effects of the herb. (Conventional pharmaceuticals
must include potential side effects in their packaging.)
With ephedra and all other dietary supplements, the
burden of proof falls on the FDA to show that the
supplement is either unsafe or ineffective before the sup-
plement can be restricted or banned. Information about
a supplement’s safety and effectiveness is normally gath-
ered only after people usingthe product develop health
problems or complain that the product does not work.
The FDA involvement with ephedra in weight-
loss supplements began in 1996 after receiving more
than 800 reports of adverse events in people taking
products containing ephedra. In 1997 the FDA pro-
posed regulating ephedra by requiring that the prod-
uct carry a warning on the label stating that adults
should take no more than 8 mg of ephedra at one time
and no more than 24 mg in one day. The proposed
regulation was fought by the diet supplement industry.
During the course of public comment about the regu-
lation, it became clear that there was little or no stand-
ardization of ephedra content among products or even
within different batches of product from the same
manufacturer. This lack of standardization made it
difficult for consumers to know and control how
much ephedra they were taking from day to day.
In 2002, the FDA commissioned and independent
organization to study ephedra-related complications
and deaths. As a result of this study, the FDA banned
the uncontrolled sale of dietary supplements contain-
ing ephedra based on the what the FDA called an
‘‘unreasonable risk of illness or injury.’’ The ban
took effect on April 14, 2005.
Several supplement makers have challenged the
ban on ephedra-containing supplements in federal
and state courts. They argue that the FDA did not
test supplements containing low doses of ephedra for
safety and effectiveness and that a total ban on ephe-
dra supplements based only on high-dose products
was illegal. The FDA took the position that it was
unethical to do more human testing of ephedra given
the findings that ephedra-containing supplements
increase the risk of stroke, heart attack, irregular
heart beat, and similar serious cardiovascular events.
On October 18, 2006, after several legal challenges, the
United States Court of Appeals Tenth Circuit upheld
the FDA ban on all ephedra-containing supplements
regardless of dose. Nutraceutical Corporation, the
plaintiff in the case, vowed to file another a petition
for review with the United States Supreme Court.
The ban on ephedra-containing supplements contin-
ues to be controversial. There is general agreement that
ephedra does treat cold symptoms and does help people
with short-term weight loss. However, these benefits
do not, in the opinion of FDA scientists, outweigh the
health risks associated with the ephedra-containing
products. Ephedra continues to be legal in countries
such as Germany, Japan, India, and China where it is
widely used. Ephedra-containing supplements are easily
available over the Internet, and it is estimated that several
million Americans continue to use them.PrecautionsThe FDA warns that no one should take dietary
supplements that contain ephedra because they canKEY TERMS
Alternative medicine—A system of healing that
rejects conventional, pharmaceutical-based medi-
cine and replaces it with the use of dietary supple-
ments and therapies such as herbs, vitamins,
minerals, massage, and cleansing diets. Alternative
medicine includes well-established treatment sys-
tems such as homeopathy, traditional Chinese medi-
cine, and Ayurvedic medicine, as well as more-
recent, fad-driven treatments.
Amphetamine—A drug that stimulates the central
nervous system and can be physically and psycho-
logically addictive.
Complementary medicine—Includes many of the
same treatments used in alternative medicine, but
uses them to supplement conventional drug and
therapy treatments, rather than to replace conven-
tional medicine.
Conventional medicine—Mainstream or Western
pharmaceutical-based medicine practiced by med-
ical doctors, doctors of osteopathy, and other
licensed health care professionals.
Dietary supplement—A product such as a vitamin,
mineral, herb, amino acid, or enzyme, that is
intended to be consumed in addition to an individ-
ual’s diet with the expectation that it will improve
health.
Traditional Chinese Medicine (TCM)—An ancient
system of medicine based on maintaining a balance
invitalenergyorqithatcontrols emotions, spiritual,
and physical well being. Diseases and disorders result
from imbalances in qi, andtreatments such as mas-
sage, exercise, acupuncture, nutritional and herbal
therapy are designed to restore balance and harmony
to the body.Ephedra