标题: [注意]中醫走向世界任重而道遠 [打印本页] 作者: 兰心 时间: 2004-3-27 09:59 标题: [注意]中醫走向世界任重而道遠 Practitioner Call to Action on Ephedra Ban March 19, 2004
Send your opinion and concerns to your Government Representatives!
No Adverse Event Reports have been associated with Pinellia (Ban Xia)
What needs to be done?
Example of letter to be sent:
Send your opinion and concerns to your Government Representatives!
The herb Pinellia (Ban Xia) has no Adverse Event Reports.
AHPA Committee Files Petition of Final Rule on Ephedrine
Requested by the Chinese herbal medicine manufacturer group, Honso is passing on this information to all CAM practitioners and doctors to ask for your participation on this action. Act now and send your opinions and concerns to your Government Representatives regarding the loss of the Ephedra and Pinellia herbs in use in Traditional Chinese Medicine.
Because of the ambivalent ruling by FDA which states that "this final rule does not affect the use of Ephedra preparations in traditional Asian Medicine. This rule applies only to products regulated as dietary supplements. Traditional Asian medicine practitioners do not typically use products marketed as dietary supplements" the access to these herbs will in effect be denied for practitioners using prepared herbal formulas. In fact some companies manufacturing these herbal formulas have already taken these two herbs out of their formulas.
No Adverse Event Reports have been associated with Pinellia (Ban Xia)
Review of the safety, benefits or traditional uses of Pinellia rhizome (ban xia from Pinellia ternate) has not been conducted. Considering the very low level of ephedrine alkaloids in this herb, the appropriateness of the ban on this herb should be questioned. In fact, the unprepared Ban Xia has 0.00344% or 34 PPM of ephedrine alkaloids and the prepared Ban Xia has ND (non-detectable) at a testing limit of 3PPM. FDA cites significant Adverse Event Reports for the herb Ephedra but none were related to a product sold to practitioners. No Adverse Event Reports have been associated with Pinellia (Ban Xia). Please note that licensed health practitioner products which contain Ma Huang exceeds 325 products and licensed health practitioner products which contain Ban Xia exceeds 950 products.
The Ruling, as interpreted by law firms specializing in FDA matters (not corporate attorneys), is confusing as to which "traditional Chinese herbal products" may be exempted by licensed health practitioners.
What needs to be done?
Practitioners should email/mail the following actions (in your own words) to your Senators and Congressman concerning the FDA Final Rule which will become effective 4/12/04 and will ban the use of ephedrine alkaloids (ie. Ma Huang and Ban Xia). For a list of the representatives in your area, please access www.congress.org or www.house.gov .
For a complete listing of your representatives email, click this.
Example of letter to be sent:
I am a Licensed Acupuncturist in your voting district and would like to voice my opinion regarding the final FDA ruling declaring Dietary Supplements containing Ephedrine alkaloids adulterated.The FDA has banned the use of Ephedra (Ma Huang) and Pinellia (Ban Xia) because they contain ephedrine alkaloids. There are no Adverse Event Reports regarding the herb Ephedra, from a practitioner restricted product. The herb Pinellia has no Adverse Event Reports. In other words, the FDA has not followed due process with this herb.
I use Ephedra and Pinellia regularly in my practice and these herbs are administered safely according to my extensive traditional Chinese herbal training and national certification. Please communicate to FDA on my behalf. I would like to request that this recent ban be revised, to allow access to dietary supplements that contain ephedrine alkaloids in my practice, for use in traditional formulas and for traditional uses. 作者: 兰心 时间: 2004-3-27 10:00 标题: [注意]中醫走向世界任重而道遠
What Practitioners Can Do:
Protecting Our Access to Herbs
Many practitioners have been contacting the AAOM to ask what they can do as individuals to help protect our access and use of herbs. The AAOM encourages practitioners to take the following actions which can lead to an actual, productive result:
As you are aware, a recent FDA regulation bans the use of ephedrine alkaloids in dietary supplements but specifically says in the preamble to the rule that this ban does not apply to ephedra preparations in traditional Asian medicine. Placing this assurance in the preamble has caused confusion among suppliers of Chinese medicine herbal formulas about the legality of their products which merits immediate clarification.
Here Is What You Can Do:
You are a licensed practitioner who votes in the legislator's district.
• Ask the legislator to contact the FDA and insist on an amendment to the ephedrine alkaloid regulation.
• Explain to the legislator that the exemption for traditional Asian medicine needs to be added in the text of the rule.
• Since the preamble to the rule does state that the ban on ephedrine alkaloids does not apply to Chinese medicine herbal formulas, by placing this statement into the actual rule will help clarify any confusion.
These products have a centuries old history of benign and effective use by practitioners of Chinese medicine. This clarification is essential to assure the continued supply of these products to practitioners and their patients.
How to make contact with your Senator or Representative
One of the best ways to make contact is by written letter, but certainly an e-mail version is fine. Some of you who have a relationship with your legislator may also want to speak with her/him personally. Nevertheless, having a written copy of your request is important. Keep your letter simple, and to the point.
We are providing you with a link to the United State House of Representatives and the United State Senate. Click on one of the links below and you will be directed to the main web site of either the Senate of House of Representatives. From the U.S. Senate web site, you will be able to select your state. From the U.S. house of Representatives web site, you will need to enter your zip code.
Senate
House of Representatives
Very Important: Send a copy of your letter or e-mail to AAOM headquarters. This way we can compile a file of hundreds of letters that will give us more leverage with the FDA.
Respectfully,
Gene Bruno, LAc, OMD
AAOM President
作者: 兰心 时间: 2004-3-27 10:16 标题: [注意]中醫走向世界任重而道遠 以上第一封信是幾天前我們收到的一個email﹐是美國中醫及相關從業者自發組織的挽救麻黃和半夏禁令的舉動。第二封是全美中醫工會主席發的。前一段時間是花椒被禁﹐現在又是麻黃和半夏﹐中醫要全面走向世界任重而道遠。雖說有一句this ban does not apply to ephedra preparations in traditional Asian medicine 但是Placing this assurance in the preamble has caused confusion among suppliers of Chinese medicine herbal formulas about the legality of their products which merits immediate clarification. 這種含糊不清的東西﹐誰也不敢輕易冒險﹐在美國上法庭可不是好玩的。
總而言之﹐還是因為世人對中醫了解不夠﹐是我們中醫的普及和宣傳工作做的不好。
很多中國人只著眼于眼前和自己的利益﹐不懂從更高更遠的角度去看去做﹐以至於
全美中醫工會竟然是猶太人辦的﹐主席也是個白人﹐而我們學了幾千年中醫的中國
人卻猶如散沙﹐怎不叫人感慨﹗
我真心希望自己能有所作為﹐為中醫的發展做出確實有效的貢獻。心中感想萬千﹐
實在一言難盡。作者: 江满月圆 时间: 2004-3-27 17:49 标题: [注意]中醫走向世界任重而道遠 兰心蕙质！
知我者，谓我心忧；不知我者，谓我何求。作者: 江满月圆 时间: 2004-3-27 17:51 标题: [注意]中醫走向世界任重而道遠
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