©1997 (may be reprinted for non-commercial use with permission)
By John C. Hammell, legislative advocate
International Advocates for Health Freedom
2411 Monroe St. #2, Hollywood, FL 33020 USA
TEL. 800-333-2553, 954-929-2905
FAX 954-929-0507, 954-927-8795 (fax on demand)
The Big Carrot, Toronto's largest health food store, was inspected by a HPB official and presented with a registered letter on Mar. 26, 1997 implying that as many as a third of the products sold on the premises were in violation of the DIN drug directorate policies. The word got out to several reporters and talk show radio personalities (e.g. Croft Woodruff, AM 1040 Vancouver, Now Magazine and numerous web sites) and, shortly after continuing negative media publicity about the HPB actions, the inspector returned to announce that it was all a mistake and that he had confused the Big Carrot with a supplement manufacturer. It's really quite magical what a little media attention accomplishes.
This article outlines what I found in Canada during a two week public speaking/fact finding tour where a Codex driven pharmaceutical takeover of the natural products industry is in full swing, opposed by a groundswell of outraged consumers, small manufacturers, distributors and health food stores which badly need the support of Americans and people all over the world who care about health freedom. Possession of DHEA is now a felony in Canada, carrying the same penalty as possession of crack cocaine, and foods are now being regulated as "drugs."
Canada, New Zealand, South Africa, the UK, Jamaica, Spain and possibly other countries are being heavily influenced by events which have already occurred in Australia and the Nordic countries where foods are being regulated as "drugs". A high official from the Australian Therapeutic Goods Administration (TGA) has brought the software for the "DIN" number classification scheme to several countries as part of the world wide Codex "harmonization" which threatens consumers world wide.
The pharmaceutically connected vitamin companies are "negotiating" with the Health Protection Branch (Canada's version of the FDA) over the creation of a quasi-drug ("nutraceutical") category which would do nothing to stop the HPB from driving manufacturers, distributors and retailers out of business- while barring consumer access to a growing list of natural products including DHEA melatonin, fish oil cranberry, hawthorne berry capsules, amino acids, chromium picolinate, and over 57 other common herbs. Ottawa now calls anything with therapeutic effects, claims or any remote toxicity A DRUG under the Minister of Health's new Food and Drug Policy. (Anyone who still doesn't think this could happen in the US had better check what the FDA says in their own web site about their intention to harmonize our domestic laws with the draconian Codex dictates. "FDA plans to amend its regulations and procedures for consideration of standards adopted by Codex. This action is being taken to provide for the systematic review of Codex standards in order to enhance consumer protection, promote international harmonization and fulfill obligations of the United States under international agreements." (http://www.fda.gov/ola/319.htm) The FDA's modus operandi is on record as ensuring that the existence of dietary supplements on the market do not act as a disincentive for drug development. (FDA Dietary Supplement Task Force Report, May 1993)
With a sigh of relief I rushed through Vancouver airport to meet Debbie Anderson, my contact from Freedom of Choice in Health Care. Due to pressure from vitamin companies with pharmaceutical connections which did not want me entering Canada to alert consumers to the truth, I had been "red flagged" by customs and it took me an hour and a half to clear. As we drove to her house in Chilliwack, British Columbia, Debbie expressed relief that I hadn't been arrested or barred from the country. I had been scheduled to speak at the Public Forum on Health Freedom, but a few days before I left for Vancouver I was blocked from the podium by several pharmaceutically connected vitamin companies who feared that I would expose them.
We got to the hotel before the Forum took place so that I could get a seat right next to one of the two microphones in the auditorium that had been placed for audience participation. Dr. Zoltan Rona gave a rousing keynote speech in which he eloquently discussed the threat to health freedom as posed by the HPB and by the German and Canadian proposals currently before the Codex Alimentarius Commission which threaten consumer access to herbs and dietary supplements. Dr. Rona spoke of the need to file a class action suit against the HPB, to pass the "Foods are Not Drugs" Amendment, and to get an injunction against the HPB. Rona endorsed the effort of Freedom of Choice in Health Care while stating that the "Third Category" espoused by the Canadian Coalition for Health Freedom would do nothing to stop the HPB from banning products, and would create a whole new layer of bureaucracy which small manufacturers and consumers could not afford.
