Notice Preparation
Develop a scientifically sound notice outlining the ingredient's safety profile, including its chemical composition, intended use, manufacturing process, and supporting safety data.
Submitting a successful notification ensures your ingredient receives official recognition as Generally Recognized As Safe by the US Food and Drug Administration (FDA). This paves the way for confident market entry and consumer trust. Learn more about this essential process and how our team of FDA regulatory specialists can guide you every step of the way.
The FDA GRAS Notification program allows companies to formally notify the FDA of their conclusion that an ingredient is Generally Recognized As Safe for its intended use in human food. This notification triggers a review process by the FDA, who will assess the submitted data and determine whether they agree with the safety conclusion.
If you’re a food ingredient supplier or manufacturer, you can apply for GRAS notification for below use cases:
The GRAS notification procedure involves submitting a document called a GRAS notice to the FDA. Here’s a breakdown of the steps:
Develop a scientifically sound notice outlining the ingredient's safety profile, including its chemical composition, intended use, manufacturing process, and supporting safety data.
Gather relevant scientific literature, historical use data, toxicology studies, and any existing safety evaluations to support your conclusion of safety.
Engage qualified experts to review the compiled data and ensure it meets FDA's scientific standards for safety assessment.
Submit the completed notification package to the FDA for their review and evaluation. This notice should include the scientific basis for the GRAS conclusion. The FDA offers guidance documents to help with the submission process.
The FDA will review the notification and issue a response letter indicating their conclusion regarding the ingredient's GRAS status.
Navigate the complex regulatory landscape with confidence and ensure your product’s safety and market readiness with GRAS Experts.
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To prepare an FDA GRAS notification, you must compile comprehensive safety data, including toxicology studies, manufacturing processes, and historical usage evidence. A scientifically sound dossier ensures your submission aligns with FDA requirements and increases the likelihood of being listed in the GRAS notice inventory. This listing demonstrates compliance and builds credibility with consumers and regulators.
The FDA typically takes 6 to 12 months to review a GRAS notification, depending on the complexity of the ingredient and the completeness of your submission. During this time, they evaluate whether the data supports the ingredient’s GRAS status and may request additional details if necessary.
No, you cannot market your ingredient as GRAS during the notification process. The FDA must first review and accept your submission, confirming it meets safety and regulatory requirements. Once the FDA provides a “no questions” letter, you can confidently market your ingredient under FDA guidelines.
If the FDA disagrees with your GRAS notification, they will provide feedback on areas requiring clarification or additional data. Addressing their concerns promptly with a revised submission ensures compliance with FDA GRAS standards. Partnering with regulatory experts can streamline this process and help refine your notification to meet expectations.
The FDA’s GRAS notice inventory is a public database listing all reviewed GRAS notices. Being included in this inventory provides official recognition of your ingredient’s safety and compliance with FDA standards. It also builds transparency, enhancing trust among consumers, retailers, and regulatory bodies.
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