Have you heard the hype about future restrictions on natural health products?
Find out how the ‘boil-the-frog-slowly’ method masterminded by governments and transnational corporations is out to restrict YOUR FREEDOM OF CHOICE in the area of natural healthcare.
Read on……find out here what else is really going on. This is about your future, and that of the next generation.
- Campaign Summary
- Where in the world are restrictions most imminent?
The European Union (EU)
United States of America (USA)
- ANH leaflets [October 2012] and briefing papers on EU directives and regulations
- Why do we need to keep therapeutic natural health products on the market?
- EU dumbing down our food supplements
- Making different health choices can change the world
- Related pages
- As a consequence of moves to harmonise global food laws, concerted attempts to control consumer access to natural heath products are being made by governments and trans-national corporations.
- At a global level the regulatory framework is being developed through the Codex Alimentarius Commission (see our Codex campaign page).
- The system of control essentially moves natural health products from a category of food to products requiring pre-market authorisation, where the authorisation systems being used or proposed are very onerous and so lock out large numbers of products (e.g. around 50% of pre-2004 products in Canada).
- All this is being enacted under the often conflicting guises of ‘consumer protection’ and ‘free trade’, nearly always creating a situation where big business gets what it wants while our freedom to choose natural health products is dramatically curtailed.
Share information and work with us at the Alliance for Natural Health International (ANH-Intl) so that you can connect the dots, and see why there has never been a more important time for action.
Click here if your computer is wired for sound and you can make the time to listen to a lecture on the subject Natural Health at Risk given Dr Robert Verkerk on 17th June 2008 for Changing Times. It will help you understand why our health choices—particularly natural ones—are so severely threatened.
Where in the world are restrictions most imminent?
The European Union (EU)
Europe is becoming the central platform for global harmonisation of food laws relating to natural health. The ANH-Intl is based in Europe so we are right at the cutting edge. Much of the legal infrastructure that is set to cause major problems downstream has been in place for some time—and is finally beginning to be felt, as key parts of the European regulations and directives are now being implemented.
The EU framework has started to really bite between 2010 and 2011 when—although pro-natural health interests like us have continued to positively influence the process—we have seen:
- massive restrictions on allowed ingredients, including vitamin and mineral forms, as well as botanicals
- further threatened restrictions on maximum permitted doses of vitamins and minerals
- massive restrictions on what can be said about any product with beneficial properties
- imposition of pharmaceutical-type standards, making it difficult for many truly natural products to comply
There are a number of Directives and Regulations in the EU, many of which are in the process of coming into force, that are particularly problematic. Some of the key pieces of European legislation—or shortly to be implemented legislation—along with ANH-Intl’s key concerns about them and responses, are detailed in a series of leaflets [issued October 2012] and one-page ANH-Intl Briefing Papers that can be downloaded below:
2012 Downloadable summary information leaflets:
- ‘Food supplements in Europe’ leaflet
- ‘Health claims in Europe’ leaflet
- ‘Plant and herbal ingredients (botanicals)’ in Europe leaflet
- ‘Codex Alimentarius’ leaflet – the international standard-setting body controlling the global food trade
- ‘Practitioners’ leaflet – Building your practice while negotiating the EU regulatory minefield
- Our general leaflet about ANH, with information about out ten campaigns, and how to get involved
- EU Food Supplements Directive (FSD)
- Maximum Permitted Levels (MPLs) of vitamins and minerals
- (German translation)
- EU Nutrition and Health Claims Regulation (NHCR)
- EU Traditional Herbal Medicinal Products Directive (THMPD)
- (German translation)
The copius scientific problems associated with the proposed approaches to nutrient risk analysis have now been detailed and elaborated in two scientific papers published in the leading peer-reviewed journal, Toxicology
To read the papers click on the titles below:
- ANH Summary of key challenges to nutritional and botanical forms of natural healthcare, and the ANH’s responses to these challenges
- One-page A4 flyer on EU Legislation
- the Good, the Bad and the Ugly of EU Natural Health Regulation.
March 2012: Health Claims Veto Campaign Update
You have a fundamental right to the information that will help you to understand what you are eating and drinking; to give you the ability to make informed choices; and ultimately, to have control over your health and wellbeing.
