Letter to the Congress – Follow Up (1)
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Letter to the Congress – Follow Up (1)
TO:
United States Congress
FROM:
American Chinese Medicine Association (ACMA)
http://www.AmericanChineseMedicineAssociation.org
RE:
(1) Ephedra Event Follow-up; (2) Amendment of Medical Practice Act;
(3) Amendment of Federal Food, Drug, and Cosmetic Act; (4) On Herbal
Ban vs. Herbal Regulation
DATE:
February 16, 2004
Dear Honorable Congressional Representatives:
In August 2002, in response to the widely publicized Ephedra event and the inappropriate
attitudes towards a number of Chinese herbs, practitioners of Chinese Medicine, and
Chinese Herbal Medicine, Dr. Bob Xu of the American Chinese Medicine Association
(ACMA) initiated a “Letter to the Congress” [1] to clarify confusion along with other
issues relative to the Ephedra event in order to prevent similar incidents from happening
again.
On February 11, 2004, the Food and Drug Administration (FDA) issued a final rule
prohibiting the sale of dietary supplements containing ephedrine alkaloids (Ephedra)
because such supplements present an unreasonable risk of illness or injury.
As a follow up of the previous “Letter to the Congress”, this letter serves as a response
from the ACMA to the FDA’s action on the Ephedra event and related issues.
1. Background
The original “Letter to the Congress” has addressed many issues relating to the Ephedra
event, which include medicine in general and Chinese Herbal Medicine (also called
traditional Chinese herbal remedies, traditional Asian medicine, and Oriental Medicine
[2]) in particular. Among those issues, four are as follows:
(1) Abuse of Ephedra
Based on the Pharmacopoeia of the People's Republic of China and other authoritative
references on Chinese Herbal Medicine, the “Letter to the Congress” explained in detail
that there are rigorous indications for the application of Ephedra. If people ingest
Ephedra without appropriate indications, serious side effects might result. Many victims
of the Ephedra events in America took Ephedra for weight loss and sport performance
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enhancement. However, neither weight loss nor sports performance enhancement fall
into any of the appropriate categories of indications for Ephedra. Obese people and
athletes should not take Ephedra for those purposes. Therefore, the Ephedra events
occurred in part due to the wrong application of Ephedra to weight loss and athlete
performance enhancement. So the nature of the Ephedra event belongs to public abuse
of Ephedra used in a misguided fashion – which is a medicinal material used in Chinese
Herbal Medicine.
(2) Regulating Ephedra
The “Letter to the Congress” stated that Ephedra, together with some other herbs used in
Chinese Herbal Medicine, should not be categorized simply as dietary supplements.
They are herbal medicines in nature. For patients with the appropriate indications for
applying these Chinese herbal medicines, they can be life saving. However, as medicinal
materials, they can cause severe side effects (including deaths) if the uninformed or
misinformed public abuses or misuses them.
The complete ban of Ephedra will potentially harm patients and the public when those
patients have indications needing the application of Ephedra or any of its alkaloids.
Therefore, Ephedra should be regulated as a “prescription herb” or “professionally
recommended herb” [3] authorized for use primarily by qualified practitioners of Chinese
Herbal Medicine, rather than be completely banned.
In the best interests of public health, welfare, and safety along with protecting the
integrity of Chinese Herbal Medicine, the “Letter to the Congress” emphasized that
Chinese Herbal Medicines should be regulated and be available ONLY to Doctors of
Chinese Medicine (CMD) and other qualified practitioners of Chinese Herbal Medicine.
It is inappropriate for the public to have freedom of access to some of these Chinese
herbal medicines. In the meantime, it is also inappropriate for these Chinese herbal
medicines to be prescribed, recommended, or administered by other health care providers
who lack the appropriate and sufficient education and training in Chinese Herbal
Medicine.
(3) Inappropriate Classification of Herbs
Historically, Chinese Herbal Medicine has accumulated millions of clinical cases and
experiences. Based on these facts, the “Letter to the Congress” elucidated in detail the
inappropriate classification of a number of these herbs into the dietary supplement
category.
Herbs, or ‘Materia medica’ used in Chinese Herbal Medicine, are very important
medicinal materials or herbal medicines, which have been used to treat diseases and
illnesses for thousands of years. They belong to a special category, which differs, in
some cases, from both food dietary supplements and western pharmaceutical drugs.
