Supplement Regulations

New laws come into effect throughout the European Union (EU) with regard to Herbal Supplements next month which will see hundreds if not thousands of herbal products removed from the market. The laws apply to natural foods, herbs, vitamins, minerals, supplements and indigenous remedies.
If you are reading this from a country outside of Europe and thinking that it doesn't apply to you - think again. Similar legislation is currently under consideration and will probably be introduced soon if Codex Alimentarius gets its way.
The Traditional Herbal Medicinal Products Directive (THMPD) has been introduced to 'harmonise' the regulations governing the provision of natural products and herbs across the EU amid confusion as to what products could be sold in which countries.
These laws are also ostensibly to provide greater consumer protection in spite of natural foods and herbal remedies having an exceptionally high record for safety and effectiveness going back millennia.
The process has been rolling on since 2002, with 300 different EU legislations and amendments to legislations secretly approved behind closed doors now coming into force. This has been done without media coverage so that for most people the first they will know about it is that they can longer buy a product they may have come to rely upon.
There are probably no surprises that the pharmaceutical companies which sat on the original EU committee decided to crack down and have the regulations enforced by a country's 'pharmaceutical police'.
In the UK these organisations include the Advertising Standards Agency (ASA), the Medicines and Healthcare Products Regulatory Agency (MHRA), Trading Standards, Environmental Health, and others. These organisations have been given more powers than the police to impose heavy fines, imprison manufacturers and practitioners, confiscate products, remove ingredients or force a business to close.
Ironically, the original legislation was introduced in 1965 to protect the public from another Big Pharma disaster such as thalidomide! Authorisations will be governed by the Committee on Herbal Medicinal Products (HMPC), which is heavily weighted towards pharmacologists.
The nuts and bolts of the legislation are that:
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The definition of what constitutes a medicinal product is so broad that it classifies all food products, herbs, nutrients and even water as being 'drugs'.
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However, it may be possible to sell some herbs classifiable as foods, such as cayenne pepper, under food law.
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Whilst the original, 1965 Directive had exclusions for food, toiletries and cosmetics these have now been transferred to the preamble section where they are not legally binding and the default setting is to regard any substance as a medicine if there is any doubt.
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Practitioners and lecturers also need to be extremely mindful of any claims that they make and this may effectively mean that centuries of wisdom are lost in a relatively short period of time.
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The Directive introduces a complete ban on all non-European herbal medicines such as Traditional Chinese, Ayurvedic and Amazonian medicines unless they can demonstrate 15 years of use within the EU.
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Particular combinations of herbal products may be banned, preventing the creation of any new or innovative herbal combinations that might be supported by the emerging science.
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Manufacturers must meet pharmaceutical standards for purity and stability. Many multi-herbal products will not be able to meet these criteria due to the complexity of the mixtures.
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Traditional medicines are eligible for registration only if they are intended for minor ailments.
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The cost of complying with the data requirements, assembling the dossiers of bibliographic and expert evidence, as well as commissioning genotoxicity data is estimated to be upwards of £80,000 per herb and will prove prohibitive for most small to medium sized manufacturers.
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Herbal products containing significant levels of vitamins and minerals will be prohibited and permitted only if the action of those nutrients is considered ‘ancillary’ to that of the herbal ingredients.
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Herbal products containing non-herbal ingredients other than vitamins and minerals will be disallowed.
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The costs of administrating a whole new raft of beaurocracy will have to be passed on to the consumer and this will mean less choice and make using supplements uneconomic for some.
The collective effect of this legislation is to effectively remove the natural healthcare option and impose a pharmaceutical, drug-dependent, symptom management culture.
Big pots, tiny kettles
All this brings to mind people in glass houses throwing stones, or the case of the very, very big pot calling a miniscule kettle 'black'.
Allopathic medicine is always happy to recite the few recognised and minor effects associated with some supplements such as the problems posed to the developing foetus by excessive vitamin A intake, the fact that St John's Wort may interfere with the contraceptive pill and the possible contamination of Traditional Chinese medicines with toxic metals. Whilst completely disregarding the facts that:
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Allopathic medicine is at least the third biggest killer in the US, and is reckoned by some to be the leading cause of death.
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A third of a million Americans each year are killed by their doctors.
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The number of strokes in the last 25 years has increased 7 fold as a result of people being advised to take aspirin to prevent cardiovascular disease (Lancet 2007).
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The anti-inflammatory drug, Vioxx was estimated to have killed 55,000 people and induced heart attacks or strokes in 85,000 more.
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Bayer sent batches of factor 8 for the treatment of haemophilia which had been withdrawn from the US market because they were contaminated with HIV to Japan, Spain and France. This killed an unknown number of people who were mostly children and also infected their families. No action was taken in the US by the FDA.
