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Inserts a new section 409A ('Substances generally recognized as safe') into Chapter IV of the Federal Food, Drug, and Cosmetic Act by placing it after section 409 (codified at 21 U.S.C. 348). The added section establishes GRAS notice and review procedures, definitions, timelines, and an authorization of appropriations.
Amends section 402(a)(2)(C)(i) (codified at 21 U.S.C. 342(a)(2)(C)(i)) by inserting additional text (the section text shows the amendment but the insertion text is not provided in this section).
Amends section 201(s) of the FD&C Act by making punctuation edits to existing paragraphs and adding a new paragraph (7) that defines 'a substance generally recognized as safe in compliance with section 409A.'
Creates a new FDA regulatory framework that tightens how substances that may become part of food are treated and redefines when a substance is not "generally recognized as safe" (GRAS). It requires manufacturers to notify the FDA, sets agency review and publication duties with deadlines, and authorizes funding to implement the new rule. The bill also adds a new food-chemical reassessment program requiring the FDA to periodically re-evaluate at least 10 food-related substances or classes, to compel data from manufacturers when needed, and to consider specific safety factors when deciding whether substances remain safe.
Creates a new section 409A titled "Substances generally recognized as safe" and inserts it into Chapter IV of the Federal Food, Drug, and Cosmetic Act. This new section sets rules about when a substance intended for use in or on food is deemed unsafe unless specific conditions are met.
Default rule: Any substance whose intended use results or may reasonably be expected to become a component of food is deemed unsafe for purposes of clause (2)(C) of section 402(a) unless one of the listed exceptions applies.
Exception 1: The substance is a food additive in compliance with section 409.
Exception 2: If, prior to the date of enactment, the manufacturer submitted a notice that it concluded the substance is GRAS and the Secretary either has not responded or has responded that the Secretary does not question the basis for that conclusion, the substance is not deemed unsafe (subject to subsection (e)(2) regarding prior submissions).
Exception 3 (transition notices): For notices submitted between the date of enactment and the day before the Act's effective date, the manufacturer must submit a notice including supporting information (full investigation reports, methods and controls, cumulative effects, hazard/dose/exposure information, protective safety factors, weight-of-evidence showing not carcinogenic, and weight-of-evidence showing not reproductive or developmental toxic) and the Secretary must not object. If these conditions are met, the substance is not deemed unsafe.
Who is affected and how:
Food manufacturers and ingredient suppliers: Face new compliance obligations, including notification requirements, potential data requests during reassessments, and the risk that prior GRAS-based uses could be reconsidered or withdrawn. This may increase testing, recordkeeping, and possible reformulation or relabeling costs.
Consumers and public health advocates: May gain greater protection and transparency as the FDA re-evaluates substances on a recurring schedule and publishes determinations; potential long-term benefits include reduced exposure to harmful substances.
FDA and federal regulators: Will take on additional workload to implement the rule, meet review timelines, conduct reassessments, and manage possible withdrawals of prior determinations; the bill authorizes funding to support these tasks but will still require resource planning and capacity building.
Food supply chain and importers: Could experience disruptions if reassessments lead to restrictions or changes in accepted uses for certain ingredients; importers may need to provide additional documentation.
Industry litigation and market effects: The authority to withdraw prior non-objection decisions and to reassess established substances may increase regulatory risk and could lead to litigation or market shifts if commonly used substances are restricted.
Overall, the legislation increases regulatory scrutiny of food-related substances, likely raising short-term costs for affected businesses while aiming to improve long-term consumer safety and regulatory transparency.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced July 17, 2025 by Edward John Markey · Last progress July 17, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate