Sponsors (3)
The bill increases consumer safety and public transparency around GRAS substances but imposes compliance, administrative, reformulation, and market-entry costs and potential supply disruptions for food producers—especially small businesses.
Consumers (including hospitals and health systems) gain clearer safety protections because substances claimed as GRAS must be listed or be under FDA review within two years, reducing use of unreviewed ingredients.
The public and businesses gain transparency because the FDA must maintain a publicly accessible GRAS list and respond to submissions within 180 days, improving information about food ingredients.
Small manufacturers get a clearer, documented pathway to market because they can submit notices to petition inclusion on the GRAS list, lowering uncertainty for some product developers.
Small food producers and manufacturers may face significant compliance costs and supply disruptions if widely used GRAS substances are not listed within two years and are thereby treated as unsafe.
Companies using substances that become preliminarily excluded must, within 180 days, provide additional data, submit a food additive petition, or phase out the ingredient, imposing administrative, testing, and reformulation costs.
Product introductions and new uses may be delayed because new uses must be notified 120 days before first interstate use and may require waiting for FDA action, slowing market entry.
Based on analysis of 3 sections of legislative text.
Introduced November 6, 2025 by Roger Wayne Marshall · Last progress November 6, 2025
Creates a mandatory, public listing process for substances ‘‘generally recognized as safe’’ (GRAS). Two years after enactment, any GRAS substance is treated as unsafe for a given use unless it appears on the new public GRAS list or is under active FDA review. The law requires firms to submit notices for existing and new GRAS uses, sets submission and agency response deadlines, forces FDA to write procedures for the list, and allows FDA to automatically list substances if it misses a deadline. It also gives FDA authority to reexamine approved food and color additives and listed GRAS substances, requires career scientists to review reevaluations, and makes final actions subject to notice-and-comment rulemaking. The act changes statutory definitions to add a new GRAS term, removes language that previously distinguished certain substances from the food-additive definition, and makes conforming edits across the food law to reference the new listing and reevaluation authorities. The law increases transparency and creates new regulatory and compliance work for industry and for FDA, with specific timelines for submissions, agency rulemaking, and reviews.