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Effective: [See Text Amendments]
United States Code Annotated Currentness
Title 21. Food and Drugs (Refs & Annos)
Chapter 9. Federal Food, Drug, and Cosmetic Act (Refs & Annos)
Subchapter I. Short Title (Refs & Annos)
§ 301. Short title
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
CREDIT(S)
(June 25, 1938, c. 675, § 1, 52 Stat. 1040.)
HISTORICAL AND STATUTORY NOTES
Revision Notes and Legislative Reports
1997 Acts. House Conference Report No. 105-399, see 1997 U.S. Code Cong. and Adm. News,
p. 2881.
Effective and Applicability Provisions
1938 Acts. Section 902(a) of Act June 25, 1938, provided that: "This Act [affecting former
section 1 et seq. of this title and this chapter], shall take effect twelve months after the date of its
enactment [June 25, 1938]. The Federal Food and Drugs Act of June 30, 1906, as amended
(U.S.C., 1934 ed., title 21, secs. 1 to 15) [former section 1 et seq. of this title], shall remain in
force until such effective date, and, except as otherwise provided in this subsection, is hereby
repealed effective upon such date: Provided, That the provisions of section 701 [section 371 of
this title] shall become effective on the enactment of this Act [June 25, 1938], and thereafter the
Secretary is authorized hereby to (1) conduct hearings and to promulgate regulations which shall
become effective on or after the effective date of this Act as the Secretary shall direct, and (2)
designate prior to the effective date of this Act food having common or usual names and exempt
such food from the requirements of clause (2) of section 403(i) [section 343(i) of this title] for a
reasonable time to permit the formulation, promulgation, and effective application of definitions
and standards of identity therefor as provided by section 401 [section 341 of this title]: Provided
further, that sections 502(j), 505, and 601(a) [sections 352(j), 355, 361(a), respectively of this
title], and all other provisions of this Act to the extent that they may relate to the enforcement of
such sections, shall take effect on the date of the enactment of this Act [June 25, 1938], except
that in the case of a cosmetic to which the proviso of section 601(a) [section 361(a) of this title],
relates, such cosmetic shall not, prior to the ninetieth day after such date of enactment [June 25,
1938], be deemed adulterated by reason of the failure of its label to bear the legend prescribed in
such proviso: Provided further, That the Act of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6
[now section 321(a) of this title]; 42 Stat. 1500, ch. 268), defining butter and providing a
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standard therefor; the Act of July 24, 1919 (U.S.C., 1934 ed., title 21, sec. 10 [now section
321(b) of this title]; 41 Stat. 271, ch. 26), defining wrapped meats as in package form; and the
amendment to the Food and Drugs Act, section 10A, approved August 27, 1935 (U.S.C., 1934
ed., Sup. III, title 21, see. 14a [now section 372a of this title] ), shall remain in force and effect
and be applicable to the provisions of this Act."
Effective Date; Postponement in Certain Cases
Sections 342(c), 343(e)(1), (g) to (k), 351(a)(4), 352(b), (d) to (h), 361(e) and 362(b) of this title
effective Jan. 1, 1940, and § § 343(e)(1), (g) to (k), 352(b), (d) to (h) and 362(b) of this title
effective July 1, 1940, as provided by regulations for certain lithographed labeling and containers
bearing certain labeling, see Act June 23, 1939, c. 242, § § 1, 2, 53 Stat. 853, set out as a note
under 21 U.S.C.A. § 392.
Short Title
2006 Amendments. Pub.L. 109-462, § 1, Dec. 22, 2006, 120 Stat. 3469, provided that: "This
Act [enacting 21 U.S.C.A. § § 379aa and 379aa-1, amending 21 U.S.C.A. § § 331, 343, 352,
and 381, and enacting provisions set out as notes under 21 U.S.C.A. § § 331, 352, 343, 379aa,
and 381] may be cited as the 'Dietary Supplement and Nonprescription Drug Consumer
Protection Act'."
2005 Amendments. Pub.L. 109-59, Title VII, § 7201, Aug. 10, 2005, 119 Stat. 1911, provided
that: "This subtitle [enacting 21 U.S.C.A. § 350e, amending chapter 57 of Title 49, 49 U.S.C.A.
§ 5701 et seq., amending 21 U.S.C.A. § § 331, 342, and 373, and enacting a provision set out as
a note under 21 U.S.C.A. § 301] may be cited as the 'Sanitary Food Transportation Act of
2005'."
Pub.L. 109-43, § 1, Aug. 1, 2005, 119 Stat. 439, provided that: "This Act [amending 21
U.S.C.A. § § 352 and 379j, enacting provisions set out as notes under 21 U.S.C.A. § 352, and
amending provisions set out as a note under 21 U.S.C.A. § 379i] may be cited as the 'Medical
Device User Fee Stabilization Act of 2005'."
2004 Amendments. Pub.L. 108-282, Title I, § 101, Aug. 2, 2004, 118 Stat. 891, provided that:
"This title [enacting 21 U.S.C.A. § § 360ccc, 360ccc-1, and 360ccc-2, amending 21 U.S.C.A. §
§ 321, 331, 352, 353, 354, and 360b, enacting provisions set out as notes under 21 U.S.C.A. § §
360ccc and 393, and amending provisions set out as notes under 21 U.S.C.A. § 360b] may be
cited as the 'Minor Use and Minor Species Animal Health Act of 2004'."
Pub.L. 108-282, Title II, § 201, Aug. 2, 2004, 118 Stat. 905, provided that: "This title [enacting
21 U.S.C.A. § 374a and 42 U.S.C.A. § 242r, amending 21 U.S.C.A. § § 321, 343, and 343-1,
and enacting provisions set out as notes under 21 U.S.C.A. § § 321, 343, and 42 U.S.C.A. § §
243 and 300d-2] may be cited as the 'Food Allergen Labeling and Consumer Protection Act of
2004'."
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Pub.L. 108-214, § 1, Apr. 1, 2004, 118 Stat. 572, provided that: "This Act [amending 21
U.S.C.A. § § 331, 352, 360, 360e, 374, 379i, and 379j, and amending provisions set out as notes
under 21 U.S.C.A. § § 352, 360l, and 379j] may be cited as the 'Medical Devices Technical
Corrections Act'."
2003 Amendments. Pub.L. 108-155, § 1, Dec. 3, 2003, 117 Stat. 1936, provided that: "This Act
[enacting 21 U.S.C.A. § 355c, amending 21 U.S.C.A. § § 355, 355a, and 355b, 42 U.S.C.A. § §
262 and 284m, enacting provisions set out as a note under 21 U.S.C.A. § 355c, and amending
provisions set out as notes under 21 U.S.C.A. § 355a and 42 U.S.C.A. § 284m] may be cited as
the 'Pediatric Research Equity Act of 2003'."
Pub.L. 108-130, 1, Nov. 18, 2003, 117 Stat. 1361, provided that: "This Act [enacting 21
U.S.C.A. § § 379j-11, 379j-12, and provisions set out as notes under 21 U.S.C.A. § 379j-11]
may be cited as the 'Animal Drug User Fee Act of 2003'."
2002 Amendments. Pub.L. 107-281, § 1, Nov. 6, 2002, 116 Stat. 1992, provided that: "This Act
[amending 21 U.S.C.A. § § 360cc and 360ee and enacting provisions set out as a note under 21
U.S.C.A. § 360ee] may be cited as the 'Rare Diseases Orphan Product Development Act of
2002'."
Pub.L. 107-250, § 1(a), Oct. 26, 2002, 116 Stat. 1588, provided that: "This Act [enacting 21
U.S.C.A. § § 379i and 379j and 42 U.S.C.A. § 289g-3, amending 21 U.S.C.A. § § 321, 331,
333, 335a, 352, 353, 360, 360c, 360e, 360m, 374, and enacting provisions set out as notes under
21 U.S.C.A. § § 352, 360e, 360j, 360l, 379i, and 379j and 42 U.S.C.A. § 289g-3] may be cited
as the 'Medical Device User Fee and Modernization Act of 2002'."
Pub.L. 107-188, Title V, § 501, June 12, 2002, 116 Stat. 687, provided that: "This subtitle
[Pub.L. 107-188, Title V, Subtitle A, § § 501 to 509, June 12, 2002, 116 Stat. 687, amending 21
U.S.C.A. § § 356b, 379g, and 379h, and enacting provisions set out as notes under 21 U.S.C.A.
§ § 356b and 379g] may be cited as the 'Prescription Drug User Fee Amendments of 2002'."
Pub.L. 107-109, § 1, Jan. 4, 2002, 115 Stat. 1408, provided that: "This Act [enacting 21
U.S.C.A. § § 355b and 393a and 42 U.S.C.A. § 284m, amending 21 U.S.C.A. § § 321, 355a
and 379h and 42 U.S.C.A. § § 282, 284k, 284l, 285a-2 and 290b, and enacting provisions set out
as notes under 21 U.S.C.A. § § 355 and 355a and 42 U.S.C.A. § § 284m and 289] may be cited
as the 'Best Pharmaceuticals for Children Act'."
2000 Amendments. Pub.L. 106-387, § 1(a) [Title VII, § 745(a)], Oct. 28, 2000, 114 Stat. 1549,
1549A-35, provided that: "This section [enacting section 384 of this title, amending sections
331, 333, and 381 of this title, and enacting note provisions under this section and section 384 of
this title] may be cited as the 'Medicine Equity and Drug Safety Act of 2000'."
Pub.L. 106-387, § 1(a) [Title VII, § 746(a)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40, provided
that: "This section [amending section 381 of this title and enacting note provisions under this
section and section 381 of this title] may be cited as the 'Prescription Drug Import Fairness Act
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of 2000'."
1998 Amendments. Pub.L. 105-324, § 1, Oct. 30, 1998, 112 Stat. 3035, provided that: "This
Act [amending sections 321 and 346a of this title] may be cited as the 'Antimicrobial Regulation
Technical Corrections Act of 1998'."
1997 Amendments. Pub.L. 105-115, § 1(a), Nov. 21, 1997, 111 Stat. 2296, provided that: "This
Act [enacting sections 343-3, 353a, 355a, 356, 356a, 356b, 356c, 360m, 360aaa, 360aaa-1,
360aaa-2, 360aaa-3, 360aaa-4, 360aaa-5, 360aaa-6, 360bbb, 360bbb-1, 360bbb-2, 379k, 379l,
379o, 379r, 379s, 379v, 396, and 397 of this title, sections 247b-8 and 299a-3 of Title 42, this
note, and provisions set out as notes under sections 321, 348, 351, 352, 353a, 355, 356, 356a,
356b, 360i, 360l, 360m, 360aaa, 371, 379g, 379h, 379k, 379q, and 393 of this title, and sections
247b-8 and 282 of Title 42; amending sections 321, 331, 334, 335a, 343, 348, 351, 352, 353,
355, 360, 360b, 360c, 360d, 360e, 360g, 360i, 360j, 360l, 360aa, 360bb, 360cc, 360ee, 371, 374,
379a, 379g, 379h, 381, 382, 383, 393, and 802 of this title, and section 45C of Title 26, section
156 of Title 35, section 8126 of Title 38, and sections 262, 263a, and 282 of Title 42; and
repealing sections 356 and 357 of this title. For complete classification of this Act to the Code,
see Tables] may be cited as the 'Food and Drug Administration Modernization Act of 1997'."
