New Dietary Ingredient Notification (NDIN)

We provide expert advice on New Dietary Ingredients, full dossier preparation for New Dietary Ingredient Notifications and quick support for FDA pre-submission meetings and responding to FDA questions!

New Dietary Ingredient (NDI)

The FD & C Act defines New Dietary Ingredients (NDIs) as ingredients that were not marketed in the US in a dietary supplementbefore October 15, 1994. Any manufacturer or distributor tending to market dietary supplements with ‘New Dietary Ingredients’ (NDI) in the US, must submit a notification about these ingredients to the 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)

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

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

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 FDA’s view on NDINs over time, criteria to choose NDIN over GRAS and regulatory analysis of the Food Ingredients under the DSHEA 1994.”

New Dietary Ingredient 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 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.

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