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To clarify the confusion and to prevent similar incidents from occurring again, the “Letter
to the Congress” recommended the separation of some herbs from food dietary
supplements, and the establishment of an independent “herbal medicine” category within
the domain of practitioners of Chinese Herbal Medicine [1].
(4) Disclaimer Dilemma
For many years, the FDA has required that all herbal products make a disclaimer stating,
"This product is not intended to diagnose, treat, cure, or prevent any disease".
Based on thousands of years of clinical practice of Chinese Herbal Medicine, the “Letter
to the Congress” pointed out that this disclaimer is in direct opposition to the facts and
truths, which have existed in the long-term practice of Chinese Herbal Medicine. This
disclaimer has caused a dilemma for both the profession of Chinese Herbal Medicine and
within the FDA.
The above noted four issues, and the other issues addressed in the original “Letter to the
Congress”, are of significant importance to millions of patients, the American public, the
profession of Chinese Herbal Medicine, and to the FDA. Any actions towards resolving
above issues are of positive benefit for all parties.
2. FDA’s Action
The FDA’s final rule publicized on February 11, 2004 states:
“… Therefore, we conclude that dietary supplements containing ephedrine alkaloids
labeled or used for weight loss present an unreasonable risk.”
“… Therefore, we conclude that the use of dietary supplements containing ephedrine
alkaloids to enhance athletic performance for any duration of use present an unreasonable
risk.”
“… The final rule does not apply to conventional food products that contain ephedrine
alkaloids. …”
“…This final rule does not affect the use of Ephedra preparations in traditional Asian
medicine (Note: “traditional Asian medicine” is an inappropriate term for “Chinese
Herbal Medicine” [2]), although we considered the comment’s 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. …”
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“… Moreover, even if we could say that the absence of recorded adverse events with the
use of Ephedra in traditional Asian medicine was due to its safety for that use rather than
due to a lack of mechanism for reporting, the history of use of Ephedra in traditional
Asian medicine primarily for the treatment or mitigation of respiratory illness cannot
provide assurance about the safety of dietary supplements containing ephedrine alkaloids
for other uses.”
Based on the info available, the FDA’s final rule is a positive initiative towards resolving
the above four issues raised in the original “Letter to the Congress”.
The FDA’s final rule addresses the above four issues in the following ways:
(1) The FDA banned the inappropriate applications of Ephedra products to weight
loss and athlete performance enhancement. This directly addresses the first issue
mentioned above: Abuse of Ephedra.
(2) The FDA banned the public from getting access to dietary supplements containing
ephedrine alkaloids, which, qualitatively does not ban the use of Ephedra
preparations (which also contain ephedrine alkaloids) in the practice of Chinese
Herbal Medicine. This is in fact to regulate Ephedra instead of completely
banning it. This addresses the second issue mentioned above: Regulating
Ephedra.
(3) The FDA acknowledges, “Traditional Asian medicine practitioners do not
typically use products marketed as dietary supplements”. This actually
differentiates the dietary supplements containing ephedrine alkaloids from the
Ephedra preparations used in Chinese Herbal Medicine. In other words, the FDA
recognizes that dietary supplements and Chinese herbs (herbal medicines) are
different in nature. This in fact separates the Chinese herbs (herbal medicines)
from the dietary supplements. This is a good beginning to remove Chinese herbs
(herbal medicines) from the dietary supplement category. This addresses the third
issue mentioned above: Inappropriate Classification of Herbs.
(4) The FDA’s final rule states that “…the history of use of Ephedra in traditional
Asian medicine primarily for the treatment or mitigation of respiratory illness …”.
This acknowledges that the Ephedra used in Chinese Herbal Medicine can treat
respiratory diseases. This recognizes that Ephedra has medicinal functions and
properties, and cannot be used simply as a dietary supplement, which does not
contain medicinal functions and properties. This differentiation of Ephedra under
different settings respects the medicinal status of Ephedra and Chinese Herbal
Medicine. By honoring the medicinal status of Chinese Herbal Medicine, the
FDA implies that Chinese Herbal Medicine can diagnose, prevent, and treat
diseases. Thus, the FDA has avoided the dilemma caused by the previous
disclaimer with respect to Chinese Herbal Medicine. This addresses the fourth
issue mentioned above: Disclaimer Dilemma.
