The U.S. Food and Drug Administration (FDA) has issued a final rule regarding the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS). Although GRAS substances are not subject to FDA pre-market approval, they must meet the same safety standards as approved food additives. The rule addresses the types of evidence that can be used to demonstrate safety and also finalizes the notification procedure companies can use to inform FDA of GRAS conclusions. The Tax and Trade Bureau (TTB) issued the following statement concerning this rule: Each producer and importer of alcohol beverages is responsible for ensuring that the ingredients in its products comply with the laws and regulations that FDA administers, including rules regarding criteria for concluding that a substance is “generally recognized as safe” (GRAS). Industry members are reminded that TTB’s approval of a COLA or formula does not imply or otherwise constitute a determination that the product complies with the Federal Food, Drug, and Cosmetic Act.
Pete Johnson serves as the State & Regulatory Affairs Manager for the Brewers Association (BA). He joined the BA at its inception in 2005, having previously worked as Programs Director for the Brewers Association of America. Before coming to the small brewing industry in 2001, Pete worked for 14 years with both state and federal elected officials in Pennsylvania and Washington, D.C.See Pete Johnson's Articles