21CFR111简介膳食补充剂.doc

INTRODUCTION to 21CFR111: DIETARY SUPPLEMENTS 21CFR111简介：膳食补充剂I appreciate the opportunity to speak to your group today.我很高兴有机会向在座的各位发言。I want to start by briefly talking about three laws passed by the U.S. Congress which have established the legal framework within which FDA operates. The first of these laws is the Federal Food, Drug, and Cosmetic Act (FDC Act). Two other laws are the Dietary Supplement Health and Education Act (or DSHEA) and the Dietary Supplement and Nonprescription Drug Consumer Act both of which amended the FDC Act. FDA develops regulations based on the laws set forth in the FDC Act and other laws under which FDA operates.我想首先简要地谈论一下在美国国会通过的三部法律，FDA正是这些法律建立的法律框架内进行运作的。第一部法律是《联邦食品，药品和化妆品法》（FDC Act）。另外两部法律是膳食补充品健康教育法（DSHEA）和膳食补充剂和非处方药消费者保护法, 两个法律都补充了食品，药品和化妆品法。 在上述FDA赖以运作的三部法律基础上，FDA制定了相关规章。 It is one of these regulations which I am going to discuss this afternoon. That is Title 21 Part 111 of the Code of Federal Regulations which is entitled “Current Good Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements” or as this regulation is also known “the Dietary Supplement GMP’s”. Before I talk about the Dietary Supplement GMP’s, I need to first talk about the Dietary Supplement Health and Education Act.我今天下午要讨论的正是这些规章之一。这是标题21部的联邦规例,标题是“膳食补充剂现行优良制造，包装，标签，或控股经营”,亦称为“膳食补充的GMP”。在我谈论的膳食补充剂GMP之前，我有必要先讲一下膳食补充剂健康教育法。In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Under DSHEA, a dietary supplement is defined as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can al