美国FDA更新膳食补充剂上市前安全通告指导意见草案

 

    按照膳食补充剂健康教育法案的要求，生产商或者经销商需要在含新原料膳食补充剂上市前的75天前向FDA汇报，该新原料已被用于食品无风险的情况除外。如果含有非食品原料并且未在销售的75天前向FDA汇报，那么会被判为掺假。

 

    部分原文报道如下：

 

    The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies' new dietary ingredient （NDI） premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.

 

    Under the Dietary Supplement Health and Education Act （DSHEA）， the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient （one that was not marketed in the United States before Oct. 15, 1994）， unless the NDI is used in the food supply without chemical alteration. Dietary supplements are considered adulterated if they contain an NDI not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.

 

    原文链接：

 

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm516197.htm