What’s Next for the GRAS Process?

There is no disputing the fact that the Generally Recognized As Safe (GRAS) process is under attack: first, by the General Accountability Office report, then the PEW report and more recently, by the National Resources Defense Council (NRDC).  In common with all of these reports is an obvious lack of in-depth knowledge and only a superficial understanding of the rationale behind the GRAS process.  In the latter two instances, regarding PEW and the NRDC (which incidentally, include the same people) the commentaries have been subject to innuendo, hyperbole, conflation and unsupported allegations of corruption among GRAS experts.  However, despite all the sensationalism and attempts to shake consumer faith in the GRAS process, absolutely no evidence is offered of the public having been harmed as the result of a GRAS determination.

However misguided these attacks may be we should look on this occasion as an opportunity to discuss possible improvements to a nearly 60 year-old process.  But before we discuss potential improvements to the GRAS process, we should examine some solutions proposed by Mr. Neltner [of NRDC] and his colleagues.

1. First, their demand that all GRAS determinations should undergo mandatory Notification. My response is no, not all GRAS determinations should be notified and one the reasons for not so doing, is the ability of companies to keep R&D and marketing information proprietary. The safety of the ingredient will have met the “threshold of common knowledge” through publication of the safety data and, it is the responsibility of the user to limit his use of the ingredient to its acceptable daily intake (ADI), just as he would have to do with an approved food additive – not doing so would be a violation of the law.  Further, why should a company invest all the time and money in research and development when anyone could then piggy-back on a GRAS Notification?  At the very least, this discourages innovation.  It does not make sense for extensive public disclosure of proprietary information and marketing plans, simply on the basis of these unsubstantiated threats. Realistically, if all new drug candidates were required post comprehensive information on specifications, manufacturing, uses and safety, would we have many new drugs today?