Overview
Marc Sorini discussed the difficulty for distillers of completing a Food Additive Petition to earn FDA approval that a substance or additive is GRAS (Generally Recognized as Safe). Calling the petition process slow and expensive, Mr. Sorini suggested that if distillers summarize for the FDA why a substance is GRAS, “ FDA generally sends a letter back that says, ‘We looked at this, we don’t see anything we disagree with, but of course all bets are off if we decide to come after you sometime in the future.’”