"Insufficient Data" Linked To Most NDI Notification Failures At FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA rejects nearly 75% of new dietary ingredient notifications, with failure to provide sufficient ingredient identity or supporting data the most common reasons for rejection, says American Herbal Products Association President Michael McGuffin.
You may also be interested in...
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.”
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.”
NDI Needed In Absence Of "Concrete Evidence" Of Prior Sale – Attorney
Until FDA issues new dietary ingredient notification guidance, a company must consider several factors when deciding whether an NDI is necessary, an attorney says.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: