Interim Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of NDIs

this in-depth and practical guide explains the new dietary ingredient (NDI) regulations and identifies information to include-and exclude- in an NDI notification.

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The Interim Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of NDI's Under 21 U.S.C 350b. Originally published in May 2006 and updated September 2011, this in-depth and practical guide explains the new dietary ingredient (NDI) regulations and identifies information to include-and exclude- in an NDI notification. This AHPA guide also provides three worksheets to help companies file and complete NDI notifications" Determination of requirement to submit, Submission of NDI notification, and Form for cover to submission.

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