1996 Amendments. Pub.L. 104-250, § 1(a), Oct. 9, 1996, 110 Stat. 3151, provided that: "This
Act [enacting section 354 of this title, amending sections 331, 353, and 360b of this title, and
enacting provisions set out as notes under section 360b of this title] may be cited as the 'Animal
Drug Availability Act of 1996'."
Pub.L. 104-170, Title IV, § 401(a), Aug. 3, 1996, 110 Stat. 1513, provided that: "This title
[amending sections 321, 331, 333, 342, and 346a of this title] may be cited as the 'Food Quality
Protection Act of 1996'."
Pub.L. 104-134, Title II, § 2101(a), Apr. 26, 1996, 110 Stat. 1321-313, provided that: "This
chapter [enacting section 382 of this title and amending sections 331 and 381 of this title and
section 262 of Title 42, The Public Health and Welfare] may be cited as the 'FDA Export Reform
and Enhancement Act of 1996'."
1994 Amendments. Pub.L. 103-417, § 1(a), Oct. 25, 1994, 108 Stat. 4325, provided that: "This
Act [enacting sections 343-2 and 350b of this title and section 287c-11 of Title 42, The Public
Health and Welfare, amending sections 321, 331, 342, 343, and 350 of this title and section 281
of Title 42, and enacting provisions set out as notes under sections 321 and 343 of this title] may
be cited as the 'Dietary Supplement Health and Education Act of 1994'."
Pub.L. 103-396, § 1, Oct. 22, 1994, 108 Stat. 4153, provided that: "This Act [amending sections
331, 343-1, 360b, and 371 of this title and enacting provisions set out as notes under section
360b of this title] may be cited as the 'Animal Medicinal Drug Use Clarification Act of 1994'."
1993 Amendments. Pub.L. 103-80, § 1, Aug. 13, 1993, 107 Stat. 773, provided that: "This Act
[amending sections 321, 331, 332, 333, 334, 335b, 341, 342, 343, 346a, 350a, 352, 355, 356,
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357, 358, 360b, 360c, 360d, 360e, 360i, 360cc, 360hh to 360ss, 361, 371, 372, 373, 374, 376,
379e, and 381 of this title and enacting provisions set out as notes under section 343 of this title]
may be cited as the 'Nutrition Labeling and Education Act Amendments of 1993'."
1992 Amendments. Pub.L. 102-571, Title I, § 101(a), Oct. 29, 1992, 106 Stat. 4491, provided
that: "This title [enacting sections 379g and 379h of this title, amending sections 321, 331, 342,
343, 346a, 351, 352, 360j, 361, 362, 379d, 453, 601 and 1033 of this title, and redesignating
former sections 372, 376 an 379c of this title as sections 376, 379e and 379f respectively of this
title; and enacting provisions set out as notes under sections 379g of this title, and amending
provisions set out as notes under sections 343 and 343-1 of this title] may be cited as the
'Prescription Drug User Fee Act of 1992'."
Pub.L. 102-571, Title II, § 201, Oct. 29, 1992, 106 Stat. 4500, provided that: "This title
[enacting provisions set out as notes under sections 343 and 393 of this title, and amending
provisions set out as notes under sections 343 and 343-1 of this title] may be cited as the 'Dietary
Supplement Act of 1992'."
Pub.L. 102-353, § 1(a), Aug. 26, 1992, 106 Stat. 941, provided that: "This Act [amending
sections 333, 353, and 381 of this title] may be cited as the 'Prescription Drug Amendments of
1992'."
Pub.L. 102-300, § 1(a), June 16, 1992, 106 Stat. 238, provided that: "This Act [amending
sections 321, 331, 334, 346a, 352, 353, 356, 357, 360c, 360d, 360g, 360h, 360i, 360i note, 360l,
371, 372, 372a, 376, and 381 of this title and section 262 of Title 42, The Public Health and
Welfare, and enacting provisions set out as notes under section 360i of this title] may be cited as
the 'Medical Device Amendments of 1992'."
Pub.L. 102-282, § 1(a), May 13, 1992, 106 Stat. 149, provided that: "This Act [enacting
sections 335a, 335b, and 335c of this title, amending sections 321, 336, 337, and 355 of this title,
and enacting provisions set out as notes under section 335a of this title] may be cited as the
'Generic Drug Enforcement Act of 1992'."
1990 Amendments. Pub.L. 101-635, § 1(a), Nov. 28, 1990, 104 Stat. 4583, provided that: "This
Act [enacting sections 379b, 379c, 379d, and 394 of this title] may be cited as the 'Food and
Drug Administration Revitalization Act'."
Pub.L. 101-629, § 1(a), Nov. 28, 1990, 104 Stat. 4511, provided that: "This Act [enacting
sections 360l and 383 of this title, redesignating sections 263b to 263n of Title 42, The Public
Health and Welfare, as sections 360gg to 360ss of this title, amending sections 321, 333, 351,
353 and 360c to 360j of this title and 263d, 263f to 263k and 263n of Title 42, repealing section
263b of Title 42 and enacting provisions set out as notes under sections 333, 360c, 360i, 360j,
360hh, and 383 of this title] may be cited as the 'Safe Medical Devices Act of 1990'."
Pub.L. 101-535, § 1(a), Nov. 8, 1990, 104 Stat. 2353, provided that: "This Act [enacting section
343-1 of this title, amending sections 321, 337, 343, 345 and 371 of this title and enacting
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provisions set out as notes under sections 343 and 343-1 of this title] may be cited as the
'Nutrition Labeling and Education Act of 1990'."
1988 Amendments. Pub.L. 100-670, § 1(a), Nov. 16, 1988, 102 Stat. 3971, provided that: "This
Act [amending sections 321, 353 and 360b of this title, section 2201 of Title 28, Judiciary and
Judicial Procedure, and sections 156 and 271 of Title 35, Patents, and enacting provisions set out
as notes under section 360b of this title] may be cited as the 'Generic Animal Drug and Patent
Term Restoration Act'."
Pub.L. 100-607, Title V, § 501, Nov. 4, 1988, 102 Stat. 3120, provided that: "This title
[enacting section 393 of this title, amending sections 5315 and 5316 of Title 5, Government
Organization and Employees, and enacting provisions set out as a note under section 393 of this
title] may be cited as the 'Food and Drug Administration Act of 1988'."
Pub.L. 100-293, § 1(a), Apr. 22, 1988, 102 Stat. 95, provided that: "This Act [amending
sections 331, 333, 353, and 381 of this title and enacting provisions set out as notes under section
353 of this title] may be cited as the 'Prescription Drug Marketing Act of 1987'."
Pub.L. 100-290, § 1, Apr. 18, 1988, 102 Stat. 90, provided that: "This Act [amending sections
360bb and 360ee of this title, enacting a provision set out as a note under section 360aa of this
title, and amending a provision set out as a note under section 236 of Title 42, The Public Health
and Welfare] may be cited as the 'Orphan Drug Amendments of 1988'."
1986 Amendments. Pub.L. 99-660, Title I, § 101(a), Nov. 14, 1986, 100 Stat. 3743, provided
that: "This title [enacting section 382 of this title, amending sections 241 and 262 of Title 42,
The Public Health and Welfare, and enacting provisions set out as notes under section 333 of this
title and section 262 of Title 42] may be cited as the 'Drug Export Amendments Act of 1986'."
1985 Amendments. Pub.L. 99-91, § 1, Aug. 15, 1985, 99 Stat. 387, provided that: "This Act
[amending sections 360aa to 360cc, and 360ee of this title, and sections 295g-1 and 6022 of Title
42, The Public Health and Welfare, and enacting provisions set out as notes under section 360aa
of this title and section 236 of Title 42] may be cited as the 'Orphan Drug Amendments of
1985'."
1984 Amendments. Pub.L. 98-417, § 1, Sept. 24, 1984, 98 Stat. 1585, provided: "That this Act
[enacting section 156 of Title 35, Patents, amending sections 355 and 360cc of this title and
sections 68b, 68c, and 70b of Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary
and Judicial Procedure, and section 271 of Title 35, and enacting provisions set out as notes
under section 68b of Title 15 and section 355 of this title] may be cited as the 'Drug Price
Competition and Patent Term Restoration Act of 1984'."
1983 Amendments. Pub.L. 98-22, § 1, Apr. 22, 1983, 97 Stat. 173 provided: "That this Act
[amending provisions set out as a note under section 348 of this title] may be cited as the
'Saccharin Study and Labeling Act Amendment of 1983'."
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Pub.L. 97-414, § 1(a), Jan. 4, 1983, 96 Stat. 2049 provided that: "This Act [enacting part B of
subchapter V of chapter 9 of this title (§ 360aa et seq. of this title) and section 360ee of this title,
section 44H of Title 26, the Internal Revenue Code, section 155 of Title 35, Patents, and sections
236, 255, and 298b-4 of Title 42, Public Health and Welfare, amending sections 1274, 1472,
2055, 2060, 2064, 2068, and 2080 of Title 15, Commerce and Trade, section 904 of this title,
sections 280C and 6096 of Title 26, and sections 209, 231, 242k, 242m, 243, 254c, 254j, 254m,
254o, 254p, 256, 294j, 295g-1, 295g-4, 295h, 297-1, 300, 300a-1, 300b, 300e-1, 300g-2, 300m,
300u-5, 300w-3, 300x-1, 300x-4, 300y-11, 4577, and 4587 of Title 42, enacting provisions set
out as notes under section 44H of Title 26, sections 241, 255, 287i, and 300x-1 of Title 42, and
repealing provisions set out as a note under section 300t-11 of Title 42] may be cited as the
'Orphan Drug Act'."
1981 Amendments. Pub.L. 97-42, § 1, Aug. 14, 1981, 95 Stat. 946, provided: "That this Act
[amending provisions set out as a note under section 348 of this title] may be cited as the
'Saccharin Study and Labeling Act Amendments of 1981'."
1980 Amendments. Pub.L. 96-359, § 1, Sept. 26, 1980, 94 Stat. 1190, provided: "That this Act
[enacting section 350a of this title amending sections 321, 331, 374, 830, 841 to 843, and 873 of
this title, and enacting provisions set out as a note under section 350a of this title] may be cited
as the 'Infant Formula Act of 1980'."
1977 Amendments. Pub.L. 95-203, § 1, Nov. 23, 1977, 91 Stat. 1451, provided that: "This Act
[which enacted section 343a of this title, amended sections 321 and 343 of this title, enacted
provisions set out as notes under sections 343 and 348 of this title, and amended provisions set
out as notes under sections 218 and 289l-1 of Title 42, The Public Health and Welfare] may be
cited as the 'Saccharin Study and Labeling Act'."
1976 Amendments. Pub.L. 94-295, § 1(a), May 28, 1976, 90 Stat. 539, provided that: "This Act
[enacting sections 360c to 360k, 379, and 379a of this title and section 3512 of Title 42, The
Public Health and Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360, 374, 376,
and 381 of this title and section 55 of Title 15, Commerce and Trade] may be cited as the
'Medical Device Amendments of 1976'."
1972 Amendments. Pub.L. 92-387, § 1, Aug. 16, 1973, 86 Stat. 559 provided that: "This Act
[amending sections 331, 355, and 360 of this title and enacting provisions set out as notes under
section 360 of this title] may be cited as the 'Drug Listing Act of 1972'."
1968 Amendments. Pub.L. 90-602, § 1, Oct. 18, 1968, 82 Stat. 1173, provided that: "This Act
[enacting provisions now comprising part C of subchapter III of this chapter, 21 U.S.C.A. § §
360hh to 360ss, and enacting provisions set out as notes under 21 U.S.C.A. § 360hh] may be
cited as the 'Radiation Control for Health and Safety Act of 1968'."
