From the January 2004 Idaho Observer:

Codex Alimentarius Commission: A threat to mankind

"There is an entire industry with an innate economic interest to obstruct, suppress and discredit any information about the eradication of diseases. The pharmaceutical industry makes over one trillion dollars from selling drugs for ongoing diseases. These drugs may relieve symptoms, but they do not cure. We have to realize that the mission of this industry is to make money from ongoing diseases. The cure or eradication of a disease leads to the collapse of a multi-billion dollar market of pharmaceuticals." ~Dr. Matthias Rath

If you have discovered the value of such products as vitamin C and oil of oregano, what would you do if you were to find out that such products can no longer be purchased from your local health food store but must be prescribed to you through a licensed medical doctor? What if your medical doctor decided that your health condition did not warrant the use of these natural, non-pharmaceutical products?

This scenario may sound far-fetched but, in reality, what is known as Codex Alimentarius is being adopted worldwide at record breaking speed. In Australia, Canada, and parts of Europe, they have already banned many nutritional supplements. Remember that America is also a member of the U.N. and will be adopting these Codex standards in the near future. If this happens, no more supplements would be available in health food stores. We would have to “pay for a visit to a doctor,” and then we would have to “pay for a prescription” -- just to purchase our vitamins. The pharmaceutical companies would have complete control over pricing of food supplements and vitamins. The cost of vitamins would be three to four times the cost of what they are now with many supplements simply being “unavailable.”

Both doctors and those vested in the pharmaceutical companies would benefit from such an arrangement. There would be no system in place to protect the consumer. The people would lose. Their overall health would decline, and “free choice” would be curtailed since millions of Americans would not be able to afford vitamins -- especially since so many of their jobs are being “outsourced” to other countries.

This is a very serious issue for all of us. Many are not aware of what has already been in the works. Below is information on what many consider the most important legal challenge happening today -- one whose outcome will affect the health rights of consumers worldwide. This legal challenge to the implementation of Codex Alimentarius in Europe is vital for ALL health freedom loving Americans to support -- and they need our financial support. If you want to ensure your right to purchase oil of oregano and vitamin C without a doctor's prescription, we suggest you donate to this cause via the addresses at the end of this article.

So how did we get top this point and who is leading the charge to oppose these Codex directives? Louise McLean of Zeus Information Service (www.zeusinfoservice.com) beautifully summarizes the answer to this question:

“The battle between the rights of consumers, natural health practitioners and health food manufacturers versus corporate health care and the pharmaceutical giants is presently being stepped up worldwide. The natural health industry -- which is thriving and growing in our polluted world -- is constantly under attack.

“The pharmaceutical cartel is extremely powerful and its agenda is being followed and adhered to by governments around the world. It is involved in the creation, distribution and consumption of food, cosmetics, toiletries, veterinary products, insecticides, and vaccines worldwide, not to mention the $billion drug industry.

“The pharmaceutical industry lobbies governments and trade groups, bringing pressure to bear on newspaper editors and media outlets. As a result, health and medical writers often write negative articles about natural health therapies and products.

“During the last few years, it has been organic high potency vitamins, minerals and food supplements receiving bad press, as well as any therapy such as herbs or homeopathy that involves taking pills or capsules since these therapies are in direct competition with orthodox medicine. These products and therapies cause the pharmaceutical industry to lose $millions each year.

“Many of my favorites -- arnica, echinacea, evening primrose, black cohosh, St. John's Wort, gingko and chapparrel have been subjected to “scientific” trials in an attempt to show they don't work. A scientific trial can, of course, be made to show any desired outcome. After all, we know scientific trials of pharmaceutical drugs are conducted, leading to product approval, and then years later these products are taken off the market when they have been shown to cause harm.

“The reason for these attacks and the current push for worldwide implementation of Codex directives is the fact that these pharmaceutical cartels want to take over and control this highly lucrative market in order to produce synthetic, low dose vitamins, supplements and herbal preparations of questionable benefit to consumers. Presently, many vitamin and supplement manufacturers are being bought out by pharmaceutical companies.

“The EU Food Supplements Directive was transposed into UK law on July 3, 2003. This Directive will be followed by the EU Traditional Herbal Medicinal Products Directive and the EU Pharmaceuticals Directive. These are highly controversial and restrictive Directives.

“On October 13, 2003, the Alliance for Natural Health (ANH) mounted a legal challenge to the EU Food Supplements Directive and is seeking ways to recommend modifications of the other two Directives.”

Alliance for Natural Health Legal Challenge: Court Hearing

Friday, January 30, 2004, 10:30 AM in the High Court of Justice, London.

ANH's application (which will be heard jointly with that of the National Association of Health Stores and Health Food Manufacturers Association) to bring Judicial Review proceedings challenging the validity of the Food Supplements Directive ban on vital nutrients will be heard in Court on this day. This is a public hearing and anyone can attend.

