Guest guest Posted August 20, 2005 Report Share Posted August 20, 2005 There is big trouble afoot and the AAOM needs your help. Will Morris reports some disturbing information in the AAOM President's Report at http://www.acupuncturetoday.com/ archives2005/sep/09willmorris.html [Todd: while we had our heads in the sand ... again] Herb Committee Herb importation and access: Ma huang will likely continue to be restricted at the border, despite the release of a manufacturer’s bulk ma huang from the FDA. [i thought bulk ma huanghuang was food and not covered under the rule] There is concern that a new category for herbs will not be inadvertently created as hoped but that Asian herbs will now be seen as a drug category. The FDA has demanded proof from manufacturers that products in their warehouse have passed border inspection. No further sale of products containing ma huang will be permitted. [Todd: I am pretty confident that the utah FEDERAL judge's order restraining the FDA would be upheld in other jurisdictions nationwide. low dosed products, which would probably be all patents are legal. however, you may have to get them tested to prove they are low in ephedrines to CYA; from http://www.gorillavitamins.com/ the_ephedra_decision_what_you.cfm The Ephedra Decision: What You Need to Know about its Effect on the Marketplace 2005-04-28 - National Nutritional Foods Association (NNFA) Recently we informed members of a district judge’s ruling that partially lifted the Food and Drug Administration’s (FDA) ban on the dietary supplement ephedra. As a result, NNFA has been fielding many questions from its retail and manufacturer members about what the decision means for the industry in both the long and short term. For instance, NNFA has learned that retailers are now being approached by ephedra manufacturers or their representatives about putting ephedra products back on store shelves. Although the court decision leaves room for interpretation and an appeal by the FDA is anticipated, following is some clarification and guidance in complying with the court decision. Was the ban on ephedra overturned? No. The ban on ephedra products of more than 10 milligrams per dose is still in effect. The ruling only invalidated the ban on ephedra products with 10 milligrams or less of ephedrine alkaloids and with important restrictions, as indicated below. Can retailers and manufacturers begin selling ephedra products again? The decision only applies to ephedra products with 10 milligrams or less and only within Utah’s Central Division district court jurisdiction. FDA may challenge sales outside of that jurisdiction. Only in single and daily doses of 10 milligrams or less. Only in states that have not prohibited or restricted sale of ephedra. What are the risks of selling ephedra? Liability. NNFA understands that no insurance companies are currently underwriting coverage for either manufacturers or retailers who sell ephedra. This means full exposure financially in the event of a civil lawsuit. To date, there have been numerous lawsuits regarding the use of ephedra products for damages in the millions of dollars. Enforcement action. Those retailers or manufacturers selling ephedra product in any federal court district other than Utah’s Central Division can still be sued by the FDA. Ruling reversal. If the FDA appeals the ruling, and indications are it will, there is no guarantee the recent Utah decision will be upheld. Should the ruling be overturned, the ban on all ephedra products – regardless of dosage and where they are sold or manufactured – will remain in force. Availability. While the ban on ephedra products of 10 milligrams or less sold in the United States has been lifted – with important restrictions – an embargo on imports remains in effect. This means that foreign shipments of ephedra product to the United States can be turned away at the point of entry. As further events develop, NNFA will continue to inform its members about the effects of this important court ruling.] Animal products are also being detained, as is shen qu. The FDA is asking for proof of use of animal products prior to 1994 in order to allow their continued use. The American Herbal Products Association is working to provide requested evidence. [this is being done under the authority of the new dietary ingredient (NDI) provision of DSHEA. there are a bunch of article about DHSEA in the current American Journal of Law and Medicine, including one specifically on NDIs. That article is quite germane to this issue. Any products not in use before 1994 must get premarket safety (not efficacy) approval. However, the FDA is using another portion of DSHEA to reject applications for certain products before doing any safety tests. That criteria is if the product is not explicitly included in DSHEA's definition of a dietary supplement, then it cannot even be considered for inclusion regardless of how long it has been used (again, this should apply only to products, not bulk medicinals). It certainly would be a simple matter to prove that companies like mayway, taisang, health concerns and seven forests have been selling these items long before 1994. However it is true that DHSEA does not explicitly allow for the use of whole animals or their parts as dietary supplements. This would not be the end of the world for me as I rarely use animals and have always had serious safety concerns about the use of rancid flesh and bones in my patients. We have no documentation how effectively these items are stored or preserved. Are they tested for