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We welcome the FDA’s initiatives towards resolving the above four issues addressed in
the original “Letter to the Congress”. These initiatives will hopefully open channels of
dialogue and communication between the FDA and the profession of Chinese Herbal
Medicine. They will further lead to building a constructive relationship between the FDA
and the profession of Chinese Herbal Medicine, which will benefit not only the FDA and
the profession of Chinese Medicine, but also millions of Americans who seek health care
and treatments by means of Chinese Medicine in general.
3. Problems to be Resolved
In resolving the above four issues, we found that three problems relating to legislation are
still entangled. These problems are confusing not only to patients and the public, but also
to the profession of Chinese Medicine and the FDA. Because legislative issues are
beyond the capacity of the FDA, these three problems continue to seriously affect the
normal operation of the FDA, which in turn affects the profession of Chinese Herbal
Medicine and millions of American patients.
(1) Definition of the Dietary Supplement
Congress defined the term “dietary supplement” in the Dietary Supplement Health and
Education Act (DSHEA) of 1994. A dietary supplement is defined as a product taken by
mouth that contains a “dietary ingredient” intended to supplement the diet. Here, “an
herb or other botanical” are included into the dietary supplement category.
As pointed out in the original “Letter to the Congress”, the 1994 DSHEA has made a
mistake by including herbs in the dietary supplement category [1]. This can only be
rectified by having Chinese Medicine professionals who have expertise in Chinese
Herbal Medicine to work with the FDA to develop criteria and standards of efficacy and
safety for herbal medicines.
According to this definition, both the extract form of Ephedra and the raw herb (plant)
form of Ephedra would be classified as a dietary supplement.
The FDA’s Final Rule on Ephedra, published on February 11, 2004, took a great step by
removing the raw herb (plant) Ephedra, as used in the practice of Chinese Herbal
Medicine, from the dietary supplement category. In doing so, the FDA made a right and
courageous step. We applaud the FDA’s action because removing some herbs from the
dietary supplement definition is in the right direction. However, since the law regarding
the definition of dietary supplements has not yet been changed, the FDA is unable to
advance further in this direction.
Redefining the dietary supplement by removing some herbs (herbal medicines)
completely away from the dietary supplement category is the most important task in
amending the 1994 DSHEA [1]. The definition of dietary supplements, therefore, ought
not to include Chinese Herbal Medicine.
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(2) Medical Practice Act
During our contact with the FDA, we noted that the FDA was aware of the fact that
Chinese herbs have medicinal functions in treating diseases and curing illnesses.
However, the FDA further mentioned that due to historic reasons, this fact might conflict
with state Medical Practice Acts, which govern the practice of medicine in the respective
states and are outside the regulatory jurisdiction of the FDA.
As a result, a new dilemma has been generated. On one hand, the FDA’s final rule
acknowledges that Chinese Herbal Medicine can treat and cure diseases. On the other
hand, state Medical Practice Acts do not provide a legal status for Chinese Herbal
Medicine to diagnose, treat, and cure diseases.
We contend, therefore, that the Congress should resolve this dilemma by enacting
legislation that would preempt state regulation of the practice of Chinese Herbal
Medicine in state Medical Practice Acts.
This is another legislative issue to be resolved by the Congress.
(3) Federal Food, Drug, and Cosmetic Act
Due to historic reasons, the “Federal Food, Drug, and Cosmetic Act” has not included
herbal medicine in it. The FDA’s Final Rule on Ephedra, however, acknowledges the
medicinal usage of the raw herb Ephedra in Chinese Herbal Medicine. This decision by
the FDA, in the context of the Federal Food, Drug and Cosmetic Act, makes it difficult
for the FDA to classify medicinal Chinese herbs into an appropriate category. It ended
up that the FDA separated the raw medicinal Chinese herb Ephedra from the dietary
supplement category, and placed it into the food category instead. This is in fact a shortterm solution to a long-term problem.
By definition, foods are not classified to have medicinal functions and properties.
