See update at end of this article
Audrey has multiple sclerosis. High dose vitamins gave her back her life. Now Brussels, the UN’s Codex Alimentarius Commission (and the world’s ‘FDA’s’) want to ban them, and push all innovative dietary supplements through a torturous regulatory process designed to force them off the market so they can no longer compete with pharmaceutical prescription drugs. The immediate assistance of vitamin companies, health food stores, and consumers is badly needed to help fund a lawsuit being spearheaded by the UK’s Alliance for Natural Health which has global implications. This lawsuit must be filed by Mid-October. ANH warns that we must get Europe to harmonize to the Dietary Supplement Health and Education Act of 1994, otherwise, the USA will be forced to harmonize to the EU’s mindlessly restrictive vitamin standards.
I am writing from England where I spoke at the Vitality Vitamin Trade Show in London’s Olympia ( March 29th 2003) before a group of alternative medical practitioners and consumers who form the backbone of a fledgling European health freedom movement.
I assured our English and European allies that we, in America, would not turn our backs on them in their hour of need. Recognizing that the Free Trade Area of the Americas threatens to be a carbon copy of a pan- European regulatory dictatorship in our hemisphere, I promised to educate American vitamin companies and consumers to this threat. There is an urgent need to legally overturn the EU Food Supplements Directive, to continue lobbying to kill the EU Traditional Herbal Medicinal Products Directive, and to make proposed amendments to the EU Pharmaceuticals Directive. These EU Directives threaten to force the creation of a draconian vitamin standard at the UN’s Codex Alimentarius Commission. The Congressional Research Service confirmed to Congressmen De Fazio and Paul that due to our membership in the World Trade Organization, America could be forced to harmonize its vitamin laws to this emerging very restrictive international standard, leaving us with no choice but to try to shape things to our advantage on the world stage. Sadly, Congressman Dan Burton ignored Paul’s and Defazio’s letter about this, [jpeg file at http://www.iahf.com/index2.html ] and whitewashed the Codex oversight hearing on March 20, 2001 such that the truth did not come out, and the FDA continues to set us up for harmonization. The fix is in, and we must take action to help ANH with their lawsuit. They will win, but only if they receive our direly needed financial assistance.
I told our English allies that I recognize current actions of the FDA to hire the National Academy of Sciences to generate a supposed "Safety Evaluation Framework for Dietary Supplements" (including draft "safety monographs" by way of prototypes, for saw palmetto, chromium picolinate, shark cartilage, chaparral, melatonin, and DHEA) as just another example of the FDA’s ongoing efforts to help the Pharma Cartel make an end run around the Dietary Supplement Health and Education Act ("DSHEA") to harmonize our law to an emerging, very restrictive international standard.
I told them about the AMA’s recent editorial in JAMA calling for the repeal of DSHEA as only the beginning of a relentless pharmaceutical push to destroy the dietary supplement industry world wide
. [Phil B. Fontanarosa, Drummond Rennie, and Catherine D. DeAngelis
The Need for Regulation of Dietary Supplements—Lessons From Ephedra JAMA 2003 289: 1568-1570.]
Accordingly, vitamin consumers and companies around the world MUST support initiatives in Europe which seek to challenge the EU Directives, especially the Food Supplements Directive. These European laws, it should be understood, are as relevant to us over here as they are to Europeans.are highly relevant to us back here in the US.
