The Food and Drug Administration (FDA) is responsible for ensuring that all food additives, including dietary ingredients and processing aids, are safe for use in foods. The FDA has established a process for notifying the agency of new dietary ingredients (NDIs) that are intended to be used as food additives or processing aids in the United States. This page gives a brief overview of this process, which can be confusing due to its complexity.
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!
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.
A new dietary ingredient (NDI) is a dietary ingredient that was not sold in the U.S. as a dietary supplement before October 15, 1994. NDIs are regulated by the FDA under section 413(a) of the Federal Food, Drug, and Cosmetic Act (FDCA). NDIs are not common in the U.S., but some examples include certain probiotics, dendrobium stem extract, and pomegranate extracts.
Under section 413(a)(1)(A) of FDCA (21 U.S.C.), NDI notification is required if an ingredient or product:
Examples of substances that are considered NDIs include:
Anyone who wants to use a new dietary ingredient (NDI) in food should file an NDI Notification (NDIN) to the FDA. This includes:
If you have questions about submitting an NDI notification electronically, self-affirming your notice, or other aspects of the process please visit The FDA NDI Notifications Page.
A notification is a letter to FDA that describes a new substance and its use in food. The notification must be submitted well before your company intends to use the NDI on food products, to allow the agency time to review the information and decide whether it needs additional information from you. It can take several months for FDA to respond if further details about your product are needed. The notification includes:
The FDA will review your NDI Notification and issue an NDI notification letter.
You may receive one of the following letters:
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.”
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:
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.
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