Ron Birckhead is an American vitamin distributer living in Bergen, Norway. He and I have joined forces across the internet to form the International Health Alliance to defend consumers of dietary supplements from a largely covert threat to health freedom which looms large in the form of a fast approaching meeting in October, in Bonn Germany.

SUMMARY OF THE PROBLEM

We are conducting our work under the auspices of the non profit, educational , Life Extension Foundation of Hollywood, Florida where I am the political coordinator.

IN a nutshell, the German delegate to a joint UN/WHO commission called the Codex Alimentarius Commission has made the draconian proposal that consumer access to deitary supplements be limited to the RDA dosage as a maximum limit for vitamins (C 60mg, E 15mg, etc). Supplements that don't have an RDA (such as coenzyme Q-10, trace minerals and amino acids) would be illegal to sell as foods. They would all become drugs.

In October, the World Trade Organization will be voting on whether or not to adopt this harsh German proposal.

This would create an intolerable regulatory climate very similar to that existing in Norway where the health food industry is in the process of being literally taken over by the drug companies. In Norway, vitamin C above 200 mg is illegal. The Norwegian FDA attempted to incarcerate Ron Birckhead for importing vitamin C and E powder (he fought back furiously and won, but his battle there is ongoing!)

Very few herbal products remain on the shelves of the few remaining health stores in Norway.

You can't get vitamin E above 45 IU, more than 2.4 mg of Vitamin B-1, or more than the infinitesimal 4.2 mg of B-6 in Norway. The New World Order wants to reduce supplement availability world wide in this same fashion, using the World Trade Organization as a weapon, to impose trade sanctions on any nation that does not get into line.

SUPPLEMENTS BECOME DRUGS IN NORWAY

In Norway, Shering-Plough, the pharmaceutical giant, now controls an Echinacea tincture which is being sold there as an OTC drug, at grossly inflated prices. Ginkgo-Biloba is similarly controlled as an OTC drug, but not by a pharmaceutical company-- by a powerful Danish vitamin distributor who's owner owns a lear Jet. (American readers take note: this Danish vitamin distributor will do ANYTHING to sell a product, and there are plenty of American vitamin companies and distriibutors who are JUST AS QUICK to sell out the consumer in their lust for monry. This fact is already weakening the US Health Freedom Front as our trade associations have been compromised by owners who now have their feet in both the supplement and pharmaceutical camps. The powerful Danish vitamin distributor is beginning to buy up health food stores throughout Scandinavia, and some day he will undoubtedly sell his company to a pharmiceutical company, with ZERO concern for the consumer. We urge NNFA members to scrutinize their Board Members accordingly, as we distrust several them.

Although both echinacea and ginkgo-biloba ae among the few herbs that are still available in Norwegian health food stores, they are unallowed to make health claims- those can only be made by the OTC drug versions which are only available in tightly government controlled pharmacies.

The point to understand here is that in Norway, only one government controlled pharmacy has the right to import supplements as MEDICINES which they can sell to health food stores, convenience stores, or pharmacies. Understand that these products are 1) defined as drugs, 2) only products which are guaranteed not to vary from batch to batch in potency (read pharmaceutical extracts, NOT herbs themselves) are allowed to be sold, 3) to get the license to import and distribute that single company had to comply with a raft of regulations inconsistent with the natural foods movement, and to boot had to employ someone who has worked for the Norwegian FDA.

In the late 80's when Ron first moved to Norway, you could buy any dietary supplement that was then available in the US. No more. Many dietary supplement companies got greedy, and sold out in anticipation of making vast profits if their supplements could become drugs.

SUPPLEMENTS TO BECOME DRUGS IN THE US?

A CRITICAL LOOK AT WURTMAN/DE FELICE

We have evidence of this beginning to occur here in the United States as the top tier of the supplement industry has become the lower tier of the pharmaceutical industry, and we are working overtime to document these facts. Witness Dr. Steven De Felice's so called "Nutraceutical Initiative." De Felice has been holding a series of black tie events in Washington DC, and it appears that his proposal for exclusive rights to sell l-carnitine and other nutrients will usurp our health freedom.

DeFelice showed his true colors on August 29th, 1990 at the Masur auditorium of National Institutes of Health when C.Kenneth Mehrling, Director of Marketing and Sales of Sigma Tau Pharmaceuticals strongly advocated the removal of the amino acid l-carnitine from the health food stores, recommending that Sigma Tau's "Carnitor" be the ONLY l-carnitine product available to the public, and only be prescription.

