Available Now! White Paper Series - Guide to U.S. New Dietary Ingredient (NDI) Notifications Officially Released

Following the launch of our first Guide to U.S. GRAS Notification, CIRS Group is proud to unveil our second guidebook in our Global Ingredient Compliance Series: Guide to U.S. New Dietary Ingredient (NDI) Notifications. This guide rounds out the essential compliance roadmap for companies bringing new dietary ingredients (NDI) to the U.S. market.

Submitting an NDI notification is a mandatory regulatory requirement for entering the U.S. dietary supplement sector. Under FDA regulations, manufacturers or distributors of a New Dietary Ingredient—or a supplement containing one—must submit a notification at least 75 days before launching the product. As the FDA continues to tighten review standards, the success rate for NDI submissions has dropped below 60% in recent years. The primary culprits behind these rejections are missing safety data, failure to meet the definition of a dietary ingredient, insufficient identity specification, and incomplete documentation.

What’s Covered in the Guide?

Drawing on the deep expertise of our U.S. regulatory team and multiple practical NDI cases, this guide directly addresses key pain points throughout the filing process:

• Precise definitions for NDI exemptions and grandfathered status, alongside a clear comparison of when to pursue an NDI vs. a GRAS notification.
• A breakdown of dossier drafting standards, including mandatory data checklists for ingredient characterization, manufacturing processes, and toxicological safety.
• Detailed guidance on the online submission portal, review timelines, and how to interpret different types of FDA response letters.
• An overview of frequent rejection grounds and critical documentation mistakes, paired with actionable strategies to maximize approval success.

This guide is one of our Global New Food and Feed Ingredient Notification White Paper Series. Combined with our previous release—Guide to U.S. GRAS Notifications—they provide comprehensive coverage of the two primary regulatory pathways for exporting ingredients to the U.S. market.

Designed to help ingredient suppliers enter North America smoothly, avoid costly risks like detention at port or product recalls, and accelerate review timelines, the Guide to U.S. New Dietary Ingredient (NDI) Notifications is an essential tool for market entry.

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Special Pricing & Purchasing Options

● Single Guide: $99

Get immediate access to the newly released Guide to U.S. New Dietary Ingredient (NDI) Notifications or any single market report.

● Complete 12-Market Series Bundle: $799 (Best Value)

Secure full access to the Guide to U.S. New Dietary Ingredient (NDI) Notifications today plus all upcoming white papers across all 12 key regions as they roll out.

Contact Us

Hangzhou REACH Technology Group Co., Ltd.

Addr: 11F Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China

Email: service@cirs-group.com

Tel: +86 571 87206538

Note: The content of this white paper series is based on the latest regulations as of June 2026. For subsequent updates, please follow the official CIRS Group channels.