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Much
has been written and spoken about Ma Huang
(Ephedrine) lately, and some concerns have
been raised regarding its use as a dietary
supplement. Unfortunately, as Dr. Zoltan P.
Rona, a practicing medical doctor in Toronto,
Canada, has noted, "much of the information
being released on Ma Huang is misleading."
While TSN Labs, Inc. sees it as a positive
sign that people are taking an interest in
the safety of the supplements they use, we
feel it is extremely important that these
people have available to them accurate and
credible information upon which to base their
judgements. For this reason, the following
information is provided with the intent of
educating supplement users as to the background
and current situation surrounding the use
of one of nature's oldest medicines. Simply
put --- Don't believe the hype..... Educate
yourself!!!! For more information on one of
the Safest, Simplest and most Effective natural
weight loss Ma Huang products available, check
out Thin & Slim Naturally. Choose from
the following categories, or scroll down through
the page.
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Ma
Huang History
Ma
Huang is known as one of the world's oldest medicines.
Ma Huang (also known as Ephedra herb) is a member
of the family of herbs known as the Ephedraceae. It
has been used in China for more than 5,000 years to
treat symptoms of asthma and upper respiratory infections.
Related varieties of the herb are also grown in India,
Europe, Australia, and Afghanistan. American ephedra,
native to the dry southwest, was used as a tea by
the area's native people and introduced to early American
settlers, who called it "Mormon Tea." It has also
been used in the treatment of headaches, fevers, colds,
and hay fever. Today, compounds derived from this
herb are commonly found in many over-the-counter (OTC)
cold and allergy medications. Ma Huang is also found
in some weight loss and energy products. For dieters,
it suppresses the appetite and stimulates metabolism
through a process known as thermogenesis. Recently, Ma Huang has been the subject
of scientific research for obesity because of this
thermogenic fat-burning effect.
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The
Current Situation
Congress
enacted the Dietary Supplement Health & Education
Act (DSHEA) to protect consumers and prevent the arbitrary
regulation of herbal dietary supplements. DSHEA provides
that herbal supplements may be restricted only
when a product poses an imminent hazard to the public
health when consumed at its labeled servings.
Nevertheless, the Food and Drug Administration (FDA)
and several states are now considering violating DSHEA,
by taking severe regulatory action that would remove
ephedra herb dietary supplements from the market,
or so restrict their content and labeling as to effectively
preclude their use. These drastic actions purposefully
ignore the wide body of scientific literature, several
dozen clinical trials in humans, extensive animal
studies, and recent reviews by expert toxicologists,
all showing that ephedra herb products are safe when
used as directed. Indeed, while the FDA is considering
limiting these products to less than 10 mg per serving
four times a day, the FDA's own drug regulations
provide for safe use of ephedrine at 25 mg six times
a day, and there are no indications of injuries from
that dose. Medical science says ephedra herb
products are safe and effective when used as directed
in helping you lose weight and increase your energy
level. But FDA politics may deprive you of your right
to distribute, purchase and use safe ephedra herb
dietary supplements. Let the FDA and your elected
officials know that you value your rights and oppose
arbitrary restrictions on the sale and purchase of
ephedra herb products. You can write the FDA at:
|
| Commissioner
of Food and Drugs |
| Parklawn
Building, Room 1471 |
| 5600
Fisher's Lane |
| Rockville,
MD 20857 |
| FAX:
(301) 443-3100 |
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Ma
Huang...
Medical
Science or Political Hype?
| Medical Science |
Political Hype
|
| Scientific
Literature |
|
| "A
recent study found that in the most overweight
individuals, the combination of ephedrine
+ caffeine(EC) was 29% more effective than
dexfenfluramine. Another study found that
when compared to losing weight by diet alone,
EC had a positive influence on body composition,
increasing fat loss by 100% and decreasing
muscle loss by 72%." Townsend
Letter for Doctors & Patients - June 1996 |
During the Food
Advisory Committee's recent hearings in Washington,
D.C., the FDA attempted to discourage speakers
and members of the committee from discussing
the benefits of ephedra as an agent to aid
in weight loss. |
| "None of the literature
reports support the contention that ephedrine
in reasonable dosage would represent a hazard
to health... In the formal study, 100 subjects
received...Ma Huang at an average dose of
5 tablets [23 mg/tablet] per day for 8 weeks.
