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15 U.S.C. § 1263 — Prohibited acts
Federal law — U.S. Code and appendices · legal_authorities
Page 1370
TITLE 15—COMMERCE AND TRADE
§ 1263
hazardous substance’’ for ‘‘any container of such haz-
ardous substance, intended or suitable for household
use, which fails to bear a label in accordance with such
regulations shall be deemed to be a misbranded pack-
age of a hazardous substance’’.
Subsec. (d). Pub. L. 89–756, § 2(e), inserted ‘‘hazardous
substance or’’ before ‘‘container of a hazardous sub-
stance’’.
Statutory Notes and Related Subsidiaries
CHANGE OF NAME
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on En-
ergy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and ex-
changes and insurance generally transferred to Com-
mittee on Financial Services of House of Representa-
tives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by Pub. L. 97–35 applicable with respect
to regulations under this chapter and chapters 25 and 47
of this title for which notices of proposed rulemaking
are issued after Aug. 14, 1981, see section 1215 of Pub. L.
97–35, set out as a note under section 2052 of this title.
EFFECTIVE DATE OF 1969 AMENDMENT
Amendment by Pub. L. 91–113 effective on sixtieth
day following Nov. 6, 1969, see section 5 of Pub. L.
91–113, set out as a note under section 1261 of this title.
NATIONAL COMMISSION ON PRODUCT SAFETY
Pub. L. 90–146, Nov. 20, 1967, 81 Stat. 466, as amended
by Pub. L. 91–51, Aug. 4, 1969, 83 Stat. 86, established a
National Commission on Product Sa
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Page 1370
TITLE 15—COMMERCE AND TRADE
§ 1263
hazardous substance’’ for ‘‘any container of such haz-
ardous substance, intended or suitable for household
use, which fails to bear a label in accordance with such
regulations shall be deemed to be a misbranded pack-
age of a hazardous substance’’.
Subsec. (d). Pub. L. 89–756, § 2(e), inserted ‘‘hazardous
substance or’’ before ‘‘container of a hazardous sub-
stance’’.
Statutory Notes and Related Subsidiaries
CHANGE OF NAME
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on En-
ergy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and ex-
changes and insurance generally transferred to Com-
mittee on Financial Services of House of Representa-
tives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by Pub. L. 97–35 applicable with respect
to regulations under this chapter and chapters 25 and 47
of this title for which notices of proposed rulemaking
are issued after Aug. 14, 1981, see section 1215 of Pub. L.
97–35, set out as a note under section 2052 of this title.
EFFECTIVE DATE OF 1969 AMENDMENT
Amendment by Pub. L. 91–113 effective on sixtieth
day following Nov. 6, 1969, see section 5 of Pub. L.
91–113, set out as a note under section 1261 of this title.
NATIONAL COMMISSION ON PRODUCT SAFETY
Pub. L. 90–146, Nov. 20, 1967, 81 Stat. 466, as amended
by Pub. L. 91–51, Aug. 4, 1969, 83 Stat. 86, established a
National Commission on Product Safety to study and
investigate the scope and adequacy of measures to pro-
tect consumers against unreasonable risk of injuries
which may be caused by hazardous household products
and required the Commission to transmit its final re-
port to the President and to the Congress by June 30,
1970. Ninety days after submission of its final report
the Commission ceased to exist by the express terms of
Pub. L. 90–146.
§ 1263. Prohibited acts
The following acts and the causing thereof are
prohibited:
(a) The introduction or delivery for introduc-
tion into interstate commerce of any mis-
branded hazardous substance or banned haz-
ardous substance.
(b) The alteration, mutilation, destruction,
obliteration, or removal of the whole or any
part of the label of, or the doing of any other act
with respect to, a hazardous substance, if such
act is done while the substance is in interstate
commerce, or while the substance is held for
sale (whether or not the first sale) after ship-
ment in interstate commerce, and results in the
hazardous substance being a misbranded haz-
ardous substance or banned hazardous sub-
stance.
