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U.S. Ingredient Approval- Which is Best? A Food Additive Petition or Generally Recognized As Safe

*This article will be published in the Summer issue of

Food ingredient regulation in the United States (U.S.) is unique among other regulatory domains in the U.S. and worldwide by incorporating two equally legitimate and parallel processes of compliance to the law – one that is government managed (a Food Additive Petition or FAP) and another that is a self-approval system (Generally Recognized As Safe or GRAS). Further, once a GRAS determination has been made by qualified experts, it can be submitted to FDA for its review in the form of a GRAS notification, but there is no legal or regulatory obligation to do so and many are not submitted to FDA. This means of compliance with federal law offers several advantages and the latter of which, GRAS, can offer a lower cost of regulatory compliance and a faster route to market, but should not be mistaken as a method for circumventing the burden of proof of safety-in-use or as a method for keeping proprietary information secret. Please note also, that regardless of the process of federal compliance (FAP or GRAS), the approval is very specific – the approval is for a particular use of the ingredient (i.e., at a specific concentration for each specific purpose and food category, and including its specifications and method of manufacture), not the ingredient per se (i.e., a generalized approval of the ingredient for any use in any food or amount, produced by any method).