Workshop B – FDA Food and Food Ingredient Classification: Examining GRAS and GRAS Reform Premarket Review, and the Approval Process for Food and Color Additives

Jul 23, 2025 2:00 pm – 5:00 pm

Suzie Trigg
Partner
Haynes & Boone LLP

  • Defining food, food ingredients and food additives
  • Exploring the current GRAS process and understanding its relationship to the premarket and approval process for food additives
    • Distinguishing the criteria and process for GRAS with the criteria and process for food additives
  • Understanding the concept of a substance’s intended condition of use
  • Examining proposed changes to the GRAS process, including potential reforms of the GRAS notice system and FDA’s review criteria
    • Analyzing the Delaney Clause’s role in the deauthorization of Red No. 3 and its potential use going forward
  • Evaluating the possibility that FDA will revisit prior GRAS safety determinations
  • Taking stock of recent developments regarding the GRAS Pathway and Pre-market Consultations for Novel Food Ingredients
  • Identifying the industry significance of GRAS Notifications for alternative proteins and use of precision fermentation
  • Comparing food additives regulations and pre-approval requirements in Europe
  • Addressing state bills to reform GRAS process and ban ingredients