§ 343-1. — National uniform nutrition labeling.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC343-1]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV--FOOD
Sec. 343-1. National uniform nutrition labeling
(a) Except as provided in subsection (b) of this section, no State
or political subdivision of a State may directly or indirectly establish
under any authority or continue in effect as to any food in interstate
commerce--
(1) any requirement for a food which is the subject of a
standard of identity established under section 341 of this title
that is not identical to such standard of identity or that is not
identical to the requirement of section 343(g) of this title, except
that this paragraph does not apply to a standard of identity of a
State or political subdivision of a State for maple syrup that is of
the type required by sections 341 and 343(g) of this title,
(2) any requirement for the labeling of food of the type
required by section 343(c), 343(e), or 343(i)(2) of this title that
is not identical to the requirement of such section, except that
this paragraph does not apply to a requirement of a State or
political subdivision of a State that is of the type required by
section 343(c) of this title and that is applicable to maple syrup,
(3) any requirement for the labeling of food of the type
required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or
343(k) of this title that is not identical to the requirement of
such section, except that this paragraph does not apply to a
requirement of a State or political subdivision of a State that is
of the type required by section 343(h)(1) of this title and that is
applicable to maple syrup,
(4) any requirement for nutrition labeling of food that is not
identical to the requirement of section 343(q) of this title, except
a requirement for nutrition labeling of food which is exempt under
subclause (i) or (ii) of section 343(q)(5)(A) of this title, or
(5) any requirement respecting any claim of the type described
in section 343(r)(1) of this title made in the label or labeling of
food that is not identical to the requirement of section 343(r) of
this title, except a requirement respecting a claim made in the
label or labeling of food which is exempt under section 343(r)(5)(B)
of this title.
Paragraph (3) shall take effect in accordance with section 6(b) of the
Nutrition Labeling and Education Act of 1990.
(b) Upon petition of a State or a political subdivision of a State,
the Secretary may exempt from subsection (a) of this section, under such
conditions as may be prescribed by regulation, any State or local
requirement that--
(1) would not cause any food to be in violation of any
applicable requirement under Federal law,
(2) would not unduly burden interstate commerce, and
(3) is designed to address a particular need for information
which need is not met by the requirements of the sections referred
to in subsection (a) of this section.
(June 25, 1938, ch. 675, Sec. 403A, as added Pub. L. 101-535, Sec. 6(a),
Nov. 8, 1990, 104 Stat. 2362; amended Pub. L. 102-108, Sec. 2(b), Aug.
17, 1991, 105 Stat. 549; Pub. L. 103-396, Sec. 3(a), Oct. 22, 1994, 108
Stat. 4154.)
References in Text
Section 6(b) of the Nutrition Labeling and Education Act of 1990
[Pub. L. 101-535], referred to in subsec. (a), is set out below.
Amendments
1994--Subsec. (a)(1). Pub. L. 103-396, Sec. 3(a)(1), inserted at end
``except that this paragraph does not apply to a standard of identity of
a State or political subdivision of a State for maple syrup that is of
the type required by sections 341 and 343(g) of this title,''.
Subsec. (a)(2). Pub. L. 103-396, Sec. 3(a)(2), inserted at end
``except that this paragraph does not apply to a requirement of a State
or political subdivision of a State that is of the type required by
section 343(c) of this title and that is applicable to maple syrup,''.
Subsec. (a)(3). Pub. L. 103-396, Sec. 3(a)(3), inserted at end
``except that this paragraph does not apply to a requirement of a State
or political subdivision of a State that is of the type required by
section 343(h)(1) of this title and that is applicable to maple
syrup,''.
1991--Subsec. (a)(5). Pub. L. 102-108 substituted ``section
343(r)(5)(B) of this title'' for ``clause (B) of such section''.
Effective Date
Section 10(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title I, Sec. 107(16), title II, Sec. 202(a)(4), Oct. 29, 1992, 106
Stat. 4499, 4501, provided that:
``(1) In general.--Except as provided in paragraph (2), the
amendments made by section 6 [enacting this section] shall take effect--
``(A) with respect to a requirement of a State or political
subdivision described in paragraph (1) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act [subsec. (a)(1) of this
section], on the date of the enactment of this Act [Nov. 8, 1990],
``(B) with respect to a requirement of a State or political
subdivision described in paragraph (2) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, one year after the date of the
enactment of this Act,
``(C) with respect to a requirement of a State or political
subdivision described in paragraph (3) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, as prescribed by section 6(b)
of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101-
535, set out below],
``(D) with respect to a requirement of a State or political
subdivision described in paragraph (4) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, on the date regulations to
implement section 403(q) of such Act [21 U.S.C. 343(q)] take effect,
and
``(E) with respect to a requirement of a State or political
subdivision described in paragraph (5) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, on the date regulations to
implement section 403(r) of such Act take effect.
``(2) Exception.--If a State or political subdivision submits a
petition under section 403A(b) of the Federal Food, Drug, and Cosmetic
Act for a requirement described in section 403A(a) of such Act within 18
months of the date of the enactment of this Act, paragraphs (3) through
(5) of such section 403A(a) shall not apply with respect to such State
or political subdivision requirement until--
``(A) 24 months after the date of the enactment of this Act, or
``(B) action on the petition,
whichever occurs later.
