Washington (August 12, 2016) – The Food and Drug Administration (FDA) today issued a final rule on its process for handling a substance in food that is "Generally Recognized as Safe", commonly referred to as GRAS. This final rule was initiated as a result of a settlement agreement following a 2014 lawsuit filed by the Center for Food Safety. GRAS substances are not subject to FDA pre-market approval and manufacturers are allowed to self-determine that a substance is GRAS without informing the FDA. The final rule released today by the FDA formalizes this voluntary GRAS notification procedure, which was first put in place for human food in 1997, and lays out the type of scientific evidence that can be used to self-determine a substance as GRAS.
“The health and well-being of the American people depend on a meaningful food safety regulatory policy, not a self-graded take home exam that industry doesn’t even have to hand in,” said Senator Markey. “The FDA missed an opportunity to strengthen the GRAS process by requiring mandatory reporting of GRAS substances. I plan to explore whether a legislative remedy is needed to ensure the safety of our food supply.”
Senator Markey sent FDA a letter in April encouraging a swift release of this final GRAS rule and inquiring whether the agency needs statutory authority to ensure the safety of GRAS substances and impose labeling requirements for self-determined GRAS ingredients. The letter also encouraged the FDA to release guidance to mitigate conflicts of interest for outside experts evaluating GRAS substances.