Explore Our Services

We offer flexible, expert support and opinions on an hourly basis across a wide range of regulatory and scientific topics, from strategic planning through active problem-solving.

We gather key information from your company and relevant publicly available scientific literature to evaluate the regulatory viability of your ingredient. We then provide a clear, independent assessment and a practical path forward, including options to address any identified data gaps.

More extensive projects—such as GRAS conclusions (Self-Affirmed GRAS), FDA GRAS Notifications (GRNs), Animal Feed GRAS , and New Dietary Ingredient (NDI) notifications—typically require preparation of a comprehensive ingredient safety assessment dossier. These projects are generally offered on a flat-fee basis, allowing for predictable budgeting without unexpected costs. We take a business-friendly approach, working closely with you to understand your objectives and to develop proven, effective strategies that resonate with senior management and potential investors.

GRASroots Consulting™ provides Expert Panel services to support GRAS conclusions, backed by 40+ years of combined experience in GRAS determinations and successful FDA GRAS Notices. Our toxicology and regulatory expertise meets FDA expectations while instilling confidence across internal leadership and customers alike.

Our team has decades of experience serving on GRAS Expert Panels and is recognized for being organized, science-driven, collaborative, and aligned with FDA’s review standards—serving clients ranging from startups to multinational companies.

A key component of any GRAS conclusion is a scientifically valid estimation of dietary exposure, often at the 50th and 90th percentiles. Such exposure levels must be reasonably certain to be safe in order to meet the GRAS standard.

We routinely prepare exposure assessments for Part 3 of GRAS Conclusions and FDA GRNs or as standalone deliverables on an as needed basis. Exposure estimates are made using science-based probabilistic modeling to predict consumer exposure.

Compliance with Federal Trade Commission (FTC) and FDA requirements is essential to protecting your company from potential liability. When approached strategically, compliance becomes a foundation for success in the marketplace—not a hindrance or obstacle.

Claim substantiation requires careful evaluation of the scientific evidence supporting product claims, a process that can be complex and time-intensive. We help develop efficient, cost-effective substantiation strategies tailored to your goals, timelines, and risk tolerance.

Our team of toxicologists has extensive experience designing, overseeing, and publishing tox studies that meet the requirements of major international regulatory authorities, supporting GRAS Self-affirmations, FDA GRAS Notifications, EFSA Novel Food applications, and other related regulatory submissions.

Our team has a nearly 100% success rate with FDA GRAS Notices. We work well with, and have a strong mutually respectful relationship with FDA’s Human Foods Program.

Through extensive experience organizing and leading GRN) pre-notification meetings, we have developed a strong understanding of FDA’s perspective and review priorities—experience that translates into FDA Notices that are strategically prepared for the greatest chance of success.