April 25, 2025

Rethinking GRAS Requires More Resources

Food safety expert Steven Gendel examines the implications of proposed changes to the GRAS system and emphasizes that increased transparency will require increased resources for the FDA.

Steven Gendel

Food Technology Magazine

The Generally Recognized as Safe (GRAS) system has been a foundational part of food ingredient regulation in the United States since 1958. It permits manufacturers to determine that a substance added to food is safe, based on publicly available scientific evidence and expert consensus, without requiring premarket approval from the U.S. Food and Drug Administration (FDA).

Now, U.S. Dept. of Health and Human Services Secretary Robert F. Kennedy Jr. has directed the FDA to begin exploring rulemaking to revise the GRAS final rule.

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Authors

Steven Gendel Food Safety Consultant

Steven Gendel is a food safety consultant and former FDA official with deep expertise in food allergens, risk assessment, and regulatory policy. Over more than two decades at the FDA, he played a key role in developing science-based food safety rules and guidance, including the Gluten-Free Labeling Rule and Preventive Controls for Human Foods. He has been an instructor in programs organized by FDA, the Institute of Food Technologists, the International Association for Food Protection, state agencies, and the National Center for Food Safety and Technology (now IFSH).