Overview of Three U.S. Congressional Proposals Related to GRAS Regulations in 2025

In 2025, the U.S. Congress introduced three proposals related to food substances “Generally Recognized As Safe” (GRAS): S.2341, H.R.4958, and S.3122. These proposals all focus on improving the GRAS evaluation process, substance safety, and regulatory requirements for self-GRAS.

Summary of the three bills

Senate Bill No. 2341, the “Ensuring Safe and Nontoxic Food Act of 2025” (S.2341)

• Date Introduced: July 17, 2025
• Sponsors: Senators Markey and Warren (D-MA); Senator Booker (D-NJ); and Senator Blumenthal (D-CT)
• Current Status: Bill introduced

Key Provisions

• Effective as of the date this bill takes effect, food ingredients may not be deemed GRAS through self-GRAS.
• The GRAS “grandfather clause” stipulates that substances for which a GRAS notification was submitted to the U.S. FDA prior to the bill’s effective date may continue to be recognized as GRAS.
• The “grandfather clause” does not apply to substances that have obtained self-GRAS status but for which no GRAS notification has been submitted to the FDA, unless a GRAS notification for the substance was submitted prior to the bill’s effective date.
• Clarifies the safety assessment requirements for GRAS notifications (including carcinogenicity, reproductive and developmental toxicity, and cumulative effects).
• Requires periodic reevaluation of GRAS substances that have been granted “grandfather clause” exemptions.

House Bill No. H.R. 4958, the “GRAS Act of 2025” (H.R. 4958) Key Provisions of the Bill

• Date Proposed: August 12, 2025
• Sponsor: Rep. Pallone (D-NJ)
• Current Status: Proposal Submitted

Key Provisions

Eliminates the GRAS exemption from the definition of food additives, reclassifies GRAS substances as food additives, and establishes a separate regulatory pathway (GRAS notification, distinct from other food additive applications). Requires the submission of a GRAS notification under new mandatory procedures for substances not currently used in food or for new uses in food that were approved prior to the bill’s effective date.

Effective as of the date of enactment, food ingredients may no longer be self-GRAS-certified and must be submitted to the FDA via notification.

• Clarify the safety assessment for GRAS notifications (including carcinogenicity, reproductive and developmental toxicity, and cumulative effects).
• Before placing new GRAS substances or new intended uses of existing GRAS substances on the market, a “no objections letter” from the U.S. FDA must be obtained (which effectively constitutes premarket approval).
• The GRAS “grandfather clause” stipulates that substances for which a GRAS notification was submitted to the U.S. FDA and a “no objections letter” was received prior to the effective date of the Act may continue to be recognized as GRAS.
• The “grandfather clause” exemption appears to apply equally to substances that have completed the Self-GRAS process but have not submitted a GRAS notification to the FDA.
• Approved food additives, GRAS substances (including exempted substances), color additives, and previously approved substances must be reevaluated periodically.
• The FDA may opt to require market notification for all GRAS substances and establish a list of GRAS substances that includes self-GRAS substances not submitted via GRAS notification prior to the Act’s effective date.
• The Act assesses the costs associated with the initial evaluation and reevaluation of food additives and GRAS substances.

Senate Bill No. S.3122, the “FDA Improvement Act of 2025” (S.3122) Key Provisions: III. Conclusion

• Date Introduced: November 6, 2025
• Sponsors: Senator Marshal (R-Kansas), Senator Britt (R-Alabama), and Senator Scott (R-Florida)
• Current Status: Bill Introduced

Key Provisions

• Eliminates the GRAS exemption clause from the definition of food additives and reclassifies GRAS substances as exceptions to the definition of food additives (placing them on the same footing as color additives, pesticides, and previously approved substances).
• Require the U.S. FDA to establish new procedures for developing and maintaining the GRAS list.
• Require owners of GRAS substances to submit notifications to the FDA (for GRAS substances already in use when the regulation takes effect, notifications must be submitted within 2 years of the regulation’s effective date; for new GRAS substances added thereafter, premarket notifications must be submitted 120 days prior to their first use in food).
• Substances not included on the GRAS list or currently under review for inclusion on the GRAS list are deemed unsafe, and foods containing such substances are considered adulterated.
• The FDA is required to approve or reject submitted GRAS substance listings within 180 days. For rejected substances, the submitter may request a reconsideration, and the FDA must make a final decision within 180 days of receiving supplemental information.
• Procedures are established such that, upon receipt of a citizen petition, a request from state officials, or at the FDA’s own initiative, the safety of the use of GRAS substances already on the list, approved food additives, or approved color additives must be reevaluated.

The U.S. Congress regularly proposes various legislative bills related to food regulation, and issues concerning GRAS substances have been a key focus year after year; this is not the first time such discussions have arisen.

It should be noted that the three proposals related to the GRAS system—S.2341, H.R. 4958, and S. 3122—all three proposals related to the GRAS system—are still in the initial “submission” stage. There remains significant uncertainty as to whether they will pass votes in the U.S. Senate and House of Representatives, be submitted to the President for signature, and become official law. Regarding the future direction of the GRAS system, Ruixu Group will continue to monitor relevant developments to ensure that companies are promptly informed of potential changes in regulatory rules.

What CIRS Can Do for You

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The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
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