S. 2341: Ensuring Safe and Toxic-Free Foods Act of 2025

This bill, known as the Ensuring Safe and Toxic-Free Foods Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act by introducing new regulations regarding substances that are generally recognized as safe (GRAS) for use in food. Here is an overview of the key provisions of the bill:

1. GRAS Substances Regulations

The bill establishes that any substance intended to affect food characteristics must meet specific safety criteria to be deemed GRAS. Specifically, a substance will be considered unsafe unless:

• It is a food additive compliant with existing regulations.
• The manufacturer has submitted a notice to the Secretary of Health and Human Services, asserting its GRAS status with corresponding data that the Secretary has not objected to.
• During a specified period, the manufacturer can submit a notice which includes sufficient supporting information regarding the safety of the substance.

2. Public Availability and Comment

The Secretary of Health and Human Services will make any notices regarding GRAS substances publicly available and allow for public comment for at least 60 days following the notice receipt.

3. Secretary's Determination

The Secretary must assess the provided information and may object if:

• The manufacturer did not provide complete documentation.
• The expert assessments supporting the GRAS determination show a conflict of interest.
• The evidence does not adequately substantiate the safety of the substance in question.

All decisions on objections will be considered final agency actions by the Secretary.

4. Expert Evaluation Standards

The Secretary will publish guidance to strengthen expert evaluation standards for assessing GRAS substances within 180 days after the bill's enactment.

5. Reassessments of Safety

The bill mandates that substances deemed GRAS must undergo safety reassessment regularly. The Secretary will reassess at least 10 substances or classes of substances every three years to ensure continued safety standards are met.

6. Compliance and Reporting Requirements

Manufacturers will be required to conduct evaluations and provide data on substances under reassessment. The Secretary may prioritize assessments based on public petitions for reconsideration of existing substances.

7. Definitions and Exclusions

The bill includes various definitions for terms such as "carcinogenic," "cumulative effects," and "developmental toxicity." Notably, a substance cannot be classified as GRAS if it is identified as:

• Carcinogenic.
• Reproductively or developmentally toxic.
• Recognized as toxic by several authoritative health agencies.

8. Funding Authorization

The bill authorizes necessary funding to implement its provisions.

9. Effective Date

The enacted amendments will take effect two years after the bill's enactment.

Relevant Companies

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