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Alan Richman, Editor
Whole Foods Magazine
Box 3000, Denville, New Jersey
Fax 908-769-1171
email user 886276@aol.com
7/27/97
To the Editor:
In the August issue on p.12 in your Newslinks Section, under the header "Presidential Commission Issues Proposals" you correctly state that the draft report of the Commission on Dietary Supplement Labels may lead to extensive revisions in the regulations governing nutritional support and therapy, that it strongly advocates the barrier of "significant scientific agreement" with regards to these claims, and that it makes numerous safety recommendations.
You also correctly state that it makes its most sweeping suggestions in the area of herbal products, opening the door to the creation of an OTC drug category for herbs, while also urging that a study be implemented to determine whether herbal remedies should be placed in a whole new category- neither OTC medicine nor dietary supplement- which would carry its own efficacy standards. You state that such herbal review systems already are part of the regulatory machinery in other nations, including Germany, France, and Canada.
I maintain that the Commission on Dietary Supplement Labels (CDSL) is pushing Codex harmonization inside the United States, and that consumers should strongly oppose both a move to an OTC drug category as well as any move towards a "neither foods nor drugs" (a so called "nutraceutical" category, because if we don't oppose these efforts, health freedom will be destroyed in the US much as it has been in the Nordic countries, Australia, Canada, and as they're attempting to do now in the UK where a massive push is occurring to limit consumer access to vitamin B-6 to just 10 mg, despite the best efforts of groups such as CRN to present the British government with reams of safety data attesting to the safety of B-6.
The real problem American consumers are facing here is the greed of a small number of manufacturers who see megabucks to be made if they can only create an OTC drug category. These manufacturers control NNFA, UNPA, and AHPA-- to the detriment of consumers.
We worked very hard to create a foods definition for dietary supplements and herbs via DSHEA, and it hardly makes any sense to now blur the boundaries between foods and drugs by pushing for either an OTC drug category or a so called "third" or "neither food nor drugs" category. At the top of the food chain, this push is coming from the pharmaceutical industry, which has been trying for years to take over and dominate the dietary supplement industry, and consumers had better wake up to what is going on or it will soon be too late to act.
In Canada, this has become painfully apparent to consumers who are pushing hard for a "foods are not drugs" amendment, while they have simultaneously filed two lawsuits against the so called "Health Protection Branch" to protest an overly broad definition of what constitutes a drug (fish oil capsules, hawthorne berry capsules, and cranberry capsules are all illegal to sell in Canada because no one has been willing to spend the $10-$20,000 necessary to attempt to get a so called "Drug Identification Number" approved on these products, and unless a "DIN" is approved, and manufacturers and distributors pay an additional DIN registration fee of $720. Per product, it is illegal to sell them.
Is this sort of nonsense currently being pushed on Americans via new GMPs, and via FDA rulemaking soon to result from the Commission on Dietary Supplement Labels Final Report? Will we soon see a legislative push to create to create a "Drug Identification Numbering System" currently being used to strangle health freedom in Australia and Canada? Unfortunately, this seems to be the case as the large, pharmaceutically owned/connected vitamin companies gear up to sweep their smaller competition off a cliff, just as has already happened in Scandinavia, Australia, and is happening with increasing speed in Canada and in many other countries.
When we tried to introduce a Senate companion bill to HR 1951 (Food and Dietary Supplement Consumer Act), our efforts were actively blocked on Capital Hill by NNFA's lobbyists.
Why? The reason should be obvious. Elements within NNFA actually WANT dietary supplements to be regulated as drugs, because they are greedy and don't really give a damn about consumers. Consumers around the world had better wake up, and take a much closer look at what is going on so that we can band together to fight for OUR rights.
In the FDA website (http://www.fda.gov/ola/319.htm) under number 6 "FDA and the Global Marketplace: International Harmonization" they freely state their intention to "harmonize" their regulations with emerging international reference standards (They don't discuss the draconian German proposal which threatens to limit consumer access to only RDA level products.)
