Dietary Supplement Labeling Guide: Chapter VII. Premarket Notification of New Dietary Ingredients

April 2005

Contains Nonbinding Recommendations

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Questions

1. What is a new dietary ingredient?
2. Is premarket notification required for new dietary ingredients?
3. Are there regulations about premarket notification for new dietary ingredients?
4. Where do I submit my new dietary ingredient premarket notification?
5. What information must I include in my premarket notification for a new dietary ingredient?
6. What does FDA do with my premarket notification for a new dietary ingredient?
7. What happens if I submit additional information?
8. Will FDA maintain the confidentiality of my premarket notification for a new dietary ingredient?
9. Is no response from FDA to a new dietary ingredient premarket notification an indication that FDA finds that the product is safe and not adulterated?

Answers

1. What is a new dietary ingredient?

   A new dietary ingredient is a dietary ingredient that was not marketed in the United States before October 15, 1994, and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.

   21 U.S.C. 350b(c)

2. Is premarket notification required for new dietary ingredients?

   Yes. The manufacturer or distributor of a new dietary ingredient or of a dietary supplement that contains a new dietary ingredient must submit a notification to FDA at least 75 days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains the new dietary ingredient.

   21 U.S.C. 305b(a)

3. Are there regulations about premarket notification for new dietary ingredients?

   Yes. FDA has issued regulations on premarket notification for new dietary ingredients in 21 CFR 190.6.

   21 CFR 190.6

4. Where do I submit my new dietary ingredient premarket notification?

   You must send the premarket notification to the Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835. You must submit the original and two copies of the document.

   21 CFR 190.6(a)

5. What information must I include in my premarket notification for a new dietary ingredient?

   You must submit the following information:

   • The name and complete address of the manufacturer or distributor of a dietary supplement that contains the new dietary ingredient, or of the new dietary ingredient;
   • The name of the new dietary ingredient that is the subject of the premarket notification, including the Latin binomial name (including the author) of any herb or other botanical;
   • A description of the dietary supplement or dietary supplements that will contain the new dietary ingredient including:
     1. the level of the new dietary ingredient in the dietary supplement; and
     2. the conditions of use recommended or suggested in the labeling of the dietary supplement, or if no conditions of use are recommended or suggested in the labeling of the dietary supplement, the ordinary conditions of use of the supplement;
   • 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 reasonably be expected to be safe, including any citation to published articles or other evidence that is the basis on which you have concluded that the new dietary supplement will reasonably be expected to be safe. You must submit reprints or photostatic copies of published information that you reference in support of the notification material. You must submit an accurate and complete English translation of any material you submit in a foreign language; and
   • Your signature, or that of a person you designate.

   21 CFR 190.6(b)

6. What does FDA do with my premarket notification for a new dietary ingredient?

   FDA will acknowledge its receipt of a notification made under section 413 of the act and will notify you of the date of receipt of such a notification. The date that the agency receives the notification is the filing date for the notification. For 75 days after the filing date, you must not introduce, or deliver for introduction, into interstate commerce any dietary supplement that contains the new dietary ingredient.

   21 CFR 190.6(c)

7. What happens if I submit additional information?

   If you provide additional information, including responses you make to inquiries from the agency, in support of your new dietary ingredient notification, the agency will review the information to determine whether it is substantive. If the agency determines that the new submission is a substantive amendment, the agency will designate the date of its receipt by FDA as the new filing date. FDA will acknowledge receipt of the additional information and, when applicable, will notify you of the new filing date, which restarts the 75-day period.

   21 CFR 190.6(d)

8. Will FDA maintain the confidentiality of my premarket notification for a new dietary ingredient?

   FDA will not disclose the existence of, or the information contained in, a new dietary ingredient notification for 90 days after the filing date of the notification. After the 90^th day, FDA will place all information in the notification on public display, except for any information that is trade secret or otherwise confidential commercial information.

   21 CFR 190.6(e)

9. Is no response from FDA to a new dietary ingredient premarket notification an indication that the FDA finds that the product is safe and not adulterated?

   No. Failure of the agency to respond to your notification does not constitute a finding by the agency that the new dietary ingredient or the dietary supplement that contains the new dietary ingredient is safe or is not adulterated under section 402 of the act (21 U.S.C. 342).

   21 CFR 190.6(f)