Guest guest Posted February 17, 2004 Report Share Posted February 17, 2004 Hi All, & Hi Richard, Richard, may I have your permission to cross-post this to the CHA & VBMA Lists? The topic of adequate specification and labelling of herbal formulas is ongoing there also. I have argued that the labels of all CHM formulas [indeed, all medicines and health supplements] should display the % of all raw ingredients used. I did not include " fillers (starch, etc) in my original note, but I include it here. Richard replied: > Hi Phil Many would tell us that CHM cannot or should not post > percentages of ingredients - to which I also disagree. After > working closely with Prof. Dr. Wu, Boping especially on several > 'one size fits most' templated formulations (such as Gan Su Pian > (any type of cold/flu), Chang Ji Re Pian (IBS/IBD), Yang Gan Xi > Feng Pian (yang rising, yin def syndromes)......it is pure nonsense > to hide. I understand the economic rationale to keep formulations > secret but any CH herbalist worth their salt doesn't worry about > that and can easily figure out percentages. In many of the better > CM herb books we will find formulations and their percentages and > then the better books list the modification potentials. Richard, I hope that most herbalists, especially the teachers and policy-makers on these lists, will note your comments and ACT to ensure proper labelling! IMO, the label on ALL medicines and supplements should state clearly the % of EVERY raw ingredient in the medicine, preferably on a " dry matter " basis. Some colleagues argue that specific labelling is not necessary because " experienced herbalists " can work out the percentage of ingredients for themselves. Others say that specific labelling may be dangerous because it may encourage patients to self-prescribe and get their medications in Chinatown or from WWW. IMO, those arguments are simply NOT good enough. Failure to label medicines & supplements adequately just gives ammunition to the enemies of TCM, esp the FDA and the EU Medicines' Boards. Our use of inadequately specified medicines is further " proof " to them that we practise unethically and unscientifically by not knowing precisely what we are administering to our patients. Richard also wrote: > As to what the FDA is up-to with their recent presentation of their > final promulgation of administrative code ban on ephedrine > alkaloids as diestary supplements ...THIS IS the 'end run' game > plan to go after the removal of ALL herbs from the market place. A > high ranking official at the FDA told AOMNC directly (in no > uncertain terms) that all acupuncturists utilziing herbs to treat > illnesses are using ILLEGAL DRUGS contrary to the US Federal Food > & Drug Act's definition of 'drug'. And he is correct as it stands. > The only reason they are not coming after acupuncturists NOW has to > do with limited funding. But make NO MISTAKE that is within their > future plans. Federal law trumps state law. It makes no difference > what some states have said in their laws regarding scopes of > practice. When [the FDA] get around to it ...we are already > defeated UNLESS ... That is why nationally and internationally we > MUST call for and demand legislative exemptions by an Act of > Congress (in the US). > So what is the profession doing besides sitting on it's thumbs and > twiddling? Not very much. Since this is the status quo and sad > state of affairs. I am already working on filing an Administrative > challenge AGAINST the FDA's rule and if I have to do it 'pro se' > ...so be it. Richard Although THIS particular battle is within the USA, we in the EU and other non-oriental states can only applaud your efforts. The Medicines' Boards outside of USA will note very carefully what happens in USA [especially if the FDA can be defeated in Court]. What frustrates the hell out of me is the relative sacrcity of high- quality scientific papers to confirm the clinical benefits of herbal medicine. In that regard, you might consider the following tactics in your fight with FDA: 1. Document (at least with some specific examples) the iatrogenic effects of some " currently accepted " allopathic medicines and therapeutic and surgical procedures. Take some specific examples from the following list: (a) risky drugs (cytotoxic chemotherapy, longterm use of steroids, NSAIDs, sedatives, etc) (b) risky diagnostic methods (certain biopsies, invasive myelography, etc), © cytotoxic radiotherapy; (d) risky surgical procedures, expecially those for which there are not very sound data to support their use in terms of clinical success and prolonged survival times, etc, 2. Argue for a " Level Playing-field " and the elimination of blatant discrimination against TCM. If FDA allows allopathic doctors to use very risky drugs, diagnostic methods, radiotherapy, or inadequately-supported surgical procedures, they MUST also allow properly trained OMDs, NDs, herbalists, acupuncturists etc to use THEIR professional judgement on the most appropriate remedies to use in their patients. 