bacteria, fungi, etc? I don't approve of the ban, but when going to battle, we need to be clear that this will be a tough fight if FDA is allowed to apply this provision this way. However, according to AJLM, they are about to be sued as a careful reading of the rule does not appear to give them that authority at all. If the products a have been used safely in America for decades, that was the intent of congress. They could not be expected to define every possible future natural product it might cover. FDA loses pretty much every time it goes to court, so I don't know why we bother negotiating with them anymore. just sue em until they beg for mercy.] Mu tong and fang ji have been held in question regarding their aristolochic acid (AA) content. [as well they should; I found guang mu tong at PCOM a few months back; definitely quite a few patients took it] The FDA was unable to locate any quantifiable amount of AA, and has requested that each batch of mu tong or fang ji-containing products be tested in FDA labs five times prior to release for sale. On a positive note, trichosanthes has finally been released. At this time, we have no word on a meeting date between AAOM and HHS, although a meeting has been promised to AAOM counsel Mark Thoman as it relates to the herbal access project under the new HHS administration. The AAOM suggests that HHS be provided suggestions for a new herb category rather than waiting for FDA to determine one for the profession. The AAOM strongly recommends that vendor category sales are only to professionals not consumers, thus demonstrating responsibility for public safety. [i have long advocated for this type of proactive voluntary self regulation before the feds end the party altogether. I strongly support AAOM in this effort and urge everyone to send them money] AAOM recommends a definition of “Asian Traditional Medicine” before the FDA attempts to do so. Part of that definition should be that this category of products is reserved strictly for licensed health care providers and that consideration be given, especially in the case of ma huang to the traditional application or use of these herbs. Part of the definition would be the traditional theory and use of these herbs. For example, traditionally, ma huang is never used to assist in weight loss or to increase energy. [its all just bad science; ma huang is safe for weight loss if used under professional supervision; no one ever died under those circumstances; we are not the only professionals who use ma huang safely; the issue is corporate greed in marketing and a public desperate for quick fixes; lets be sure not alienate our peers;] Chinese Herbs Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 22, 2005 Report Share Posted August 22, 2005 What sort of help can we, as individuals, provide? Mark - " " < Saturday, August 20, 2005 9:12 PM AAOM President's Report There is big trouble afoot and the AAOM needs your help. Will Morris reports some disturbing information in the AAOM President's Report at http://www.acupuncturetoday.com/ archives2005/sep/09willmorris.html [Todd: while we had our heads in the sand ... again] Herb Committee Herb importation and access: Ma huang will likely continue to be restricted at the border, despite the release of a manufacturer’s bulk ma huang from the FDA. [i thought bulk ma huanghuang was food and not covered under the rule] There is concern that a new category for herbs will not be inadvertently created as hoped but that Asian herbs will now be seen as a drug category. The FDA has demanded proof from manufacturers that products in their warehouse have passed border inspection. No further sale of products containing ma huang will be permitted. [Todd: I am pretty confident that the utah FEDERAL judge's order restraining the FDA would be upheld in other jurisdictions nationwide. low dosed products, which would probably be all patents are legal. however, you may have to get them tested to prove they are low in ephedrines to CYA; from http://www.gorillavitamins.com/ the_ephedra_decision_what_you.cfm The Ephedra Decision: What You Need to Know about its Effect on the Marketplace 2005-04-28 - National Nutritional Foods Association (NNFA) Recently we informed members of a district judge’s ruling that partially lifted the Food and Drug Administration’s (FDA) ban on the dietary supplement ephedra. As a result, NNFA has been fielding many questions from its retail and manufacturer members about what the decision means for the industry in both the long and short term. For instance, NNFA has learned that retailers are now being approached by ephedra manufacturers or their representatives about putting ephedra products back on store shelves. Although the court decision leaves room for interpretation and an appeal by the FDA is anticipated, following is some clarification and guidance in complying with the court decision. Was the ban on ephedra overturned? No. The ban on ephedra products of more than 10 milligrams per dose is still in effect. The ruling only invalidated the ban on ephedra products with 10 milligrams or less of ephedrine alkaloids and with important restrictions, as indicated below. Can retailers and manufacturers begin selling ephedra products again? The decision only applies to ephedra products with 10 milligrams or less and only within Utah’s Central Division district court jurisdiction. FDA may challenge sales outside of that jurisdiction. Only in single and daily doses of 10 milligrams or less. Only in states that have not prohibited or restricted sale of ephedra. What are