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Submitting a New Dietary Ingredient Notification (NDIN) to the FDA can be complex and time-sensitive. Our regulatory specialists guide you through every stage of the NDIN submission process, from data preparation to FDA communication, ensuring your dietary ingredient meets all safety and compliance expectations.
Before marketing a dietary ingredient in the U.S., companies must notify the FDA at least 75 days before introducing it into commerce. A strong NDIN dossier demonstrates that your ingredient is safe for its intended use, helping you avoid costly rejections or enforcement actions.
At Quality Smart Solutions, we simplify this process with end-to-end support — from confirming eligibility to managing the full submission. We help you move confidently through FDA expectations, timelines, and documentation.
Our step-by-step process ensures your dossier is complete, compliant, and ready for FDA review.
Determine whether your ingredient qualifies as a new dietary ingredient (NDI) or falls under another FDA pathway.
Review available data, identify missing safety studies, and plan any additional testing.
Evaluate toxicology, manufacturing, and usage data to support safety conclusions.
Compile scientific summaries, safety narratives, and manufacturing information following FDA format.
Submit the NDIN dossier and act as your liaison with FDA reviewers throughout the process.
Support you in answering FDA inquiries, providing clarifications, or updating submissions as needed.
Advise on next steps after FDA response to ensure smooth commercialization.
Understanding these factors early can help ensure your NDIN submission is compliant and well-supported before you contact the FDA:
Confidentiality
Unlike GRAS Notices, NDIN submissions can remain confidential, protecting proprietary information.
FDA Requirement
FDA review is mandatory. A response must be received before your product can be marketed.
Timing
Submissions must be made at least 75 days before marketing. Delays may occur if FDA requests additional data.
Strategy Tip
A well-prepared dossier minimizes questions and prevents review delays.
Yes, if used in both food and dietary supplements. Each use may require a separate submission.
If no objections are raised, the ingredient can be marketed as planned unless FDA follows up afterward.
Yes, as long as it is relevant, current, and applicable to the new intended use.
Yes, if they meet the criteria for a new dietary ingredient sold in the U.S.
Optional but beneficial, especially for complex cases or novel ingredients, to align expectations and minimize review delays.