HHS NEWS FDA Statement on Street Drugs Containing Botanical Ephedrine

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HHS NEWS: FDA Statement on Street Drugs Containing Botanical Ephedrine

HHS NEWS

U.S. Department of Health and Human Services

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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.

 

-More-* Page 2, Statement, Ephedrine

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

 

More-* Page 3, Statement, Ephedrine

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

 

 

 

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