Roadmap to GRAS Reform: Exploring the Current Landscape of Self-GRAS and How Food Manufacturers are Preparing for Changes to FDA Requirements

Melissa Card-Abela
Senior FDA Regulatory Counsel
Whole Foods Market

Mara Burr
Vice President, Regulatory & Technical Affairs
Consumer Brands Association

Ashish Talati
Founding Member
Talati Law Firm PLLC

Stuart M. Pape
Senior Partner; Head of FDA Practice
Polsinelli PC
FDA’s approach to the GRAS certification process is changing, with expected impacts to the current GRAS review and notification system that will impact how ingredients are evaluated and approved. During this session, we examine the current landscape of GRAS and best practices for navigating anticipated changes to self-GRAS. Discussion points include:
- Understanding the current state of GRAS review in the food industry
- Examining potential changes to the GRAS certification process
- Assessing changes to the GRAS notification index; and exploring FDA’s approach with this change
- Understanding FDA’s criteria for reviewing GRAS affirmation petitions
- Examining lessons from the “tara flour” ingredient incident
- Exploring a potential FDA revisit to the safety of previously introduced GRAS substances