21 USC 331(j): Trade Secrets

          
Sec. 331. Prohibited acts

    The following acts and the causing thereof are prohibited:
    (a) The introduction or delivery for introduction into interstate 
commerce of any food, drug, device, or cosmetic that is adulterated or 
misbranded.
    (b) The adulteration or misbranding of any food, drug, device, or 
cosmetic in interstate commerce.
    (c) The receipt in interstate commerce of any food, drug, device, or 
cosmetic that is adulterated or misbranded, and the delivery or 
proffered delivery thereof for pay or otherwise.
    (d) The introduction or delivery for introduction into interstate 
commerce of any article in violation of section 344, 355, or 360bbb-3 of 
this title.
    (e) The refusal to permit access to or copying of any record as 
required by section 350a, 350c,
350e, 354, 360bbb-3, 373, 374(a), 379aa, or 379aa-1 of this title; or 
the failure to establish or maintain any record, or make any report, 
required under section 350a, 350c(b), 350e, 354, 355(i) or (k), 
360b(a)(4)(C), 360b(j), (l) or (m), 360ccc-1(i).,\1\ 360e(f), 360i, 
360bbb-3, 379aa, or 379aa-1 of this title, or the refusal to permit 
access to or verification or copying of any such required record.
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    \1\ So in original.
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    (f) The refusal to permit entry or inspection as authorized by 
section 374 of this title.
    (g) The manufacture within any Territory of any food, drug, device, 
or cosmetic that is adulterated or misbranded.
    (h) The giving of a guaranty or undertaking referred to in section 
333(c)(2) of this title, which guaranty or undertaking is false, except 
by a person who relied upon a guaranty 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 food, drug, 
device, or cosmetic; or the giving of a guaranty or undertaking referred 
to in section 333(c)(3) of this title, which guaranty or undertaking is 
false.
    (i)(1) Forging, counterfeiting, simulating, or falsely representing, 
or without proper authority using any mark, stamp, tag, label, or other 
identification device authorized or required by regulations promulgated 
under the provisions of section 344 or 379e of this title.
    (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other thing designed to print, imprint, or reproduce the trademark, 
trade name, or other identifying mark, imprint, or device of another or 
any likeness of any of the foregoing upon any drug or container or 
labeling thereof so as to render such drug a counterfeit drug.
    (3) The doing of any act which causes a drug to be a counterfeit 
drug, or the sale or dispensing, or the holding for sale or dispensing, 
of a counterfeit drug.

        

            
 
