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21 U.S.C. § 343a — Repealed. Pub. L. 106–554, § 1(a)(1) [title V,
Federal law — U.S. Code and appendices · legal_authorities
Page 102
TITLE 21—FOOD AND DRUGS
§ 343–2
DELAYED APPLICABILITY OF CERTAIN PROVISIONS
Pub. L. 102–408, title III, § 310, Oct. 13, 1992, 106 Stat.
2090, provided that: ‘‘Notwithstanding any other provi-
sion 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 Sep-
tember 1, 1994.’’
§ 343–2. Dietary supplement labeling exemptions
(a) In general
A publication, including an article, a chapter
in a book, or an official abstract of a peer-re-
viewed scientific publication that appears in an
article and was prepared by the author or the
editors of the publication, which is reprinted in
its entirety, shall not be defined as labeling
when used in connection with the sale of a die-
tary supplement to consumers when it—
(1) is not false or misleading;
(2) does not promote a particular manufac-
turer or brand of a dietary supplement;
(3) is displayed or presented, or is displayed
or presented with other such items on the
same subject matter, so as to present a bal-
anced view of the available scientific informa-
tion on a dietary supplement;
(4) if displayed in an establishment, is phys-
ically separate from the dietary supplements;
and
(5) does not have appended to it any infor-
mation by sticker or any other method.
(b) Application
Subsection (a) shall not apply to or restrict a
retailer or wholesaler of dietary supplements in
any way whatsoever in the sale of books or
other publications as a part of the business of
such retailer or wholesaler.
(c) Burden of proof
In any proceeding brought under subsection
(a), the burden of proof shall be on the United
States to establish that an article or other
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Source file: Laws/federal/codes/united-states-code-2024/title-21/section-343a-repealed-pub-l-106554-1-a-1-title-v--49f9b29134.md
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Source location: USCODE-2024-title21-chap9-subchapIV-sec343a.pdf
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Page 102
TITLE 21—FOOD AND DRUGS
§ 343–2
DELAYED APPLICABILITY OF CERTAIN PROVISIONS
Pub. L. 102–408, title III, § 310, Oct. 13, 1992, 106 Stat.
2090, provided that: ‘‘Notwithstanding any other provi-
sion 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 Sep-
tember 1, 1994.’’
§ 343–2. Dietary supplement labeling exemptions
(a) In general
A publication, including an article, a chapter
in a book, or an official abstract of a peer-re-
viewed scientific publication that appears in an
article and was prepared by the author or the
editors of the publication, which is reprinted in
its entirety, shall not be defined as labeling
when used in connection with the sale of a die-
tary supplement to consumers when it—
(1) is not false or misleading;
(2) does not promote a particular manufac-
turer or brand of a dietary supplement;
(3) is displayed or presented, or is displayed
or presented with other such items on the
same subject matter, so as to present a bal-
anced view of the available scientific informa-
tion on a dietary supplement;
(4) if displayed in an establishment, is phys-
ically separate from the dietary supplements;
and
(5) does not have appended to it any infor-
mation by sticker or any other method.
(b) Application
Subsection (a) shall not apply to or restrict a
retailer or wholesaler of dietary supplements in
any way whatsoever in the sale of books or
other publications as a part of the business of
such retailer or wholesaler.
(c) Burden of proof
In any proceeding brought under subsection
(a), the burden of proof shall be on the United
States to establish that an article or other such
matter is false or misleading.
(June 25, 1938, ch. 675, § 403B, as added Pub. L.
103–417, § 5, Oct. 25, 1994, 108 Stat. 4328.)
§ 343–3. Disclosure
(a) No provision of section 321(n), 343(a), or 348
of this title shall be construed to require on the
label or labeling of a food a separate radiation
disclosure statement that is more prominent
than the declaration of ingredients required by
section 343(i)(2) of this title.
(b) In this section, the term ‘‘radiation disclo-
sure statement’’ means a written statement
that discloses that a food has been intentionally
subject to radiation.
(June 25, 1938, ch. 675, § 403C, as added Pub. L.
105–115, title III, § 306, Nov. 21, 1997, 111 Stat.
2353.)
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105–115,
set out as an Effective Date of 1997 Amendment note
under section 321 of this title.
§ 343a. Repealed. Pub. L. 106–554, § 1(a)(1) [title V,
§ 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73
Section, Pub. L. 95–203, § 4(c), (d), Nov. 23, 1977, 91
Stat. 1453, 1454, related to distribution of information
on health risks of saccharin.
