Freedom of Health Choice

Did you know that your ability to choose natural health products or therapeutic foods is severely threatened through a global effort, masterminded by governments and transnational corporations? 

Share information and work with us at the Alliance for Natural Health (ANH) 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 is based in Europe so we are right at the cutting edge. Much of the legal infrastructure is already in place—but has yet to be felt fully as key parts of the regulation and directives are in a transitional phase. 

Find out from the ANH about the Good, the Bad and the Ugly of EU Natural Health Regulation.

The EU framework starts to really bite between 2010 and 2011 when—unless pro-natural health interests like us can continue to positively influence the process—we could see:

• massive restrictions on allowed ingredients, including vitamin and mineral forms, as well as botanicals
• massive 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 

European laws also form the template being developed by Codex for international harmonisation. If this matters to you, see the ANH Codex campaign and follow our key work on risk assessment.

There are a number of Directives and Regulations in the EU, many of which have yet to fully come into force, that are particularly problematic. Some of the key pieces of European legislation—or shortly to be implemented legislation—along with ANH's key concerns about them, are detailed in a series of one-page ANH Briefing Papers (dated June 2008) that can be downloaded below:

• Download ANH Briefing Paper on the EU Food Supplements Directive
• Download ANH Briefing Paper on Maximum Permitted Levels (MPLs) of vitamins and minerals
• Download ANH Briefing Paper on the EU Nutrition and Health Claims Regulation
• Download ANH Briefing Paper on the EU Traditional Herbal Medicinal Products Directive

Canada

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. 

Then there was Bill C-51. This Bill, an amendment introduced by the Harper government to the Canadian Food & Drugs Act, if enacted into law, would hand Health Canada obscene powers to police the natural products industry! It would, for example, give the government the power to seize any amount of any 'therapeutic food' indefinitely—with no reasons given. Bill C-51 not only forces 'natural health products' into a drug regime, it also provides new pharmaceutical drugs with a much quicker pathway to market—allowing them to circumvent many of the safety trials typically required for a drugs license.

Bill C-51 aims to create a new category called 'therapeutic products' which would include all drugs, 'therapeutic foods' and cosmetics. Aren't all wholesome foods and good quality supplements therapeutic foods—we hear you say? Quite right. This was a very bad proposed amendment, which has no place to play in a sustainable healthcare environment where high quality, therapeutic foods need to be as widely available to as many people as possible at the lowest cost.  

But pressure from around one million of the 30 million strong Canadian population defeated Bill C-51 in the last session of the Canadian Parliament. Bill C-51 died, at least temporarily, on 20 June 2008. However, given the apparent enthusiasm over tyrannical restriction of natural health products in Canada, it may well be resurrected in the forthcoming session of Fall 2008.

But if that wasn't enough......then there was Bill C-52—a back door that can be used by Health Canada to prevent Canadian citizens accessing any products viewed as potentially unsafe in their eyes! Find out more about this in our 24 June 2008 news item.

Following a meeting of experts, including ANH's Dr Robert Verkerk, in Toronto between 17-19 September 2008, a emergency task force was established to coordinate scientific and legal efforts to prevent further restrictions on products and truthful health claims concerning them. See release of September 23, 2008. 

United States of America

Although the US has enjoyed a liberal legal regime for natural health products since the passage of the Dietary Supplements and Health Education Act (DSHEA) was passed in 1994 following mass public opposition to excessive restriction and 'medicalization' of natural health products—things are beginning to get progressively tighter. The US signalled its intent back in 2002 when the Food & Drug Administration (FDA) published a paper on the "Proposed Framework for Evaluating the Safety of Dietary Supplements".   

Since this time, the US has seen the imposition of adverse event reporting (AERs) and much tighter "Good Manufacturing Practices' (GMPs) will be introduced by the end of 2002. Combined with tighter health claims regulations that could ultimately dispense of many of the structure/function claims that have been invaluable to US consumers, which are paralleling those in Europe, the US government's support of the Codex agenda for nutrition  and an increasingly aggressive 'witch hunt' by the FDA and the Federal Trade Commission (FTC), suggest the US is on course to harmonise to a model that is at least as restrictive as that of Europe.

It's just that the process in the US is on a slower burn than the European agenda. Why? The main reason is likely to be that the US government is well aware—based on recollections of the backlash in the lead up to DHEA in 1994—that Americans won't take restrictions on their health freedom or freedom of speech lying down.

Be aware of just how aggressive the Pharma companies are becoming against the natural products industry! Check out the ANH news item from 23 June 2008, where we show how two Pharma companies—one of them being none other than GSK—are trying to rule the roost. US citizens and natural health companies need to engage with this process as both cases are subject to citizen's petitions.  

To find out more, see the website of the ANH's US affiliate, the American Association for Health Freedom (AAHF). Dr Rob Verkerk, ANH's Executive & Scientific Director, acts as Scientific Advisor to the AAHF, as well as to another US health freedom organisation, the National Health Federation. 

New Zealand

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'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.

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 [1] and modified in the first issue of this journal in 1990, as follows.

1. 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.
2. 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.
3. Illness is inevitably linked with an abnormal biochemistry and an alteration in the metabolism of nutrients and their by-products.
4. 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.
5. 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. Levels are likely to proposed by the European Commission in January 2009. 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? 

Find out why you should be concerned and download the ANH position paper on MPLs (October 2007).

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 2009 or 2010, when MPLs find their way into EU law.  

How the European institutions are responding

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 or very 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 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.

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