the risks of selling ephedra? Liability. NNFA understands that no insurance companies are currently underwriting coverage for either manufacturers or retailers who sell ephedra. This means full exposure financially in the event of a civil lawsuit. To date, there have been numerous lawsuits regarding the use of ephedra products for damages in the millions of dollars. Enforcement action. Those retailers or manufacturers selling ephedra product in any federal court district other than Utah’s Central Division can still be sued by the FDA. Ruling reversal. If the FDA appeals the ruling, and indications are it will, there is no guarantee the recent Utah decision will be upheld. Should the ruling be overturned, the ban on all ephedra products – regardless of dosage and where they are sold or manufactured – will remain in force. Availability. While the ban on ephedra products of 10 milligrams or less sold in the United States has been lifted – with important restrictions – an embargo on imports remains in effect. This means that foreign shipments of ephedra product to the United States can be turned away at the point of entry. As further events develop, NNFA will continue to inform its members about the effects of this important court ruling.] Animal products are also being detained, as is shen qu. The FDA is asking for proof of use of animal products prior to 1994 in order to allow their continued use. The American Herbal Products Association is working to provide requested evidence. [this is being done under the authority of the new dietary ingredient (NDI) provision of DSHEA. there are a bunch of article about DHSEA in the current American Journal of Law and Medicine, including one specifically on NDIs. That article is quite germane to this issue. Any products not in use before 1994 must get premarket safety (not efficacy) approval. However, the FDA is using another portion of DSHEA to reject applications for certain products before doing any safety tests. That criteria is if the product is not explicitly included in DSHEA's definition of a dietary supplement, then it cannot even be considered for inclusion regardless of how long it has been used (again, this should apply only to products, not bulk medicinals). It certainly would be a simple matter to prove that companies like mayway, taisang, health concerns and seven forests have been selling these items long before 1994. However it is true that DHSEA does not explicitly allow for the use of whole animals or their parts as dietary supplements. This would not be the end of the world for me as I rarely use animals and have always had serious safety concerns about the use of rancid flesh and bones in my patients. We have no documentation how effectively these items are stored or preserved. Are they tested for bacteria, fungi, etc? I don't approve of the ban, but when going to battle, we need to be clear that this will be a tough fight if FDA is allowed to apply this provision this way. However, according to AJLM, they are about to be sued as a careful reading of the rule does not appear to give them that authority at all. If the products a have been used safely in America for decades, that was the intent of congress. They could not be expected to define every possible future natural product it might cover. FDA loses pretty much every time it goes to court, so I don't know why we bother negotiating with them anymore. just sue em until they beg for mercy.] Mu tong and fang ji have been held in question regarding their aristolochic acid (AA) content. [as well they should; I found guang mu tong at PCOM a few months back; definitely quite a few patients took it] The FDA was unable to locate any quantifiable amount of AA, and has requested that each batch of mu tong or fang ji-containing products be tested in FDA labs five times prior to release for sale. On a positive note, trichosanthes has finally been released. At this time, we have no word on a meeting date between AAOM and HHS, although a meeting has been promised to AAOM counsel Mark Thoman as it relates to the herbal access project under the new HHS administration. The AAOM suggests that HHS be provided suggestions for a new herb category rather than waiting for FDA to determine one for the profession. The AAOM strongly recommends that vendor category sales are only to professionals not consumers, thus demonstrating responsibility for public safety. [i have long advocated for this type of proactive voluntary self regulation before the feds end the party altogether. I strongly support AAOM in this effort and urge everyone to send them money] AAOM recommends a definition of “Asian Traditional Medicine” before the FDA attempts to do so. Part of that definition should be that this category of products is reserved strictly for licensed health care providers and that consideration be given, especially in the case of ma huang to the traditional application or use of these herbs. Part of the definition would be the traditional theory and use of these herbs. For example, traditionally, ma huang is never used to assist in weight loss or to increase energy. [its all just bad science; ma huang is safe for weight loss if used under professional supervision; no one ever died under those circumstances; we are not the only professionals who use ma huang safely; the issue is corporate greed in marketing and a public desperate for quick fixes; lets be sure not alienate our peers;] Chinese Herbs 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...
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