TAKING IT TO THE STREETS
On June 15th, the UK- based Health Freedom Movement (http://www.healthfreedommovement.com), a consortium of over 700 health freedom organizations http://www.healthfreedommovement.com will be holding a street march and health freedom rally in central London in opposition to England harmonizing their vitamin law to the Food Supplements Directive. The march will go from Hyde Park to Trafalgar Square. Lynne McTaggart of HFM told me in an interview that she hopes to carry a message to the government and to the EU that the FSD is totally unacceptable, and also hopes to generate donations for the Alliance for Natural Health ("ANH") which is a non-profit organization seeking ways to change, reshape or revoke laws affecting dietary supplement consumers, practitioners and manufacturers in Europe. As publisher of What Doctors Don’t Tell You (http://www.wddty.co.co.uk), the UK’s leading alternative medical newsletter, McTaggart, who is in constant contact with alternative practitioners, supplement manufacturers and consumers is painfully aware of what is at stake here, and has this message for American vitamin companies and consumers:
"Will all of us along with future generations be deprived of access to the most innovative dietary supplements currently on the market including many of the Life Extension Foundation’s products? Will the Foundation be forced to reformulate Life Extension Mix by removing all the most bio-available, effective and natural-state nutrients? Will the Foundation be blocked from selling vast numbers of products due to future harmonization to a grossly restrictive international standard? We stand at a crossroad - and the fate of this global industry is literally in all of our hands - right now. We sink, or swim, together. This is the battle for DSHEA all over again but this time on a world stage."
We can be negatively impacted here via the mechanisms of globalization unless we actively assist our international allies. Those which think DSHEA posed the ultimate bulwark against the Pharma Cartel are sadly mistaken.
Clinton Miller- Veteran American Health Freedom Fighter Travels to London
With me in London, while I presented at the Vitality Trade Show in London was 81- year- old Clinton Ray Miller, the most experienced health freedom lobbyist in the world, from Statesville NC who joined me in sharing our many years of experience with the raptly attentive British audience. Miller would not have traveled across the Atlantic at his age to sound an alarm unless this was a very serious matter. Supplement manufacturers and consumers world wide must awaken to our hard reality and help get behind and support fund the Alliance for Natural Health’s proposed lawsuit .
Veteran health freedom advocate Clinton Ray Miller (L) and Bonnie Miller
advise ANH Attorney David Hinde re defending vitamin access, world wide.
THE BAD NEWS
The bad news is that in July of this year, unless a challenge is made to overturn the EU Food Supplements Directive (which passed into EU law on June 10, 2002), the draconian EU Food Supplements Directive (FSD) will be forcibly transposed into the national laws of all EU member states including England, Ireland, Netherlands and Sweden which presently have relatively liberal vitamin laws not unlike those of the USA. If the EU gets its way, the railroad tracks will be laid to AUSCHWITZ, not only for people in England, but for vitamin consumers worldwide because of the way this threatens to impact us via harmonization. The FSD currently addresses only vitamins and minerals by creating a very restrictive positive list of "allowed" ingredients, and banning all others; but by not later than 2007 the EU is obliged to provide detailed proposals to expand the FSD to cover all other types of nutrients - again allowing limited ingredients stipulated on inevitably restrictive positive lists.
This incremental attack on food supplements is difficult to stop, and most supplement companies have simply gone along with the advice from their pharmaceutically-dominated trade associations and believe they have no option other than reformulation.. This means taking out all the most bio-available vitamins and minerals and substituting them for less bio-available and often potentially more toxic forms better suited to the pharmaceutical industry-affiliated supplement companies. In other cases, entire minerals would need to be removed (such as boron, sulphur, vanadium) as these will be disallowed altogether under the new EU law! And who loses out?
Threatening to dovetail with the FSD is the Traditional Herbal Medicinal Products Directive and amendments to the Pharmaceuticals Directive both of which have the potential to further severely damage the innovative sector of the industry by essentially imposing medicinal law on herbs and other so-called 'borderline' supplements. However, the Alliance for Natural Health last year managed to positively amend at First Reading of the EU Parliament both their Directives, so there is some light at the end of the tunnel if these amendments can be made to stick through to Second Reading. This will require a huge amount of public and lobbying pressure, as we found for DSHEA in 1994. ANH must have sufficient donations by July to file their lawsuit and for ongoing lobbying in Brussels, or the world will be negatively impacted via harmonization.
Rob Verkerk, PhD, Executive Director, Alliance for Natural Health (center) confers
with Dr. Sarah Noble, President, British Complementary Medicine Assn
Table 1 shows the status of these Directives as well as achievements
to-date of the Alliance for Natural Health.
