21 U.S.C. § 350b : US Code - Section 350B: New dietary ingredients

Search 21 U.S.C. § 350b : US Code - Section 350B: New dietary ingredients

(a) In general
A dietary supplement which contains a new dietary ingredient
shall be deemed adulterated under section 342(f) of this title
unless it meets one of the following requirements:
(1) The dietary supplement contains only dietary ingredients
which have been present in the food supply as an article used for
food in a form in which the food has not been chemically altered.
(2) There is a 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 and, at
least 75 days before being introduced or delivered for
introduction into interstate commerce, the manufacturer or
distributor of the dietary ingredient or dietary supplement
provides the Secretary with information, including any citation
to published articles, which 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.
The Secretary shall keep confidential any information provided
under paragraph (2) for 90 days following its receipt. After the
expiration of such 90 days, the Secretary shall place such
information on public display, except matters in the information
which are trade secrets or otherwise confidential, commercial
information.
(b) Petition
Any person may file with the Secretary a petition proposing the
issuance of an order prescribing the conditions under which a new
dietary ingredient under its intended conditions of use will
reasonably be expected to be safe. The Secretary shall make a
decision on such petition within 180 days of the date the petition
is filed with the Secretary. For purposes of chapter 7 of title 5,
the decision of the Secretary shall be considered final agency
action.
(c) "New dietary ingredient" defined
For purposes of this section, the term "new dietary ingredient"
means 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.