SEC. 102. ACCESS TO DIETARY SUPPLEMENTS.
(a) FDA MAY NOT REQUIRE PRESCRIPTIONS FOR
DIETARY SUPPLEMENTS.—Section 503(b) (21 U.S.C.
353(b)) is amended by adding at the end the following:
‘‘(6) For a dietary supplement marketed on or before
November 15, 1993, the Secretary may not, after Novem-
ber 15, 1993, require a prescription . For a dietary supple-
ment first marketed after November 15, 1993, this sub-
section as it was in effect on the date of the enactment
of the Dietary Supplement Access and Claims Moratorium
Act of 1993 shall apply.’’.
(b) FDA MAY NOT REQUIRE PREMARKET APPROVAL
FOR DIETARY SUPPLEMENTS.—
(1) FOOD
ADDITIVES.—Section 201(s) (21
U.S.C. 321(s)) is amended—
(A) by striking out the period at the end
of subparagraph (5) and inserting in lieu there-
of ‘‘; or’’; and
(B) by adding after subparagraph (5) the
following:
‘‘(6) any dietary ingredient in a dietary supple-
ment.’’.
(2) DRUGS.—Section 201(g)(1) (21 U.S.C.
321(g)(1)) is amended by adding at the end the fol-
lowing: ‘‘A dietary supplement which was on the
market on or before November 15, 1993, and for
which no claim is made is not a drug.’’.
(c) BURDEN OF PROOF ON FDA.—
(1) IN GENERAL.—Section 402 (21 U.S.C. 342)
is amended by adding at the end the following:
‘‘(f) If it contains a dietary ingredient at a level that
may be injurious to health or is a dietary supplement
which when used in accordance with the conditions of use
may be injurious to health.’’.
(2) CONFORMING
AMENDMENT.—Section 402
(21 U.S.C. 342) is amended by striking ‘‘food’’ in
the matter preceding paragraph (a) and inserting
‘‘food or dietary supplement’’.
(d) DEFINITIONS.—
(1) IN GENERAL.—Section 201 (21 U.S.C. 321)
is amended by adding at the end the following:
‘‘(gg) The term ‘dietary ingredient’ means—
‘‘(1) a vitamin,
‘‘(2) a mineral,
‘‘(3) an herb,
‘‘(4) an amino acid, or
‘‘(5) other ingredient,
contained in a product marketed in the United States as
a dietary supplement on or before November 15, 1993.
‘‘(hh) The term ‘dietary supplement’ means a product
which contains one or more dietary ingredients and—
‘‘(1) which is marketed to supplement the diet,
‘‘(2) which is intended for use in tablet, cap-
sule, powder, softgel, or liquid form and if in liquid
form is formulated in a fluid carrier and is intended
for ingestion in daily quantities measured in drops
or similar small units of measure,
‘‘(3) which is not represented for use as conven-
tional food or as a sole item of a meal or of the diet,
and
‘‘(4) which does not include any ingredient
other than a vitamin or mineral which has been ap-
proved as the active ingredient of a drug.’’.
(2) SECRETARIAL
ACTION.—For purposes of
the definitions added by paragraph (1), the Sec-
retary of Health and Human Services shall, not
later than 180 days after the date of the enactment
of this Act, issue a regulation identifying the dietary
ingredients which were marketed on or before No-
vember 15, 1993.
TITLE II—MORATORIUM ON
DIETARY SUPPLEMENT CLAIMS
SEC. 201. REFERENCE.
Whenever in this title an amendment or repeal is ex-
pressed in terms of an amendment to, or repeal of, a sec-
tion or other provision, the reference shall be considered
to be made to a section or other provision of the Prescrip-
tion Drug User Fee Act of 1992.
SEC. 202. PROHIBITION OF IMPLEMENTATION.
Section 202(a)(1) (21 U.S.C. 343 note) is amended—
(1) by striking ‘‘December 15, 1993’’ and in-
serting ‘‘June 30, 1994’’, and
(2) by inserting ‘‘amino acids,’’ after ‘‘herbs,’’.
SEC. 203. ISSUANCE OF REGULATIONS.
The amendments made by sections 202(a)(2)(B)(i)
and 202(a)(2)(B)(ii) (21 U.S.C. 343 note) are each
amended—
(1) by striking ‘‘December 31, 1993’’ and in-
serting ‘‘June 30, 1994’’, and
(2) by inserting ‘‘amino acids,’’ after ‘‘herbs,’’.
SEC. 204. STATE ENFORCEMENT.
The amendment made by section 202(a)(3) (21
U.S.C. 343 note) is amended by striking ‘‘to such dietary
supplement on December 31, 1993’’ and inserting ‘‘to die-
tary supplements of vitamins, minerals, herbs, amino
acids, or other similar nutritional substances on June 30,
1994’’.
SEC. 205. CLAIM APPROVAL.
Section 202(b) (21 U.S.C. 343 note) is amended—
(1) by striking ‘‘December 15, 1993’’ and in-
serting ‘‘June 30, 1994’’, and
(2) by inserting ‘‘amino acids,’’ after ‘‘herbs,’’.
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