Why American companies and consumers need to act immediately in support of the ANH lawsuitfrom the Alliance for Natural Health

from the Alliance for Natural Health

Divergent views on the EU Directives

Manufacturers, suppliers, retailers, practitioners and consumers in Europe have received a very wide range of sometimes conflicting messages about the likely impact of the EU legislation. Information filtering across the Atlantic is even more inconsistent. With so much confusion, many companies are doing nothing. (See article on Council for Responsible Nutrition page 15)

Summary of key EU Directives

Amendments to the Pharmaceuticals Directive

This amends the existing Pharmaceuticals Directive (which governs the supply of drugs in the EU) by expanding the reach of the definition of a drug still further so as to enable reclassification of any supplement as a drug if it “restores, corrects, or modifies physiological functions” in the body. The proposed wider definition will cover practically all natural health products so that they are at grave risk of being reclassified as drugs.

It also extends jurisdiction of the Pharmaceuticals Directive so that it takes precedence over any product defined as a drug under the wide definition, even if that product was already regulated and permitted under other EU legislation (e.g. Food Supplements Directive, Traditional Herbal Medicinal Products Directive, Cosmetics Directive).

The Food Supplements Directive (passed into EU member state laws by 31 July, 2003)

Creates a “safe harbor” for “food supplements” (so that they are not classified as drugs) but limits the spectrum of nutrients, initially only vitamins and minerals, and could in the near future substantially limit the potency of nutrients in such products by reducing maximum permitted levels. It provides a severe restriction on freedom of speech by preventing publicity over inadequacies of a normal diet. By 2007 it will also apply to other nutrient groups such as fatty acids, amino acids, fiber, plant extracts, etc. The Directive has already passed into EU law and is now being transposed into the law of member states. ANH began its challenge against the legality of this Directive in October 2003 (see www.alliance-natural-health.org).

Traditional Herbal Medicinal Products Directive

This Directive, currently working its way through the EU legislature, creates a new class of “traditional herbal medicinal products” by providing for a “simplified pharmaceutical registration” (e.g. avoiding provision of safety and efficacy data). This applies to specific “'traditionally used' herbal medicinal products” -- but only if the products contain the same combination of herbal ingredients and complies with a range of conditions -- including having been in safe use for 30 years (15 of which must be in the EU). This will mean that herbs from traditions outside of the EU, that have yet to be used in the EU, would not be eligible and could only be used following compliance with a full drug approval and registration regimen.

The reality is that a clutch of EU legislation is making its way through the EU lawmaking pipeline covering the full spectrum of dietary supplements, including herbal products, so-called “borderline products,” fortified foods, and sports nutrition products. In addition, new EU regulations on health claims have recently been proposed and these are more or less identical to those just proposed in the U.S. For many it is the combined effect of all the EU laws that is of greatest concern.

Fortunately, only one directive has so far been passed in to EU law and EU member country legislation, this being the Food Supplements Directive. Therefore, there is still considerable scope to amend and shape the other legislation -- assuming European and international interests get behind the appropriate campaigns.

One of the reasons the Food Supplements Directive managed to scrape through the European Parliament is that major international and European trade associations advised their member companies that the directive was going to be generally beneficial for the industry and they should plan ahead to comply with it. In contrast, it has been consumer, retailer and practitioner groups, especially in the UK, Sweden and Ireland, that have consistently claimed that the legislation could be catastrophic for particular sectors.

Since the directive's passage into EU law, many of the leading companies and associations with interests in the innovative sector of the European dietary supplement industry have come together under the umbrella of the pan-European and international Alliance for Natural Health.

A detailed look at the legislation suggests that the primary reason for discrepancies in viewpoints over the Food Supplement Directive's impact is the difference in the impact of the legislation on different sectors of the industry. Innovative suppliers and those who are dependent on their products will inevitably be hit hardest. Companies manufacturing or selling relatively low-dose, synthetic vitamins and inorganic minerals will actually be set to gain considerably from the legislation, benefiting from the single market conditions across the 15 EU member countries (soon to be enlarged to 25).

But for others, the loss of many food-state vitamins (e.g. mixed tocopherols, tocotrienols, natural carotenoids, methylcobalamin (a form of B12), a range of minerals such as sulphur, boron, vanadium, silicon and many chelated or plant-derived forms is of great concern. Since the Food Supplements Directive (FSD) is incremental in its effects, with even the bans on nutrient forms not coming into force until August 1, 2005, many detractors argue that future effects could cumulatively have catastrophic impacts on innovators, independent retailers and practitioners.

