The GRAS Process Under the Final Rule (Part 2): Increased Emphasis on Exposure
The finalized GRAS rule and associated Federal Register Notice1 emphasizes the FDA’s opinion that dietary exposure is a factor that must be considered in determining safety, regardless of whether the conclusion of GRAS status is through scientific procedures or experience based on common use in food, or even if a GRAS conclusion is notified or not. While we agree with the assertion that exposure is integral to a safety determination, the new requirements for how exposure ass