This article gives a brief historical perspective on dietary supplement regulation and discusses the evolution of drug regulation by the FDA. Part II concludes with a discussion of the political environment in which these regulations occur. Part III gives examples and show how the current system has caused injury and harm to consumers of dietary supplements. Part IV discusses the current burden of proof and how it was applied in the case of ephedra. Part V discusses how, under the current regulatory structure, consumers cannot be adequately protected, either by the FDA or the tort system. Part VI discusses the benefits that would likely be derived from shifting the burden of proving safety onto the dietary supplement industry. Finally, Part VII concludes the article.
Morgan J. Wais, Stomaching the Burden of Dietary Supplement Safety: The Need to Shift the Burden of Proof Under the Dietary Supplement Health and Education Act of 1994, 28 SEATTLE U. L. REV. 849 (2005).