Following the keynote speech, a spirited panel discussion ensued about what should be done in Canada to protect health freedom, with most panelists favoring the Foods are Not Drugs Amendment and Class Action suit approach of Freedom of Choice in Health Care over the Canadian Coalition for Health Freedom's "Third Category".
Debbie Anderson, who represented consumers on the panel, clearly voiced the need to pass the Foods are Not Drugs amendment in order to stop the HPB from being able to regulate foods as drugs. Anderson discussed the hypocrisy of the HPB which routinely approves dangerous drugs, citing that in Ontario hospitals alone, over 600 deaths annually are attributed to adverse effects of correctly administered drugs and that perhaps 10,000 Canadians per year are killed by prescription and OTC drugs while there were no deaths known to have been caused by vitamins and herbs.
In Canada, if claims are made on a natural product, the HPB then requires that a "Drug Identification Number" be applied for. If this is done, and HPB deems the product safe, it can be marketed as long as the manufacturer, distributer, and retailer pay costs of up to $720. per DIN number. (If no one has applied for a DIN, then no one can sell the product, and you can even be arrested for selling such innocuous products as fish oil, hawthorne berry, and cranberry capsules.) (If the DIN system were ever adopted in the US, these costs would be 10-20 times higher due to the market being so much bigger.)
On top of this outrage, under a "Cost Recovery" program, manufacturers will be assessed huge "site licensing fees". For example, if a manufacturer sells 4 DIN products, he will have to pay an annual fee of $1250. for Good Manufacturing Practice inspections, plus an annual importer assessment fee of $1562, plus an analysis fee of $1250. plus foreign assessment fees which are $2500. plus all expenses for an HPB inspector to travel to the foreign facility to inspect it- which could easily cost $5000/ foreign facility, (these costs, of course would be passed on to the consumer.)
Upon conclusion of the panel discussion, the moderator called for questions from the audience and I popped up from the crowd to seize the microphone I'd been eyeing all evening. You could have heard a pin drop as I announced my name and stated why I'd been barred from the podium. I explained to everyone that in Norway and Australia health freedom had already been destroyed by the same process now underway in Canada. I warned consumers not to be seduced by the "third category" stating that it favored the large vitamin companies which have pharmaceutical ties and would enable them to drive all the small companies out of business. I urged them to stand fast on principle and to write to members of parliament in support of the Foods are Not Drugs Amendment. I related the story of John Hansen in Norway whose vitamin distribution business had been destroyed by NONA, the Norwegian vitamin trade association which had been taken over by pharmaceutical interests, and told about how he had been chased by undercover agents for selling vitamin C above the 200 mg limit.
At the Public Forum Inga, (who expressed anger that I had been silenced) announced that I would be speaking the next day at her church and handed out several hundred flyers. The church was packed, and I showed them evidence that Shoppers Drug Mart, Canada's largest chain pharmacy, is planning on getting into health products in a big way, JUST AS THEY'RE TURNED INTO DRUGS. I learned this from a memo leaked by a disgruntled employee of one of the vitamin companies which had contracted with Shoppers Drug Mart. According to the memo, Swiss Herbal, Canada's largest herb distributor will be in all Shoppers Drug Marts with 20 or more feet of shelf space. Nutravite, Holista and Amazonika share a four foot section, while Quest and Wellspring show up in stores with four or more feet of space, and Natural Factors show up in stores with 28 feet.
Many other companies with good products cannot afford the government's "cost recovery and compliance" measures. Their products will no longer be available in local health food stores, many of which will be driven out of business unless the Foods are Not Drugs Amendment passes. But guess what the big companies are doing? They have launched the "Canadian Coalition for Health Freedom" which is dominated by the large companies such as Quest and Nu Life.