Table 1. Summary of key European legislation affecting dietary supplements
Food Supplements Directive (FSD)
Pharmaceuticals Directive (PD)
Traditional Herbal Medicinal Products Directive (THMPD)
Passed into EU law 10 June 2002
First Reading 23 October 2002
First Reading 21 November 2002
Limits ingredients (nutrient sources) and maximum dosages.
Framework structure; only applies to vitamins and minerals at present, will cover other nutrients in future. Full impact will not be felt until 2005 - 2009. Is likely to omit 285 nutrient sources that are currently used in Europe. Improved prospects for trade between European countries.
All dietary supplements that are not controlled under FSD will be controlled under PD. A drugs regime would therefore apply and this would not be affordable for many non-pharmaceutical-owned supplement manufacturers.
A derogation of PD which allows fast-track legislation for eligible herbal products. The number of products caught will ultimately depend on PD definition of a medicine. Allows for improved labeling and quality control of medicinal herbs.
Potential for improvements to Directive
Can affect implementation in EU member states through national authorities.
Can influence maximum permitted levels of nutrients. Consider challenging entire legality of directive.
Can alter the definition of a medicine, as well as scope of directive, to ensure that most dietary supplements cannot fall under PD.
Can positively exclude non-medicinal food supplements, herbs and cosmetics.
First Reading amendments allow for combinations of herbs and nutrients, but make ineligible herbs that have less than 10 years use in EU.
Can promote amendments for Second Reading which allow traditional (e.g. 30-year) use from outside the EU with evidence from a competent authority.
Summary of ANH achievements in 2002
Mounted Brussels and UK-based campaign which helped to almost block FSD’s passage through Second (final) Reading in EU Parliament.
Lobbied to ensure tabling of critical amendments on definition of a medicine, scope of directive and exclusions. All amendments successfully voted for at First Reading.
Lobbied to help ensure major amendments were supported. Key amendment on non-EU traditional use was lost in pre-First Reading vote but successfully re-tabled by European Liberal Democrats at First Reading plenary. Although it again failed, it can be re-tabled at Second Reading.
Source: Alliance for Natural Health Newsletter, March 2003.
Under the Food Supplement Directive, only 15 out of the more than 60 minerals known to be important in human metabolism will be allowed to be manufactured. Although the 13 key vitamins are to be allowed via the so-called 'positive list', excluded are the most bioavailable forms of vitamin complexes. For example, the FSD bans any chelated or other organically complexed mineral forms such as selenomethionine. Regarding Vitamin E, it only allows the alpha-tocopherols, but excludes the complete tocopherol range as found in nature (including the lambda-tocopherols) which are far more effective as antioxidants than the simpler alpha-tocopherol group. Research has proven that many vitamins and minerals are most bioavailable when in the forms found in nature. Unless the current FSD is overturned, even replaced by a reworked and substantially improved version,, numerous LEF products (and the most innovative products from other companies) will be banned, and the Foundation will be forced to either cease selling particular products into the European market or it would have to reformulate to comply with the EU Directives. This would mean LEF losing a large part of the uniqueness and effectiveness of its products, with clear commercial as well as health implications.
Vitamin Companies: Led to the Cliff By Pharma Dominated Trade Associations
If dietary supplements could be likened to computers, the effect of the FSD is analogous to banning any microprocessor more powerful than a 286. Do you want to use any form of Pentium? Too bad! They’ve been BANNED! The Cartel has decided dietary supplements are harmful to their profits, and they WILL take them away unless we act! All of the vitamin trade associations world- wide are controlled from the top-down by pharmaceutical interests which are leading the whole industry to the cliff. For this reason, the estimated 20% percent of the supplement industry manufacturing the most innovative products MUST come to the aid of consumers by backing the Alliance for Natural Health’s lawsuit, which MUST be filed by Mid-October!
The pharmaceutical industry has established controlled opposition groups around the world that only go through the motions of fighting back, and all too often consumers and vitamin companies get sucked in to them, not understanding either the concept or the tactics used to deceive.
An example of a controlled opposition group is the International Alliance of Dietary Supplement Associations (IADSA) (see http://IadsaExposed.freewebsites.com).
