On September 23, 1997, FDA published in the Federal Register a final rule that established regulations that you must follow when you make a premarket new dietary ingredient notification (NDIN). The regulations are codified at 21 CFR §190.6.
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:
- level of the new dietary ingredient in the product;
- conditions of use of the product stated in the labeling or if no conditions of use are stated, the ordinary conditions of use; and
- 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.
- Any reference to published materials must be accompanied by reprints or photostatic copies.
- Any material in a foreign language must be accompanied by a translation.
- A signature by a person designated by you who can be contacted if we have questions.
See New Dietary Ingredients in Dietary Supplements - Background for Industry for an more information on these notifications.
FDA provides an ePortal for electronic submissions.
Send written submissions to:
Office of Dietary Supplement Programs (HFS-810)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740-3835
Contact FDA by phone at (240) 402-2375 or by email at ODSP@fda.hhs.gov.