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