          
    (j) The using by any person to his own advantage, or revealing, 
other than to the Secretary or officers or employees of the Department, 
or to the courts when relevant in any judicial proceeding under this 
chapter, any information acquired under authority of section 344, 348, 
350a, 350c, 355, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 
360ccc, 360ccc-1, 360ccc-2.,\1\ 374, 379, or 379e of this title 
concerning any method or process which as a trade secret is entitled to 
protection; or the violating of section 346a(i)(2) of this title or any 
regulation issued under that section..\1\ This paragraph does not 
authorize the withholding of information from either House of Congress 
or from, to the extent of matter within its jurisdiction, any committee 
or subcommittee of such committee or any joint committee of Congress or 
any subcommittee of such joint committee.
    (k) The alteration, mutilation, destruction, obliteration, or 
removal of the whole or any part of the labeling of, or the doing of any 
other act with respect to, a food, drug, device, or cosmetic, if such 
act is done while such article is held for sale (whether or not the 
first sale) after shipment in interstate commerce and results in such 
article being adulterated or misbranded.
    (l) Repealed. Pub. L. 105-115, title IV, Sec. 421, Nov. 21, 1997, 
111 Stat. 2380.
    (m) The sale or offering for sale of colored oleomargarine or 
colored margarine, or the possession or serving of colored oleomargarine 
or colored margarine in violation of subsections (b) or (c) of section 
347 of this title.
    (n) The using, in labeling, advertising or other sales promotion of 
any reference to any report or analysis furnished in compliance with 
section 374 of this title.
    (o) In the case of a prescription drug distributed or offered for 
sale in interstate commerce, the failure of the manufacturer, packer, or 
distributor thereof to maintain for transmittal, or to transmit, to any 
practitioner licensed by applicable State law to administer such drug 
who makes written request for information as to such drug, true and 
correct copies of all printed matter which is required to be included in 
any package in which that drug is distributed or sold, or such other 
printed matter as is approved by the Secretary. Nothing in this 
paragraph shall be construed to exempt any person from any labeling 
requirement imposed by or under other provisions of this chapter.
    (p) The failure to register in accordance with section 360 of this 
title, the failure to provide any information required by section 360(j) 
or 360(k) of this title, or the failure to provide a notice required by 
section 360(j)(2) of this title.
    (q)(1) The failure or refusal to (A) comply with any requirement 
prescribed under section 360h or 360j(g) of this title, (B) furnish any 
notification or other material or information required by or under 
section 360i or 360j(g) of this title, or (C) comply with a requirement 
under section 360l of this title.
    (2) With respect to any device, the submission of any report that is 
required by or under this chapter that is false or misleading in any 
material respect.
    (r) The movement of a device in violation of an order under section 
334(g) of this title or the removal or alteration of any mark or label 
required by the order to identify the device as detained.
    (s) The failure to provide the notice required by section 350a(c) or 
350a(e) of this title, the failure to make the reports required by 
section 350a(f)(1)(B) of this title, the failure to retain the records 
required by section 350a(b)(4) of this title, or the failure to meet the 
requirements prescribed under section 350a(f)(3) of this title.
    (t) The importation of a drug in violation of section 381(d)(1) of 
this title, the sale, purchase, or trade of a drug or drug sample or the 
offer to sell, purchase, or trade a drug or drug sample in violation of 
section 353(c) of this title, the sale, purchase, or trade of a coupon, 
the offer to sell, purchase, or trade such a coupon, or the 
counterfeiting of such a coupon in violation of section 353(c)(2) of 
this title, the distribution of a drug sample in violation of section 
353(d) of this title or the failure to otherwise comply with the 
requirements of section 353(d) of this title, or the distribution of 
drugs in violation of section 353(e) of this title or the failure to 
otherwise comply with the requirements of section 353(e) of this title.
    (u) The failure to comply with any requirements of the provisions 
of, or any regulations or
orders of the Secretary, under section 360b(a)(4)(A), 360b(a)(4)(D), or 
360b(a)(5) of this title.
    (v) The introduction or delivery for introduction into interstate 
commerce of a dietary supplement that is unsafe under section 350b of 
this title.
    (w) The making of a knowingly false statement in any statement, 
certificate of analysis, record, or report required or requested under 
section 381(d)(3) of this title; the failure to submit a certificate of 
analysis as required under such section; the failure to maintain records 
or to submit records or reports as required by such section; the release 
into interstate commerce of any article or portion thereof imported into 
the United States under such section or any finished product made from 
such article or portion, except for export in accordance with section 
381(e) or 382 of this title, or with section 262(h) of title 42; or the 
failure to so export or to destroy such an article or portions thereof, 
or such a finished product.
    (x) The falsification of a declaration of conformity submitted under 
section 360d(c) of this title or the failure or refusal to provide data 
or information requested by the Secretary under paragraph (3) of such 
section.
    (y) In the case of a drug, device, or food--
        (1) the submission of a report or recommendation by a person 
    accredited under section 360m of this title that is false or 
    misleading in any material respect;
        (2) the disclosure by a person accredited under section 360m of 
    this title of confidential commercial information or any trade 
    secret without the express written consent of the person who 
    submitted such information or secret to such person; or
        (3) the receipt by a person accredited under section 360m of 
    this title of a bribe in any form or the doing of any corrupt act by 
    such person associated with a responsibility delegated to such 
    person under this chapter.

