April 9, 2004
SECOND
NOTICE
Greetings Friends and Colleagues:
On March 24, 2004, I emailed this "Call
to Action" Alert, providing an update on
the FDA Ephedra Ban. While we have received
significant response confirming that the
practitioner community has written their federal
representatives (congressional
& senate),
it is important that we keep the pressure on in
Washington. Following, you will find the
background information necessary to understand,
respond and take action.
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.
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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 Acupuncturists
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 your practice and they
are used safely according to your
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 your practice for use
in traditional formulas and for
traditional uses.
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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 subject 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
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