Expert Insights for U.S. FDA New Dietary Ingredient (NDI) Notification

Introduction

U.S. FDA New Dietary Ingredient (NDI) notification is a pivotal step for manufacturers and distributors aiming to launch dietary supplements in the United States. This guide provides an overview of NDI notification requirements, explains why timely notification is crucial, and outlines the steps for seamless FDA compliance.

What is a New Dietary Ingredient (NDI)?

A New Dietary Ingredient (NDI) is any dietary supplement ingredient that was not sold in the U.S. before October 15, 1994. This includes:

• Vitamins
• Minerals
• Herbs or botanicals
• Amino acids
• Concentrates, metabolites, extracts, or combinations of the above

Under the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act), any dietary supplement containing an NDI must submit an NDI Notification to the FDA at least 75 days before the product is marketed. This notification demonstrates that the ingredient is safe under the recommended conditions of use.

Why Do You Need NDI Notification?

The FD&C Act requires that any dietary supplement containing an NDI must either:

1. Contain only ingredients that have been part of the food supply and are not chemically altered, or
2. Provide evidence (such as history of use or scientific data) showing that the ingredient is safe under the recommended conditions of use.

If your product contains an NDI and doesn’t meet these requirements, it will be considered adulterated and cannot legally be sold in the U.S.

Who Needs NDI Notification?

You need to apply for NDI notification if:

1. You plan to sell an NDI in the U.S. market, or
2. You plan to sell a dietary supplement containing an NDI in the U.S. market.

NDI Notification Submission Time

NDI Notification Documentation

To submit an NDI notification, companies should prepare a comprehensive filing that includes:

• Applicant Details: Complete name and address.
• NDI name: If it is an herb or other botanical, the Latin name must be included.
• Describe the dietary supplement or dietary supplement containing the NDI, including:
  • The amount of the NDI in the dietary supplement;
  • The recommended or suggested conditions of use of the product in the label; if not, the normal conditions of use;
  • The history of use or other safety evidence that the dietary ingredient can be reasonably expected to be safe when used under the conditions recommended or suggested on the dietary supplement label.

Note: References to any published material must be accompanied by a reprint or photocopy. Any foreign language material must be accompanied by an English translation.

• Contact Designation: The designated person responsible for the content of the notification signs and can be contacted by the FDA if it has any questions.

What We Offer for Your NDI Notification?

We provide end-to-end support to help you successfully navigate the NDI Notification process:

1. NDI Necessity and Feasibility Analysis

We’ll evaluate your product and ingredients to determine whether an NDI Notification is required. If it is, we’ll assess the feasibility of your submission and outline the steps needed to comply with FDA regulations.

2. NDI Notification Preparation and Submission

Our experts will handle the entire NDI Notification process, including:

• Gathering and organizing required documentation (e.g., safety evidence, usage history, and scientific data)
• Preparing the notification with all necessary details, such as ingredient descriptions, usage conditions, and safety evidence
• Submitting the notification to the FDA at least 75 days before your product launch

3. Consultation Service

We’re here to answer your questions, provide regulatory updates, and ensure your product remains compliant even after it hits the market.

Why Choose Us?

• Expert Team: Our team of regulatory specialists and food scientists brings deep expertise in U.S. food regulations, ensuring accurate and efficient solutions.
• Proven Client Satisfaction: We have earned high praise from global clients, including Fortune 500 companies, for successfully guiding them into the Chinese market.
• Global Network: With offices worldwide and strong ties to regulatory authorities and industry organizations, we deliver localized support with a global perspective.
• End-to-End Solutions: From initial assessment to post-approval support, we offer one-stop services to ensure your product remains compliant.