    (z) The dissemination of information in violation of section 360aaa 
of this title.
    (aa) The importation of a prescription drug in violation of section 
384 of this title, the falsification of any record required to be 
maintained or provided to the Secretary under such section, or any other 
violation of regulations under such section.
    (bb) The transfer of an article of food in violation of an order 
under section 334(h) of this title, or the removal or alteration of any 
mark or label required by the order to identify the article as detained.
    (cc) The importing or offering for import into the United States of 
an article of food by, with the assistance of, or at the direction of, a 
person debarred under section 335a(b)(3) of this title.
    (dd) The failure to register in accordance with section 350d of this 
title.
    (ee) The importing or offering for import into the United States of 
an article of food in violation of the requirements under section 381(m) 
of this title.
    (ff) The importing or offering for import into the United States of 
a drug or device with respect to which there is a failure to comply with 
a request of the Secretary to submit to the Secretary a statement under 
section 381(o) of this title.
    (gg) The knowing failure to comply with paragraph (7)(E) of section 
374(g) of this title; the knowing inclusion by a person accredited under 
paragraph (2) of such section of false information in an inspection 
report under paragraph (7)(A) of such section; or the knowing failure of 
such a person to include material facts in such a report.
    (hh) The failure by a shipper, carrier by motor vehicle or rail 
vehicle, receiver, or any other person engaged in the transportation of 
food to comply with the sanitary transportation practices prescribed by 
the Secretary under section 350e of this title.
    (ii) The falsification of a report of a serious adverse event 
submitted to a responsible person (as defined under section 379aa or 
379aa-1 of this title) or the falsification of a serious adverse event 
report (as defined under section 379aa or 379aa-1 of this title) 
submitted to the Secretary.

(June 25, 1938, ch. 675, Sec. 301, 52 Stat. 1042; Dec. 22, 1941, ch. 
613, Sec. 1, 55 Stat. 851; July 6, 1945, ch. 281, Sec. 1, 59 Stat. 463; 
Mar. 10, 1947, ch. 16, Sec. 1, 61 Stat. 11; June 24, 1948, ch. 613, 
Sec. 1, 62 Stat. 582; Mar. 16, 1950, ch. 61, Sec. 3(b), 64 Stat. 20; 
Aug. 7, 1953, ch. 350, Sec. 2, 67 Stat. 477; Pub. L. 85-929, Sec. 5, 
Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86-618, title I, Secs. 104, 
105(a), July 12, 1960, 74 Stat. 403; Pub. L. 87-781, title I, 
Secs. 103(c), 104(e)(1), 106(c), 114(a), title III, Sec. 304, Oct. 
10, 1962, 76 Stat. 784, 785, 788, 791, 795; Pub. L. 89-74, Secs. 5, 
9(c), July 15, 1965, 79 Stat. 232, 235; Pub. L. 90-399, Sec. 103, July 
13, 1968, 82 Stat. 352; Pub. L. 90-639, Sec. 2(b), Oct. 24, 1968, 82 
Stat. 1361; Pub. L. 91-513, title II, Sec. 701(a), Oct. 27, 1970, 84 
Stat. 1281; Pub. L. 92-387, Sec. 4(e), Aug. 16, 1972, 86 Stat. 562; Pub. 
L. 94-295, Secs. 3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 
580, 582; Pub. L. 96-359, Sec. 5, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 
99-570, title IV, Sec. 4014(b)(2), Oct. 27, 1986, 100 Stat. 3207-120; 
Pub. L. 100-293, Sec. 7(a), Apr. 22, 1988, 102 Stat. 99; Pub. L. 101-
502, Sec. 5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 101-508, title IV, 
Sec. 4755(c)(2), Nov. 5, 1990, 104 Stat. 1388-210; Pub. L. 102-300, 
Sec. 3(a)(1), June 16, 1992, 106 Stat. 238; Pub. L. 102-571, title I, 
Sec. 107(2), (3), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, 
Sec. 3(c), Aug. 13, 1993, 107 Stat. 775; Pub. L. 103-396, Sec. 2(b)(1), 
Oct. 22, 1994, 108 Stat. 4154; Pub. L. 103-417, Sec. 10(b), Oct. 25, 
1994, 108 Stat. 4332; Pub. L. 104-134, title II, Sec. 2103, Apr. 26, 
1996, 110 Stat. 1321-319; Pub. L. 104-170, title IV, Sec. 403, Aug. 3, 
1996, 110 Stat. 1514; Pub. L. 104-250, Sec. 5(d), Oct. 9, 1996, 110 
Stat. 3156; Pub. L. 105-115, title I, Sec. 125(a)(2)(A), (C), (b)(2)(B), 
title II, Secs. 204(b), 210(c), title IV, Secs. 401(b), 421, 
Nov. 21, 1997, 111 Stat. 2325, 2336, 2345, 2364, 2380; Pub. L. 106-387, 
Sec. 1(a) [title VII, Sec. 745(d)(1)], Oct. 28, 2000, 114 Stat. 1549, 
1549A-39; Pub. L. 107-188, title III, Secs. 303(b), 304(d), 305(b), 
306(c), 307(b), 321(b)(2), 322(b), June 12, 2002, 116 Stat. 664, 666, 
668, 670, 672, 676, 677; Pub. L. 107-250, title II, Sec. 201(d), Oct. 
26, 2002, 116 Stat. 1609; Pub. L. 108-136, div. A, title XVI, 
Sec. 1603(c), Nov. 24, 2003, 117 Stat. 1690; Pub. L. 108-173, title XI, 
Sec. 1121(b)(1), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 108-214, 
Sec. 2(b)(2)(A), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108-282, title I, 
Sec. 102(b)(5)(C), (D), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109-59, 
title VII, Sec. 7202(d), (e), Aug. 10, 2005, 119 Stat. 1913; Pub. L. 
109-462, Secs. 2(c), 3(b), 4(a), Dec. 22, 2006, 120 Stat. 3472, 
3475.)
                          Amendment of Section

        For termination of amendment by section 401(e) of Pub. L. 105-
    115, see Effective and Termination Dates of 1997 Amendment note 
    below.
                               Amendments

    2006--Par. (e). Pub. L. 109-462, Sec. 3(b), substituted ``374(a), 
379aa, or 379aa-1'' for ``374(a), or 379aa'' and ``360bbb-3, 379aa, or 
379aa-1'' for ``360bbb-3, or 379aa''.
    Pub. L. 109-462, Sec. 2(c), substituted ``, 374(a), or 379aa'' for 
``, or 374(a)'' and ``, 360bbb-3, or 379aa'' for ``, or 360bbb-3''.
    Par. (ii). Pub. L. 109-462, Sec. 4(a), added par. (ii).
    2005--Par. (e). Pub. L. 109-59, Sec. 7202(d), inserted ``350e,'' 
before ``354,'' in two places.
    Par. (hh). Pub. L. 109-59, Sec. 7202(e), added par. (hh).
    2004--Par. (e). Pub. L. 108-282, Sec. 102(b)(5)(C), which directed 
the substitution of ``360b(a)(4)(C), 360b (j), (l) or (m), 360ccc-
1(i).'' for ``360b(a)(4)(C), 360b(j), (l) or (m)'' was executed by 
making the substitution for ``360b(a)(4)(C), 360b(j), (l), or (m)'', to 
reflect the probable intent of Congress.
    Par. (j). Pub. L. 108-282, Sec. 102(b)(5)(D), substituted ``360j, 
360ccc, 360ccc-1, 360ccc-2.'' for ``360j''.
    Par. (gg). Pub. L. 108-214 amended par. (gg) generally. Prior to 
amendment, text read as follows: ``The knowing failure of a person 
accredited under paragraph (2) of section 374(g) of this title to comply 
with paragraph (7)(E) of such section; the knowing inclusion by such a 
person of false information in an inspection report under paragraph 
(7)(A) of such section; or the knowing failure of such a person to 
include material facts in such a report.''
    2003--Par. (d). Pub. L. 108-136 substituted ``section 344, 355, or 
360bbb-3'' for ``section 344 or 355''.
    Par. (e). Pub. L. 108-136 inserted ``360bbb-3,'' after ``350c, 
354,'' and substituted ``360i, or 360bbb-3'' for ``or 360i''.
    Par. (aa). Pub. L. 108-173 substituted ``prescription drug in 
violation of section 384'' for ``covered product in violation of section 
384''.
    2002--Par. (e). Pub. L. 107-188, Sec. 306(c)(1), substituted ``by 
section 350a, 350c, 354, 373, or 374(a) of this title'' for ``by section 
350a, 354, or 373 of this title'' and ``under section 350a, 350c(b)'' 
for ``under section 350a''.
    Par. (j). Pub. L. 107-188, Sec. 306(c)(2), inserted ``350c,'' after 
``350a,''.
    Par. (w). Pub. L. 107-188, Sec. 322(b), amended par. (w) generally. 
Prior to amendment, par. (w) read as follows: ``The making of a 
knowingly false statement in any record or report required or requested 
under subparagraph (A) or (B) of section 381(d)(3) of this title, the 
failure to submit or maintain records as required by sections 
381(d)(3)(A) and 381(d)(3)(B) of this title, the release into interstate 
commerce of any article imported into the United States under section 
381(d)(3) of this title or any finished product made from such article 
(except for export in accordance with section 381(e) or 382 of this 
title or section 262(h) of title 42), or the failure to export or 
destroy any component, part or accessory not incorporated into a drug, 
biological product or device that will be exported in accordance with 
section 381(e) or 382 of this title or section 262(h) of title 42.''
    Par. (bb). Pub. L. 107-188, Sec. 303(b), added par. (bb).
    Par. (cc). Pub. L. 107-188, Sec. 304(d), added par. (cc).
    Par. (dd). Pub. L. 107-188, Sec. 305(b), added par. (dd).
    Par. (ee). Pub. L. 107-188, Sec. 307(b), added par. (ee).
