What Regulatory Strategies Should Companies Consider if FDA Finalizes Mandatory GRAS Notifications?

09 Sep 2026

Throughout this blog series, we've discussed the United States Food and Drug Administration's (FDA's) proposed mandatory Generally Recognized as Safe (GRAS) notification rule, which industries may be affected, and the steps companies can take to prepare.

At Intertek, our clients often come to us with a simple question: What's the most efficient regulatory pathway for our product?

For companies currently relying on independent GRAS conclusions, whether based on scientific procedures or, where applicable, common use in food—the proposed rule raises an important question: Does the existing safety and risk assessment, along with the supporting documentation, remain sufficient to support the company's current regulatory position?

The proposed rule would not change the underlying criteria for determining whether a use is GRAS; rather, it would generally require companies to notify FDA of applicable GRAS conclusions. The appropriate strategy will depend on the type of substance, its intended use, existing safety and exposure data, the strength of the supporting documentation, and the company's commercial objectives.

The good news? Companies may have more than one regulatory path forward. The right choice starts with understanding what information and support already exist, identifying any gaps, and then determining which regulatory pathway best fits the substance and its intended use.

For existing self-GRAS substances, this assessment is particularly important. Companies should consider whether the original safety assessment remains current, whether new scientific or toxicological information is available, whether exposure has changed, and whether there have been changes to the substance, manufacturing process, specifications, use levels, food categories, or other conditions of use.

For new substances, a similar assessment can help companies determine the most appropriate regulatory strategy before investing in a submission.

Several strategies may be available.

Strategy 1: Reassess the Existing Safety and Risk Basis

For companies currently relying on independent GRAS conclusions, the first step should be to reassess the existing safety and risk basis for the substance and its intended use.

This assessment can help determine whether the available scientific, toxicological, exposure, manufacturing, identity, and other supporting information remains sufficient to support the existing GRAS conclusion and whether additional information may be needed.

Companies should consider questions such as:

• Does the existing safety assessment reflect the current scientific and toxicological understanding of the substance?
• Has new scientific or toxicological information become available?
• Has the intended use, use level, or potential consumer exposure changed?
• Have there been changes to the substance's identity, manufacturing process, specifications, or impurity profile?
• Does the existing documentation adequately address the current conditions of use?
• Are there data gaps that could affect the strength of the existing safety conclusion?

For food-contact materials, this assessment may need to consider the complete composition and intended use of the material, including polymers, additives, colorants, processing aids, adhesives, coatings, and potential migrants or degradation products.

The goal is not simply to determine whether additional testing is needed. It is to determine whether the existing regulatory position remains appropriate and, if not, what regulatory strategy may best address the identified gaps.

A structured data gap analysis can help companies make this determination before significant resources are invested in a new regulatory submission.

Strategy 2: Consider the Proposed Transitional Submission Pathway

For eligible substances already in commerce based on an independent GRAS conclusion, the proposed transitional submission program may provide a practical short-term option.

The proposed streamlined submission is a time-limited option for providing FDA with information about substances already introduced into interstate commerce under an independent GRAS conclusion. The proposed rule provides for this streamlined option for one year following the effective date of the final rule.

Instead of requiring an immediate full GRAS notification, companies would be permitted to submit basic information regarding the substance, its intended use, use levels, and evidence that it was already being marketed.

This pathway has several potential advantages:

• Potentially lower submission burden than a full GRAS notice;
• Potentially more efficient management of large product portfolios;
• Increased FDA visibility into existing products; and
• Additional time to evaluate longer-term regulatory strategies.

For companies with large portfolios of legacy substances, the transitional option may provide an opportunity to prioritize substances based on existing documentation, intended use, exposure, and the strength of the underlying GRAS conclusion.

However, it is important to recognize that the transitional pathway is a time-limited regulatory option rather than a long-term substitute for evaluating and substantiating GRAS status. Companies should therefore consider how the transitional submission fits within their longer-term regulatory strategy.

Strategy 3: Prepare a Full GRAS Notification

For some food ingredients and food-contact substances, preparing a full GRAS notice may be the most appropriate long-term regulatory strategy.

A GRAS notice allows companies to formally present the scientific basis supporting their conclusion that a substance is GRAS under its intended conditions of use. This generally includes:

• Substance identity and characterization;
• Manufacturing information;
• Specifications;
• Impurity profile;
• Exposure assessments;
• Toxicological evaluations;
• Scientific literature reviews; and
• Expert assessment supporting safety conclusions.

While preparing a GRAS notification requires a meaningful investment of scientific and regulatory resources, it remains a familiar and well-established pathway.

The proposal would also create an exception for uses covered by an existing FDA "no questions" letter, provided the letter covers the substance under the same relevant conditions of intended use. Companies should therefore evaluate whether changes to the substance, manufacturing process, specifications, use levels, food categories, or other conditions of use could affect applicability.