CCHF member companies are signing contracts with large chain pharmacies such as Shoppers Drug Mart, and are funded by large interests who will gain market share as small companies go under. One company insider admitted that his company would lose 20-30% of its products, but because his gross revenues exceeded more than $2 million, he would survive while others would not. Steering committee meetings of the CCHF were changed without notice to block dissenters from participating, much as I had been blocked from speaking at the Public Forum in Vancouver.
Del Anderson, owner of a small vitamin business in Calgary has asked CCHF some very tough questions about the potential fiscal impact of their policy to which CCHF cannot respond. Based upon STATS CAN and government figures, the overall cost for Agencies and bodies as envisioned by the CCHF proposal works out to $135,000. per staff member, per year. An estimated staff of some 150 persons (all across Canada) would be necessary for the operation of the Agency called for by the formation of the "third category" which supposedly helps consumers, and supposedly protects people from the predations of the HPB. (A full breakdown of staffing levels and functions is not included in this summary.) Therefor, 150 x $130,000.amounts to some $20 million dollars per year (!!) In addition, lab costs, equipment costs, and advisory board costs would be extra.
If projected manufacturers and importers sales are $100 million (which Anderson was told is high), then the surtax imposed on manufacturers by CCHF's "Third Category" would have to be at least 20-25%, with the very real possibility that these numbers would go even higher, much higher. Freedom of Choice in Health Care has seen verification that these numbers seem to be quite realistic. Thus, with the base costs rising some 20-25%, the retail costs would increase some 30-50%! Anderson warns that most Canadian business would be driven south to the states at these prices, and even so, the "underground" would flourish, posing great harm to the health of consumers.
FCHC and Anderson were very surprised to learn that under the CCHF proposal, "meal replacements", "ginseng", "creatine monohydrate", "protein supplements", and numerous other commonly used health products would be RECLASSIFIED, likely under the watchful eye of the HPB Drugs Directorate.
Madaus AG, a phytopharmaceutical company from Cologne, Germany is spending $385,000. to conduct double blind studies on echinacea at Bastyr University. (Natural Foods Merchandiser- April '97, p.10.) They wouldn't be doing this unless they thought they could get an OTC drug category in the United States and Canada through which to market their product. According to CCHF's literature, Nature's Way, which is closely affiliated with Madaus AG, has distributed CCHF's propaganda to all the health food stores in Canada.
In the United States, the Utah Natural Products Alliance, of which Nature's Way is a member, has jointly signed a memo with the National Nutritional Foods Assn, and the American Herbal Products Association calling for an OTC drug category to be created for herbs and botanicals. The statement was issued to the Dietary Supplement Label Commission at their last meeting in Baltimore. In the memo they referenced recommended changes to the OTC drug product review process which could be found in comments filed by the European-American Phytomedicine Coalition to Docket No. 96N-0277 which they provided to the Commission. This illustrates how the pharmaceutical industry is attempting to infiltrate and dominate the dietary supplement industry.
When Nature's Way attempted to influence Marilyn Nelson of Freedom of Choice in Health Care by sending a check for $1000., she refused the money and sent it back in a certified letter dated April 11, 1997, stating that they had a copy of the flyer for the Drug Information Association's Thirty Third Annual Meeting to be held in Montreal from June 22-26 which lists Loren Israelson, JD, Executive Director of Utah Natural Products Alliance as a speaker. Nelson, and many others are wondering how Nature's Way can claim to be working for health freedom when they are hobnobbing so closely with pharmaceutical companies which seem intent on taking over the supplement industry?
On March 19, 1997 Svend J. Robinson, a member of parliament from Burnaby B.C., placed a motion before the House of Common urging that an immediate moratorium be placed on the enforcement of HPB imposed restrictions and user fees on natural products, and strongly opposed implementation of these fees while simultaneously urging strong opposition to the multinational pharmaceutical corporations and the Codex efforts to restrict consumer access to natural products around the world.
Minister of Health David Dingwall responded to Robinson by stating that he does "not think it would be appropriate for the Minister of Health to give a carte blanche directive to the department when its very reason for existence is to make sure that the product is safe and efficacious."
