Swann John P
History Office, Office of Communications, Office of External Affairs, Office of the Commissioner, FDA.
Drug Test Anal. 2016 Mar-Apr;8(3-4):271-82. doi: 10.1002/dta.1919. Epub 2015 Nov 23.
This review examines the emergence of dietary supplements and how the Food and Drug Administration (FDA) attempted to regulate these, beginning with the arrival of vitamins and how these were managed under the 1906 Food and Drugs Act, and ending with the seismic influence of the 1994 Dietary Supplement Health and Education Act (DSHEA). Included are the impact of major laws, key court decisions, and the construction of the FDA's supplement actions and rules from the 1920s to the 1990s for products that were neither drugs nor typical foods. Stiff resistance to the regulations by supplement manufacturers, trade associations, politicians, and especially the public at large is an important part of this story. The paper closes with the passage of DSHEA and how it literally changed the definition and parameters of control of dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd.
本综述考察了膳食补充剂的兴起，以及美国食品药品监督管理局（FDA）如何尝试对其进行监管，从维生素的出现以及它们在1906年《食品和药品法》下的管理方式，到1994年《膳食补充剂健康与教育法》（DSHEA）产生的巨大影响。内容包括主要法律的影响、关键法庭裁决，以及20世纪20年代至90年代FDA针对既非药品也非典型食品的产品所采取的补充剂行动和规则的制定。补充剂制造商、行业协会、政界人士，尤其是广大公众对这些法规的强烈抵制是这个故事的重要组成部分。本文最后讲述了DSHEA的通过及其如何从字面上改变了膳食补充剂的定义和管控范围。版权所有© 2015约翰·威利父子有限公司。
