Application for NDIN in the US
What is a "new dietary ingredient?"
The term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994.
There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors (you) are responsible for determining if an ingredient is a "new dietary ingredient" and, if not, for documenting either that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994, or that the dietary ingredient was marketed for use in dietary supplements before that date.
When Must You Submit a New Dietary Ingredient Notification
If you plan to market a dietary supplement that contains a new dietary ingredient, you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.
What Must You Submit
FDA regulations require that you submit an original and two (2) copies of the notification and all of its attachments. You must also provide in the notification:
* Your name and complete address.
* The name of the new dietary ingredient. If the new dietary ingredient is an herb or other botanical, you must include the Latin binomial name (including the author).
* A description of the dietary supplement or dietary supplements that contain the new dietary ingredient, including the:
* History of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will be reasonably be expected to be safe.
* A signature by a person designated by you who can be contacted if we have questions.
How long dose it generally take to make the notification of NDIN?
In general, it takes 1-3 years to complete a notification for NDIN in the US.
* Feasibility Study
* Pre-market Notification
* Testing Service
* Other Customized Services