Balancing Safety of Dietary Supplements with the Free Market
Authors: James D. Lewis, Brian L. Strom
Journal: Annals of Internal Medicine (2002)

Editorials16 April 2002Balancing Safety of Dietary Supplements with the Free MarketJames D. Lewis, MD, MSCE and Brian L. Strom, MD, MPHJames D. Lewis, MD, MSCEUniversity of Pennsylvania; Philadelphia, PA 19104 (Lewis, Strom) and Brian L. Strom, MD, MPHUniversity of Pennsylvania; Philadelphia, PA 19104 (Lewis, Strom)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-136-8-200204160-00011 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail A desire to take medications is, perhaps, the greatest feature which distinguishes man from other animals.–Sir William Osler, 1891In this issue, Favreau and colleagues report on cases of hepatotoxicity in users of the dietary supplement LipoKinetix (1). This dietary supplement was marketed as a weight-loss product and contained norephedrine (also known as phenylpropanolamine), caffeine, yohimbine, diiodothyronine, and sodium usniate. The authors report the experience of seven patients, each taking LipoKinetix for weight loss, who experienced severe liver injury within 12 weeks of ingesting this product.This and other recent reports of adverse outcomes associated with use of supplements [2, ...References1. Favreau JT, Ryu ML, Braunstein G, Orshansky G, Park SS, Coody GL, et al . Severe hepatotoxicity associated with the dietary supplement LipoKinetix. Ann Intern Med. 2002;136:590-5. LinkGoogle Scholar2. Lord GM, Tagore R, Cook T, Gower P, Pusey CD. Nephropathy caused by Chinese herbs in the UK [Letter]. Lancet. 1999;354:481-2. [PMID: 10465175] CrossrefMedlineGoogle Scholar3. Haller CA, Benowitz NL. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. N Engl J Med. 2000;343:1833-8. [PMID: 11117974] CrossrefMedlineGoogle Scholar4. . Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body. Food and Drug Administration, HHS. Final rule. Fed Regist. 2000;65:1000-50. [PMID: 11010621] MedlineGoogle Scholar5. FDA Talk Paper: FDA Finalizes Rules for Claims on Dietary Supplements. January 5, 2000 ed: United States Food and Drug Administration; 2000. Available at www.fda.gov/bbs/topics/ANSWERS/ANS00994.html. Accessed on 27 February 2002. Google Scholar6. Kennedy D, Goldman S, Lillie R. Spontaneous reporting in the United States.. In: Strom BL, eds. Pharmacoepidemiology. 3rd ed. Chichester: Wiley; 2000:151-74. Google Scholar7. Graham D, Waller P, Kurz X. A view from regulatory agencies.. In: Strom BL, eds. Pharmacoepidemiology. 3rd ed. Chichester: Wiley; 2000:91-108. Google Scholar8. . FDA drug review: postapproval risks, 1976-1985: report to the chairman, Subcommittee on Human Resources and Intergovernmental Relations, Committee on Government Operations, House of Representatives. Washington, DC: U.S. General Accounting Office; 1990. Google Scholar9. Mueller C. The regulatory status of medical foods and dietary supplements in the United States. Nutrition. 1999;15:249-51. [PMID: 10198926] CrossrefMedlineGoogle Scholar10. Zeisel SH. Regulation of "nutraceuticals.". Science. 1999;285:1853-5. [PMID: 10515789] CrossrefMedlineGoogle Scholar11. Dietary Supplement Health and Education Act of 1994. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition. 1995. Available at vm.cfsan.fda.gov/~dms/dietsupp.html/. Accessed on 27 February 2002. Google Scholar12. Overview of Dietary Supplements. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition. 2001. Available at www.cfsan.fda.gov/~dms/ds-oview.html#regulate/. Accessed on 27 February 2002. Google Scholar13. Letter to Distributor on Hazardous Dietary Supplement LipoKinetix. November 19, 2001. U.S. Food and Drug Administration. Available at www.cfsan.fda.gov/~dms/ds-ltr26.html/. Accessed on 27 February 2002. Google Scholar14. Rosebraugh CJ, Honig PK, Yasuda SU, Pezzullo JC, Flockhart DA, Woosley RL. Formal education about medication errors in internal medicine clerkships [Letter]. JAMA. 2001;286:1019-20. [PMID: 11559279] MedlineGoogle Scholar15. Ernst E. Herbal medicines: where is the evidence? [Editorial]. BMJ. 2000;321:395-6. [PMID: 10938031] CrossrefMedlineGoogle Scholar16. Keane FM, Munn SE, du. Vivier AW, Taylor NF. Higgins EM, Analysis of Chinese herbal creams prescribed for dermatological conditions. BMJ. 1999;318:563-4. [PMID: 10037629] CrossrefMedlineGoogle Scholar17. Goldman P. Herbal medicines today and the roots of modern pharmacology. Ann Intern Med. 2001;135:594-600. [PMID: 11601931] LinkGoogle Scholar Author, Article, and Disclosure InformationAffiliations: University of Pennsylvania; Philadelphia, PA 19104 (Lewis, Strom)Acknowledgments: The authors thank Gerald Faich, MD, MPH, and Peter Honig, MD, for their thoughtful review of an earlier version of this editorial.Corresponding Author: James D. Lewis, MD, MSCE, Center for Epidemiology and Biostatistics, University of Pennsylvania, 7th Floor Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104-6021; e-mail, [email protected]med.upenn.edu.Disclaimer: Dr. Lewis has served as a consultant for several pharmaceutical companies, including Bayer, Centocor, Wyeth, and McNeil. He has also had research funded by Bayer, Centocor, and Whitehall-Robins. He has consulted for Bayer on issues related to phenylpropanolamine, a component of LipoKinetix. Otherwise, none of the consulting or research was related to dietary supplements. Dr. Strom is funded for his research and has served as a consultant to most of the major pharmaceutical manufacturers. He has worked with Wyeth on issues related to fen/phen. He has also consulted with Whitehall on issues related to phenylpropanolamine, a component of LipoKinetix. Otherwise, he has not been a consultant to any supplement manufacturer or researched supplements per se, although some pharmaceutical manufacturers market supplements as well.Current Author Addresses: Drs. Lewis and Strom: Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, 7th Floor Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.Ann Intern Med. 2002; 136:616-618. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoSevere Hepatotoxicity Associated with the Dietary Supplement LipoKinetix Joya T. Favreau , Mina L. Ryu , Glenn Braunstein , Greg Orshansky , Sean S. Park , Gary L. Coody , Lori A. 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