Pub.L. 90-399, § 1, July 13, 1968, 82 Stat. 342, provided: "That this Act [which enacted
section 360b of this title, amended sections 321, 331, 342, 351, 352, 357, 381, and 392 of this
title, and enacted provisions set out as a note under section 360b of this title] may be cited as the
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'Animal Drug Amendments of 1968'."
1965 Amendments. Pub.L. 89-74, § 1, July 15, 1965, 79 Stat. 226, provided: "That this Act
[which enacted former section 360a of this title, amended sections 321, 331, 333, 334, 360, and
372 of this title and section 1114 of Title 18, Crimes and Criminal Procedure, and enacted
provisions set out as notes under sections 321 and 352 of this title] may be cited as the 'Drug
Abuse Control Amendments of 1965'."
1962 Amendments. Pub.L. 87-781, § 1, Oct. 10, 1962, 76 Stat. 780, provided in part that Pub.L.
87-781 [adding sections 358 to 360, amending sections 321, 331, 332, 348, 351 to 353, 355, 357,
372, 374, 376, and 381 of this title, and enacting provisions set out as notes under sections 321,
331, 332, 352, 355, 360, and 374 of this title] may be cited as the "Drug Amendments of 1962".
1960 Amendments. Section 1 of Pub.L. 86-618 provided that: "This Act [which amended this
section and sections 321, 331, 333, 342, 346, 351, 352, 361, 362 and 371 of this title, repealed
sections 354 and 364 of this title, and enacted notes set out under this section], may be cited as
the 'Color Additive Amendments of 1960'."
1958 Amendments. Pub.L. 85-929, § 1, Sept. 6, 1958, 72 Stat. 1784, provided: "That this Act
[amending sections 321, 331, 342, 346, 348 of this title and section 210 of Title 42, The Public
Health and Welfare, and enacting provisions set out as notes under sections 321, 342, and 451 of
this title] may be cited as the 'Food Additives Amendment of 1958'."
Hazardous Substances
Federal Hazardous Substances Act as not modifying this chapter, see Pub.L. 86-613, § 18, July
12, 1960, 74 Stat. 380, as amended, set out as a note under § 1261 of Title 15, Commerce and
Trade.
LAW REVIEW COMMENTARIES
"After you, my dear alphonse!": Should the courts defer to the FDA's new interpretation of
§ 360k(a) of the medical device amendments? Richard C. Ausness, 80 TLNLR 727
(2006).
Brother can you spare a drug: Should the experimental drug distribution standards be
modified in response to the needs of persons with Aids? 19 Hofstra L.Rev. 191 (1990).
Can FDA seek restitution or disgorgement? Jeffrey N. Gibbs and John R. Fleder, 58 Food
& Drug L.J. 129 (2003).
Challenge to the FDA's authority. Felix H. Kent, 212 N.Y.L.J. 3 (Sept. 23, 1994).
Challenging Food and Drug Administration interpretations of the Federal Food, Drug, and
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Cosmetic Act. Richard M. Cooper, 58 Food & Drug L.J. 1 (2003).
Constitutional limits on using civil remedies to achieve criminal objectives: Understanding
and transcending the criminal-civil law distinction. Mary M. Cheh, 42 Hastings L.J. 1325
(1991).
Corporation's liability in criminal law. Louis M. Barbone (1985) 9 Crim.Just.Q. 38.
Crop biotechnology: The case for product stewardship. Stanley H. Abramson and J.
Thomas Carrato, 20 Va. Envtl. L.J. 241 (2001).
Developing, testing, and marketing an AIDS vaccine: Legal concerns for manufacturers.
Alison Joy Arnold, 139 U.Pa.L.Rev. 1077 (1991).
Direct-to-consumer marketing: the Food and Drug Administration is not alone. Paul E.
Kalb, Karen O. Dunlop, Diane C. McEnroe and Scott D. Stein, 58 Food & Drug L.J. 25
(2003).
Environmental claims in bankruptcy: Policy conflicts, procedural pitfalls and problematic
precedent. Thomas G. Gruenert, 32 S.Tex.L.Rev. 399 (1991).
Environmental justice critique of risk assessment. 3 N.Y.U.Envtl.L.J. 469 (1995).
Estrogens in the environment. Susan M. Salvatore, 69 Fla.B.J. 39 (1995).
Expediting the drug approval process: An analysis of the FDA Modernization Act of 1997.
Deborah G. Parver, 51 Admin.L.Rev. 1249 (1999).
Exploring the frontiers of law and science: FDAMA's pediatric studies incentive.
Christopher-Paul Milne, 57 Food & Drug L.J. 491 (2002).
FDA: It's not just about tobacco. Richard L. Waters, 52 J.Mo.B. 231 (1996).
Fatal flaws in the Food and Drug Administration's drug-approval formula. Melissa Marie
Bean, 2003 Utah L.Rev. 881.
FDA regulation of human cloning: Usurpation or statesmanship? Richard A. Merrill and
Bryan J. Rose, 15 Harv. J.L. & Tech. 85 (2001).
Federal regulation of food and food additive biotechnology. Jeffrey N. Gibbs and Jonathan
S. Kahan. 38 Admin.L.Rev. 1 (1986).
Federal regulation of genetically engineered food additives and pesticides.
Ausubel, 4 High Tech.L.J. 115 (1989).
© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.
Warren
FOR EDUCATIONAL USE ONLY
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21 U.S.C.A. § 301
Going 90 in a 55 m.p.h. speed zone: Reprocessing of used single-use medical devices and
the Food and Drug Administration's non-enforcement of the Food, Drug, and Cosmetic
Act. Kurt R. Karst, 56 Food & Drug L.J. 57 (2001).
Industry standards in product liability cases. E. Stewart Jones Jr. and Leonard W. Krouner,
214 N.Y.L.J. 1 (August 24, 1995).
Information economics and chemical toxicity: Designing laws to produce and use data.
Mary L. Lyndon, 87 Mich.L.Rev. 1795 (1989).
Medical devices: Cure the harm or harm the cure? 4 Cooley L.Rev. 159 (1986).
Medical standard setting in the current malpractice environment: Problems and
possibilities. Eleanor D. Kinney and Marilyn M. Wilder, 22 U.C.Davis.L.Rev. 241 (1989).
More gold and more fleece: Improving the legal sanctions against medical research fraud.
James T. O'Reilly, 42 Admin.L.Rev. 393 (1990).
Myth of dual sovereignty: Multijurisdictional drug law enforcement and double jeopardy.
Sandra Guerra, 73 N.C.L.Rev. 1159 (1995).
OMB involvement in FDA drug regulations: Regulating the regulators. Comment, 38
Cath.U.L.Rev. 175 (1988).
Premarket notifications of new dietary ingredients--A ten-year review. Michael McGuffin
and Anthony L. Young, 59 Food & Drug L.J. 229 (2004).
Product recall effectiveness. E. Patrick McGuire, 22 Trial 48 (Jan. 1986).
Prosecution of corporations and corporate officers for environmental crimes: Limiting
one's exposure for environmental criminal liability. Kenneth A. Hodson, Sarah N.
McGiffert and Marianne T. Bayardi, 34 Ariz.L.Rev. 553 (1992).
Recent developments in direct consumer advertising of attention disorder stimulants and
creating limits to withstand constitutional scrutiny. Comment, 19 J.Contemp.Health
L.&Pol'y 495 (2003).
Regulation of the export of pharmaceuticals to developing countries. Nancy E. Pirt, 25
Duq.L.Rev. 255 (1987).
Responsible corporate officer: Designated felon or legal fiction? Brenda S. Hustis and
John Y. Gotanda, 25 Loy.U.Chi.L.J. 169 (1994).
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21 U.S.C.A. § 301
Scientific basis of causality in toxic tort cases. Andrew A. Marino, Ph.D., J.D. and
Lawrence E. Marino, J.D., 21 Dayton L.Rev. 2 (1995).
State incorporation of federal law: A response to the demise of implied federal rights of
action. (1985) 94 Yale L.J. 1144.
Survey of law regarding the liability of manufacturers and sellers of drug products and
medical devices. Bryan J. Maedgen and Sheree Lynn McCall, 18 St.Mary's L.J. 395
(1986).
The authority of a court to order disgorgement for violations of the current good
manufacturing practices requirement of the Federal Food, Drug, and Cosmetic Act. Erika
King and Elizabeth M. Walsh, 58 Food & Drug L.J. 149 (2003).
The development of direct-to-consumer prescription drug advertising regulation. Francis
B. Palumbo, Ph.D., J.D. & C. Daniel Mullins, Ph.D., 57 Food & Drug L.J. 423 (2002).
The Drug Price Competition and Patent Term Restoration Act of 1984: fine-tuning the
balance between the interests of pioneer and generic drug manufacturers. Holly Soehnge,
58 Food & Drug L.J. 51 (2003).
The promise and peril of direct-to-consumer prescription drug promotion on the Internet.
Timothy S. Hall, 7 DePaul J. Health Care L. 1 (2003).
Universal Management, Abbott, Wyeth, Schering-Plough, and . . . : Restitution and
disgorgement find another home at the Food and Drug Administration. Eric M. Blumberg,
58 Food & Drug L.J. 169 (2003).
LIBRARY REFERENCES
American Digest System
Drugs and Narcotics
Food
2.
2.
Corpus Juris Secundum
CJS Commerce § 55, Concerning Particular Articles.
CJS Commerce § 92, Manufacture and Sale of Goods and Products -- Food and Drugs.
CJS Intoxicating Liquors § 306, Quality and Purity of Liquors.
© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.
FOR EDUCATIONAL USE ONLY
Page 12
21 U.S.C.A. § 301
CJS Products Liability § 40, Federal Statutes.
CJS Products Liability § 43, Preemption and Preclusion of State-Law Claims -- Under
Federal Food, Drug, and Cosmetic Act.
CJS Products Liability § 124, Health, Medical, and Hospital Machinery, Equipment, and
Supplies.
CJS Products Liability § 126, Prosthetic Devices -- Federal Preemption.
RESEARCH REFERENCES
ALR Library
182 ALR, Fed. 467, Validity of Warrantless Administrative Inspection of Business that is
Allegedly Closely or Pervasively Regulated; Cases Decided Since Colonnade Catering Corp. v.
U. S., 397 U.S. 72, 90 S. Ct. 774, 25 L. Ed. 2d 60...
180 ALR, Fed. 487, Construction and Application of Hatch-Waxman Act, Pub. L. No. 98-417,
98 Stat. 1585 (1984) (Codified as Amended at 21 U.S.C.A. § 355 and 35 U.S.C.A. § 271(E)
(1994)).
129 ALR, Fed. 1, Construction and Application of National Childhood Vaccine Injury Act (42
U.S.C.A. § § 300aa et seq.).
126 ALR, Fed. 347, What Constitutes "Interpretative Rule" of Agency So as to Exempt Such
Action from Notice Requirements of Administrative Procedure Act (5 U.S.C.A. § 553(B)(3)(a)).
127 ALR, Fed. 141, What is "Drug" Within Meaning of § 201(G)(1) of Federal Food, Drug, and
Cosmetic Act (21 U.S.C.A. § 321(G)(1)).
108 ALR, Fed. 380, Books, Papers, and Documents Subject to Discovery by Defendant Under
Rule 16 of Federal Rules of Criminal Procedure.
