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.

Stakeholders say FDA steeply lowballs costs in its latest estimate for the burden on industry of new dietary ingredient notifications, further underscoring the gap between agency and industry over NDI issues.

The agency estimates a firm needs 20 hours to prepare an NDI notification and says no capital costs are associated...

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