    Par. (ff). Pub. L. 107-188, Sec. 321(b)(2), added par. (ff).
    Par. (gg). Pub. L. 107-250 added par. (gg).
    2000--Par. (aa). Pub. L. 106-387 added par. (aa).
    1997--Par. (e). Pub. L. 105-115, Sec. 125(b)(2)(B), struck out 
``357(d) or (g),'' after ``355(i) or (k),''.
    Par. (i)(1). Pub. L. 105-115, Sec. 125(a)(2)(C), struck out ``, 356, 
357,'' before ``or 379e of this title''.
    Par. (j). Pub. L. 105-115, Sec. 125(a)(2)(A), struck out ``356, 
357,'' before ``360,''.
    Par. (l). Pub. L. 105-115, Sec. 421, struck out par. (l) which read 
as follows: ``The using, on the labeling of any drug or device or in any 
advertising relating to such drug or device, of any representation or 
suggestion that approval of an application with respect to such drug or 
device is in effect under section 355, 360e, or 360j(g) of this title, 
as the case may be, or that such drug or device complies with the 
provisions of such section.''
    Par. (x). Pub. L. 105-115, Sec. 204(b), added par. (x).
    Par. (y). Pub. L. 105-115, Sec. 210(c), added par. (y).
    Par. (z). Pub. L. 105-115, Sec. 401(b), (e), temporarily added par. 
(z). See Effective and Termination Dates of 1997 Amendment note below.
    1996--Par. (e). Pub. L. 104-250 inserted ``, 354,'' before ``or 373 
of this title'' and ``354,'' before ``355(i) or (k)''.
    Par. (j). Pub. L. 104-170 inserted before period at end of first 
sentence ``; or the violating of section 346a(i)(2) of this title or any 
regulation issued under that section.''
    Pars. (u) to (w). Pub. L. 104-134 redesignated par. (u) relating to 
introduction into interstate commerce of unsafe dietary supplement as 
(v) and added par. (w).
    1994--Par. (e). Pub. L. 103-396, Sec. 2(b)(1)(A), substituted 
``357(d) or (g), 360b(a)(4)(C),'' for ``357(d) or (g),''.
    Par. (u). Pub. L. 103-417 added par. (u) relating to introduction 
into interstate commerce of unsafe dietary supplement.
    Pub. L. 103-396, Sec. 2(b)(1)(B), added par. (u) relating to failure 
to comply with regulations or orders of Secretary.
    1993--Par. (j). Pub. L. 103-80, Sec. 3(c)(1), substituted ``379, or 
379e'' for ``379e, or 379''.
    Par. (s). Pub. L. 103-80, Sec. 3(c)(2), substituted ``350a(e)'' for 
``350a(d)''.
    1992--Pars. (i)(1), (j). Pub. L. 102-571 substituted ``379e'' for 
``376''.
    Par. (q)(1)(C). Pub. L. 102-300 added cl. (C).
    1990--Par. (e). Pub. L. 101-502 substituted ``or (k)'' for ``or 
(j)''.
    Par. (j). Pub. L. 101-508 inserted at end ``This paragraph does not 
authorize the withholding of information from either House of Congress 
or from, to the extent of matter within its jurisdiction, any committee 
or subcommittee of such committee or any joint committee of Congress or 
any subcommittee of such joint committee.''
    1988--Par. (t). Pub. L. 100-293 added par. (t).
    1986--Par. (s). Pub. L. 99-570 amended par. (s) generally. Prior to 
amendment, par. (s) read as follows: ``The failure to provide the notice 
required by section 350a(b) or 350a(c), the failure to make the reports 
required by section 350a(d)(1)(B), or the failure to meet the 
requirements prescribed under section 350a(d)(2).''
    1980--Par. (e). Pub. L. 96-359, Sec. 5(b), inserted reference to 
section 350a of this title in two places.
    Par. (j). Pub. L. 96-359, Sec. 5(c), inserted reference to section 
350a of this title.
    Par. (s). Pub. L. 96-359, Sec. 5(a), added par. (s).
