New Dietary Ingredient Notification (NDIN)

Expert advice on New Dietary Ingredient, full dossier preparation for New Dietary Ingredient Notification and quick support for FDA pre-submission meetings and responding to FDA questions!

New Dietary Ingredient (NDI)

FD & C Act defines New Dietary Ingredients (NDIs) as ingredients that were not marketed in US in a dietary supplement before October 15, 1994. Any manufacturer or distributor tending to market dietary supplements with ‘New Dietary Ingredients’ (NDI) in US, must submit a notification about these ingredients to FDA.
NDI Requirements - A new dietary ingredient must adhere to two requirements:
  1. They must have been present in the food supply and should not be chemically altered.
  2. The source of evidence (history of use or safety evidence) includes published articles, scientific literature. Other forms of evidence may be accepted by the FDA.

New Dietary Ingredient Notification (NDIN) Submission

If you are planning to launch your product containing NDI for commercial circulation in US, you need to submit the premarket New Dietary Ingredient Notification (NDIN) application to FDA.

  • The application is submitted at least 75 days before the proposed date of the NDI introduction to the market.
  • Your NDIN application must contain the information that proves the safety of an NDI
New Dietary Ingredient Notification (NDIN) Submission

Why the Need for An NDIN Consultant

The notification process is quite lengthy and the new revisions drafted in the 2016 guidance made the paperwork even more complex and confusing. Therefore, along with basic knowledge of NDIN, you must be aware of the view of FDA on NDIN over time, criteria to choose NDIN over GRAS and regulatory analysis of the Food Ingredients under the DSHEA 1994.

new dietary ingredient ndi notification

Changes in the NDIN Submission Process

Note that as of October 19, 2019, notifications are not being accepted via the FURLS portal. All notifications are not 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 gap and point out if any other data required
  • Complete a full dossier for a New Dietary Ingredient Notification (NDIN)
  • Prepare and request an FDA pre-submission meeting

Apart from these, our experts will also help you understand NDIN: Process, Approval and Timeline. You will be able to meet Notification to the FDA and submission requirements, understand the timeline and know the documents to be submitted, be familiar with the submission modes and Post-submission NDIN process.

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