

Bernarr Macfadden (1868-1955), who about 100 years ago established the Natural Health Sanatorium in Brighton, England, is referred to as the 'father of physical culture' (as reflected in today's fitness centres). He was the man who, with total determination, promoted fasting, and dietary and lifestyle changes, together with sound naturopathic principles. To this day, his then-revolutionary ideas-naturopathic diet modifications, increased physical activity and appropriate lifestyle changes-remain the most effective measures for achieving weight loss.

Nevertheless, further help can be obtained from the following scientifically proven ways to shift excess pounds.

Acupuncture

This traditional Chinese technique has shown promise in weight loss. In one randomized controlled trial, 60 overweight patients were given either electroacupunc-ture or sham acupuncture (using non-acupoints) on the ear, twice daily for four weeks. The number of patients who lost weight as well as the mean weight loss were significantly greater in those given the genuine acupuncture (Aust Fam Physician, 1998, 27 [suppl 2]: S73-7).

Nutritional supplements

Chitosan is a form of fibre derived from the shells of crabs, prawns and other crustaceans. A meta-analysis of randomized controlled trials of chitosan concluded that it can assist weight loss (Perfusion, 1998; 11: 461-5).

Diet and hypnotherapy

Losing weight often involves a high-fibre, low-fat diet, but an alkaline-ash diet can also help. This consists mostly of fruit, vegetables and milk, with little meat, fish, eggs, cheese or cereals. When 'burned' in the body, it leaves an alkaline residue that is excreted in the urine.

Literally hundreds of diets claim to be the answer to excess weight. Yet, the simplest equation for weight loss never changes: energy intake must be less than energy output. This means reducing calories (dieting) while increasing the rate of calories burned (exercising). To lose 1 kg of weight, you must take in 7000 fewer calories than you burn. Anecdotal evidence shows that hypno-therapy or allergy identification can assist.

Fasting

Fasting is the voluntary abstention from food for a period of 12 hours to 30 days or more. Most therapeutic fasts last between three to seven days. Liquids are taken as boiled or mineral water, or as fruit or vegetable juices.

There is much published research demonstrating the use of fasting for treating schizophrenia, acute glom-erulonephritis, arthritis, skin complaints, epilepsy, a range of cardiovascular diseases and acute pancreatitis, to name but a few (see WDDTY vol 5 no 1 [1994], page 9). However, as with any form of therapy, fasting should only be undertaken with the supervision of a qualified practitioner. Also, it's not a slimming aid because any weight lost during a fast soon returns (often with interest) on ending the fast.

Herbs

Weight loss is one area where medicinal herbs have been widely used, though not always judiciously. A variety of infusions and capsules are available over the counter, made up of a combination of herbs. However, they usually contain the same basic formula: a potent laxative plus a diuretic, to produce diarrhoea and diuresis (excessive urination). They also include herbs that counteract these effects. Such preparations are to be avoided as, initially, they produce a see-saw effect and, later, generally cease to work altogether.

There are, however, some genuinely effective herbs. A gentle appetite suppressant such as a tea made from the grapple plant or Devil's claw (Harpagophytum procumbens) can be a useful adjunct to a proper diet and exercise plan (Gen Pharmacol, 1987; 18: 559-61).

Green tea extract is also promising. A study of green tea powder combined with wall germander (Teucrium chamaedys) in capsules compared with a common amphetamine-like anti-obesity drug found that, after 45 days, those taking the herbs each lost, on average, 0.8 kg more weight than those taking the drug. Also, unlike the herb group, the drug group reported increased blood pressure, insomnia and nausea (Arkopharma's Phyto-Facts, 1989; 2: 2).

It's also been found that eating 1 g of Malabar tamarind fruit before each meal gradually led to considerable weight loss (Med Hypoth, 1988; 27: 39-40). The hydroxycitric acid (HCA) contained in the fruit is thought to be responsible for the effect. In fact, there's more than 40 years of peer-reviewed, published studies on HCA's natural capacity to reduce the desire for food, and to inhibit the synthesis of fat and cholesterol safely and effectively (Biochem J, 1990; 272: 181-6; Fed Proc, 1985; 44: 139-44). Should you want to try it, there's a standardized extract of HCA called Citrimax.

Ayurvedic herbal medicine can also successfully treat obesity. In one trial, 70 obese patients received one of three Ayurvedic herbal formulations for three months. Those taking the herbals experienced significant weight loss compared with those taking a placebo. Measurements such as skin-fold thickness, and hip and waist circumferences were significantly reduced. Even better, these benefits came with no side-effects (J Ethnopharmacol, 1990; 29: 1-11).

Harald Gaier

Harald Gaier, a registered naturopath, osteopath, homeopath and herbalist, practises at The Allergy and Nutrition Clinic, 22 Harley Street, London, and the Irish Centre of Integrated Medicine, Co. Kildare (www.drgaier.com).


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