Speaking at a Canadian Health Food Association meeting in Calgary, AB on April 11th, Julian Whitaker, MD of the Whitaker Wellness Institute in California expressed the view that Canadian consumers did not need, could not afford, and should not have to pay bureaucratic costs stemming from the third category and he urged them to fight for the "foods are not drugs" amendment.
Zoltan Rona, MD, a strong opponent of the CCHF and HPB has just been blocked from speaking at events in Toronto and Calgary due to their influence. With customs blocking him from importing amino acids and other products needed by his patients, Canada is clearly violating the Helsinki accord which is supposed to prevent human rights abuses of this kind. Governments aren't supposed to interfere with a physicians efforts to help his patients. Dr. Rona could prescribe amino acids as "drugs", but if he did he'd run the risk of being attacked by the medical board which is strongly prejudiced against the use of natural substances and which would be looking for any excuse to go after his license.
In Canada, to get a list of members of the House of Commons (with phone numbers) call 613-992-4793. Sign petitions and write letters to support the Foods are Not Drugs Amendment. Especially write to members of parliament who sit on the Health Committee of the House of Commons. In parliament a drug policy review is being conducted, but won't think to address the issue of foods being turned into "drugs" unless you complain. They are making massive changes in your health products industry. One letter is distributed to 12 M.P.s on the committee from both sides of the House. Send it c/o Pierre Rodrigue, Clerk, House of Commons Health Committee, 180 Wellington St. rm 604, Ottawa Ont. KIA OA6 (postage free). Call 613-947-6728/fax 996-1626 to get a list of members or to appear before a committee. Send Checks to Freedom of Choice in Health Care located at 5863 Willow St., Ste. 711, Willowdale, Ontario M2-1J8. In Ontario call 416-282-6496, FAX 2434. BC: 604-685-7835. In Alberta: 403-653-3336, or 403-468-0950, Manitoba: 204-222-8823. The Health Action Network Society in B.C. has announced their next Public Forum to be June 1, 1997 at the Hyatt Hotel in Vancouver. Speaking will be Dr. Michelle Brille- Edwards, ex HPB, who quit because of manipulation by the pharmaceutical industry, and Suzanne Harris, JD, of the Law Loft, Johnstown, CO- a multi disciplinary think tank which has studied the Codex international threat to health freedom and was the first to call this problem to people's attention. HANS also sells a video from the Public Forum With Dr. Zoltan Rona (Debate between proponents of the "Foods are Not Drugs Amendment" (who favor suing HPB) and proponents of a "third" or nutraceutical category for herbs and other natural products.) I popped out of the crowd to denounce the pharmaceutically sponsored vitamin companies which had silenced me. Cost: $17. + pst in Canada, ($3. Shipping) (Foreign orders add $7. Surface Rate, $10. Air Rate.) 604-435-0512, FAX 604-435-1561, firstname.lastname@example.org, http://www.hans.org
In the US we must beware of efforts to create an over the counter (OTC) drug category for herbs and botanicals. Such an effort is being spearheaded now by National Nutritional Foods Association, Utah Natural Products Alliance, and American Herbal Products Association. An OTC category would be a slippery slope to oblivion for the industry and is another form of Codex harmonization, just like the Canadian "third category."
JB Cordaro of the Council for Responsible Nutrition stated the following concern with regards to an OTC drug category for herbs and botanicals: "We urge the Commission not to blur the food-drug line, a distinction that CRN and others have worked for years to develop. We vigorously oppose any recommendations that require preclearance or review of labels and label copy." A debate on this subject between Loren Israelson and JB Cordaro would help consumers to better understand this issue. Consumers have both a right, and a responsibility, to participate in this debate because the availability and afford ability of natural products hangs in the balance.
The medicines control act of 1968 exempted many widely used herbal remedies from licensing. Although consumer outrage prevented the Department of Health's Medicine Control Council from harmonizing the Act with E.C. Directives that would have removed licensing exemption, it is not known whether the European Commission will accept this decision. Medicines Directive 65/65/EEC imposes full medical licensing on any dietary supplement on which claims are made. (Any vitamin or mineral above approximately 1.5 times the RDA will be placed under 65/65/EEC.) The Medicines Control Council can't consider soft licensing, even if it wanted to, otherwise the UK government would risk being prosecuted and fined by the European Court of Justice whose task it is to enforce European treaty and directive obligations.
