Unlike pharmaceutical drugs and food additives,
dietary supplements are largely unregulated by
the FDA (Food and Drug Administration) for
consumer protection.
Supplement manufacturers can put
structure-function claims on their labels, so
long as they don't claim to prevent or
treat a specific disease. Supplements do not have to be
manufactured according to any standards.
I, myself, don't believe that this combination is at all safe. Because Ephedra reacts much the same as
phentermine, insofar as building a tolerance, it most often is abused.
Supplements do not have to prove they work to be
sold.
Before drugs or food additives go on the market,
hundreds of research studies must be submitted to
the FDA for review of the product¡¯s efficacy.
In fact, the average evaluation of a new drug may
take 15 years and cost $500 million! With
dietary supplements, manufacturers are simply
required to notify the FDA (as a courtesy) within
30 days of marketing their product. The FDA does
not evaluate the research to make sure that the
product does what the manufacturer claims it
does.
Supplements do not have to prove they are safe to
be sold.
With a new dietary supplement, however,
manufacturers simply need to submit safety data
to the FDA 75 days before marketing it. The data
need not be evaluated or approved by the FDA, so
the quality of research may be questionable. If
the FDA suspects that a product is unsafe and
wants to take a product off the market, the FDA
has to prove it is unsafe. In other words, the
"burden of proof" that a product is unsafe is
placed on the FDA.
Given the huge number of new dietary supplements
added to the market each year and the FDA¡¯s
limited resources, it is impossible for the FDA
to finance and conduct safety studies for all of
these products. As a result, many potentially
dangerous products are sold over-the-counter to
unsuspecting consumers.
Ephedra or Ma huang, a popular herbal
supplement added to many
weight loss formulas for
its stimulant and appetite-suppressing effects,
has been linked with over 1100 reports of adverse
effects and 534 deaths since 1993. Yet anyone can
get this supplement over-the-counter without a
doctor¡¯s prescription or supervision.
Many herbs can have dangerous
interactions with drugs or other supplements. But
because their use is not supervised by a
qualified clinician, consumers are not aware of
these interactions. For instance, St. John¡¯s
Wort, a popular (and potentially helpful) herbal
supplement for mild depression can interfere with
the action of HIV medications and birth control
pills.
Structure-function claims can often be
misleading. For example, carnitine is added to
many weight loss products with the claim:
"promotes fat burning." This claim is perfectly
legal and somewhat true since it describes the
function of carnitine in the human body.
Carnitine plays an essential role in transporting
fatty acids into the part of the cell responsible
for producing energy. This implies that
carnitine's function is to support or promote
fat burning.
But taking carnitine supplements does not speed
up the fat burning process and it does not cause
weight loss. The healthy body knows how to
synthesize carnitine and already has all the
carnitine it can use.
The manufacturer can make this misleading claim
by including a simple disclaimer: This
statement has not been evaluated by the FDA.
This product is not intended to diagnose, treat,
cure, or prevent any disease. In other words,
the supplement can't claim to "prevent" or
"treat"
obesity (a disease)--that would imply
that the supplement has drug-like actions. But,
it can claim to "support" or "promote" fat
burning.
Supplements do not have to be manufactured
according to any standards.
Regardless of whether or not a supplement
actually does what it claims to do, you might not
be getting what you think you are. Products may
or may not contain the right amount of the active
ingredient that was used in research studies
showing a positive effect. And, even if the
product label states that it has the right
amount, it may actually contain much less or none
at all. Contaminants that are not listed on the
lable may also be present.
Several independent labs are testing products'
contents and finding that several don't contain
what is stated on the label. One company,
ConsumerLab.com ran independent tests of herbal, vitamin, and mineral supplement analyzes several brands of
supplements for quality and purity and reports
its findings on its web site. For instance, in
October and November 2000, ConsumerLab.com
purchased and tested 21 leading brands of St.
