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What is Needed for a Successful GRAS? Part III

“Zig” Zigler, the motivational speaker, likes to tell the story of the $65 bargain bicycle he bought for his son many years ago. The $100 bike was just too expensive, when the $65 bike “was nearly as good.” You probably know how the story ends, with Zigler castigating himself and finally buying the $100 bike after having put nearly $50 into the bargain bike as various items were broken or prematurely wore out.

The same can be said for a bargain GRAS determination or a “GRAS lite.” Many of these bargains do not undergo FDA GRAS Notification, because their fate is predictable and the few that do, are withdrawn at the suggestion of FDA. At this point the manufacturer must decide if a GRAS “re-do” is necessary.

Ironically, for the “re-dos,” the manufacturer may claim not to have had the budget to “do it right” the first time, but there always seems to be enough in the budget to do the GRAS over again, effectively erasing any bargain in price. The take home lesson is that the success of the GRAS is based on the thoroughness and soundness of the science, the rationale supporting it and the reputation of the notifier or his agent for getting it right the first time. What does it take to get it right the first time? No one single thing, but a combination of many, without which, the Expert Panel or the FDA cannot have the required high level confidence in the dossier.

Experience of the staff: Knowing how to review and interpret data, knowing the history of the issues (such as IBT studies and the CHEST assay, both now in disrepute), and knowing the regulations regarding standards of identity and 21 CFR 184.1(b)(2), to name a few.

Staff credibility: Degrees in toxicology, documented continuing education and frequent publication