Millions of Americans use dietary supplements without full knowledge of their effects. Given the serious safety issues surrounding dietary supplements and the potential for nurses to play pivotal roles as patient educators and policy advocates, this article describes laws and regulations pertaining to dietary supplements, relevant research, the role of organized interests in policy making for dietary supplements, and how other countries regulate dietary supplements. We offer recommendations for policy change and identify implications of this issue for nursing practice.
Aggarwal, A. , & Ades, P. A. (2001). Interactions of herbal remedies with prescription cardiovascular medications. Coronary Artery Disease, 12(7), 581-584.
2.
American Holistic Nurses’ Association . (2003). Position on the role of nurses in the practice of complementary and alternative therapies. Retrieved December 2, 2003, from http://www.ahna.org/about/statements.html
3.
American Medical Association . (2003). H-150.954 Dietary supplements and herbal remedies. Retrieved April 21, 2003, from http://www.amaassn.org/apps/pf_online/pf_online?f_n=browse&doc=policyfiles/HOD/H-150.954.HTM
4.
Benzi, G. , & Ceci, A. (1997). Herbal medicines in European regulation. Pharmacological Research, 35(5), 355-362.
5.
Blendon, R. J. , DesRoches, C. M., Benson, J. M., Brodie, M., & Altman, D. E. (2001). Americans’ views on the use and regulation of dietary supplements. Archives of Internal Medicine, 161(6), 805-810.
6.
Brazier, N. C. , & Levine, M. A. (2003). Drug-herb interaction among commonly used conventional medicines: A compendium for health care professionals. American Journal of Therapeutics, 10(3), 163-169.
7.
Briggs, D. R. (2002). The regulation of herbal medicines in Australia. Toxicology, 181-182, 565-570.
8.
Center for Responsive Politics . (2000). Lobbyist spending: Nutritional & dietary supplements. Retrieved January 26, 2004, from http://www.opensecrets.org/lobbyists/induscode.asp?code=H4600&year=2000
9.
Chass, M. (2003, March 14). Pitcher’s autopsy lists ephedra as one factor. The New York Times,D5.
10.
Choi, D. W. , Kim, J. H., Cho, S. Y., Kim, D. H., & Chang, S. Y. (2002). Regulation and quality control of herbal drugs in Korea. Toxicology, 181-182, 581-586.
11.
Cohen, S. S. , Mason, D. J., Kovner, C., Leavitt, J. K., Pulcini, J., & Sochalski, J. (1996). Stages of nursing’s political development: Where we’ve been and where we ought to go. Nursing Outlook, 44(6), 259-266.
12.
DePalma, J. A. (2002). Proposing an evidence-based policy process. Nursing Administration Quarterly, 26(4), 55-61.
13.
Eisenberg, D. M. , Davis, R. B., Ettner, S. L., Appel, S., Wilkey, S., Van Rompay, M., et al. (1998). Trends in alternative medicine use in the United States, 1990-1997: Results of a follow-up national survey. JAMA, 280(18), 1569-1575.
14.
Fontanarosa, P. B. , Rennie, D., & DeAngelis, C. D. (2003). The need for regulation of dietary supplements—lessons from ephedra [Comment]. JAMA, 289(12), 1568-1570.
15.
General Accounting Office . (2000). Food safety: Improvements needed in overseeing the safety of dietary supplement and “functional foods” (Report to Congressional Committees No. GAO/RCED-00-156). Washington, DC: Author.
16.
Gurley, B. J. , Gardner, S. F., White, L. M., & Wang, P. L. (1998). Ephedrine pharmacokinetics after the ingestion of nutritional supplements containing Ephedra sinica (ma huang) [Comment]. Therapeutic Drug Monitoring, 20(4), 439-445.
17.
Haller, C. A. , & Benowitz, N. L. (2000). Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids [Comment].New England Journal of Medicine, 343(25), 1833-1838.
18.
Hoffman, F. A. (2001). Regulation of dietary supplements in the United States: Understanding the Dietary Supplement Health and Education Act. Clin Obstet Gynecol, 44(4), 780-788.
19.
Hutchins, G. M. (2001). Dietary supplements containing ephedra alkaloids [Comment]. New England Journal of Medicine, 344(14), 1095-1097.
20.
International Communications Research . (1999, December 16). Dietary supplements survey. Sponsored by Henry J. Kaiser Family Foundation, Harvard Kennedy School of Government, and National Public Radio. Storrs: Roper Center for Public Opinion Research at University of Connecticut.
21.
Khatcheressian, L. A. W. (1999). Regulation of dietary supplement: Five years of DSHEA. Food and Drug Law Journal, 54, 623.
22.
Kingdon, J. W. (1995). Agendas, alternatives, and public policies (2nd ed.). New York: HarperCollins College.
23.
Kurzer, M. S. (2003). Phytoestrogen supplement use by women. Journal of Nutrition, 133(6), 1983S-1986S.
24.
Lueck, S. , & Mathews, A. (2003). FDA is expected to ban ephedra, citing supplement’s health risks. Wall Street Journal, A1, A4.
25.
Ly, J. , Percy, L., & Dhanani, S. (2002). Use of dietary supplements and their interactions with prescription drugs in the elderly. American Journal of Health-System Pharmacy, 59(18), 1759-1762.
26.
Michaud, L. B. (2000). Complementary/alternative therapies. Potential safety issues in cancer care. Cancer Practice, 8(5), 243-247.
