Science-based FDA regulatory consulting with over 20 years of food, animal feed, and dietary ingredient expertise
Rigorous Science, Expert Guidance, Strong History of FDA Regulatory Success
GRASroots Consulting™ partners with companies worldwide to achieve U.S. regulatory approval for food, dietary supplement, cosmetic, pet food, and animal feed ingredients. With more than four decades of combined scientific and regulatory experience, we guide clients through Generally Recognized as Safe (GRAS) conclusions, New Dietary Ingredient (NDI) notifications, and related U.S. FDA regulatory pathways.
Since 2006, our team members have maintained a near-100% success rate in obtaining FDA “no questions” letters for GRAS notices. We combine scientific expertise with a proven regulatory strategy to help you bring innovation to market—efficiently, responsibly, and with confidence.
Services
Prepare Feasibility (Gap) Assessments, Independent GRAS Conclusions (“self GRAS”), FDA GRAS Notices (GRNs), New Dietary Ingredient (NDI) notifications, supplements, and amendments
Support and participate in FDA Pre-Notification Meetings
Serve as independent Expert Panel Members for GRAS determinations
Conduct thorough, science-based safety assessments and risk evaluations
Develop exposure estimates (individually or as part of larger projects) tailored to intended use(s) and population
Toxicology study design, monitoring, and manuscript publication to meet regulatory requirements
Support regulatory strategies for food, dietary supplement, cosmetic, and pet food ingredients
How We Work
Our objective is to understand and help your company reach its goals. For us, clients come first. We value prompt communication, understand your timelines, and believe in long-term, professional partnerships. We work with start-ups through global enterprises, offering practical, science-driven guidance grounded in the highest ethical, safety, and regulatory standards.
We stay ahead of the constantly evolving regulatory landscape, ensuring your ingredients have the best chance of success—today and in the future.
Summing It Up
GRASroots Consulting™ is your trusted partner in navigating U.S. regulatory requirements and bringing safe, innovative ingredients to market.