New Dietary Ingredient Notification Decision Tool is an interactive tool. It helps determine if a New Dietary Ingredient (NDI) Notification is required before commercial distribution in the United States. It is intended to support dietary supplement developers.
NDI is a dietary ingredient that was not marketed in the United States in dietary supplement before October 15, 1994.
To better understand about NDI and its regulatory implications, you may watch our introductory video on NDI. It explains what constitutes an NDI and why NDI notification is essential for regulatory compliance.
The video also discusses possible scenarios where an NDI notification may be required. It outlines the NDI submission process and key data elements, and highlights common challenges applicants face, including typical FDA response outcomes. In addition, it clarifies the difference between NDI Notification and GRAS status, the two regulatory pathways that are often misunderstood.
Feel free to check out the below podcast-style NDI-N audio overview, which walks you through the FDA’s NDI-N requirements and recommendations. The content presented here is based on the below U.S. FDA regulatory sources:
- 21 CFR Part 190 – New Dietary Ingredient Notification
- Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes – Dietary Supplements, March 2024
- Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification, May 2022
- Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues, April 2024
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements, April 2024
The New Dietary Ingredient Notification Decision Tool guides users step-by-step through key regulatory considerations as to whether an ingredient is an NDI or not and if it is an NDI, does it require NDI notification and situations where consultations with FDA may be advisable.
The decision logic is based on the FDA draft guidance document Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, dated April 2024.
This tool is intended to support regulatory decision-making and strengthen early-stage compliance assessment during dietary supplement product development.
Disclaimer: This tool is for informational use only and is not a substitute for professional regulatory evaluation or legal advice.