The U.S. Food and Drug Administration (FDA) is proposing a major change to how companies demonstrate the regulatory status of certain substances used in food.

On August 10, 2026, FDA proposed a rule that would make GRAS notifications mandatory for certain uses of substances added to human and animal food. The proposal is intended to increase transparency and give FDA greater visibility into the scientific basis behind GRAS conclusions.

The proposal is still under review, but for food brands and ingredient manufacturers, it raises a bigger question:

Can you demonstrate why an ingredient is compliant for the way you intend to use it?

That question could become increasingly important as FDA moves toward greater oversight of GRAS substances.

From "GRAS" status to documented evidence

Under the current framework, companies can reach an independent conclusion that a substance is GRAS without submitting a notification to FDA. FDA's GRAS notification program is currently voluntary.

The proposed rule would change this by requiring notifications for certain uses, subject to proposed exceptions.

Importantly, GRAS is not a blanket approval for an ingredient.

FDA considers whether a substance is safe under its conditions of intended use, including factors such as what the substance is, how it is made, how much is used and how it will be used in food.

That means the regulatory status of an ingredient cannot always be assessed independently from the product it is going into.

For brands, this makes the connection between ingredient, formulation and intended use increasingly important.

What is FDA proposing?

If finalized, the proposal would:

• Make GRAS notifications mandatory for certain uses of substances currently relying on the GRAS provision

• Give FDA greater visibility into the scientific basis supporting GRAS conclusions

• Maintain a public inventory of GRAS notices

• Establish a process for FDA to determine that a substance is not GRAS

• Provide a streamlined pathway for certain substances already in commerce under proposed transitional provisions

The proposal applies to substances used in both human and animal food.

It is not yet a final rule. Companies can submit comments to FDA under Docket FDA-2025-N-3262.

Why this matters for food brands

The biggest practical change may not be the notification itself.

It is the increased importance of the evidence behind the regulatory conclusion.

For many brands, ingredient information sits across multiple parties. Suppliers may hold GRAS documentation, manufacturers may maintain specifications and testing records, while regulatory teams manage product assessments.

When this information is fragmented, it can be difficult to quickly answer:

Why is this ingredient acceptable for this specific product and use?

As regulatory expectations evolve, brands may need a more connected view of their ingredient and product compliance information.

GRAS is not the same as cGMP

GRAS and current Good Manufacturing Practices (cGMP) address different aspects of compliance.

GRAS relates to whether a substance qualifies for the GRAS provision based on its safety under the conditions of intended use. cGMP requirements address how food is manufactured, processed, packed and held.

For human food, FDA's CGMP requirements are established under 21 CFR Part 117. Dietary supplements have additional CGMP requirements under 21 CFR Part 111.

Both can therefore form part of a product's overall regulatory readiness, but they should not be treated as interchangeable requirements.

What should brands do now?

The proposed rule is not final, so companies do not need to immediately overhaul their compliance systems.

However, it is a good opportunity to review how ingredient compliance is managed.

1. Review your GRAS documentation

For key ingredients, identify the basis for the GRAS conclusion, supporting scientific evidence and conditions of intended use.

2. Connect ingredients to formulations

Consider how an ingredient's regulatory status applies to its actual use level, product category and intended application, rather than treating GRAS as a simple yes/no attribute.

3. Review supplier documentation

Make sure current GRAS statements, specifications and supporting documents are available and traceable, particularly when relying on information from ingredient suppliers.

4. Map GRAS status across your portfolio

For companies managing multiple SKUs, identify which products rely on existing GRAS notices, independent GRAS conclusions or other regulatory pathways.

This can make future reformulations and new product assessments significantly easier.

The bigger shift: compliance is moving upstream

FDA's proposed rule is ultimately about more than submitting another regulatory document.

It signals a broader shift toward greater transparency around the evidence supporting ingredients used in the food supply. FDA has said that mandatory notifications would give the agency and public more information while helping identify substances or uses that may require further regulatory review.

For food brands, that means compliance increasingly needs to happen before the finished product reaches the market.

Ingredient selection, formulation, manufacturing and regulatory assessment are becoming increasingly interconnected.

The companies that build those connections early will be better positioned to respond as requirements evolve.

Because knowing that an ingredient is "GRAS" may not be enough. Brands need to know why, under what conditions, and where the supporting evidence sits.

Official FDA sources

• FDA: Generally Recognized as Safe (GRAS)

• FDA: GRAS Notification Program

• FDA: Current Good Manufacturing Practices for Food and Dietary Supplements

• FDA: Frequently Asked Questions on FSMA