S. 3122 — Better FDA Act of 2025

This section inserts new FFDCA §409A to deem a food substance generally recognized as safe (GRAS) adulterated under FFDCA §402(a)(2)(C)—beginning two years after enactment—unless listed on an FDA-maintained public list of GRAS substances or under FDA review without a final determination. (As background, GRAS substances are food ingredients exempt from premarket approval as food additives if qualified experts deem them safe based on scientific procedures or, for pre-1958 uses, common experience.) It requires any person to file a notice proposing FDA listing of a GRAS substance for its intended use—by two years after enactment for substances already in interstate commerce or 120 days before first use for new substances—and directs FDA to issue regulations for the list within two years of enactment. Within 180 days of a notice, FDA must add the substance to the list or issue a preliminary exclusion determination (with automatic listing if no timely determination); for excluded or delisted substances, users must submit within 180 days a reconsideration request (with FDA final determination within 180 days of sufficient information), a food additive petition under FFDCA §409, or a phase-out plan. This section further amends FFDCA §201(s) (food additive definition) by striking the prior GRAS exclusion and adding GRAS substances (as defined in new §201(tt)) as a seventh category of food additives; it defines GRAS in new §201(tt) using the prior standard but excluding food additives subject to §409 and certain other articles.

This section establishes a postmarket safety assessment process under the Federal Food, Drug, and Cosmetic Act for food additives (regulated under section 409), color additives (regulated under section 721), and food substances generally recognized as safe (GRAS, listed under new section 409A(c)). (a) Upon receiving a citizen petition or notice from a state official regarding safety concerns—or on the Secretary's own initiative—the Secretary of Health and Human Services (through FDA) may reevaluate the substance and, as appropriate, amend or revoke relevant regulations, reclassify a GRAS substance as a food additive subject to section 409, or remove it from the GRAS list via notice-and-comment rulemaking under 5 U.S.C. §553. (b) FDA must prioritize petitions and notices supported by clear and convincing scientific evidence. (c) FDA must publish a Federal Register request for safety information on substances under reevaluation. (d) All such determinations are subject to review by career FDA experts (not delegable to presidential appointees) and notice-and-comment rulemaking under 5 U.S.C. §553.