Get the free Fda New Dietary Ingredient Notification Safety Information

This document provides instructions and detailed information regarding the safety of New Dietary Ingredients (NDIs) that are expected to be safe for use in dietary supplements. It includes guidelines for verifying the identity of NDIs, history of use, and required safety data. The document outlines the safety assessments and provides recommendations for completing the notification process to the FDA.

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What is fda new dietary ingredient?

A new dietary ingredient (NDI) is defined by the FDA as a dietary ingredient that was not marketed in the United States before October 15, 1994. This includes vitamins, minerals, herbs, amino acids, or other substances that may be used to supplement the diet.

Who is required to file fda new dietary ingredient?

Manufacturers and distributors of dietary supplements that include a new dietary ingredient must submit a notification to the FDA if the ingredient was not marketed in the U.S. before October 15, 1994.

How to fill out fda new dietary ingredient?

To fill out an FDA NDI notification, manufacturers must provide data that establishes the ingredient’s safety when used as intended, including evidence of safety, manufacturing details, and intended use.

What is the purpose of fda new dietary ingredient?

The purpose of the FDA new dietary ingredient notification is to ensure that any new ingredients used in dietary supplements are safe for consumption and do not pose any risks to public health.

What information must be reported on fda new dietary ingredient?

The information that must be reported includes the identity of the new dietary ingredient, the basis for the determination of safety, a description of how the ingredient is manufactured, and the intended conditions of use.