A full GRAS notification strategy may be particularly appropriate for substances that are broadly commercialized, intended for multiple customers, and supported by strong safety datasets, as well as for novel food technologies where public transparency provides a business advantage.

Because successful GRAS submissions require expertise across multiple scientific disciplines, many companies benefit from a coordinated approach involving regulatory, toxicology, exposure assessment, and analytical teams.

Strategy 4: Evaluate a Threshold of Regulation (TOR) Exemption

For certain low exposure uses, a TOR exemption may eliminate the need for food additive authorization and, under the proposed rule, would also provide an exception from the mandatory GRAS notification requirement.

The Threshold of Regulation (TOR) process provides a regulatory exemption for certain substances where dietary exposure is sufficiently low and specified regulatory criteria are met. The existing TOR framework includes specific criteria, including the 0.5 ppb dietary concentration criterion for food-contact uses, along with other requirements.

The proposed rule would expand the scope of 21 CFR 170.39 to cover substances used in food and as food-contact substances, rather than limiting the regulation to food-contact articles. The FDA's proposal specifically recognizes the TOR framework and would exempt qualifying materials from mandatory GRAS notification requirements.

Potential applications may include certain low-migration food-contact substances, packaging constituents, and substances used in food-processing equipment where the resulting dietary exposure can be demonstrated to meet the applicable TOR criteria.

The central focus of a TOR exemption is demonstrating that the substance falls below specified exposure thresholds and meets the applicable safety criteria. For food-contact materials, TOR eligibility can depend heavily on reliable migration and exposure data. This makes analytical characterization, migration testing, and exposure modeling particularly important.

Intertek's food-contact and analytical teams can support clients in evaluating whether a TOR strategy may be scientifically and commercially viable before significant regulatory resources are invested.

Strategy 5: Consider a Food Contact Notification

For many food-contact applications, a Food Contact Notification (FCN) may offer valuable advantages to food-contact substance (FCS) manufacturers and suppliers.

The proposed rule would recognize effective FCNs as an alternative to mandatory GRAS notification where applicable. An FCN is particularly relevant when the substance and use are being authorized as a food-contact substance.

One important distinction when considering this route is that FCNs are generally manufacturer-specific and therefore can provide a different regulatory and commercial framework than GRAS. GRAS status is not inherently manufacturer-specific, whereas an effective FCN is specific to the manufacturer or supplier identified in the notification, the notified substance, and the conditions of use.

Other companies remain responsible for ensuring that their own use is lawfully covered. This manufacturer-specific framework can provide companies with a degree of competitive differentiation that may not be available through a GRAS-based approach.

FCN submissions also provide important confidentiality protections for qualifying proprietary information. FDA's regulations identify information in an FCN that may be exempt from public disclosure, although the submission also contains information that may be publicly available.

An FCN strategy may be particularly attractive for:

• Novel food-contact materials;
• Advanced packaging systems;
• New polymer technologies;
• Barrier coatings;
• Adhesives;
• Processing aids;
• Functional barriers;
• Recycled-content technologies; and
• Sustainable packaging innovations.

As sustainability and circular packaging initiatives continue to accelerate, FCNs are likely to remain an important regulatory pathway for organizations bringing innovative food-contact technologies to market.

Why an Integrated Scientific Approach Matters

Determining the most appropriate regulatory strategy under FDA's proposed GRAS notification requirements requires more than simply identifying a potential submission pathway. Companies need to understand the strength of their existing safety and exposure assessment, identify data gaps, and determine how those gaps may affect their regulatory options.

This may require collaboration between regulatory specialists, toxicologists, exposure scientists, migration experts, and analytical chemists. Fortunately, Intertek maintains dedicated teams in each of these disciplines, allowing us to evaluate materials from both scientific and strategic perspectives and identify solutions that support compliance and align with our clients' business goals.

Whether FDA's proposed rule is finalized as written or evolves through the rulemaking process, one thing is already clear: companies that understand the strength of their existing data and regulatory position today will be better positioned to respond tomorrow.

Intertek offers a Phase One Data Gap Analysis (DGA) to help companies evaluate their materials, existing documentation, intended conditions of use, exposure profile, and available safety information. The assessment can identify potential gaps and help determine which regulatory strategies may be appropriate including whether additional safety assessment or testing is needed and whether a transitional submission, GRAS notification, TOR exemption, FCN, or another regulatory approach should be considered.

The goal is not simply to prepare another regulatory submission. It is to identify the regulatory strategy that best fits the substance, the science, and the business objectives.

Having the right scientific, analytical, toxicological, and regulatory partners can make all the difference. If interested in discussing the next steps, contact Rebekah Morrow, Director, Regulatory Notifications, at Rebekah.Morrow@Intertek.com.