Dr. DeFelice holds the patent on Carnitor, and would still like exclusivity rights to sell l-carnitine. If his so called "nutraceutical initiative" succeeds, it will be to the detriment of the consumer who will be forced to pay much higher prices for a drug product that they'd have to get a prescription for through a physician.

On p. 170 of the transcript of the FDA's public hearing on dietary supplements held on August 29th, 1990, Mehrling stated: "The availablity of nutitional food supplement l-carnitine since late 1983 has effectively prevented our company from realizing the market exclusivity afforded by the Orphan Drug Act to Carnitor. Additionally, we feel that consumers cannot safely use l-carnitine based on the labeled use l-carnitine content of the drug product, and levocarnitine's use in the treatment of patients with inborn errors of metabolism and other causes of carnitine deficiency require continuous professional intervention to establish individual treatment regimens, which can include dosages that vary by several fold in the same patient. The current lack of regulations cannot insure a consistent level of bioavailable l-carnitine in nutritional food supplements or prevent their use in the outside regulation treatment of these inborn errors of metabolism patients."

EFFORTS TO CONTROL L-CARNITINE = SELF SERVING PROPAGANDA

This is purely self serving propaganda, of course. While some l-carnitine products available in health food stores may have been of questionable quality in 1990, this certainly can't be said of ALL l-carnitine, or all other amino acids for that matter. Prolongevity is just one reputable supplement company that manufactures high quality l-carnitine. Prolongevity's l-carnitine costs $14.63 for 30 capsules at 600 mg, while Carnitor costs $60.89 for 60 330 mg tablets. Prolongevity's price is substantially cheaper per milligram with no difference in quality.

On May 9th,1996, DeFelice urged that the Dietary Supplement Health and Education Act be amended in order to allow eclusive medical claims made on new products in order to provide an incentive for research. He criticizes DSHEA as "not driving research because its too vaque." If De Felice is able to amend DSHEA the way he wants to, consumers will have to pay far more for products, and many would not be available without a prescription.

EFFORTS TO CONTROL MELATONIN

Richard Wurtman of MIT is another adversary. He appears to want to control melatonin and has use patents on the whole serotonin pathway. He has gone on TV numerous times to condemn the sale of melatonin through health food stores, claiming "safety" concerns despite the fact that no one has ever been injured. On September 25, 1995, Wurtman appeared on the NBC Nightly News alleging that melatonin has "dangerous side effects" and stated: "I'm really scared someone's going to take chronic doses of melatonin in high doses for a long time, and have all kinds of disturbances in their other biologic rhythms, maybe crash into a telephone pole. (NBC did not disclose Wurtman's conflict of interest by failing to discuss his ties with Interneuron Pharmaceutical Co. which hopes to control the rights to melatonin.)

Wurtman's concerns about safety are groundless. Life Extension Foundation has been selling it to thousands of people for the past 3 years with only a few minor complaints. Researchers have given people up to 6000 mg/day- 600-3,000 times the usual doses with no toxicity. Despite the recent surge in its use, the FDA has received only 4 complaints about melatonin. Two people said it disrupted their sleep patterns, one complained about genital pain, and a forth reported feeling nauseated. FDA spokesman Brad Stone stated: "We can't substantiate that melatonin was in part or largely responsible for these problems." (Newsweek, November 6, 1995 "Melatonin Mania.")

Wurtman appears to want to sweep all amino acids off the shelves of our health food stores along with melatonin, and constantly harps on the contaminated l-tryptophan from the late 80's that was manufactured by Showa Denko pharmaceutical company in Japan as "proof" that the supplement industry can"t be trusted.

The fact remains that Showa Denko was just one of several manufacturers of l-tryptophan (all were in Japan), and the others DID follow good manufacturing practices, which are now mandated by law. The fact also remains that even in countries where l-tryptophan is regulated as a drug, such as Germany, people still received the contaminated tryptophan, so Wurtman is incorrect in stating that regulation will always prevent the public from being exposed to contaminated products. In any case, Wurtman and DeFelice can no longer use the argument that the dietary supplement industry has no quality control because on October 8th, 1994, the Dietary Supplement Health and Education Act passed requiring that manufacturers conform to stringent quality control requirements known as Good Manufacturing Practices.

Unless consumers of dietary supplements world wide unite, it is no likely that health freedom will survive over the course of the next 5 years as the multnational corporations and drug companies which dominate the Codex Commission have devised a scheme through the GATT treaty to make an end run around US Sovereignty in a determined effort to consolidate their power.

Thus far, voting within the Codex Commission's Committee on Nutrition and Foods for Special Dietary Use have gone 16-2, and 10-1 in favor of the draconian German proposal, with only the US, and the UK taking a stand against it. (The US and the UK are the worlds two largest manufacturers of dietary supplements.)