IADSA has UN NGO (non-governmental organization) status to represent the supplement industry at Codex meetings in Germany. Their chairman is Randy Dennin, an employee of Pfizer, the largest pharmaceutical company in the world. IADSA’s agenda was made transparent via their interactions with a member trade association: NNFA New Zealand, which they kicked out under highly unusual circumstances.
You can view JPEG files of correspondence between NNFA New Zealand and IADSA at the above mentioned website. This shows that IADSA was unwilling to assist New Zealand in its effort to defend its very liberal, food-based dietary supplement laws from harmonization to Australia's far more stringent pharmaceutical regulations under which consumers have far less access to products and via which many innovative vitamin companies were driven off a cliff. When NNFA New Zealand raised the issue of Conflict of Interest, and questioned IADSA's true intentions to defend health freedom, IADSA kicked them out from their association.
IAHF ally Ron Law from New Zealand attempted to get IADSA's Simon Pettman to issue a press release defending the herb kava kava when it came under global media attack. But Pettman refused, even when Law provided him with expert risk analysis data showing the comparative safety of kava. Pettman refused repeatedly to issue this press release, even when Law scripted him with an excellent press release which he would only have to have put on IADSA letterhead and sent out, but it never happened.
Pettman publicly declared a desire that the EU Food Supplements Directive be passed into law, and has also publicly declared a desire that a finalized Codex vitamin standard be created for vitamins. These positions are highly contradictory, because of the impact the passage of the EU FSD threatens to have at Codex, especially after 2004 when the EU expands by ten more countries, none of which will dare to go against an EU Directive. This will threaten to push a very restrictive vitamin standard through at Codex which the US would be obligated under international law to adhere to given that they are members of the WTO and signatories of the Sanitary Phytosanitary Measures Agreement. The FDA Modernization Act of 1997 was amended to specifically exclude dietary supplements from the harmonization language. This makes it illegal for the FDA to take any action that threatens to set us up for harmonization to a restrictive international standard. However, the FDA has stated to me in writing that they intend to ignore the will of the people, and the will of Congress. Congress whitewashed an oversight hearing on March 20, 2001 in which the effects of Codex on the US would have most likely emerged. IADSA member Karl Reidel testified at this hearing that events in Europe pose "no threat" to American law. Just 10 days later, on 30 March 2001, Reidel’s co- chair on NNFA’s International Committee, as well as IADSA’s Chair, Randy Dennin, both, (now an employee of Pfizer) chaired a meeting in Capetown, South Africa titled "Toward a Global Regulatory Model." An IAHF ally attended this meeting and almost got thrown out for daring to ask difficult questions about conflicts of interest within IADSA. This served to raise serious questions about whose interests IADSA were really representing. It became abundantly clear that IADSA is all about maintaining the interests of its predominant membership which are pharma affiliated supplement companies and Big Food interests such as vitamin trade associations like EHPM (European Health Product Manufacturers Association) and ERNA (European Responsible Nutrition Alliance).. These happen to be key associations that Pettman consults to via EAS, his consulting firm in Brussels.
If you view IADSA’s actions through the eyes of the drug companies, and particularly through the eyes of Pfizer, the world’s largest drug company (whose employee Randy Dennin, you will recall Randy Dennin, chairs IADSA), - then all of this starts to make rather more sense.everything that is happening "makes sense." While going through the motions of "defending" the industry, IADSA appears to be actually helping the pharmaceutical interests which dominate it to get control of the supplement industry by helping to usher in a global regulatory model which drives numerous products off the shelves.
EU NAZI ROOTS DOCUMENTED
Others go further and have provided evidence that the European Union’s plans which so directly benefit the Pharma Cartel can be linked directly with the Nazis and historical events going back even earlier. With Germany being the host country of the UN’s Codex Alimentarius Commission’s Committee on Nutrition, which is developing what could become a horribly restrictive global vitamin standard- these facts become noteworthy.
