S. 2341 — Ensuring Safe and Toxic-Free Foods Act of 2025

This section establishes requirements for substances generally recognized as safe (GRAS) by inserting new section 409A into the Federal Food, Drug, and Cosmetic Act (after section 409 on food additives). (As background, GRAS substances—used as ingredients in food based on expert consensus of safety from scientific data or prior use—are currently exempt from premarket approval as food additives.) The section deems any such substance unsafe under section 402(a)(2)(C) (adulterated food) unless (1) it complies with food additive requirements in section 409; (2) subject to subsection (e)(2), its manufacturer submitted a GRAS notice to FDA before enactment of the Ensuring Safe and Toxic-Free Foods Act of 2025 that FDA did not question; or (3) during the transition period from enactment through the day before the effective date specified in section 2(d) of the act, its manufacturer submits a GRAS notice with detailed safety data—including methods and controls, cumulative effects, hazard/dose-response/exposure analyses, protective safety factors, and weight-of-evidence findings of no carcinogenicity or reproductive/developmental toxicity (including endocrine effects)—and FDA does not object. On receiving a transition-period notice, FDA must post it publicly with supporting information and allow at least 60 days for comment; FDA must then issue a written determination objecting if documentation is incomplete, experts have conflicts of interest (i.e., financial interests compromising judgment), or evidence does not support GRAS status (FDA may request more information first), or stating no objection if all criteria are met. FDA determinations are final agency action, must be published with supporting memoranda (nonpublication does not imply GRAS approval), and within 180 days of enactment, FDA must issue guidance strengthening its December 2022 best practices for GRAS expert panels.

This section establishes a food chemical reassessment program under the Federal Food, Drug, and Cosmetic Act requiring the Secretary of Health and Human Services, not later than three years after enactment and every three years thereafter, to reassess the safety (under sections 409 or 409A) of not less than 10 substances or classes of substances added to food and to establish any safe conditions of use. The Secretary may require manufacturers to provide data or conduct evaluations; may prioritize substances subject to food additive petitions (section 409(b)), color additive petitions (section 721(d)), or citizen petitions for reassessment, restriction, or revocation; and must consider factors specified in section 409A(a)(3)(B) (i.e., exposure data, cumulative effects, and susceptible subpopulations) in determining safety. This section does not alter the Secretary's existing authorities or duties under sections 409 or 409A.