Therefore, food is an inappropriate category to accommodate the raw Chinese herbal
medicines that are medicinal materials in nature. As explained in detail in the original
“Letter to the Congress”, a new “Herbal Medicine” category is necessary in order to reclassify some of the herbal medicines [1]. We contend, therefore, that an amendment of
the “Federal Food, Drug, and Cosmetic Act”, which reflects this re-classification,
becomes necessary.
Facing the above situation, in which legislation lags behind the FDA’s action, we
appreciate the FDA’s understanding about Chinese Herbal Medicine. In order, therefore,
to resolve the difficulty, which exists in current law, vis-à-vis the proper classification of
Chinese Herbal Medicine, we ask the Congress to introduce appropriate bills to provide
the legal basis for the FDA to operate more efficiently, and for Chinese Herbal Medicine
to be practiced more freely and effectively. In the end, millions of American patients will
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have the healthcare freedom and convenience to seek the treatment of one of the world’s
most time-tested medicines -- Chinese Herbal Medicine.
4. Legislation Actions
From the above discussion, we can see that legislative action is now necessary to amend
and enact several laws.
(1) Amendment of DSHEA
This is a very important amendment relating not only to the profession of Chinese Herbal
Medicine, but also to the FDA, patients, and the public safety. In the previous “Letter to
the Congress” we elucidated in detail the necessity to amend DSHEA [1]. To save space,
we will not repeat this amendment here.
(2) Federal Preemption of State Medical Practice Acts
By honoring the medicinal status of Chinese Herbal Medicine, by separating and
removing some Chinese herbs from the dietary supplement category, and by establishing
an independent category for herbal medicine, Chinese Herbal Medicine would therefore
be granted a professional medicine status. This medicinal status, however, would be in
conflict with states Medical Practice Acts.
In order to resolve this conflict, it is necessary to enact federal legislation that would
preempt state Medical Practice Acts and provide federal protection for the professional
medicine status of Chinese Herbal Medicine in the United States, and its recognized
trained practitioners.
State Medical Practice Acts were originally enacted several dozen years ago. At that
time, except for allopathic medicine, there was no other medicine, which existed in the
United States. Therefore, in state Medical Practice Acts, the term “medicine” means
exactly the same as “allopathic medicine”. Chinese Medicine and other alternative
medicines were not included in the term “medicine” when the State Medical Practice
Acts were first enacted.
Therefore, there existed an assumption in the usage of the term “medicine” when these
state laws were first passed that the term “medicine” was equivalent to the term
“allopathic medicine”. This assumption permeates state Medical Practice Acts. In other
words, the term “medicine” in state Medical Practice Acts actually refers to “allopathic
medicine” only. It does not include Chinese Medicine or other alternative medicines
such as Chiropractic or Naturopathic medicine.
Today, many years later, after Chinese Herbal Medicine and other alternative medicines
have grown in the United States, both the connotation and the extension of the term
“medicine” have evolved. The term “medicine” today includes not only allopathic
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medicine, but also Chinese Herbal Medicine, as well as many other Complementary and
Alternative Medicines. So the term “medicine” today is quite different from the term
“medicine” as originally used in the state Medical Practice Acts when they were first
enacted. In America today, the term “medicine” is no longer equivalent to “allopathic
medicine”. The former is much larger than the latter.
In order to resolve this confusion and conflict between Chinese Herbal Medicine and
other Complementary and Alternative Medicine with the state Medical Practice Acts, it is
necessary for the Congress to preempt state Medical Practice Acts by redefining the term
“medicine” used in the state Medical Practice Acts as “allopathic medicine” only.
(3) Amendment of the “Federal Food, Drug, and Cosmetic Act”
Historically the “Federal Food, Drug, and Cosmetic Act” did not include herbal
medicine. It was based solely on allopathic medicine.
Today, there are two medicinal systems co-existing in the world: allopathic medicine
(led and represented by Western Medicine) and holistic medicine (led and represented by
Chinese Medicine). Herbal medicine is an independent medicine parallel to
pharmaceutical drugs in treating diseases and curing illnesses. More and more people are
seeking herbal medicine treatments. Therefore, Chinese Herbal Medicine should be
included in the “Federal Food, Drug, and Cosmetic Act” in order to include the holistic,
herbal medicine system into this important law on healthcare.
