Dear Laura Lee- I am ccing this to a large distribution list, which may well cause more people to tune in your show. I appreciate your skills as a radio talk show host, and know that you are well informed on issues which you endeavor to address on the air.
I see from your website (www.lauralee.com) that on your nationally syndicated radio show tomorrow (8/30) Susan Haeger and Craig Winter of Citizens for Health will be addressing the Codex International Threat to Health Freedom, which they seem to think poses no threat to consumers (!!!) I will be taping the program with great interest, as I see no reason to trust their (spin control) "message"-- which I have already heard at the NNFA meeting in Las Vegas, Nevada at the NNFA Convention.
As a past member of the American Codex delegation who attended the Codex Committee on Nutrition and Foods for Special Dietary Use meeting in Bonn, Germany last October, and as someone who has been actively networking with health freedom activists world wide as part of a TRUE grass roots effort to derail the German Codex proposal as well as world wide Codex harmonization efforts, I do not feel that Susan Haeger or Craig Winters are qualified by experience to call themselves experts with regards to the Codex International Threat to Health Freedom.
Neither Haeger or Winters have ever been on the American delegation to a Codex meeting, so they have no first hand experience with the way the meetings are run. They have never had the opportunity to mingle with people at these meetings, and they don't have the legal or professional background necessary to properly examine this complex issue. Moreover, Haeger and Winter are perpetuating what I regard to be a LIE when they attempt to inform consumers that we are currently being protected by the Dietary Supplement Health and Education Act of 1994. Their assertions that the German Codex proposal is not an attempt to limit consumer access to dietary supplements is spin control, which I feel may be influenced strongly by one or more companies which fund their organization.
*****I really wonder what sort of spin they will try to put on my assertion that it is not in the best interests of Americans for ***Section 202 of S.830*** to go into effect? This section of the FDA Modernization and Accountability Act of 1997 orders FDA to harmonize their regulations with those of the European Union.************
"Harmonize" doesn't mean "make compatible with" it means "make the same as" (!) This is Codex harmonization. It is being pushed by the sanitary and phytosanitary measures sections of both NAFTA and GATT, which are identical, yet which neither Haeger or Winters have ever looked at, to my knowledge. (I also doubt very much if they have bothered to consider the implications of the G-7 Summit in Denver in June where President Clinton announced the signing of a MRA (Mutual Recognition Agreement between the USA and the European Union.)
Multilateral Recognition Agreements by one nation or trading bloc represent another nation's or trading bloc's regulatory standards as equivalent to our own. (Do we REALLY want dietary supplements to be regulated as DRUGS in the STATES? This is the direction things are heading in.
The sanitary and phytosanitary measures sections of NAFTA and GATT, which are pushing these so called "Mutual Recognition Agreements" are ambiguously worded, open ended statements which our Congressly treasonously agreed to upon committing the unconstitutional act of backing the NAFTA and GATT trade agreements. You would never sign a blank contract, and then allow the other party to fill it in later, would you? Well neither would I, but this is analogous to what is happening here with this whole process-- it is a SHELL GAME, much like those 3 card monte games played on the streets of NY in an effort to sucker the unwary tourist who doesn't pick up on the sleight of hand involved as the cards are dexterously shuffled, and...maneuvered.
The section of S.830 that must be cut out to protect Americans consumer access to dietary supplements reads as follows: Sec. 202: "Sense of the Committee Regarding Mutual Recognition Agreements and Global Harmonization Efforts"
"It is the sense of the Committee on Labor and Human Resources of the Senate that--
There were three Trojan Horses built into DSHEA which Haeger and Winter would rather that people not look too closely at:
The Commission on Dietary Supplement Labels, the so called "Significant Scientific Agreement Standard" which FDA can arbitrarily use to block truthful claims, and FDA was given the right to draft new Good Manufacturing Standards (GMP) regulations for dietary supplements.
