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EU Legislation On Health Supplements :
It is incredibly frustrating for us to have to devote huge amounts of our newsletters to issues surrounding the simple availability of our products, as opposed to telling you about their benefits. It is equally frustrating to see that the majority of our competitors seem to be concentrating purely on making as much dosh as possible, doing virtually nothing to fight for your legal rights, and concentrating purely on the benefits of short term financial gains at the expense of long term customer choice. It's been a couple of months since we sent our newsletter focusing on the question Will Our Vitamins and Minerals Be Banned? I still urge everyone who cares about their right to put the health products they want into their own body in worthwhile, as opposed to mickey mouse dosages, free of nannying regulations from Brussels to help us oppose the appalling directives currently coming into force. As well as reading the previous newsletter which focussed primarily on the Food Supplements Directive, we urge all customers to read the information below, and take action. Don't just leave it to us. If you do, we definitely WILL fail. We do not agree that ignorance is bliss where it comes to fighting for your right to choose to take your health into your own hands, and to choose natural products which are currently freely available rather than pharmaceutical products. 1) The Food Supplements Directive (Directive 2002/46/EC) My own letter to the EU commission received a totally inadequate and frankly pathetic reply. I will not regurgitate it all here, but amongst other things were their claims that 1) "The vast majority of the supplements industry favour the directive". The technical word for this statement is lying. Every company we have spoken to is opposed to it. 2) It was not the intention of the unelected and unaccountable officials at the EU to reduce consumer choice, but the letter admitted that "the reference intakes of vitamins and minerals will also be considered" (in their final decision on Maximum Permitted Levels)". Translated into English, the "reference intakes" means the often hopelessly low levels we get from our diets, if we're lucky, if we eat a good diet, and even then if we then absorb the nutrients properly. None of which have a bearing on therapeutic quantities anyway. 3) Their reply also referred to excessive intakes leading to "adverse health effects" but failed to respond to ANY of the following part of my own letter (this was presumably because they were unable to supply an intelligent response) raising the very point that the facts actually demonstrate the opposite - namely the incredibly safety of vitamins, minerals amino acids and herbs when compared with mainstream 'medicines', and almost total absence of adverse effects. No Deaths from Vitamins, Minerals, Amino Acids or Herbs: Poison Control Statistics Prove Supplements' Safety(OMNS, January 19, 2010) There was not even one death caused by a dietary supplement in 2008, according to the most recent information collected by the U.S. National Poison Data System. The new 174-page annual report of the American Association of Poison Control Centers, published in the journal Clinical Toxicology, shows zero deaths from multiple vitamins; zero deaths from any of the B vitamins; zero deaths from vitamins A, C, D, or E; and zero deaths from any other vitamin.
Additionally, there were no deaths whatsoever from any amino acid or herbal product. This means no deaths at all from blue cohosh, echinacea, ginkgo biloba, ginseng, kava kava, St. John's wort, valerian, yohimbe, Asian medicines, Ayurvedic medicines, or any other botanical. There were zero deaths from creatine, blue-green algae, glucosamine, chondroitin, melatonin, or any homeopathic remedies. No man, woman or child died from nutritional supplements. 61 poison centers provide coast-to-coast data for the U.S. National Poison Data System, which is then reviewed by 29 medical and clinical toxicologists. NPDS, the authors write, is "one of the few real-time national surveillance systems in existence, providing a model public health surveillance system for all types of exposures, public health event identification, resilience response and situational awareness tracking."
