HHS NEWS

P97-15                          Food and Drug Administration
FOR IMMEDIATE RELEASE           Arthur Whitmore:  (202) 205-4144
June 2, 1997                    
                                Consumer Hotline: (800) 532-4440
                              
     
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
warningand 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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