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In March 2025, U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., directed the Food and Drug Administration (FDA) to explore potential rulemaking to revise the 2016 Final Rule on Substances Generally Recognized as Safe. This webinar will describe the history of the FDA’s GRAS process and its current requirements, including the level of evidence required for GRAS affirmation. Webinar speakers will then discuss how the FDA could improve or replace aspects of the GRAS program to improve food ingredient and additive safety and further protect human health.

Organized by ASN's Committee on Advocacy and Science Policy (CASP)

Speakers

How the GRAS Notification Program Works 
Erik Hedrick, PhD
Executive Vice President and Director of Toxicology, Burdock Group

The Scientific Rigor to Show Safety in GRAS
Steven M. Gendel, PhD
Former Scientist, Risk Assessor, and Policy Coordinator in the FDA CFSAN 

Concerns with GRAS and How to Strengthen the Process
Jennifer L. Pomeranz, JD, MPH
NYU School of Global Public Health 

Moderators

Alana Chaney, MS, PhD Candidate
University of California, Davis, and ASN Science Policy Fellow

Hope Craig, MSPH, PhD Student
Tufts University Friedman School of Nutrition Science and Policy, and ASN Science Policy Fellow

Learning Objectives

1. Describe the history and requirements of the FDA’s GRAS process

2. Understand the level of evidence required for GRAS affirmation

3. Learn how the GRAS process could be improved or replaced to improve food ingredients and additive safety and protect human health