Get the free New Dietary Ingredient Notification

This document serves as a notification to the U.S. Food and Drug Administration regarding the intent to market Rexflavone, a dietary ingredient derived from the fruit of Sophora japonica L. The notification includes details on the ingredient\'s safety, manufacturing process, recommended usage, and targeted populations. It aims to substantiate that Rexflavone is safe for consumption, particularly for menopausal women seeking to maintain bone health, and outlines the scientific and...

How to fill out new dietary ingredient notification

How to fill out new dietary ingredient notification

1. Review the requirements set by the FDA for new dietary ingredient notifications.
2. Gather relevant safety and substance information about the new dietary ingredient.
3. Complete the notification form by providing details such as the name of the ingredient, the intended use, and the expected intake levels.
4. Include any relevant studies or data demonstrating the safety of the ingredient.
5. Submit the completed notification to the FDA, ensuring compliance with all formatting and submission guidelines.

Who needs new dietary ingredient notification?

1. Manufacturers of dietary supplements who introduce new dietary ingredients.
2. Importers or distributors aiming to market dietary products containing new ingredients.
3. Companies seeking to ensure compliance with FDA regulations related to dietary supplements.

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What is new dietary ingredient notification?

A New Dietary Ingredient Notification (NDIN) is a submission required by the FDA for certain dietary ingredients that were not marketed in the U.S. before October 15, 1994. The notification must demonstrate that the ingredient is safe for use in dietary supplements.

Who is required to file new dietary ingredient notification?

Manufacturers or distributors of dietary supplements that contain new dietary ingredients must file the NDIN with the FDA.

How to fill out new dietary ingredient notification?

To fill out an NDIN, the submitter must provide specific information including the identity and characteristics of the new dietary ingredient, the proposed use, the level of intake, and safety data supporting its use.

What is the purpose of new dietary ingredient notification?

The purpose of NDIN is to ensure that new dietary ingredients are safe for consumption and to provide the FDA with data to assess their safety prior to marketing.

What information must be reported on new dietary ingredient notification?

The NDIN must report information such as the identity of the ingredient, its history of use, the manufacturer or distributor's information, proposed uses, and any relevant safety data.