The Federal Food, Drug, and Cosmetic Act (the FD&C 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 the manufacturer or distributor has 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.
**IMPORTANT: As of October 19, 2019, notifications are no longer being accepted via the FURLS portal. All notifications must now be submitted in COSM.
See How to Submit Notifications for details on how to submit a notification including timeframe, format, and method of submission.
Guidance and Rules
- Final Rule: Premarket Notification for a New Dietary Ingredient
- Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues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
New Dietary Ingredient Draft Guidance
FDA issued a revised draft guidance for industry on dietary ingredient notifications and related issues. The revised draft guidance supersedes FDA's July 2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications).
Read and Comment on the Draft Guidance: New Dietary Ingredient Notifications and Related Issues.
A public meeting to discuss the development of a list of pre-DSHEA dietary ingredients was held on October 3, 2017.