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CFSAN/Office of Nutritional Products, Labeling, and Dietary Supplements
April 2005
Guidance for Industry
Chapter VII. Premarket Notification of New Dietary Ingredients
Contains Nonbinding Recommendations.
Questions
- What is a new dietary ingredient?
- Is premarket notification required for new
dietary ingredients?
- Are there regulations about premarket notification
for new dietary ingredients?
- Where do I submit my new dietary ingredient
premarket notification?
- What information must I include in my premarket
notification for a new dietary ingredient?
- What does FDA do with my premarket notification
for a new dietary ingredient?
- What happens if I submit additional information?
- Will FDA maintain the confidentiality of my
premarket notification for a new dietary ingredient?
- 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
- 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)
- 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)
- 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
- 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)
- 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:
- the level of the new dietary ingredient in the dietary supplement;
and
- 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)
- 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)
- 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)
- 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 90th 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)
- 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)
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