[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR190.6]
 
[Page 571-572]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                          SERVICES (CONTINUED)
 
PART 190--DIETARY SUPPLEMENTS--Table of Contents
 
             Subpart B--New Dietary Ingredient Notification
 
Sec. 190.6  Requirement for premarket notification.
 
 
    (a) At least 75 days before introducing or delivering for
introduction into interstate commerce a dietary supplement that contains
a new dietary ingredient that has not been present in the food supply as
an article used for food in a form in which the food has not been
chemically altered, the manufacturer or distributor of that supplement,
or of the new dietary ingredient, shall submit to the Office of
Nutritional Products, Labeling and Dietary Supplements (HFS-820), Center
for Food Safety and Applied Nutrition, Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, information including
any citation to published articles that is the basis on which the
manufacturer or distributor has concluded that a dietary supplement
containing such dietary ingredient will reasonably be expected to be
safe. An original and two copies of this notification shall be
submitted.
    (b) The notification required by paragraph (a) of this section shall
include:
    (1) The name and complete address of the manufacturer or distributor
of the dietary supplement that contains a new dietary ingredient, or of
the new dietary ingredient;
    (2) 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;
    (3) A description of the dietary supplement or dietary supplements
that contain the new dietary ingredient including:
    (i) The level of the new dietary ingredient in the dietary
supplement; and
    (ii) 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;
    (4) The history of use or other evidence of safety establishing that
the dietary ingredient, when used under
 
[[Page 572]]
 
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 the distributor or manufacturer of the dietary supplement that
contains the new dietary ingredient has concluded that the new dietary
supplement will reasonably be expected to be safe. Any reference to
published information offered in support of the notification shall be
accompanied by reprints or photostatic copies of such references. If any
part of the material submitted is in a foreign language, it shall be
accompanied by an accurate and complete English translation; and
    (5) The signature of the person designated by the manufacturer or
distributor of the dietary supplement that contains a new dietary
ingredient.
    (c) FDA will acknowledge its receipt of a notification made under
section 413 of the Federal Food, Drug, and Cosmetic Act (the act) and
will notify the submitter of the date of receipt of such a notification.
The date that the agency receives the notification submitted under
paragraph (a) of this section is the filing date for the notification.
For 75 days after the filing date, the manufacturer or distributor of a
dietary supplement that contains a new dietary ingredient shall not
introduce, or deliver for introduction, into interstate commerce the
dietary supplement that contains the new dietary ingredient.
    (d) If the manufacturer or distributor of a dietary supplement that
contains a new dietary ingredient, or of the new dietary ingredient,
provides additional information in support of the new dietary ingredient
notification, the agency will review all submissions pertaining to that
notification, including responses made to inquiries from the agency, to
determine whether they are substantive and whether they require that the
75-day period be reset. If the agency determines that the new submission
is a substantive amendment, FDA will assign a new filing date. FDA will
acknowledge receipt of the additional information and, when applicable,
notify the manufacturer of the new filing date, which is the date of
receipt by FDA of the information that constitutes the substantive
amendment.
    (e) FDA will not disclose the existence of, or the information
contained in, the new dietary ingredient notification for 90 days after
the filing date of the notification. After the 90th day, all information
in the notification will be placed on public display, except for any
information that is trade secret or otherwise confidential commercial
information.
    (f) Failure of the agency to respond to a 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.
 
[62 FR 49891, Sept. 23, 1997, as amended at 66 FR 17359, Mar. 30, 2001]