美国FDA更新膳食补充剂上市前安全通告指导意见草案

The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies' new dietary ingredient （NDI� premarket safety notifications to the agency.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 co ncerns 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 co ntains 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 co nsidered adulterated if they co ntain an NDI not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.

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