The U.S. GRAS (Generally Recognized as Safe) framework has been remarkably stable for decades. That stability is ending. Federal rulemaking, multiple Congressional bills, and State-level reporting initiatives are converging to reshape how food ingredients, including food contact substances, are reviewed and disclosed.
Here are the five most important GRAS-related issues that food companies need to understand right now.
1. Self-GRAS Is Under Political and Public Pressure
Under existing law, companies may determine that an ingredient is GRAS without notifying FDA. GRAS was invented and intended for low-risk substances that are widely used, focusing FDA resources more on important moderate risk substances like Food Additives and Food Colorants which require more formal documentation and review, and are published in the Federal Register. This system has existed since 1958 and was formalized and extended through FDA’s voluntary notification program in 1997.
However, NGOs and policymakers increasingly characterize self-determined GRAS as a “loophole.” Whether that description is accurate or fair, it is currently driving reform efforts.
Legislative proposals and FDA rulemaking efforts are focused squarely on eliminating or limiting the self-affirmation pathway. The direction is clear: more oversight and more transparency.
What this means: Even if the FD&C law and regulations have not changed yet, reliance on purely internal GRAS determinations is facing heightened scrutiny — from regulators, legislators, NGOs, and customers.