Generally recognized as safe

Generally recognized as safe (GRAS) is a specific regulatory classification that provides authorization of ingredients for use in food.

The GRAS dossier must provide adequate manufacturing and scientific evidence that an ingredient is safe.

Safe is defined by the U.S. Food and Drug Administration (FDA) as: “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use”.

A substance that is GRAS is not required to undergo premarket approval by FDA, however, FDA does require that the Sponsor compile scientific data and information on the substance and demonstrate a consensus among qualified experts that the substance is safe under the conditions of its intended use.

If a GRAS ingredient is present in the food supply, it can also be used in dietary supplements; however, in some cases a New Dietary Ingredient (NDI) notification may be more appropriate for an ingredient intended for use in dietary supplement products.

The GRAS pathway can be a valuable approach to achieve regulatory compliance for new and innovative ingredients. FDA requires specific information and a specific format for a GRAS dossier and RNI can provide the expertise you need to understand the GRAS process.

RNI can also walk you through the NDI notification process to help determine which pathway is most appropriate for your specific ingredient.

RNI can provide:

Specific ingredient reviews to determine if a GRAS or NDI notification is needed

Regulatory framework for GRAS and NDIN pathways

Strategic assessment of unique ingredients to determine the best approach for regulatory compliance

Analysis of your safety data to identify potential gaps

Full GRAS dossier for a notified (submitted to FDA) or an independent (self-affirmed) GRAS

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