GRAS Notice delays can seriously affect your product’s time to market and create regulatory headaches. If your business is preparing a GRAS Notice for FDA review, minimizing delays should be a top priority for a smoother path to market.
The good news? There are simple steps you can take to avoid the common mistakes that lead to delays. In this article, we’ll show you how to stay ahead of the game. Plus, you’ll learn how to get your GRAS Notice moving smoothly through the FDA review process. Keep reading to learn how to get your submission on the fast track.
Understand the GRAS notice process inside and out
Do you know what the FDA really expects from a GRAS Notice? Many businesses aren’t sure where to begin, and that’s where delays often start. A GRAS Notice is a formal document you send to the FDA to show that your ingredient is Generally Recognized as Safe (GRAS) when used as intended in food or beverages.
In simple terms, you’re proving to the FDA that experts agree your ingredient is safe. This means gathering strong scientific evidence and safety data. Additionally, you will need a clear explanation of how and where the ingredient will be used.
When your team understands this process fully, you avoid unnecessary back-and-forth with the FDA. As a result, you can put together a stronger submission from the start.
Build a comprehensive GRAS dossier
Your dossier is basically the heart of your submission. It needs to give the FDA a full picture of your ingredient and how it will be used. Many delays happen simply because important details are missing or hard to follow. At a minimum, a GRAS dossier should cover:
A full description of the ingredient, including its source, how it is made, and its intended use in food or beverages
Specifications and three non-consecutive batch Certificates of Analysis (CoAs) to show a consistent manufacturing process
Safety studies and toxicology reports to demonstrate that the ingredient will not cause harm
A detailed explanation of the manufacturing process, from raw materials to the final product
Estimates of the amount consumers are expected to ingest under normal use
If any of these sections are incomplete or confusing, the FDA might ask for an Additional Information Request (AIR). This can slow down your review by weeks or even months.
Taking the time to get your dossier right the first time can make a big difference in keeping your submission on track.
Engage qualified experts early
FDA reviewers expect your GRAS Notice to be supported by credible experts with strong scientific backgrounds. That’s why involving toxicologists, food scientists, and other qualified professionals early in the process helps identify gaps in your data and strengthens the safety assessment.
Working with a consulting partner like GRAS Experts can help simplify this step. Our team collaborates with businesses to bring together the right specialists, making sure your submission meets FDA expectations and stands up to regulatory scrutiny.
To strengthen your GRAS Notice even further, it’s important to include a final layer of review and risk assessment. Consider adding the following steps:
- Expert review: Have qualified experts evaluate the full data package to ensure it meets FDA’s scientific standards for safety.
- Address potential concerns: Identify any information that might raise questions and clearly explain why, based on the total evidence, the ingredient remains GRAS under the intended conditions of use.
Maintain open communication with the FDA
Clear communication with the FDA is key to staying on track. Therefore, assign a dedicated team member to monitor and respond promptly to any FDA inquiries or clarification requests related to your GRAS Notice.
Also, a proactive communication strategy shows that your business is engaged and responsive, which can help move the process forward with fewer interruptions.
Stay current with regulatory updates
The FDA’s approach to GRAS Notices can evolve over time. Submitting outdated information or failing to follow new guidelines may result in delays. Stay informed by checking updates on the FDA’s official GRAS Notification Program page regularly.
Final thoughts
Avoiding GRAS Notice delays is possible when you combine preparation, expert input, and regulatory know-how. By submitting a complete and well-supported GRAS Notice and keeping open lines of communication with the FDA, you can help ensure a smoother and faster review process.
Need assistance navigating your next GRAS Notice? Contact us today to get started or fill out the form below for a free consultation with one of our regulatory experts.
