Expert guide to GRAS Pathways: GRAS Notice vs. Self-Affirmed

Expert guide to GRAS Pathways: GRAS Notice vs. Self-Affirmed

A Comprehensive Guide to GRAS Pathways: GRAS Notice vs. Self-Affirmed Navigating the intricate landscape of food and food additive regulation in the United States involves understanding the GRAS concept – “Generally Recognized as Safe.” GRAS status is a pivotal determinant of whether a substance can be used in food without requiring formal approval from the U.S. Food and Drug Administration (FDA). This status relies on two primary pathways: the GRAS Notice and Self-Affirmed GRAS. In this article, we’ll explore these pathways in-depth, highlighting their differences, processes, and significance for businesses in the food industry.

Deciphering GRAS: What It Means

Before delving into the two GRAS pathways, it’s essential to grasp the essence of “Generally Recognized as Safe.” When a substance achieves GRAS status, qualified experts have reached a consensus that it is safe for its intended use in food based on rigorous scientific evaluations of its safety profile.

GRAS Notice: The Regulatory Route

1. Definition: The GRAS Notice pathway necessitates the submission of a formal notification to the FDA, accompanied by comprehensive scientific evidence and data substantiating the substance’s safety. The FDA meticulously reviews the compliance and affirms or disputes the GRAS status.

2. Scientific Evidence: Crafting a GRAS Notice mandates compiling substantial scientific evidence. This evidence encompasses toxicological studies, clinical trials, and historical data demonstrating the substance’s safety.

3. Independent Panel Review: A distinctive aspect of the GRAS Notice process is the engagement of an independent panel of experts. This panel meticulously evaluates the safety data and provides an impartial opinion on whether the substance qualifies as GRAS.

4. FDA’s Verdict: Following the company’s submission and the independent panel’s evaluation, the FDA conducts its independent review. If the FDA concurs with the GRAS determination, it issues a “no questions” letter, effectively confirming the substance’s GRAS status. Should the FDA have inquiries or concerns, it may release a response outlining the need for additional data or clarifications.

Self-Affirmed GRAS: The Internal Affirmation

1. Definition: The Self-Affirmed GRAS pathway empowers a company to establish a substance’s GRAS status without submitting a formal notification to the FDA. This method hinges on the company’s self-assessment and the consensus of qualified experts.

2. Scientific Evidence: In the Self-Affirmed GRAS route, companies must still compile extensive scientific evidence attesting to the substance’s safety. Experts within the company or external consultants usually evaluate and assess this evidence.

3. Internal Expert Consensus: A crucial distinction in Self-Affirmed GRAS is that the determination resides within the company. It is paramount that the company can provide evidence of consensus among qualified experts regarding the substance’s safety.

Key Differences and Strategic Insights

  • FDA Involvement: The most notable distinction between the two pathways lies in the level of FDA engagement. GRAS Notice mandates formal FDA review and approval, imparting a higher degree of FDA endorsement. In contrast, Self-Affirmed GRAS relies on the company’s internal evaluation.
  • Independent Panel: The GRAS Notice’s requirement for an independent expert panel can bolster the credibility of the GRAS determination. Self-affirmed GRAS does not require an independent panel but may involve external experts.
  • Transparency: GRAS Notice offers a more transparent process, which entails public access to information submitted to the FDA. Self-affirmed GRAS determinations are not compelled to be made public, though many companies voluntarily do so.
  • Legal Liability: Both pathways come with legal responsibility. Suppose a substance is later found to be unsafe. In that case, the FDA can take action against the company that made the GRAS determination, irrespective of the chosen pathway.


In summary, the GRAS pathways, GRAS Notice and Self-Affirmed GRAS, provide flexibility for companies seeking to establish the safety of substances in food products. Choosing the correct path hinges on several factors, including available resources, desired FDA involvement, and transparency preferences. Regardless of the pathway selected, ensuring the safety of food additives and substances’ safety is paramount, as it directly influences consumer health and trust in the food industry. Navigating these pathways with care and consideration is essential for the success of food businesses in the United States.

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health and the environment. If you want to learn even more about GRAS, reach out to us today about GFSI certification requirements, GRAS Notifications, or GRAS self-affirmation!

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About the author

Andrew Parshad
Andrew Parshad
Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.


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