3. Argue that most if not all the " documented " adverse effects of CHMs / Chinese supplements were because of OTC (non- professionally prescribed) use, and that the effects in most cases involved INTERACTION with other (allopathic) drugs in patients with already compromised LV, KI or HT function. Also, argue that car accidents and abuse of alcohol kill more people every year than CHM. Will the FDA be logical and ban the use of cars and alcohol in USA? 4. Contact Tim Bolen <jurimed2, or find his Newsletter by searching Google for the phrase " Millions of Health Freedom Fighters " . Some may find Mr. Bolen's methods distasteful because of his (IMO) unnecessarily personal insults and attacks (in public) on his perceived " enemies " . However, he has some great contacts and is having some success in tackling " Quackbusters " in Court. I wish you every success in this battle. If there you need any specific literature research to help your case, let me know. I have access to several professional abstracts databases and will do what I can to help you. Best regards, Email: < WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland Mobile: 353-; [in the Republic: 0] HOME : 1 Esker Lawns, Lucan, Dublin, Ireland Tel : 353-; [in the Republic: 0] WWW : http://homepage.eircom.net/~progers/searchap.htm Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 17, 2004 Report Share Posted February 17, 2004 I'm chiming in a little late on this thread, but why the percentage of ingredients. Why not in mgs???? Virtually all supplements are already list ingredients in mgs. I believe it will be a better idea to conform our standards to what is already out there. Less confusion. IF you insist we label our stuff. Go for mgs. Please. Chris In a message dated 2/17/2004 1:25:38 AM Eastern Standard Time, writes: I have argued that the labels of all CHM formulas [indeed, all medicines and health supplements] should display the % of all raw ingredients used. I did not include " fillers (starch, etc) in my original note, but I include it here. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 19, 2004 Report Share Posted February 19, 2004 This is a critical paragraph with importance that seems to be overlooked. Question,,,,,,, Do we treat illness, or treat imbalances and symptoms??????? In talking to a homeopathic manufacture the other day, there is a clear line that his company must follow to be within the law. They treat the symptoms of " ________ " . They don't treat any illness. I will suggest that according to TCM diagnosis, we don't treat illness either. IF we are very clear about this distinction, we will be within the law. Start treating disease, and we are using drugs. Very bad situation to be in. Another question is,,, can the herbs be considered a part of the diet according to the Chinese??? Many of the " herbs " are plants that we would naturally find in a wide and varied diet. The foods we eat affect how the meridians balance themselves within our bodies. So do the concentrated food called herbs. What is the legal difference? Only the desire of treating disease. I believe we must understand what the law states, and see how we fit under the law. This would take the impetus away from the FDA to stop the illegal drug pushing Acupuncturists. The next step, is to guarantee our rights to practice with specific legislation. If the FDA see us as Druggists, we stand a chance in hell of getting our agenda through. Using food preparations and concentrations of food preparations, to rebalance meridians, is going to be the simplest safest path for our right to practice. Chris In a message dated 2/19/2004 7:46:01 AM Eastern Standard Time, writes: A high ranking official at the FDA told AOMNC directly (in no uncertain terms) that all acupuncturists utilziing herbs to treat illnesses are using ILLEGAL DRUGS contrary to the US FDA's definition of 'drug'. And he is correct as it stands. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 19, 2004 Report Share Posted February 19, 2004 Hi All, Richard Freiberg [ http://www.aomnc.com ] is a very experienced practitioner of TCM. He is looking for allies in a campaign to get the FDA to approach TCM fairly and without prejudice. I have Richard's permission to post an edited version of his note on labelling of herbal medicines and his belief that the FDA is entering the " end-game " in clamping down heavily on CHM (and other non- mainstream therapies). Here are some of his points (and my replies) from the TCM List. I had written: I have argued that the labels of all CHM formulas [indeed, all medicines and health supplements] should display the % of all raw ingredients used. I did not include " fillers (starch, etc) in my original note, but I include it here. Richard replied: Hi Phil, Many would tell us that CHM cannot or should not post percentages of ingredients. Like you, I disagree with that view. After working closely with Prof. Dr. Wu, Boping especially on several 'one size fits most' templated formulations (such as Gan Su Pian (any type of cold/flu), Chang Ji Re Pian (IBS/IBD), Yang Gan Xi Feng Pian (yang rising, yin def syndromes). It is pure nonsense to hide the percentages of herbal ingredients. I understand the economic reasons to keep formulations secret but any CH herbalist worth their salt doesn't worry about that and can easily figure out percentages. In many of the better CM herb books we will find formulations and their percentages and then the better books list the modification potentials. [Phil replied]: Richard, I hope that most herbalists, especially the teachers and policy-makers on these lists, will note your comments and ACT to ensure proper labelling! IMO, the label on ALL medicines and supplements should state clearly the % of EVERY raw ingredient in the medicine, preferably on a " dry matter " basis. Better still, as remarked by Chris and others, the specification should include the daily doseof the formula (in grams (g)), PLUS the daily dose (in mg dry metter) of every raw herb or ingredient in a formula, PLUS the amounts of binder/filler per standard dose. Some colleagues argue that specific labelling is not necessary because " experienced herbalists " can work out the percentage of ingredients for themselves. Others say that specific labelling may be dangerous because it may encourage patients to self-prescribe and get their medications in Chinatown or from WWW. IMO, those arguments are simply NOT good enough. Failure to label medicines & supplements adequately just gives ammunition to the enemies of TCM, esp the FDA and the EU Medicines' Boards. Our use of inadequately specified medicines is further " proof " to