Over half of the U.S. population takes daily nutritional supplements. Even if each of those people took only one single tablet daily, that makes 154,000,000 individual doses per day, for a total of over 56 billion doses annually. Since many persons take more than just one vitamin or mineral tablet, actual consumption is considerably higher, and the safety of nutritional supplements is all the more remarkable. These are remarkable statistics given that in the USA, 200,000 people per year are conservatively estimated to die from the use of correctly prescribed medical drugs, and in the UK 40,000. As an example, the drug Avandia (for diabetes) has been associated with 100,000 heart attacks, and the manufacturers are currently being sued by 13,000 people in a class action for damages in the USA. Part of the action concerns allegation that the manufacturers, GlaxoSmithKline, knew about the potentially life threatening side effects and knowingly failed to disclose them to the FDA and to the general public. Nice guys huh? Well, if the EU regulators, under pressure directly and indirectly from these and other similar organizations succeed in putting companies like ours out of business, or at the very least unable to supply effective products, that's who you'll be left with to maintain your health. I don't want to repeat myself excessively as I discussed this at some length in my previous newsletter, but to learn what you should be doing to help save our vitamins and minerals from being banned or reduced to virtually useless maximum dosages, please visit the web site Consumers for Health Choice or the Alliance for Natural Health for further information. Just to dispel any confusion, these organizations have nothing to do with The Finchley Clinic Ltd (we are a business, not a political organization), except that we support their vital work. 2) The EU Traditional Herbal Medicinal Products Directive (1924/2004) (THMPD). (In English, this is 'the protection of vested interests') Directive This is the other piece of evil rubbish currently being imposed on us by the unelected officials in Brussels. And it makes the Food Supplements Directive look like a walk in the park! I have used the word "evil" to describe this directive quite intentionally. It is not just wrong, it is not just bad, it is evil, and the organizations who have lobbied for it are evil, and have no genuine interest whatsoever in public health. As things stand it will ban the majority of the herbal remedies we provide in their current form, as all but "culinary herbs" will be for all intents and purposes banned from April 1st 2011. Yes folks, this will ban herbs which you could grow in your garden from sale. All herbal medicines have to be registered, which involve very expensive fees which have to be constantly renewed, making the organizations that implement the directive in the UK and across Europe very, very rich, and the pharmaceutical companies even richer. But lets face it, it's about money. It's ALWAYS about money. We know this. They know this. Traditional medicines are eligible for registration only if they are intended for minor ailments. They have to be produced to pharmaceutical standards, at such great cost to manufacturers as to no longer make the products marketable. If that wasn't enough, there is the additional cost of meeting the data requirements. This includes the assembly of dossiers of bibliographic and expert evidence, as well as the requirements for genotoxicity data (which typically have to be commissioned as existing data is not available) which are more or less impossible for small companies producing herbal remedies to afford, and even if they could are not really appropriate or necessary for herbal remedies anyway. Oh yes, if this still wasn't enough, for ANY remedy to be passed it has to have had traditional use and been sold within the EU for at least 30 years. So that's it for most non European herbs. Some have even claimed that the degree to which the directive discriminates against traditional medicines from the Indian, Chinese and South American cultures borders on outright racism. The only organization I am aware of in the UK actively and robustly attempting to oppose this dreadful legislation, is the Alliance for Natural Health and you can read about their work opposing the herbal medicines regulatory nonsense here. They can't succeed alone and they need support, both practical and financial. We encourage you to support them in whatever way you can.
Please watch a 5 minute Youtube video on this directive here 3) The Nutrition and Health Claims Regulation (Regulation (EC) No 1924/2006)
Under this little racket disguised as "public protection", when it actually suppresses thousands of years of acquired knowledge and information, only claims that are approved by European authorities, notably the European Food Safety Authority (EFSA), will be allowed. More or less anything we say will potentially be a medical claim. For the all-important category of disease risk reduction claims (Article 14), there will be a very onerous data requirement, beyond the economic reach of virtually all companies within the natural health field. Even statements which are true such as "Studies carried out at XYZ University demonstrated a 50% improvement in condition A" will be illegal, unless they have approval, which it is clear will be almost impossible to get. Similarly the statement "Herb X has traditionally been used for over 3,000 years by Chinese herbalists for condition Y" may be be a medical claim under the current rules. Approvals for any claims we can make will be product-specific, so we won't able to say "Vitamin C (in general) has such and such an effect". It will only be legal to say "this brand of vitamin C has this effect" and even then only after the data requirements have been passed for that brand, which most companies will be unable to get anyway. This pathway has effectively created a passport system available for big business / pharmaceutical companies who can afford the cost only. And we all know how much the pharmaceutical industry care about public interest given that 6 out of 10 of the largest pharmaceutical companies were prosecuted for fraud by the government in the USA last year. All 6 were found guilty, and they paid over $5 billion in fines. Of the remaining 4 of the top 10 who were not prosecuted, 3 are under Federal investigation. According to the organization "Taxpayers Against Fraud", these fines were so paltry compared with the pharmaceutical companies profits, that it was actually good business for the big pharma to use "improper promotional practices" (this involved bribery, exaggeration and lying) and absorb the fines than to be lawful and ethical. Get behind the organizations above, and defend your right to take what you want, and be supplied the information you need to make informed choices. Do it now, not when you can bothered, and too late anyway.
“It is the greatest of all mistakes to do nothing because
Wishing Good Health to All
Mark G. Lester |
It would probably be more accurate if this were renamed the "Keep Your Mouth Shut" or "The Public Do Not Have The Right To Be Given Information" regulation if it were to be named in a way as to reflect the true nature of this regulation / suppression of free speech.