The Single European Act and the European Communities Act seem to quash all debate on the subject, and removes all statutory obligations to consult interested parties.
Major Gordon Smith of the Maperton Trust has urged consumers to write letters protesting this to members of parliament, along with protests against Codex harmonization which threatens to reduce nutritional supplements to the European Union's RDA's (Vitamin C- 60mg, B complex with no more than 1.4 mg of B1 and 2 mg of B6, instead of the optimum amounts of these nutrients.
In a letter dated March 6, 1977, Dr. Dorian Kennedy from the Consumers & Nutrition Policy Division of the Ministry of Agriculture, Fisheries and Food wrote to Greg Branford that although there are no current proposals for European wide restrictions on dietary supplements "there is concern that differences in the controls on dietary supplements within the European Community are causing trade difficulties and that the EU Commission is planning to issue a discussion paper on the possible harmonization of such controls." The Commission has been appraised of the UK's views that the sale of dietary supplements should only be restricted on grounds of safety. Kennedy stated that although Codex standards are advisory, "they are increasingly used as a basis for settling trade disputes." Kennedy made no mention of the fact that the UK and other opponents of the German proposal were heavily outvoted in October, 1996, and didn't say a word about the threat of the German proposal being finalized in September of 1998. His letter seems very similar to similar letters written by American Congressmen, and Canadian members of parliament in that it seems designed to lull the reader into a false sense of security.
In Nutrition Therapy Today, (newsletter or the Society for the Promotion of Nutritional Therapy) Vol 7, No. 1, they state that the Department of Health's Committee on Toxicity has recommended that vitamin B-6 supplements with a potency of more than 10 mg should be banned. The advice was accepted by MAFF's Food Advisory Committee, which issued a press release on December 19, 1996 announcing that prolonged high intakes of B-6 could cause nerve damage. Responding during a comments period, SPNT replied immediately to the Dept. of Health with studies refuting the assertion, finding 20 references which regulators had missed. SPNT issued a press release asking why the government issued its release on B-6 based on incorrect information, whether or not they would be issuing reassurance to consumers that B-6 does not in fact put consumers at risk of nerve damage from products currently on the market, when taken in accordance with manufacturers instructions. SPNT was to meet with government officials in March to discuss these issues further.
For more information contact: Major Gordon Smith, Maperton Stud, Wincanton, Somerset, RA9 8EH UK 01963 32651/FAX +44 (0) 1963 32626. Linda Lazerides, Society for the Promotion of Nutritional Therapy, PO Box 47, Heathfield, East Sussex, UK TN21 8ZX, Tel. 01435 867007, email: email@example.com
In New Zealand, reports are coming in from Janice Priest, editor of Healthy Options magazine that although melatonin has been banned, the grass roots is doing a good job of repelling Australian efforts to force Kiwis to harmonize New Zealand's laws with Australia's. A high official from the Australian Therapeutic Goods Administration went to Canada, New Zealand, South Africa, and possibly other countries to give the regulators the software used for DIN numbers in Australia.
Acting under the 1981 Medicines Act, the New Zealand Dept. of Health has begun to restrict dietary supplements as well as the information you can receive about them. Even if a product works and independent studies confirm it, the Health Department Compliance Division under Peter Pratt has been threatening media who accept advertising from herbal and vitamin companies. Section 28 of the Act states that a herbal remedy may be manufactured and sold, but only "without any written recommendation (whether by means of a labeled container or package or leaflet or in any way as to the use of the remedy." For more information send email to firstname.lastname@example.org, or call (07)577-6085, fax (07)578-5120
Last November the Medicines Control Council (MCC) announced its intention to regulate all natural health substances as medicines. Just as in Canada and the United States, the vitamin trade association (Health Products Association) is being dominated by the larger natural pharmaceutical companies. The same kind of "DIN" registration scheme forced on natural products in Canada is being used in South Africa.
