Division of Dietary Supplement Programs, US Food and Drug Administration, College Park, Maryland, USA.
Clin Pharmacol Ther. 2010 Feb;87(2):239-44. doi: 10.1038/clpt.2009.263. Epub 2009 Dec 23.
In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FDC Act) to set up a distinct regulatory framework for what we now call dietary supplements. The DSHEA was passed with the intent of striking a balance between providing consumers access to safe dietary supplements to help maintain or improve their health and giving the US Food and Drug Administration (FDA) authority to regulate and take action against manufacturers of supplements or supplement ingredients that present safety problems, are presented with false or misleading claims, or are adulterated or misbranded. This article will present FDA's recent experience in collecting and evaluating dietary supplement adverse event data for the purpose of assuring the public that the dietary supplements they purchase are safe.
1994 年，《膳食补充剂健康与教育法案》（DSHEA）修订了《联邦食品、药品和化妆品法案》（FDCA），为我们现在所说的膳食补充剂建立了一个独特的监管框架。DSHEA 的通过旨在在为消费者提供安全的膳食补充剂以帮助维持或改善他们的健康的同时，给予美国食品和药物管理局（FDA）权力来监管和对存在安全问题的补充剂或补充剂成分的制造商采取行动，这些制造商提出虚假或误导性的声明，或者是掺假或贴错标签的。本文将介绍 FDA 最近在收集和评估膳食补充剂不良事件数据方面的经验，目的是向公众保证他们购买的膳食补充剂是安全的。
