GRAS, FCNs and Food Additive Petitions – Comprehensive Design and Submission
Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive, prior-sanctioned, or determined to be generally recognized as safe (GRAS) for use in food. Today, many people choose the GRAS option as the way to meet this requirement.
The GRAS route offers two options, GRAS Notification, where a prepared notice is submitted to FDA for review and comment; or Independent (self) GRAS conclusion where the stakeholder makes the determination that the use of the substance is GRAS.
Both options require diligent study assessments of the feasibility and safety of the ingredient in question.
Choose EAS for:
Determination of required performance outcomes and appropriate studies to demonstrate
Development of study design and protocols
Identification of an appropriate Contract Research Organization (CRO)
Coordination of the study initiation and management oversight with the CRO
On-going monitoring of study protocols and outcomes
Provide input of appropriate data for inclusion in study reports
Support the writing of the dossier for FDA submission
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