We would like to thank everyone who took the time and trouble to write to their MEPs to try to convince them that a veto of the health claims proposal was necessary. So what happens next, you might ask? Watch this space, and we will let you know what our next move should be!
There are two key actions that you can help with, one intended for European consumers, the other for food supplement companies. Please sign up to the following, accordingly:
Consumers, please sign the petition (14,899 at the time of writing) at: www.sup.nl/petition
Food supplement companies, please join the signatory list (344 companies at the time of writing) established by the European Health Claims Alliance: www.healthclaimsletter.org
The Canadian government, against the wishes of its its people and its Parliament, brought in a licensing system for ‘natural health products’ in 2004 which is so onerous, it has already caused a significant loss of products from health stores. It is estimated that some 20,000 products have already been lost.
This system was forced through after a huge public outcry and demonstration of concern about unnecessary restrictions on natural health products in 1997, which culminated in the ‘third category’ for natural products, keeping them outside of both the food and drugs categories.
But, following the imposition of the Natural Health Products Regulations of 2004, things have been steadily getting worse. Like the European model—the worst of it has yet to be felt—because there is a huge backlog of products being considered for licensing that can legally be sold until the applications are evaluated.
The Canadians have been desperate to get extremely restrictive laws through any which way possible, but thanks to the work of some very concerned citizens Bills C-51, C-52 and C-6 have been abolished. Bill C-36 has just been pushed through and is almost identical to Bill C-52 and Bill C-6.
Click here for the Red Code alert about Bill C-6, and its call for immediate action by Canadians.
In A Question of Sovereignty, international award winning Writer/Director Kevin P. Miller (GENERATION RX, WE BECOME SILENT) exposes how Canadians are being stripped of their personal sovereignty by government agencies — and how free trade deals and other international agreements imperil Canadian democracy.
Quietly, over a period of many years, unconstitutional legislation encompassed in Bills C-51, C-6, and the current Bill C-36 have placed not only basic civil liberties and freedoms at risk, but Canada’s national sovereignty as well. The film shares how entangling alliances with groups like the World Trade Organization, the World Health Organization, Codex Alimentarius, the United States and even multinational corporate interests have become so powerful that they literally threaten to make elected officials in Parliament irrelevant.
A QUESTION OF SOVEREIGNTY discusses why this dramatic shift in the balance of power puts the nation and its people at a vital crossroad early in the 21st century — and why some of the past giants of Canadian politics may hold the answers to Canada’s future.
United States of America
US citizens along with the natural products industry came together in a unique effort back in 1994. This mass reaction to the Food and Drug Administration’s attempt to medicalise dietary supplements was simply not acceptable to Americans. Emerging from this people’s revolution, which saw a higher level of citizen protest in Congress than any other issue in US history, was the Dietary Supplement Health and Education Act (DSHEA). This US law not only maintained dietary supplements as a category of food it also prevented their adulteration and allowed for specific structure/function claims linked to disease risk reduction.
Since DSHEA there has been a massive growth of the US natural health product market. It’s becoming increasingly apparent that US regulators, probably in cahoots with their corporate allies in the pharmaceutical industry, are desperate to put the brakes on the dietary supplement industry. There is plenty of evidence of attempts to pass laws that are congruent with the draconian laws of Europe.
There has never been a more important time to defend the US natural products base, particularly given that it acts as the research and development arm for the rest of the world.
Find out all about that’s going on via the ANH-USA website
New Zealand citizens have being fighting for the rights to not be forced into a medicalised model, that was imposed in nearby Australia back in 1990, and continues to strangle more and more of the natural health industry.
In the front lines of this work, is ANH-Intl’s affiliate, the New Zealand Health Trust.
Although ‘Trans-Tasman harmonisation’ has recently been beaten in the New Zealand parliament, we know from experience in other parts of the world, such as Europe and Canada, the pressure won’t go away. Vigilance is one of the most important requirements for anyone concerned about maintaining their health freedom and freedom of choice in healthcare.
We’ll keep you posted on new developments—and those wanting to keep a finger on the NZ pulse—please bookmark the NZ Health Trust website.
Read ANH-Intl’s consultation response.
Why do we need to keep therapeutic natural health products available on the market?