    1976--Par. (e). Pub. L. 94-295, Sec. 3(b)(2), inserted references to 
sections 360e(f) and 360i of this title.
    Par. (j). Pub. L. 94-295, Sec. 3(b)(3), inserted references to 
sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of this 
title.
    Par. (l). Pub. L. 94-295, Sec. 3(b)(4), substituted ``drug or 
device'' for ``drug'' wherever appearing, and inserted references to 
sections 360e and 360j(g) of this title.
    Par. (p). Pub. L. 94-295, Sec. 4(b)(1), substituted ``section 360(j) 
or 360(k) of this title,'' for ``section 360(j) of this title,''.
    Par. (q). Pub. L. 94-295, Sec. 3(b)(1), added par. (q).
    Par. (r). Pub. L. 94-295, Sec. 7(b), added par. (r).
    1972--Par. (p). Pub. L. 92-387 added failure to provide information 
required by section 360(j) of this title, and failure to provide notice 
required by section 360(j)(2) of this title as prohibited acts.
    1970--Par. (q). Pub. L. 91-513 struck out par. (q) which set out 
penalties for illegal manufacture, sale, disposition, possession and 
other traffic in stimulant and depressant drugs. See section 801 et seq. 
of this title.
    1968--Par. (e). Pub. L. 90-399, Sec. 103(1), inserted reference to 
section 360b(j), (l), and (m) of this title.
    Par. (j). Pub. L. 90-399, Sec. 103(2), inserted reference to section 
360b of this title.
    Par. (q). Pub. L. 90-639 divided cl. (3), which referred simply to 
possession in violation of section 360a(c) of this title, into subcls. 
(A) and (B) which refer, respectively, to possession in violation of 
section 360a(c)(1) of this title and possession in violation of section 
360a(c)(2) of this title.
    1965--Par. (i). Pub. L. 89-74, Sec. 9(c), designated existing 
provisions as subpar. (1) and added subpars. (2) and (3).
    Par. (q). Pub. L. 89-74, Sec. 5, added par. (q).
    1962--Par. (e). Pub. L. 87-781, Secs. 103(c), 106(c), prohibited 
the failure to establish or maintain any record, or make any report, 
required under sections 355(i) or (j) and 507(d) or (g) of this title, 
or the refusal to permit access to, or verification or copying of, any 
such required record.
    Par. (l). Pub. L. 87-781, Sec. 104(e)(1), inserted ``approval of'' 
before ``an application'', and substituted ``in effect'' for 
``effective''.
    Par. (o). Pub. L. 87-781, Sec. 114(a), added par. (o).
    Par. (p). Pub. L. 87-781, Sec. 304, added par. (p).
    1960--Par. (i). Pub. L. 86-618, Sec. 105(a), struck out references 
to sections 346(b), 354, and 364 of this title and inserted reference to 
section 376 of this title.
    Par. (j). Pub. L. 86-618, Sec. 104, inserted reference to section 
376 of this title.
    1958--Par. (j). Pub. L. 85-929, inserted reference to section 348 of 
this title.
    1953--Par. (n). Act Aug. 7, 1953, added par. (n).
    1950--Par. (m). Act Mar. 16, 1950, added par. (m).
    1948--Par. (k). Act June 24, 1948, inserted ``(whether or not the 
first sale)'' so as to make it clear that this subsection is not limited 
to the case where the act occurs while the article is held for the first 
sale after interstate shipment, and extended coverage of subsection to 
acts which result in adulteration.
    1947--Par. (j). Act Mar. 10, 1947, inserted reference to sections 
356 and 357 of this title.
    1945--Par. (i). Act July 6, 1945, inserted reference to section 357 
of this title.
    1941--Par. (i). Act Dec. 22, 1941, inserted reference to section 356 
of this title.
                    Effective Date of 2006 Amendment

    Amendment by section 2(c) of Pub. L. 109-462 effective 1 year after 
Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109-462, set out as a note 
under section 352 of this title.
    Amendment by section 3(b) of Pub. L. 109-462 effective 1 year after 
Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109-462, set out as a note 
under section 343 of this title.
    Pub. L. 109-462, Sec. 4(b), Dec. 22, 2006, 120 Stat. 3475, provided 
that: ``The amendment made by this section [amending this section] shall 
take effect 1 year after the date of enactment of this Act [Dec. 22, 
2006].''
                    Effective Date of 2005 Amendment

    Pub. L. 109-59, title VII, Sec. 7204, Aug. 10, 2005, 119 Stat. 1914, 
provided that: ``This subtitle [subtitle B (Secs. 7201-7204) of 
title VII of Pub. L. 109-59, enacting section 350e of this title, 
amending this section, sections 342 and 373 of this title, and section 
5701 of Title 49, Transportation, omitting sections 5702 to 5714 of 
Title 49, and enacting provisions set out as a note under section 301 of 
this title] takes effect on October 1, 2005.''
                    Effective Date of 2002 Amendment

    Pub. L. 107-188, title III, Sec. 321(c), June 12, 2002, 116 Stat. 
676, provided that: ``The amendments made by this section [amending this 
section and sections 360 and 381 of this title] take effect upon the 
expiration of the 180-day period beginning on the date of the enactment 
of this Act [June 12, 2002].''
    Pub. L. 107-188, title III, Sec. 322(c), June 12, 2002, 116 Stat. 
678, provided that: ``The amendments made by this section [amending this 
section and section 381 of this title] take effect upon the expiration 
of the 90-day period beginning on the date of the enactment of this Act 
[June 12, 2002].''
            Effective and Termination Dates of 1997 Amendment

    Amendment by sections 204, 210, and 421 of Pub. L. 105-115 effective 
90 days after Nov. 21, 1997, except as otherwise provided, see section 
501 of Pub. L. 105-115, set out as a note under section 321 of this 
title.
    Amendment by section 401(b) of Pub. L. 105-115 effective 1 year 
after Nov. 21, 1997, or upon Secretary's issuance of final regulations 
pursuant to section 401(c) of Pub. L. 105-115, whichever is sooner, and 
ceases to be effective Sept. 30, 2006, or 7 years after date Secretary 
promulgates regulations under section 401(c) of Pub. L. 105-115, 
whichever is later, see section 401(d), (e) of Pub. L. 105-115, set out 
as an Effective and Termination Dates note under section 360aaa of this 
title.
                    Effective Date of 1994 Amendment

    Amendment by Pub. L. 103-396 effective upon adoption of final 
regulations under section 2(c) of Pub. L. 103-396, set out as a 
Regulations note under section 360b of this title, see section 2(d) of 
Pub. L. 103-396, set out as a note under section 360b of this title.
                    Effective Date of 1990 Amendment

    Section 4755(c)(2) of Pub. L. 101-508 provided that the amendment 
made by that section is effective as if included in subtitle D of title 
VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L. 101-239, 
title VI, Secs. 6601, 6602, Dec. 19, 1989, 103 Stat. 2285, see 42 
U.S.C. 300aa-1 note, 300aa-10 note.
                    Effective Date of 1988 Amendment

