Patients’ Understanding of the Regulation of Dietary Supplements
- 348 Downloads
The Dietary Supplement Health and Education Act (DSHEA) permits manufacturers to sell products without providing pre-market evidence of safety or efficacy. One fundamental reason for the passage of the DSHEA was to empower consumers to make their own choices, free from governmental restriction. Yet, little is known about the public’s understanding of the supplement regulatory process. We undertook a study to assess patients’ knowledge regarding governmental oversight of product marketing and advertising. A survey of 300 adult patients from the Baltimore Metropolitan area was administered after showing participants an advertisement for a dietary supplement. Patients were asked questions regarding their understanding of federal regulation of the advertised product. A total of 52% of respondents were unaware that the dietary supplement had not been approved by the government while 63% were unaware that the advertisement for that supplement had not been pre-approved. Factors associated with a lack of understanding of the product approval process included lower education level (OR 2.52; 95% CI 1.52–4.19) and non-Caucasian race (OR 1.99; 95% CI 1.17–3.36). Lower education level was also associated with confusion regarding the advertisement approval process (OR 2.60; 95% CI 1.48–4.57). Based on these results, patients seem unclear about the government’s role in the regulation of dietary supplements. Educational efforts should be geared towards clarifying these issues.
KeywordsDietary supplements Dietary Supplement Health and Education Act Herbal Food and Drug Administration Federal Trade Commission
We would like to thank Dr. Loh-shan Leung for his assistance in data gathering. Dr. Wright is an Arnold P. Gold Foundation Associate Professor of Medicine.
- 1.Dietary Supplement Health and Education Act of 1994. Public Law 103-417. Available at: http://www.fda.gov/opacom/laws/dshea.html. Accessed March 1, 2007.
- 2.U.S. Food and Drug Administration. Overview of dietary supplements. Available at: http://www.cfsan.fda.gov/~dms/supplmnt.html. Accessed March 1, 2007.
- 3.Palmer, M. E., Haller, C., McKinney, P. E., Klein-Schwartz, W., Tschirgi, A., Smolinske, S. C., Woolf, A., Sprague, B. M., Ko, R., Everson, G., Nelson, L. S., Dodd-Butera, T., Bartlett, W. D., & Landzberg, B. R. (2003). Adverse events associated with dietary supplements: An observational study. Lancet, 361, 101–106.PubMedCrossRefGoogle Scholar
- 10.The Federal Trade Commission. Dietary supplements: an advertising guide for industry. Available at: http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm. Accessed March 1, 2007.
- 11.The Federal Trade Commission. FTC testifies on the marketing of dietary supplements. Available at: http://www.ftc.gov/opa/2003/10/dietarysupptest.htm. Accessed March 1, 2007.
- 14.Barnes, P. M., Powell-Griner, E., McFann, K., & Nahin, R. L. (2004). Complementary and alternative medicine use among adults: United States, 2002. Advance data from vital and health statistics; no. 343. Hyattsville, Maryland: National Center for Health Statistics, 2004. Available at: http://www.cdc.gov/nchs/data/ad/ad343.pdf. Accessed March 1, 2007.
- 17.Barrett, S., & Herbert, V. (1994). The vitamin pushers: How the health food industry is selling America a bill of goods. Amherst, NY: Prometheus Books.Google Scholar
- 18.Commission on Dietary Supplement Labels. Report of the commission on dietary supplement labels. Available at: http://www.health.gov/dietsupp/final.pdf. Accessed March 1, 2007.
- 21.The Food and Drug Administration. FDA announces plans to prohibit sales of dietary supplements containing ephedra. Available at: http://www.fda.gov/oc/initiatives/ephedra/december2003/. Accessed June 27, 2006.
- 22.Beauchamp, T. L., & Childress, J. F. (1994). Principles of biomedical ethics. New York: Oxford University Press.Google Scholar
- 23.The Federal Trade Commission. Frequently asked advertising questions: A guide for small business. Available at: http://www.ftc.gov/bcp/conline/pubs/buspubs/ad-faqs.htm. Accessed June 27, 2006.
- 25.Gillis, J. (2004). Herbal remedies turn deadly for patients. Washington Post September 5, 2004; Sect A:1.Google Scholar
- 27.Durbin, R. (2003). Dietary Supplement Safety Act of 2003. Senate bill s.722. 108th Congress. Introduced: March 26, 2003.Google Scholar
- 28.U.S. Congress. Dietary Supplement and Nonprescription Drug Consumer Protection Act. Public Law No: 109-462. Passed: December 22, 2006. Available at: http://www.govtrack.us/congress/billtext.xpd?bill=s109–3546. Accessed March 1, 2007.