The Presidentially Appointed Commission on Dietary Supplement Labels currently has put out a draft report which grossly exceeds their statutory authority: See the legal brief filed as comments by attorney Jonathan Emord at www.emord.com) The Commission's report won't be finalized until the end of September, but the Commission showed no sign of listening to ANY of Emord's concerns at their final meeting which I attended in Reston VA August 14-15. The Commission has NO LEGAL AUTHORITY to move beyond their statutory mandate to do what they are doing, which is to expand the OTC drug category to include herbs and botanicals--- but Winter and Haeger feel that their knowlege of law
Moreover, on p.51 of the Commission's draft report, they strongly advocate "HARMONIZATION" with the food and drug laws of other countries and with the European Union...
Haeger and Winter, are putting out spin control saying that this move is innocous, and that in the long run it will "benefit consumers" because it will allow consumers access to therapeutic claims that they claim "can't be made under DSHEA." This is the big lie, but to understand it, you must see it from a standpoint of emerging international law-- something which Haeger and Winter would rather we not look too closely at.
I do think it would be in the best interests of the public if they, along with Karl Reidel, another (alleged) expert on this matter, were to debate Suzanne Harris,JD of the Law Loft, on the air.
Harris, a law professor and investigative reporter, has her own radio show called The Law Loft Report where she discusses constitutional issues which effect American sovereignty. Although Reidel represented NNFA on the American Codex Delegation at the recent Codex meeting in Geneva, he does not speak for the consumer, he speaks for industry, and I feel that Haeger and Winter are cut from the same cloth.
NNFA, CRN, UNPA, and AHPA have all sold out, in my opinion. (These are vitamin trade associations, however CRN's members include a huge number of pharmaceutical companies which also manufacture vitamins, and mergers and acquisitions are occurring with greater and greater frequency as pharmaceutical companies buy their way into the dietary supplement industry.... For example, Twin Lab just merged with Rexall- a pharmaceutical company with a vitamin division.
These so called "vitamin" trade associations don't represent consumer interests. They are pushing for the expansion of the O-T-C drug category to include herbs and botanicals out of _GREED_ and any statements to the contrary are merely a pretense put out in the name of smooooth public relations.
It should be noted that PharmaPrint,Inc. of Irvine California, is traded on the NASDAQ stock exchange. On December 4th, they issued a press release "Global Initiative to Bring Herbal Medicines Into Modern Medical Science Announced by WHO Group Today". This company just got the first IND on a herb-- on saw palmetto berry extract. Before Christmas they announced the world's first patent on a complex herbal molecule and they intend to go right down the list of the world's most popular herbs-- to sell them as "DRUGS." Go to my website to link to their latest press release. The so called World Health Organization is actively backing PharmaPrint's campaign. Right now, I can go to a health food store and buy saw palmetto capsules for about $20. a bottle. How much will a bottle cost after PharmaPrint spends Millions to get it through the drug approval process? After they do this, does anyone really think they will tolerate the product being sold as a dietary supplement, thus encroaching on their market??? Saw Palmetto works just fine RIGHT NOW for the treatment of benign prostate hypertrophy. It isn't NECESSARY for PharmaPrint to run the product through expensive controlled clinical trials...
From a standpoint of emerging international law, to expand the OTC drug category to include herbs and botanicals is to embark down a VERY SLIPPERY SLOPE, constituting Codex harmonization-- a trending in the direction the pharmaceutical industry is trying to push things all over the world.
My efforts to network with grass roots activists world wide was instrumental in keeping the Germans from advancing their Codex proposal from Step 5 to step 6 at the recent Codex meeting in Geneva, Switzerland at the end of June. This meeting was attended by Harris of the Law Loft, a multidisciplinary Think Tank which has been exposing the Codex International Threat to Health Freedom.
In order to understand the emerging international law perspective, please go to my website and download Harris comments to the Commission on Dietary Supplement Labels. The footnotes aren't included in the comments stored in my website because when I uploaded the file as a txt file, the formatting was lost, but if you want the footnoted copy, please give me a fax number so I can fax it to you along with a 7 page executive summary that isn't in the website.