110 ALR, Fed. 313, Reports of Tests, Experiments, or Analyses as Subject to Discovery by
Defendant Under Rule 16 of Federal Rules of Criminal Procedure.
98 ALR, Fed. 124, Federal Pre-Emption of State Common-Law Products Liability Claims
Pertaining to Drugs, Medical Devices, and Other Health-Related Items.
79 ALR, Fed. 181, Federal Pre-Emption of State Food Labeling Legislation or Regulation.
64 ALR, Fed. 946, Constitutionality of Provision in Rule C, Supplemental Rules for Certain
Admiralty and Maritime Claims, Allowing in Rem Seizure of Property.
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FOR EDUCATIONAL USE ONLY
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21 U.S.C.A. § 301
65 ALR, Fed. 725, Exemption from Provision of § 502(F) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C.A. § 352(F)) that Drug or Device is Misbranded Unless Its Label Bears
"Adequate Directions for Use".
43 ALR, Fed. 320, Necessity of Formal Hearing Prior to Issuance of Regulations Under § 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 371(E)).
34 ALR, Fed. 507, Temporary Relief Against Unfair Trade Practices Under 15 U.S.C.A. § 53.
27 ALR, Fed. 702, Modern Status of Applicability of Doctrine of Estoppel Against Federal
Government and Its Agencies.
29 ALR, Fed. 742, Federal Hazardous Substances Act: What Constitutes "Hazardous
Substance" Under 15 U.S.C.A. § 1261(F), and What Acts Involving Hazardous Substances Are
Prohibited Under 15 U.S.C.A. § 1263.
13 ALR, Fed. 747, Regulation of Health Devices Under Federal Food, Drug, and Cosmetic Act
(21 U.S.C.A. § § 301 et seq.) as Affected by Religious Guaranties of First Amendment.
6 ALR, Fed. 76, Comment Note.--Hearsay Evidence in Proceedings Before Federal
Administrative Agencies.
120 ALR 5th 351, Application of Garmon Preemption Doctrine by State Courts-- Industries
Other Than Construction and Transportation.
119 ALR 5th 205, "Responsible Corporate Officer" Doctrine or "Responsible Relationship" of
Corporate Officer to Corporate Violation of Law.
57 ALR 5th 1, Construction and Application of Learned-Intermediary Doctrine.
54 ALR 5th 1, Liability of Manufacturer or Seller for Injury or Death Allegedly Caused by Use
of Contraceptive.
59 ALR 4th 50, Products Liability: Toxic Shock Syndrome.
57 ALR 4th 911, Products Liability: Pertussis Vaccine Manufacturers.
5 ALR 4th 219, Right of Medical Patient to Obtain, or Physician to Prescribe, Laetrile for
Treatment of Illness--State Cases.
1 ALR 4th 921, Products Liability in Connection With Prosthesis or Other Products Designed to
be Surgically Implanted in Patient's Body.
2 ALR 4th 1091, Products Liability: Diethylstilbestrol (Des).
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21 U.S.C.A. § 301
96 ALR 3rd 1030, Validity and Construction of State Statutes Regulating Hearing Aid Fitting or
Sales.
94 ALR 3rd 748, Liability of Manufacturer or Seller for Injury or Death Allegedly Caused by
Failure to Warn Regarding Danger in Use of Vaccine or Prescription Drug.
53 ALR 3rd 239, Failure to Warn as Basis of Liability Under Doctrine of Strict Liability in Tort.
22 ALR 3rd 1325, Federal Prosecutions Based on Manufacture, Importation, Transportation,
Possession, Sale, or Use of Lsd.
79 ALR 2nd 301, Liability of Manufacturer or Seller for Injury Caused by Drug or Medicine
Sold.
65 ALR 2nd 225, What Constitutes False, Misleading, or Deceptive Advertising or Promotional
Practices Subject to Action by Federal Trade Commission.
160 ALR 1225, Gambling Devices, Contraband, or Other Illegally Held Personal Property, as
Subject to Taxation.
155 ALR 910, Validity, Construction, and Application of the Sampling Provisions of the Federal
Food, Drug, and Cosmetic Act, or Other Similar Acts.
158 ALR 842, Provision of Federal Food, Drug, and Cosmetic Act Authorizing the
Establishment of Definitions and Standards of Food.
148 ALR 139, Conflict of Laws, With Respect to Trademark Infringement or Unfair
Competition, Including the Area of Conflict Between Federal and State Law.
148 ALR 1270, Release of or Covenant Not to Sue One Tort-Feasor as Affecting Liability of
Others.
149 ALR 349, Justiciable Controversy Within Declaratory Judgment Act as Predicable Upon
Advice, Opinion, or Ruling of Public Administrative Officer.
152 ALR 755, Penal Offense Predicated Upon Violation of Food Law as Affected by Ignorance
or Mistake of Fact, Lack of Criminal Intent, or Presence of Good Faith.
152 ALR 1198, Decision or Ruling by Federal Trade Commission as Res Judicata.
142 ALR 1434, Implied Warranty, by Other Than Packer, of Fitness of Goods Sold in Sealed
Cans.
143 ALR 1453, Provisions of Statutes Against Misbranding or False Labeling of Food, Drug, or
Cosmetic Products, as Applicable to Literature Other Than that Attached to Product Itself.
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21 U.S.C.A. § 301
139 ALR 1370, Consent as Condition of Right to Perform Surgical Operation.
131 ALR 917, Right to Severance Where Two or More Persons Are Jointly Accused.
131 ALR 1113, Expert and Opinion Evidence as Regards Fire.
127 ALR 322, Validity, Construction, and Application of Statutes or Ordinances Relating to
Inspection of Food Sold at Retail.
129 ALR 247, Validity, Construction, and Application of Statutes Authorizing Public Officer to
Break Into Building to Serve Documents or Process or to Execute Process in Civil Proceeding.
119 ALR 1399, Constitutionality, Construction, and Application of Uniform Narcotic Drug Act.
113 ALR 964, What Constitutes "Original Unbroken Package" Within Federal Food and Drugs
Act.
114 ALR 1214, Constitutionality of Statutes, Ordinances, or Other Regulations Against
Adulteration of Food Products as Applied to Substances Used for Preservative Purposes.
114 ALR 1446, Validity and Construction of Statute or Ordinance Relating to Distribution of
Advertising Matter.
103 ALR 405, Entire Penalty as Recoverable for Breach of Bond Given to Public as Condition of
License or Other Privilege, or Conditioned on Compliance With Law.
98 ALR 1496, Statutory Provisions Relating to Purity of Food Products as Applicable to Foreign
Substances Which Get Into Product as Result of Accident or Negligence, and Not by Purpose or
Design.
90 ALR 410, Implied Warranty of Fitness on Sale of Article by Tradename, Trademark, or Other
Particular Description.
93 ALR 482, Admissibility and Effect of Testimony of Lay Witness as to Existence of a
Particular Disease, or as to Apparent Physical Condition of a Person, on the Issue of Existence of
Particular Disease.
87 ALR 1205, Declaration of Rights or Declaratory Judgments.
79 ALR 1200, Validity and Construction of Statute Creating Federal Trade Commission.
68 ALR 1503, Constitutional Provision Against Self-Incrimination as Applicable to Questions
Asked or Testimony Given in Proceeding Before Nonjudicial Officer or Body.
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21 U.S.C.A. § 301
54 ALR 730, Constitutionality of Statute Regulating Sale of Poisons, Drugs, or Medicines.
54 ALR 744, Constitutionality of Statute Regulating Sale or Dispensation of Medicines or Drugs
in Original Package.
57 ALR 686, Constitutionality of Requirement of Disclosure by Label of Materials or
Ingredients of Articles Sold or Offered for Sale.
35 ALR 249, Warranty or Condition as to Kind or Quality Implied by Sale Under Trade Term
Which by Use Has Become Generic.
35 ALR 782, Construction of Statute or Ordinance in Relation to Containers.
39 ALR 236, Harrison Narcotic Act.
17 ALR 1282, What is "Food" Within Meaning of Statute.
Encyclopedias
28 Am. Jur. Proof of Facts 629, Electrical Treatment of Cardiac Arrhythmias.
22 Am. Jur. Proof of Facts 2d 721, Plastic Surgeon's Liability in Cosmetic Surgery Cases.
23 Am. Jur. Proof of Facts 2d 293, Negligence in Use of Diet and Weight Control Drugs in
Treatment of Obesity.
38 Am. Jur. Proof of Facts 2d 589, Physician's Liability for Causing Patient's Drug Addiction.
42 Am. Jur. Proof of Facts 2d 97, Cosmetics Injuries.
49 Am. Jur. Proof of Facts 2d 543, Products Liability: Tetracycline as Cause of Tooth Damage.
1 Am. Jur. Proof of Facts 3d 1, Physician's Negligence in Using Oxytocin to Stimulate Labor in
Childbirth.
4 Am. Jur. Proof of Facts 3d 689, Ophthalmic Malpractice.
6 Am. Jur. Proof of Facts 3d 1, Anesthesia Malpractice.
7 Am. Jur. Proof of Facts 3d 1, Injuries from Drugs.
23 Am. Jur. Proof of Facts 3d 1, Optician's Negligence: Proof that an Optician Negligently
Dispensed an Optical Device.
29 Am. Jur. Proof of Facts 3d 433, Knee Injuries.
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21 U.S.C.A. § 301
87 Am. Jur. Proof of Facts 3d 1, Proof of Injury Resulting from Prescription Medication Vioxx.
87 Am. Jur. Proof of Facts 3d 119, Proof of Injury Resulting from Antidepressant Medication.
9 Am. Jur. Trials 59, Food Seizure Litigation.
17 Am. Jur. Trials 1, Drug Products Liability and Malpractice Cases.
32 Am. Jur. Trials 179, Eye Surgery Malpractice--Cataracts.
32 Am. Jur. Trials 673, Defective Prosthesis Litigation--Silicone Breast Implant.
39 Am. Jur. Trials 333, Golf Cart Accidents.
55 Am. Jur. Trials 1, Cosmetic Silicone Breast Implant Litigation.
73 Am. Jur. Trials 485, Diet Pill Litigation: the Fen-Phen Debacle.
76 Am. Jur. Trials 341, Snack Food Product Liability.
99 Am. Jur. Trials 141, the Use of Discovery in Product-Related Burn Injury Cases.
Am. Jur. 2d Animals § 41, Federal Regulation.
Am. Jur. 2d Drugs and Controlled Substances § 2, Drug, Generally -- Statutory Definitions;
Federal Food, Drug, and Cosmetic Act.
Am. Jur. 2d Drugs and Controlled Substances § 100, Generally; Purpose of Act.
Am. Jur. 2d Food § 2, "Drugs" Distinguished.
Am. Jur. 2d Food § 5, Authority of Federal Government.
Am. Jur. 2d Food § 13, Inspection.
Am. Jur. 2d Food § 25, Misbranding; Food, Drug, and Cosmetic Act.
Am. Jur. 2d Food § 61, Seizures and Forfeitures.
Am. Jur. 2d Food § 62, Condemnation Proceedings.
Am. Jur. 2d Products Liability § 2019, Federal Food, Drug, and Cosmetic Act; Generally.
Am. Jur. 2d Products Liability § 2020, Federal Food, Drug, and Cosmetic Act; Generally -© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.
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Page 18
21 U.S.C.A. § 301
Provisions Relating to Radiation Hazards from Electronic Products.
Am. Jur. 2d Social Security and Medicare § 2510, Drugs that Are "Less Than Effective".
