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This bill directs the Secretary of Health and Human Services, through the FDA Commissioner, to update and clarify the rule on substances generally recognized as safe (GRAS).
Sec. 2, Directed rulemaking regarding substances generally recognized as safe: The Secretary must publish a proposed revision to the 2016 GRAS rule within 180 days of enactment, and a final revision within 90 days after the public comment period closes. The revision must: prohibit manufacturers from marketing a substance as GRAS unless the Secretary receives notice and supporting information, including cumulative effects, safety factors, and margins for vulnerable populations; require the Secretary to make determinations and supporting information publicly available and allow at least 90 days for review and objections; clarify that newly synthesized or novel chemical substances cannot be GRAS; clarify that carcinogenic substances cannot be GRAS; prohibit the Secretary from relying on expert determinations with conflicts of interest and incorporate recommendations from the 2017 draft guidance on GRAS panels; and create a process for systematic reassessment of substances previously determined GRAS if they did not meet revised standards. The Secretary must also reestablish the Food Advisory Committee within 180 days to work on reassessment standards and provide necessary staffing and resources. The term 'GRAS' is defined as generally recognized as safe by qualified experts, and 'Secretary' means the Secretary of Health and Human Services.
Summary of the bill text as introduced in House (Sep 25, 2024), generated by SecBot from the official bill text; the Library of Congress summary is not yet published.
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Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.