Food Supplements Directive: Four primary concerns about the FSD

1. Limited range of nutrient forms allowed on the “positive list” (Annex I & II of FSD).

The UK Food Standard Agency has determined that there are at least 270 ingredients (nutrient forms) that are presently used in the UK that are not included on the positive list. The National Association of Health Stores has, in fact, determined that this is an understatement, the real figure being in excess of 300 ingredients. These “missing” ingredients are included in some 5,000 products on the UK market only. The Irish Association of Health Stores has determined that around 85 percent of vitamin/mineral products in Irish health stores contain one or more missing nutrient forms and would require reformulation to comply with the directive. One of the greatest concerns of the ANH is that many of the missing forms are food-forms that are more bio-available (and generally safer) than the synthetic or inorganic forms included on the positive list.

2. Difficulties and costs in submission of dossiers (Article 4.6) to allow derogated use of off-list nutrient forms.

The key issue here is that most supplement companies are, in fact, formulation companies who buy products from a limited number of raw ingredient manufacturers or producers. If these manufacturers choose not to supply a dossier for a specific ingredient, then the formulation company would not be able to use it.

However, if one manufacturer submits (and has approved) a particular dossier, any formulator can use that ingredient (at least until December 31, 2009). Costs for dossiers vary greatly according to the amount and nature of existing data, but estimates vary from -- 20,000 to over -- 300,000, depending on the ingredient.

In addition, because the time frames are limited (July 12, 2005), there may not be sufficient time to generate all the data for some ingredients.

3. Reductions in Maximum Permitted Levels via unnecessarily low Upper Safe Levels (USLs), being developed by the SCF/EFSA without a procedure that allows open consultation with outside scientists or other experts.

The Alliance for Natural Health Expert Committee has determined that some of the science being used by the SCF is flawed and it appears that it is being used in order to justify very low maximum levels of nutrients in food supplements (the consequence of this is that higher levels will still be regarded as drugs and can, therefore, only be administered by doctors, as is currently the protocol in many of the countries with less permissive legislative regimes [Article 5]).

4. Future restrictions on nutrients other than vitamins and minerals as of 2007, such as amino acids, fatty aids, phytonutrients, enzymes, fiber, probiotics, etc.

These restrictions could be brought in via a positive list system (Recitals 6 & 8, Article 4.8).

It seems that the intended purpose of the FSD is to protect the simplest, low-dose, food supplements, of the type typically sold in European supermarkets and pharmacies. The more specialist forms, particularly those using food-form nutrients, will only be able to remain on the market after August, 2005, if dossiers for their ingredients are submitted and accepted in spite of all the contingent difficulties inherent in the procedure.

For many companies there is simply not enough time to conduct the necessary safety studies given there has never been any incentive or reason to do this work for a large proportion of the food-form nutrients.

For others the task is too expensive. Take for example, selenomethionine, the most common form of selenium found in foods and well known as a very important antioxidant mineral: This form of selenium was rejected by the European Food Safety Authority (EFSA, formerly the Scientific Committee on Food [SCF]) in 1999 because long-term safety studies had not been conducted.

Instead, EFSA has allowed use of two inorganic forms of selenium (sodium selenate and sodium selenite) that are both more toxic and less beneficial as antioxidants.

For many consumers this is very confusing, as they hear on one hand that we should increase our consumption of Brazil nuts which contain high doses of selenomethionine, yet the EU Commission does not approve on its positive list use of this safe form of selenium simply because the studies are not available.

Are food manufacturers being asked to provide safety data on natural products? For example, who has been required to prove via clinical trials that fruits and vegetables are safe?

Legal challenge of the Food Supplements Directive

The ANH is working with its scientific Expert Committee, out-house lawyers, public affairs and media specialists to either annul or positively shape key EU legislation that is otherwise set to severely impact the innovative supplement industry and its beneficiaries. Although there is plenty that can still be achieved by effective lobbying on the amendments to the Pharmaceuticals Directive and the Traditional Herbal Medicinal Products Directive, and ANH is hard at work on this, options are far fewer for the Food Supplements Directive.

There is still some room to influence the maximum permitted levels and positive lists for nutrient groups other than vitamins and minerals, but the directive has already passed into European law and gets its full teeth once the directive is implemented fully in EU member states two years after its transposition into their laws, in August 2005.

So, on behalf of innovators and practitioners, the ANH is proposing to challenge the validity of this directive later this year and is working on this case with its out-house lawyers who are among the most experienced European lawyers in the EU.

Challenging the directive would make no sense unless there were reasonable grounds and probabilities of success. The ANH has retained the only legal team that has ever overturned an EU Directive -- and after a detailed examination of the FSD, this team has given the ANH a green light to proceed (www.alliance-natural-health.org; see Latest News, 8 August 2003). The case is being built on a number of grounds, but of particular importance are EU constitutional grounds that suggest there is a real chance of annulling the directive.

