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GRAS Self-Affirmation Fades As Sound Strategy Under FSMA

 
• By Dan Schiff

Experts at a FDLI conference say Food Safety Modernization Act obligations should convince companies to move beyond self-affirming food ingredients as “generally recognized as safe” without notifying FDA. While the GRAS process generally is considered effective, it lacks transparency in some areas.

FDA will likely use the Food Safety Modernization Act as a vehicle for ensuring that food and ingredient companies have sufficient data to support “generally recognized as safe” determinations, industry experts say.

This development could help fill some blind spots in FDA’s voluntary GRAS notification program, which the agency established in a 1997 proposed rule. Companies either can notify the agency of...

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More from North America

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

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• By Francesca Bruce

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