HHS NEWS FDA Proposes Safety Measures for Ephedrine Dietary Supplements

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HHS NEWS: FDA Proposes Safety Measures for Ephedrine Dietary Supplements

HHS NEWS

U.S. Department of Health and Human Services

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P97-15 Food and Drug Administration

FOR IMMEDIATE RELEASE Arthur Whitmore: (202) 205-4144

June 2, 1997 Broadcast Media: (301) 827-3434

 

 

FDA PROPOSES SAFETY MEASURES FOR EPHEDRINE DIETARY SUPPLEMENTS

The Food and Drug Administration today proposed to reduce risks

associated with dietary

supplement products containing ephedrine alkaloids by limiting the amount of

ephedrine alkaloids

in products and requiring labeling and marketing measures that give adequate

warning and

information to consumers.

Ephedrine alkaloids are amphetamine-like compounds with potentially

powerful stimulant

effects on the nervous system and heart. Hundreds of consumer illnesses and

injuries associated

with the use of these products have been reported.

The proposal would not ban dietary supplements that contain ephedrine

alkaloids.

" Consumers should be aware that just because a product is labeled 'natural'

or from an herbal

source it is not guaranteed to be safe, " said Dr. Michael Friedman, Deputy

Commissioner of Food

and Drugs. " The effects of ephedrine alkaloids are potentially powerful ones.

We urge people to

talk to their doctors before using dietary supplements containing ephedrine

alkaloids, and to

always use them with caution. "

Because ephedrine alkaloids are heart and nervous system

stimulants, certain individuals including those with hypertension, heart

conditions and neurologic

disorders, should avoid their use. Pregnant women, too, should avoid the use of

dietary

supplements with ephedrine alkaloids.

The proposal would prohibit the marketing of dietary supplements containing

8 milligrams or

more of ephedrine alkaloids per serving. Labeling that recommends or suggests

conditions of use

that would result in an intake of 8 mg or more in a 6-hour period or a total

daily intake of 24 mg

or more also would not be allowed.

In addition, the proposal would require label statements instructing

consumers not to use the

product for more than 7 days, and would not allow label claims for uses for

which long-term

intake would be necessary to achieve the purported effect. These safety

measures are based on

the fact that long-term intake of ephedrine alkaloids increases the likelihood

of serious adverse

events.

Another measure in the proposal would apply to products with claims that

encourage

short-term excessive intake to enhance the claimed effect, such as energy

enhancement. Such

products would be required to bear a labeling statement that " Taking more than

the recommended

serving may result in heart attack, stroke, seizure or death. "

The proposal also would prohibit the use of other stimulant ingredients

such as botanical

sources of caffeine with ephedrine

alkaloids because the combination increases the stimulant effects of ephedrine

alkaloids and the

chance of consumer injury.

Dietary supplement products containing ephedrine alkaloids are currently

sold for a variety of

purposes including weight loss, increased energy and body building.

Since 1994 the agency has received and investigated more than 800 reports

of adverse

events associated with the use of these products. Reported adverse events range

from episodes of

high blood pressure, irregularities in heart rate, insomnia, nervousness,

tremors and headaches, to

seizures, heart attacks, strokes and death. Most events occurred in young to

middle aged,

otherwise healthy adults using the products for weight control and increased

energy.

Ephedrine alkaloids in dietary supplements are usually derived from one of

several species

of herbs of the genus Ephedra, sometimes called Ma huang, Chinese Ephedra and

epitonin. Other

botanical sources include Sida cordifolia.

The proposed measures were developed based on FDA's review of its adverse

event

reports, the scientific literature, and public comments reviewed by the agency,

including

comments generated by an October 1995 advisory working group public meeting and

an August

1996 public meeting of FDA's Food Advisory Committee. These experts suggested a

number of

steps the agency might take to reduce injuries associated with use of dietary

supplements

containing ephedrine alkaloids.

FDA invites written comments on the proposal from the public and industry,

which may be

submitted to the Dockets Management

Branch, HFA-305, Food and Drug Administration, 12410 Parklawn

Drive, Room 1-23, Rockville, MD 20857. The closing date for comments is August

18, 1997.

Comments received to date and in response to the proposal are available for

public

examination in public docket No. 95N-0304 located in the Dockets Management

Branch office.

All comments received will be reviewed and considered by the agency in

developing the final rule.

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This is a mirror of the page at http://www.fda.gov/bbs/topics/NEWS/NEW00568.html

 

June 4, 1997 Proposed Rule: Dietary Supplements Containing Ephedrine Alkaloids

 

 

 

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