(c) The receipt in interstate commerce of any
misbranded hazardous substance or banned haz-
ardous substance and the delivery or proffered
delivery thereof for pay or otherwise.
(d) The giving of a guarantee or undertaking
referred to in section 1264(b)(2) of this title
which guarantee or undertaking is false, except
by a person who relied upon a guarantee or un-
dertaking to the same effect signed by, and con-
taining the name and address of, the person re-
siding in the United States from whom he re-
ceived in good faith the hazardous substance.
(e) The failure to permit entry or inspection as
authorized by section 1270(b) of this title or to
permit access to and copying of any record as
authorized by section 1271 of this title.
(f) The introduction or delivery for introduc-
tion into interstate commerce, or the receipt in
interstate commerce and subsequent delivery or
proffered delivery for pay or otherwise, of a haz-
ardous substance in a reused food, drug, or cos-
metic container or in a container which, though
not a reused container, is identifiable as a food,
drug, or cosmetic container by its labeling or by
other identification. The reuse of a food, drug,
or cosmetic container as a container for a haz-
ardous substance shall be deemed to be an act
which results in the hazardous substance being a
misbranded hazardous substance. As used in this
paragraph, the terms ‘‘food’’, ‘‘drug’’, and ‘‘cos-
metic’’ shall have the same meanings as in the
Federal Food, Drug, and Cosmetic Act [21 U.S.C.
301 et seq.].
(g) The manufacture of a misbranded haz-
ardous substance or banned hazardous substance
within the District of Columbia or within any
territory not organized with a legislative body.
(h) The use by any person to his own advan-
tage, or revealing other than to the Commission
or officers or employees of the Commission, or
to the courts when relevant in any judicial pro-
ceeding under this chapter, of any information
acquired under authority of section 1270 of this
title concerning any method of process which as
a trade secret is entitled to protection.
(i) The failure to notify the Commission with
respect to exports, pursuant to section 1273(d) of
this title.
(j) The failure to comply with an order issued
under section 1274 of this title.
(k) The introduction or delivery for introduc-
tion into interstate commerce of any lead solder
which has a lead content in excess of 0.2 percent
which does not prominently display a warning
label stating the lead content of the solder and
warning that the use of such solder in the mak-
ing of joints or fittings in any private or public
potable water supply system is prohibited.
(Pub. L. 86–613, § 4, July 12, 1960, 74 Stat. 375;
Pub. L. 89–756, §§ 2(f), 3(b), Nov. 3, 1966, 80 Stat.
1304, 1305; Pub. L. 95–631, § 7(a), Nov. 10, 1978, 92
Stat. 3745; Pub. L. 97–35, title XII, § 1211(f)(2),
Aug. 13, 1981, 95 Stat. 723; Pub. L. 99–339, title I,
§ 109(d)(2), June 19, 1986, 100 Stat. 653; Pub. L.
110–314, title II, § 204(b)(4)(B), (C), (H), Aug. 14,
2008, 122 Stat. 3041, 3042.)
Editorial Notes
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (f), is act June 25, 1938, ch. 675, 52 Stat.
1040, which is classified generally to chapter 9 (§ 301 et
seq.) of Title 21, Food and Drugs. For complete classi-
fication of this Act to the Code, see section 301 of Title
21 and Tables.
AMENDMENTS
2008—Subsec. (h). Pub. L. 110–314, § 204(b)(4)(B), (C),
substituted ‘‘Commission or officers or employees of
Page 1371
TITLE 15—COMMERCE AND TRADE
§ 1264
the Commission’’ for ‘‘Secretary or officers or employ-
ees of the Department’’.
Subsec. (i). Pub. L. 110–314, § 204(b)(4)(H), substituted
‘‘Commission’’ for ‘‘Consumer Product Safety Commis-
sion’’.
1986—Subsec. (k). Pub. L. 99–339 added subsec. (k).
1981—Subsec. (j). Pub. L. 97–35 added subsec. (j).
1978—Subsec. (i). Pub. L. 95–631 added subsec. (i).