John¡¯s Wort and found that 1/3 either did NOT
contain the stated amount of the active
ingredients or were contaminated with
unacceptable levels of cadmium (a toxic heavy
metal).
When herbs and other supplements are added to
foods and beverages, it's even less likely that
the right amount of the active ingredient is
present. For example, to get one herbal dose of
Siberian ginseng from Sobe
Green Tea, you would
have to drink 13-20 bottles. Ginseng is
expensive, so many manufacturers may not add a
therapeutic dose to their products.
Ephedrine is a powerful stimulant that is
chemically related to amphetamine (speed¡).
It occurs naturally in several plants, such as
ephedra (Ma huang) and the heartleaf plant (Sida
cordifolia); and it can be found in many popular
energy drinks, fat burner pills, herbal
preparations, and a variety of natural weight
loss products. See side bar for list of products
containing ephedrine.
Aspirin (or acetylsalicylic acid), is not a
stimulant. But, it is often added to fat burner
products because it appears to reduce urinary
excretion of ephedrine thus keeping it in the
blood longer and prolonging it's
stimulating effects. Salicin (which is
chemically similar to aspirin) can be derived
from willow bark and is often added to herbal
preparations.
Ephedrine and caffeine stimulate the sympathetic
nervous system by increasing levels of certain
brain chemicals (or neurotransmitters) such as
norepinephrine. Norepinephrine (or
noradrenaline) triggers the stress
response, causing a wide array of stimulant
effects that prepare the body to fight or
flight from a physical or emotional stressor.
These stimulant effects include: increased heart
rate, increased blood pressure (by constricting
blood vessels), expanded airways, increased
mobilization of fatty acids, and slightly
increased resting metabolic rate (RMR)--all
efforts to boost oxygen and energy supply to
muscles so that they can fight or flight a
stressor. Norepinephrine also acts on a region
of the brain called the hypothalamus that helps
to regulate appetite.
Because of these powerful effects, herbal ephedra
(or Ma huang) has been used in Chinese medicine
for more than 5000 years as a decongestant; and
synthetic ephedrine is approved by the FDA for
use in many over-the-counter medications for
relieving asthma, hayfever, and nasal congestion.
In fact, ephedrine is very effective for these
purposes because it helps to open up airways.
Some research also indicates that ephedrine may
help promote fat and weight loss because it
increases BMR slightly and curbs appetite.
Further, when caffeine is taken with ephedrine,
the thermogenic (or metabolic-boosting) effect is
doubled!
Caffeine is a well-known
(and well-studied) physical and mental
invigorator. It improves alertness, reduces
fatigue, helps improve memory and reasoning, and
enhances subjective feelings of vigor and energy.
In fact, caffeine is superior to ephedrine in
this regard. However, caffeine taken alone will
do nothing to increase fat or weight loss.
Ephedrine has a long list of negative side
effects. These include: increased blood
pressure, arrhythmias (heart rate
irregularities), insomnia, nervousness (anxiety),
tremors, headaches, seizures, heart attacks,
strokes, and even death. These dangerous side
effects are worsened when ephedrine is combined
with other stimulants such as caffeine,
synephrine (which comes from the fruit and root
of Citrus aurantium or bitter orange),
Ephedrine, Caffeine, Aspirin Combination).
ECA STACK
In fact, the FDA has linked 534 deaths to
ephedrine (including one case of a healthy
college student who died from necrosis of the
heart muscle after 6 months of taking a daily
sports drink containing 25-50 mg ephedrine).
Since 1993, the FDA has also received more than
1100 reports of adverse events linked to
ephedrine.
Clearly, the risks of ephedrine far outweigh its
potential benefits.
However, if you decide to
take it, keep these important safety tips in
mind:
Choose a product with no more than 20
mg per pill of ephedrine (or other ephedrine
alkaloids like pseudoephedrine or synephrine),
and take no more than 90 mg total per day.
If the label does not list the precise
quantities of all ingredients and/or does not
carry an extensive warning label, don't buy it.