New Dietary Ingredients (NDI) Notification Process
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.
See How to Submit Notifications for details on how to submit a notification including timeframe, format, and method of submission.
FDA provides an ePortal for electronic submissions.
Request for Comments on Notification Procedures for Statements on Dietary Supplements
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(r)(6)) and § 101.93 (21 CFR 101.93) of our regulations require that, no later than 30 days after the first marketing, we be notified by the manufacturer, packer, or distributor of a dietary supplement that it is marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in section 403(r)(6) of the FD&C Act.
Our electronic form (Form FDA 3955) allows respondents to the information collection to electronically submit notifications to FDA via an electronic system. We are upgrading our current system (the FDA Unified Registration Listing System known as FURLS) to deploy the Food Applications Regulatory Management (FARM) system. FARM is modeled after FURLS and collects the same information, but improves our operational efficiency.
Firms that prefer to submit a paper notification in a format of their own choosing still have the option to do so.
FDA is seeking comments on the new system. Draft screenshots are available below for review and comments.
- Draft Screenshots (PDF: 2.2 MB)
The comment period opens May 31, 2019 for 30 days. Submit comments electronically to docket folder FDA-2013-N-0032 on http://www.regulations.gov. For more information on how to comment, see the Federal Register Notice.
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- Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues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.