Clinical nutrition, nutritional therapy and plain old good nutritional management have long included using dosages of vitamins and minerals that are substantially higher than those typically found in the average, contemporary diet.
Our bodies’ requirement for higher dose supplements
The following set of precepts were formulated and published upon the founding of the British Society for Nutritional Medicine, now the British Society for Ecological Medicine, in June 1984  and modified in the first issue of this journal in 1990, as follows.
- Man’s diet, even in industrialized societies, may have only a borderline, or indeed low, content of certain essential nutrients. A ‘normal’ diet is not necessarily a healthy or optimum one.
- Requirements for essential nutrients vary from individual to individual depending on genetic, physiological, lifestyle and other influences. What is adequate for one person may not be adequate for another.
- Illness is inevitably linked with an abnormal biochemistry and an alteration in the metabolism of nutrients and their by-products.
- Specific nutrients such as vitamins, minerals, essential fatty acids and amino acids, as well as dietary manipulation in general, provide a potent means of influencing body biochemistry and thus disease processes.
- Reproductive processes are nutrient-dependent and sensitive to environmental pollution. Nutritional status of and environmental factors affecting both parents in the preconceptional and periconceptional period, and nutritional status of and environmental factors affecting the mother throughout pregnancy, are primary determinants of pregnancy outcome.
The EU is planning to dumb down our food supplements—imminently!
The EU is in the process of developing a regime to control the maximum permitted levels (MPLs) of food supplements EU-wide. The levels are likely to be unnecessarily low—being based on flawed science—an they could prevent you obtaining sufficient nutrients to allow you to manage your health. For example, the level of beta-carotene could be less than that found in just two carrots, and that for selenium, less than the amount found in two brazil nuts.
Can you let this happen?
The beta-carotene content of just one large (70 g) raw carrot provides around 7.2 mg of beta-carotene. This amount of beta-carotene might exceed the maximum permitted level (MPL) allowed in supplements across Europe as of late 2010, when MPLs find their way into EU law.
How the European institutions are responding?
Find out how the Irish Association for Health Stores petition is playing a critical role in bringing sense, good science and democracy to the process. In January 2009, the European Parliament’s Petitions Committee voted to keep the petition open and referred it to the key parliamentary group dealing with matters of health and consumer protection.
Markos Kyprianou, the (unelected) European Commissioner responsible for health and consumer protection, made clear in January 2007 that the European Commission does not wish to allow sale of therapeutically active food supplements.
So, while many countries in Europe have regulated maximum levels of vitamins and minerals via multiples of the Recommended Daily Allowance (RDA), the European Commission and the European Food Safety Authority (EFSA) is in the late stages of planning the methods it will use to develop EU-wide, harmonised, maximum permitted levels for food supplements and fortified foods. This process will be instigated legally through an implementing measure of the Food Supplements Directive.
A harmonised European market for maximum (and minimum) dosages will no doubt be of considerable benefit to large corporations, especially the pharmaceutical companies that dominate the low-dose end of the supplement market, as they will no longer need to reformulate products for specific EU markets.
Low doses EU-wide are also regarded by many regulators as a useful end-point for meeting the Food Supplements Directive’s requirements for a “high level of consumer protection”. Nutritional therapists may, of course, take a different view, since they are much more likely to recognise the two-tailed nature of risks associated with nutrients. At very low levels of intake there are risks of inadequacy (that go well beyond simply the risk of developing deficiency diseases, but of course significantly impact the risk of chronic and even infectious diseases). At high levels of intake of some nutrient forms, there are, of course, potential risks associated with excessive intake. This may be particularly true of certain fat soluble vitamins, especially synthetic, isolated forms, and also some minerals, that have a somewhat narrow beneficial and therapeutic dose range (e.g. selenium, vanadium). Complicating matters even further, practitioners are also much more cognisant of the differences between short and long-term exposure. Short-term, high dose therapy with certain nutrients may in fact be highly beneficial (e.g., B vitamins), while the risks associated with long-term exposure, which are generally mild, transient and fully reversible, unlike many side effects associated with pharmaceutical drugs, are well recognised.