Phillip Day, a UK researcher and investigative journalist details these linkages in his fascinating new book Ten Minutes to Midnight (Credence Publications, 2002, available from www.credence.org) Day recounts that Nazi economist Professor Horst Jecht, of Berlin University, firmly believed that Britain was the single greatest obstacle to Germany fulfilling her historic aim of dominating Europe economically as well as militarily. Jecht puts his case in his 1942 essay,
"Developments towards the European Economic Community":
"The foundation for this remarkable development of England was laid back in the period between the 16th and 18th centuries where maritime superiority was gained and a global, colonial empire acquired. By the end of this period, countries outside Europe accounted for 40% of England’s export trade. This development continued until World War I. In 1913, these countries accounted for 56 % and 65% of her imports and exports respectively. Foreign capital investment levels in these countries also started to grow significantly.
Since modern times, England’s economy has developed more and more away from Europe’s and not only during the period of English free trade. It became even more pronounced when there was protection and closer economic and political union with the nations of the Empire, particularly at the time of the Ottawa agreements of 1932. British trade became even more concentrated overseas and, like the figure of 1913, in 1937 British exports outside Europe reached 64%.
Let us look, above all, at the effect of this preferential agreement given to the nations of her Empire regarding supplies of raw materials and foodstuffs…. England’s reorientation to overseas is significant, and not just because it led to an increasing estrangement from the European continent…. Appearing to represent so-called general human principles of the free economy concealed Britain’s real ambition, which was to prevent any coalition in Europe. The aim was to ensure Europe’s economic and political fragmentation and to keep its individual nations dependent on essential goods imported [by Britain] from overseas…"
Day then comments: "In his essay and subsequent address to the Berlin economic conference during the Second World War, Dr.Jecht concludes by explaining that Germany’s true role is to lead the future new economic order of Europe after the Second World War hostilities end. Germany’s eventual defeat in 1945 however changed her immediate destiny, but not her post World War 2 desire eventually to dominate Europe, a role she is well on the way to achieving today."
Day goes on to further back up this assertion with highly unassailable facts pertaining to the structure of the EU Parliament. Here are some hot facts fully backed up with evidence from Day’s book:Examples: The new European army is headed by a German General. Europol is headed by a German police officer. Between them, Germany and France wield the most clout in the EU Parliament with Germany having 99 seats in the Parliament, France having 87, the same number as the UK. Moreover, under a new system known as Qualified Majority Voting (QMV), Britain can no longer veto any EU legislation, but must harmonize its laws, unless ANH succeeds with their lawsuit. This came about in 1985 when Thatcher signed the Single European Act. Under QMV it takes 62 votes to pass a law and 26 votes to block one. Britain only has 10 votes under QMV.
Now they intend to allow consumer access only to the sort of low potency supplements to which Germans have access, and nothing more - and this threatens to impact the world via harmonization of the laws due to Codex, the WTO, and establishment of additional so called "regional trading blocks" such as the Free Trade Area of the Americas intended to be stepping stones to a global totalitarian state. The FTAA is intended to be a carbon copy of the EU Dictatorship in our hemisphere. When the FTAA held a Summit meeting in Quebec City in 2001, the Canadian government put a 10 square kilometer fence around the perimeter of the meeting area rimmed by thousands of police clad in riot gear who squared off against righteously outraged demonstrators, many of whom were injured by tear gas and rubber bullets when they tore down this fence, and attempted to speak out against the New World Order.
[see photos, articles at http://www.infoshop.org/octo/ftaa_news.html
FDA: SETTING UP THE USA FOR "HARM- ONIZATION"
Under a guise of "fully implementing the Dietary Supplement Health and Education Act" the FDA has contracted the National Academy of Science to prepare a Report and draft "safety monographs" for several of the top selling, most effective dietary supplements: saw palmetto, chaparral, chromium picolinate, melatonin, DHEA, and shark cartilage. This scheme will eventually be applied to all dietary supplement nutrients under a three-stage process which in its final stage is very close to a full drugs regime, referred to as a "critical safety evaluation". And in time, the FDA wants all supplement ingredients to go through this third, most onerous route, as well as any new ingredients, regardless of how closely related it is to other well-known, safe ingredients. Does this sound familiar? Is it not just another system creating legislative hurdles that only pharmaceutical interests can afford to clear?
