Guidance for Industry New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements

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On March 5, 2024, FDA announced the availability of final guidance for industry titled "Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements | FDA". 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.

The guidance finalizes Section V ("NDI Notification Procedures and Timeframes") of the 2016 revised draft guidance (Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues | FDA) in addition to several related questions from other sections of the draft guidance.

The guidance provides information in a questions and answers format about the NDIN submission and review process. Topics include, among others:

Who needs to submit an NDIN?
How should the information be organized and presented?
Where should an NDIN be submitted?
What happens after an NDIN is submitted?

Who needs to submit an NDIN?

the manufacturer or distributor of a dietary supplement that contains an NDI
the manufacturer or distributor of the NDI

They must notify 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 (see 21 CFR 190.6(a)).

You can submit a single NDIN that contains safety data for a range of conditions of use and covers multiple products. FDA accepts NDINs that cover multiple dietary supplements and include safety data for a range of doses, daily intake levels, or other variations in conditions of use (e.g., serving size, duration of use, frequency of intake, target population, dosage form).

How should information be organized and presented?

FDA encourages you to submit your NDIN electronically through FDA's CFSAN Online Submission Module (COSM).
If you are submitting on paper, you must submit an original and two copies of your NDIN.
FDA recommends that the paper NDIN be organized by sections. In addition, each subject area should begin with a new page to facilitate division of the NDIN among reviewers. FDA encourages those who wish to submit NDINs on paper to consult Appendix A of this guidance, which contains a recommended template for organizing a paper NDIN.
Your NDIN should:
1. specify which of the dietary ingredient categories in section 201(ff) (1) of the FD&C Act the NDI belongs to and explain the basis for your conclusion;
2. describe the manufacturing process used to make the NDI, including process controls;
3. describe the physical properties and chemical or molecular composition and structure of the NDI; and
4. include a specification sheet that describes the critical identity and safety attributes of the NDI.
The NDIN should contain a description of the dietary supplement in which the NDI will be used, including:
1. the level of NDI in the dietary supplement per serving;
2. the identity and level of any other dietary ingredients and non-dietary ingredients (e.g., binders and fillers) in the dietary supplement per serving;
3. a description of the manufacturing process of the dietary supplement, including process controls;
4. a specification sheet for the dietary supplement that describes its critical safety attributes; and
5. the conditions of use recommended or suggested in the labeling of the dietary supplement, or if no conditions of use are recommended or suggested in the labeling of the dietary supplement, a discussion of the ordinary conditions of use of the dietary supplement.

Where should an NDIN be submitted?

If you are submitting your NDIN electronically, you may do so via COSM at Online Submission (fda.gov). FDA’s website provides details on how to use COSM.
If you are 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

What happens after an NDIN is submitted?

The date when FDA receives a complete NDIN is the date of that notification's filing. The date of filing is the start of the 75-day premarket review period.

An incomplete NDIN is one that does not contain all the information required by 21 CFR 190.6.I. Examples of omissions that can cause an NDIN to be incomplete include:

Material in a language other than English that is either not translated or is translated inaccurately or incompletely.
Citations to published literature for which a full copy of the publication is not provided.
An NDIN that is not signed, or contact information that is inaccurate and does not permit FDA to establish contact with the notifier.
Failure to provide the Latin binomial name, including the author citation, for any ingredient that is a botanical or derived from a botanical.