So how is the EU looking to take into account these differing requirements? An obvious approach, which has never been seriously contemplated by the EU authorities, is to develop a bespoke regime for practitioners—a third category, that exists between food and medicines. Whether the absence of a ‘third category’ has been the result of pressure from the pharmaceutical industry, inadequate pressure from practitioners and their associations, a requirement for simplification of the legal regimes by the regulators, or a combination of these elements, is anybody’s guess. But, all the evidence thus far suggests that a system is in development that utilises the formulaic, one-size-its-all approach already laid out in Article 5 of the Food Supplements Directive, which is likely to result in extremely low daily levels of many vitamins and minerals.
The Federal Institute of Risk Assessment in Germany (the Bundesinstitut für Risikobewertung, or BfR) has already employed their interpretation of Article 5 to determine maximum permitted levels (MPLs) and the results emphasise the concerns of many objective scientists.
Some proposed MPLs (daily doses) for food supplements, as determined by the BfR, are listed below:
Putting the BfR values into perspective….
- A 200 g sirloin steak gives you around 7.2 mg of zinc, over 3 times the BfR maximum level of zinc in food supplements
- A single large raw carrot (70 g) typically contains 7.2 mg of beta-carotene (601 mcg Retinol Equivalents), around 3.6 times the BfR maximum level of beta-carotene in food supplements
- One single (5 g) brazil nut typically contains 96 mcg of selenium, over 3 times the BfR maximum level for selenium in food supplements
- One cup of raw french beans (180 g) gives you about 346 mg magnesium, 3.5 mg zinc and 734 mcg folate—these are all above or well above the BfR maximum levels for these three nutrients!
[the above determinations have been made using the USDA National Nutrient Database]
Fortunately, there have been many objections to the BfR approach to risk assessment and management for the determination of MPLs, but other options that are under consideration still, in the main, reveal MPLs, and in several important cases even Safe Upper Levels (SULs) for most vitamins and minerals that are well beneath the therapeutic range. A dramatic reminder of how cock-eyed these risk-based assessments are is given by comparing MPLs with amounts found in our food. For example, and astonishingly, the beta-carotene in two carrots or the selenium in one Brazil nut will typically exceed the MPLs for beta-carotene and selenium respectively.
Maximum Permitted Levels, or even SULs, insinuate that higher levels may expose consumers to risk, so most people assume that therapeutic ranges would typically be risky. Several decades of clinical nutritional practice demonstrates that the therapeutic range, just like the beta-carotene in ten carrots, or a handful of brazil nuts, poses no risk and is, as the term ‘therapeutic’ would imply, beneficial to health.
The ANH-Intl has submitted detailed submissions to European Commission, EFSA and the UK Food Standards Agency, drawing attention to some of the limitations of the proposed methodologies and suggesting alternatives, that are based on rational science. It is of paramount importance that, in determining MPLs, due account is given to other factors and processes. These include:
- the speciation of the nutrient (different nutrient forms of the same nutrient [group] often follow distinct pathways in the body, resulting in differing bioavailability, metabolism and toxicology) ;
- medical records and other medical or scientific evidence which demonstrates the safety of therapeutic and beneficial dosages of nutrients;
- evidence of safety of high intakes of nutrients ingested in foods by specific population groups;
- determinations must take into account all available and relevant evidence on both risks and benefits and must not ignore relevant studies and case reports;
- Where SULs cannot be established through lack of data, it is not possible to determine MPLs. Guidance Levels, as determined by the Expert Group on Vitamins and Minerals (EVM) should not be used as surrogates for SULs.
- MPLs should be waived in situations where there are inadequate data to produce scientifically meaningful SULs or where there is no evidence of toxicity at even very high dosages (e.g., thiamine, riboflavin, vitamin B12, biotin, etc.). As such, regulation needs to be proportionate and should only be applied where genuine risks to the general public can be determined.
Making different health choices can change the world…..
Just imagine what would happen if we all just followed the 10 simple behaviours listed below.
