美国脂肪酸类产品监管比较研究

A Comparative Study on the Regulation of Fatty Acid Products in the United States

目的:本文以美国脂肪酸类产品(药品与保健食品)为例,对二者定义、上市前监管、标签标注、上市后监管进行介绍以及比较研究,为我国既注册成药品又注册成保健食品的同种物质监管提供借鉴。方法:运用文献研究方法与比较研究方法对美国脂肪酸类产品定义、上市前监管、标签标注、上市后监管进行介绍以及比较研究。结果与结论:我国应对药品与保健食品定义加以明确界定;我国保健食品监管模式应从全程监管向风险控制过渡;我国应对保健食品限制声称以及保健品含量标识进行统一。

Objective： The paper compared the definition,pre-market supervision,labeling,post-marketing supervision of the fatty acid drugs and the fatty acids dietary supplements in the United States,and to provide reference for the regulation on the same substance that is registered as a drug but also registered as health food in our country. Methods： The literature research methods and comparative research methods were used to introduce and compare the definition,pre-market supervision,label labeling and post-market supervision of fatty acid products in the United States. Results Conclusion： China should deal with the definition of drugs and health food to be clearly defined. Our country＇s health food regulatory model should be translate the whole regulatory into the risk control transition. Our country should restrict the health claims and unified the content of the health food.