§ 344. Emergency permit control
(a) Conditions on manufacturing, processing,
etc., as health measure
Whenever the Secretary finds after investiga-
tion that the distribution in interstate com-
merce of any class of food may, by reason of
contamination with micro-organisms during the
manufacture, processing, or packing thereof in
any locality, be injurious to health, and that
such injurious nature cannot be adequately de-
termined after such articles have entered inter-
state commerce, he then, and in such case only,
shall promulgate regulations providing for the
issuance, to manufacturers, processors, or pack-
ers of such class of food in such locality, of per-
mits to which shall be attached such conditions
governing the manufacture, processing, or pack-
ing of such class of food, for such temporary pe-
riod of time, as may be necessary to protect the
public health; and after the effective date of
such regulations, and during such temporary pe-
riod, no person shall introduce or deliver for in-
troduction into interstate commerce any such
food manufactured, processed, or packed by any
such manufacturer, processor, or packer unless
such manufacturer, processor, or packer holds a
permit issued by the Secretary as provided by
such regulations.
(b) Violation of permit; suspension and reinstate-
ment
The Secretary is authorized to suspend imme-
diately upon notice any permit issued under au-
thority of this section if it is found that any of
the conditions of the permit have been violated.
The holder of a permit so suspended shall be
privileged at any time to apply for the rein-
statement of such permit, and the Secretary
shall, immediately after prompt hearing and an
inspection of the establishment, reinstate such
permit if it is found that adequate measures
have been taken to comply with and maintain
the conditions of the permit, as originally issued
or as amended.
(c) Inspection of permit-holding establishments
Any officer or employee duly designated by
the Secretary shall have access to any factory
or establishment, the operator of which holds a
permit from the Secretary, for the purpose of
ascertaining whether or not the conditions of
the permit are being complied with, and denial
of access for such inspection shall be ground for
suspension of the permit until such access is
freely given by the operator.
(June 25, 1938, ch. 675, § 404, 52 Stat. 1048.)
Executive Documents
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Admin-
istrator to Secretary of Health, Education, and Welfare
[now Health and Human Services], and of Food and
Drug Administration in the Department of Agriculture
to Federal Security Agency, see notes set out under
section 321 of this title.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
A food shall be deemed to be misbranded—
**(a) False or misleading label** If (1) its labeling is false or misleading in any particular, or (2) in the case of a food to which [section 350 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350&num=0&edition=prelim) applies, its advertising is false or misleading in a material respect or its labeling is in violation of [section 350(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350/b/2&num=0&edition=prelim).
**(b) Offer for sale under another name** If it is offered for sale under the name of another food.
**(c) Imitation of another food** If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated.
**(d) Misleading container** If its container is so made, formed, or filled as to be misleading.
**(e) Package form** If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, except that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
**(f) Prominence of information on label** If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and unde
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 343
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Federal law — U.S. Code and appendices · legal_authorities
Page 83
TITLE 21—FOOD AND DRUGS
§ 343
EFFECTIVE DATE OF 1950 AMENDMENT
Amendment by act Mar. 16, 1950, effective July 1, 1950,
see section 7 of act Mar. 16, 1950, set out as an Effective
Date note under section 347 of this title.
EFFECTIVE DATE; POSTPONEMENT
Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch.
242, 53 Stat. 853, set out as an Effective Date; Postpone-
ment in Certain Cases note under section 301 of this
title.
SHORT TITLE
Pub. L. 88–625, § 1, Oct. 3, 1964, 78 Stat. 1002, provided:
‘‘That this Act [amending provisions set out as a note
under this section and section 135 of Title 7, Agri-
culture] may be cited as the ‘Food Additives Transi-
tional Provisions Amendment of 1964’.’’
UPDATING GUIDANCE RELATING TO FISH AND FISHERIES
PRODUCTS HAZARDS AND CONTROLS
Pub. L. 111–353, title I, § 103(h), Jan. 4, 2011, 124 Stat.
3898, provided that: ‘‘The Secretary shall, not later
than 180 days after the date of enactment of this Act
[Jan. 4, 2011], update the Fish and Fisheries Products
Hazards and Control Guidance to take into account ad-
vances in technology that have occurred since the pre-
vious publication of such Guidance by the Secretary.’’
GUIDANCE RELATING TO POST HARVEST PROCESSING OF
RAW OYSTERS
Pub. L. 111–353, title I, § 114, Jan. 4, 2011, 124 Stat. 3921,
provided that:
‘‘(a) IN GENERAL.—Not later than 90 days prior to the
issuance of any guidance, regulation, or suggested
amendment by the Food and Drug Administration to
the National Shellfish Sanitation Program’s Model Or-
dinance, or the issuance of any guidance or regulation
by the Food and Drug Administration relating to the
Seafood Hazard Analysis Critical Control Points Pro-
gram of the Food and Drug Administration (parts 123
and 1240 of title 21, Code of Federal
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 343
Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 343. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
### Statutory Notes
Section, Pub. L. 95–203, § 4(c), (d), Nov. 23, 1977, 91 Stat. 1453, 1454, related to distribution of information on health risks of saccharin.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 343a
Stored review status: release_metadata_unconfirmed. Same stored citation; legal effect and authority still require review.