The safety of foods and their ingredients is paramount. Several regulatory approaches are used to assess ingredient safety. One of those approaches is the Generally Recognized As Safe (GRAS) process, a voluntary process implemented in 1997. This process requires extensive review by experts recognized for their training and experience across the disciplines required to assess ingredient safety. The data used to assess ingredient safety are publicly available, enabling an expert panel to achieve a consensus on its safety for the intended use and population. This approach was codified in the 2016 final ruling of GRAS. In the decades since GRAS was implemented, the FDA has withdrawn GRAS status for a few ingredients: cyclamate (1969), partially hydrogenated vegetable oil (2015), triclosan and triclocarban (packaging components) (2016), and artificial trans-fatty acids and select flavorings (2018). Each of these was reviewed by the FDA before its use in food-based applications. Despite this rich history of ensuring safe foods and food ingredients, there is a current movement to change the GRAS affirmation process, which many contend creates a regulatory loophole that compromises public health. The history and processes of GRAS are presented, and the future of GRAS assessment is summarized.
Pressman et al. (Thu,) studied this question.