Licensing Innovative Food Additives and Ingredients by FDA

The current system for ensuring the safety of innovative food additives and ingredients was developed by Congress in 1958. It is inadequate in today’s marketplace where supply chains are more complex, dynamic, and global, and our understanding of health risks has greatly advanced. The food supply is at risk for allowing unsafe substances to threaten serious long-term health effects as long as the Food and Drug Administration (FDA) allows companies to self-certify that a substance’s use is Generally Recognized As Safe (GRAS*) without the agency’s or the public’s knowledge. Rather than embracing innovation, consumers increasingly recognize the risk, and most see substances added to food as their most important food-safety issue. Congress needs to modernize the mechanisms that ensure safety in a way that supports innovators who develop safe substances through a process that consumers can trust. To be successful, the dynamic needs to change from a race to the bottom with respect to safety research to one which strongly incentivizes companies to invest in robust safety studies by protecting them from “copycat” competitors who rely on the innovator’s research and granting a longer license from FDA when the evidence is compelling.