FOF09 FDA Official Addresses GRAS Notification Program

SCOTTSDALE, Ariz.—Attendees at the Focus on the Future executive conference learned about FDA’s GRAS Notification Program from the program director, Paulette Gaynor, Ph.D. Gaynor explained how the program works, and how it differs from the approval of food additives.

In all cases, whether food additives or GRAS (generally recognized as safe) ingredients, the only issue is that of safety, according to Gaynor. Evaluations of an ingredient’s GRAS status are safety-based only with no balancing of risk versus benefit, and the standard of safety is a “reasonable certainty of no harm.” Gaynor also explained GRAS determinations are in fact generic and are not licenses. She emphasized the data and information used to make a GRAS determination must be generally available to the public. This differs from the approved food additive process in which at least some of the data is not publicly available.

Determination of GRAS status is made by the notifier, and FDA currently receives about 25 GRAS notifications per year. The agency does not approve GRAS notifications, but will respond with a letter stating that the agency has no questions or a letter stating that the agency finds that the notice does not provide a basis for the determination of GRAS.

Details of the GRAS program, including a list of all GRAS notices, is available online.