After publication of the draft Generally Regarded As Safe (GRAS) rule in 1977, the United States Food and Drug Administration (FDA) initiated an Interim Pilot Program encouraging the notification to FDA of GRAS determinations. This presentation analyzes GRAS notifications submitted during the Interim Pilot program along with warning letters issued during the same time period to better understand the evolution of the program and anticipate the future GRAS landscape. GRAS Notifications revealed interesting trends regarding the inclusion and composition of GRAS Expert Panels; differences in notifications for substances with nutritive, processing aid, or effect; and the duration of GRAS Notifications. The review of FDA warning letters associated with GRAS issues provides additional insight into GRAS notices, from the perspective of ongoing post-market emphasis on food safety with the implementation of the GRAS Final Rule.
Understand basic GRAS history.
Become familiar with the GRAS process.
Identify trends and evolution of the GRAS Notification program.