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Regulation of Dietary Supplements—Reply

Regulation of Dietary Supplements—Reply In Reply: Despite the claim to the contrary by Ms Joseph and colleagues, the recently announced ban on ephedra1 provides excellent substantiation that the current system of postmarketing regulation of dietary supplements does indeed present a "real danger" to the public. As a result of the challenging legal standard in the DSHEA, definitive actions to prohibit sales and distribution of this dangerous product were delayed more than 9 months after clear evidence of harm was available,2 and while additional evidence of harm continues to accumulate.3 Products such as ephedra—like many other dietary supplements—certainly have biological activity and are marketed as such.4 If this agent had been regulated with at least the same degree of oversight as that used for over-the-counter drugs, some ephedra-related morbidity and mortality most likely could have been prevented. As the letter by Joseph et al also illustrates, the perception of the degree of regulation necessary for dietary supplements obviously differs whether the viewpoint is that of consumer, clinician, or manufacturer. However, from our viewpoint, the current regulations, as stipulated by the outdated and inadequate 1994 DSHEA, are insufficient to safeguard the public from the potential risks and hazards of dietary supplements. References 1. US Food and Drug Administration. FDA announces plans to prohibit sales of dietary supplements containing ephedra. December 30, 2003. Available at: http://www.fda.gov. Accessed January 13, 2004. 2. Shekelle PG, Hardy ML, Morton SC. et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. JAMA.2003;289:1537-1545.Google Scholar 3. McBride BF, Karapanos AK, Krudysz A. et al. Electrocardiographic and hemodynamic effects of a multicomponent dietary supplement containing ephedra and caffeine: a randomized trial. JAMA.2004;291:216-221.Google Scholar 4. Morris CA, Avorn J. Internet marketing of herbal products. JAMA.2003;290:1505-1509.Google Scholar http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Regulation of Dietary Supplements—Reply

DeAngelis, Catherine D.; Fontanarosa, Phil B.
JAMA , Volume 291 (5) – Feb 4, 2004
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Regulation of Dietary Supplements—Reply

Abstract

In Reply: Despite the claim to the contrary by Ms Joseph and colleagues, the recently announced ban on ephedra1 provides excellent substantiation that the current system of postmarketing regulation of dietary supplements does indeed present a "real danger" to the public. As a result of the challenging legal standard in the DSHEA, definitive actions to prohibit sales and distribution of this dangerous product were delayed more than 9 months after clear evidence of harm was...
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Publisher
American Medical Association
Copyright
Copyright © 2004 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.291.5.560-b
Publisher site
See Article on Publisher Site

Abstract

In Reply: Despite the claim to the contrary by Ms Joseph and colleagues, the recently announced ban on ephedra1 provides excellent substantiation that the current system of postmarketing regulation of dietary supplements does indeed present a "real danger" to the public. As a result of the challenging legal standard in the DSHEA, definitive actions to prohibit sales and distribution of this dangerous product were delayed more than 9 months after clear evidence of harm was available,2 and while additional evidence of harm continues to accumulate.3 Products such as ephedra—like many other dietary supplements—certainly have biological activity and are marketed as such.4 If this agent had been regulated with at least the same degree of oversight as that used for over-the-counter drugs, some ephedra-related morbidity and mortality most likely could have been prevented. As the letter by Joseph et al also illustrates, the perception of the degree of regulation necessary for dietary supplements obviously differs whether the viewpoint is that of consumer, clinician, or manufacturer. However, from our viewpoint, the current regulations, as stipulated by the outdated and inadequate 1994 DSHEA, are insufficient to safeguard the public from the potential risks and hazards of dietary supplements. References 1. US Food and Drug Administration. FDA announces plans to prohibit sales of dietary supplements containing ephedra. December 30, 2003. Available at: http://www.fda.gov. Accessed January 13, 2004. 2. Shekelle PG, Hardy ML, Morton SC. et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. JAMA.2003;289:1537-1545.Google Scholar 3. McBride BF, Karapanos AK, Krudysz A. et al. Electrocardiographic and hemodynamic effects of a multicomponent dietary supplement containing ephedra and caffeine: a randomized trial. JAMA.2004;291:216-221.Google Scholar 4. Morris CA, Avorn J. Internet marketing of herbal products. JAMA.2003;290:1505-1509.Google Scholar

Journal

JAMA – American Medical Association

Published: Feb 4, 2004

References

  • FDA announces plans to prohibit sales of dietary supplements containing ephedra.
  • Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis.
    Shekelle PG; Hardy ML; Morton SC
  • Electrocardiographic and hemodynamic effects of a multicomponent dietary supplement containing ephedra and caffeine: a randomized trial.
    McBride BF; Karapanos AK; Krudysz A
  • Internet marketing of herbal products.
    Morris CA; Avorn J