Workshop B – FDA Food and Food Ingredient Classification: Examining GRAS and GRAS Reform Premarket Review, and the Approval Process for Food and Color Additives
Suzie Trigg
Partner
Haynes & Boone LLP
Ashish Talati
Founding Member
Talati Law Firm
Brinda Mahadevan
President & Founder
Brincor Associates, LLC
- 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