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We help your business complete every step of the FDA GRAS Notification process, from data review and dossier drafting to FDA submission, so your ingredient can reach the U.S. market smoothly and on time. Our regulatory specialists guide you through the paperwork, evidence gathering, and expert panel coordination to ensure your submission meets FDA expectations.
Before an ingredient can be marketed for food use in the U.S., it must demonstrate safety under its intended conditions through the FDA GRAS process. A complete and compliant GRAS Notification helps avoid costly delays and rejections, ensuring your ingredient is recognized as safe and ready for commercialization.
At Quality Smart Solutions, we make this process easier by preparing, reviewing, and submitting every part of your GRAS dossier. Our team ensures your documentation is accurate, evidence-backed, and fully aligned with FDA requirements so you can move forward with confidence.
Navigating the GRAS Notification process involves multiple steps, from determining your ingredient’s regulatory pathway to submitting the final dossier. Our team manages every stage with clarity and efficiency.
Assess whether GRAS status is necessary for your ingredient and confirm applicable categories.
Review available safety, manufacturing, and identity data to identify what’s missing before dossier development.
Advise on appropriate clinical studies or toxicological tests, if additional evidence is needed.
Conduct research to collect published data and references that support ingredient safety.
Draft, compile, and submit the GRAS Notification dossier to the FDA, ensuring all components meet regulatory expectations.
Communicate with FDA reviewers, address questions, and provide any follow-up information required during review.
Facilitate the expert panel review process and documentation to support your GRAS conclusion.
Identify whether GRAS self-affirmation, GRAS Notification, or another pathway (e.g., ODI or NDI) is most appropriate for your ingredient.
A GRAS Notification is a voluntary submission to the FDA to demonstrate that a substance used in food is generally recognized as safe under its intended conditions.
The FDA typically reviews GRAS Notifications within 180 days, though additional time may be required if clarifications are requested.
Yes. A qualified, independent expert panel evaluates the data and issues a written conclusion that supports the GRAS determination.
Yes, you can submit a GRAS Notice after self-affirming, often to meet regulatory or marketplace expectations.
Our team assists in addressing FDA feedback, providing additional data, or revising sections as needed.
No. GRAS applies only within the U.S. market, though similar safety assessment processes exist in other jurisdictions.