Is this an attempt to harmonize US law to a grossly restrictive emerging international standard?
What the FDA is doing immediately grabbed the attention of Dr.Robert Verkerk and attorney David Hinde of the UK-based Alliance for Natural Health, who immediately recognized that the impact of the FDA scheme was more or less identical to that of the proposed EU legislation. The US and EU legislation might look rather different from the outside in a superficial sense, but the effects would be identical! Both systems are set to kill off innovation in the non-pharmaceutically-aligned sector of the dietary supplement industry, leaving it open only to the drug companies themselves. The FDA scheme is clearly an effort to set the USA up for harmonization of its dietary supplement laws to a grossly restrictive emerging international standard. As pointed out by attorney Suzanne Harris of the Law Loft in Missouri, the UN's International Conference on Drug Regulatory Authorities (ICDRA) has been coordinating the actions of the world's 'FDAs', and there is plenty of evidence on the web in official documents to prove this.
With the Journal of the American Medical Association's recent editorial calling for the repeal of DSHEA, and Illinois Senator Dick Durbin having just introduced S.722 Dietary Supplement Safety Act of 2003 for this purpose, there is no doubt in my mind whatsoever that the Alliance for Natural Health is absolutely right in drawing parallels between the proposed EU, US and other international laws.
THE GOOD NEWS
The good news is that the UK’s Alliance for Natural Health (http://www.alliance-natural-health.org) is a top-notch health freedom organization made up principally of scientists and lawyers, well up to the task of spearheading the fight back. The organization is ably led by Robert Verkerk, PhD, (Executive Director) and assisted by David Hinde, LLb Solicitor (Legal Director).
This scientist/ attorney leadership team is heavily backed up by a crackerjack scientific advisory panel, a top flight public affairs team in Brussels, the best EU law firm in Britain and a host of alternative medical practitioners including all of the top complementary practitioner associations in the UK (e.g. British Complimentary Medical Association, the Complementary Medical Association, the Institute of Complimentary Medicine, the British Association of Nutritional Therapists; the Guild of Complimentary Practitioners). The Alliance for Natural Health has also got support from a growing number of key innovative European and international manufacturers and distributors. Companies, practitioners and consumers all over Europe, as well as in other parts of the world, are beginning to climb on to the ANH bandwagon because it is fast becoming apparent that ANH is the organization in Europe best suited to fight this campaign. It has the right specialists in place, it has the right strategy and it has the right motivation.
WHAT YOU CAN DO
Check out ANH’s web site http://www.alliance-natural-health.org where you will find their detailed strategy which deals both with the FSD and the other Directives. I urge you to join them and make a donation via their website (accepts credit cards) to help their lawsuit which is likely to prove very costly, and must be filed by Mid-October. ANH is doing an excellent job and should be supported in every way possible. Along with the lawsuit to overturn the EU Food Supplements Directive, ANH must keep lobbying in the EU against the Traditional Herbal Medicines Directive and for amendments to the Pharmaceuticals Directive. You can email Robert Verkerk or David Hinde for further information at firstname.lastname@example.org.
International Advocates for Health Freedom is a consulting firm to the dietary supplement industry on legislative matters. IAHF also provides a valuable service to vitamin consumers by calling attention to threats to our access which are currently being covered up by controlled opposition groups such as IADSA, and other pharmaceutically dominated vitamin trade associations world wide.
With your assistance I can continue making trips to Europe to work directly with our allies, lobbying in Brussels and in the Parliaments of all EU Nations. With your help, ANH and IAHF intend to harmonize the world to DSHEA.
Unless we take this battle to the world stage, the USA’s vitamin laws will be forcibly harmonized to a grossly restrictive international standard.
Vitamin companies and consumers interested in supporting the work of IAHF can contact me at 800-333-2553 N.America and 540-961-0476 World. http://www.iahf.com Donations can be sent to: IAHF POB 10632 Blacksburg VA 24062 USA
John Hammell, (center holding flyer) at Vitality Vitamin Trade Show, London, UK
Urges Donations to ANH lawsuit from people world wide