Forms
Federal Procedural Forms § 61:1, Statutes of Limitation, and Other Time Limits, Within United
States Code.
Federal Procedural Forms § 31:185, Scope of Division.
Federal Procedural Forms § 31:192, Complaint -- by Drug Manufacturer -- for Declaratory
Judgment that Product is Protected by "Grandfather Clause" in New Legislation Amending
Federal Food, Drug and Cosmetic Act [5 U.S.C.A. § 702; 28 U.S.
Federal Procedural Forms § 31:204, Complaint -- by United States -- for Seizure and
Condemnation of Articles of Adulterated Food, Drugs, or Cosmetics [21 U.S.C.A. § 334(A)(1);
Fed R Civ P Rule Supp Rule C(2)].
Nichols Cyclopedia of Legal Forms Annotated § 4.1403, Research Checklist.
4 West's Federal Forms § 4543, Judgment of Condemnation, Forfeiture and Destruction of Food
Under Federal Food, Drug, and Cosmetic Act.
7 West's Federal Forms § 11241, Complaint Against Article of Food.
4A West's Federal Forms § 5838, Adulterated Items.
Am. Jur. Pl. & Pr. Forms Food § 1, Introductory Comments.
Am. Jur. Pl. & Pr. Forms Food § 4, Introductory Comments.
Am. Jur. Pl. & Pr. Forms Food § 13, Introductory Comments.
Am. Jur. Pl. & Pr. Forms Food § 16, Complaint in Federal Court -- by United States of America
-- for Seizure and Condemnation of Articles of Adulterated Food.
Am. Jur. Pl. & Pr. Forms Food § 17, Complaint, Petition, or Declaration -- in State Court -- by
State -- for Seizure and Condemnation of Articles of Misbranded Food.
Am. Jur. Pl. & Pr. Forms Products Liability § 192.1, Complaint, Petition or Declaration -- by
Purchaser -- Against Manufacturer of Prescription Drug -- Defective and Dangerous Condition
of Non-Steroidal Anti-Inflammatory Drugs -- Negligence,.
Treatises and Practice Aids
© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.
FOR EDUCATIONAL USE ONLY
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21 U.S.C.A. § 301
Callmann on Unfair Compet., TMs, & Monopolies § 5:4, Legislative Regulation of False
Advertising -- Federal Legislation.
Callmann on Unfair Compet., TMs, & Monopolies § 5:9, Means of False Advertising -- Labels
and Packages.
Callmann on Unfair Compet., TMs, & Monopolies § 25:9, Jurisdiction of the Commission
Under Section 12 of the Federal Trade Commission Act: Food, Drugs, Devices and Cosmetics
Provisions.
Callmann on Unfair Compet., TMs, & Monopolies App 15 § 15:4, Textile Fiber Products
Identification Act.
Callmann on Unfair Compet., TMs, & Monopolies App 15 § 15:6, Fair Packaging and Labeling
Act.
Courtroom Handbook of Federal Evidence CH 1, Federal Rules of Evidence.
Courtroom Handbook of Federal Evidence FRE R 1101, Applicability of Rules.
Eckstrom's Licensing in Foreign & Domestic Ops. § 13:26, Drug Price Competition and Patent
Term Restoration Act of 1984 (The Hatch-Waxman Amendments) -- Abbreviated New Drug
Applications (Anda).
Federal Evidence § 596, Proceedings in Which Rules Applicable in Part.
Federal Procedure, Lawyers Edition § 2:69, Introduction.
Federal Procedure, Lawyers Edition § 33:13, Proceedings to Which Rules Are Applicable in
Part.
Federal Procedure, Lawyers Edition § 35:18, Formal or Informal Rulemaking.
Federal Procedure, Lawyers Edition § 35:276, Availability of Exemption.
Federal Procedure, Lawyers Edition § 35:310, Requesting Certification.
Federal Procedure, Lawyers Edition § 35:389, Grounds for Seizure.
Federal Procedure, Lawyers Edition § 35:407, Appropriateness of Injunctive Relief.
Federal Procedure, Lawyers Edition § 35:421, Information or Indictment.
Federal Procedure, Lawyers Edition § 35:648, Forfeiture as Mandatory; Jurisdiction of District
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21 U.S.C.A. § 301
Courts.
Federal Procedure, Lawyers Edition § 35:709, Jurisdiction.
Federal Procedure, Lawyers Edition § 35:721, Theories of Pre-Emption of State Law Causes of
Action.
Federal Procedure, Lawyers Edition § 35:724, Design Defect Claims.
Federal Procedure, Lawyers Edition § 35:725, Warning Claims.
Federal Procedure, Lawyers Edition § 35:726, Warning Claims -- Tampons.
Federal Procedure, Lawyers Edition § 60:680, Patents Subject to Extension of Patent Term.
Federal Procedure, Lawyers Edition §
Extension of Patent Term.
60:683, Formal Requirements for Application for
Handbook of Federal Evidence (3d Ed.) R 1101, Applicability of Rules.
Norton Bankruptcy Law and Practice 2d FRE 1101, Applicability of Rules.
Patent Law Fundamentals § 5:57, Rights Against Infringement -- Direct Infringement -- Under
the Lanham Act -- Lanham Act § 43(A), 15 U.S.C.A. § 1125(a).
Practitioner's Trademark Manual of Examining Proc. App C, Appendix C. Notes of Other
Statutes.
Securities Litigation: Damages § 9:5, Implication of Private Right of Action Under Rule 10b-5 - Constitutionality of § 10(B) Implied Rights of Action -- Unconstitutionality of the Judicial
Creation and Perpetuation of the § 10(B) Private...
Securities Litigation: Damages § 9:12, Damages Under Jurisdictional Model.
Social Security Law and Practice § 67:97, Drugs that Are "Less Than Effective".
West's Federal Administrative Practice § 269, Department of Justice-Civil Division.
West's Federal Administrative Practice § 3801, Introduction.
West's Federal Administrative Practice § 3802, Significant Food, Drug and Cosmetic Laws.
West's Federal Administrative Practice §
Administration.
3807, a Brief History of the Food and Drug
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21 U.S.C.A. § 301
West's Federal Administrative Practice § 3830, Judicial Review of FDa Rules-The Regulation of
Tobacco.
West's Federal Administrative Practice § 5223, the Environmental Protection Agency.
Wright & Miller: Federal Prac. & Proc. § 4516, Filling the Interstices Within a Pervasive
Federal Framework.
Wright & Miller: Federal Prac. & Proc. § 5012, Policy of Rule 101.
Wright & Miller: Federal Prac. & Proc. § 5012, Policy of Rule 101.
Wright & Miller: Federal Prac. & Proc. § 8078, Subdivision (E)-Rules Applicable in Part.
Wright & Miller: Federal Prac. & Proc. R 1101, Applicability of Rules.
NOTES OF DECISIONS
Administration authority 8
Constitutionality 1
Construction 2, 3
Construction - Generally 2
Construction - Liberal construction 3
Construction with other laws 4
Liberal construction 3
Private right of action 7
Purpose 5
State regulation 6
1. Constitutionality
This chapter rests upon the constitutional power of Congress to regulate interstate commerce,
and seeks to keep interstate channels free from deleterious, adulterated and misbranded articles
of specified types to the end that public health and safety might be advanced. U.S. v. Walsh,
U.S.Cal.1947, 67 S.Ct. 1283, 331 U.S. 432, 91 L.Ed. 1585; Carnohan v. U. S., C.A.9 (Cal.)
1980, 616 F.2d 1120.
The forerunner of this chapter, enacted as the Federal Food and Drugs Act of 1906 [former § § 1
to 5, 7 to 14 and 15 of this title], was a legitimate exercise of the power to regulate interstate
commerce. Weeks v. U.S., U.S.N.Y.1918, 38 S.Ct. 219, 245 U.S. 618, 62 L.Ed. 513. See, also,
U.S. v. Sweet Valley Wine Co., D.C.Ohio 1913, 208 F. 85; U.S. v. Seventy-Four Cases of
Grape Juice, D.C.N.Y.1910, 181 F. 629. Commerce
60(2)
Congress has the right not only to pass laws which shall regulate legitimate commerce among the
states and with foreign nations, but has full power to keep the channels of such commerce free
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from the transportation of illicit or harmful articles, to make such as are injurious to the public
health outlaws of such commerce, and to bar them from the facilities and privileges thereof.
McDermott v. State of Wis., U.S.Wis.1913, 33 S.Ct. 431, 228 U.S. 115, 57 L.Ed. 754. See, also,
U.S. v. 40 Cases, More or Less of Pinocchio Brand 75% Corn, Peanut Oil and Soya Bean Oil
Blended with 25% Pure Olive Oil, C.A.N.Y.1961, 289 F.2d 343.
This chapter, as construed to be applicable to articles from moment of their introduction into
interstate commerce, to moment of delivery to ultimate consumer, and to embrace misbranding
while articles are held for sale after shipment in interstate commerce, does not exceed
constitutional power of Congress under U.S.C.A.Const. Art. 1, § 8, cl. 3, and does not invade
powers reserved to the states. U. S. v. 4 Devices, Labeled in Part "Color-Therm", C.A.10 (Okla.)
1949, 176 F.2d 652.
It is within the legislative power both of a state and of Congress to go beyond the protection of
the public by prohibiting false labeling or branding of goods, to more adequate protection by
prohibiting a substituted food product. U. S. v. Two Bags, Each Containing 110 Pounds, Poppy
Seeds, C.C.A.6 (Ohio) 1945, 147 F.2d 123.
Since the Constitution does not confer on Congress express power to legislate respecting food
and drugs, Food and Drugs Act of 1906, former § § 1 to 5, 7 to 14 and 15 of this title, rested for
their validity on the power of Congress to legislate for the District of Columbia and territories
and on power conferred by interstate commerce clause; hence Congress could not pass a statute
generally prohibiting misbranding. Med-A-Dent Co. v. L.D. Caulk Co., D.C.Del.1925, 4 F.2d
126.
Former § § 1 to 5, 7 to 14 and 15 of this title were not unconstitutional as an attempted exercise
by Congress of police power belonging to the states, nor were they void for uncertainty and
indefiniteness, in that no standard of grade, quality, or purity was prescribed, but that the
determination of the standard was left to the courts, as such objection might be obviated by
requiring specific and properly drawn pleadings. U.S. v. 420 Sacks of Flour, E.D.La.1910, 180
F. 518. See, also, Shawnee Milling Co. v. Temple, C.C.Iowa 1910, 179 F. 517. Statutes
47
In adopting this chapter under the commerce clause, U.S.C.A.Const. Art. 1, § 8, cl. 3, Congress
was regulating what it regarded as illicit articles of commerce. U. S. v. 7 Jugs, etc., of Dr.
Salsbury's Rakos, D.C.Minn.1944, 53 F.Supp. 746.
This chapter does not make an unlawful delegation of legislative power, and the acts of
government pursuant to this chapter do not constitute an exercise of legislative power in
violation of the Constitution, since Congress may vest discretion in executive officers of the
government to promulgate regulations interpreting statute even to the extent of providing for
penalizing one for a breach of such regulations. U. S. v. 62 Packages, More or Less, of Marmola
Prescription Tablets, W.D.Wis.1943, 48 F.Supp. 878, affirmed 142 F.2d 107, certiorari denied 65
S.Ct. 68, 323 U.S. 731, 89 L.Ed. 587. See, also, Iske v. U.S., C.A.Colo.1968, 396 F.2d 28.
