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.
Guidance and Rules
- Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification
- 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- Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues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
- Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements
- All Guidance and 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New Dietary Ingredient Draft Guidance
FDA issued a revised draft guidance for industry on dietary ingredient notifications and related issues. The revised draft guidance supersedes FDA's July 2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary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Read and Comment on the Draft Guidance: New Dietary Ingredient Notifications and Related Issues.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 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 still have questions after reviewing the related NDI webpages:
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)