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Over 300,000 US hospital patients are harmed annually by medication errors and over 190,000 incidents of out patients being harmed by adverse drug reactions
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Over 100,000 people die each year in American hospitals and 10,000 in UK hospitals from the side effects of medication, and since these are only recognised 5% of the time, this figure is probably a gross underestimate.
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The reporting of serious adverse effects of pharmaceuticals has trebled in the US in recent years and there is thought to be massive underreporting of adverse drug reactions.
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One fifth of first hospital admissions for heart failure were related to taking NSAIDs such as Ibuprofen and for those with a history of heart problems, NSAID use increases the risk of hospital admission over 10 fold.
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Pregnant women taking NSAIDs suffer an 80% increase in miscarriage.
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Up to 20,000 people were adversely affected worldwide by the devastating effects of Thalidomide for the few short years it was in use around 1960 being born with missing limbs - a lifelong health issue.
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There has been an undeniable link between a number of high school shootings in the US and the use of SSRIs such as Ritalin.
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The side effect of a surprising number of drugs includes death. Seriously, how sick would you have to be before potentially being killed by the treatment seems like a viable option?
Also, because the media in general is in the pocket of their paymasters - Big Pharma - media coverage can be very biased. Consider the following:
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The US actor, Heath Ledger, was determined to have died aged 28 from a cocktail of prescription medications he had been taking including painkillers, anti-anxiety drugs and sleeping pills. There were no calls for these drugs to be withdrawn or for warnings to be issued, but can you imagine the rumpus if bottles of herbs or vitamins had been found next to his bed?
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When a UK toddler, Lana Ameen, recently died of swine flu, there was saturation media coverage of the grieving mother appealing to all other mothers to get their children vaccinated and to the government to fund universal swine flu vaccinations.
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In the UK in 2009 a 14 year old girl, Natalie Morton, died hours after being given a prophylactic cervical cancer vaccine. Whilst the story was covered that night, her death was dismissed the following day as having been due to 'underlying health problems' and the story disappeared from the media. After a brief temporary suspension the vaccination programme rolled on.
Costs of healthcare
Whilst allopathic medicine takes the high moral ground, there is no evidence that more medicine makes us healthier. In a recent World Health Organisation study, the United States (which spends the most per capita on healthcare) was rated 15th among 25 industrialised countries.
Plus, if doctors had the answers they would all be glowing beacons of health who live longer than the rest of us, but this plainly is not the case and life expectancy is actually decreased among members of the medical profession.
Finally, the diagram below illustrates statistics compiled by the Organisation for Economic Cooperation and Development (OECD) which show that life expectancy is just over 2 years longer in the USA (which is the country with the highest per capita health spend) that that in Mexico (with the lowest per capita healthcare costs) and that this extra two years comes with a price tag 9 times greater.

The Japanese manage to life 6 years longer than the average American at one third of the health cost and people in the Czech Republic live only one year less on average at one-fifth of the health costs. The United Kingdom has an average life expectancy and healthcare costs.
Obviously more medicine is not the answer. Not only does it not help, it harms and kills literally millions each year whereas the aim of herbal medicines is to support the innate restorative powers of the body.
It's a completely different mindset, but we are firmly in the hands of the beaurocrats and Big Pharma now.
The nuts and bolts of the legislation are that:
-
The definition of what constitutes a medicinal product is so broad that it classifies all food products, herbs and nutrients and even water as being drugs.
-
Whilst the original, 1965 Directive had exclusions for food, toiletries and cosmetics these have now been transferred to the preamble section where they are not legally binding and the default setting is to regard any substance as a medicine if there is any doubt.
-
Practitioners and lecturers also need to be extremely mindful of any claims that they make and this may effectively mean that centuries of wisdom are lost in a relatively short period of time.
-
The Directive introduces a complate ban on all non-European herbal medicines such as Traditional Chinese, Ayurvedic and Amazonian medicines unless they can demonstrate 15 years of use within the EU.
-
Particular combinations of herbal products may be banned, peventing the creation of any new or innovative herbal combinations that might be supported by the emerging science.
-
Manufacturers must meet pharmaceutical standards for purity and stability. Many multi-herbal products will not be able to meet these criteria due to the complexity of the mixtures.
-
Traditional medicines are eligible for registration only if they are intended for minor ailments.
-
The cost of complying with the data requirements, assembling of dossiers of bibliographic and expert evidence, as well as commissionsing genotoxicity data is estimated to be upwards of £80,000 per herb and will prove prohibitive for most small to medium sized manufacturers.
-
Herbal Products containing significant levels of vitamins and minerals will be prohibited and permitted only if the action of those nutrients is considered ‘ancillary’ to that of the herbal ingredients.
-
Herbal products containing non-herbal ingredients other than vitamins and minerals are currently disallowed.
-
The costs of administrating a whole new raft of beaurocacy have to be passed on to the consumer and this will mean a less choice and make using supplements uneconomic for some.
-
It may be possible to sell some herbs classifiable as foods, such as cayenne pepper, under food law.
Further resources