The U.S. Food and Drug Administration (FDA) advises consumers to stop
using dietary supplements containing ephedra. In order to protect
consumers, the FDA published a final rule on April 12, 2004, that bans
the sale of dietary supplements containing ephedrine alkaloids.
After a careful review of the available evidence about the risks and
benefits of ephedra in supplements, the FDA found that these
supplements present an unreasonable risk of illness or injury to
consumers. The data showed little evidence of ephedra's effectiveness,
except for short-term weight loss, while confirming that the substance
raises blood pressure and stresses the heart. The increased risk of
heart problems and strokes negates any benefits of weight loss.
What is ephedra?
Ephedra is a naturally occurring substance that comes from
botanicals. The principal active ingredient ephedrine is an
amphetamine-like compound that can powerfully stimulate the nervous
system and heart. Ephedrine alkaloids are found naturally in a number
of plants, including the ephedra species (also known by the traditional
Chinese medicine name--ma huang or Chinese Ephedra, or epitonin). In
recent years, ephedra products have been marketed as dietary
supplements to promote weight loss, increase energy, and enhance
athletic performance.
What evidence was collected to determine the safety and effectiveness of ephedra products?
The FDA reviewed information about ephedra's pharmacology, studies
of its safety and effectiveness, newly available adverse event reports,
and the RAND Corporation report--a review of the published scientific
literature on ephedra efficacy and safety, sponsored by NCCAM and the
National Institutes of Health's Office of Dietary Supplements. In
addition, the FDA considered additional recent studies confirming that
ephedra use raises blood pressure and otherwise stresses the
circulatory system. In February 2003, the agency solicited public
comments regarding ephedra's side effects and whether
ephedra-containing dietary supplements pose a "significant or
unreasonable risk of illness or injury."
NCCAM Ephedra Research
In addition to supporting the RAND study, NCCAM supported a study of
calls to poison control centers that revealed a disproportionate rate
of reactions to ephedra relative to other herbal products. NCCAM will
support to their completion two ongoing laboratory studies to better
understand the mechanism of action and chemical properties of ephedra:
- Pharmacology of Combined Ephedrine/Caffeine Supplements (University of California, San Francisco)
- Effects of Ephedra on Human Adrenoceptor Subtypes (University of Mississippi)
NCCAM will not fund any new studies of existing ephedra-containing products.
What is covered by these actions?
Essentially all currently marketed dietary supplements that contain a source of ephedrine alkaloids, such as ephedra, ma huang, Sida cordifolia,
and pinellia, are affected by this rule. The rule does not pertain to
traditional Chinese herbal remedies. It generally doesn't apply to
products like herbal teas that are regulated as conventional foods. In
addition, products regulated as drugs that contain chemically
synthesized ephedrine are not dietary supplements and not covered by
this rule. These include drugs used for the short-term treatment of
asthma, bronchitis, and allergic reactions.
Summary
There is strong evidence that ephedra is associated with an
increased risk of side effects, possibly even fatal ones. There is no
evidence that ephedra products enhance athletic performance. There is
little evidence of any benefit except for short-term weight loss. Taken
together, the FDA recommends that consumers immediately stop using
dietary supplements containing ephedra or ephedrine alkaloids.
While respecting the traditional uses of herbal medicines, their
long history of use, and their potential health benefits, NCCAM
believes that ephedra poses unique public health risks that warrant the
FDA's actions to prohibit the sale of ephedra-containing dietary
supplements.
Consumers need to be informed of the potential risks and benefits of
herbal products. It is best to discuss use of herbal products with
one's health care provider.
More Information
Date Reviewed: April 2004
Editorial Changes Made: October 2004
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NCCAM has provided this material for your information. It is not
intended to substitute for the medical expertise and advice of your
primary health care provider. We encourage you to discuss any decisions
about treatment or care with your health care provider. The mention of
any product, service, or therapy in this information is not an
endorsement by NCCAM.
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Bethesda, Maryland 20892 USA
