New Dietary Ingredient Notification (NDIN) - Overview
For companies planning to market a dietary supplement or supply a new ingredient to the United States, it is important to determine when a New Dietary Ingredient Notification (NDIN) is required and what type of information is required to support a successful notification to the United States Food and Drug Administration (USFDA). In the United States (US), food ingredients are considered either food additives or are Generally Recognized as Safe (GRAS) for explicit uses. 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 US as a dietary supplement before October 15, 1994.
In the United States (US), food ingredients are considered either as food additives or are Generally Recognized as Safe (GRAS) for explicit uses. The significant distinction between a food additive and GRAS is the inclusion of the US Food and Drug Administration (FDA), which is required for the assessment of the safety and security of food additives. There are two separate routes for getting GRAS acknowledgment: a GRAS Notification submission to the FDA and (or) a Self-GRAS Determination or Independent GRAS Determination. To set up this recognition, a total update on safety should be examined.
The Freyr Regulatory team is experienced and proficient in NDIN process requirements and supports clients in reviewing the ingredient data and compiling the required information, identifying the gaps, preparing, and submitting the notification, and responding to FDA questions post submission. Freyr also provides Regulatory assistance on GRAS notification.
New Dietary Ingredient Notification (NDIN) - Freyr Expertise
- Preliminary feasibility assessment of the new dietary ingredient.
- New dietary ingredient data review.
- Conducting literature searches and data gathering for NDIN and GRAS applications.
- Identifying technical and scientific data gaps and recommending solutions.
- Submission to US FDA for New Dietary Ingredient Notification (NDIN).
- Communication and follow-up with the US FDA.
- GRAS dossier preparation for expert panel review
- Online submission expertise with the US FDA.
- US agent support.
- New dietary ingredient notification and GRAS Safety Data information compilation and guidance.
- Safety data file review.
- NDIN dosage calculations expertise.
New Dietary Ingredient Notification (NDIN) -Freyr Advantages
- End-to-end Regulatory consultation on NDIN and GRAS applications.
- Qualified team of experts with hands-on experience in NDIN and GRAS submissions.