Last but not least, Melanie Neumann, Vice President and Chief Financial Officer at The Acheson Group, told delegates that the FDA is under growing pressure to look again at the GRAS (Generally Recognized As Safe) process, following continued criticism from groups from the Pew Health Group to the Natural Resources Defense Council.
Their beef? That conflicts of interest are “ubiquitous” in GRAS determinations (that firms can effectively judge their own work), and that there are major flaws in a system that allows firms to affirm the safety of food ingredients without the approval - or even the knowledge - of the FDA, however ‘expert’ the panel scrutinizing them might be.
Another concern is that firms who voluntarily notify the FDA of a GRAS determination and then receive tough questions from the regulator can simply withdraw their application, and the ingredient in question can stay on the market, said Neumann.
While supporters of the current system say that going back to a pre-market approval system would be completely impractical (the huge pile of un-processed GRAS applications that clogged up the FDA’s in box in the mid-1990s was the primary reason the voluntary process we have today was put in place), it’s not beyond the realms of possibility that we might return to such an approach, said Neumann.
The most likely scenario, however, is that all firms that go through the GRAS self-determination process could in future be mandated to notify the FDA, so that at the very least, the agency has a central database of GRAS ingredients on the market, and firms are not able to simply withdraw a notification if the FDA raises concerns.