As elucidated in detail in the original “Letter to the Congress”, herbal medicine should be
separated from the food dietary supplement category. It is also completely different from
pharmaceutical drugs. Therefore, an independent “herbal medicine” category should be
established [1]. Herbal medicine should be regulated under its own rules and regulations
instead of merely copying the pharmaceutical drug’s rules and regulations.
In order to achieve this goal, an amendment to the “Federal Food, Drug, and Cosmetic
Act” is needed in order to set up standards to regulate the profession of Chinese Herbal
Medicine based on the rules and regulations of this profession. After establishing an
independent category of Chinese Herbal Medicine, we propose that the new “Federal
Food, Drug, and Cosmetic Act” become “The Federal Food, Drug, Herb, and
Cosmetic Act”. This is the legislation counterpart of the proposal to establish an
independent "FDA Division of Herbal Medicine" and restructure the current FDA to
"Food, Drug, and Herb Administration (FDHA)" [1].
(4) Remaining Issues
Besides the issues mentioned above regarding the FDA’s Final Rule on Ephedra, there
are many other issues raised in the previous “Letter to the Congress,” which have not yet
been resolved. Those issues can be appropriately addressed after the above fundamental
issues have been satisfactorily resolved.
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5. On Herbal Ban vs. Herbal Regulation
Currently, there is a bill in the US House (H. RES. 435) and a bill in the Senate (S. RES.
260) regarding to the ban of dietary supplements containing ephedrine alkaloids. These
two bills have the following problems:
(1)
Usage
These bills have not made detailed distinction between the public abuse of
ephedra and the professional practice use of ephedra in Chinese Medicine
(FDA mentioned is as Traditional Asian Medicine).
The former is very dangerous, has claimed over hundred lives in America,
and should be prohibited. The latter, however, has been practiced very
safely for over hundreds and thousands years.
Prohibition of the former should not involve the latter, which has been
treating diseases and saving lives for millions and billions of patients around
the globe.
(2)
Format
These bills have not made detailed distinction between ephedrine alkaloids
contained in pure extract format of dietary supplement ephedra and the raw
Chinese herb format of ephedra.
The former is in pure extract format, similar to manufactured chemicals and
pharmaceuticals, and does not belong to Chinese Herbal Medicine anymore.
It has lost its status as Chinese herbal medicine, and is equivalent to
chemical drugs. The profession of Chinese Herbal Medicine does not
recognize the former as Chinese Herbal Medicine although it is extracted
from Chinese herbs.
The latter has always been used in combination with many other raw herbs
to form a formula, which will offset and suppress the side effects of
ephedrine alkaloids contained in it, and has been proved to be very safe in
millions and billions of clinical practices.
(3)
Dosage
These bills have not made detailed distinction between the application of
pure extract ephedrine alkaloids at relatively high dosage and the application
of Chinese herbal formula that contain trace amount of ephedrine alkaloids.
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The former, due to its pure format, can be applied in very high dosage that
could be very harmful and dangerous.
The latter -- trace amount of ephedrine alkaloids used in Chinese herbal
formula, is very different from the former. The dosage of the ephedrine
alkaloids contained in the raw herbs and formulae are very low relative to
the former. In addition, the toxicity and side effects of the trace amount of
ephedrine alkaloids have been offset and suppressed by other herbs in the
formula. Therefore, the latter is very safe, and should not be treated in the
same way as the former.
(4)
Ephedra vs. Other Chinese Herbs
These bills have not made detailed distinction between ehpedra and other
raw Chinese herbs containing trace amount of ephedrine alkaloids.
The vague term “dietary supplements containing ephedrine alkaloids” in
these bills have not differentiated the amount of ephedrine alkaloids to be
regulated. Then, “any amount” could be assumed. This would target
dozens and hundreds of Chinese herbs and formulae that contain trace
amount of ephedrine alkaloids.
In addition to ephedra, another herb that is targeted is ban xia (rhizoma
pinelliae). The list will be growing to very long if one follows above
mindset to treat Chinese herbs.
The long history of Chinese Medicine has never met current situation
before: began with public abuse of one herb; then followed by ban of dozens
or hundreds of herbs and formulae containing ingredient of the abused herb.
Both the former (abuse of herb) and the latter (ban of related herbs) should
not happen from the beginning. If we can prevent the former, the latter will
be out of the question. Unfortunately, current solution is to use a new
mistake (the latter) to cover up the existing mistake (the former).
