§ 350b. — New dietary ingredients.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC350b]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV--FOOD
Sec. 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.
(June 25, 1938, ch. 675, Sec. 413, as added Pub. L. 103-417, Sec. 8,
Oct. 25, 1994, 108 Stat. 4331.)
Section Referred to in Other Sections
This section is referred to in section 331 of this title.
