GRAS Act
Sponsored By: Representative Rep. Pallone, Frank, Jr. [D-NJ-6]
Introduced
Summary
A formal, data-driven GRAS safety system would replace informal "generally recognized as safe" determinations with mandatory notices, public data disclosure, and routine safety reassessments. The bill would define key scientific terms, set timelines for FDA action, and add fees and appropriations to fund reviews.
Show full summary
- Families and consumers would get GRAS notices and supporting data posted on FDA's website with a public comment period of at least 60 days, increasing transparency about additives.
- Food makers and ingredient suppliers would need to file formal GRAS notices for new or previously unmarketed uses, provide robust safety data, meet a 180-day FDA decision window that can be extended by 90 days, and face civil penalties tied to reassessment requirements.
- FDA and federal oversight would run a reassessment program that must evaluate at least 10 substances or classes within 3 years and every 3 years after, use clearer hazard and toxicity definitions, and receive new fee and appropriation authority to support those reviews.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Clear safety terms for GRAS reviews
If enacted, the bill would define key safety terms used in GRAS decisions. It would define carcinogenic, conflict of interest, cumulative effects, developmental toxicity, reproductive toxicity, and more. These definitions would guide how the FDA weighs evidence and makes safety calls.
New FDA process for GRAS notices
If enacted, anyone seeking a new GRAS use would need to file a notice with the FDA. The notice would include public safety studies and data. The FDA would post the notice and data online and take public comments for at least 60 days. The FDA would respond within 180 days, with one 90‑day extension allowed. The substance could be used only if the FDA issues a written no‑objection for the stated use.
Regular FDA checks on food substances
If enacted, the FDA would recheck the safety of at least 10 substances or classes within 3 years and at least every 3 years after. Reviews could cover food additives, color additives, prior‑sanctioned substances, food contact substances, and past GRAS substances. Companies could be required to submit new safety studies and updated exposure estimates. The FDA could revoke a past no‑objection if safety concerns arise and would post the revocation online. Civil fines could apply for violations.
New FDA fees for food makers
If enacted, people who file a food‑additive petition or GRAS notice would pay a new FDA fee. Makers or importers of substances under FDA reassessment could also pay fees. Each year’s fee would cover 100% of FDA’s estimated costs for these reviews. The bill updates fee baseline years to 2026 and 2025 for budgeting.
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Sponsors & CoSponsors
Sponsor
Rep. Pallone, Frank, Jr. [D-NJ-6]
NJ • D
Cosponsors
Del. Norton, Eleanor Holmes [D-DC-At Large]
DC • D
Sponsored 12/1/2025
Rep. Tlaib, Rashida [D-MI-12]
MI • D
Sponsored 2/3/2026
Rep. Tonko, Paul [D-NY-20]
NY • D
Sponsored 2/24/2026
Rep. Khanna, Ro [D-CA-17]
CA • D
Sponsored 2/24/2026
Roll Call Votes
No roll call votes available for this bill.
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