On March 5, 2024, the U.S. Food and Drug Administration (FDA) issued an industry guidance titled Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry1(hereafter Guidance). This Guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and submit new dietary ingredient notifications (NDINs) to the FDA.
Background information According to the Federal Food, Drug, and Cosmetic Act (the FD&C Act)2, manufacturers and distributors intending to market dietary supplements containing "new dietary ingredients" must notify the FDA about these ingredients. Generally, the notification must include information that the dietary supplement containing a new dietary ingredient is reasonably expected to be safe when being used as recommended or suggested in the labeling. |
The Guidance provides information in a questions-and-answers format about the NDIN submission and review process, including topics of：
Who needs to submit an NDIN?
The submitter of NDIN, i.e., the notifier, can be either the manufacturer or distributor of a dietary supplement that contains an NDI, or the manufacturer or distributor of the NDI. The notification must be made to FDA at least 75 days before marketing the article in the United States, unless the NDI has been present in the food supply as an article used for food in a form in which the food has not been chemically altered.
How should the information be organized and presented?
The NDIN should be well organized to facilitate an efficient and timely FDA review.
Enterprises can submit the NDIN electronically or in paper.
FDA encourages electronic submission to help ensure the completeness of NDIN and enhance FDA’s ability to process and review efficiently. For a paper NDIN, FDA recommends that it is organized by sections, with continuous and consecutive pagination throughout the notification. The page number should appear in the same location on every page. In addition, each subject area should begin on a new page to facilitate the division of the NDIN among reviewers.
Where should an NDIN be submitted?
Submitting the NDIN electronically via COSM at https://cfsanonlinesubmissions.fda.gov .
Submitting a paper NDIN, send it to:
Office of Dietary Supplement Programs (HFS-810) Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740-3835 |
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