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Guidance on Dietary Ingredient Notifications for Supplements

08/12/2016

Federal Register Notice: FDA is issuing a revised draft guidance for industry entitled Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. It supersedes a 7/2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications). To download this guidance, click here. To view this notice, click here.

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