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21 U.S.C. § 343a — Repealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73
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.
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Source file: Laws/federal/codes/united-states-code/title-21/section-343a-repealed-pub-l-106554-1-a-1-title-v-517-dec-21-2000-114-stat-2763-2763a7--63e7965912.md
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Source location: Title 21, Chapter 9, § 343a; chapter-009-federal-food-drug-and-cosmetic-act.md
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### 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.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Unsafe food additives; exception for conformity with exemption or regulation** A food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2)(C) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim), unless—
(1) it and its use or intended use conform to the terms of an exemption which is in effect pursuant to subsection (j) of this section;
(2) there is in effect, and it and its use or intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or
(3) in the case of a food additive as defined in this chapter that is a food contact substance, there is—
(A) in effect, and such substance and the use of such substance are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or
(B) a notification submitted under subsection (h) that is effective.
While such a regulation relating to a food additive, or such a notification under subsection (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be considered adulterated under [section 342(a)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/1&num=0&edition=prelim).
**(b) Petition for regulation prescribing conditions of safe use; contents; description of production methods and controls; samples; notice of regulati
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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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