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膳食补充剂的监管与伦理问题

Regulatory and ethical issues with dietary supplements.

作者信息

Harris I M

机构信息

Department of Pharmaceutical Care and Health Systems, College of Pharmacy, University of Minnesota, Minneapolis, USA.

出版信息

Pharmacotherapy. 2000 Nov;20(11):1295-302. doi: 10.1592/phco.20.17.1295.34896.

Abstract

Dietary supplements are commonly used, and many are effective or hold promise for treating various conditions. However, they do not require Food and Drug Administration (FDA) approval. Impurities and adulterants have been found in the products, mostly due to the lack of requirements for good manufacturing practices. In addition, as no standardization is required, the active ingredient may be absent or highly variable among manufacturers. The FDA published its 10-year plan for dietary supplements that addresses safety, labeling, boundaries, enforcement, research, and outreach. This endeavor, if put into place, will be instrumental in providing consumers with more confidence in the safety, composition, and labeling of dietary supplements.

摘要

膳食补充剂被广泛使用,许多对治疗各种病症有效或具有潜在疗效。然而,它们无需获得美国食品药品监督管理局(FDA)的批准。在这些产品中发现了杂质和掺假物质,这主要是由于缺乏对良好生产规范的要求。此外,由于无需标准化,不同制造商生产的产品中活性成分可能缺失或差异很大。FDA公布了其针对膳食补充剂的十年计划,该计划涉及安全性、标签、界限、执法、研究及宣传推广。这项工作若得以实施,将有助于增强消费者对膳食补充剂的安全性、成分及标签的信心。

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