On August 11, 2016, FDA issued a revised draft guidance replacing the original draft guidance of 2011, "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," and requesting comments to issue a final guidance on the notification of new dietary ingredients ("NDI") in dietary supplements. Under the Dietary Supplement Health and Education Act, a manufacturer or distributor must notify 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 October 15, 1994), unless the NDI is used in the food supply without chemical alteration. The revised guidance addresses topics such as: (i) what qualifies as an NDI; (ii) when an NDI notification is required; (iii) what are the procedures for submitting an NDI notification; (iv) what types of data and information FDA recommends industry consider when evaluating the safety of NDIs and dietary supplements containing an NDI; and (v) what FDA recommends industry include in an NDI notification. In addition, the guidance contains questions and answers about the definitions of "dietary supplement," "chemical alteration," "NDI," and "grandfathered" ingredients. These definitions can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement. FDA is accepting comments until October 11, 2016.
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