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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Every ingredient is unique, and so is our approach. We tailor our services to your specific needs.
Safety is our top priority. We make sure your ingredients meet all the requirements.
Avoid costly delays, fines and potential product recalls with our expert guidance.
Regulations can change. We’ll keep you compliant for the long haul.
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