- Take responsibility for your own health, foster awareness and lead by example
- Eat a diet that’s varied, balanced and made up largely of whole foods—choose not to buy processed or GM foods
- Buy/cultivate local/regional whole, organic/biodynamic/sustainable foods, including heirloom varieties—avoid relying on supermarkets as your primary source of food if possible or at least choose wisely
- Enjoy a healthy lifestyle—exercise moderately, breathe fresh air, drink clean water, manage stress effectively, get enough quality sleep, minimise your exposure to toxins and harmful radiation sources as much as possible
- Micronutrients—prefer fully natural products and ingredients
- Support ethically sound, enviromentally friendly companies and products
- Where possible support the self-healing capacities of your body and try to choose a healthcare practitioner/doctor who is qualified in and respects the fields of medicine you believe are most appropriate to your needs. Or you can educate your doctor—do your own research and show him/her the options that are out there. That’s Health Choice!
- Communicate the challenges and ways to overcome them to ensure that our fundamental right to natural health is not eroded. Awareness and education offer empowerment to make positive change
- Act local, think global! Focus on the ‘next generation’ and work with kids—help them to understand and get involved with nature, natural food and wholefood preparation
- Support pro-health freedom, pro-organic, anti-GM organisations—these organisations are on the front lines on your behalf.
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5th July 2011 Local UK council trounces a family’s human rights and sustainable lifestyle
5th July 2011 Polypharmacy increases risk of death in over-65s
30th June 2011Natural healthcare and ‘patient-centred outcomes’
17th June 2011 NHS reforms itself to suit European line on food supplements
10th June 2011 More anti-alternative medicine propaganda in major publication
27th May 2011 Marmite not banned in Denmark – just not specifically allowed!
6th May 2011 EFSA carries on regardless
21st April 2011 European Commission sets new standards – in hypocrisy
1st April 2011 Health claims clampdown begins in UK
1st April 2011 ANH-Intl Press Release: Alliance for Natural Health launches poster campaign
10th March 2011 MEP concerns mount over regulatory threats to natural healthcare
4th March 2011 ANH-Intl Press Release: CAM practitioners in cross-hairs of UK skeptics
24th February 2011 More Alice in Wonderland decisions on health claims
10th Febraury 2011 ANH-Intl reports on the first ever Hygeia Symposium
28th January 2011 Wakefield hits back at BMJ over “fraud” claims
27th January 2011 UK cancer survival lags behind
25th January 2011 ANH Press Release: ANH launches campaign to save Park Pharmacy Trust
20th January 2011 ANH-Intl introduces the first ever Hygeia Syposium
20th January 2011 Injectable vitamin C branded an “unapproved drug”
18th January 2011 ANH-Intl Feature: Why the healthy ‘school dinner’ revolution is vital to our kids’ futures
12th January 2011 Natural healthcare proven amazingly safe – once again
10th January 2011 BMJ joins anti-Wakefield bandwagon
23rd December 2010 Festive wishes from the ANH-Intl core team
6th December 2010 Polish researchers brand EU Food Supplements Directive “useless”
2nd December 2010 More bad vitamin science from the BMJ
18th November 2010 ANH Feature: Ground-breaking CAM Interest Group meeting in European Parliament
11th November 2010 ANH Feature: Are medical students being manipulated by Astroturfers?
28th October 2010 Analysis of clinical trials reveals that placebo content is rarely described
27th October 2010 EFSA holds consultation on possibility of expanding specific health claims
19th October 2010 Ontario considers curbing vitamin D testing
13th October 2010 Have you fallen victim to “disease branding”?
20th September 2010 BMJ research says glucosamine and chondroitin don’t work
10th September 2010 Pharma game plan revealed?
9th September 2010 ANH Feature: What is ‘natural’?
8th September 2010 Osteoporosis drugs linked to oesophageal cancer and jaw tissue death
18th August 2010 Would you like chips, tomato sauce and statins with your burger?
9th August 2010 ANH Feature: Graced by breast cancer
6th August 2010 ANH-Intl Summary: Key challenges to natural methods of healthcare in Europe
4th August 2010 BMJ analysis of calcium studies ‘finds’ cardiovascular risk
28th July 2010 Homeopathy choice within the UK survives propaganda-style attacks
23rd July 2010 UK school bans playground football after copycat World Cup fouling
14th July 2010 Homeopathy under attack in its founding father’s homeland Germany
2nd July 2010 Healthy eater? You may need to see your doctor urgently
2nd July 2010 Victory for whales proves ‘people-power’
28th June 2010 ANH Feature: ANH contests European regulators in Brussels
25th June 2010 US professor who faked Pfizer drug research is jailed for 6 months
4th June 2010 Swine flu: BMJ investigation confirms WHO experts in pay of ‘pharma’
2nd June 2010 EFSA confirm health claim nightmare at Parma meeting
31st May 2010 ANH Press Release: Court victory against FDA for free speech
6th May 2010 ‘Mixed bag’ ruling from European Court on French vitamin case
27th April 2010 ANH petition on Maximum Permitted Levels still open
19th April 2010 ANH Feature: Beware scientism’s onward march!
