The FDA and the Past, Present, and Future of Herbal Medicine

By Dr. Quinn Takei

For thousands of years Ma Huang (Herba Ephedrae) has been a standard and important herb in the Chinese Pharmacopoeia. Traditionally, this herb is used to release the exterior and disperse cold, facilitate the movement of lung qi, and promote urination to reduce edema. In recent years, herbal supplement companies, usually selling directly to the public, have used ephedra, frequently combined with other stimulants such as caffeine, for weight loss. As a result of what many Oriental Medicine practitioners consider an inappropriate use of this herb, consumers of these weight loss herbal supplements have developed a variety of health problems. Approximately 150 people died.

The FDA first tried to take control over the distribution of ephedra in 1997. This attempt was unsuccessful due to strong opposition from mainstream herbal industries and Congress. However, the FDA did create tighter guidelines for label warnings and proper dosages.

In 2003 Baltimore Orioles pitcher, Steve Bechler, unexpectedly died as what was believed to be the result of a supplement containing ephedra. This incident, as well as numerous other reports, prompted the FDA to take steps to ban all ephedrine alkaloids. The FDA concluded that dietary supplements containing ephedrine alkaloids are adulterated and present a significant and unreasonable risk of illness or death [Section 402(f)(1)(A) of the FD&C Act]. New rules placed a ban on all “dietary supplement” products containing ephedra alkaloids effective April 14, 2004. A passage in this ruling appeared to exempt herbs used in Oriental Medicine. The FDA stated, “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.” However, by FDA definition, herbs and herbal products are technically considered “dietary supplements”.

Recently the Oriental Medicine community has learned that this ban not only will affect the distribution of ma huang, but also ban xia (Rhizoma pinelliae ternatae). According to the FDA, ephedrine alkaloids were discovered in ban xia.

Traditional Asian Medicine's “exemption” The FDA's statement that this ban is not applicable to traditional Asian medicine introduces a wide variety of questions and problems.

1. As already stated, herbs and herbal products are technically considered “dietary supplements”. “FDA” stands for Food and Drug Administration. They have only two classifications to which all products are grouped. Products are either a food (and dietary supplements) or a drug. One or the other. Herbal products fall into the food and dietary supplement group. The FDA stated that the ban is not applicable to traditional Asian medicine, only to dietary supplements; however, the heart of traditional Asian medicine is herbs a.k.a. “dietary supplements”. This ambiguous wording leaves many practitioners and herbal companies confused and unsure of their liability. Numerous organizations and individuals have requested clarification from the FDA.

2. Another problem is the ambiguity of the term “traditional Asian medicine”. The FDA did say that traditional Asian medicine is exempt from the ban, yet has not clarified specifically how “traditional Asian medicine” is defined. Does this mean only licensed practitioners of Traditional Chinese Medicine? What about Japanese style practitioners or people that are Worsley trained? What about practitioners in states that do not require licensing? Does this mean that these herbs can only be purchased from a person of Asian blood or only sold in a “Chinatown”? Does this only mean people that have successfully completed the NCCAOM herbal examination? What about all the licensed DOM's that have not taken the NCCAOM herbal examination? Does “traditional Asian medicine” include ayurevedic medicine? What about individuals trained in western herbal medicine who wish to use these herbs to help their clients? Can companies selling weight loss supplements claim that their miracle herbal products containing ephedra alkaloids are actually an ancient “traditional Asian medicine” formula? Lack of clarification behind the meaning of “traditional Asian medicine” can easily lead to confusion. And of course, each party mentioned above will have strong opposing opinions on just how “traditional Asian medicine” is defined.

3. Even if it is decided that these herbs are still accessible to practitioners of “traditional Asian medicine”, however defined, will they be able to pass port authorities and inspectors and be imported? Herbal companies seem to have differing opinions on this issue. In an attempt to protect our country after 9/11, security at our entry ports has become much tighter. Unfortunately port authorities are not trained to determine which herbs are harmful and which are healthy. Nor are they aware which companies should and should not be able to receive certain shipments. Some herbal companies I have spoken with state that they simply cannot get ma huang or ban xia into the country. Other companies are attempting to complete paperwork testifying that they are in fact in the business of “traditional Asian medicine” and not selling these substances as weight loss products. It remains uncertain if these steps will work. One company remarked that the FDA's statement exempting “traditional Asian medicine” is basically meaningless because no one can get the products into the country anyway.