Health
105; Food
2; Constitutional Law
62(10)
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Congress under its powers to exclude from interstate commerce impure and adulterated foods
may itself determine the means appropriate to such purpose and so long as Congress does no
violence to the Constitution, Congress is itself the judge of the means to be employed in
exercising the powers conferred upon it in such respect. U.S. v. Commercial Creamery Co.,
E.D.Wash.1942, 43 F.Supp. 714.
2. Construction--Generally
In construing this chapter courts must be mindful of its approach in terms of draftsmanship and
neither add nor subtract, delete nor distort. Flemming v. Florida Citrus Exchange, U.S.Fla.1958,
79 S.Ct. 160, 358 U.S. 153, 3 L.Ed.2d 188, rehearing denied 79 S.Ct. 349, 358 U.S. 948, 3
L.Ed.2d 353.
Although, in construing this chapter to effectuate Congressional purpose of protecting the public,
Supreme Court must take care not to extend scope of this chapter beyond point where Congress
indicated it would stop, a regard for purpose to touch phases of the lives and health of people
which in circumstances of modern industrialism are largely beyond self-protection should infuse
construction of this chapter. 62 Cases, More or Less, Each Containing Six Jars of Jam v. U.S.,
U.S.N.M.1951, 71 S.Ct. 515, 340 U.S. 593, 95 L.Ed. 566. See, also, U.S. v. El-O-Pathic
Pharmacy, C.A.Cal.1951, 192 F.2d 62; Arner Co. v. U.S., C.C.A.Mass.1944, 142 F.2d 730,
certiorari denied 65 S.Ct. 66, 323 U.S. 730, 98 L.Ed. 586. Food
2
Congress intended this chapter to apply to food processed within a state after shipment in
interstate commerce and this chapter must be read and applied broadly in order to effectuate its
remedial purpose. U.S. v. 40 Cases, More or Less of Pinocchio Brand 75% Corn, Peanut Oil and
Soya Bean Oil Blended with 25% Pure Olive Oil, C.A.2 (N.Y.) 1961, 289 F.2d 343, certiorari
denied 82 S.Ct. 54, 368 U.S. 831, 7 L.Ed.2d 34.
Where language of this chapter is unambiguous its words must be given their ordinary meaning.
Penobscot Poultry Co. v. U.S., C.A.1 (Me.) 1957, 244 F.2d 94.
This chapter must be given a reasonable construction to effectuate its salutary purpose, which is
to advance health and safety of public by keeping interstate channels free from deleterious,
adulterated and misbranded articles of specified types; and the various sections of this chapter
must be viewed in that interstate setting. U. S. v. Sanders, C.A.10 (Okla.) 1952, 196 F.2d 895,
certiorari denied 73 S.Ct. 33, 344 U.S. 829, 97 L.Ed. 645. See, also, United States v. Kordel,
D.C.Ill.1946, 66 F.Supp. 538, affirmed 164 F.2d 913, affirmed 69 S.Ct. 106, 335 U.S. 345, 93
L.Ed. 52, rehearing denied 69 S.Ct. 298, 335 U.S. 900, 93 L.Ed. 435, rehearing denied 69 S.Ct.
513, 336 U.S. 911, 93 L.Ed. 1075. Health
302
This chapter should be construed to effect the purpose of securing the purity of food and drugs
and informing purchasers of what they are buying. U. S. v. Two Bags, Each Containing 110
Pounds, Poppy Seeds, C.C.A.6 (Ohio) 1945, 147 F.2d 123. See, also, Federal Security Adm'r v.
Quaker Oats Co., 1943, 63 S.Ct. 589, 318 U.S. 218, 87 L.Ed. 724, 158 A.L.R. 832; U.S. v. 75
Cases, More or Less, Each Containing 24 Jars of Peanut Butter, Labeled in Part (Jars): "Top
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Notch Brand", C.C.A.Md.1944, 146 F.2d 124, certiorari denied 65 S.Ct. 1183, 325 U.S. 856, 89
L.Ed. 1976; Glaser, Kohn & Co. v. U.S., Ill.1915, 224 F. 84, 139 C.C.A. 566; Libby, McNeil &
Libby v. U.S., C.C.A.Va.1913, 210 F. 148.
It was the duty of the court to give former § § 1 to 5, 7 to 14 and 15 of this title a fair and
reasonable construction for the accomplishment of its object. U.S. v. 1,950 Boxes of Macaroni,
N.D.Ill.1910, 181 F. 427. See, also, U.S. v. 48 Dozen Packages, More or Less, of Gauze
Bandage Labeled in Part Sterilized, C.C.A.N.Y.1938, 94 F.2d 641.
Cardiac patient's fraud claim based on pacemaker manufacturer's alleged failure to provide the
Food and Drug Administration (FDA) with information required by the Medical Device
Amendments (MDA) was barred by Supreme Court precedent regarding federal preemption.
Webster v. Pacesetter, Inc., D.D.C.2003, 259 F.Supp.2d 27. Courts
96(3); Products
Liability
46.1; States
18.65
This chapter is to be construed so that its overriding purpose, protection of public health, is
attained. U.S. v. Articles of Food Consisting of Pottery Labeled Cathy Rose, E.D.Mich.1974,
370 F.Supp. 371.
This chapter must be construed in light of power exerted by Congress to prevent facilities of
commerce from being used to enable adulterated food to be transported to people who consume
them. U. S. v. 1851 Cartons, More or Less, etc., D.C.Colo.1944, 55 F.Supp. 343, reversed on
other grounds 144 F.2d 356. See, also, U.S. v. 43 1/2 Gross Rubber Prophylactics Labeled in
Part "Xcello's Prophylactics", D.C.Minn.1946, 65 F.Supp. 534, affirmed 159 F.2d 881; U.S. v.
Commercial Creamery Co., D.C.N.Y.1942, 43 F.Supp. 714. Food
2
In construing this chapter consideration should be given to purpose of this chapter, its history,
specific terminology used therein, and enforcement procedures adopted. U. S. v. 7 Jugs, etc., of
Dr. Salsbury's Rakos, D.C.Minn.1944, 53 F.Supp. 746.
This chapter is a "criminal statute" which is not to be extended by intendment. U. S. v. Lee,
E.D.Wis.1941, 40 F.Supp. 801, reversed on other grounds 131 F.2d 464.
Food and Drug Act is not to be construed restrictively but rather is to be construed in manner
consistent with its purpose of protecting public. Retkwa v. Orentreich, N.Y.Sup.1991, 579
N.Y.S.2d 577, 152 Misc.2d 691.
The Food and Drugs Act of 1906, former § § 1 to 5, 7 to 14 and 15 of this title, had to be so
interpreted in regard to the labeling of drugs as to give effect, if possible, to the purposes of that
statute. 1909, 27 Op.Atty.Gen. 143.
3. ---- Liberal construction
This chapter should be given liberal construction consistent with its statutory purpose.
International Nutrition, Inc. v. U. S. Dept. of Health and Human Services, C.A.8 1982, 676 F.2d
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338. Statutes
236
This chapter, although containing criminal penalties, is intended to protect public health and so
should be given a liberal construction. U. S. v. Kordel, C.C.A.7 (Ill.) 1947, 164 F.2d 913,
certiorari granted 68 S.Ct. 902, 333 U.S. 872, 92 L.Ed. 1149, affirmed 69 S.Ct. 106, 335 U.S.
345, 93 L.Ed. 52, rehearing denied 69 S.Ct. 298, 335 U.S. 900, 93 L.Ed. 435, rehearing denied
69 S.Ct. 513, 336 U.S. 911, 93 L.Ed. 1075. See, also, U.S. v. Colosse Cheese & Butter Co.,
D.C.N.Y.1955, 133 F.Supp. 953; U.S. v. 62 Packages, More or Less, of Marmola Prescription
Tablets, D.C.Wis.1943, 48 F.Supp. 878, affirmed 142 F.2d 107, certiorari denied 65 S.Ct. 68,
323 U.S. 731, 89 L.Ed. 587. Health
302
Whenever there is a problem of construction, duty of court is to liberally construe provisions of
this chapter, being mindful of its overriding purpose to protect public health. Meserey v. U. S.,
D.C.Nev.1977, 447 F.Supp. 548.
Remedial legislation, such as this chapter, should be given a liberal construction consistent with
its overriding purpose to protect the public health. U. S. v. An Article of Drug Labeled "EntrolC Medicated", S.D.Cal.1973, 362 F.Supp. 424, affirmed 513 F.2d 1127.
This chapter should be given a liberal construction to effectuate the purpose of protecting unwary
customers in vital matters of health. U.S. v. 250 Jars, etc., of U.S. Fancy Pure Honey,
E.D.Mich.1963, 218 F.Supp. 208, affirmed 344 F.2d 288. See, also, Pasadena Research
Laboratories v. U.S., C.A.Cal.1948, 169 F.2d 375, certiorari denied 69 S.Ct. 83, 335 U.S. 853,
93 L.Ed. 401; Research Laboratories v. U.S., C.C.A.Wash.1948, 167 F.2d 410, certiorari denied
69 S.Ct. 65, 335 U.S. 843, 93 L.Ed. 393; U.S. v. Lee, C.C.A.Wis.1942, 131 F.2d 464, 143
A.L.R. 1451; U.S. v. Research Laboratories, C.C.A.Wash.1942, 126 F.2d 42, certiorari denied
63 S.Ct. 54, 317 U.S. 656, 87 L.Ed. 528; Dade v. U.S., 1913, 40 App.D.C. 94; Galt v. U.S.,
1913, 39 App.D.C. 470; U.S. v. Article Consisting of 36 Boxes, More or Less, Labeled "Line
Away, Temporary Wrinkle Smoother, Coty", D.C.Del.1968, 284 F.Supp. 107, affirmed 415 F.2d
369; U.S. v. Paddock, D.C.Mo.1946, 67 F.Supp. 819; U.S. v. 55 Cases Popped Corn, D.C.Idaho
1943, 62 F.Supp. 843; U.S. v. Commercial Creamery Co., D.C.N.Y.1942, 43 F.Supp. 714.
Health
302
This chapter should be liberally construed more effectively to protect the public from adulterated
and misbranded products. U. S. v. Bodine Produce Co., D.C.Ariz.1962, 206 F.Supp. 201. See,
also, A. O. Andersen & Co. v. U.S., C.C.A.Wash.1922, 284 F. 542; U.S. v. 233 Tins, More or
Less, Grove Brand Whole Blakemore Strawberries, D.C.Ark.1959, 175 F.Supp. 694; U.S. v.
Paddock, D.C.Mo.1946, 67 F.Supp. 819; U.S. v. 7 Jugs, etc., of Dr. Salsbury's Rakos,
D.C.Minn.1944, 53 F.Supp. 746. Adulteration
3; Food
4.1; Food
5
4. Construction with other laws
This chapter and the Poultry Products Inspection Act, § 451 et seq. of this title, are
complementary. Bell v. Goddard, C.A.7 (Ind.) 1966, 366 F.2d 177.
