[Congressional Record (Bound Edition), Volume 149 (2003), Part 20]
[Senate]
[Page 28030]
[From the U.S. Government Publishing Office, www.gpo.gov]




                         SUBMITTED RESOLUTIONS

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  SENATE RESOLUTION 260--EXPRESSING THE SENSE OF THE SENATE THAT THE 
  SECRETARY OF HEALTH AND HUMAN SERVICES SHOULD TAKE ACTION TO REMOVE 
   DIETARY SUPPLEMENTS CONTAINING EPHEDRINE ALKALOIDS FROM THE MARKET

  Mr. DURBIN (for himself and Mr. McCain) submitted the following 
resolution; which was referred to the Committee on Health, Education, 
Labor, and Pensions:

                              S. Res. 260

       Whereas, a RAND Corporation study commissioned by the 
     Department of Health and Human Services found no evidence for 
     long-term efficacy of ephedrine alkaloids for weight loss and 
     that there is no credible science showing that ephedrine or 
     dietary supplements containing ephedrine alkaloids, as those 
     products are used by the general population, improve athletic 
     performance;
       Whereas ephedrine alkaloids can--
       (1) increase heart rate and blood pressure;
       (2) stimulate the central nervous system; and
       (3) lead to strokes, seizures, psychosis, cardiac 
     arrhythmia, heart attacks, and deaths;
       Whereas the Food and Drug Administration has received 
     approximately 16,500 adverse events reports for consumers who 
     have used dietary supplements containing ephedrine alkaloids, 
     including approximately 155 reports of death;
       Whereas the Inspector General of the Department of Health 
     and Human Services has noted with concern that about 60 
     percent of persons suffering adverse events related to the 
     use of dietary supplements containing ephedrine alkaloids are 
     under the age of 40;
       Whereas a study published in the Journal of Neurology found 
     that there may be an association between the use of more than 
     32 milligrams per day of ephedra and an increased risk of 
     hemorragic stroke, but the daily dose recommended by the 
     dietary supplement industry is about 3 times that much;
       Whereas a study published in Mayo Clinical Proceedings 
     found that in 36 out of 37 serious cardiovascular events 
     associated with ephedrine alkaloids examined, the patient had 
     consumed doses of a dietary supplement containing ephedrine 
     alkaloids at or below the dose recommended by the 
     manufacturer;
       Whereas a study commissioned by the Food and Drug 
     Administration to review reports of ephedrine alkaloid-
     related adverse events (including serious adverse events such 
     as seizures, strokes, and death), which resulted in 
     publication in the New England Journal of Medicine of an 
     article in 2000, found that 31 percent of the reports were 
     definitely or probably related to ephedrine alkaloid use and 
     an additional 31 percent were possibly related to ephedrine 
     alkaloid use;
       Whereas a study published in the Annals of Internal 
     Medicine concluded that--
       (1) the risk for an adverse reaction after the use of 
     ephedra is substantially greater than with other herbal 
     products; and
       (2) the sale of ephedra as a dietary supplement should be 
     restricted or banned to prevent serious adverse reactions in 
     the general population;
       Whereas approximately 30 members of the United States Army 
     have died after taking a dietary supplement containing 
     ephedrine alkaloids, and the Department of Defense has banned 
     the sale of dietary supplements containing ephedrine 
     alkaloids from military commissaries worldwide because of 
     safety concerns;
       Whereas the American Medical Association has called on the 
     Secretary of Health and Human Services to ban the sale of 
     dietary supplements containing ephedrine alkaloids;
       Whereas the National Football League, the International 
     Federation of Football Associations, the National Collegiate 
     Athletics Association, the Commissioner of the National 
     Association of Baseball with regard to the Minor Leagues, 
     Major League Soccer, the National Basketball Association, and 
     the International Olympics Committee have banned the use of 
     ephedrine alkaloids by their athletes;
       Whereas 3 States, representing 65,000,000 Americans, have 
     banned dietary supplements containing ephedrine alkaloids;
       Whereas major drug store chains representing 17,300 stores 
     nationwide have pulled ephedrine alkaloid-containing dietary 
     supplements from their shelves; and
       Whereas the largest specialty retailer of dietary 
     supplements in the country, which has 5,300 stores 
     nationwide, has pulled ephedrine alkaloids from its shelves: 
     Now, therefore, be it
       Resolved by the Senate (the House of Representatives 
     concurring), That it is the sense of Congress that--
       (1) the Secretary of Health and Human Services has 
     authority under subsections (a) and (f) of section 402 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) to 
     determine that dietary supplements containing ephedrine 
     alkaloids--
       (A) present a significant or unreasonable risk of illness 
     or injury;
       (B) pose an imminent hazard to public health or safety; or
       (C) contain poisonous or deleterious substances that may 
     render dietary supplements injurious to health;
       (2) there is sufficient evidence to make such a 
     determination; and
       (3) the Secretary should take immediate action to remove 
     dietary supplements containing ephedrine alkaloids from the 
     marketplace.

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