Navigate FDA compliance with confidence through our comprehensive GRAS determination and expert panel coordination services
Achieve Generally Recognized as Safe status for your food ingredients through our proven Self-Affirmed GRAS and FDA notification pathways, backed by rigorous scientific evaluation and regulatory expertise.
GRAS (Generally Recognized as Safe) is an FDA designation that allows food ingredients to be used without premarket approval. Our services include both Self-Affirmed GRAS determinations and FDA GRAS notification submissions, providing comprehensive safety evaluations, expert panel coordination, and complete regulatory documentation to establish safety under intended use conditions.
GRAS status provides a faster, more cost-effective pathway to market compared to food additive petitions. It demonstrates safety through qualified expert consensus and published scientific evidence, enabling immediate market entry while ensuring regulatory compliance. This designation builds consumer confidence and facilitates global market expansion for innovative food ingredients.
Food manufacturers, ingredient suppliers, nutraceutical companies, and novel food developers seeking to introduce new ingredients or expand existing ingredient applications. Our services benefit companies requiring scientific justification for ingredient safety, regulatory compliance documentation, and expert validation for market entry in the United States and internationally.
Our GRAS evaluation process begins with a thorough assessment of your ingredient, intended use, and target applications. We conduct comprehensive literature reviews, analyze existing safety data, and identify any gaps that require additional studies or expert evaluation.
We coordinate qualified expert panels comprising toxicologists, food scientists, and regulatory specialists who independently review all safety evidence. Our panels follow FDA guidelines and best practices to ensure unbiased, scientifically sound conclusions that meet regulatory standards.
For Self-Affirmed GRAS determinations, we prepare complete documentation demonstrating general recognition among qualified experts. For FDA GRAS notifications, we manage the entire submission process, including agency interactions and response to FDA questions.
Our toxicological assessments include genotoxicity studies, repeat-dose toxicity evaluations, and specialized testing as required. We conduct thorough dietary exposure calculations and risk assessments to establish safe use levels and consumption patterns.
We validate manufacturing processes, establish quality specifications, and ensure consistent ingredient identity and purity. Our approach includes ongoing compliance monitoring and support for any regulatory updates or market expansion needs.
Complete GRAS Dossier - Comprehensive scientific documentation including safety data summary, use conditions, and regulatory justification
Expert Panel Opinion - Independent safety evaluation by qualified experts with detailed scientific rationale and consensus statement
Toxicological Assessment Report - Detailed analysis of safety studies, including genotoxicity, acute, and chronic toxicity evaluations
Literature Review and Analysis - Systematic review of published scientific evidence supporting ingredient safety and GRAS determination
Dietary Exposure Assessment - Comprehensive analysis of estimated daily intake, consumption patterns, and safety margins
Manufacturing and Specifications - Detailed ingredient specifications, manufacturing process validation, and quality control standards
FDA Submission Package - Complete regulatory filing for FDA GRAS notification pathway with all required documentation
Regulatory Strategy and Support - Ongoing compliance guidance, market entry strategy, and post-submission regulatory assistance
Our GRAS services strictly adhere to FDA regulatory requirements established under the Federal Food, Drug, and Cosmetic Act and implemented through 21 CFR Part 170. We ensure all determinations meet the same safety standards required for food additive approval.
For Self-Affirmed GRAS pathways, we follow FDA guidance on expert panel best practices, ensuring unbiased evaluation, appropriate expertise representation, and transparent decision-making processes that meet regulatory expectations.
Scientific evidence standards require the same quantity and quality of data as food additive approvals, based on generally available and accepted scientific methods, typically published research, and may include unpublished proprietary studies when appropriate.
Our GRAS evaluation services support diverse food ingredient categories including novel sweeteners, functional fibers, plant-based proteins, fermentation-derived ingredients, botanical extracts, and innovative food processing aids across multiple industry sectors.
Self-Affirmed GRAS pathways are ideal for ingredients with substantial safety databases, established use histories, or clear structural analogs to recognized safe substances, providing faster market entry with comprehensive expert validation.
FDA GRAS notification services benefit novel ingredients, complex formulations, or ingredients requiring enhanced regulatory confidence, providing formal FDA review and potential "no questions" letters that strengthen market position globally.
Our services extend to use expansion for existing GRAS ingredients, supporting new applications, increased use levels, or different food categories while maintaining regulatory compliance and safety documentation.
Achieving GRAS status requires specialized expertise, rigorous scientific evaluation, and deep understanding of FDA regulatory requirements. Indivirtus Healthcare Services combines extensive regulatory experience with comprehensive safety assessment capabilities to deliver successful GRAS outcomes.
Our proven track record includes successful Self-Affirmed GRAS determinations and FDA GRAS notifications across diverse ingredient categories, supported by qualified expert networks, advanced toxicological assessment capabilities, and strategic regulatory guidance.
From initial feasibility assessment through final regulatory approval, our team provides end-to-end support ensuring your ingredients achieve GRAS status efficiently while meeting the highest scientific and regulatory standards for market success.
Self-Affirmed GRAS allows companies to independently determine GRAS status through expert panel evaluation without FDA notification, typically taking 6-9 months. FDA GRAS notification involves submitting the determination to FDA for review, taking 12-18 months but providing formal agency acknowledgment.
GRAS determination typically requires toxicological studies including genotoxicity assays (Ames test, chromosomal aberration), acute and subchronic toxicity studies, literature reviews, dietary exposure assessments, and manufacturing specifications. Requirements vary based on ingredient type and intended use.
Self-Affirmed GRAS typically takes 6-9 months from initiation to completion. FDA GRAS notification process takes 12-18 months including preparation (3-6 months), FDA filing and review (6-12 months), and potential follow-up communications. Timeline depends on data availability and complexity.
GRAS expert panel members must be qualified scientists with relevant expertise in toxicology, food science, or related fields. They should be independent from the sponsor, have appropriate credentials and experience, and follow FDA guidance for conflict of interest and bias management.