[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR190.6]

[Page 598-599]
 
                        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 599]]

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]

                        PARTS 191	199 [RESERVED]