US New Dietary Ingredient (NDI) Application - USA - Food & Food Contact Materials

Introduction

A New Dietary Ingredient (NDI) is defined in section 413(d) of the FD&C Act as a dietary ingredient that was not marketed in the United States before October 15, 1994 (21 U.S.C. 350b(d)).

New Dietary Ingredient, NDI

As defined in section 201(ff)(1) of the FD&C Act (21 U.S.C. 321(ff)(1)), a “dietary ingredient” is any one of the following:

A vitamin;
A mineral;
An herb or other botanical;
An amino acid;
A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
A concentrate, metabolite, constituent, extract, or combination of any of the above listed items.

An NDI refers to a dietary ingredient that, based on the above definition of dietary ingredients, was not marketed in the United States before October 15, 1994. It is limited to products administered in the form of tablet, capsule, powder, softgel, liquid, or other forms (products containing sublingual administration, topical application, or injection are strictly prohibited).

Additionally, an NDI does not include substances that have been approved for investigation as new drugs, antibiotics, or biological agents with substantial public clinical research, unless such substances were previously sold as dietary supplements or food.

New Dietary Ingredient Notification, NDIN

Under section 342(f) of the FD&C Act (21 U.S.C. 342(f)), the dietary supplement containing the NDI is deemed adulterated unless it meets one of the following requirements:

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;
The manufacturer or distributor of the NDI, or of the dietary supplement that contains the NDI, has submitted an NDIN or premarket notification to FDA.

Under section 413(a)(2) of the FD&C Act (21 U.S.C. 350b(a)(2)), the manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, must submit an NDIN to FDA at least 75 days before marketing the article in the United States, in which it must concludes that the dietary supplement containing the NDI will reasonably be expected to be safe.

The notifier for NDIN

The manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI.

Materials required for NDIN application

Businesses are required to provide the following materials for data analysis:

1. NDI basic information

Substance name, types of dietary ingredients, physical and chemical properties, production processes, product specifications and Certificate of Analysis (COA), key characteristics, safety description, and supporting materials.

2. Information on the dietary supplement containing the NDI

NDI content, characteristics and content of other dietary and non-dietary ingredients, the production processes, recommended conditions of use/use levels, safety description of the dietary supplement, and supporting materials.

Procedures for NDIN application

Steps	Remarks
FDA pre-notification meeting (optional)	Provide information, raise questions, and receive preliminary feedback from FDA.
Fist-time submission	Submit the complete NDIN to FDA
FDA provides the NDIN number	After receiving an NDIN, FDA sends an acknowledgement of receipt to the notifier stating the date of receipt of the notification and provides the NDIN number assigned to the notification. That specific date is the start of the 75-day premarket review period.
Feedback from FDA	During the review period, FDA may raise questions and request the notifier to submit additional information or materials. Examples of the types of response FDA commonly sends include: Letter of acknowledgement without objection; Letter listing deficiencies that make the NDIN incomplete under 21 CFR 190.6; Objection letter raising concerns with the adequacy of the identity information or safety information (e.g., identifying gaps in the history of use or that the safety information on the NDI does not support the conditions of use); and Letter raising other regulatory issues with the ingredient or product (e.g., the ingredient is not a dietary ingredient under 21 U.S.C. 321(ff)(1), or the product does not satisfy all parts of the dietary supplement definition under 21 U.S.C. 321(ff))
The notifier submits additional information (if required)	After reviewing a submission of additional information, FDA may determine that the submission is a substantive amendment and reset the 75-day filing date (21 CFR 190.6(d)).
Approval	After finishing the review, FDA sends the letter of acknowledgement without objection. After the 90-day date, the NDIN and the response letter will be placed on public display at www.regulations.gov, except for any information that is trade secret.