PUBLIC LAW 103-417—OCT. 25, 1994
108 STAT. 4331
"(F) Subclause (i) clause (A) does not apply to a statement
in the labeling of a dietary supplement that characterizes the
percentage level of a dietary ingredient for which the Secretary
has not established a reference daily intake, daily recommended
value, or other recommendation for daily consumption.".
(d) VITAMINS AND MINERALS. — Section 411(b)(2) (21 U.S.C.
350(b)(2)) is amended—
(1) by striking 'Vitamins or minerals" and inserting "dietary
supplement ingredients described in section 201(fO";
(2) by striking "(2)(A)" and inserting "(2)"; and
(3) by striking subparagraph (B).
(e) EFFECTIVE DATE.— D ietary supplements—
21 USC 343
(1) may be labeled after the date of the enactment of note,
this Act in accordance with the amendments made by this
section, and
(2) shall be labeled after December 31, 1996, in accordance
with such amendments.
SEC. 8. NEW DIETARY INGREDIENTS.
Chapter IV of the Federal Food, Drug, and Cosmetic Act is
amended by adding at the end the following:
" NEW DIETARY INGREDIENTS
"SEC. 413. (a) IN GENERAL.— A dietary supplement which con- 21 USC 350b.
tains a new dietary ingredient shall be deemed adulterated under
section 402(f) 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 ^icle
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 Classified
under paragraph (2) for 90 days following its receipt. After the ^formation,
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 seife. 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, United States Code, the decision of the Secretary
shall be considered final agency action.
"(c) DEFINITION. —For purposes of this section, the term 'new
dietary ingredient' means a dietary ingredient that was not mar-
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