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Companies introducing new food ingredients into the United States must demonstrate that those ingredients are safe under their intended conditions of use. In practice, this often leads to a decision between a GRAS Notice and a self-affirmed GRAS determination, two regulatory pathways that rely on the same legal definition of safety but differ significantly in how that safety conclusion is documented and communicated.

The implications extend far beyond terminology. Understanding how each pathway works, how regulators view them, and how expectations may evolve is essential for making informed compliance decisions. This article explains those differences clearly and helps you prepare for what lies ahead without speculation.