Guest guest Posted April 25, 2004 Report Share Posted April 25, 2004 Zev and all, I'm pasting herebelow the recent emailing that went out to ASNY(Acupuncture Society of New York) members. The internet affords a great way to shoot out info on timely topics, yet i still wonder about those practitioners who do not have computers or use the internet regularly. It doesn't seem there is much sent out in paper, tho i think Evergreen/John Chen did mail something. In any case, the ASNY post is a reasonable summation..... Regards to all, Ann Brameier Information and Update Regarding Herbal Products and the FDA ASNY E-News April 20,2004 At this point most practitioners of East Asian medicine are aware that in early February the FDA issued a final ruling on the sale and use of Chinese herbal products containing ephedrine alkaloids, this includes Ephedra (Ma Huang) and Pinellia (Ban Xia). In essence, the ruling prohibits the sale of the herbs. Despite language that seems to exempt providers of East Asian medicine from the ban, there is much debate about the exemption's long term reality. Understandably, this creates a tremendous issue for suppliers and practitioners of Asian herbal medicine. At this time a 'bottom line' answer as to how the ruling will impact the profession is not clear. There are a few reasons for this lack of clarity. Most relevant is the ambiguity of the language in the ruling. It is unclear how the language will be interpreted to either support the use of the herbs in any form be it dried, tableted, granule, or liquid by a qualified practitioner of East Asian medicine, or not. In the ruling the language used by the FDA states that " these products are beyond the scope of this rule because they are marketed as dietary supplements " and " this final rule does not affect the use of Ephedra preparation in traditional Asian medicine.. " It is clear that the FDA was attempting to exempt, to a certain extent, the use of the herbs by professional practitioners but, again, the reality is, the mud has far from cleared in the water. There are differing opinions within the profession as to how this issue will move forward. In reading the many different opinions of national organizations, state organizations and suppliers of Chinese herbs one fact is clear. Each individual in the profession can take part in how this issue will ultimately affect the use of not just the currently targeted herbs, but the use of many herbs in the future. Lawmakers, the elected officials that represent us in Washington D.C., must hear from members of the profession on this issue. It is imperative that each provider takes the time to contact both New York Senators Clinton and Schumer as well as your congressional representative in Washington. This act is the manner of both an individual and collective professional voice on the issue and supports the front line organizations working closely with the FDA. As always, when contacting legislators, diplomacy and calm, clear intent is imperative. The points to be made in the contact be it letter, email, telephone, or personal visit should not ever be made in an attacking or aggressive manner and should always be polite and follow standard etiquette. Most lawmakers are unfamiliar with our medicine and it is a golden opportunity to educate them about the history, efficacy and safety of the medicine. Suggestions for your message are: 1) Let them know you are a voter in their district. 2) Let the legislator know that you are a fully licensed acupuncturist/East Asian medicine practitioner, who uses traditional Asian herbal medicine products safely. Mention your route of training, the years involved, national certification and state license. 3) Let the legislator know that the ruling is unclear and that you want them to contact the FDA on your behalf and support continued access to the full compendium of herbs in the tradition, including the current herbs in question. That access includes all forms of the herb currently used by the profession, be it dried, tablet, liquid, granule etc. 4) According to the Rand Report on Adverse Events related to ephedra that was used by the FDA in their safety review, none of the named products were professional use Asian herbal medicine products. In addition, in the event of an emergency related to use of East Asian medicine products the patients would use the same emergency rooms as anyone else. The FDA adverse event reporting hotline or website would also be used. Therefore, it is relevant that there is an absence of reports related to the use of East Asian herbs when administered by a qualified provider. 5) There are no adverse events reports related to Pinellia (Ban Xia). 6) Let the legislator know that professional use traditional Asian herbal medicine products are used safely and responsibly and that acupuncturists provide important healthcare in the community. 7) Repeat that our professional use is safe and that we want their support for continued access to professional use products. To contact federal legislators, log onto these sites to find your individual representative: www.congress.org www.house.gov Also contact the FDA: Mark McClellan, MD @ commissioner Thomas Thompson @ tthompson Robert Moore @ robert.moore Joseph Baca @ joseph.baca It is also important to look at the ruling yourself. The document is rather long but it is helpful to be familiar with the language. The website for the ruling is: www.cfsan.fda.gov In addition, it is advisable to look at the websites for the national organizations, each of which is involved in working towards a favorable interpretation for the ruling. The websites are: www.aaom.org www.aomalliance.org There are additional websites to view that present various discussions of the issue: www.ahpa.org www.bluepoppy.com www.csomaonline.org www.honsousa.com ASNY will continue to monitor this very important issue and keep membership informed of events as they unfold. If you would like to be added to or removed from the ASNY E-list, click on this link http://www.asny.org/elist.asp For all office, event and membership matters, do not reply to this e-mail. Instead, e-mail the office directly at info. Schools and ASNY school representatives: please post. Please forward to any students or practitioners you know. Acupuncture Society of New York Promoting the growth and preserving the integrity of the acupuncture profession in New York since 1990 1858 Pleasantville Road #112 Briarcliff, NY 10510-1038 Phone: 914.923.0632 Fax: 914.923.0250 Website: www.asny.org E-mail: info Quote Link to comment Share on other sites More sharing options...
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