15th April 2010 The apparent turn around of Professor Ernst
8th April 2010 ANH Feature: The Mediterranean Diet—Can It Help You Live Longer?
26th March 2010 ANH Press Release: New ANH study says EU vitamin laws must change track
12th March 2010 ANH taking action today with EU strategy on cancer
10th March 2010 Update on Senator McCain’s plans to ‘Europeanise’ US supplement laws
9th March 2010 Snake oil—or a breakthrough for bipolar disorder?
1st March 2010 UK homeopathy groups unite as hundreds lobby MPs at Westminster
19th February 2010 European Commission to fund research into complementary medicine
2 February 2010 EU border contols stepped up to enforce feed and food law
22 January 2010 Over-reliant pill poppers
14 January 2010 ANH Press Release: New ANH study exposes flawed nature of EU plans to limit vitamins
12th January 2010 Orthomolecular doctors turn to humour
8th January 2010 ANH Feature: US health claims regime under Euro-threat
18th December 2009 ANH Press Release: ‘United we are stronger’ – ANH announces merger
15th December 2009 Jonathan Emord affirms EU health claims Regulation basis for legal challenge
14th December 2009 UK FSA tells ANH it won’t be swayed from ‘Eurotrack’ on FSD
10th December 2009 Unexpected incidence of cancer from higher dose synthetic folic acid
3rd December 2009 Downing street e-Petition shown to be a farce
30th November 2009 Downing Street ignores weight of public concern over Codex
30th November 2009 Congratulations given to the AAHF/ANH
12th November 2009 ANH Press Release: Food supplement ban in 2010 may contravene EU law
3rd November 2009 UK Conservative MP voices support for herbalists at Westminster demonstration
30th October 2009 UK herbalists threatened by Government inaction over statutory regulation
20th October 2009 UK plans for mass medication with folic acid gear up
10th October 2009 Neutering our freedom of speech: EFSA health claims opinions
9th October 2009 Preventative healthcare must be UK NHS priority says HSC Chairman
30th September 2009 Pressure against Lisbon intensifies
24th September 2009 Volunteers needed for sweetener study
22nd September 2009 News item – Irish trade group campaigns for truth about supplements
10th September 2009 Vitamin C deficiency worse than feared: research news
18th August 2009 Industry win against FTC: is the tide finally turning?
14th August 2009 ANH-US files third suit against FDA for suppression of antioxidant claims
7th August 2009 ANH’s US arm files suit against FDA over new GMP rule
6th August 2009 Welsh magistrates return guilty verdict in novel foods case
30th July 2009 ANH sues FDA over suppression of free speech on selenium health benefits
18th July 2009 US agencies challenge natural products in advance of vaccination program
30th June 2009 New campaign to defend Poland’s rich natural traditions
19th June 2009 Vitamins / minerals reduce cancer risk, may lengthen life & prevent bone loss
6th May 2009 Vitamins and minerals reduce asthma symptoms
28th April 2009 Another question mark over mandatory food fortification with synthetic folic acid
9th April 2009 Higher dose vitamin D reduces fractures by 20% in over 65s
1st April 2009 Study shows vitamin E tocotrienols delay tumour growth
23rd March 2009 Researchers confirm nature’s folates best for baby
18th March 2009 Vitamin D: Another study shows RDAs/RDIs grossly inadequate
3rd March 2009 Three-in-one: three positive studies in one scientific journal!
22nd August 2008 Vitamin D: as close to a magic bullet as you can get?
18th July 2008 Three ways to die: putting together some of the jigsaw pieces
30th January 2004 ANH PRESS RELEASE: Landmark legal challenge
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