FDA Adopts new Criteria for Declaring Food Ingredients 'Generally Recognized as Safe'

The Food and Drug Administration clarified criteria for declaring food ingredients are “generally recognized as safe” (GRAS) and are not “food additives” requiring agency approval, in a final rule (here). Under the amended regulations, FDA is replacing the former affirmation petition process, whereby companies could petition FDA for a rulemaking declaring a substance is GRAS, with a notification procedure the agency has been piloting since 1998. FDA will respond to the notifier in writing, raising any issues the agency has with the company’s conclusion that a substance is GRAS, and will make “readily accessible to the public a basic description of the notified substance, the conditions of its intended use, and the statutory basis for its GRAS status,” it said. The final rule takes effect Oct. 17.