The Safety and Regulation of Natural Products Used as Foods and Food Ingredients

被引:116
作者
Abdel-Rahman, Ali [2 ]
Anyangwe, Njwen [2 ]
Carlacci, Louis [2 ]
Casper, Steve [2 ]
Danam, Rebecca P. [1 ]
Enongene, Evaristus [2 ]
Erives, Gladys [1 ]
Fabricant, Daniel [2 ]
Gudi, Ramadevi [2 ]
Hilmas, Corey J. [2 ]
Hines, Fred [2 ]
Howard, Paul [3 ]
Levy, Dan [2 ]
Lin, Ying [2 ]
Moore, Robert J. [2 ]
Pfeiler, Erika [4 ]
Thurmond, T. Scott [1 ]
Turujman, Saleh [2 ]
Walker, Nigel J. [5 ]
机构
[1] US FDA, Off Food Addit Safety, Ctr Food Safety & Appl Nutr, College Pk, MD 21029 USA
[2] US FDA, Div Dietary Supplement Programs, Off Nutr Labeling & Dietary Supplements, College Pk, MD 21029 USA
[3] US FDA, Off Sci Coordinat, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA
[4] US FDA, Off Commissioner, Off Chief Scientist, Laurel, MD 20708 USA
[5] NIEHS, NIH, Res Triangle Pk, NC 27709 USA
关键词
botanicals; dietary supplements; food; food ingredients; safety; regulation; GREEN TEA; ARISTOLOCHIC ACID; REBAUDIOSIDE-A; STEVIA-REBAUDIANA; STEVIOSIDE; NEPHROPATHY; CARCINOGENICITY; EXTRACTS;
D O I
10.1093/toxsci/kfr198
中图分类号
R99 [毒物学(毒理学)];
学科分类号
100405 [卫生毒理学];
摘要
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.
引用
收藏
页码:333 / 348
页数:16
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