As the pharmaceutical industry buys its way into the dietary supplement industry, spin masters such as Haeger and Winter seem to me to be paving the way.
If you go to the website of Nature's Way, incorporated, you will see that they are licensed by the FDA to sell O-T-C DRUGS. Moreover, you will see that Nature's Way has just more than doubled the size of their manufacturing plant, most likely in gleeful anticipation of driving a lot of smaller competitors off a cliff once the FDA has completed their (soon to be announced) new regs for Good Manufacturing Practices (which the ANPR in the Federal Register states features costly and unecessary HAACP measures that ARE needed for pharmaceutical quality control, but NOT for dietary supplement quality control. Red Tape associated with compliance with the new GMPs will drive a lot of small manufacturers out of business. Moreover, Nature's Way is a joint venture between Madaus-Murdock-and Schwabe. This is stated in Nature's Way's incorporation papers in the state of Utah, and is no secret. The spin that they try to put on this is that Madaus and Schwabe are "old and respected family businesses that manufacture NATURAL O-T-C drugs"
Madaus AG and Schwabe are two of Germany's largest phytopharmaceutical manufacturers. In my opinion they want very much to move into the North American market in natural products, and are working through a consortium of pharmaceutical interests called the European-American Phytomedicines Coalition, a multi million dollar lobby that is working through the Multinational Law Firm of Akin,Gump,Strauss,Hauer, and Feld, L.L.P. which has offices in Austin, Brussels, Dallas, Houston, London, Moscow, New York, Philadelphia, and San Antonio.
How much money does Nature's Way contribute each year to Citizens for Health? I wouldn't mind knowing the answer, but feel certain that it is probably significant. CFH certainly does work closely with Nature's Way, which I regard to be a pharmaceutical company in disguise. Madaus AG is currently funding a $300,000+ controlled clinical trial on the herb echinacea at Bastyr University, undoubtedly in anticipation of selling the herb as a drug in North America. The fact that Bastyr is a naturopathic school is irrelevant. They have sold out, in my opinion, and in many other people's opinions. Nature's Way and CFH actively tryed to interfere with my efforts to defend health freedom in Canada where they are behind a fake grass roots group there called the "Canadian Coalition for Health Freedom". This group would NOT get behind our effort to sue the HPB, and would NOT get behind the effort to pass the Foods are Not Drugs Amendment, because they have SOLD OUT. They have climbed in bed with the HPB, and won't stand on principle. Foods are NOT Drugs!!! I don't endorse either CFH or CCHF. The people of Canada are seeing through this scam quite readily now as they rally behind the lawsuit filed at the end of June by Freedom of Choice in Health Care.
The properties of echinacea have been well known for thousands of years. Is it really necessary to conduct expensive drug trials of the sort occurring at Bastyr? Should it be necessary to conduct trials of this sort to be able to make therapeutic claims on echinacea? Many herbalists who I know do not think so. This seems more like a means of shutting small herbal manufacturers out of the market, and costs will certainly be passed on to the consumer as roll up occurrs within the supplement industry.
At the NNFA meeting in Las Vegas, Haeger shared a podium with a number of people discussing the Codex Issue who appear to have an agenda. Among the people sharing this podium with Haeger was Bill Reynolds, a Canadian lobbyist who used to be the executive director of the Canadian Health Food Association but was forced to resign. For details on why Reynolds was forced to resign, I urge you to contact Croft Woodruff, Past President of the Canadian Health Food Assn at 604-324-2121. Woodruff has owned a health food store in British Columbia since 1968, and has a radio show called "Healthy Living" which is broadcast out of Vancouver. Woodruff does not trust Reynolds, who clearly has no problem with the Canadian Drug Identification Numbering System currently in place in Canada.
