April 10, 1996 Contact: Arthur Whitmore
202-205-4144
FDA Statement on Street Drugs Containing Botanical Ephedrine
The Food and Drug Administration is warning consumers not to
purchase or consume ephedrine-containing dietary supplements with
labels that often portray the products as apparent alternatives
to illegal street drugs such as "ecstacy," because these products
pose significant health risks to consumers. These products
contain botanical, or so-called "natural," sources of ephedrine.
Ephedrine is an amphetamine-like stimulant that can have
potentially dangerous effects on the nervous system and heart.
These types of products are marketed under a variety of
brand names with labels that claim or imply that they produce
such effects as euphoria, increased sexual sensations, heightened
awareness, increased energy, and other effects.
Possible adverse effects of ephedrine range from clinically
significant effects such as heart attack, stroke, seizures,
psychosis and death, to clinically less significant effects that
may indicate the potential for more serious effects (for example,
dizziness, headache, gastrointestinal distress, irregular
heartbeat, and heart palpitations). "Ecstacy" is the street name
for MDMA (4-methyl-2,dimethoxyamphetamine), which produces
euphoria.
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Ingredient panels on these products may list ma huang,
Chinese ephedra, ma huang extract, ephedra, Ephedra sinica,
ephedra extract, ephedra herb powder, epitonin or ephedrine. Any
one of these ingredients listed on the label indicate the
presence of ephedrine in the product.
Many of these ephedrine-containing products bear labels that
appear to be targeted at adolescents and young adults and that
imply the products can produce a "high." The agency considers
this type of promotion and these claims to violate the Federal
Food, Drug, and Cosmetic Act, even as amended by the Dietary
Supplement Health and Education Act of 1994 (DSHEA), which
governs the U.S. marketing of dietary supplement products.
The FDA takes seriously the health risks inherent in these
products and is currently investigating the production and
marketing of ephedrine-containing products marketed as
alternatives to illicit street drugs. The agency is committed to
taking whatever action is necessary to remove dangerous products
from the market. However, under recent amendments to the Federal
Food, Drug, and Cosmetic Act, the agency has to act product-by-
product and the legal burden is now on the FDA to show that a
marketed product is unsafe, rather than on the company to gain
FDA approval by showing that the product is safe before it is
marketed.
Consumers who have been injured or suffered an adverse
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effect after taking a dietary supplement or any product
containing an ephedrine alkaloid should call 1-800-FDA-4010.
Health professionals who have treated patients suffering from an
adverse event to these products are urged to report the event to
the FDA's MedWatch adverse event and product problem hot line at
1-800-FDA-1088.
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This is a mirror of the page at http://www.fda.gov/bbs/topics/NEWS/NEW00531.html
June 2, 1997 FDA Proposes Safety Measures for Ephedrine Dietary Supplements
June 4, 1997 Proposed Rule: Dietary Supplements Containing Ephedrine Alkaloids