The GAO Report on GRAS: “Déjà vu all over again”

On March 4, 2010, the General Accounting Office (GAO) released a report to the public titled, “FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS).”[1]  The report lamented the fact that there is no requirement in the law or regulation that FDA be informed of a GRAS determination and that the GRAS Notification Process (Federal Register 62:18937-18964, 1997), is inadequate because of its voluntary nature. The GAO’s rationale for compulsory notification was that it felt potentially harmful ingredients could be GRASed and the Food and Drug Administration (FDA) needed to have a better level of understanding, documentation and control of what was being added to the food supply.

Two suggestions were offered for keeping FDA informed, both requiring compulsory notification to FDA of a GRAS determination by either (1) creating a two-tiered system of informal and formal notification or; (2) requiring all GRAS determinations to go through the formalized GRAS Notification Program now in place.

The first, a two-tiered system, would offer two alternatives, both compulsory. Either a substance would go through the GRAS Notification Program as we know it today or, as an alternative, the FDA would be informed of the identity of the substance determined GRAS, but the notifier would not have to submit safety data, nor would there be any input or feedback from FDA – sort of a “notification lite.”  Although in its response, FDA rejected the “notification lite” concept, this practice is actually in use today and is exemplified by the arrangement between the Flavor and Extract Manufacturers’ Association (FEMA) and FDA, wherein FEMA only shares information with FDA on the identity and use levels of new flavor ingredients have been declared GRAS.  Presumably, there is no feedback from FDA on the FEMA determinations, nor does this information make it to the Center for Food Safety and Applied Nutrition (CFSAN) website.

The second GAO proposed system would consist of requiring all GRAS determinations to go through the GRAS Notification Program, presumabl