Note that as of October 19, 2019, notifications are not being accepted via the FURLS portal. All notifications are now submitted in COSM. So, submitting notifications (timeframe, format, and method submission) is complex. The occurrence of misinterpreting the Regulatory requirements will result in a product recall. When you partner with us, we will help you:
- Ensure whether your ingredient is a New Dietary Ingredient
- Analyze documentation gaps and point out if any other data is required
- Complete a full dossier for a New Dietary Ingredient Notification (NDIN)
- Prepare and request an FDA pre-submission meeting
Apart from this, our experts will also help you understand the NDIN process and timeline. You will be able to meet requirements for notification to the FDA, including which documents are to be submitted. You will also become familiar with the submission modes and post-submission NDIN process.
NDI notifications are required for all substances that are not generally recognized as safe (GRAS). Once you have submitted an NDI Notification, the FDA has 180 days (e.g., six months) to make a determination on whether the notification is complete and meets all of the criteria. If it does, then your ingredient can be used in supplements and foods without prior approval from the agency. Click here for more on food clarification of GRAS & NDI Ingredients.