S. 3122: Better Food Disclosure Act of 2025

The proposed bill, known as the Better Food Disclosure Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act to establish new requirements for the regulation and reporting of food substances deemed generally recognized as safe (GRAS). Here are the key components of the bill:

Mandatory Reporting

Beginning two years after the bill's enactment, any substance currently classified as GRAS will be considered unsafe unless it is:

• Included on a list maintained by the Secretary of the Department of Health and Human Services (HHS), or
• Under review by the Secretary, and a final determination has not been made.

This means that if a substance is not on the official list, its safety is questioned, requiring additional actions to clarify its status.

Notification to the FDA

Individuals or entities may submit a notice to the Secretary proposing that a specific GRAS food substance be added to the official list. The timeframes for these notifications are:

• For substances used in food prior to the bill's enactment: they must be submitted within two years.
• For new substances used after the bill's enactment: notifications must be submitted 120 days before their intended use.

Creating a Public List

The Secretary is also required to develop regulations to create and maintain a publicly accessible list of food substances that are recognized as safe.

FDA Response to Notifications

Upon receiving a notification about a GRAS substance, the Secretary must respond within 180 days. The options include:

• Accepting the notice and adding the substance to the list, or
• Initiating a preliminary determination to exclude it from the list.

If the Secretary does not make a determination in time, the substance is automatically added to the list.

Handling Excluded or Delisted Substances

If a substance is excluded from the list or removed after a reevaluation, the entity using that substance must:

• Request a reconsideration of the decision,
• File a food additive petition, or
• Develop a phase-out plan for the substance.

Definitions and Amendments

The bill modifies definitions within the Federal Food, Drug, and Cosmetic Act to clarify what constitutes a food substance that is generally recognized as safe, as well as revising the classification for adulterated food. This includes specific exclusions for substances that are defined as food additives.

Postmarket Assessments

A new section mandates that if the Secretary receives concerns regarding the safety of any food additive or GRAS food substance, there will be a reevaluation process to determine if safety regulations need to be amended or revoked. This will prioritize those concerns that are substantiated by clear scientific evidence.

Review and Recommendations

Any safety determinations made under this bill will require review and recommendations from qualified FDA staff, and the public will have the opportunity to provide comments during the regulatory process.

Implementation Timeline

• The establishment of regulations, creation of the GRAS list, and initial notifications and evaluations will occur in phases, starting within two years of the bill's enactment.

Relevant Companies

• MDLZ (Mondelez International, Inc.) - A major player in the food industry who may need to review and possibly adapt their ingredient processes to comply with the new reporting requirements.
• CPB (Campbell Soup Company) - This food company could be impacted as it utilizes various food substances and may need to submit notices for those considered GRAS under the new amendments.
• HRL (Hormel Foods Corporation) - The requirements for notification and reevaluation of generally recognized safe substances could significantly affect product development and ingredient sourcing.