Navigating the Changing GRAS Landscape with Confidence

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Food & Agriculture

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28 Apr 2026

As consumer expectations around transparency and the Food and Drug Administration’s (FDA) oversight of the United States food supply evolve, navigating the Generally Recognized as Safe (GRAS) pathway has become a critical consideration for food and ingredient manufacturers. Regulatory change is creating new expectations, making proactive, science-led GRAS strategies more important than ever.

What Is GRAS and Why Does It Matter?

In the United States, food ingredients must either be approved as food additives or qualify as GRAS based on publicly available scientific evidence and consensus among qualified experts. As the food additive petition (FAP) process is long and cumbersome, ingredient manufacturers prefer the GRAS route by filing a GRAS notification that presents data on the ingredient’s safety and intended food uses. While GRAS notification is currently voluntary, it is widely considered best practice, offering credibility through FDA engagement and builds confidence in their customers and consumers that the ingredient has undergone a rigorous review by the FDA.

Is GRAS Notification Becoming Mandatory?

Recent FDA communications and public discussions indicate growing momentum toward enhanced oversight of the GRAS program. This is to assure the general public in the U.S. that the ingredients in their food supply have been thoroughly reviewed for safety. With the anticipated release of the FDA’s newly proposed rule for mandatory GRAS notification occurring anytime from spring of 2026, manufacturers will need to act proactively to avoid uncertainty over the regulatory status of their ingredients. Companies with well‑documented, scientifically robust GRAS conclusions and thoughtful FDA engagement will be better positioned to manage regulatory change and minimize business risk.

How Can a Proactive GRAS Strategy Reduce Risk?

A successful GRAS approach requires more than regulatory familiarity; it demands credible science, clear documentation, and alignment with evolving FDA expectations. Forward‑looking organizations are leveraging the FDA’s voluntary GRAS notification program as a strategic tool to support innovation, protect market access, and reinforce stakeholder confidence. Depending on the details of this new rule, a proactive approach would mitigate against any potential consequences of non-compliance, resulting in cost saving and create business opportunities.

How Does Intertek Health Sciences Support the GRAS Process?

At Intertek, we partner with food and ingredient manufacturers across every stage of the GRAS notification journey, combining scientific rigor with practical regulatory insight.

Our GRAS services include:

Regulatory Strategy and Consultation
Guidance on GRAS pathways, FDA engagement, and compliance considerations.
GRAS Determination and Independent Expert Panels
Scientifically robust safety evaluations supported by independent expert review.
GRAS Notification Preparation and FDA Support
Development of comprehensive dossiers designed to support successful outcomes with the FDA.

What Types of Ingredients Does Intertek Support?

Intertek supports a broad range of ingredient categories, including human milk identical ingredients, botanicals, enzymes and probiotics, ingredients from precision fermentation, novel fats and oils, and many more. Our multidisciplinary teams integrate toxicology, regulatory science, and food safety expertise to help ensure GRAS conclusions are defensible and aligned with FDA expectations.

How Can Companies Stay Ahead of Regulatory Change?

With the possibility of mandatory GRAS notification on the horizon, careful preparation today can help reduce uncertainty tomorrow. Organizations that build strong scientific foundations and engage with the regulatory process early will adapt with confidence.

Assurance Built on Science. Confidence Built on Experience.

Intertek brings clarity, credibility, and confidence to the GRAS process, helping food and ingredient manufacturers navigate regulatory change with assurance.

Wherever you are in the multi-stage process of regulatory compliance, our experts are ready to support your pathway to market.

Connect with Intertek Health Sciences to strengthen your GRAS strategy and move forward with confidence.

Intertek. Total Quality. Assured.

James Akingbasote

Scientific Consultant II, Safety and Regulatory Affairs, Food and Nutrition Group, Intertek Assuris

Dr. Akingbasote is a scientific consultant in safety and regulatory affairs (Food & Nutrition) at Intertek. He has nearly two decades of experience across academia, clinical research, and regulatory consulting. A Diplomate of the American Board of Toxicology (DABT), Dr. Akingbasote holds a Bachelor of Pharmacy (B. Pharm), a Master of Research (MRes) in Mechanistic Molecular Toxicology, and a Doctor of Philosophy (Ph.D.) in Clinical and Molecular Pharmacology. He has authored several peer‑reviewed journal articles and book chapters in the fields of pharmacology and toxicology.

He has successfully led and managed the preparation and submission of multiple New Dietary Ingredient Notifications (NDINs), Health Canada Master Files, as well as Novel Food and Natural Health Product License applications. In his current role, he supports food ingredient manufacturers across a broad range of ingredient types, delivering successful GRAS notifications from pre‑submission strategy and dossier preparation through regulatory completion.

Labiba Nahian

Scientific Associate II – Safety and Regulatory, Food & Nutrition Group, Intertek Assuris

Labiba Nahian is passionate about biochemistry, with a professional focus on food enzymes and live microbial ingredients. She has been involved in the preparation of regulatory submissions for these ingredients across multiple jurisdictions, including the United States, European Union, Canada, and Australia and New Zealand.

In her role, Labiba has experience conducting GRAS Panels and preparing and submitting GRAS Notices, supporting the safety evaluation and regulatory acceptance of novel ingredients. She has a particular interest in bioinformatics and integrates these tools into her work to strengthen scientific assessments. Across all of her work, she is committed to ensuring that scientific rigour underpins the safety and compliance of ingredients brought to market.