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A New Dietary Ingredient Notification (NDIN) is a notification that must be submitted to the FDA for a dietary ingredient that was not marketed in the U.S. as a dietary supplement before October 15, 1994.
Bringing a new dietary ingredient (NDI) to market but are unsure if this pathway is right for you? Consider the following questions:
- Would the FDA consider your ingredient new/novel?
- Does the ingredient qualify as a dietary ingredient?
- Does your ingredient need an NDIN?
Unsure where your ingredient fits? Connect with our experts to obtain a feasibility and gap assessment to determine what pathway is the best fit for your ingredient.
Our team provides:
- Expert Guidance: Our team of regulatory specialists will assist you in navigating the complexities of NDI regulations, ensuring your product complies.
- Regulatory Strategy: Our team of experts advises on the most appropriate regulatory pathway to achieve your company goals.
- Comprehensive Support: From ingredient safety documentation to NDI Notification preparation, we cover every aspect of your product’s regulatory needs.
Our regulatory team is well-versed in NDIN requirements and assists clients in compiling the required information, preparing and submitting the notification, and responding to FDA questions along the way. We will help you prepare and submit your NDIN to an exceptional degree of quality.
Ensure your product meets regulatory requirements and stands out in a competitive industry with our expert NDI Services.
Learn how we can help you fulfill the regulatory requirements for your NDI.