In fact, most, if not all, pharmaceutical drugs can be found with various
amounts (from trace to moderate) in Chinese herbs. Then why Chinese
Herbal Medicine has been practiced very safely for thousands of years by
qualified doctors and practitioners of Chinese Medicine? The answer is that
the ingredients of pharmaceutical drugs existed in Chinese herbs have very
different purities from the pharmaceutical drugs manufactured in the labs.
The combination of many different ingredients in one herb, and further in a
well-designed formula help buffer, offset, and suppress the side effects of
most pharmaceutical drugs existed in the herb or formula.
For the same chemical ingredient (for example, the ephedrine alkaloids), its
toxicity and side effects completely depend on its format. Its toxicity and
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side effects can reach that of the pharmaceutical drug’s level if it’s in a pure
extract form (as in the ephedra dietary supplement extract) although it is
extracted from raw Chinese herbs. However, its toxicity and side effects are
very low when it’s in the raw herb format. Furthermore, its toxicity and side
effects can be reduced to non-observable if it is applied appropriately in a
well-designed formula by qualified doctors and practitioners of Chinese
Medicine.
Therefore, from the safety viewpoint, all Chinese herbs (including ephedra
and ban xia) should be regulated (public should not get access to them)
rather than banned (doctors and practitioners of Chinese Medicine should be
able to get access to them).
From the efficacy viewpoint, ephedra, ban xia, and all other Chinese herbs
and formulae are very important in treating diseases and saving lives for
millions and billions of patients around the world. If these Chinese herbs
containing various amounts of ephedrine alkaloids are banned, millions of
patients will suffer due to lack of these herbs. Some of them will end up
with undue death due to inaccessible to these life-saving herbs.
Therefore, from the efficacy viewpoint, these Chinese herbs (ephedra, ban
xia, etc.) should be regulated (public should not get access to them) rather
than banned (doctors and practitioners of Chinese Medicine should have full
access to them).
More detailed discussions and information on herbal ban vs. herbal
regulation are available at [1,3].
(5)
Exemption for Chinese Herbal Medicine
Unlike the FDA’s final rule, these bills have not made exemption for the
professional use of Chinese herbs containing various amounts of ephedrine
alkaloids in the professional practice of Chinese Herbal Medicine.
As mentioned above, Chinese herbs containing various amounts of
ephedrine alkaloids have been proved to be very safe in the professional
practice of Chinese Herbal Medicine for thousands of years. Professional
practice use of Chinese herbs containing ephedrine alkaloids has not been a
problem for thousands years. It is the recent public abuse of Chinese herbs
containing ephedrine alkaloids that brought this issue up. Therefore, what is
needed is to regulate (prevent the public from getting access to Chinese
herbs containing ephedrine alkaloids) rather than to completely ban (in
which professionals of Chinese Medicine also cannot get access to these
herbs) Chinese herbs containing ephedrine alkaloids.
(6) Pharmaceutical Research vs. Herbal Medicine Research
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The two bills rely on many pharmaceutical studies and research on Chinese
herbs. This approach is inappropriate.
As pointed out in the original "Letter to the Congress" [1] and the
"Recommendation on Chinese Medicine in the United States of America."
[3], the herbal medicine system is completely different from the
pharmaceutical system. It is inappropriate to apply conclusions obtained in
the pharmaceutical system directly to the herbal medicine system. For
pharmaceutical system, the single body or linear system nature usually will
generate severe toxicity and side effects. For herbal medicine system, the
multi-body, non-linear system nature usually will be able to offset and
suppress the toxicity and side effects.
Another flaw of the pharmaceutical studies and research on herbal medicine
is that they violate the fundamental characteristics of Chinese Herbal
Medicine -- Bian Zheng Lun Zhi. The ephedra event actually originated
from some pharmaceutical research on ephedra conducted around 70s.
Those pharmaceutical research on ephedra were reliable from the
pharmaceutical viewpoint. However, because they did not follow Bian
Zheng Lun Zhi, their conclusions were invalid from the Chinese Herbal
Medicine viewpoint. It is inappropriate, inaccurate, and misleading to draw
those conclusions based simply on pharmaceutical research on ephedra.
