FDA Issues a Final Rule on Substances Generally Recognized as Safe (GRAS) for Their Intended Use in Food

This morning, August 17, 2016, FDA published in the Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in food. Coming nineteen years after the proposed rule, under which industry has effectively been operating for some time, the final rule mostly codifies the status quo. The final rule formalizes, through regulation, the voluntary notification program that has been running as an interim pilot for nearly two decades. It also modernizes the regulations in a few key respects, sweeping out obsolete provisions about a GRAS petition process that is no longer used and replacing them with a description of the voluntary GRAS notification procedure already familiar to the food industry.