Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 http://www.fda.gov/oc/initiatives/ephedra/december2003/qa.html Chinese Herbs FAX: Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 Re: the below from the FDA comments. Does pinellia refer to Ban Xia here? Also, the reference to " traditional Chinese herbal remedies " does not specify who can prescribe these, or any restrictions on where one can purchase ephedra for these. Do you know anything more? Pat _________ " What types of products are subject to the rule? Dietary supplements that contain a source of ephedrine alkaloids, such as ephedra, Ma huang, Sida cordifolia, and pinellia. Are all products containing ephedra affected? Essentially all currently marketed dietary supplements will be affected by the rule. The rule does not pertain to traditional Chinese herbal remedies. It generally doesn't apply to products like herbal teas that are regulated as conventional foods. ============================================================================== NOTE: The information in this email is confidential and may be legally privileged. If you are not the intended recipient, you must not read, use or disseminate the information. Although this email and any attachments are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Cadwalader, Wickersham & Taft LLP for any loss or damage arising in any way from its use. ============================================================================== Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 In addition to pinellia , sida cordifolia/huang hua zi is also mentioned. I am not aware of any ephedra alkaloids in ban xia, I am investigating huang hua zi in the zhong yao da ci dian. It is entry # 4181 in that text. On Dec 30, 2003, at 9:59 AM, Pat Ethridge wrote: > > > Re: the below from the FDA comments. Does pinellia refer to Ban Xia > here? > > Also, the reference to " traditional Chinese herbal remedies " does not > specify who can prescribe these, or any restrictions on where one can > purchase ephedra for these. Do you know anything more? > > Pat Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 , " Pat Ethridge " <pat.ethridge@c...> wrote: > > > Re: the below from the FDA comments. Does pinellia refer to Ban Xia here? yes > > > Essentially all currently marketed dietary supplements will be affected by > the rule. The rule does not pertain to traditional Chinese herbal remedies. > It generally doesn't apply to products like herbal teas that are regulated > as conventional foods. it looks like there is an exemption for raw herb teas, but pills are probably considered supplements whether they are TCM or not, I think. probably granules, too. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 , " " wrote: > , " Pat Ethridge " <pat.ethridge@c...> > wrote: >>traditional Chinese herbal remedies. it all comes down to this. what does this term mean. the final rule will probaly have to define this term. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 > Are all products containing ephedra affected? The rule does not pertain to traditional Chinese herbal remedies. > It generally doesn't apply to products like herbal teas that are regulated > as conventional foods. What does that mean? does that exclude bulk or powdered formulas from the ban? fernando Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 From the FDA site http://www.fda.gov/oc/initiatives/ephedra/december2003/qa.html or just fda.gov _____________ What types of products are subject to the rule? Dietary supplements that contain a source of ephedrine alkaloids, such as ephedra, Ma huang, Sida cordifolia, and pinellia. Are all products containing ephedra affected? Essentially all currently marketed dietary supplements will be affected by the rule. The rule does not pertain to traditional Chinese herbal remedies. It generally doesn't apply to products like herbal teas that are regulated as conventional foods. ______________ I think if the California and/or national licenses will allow us the use (which I think it will) this ruling is good and pretty much what we wanted. It may take Er Chen Wan off the shelves at the local Co-op and hopefully they will rescind the ban xia part. I guess they are worried that people will " cook down " ban xia... good luck, but never underestimate the determination or overestimate the intelligence of some one on speed. Meanwhile, I'm gonna have my organic beef and wait till the FDA makes a ruling on THAT mess. doug Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 , " " wrote: It may take Er Chen Wan off > the shelves at the local Co-op and hopefully they will rescind the ban xia part. actually the rule is final. I talked to the FDA. ban xia is included and only an act of congress can change that now. apparently there was a long public comment period that has expired. er chen wan may also be removed from the shelves of our offices. the exemption does not appear to specify who can sell, but what can be sold and ban xia products thus may be banned. however this depends on the exact wording of the final rule which will be published in 2 weeks. but a dietary supplement is a dietary supplement regardless of where it is sold and FDA trumps CA law. if chinese prepared meds are dietary supplements, then er chen wan is totally banned. if they exhibit some ill defined exempt limbo land called traditional chinese remedies, great. But I doubt this is the case. sorry to be alarmist, but did anyone here make public comment on this matter. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 , " Fernando Bernall " <fbernall> wrote: > > Are all products containing ephedra affected? > The rule does not pertain to traditional Chinese herbal remedies. > > It generally doesn't apply to products like herbal teas that are > regulated > > as conventional foods. > > What does that mean? does that exclude bulk or powdered formulas from > the ban? > > fernando my guess is bulk exclusion, but powders are prepared products are subject to FDA labeling laws (unlike celery, for example). Basically, I think if the law already requires one of those nutritional labels on the product, then it falls under this rule. my bottle of KPC bai ji li purchased last month has such a label as required by law. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 Well, I think in a day or so we should be getting some clarification from the different organizations. I'll try to remain opitimistic.... I'm suspicious of the FDA but I don't see why the FDA would use this language unless they knew how and why we prescribe and leave us the ability to do so. Without this clause we would be totally ... fried. , " " wrote: > , " " wrote: > > It may take Er Chen Wan off > > the shelves at the local Co-op and hopefully they will rescind the ban xia part. > > actually the rule is final. I talked to the FDA. ban xia is included and only an act of > congress can change that now. apparently there was a long public comment period > that has expired. er chen wan may also be removed from the shelves of our offices. > the exemption does not appear to specify who can sell, but what can be sold and ban > xia products thus may be banned. however this depends on the exact wording of the > final rule which will be published in 2 weeks. but a dietary supplement is a dietary > supplement regardless of where it is sold and FDA trumps CA law. if chinese > prepared meds are dietary supplements, then er chen wan is totally banned. if they > exhibit some ill defined exempt limbo land called traditional chinese remedies, great. > But I doubt this is the case. sorry to be alarmist, but did anyone here make public > comment on this matter. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 Greetings, According to You Ping Zhu's materia medica, Ephedra sinica contains 0.487% - 1.382% total alkaloids, of which 55-78% represents ephedrine and 12-23% pseudoephedrine. E. equisetina yields 2.093-2.436% total alkaloids. By contrast, the same text reports that ban xia only contains 0.002% l-ephedrine. Stephen Tuesday, December 30, 2003 10:42 AM Re: more on fda , " Pat Ethridge " <pat.ethridge@c...> wrote: > > > Re: the below from the FDA comments. Does pinellia refer to Ban Xia here? yes > > > Essentially all currently marketed dietary supplements will be affected by > the rule. The rule does not pertain to traditional Chinese herbal remedies. > It generally doesn't apply to products like herbal teas that are regulated > as conventional foods. it looks like there is an exemption for raw herb teas, but pills are probably considered supplements whether they are TCM or not, I think. probably granules, too. Chinese Herbal Medicine offers various professional services, including board approved continuing education classes, an annual conference and a free discussion forum in Chinese Herbal Medicine. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 , " " wrote: > , " " wrote: > > It may take Er Chen Wan off > > the shelves at the local Co-op and hopefully they will rescind the ban xia part. > > actually the rule is final. I talked to the FDA. ban xia is included and only an act of > congress can change that now. I just spoke with Mayway. They say that they have not been contacted regarding their sales of Ma Huang or Ban xia. The issue was brought up about the use of processed Ban Xia. They felt that it was ok to use because it was processed. Not sure how processing would rid the herb of ephedrine alkaloids. fernando Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 Todd: I have to disagree. >The rule does not pertain to traditional Chinese herbal remedies. It generally doesn't apply to products like herbal teas that are regulated as conventional foods.> The last time I looked er chen wan was a traditional Chinese herbal remedy. This sounds very much like the New York law. The subtext here is that they recognize that we are here and acknowledege our responsible use of herbs. Thus could be good news. Warren In , " " wrote: > , " Fernando Bernall " <fbernall> > wrote: > > > Are all products containing ephedra affected? > > The rule does not pertain to traditional Chinese herbal remedies. > > > It generally doesn't apply to products like herbal teas that are > > regulated > > > as conventional foods. > > > > What does that mean? does that exclude bulk or powdered formulas from > > the ban? > > > > fernando > > my guess is bulk exclusion, but powders are prepared products are subject to FDA > labeling laws (unlike celery, for example). Basically, I think if the law already requires > one of those nutritional labels on the product, then it falls under this rule. my bottle > of KPC bai ji li purchased last month has such a label as required by law. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 , " Fernando Bernall " <fbernall> wrote: > > I just spoke with Mayway. They say that they have not been contacted > regarding their sales of Ma Huang or Ban xia. they should check their mail in the next few days The issue was brought > up about the use of processed Ban Xia. They felt that it was ok to > use because it was processed. Not sure how processing would rid the > herb of ephedrine alkaloids. incorrect, according to Dharmananda, processing does not remove the ephedrines, but other unknown irritants. The FDA lists pinellia as banned on their own website. this is not hearsay. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 , " wsheir " <wsheir> wrote: > > The last time I looked er chen wan was a traditional Chinese herbal > remedy. This sounds very much like the New York law. The subtext > here is that they recognize that we are here and acknowledege our > responsible use of herbs. Thus could be good news. The NY law exempts a type of practitioner, not a type of substance. This is something altogether different. There is no practitioner exemption in this law. Have you spoken with the FDA? I have. They say this rule does not exempt prepared products containing chinese herbs, only chinese herb teas made from raw materials. But feel free to check with them yourself. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 >> I just spoke with Mayway. They say that they have not been contacted >> regarding their sales of Ma Huang or Ban xia. >> > they should check their mail in the next few days > None of our herbal suppliers are listed as having been sent the letter on the FDA's ephedra website. http://www.fda.gov/oc/initiatives/ephedra/december2003/letterslist.html The main FDA ephedra page is http://www.fda.gov/oc/initiatives/ephedra/december2003/default.htm Hopefully they will draft an intelligently worded rule. Chances are that they will have to revise it before too long anyway as the diet pill manufacturers will undoubtedly bring a lawsuit. Maybe by then we can lobby to have it modeled after the NY law. Judy Saxe, L.Ac. -- QingTing Acupuncture & Chinese Herbal Medicine Denver, Colorado 303-964-1996 http://www.QingTingAcupuncture.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 31, 2003 Report Share Posted December 31, 2003 , Judy Saxe <jsaxe@q...> > Maybe by then we can lobby to have it modeled after the NY law. > I also think we need to keep an eye out for herbs such as chen pi, zhi shi, and zhi ke. Some of these are being used as a substitute for ma huang on weight reduction supplements. Fernando Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 31, 2003 Report Share Posted December 31, 2003 Being the deeply pessimistic individual that I am, I have a couple of questions: Assuming the ban is effected and powder concentrates are out for ban xia is it possible to powder bulk ban xia (processed of course) and use it instead? If so, does anyone have an idea of what the dosage would be (lower than decoction, since the herb is consumed, but higher than .17 of original)? Does the toxic nature of ban xia preclude ingestion in this manner? Par Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 31, 2003 Report Share Posted December 31, 2003 Dear Fernando, If G-d forbid, there is an FDA move toward more sweeping public availability of herbs beyond ma huang, your concern takes it to the level of the absurd. It is Kafkaesque to imagine government agencies moving toward banning oranges and tangerines and their derivitives, don't you think? Au contrare, I strongly believe that the key here is education, and when given lemons (no pun intended), to make them into lemonade. I actually believe that this directive, with the proper lobbying and nurturing, could be a wonderful opportunity to enpower us, stop the gullible and ignorant public from using herbs wrongly, and adding to our already growing prestige as practitioners of a very specific, scientific, different and successful medicine. I have to tell you that I cringe, every time I stand in line at the local health food and supplement store, and I see these sincere people spending hundreds of dollars on herbs, powders and vitamins, (and " natural " , organic cigarettes!-oxymoron?), buying little or no food, looking pretty haggard, and generally quite difficient. Does this not present us with an opportunity to correct this iniquity through education. I strongly feel that this tremendous waste of money and health is completely attributable to selective freedom of information by non-scrupulous advertisers, offering the hope of another magic bullet, albeit natural, to solve their problems created by excess consumption and abuse. Yehuda ______________ The best thing to hit the internet in years - Juno SpeedBand! Surf the web up to FIVE TIMES FASTER! Only $14.95/ month - visit www.juno.com to sign up today! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 31, 2003 Report Share Posted December 31, 2003 On Dec 31, 2003, at 9:50 AM, wrote: > I actually believe that this directive, with the proper lobbying and > nurturing, could be a wonderful opportunity to enpower us, stop the > gullible and ignorant public from using herbs wrongly, and adding to > our already growing prestige as practitioners of a very specific, > scientific, different and successful medicine. Yin and Yang arise together, and every crises presents an opportunity. Couldn't agree with you more, Yehuda. -- Pain is inevitable, suffering is optional. -Adlai Stevenson Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 31, 2003 Report Share Posted December 31, 2003 I wrote to my congressional representatives some time ago. sorry to be alarmist, but did anyone here make public > comment on this matter. > Free Pop-Up Blocker - Get it now Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 2, 2004 Report Share Posted January 2, 2004 , " Stephen " <stephen@b...> wrote: > Greetings, > > According to You Ping Zhu's materia medica, Ephedra sinica contains > 0.487% - 1.382% total alkaloids, of which 55-78% represents ephedrine > and 12-23% pseudoephedrine. E. equisetina yields 2.093-2.436% total > alkaloids. By contrast, the same text reports that ban xia only > contains 0.002% l-ephedrine. that's a difference of 133-539 times in amount of ephedrines between the two. the scientists at the FDA must know there is no way to deliver anything near a dangerous dose of ephedrine using ban xia. so again, why the inclusion? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 3, 2004 Report Share Posted January 3, 2004 On Jan 2, 2004, at 7:37 PM, wrote: > the > scientists at the FDA must know there is no way to deliver anything > near a dangerous > dose of ephedrine using ban xia. so again, why the inclusion? Well, raw Ban Xia is toxic after all. Perhaps the FDA is preparing to regulate those herbs that have a toxicity involved. -- Pain is inevitable, suffering is optional. -Adlai Stevenson Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 3, 2004 Report Share Posted January 3, 2004 , Al Stone <alstone@b...> wrote: > > Well, raw Ban Xia is toxic after all. Perhaps the FDA is preparing to > regulate those herbs that have a toxicity involved. > no, they say its the ephedrine Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 3, 2004 Report Share Posted January 3, 2004 , " " wrote: > , Al Stone <alstone@b...> wrote: > > > > Well, raw Ban Xia is toxic after all. Perhaps the FDA is preparing to > > regulate those herbs that have a toxicity involved. > > > > > no, they say its the ephedrine Here's a little handwriting on the wall. http://www.chron.com/cs/CDA/ssistory.mpl/metropolitan/2333089 fernando Quote Link to comment Share on other sites More sharing options...
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