FDA's seemingly innocuous announcement should be viewed against the backdrop of their June 2 proposal for rulemaking on dosage limits on the herb ma huang, which is a natural form of ephedrine. In a desperate effort to attack the natural products industry in the aftermath of the passage of DSHEA, the FDA is proposing that a double standard be created which would block the use of ma huang as a weight loss product, while favoring the far more dangerous, synthetic forms of ephedrine, as well as such dangerous prescription drugs as dexfenfluouramine. FDA is proposing only allowing a 24 mg daily intake of ma huang/ephedra, while for years they've allowed a maximum daily intake of 150 mg of synthetic ephedrine drug products, including children's cough syrup which can be bought by anyone, of any age, in the local neighborhood supermarket, despite numerous peer reviewed incidents of death caused by ephedrine and pseudoephedrine.
In a sworn affidavit, Miloslav Nosal, M.Sc., Ph.D. a biostatistician, CEO of Statistical Consulting Co., Calgary, Alberta, Canada reviewed both the Canadian HPB and US FDA's positions against ephedra and found that a medline search on ephedra yielded 57 references. " A great majority of which gave detailed documentation of the significant beneficial effects of ephedra on human health. Not even one article documented human death caused by Ephedra (or even linked a death to its use.) Among the 57 references, there was only one negative report linking use of Ephedra with acute hepatitis. Even in this paper, the authors speculate that "the ma huang product our patient took contained some other ingredient or contaminant or was misidentified."
Nosal went on to state: "The complete lack of Ephedra as a cause of death in professional medical literature contrasts with the media release of Micheline Ho of Drugs Directorate, Health Protection Branch (HPB), Health Canada. For this reason, I asked Ms. Ho to provide me with factual evidence on which she based her statement. She stated that her claims are based on information she received from Michael Weintraub, Director of Drug Evaluation Section of the US FDA. Furthermore, she said that she does not have any specific evidence or any FDA reports documenting human death caused by ephedra. I asked Dr. Weintraub whether he could provide me with documents and reports related to Ms. Ho's claims. He said that his department does not have any documents providing such evidence. Instead, I was referred to Dr. Lori Love of the Food Section of FDA. Dr. Weintraub told me that the FDA held hearings related to Ephedra which linked the use of Ephedra containing compounds to about 17 causes of death. In addition he stated that the hearings did not clearly indicate the use of Ephedra as the actual cause of death.
He also said that none of this information was ever published in professional medical literature (for peer review and assessment of validity.) Subsequent discussions with Dr. Love yielded similar results. She stated that her department does not possess factual evidence or actual reports of death caused by Ephedra. She referred me to docket number 95N0304 accessible from the Freedom of Information Office (FOI) which contains some materials from the FDA hearings. Dr. Love clearly again emphasized that some negative effects of the Ephedra constituent Ephedrine, have been clearly documented in a number of cases but that it is "very, very, very difficult to attribute death uniquely to ephedrine use."
At present, I am attempting to obtain contents of the FOI docket on ephedra, but the response time of the office is very slow. At this time it appears to me that there is not any available factual or scientific evidence supporting the validity of Ms. Ho's claims regarding ephedra."
Nosal goes on to discuss the fact that there are numerous reports of death associated with synthetic ephedrine, and lists a number of freely available OTC drugs containing it, including Vick's cough syrup, and many others available on supermarket shelves, even to children. His affidavit is being used as part of two lawsuits filed against the Canadian so called "Health Protection Branch" by Freedom of Choice in Health Care of Toronto, Canada.
Additional information about the Codex International Threat to health freedom, and how consumers can band together to defend their rights can be found at http://www.pnc.com.au/~cafmr/hammell/index.html or retrieved by fax on demand via 954-927-8795.
For Health Freedom,
John C. Hammell, founder, IAHF
I continue to interact with true grassroots health freedom groups around the world, and feel that Americans are sound asleep on an issue which they need to be aware of. Americans had better wake up, and fast, or we will soon see health freedom destroyed here the same way Ron Birckhead saw it destroyed in Norway, the way John Lesso saw it destroyed in Australia, the way Greg Bramford is seeing it being destroyed in the UK, the way Debbie Anderson is seeing it destroyed in Canada, the way Stuart Thomson is seeing it destroyed in South Africa, and Vance Lanneman is seeing it happen in Jamaica. I am networking with all of these consumers, and more, around the world in an effort to defend our access to dietary supplements. Please join our effort to alert more people..
******************************************
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, jham@concentric.net
http://www.pnc.com.au/~cafmr/hammell/index.html
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