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establish provisions regarding the composition and label-
ing of dietary supplements.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Health Freedom Act
of 1993’’.
SEC. 2. DEFINITIONS.
(a) DIETARY SUPPLEMENT.—Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)
is amended by adding at the end the following new para-
graph:
‘‘(ff) The term ‘dietary supplement’ means an article
that—
‘‘(1) includes, and is intended to supplement
the diet with—
‘‘(A) a vitamin;
‘‘(B) a mineral;
‘‘(C) an herb; or
‘‘(D) another similar nutritional substance,
including a concentrate or extract of an item
described in clause (A), (B), or (C); and
‘‘(2)(A) is intended for ingestion in a form de-
scribed in paragraph (1)(B)(i) or (2) of section
411(c), or another similar form; or
‘‘(B) complies with section 411(c)(1)(B)(ii).’’.
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(b) DRUG.—Section 201(g)(1) of such Act is amend-
ed by adding at the end the following: ‘‘A dietary supple-
ment shall not be considered to be a drug solely because
of the potency of a substance in the dietary supplement.
A dietary supplement shall not be considered to be a drug
under clause (B) solely because the labeling or advertising
for the supplement contains a claim, or provides informa-
tion, that is described in section 413(b) and meets the re-
quirements specified in paragraphs (1) and (2) of such
section, or that concerns the potency of a substance in
the supplement.’’.
(c) FOOD ADDITIVE.—Section 201(s) of such Act is
amended—
(1) by redesignating subparagraphs (1) through
(5) as clauses (A) through (E), respectively;
(2) by inserting ‘‘(1)’’ after ‘‘(s)’’; and
(3) by adding at the end the following:
‘‘(2) A substance in a dietary supplement is not a
food additive if the substance is identified in the labeling
of the dietary supplement as a substance provided by the
product to supplement the diet.’’.
SEC. 3. DIETARY SUPPLEMENTS.
(a) IN GENERAL.—Chapter IV of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend-
ed by adding at the end the following new section:
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‘‘SEC. 413. LABELING AND ADVERTISING OF DIETARY SUP-
PLEMENTS.
‘‘(a) DESCRIPTION.—Notwithstanding any other pro-
vision of this Act, an article that is a dietary supplement
may be described as a dietary supplement in labeling or
advertising.
‘‘(b) RELATIONSHIP TO DISEASE OR HEALTH-RE-
LATED CONDITION.—Notwithstanding any other provision
of this Act, labeling or advertising for a dietary supple-
ment may include a claim or other information that char-
acterizes the relationship of the dietary supplement, or of
one or more of the substances provided by the dietary sup-
plement, or of the absence of one or more of the sub-
stances, to a disease or health-related condition, if—
‘‘(1) such claim or other information is truthful
and not misleading; and
‘‘(2) there is scientific evidence, whether pub-
lished or unpublished, that provides a reasonable
basis for such claim or other information.
‘‘(c) PROHIBITION ON PRIOR APPROVAL OR REGULA-
TION.—Notwithstanding any other provision of this Act,
the Secretary shall not establish any requirement that
such a claim or other information that meets the require-
ments specified in paragraphs (1) and (2) of subsection
(b) shall be approved by or conform to a regulation issued
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by the Secretary before the claim or information may be
used.
‘‘(d) ACTIONS.—
‘‘(1) RIGHT OF ACTION.—If the Secretary as-
serts that labeling or advertising for a dietary sup-
plement includes such a claim or other information
that fails to comply with paragraph (1) or (2) of
subsection (b), whether the Secretary makes the as-
sertion in a warning letter issued by an officer or
employee of the Department, or in connection with
another action to enforce a provision of this Act, the
manufacturer, processor, packer, distributor, or re-
tailer, of the dietary supplement, or other person to
whom the assertion is addressed, may—
‘‘(A) bring an action in a United States
district court in any appropriate judicial district
under section 1391 of title 28, United States
Code, to secure a declaratory judgment regard-
ing the validity of the assertion; and
‘‘(B) obtain any other means of judicial re-
view authorized by law.
‘‘(2) INFERENCE.—The absence of any action
described in subparagraph (A) or (B) in paragraph
(1) with respect to an assertion shall not establish
any inference that the assertion is valid.’’.
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(b) CONFORMING AMENDMENT.—Section 403(r)(5)
of such Act (21 U.S.C. 343(r)(5)) is amended by striking
clause (D).
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