The FDA has proposed a major change to how companies use GRAS, which stands for “Generally Recognized as Safe.” In simple terms, GRAS is one way a company can show that an ingredient is considered safe for its intended use in food. Under the proposed rule, companies could still bring ingredients to market without waiting for FDA pre-approval, but they would need to tell the FDA when they are relying on a GRAS determination.
What Is Changing?
Today: A company can decide on its own that an ingredient is GRAS and use that ingredient without notifying the FDA.
Under the proposed rule: A company would need to notify the FDA when it uses a GRAS determination to support bringing an ingredient to market.
What this means for you: This proposal is about transparency. It is not the same as requiring FDA approval before a product can be sold. Products could still be sold before, during, and after FDA review.
However, companies that do not notify the FDA may face more attention later if the agency reviews the ingredient after it is already on the market.
Why This Matters for Food Brands
Even if your business does not make ingredients, this proposed rule may still affect you because your products depend on ingredients supplied by others.
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Your products may include ingredients that another company has determined are GRAS.
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Your suppliers may need to notify the FDA about certain ingredients.
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If the FDA later decides an ingredient is not GRAS for a specific use, products that contain that ingredient could face regulatory action.
Bottom line: A supplier’s regulatory status can become your business risk, so it is important to understand how your ingredients are supported.
Existing Ingredients May Have a Simpler Path
The proposal includes a more streamlined process for ingredients that are already being sold before the final rule takes effect.
For many existing ingredients, companies may only need to provide basic information, such as:
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Company information
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The ingredient name
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How the ingredient is intended to be used
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Proof that the ingredient was already being sold
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If applicable, the file number for any earlier GRAS notice that received a “cease to evaluate” letter from the FDA
Why this matters: This streamlined option could help some companies avoid submitting extensive safety studies for ingredients that are already in commerce.
FEMA GRAS Is Not the Same as FDA Review
Some flavor ingredients may have FEMA GRAS status. This is important to understand, but it is not the same as FDA review.
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FEMA GRAS is an industry determination.
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It is not the same as an FDA “No Questions” letter.
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FEMA GRAS ingredients are not separately exempted under the proposed rule. They may need to use the streamlined pathway or submit a full GRAS notice.
What this means for you: If your products use specialty flavor systems, ask suppliers how those flavor ingredients are supported and whether any future FDA filing would cover your specific use.
Questions to Ask Your Suppliers
Use these questions to start a practical conversation with ingredient and flavor suppliers:
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What is the regulatory basis for this ingredient?
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Is there an FDA “No Questions” letter?
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Is the ingredient self-affirmed GRAS?
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Will any future FDA filing cover my specific use of the ingredient?
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Do you have documentation that supports the ingredient’s GRAS status?
Remember: GRAS status depends on how an ingredient is used, how much is used, and what type of food it is used in.
Potential Challenges for Small Businesses
For smaller food businesses, the proposed rule may create more work behind the scenes. Companies may need to spend more time on:
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Reviewing ingredients
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Communicating with suppliers
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Organizing documentation
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Understanding regulatory responsibilities
What this means for you: This may not require immediate changes to your products, but it is a good reason to start organizing ingredient information now.
Public Disclosure Considerations
When a company submits a GRAS notice, some information may become publicly available. This could include:
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The ingredient’s identity
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Manufacturing details
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Specifications
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Use levels
What this means for you: Businesses should think carefully about what information may be confidential commercial information before submitting materials.
What Should You Do Now?
You do not need to wait until the rule is final to start preparing. A few practical next steps include:
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Make a list of the ingredients used in your products.
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Identify which ingredients may be self-affirmed GRAS.
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Ask suppliers for supporting documentation.
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Confirm whether suppliers plan to notify the FDA if the rule is finalized.
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Save records that show existing ingredients were already being sold.
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Review supply agreements to understand who is responsible for regulatory documentation.
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Consider submitting comments to the FDA if the proposal could affect your business.
Important Date
FDA comment period deadline: December 9, 2026
Companies and trade associations can submit feedback during the comment period. The FDA is required to review and consider comments it receives.
Final Thought
The proposed rule is not final yet, but it signals a clear push toward more transparency around food ingredients. Specialty food businesses can prepare by learning which ingredients they use, asking suppliers the right questions, and keeping strong documentation before any new requirements take effect.
SFA members can stay up to date on food industry regulations and legislative changes on our dedicated resource page (log in required).