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FDA “Undercuts” NDI Guidance Opposition With Compliance Cost Estimate – CRN

This article was originally published in The Tan Sheet

Executive Summary

OMB approves FDA’s estimate as the official measure for the supplement industry’s anticipated burden in complying with the NDI notification regulation.

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FDA NDI Notification Cost Estimate Widens Gulf With Stakeholders

Stakeholders widely criticize FDA estimates for the industry’s NDI costs – 20 hours to prepare a notification and no capital costs. Industry reps argue the agency’s evolving approach to NDIs will increase costs, and the two sides disagree over the role and cost of research.

FDA NDI Notification Cost Estimate Widens Gulf With Stakeholders

Stakeholders widely criticize FDA estimates for the industry’s NDI costs – 20 hours to prepare a notification and no capital costs. Industry reps argue the agency’s evolving approach to NDIs will increase costs, and the two sides disagree over the role and cost of research.

Guidances Will Address NDI “Misperceptions,” Energy Drinks

FDA is working on two guidances that will affect the supplement industry: a revised new dietary ingredient notification draft guidance and a drinks guidance that will address whether energy drinks are supplements or conventional foods, CFSAN director Michael Landa said.

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