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.
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