Several companies feel that getting these herbs through the port authorities and into the USA is based on the luck of the draw and which inspector happens to be working the day the herbs are inspected. Some inspectors are more willing to let certain products enter. One herbal company has had a shipment of wu ling zhi (Excrementum trogopteri seu pteromi) detained at the port for over 6 months. Why? (Wu ling zhi has not been found to contain ephedrine alkaloids or aristolochic acid) Again, remember, the FDA only has 2 classifications; drugs and food. A port inspector deemed wu ling zhi not fit for consumption as a “food” and the shipment was seized. Despite the fact this particular herbal company has sent the port authorities extensive documentation testifying to facts of this herbs' uses in “traditional Asian medicine” the shipment to this day is still confiscated. Apparently once a shipment has been seized it is very difficult to have it released. Their only chance of gaining custody of their shipment is to go to court which is bound to cost significant amounts of money. Can herbal companies afford to spend thousands of dollars in court battles for each herb that port inspectors deem unfit for food? Wu ling zhi, while listed as a standard herb in the Chinese Pharmacopoeia, is not used as frequently as other herbs. Perhaps Asian medicine can forgo the expensive court fees and live without it, but what herbs will next be detained?

Does Ban Xia REALLY contain ephedrine alkaloids?
When the FDA stated that all herbs containing ephedrine alkaloids were going to be banned, we all knew that included ma huang. It was not until later that the Oriental Medicine community realized ban xia, a much more commonly used herb, would be included. In fact, ban xia is considered to be used in at least 20% of all tradition Chinese herbal formulas. Why did we not know that this ban on ephedrine alkaloids would also include ban xia? The answer is simple according to the organizations and individual I have spoken with while organizing this article…we did not know this ban would include ban xia because there are no ephedrine alkaloids in ban xia. Why then was ban xia included? Because the FDA found documentation from the 1970's stating that trace amounts of ephedrine alkaloids were present in ban xia. However they admittedly have not done their own testing to ensure that this information was accurate. Herbal companies are currently working with laboratories to have ban xia examined in the attempt to scientifically verify that ban xia is free of ephedrine alkaloids and should be removed from the ban. Some herbal companies I have spoke with are optimistic that ban xia can be saved due to the mass amount of information being submitted to the FDA. This seems to be only a ban-aid fixing the current problem. What is next?

The Herbal supplement business; our best friend and worst enemy.
It is clear that the fundamental classification system of the FDA could be revised to better address our herbal products, however we are working within the current system which categorizes medicinal herbs as a food and dietary supplement. Though Oriental Medicine does not use ma huang or ephedrine alkaloids as herbs for weight loss, herbal supplement companies such as Metabolife and Xenadrine have used herbs of this nature extensively for this reason. In fact, according to the RAND report which analyzed the ma huang based supplements, not one adverse incident was reported when this herb was used within the context of Chinese medicine treatment protocols. Clearly it is not the traditional use of ma huang that has caused injury but the “misuse” of this herb by herbal supplemental companies and individuals taking an inappropriate dosages. Sure, it would be great to point our fingers at them and say, “they did it, it wasn't our fault… they're the enemy, we are the good guys” but according to current FDA structure we are all one group.

At the same time these companies are our best friend because they can afford to pay out hundreds of thousands of dollars in lobbyists and as campaign contributions to our legislators. The Oriental Medicine profession simply does not have the muscle to do so on our own…yet. It has been estimated that herbs used for traditional Asian medicinal purposes compose only about 2% of all herbal sales in the United States. In short, Oriental Medicine is a little fish in a big pond and could easily be eaten up by the bigger fish if we take a wrong step and make one of them upset.

While working together with the herbal supplement business may appear the best way to go, can we buddy up with organizations whose use of herbs is philosophically different and problematic with our own? Though we may disagree on the use of certain herbs, given the current FDA structure we may have to work together. But how?

The Next Endangered Herb:
Zhi shi (Fructus immaturus citri arantii) and other citrus herbs (including chen pi) appear to be the next herbs that may be in danger of being banned. Consumer Reports printed an article this spring which has drawn a great amount of attention to the “dangers” of taking herbs. This article stated, “These unsafe supplements include Aristolochia, an herb conclusively linked to kidney failure and cancer in China, Europe, Japan, and the U.S.; yohimbe, a sexual stimulant linked to heart and respiratory problems; bitter orange, whose ingredients have effects similar to those of the banned weight-loss stimulant ephedra; and chaparral, comfrey, germander, and kava, all known or likely causes of liver failure.”

Herbal companies I have spoken with believe all citrus herbs and especially zhi shi are in danger of being banned. Can herbal companies remain in business if they can no longer sell herbal products containing herbs from the citrus family not to mention the already banned ma huang and ban xia? This group of herbs includes: zhi ke (fructus citri aurantii), zhi shi (fructus immaturus citri aurantii), qing pi (pericarpium citri retculatae viride), chen pi (pericarpium citri reticulati), ju he (semen citri reticulati), fo shou hua (flos citri sarcodactylis), fo shou (fructus citri sarcodatylis). As the use of our herbs becomes diminished it calls into question the entire future of our profession.

A Possible Solution:
As discussed, the current FDA is composed of two categories: food (and dietary supplements) and drugs. A possible solution currently being discussed is the creation of a third category: Traditional Medicinal Botanicals. The implementation of such a category could prove to be very advantageous for the Oriental Medicine profession. This category would take medicinal herbs out of the “food and dietary supplement” category and eliminate restrictions placed on such products considered foods or dietary supplements. This could separate our use of herbs from larger herbal supplement companies selling primarily directly to the public.

