In an effort to inform the acupuncture and Oriental medicine community about the effects the FDA's final ruling could have on the use of ephedra and pinellia, Evergreen Herbs, an herbal supply company, has issued the following "call to action" for practitioners and interested parties.
Practitioner Call to Action on Ephedra Ban
Evergreen Herbs 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 ephedra and pinellia in the use of traditional Chinese medicine. Because of the ambivalent ruling by the FDA, which states, "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.
What Needs to Be Done?
Practitioners should e-mail/mail the following actions (in your own words) to your senators and congressperson concerning the FDA's final rule, which will become effective April 12, 2004 and will ban the use of ephedrine alkaloids (i.e., ma huang and ban xia).
For a list of government representatives in your area, please access:
www.congress.org
www.house.gov
www.contactingthecongress.org
For a list of FDA representatives, call/fax/e-mail:
Mark McClellan, MD
commissioner@fda.gov
Tel: 301-827-2410
Thomas Thompson
tthompson@nctr.fda.gov
Tel: 870-543-7248
Robert Moore
robert.moore@fda.hhs.gov
Tel: 301-436-1441
Joseph Baca
joseph.baca@cfsan.fda.gov
Tel: 301-436-2359
Fax: 301-436-2717
Wayne Amchin, ephedra contact
Center for Food Safety and Applied Nutrition (HFS-007)
Food and Drug Administration
5600 Fishers Lane Rockville, MD 20857
Tel: 301-827-6733
Sample Letter
Date
Dear:
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 herbs Ephedra (Ma Huang) and Pinellia (Ban Xia), from a practitioner restricted product. In other words, the FDA has not followed due process with this herb.
I use Ephedra (Ma Huang) and Pinellia (Ban Xia) regularly in my practice, and these herbs are administered safely according to my extensive traditional Chinese herbal training and national certification. Please communicate this to the 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.
Sincerely,
Name
Address
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