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FDA Requiring GRAS-Level Safety Standards For NDI Submissions, Experts Say

This article was originally published in The Tan Sheet

Executive Summary

FDA has gradually raised the safety standard for new dietary ingredients above the level intended by DSHEA, according to several experts

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CFSAN Addresses AER Duplication, NDI Definition In Developing Guidances

FDA is working on a method to avoid duplication when tracking adverse event reports, according to the director of CFSAN's Division of Dietary Supplement Programs

New NDIs

Pom Wonderful's POMX, Procter & Gamble's psyllium hemicellulose and Exquim's Diosvein are new dietary ingredients recently included in the American Herbal Products Association's NDI Database, the trade group says May 4. While 17 NDIs were added to the database, only POMX, psyllium hemicellulose and Diosvein were filed by FDA to acknowledge their receipt, AHPA says. FDA cites a lack of sufficient information to clearly identify the new ingredient as an example of one objection to the other 14 NDIs, AHPA says. In November several experts said FDA has gradually raised the safety standard for NDIs above the level intended by DSHEA (1"The Tan Sheet" Nov. 13, 2006, p. 11)...

FDA Accomplishes A-List Goals, Will Publish NDI Guidance – CFSAN

FDA will publish guidance documents on new dietary ingredient submissions as part of an effort to update the industry on its premarket notification program, CFSAN announced in an Aug. 18 conference call on its program priorities

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