What is Needed for a Successful GRAS? Part III

May 1, 2009 - 4 minutes read

“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Many of these bargains do not undergo FDA GRAS Notification, because their fate is predictable and the few that do, are withdrawn at the suggestion of FDA.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 in peer reviewed journals (publication is the “currency of credibility”).

 

Staff interaction: Staff should be full time employees in a single location where collegial interaction can occur and where a system of peer review is in place. Generating safety monographs should not be a part-time job or left to someone whose experience cannot be documented and real expertise is probably elsewhere.

 

Resources and infrastructure: Professionally-trained database searchers of the scientific literature using proprietary databases as well as publicly available material, documented search algorithms and reproducible searches. Consumption databases should be based on NHANES data with a wide variety of food category choices and a rigorous statistical application that is tested, documented and verifiable.

 

Dossier templates: Re-inventing the wheel each time for a new dossier is a gross waste of an opportunity to learn from mistakes and sharpen the presentation. Skills improve with experience and self-criticism makes the final product better. A focus on what can be done better results in the production of a better product every time.

 

These are days of tight budgets and an excess supply of willing, but untrained personnel that are ready to do whatever it takes to sell their services. Dentists are giving Botox injections, landscapers are performing electrical work and anyone with a word processor is advertising cheap GRAS determinations or even promoting “GRAS lite.” Like Zigler experienced, you will get what you pay for.