GRAS Procedural Alternatives

A GRAS determination can be either self-determined (independent of the FDA) or submitted to the FDA in the form of a notification for the Agency’s assessment.  FDA notification of GRAS status for a substance to be used in food or may come in contact with food for human consumption becomes publically available information. Often, a company will choose to perform a self-determined GRAS assessment rather than FDA notification in order to keep certain information proprietary and to control the release of the information up on request. Often this information is proprietary manufacturing information.

Both regulatory pathways--the self-determined GRAS or FDA GRAS notification--are performed by appropriately qualified scientific entities, such as GRAS Associates, on behalf of sponsoring firms. The findings result in establishing compliance with FDA regulations for the subject food ingredient.

It is important to note that a self-determined GRAS status should be of the same scientific rigor as a GRAS notification submitted to the FDA. Often a sponsoring company, after having obtained self-determined GRAS status, may voluntarily elect to “notify” the FDA and subsequently get their opinion. This constitutes the FDA GRAS notification process, and a favourable review results in feedback from the FDA that is referred to as a “no questions” letter.