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 (FDA) 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.
See How to Submit Notifications for a New Dietary Ingredient for details on how to submit a notification including timeframe, format, and method of submission.
Guidance and Rules
- Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification (2022)
- Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (2016)
- Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2009)
- Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements (1999)
- Final Rule: Premarket Notification for a New Dietary Ingredient (1997)
- All Guidance and Regulations about Dietary Supplements
A public meeting to discuss responsible innovation in dietary supplements was held on May 16, 2019.
A public meeting to discuss the development of a list of pre-DSHEA dietary ingredients was held on October 3, 2017.
If you have any questions about the NDI notification process:
Contact the Office of Dietary Supplement Programs by email at NDIN@fda.hhs.gov.
To reach FDA’s Food and Cosmetics Information Center, call: 1-888-SAFEFOOD (1-888-723-3366).