Additional Information & Resources

In addition to the AHPA NDI Database, AHPA has produced materials that may help companies successfully navigate the process of submitting NDI notifications to FDA. These include:

  • An AHPA-developed guidance document: Interim Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of New Dietary Ingredients Under 21 U.S.C. 350b (May 2006, updated September 2011). This in-depth and practical guide explains the NDI regulations and identifies information to include-and exclude-in an NDI notification. This AHPA guide also provides three worksheets to help companies file complete NDI notifications: Determination of requirement to submit; Submission of NDI notification; and Form for cover to submission. This document is available for purchase at the AHPA Bookstore.



  • The AHPA NDI Notifications Submissions Package, which contains a number of tools to successfully navigate FDA's NDI notification requirements. The AHPA NDI Notifications Submissions Package includes:



    • The Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of New Dietary Ingredients Under 21 U.S.C. 350b (May 2006, updated September 2011)



    • The transcript and audio file of an AHPA-sponsored teleseminar conducted on July 19, 2011, by industry legal, nutrition, and regulatory experts titled "Navigating FDA's New Dietary Ingredient (NDI) Notification Requirements." Includes post-presentation Q&A session and course outline and speaker bios.

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    • A Food and Drug Law Journal article by Michael McGuffin, AHPA President, and Anthony Young, AHPA General Counsel, titled, "Premarket Notifications of New Dietary Ingredients: A Ten-Year Review"

             

    The AHPA NDI Notifications Submissions Package is available for purchase at the AHPA Bookstore.