FDA Issues Final Rule On Food Ingredients That May Be “Generally Recognized As Safe”

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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.