How to Submit Notifications for a New Dietary Ingredient
Announcement: FDA invites comment on a new form it is developing, Form FDA 3880 - Electronic New Dietary Ingredient Notification (NDIN) Submission, that allows manufacturers and distributors to electronically submit premarket notifications of new dietary ingredients electronically. This electronic form could be used in lieu of submitting the same notification as a hard copy. View more information and provide us with your comments on Draft Form FDA 3880 - Electronic New Dietary Ingredient Notification (NDIN) Submission.
What information must the notification contain?
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.
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 an more information on these notifications.You can find the regulations at http://www.cfsan.fda.gov/~lrd/cfr190-6.html
Where do I send my premarket notification and who can I contact at FDA, if I have questions?
Division of Standards and Labeling Regulations
Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-820)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD, 20740-3835
Telephone Number: (240) 402-2371