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Food, Drug, and Cosmetic Act (FDCA) did not preclude false advertising and unfair competition
claims asserted against competitors by pharmaceutical company under common law and Lanham
Act, which were based on allegations that competitors improperly compared generic drug to
company's drug, given that both drugs fell within class of drugs for which new drug applications
or abbreviated new drug applications (ANDA) were not required, that, as a result, neither drug
was listed in "Orange Book" setting forth drug substitution standard of Food and Drug
Administration (FDA), that there was no evidence that FDA had or would determine whether
competitors' drug was generic or therapeutic equivalent to company's drug, and that competitors
identified no portion of FDCA or implementing regulations supporting assertion that claims were
based on FDCA or its regulations. Pediamed Pharmaceuticals, Inc. v. Breckenridge
Pharmaceutical, Inc., D.Md.2006, 419 F.Supp.2d 715. Trade Regulation
870(1)
Statutory remedies of the FDA and FTC are cumulative and not mutually exclusive. WarnerLambert Co. v. F. T. C., D.C.D.C.1973, 361 F.Supp. 948.
There was no such repugnancy between the special Tea Inspection Act, § 41 et seq. of this title,
and former § § 1 to 5, 7 to 14 and 15 of this title, as to prevent them, generally speaking, from
standing together. 1907, 26 Op.Atty.Gen. 166.
5. Purpose
Purpose of this chapter is to protect consumers who, in circumstances of modern industrialism,
are largely beyond self-protection. 62 Cases, More or Less, Each Containing Six Jars of Jam v.
U.S., U.S.N.M.1951, 71 S.Ct. 515, 340 U.S. 593, 95 L.Ed. 566. See, also, U.S. v. Article . . .
Consisting of 216 Cartoned Bottles, More or Less, Sudden Change, C.A.N.Y.1969, 409 F.2d
734; U.S. v. Vitasafe Corp., C.A.N.J.1965, 345 F.2d 864, certiorari denied 86 S.Ct. 290, 382
U.S. 918, 15 L.Ed.2d 232; Strey v. Devine's, Inc., C.A.Ill.1954, 217 F.2d 187; U.S. v. El-OPathic Pharmacy, C.A.Cal.1951, 192 F.2d 62; U.S. v. Two Bags, Each Containing 110 Pounds,
Poppy Seeds, C.C.A.Ohio 1945, 147 F.2d 123; Barnes v. U.S., C.C.A.Cal.1944, 142 F.2d 648;
U.S. v. Diapulse Mfg. Corp. of America, D.C.Conn.1967, 269 F.Supp. 162; U.S. v. Various
Articles of Drugs Consisting of Unknown Quantities of Prescription Drugs, D.C.N.Y.1962, 207
F.Supp. 480; Toole v. Richardson-Merrell Inc., 1967, 60 Cal.Rptr. 398, 251 C.A.2d 689, 29
A.L.R.3d 988; U.S. v. Grayce, Inc., D.C.Ind.1954, 126 F.Supp. 6; U.S. v. 38 Cases, More or
Less, D.C.N.Y.1951, 99 F.Supp. 460; U.S. v. 30 Cases, More or Less, Leader Brand Strawberry
Fruit Spread, D.C.Iowa 1950, 93 F.Supp. 764; U.S. v. Roma Macaroni Factory, D.C.Cal.1947,
75 F.Supp. 663; U.S. v. Crown Rubber Sundries Co., D.C.Ohio 1946, 67 F.Supp. 92; U.S. v.
Alberty, D.C.Cal.1946, 65 F.Supp. 945, reversed on other grounds 159 F.2d 278; U.S. v. LordMott Co., D.C.Md.1944, 57 F.Supp. 128. Food
2
This chapter is not concerned with the purification of the steam of commerce in the abstract, and
the problem with which it is concerned is a practical one of consumer protection, not dialectics.
U. S. v. Urbuteit, U.S.Fla.1948, 69 S.Ct. 112, 335 U.S. 355, 93 L.Ed. 61. See, also, U.S. v. 3
Cartons, More or Less, "No. 26 Formula GM etc.", D.C.Cal.1952, 132 F.Supp. 569. Health
302
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This chapter was designed to protect consumers from dangerous products by applying this
chapter to articles from the moment of their introduction into interstate commerce to the time of
their delivery to ultimate consumer. U. S. v. Sullivan, U.S.Ga.1948, 68 S.Ct. 331, 332 U.S. 689,
92 L.Ed. 297. See, also, U.S. v. 4 Devices, Labeled in Part "Color-Therm", C.A.Okl.1949, 176
F.2d 652; U.S. v. 1,800.2625 Wine Gallons of Distilled Spirits, D.C.Mo.1954, 121 F.Supp. 735.
Health
302
This chapter was designed to extend control over illicit and noxious articles, and to enlarge and
stiffen the penalties for disobedience. U. S. v. Dotterweich, U.S.N.Y.1943, 64 S.Ct. 134, 320
U.S. 277, 88 L.Ed. 48, rehearing denied 64 S.Ct. 367, 320 U.S. 815, 88 L.Ed. 492.
The purpose of this chapter is not confined to a requirement of truthful and informative labeling.
Federal Security Adm'r v. Quaker Oats Co., U.S.1943, 63 S.Ct. 589, 318 U.S. 218, 87 L.Ed. 724.
See, also, U.S. v. 716 Cases, More or Less, etc., Del Comida Brand Tomatoes, C.A.Okl.1950,
179 F.2d 174. Food
2
The statute upon its face shows that the primary purpose of Congress was to prevent injury to the
public health by the sale and transportation in interstate commerce of misbranded and adulterated
articles. U.S. v. Lexington Mill & Elevator Co., U.S.Mo.1914, 34 S.Ct. 337, 232 U.S. 399, 58
L.Ed. 658. See, also, U.S. v. Coca Cola Co., Tenn.1916, 36 S.Ct. 573, 241 U.S. 356, 60 L.Ed.
995, Ann.Cas.1917C, 487; Galt v. U.S., 1913, 39 App.D.C. 470; U.S. v. Wilhelm Reich
Foundation, D.C.Me.1954, 17 F.R.D. 96, affirmed 221 F.2d 957, certiorari denied 76 S.Ct. 82,
350 U.S. 842, 100 L.Ed. 750; Whitehall Laboratories Division of Am. Home Products Corp. v.
Wilbar, 1959, 154 A.2d 596, 397 Pa. 223.
The purpose of former § § 1 to 5, 7 to 14 and 15 of this title was to secure the purity of food and
drugs and to inform purchasers of what they were buying and the provisions were directed to that
purpose and had to be construed to effect it. U. S. v. Antikamnia Chemical Co.,
U.S.Dist.Col.1914, 34 S.Ct. 222, 231 U.S. 654, 58 L.Ed. 419. See, also, Savage v. Jones,
Ind.1912, 32 S.Ct. 715, 225 U.S. 501, 56 L.Ed. 1182; U.S. v. Ten Cases, More or Less, Bred
Spred, C.C.A.Iowa 1931, 49 F.2d 87; Philadelphia Pickling Co. v. U.S., N.J.1913, 202 F. 150,
120 C.C.A. 429; U.S. v. Five Boxes of Asafoetida, D.C.Pa.1910, 181 F. 561.
In dealing with the public health, language of this chapter should not be read too restrictively, but
rather as consistent with the overriding purpose to protect the public health. U. S. v. Nova Scotia
Food Products Corp., C.A.2 (N.Y.) 1977, 568 F.2d 240.
This chapter has as its purpose protection of public from products not proven to be safe and
effective for their alleged uses and safeguarding of public health by enforcement of certain
standards of purity and effectiveness, and reach of this chapter is broad and the provisions,
touching the public interest in a direct way, are to be given a liberal construction. U. S. v.
Diapulse Corp. of America, C.A.2 (N.Y.) 1972, 457 F.2d 25.
This chapter was intended to deal with misleading claims only when made in immediate
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connection with sale of a product, and was not intended to deal generally with misleading claims.
U.S. v. 24 Bottles "Sterling Vinegar and Honey Aged in Wood Cider Blended With Finest
Honey Contents 1 Pint Product of Sterling Cider Co., Inc., Sterling, Mass.", C.A.2 (N.Y.) 1964,
338 F.2d 157.
Purpose of this chapter is to prevent other than harmless colors from being used in food, drugs
and cosmetics. Certified Color Indus. Com. v. Secretary of Health, Education, and Welfare,
C.A.2 1960, 283 F.2d 622. Health
302; Food
5
This chapter is intended to strike at not only palpably false claims but also at clever indirection
and ambiguity in creation of misleading impressions. V. E. Irons, Inc. v. U. S., C.A.1 (Mass.)
1957, 244 F.2d 34, certiorari denied 77 S.Ct. 1383, 354 U.S. 923, 1 L.Ed.2d 1437.
This chapter was intended to make provisions against misbranding stricter and not more lenient
than under pre-existing laws. Research Laboratories v. U.S., C.C.A.9 (Wash.) 1948, 167 F.2d
410, certiorari denied 69 S.Ct. 65, 335 U.S. 843, 93 L.Ed. 393.
Former § § 1 to 5, 7 to 14 and 15 of this title were not enacted to punish merchants who were
conducting their business by customary and approved methods or to injure the public health for
the mistakes of third person over whom they had no control or for trivial errors of their own.
Hall-Baker Grain Co. v. U.S., C.C.A.8 (Mo.) 1912, 198 F. 614, 117 C.C.A. 318.
The purpose of former § § 1 to 5, 7 to 14 and 15 of this title was to protect the public against
deception in the purchase of drugs by punishing adulteration and misbranding as therein defined,
and a manufacturer of a face cream was not liable for misstatements as to its curative or remedial
effects. U. S. v. American Druggists' Syndicate, C.C.N.Y.1911, 186 F. 387.
Primary objective of this chapter is the protection of the public health. Pharmaceutical Mfrs.
Ass'n v. Food and Drug Administration, D.C.Del.1980, 484 F.Supp. 1179.
Congress, in enacting this chapter and the Comprehensive Drug Abuse Prevention and Control
Act, section 801 et seq. of this title, intended to create two complementary institutional checks on
production and marketing of new drugs; at the production or premarketing stage, the Food and
Drug Administration is given the primary responsibility in determining which new drugs should
be permitted to enter the flow of commerce; but once a drug is cleared for marketing by way of
a new drug application approval, the question of permissible distribution of the drug, when that
drug is a controlled substance, is one within jurisdiction of the Justice Department. American
Pharmaceutical Ass'n v. Weinberger, D.C.D.C.1974, 377 F.Supp. 824, affirmed 530 F.2d 1054,
174 U.S.App.D.C. 202.
Total scheme of this chapter contemplates judicial obligation to enjoin distribution of unsafe
foods even in absence of formally promulgated regulation and it is not mandatory for
administrator to promulgate regulations establishing tolerances.
U. S. v. Goodman,
E.D.Wis.1972, 353 F.Supp. 250, affirmed 486 F.2d 847, affirmed 502 F.2d 715, certiorari denied
95 S.Ct. 1324, 420 U.S. 945, 43 L.Ed.2d 423.
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This chapter was intended to protect consumers from misleading claims in connection with sale
of certain products and from hazards of adulteration, mislabeling and misbranding. U. S. v.
Kuch, D.C.D.C.1968, 288 F.Supp. 439. See, also, U.S. v. H. L. Moore Drug Exchange, Inc.,
D.C.Conn.1965, 239 F.Supp. 256. Health
307; Food
2; Health
314
One of the primary concerns of this chapter is to safeguard health. U. S. v. Article Consisting of
216 Cartoned Bottles, More or Less, Sudden Change, E.D.N.Y.1968, 288 F.Supp. 29, reversed
on other grounds 409 F.2d 734. See, also, C.C. Co. v. U.S., C.C.A.Ga.1945, 147 F.2d 820.
