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
- What Must You Submit
- Electronic Submissions
- Information Needed for a Catch-up New Dietary Ingredient Submission (CND)
- Written Submissions
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.
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 more information on these notifications.
FDA provides an ePortal (COSM) for electronic submissions.
On May 19, 2022, FDA announced the availability of a draft guidance for industry entitled “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” The purpose of the temporary enforcement discretion policy outlined in the draft guidance is to encourage manufacturers and distributors of NDI-containing dietary supplements to correct any past failures to submit a required NDI notification.
FDA is developing a new submission type in COSM called a “Catch-up New Dietary Ingredient Submission” (CND) that will be used for late notifications submitted under the temporary enforcement policy if the draft guidance is finalized. The CND will contain three new fields that do not appear in a standard NDI notification.
If the draft guidance is finalized, interested persons will be asked to complete the three new fields in the CND if they would like their late notifications to be considered under FDA’s temporary enforcement discretion policy. If a manufacturer or distributor submits a late notification without completing all three new fields, FDA intends to review the notification under the standard NDI notification procedures in 21 CFR 190.6.
IMPORTANT NOTICE REGARDING WRITTEN SUBMISSIONS: Due to the pandemic, there may be a delay in receiving and processing written submissions. We recommend submitting a new dietary ingredient notification (NDIN) electronically, if possible. If you send a written submission, please follow-up with an email including the subject line -- Written Submission -- to NDITEAM@fda.hhs.gov. Failure to follow these processes may add to further delays in receiving and processing your written submission.
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 the Office of Dietary Supplement Programs by email at NDIN@fda.hhs.gov
To reach FDA’s Food and Cosmetics Information Center, call: 1-888-SAFEFOOD (1-888-723-3366)