What are new dietary ingredients?

New dietary ingredients (NDIs) are ingredients that had not been used in dietary supplements before October 15, 1994. These ingredients can include botanicals, vitamins, minerals, amino acids, and other substances. NDIs are often used in dietary supplements to provide health benefits, but they can also pose potential risks to consumers if they are not properly regulated. The FDA has established guidelines for the safety and labeling of NDIs in dietary supplements to ensure that consumers are protected.

How are new dietary ingredients regulated?

The FDA regulates new dietary ingredients (NDIs) in dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under DSHEA, manufacturers are responsible for ensuring the safety of their products and providing accurate labeling information. The FDA can take action against manufacturers if they fail to comply with these regulations, including removing products from the market or taking legal action. Additionally, the FDA has established a pre-market notification process for NDIs, which requires manufacturers to provide safety information to the agency before introducing a new ingredient into the market.

What is the process for introducing a new dietary ingredient?

The process for introducing a new dietary ingredient (NDI) involves submitting a pre-market notification to the FDA. This notification must include information about the safety of the ingredient, including any potential adverse effects. The FDA then has 75 days to review the notification and determine whether the ingredient is safe for use in dietary supplements. If the FDA determines that the ingredient is not safe, it can take action to remove the product from the market or take legal action against the manufacturer. It is important for manufacturers to ensure that their NDIs are safe and comply with FDA regulations to avoid any potential legal or financial consequences.

What are the safety considerations for new dietary ingredients?

Safety is a top priority when it comes to introducing new dietary ingredients. Manufacturers must conduct thorough safety assessments and provide evidence that the ingredient is safe for use in dietary supplements. This includes evaluating potential adverse effects, determining safe levels of use, and ensuring that the ingredient does not interact negatively with other ingredients or medications. It is also important for manufacturers to monitor the safety of their products after they are on the market and report any adverse events to the FDA. Failure to comply with safety regulations can result in legal and financial consequences for manufacturers.

How can consumers make informed choices about products containing new dietary ingredients?

Consumers can make informed choices about products containing new dietary ingredients by doing their research and reading labels carefully. Look for products that have been tested for safety and efficacy, and that have been approved by regulatory agencies like the FDA. It’s also important to talk to your healthcare provider before starting any new dietary supplement, especially if you have a pre-existing medical condition or are taking other medications. Your healthcare provider can help you determine if a particular supplement is safe and appropriate for you.

New Dietary Ingredient Notification (NDIN)

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!

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 supplement before 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:

They must have been present in the food supply and should not be chemically altered.
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.

What is NDI?

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:

Contains a dietary substance for which there is no history of consumption OR
Has been present in traditional food consumed by large populations outside the United States OR
Is significantly derived from a plant/animal source with no history of consumption as a food OR
May be chemically synthesized or derived from naturally occurring substances

What constitutes a new dietary ingredient?

Something that was not marketed in the United States before October 15, 1994, is considered an NDI. This date was chosen because it was the date by which manufacturers should have been able to submit their first notifications to the FDA with information about the safety and nutritional value of their new ingredient.
A dietary ingredient for which there is no history of use or other evidence of safety sufficient to establish general recognition of safety by qualified experts under conditions prescribed or recommended in its proposed labeling (section 201(s) (21 U.S.C., § 321(s))).
A substance from botanicals, vitamins, minerals, or amino acids that have not been frequently consumed as part of an unprocessed diet; this includes ingredients derived from algae such as DHA and EPA found in fish oil supplements.

What are some examples of substances that are considered NDIs?

Examples of substances that are considered NDIs include:

- Food additives, such as coloring agents and preservatives
- Vitamins and minerals
- Botanicals, such as carotene (a precursor to vitamin A), folic acid (a B vitamin), probiotics, aminos acids, protein concentrates, natural and artificial flavors/flavors enhancers
- Dietary fiber and polyols (e.g., sorbitol)

Who needs an NDI Notification (NDIN)?

Anyone who wants to use a new dietary ingredient (NDI) in food should file an NDI Notification (NDIN) to the FDA. This includes:

Manufacturers, importers, packagers, processors, and distributors of foods that contain NDIs
Dietary supplement manufacturers or distributors (not required for dietary supplements)
Food ingredients that were marketed prior to January 1, 1997, that are not generally recognized as safe (GRAS). Some of these may be exempt from filing an NDIN under certain circumstances; check the FDA website for more information on filing exemptions. The agency has posted guidance materials on its website.

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.

The NDI Notification Process

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:

Information about the new ingredient (e.g., what it is made of and how much of it will be used)
Information about who manufactured or imported the ingredient (manufacturer, distributor, and importer)
How much of each type of food might contain this ingredient

What happens after the NDI notification is submitted?

The FDA will review your NDI Notification and issue an NDI notification letter.

You may receive one of the following letters:

Letter of No Objection: This means that the FDA has no objections to your product’s being marketed in its current form. You can begin marketing your product immediately (assuming there are no other restrictions or requirements).
Letter of Objection: This means that the FDA does have objections to some aspect(s) of how you plan to market your product, but not necessarily to all aspects. For example, it might object only if you intend for this ingredient/product to be used in a way not authorized by law; however, it would not object if you were selling it as an herb or dietary supplement with a label claim such as “supports immune health.” In this case, you would need to comply with any requests made by the agency regarding how this ingredient/product must be labeled and advertised before they would allow its marketing without further objections raised by them first (if ever).

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.”

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.

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.

New Dietary Ingredient Notification (NDIN)

New Dietary Ingredient (NDI)

New Dietary Ingredient Notification (NDIN)

What is NDI?

Who needs an NDI Notification (NDIN)?

The NDI Notification Process

What happens after the NDI notification is submitted?

Why the Need for An NDIN Consultant?

Changes in the NDIN Submission Process

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