FDA Food and Food Ingredient Classification: Examining GRAS, Premarket Review and the Approval Process for Food Additives

November 13, 2017 2:15pm

Stuart M. Pape
Head of FDA Practice & Shareholder
Polsinelli P.C. (Washington, DC)

  • Defining food, food ingredients and food additives
  • Exploring the GRAS process and understanding its role and relationship to the food additive process
  • Deciding between GRAS and food additive; advantages and disadvantages of each
  • Establishing “general recognition; ” comparing GRAS classification made through scientific procedures vs. food additive safety determinations
  • Understanding when a GRAS determination can be made based on “history of common use in food”
  • Identifying how to describe a substance’s intended condition of use
  • Clarifying what happens once you file