Clive Buirski reported by email that Customs had seized his entire shipment of vitamins which he was distributing to 15 alternative physicians who were getting great results with them. In an article titled "Medicines Control or Conspiracy" Buirski challenged Prof. Falb, MCC Director to a public debate at the City Hall in Capetown, but the challenge was never accepted. The MCC's detention of Buirski's products put many lives at risk, yet complaints from patients and doctors fell on deaf ears and Buirski was driven out of South Africa. He now lives in California.
Stuart Thomson, Director of the Gaia Research Institute in Knysna has formed a coalition called PHARMAPACT which stands for People's Health Alliance Rejecting Medical Authoritarianism, Prejudice and Conspiratorial Tyranny.
Thompson reports that the MCC has been working closely with South African customs to seize shipments of imported vitamins mostly coming from the US and the UK. The MCC then attempts to coerce these companies into accepting their agenda. Those who sell out and work with the MCC get their seized products back and have an edge over competitors. Thomson reports that the MCC is being aided by the Complementary Medicines Committee, which is under the direct control of MCC.
PHARMAPACT is supporting the legal challenge of the Reitzer Pharmaceutical Constitutional Court application, which is awaiting a Judge's decision. MCC's hands are at least partially tied, pending a decision. They are filing submissions to document MCC harassment with the Public Protector, which will become part of the Protectors report to Parliament. Just as in Canada and the United States, PHARMAPACT has identified a number of vitamin companies who have sold out and are working hand in glove with the MCC. Some PHARMAPACT members who have been forced to cease trading, or who badly need supplements for medical reasons have banded together in a class action lawsuit, and there needs to be communication about this with Freedom of Choice in Health Care in Canada which is actively launching a similar suit right now.
South Africa has a new Constitution, and Thomson is demanding protection under it, stating that bias in favor of the pharmaceutical industry against natural products and traditional African remedies is in conflict with Section 8 of the Constitution, the Equality Clause, which forbids discrimination on a basis of culture. Thomson can be reached at Gaia Research Institute, P.O. Box 2147, Knysna, South Africa, 6570. Tel. 04457-7765/FAX 7695.
On August 2, 1996 the King of Spain issued a Royal Decree banning all advertising on natural products. They can be sold, but not advertised by any means. In Spain, it is not even legal to use the word "natural" or to make non promotional truthful statements about the benefits of dietary supplements. This heavily infringes on people's God given right to free speech. (Ministerio De Sanidad y Consumo 18085 Real Decreto 1907/1996.) A class action lawsuit is being spearheaded in Spain. Manuel Tevar, Life Extension Foundation distributor to Spain told me that the pharmacists are attempting to take over the natural products industry in Spain. For more information contact: D. Jaime Sanchez-Monero y Fillol Tel and Fax: (H) 00-34-1-632-01-80, (W) 00-34-1-580-08-27, FAX 00-34-1-531-32-43
Einar Thorstein reports from Iceland that he has founded HEISUFRELSI (Medical Freedom in Iceland) to oppose the same highly restrictive bans on supplement that exist in all the Nordic countries where you can't buy supplements much above RDA levels and many supplements aren't available at all. Alternative medicine is under attack. Upon last contact, Thorstein was hard at work writing a 300 page book: A Question of LIFE, to be used in their political battle. Thorstein has been in touch with Berkley Bedell in the United States in order to learn about the Access to Medical Treatments Act which is currently pending (HR 746, S. 578). He can be reached at +3545 668 333, email email@example.com Mailing Address: HEISUFRELSI P.O. Box 62, IS 121 Reykjavik, Iceland.
Vance Lannaman of Fit for Life Ltd. reports that the Pharmaceutical Services Division of the Ministry of Health is set to take action against Health-Pro Jamaica Ltd., a promoter of pycnogenol who has been advertising its benefits as a powerful antioxidant.
The company is being charged with violating the Food and Drugs Regulation of 1974 which requires that all drugs or supplements, whether they be registered, over the counter, or prescription should be approved by the Pharmaceutical Services Division. In addition, all advertising is required to be approved by the Ministry before being placed with the media.
