Sponsors (5)
The bill strengthens science‑based safety oversight and transparency for food additives—improving consumer protections—but does so at the cost of higher compliance burdens, greater regulatory risk for producers, potential product disruptions/pricing effects, and added demands on FDA resources.
Consumers (general public, low‑ and middle‑income households) will see stronger, more regular safety oversight because the bill requires reassessing at least 10 food substances every 3 years, prioritizes petitions with known concerns, and codifies clear toxicological criteria (carcinogenicity, cumulative effects, developmental/reproductive toxicity) and reliance on authoritative assessments (NTP,
Consumers benefit from clearer, more transparent GRAS procedures because the bill establishes statutory rules for GRAS determinations and requires more consistent FDA review and public posting of GRAS notices.
Manufacturers who timely submit complete GRAS notices and meet documentation/conflict‑of‑interest requirements can obtain explicit FDA non‑objection status, reducing legal uncertainty for compliant firms.
Small manufacturers and other firms will face higher compliance costs because preparing more detailed GRAS notices, meeting conflict‑of‑interest/data requirements, and responding to reassessments will require more studies, data, and legal work.
Producers face increased regulatory risk and uncertainty because the bill creates a statutory reassessment/withdrawal pathway that can lead to product restrictions or removal even after a prior FDA non‑objection.
The FDA may be strained by the new reassessment workload (≥10 substances every 3 years), potentially delaying other reviews or requiring additional funding and staffing (a burden on taxpayers and a risk to timely regulatory decisions).
Based on analysis of 3 sections of legislative text.
Creates a statutory GRAS framework, narrows when a substance can avoid being an "unsafe" additive, and requires FDA to reassess at least 10 substances every 3 years.
Introduced July 17, 2025 by Edward John Markey · Last progress July 17, 2025
Creates a new statutory framework for "generally recognized as safe" (GRAS) determinations and requires the FDA to re-evaluate food additives and related substances on a recurring schedule. It makes substances that become or affect food adulterants unless they meet one of three narrow conditions tied to existing food additive approval or specific GRAS notice processes, and it mandates FDA reassess at least 10 substances or classes every three years.