    Amendment by Pub. L. 100-293 effective upon expiration of 90 days 
after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out as a 
note under section 353 of this title.
                    Effective Date of 1972 Amendment

    Amendment by Pub. L. 92-387 effective on first day of sixth month 
beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set out 
as a note under section 360 of this title.
                    Effective Date of 1970 Amendment

    Amendment by Pub. L. 91-513 effective on first day of seventh 
calendar month that begins after Oct. 26, 1970, see section 704 of Pub. 
L. 91-513, set out as an Effective Date note under section 801 of this 
title.
                    Effective Date of 1968 Amendments

    Amendment by Pub. L. 90-399 effective on first day of thirteenth 
calendar month after July 13, 1968, see section 108(a) of Pub. L. 90-
399, set out as an Effective Date and Transitional Provisions note under 
section 360b of this title.
    Amendment by Pub. L. 90-639 applicable only with respect to 
violations of this chapter committed after Oct. 24, 1968, see section 6 
of Pub. L. 90-639, set out as an Effective Date of 1968 Amendments; 
Transitional Provisions note under section 321 of this title.
                    Effective Date of 1965 Amendment

    Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11 of 
Pub. L. 89-74, set out as a note under section 321 of this title.
                    Effective Date of 1962 Amendment

    Amendment by sections 103(c) and 106(c) of Pub. L. 87-781 effective 
on first day of seventh calendar month following Oct. 1962, and 
amendment by section 104(e)(1) of Pub. L. 87-781 effective Oct. 10, 
1962, see section 107 of Pub. L. 87-781, set out as a note under section 
321 of this title.
    Section 114(b) of Pub. L. 87-781 provided that: ``This section 
[amending this section] shall take effect on the first day of the 
seventh calendar month following the month in which this Act is enacted 
[October 1962].''
                    Effective Date of 1960 Amendment

    Amendment by Pub. L. 86-618 effective July 12, 1960, subject to 
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub. L. 
86-618, set out as a note under section 379e of this title.
                    Effective Date of 1958 Amendment

    Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section 
6(a) of Pub. L. 85-929, set out as a note under section 342 of this 
title.
                    Effective Date of 1950 Amendment

    Amendment by act Mar. 16, 1950, effective July 1, 1950, see section 
7 of that act, set out as an Effective Date note under section 347 of 
this title.
                               Regulations

    Secretary of Health and Human Services to promulgate regulations to 
implement amendments made by section 401 of Pub. L. 105-115 not later 
than 1 year after Nov. 21, 1997, see section 401(c) of Pub. L. 105-115, 
set out as a note under section 360aaa of this title.
                            Savings Provision

    Amendment by Pub. L. 91-513 not to affect or abate any prosecutions 
for violation of law or any civil seizures or forfeitures and injunctive 
proceedings commenced prior to the effective date of such amendment, and 
all administrative proceedings pending before the Bureau of Narcotics 
and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 
27, 1970, to be continued and brought to final determination in accord 
with laws and regulations in effect prior to Oct. 27, 1970, see section 
702 of Pub. L. 91-513, set out as a note under section 321 of this 
title.
              Construction of Amendments by Pub. L. 107-188

    Pub. L. 107-188, title III, Sec. 315, June 12, 2002, 116 Stat. 675, 
provided that: ``Nothing in this title [enacting sections 350c, 350d, 
398, 399, and 679c of this title, sections 3353, 3354, 8319, and 8320 of 
Title 7, Agriculture, and section 247b-20 of Title 42, The Public Health 
and Welfare, amending this section, sections 334, 335a, 342, 343, 360, 
372, 374, and 381 of this title, and section 43 of Title 18, Crimes and 
Criminal Procedure, and enacting provisions set out as notes under this 
section and sections 341, 350c, 350d, and 381 of this title], or an 
amendment made by this title, shall be construed to alter the 
jurisdiction between the Secretaries of Agriculture and of Health and 
Human Services, under applicable statutes and regulations.''

                          Transfer of Functions

    For transfer of functions of Federal Security Administrator 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.