Taking GRAS to Task

The U.S. Food and Drug Administration’s “generally recognized as safe” (GRAS) designation is under fire. And this time, it’s not just the Food Babe who’s taking GRAS to task. 

Expert opinions: Medical and food law experts Pieter A. Cohen, M.D. and Emily M. Broad Leib, J.D., authored an article in the New England Journal of Medicine that raised a red flag on the GRAS process. These experts—tied to the Cambridge Health Alliance and Harvard—asked the FDA to take additional steps to make sure new food additives are safe. 

Their concern dates back to 2022 liver injuries caused by tara flour, a GRAS ingredient that was used in a substitute for ground beef. 

FDA feedback: A spokesperson for the FDA says the agency doesn’t have authority to make the changes the authors asked for. They pointed to the Federal Food, Drug, and Cosmetic Act as where the buck stops. They also noted that GRAS substances must have publicly available safety data. 

Legislator leans in: Representative Rosa DeLauro of Connecticut is trying to get the FDA to close the GRAS loophole with the Toxic Free Food Act. Her act would require chemical food additives to go through an FDA review of specific requirements before making it to market. 

Soundbite: “The FDA currently reviews GRAS conclusions under the voluntary GRAS notification program. The FDA encourages industry to engage with our GRAS notification program in which FDA experts evaluate the publicly available safety data to see if the use of the ingredient raises any regulatory or safety questions.” — FDA spokesperson