Name: FDA Proposes Major GRAS Reform: What It Could Mean for Your Business
Start: 2026-10-29T14:00:00-04:00
End: 2027-10-29T00:00:00-04:00

FDA Proposes Major GRAS Reform: What It Could Mean for Your Business

10/29/26 2:00 pm to 10/29/27 EDT

Contact: Vania Halabou

The U.S. Food and Drug Administration's (FDA's) August 2026 proposed GRAS (Generally Recognized as Safe) rule could significantly change how companies establish and document GRAS status in the U.S., including potential FDA notification requirements. What does the proposal require, and how could it affect current practices?

FDA proposes to replace the existing voluntary GRAS notification framework with mandatory notification requirements, but important questions remain about scope, implementation, enforcement, and FDA resources. Join our speakers for a practical discussion of FDA’s proposal, the changes it could bring, and the questions that remain. Topics will include existing self-GRAS conclusions, food-contact substances, FDA resources, related congressional GRAS reform efforts, and general steps companies can consider as the rulemaking process continues.

Attendees will:

Understand the changes FDA is proposing and areas that may remain unchanged
Examine potential implications for self-GRAS, Flavor and Extract Manufacturers Association (FEMA) GRAS, and food-contact substances
Review key questions involving implementation, enforcement, and FDA resources
Consider practical steps that organizations can take now to prepare as the rulemaking process moves forward

Speakers:

Kevin C. Kenny, J.D., LL.M., Senior Advisor, FoodChain ID. Kevin C. Kenny is a regulatory attorney and food regulatory consultant with more than 30 years of experience in food regulation, food-contact materials, product stewardship, and regulatory compliance. His work focuses on U.S. and international food and food-contact regulation, including GRAS determinations, GRAS Notifications, FDA pre-market requirements and global regulatory strategy. He has advised companies and worked with regulatory authorities in more than 50 countries and has extensive experience preparing and reviewing GRAS determinations and FDA submissions.

Tom Jonaitis, Toxicology and Regulatory Advisor, FoodChain ID. Tom Jonaitis is a board-certified toxicologist (DABT) and regulatory consultant with more than 20 years of experience in toxicology, safety assessment, and regulatory affairs. His work focuses on the safety and regulatory evaluation of food ingredients and additives, including GRAS determinations, FDA pre-market requirements, novel ingredients, and Canadian food and natural health product regulations. He regularly supports companies with toxicological risk assessment, exposure evaluation, regulatory strategy, and preparation of scientific dossiers for North American markets.

Moderator: Adrienne Blume, Editorial Director, Food Safety Magazine

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