Zhao Hongjing,Wan Chao,Zhang Liwei,et al.Case analysis and inspiration on a case of American dietary supplements management [J].,2016,38(06):487-491.[doi:10.3760/cma.j.issn.1673-4246.2016.06.002]
美国膳食补充剂管理案例分析及启示
- Title:
- Case analysis and inspiration on a case of American dietary supplements management
- 关键词:
- 保健食品; 美国食品和药物管理局; 膳食补充剂; 原料管理
- Keywords:
- Health food; United States Food and Drug Administration; Dietary supplement; Ingredient management
- 摘要:
- 2015年10月，俄勒冈州政府起诉美国某知名膳食补充剂经销商涉嫌销售含非法添加成分的膳食补充剂。该事件暴露出美国对于膳食补充剂原料管理存在的问题；同时，也引发了各利益相关方对于FDA与州政府在监管职责及执法程序等方面的关注与讨论。通过对该事件进行分析，提出我国加强保健食品及原料监管的政策性建议，希望为相关部门及研究者提供借鉴与参考。
- Abstract:
- Oregon sued a certain American well-known supplements’agency contained illegal ingredients on Oct.22, 2015. The event presented that FDA showed the problem of the management issues on the supplement ingredients. This event also triggered the discussions about the role of supervisation and law enforcement of FDA and State government. This paper aimed to systematically analyze the related problems in such issue and tried to offer suggestion of food regulation and ingredient management to the researchers and administrators in China.
参考文献/References:
［1］ 卫生部. 关于进一步规范保健食品原料管理的通知[Z]. 2002-02-28. ［2］ 国家食品药品监督管理局. 关于发布保健食品中可能非法添加的物质名单(第一批)的通知[Z]. 2012-03-16. ［3］ 曾亮亮. 美国保健品公司GNC涉非法添加[N]. 经济参考报, 2015-10-30. ［4］ Rick Polito. Oregon sues GNC over ‘spiked’products,but is the more troubling headline the FDA’s role?[N/OL]. Nutrition Business Journal,2015-10-22. http://newhope360.com/nutrition- business-journal-1. ［5］ Sara Germano. Oregon sues GNC,Alleging supplements contained illegal ingredients[N/OL]. Wall Street Journal,2015-10-22. http://www.huffingtonpost.com/news/wall-street- journal-online. ［6］ USA Act. Dietary Supplement Health and Education Act 1994[Z]. 1994. ［7］ FDA Regulation Draft. Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues[Z].2011-07. ［8］ 十二届全国人大常务委员会. 中华人民共和国食品安全法[Z]. 2015-04-24. ［9］ 国家卫生和计划生育委员会. 新食品原料安全性审查管理办法[Z]. 2013-05-31. ［10］ 于守洋,崔洪斌. 中国保健食品的进展[M]. 北京:人民卫生出版社,2001:1-18. ［11］ 国家食品药品监督管理局. 保健食品注册与备案管理办法[Z]. 2016-02-26.
相似文献/References:
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Guo Xiaofang,Ma Huanghuang,Wu Jinrong..Determination of 9 PDE5 inhibitors in Chinese patent medicines and dietary supplements by UHPLC-HRMS[J].,2016,38(06):1107.[doi:10.3760/cma.j.issn.1673-4246.2016.12.014]
备注/Memo
通信作者：宛超，Email: wanchao@zybh.gov.cn
更新日期/Last Update:
2016-06-02