Lanneman and others have met with the Minister of Health in hopes of rectifying this situation, and are awaiting his decision. If it does not help, they plan to sue the Ministry of Health. For more information, Vance Lannaman, Fit for Life Ltd., 8 South Ave. Kingston 10, Jamaica, W.I. 809-960-3447, FAX 809-937-7256.
The urgency of the Canadian, South African, and New Zealand situations can't be overemphasized. People are already dying for lack of nutrients and need our help. If health freedom falls in Canada, South Africa, New Zealand and other countries we won't be able to keep it from falling in the United States. The medical industrial complex is attempting to take health freedom all over the world in an effort to isolate the United States. Discuss this problem with your elected officials and demand that your country pull out of the UN immediately. Report the human rights abuses discussed in this article to: Human Rights Watch/Helsinki 212-972-8400, FAX 0905, email firstname.lastname@example.org
On December 4, 1996, PharmaPrint Inc. of Irvine, California announced the world's first patent on a complex herbal molecule. (PR Newswire). The publicly traded company has the direct backing of the World Health Organization and has developed a process which can identify the active compounds of multi-molecules in herbs making it possible to standardize herbal medicines. PharmaPrint has announced efforts to create pharmaceutical versions of three of the most commonly traded herbs: Saw Palmetto, which will be patented to treat enlarged prostates; Ginger, to be patented for motion sickness; and St.John's Wort, to be patented for moderate and mild forms of depression.
According to Business Wire, which released this story in early February, PharmaPrint is targeting these herbs first because they have already been tested on humans in Europe and are considered safe and effective. PharmaPrint has already been licensing other pharmaceutical companies to use their patented technology.
The question we should all be asking is do we REALLY need to spend millions patenting these natural products and running them through clinical drug trials? Won't this make them a lot more expensive? Won't companies like PharmaPrint try to protect their investments by trying to get Good Manufacturing Practices raised to such extremes that their small competitors wouldn't be able to compete with them? Shouldn't herb companies band together to challenge PharmaPrint's patents?
In the Federal Register, Vol. 62, No. 25/February 6, 1997 the US FDA has announced an Advance notice of proposed rulemaking on the creation of new Good Manufacturing Practices as mandated by the passage of the Dietary Supplement Health and Education Act of 1994. The purpose of these proposed GMPs is to drive small manufacturers out of business, allowing the big companies like PharmaPrint to move in and dominate. Public comments are being solicited now, and the FDA will be coming out with proposed rules which must be strenuously opposed. While carefully considered GMPs are desirable, the FDA is proposing GMPs which constitute bureaucratic overkill. No small company would be able to afford the costs of compliance. This is Codex harmonization, just as it has been occurring in Canada, and Australia. Are we willing to just sit back and allow the pharmaceutical industry to get away with this scam? In September, 1998, the next Codex meeting of the Committee on Nutrition and Foods for Special Dietary Use will be held in Bonn, Germany. In the last meeting, the draconian German Codex proposal easily advanced from step 3 to step 5. It could easily be driven through to finalization at step 8 unless enough countries oppose it. The Canadian negative list proposal for herbs has been handed to a so called "panel of experts." Will the international consuming public have a voice in these proceedings? Will consumers around the world be able to unite fast enough to stop these pharmaceutical efforts to dominate the natural products industry?
With your generous donations I will be able to keep carrying my public health message to the world, hopefully in time to save health freedom. I started International Advocates for Health Freedom in order to rapidly educate consumers world wide and to assist groups in fighting back by linking the international health movement together. I badly need to be able to hire at least one full time helper. I am writing articles for publication world wide, and am doing a lot of public speaking both live and by radio and TV. I have a new website and fax on demand server. I need donations to travel to the Codex meeting in Geneva, June 23-28 and I need to be able to travel to those countries which were with us in opposition to the German Codex proposal prior to the next meeting of the Codex Committee on Nutrition and Foods for Special Dietary Use which is September, 1998 in Bonn Germany.
Please send your most generous donation made out to:
"International Advocates for Health Freedom"
John Hammell, 2411 Monroe St. #2, Hollywood, FL 33020, USA.
For more information: Fax on Demand: 954-927-8795,
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