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Self-Affirmed GRAS

A Self-affirmed GRAS dossier follows all of the same steps as a GRAS notification and format with the exception that the dossier is not submitted to the FDA.  Expert panels for GRAS notifications are optional and recommended but for self-affirmed GRAS dossiers it is highly recommended given the level of scrutiny that a self-affirmed GRAS would have by FDA.

Quality Smart Solutions can assist in preparing a self-affirmed GRAS dossier.