1966—Subsec. (a). Pub. L. 89–756, §§ 2(f)(1), 3(b), sub-
stituted ‘‘misbranded hazardous substance or banned
hazardous substance’’ for ‘‘misbranded package of a
hazardous substance’’.
Subsec. (b). Pub. L. 89–756, §§ 2(f)(2), 3(b), substituted
‘‘being a misbranded hazardous substance or banned
hazardous substance’’ for ‘‘being in a misbranded pack-
age’’.
Subsec. (c). Pub. L. 89–756, §§ 2(f)(1), 3(b), substituted
‘‘misbranded hazardous substance or banned hazardous
substance’’ for ‘‘misbranded package of a hazardous
substance’’.
Subsec. (f). Pub. L. 89–756, § 2(f)(2), substituted ‘‘being
a misbranded hazardous substance’’ for ‘‘being in a mis-
branded package’’.
Subsec. (g). Pub. L. 89–756, §§ 2(f)(1), 3(b), substituted
‘‘misbranded hazardous substance or banned hazardous
substance’’ for ‘‘misbranded package of a hazardous
substance’’.
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–339 effective 24 months
after June 19, 1986, see section 109(d)(3) of Pub. L. 99–339,
set out as a note under section 1261 of this title.
EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by Pub. L. 97–35 effective Aug. 13, 1981,
see section 1215 of Pub. L. 97–35, set out as a note under
section 2052 of this title.
§ 1264. Penalties; exceptions
(a) Criminal penalties
Any person who violates any of the provisions
of section 1263 of this title shall be guilty of a
misdemeanor and shall on conviction thereof be
subject to a fine of not more than $500 or to im-
prisonment for not more than ninety days, or
both; but for offenses committed with intent to
defraud or mislead, or for second and subsequent
offenses, the penalty shall be imprisonment for
not more than 5 years, a fine determined under
section 3571 of title 18, or both.
(b) Exceptions
No person shall be subject to the penalties of
subsection (a) of this section, (1) for having vio-
lated section 1263(c) of this title, if the receipt,
delivery, or proffered delivery of the hazardous
substance was made in good faith, unless he re-
fuses to furnish on request of an officer or em-
ployee duly designated by the Commission, the
name and address of the person from whom he
purchased or received such hazardous substance,
and copies of all documents, if any there be, per-
taining to the delivery of the hazardous sub-
stance to him; or (2) for having violated section
1263(a) of this title, if he established a guarantee
or undertaking signed by, and containing the
name and address of, the person residing in the
United States from whom he received in good
faith the hazardous substance, to the effect that
the hazardous substance is not a misbranded
hazardous substance or a banned hazardous sub-
stance within the meaning of those terms in this
chapter; or (3) for having violated subsection (a)
or (c) of section 1263 of this title with respect to
any hazardous substance shipped or delivered for
shipment for export to any foreign country, in a
package marked for export on the outside of the
shipping container and labeled in accordance
with the specifications of the foreign purchaser
and in accordance with the laws of the foreign
country, but if such hazardous substance is sold
or offered for sale in domestic commerce or if
the Commission determines that exportation of
such substance presents an unreasonable risk of
injury to persons residing within the United
States, this clause shall not apply.
(c) Civil penalties
(1) Any person who knowingly violates section
1263 of this title shall be subject to a civil pen-
alty not to exceed $100,000 for each such viola-
tion. Subject to paragraph (2), a violation of
subsections (a), (b), (c), (d), (f), (g), (i), (j), and
(k) of section 1263 of this title shall constitute a
separate offense with respect to each substance
involved, except that the maximum civil pen-
alty shall not exceed $15,000,000 for any related
series of violations. A violation of section 1263(e)
of this title shall constitute a separate violation
with respect to each failure or refusal to allow
or perform an act required by section 1263(e) of
this title; and, if such violation is a continuing
one, each day of such violation shall constitute
a separate offense, except that the maximum
civil penalty shall not exceed $15,000,000 for any
related series of violations.
