The following announcement was sent to Acupuncture Today on March 24 from the California State Oriental Medical Assocation (CSOMA). Readers are also encouraged to visit CSOMA's Web site for more information.
* * *
Greetings, Friends and Colleagues:
On February 11, 2004, the Food and Drug Administration issued a 263-page final ruling that prohibited the sale of dietary supplements containing ephedrine alkaloids.They cited that these supplements present an "unreasonable risk of illness or injury" to the general public. The complete 263-page rule was published in the Federal Register Feb. 11, and becomes effective April 12, 2004, sixty days from the date of publication. Important links regarding the ruling from the FDA website follow.
Questions and Answers about FDA's Actions on Dietary Supplements Containing Ephedrine Alkaloids
Federal Register - Final Rule
Final Rule Summary
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
I am writing to inform you something quite disturbing that I have just learned. Over the past week, I have had extensive conversations with four FDA attorneys, a government personnel, and a few other sources, and they have all confirmed that while FDA's intention is to remove unsafe products from the market, the implication is that the FDA has banned the use of any product that contains Ma Huang (Herba Ephedrae) and Ban Xia (Rhizoma Pinelliae) altogether.
As you may be aware, on February 11, 2004, the FDA published a final regulation to ban over-the-counter sales of products that contain ephedrine alkaloids (21 CFR Part 119). In this regulation, it stated that products that contain ephedrine alkaloids cannot be sold as "food" because it is unsafe as food. Further, it stated that it will "ban all products marketed as dietary supplements that contain any amount of ephedrine alkaloids." If these products cannot be sold as "food" or "dietary supplement," the only other place where it can be classified is as a "drug." This essentially will be the end of any product that contains ephedra or pinellia (it costs about 900 million dollars R&D to get a drug approved by the FDA).
[The FDA's statement: that "these products are beyond the scope of this rule because they are not marketed as dietary supplements" and "This final rule does not affect the use of Ephedra preparations in traditional Asian medicine..."] This is not correct because all Chinese herbal products are regulated as dietary supplements - according to the law, this is the only place they can be classified. We may think of them as Chinese herbs or herbal medicine, but they legal classification is "dietary supplements." Chinese herbs are not food, and they are definitely not drugs. So the only way for traditional Asian medicine to be exempt is they have to literally be approved and classified as "medicine." And even [if] this were the case, acupuncturists would not be able to use it because we are not licensed to prescribe "medicine" or "drugs."
This regulation will be in effect on April 12, 2004. I know we need to do something and we need to do it quickly. I am hoping that above information above will be a catalyst to bring the TCM community together, and hopefully, we can fight to preserve our right for continued access to our medicine.
John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac.
In follow-up discussions with John Chen and Gene Bruno, President, of the AAOM, CSOMA has pledged Board support to their ongoing discussions with the FDA on behalf of the profession. We feel that it has been the result of the effective work of the AAOM that has warranted the current "exemptions" that appear to have been afforded to the traditional Asian medical practitioners community. To that extent, this represents a "Call to Action" for our members to initiate a campaign to inform our federal representatives (congressional & senate) of our need for continued access to these potentially banned herbs. When writing, please indicate the following:
- You are a Licensed Acupuncturist in their voting district.
- The FDA has potentially banned your use of ephedra (ma huang) and pinellia (ban xia) because they have ephedrine alkoloids.
- There have been no adverse events reports with ephedra or pinellia being prescribed by a practitioner, ever.
- You use ephedra and pinellia regularly in my practice and they are used safely according to my extensive traditional Asian herbal training.
- Request they communicate to the FDA on your behalf to ask that the FDA's recent ephedrine alkoloid ban be revised to allow your (and other appropriately licensed practitioners) access to dietary supplements that contain ephedrine alkaloids in my practice for use in traditional formulas and for traditional uses.
We ask that letters be addressed to your federal congressional and senate representatives as well as FDA representatives [see John Chen's "call to action" addendum] and that a copy be sent to CSOMA's office at advocacycsomaonline.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 advocacycsomaonline.org with a title of Response to Ephedra Ban, or you may fax your responses to 916-455-0356.
Howard Kong, MS, LAC, President
CSOMA Board of Directors