27.
Noller, B. N. , Myers, S., Abegaz, B., Singh, M. M., Kronenberg, F., & Bodeker, G. (2001). Global forum on safety of herbal and traditional medicine: July 7, 2001, Gold Coast, Australia. Journal of Alternative & Complementary Medicine, 7(5), 583-601.
28.
Palmer, M. E. , Haller, C., McKinney, P. E., Klein-Schwartz, W., Tschirgi, A., Smolinske, S. C., et al. (2003). Adverse events associated with dietary supplements: An observational study. Lancet, 361(9352), 101-106.
29.
Princeton Survey Research Associates . (1999, February 19). Health news interest index poll. Sponsored by Henry J. Kaiser Family Foundation and Harvard School of Public Health. Storrs: Roper Center for Public Opinion Research at University of Connecticut.
30.
Public Citizen Health Research Group . (2003). Dietary and herbal supplements. Retrieved April 28, 2003, from http://www.citizen.org/hrg/drugs/articles.cfm?ID=5195
31.
Randel, S. , & Soong, L. L. (1983). Traditional Chinese medicine in China. Western Journal of Medicine, 139(2), 236-238.
32.
Richardson, M. A. , Sanders, T., Palmer, J. L., Greisinger, A., & Singletary, S. E. (2000). Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology. Journal of Clinical Oncology, 18(13), 2505-2514.
33.
Saito, H. (2000). Regulation of herbal medicines in Japan. Pharmacological Research, 41(5), 515-519.
34.
Scott, G. N. , & Elmer, G. W. (2002). Update on natural product—drug interactions. American Journal of Health-System Pharmacy, 59(4), 339-347.
35.
Shekelle, P. G. , Hardy, M. L., Morton, S. C., Maglione, M., Mojica, W. A., Suttorp, M. J., et al. (2003). Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: A meta-analysis [Comment]. JAMA, 289(12), 1537-1545.
36.
Shumay, D. M. , Maskarinec, G., Kakai, H., & Gotay, C. C. (2001). Why some cancer patients choose complementary and alternative medicine instead of conventional treatment. Journal of Family Practice, 50(12), 1067.
37.
Six years after the establishment of DSHEA: The status of national and international dietary supplement research and regulation: Hearing before the Committee on Government Reform , 107th Cong., 26 (2001).
38.
Smolinske, S. C. (1999). Dietary supplement-drug interactions. Journal of the American Medical Women’s Association, 54(4), 191-192,195.
39.
Sohn, P. M. , & Loveland Cook, C. A. (2002). Nurse practitioner knowledge of complementary alternative health care: foundation for practice. Journal of Advanced Nursing, 39(1), 9-16.
40.
Stein, C. M. (2002). Are herbal products dietary supplements or drugs? An important question for public safety [Comment]. Clinical Pharmacology & Therapeutics, 71(6), 411-413.
41.
Torpy, J. M. , Lynm, C., & Glass, R. M. (2003). Ephedra and ephedrine. JAMA, 289(12), 1590.
42.
Traub, S. J. , Hoyek, W., & Hoffman, R. S. (2001). Dietary supplements containing ephedra alkaloids. New England Journal of Medicine, 344(14), 1096-1097.
43.
U.S. Food and Drug Administration . (1994). A food labeling guide-Appendix C. Retrieved January 20, 2004, from http://www.cfsan.fda.gov/dms/flg-6c.html
44.
U.S. Food and Drug Administration . (1997). Premarket notification for a new dietary ingredient (21 CFR Part 190). Federal Register, 62(184), 49886-49892.
45.
U.S. Food and Drug Administration . (1999, November). FDA warns against consuming TRIAX metabolic accelerator. Retrieved May 2, 2004, from http://www.cfsan.fda.gov/%7Elrd/tptriax.html
46.
U.S. Food and Drug Administration . (2001a). New dietary ingredients in dietary supplements. Retrieved January 20, 2004, from http://www.cfsan.fda.gov/dms/ds-ingrd.html
47.
U.S. Food and Drug Administration . (2001b). Overview of dietary supplements. Retrieved June 14, 2004, from http://www.cfsan.fda.gov/%7Edms/ds-oview.html%23what
48.
U.S. Food and Drug Administration . (2002). 21CTR101.13—Nutrient content claims—general principles. Retrieved January 20, 2004, from http://www.access.gpo.gov/nara/cfr/waisidx_02/21cfr101_02.html
49.
U.S. Food and Drug Administration . (2003a, December 30). FDA announces plans to prohibit sales of dietary supplements containing ephedra. Retrieved January 18, 2004, from http://www.cfsan.fda.gov/%7Elrd/hhsephe2.html
50.
U.S. Food and Drug Administration . (2003b, March 7). FDA proposes manufacturing and labeling standards for all dietary supplements. Retrieved March 10, 2003, from http://www.fda.gov/bbs/topics/NEWS/dietarysupp/background.html
51.
U.S. Food and Drug Administration . (2003c, August 28). Labeling of dietary supplements. Retrieved November 26, 2003, from http://www.cfsan.fda.gov/dms/ds-labl.html
52.
U.S. Food and Drug Administration . (2004, April 27). Med Watch: The FDA safety information and adverse event reporting program. Retrieved May 2, 2004, from http://www.fda.gov/medwatch/report/hcp.htm
