GRAS Loophole

For more than two decades, the FDA’s “generally recognized as safe” (GRAS) framework has allowed food ingredients to enter the U.S. market either through FDA notification or through a company’s internal “self-GRAS” determination without notifying the agency. That flexibility is now under renewed scrutiny.

Four separate bills introduced in the 118th and 119th Congresses would significantly restructure—or in some cases effectively eliminate—the traditional self-GRAS pathway. While none has yet been enacted, together they signal a clear policy direction: mandatory FDA visibility, increased public transparency, and expanded post-market reassessment of food ingredients.

This post summarizes what each bill would do, where the debates are converging, and what food and ingredient companies should be planning for now.

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Why Congress Is Revisiting GRAS

Under current FDA regulations (21 CFR Part 170), companies may determine that a substance is GRAS based on publicly available scientific data and expert consensus, without notifying FDA. Critics argue that this system allows ingredients to enter the food supply without FDA awareness or public disclosure, while supporters note that GRAS was designed to preserve flexibility for widely accepted, low-risk substances.

Recent congressional proposals reflect growing concern over:

• FDA’s lack of visibility into self-affirmed GRAS determinations
• Limited public access to safety data
• The absence of a formal post-market reassessment mechanism
• Increased attention to cumulative exposure, endocrine effects, and vulnerable populations

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The Four GRAS Reform Bills at a Glance

1. S. 3122 (119th Congress) – Better Food Disclosure / Better FDA Act

Core focus: Mandatory GRAS reporting and post-market oversight.

Key provisions include:

• Creation of a mandatory FDA-maintained GRAS list
• GRAS substances not listed (or under review) would be treated as unsafe by default
• FDA review timelines (generally 180 days)
• Authority to exclude or delist substances, triggering reconsideration, food additive petitions, or market exit
• A formal post-market reassessment framework for GRAS substances, food additives, and color additives

Why it matters: This bill would largely eliminate “silent” self-GRAS determinations and introduce ongoing lifecycle oversight.

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2. H.R. 9817 (118th Congress) – Toxic Free Food Act of 2024

Core focus: Forcing FDA to rewrite the existing GRAS rule.

Key provisions include:

• Mandatory FDA rulemaking to revise the 2016 GRAS final rule
• Prohibition on marketing substances as GRAS without FDA notice
• Required public posting of GRAS submissions
• A minimum 90-day public and FDA review period
• Reestablishment of FDA’s Food Advisory Committee

Why it matters: Rather than amending the statute, this bill targets FDA’s regulatory discretion—effectively ending self-GRAS through rulemaking.

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3. H.R. 4958 (119th Congress) – Grocery Reform and Safety (GRAS) Act

Core focus: Statutory restructuring, reassessments, and fees.

Key provisions include:

• Amendments to the FD&C Act’s food additive definition
• Mandatory GRAS notices with public posting and comment
• FDA-led reassessment of at least 10 substances or classes every three years
• Authority to require updated safety data (exposure, cumulative effects, endocrine and developmental endpoints)
• Expansion of user fees to support FDA review and reassessment activities

Why it matters: This bill introduces the concept of routine, periodic GRAS reassessment, making compliance an ongoing obligation rather than a one-time exercise.

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4. S. 2341 (119th Congress) – Ensuring Safe and Toxic-Free Foods Act of 2025

Core focus: Narrowing what can qualify as GRAS.

Key provisions include:

• Mandatory GRAS submissions with detailed safety analyses
• Public disclosure and comment requirements
• Formal FDA “object” or “not object” determinations
• Conflict-of-interest requirements for expert data
• Exclusion of substances associated with carcinogenicity, reproductive or developmental toxicity, or endocrine disruption
• Minimum FDA review quotas (≥50 notices per year)

Why it matters: This is the most restrictive proposal and could dramatically shrink the universe of substances eligible for GRAS treatment.

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Where the Bills Converge

Despite different legislative strategies, the bills share several themes:

• Mandatory FDA notification rather than voluntary participation
• Public transparency as the default for GRAS safety data
• Higher evidentiary standards, including cumulative exposure and sensitive populations
• Post-market reassessment authority
• A gradual shift away from industry-controlled determinations toward formal FDA oversight

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Practical Implications for Food and Ingredient Companies

Even if none of these bills passes as written, they reflect a clear regulatory trajectory. Companies should consider:

• Auditing existing GRAS positions, especially self-affirmed determinations
• Upgrading safety dossiers to address cumulative exposure, margins of safety, and emerging toxicological concerns
• Planning for public disclosure of at least portions of GRAS safety support
• Preparing for reassessment, including supplier obligations and data-generation contingencies

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Bottom Line

Congress is signaling that the current GRAS framework may no longer be politically sustainable in its existing form. Whether through mandatory notification, public disclosure, or routine reassessment, the direction is clear: greater FDA oversight and less regulatory silence.

Companies that proactively strengthen their GRAS foundations now will be better positioned—regardless of which legislative vehicle ultimately moves forward.