On April 29th, Reuters news service published an article titled "U.S. Disappointed in Appeal of WTO Gasoline ruling." In this ruling, the United States is being FORCED by the WTO to make changes in our Clean Air Act because an appellate body of the WTO in Geneva found that U.S. clean air gasoline rules discriminante against imports from Venezuela and Brazil.

This is the first time the WTO has imposed a ruling on the United States on the now powerless group called Congress, and vitamin consumers had BETTER TAKE NOTE, because if the WTO can force us to scuttle our Clean Air Act, they can force us to accept a WTO ruling on dietary supplements EVEN IF IT CONTRADICTS US LAW!

The American public in correctly believes that Congress can protect us against the WTO! In this case, the WTO's three judge appeals panel composed of officials from the Philippines, Japan, and New Zealand upheld the overall ruling that the regulations were "a disguised restriction on international trade" because they set different rules for foreign producers than for domestic refiners.

In October, in Bonn, unless people all over the world unite in an effort to monkeywrench the "drug cartels" plans, health freedom will be steamrolled because tiny little WTO member nations such as Togo, in West Africa, have as much voting power on this matter as the U.S., and companies like Shering-Plough are making a concerted effort to swing their delegates in favor of the German proposal.

Quite simply, unless we are able to swing enough delegates against the German proposal through a laser like campaign, the US and UK will be overwhelmingly outvoted by the other 124 WTO member nations.

On the 15th of April, the National Institutes of Health issued a press release which seems intent on directing the public to avoid dietary supplements and to think in terms of a maximum dosage limit for Vitamin C, and by implication other nutrients.

Although it has been widely refuted, they once again dragged out the long discredited assertion that vitamin C causes kidney stones. This fallacious assertion and propaganda of the pharmaceutical industry was first splashed through the media prior to the passage of the Proxmire legislations which protected consumer access to dietary supplements in the 1970s.

On May 22, Ron emailed a message from Norway saying that he was just informed by a second company which imports and distributes supplements that they have received a license to distribute and import natural medicines into Norway. Again this system will be the model first in other Scaninavian countries, then in the European Union and later it is intended for the rest of the world via Codex and the GATT/WTO agreement.

To obtain the license to sell the most effective herbs (Ginkgo, Valeria, Goldenseal, etc) and other products defined in Norway as medicines (as it is in the German Codex Proposal) each company has to employ a pharmacist who has worked in the pharmaceutical industry for at least two years.

There is now a third health food supplement company applying for a license and hiring a pharmacist that Ron knows of and it is expected that all health food supplement distributors and import companies will be hiring pharmacists or else be expected to be eliminated from the marketplace quickly. Only a few of the biggest in the small country of Norway (population 4 million) can afford to hire a pharmacist. Now the stampede is on.

Ron and I are working closely with Suzanne Harris, JD of the Law Loft of Arcadia, CA to formulate an international counterattack against the drug cartel. Our articles (available through our website or via 800-841-LIFE) have been translated into German, French, and several other foreign languages as we unite with others across the internet to warn the world.

We are badly in need of donations to assist in conducting a think tank on this complex issue. Eventually we will have enough of a plan to conduct a targeted domestic Congressional campaign here in the United States, but we will not publicly reveal some aspects of our strategy- at least not yet.

For the time being, we badly need your donations to help with transatlantic and transcontinental phone bills and to fund Suzanne's legal efforts. Suzanne is a seasoned Think Tank veteran who is an expert on the GATT treaty and has been actively studying the Codex threat to health freedom, while Ron and I are dedicated activists who have numerous international connections in the health freedom movement. We need all of you to help. I am going on talk radio nation wide and am always looking for shows to appear on, and also need help in Usenet on the internet.

My email address is jhammell@ix.netcom.com. The LEF url is http://www.lef.org/lef/index.html. There you will find more details. You may also call our main office at 800-841-LIFE to request copies of our February and April magazines with articles by Ron and I about this international threat to health freedom!

We need all of your assistance, especially if you can donate funds for a think tank, or are on the internet. If you wish to donate to our cause, please make your most generous tax deductible check out to: Life Extention Foundation, and send it to: LEF Political Office, 1534 Polk St., Hollywood, FL 33020. Please relay this article far and wide! Please alert your friends to this largely covert international threat to health freedom!

John C. Hammell, legislative advocate, The Life Extension Foundation,
PH 800-333-2553, 305-929-2905
FAX 305-929-0507
jhammell@ix.netcom.com
http://www.lef.org/lef/index.html
Political Office 1534 Polk St. Hollywood, FL 33020