Information on the FDA Ephedra Ban
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
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
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)
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.
For a list of the government representatives in your area, please
The following is a partial list of FDA representatives. Call/email/fax:
Mark McClellan, MD
Wayne Amchin, Ephedra contact
Center for Food Safety and Applied Nutrition (HFS-007)
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857
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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