Better FDA Act of 2025

Bill Number

S. 3122

Origin Chamber

Senate

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-11-06: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Last Updated

2025-11-19T15:21:06Z

AI-Generated Summary

Purpose

The Better Food Disclosure Act of 2025 aims to enhance food safety oversight by requiring notifications to the Food and Drug Administration (FDA) for substances considered "generally recognized as safe" (GRAS) for use in food. GRAS substances are ingredients that experts deem safe based on scientific evidence or historical use, without prior FDA approval. The bill seeks to create a transparent, public list of these substances and enable post-market reviews to ensure ongoing safety.

Key Provisions

• GRAS Notification and Listing (Section 409A):
• Starting 2 years after enactment, a GRAS substance is deemed unsafe (and thus adulterated under food safety laws) unless it is on the FDA's public list or under active review.
• Any person (e.g., a company) using a GRAS substance must notify the FDA to propose its inclusion on the list.
• For substances already in use as of enactment: Notification due within 2 years.
• For new substances: Notification at least 120 days before first use in interstate commerce.
• The FDA must issue regulations within 2 years to create and maintain a publicly accessible GRAS list.
• Within 180 days of receiving a notification, the FDA must either add the substance to the list or issue a preliminary determination to exclude it. If no decision is made, it is automatically added.
• If excluded or later removed, users have 180 days to: request FDA reconsideration with additional data, submit a formal food additive petition for approval, or plan to phase out its use. The FDA must make a final safety determination within 180 days of receiving requested information.

• Post-Market Safety Assessments (Section 409B):
• The FDA can reevaluate approved food additives, color additives, or listed GRAS substances if prompted by a citizen petition, notice from a state official, or its own initiative.
• Priority is given to cases with "clear and convincing scientific evidence" of safety concerns.
• The FDA must publish a Federal Register notice requesting safety information for reevaluated substances.
• Reevaluations follow existing approval processes and may result in amendments, revocations, or reclassification (e.g., treating a GRAS substance as a regulated food additive).
• Decisions require review by career (non-political) FDA experts with scientific expertise and must use public notice-and-comment rulemaking procedures. The FDA cannot delegate these reviews to political appointees.

• Definitions and Conforming Changes:
• Updates the definition of "food additive" to exclude properly listed GRAS substances.
• Explicitly defines "GRAS substance" as any ingredient safe for intended food use based on expert consensus, excluding regulated additives or other specified items.
• Amends food adulteration rules to treat unlisted GRAS substances as unsafe.
• Makes technical updates to related laws on prohibited acts, pesticide tolerances, cosmetic ingredients, imports, and international agreements to incorporate GRAS listing requirements.

Significant Changes to Existing Law

• From Self-Determination to Mandatory Oversight: Under current law, companies can self-determine GRAS status without notifying the FDA, relying on expert consensus. This bill shifts to a mandatory notification and listing system, making unlisted GRAS substances presumptively unsafe and subject to enforcement as adulterated food.
• Public Transparency: Introduces a required public FDA-maintained list of GRAS substances, which did not exist before, along with timelines for notifications and decisions.
• Enhanced Post-Market Review: Adds a formal process for ongoing safety checks, including citizen and state input, with safeguards against political influence—previously, such reviews were more ad hoc.
• Integration with Existing Frameworks: Aligns GRAS with food additive and color additive regulations, closing loopholes where GRAS substances bypassed pre-market approval.

Potential Impacts

• On Government Agencies: The FDA will face increased workload to build the GRAS list, process notifications (potentially thousands for existing substances), and conduct reevaluations. This could require additional resources but strengthens the agency's role in evidence-based food safety. States gain a formal channel to raise concerns.
• On Citizens: Consumers may benefit from greater transparency via the public list, potentially reducing exposure to unverified ingredients and enabling better-informed choices. However, short-term disruptions (e.g., product reformulations) could affect food availability or prices.
• On International Relations: Imported foods containing unlisted GRAS substances could face stricter U.S. scrutiny, potentially affecting trade with countries relying on self-GRAS determinations. The bill updates import rules to include GRAS, which might harmonize with or challenge international standards like those from the Codex Alimentarius.

Main Stakeholders Affected

• Food Industry (Manufacturers and Processors): Primary targets for notifications and compliance; must invest in data submission and potential reformulations, facing risks of enforcement if non-compliant.
• FDA and Regulatory Bodies: Gains authority and responsibilities for listing, reviews, and enforcement.
• Consumers and Public Health Advocates: Benefit from transparency and safety checks; can submit petitions to trigger reviews.
• State Governments: Empowered to notify the FDA of safety concerns, enhancing local-federal coordination.
• Scientists and Experts: Involved in providing evidence for GRAS determinations and FDA reviews.

Notable Legal, Constitutional, or Political Implications

• Legal Implications: Strengthens enforcement under the Federal Food, Drug, and Cosmetic Act by treating unlisted GRAS as adulterated, potentially increasing litigation over safety data and FDA decisions. The 180-day deadlines create enforceable timelines, reducing administrative delays but risking court challenges if unmet.
• Constitutional Implications: Emphasizes due process through notice-and-comment rulemaking and expert reviews, insulating decisions from political interference (e.g., no delegation to presidential appointees), which aligns with separation of powers principles. However, mandatory notifications could be seen as expanding federal regulatory reach over private industry.
• Political Implications: Introduced by bipartisan senators, it addresses criticisms of lax GRAS oversight (e.g., "GRAS loophole") without fully eliminating self-determination. It may spark debates on regulatory burden versus public health, influencing future food policy amid growing scrutiny of additives like ultra-processed ingredients. No direct impact on free speech or other rights, but it promotes accountability in agency actions.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Marshall, Roger [R-KS]

Cosponsors (2)

Sen. Britt, Katie Boyd [R-AL], Sen. Scott, Rick [R-FL]

Recent Actions

• 2025-11-06: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
• 2025-11-06: Introduced in Senate

Bill Versions

• Better Food Disclosure Act of 2025 — issued 2025-11-06 — PDF (11 pages)