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Natural Health Products – Guilty Until Proven Innocent?
Part 1 The complementary medicine/natural healthcare industry is huge. Worldwide it nets billions of dollars annually, and in developed countries more than half the population is increasingly turning to complementary medicine as their preferred treatment. Given these statistics, it is hardly surprising that governments
wish to rationalise the industry along similar lines to the medical industry.
What more could we hope for? Most consumers want guaranteed
quality service and products. We want to know that what we buy works and
that we are not wasting our money. We want safe products and ready access
to them. Food supplements to be classed as drugs? We all know that vitamin C is not a drug – or is it? Well, let's look at definitions of what a drug is. The pharmaceutical classification of a drug or medicine is any product that "restores, corrects, or modifies physiological functions" in the body.[1] So technically, all our food supplements, herbs and other natural health products for which any therapeutic claims are made (on the label, through advertising or via educational articles) could be classified as drugs. In Australia, the political stance of the National Medicines Policy 2000 of Australia[2] states that "The term 'medicine' includes prescription and non-prescription medicines, including complementary healthcare products". In the UK, food supplements come under a Food Directive (as opposed to a Pharmaceuticals Directive), but they are still defined as "substances with a nutritional or physiological effect". If the pharmaceutical lobby pushes ahead to have its broad definition enshrined in law, then there will be plenty of hair-splitting over products that have been used safely and effectively by a large percentage of the community over many years. The Codex Commission – our protector! We are told that we are being protected. Our interests are represented by various government and industry bodies at the Codex Alimentarius Commission,[3] an international organisation of 146 nations (backed by the World Health Organization under the UN), established in 1962 with the aim of setting international standards and codes for foods. The majority of representations are from the pharmaceuticals industry, with little input from consumer groups or the natural healthcare industry. Via a series of meetings, regulatory frameworks are drawn up by the Commission through delegate consensus. Bringing you up to date on activities, on 4 November 2003 the Codex Commission met to discuss a science-based framework to establish upper limits on vitamin and mineral supplement dosage, where any finalised recommendations become the international standard. It announced a positive outcome which would pave "the way for the global sale and marketing of dietary supplements based on objective standards that will simultaneously preserve consumer safety and fair trade".[4] However, the Codex Alimentarius Commission deals with food regulations, and its stance is that under their specific Directive you cannot make statements that ascribe a therapeutic action or even the prevention of disease to a food or food supplement, as the two do not go together. In simple terms, the Codex stance is that as soon as a therapeutic action is attributed to a product or a food, it becomes a medicine. So we have an organisation that is going to regulate the
industry according to the view that vitamins and minerals must only be
sold in amounts to prevent deficiencies and be designed to be taken as
small-unit quantities. Easily obtaining your large dose of vitamin C,
which you take when you get a common cold, could become impossible in
the future.[5] ANH: fighting the EU's restrictions A professional, UK-based, pan-European international campaign and advisory organisation, the Alliance for Natural Health (ANH, http://www.alliance-natural-health.org/) is currently fighting EU legislation in an attempt to maintain continued access to and supply of safe, innovative and effective dietary supplements. If it hadn't been for the ANH lawsuits[7] lodged against
the Food Supplements Directive, then probably all food supplements in
Europe would now be classified as drugs. Already the EU has passed a law,
which will come into effect in 2005, to ban the sale of 300 nutrient forms
from the list of 420 that are currently available. This will affect over
5,000 products (85% of vitamin/mineral products). The banned items include natural vitamin forms such as the mixed tocopherols (natural vitamin E), carotenoids and methylcobalamin (B12), selenomethionine (the common form of selenium found in foods, but the list does allow inorganic selenium such as sodium selenate and sodium selenite, which are known to be more toxic and deliver less-beneficial results), all forms of sulphur (no MSM!), boron, vanadium, silicon and most trace elements, the most readily absorbed and safest forms of calcium, magnesium, zinc, chromium and molybdenum, and many chelated and plant-derived forms. The EU is planning to apply similar restrictions by 2007 to other nutrient groups such as fatty acids (no more fish oils?), amino acids, fibre and plant extracts. The ANH began its challenge against the legality of this Directive in October 2003. It argues that the law is irrational from both scientific and economic standpoints, and that it will devastate the industry – the innovators, retailers and practitioners. It also says the ban is unlawful and not necessary for the achievement of the Food Supplements Directive's stated purpose, i.e., to harmonise legislation relating to food supplements across the 15 EU member countries in order to facilitate trade in and availability of these supplements.[8] As agreements are made via consensus within the Codex Commission,
and as there is an unfair representation strongly biased towards the pharmaceuticals
industry and the European Union (the EU carries 15 votes), it is not surprising
that the Codex can be used as a tool to force all natural health products
out of the Food Directive and into the Pharmaceuticals Directive. A new definition of "first do no harm" Many would argue that this type of rationalisation of the industry may be a good thing, as we would be guaranteed the same rigorous controls applied to drugs to ensure safety, quality and efficacy of the products we buy. However, in most countries, the safety and quality of natural health products is not the issue: international GMP (good manufacturing practice) standards prevail and government agencies such as the TGA (Therapeutic Goods Administration, Australia) have enormous powers to enforce regulations or to remove licences as appropriate – as we saw in last year's recalls of various Pan Pharmaceuticals products. Endnotes
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