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Firms Share NDI Notification Tips And Experts Reveal Common Pitfalls

This article was originally published in The Tan Sheet

Executive Summary

Early and frequent communication with FDA is key to earning an elusive FDA acceptance of a new dietary ingredient notification on the first try, an agriculture-tech firm executive says

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Artful Approach Improves NDI Notifications’ Chances At FDA

FDA accepts only 25% of NDI notifications on first submission, but firms can improve their chances by organizing notifications in easy-to-read narratives, suggests attorney Ashish Talati. Hiring independent toxicologists to review safety also can boost a firm’s chance at success.

Artful Approach Improves NDI Notifications’ Chances At FDA

FDA accepts only 25% of NDI notifications on first submission, but firms can improve their chances by organizing notifications in easy-to-read narratives, suggests attorney Ashish Talati. Hiring independent toxicologists to review safety also can boost a firm’s chance at success.

GRAS Path Draws Interest As New Dietary Ingredient Alternative, But Carries Challenges

In the wake of FDA’s draft guidance on NDI notifications, more companies reevaluate the status of their ingredients before going to market. The GRAS for use in foods process is a clear – but rigorous – alternative pathway.

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