GRAS Act

Bill Number

H.R. 4958

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-08-12: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-07-10T08:06:33Z

AI-Generated Summary

Purpose of the Legislation

The Grocery Reform And Safety Act (GRAS Act), H.R. 4958, aims to improve food safety by increasing oversight of substances used in food that are claimed to be "generally recognized as safe" (GRAS). It requires companies to notify the Food and Drug Administration (FDA) before using such substances in new ways and mandates periodic safety reviews to ensure they remain safe for consumers.

Key Provisions

• Redefinition of Food Additives and GRAS:
• Expands the legal definition of a "food additive" to include all GRAS substances, ending their previous exemption from FDA pre-approval.
• Defines GRAS as a substance proven safe by scientific experts (or, for pre-1958 uses, by common experience) under intended conditions.

• GRAS Notification Process:
• Companies must submit a notice to the FDA before marketing a new use of a GRAS substance or one not previously sold in U.S. foods.
• Notices must include detailed public data on the substance's identity, manufacturing, intended effects, and safety, covering topics like exposure risks, cancer potential, reproductive harm, and cumulative health effects (explained as combined impacts from related chemicals).
• The FDA reviews notices within 180 days (extendable by 90 days) and issues a statement either approving (not objecting) or rejecting the GRAS claim, based on data sufficiency, expert conflicts of interest (personal or financial biases affecting judgment), and overall safety evidence.
• Notices and FDA decisions are posted online for public comment (at least 60 days), promoting transparency.
• The FDA can later revoke approval if new safety concerns arise.

• Reassessments of Existing Substances:
• Starting 3 years after enactment, the FDA must review the safety of at least 10 food additives, prior GRAS substances, color additives, prior-sanctioned substances (pre-1958 approved ones), or food contact substances (materials touching food without altering it) every 3 years.
• Manufacturers may be required to provide updated safety data, including exposure estimates and toxicity analyses.
• If safety issues are found, the FDA can revoke GRAS status and impose civil penalties (fines) for non-compliance.
• Companies marketing pre-existing GRAS substances must notify the FDA of their use.

• Fees and Resources:
• Establishes fees for GRAS notices and reassessments to cover 100% of FDA costs, starting in fiscal year 2026.
• Authorizes funding (appropriations) for these activities.

• New Definitions:
• Clarifies terms like "carcinogenic" (cancer-causing in humans or animals, per expert bodies like the EPA), "cumulative effects," "reproductive toxicity" (harm to fertility or pregnancy), "developmental toxicity" (harm to unborn or young from exposure), and "new use" (any non-traditional application).

Significant Changes to Existing Law

• Ends GRAS Self-Certification Loophole: Previously, companies could declare substances GRAS without FDA review if experts agreed; now, all new or unmarketed GRAS uses require FDA notification and approval, integrating them into the food additive approval process under the Federal Food, Drug, and Cosmetic Act.
• Mandates Ongoing Reviews: Introduces regular reassessments (every 3 years) for legacy GRAS substances, which were previously unregulated post-initial determination.
• Enhances Transparency and Enforcement: Adds public disclosure, comment periods, conflict-of-interest checks, and penalties, replacing informal voluntary notifications with binding requirements.
• Updates Fee Structure: Expands user fees to fund GRAS-related work, shifting costs from taxpayers to industry.

Potential Impacts

• On Government Agencies: The FDA gains authority, resources (via fees and appropriations), and tools to proactively monitor food safety, potentially reducing long-term public health risks but increasing workload for reviews.
• On Citizens: Could lead to safer foods by catching hazards like cancer or reproductive risks earlier, benefiting public health; however, it might raise food prices if companies pass on compliance costs.
• On International Relations: Minimal direct impact, but stronger U.S. standards may influence global trade in food ingredients, pressuring exporters to meet FDA reassessment criteria.

Main Stakeholders Affected

• Food Industry (Manufacturers and Processors): Face new notification, data submission, and fee requirements, increasing compliance costs and timelines for introducing ingredients.
• FDA and Regulators: Receive expanded oversight powers and funding to enforce safety.
• Consumers and Public Health Advocates: Benefit from greater transparency and safety assurances for everyday food additives.
• Scientific Experts: Involved in safety evaluations, with new rules on disclosing conflicts of interest.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens the FDA's regulatory framework under the Federal Food, Drug, and Cosmetic Act, potentially reducing litigation over unsafe additives by providing clearer approval processes; civil penalties align with existing enforcement tools but apply newly to GRAS violations.
• Constitutional: No direct challenges anticipated, as it involves Congress's authority over interstate commerce and public health (Commerce Clause); however, industry may argue it imposes undue burdens on business, though balanced by public safety goals.
• Political: Represents a bipartisan push for food safety reform (introduced by Rep. Pallone), addressing criticisms of lax GRAS oversight; could spark debates on regulatory costs versus health benefits, influencing future agriculture and consumer protection policies.

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

Sponsor

Rep. Pallone, Frank [D-NJ-6]

Cosponsors (5)

Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Tlaib, Rashida [D-MI-12], Rep. Tonko, Paul [D-NY-20], Rep. Khanna, Ro [D-CA-17], Rep. Schrier, Kim [D-WA-8]

Recent Actions

• 2025-08-12: Referred to the House Committee on Energy and Commerce.
• 2025-08-12: Introduced in House
• 2025-08-12: Introduced in House

Bill Versions

• Grocery Reform And Safety Act — issued 2025-08-12 — PDF (16 pages)