No side effects of any kind were reported,
no changes in blood pressure were seen, rates
of weight loss improved..." Safety
of Ephedra Herb: A Preliminary Report. |
The FDA's allegations
of risk are not supported by scientific or
empirical data. The FDA has not cited a single
article to support its conclusions, nor has
it made any attempt to rebut the studies and
over 200 articles from scientific literature
supporting the safety of ephedra herb which
have been submitted.. |
| Scientifically
Recognized Dosage |
|
| "There
have been more than 20 significant publications
in prestigious scientific journals, describing
the effects of ephedrine in doses of 60-150
mg per day for periods of up to 26 months...
Ephedrine...did not cause increases in blood
pressure or heart rate...There were no clinically
important side effects in the reviewed studies..."
Ad Hoc Committee On the Safety of Ma Huang
- June 1995. |
FDA is considering
a serving limitation of 2-10 mg without having
any studies suggesting that larger servings
are unsafe and contrary to its own OTC Regulations.
|
| "25 mg up to six
times per day." FDA's Over-The-Counter Drug Regulations. |
|
| Safety
Factor |
|
| "The drug ephedrine...poses
little risk when compared to common household
products such as aspirin, ibuprofen, acetaminophen,
sleep aids and caffeine." Ad
Hoc Committee On the Safety of Ma Huang- September
1996. |
There are only
about 36 reports available to the FDA in which
it can even be determined what amount of ephedra
was claimed to have been consumed by the reporting
individual. |
| The Committee on
Safety of Medicine in the United Kingdom recently
acknowledged that it had only received 22
reports of adverse reactions associated with
ephedrine drug weight loss products over a
multi-year period. Recent Danish data on an
ephedrine-caffeine combination for weight
loss indicated only 86 reportable adverse
reactions over a two-year period from 9.6
million reported 25 mg servings. |
Even the FDA concedes
that most cases are complex, with patient
factors that make interpretation of individual
events problematic. Moreover, these reports
come from a population of at least 8 million
Americans who consume over 1 billion servings
of ephedra herb products each year. |
| "A retrospective
study of 230,000 subjects, who over a three-year
period had used ephedra herb supplements at
single servings of about 20 mg/3-5 times per
day, for periods of six to eleven weeks, revealed
no serious adverse effects, including no increases
in blood pressure and no increases in heart
rates." Ad Hoc Comm.
on the Safety of Ma Huang- Sept. 1996 |
FDA has received
only 602 unverified and unevaluated
reports, many of which have been subsequently
proven to be erroneous, unrelated or involve
consumption at extreme levels. |
| Alleged
Injuries |
|
| "The
scientific literature reviews, clinical testing,
animal studies, known toxicology, absence
of injuries in over-seas or other defined
populations, and the safe use of ephedra herb
products at 25 mg doses without adverse incidents
all demonstrate that ephedra herb dietary
supplements are unlikely to pose a risk of
injury at labeled servings, a fact confirmed
by thousands of years of use. Given this scientific
background, any reported injuries should be
scrutinized with great care, because such
reports are at odds with all that is known
about these products' safety."Ad
Hoc Comm.on the Safety of Ma Huang -Sept.
1996. |
The FDA treats
all alleged complaints as valid, regardless
of whether an actual injury occurred. For
instance:
-Several reports failed to
state an injury
-Dozens of cases were included
where the patient was taking multiple prescription
drugs with known side effects and such side
effects were erroneously attributed to ephedra
|
| Internationally
respected toxicologists reviewed the reports
collected by the FDA and the Texas Dept. of
Health. Their response was that "it is impossible
to establish any causal relationship between
ingestion of these products and any serious
adverse effect...It is our opinion that at
the labeled doses...there is virtually no
basis, in these materials or the literature,
to conclude [that these products] would cause
any serious adverse effect in human beings."
