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 Information on the FDA Ephedra Ban


by Marc Sklar, L.Ac.

Fear is being infused into the natural supplement industry, and licensed healthcare practitioners such Chinese Herbalists, Acupuncturists, Chiropractors, and Naturopaths alike are being affected.  The hysteria concerning safe, effective, and potent natural supplements for various health concerns is warranted.  The American and world public have the right to be concerned about the supplements they buy and ingest.  They also have the right to, and should demand, that higher standards and regulations be implemented to ensure the safety and health of those individuals taking supplements for their health conditions.  

Walking into your local health food store to purchase your multivitamin has become routine for most Americans.  We stare at the isles of bottles with dismay wondering which brand is better, yet not over priced.  Who better to answer this question then the sales person behind the counter, right?  Wrong.  These individuals are usually not trained in nutrition and herbal therapy.  They are informed by the company's sales representative who is feeding the sales person the information necessary to better sale their product.  This is what we as consumers have been depending on for our health care needs.  When it comes to vitamins and minerals the sales person at your local health food store may be suited just fine.  However this is not the case when it comes to finding effective, trustworthy, and dependable herbal supplements.  

Herbal medicines are supplements comparable to pharmaceuticals.  Many of today's pharmaceutical drugs were and are derived from herbal products such as trees, plants, and fruits.  Chinese herbal medicine has been utilized for centuries to treat various health disorders, yet the formulas given to patients were prescribed by trained practitioners.  The same is true to all forms of herbal medicine.  Herbal medicine is not benign, when prescribed and taken inappropriately, like ephedra, dangerous health conditions may arise.

The issue of ephedra is a recent one.  The use of ma huang/herba ephedra and ban xia/rhizoma pinelliae in chinese patent medicines is effectively banned in the US.  This is because 155 deaths have occurred in the past five years due to the inappropriate use of this herb in products used for weight loss, body building, energy and recreation.  Chinese Medicine has safely used ma huang and ban xia for asthma for thousands of years. There is not one adverse incident reported for these herbs when prescribed by licensed healthcare practitioners.

Let me give you a brief explanation of how Chinese Herbal Medicine works.  Individual substances are rarely prescribed alone in Traditional Chinese Medicine.  A carefully balanced recipe of several different herbs is specifically tailored for each person's entire health condition.  Each herb is chosen for its own specific functions.  A Chinese Herbal formula has as many as 20 different herbs. The herbs are selected to work synergistically to treat the whole person.   In Chinese medicine, due to our diagnostic system, we are able to assess a persons whole constitution (the health of their whole body) and treat the root (or cause) of a health concern along with a branch (or the symptoms) of a health concern.  In addition, herbs can enhance the strengths and reduce the side effects of each other.  The combination of substances in a formula creates a new therapeutic agent that can treat conditions much more effectively and completely than that of a single substance.  It is in this way that we are able to treat a person's whole body and mind, rather than just a symptom.

We in the Chinese Herbal Medicine community would like to show our support for higher regulations of herbal products.  We would also like to ask for your support (the public) in our fight for the continued use of Chinese Herbal Medicine, by licensed healthcare practitioners, with higher regulatory standards.  If you are a proponent of Chinese Herbal Medicine and would like to continue to have access to its health benefits you can help be writing your local congressperson and to Food and Drug Administration.  For your benefit we have included a sample letter for your use.  Feel free to use this letter as is, or to modify this letter as you see fit.  We have also included a link to help you find out who your local representatives are.
 
More detailed information about the recent FDA ruling on ephedra, its effects and the professional response, including government contact information it can be found HERE.

Example Letter (should be cut and pasted into a word document)

Dear ......,

I am a citizen in your voting district and I am writing to express my concern as a patient of Traditional Oriental Medicine with regard to the final FDA ruling declaring Dietary Supplements containing Ephedrine alkaloids adulterated.  As an individual who uses Herbal Supplements, Vitamins and Minerals I appreciate your concern for the health of the general public.  I also agree with the FDA that higher regulatory standards need to be established and enforced.  However the FDA has banned the use of Ephedra (Ma Huang) and Pinellia (Ban Xia), by licensed herbalist and healthcare practitioners because they contain ephedrine alkaloids. There are no Adverse Event Reports (AER) regarding the herbs Ephedra (Ma Huang) and Pinellia (Ban Xia), from a practitioner-restricted product. In other words, the FDA has not followed due process with this herb.

Review of the safety, benefits, or traditional uses of Pinellia rhizome (ban xia  or Pinellia ternatae) has not been conducted. Considering the very low level of ephedrine alkaloids in this herb, the appropriateness of the ban on this herb should be questioned.  FDA cites significant Adverse Event Reports for the herb Ephedra but none were related to any product sold to or by professional practitioners.  No Adverse Event Reports at all have been associated with Pinellia (Ban Xia).   

I use Ephedra (Ma Huang) occasionally and Pinellia (Ban Xia) regularly as prescribed by my healthcare practitioner, and fear that I will no longer be able to gain the benefits it provides due to the current ban.  My concern does not stop with these two herbs, it begins here.  Chinese herbal medicines are not like other nutritional supplements on the market and should not be regulated in the same manner.  They are utilized by specialists trained in its history, theory, dosages, and side effects.  Thus, they should be classified under their own regulatory category.    

Please communicate to the FDA on my behalf that I would like to request that this recent ban be amended, to allow access to dietary supplements that contain ephedrine alkaloids for use in traditional formulas and for traditional uses, as prescribed by a licensed herbalist, acupuncturist, and naturopath.

Please be aware that the preamble to the rule (Docket No. 1995N-0304, RIN 0910-AA59) does state that the ban on ephedrine alkaloids does not apply to Chinese medicine herbal formulas, however this statement is not found in the text of the ruling.  This exemption needs to be placed into the actual rule to help clarify the confusion surrounding its use in Traditional Chinese Medicine.

Sincerely,

XXXXXXXXX


For a list of the government representatives in your area, please access:
www.congress.org
www.house.gov
www.visi.com/juan/congress/
 
The following is a partial list of FDA representatives. Call/email/fax:
Mark McClellan, MD
commissioner@fda.gov
Phone: 301-827-2410

Thomas Thompson
tthompson@nctr.fda.gov
Phone: 870-543-7248

Robert Moore
robert.moore@fda.hhs.gov
phone: 301-436-1441

Joseph Baca
Joseph.baca@cfsan.fda.gov
Phone: 301-436-2359
Fax: 301-436-2717

Wayne Amchin, Ephedra contact
Center for Food Safety and Applied Nutrition (HFS-007)
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857
Phone: 301-827-6733


Marc Sklar completed his undergraduate degree in Comparative Religion at the University of Florida . While attending the University, Sklar was exposed to Oriental medicine after searching for the most effective way to recover from an illness. This experience was a catalyst to expand his studies of Asian religions to include Oriental medicine. To pursue his interest, he explored the Middle East, India , and Nepal . Upon returning to the United States , Marc moved to San Diego to pursue and complete his Masters of Science in Traditional Oriental Medicine at the Pacific College of Oriental Medicine. While studying at the Pacific College , Sklar became involved with the politics of the profession and its need for continued acceptance and integration in the American medical system. During his last two years, Sklar represented his contemporaries on the student council in several executive positions and ultimately as their president. While in college, he helped establish the student organization of the California State Oriental Medical Association and now serves on the board of directors.



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