Division of Dietary Supplement Programs, Office of Nutrition, Labeling, and Dietary Supplements, College Park, Maryland 20740, USA.
Toxicol Sci. 2011 Oct;123(2):333-48. doi: 10.1093/toxsci/kfr198. Epub 2011 Aug 5.
The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.
在美国，人们越来越多地使用从天然物质中提取的植物药和膳食补充剂来提高生活质量或因其所谓的医疗益处。本综述介绍了美国食品和药物管理局 (FDA) 对含有这些物质的食品产品进行安全性评估和监管的情况。鉴于一些产品的毒性信息非常有限，安全性问题尤其关键。第一节使用甜菊糖和绿茶提取物的案例研究，介绍了 FDA 如何评估提交的植物药和草药产品的安全性，这些产品是根据《联邦食品、药品和化妆品法案》作为一般认为安全 (Generally Recognized as Safe, GRAS) 进行审议的。1994 年《膳食补充剂健康与教育法案》（Dietary Supplement Health and Education Act，DSHEA）为膳食补充剂制定了监管框架。本文还讨论了根据 DSHEA 对这一类膳食补充剂的监管，并介绍了 FDA 在分析上市前安全性提交中描述的天然成分安全性方面的经验。最后，我们讨论了正在进行的机构间合作，以对指定的膳食补充剂进行安全性测试。
