[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. Res. 260 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
S. RES. 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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            November 6, 2003

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

_______________________________________________________________________

                               RESOLUTION


 
  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.

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.
                                 <all>