(8) in paragraph (r)(1)(B), by inserting ‘‘or any
dietary supplement’’ after ‘‘food’’ and by striking
out ‘‘or (5)(D)’’,
(9) in paragraph (r)(3)(A)(ii), by inserting ‘‘or
dietary supplement’’ after ‘‘food’’ each place it oc-
curs and by inserting ‘‘or dietary ingredient’’ after
‘‘nutrient’’,
(10) in paragraph (r)(3)(B)(ii)(I), by inserting
‘‘or dietary supplements’’ after ‘‘food’’ and by insert-
ing ‘‘or dietary ingredient’’ after ‘‘(q)(2)’’,
(11) in paragraph (r)(3)(B)(ii)(II), by inserting
‘‘or dietary ingredient’’ after ‘‘nutrient’’,
(12) in paragraph (r)(5), by striking out clause
(D), and
(13) by adding at the end the following:
‘‘(s) If it is a dietary supplement, unless its label and
labeling contain the date after which it should no longer
be consumed as prescribed by the Secretary by regulation.
‘‘(t) If it is a dietary supplement, unless its label and
labeling contain, where appropriate, a statement regarding
possible adverse effects as prescribed by the Secretary by
regulation. Such a statement shall indicate the level, if
any, at which a dietary supplement can cause adverse ef-
fects and the specific nature of any adverse effects and
shall identify segments of the population, including the el-
derly and children, that may be affected.’’.
SEC. 6. SAFETY PROVISIONS AND NOTIFICATION REQUIRE-
MENTS FOR DIETARY INGREDIENTS.
Subchapter IV of chapter 4 is amended by adding
at the end the following:
‘‘DIETARY INGREDIENTS SAFETY
‘‘SEC. 413. (a) A dietary ingredient shall, with re-
spect to any particular or intended use of such ingredient,
be deemed unsafe for the purposes of section 402(f) un-
less—
‘‘(1) there is in effect, and it and its use or in-
tended use are in conformity with, a regulation is-
sued under this section prescribing the conditions
under which such dietary ingredient may be safely
used,
‘‘(2) such ingredient is generally recognized,
among experts qualified by adequate training and
experience to evaluate its safety, as having been ade-
quately shown through scientific procedures to be
safe under the conditions of its intended use, or
‘‘(3) in the case of a dietary ingredient in use
in a dietary supplement before August 5, 1993, it
has been adequately shown, through either scientific
procedures or experience based on common use in a
dietary supplement, to be safe under the conditions
of its intended use pending completion of the review
required by subsection (f).
‘‘(b) Any person may with respect to any intended
use of a dietary ingredient file with the Secretary a peti-
tion proposing the issuance of a regulation prescribing the
conditions under which such ingredient may be safely
used. The Secretary shall by regulation establish require-
ments for petitions submitted under this subsection.
‘‘(c) The Secretary shall by order—
‘‘(1) establish a regulation (whether or not in
accord with the regulation proposed by the peti-
tioner) prescribing, with respect to one or more pro-
posed uses of the dietary ingredient involved, the
conditions under which such ingredient may be safe-
ly used, including specifications as to the—
‘‘(A) particular dietary supplement or
classes of dietary supplements in which such in-
gredient may be used,
‘‘(B) the maximum quantity which may be
used or permitted in the dietary supplement,
‘‘(C) the manner in which such ingredient
may be added to or used in the dietary supple-
ment, and
‘‘(D) any directions or other labeling or
packaging requirements for such ingredient
deemed necessary by the Secretary to assure
the safety of its use, and
notify the petitioner of such order and the reasons
for it, or
‘‘(2) deny the petition and notify the petitioner
of such order and the reasons for it.
‘‘(d) The Secretary may at any time, upon the Sec-
retary’s own initiative, propose the issuance of a regula-
tion prescribing, with respect to any particular use of a
dietary ingredient, the conditions under which such ingre-
dient may be safely used and the reasons therefor.
‘‘(e) Each person who proposes to begin the introduc-
tion or delivery into interstate commerce of a dietary in-
gredient that it determines to be subject to subsection
(a)(2) shall, at least 90 days before making such introduc-
tion or delivery, notify the Secretary, in such form and
manner as the Secretary shall by regulation prescribe, of
such introduction or delivery.
‘‘(f) The Secretary shall commence a safety review
of those dietary ingredients subject to subsection (a)(3)
within 60 days of the date of the enactment of this
section.’’.
‘‘NOTIFICATION
‘‘SEC. 414. If the manufacturer, distributor, or re-
tailer of a dietary supplement or ingredient has knowledge
which reasonably supports the conclusion that a dietary
supplement or ingredient may be adulterated or mis-
branded, such manufacturer, distributor, or retailer shall
promptly notify the Secretary of such knowledge.’’.
SEC. 7. ADVISORY COMMITTEE.
The Secretary of Health and Human Services shall
establish an advisory committee, in accordance with the
Federal Advisory Committee Act, to assist in the imple-
mentation of the amendments made by this Act.
SEC. 8. RESEARCH.
(a) ESTABLISHMENT.—The Director of the National
Institutes of Health shall expand and intensify programs
with respect to research and related activities regarding
dietary supplements.
(b) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out subsection (a), there are author-
ized to be appropriated $10,000,000 for fiscal year 1994
and such sums as may be necessary for each of the fiscal
years 1995 through 1997.
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