Guest guest Posted February 11, 2004 Report Share Posted February 11, 2004 On Tuesday, February 10, 2004, at 10:48 PM, Marc Sklar, L.Ac wrote: > Read the actual Page #361-363 regarding the Final Rule the final rule posted on these pages makes no mention at all of an exemption for traditional chinese use of ma huang. it would appear that the the so-called exemption is just a verbal promise by FDA to not enforce this rule against some of our formulas (which ones are still unclear). the actual rule clearly gives the FDA immediate authority to ban any ephedra containing product regardless of the labeling or intended use. I don't know where people get the idea that this rule is only directed against weight loss products. It very clearly states that these products are banned even " if no conditions of use are recommended or suggested in the labeling, under conditions of ordinary use " . Gee, what is the ORDINARY use of ephedra for which it is now banned. Perhaps asthma or sinus congestion or body pain???? It really appears that the FDA may have consciously weakened the opposition to this rule by pacifying opponents along the way with promises that were NOT encoded into the final rule itself. Everyone knew this rule was coming down the pike. Fear has already had major ramifications. check with your malpractice insurer. You may find you are not covered for he use of ephedra containing formulas. On Saturday, February 7, 2004, at 02:28 PM, Subhuti Dharmananda wrote: > ITM removed ma-huang from all its products quite a while ago. It has > nothing to do with the FDA ban (though, of course, that doesn’t > help). Insurance companies won’t provide product liability insurance > coverage. When practitioners compound a formula to give to a patient, > FDA does not ban it and as long as the raw materials suppliers (e.g., > crude herb and granule suppliers) can keep bringing it in, maybe > working with their insurance companies to get some kind of coverage. > > Scenario: you prescribe a formula with ma-huang to a patient. The > patient takes it for three days and has a heart attack (he was going > to have one anyway, but he didn’t know that). His wife, son, > daughter, or someone discovers that he’s been taking a formula with > ma-huang. They are angry as you can possibly imagine, blaming you for > inducing the heart attack. You think to yourself: but this fellow > probably had some heart disease going and he may have been taking some > drugs and that is what caused it. But, they are thinking, if it > weren’t for the ma-huang, he wouldn’t have had the heart attack. You > should have known it was dangerous. A few weeks later, a large packet > of papers is delivered to you. It is a lawsuit naming you and every > company that had anything to do with supplying you with the product. > They say that you and all suppliers should have known this herb is > dangerous, is on an FDA listing, is in the news, and you recklessly > used it anyway, and you didn’t tell your patient that he might suffer > a heart attack if you gave him this formula. If practitioners > continue to prescribe ma-huang, this will happen. The herb does not > have to cause the heart attack, it only has to be considered to > potentially have contributed. > > The weight loss pill industry is destroying herbal medicine bit by > bit. The new “ephedrine free” products often have synephrine from > zhishi (chih-shih), and that is the next problematic area. See also > my article on usnea, posted on our website with link from our home > page. > > Subhuti Dharmananda, Ph.D. , Institute for Traditional Medicine (ITM) > > www.itmonline.org; itm > Chinese Herbs FAX: Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2004 Report Share Posted February 11, 2004 At 9:42 AM -0800 2/11/04, wrote: >the final rule posted on these pages makes no mention at all of an >exemption for traditional chinese use of ma huang. -- On my PDF download relevant discussion is on page 106. It seems to say that Chinese remedies are not dietary supplements, so the rule doesn't apply. Rory -- Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2004 Report Share Posted February 11, 2004 , Rory Kerr <rorykerr@o...> wrote: > At 9:42 AM -0800 2/11/04, wrote: > >the final rule posted on these pages makes no mention at all of an > >exemption for traditional chinese use of ma huang. > -- > On my PDF download relevant discussion is on page 106. It seems to > say that Chinese remedies are not dietary supplements, so the rule > doesn't apply. > > Rory > -- I think what you are missing here is that passage you are stating is not included in the text of the final rule itself, which is only a few lines long. I think it says that chinese herbs are not marketed as dietary supplements and that is incorrect if applied to patents, which fall under the jurisdiction of DSHEA. It only applies to loose herb teas, which are regulated as foods. I have to ask if you are suggesting we just sit back and hope you are correct instead of demanding clarification of amendment by congress now. what could possibly be gained by that tactic and what could be lost by being proactive. Even if you are right about the meaning of the rule, I think you are definitely wrong about what action should be now taken to insure you are right. If I am right, we lose bigtime by sitting on our butts. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2004 Report Share Posted February 11, 2004 At 2:47 AM +0000 2/12/04, wrote: >I have to ask if you are suggesting we just sit back and hope you >are correct instead of demanding clarification of amendment by >congress now. what could possibly be gained by that tactic and what >could be lost by being proactive. Even if you are right about the >meaning of the rule, I think you are definitely wrong about what >action should be now taken to insure you are right. If I am right, >we lose bigtime by sitting on our butts. -- Woah Neddy!... I wasn't trying to argue for or against anything, or suggest anything. It seemed as though you, or someone, was trying to locate the language of the exception, and because the document wasn't indexed or searchable, was having a problem finding it amongst the 323 pages. I happened upon some relevant language and reported the page number, that's all. I agree we should be proactive. Rory -- Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.