H.R. 7291 — GRAS Oversight and Transparency Act

This section establishes a Board, chaired by the Secretary of Health and Human Services (HHS) and composed of specified voting members from HHS, the Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) as well as non-voting members from academia and the food industry (all appointed for 5-year terms without compensation), to review the validity of covered GRAS designations (i.e., substances exempt from food additive premarket approval under the Federal Food, Drug, and Cosmetic Act because generally recognized as safe by scientific experts). The Board must (1) identify covered GRAS designations through notices required from food manufacturers within 90 days of enactment (with civil penalties or treatment of non-compliant substances as unapproved food additives for noncompliance); (2) categorize them into tier 1 (highest priority), tier 2, or tier 3 for review; (3) determine each designation's validity and, if a substance is not shown safe, notify the Secretary and Congress within 90 days recommending revocation; and (4) report results publicly on the FDA website (tier 1 within 2 years of enactment, tier 2 within 4 years). Upon such notification, the Secretary may revoke a designation by notifying the manufacturer (with 180 days to submit rebuttal evidence), reviewing it, and establishing compliance procedures including timelines for ceasing distribution and recalling the substance. (Thus, affected manufacturers may need to seek food additive approval or reformulate products using revoked GRAS substances.)