Overview of Federal Regulation of Dietary Supplements: Past, Present, and Future Trends

Abstract

This paper seeks to provide the researcher with a general overview of the past, present, and future of the federal regulation of dietary supplements. Part I of the paper briefly describes the regulation of dietary supplements between the enactment of the Food, Drug, and Cosmetic Act in 1938 and the enactment of the DSHEA in 1994. Part II of this paper explores the legislative history of the enactment of the DSHEA. Specifically, it details the relevant congressional hearings, reports and amendments to the bill that would eventually become the DSHEA. Part III of this paper explores each of the major provisions of the DSHEA. The next sections of the paper focus on the post-DSHEA dietary supplement regulatory developments. Part IV addresses the regulation of dietary supplement health and structure/function claims. Part V examines the aftermath of the DSHEA's broadening of the definition of "dietary supplement." Part VI of the paper details the safety and burden of proof issues established by the DSHEA, and Part VII describes the specific regulatory developments of the DSHEA's labeling and third party literature provisions. As Parts IV-VII will demonstrate, the post-DSHEA regulatory arena has been marked by attempts on the part of the FDA to tighten its regulatory hold. Part VIII of the paper looks to the future of the federal regulation of dietary supplements by examining recent bills proposed in Congress.