Ad Hoc Comm. on the
Safety of Ma Huang -Sept '96 |
-Several reports
came from unidentified "friends" who alleged
bad experiences without any detail
-Several claims counted by
the FDA concerned products containing no
ephedrine. Even more alarming is that the
FDA was advised of this fact in 1995 yet
continued to include them.
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Drugs
vs. Nature
While
the above table demonstrates the safety of the drug
ephedrine, it should be noted that many scientists
and herbalists argue that use of the herb in whole
plant form (Ma Huang) is even safer than the refined
derivative (pure ephedrine & psuedoephedrine).
In fact, studies show that the whole herb Ma Huang
has a very low toxicity and little potential for side
effects (Tang & Eisenbrand, 1992), and animal
studies have failed to demonstrate carcinogenic or
mutagenic potential for ephedrine. Further, ephedrine
is rapidly eliminated from the human body -- 88% of
an oral dose is excreted in the urine within 24 hours,
97% after 48 hours (Hobbs, 1996). In Herbal Medicine
for Everyone, British herbalist Michael McIntyre
writes that while pure ephedrine may raise blood pressure,
the "whole (ephedra) plant actually reduces blood
pressure." German medical herbalist Rudolph Fritz
Weiss, M.D., maintains that the whole plant "has certain
advantages (over psuedoephedrine). Above all, it is
better tolerated, causing fewer...symptoms." Finally,
practitioners of Traditional Chinese Medicine (TCM)
would regularly prescribe Ma Huang with other tonic
herbs to improve safe consumption. This theory is
maintained by TSN Labs, Inc. Our product, Thin & Slim Naturally, was formulated
by Mr. Steve Lee, a native of Taiwan. He is a graduate
of Duquesne University of Pharmacy in Pennsylvania,
with a Masters Degree in Industrial Pharmaceutics.
Steve Lee's professional experience in pharmaceutical
chemistry has been extensive and diverse, including
Laboratory Manager at the U.S. National Institute
of Health. He has been instrumental in the formulation
of a wide variety of health and nutritional products
for as many as eight different companies. Mr. Lee
has served on the FDA Advisory Committee for Herbal
Medicines. Steve Lee brings to TSN Labs, Inc., a thorough
understanding of pharmaceuticals and western medical
practices, as well as a deep background in herbal
medicines, whose safety and effectiveness have been
proven in China and the rest of Asia for more than
5000 years. It is through this diverse knowledge of
both the Oriental and Occidental worlds, that Mr.
Lee has been able to formulate one of the safest and
most effective natural dietary supplements on the
market today. That product is Thin
& Slim Naturally.
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References:
American Medical Association.
Drug Evaluations. Chicago: American Medical
Assoc. 1986.
Barnhart, E. (pub.) Physicians'
Desk Reference. Oradell, NJ: Medical Economics
Co., Inc. 1989.
Bensky, D. and A. Gamble. Chinese
Herbal Medicine. Seattle: Eastland Press. 1986.
Chang, H.M. Pharmacology
and Applications of Chinese Materia Medica. Philadelphia:
World Scientific. 1986.
German Commission E Monograph,
Ephedra herba, published January 17, 1991.
Hsu, H.Y. (pub.). Oriental
Materia Medica. Long Beach: Oriental Healing
Arts Institute. 1989.
Huang, K.C. The Pharmacology
of Chinese Herbs. Boca Raton: CRC Press. 1993.
Tang, W. & G. Eisenbrand.
Chinese Drugs of Plant Origin. Berlin: Springer-Verlag.
1992.
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The
statements herein have not been evaluated by the
FDA, and are intended for educational purposes only.
These products are not intended to treat, diagnose,
cure , mitigate or prevent any disease. If you have
a serious medical condition, consult with your doctor
before using.
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You can
also find TSN products at www.4-WomensHealth.com
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