We are a scientific & regulatory consulting firm, providing GRAS (Generally Recognized as Safe) Independent Conclusion and FDA GRAS services.
AIBMR offers GRAS Independent Conclusions and FDA GRAS Notification services. Ingredients to be added to foods in the US require GRAS status or approval from FDA as a food additive. It is important to understand that it is the intended use of an ingredient that is GRAS, not the ingredient itself. On April 17, 1997 the FDA published the proposed GRAS rule in the Federal Register. This proposed rule was finalized in August of 2016, allowing for an Independent GRAS Conclusion process, while leaving the FDA GRAS Notification process as voluntary.
For many years, companies have engaged AIBMR to prepare both Independent GRAS Conclusions (formerly GRAS Self-Determination or Self-Affirmed GRAS) and FDA GRAS Notifications. AIBMR has coordinated many toxicological safety assessments for novel ingredients and has published the results of these studies in peer-reviewed academic journals specializing in toxicology (e.g. Regulatory Pharmacology and Toxicology, Toxicology, Journal of Agricultural and Food Technology, and Food and Chemical Toxicology).
We have an excellent expert panel well-qualified by training and experience to evaluate the safety of ingredients to be added to foods in the USA. GRAS ingredients must be reasonably certain to be safe for their intended use.
Recognition of a substance as safe requires reasonable certainty in the minds of competent scientists that the substance is not harmful when used as intended. GRAS Independent Conclusions require a complete review and assessment of the safety of the ingredient. The process of achieving GRAS requires a consensus of safety by a panel of experts who are qualified by training and expertise to evaluate the safety of food.
AIBMR’s experience, knowledge and success with GRAS services are key assets for guiding you through the process. We create a detailed, professional GRAS dossier for your product that is signed by the expert panel. The dossier includes a thorough introduction of your product, all available toxicology and safety data, extensive literature reviews and references. When appropriate, we prepare GRAS dossiers for FDA review.