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Expanding into the U.S. ingredient market can feel overwhelming, with strict FDA rules to follow. That’s why we offer support with GRAS notices, self‑affirmed GRAS reviews, and NDI notifications. From identifying the right pathway to preparing submissions, we’re here to ease the process and help you move forward with your ingredient launch.
Launching an ingredient in the U.S. offers great opportunities but requires meeting FDA expectations. GRAS (Generally Recognized as Safe) applies to food ingredients proven safe through expert review, while NDIN (New Dietary Ingredient Notification) is needed for dietary ingredients not sold before October 15, 1994.
Both demand solid documentation and planning. With the right approach, compliance enables faster approvals, smoother market entry, and stronger trust with regulators and partners. Our team helps you meet requirements, avoid pitfalls, and move forward confidently.
The GRAS pathway reviews safety data, prepares a dossier, and includes an expert panel before FDA submission. NDIN applies to dietary ingredients not marketed before October 15, 1994 and requires a notification with identity, use, and safety data. Here’s how both processes typically flow:
Review available safety, manufacturing, and identity data, and identify what’s missing.
Draft a dossier with identity, manufacturing, safety, and evidence.
For those taking the self-affirmed GRAS pathway, independent experts evaluate the dossier.
Submit to FDA and address feedback.
Review available data including safety, manufacturing, and identity, and identify what’s missing.
Draft letter with ingredient details, intended use, and safety data.
Send before launch for review.
FDA reviews safety and intended use.
Provide clarifications or additional info.
We focus on three core ingredient compliance services that are essential when entering the U.S. market. These pathways form the foundation for proving safety, meeting FDA expectations, and moving your ingredient forward with clarity and support:
Preparation and submission of GRAS notices to the FDA, ensuring your ingredient meets safety standards for food use.
Coordination of expert panel reviews and evidence packages so safety can be established without formal FDA review.
Guidance through the FDA’s NDI notification process for dietary ingredients introduced after October 15, 1994.
Beyond the core pathways, several supporting services can help strengthen your submission and improve the chances of smooth acceptance:
We help organize safety studies through our trusted CRO network, following OECD and FDA standards.
Our team supports the drafting and publishing of scientific data to strengthen your submission.
We calculate expected intake using ADI and EDI models to support your safety justification.
We write a new dossier or review your draft dossier to ensure regulatory completeness and consistency before submission.
Yes, you can submit a GRAS Notice after self-affirming. This is often done to meet buyer or market demands.
Not always. If there is enough publicly available safety data, clinical studies may not be required. A gap assessment helps confirm this.
Panel members must be qualified in fields like toxicology, pharmacology, or food science, and must be independent from the company.
Yes, if it is used in both food and dietary supplements. Each use may require a separate assessment or submission.
Yes, if they meet the criteria for a new dietary ingredient and are used in supplements sold in the U.S.
We help identify gaps, strengthen your evidence, and resubmit to improve approval chances.
No. GRAS is a U.S.-specific regulatory path and is not automatically accepted in other markets.
Stay informed on the latest developments in GRAS and ingredient compliance. Explore blogs, webinars, and news curated specifically for this category.
Let’s make your FDA compliance journey clear and achievable. Our team is ready to support your next steps.