``(3) Requirements pertaining to certain claims.--Notwithstanding
subparagraphs (D) and (E) of paragraph (1) and except with respect to
claims approved in accordance with section 202(b) of the Dietary
Supplement Act of 1992 [Pub. L. 102-571, set out as a note under section
343 of this title], the requirements described in paragraphs (4) and (5)
of section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343-1(a)(4) and (5)) that pertain to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances shall
not take effect until the date final regulations take effect to
implement subsection (q) or (r), as appropriate, of section 403 of such
Act with respect to such dietary supplements.''
Section 6(b) of Pub. L. 101-535 provided that:
``(1) For the purpose of implementing section 403A(a)(3) [21 U.S.C.
343-1(a)(3)], the Secretary of Health and Human Services shall enter
into a contract with a public or nonprofit private entity to conduct a
study of--
``(A) State and local laws which require the labeling of food
that is of the type required by sections 403(b), 403(d), 403(f),
403(h), 403(i)(1), and 403(k) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 343(b), (d), (f), (h), (i)(1), (k)], and
``(B) the sections of the Federal Food, Drug, and Cosmetic Act
referred to in subparagraph (A) and the regulations issued by the
Secretary to enforce such sections to determine whether such
sections and regulations adequately implement the purposes of such
sections.
``(2) The contract under paragraph (1) shall provide that the study
required by such paragraph shall be completed within 6 months of the
date of the enactment of this Act [Nov. 8, 1990].
``(3)(A) Within 9 months of the date of the enactment of this Act,
the Secretary shall publish a proposed list of sections which are
adequately being implemented by regulations as determined under
paragraph (1)(B) and sections which are not adequately being implemented
by regulations as so determined. After publication of the lists, the
Secretary shall provide 60 days for comments on such lists.
``(B) Within 24 months of the date of the enactment of this Act, the
Secretary shall publish a final list of sections which are adequately
being implemented by regulations and a list of sections which are not
adequately being implemented by regulations. With respect to a section
which is found by the Secretary to be adequately implemented, no State
or political subdivision of a State may establish or continue in effect
as to any food in interstate commerce any requirement which is not
identical to the requirement of such section.
``(C) Within 24 months of the date of the enactment of this Act, the
Secretary shall publish proposed revisions to the regulations found to
be inadequate under subparagraph (B) and within 30 months of such date
shall issue final revisions. Upon the effective date of such final
revisions, no State or political subdivision may establish or continue
in effect any requirement which is not identical to the requirement of
the section which had its regulations revised in accordance with this
subparagraph.
``(D)(i) If the Secretary does not issue a final list in accordance
with subparagraph (B), the proposed list issued under subparagraph (A)
shall be considered the final list and States and political subdivisions
shall be preempted with respect to sections found to be adequate in such
proposed list in accordance with subparagraph (B).
``(ii) If the Secretary does not issue final revisions of
regulations in accordance with subparagraph (C), the proposed revisions
issued under such subparagraph shall be considered the final revisions
and States and political subdivisions shall be preempted with respect to
sections the regulations of which are revised by the proposed revisions.
``(E) Subsection (b) of section 403A of the Federal Food, Drug, and
Cosmetic Act shall apply with respect to the prohibition prescribed by
subparagraphs (B) and (C).''
Construction of Pub. L. 101-535
Section 6(c) of Pub. L. 101-535 provided that:
``(1) The Nutrition Labeling and Education Act of 1990 [Pub. L. 101-
535, see Short Title of 1990 Amendment note set out under section 301 of
this title] shall not be construed to preempt any provision of State
law, unless such provision is expressly preempted under section 403A of
the Federal Food, Drug, and Cosmetic Act [this section].
``(2) The amendment made by subsection (a) [enacting this section]
and the provisions of subsection (b) [set out as a note above] shall not
be construed to apply to any requirement respecting a statement in the
labeling of food that provides for a warning concerning the safety of
the food or component of the food.
``(3) The amendment made by subsection (a), the provisions of
subsection (b) and paragraphs (1) and (2) of this subsection shall not
be construed to affect preemption, express or implied, of any such
requirement of a State or political subdivision, which may arise under
the Constitution, any provision of the Federal Food, Drug, and Cosmetic
Act [this chapter] not amended by subsection (a), any other Federal law,
or any Federal regulation, order, or other final agency action
reviewable under chapter 7 of title 5, United States Code.''
Amendments by Pub. L. 101-535 not to be construed to alter the
authority of the Secretary of Health and Human Services and the
Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see
section 9 of Pub. L. 101-535, set out as a note under section 343 of
this title.
Delayed Applicability of Certain Provisions
Pub. L. 102-408, title III, Sec. 310, Oct. 13, 1992, 106 Stat. 2090,
provided that: ``Notwithstanding any other provision of law, section
403A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-
1(a)(1)) shall not apply with respect to any requirement of any State or
political subdivision regarding maple syrup until September 1, 1994.''