What can you do to help?
Join your state and national associations. It is generally agreed that the days of less regulation are over and from this point on joining your state and national associations can have a dramatic impact on our future in two primary ways:

1. There is strength in numbers. During a recent conversation with the AAOM Executive Director it was pointed out that less than 10% of all practitioners belong to a professional association. We as practitioners all want the same thing; to protect our profession and our ability to practice. Yet very few are doing something about it, and even less have united to do something about it together. The practice of Oriental Medicine is constantly “under attack” or being threatened by numerous parties or individuals such as the FDA, some western MD's, some chiropractors, and other models of medicine. It is a fact that larger groups have bigger voices and the time has come that it is necessary for each of us to get involved and come together to preserve Oriental Medicine.
The AAOM is in the process of organizing “ The Presidents Campaign for Unification ”. This will attempt to unite each state association to collect valuable information from each member as well as an effective vehicle of disseminating information to each and every practitioner.
In addition to “The Presidents Campaign for Unification” there are discussions by state organizations and the AAOM considering “dual” or “joint” association memberships in an attempt to increase membership numbers. The idea being considered is when an individual joins one association, they automatically become a member of another and can take advantage of the benefits offered by each.

2. It will take more funding than state and national organizations are currently capable of to preserve our ability to use herbs. The preservation of our herbs could be a long uphill political fight that will take funding to support lobbyists and all the other necessary political maneuvering.
The OMANM is considering creating a fund specifically to be used in preserving our access to herbs. Money raising activities for this fund are being discussed. Please keep your eye on these fund raising events and join your state and national associations.
Communicate with your representatives and political leaders. In the world of politics, personal relations and who you know goes a long way. It is important, now more than ever, to foster political ties. We must educate our representatives on herbs and how they are used and most importantly, express to these representatives what we want for our profession.
Enclosed with this newsletter is a letter drafted by Dr. John Chen that we ask you to send to your representatives. Our representatives are more apt to listen knowing there is a large group of individuals sharing the same concerns. As a New Mexico resident, please copy the attached letter or create your own letter and send to the following individuals within one week of receipt of the Point:
Send one letter to your district representative :

Steve Pearce (District 2: South NM, Roswell, Las Cruses)
1408 Longworth House Office Building
Washington, DC 20515
202-225-2365
Fax: 202-225-9599
Email: http://www.house.gov/writerep/

Thomas Udall (District 3: North NM, Santa Fe, Taos)
1414 Longworth House Office Building
Washington, DC 20515
Telephone: 202-225-6190
Fax: 202-226-1331
Email: http://www.house.gov/tomudall/letstalk.htm

Heather A. Wilson (District 1: Albuquerque)
318 Cannon House Office Building
Washington, DC 20515
202-225-6316
Fax: 202-225-4970
Email: http://wilson.house.gov/Contact.asp

Send a letter to each of the following senators :

Senator Jeff Bingaman
Class I 703 Hart Senate Office Building
Washington, DC 20510
(202) 224-5521
E-mail: senator_bingaman@bingaman.senate.gov

Senator Pete Domenici
Class I 703 Hart Senate Office Building
Washington, DC 20510
(202) 224-6621
Web Form: domenici.senate.gov/resources/contactform.cfm

Send a letter to each of the following individuals who are believed to be in strong opposition to the use of herbal medicines and supplements:

Henry Waxman
8436 West 3rd St., Suite 600
Los Angeles, CA 90048
(323) 651-1040


Edward Kennedy
2400 JFK Building
Boston, MA 02203
617/565-3170

Please also send a copy of each letter you send to your representatives to the OMANM at PO Box 91293, Albuquerque, NM 87199, so that there is a record of your concerns; so that we can show our representatives how many people are affected. Once these letters have been sent, the OMANM Herbal Committee will contact these representatives and request a meeting to discuss how herbs are used in our profession and our suggestions for ensuring availability in the future.

In Conclusion : Without doubt herbs are becoming more regulated. The AAOM and AHPA are working with the FDA to help the Oriental Medicine profession, but more has to happen. As much as I hate to sound like an alarmist, look at the facts. Two important herbs in Oriental Medicine are already gone and other herbs are under scrutiny, following in their footsteps down the path to becoming banned. We may hope that someone else or some other group does something to protect our herbs, our living, and our medicine that helps our patients everyday, or we can aid in this effort ourselves.

Thank you Dr. John Scott and Golden Flower Herbs, Dr. John Chen and Evergreen Herbs, AAOM, AOMA, AHPA, and all the herbal companies I have spoke with for your information and input in this article.

For more information please contact:
The Herbal Committee Chair, Dr. Quinn Takei at (505) 306-3155 or
Dr. Selah Chamberlin (505) 751-3284 .

Sample Letter