Potential GRAS Changes Afoot

LAS VEGASIn the wake of two important eventsa recent Government Accountability Office (GAO) review of how FDA handles GRAS issues and a clause embedded in the FDA Accountability Act of 2007 (FDAAA)its quite possible that manufacturers should reevaluate how they deal with GRAS notifications. Such was the gist of a lively session today at SupplySide West 2010 presented by Richard C. Kraska, Ph.D., DABT, and Robert S. McQuate, Ph.D., both of GRAS Associates, and Marc S. Ullman, Esq., of Ullman, Shapiro & Ullman, entitled, Are Changes Coming With GRAS Processes and Procedures?

The recent GAO review of how FDA currently handles GRAS ingredient notifications has brought some issues to light, namely raising the question of whether or not FDA couldand/or shouldtighten its approach to such matters. Although Kraska noted that the success rate of GRAS notifications submitted to FDA for approval has increased over the yearsin tandem with an overall increase in submissionsMcQuate pointed out that the fallout from the GAO evaluation very well might change how GRAS issues are handled. The speakers noted that although FDA has questioned its ability to broaden the scope of its approach to GRAS issues, the agency is considering changes. McQuate posited that these changes could range from the extreme position of requiring all GRAS claims be submitted to FDA (thereby eliminating the concept of a self-affirmed GRAS status for an ingredient) to a more-moderate level of increased communication between FDA and companies dealing with new and existing GRAS ingredients.

To further complicate matters, Ullman noted that even though a GRAS notification may have been successfully submitted to FDA, achieving a no questions status in the agencys eyes, it very well might still violate terms outlined in FDAAA Section 912/301 (ll), which deals with the rather nebulous concept of drugs that have not been approved but nevertheless have been subject to substantial clinical investigations traveling over state lines in the name of commerce. He noted that any new FDA GRAS approvals will likely contain a disclaimer to that effect. He stressed that industry members contact FDA to comment further on this subject.

At the end of the day, as McQuate recommended, now might be the time to analyze any and all details related to GRAS ingredientsself-affirmed or FDA-submitted, new and oldand tighten up accountability, helping ensure that no stones have been left unturned.