Original Session Time: SupplySide West - Tuesday, October 11, 4-4:50pm
Speaker: Robert S. McQuate, Ph.D., CEO and Co-Founder, GRAS Associates LLC
Duration: 42 minutes
Finalizing FDA’s Operating Procedures for GRAS Determinations
Administrative procedures presently governing FDA’s voluntary GRAS notification program date to the publication of the proposed rule in 1997, which has not yet been finalized. In early 2010, GAO published a detailed evaluation of FDA’s administration of the GRAS program, and was critical of the fact FDA had not issued final regulations by which the GRAS program was to be administered. FDA reopened the comment period to obtain updated feedback as an important step to be taken in finalizing the GRAS operating procedures. What feedback has been provided to FDA? What practices currently in place are expected to remain unchanged? What changes in GRAS operations are anticipated? Will confidentiality considerations be modified? Will the substantive treatment of notified substance identification or estimates of dietary consumption be altered? How will GRAS procedural changes impact the regulated food industry? Watch and listen as Robert McQuate reviews and analyzes these and other issues enabling ingredient suppliers and formulated food manufacturers to develop a “road map” and better navigate anticipated regulatory changes.