New Dietary Ingredients Notification Process
The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. Generally, the notification must include information that is the basis on which manufacturers/distributors have concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.
New Dietary Ingredients in Dietary Supplements - Background for Industry
Explanation including: definition, notification process, and table of notifications received
How to Submit Notifications
Information on how to submit a notification including timeframe, format, and method of submission.
Final Rule: Premarket Notification for a New Dietary Ingredient
Federal Register September 23, 1997
Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Guidance for Industry: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Small Entity Compliance Guide
- See all Guidance & Regulations about Dietary Supplements