Dietary Supplements: A Historical Examination of its Regulation

Abstract

The subject of this paper is the regulation of dietary supplements, with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) marked as a turning point. The paper examines the history of regulation prior to DSHEA, and then it proceeds to examine DSHEA itself as legislation. The problems with DSHEA and its enforcement by the Food and Drug Administration (FDA) are then discussed, and I use ephedra as a specific example in illustrating those problems. To complete the examination of the entire regulatory scheme behind dietary supplements, I then address the concurrent regulatory responsibilities that the Federal Trade Commission (FTC) has with the FDA in regulating supplements. As a counterpoint to government regulation, I also examine some areas of products liability law that will be relevant in dietary supplement litigation as an illustration of private regulation via litigation. I conclude the paper by discussing some proposals that can be implemented to improve the dietary supplement regulatory scheme.