(2) The second sentence of paragraph (1) of this
subsection shall not apply to violations of sub-
section (a) or (c) of section 1263 of this title—
(A) if the person who violated such sub-
section is not the manufacturer, importer, or
private labeler or a distributor of the sub-
stances involved; and
(B) if such person did not have either (i) ac-
tual knowledge that such person’s distribution
or sale of the substance violated such sub-
section, or (ii) notice from the Commission
that such distribution or sale would be a viola-
tion of such subsection.
(3) In determining the amount of any penalty
to be sought upon commencing an action seek-
ing to assess a penalty for a violation of section
1263 of this title, the Commission shall consider
the nature, circumstances, extent, and gravity
of the violation, including the nature of the sub-
stance, the severity of the risk of injury, the oc-
currence or absence of injury, the amount of the
substance distributed, the appropriateness of
such penalty in relation to the size of the busi-
ness of the person charged, including how to
mitigate undue adverse economic impacts on
small businesses, and such other factors as ap-
propriate.
(4) Any civil penalty under this subsection
may be compromised by the Commission. In de-
termining the amount of such penalty or wheth-
er it should be remitted or mitigated, and in
what amount, the Commission shall consider
the appropriateness of such penalty to the size
of the business of the persons charged, including
how to mitigate undue adverse economic im-
pacts on small businesses, the nature, cir-
cumstances, extent, and gravity of the viola-
Cross-references
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Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any misbranded hazardous substance or banned hazardous substance.
**(b)** The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the label of, or the doing of any other act with respect to, a hazardous substance, if such act is done while the substance is in interstate commerce, or while the substance is held for sale (whether or not the first sale) after shipment in interstate commerce, and results in the hazardous substance being a misbranded hazardous substance or banned hazardous substance.
**(c)** The receipt in interstate commerce of any misbranded hazardous substance or banned hazardous substance and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The giving of a guarantee or undertaking referred to in [section 1264(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1264/b/2&num=0&edition=prelim) which guarantee or undertaking is false, except by a person who relied upon a guarantee or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the hazardous substance.
**(e)** The failure to permit entry or inspection as authorized by [section 1270(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1270/b&num=0&edition=prelim) or to permit access to and copying of any record as authorized by [section 1271 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1271&num=0&edition=prelim).
**(f)** The introduction or delivery for introduct
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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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
Page 30
TITLE 21—FOOD AND DRUGS
§ 301
Sec.
398.
Notices to States regarding imported food.
399.
Grants to enhance food safety.
399a.
Office of the Chief Scientist.
399b.
Office of Women’s Health.
399c.
Improving the training of State, local, terri-
torial, and tribal food safety officials.
399d.
Employee protections.
399e.
Nanotechnology.
399f.
Ensuring
adequate
information
regarding
pharmaceuticals for all populations, par-
ticularly underrepresented subpopulations,
including racial subgroups.
399g.
Food and Drug Administration Intercenter
Institutes.
399h.
National Centers of Excellence in Advanced
and Continuous Pharmaceutical Manufac-
turing.
399i.
Food and Drug Administration Working Cap-
ital Fund.
SUBCHAPTER I—SHORT TITLE
§ 301. Short title
This chapter may be cited as the Federal
Food, Drug, and Cosmetic Act.
(June 25, 1938, ch. 675, § 1, 52 Stat. 1040.)
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro-
vided that:
‘‘[SEC. 1] (a) The effective date of the following provi-
sions of the Federal Food, Drug, and Cosmetic Act is
hereby postponed until January 1, 1940: Sections 402(c)
[342(c) of this title]; 403(e)(1) [343(e)(1) of this title];
403(g), (h), (i), (j), and (k) [343(g) to (k) of this title];
501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g),
and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of
this title]; and 602(b) [362(b) of this title].
‘‘(b) The Secretary of Agriculture shall promulgate
regulations further postponing to July 1, 1940[,] the ef-
fective date of the provisions of sections 403(e)(1)
[343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g)
to (k)]; 502(b), (d), (
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