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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?

1. 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.
2. 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))).
3. 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)
• 
  

How can we help you with your NDNI

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.