In Canada, all dietary supplements are regulated as drugs. On a basis of basic principle, foods are _NOT_ drugs, but in Canada, under existing law, they could consider WATER to be a drug if they wanted to! It is illegal to market a product in Canada unless you first get a DIN number approved by the HPB (Health Protection Branch). The cost of getting a DIN approved runs between $10,000- $20,000. Unless someone breaks the ice by getting a DIN number approved, no manufacturer or distributor can market the product.
For example, it is currently illegal in Canada to sell such innocous products as fish oil capsules, hawthorne berry capsules, or cranberry capsules because DIN numbers haven't been approved for these products. Once a DIN number has been approved, a manufacturer or distributor is required to pay an annual fee averaging $720. to keep the DIN current, otherwise, they cannot market the product.
Due to the comparative sizes of the US and Canadian markets, if the DIN system is adopted in the United States, the cost of getting a DIN number approved here would be correspondingly much higher, perhaps 10x the Canadian fee.
Moreover, in Canada, a lawsuit filed against the HPB at the end of June by Freedom of Choice in Health Care is the only thing currently stopping the HPB from putting an illegal tax and other bureaucratic measures into play is the only thing keeping small to mid sized Canadian vitamin manufacturers from being driven out of business. The lawsuit is currently blocking the Third Phase of Cost Recovery from going into effect. Under the Canadian Financial Administration Act, the HPB has a legal right to charge a flat fee to regulated companies to compensate for budget cuts, but they don't have any legal right to charge on a percentage of annual sales basis, because then they have crossed a line and would be levying a TAX that was never debated in Parliament.
HPB wants to charge a 1.5% TAX based on a percentage of annual sales, but Parliament has never debated the matter. Moreover, HPB wants to charge manufacturers site licensing fees, which many small manufacturers can't afford, and they want to require anyone importing American products to pay very high fees to send an HPB inspector to inspect the American manufacturing facility to insure that it meets Canadian GMP standards.
Haeger argues that the Codex Alimentarius Commission is innocous and that their decisions are strictly "science based."
BULL. When I was on the American delegation, it was quite clear to me that the vast majority of delegates represented pharmaceutical interests. During the coffee breaks, when I told people from other delegations that I have taken 20 grams of vitamin C per day for the past 18 years, their response was one of total incredulity. "Why don't you just eat an orange?" They'd say. "You are just enriching your urine." "You don't need more than the RDA level of any given nutrient" was the brainwashed refrain I heard time and time again from the vast majority of delegates at the Bonn meeting that I attended.
Should Americans trust section 202 of S.830 when it calls for American food and drug laws to be harmonized with those of the EU where foods are regulated as "DRUGS" and where consumer access to dietary supplements is severely limited?
I think _NOT_.
Should anyone trust the message being put out by Haeger when she states that Suzanne Harris does not understand this issue?
I think _NOT_.
Is Haeger engaging in spin control? How much money is she getting from supplement manufacturers that want to enter the O-T-C drug market? From a standpoint of emerging international law, per Harris comments submitted to the Commission on Dietary Supplement Labels, is it WISE to want to blur the lines between foods and drugs when we worked so hard under DSHEA to create a FOOD definition for dietary supplements? I urge people to go to the IAHF website and download Harris Comments to the Commission on Dietary Supplement Labels. These comments were filed by Harris who represented the National Health Federation, and the Life Extension Foundation. Is Haeger TRULY representing the grass roots??? I may be wrong, but it sure seems to me that she is representing people who want to sell dietary supplements, as drugs, in order to make fantastic profits at the expense of consumers.
Could the United States one day become as restrictive as Canada or Norway? I'll let you be the judge after you carefully review all aspects of this complex issue, especially Section 202 of S.830, which Senator Harkin wants to attach the Access to Medical Treatment Act to. (Is _THAT_ a wise move? I think _NOT_!)
August 29, 1997
International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St.#2 Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,
FAX ON DEMAND 954-927-8795,firstname.lastname@example.org