Letter to Congress-Follow Up (1)

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 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.

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. …”

“… 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.

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.

(2) Medical Practice Act

During our contact with the FDA, the FDA acknowledged that Chinese herbs have medicinal functions in treating diseases and curing illnesses. However, the FDA further pointed out 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 short-term 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 re-classify 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 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 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 “Federal Food, Drug, Herb, and Cosmetic Act”. This is the legislative 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.

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 it 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.

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 term “dietary supplements containing ephedrine alkaloids” in these bills has not differentiated the amount of ephedrine alkaloids to be regulated. Then, “any amount” could be assumed. This would lead to 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 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).

(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 never been a problem in the profession of Chinese Herbal Medicine. It is the recent public abuse of Chinese herbs containing ephedrine alkaloids that brought up this issue and other problems. 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
　
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 became 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).
　
More detailed discussions and information on herbal ban vs. herbal regulation are available at [1,3].
　
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.

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:

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

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