In addition, it appears that the effects of the directive can be challenged on grounds of proportionality, based on the fact that it will impact certain sectors of the industry, notably those associated with innovative products, in a disproportionate manner.

The challenge was mounted on October 13, 2003, but this is just the start of it. Legal, scientific and commercial experts remain hard at work on the case to strengthen the already solid foundations of the case. Interestingly, if the directive is annulled, all national laws reliant on the directive are likely to be invalid.

Dr. Robert Verkerk, Executive Director of the ANH, said, “the case will allow the real science of nutrients to be showcased to the Commission, to the Parliament and to the public generally. People will understand that supplementation of a good diet with high quality nutrients is a valid and effective way towards optimum health. There is no scientific rationale for accepting synthetic vitamins and a limited range of inorganic mineral forms while rejecting the plethora of naturally occurring vitamins and minerals.

Winning the case will pave the way to a very bright future for the food supplement industry. We are not suggesting that there should be no directive at all, but the existing directive needs to be replaced with a re-worked version that allows for high quality, effective supplements across the whole of Europe. It's about harmonizing to good standards, not bad ones.”

It is time for all manufacturers, suppliers, retailers and practitioners who believe their businesses are at risk to join the ANH campaign -- and support the legal challenge. Contact Henrietta Lee, the ANH Campaign Manager at info@alliance-natural-health.org or phone + 44 1252 371 275 to find out how you can join the campaign and be part of the ANH's rapidly expanding Support Base. Support is needed NOW. www.alliance-natural-health.org

The other Directives

The two key EU directives that will regulate basic supplements will be the FSD (but only those containing ingredients on the positive list or for which dossiers have been approved) and the amended pharmaceutical directive (PD) 2001/83/EC, of which the traditional herbal medicinal products directive (THMPD) is a part. So if a product is not able to be controlled under the FSD, it will default to the PD. If it falls under the PD, it will either require a full drug license (with the very substantial data requirements and costs required for drug approvals) or, if appropriate, botanically-based products can be classified as “medicinal herbs” and benefit from a “fast-track” licensing scheme. This “fast-track” THMPD procedure requires that the applicant demonstrate 30 years of safe, traditional use in lieu of safety data (the major component of data required for market authorization as a drug).

The THMPD is passing through the European regulatory process now and one particularly contentious issue is the requirement in the EU Commission's proposed legislation for 15 years EU use, out of the total 30 years of traditional use.

The Alliance for Natural Health, along with several other organizations, have tabled amendments and are campaigning to allow 30 years demonstrated safe use be from anywhere in the world. They argue that limiting non-EU use will prevent interesting and beneficial herbs discovered in parts of the world with very strong herbal cultures (e.g. China, India, South East Asia, South Africa, South America) from being brought into Europe. It will therefore strongly impact future innovation. The legislation would essentially have the effect of freeze-framing the industry in the early 1990s.

In addition to this, further directives are being prepared by the EU Commission on sports nutrition products and fortified foods. Draft Health Claims Regulations were tabled in Brussels in July 2003.

Conclusion

The U.S. dietary supplement industry has flourished in the face of what must be regarded relatively as very liberal laws. There are steps being taken by the FDA and others to alter this, but it seems the industry together with its huge consumer support base has so far defended itself very well against unnecessary and restrictive legislation. The U.S. campaigns against Durbin's Bill S722 is a good example of how a diverse range of interested parties can work together.

The U.S. industry is, without question, the world leader in this field, and there is growing evidence that nutrients in dietary supplements may be used very successfully in the prevention, or even treatment, of diseases.

Owing to the trends towards global harmonization and, in particular, increased pressure towards trans-Atlantic harmonization, the EU Directives have a direct influence on the shape of future U.S. laws. In addition to this, many U.S. companies have substantial and growing markets in Europe, which will, following enlargement in two years time, have a population of some 450 million people.

The Alliance for Natural Health developed initially as a diverse range of largely European interests who were not against legislation per se, but were concerned about legislation that would potentially kill off innovation in the future. It has now developed an increasingly strong support base across Europe as well as in the U.S.

The joint international committee of the NNFA and AHPA in July unanimously put forward a motion that supported the ANH's legal action against the Food Supplements Directive. Some have gone so far as suggesting that the EU Directives are an even bigger threat to U.S. industry than the original proposal for the Dietary Supplement Health and Education Act, which was positively amended in 1994 following huge protests in Congress.

Time is of the essence -- and every company or individual with interests in the future of the dietary supplement industry, both in Europe and the U.S., should now very seriously consider whether they want to accept the Food Supplements Directive, or be part of the potentially ground-breaking challenge that could pave the way to a very bright future for the food supplement industry.