them that we practise unethically and unscientifically by not knowing precisely what we are administering to our patients. [Richard again]: As to what the FDA is up-to with their recent presentation of their final promulgation of administrative code ban on ephedrine alkaloids as diestary supplements ...THIS IS the 'end run' game plan to go after the removal of ALL herbs from the market place. A high ranking official at the FDA told AOMNC directly (in no uncertain terms) that all acupuncturists utilziing herbs to treat illnesses are using ILLEGAL DRUGS contrary to the US FDA's definition of 'drug'. And he is correct as it stands. The only reason that the FDA is not coming after acupuncturists NOW has to do with limited funding. But make NO MISTAKE that is within their future plans. Federal law trumps state law. It makes no difference what some states have said in their laws regarding scopes of practice. When [the FDA] get around to it ...we are already defeated UNLESS ... That is why nationally and internationally we MUST call for and demand legislative exemptions by an Act of Congress (in the US). Richard then goes on to give a WAKE-UP call to he whole TCM profession in the USA; that wake-up call also aplies to EU professionals, because I suspect that the EU has similar plans to crackdown on herbs, homeopathics and other non-mainstream therapies. [He wrote]: So what is the profession doing besides sitting on it's thumbs and twiddling? Not very much. Since this is the status quo and sad state of affairs. I am already working on filing an Administrative challenge AGAINST the FDA's rule and if I have to do it 'pro se' ...so be it. Richard [Phil again]: Although THIS particular battle is within the USA, we in the EU and other non-oriental states can only applaud your efforts. The Medicines' Boards outside of USA will note very carefully what happens in USA [especially if the FDA can be defeated in Court]. What frustrates the hell out of me is the relative scarcity of high- quality scientific papers to confirm the clinical benefits of herbal medicine. In that regard, you might consider the following tactics in your fight with FDA: 1. Document (at least with some specific examples) the iatrogenic effects of some " currently accepted " allopathic medicines and therapeutic and surgical procedures. Take some specific examples from the following list: (a) risky drugs (cytotoxic chemotherapy, longterm use of steroids, NSAIDs, sedatives, etc) (b) risky diagnostic methods (certain biopsies, invasive myelography, etc), © cytotoxic radiotherapy; (d) risky surgical procedures, expecially those for which there are not very sound data to support their use in terms of clinical success and prolonged survival times, etc, 2. Argue for a " Level Playing-field " and the elimination of blatant discrimination against TCM. If FDA allows allopathic doctors to use very risky drugs, diagnostic methods, radiotherapy, or inadequately-supported surgical procedures, they MUST also allow properly trained OMDs, NDs, herbalists, acupuncturists etc to use THEIR professional judgement on the most appropriate remedies to use in their patients. 3. Argue that most if not all the " documented " adverse effects of CHMs / Chinese supplements were because of OTC (non- professionally prescribed) use, and that the effects in most cases involved INTERACTION with other (allopathic) drugs in patients with already compromised LV, KI or HT function. Also, argue that car accidents and abuse of alcohol kill more people every year than CHM. Will the FDA be logical and ban the use of cars and alcohol in USA? 4. Contact Tim Bolen <jurimed2, or find his Newsletter by searching Google for the phrase " Millions of Health Freedom Fighters " . Some may find Mr. Bolen's methods distasteful because of his (IMO) unnecessarily personal insults and attacks (in public) on his perceived " enemies " . However, he has some great contacts and is having some success in tackling " Quackbusters " in Court. I wish you every success in this battle. If there you need any specific literature research to help your case, let me know. I have access to several professional abstracts databases and will do what I can to help you. Colleagues, I urge you all to heed Richard's WAKE-UP call. I know that many of you are already active in the political area, but I feel that many also have their " heads in the sand " and expect that the FDA will stop hassling herbal medicine when it bans a few more herbs. Unfortunately an ostrich with its head in the sand leaves its butt in the air, an easy target for a steel-capped boot! US colleagues may make their voices heard by joining AOMNC [ http://www.aomnc.com ], by lobbying their political representatives, and by cooperating with those, like Richard, who may need moral support, research papers, literature searches, etc in preparation for more direct dialogue with the FDA. What are EU colleagues doing re the EU Medicines Boards? I suspect that most are (as in my case) acting like ostriches also. I'm an old-timer now and I dislike most committee work and political matters. But can I encourage some of the younger members on the lists to become actively involved in the political issues? If you do not do so (and quickly), you may find yourselves retraining to join a different profession in the future. The TCM that WE value will be so emasculated, straight-jacketed and hog-tied in red-tape that it will be gone in a few decades if we do not act now. Best regards, Email: < WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland Mobile: 353-; [in the Republic: 0] HOME : 1 Esker Lawns, Lucan, Dublin, Ireland Tel : 353-; [in the Republic: 0] WWW : http://homepage.eircom.net/~progers/searchap.htm Quote Link to comment Share on other sites More sharing options...
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