FDA Issues a Revised Draft Guidance on New Dietary Ingredients Used in Dietary Supplements

FDA Issues a Revised Draft Guidance on New Dietary Ingredients Used in Dietary Supplements

August 15, 2016, Covington Alert

On August 11, 2016, FDA published its long-awaited revised draft guidance on Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Like the 2011 draft it replaces, the revised draft guidance is intended to help a dietary supplement company decide (1) whether a substance is a dietary ingredient; (2) when a new dietary ingredient (NDI) notification is required before a dietary ingredient can be used; and (3) how to prepare and submit an NDI notification.