A new proposal in the U.S. Senate could bring mandatory GRAS notification to the forefront of food regulation, changing how companies manage Generally Recognized as Safe (GRAS) ingredients. If passed, it would require the FDA to maintain a public list of all GRAS substances and make notification mandatory for every use. This shift would remove the long-standing option for companies to self-affirm GRAS status without FDA involvement.
This article explains what the bill means for food manufacturers, importers, ingredient suppliers, and retailers. If you rely on self-affirmed GRAS determinations, you will want to understand these changes and prepare early.
Keep reading to learn how this possible new law affects your compliance obligations and what steps you can take to stay ready.
What Is the new Senate proposal for mandatory GRAS notification?
The new Senate proposal for mandatory GRAS notification, introduced on November 6, 2025 and also known as the Better FDA Act 2025, is a proposed amendment to the Federal Food, Drug, and Cosmetic Act. The bill introduces a new GRAS framework that requires FDA oversight for all GRAS substances.
According to the legislative text, any GRAS ingredient that is not listed on the FDA’s public GRAS list would be considered unsafe for use in food.
Today, companies may choose between submitting a voluntary GRAS notice or performing a self-affirmed GRAS evaluation without FDA review. The bill removes this flexibility. Instead, every GRAS substance must be reviewed or accepted by the FDA through a formal notice.
The bill also directs the FDA to create regulations for a mandatory GRAS list, maintain public access to the list, and outline the full process for listing, delisting, review, and reconsideration.
How the Bill Changes GRAS Requirements
If enacted, the new Senate proposal for mandatory GRAS notification would introduce several major changes that affect how you bring food ingredients to market.
1. Mandatory GRAS Notification
All GRAS determinations would require formal submission to the FDA. Any ingredient not included in the FDA’s public list would be deemed unsafe until it is reviewed or accepted.
2. Public FDA List of GRAS Ingredients
The FDA would create a comprehensive, publicly accessible list of all GRAS substances. This list would serve as the official source for determining whether an ingredient is considered safe.
3. Deadlines for Existing and New Ingredients
The bill establishes clear timelines:
- Existing GRAS ingredients must be submitted within two years of enactment.
- New ingredients must be submitted at least 120 days before first use in food.
These requirements create a compliance clock that businesses will need to plan for.
4. Delisting and Reevaluation
Under the bill, the FDA can:
- Exclude ingredients from the GRAS list
- Reevaluate any listed substance
- Request additional data
- Require companies to phase out unsafe ingredients
A new section of the Act allows FDA to review GRAS substances based on petitions, state notices, or internal safety concerns.
Why This Matters to Your Business
If your products rely on GRAS ingredients, this bill could significantly change your compliance pathway. The removal of the self-affirmation option creates new operational and regulatory risks.
Key impacts include:
- Increased documentation requirements
- Longer timelines for ingredient approval
- Ongoing FDA review obligations
- Higher expectations for transparency
- A need to verify every supplier’s GRAS claims
You will need clear evidence, updated dossiers, and robust scientific support to meet FDA expectations under this new framework.
How to Prepare for the new Senate proposal for mandatory GRAS notification
If your company uses self-affirmed GRAS determinations today, planning ahead will help you avoid delays and compliance issues. Consider the following steps:
- Identify all self-affirmed GRAS ingredients in your portfolio or supply chain.
- Gather scientific evidence that aligns with FDA review standards.
- Evaluate safety data to ensure it meets modern toxicology expectations.
- Prepare to submit GRAS notices within required timelines.
- Work with regulatory experts who understand FDA GRAS review processes.
At Quality Smart Solutions, we help businesses complete ingredient evaluations, prepare strong GRAS dossiers, and manage FDA communication. Our team can support you with scientific documentation, regulatory strategy, and submission readiness.
Key Takeaways
- The new Senate proposal for mandatory GRAS notification creates mandatory GRAS submissions.
- FDA would maintain a public list of all GRAS substances.
- Unlisted ingredients would be considered unsafe until reviewed.
- Existing ingredients must be submitted within two years of enactment.
- Early preparation will help you avoid delays and ensure compliance.
FAQ: new Senate proposal for mandatory GRAS notification
Is self-affirmed GRAS still allowed today?
Yes. Self-affirmed GRAS remains valid until legislation or rulemaking changes the requirements.
Will every GRAS ingredient require FDA review?
If this bill passes, yes. Every GRAS determination would need formal submission to be included on the FDA’s list.
Will the FDA reject GRAS ingredients under this new law?
The FDA may exclude or delist ingredients that do not meet safety standards. However, companies can submit additional information or request reconsideration.
Does this affect small or emerging businesses?
The bill applies to all companies, but early preparation can help avoid costly delays.
How can I prepare now?
You can begin reviewing safety data, updating GRAS dossiers, and working with qualified regulatory consultants.
Conclusion
The new Senate proposal for mandatory GRAS notification represents a major shift in how GRAS determinations will be managed in the United States. That’s why preparing early can help you move forward with confidence and reduce the risk of costly delays.
If you need support adapting to these changes, our team can help you prepare for mandatory GRAS notification, complete a full GRAS dossier, or transition a self-affirmed GRAS into a submission-ready format.
