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). 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.
In the United States (U.S.), food ingredients are considered either as a food additive or are Generally Recognized as Safe (GRAS) for explicit uses. The significant distinction between the two is the inclusion of the U.S. 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. To set up this recognition, a total update of safety should be examined.
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.
- 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 USFDA for New Dietary Ingredient Notification (NDIN) on behalf of client
- Communication and follow up with USFDA
- GRAS dossier preparation for expert panel review
- Online submission expertise with US FDA
- USA agent services
- NDIN and GRAS Safety Data information compilation and guidance
- Safety data file review
- NDIN dosage calculations expertise
- End-to-end Regulatory consultation on NDIN and GRAS applications
- Qualified team of experts with hands-on experience in NDIN and GRAS submissions