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FDA Errs On Estimates For NDIs, Claims Substantiation – CRN

This article was originally published in The Tan Sheet

Executive Summary

FDA “grossly underestimated” firms’ costs for filing new dietary ingredient notifications and ignored their costs for substantiating claims, the Council for Responsible Nutrition says in July 25 comments.

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FDA’s formal acknowledgment of Embria’s NDI notification for EpiCor comes after the firm called FDA early in the process to discuss the pending notification and worked to understand the agency’s expectations fully. Kevin Boot, Embria’s regulatory counsel, recommends simple notifications that are “readable by everyone.”

Embria Studies FDA Expectations Before Successful EpiCor NDI

FDA’s formal acknowledgment of Embria’s NDI notification for EpiCor comes after the firm called FDA early in the process to discuss the pending notification and worked to understand the agency’s expectations fully. Kevin Boot, Embria’s regulatory counsel, recommends simple notifications that are “readable by everyone.”

FDA Defends Estimate For NDI Notification Preparation

Supplement firms already should have compiled the information for a new dietary ingredient notification when they substantiated the safety of the ingredient, FDA says.

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