GRAS Oversight and Transparency Act

Bill Number

H.R. 7291

Origin Chamber

House

Congress

119th Congress, Session 2

Policy Area

Health

Status

Introduced

Latest Action

2026-01-30: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-02-19T19:05:50Z

AI-Generated Summary

Purpose of the Legislation

The GRAS Oversight and Transparency Act aims to improve food safety by establishing a review process for older designations of substances as "generally recognized as safe" (GRAS). GRAS refers to substances that food manufacturers have determined are safe for use in food without needing pre-approval from the Food and Drug Administration (FDA), based on scientific evidence and common use. The bill focuses on designations made before 2000 that were not reported to the FDA, ensuring they meet current safety standards.

Key Provisions

• Establishment of the GRAS Review Board: The Secretary of Health and Human Services (HHS), through the FDA Commissioner, must create a board to evaluate the validity of "covered GRAS designations" (pre-2000 self-determinations by manufacturers that a substance is safe for food use, without FDA notification).
• Membership:
• Voting members include the HHS Secretary, USDA Secretary, two FDA Human Foods Program representatives, and one each from various FDA and USDA offices (e.g., legal counsel, scientists, food safety inspectors).
• Non-voting members: One academic expert in food toxicology and one food industry representative.
• Terms: Five years for appointed members; no compensation; HHS Secretary appoints the chairperson from voting members.
• Board terminates 10 years after enactment.
• Board Duties:
• Identify covered GRAS substances by requiring food manufacturers to submit notices within 90 days of enactment, including relevant details.
• Categorize them into three tiers (Tier 1: highest priority; Tier 3: lowest) for review.
• Review each for safety validity; if a substance is deemed unsafe, notify the HHS Secretary and Congress within 90 days, recommending revocation.
• Manufacturer Compliance and Penalties:
• Non-compliant manufacturers face civil penalties (up to those under existing FDA law) or treatment of the substance as an unapproved, unsafe food additive, potentially leading to bans or recalls.
• Revocation Process:
• If recommended, the HHS Secretary may revoke a GRAS designation using available evidence.
• Notify the manufacturer, give 180 days to submit safety evidence, review it, and inform of the final decision.
• Establish procedures for compliance, including timelines for stopping distribution and recalling substances.
• Reporting Requirements:
• Board submits reports to HHS, Congress, and posts them publicly on the FDA website, detailing reviews and recommendations.
• Timelines: Tier 1 (2 years), Tier 2 (4 years), Tier 3 (10 years) after enactment.

Significant Changes to Existing Law

• Under current law (Federal Food, Drug, and Cosmetic Act), manufacturers can self-determine GRAS status without FDA pre-approval or notification, as long as the substance is safe based on expert consensus.
• This bill introduces mandatory FDA oversight for pre-2000 GRAS designations not previously notified, including a structured review board, categorization system, and potential revocations—none of which exist today.
• It adds enforcement tools, like penalties and deeming non-compliant substances unsafe, to compel transparency and compliance.

Potential Impacts

• Government Agencies: Increases workload for FDA, HHS, and USDA through board operations, reviews, and reporting; may strain resources but enhance inter-agency coordination on food safety.
• Citizens (Consumers): Could lead to safer food by removing potentially unsafe additives, reducing health risks from unverified substances; however, short-term disruptions (e.g., product reformulations) might affect food availability or prices.
• Food Manufacturers: Requires disclosure and evidence submission, potentially leading to revocations, recalls, and compliance costs; may encourage more rigorous safety testing in the future.
• International Relations: Minimal direct impact, but could influence U.S. food exports if revocations affect ingredients in global supply chains, aligning U.S. standards more closely with international safety norms.

Main Stakeholders Affected

• Food Manufacturers: Primary targets for notifications, reviews, and potential revocations; must comply or face penalties.
• Government Agencies: FDA (leads board and enforcement), HHS (oversight), USDA (multiple representatives), and EPA (toxicology input).
• Consumers and Public Health Advocates: Benefit from increased transparency and safety reviews.
• Congress: Receives reports and notifications, enabling ongoing oversight.
• Academic and Industry Experts: Involved as non-voting members, providing specialized input.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens FDA's authority under the Federal Food, Drug, and Cosmetic Act by closing a loophole in self-regulation, potentially reducing litigation over unsafe additives; ensures due process through notice, evidence review, and appeal-like steps before revocations.
• Constitutional: No direct challenges anticipated, as it regulates commerce (food safety) under Congress's commerce clause powers; balances industry autonomy with public health protections.
• Political: Promotes transparency in food regulation, appealing to consumer safety advocates, but may face opposition from industry groups concerned about regulatory burdens and costs; the 10-year sunset clause limits long-term commitment, allowing future Congresses to reassess.

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

Sponsor

Rep. Lawler, Michael [R-NY-17]

Recent Actions

• 2026-01-30: Referred to the House Committee on Energy and Commerce.
• 2026-01-30: Introduced in House
• 2026-01-30: Introduced in House

Bill Versions

• GRAS Oversight and Transparency Act — issued 2026-01-30 — PDF (9 pages)