- On February 3, 2026, Rep. Mike Lawler introduced the GRAS Oversight and Transparency Act, which, if passed, would require a newly-created Board to review all “covered GRAS designations.”
- “Covered GRAS designations” are defined in the bill as substances that were designated by their manufacturers as generally recognized as safe (GRAS) prior to 2000. Voting members of the Board would include the Secretary of Health and Human Services, the Secretary of Agriculture, and other staff members from those agencies; a toxicologist from the Environmental Protective Agency; a representative from the food manufacturing industry; and an academic expert in food toxicology.
- If passed, manufacturers would need to identify “covered GRAS designations” within 90 days. The Board would then assign each substance to one of three categories based on its priority for review. The Board would be required to notify the Secretary and Congress of any determination that a substance has not been shown to be safe within 90 days of completing the review.
- The issue of GRAS substances has been the center of recent state and federal-level action. As we’ve previously blogged, FDA sent a proposed rule related to GRAS to the Office of Management & Budget (OMB) in December of 2025, but the timing, scope, and substance of the rulemaking remain uncertain. Additionally, states continue to pursue their own regulatory approaches, raising the potential for a more fragmented compliance landscape.
- Keller and Heckman will continue to report on developments regarding GRAS designations.