Unfortunately, many people followed those conclusions, and become
victims of ephedra event.
Therefore, the conclusions drawn from pharmaceutical studies cannot be
applied to herbal medicine system directly. Well designed herbal medicine
research based on Bian Zheng Lun Zhi should be conducted in order to reach
reliable and valid conclusions on herbal medicine system.
In order to achieve this, another issue addressed in the original "Letter to the
Congress" need to be resolved. It is necessary to establish an independent
"FDA Division of Herbal Medicine" in order to supervise and regulate the
studies and research of herbal medicine system [1]. Accordingly, the
"Federal Food, Drug, and Cosmetic Act" should be amended in order to
provide a legal status for professional herbal medicine in America (see
above).
In sum, from both safety and efficacy viewpoints, Chinese herbs containing ephedrine
alkaloids form an integral part of the Chinese Medicine system, and are very important in
fighting diseases and saving lives for millions of patients. It is necessary to introduce
bills to regulate, rather than to ban, Chinese herbs containing ephedrine alkaloids so that
the public abuse of these herbs will be prohibited, while the professionals of Chinese
Medicine are still able to use these herbs to fight diseases and save lives.
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Due to above reason, the bills H. RES. 435 and S. RES. 260 need to be revised in order to
incorporate above viewpoints and to resolve these issues appropriately and
professionally.
6. Acknowledgements
Around August 2002 and a few months thereafter, due to lack of understanding about the
nature of the Ephedra event, the media associated the Ephedra event with Chinese herbs
and Chinese Herbal Medicine, which left people and the public with an impression that
Chinese herbs were toxic and that Chinese Herbal Medicine was dangerous. As a result,
many patients and the public feared not only Ephedra, but also all Chinese herbs and
Chinese Herbal Medicine. The reputation and image of Chinese Herbal Medicine were
severely damaged. If that situation were to continue, the future of Chinese Herbal
Medicine would be unpredictable. The original “Letter to the Congress” was initiated in
direct response to that situation and its impact on Chinese Herbal Medicine.
We noticed that the media’s inappropriate attitude towards Chinese herbs and Chinese
Herbal Medicine had changed after the original “Letter to the Congress” was submitted to
The New York Times, CNN, The Associated Press, The Chicago Tribune, to radio
stations, etc. Today, media coverage of the Ephedra event and the environment
surrounding Chinese herbs and Chinese Herbal Medicine is more objective and
constructive than in August 2002. We would therefore like to thank everyone in the
media whose time, understanding, and work have directly and/or indirectly led to these
positive changes.
We also noticed that since the initiation of the original “Letter to the Congress”, some
positive changes have taken place in the FDA surrounding the Ephedra event (see the
four issues mentioned above). These changes will benefit not only the profession of
Chinese Herbal Medicine and the FDA, but also millions of Americans. As a follow-up
to the original “Letter to the Congress”, we would like to thank the members and their
staffs in the U.S. House, the U.S. Senate, the U.S. House Committee on Energy and
Commerce – Subcommittee on Health, the U.S. Senate Committee on Health, Education,
Labor and Pensions, and Secretary Thompson of Health and Human Services for their
time, understanding, and work that helped to bring about these positive changes. Thanks
also to the Honorable Congresswoman Judy Biggert and her staff for their time and
understanding on issues addressed in the original “Letter to the Congress”.
Finally, ACMA would like to thank Dr. Richard Freiberg, President, Acupuncture and
Oriental Medicine National Coalition (AOMNC); Mr. Robert Marcus, Marcus &
Associates; and Dr. David Molony, Vice President, American Association of Oriental
Medicine (AAOM) for valuable discussions and feedbacks on this follow up letter.
References:
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1. Xu, B. Letter to the Congress. American Chinese Medicine Association (ACMA)
Publication Issue Aug 2002. http://www.americanchinesemedicineassociation.org
2. Xu, B. On Chinese Medicine vs. Oriental Medicine. American Chinese Medicine
Association (ACMA) Publication Issue May 2003.
http://www.americanchinesemedicineassociation.org
3. Xu, B. Recommendation on Chinese Medicine in the United States of America.
American Chinese Medicine Association (ACMA) Publication Issue Dec 2001.
http://www.americanchinesemedicineassociation.org