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CSOMA
Call to Action Alert
March 24, 2004
Greetings Friends and Colleagues:
On February 11, 2004, the Food and Drug Administration issued a 263-page
final ruling that prohibited the sale of dietary supplements containing
ephedrine alkaloids. They cited that these supplements present an "unreasonable
risk of illness or injury" to the general public. The complete 263-page
rule was published in the Federal Register Feb. 11, and becomes effective
April 12, 2004, sixty days from the date of publication. Important links
regarding the ruling from the FDA website follow.
Questions and Answers about FDA's Actions on Dietary Supplements Containing
Ephedrine Alkaloids
Federal Register - Final Rule
Final Rule Summary
Background Information
FDA Press Release - Dated: February 6, 2004
Section IIIB "What Products are Covered" of the ruling states: "Several
Ephedra species (including those known as ma huang) have a long history
of use in traditional Asian medicine. These products are beyond the scope
of this rule because they are not marketed as dietary supplements."
Section VB5 "Scientific Evaluation: What are the Known and Reasonably
Likely Risks presented by Dietary Supplements containing Ephedrine Alkaloids?:
Traditional Asian Medicine" continues with a response to some public comments:
"This final rule does not affect the use of Ephedra preparations in traditional
Asian medicine, although we considered the comments' views and information
on the use of Ephedra in traditional Asian medicine in the context of
their possible relevance to the risks of dietary supplements containing
ephedrine alkaloids. This rule applies only to products regulated as dietary
supplements (See 62 FR 30678 at 30691). Traditional Asian medicine practitioners
do not typically use products marketed as dietary supplements."
However, it was through CSOMA member John Chen's analysis of the FDA ban
that he was able to clarify the ambiguities of this ruling to the extent
that the CSOMA board concluded a very real threat does exist. Dr. Chen's
March 11, 2004 letter to the TCM community states:
From: John K.
Chen, Pharm.D., O.M.D., LAc
To: TCM Community
I am writing to inform you something quite disturbing that I have just
learned. Over the past week, I have had extensive conversations with
four FDA attorneys, a government personnel, and a few other sources,
and they have all confirmed that while FDA's intention is to remove
unsafe products from the market, the implication is that the FDA has
banned the use of any product that contains Ma Huang (Herba Ephedrae)
and Ban Xia (Rhizoma Pinelliae) altogether.
As you may be aware, on February 11, 2004, the FDA published a final
regulation to ban over-the-counter sales of products that contain ephedrine
alkaloids (21 CFR Part 119). In this regulation, it stated that products
that contain ephedrine alkaloids cannot be sold as "food" because it
is unsafe as food. Further, it stated that it will "ban all products
marketed as dietary supplements that contain any amount of ephedrine
alkaloids." If these products cannot be sold as "food" or "dietary supplement,"
the only other place where it can be classified is as a "drug." This
essentially will be the end of any product that contains ephedra or
pinellia (it costs about 900 million dollars R&D to get a drug approved
by the FDA).
[The FDA's statement: that "these products are beyond the scope of this
rule because they are not marketed as dietary supplements" and "This
final rule does not affect the use of Ephedra preparations in traditional
Asian medicine"] This is not correct because all Chinese herbal products
are regulated as dietary supplements – according to the law, this
is the only place they can be classified. We may think of them as Chinese
herbs or herbal medicine, but they legal classification is "dietary
supplements." Chinese herbs are not food, and they are definitely not
drugs. So the only way for traditional Asian medicine to be exempt is
they have to literally be approved and classified as "medicine." And
even [if] this were the case, acupuncturists would not be able to use
it because we are not licensed to prescribe "medicine" or "drugs."
This regulation will be in effect on April 12, 2004. I know we need
to do something and we need to do it quickly. I am hoping that above
information above will be a catalyst to bring the TCM community together,
and hopefully, we can fight to preserve our right for continued access
to our medicine.
John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac.
In follow-up discussions
with John Chen and Gene Bruno, President, of the AAOM, CSOMA has pledged
Board support to their ongoing discussions with the FDA on behalf of the
profession. We feel that it has been the result of the effective work
of the AAOM that has warranted the current "exemptions" that appear to
have been afforded to the traditional Asian medical practitioners community.
To that extent, this represents a "Call to Action" for our members to
initiate a campaign to inform our federal representatives (congressional
& senate) of our need for continued access to these potentially banned
herbs. When writing, please indicate the following:
* You are a Licensed Acupuncturist in their voting district.
* The FDA has potentially banned your use of ephedra (ma huang) and pinellia
(ban xia) because they have ephedrine alkoloids.
* There have been no adverse events reports with ephedra or pinellia being
prescribed by a practitioner, ever.
* You use ephedra and pinellia regularly in my practice and they are used
safely according to my extensive traditional Asian herbal training.
* Request they communicate to the FDA on your behalf to ask that the FDA's
recent ephedrine alkoloid ban be revised to allow your (and other appropriately
licensed practitioners) access to dietary supplements that contain ephedrine
alkaloids in my practice for use in traditional formulas and for traditional
uses.
We ask that letters be addressed to your federal congressional and senate
representatives as well as FDA representatives [see John Chen's "call
to action" addendum] and that a copy be sent to CSOMA's office at advocacy@csomaonline.org,
or by fax to: 916-455-0356. The input received from members, peers, and
colleagues will be combined and provided to Dr. Chen, the AAOM, and the
American Herbal Products Association.
The need for unification in addressing this issue cannot be stressed strongly
enough as there must be "one voice" that represents the profession with
the FDA. To that extent, CSOMA recommends that all state associations
to reach out to their memberships in doing what they can to support the
AAOM's efforts on this important issue.
We also feel it is important to inform our membership of the efforts of
the American Herbal Product's Association in submitting a March 12, 2004
Petition for Reconsideration and Petition for stay of Action to the FDA,
Docket No. 1995N-0304. CSOMA was unable to take a formal position on this
petition due to the timing of the petition. CSOMA will remain in contact
with members of the American Herbal Products association and will provide
updates on the status of their petition.
We ask your assistance in supporting this effort by emailing your responses
to advocacy@csomaonline.org with a title of Response to Ephedra Ban, or
you may fax your responses to 916-455-0356.
Sincerely,
Howard Kong, MS, LAC,
President CSOMA Board of Directors
CSOMA
2710 X Street, Suite 2A
Sacramento, CA 95818
916-455-0347
800-477-4564
Fax: 916-455-0356
rchristensen@csomaonline.org | www.csomaonline.org
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