Better FDA Act of 2025
- Sponsor
- Sen. Marshall, Roger [R-KS]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Nov 6, 2025
Bottom line
The bill transforms the voluntary GRAS notification system into a mandatory one, enhancing FDA oversight and transparency for food substances, and introduces a formal mechanism for postmarket safety reevaluation of food ingredients.
What it actually does
This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to mandate that all food substances generally recognized as safe (GRAS) must be formally notified to the Food and Drug Administration (FDA) and included on a publicly accessible list. After a two-year grace period, any GRAS substance not on this list or under active review will be deemed unsafe. The bill also establishes a new postmarket assessment process, allowing the FDA to reevaluate the safety of food additives, color additives, and GRAS substances based on new scientific concerns.
Proponents argue
Supporters argue this bill significantly enhances food safety transparency and oversight by closing a long-standing regulatory loophole. By requiring formal FDA notification and listing for all GRAS substances, it ensures that substances in the food supply are subject to a more rigorous and public safety assessment, providing the FDA with a comprehensive inventory and better data to protect consumers.
Opponents contend
Critics might contend that this bill imposes an unnecessary and potentially costly regulatory burden on food manufacturers, particularly small businesses, by formalizing a system that has largely functioned effectively. They may argue it could stifle innovation in food product development and lead to delays in bringing new, safe ingredients to market without a clear demonstration of widespread public health risk under the current system.
The bill is concise and its core provisions are relatively straightforward, making it accessible for an informed reader to understand its implications within a short timeframe.
Section 2(a), inserting new Section 409A into FFDCA
Mandatory Reporting and FDA Listing for GRAS Substances
This provision mandates that, two years after enactment, any food substance generally recognized as safe (GRAS) will be considered unsafe for food use unless it is included on a new public list maintained by the FDA or is currently under FDA review. It requires persons using GRAS substances to file a notice with the FDA for inclusion on this list, with specific deadlines for existing and new substances entering interstate commerce.
Supporters argue
Supporters argue this provision closes a significant regulatory loophole, ensuring that all GRAS substances, including those previously self-affirmed by manufacturers, undergo a formal FDA notification process. This increases transparency and provides the FDA with a comprehensive inventory and oversight of substances in the food supply, enhancing public health protection.
Critics contend
Opponents may argue that this provision creates an unnecessary and potentially costly bureaucratic hurdle for substances already deemed safe by scientific consensus. They might contend it could slow down innovation and product development without a clear benefit, as the current voluntary system has largely functioned without widespread safety issues.
Tradeoffs
The bill balances the desire for increased regulatory oversight and transparency in food safety with potential burdens on industry and the risk of slowing down the introduction of new, safe ingredients.
Section 2(a), new FFDCA Section 409A(d) and (e)
FDA Review and Final Determination for GRAS Listing
This section outlines the FDA's process for reviewing GRAS notices. The FDA must either add a substance to the public list or make a preliminary determination to exclude it within 180 days. If excluded, the person using the substance must then request reconsideration, submit a food additive petition, or provide a plan for phasing out its use. The FDA then makes a final determination within 180 days of receiving sufficient information for reconsideration.
Section 2(b), amending Section 201(s) and adding Section 201(tt) of FFDCA
Clarification of Food Additive and GRAS Definitions
This section amends the definition of 'food additive' to explicitly exclude substances defined as 'food substance generally recognized as safe' (GRAS). It then adds a new, positive definition for 'food substance generally recognized as safe' that largely mirrors the previous exclusionary language from the 'food additive' definition, making it clear which substances fall under the new Section 409A requirements.
Section 2(c), amending Section 402(a)(2)(C) of FFDCA
Deeming Unlisted GRAS Substances as Adulterated
This amendment expands the definition of 'adulterated food' to include any food containing a GRAS substance that is not on the FDA's new public list or is currently under review by the Secretary pursuant to the new Section 409A(e). This means that after the two-year grace period, such food cannot be legally sold in interstate commerce.
Section 3, inserting new Section 409B into FFDCA
Postmarket Safety Reevaluation
This section establishes a process for the FDA to reevaluate the safety of food additives, color additives, and listed GRAS substances if concerns arise from citizen petitions, state officials, or the Secretary's own initiative. Based on reevaluation, the FDA can amend or revoke regulations for additives, or determine a GRAS substance to be a food additive and remove it from the GRAS list. It prioritizes petitions with clear and convincing scientific evidence.
This subsection makes several conforming amendments throughout the FFDCA, integrating the new GRAS listing requirement into existing sections related to prohibited acts (301(ll)(3)(A)), pesticide chemical residues (408(l)(5)(B)), color additives (721(b)(4)), and imports/exports (801(d), 803(c)(2)). These amendments ensure that GRAS substances are treated consistently with other regulated substances under various FFDCA provisions.
Section 2(d)
Why it matters:This is standard legislative practice to ensure consistency and avoid conflicts with existing law when introducing new regulatory frameworks. It's not evasive but requires detailed legal knowledge to fully appreciate.
Case for: Supporters argue these amendments are essential for the coherent and effective implementation of the new GRAS framework, ensuring that the FDA has the necessary legal tools to regulate GRAS substances across all relevant aspects of food law, from domestic commerce to imports.
Case against: No specific opposition is typically raised against necessary conforming amendments, as they are technical adjustments to make the primary policy functional.
Estimated impact: Ensures the new GRAS framework is legally integrated throughout the FFDCA, impacting all regulatory and enforcement activities related to GRAS substances.
This subsection mandates that any determination or reevaluation under the postmarket assessment section (409B) must be subject to review and recommendation by career appointees in the FDA with relevant scientific and regulatory expertise, and must follow notice and comment rulemaking procedures. Crucially, it prohibits delegation of this review to political appointees (individuals appointed by the President) or non-career FDA staff.
Section 3, new FFDCA Section 409B(d)
Why it matters:This provision aims to ensure scientific integrity and independence in critical safety determinations, shielding them from potential political influence. It's a deliberate structural safeguard, not an evasive tactic.
Case for: Proponents argue this ensures that crucial food safety decisions are based on sound science and expert judgment, free from political interference. It strengthens public trust in the FDA's regulatory process by empowering career scientists.
Case against: No direct opposition, but some might argue that limiting the review to career appointees could potentially slow down decision-making or reduce accountability to elected officials, though this is a less common argument against scientific independence.
Estimated impact: Enhances the scientific rigor and independence of FDA's postmarket safety reviews for food additives, color additives, and GRAS substances.