Health
302; Food
2
Congress intended under this chapter that all persons in national domain be protected against
injury from delaying treatment by competent doctors, and such is reason enough to prevent
irreparable injury existing or threatening public. U. S. v. Nutrition Service, Inc., W.D.Pa.1964,
227 F.Supp. 375, affirmed 347 F.2d 233.
Purpose of this chapter is to keep misbranded drugs and devices out of channels of commerce.
U. S. v. One Device, More or Less, Ellis Micro-Dynameter, E.D.Pa.1963, 224 F.Supp. 265. See,
also, U.S. v. Two Bags, Each Containing 110 Pounds, Poppy Seeds, C.C.A.Ohio 1945, 147 F.2d
123; U.S. v. 1851 Cartons Labeled in Part H. & G. Famous Booth Sea Foods Whiting Frosted
Fish, C.C.A.Colo.1945, 146 F.2d 760; U.S. v. Sullivan, D.C.Ga.1946, 67 F.Supp. 192, reversed
161 F.2d 629, reversed 68 S.Ct. 331, 332 U.S. 689, 92 L.Ed.2d 297. Health
313
This chapter and state statutes providing that only licensed physicians may prescribe drug were
intended to protect public from abuses in sale and dispensing, and from hazards of mislabeling,
misbranding, and adulteration, and fact that unlicensed residents in state hospital prescribed drug
in violation of statutes was not negligence as matter of law. Cox v. Hecker, E.D.Pa.1963, 218
F.Supp. 749, affirmed 330 F.2d 958, certiorari denied 85 S.Ct. 46, 379 U.S. 823, 13 L.Ed.2d 33,
rehearing denied 85 S.Ct. 258, 379 U.S. 917, 13 L.Ed.2d 188.
Purpose of this chapter is to protect the public and to make self-medication safer and more
effective, and to require that drugs moving in interstate commerce be properly labeled so that
their use as prescribed may not be dangerous to the health of the user. U. S. v. 39 Bags, More or
Less, "Elip Tablets", E.D.N.Y.1957, 150 F.Supp. 648. See, also, U.S. v. 62 Packages, More or
Less, of Marmola Prescription Tablets, D.C.Wis.1943, 48 F.Supp. 878, affirmed 142 F.2d 107,
certiorari denied 65 S.Ct. 68, 323 U.S. 731, 89 L.Ed. 587. Health
302
The purpose of this chapter was not merely to require informative and truthful labeling of food
products, but to authorize administrator to promulgate definitions and standards of identity under
which integrity of such products can be effectively maintained. U.S. v. Omar, Inc.,
D.C.Neb.1950, 91 F.Supp. 121. See, also, U.S. v. 306 Cases Containing Sandford Tomato
Catsup With Preservative, D.C.N.Y.1944, 55 F.Supp. 725, affirmed 148 F.2d 71. Food
2
Quaesitum of this chapter is to protect public health by keeping adulterated and harmful articles
out of interstate commerce, and thus, it applies to raw materials shipped for use in final product
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and also controls intrastate sales made with knowledge that purchaser intends to introduce
product into interstate commerce. Monsanto Co. v. Miller, Ind.App. 1 Dist.1983, 455 N.E.2d
392.
The obvious purpose of the pure food law, former § § 1 to 5, 7 to 14 and 15 of this title, was
altogether different from that of the provisions of law relating to internal revenue. 1908, 26
Op.Atty.Gen. 474.
6. State regulation
Regulation of state board, pursuant to Food and Drugs Law Kan., Gen.St.1915, § § 4095 to
4134, requiring label of proprietary foods to state percentage of each ingredient, was not as to
such foods, even while still in interstate commerce, precluded by former § § 1 to 5, 7 to 14 and
15 of this title. Corn Products Refining Co. v. Eddy, U.S.Kan.1919, 39 S.Ct. 325, 249 U.S. 427,
63 L.Ed. 689. Commerce
60(2)
Former § § 1 to 5, 7 to 14 and 15 of this title did not prevent state regulation of domestic retail
sales of food shipped in from another state. Hebe Co. v. Shaw, U.S.Ohio 1919, 39 S.Ct. 125,
248 U.S. 297, 63 L.Ed. 255.
Former § § 1 to 5, 7 to 14 and 15 of this title did not affect the question when interstate
commerce in an article of food satisfying such sections ceased and the article became subject to
the laws of the state, into which it was brought, prohibiting its sale. Weigle v. Curtice Bros. Co.,
U.S.Wis.1919, 39 S.Ct. 124, 248 U.S. 285, 63 L.Ed. 242.
Laws N.D.1911, p. 355, prohibiting the sale of lard not in bulk unless put up in packages of
specified weights, was not repugnant to former § § 1 to 5, 7 to 14 and 15 of this title, which had
reference merely to adulteration and misbranding. Armour & Co. v. State of North Dakota,
U.S.N.D.1916, 36 S.Ct. 440, 240 U.S. 510, 60 L.Ed. 771, Am.Ann.Cas. 1916D,548.
A state statute prohibiting the sale of food preservatives containing boric acid is not invalid as to
sales within the state. Price v. People of State of Illinois, U.S.Ill.1915, 35 S.Ct. 892, 238 U.S.
446, 59 L.Ed. 1400.
A state statute in conflict with the provisions of the Food and Drugs Act of 1906, former § § 1 to
5, 7 to 14 and 15 of this title, was void. McDermott v. State of Wis., U.S.Wis.1913, 33 S.Ct.
431, 228 U.S. 115, 57 L.Ed. 754.
There was no conflict between the provisions for the prevention of adulteration and misbranding
of foods and drugs when the subject of interstate commerce, and Code Supp.Iowa 1907, § §
5077a6 to 5077a24, as applied to sales by importers in original packages of concentrated
commercial feeding stuffs. Standard Stock Food Co. v. Wright, U.S.Iowa 1912, 32 S.Ct. 784,
225 U.S. 540, 56 L.Ed. 1197.
Congress did not by passage of former § § 1 to 5, 7 to 14 and 15 of this title for the prevention
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of adulteration and misbranding of foods and drugs when the subject of interstate commerce,
prohibit the enactment of Acts Ind.1907, c. 206, relating to sales of foodstuffs in original
packages. Savage v. Jones, U.S.Ind.1912, 32 S.Ct. 715, 225 U.S. 501, 56 L.Ed. 1182.
Federal law did not implicitly preempt state law claims that vaccine manufacturer breached duty
to warn of product risks and duty not to place unreasonably dangerous products into commerce
absent evidence that preemption was intended. Hurley v. Lederle Laboratories Div. of American
Cyanamid Co., C.A.5 (Tex.) 1988, 863 F.2d 1173.
Where Tennessee Food, Drug and Cosmetic Act, T.C.A. § § 52-101 to 52-124, was patterned
upon the provisions of this chapter, and there were no adjudications by Tennessee courts
involving meaning of provisions of the Act, resort may be had to federal court decisions
construing this chapter. Merck & Co. v. Kidd, C.A.6 (Tenn.) 1957, 242 F.2d 592, certiorari
denied 78 S.Ct. 15, 355 U.S. 814, 2 L.Ed.2d 31.
Where a state law was not in conflict with former § § 1 to 5, 7 to 14 and 15 of this title, a broad
latitude was allowed states in protecting their citizens from adulterated or misbranded articles.
Royal Baking Powder Co. v. Emerson, C.C.A.8 (Ark.) 1920, 270 F. 429, appeal dismissed 43
S.Ct. 166, 260 U.S. 752, 67 L.Ed. 496.
Former § § 1 to 5, 7 to 14 and 15 of this title did not prevent a similar act by the state in respect
to intrastate transactions. Royal Baking Powder Co. v. Donohue, D.C.Mont.1920, 265 F. 406.
A state statute prescribing a standard of purity for a product to entitle it labeled or branded in a
certain manner and sold at retail under such label or brand, did not contravene former § § 1 to 5,
7 to 14 and 15 of this title. Cleveland Macaroni Co. v. State Bd. of Health of Cal., N.D.Cal.1919,
256 F. 376.
Gen.Code Ohio, § 12725, prohibiting manufacture and sale of condensed milk made from
skimmed milk, was not inoperative because condensed milk made from skimmed milk and
cocoanut oil was properly labeled under former § § 1 to 5, 7 to 14 and 15 of this title, and
shipped into Ohio in interstate commerce; neither such sections nor Constitution depriving state
of power to protect citizens against deception. Hebe Co. v. Calvert, S.D.Ohio 1917, 246 F. 711.
Laws N.Y.1914, c. 494, required proprietary food products consisting of mixtures and
combinations to be so labeled as to disclose their character and constituents, and did not conflict
with former § § 1 to 5, 7 to 14 and 15 of this title. Crescent Mfg. Co. v. Wilson, N.D.N.Y.1916,
233 F. 282, appeal dismissed 242 F. 462, 155 C.C.A. 238.
The laws of Wisconsin relative to branding articles containing glucose were void as applied to
interstate commerce, because in conflict with former § § 1 to 5, 7 to 14 and 15 of this title. Corn
Products Refining Co. v. Weigle, W.D.Wis.1915, 221 F. 988.
In a case of misbranding and adulteration under the food laws of Oregon, where it was urged that
Congress had by its legislation fully occupied and covered the field relative to the protection of
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the public against the adulteration or misbranding of articles of food, and therefore that the state
legislation as it might affect foods dealt in in interstate commerce was void and inoperative, the
court did not decide the question, since in its view the product involved in the instant case did
not fall within the denunciation of the local act. In Crescent Mfg. Co. v. Mickle, D.C.Or.1914,
216 F. 246.
The Kentucky Pure Food Law, Laws 1906, p. 282, c. 48, was not rendered invalid by the
enactment of former § § 1 to 5, 7 to 14 and 15 of this title which did not conflict with its
provisions. Savage v. Scovell, C.C.E.D.Ky.1908, 171 F. 566.
Consumer's state law failure-to-warn claim against manufacturer of drug for skin condition was
not preempted by Food and Drug Administration (FDA) drug labeling regulations, to extent
claim was based on state law requirement to provide additional warnings following FDA's
approval of original label; such requirement would not conflict with FDA's regulations, which
provided avenues by which pharmaceutical companies could strengthen warnings following
approval of original label. Weiss v. Fujisawa Pharmaceutical Co., E.D.Ky.2006, 2006 WL
3422688. States
18.65
Federal law did not preempt failure to warn claims brought by parents of patient who developed
lymphoblastic lymphoma following use of Elidel, a prescription drug for the treatment of atopic
dermatitis; a state law requirement to provide an additional warning would not force the drug
company to choose between violating state and federal law, as at the time Elidel was prescribed,
the Food and Drug Administration (FDA) had made no finding regarding a link between use of
topical calcineurin inhibitors and increased cancer risk in children and no statute or regulation
prevented the drug maker from adding the warning, and, requiring company to add a warning to
the Elidel label would not disturb the balance of the regulatory scheme since FDA regulations
made specific accommodation for adding a warning in the situation the parents alleged. Perry v.
Novartis Pharma. Corp., E.D.Pa.2006, 456 F.Supp.2d 678. States
18.65
Patient's claim under the Louisiana Products Liability Act, alleging that pain pump implanted in
her back was unreasonably dangerous for its intended use, because its manufacturer failed to
sponsor or endorse large scale radiological screenings to prevent and diagnose newly discovered
complications associated with the pump, was not completely preempted by federal law, as would
warrant removal under complete preemption exception to well-pleaded complaint rule, although
pump was a Class III medical device that was subjected to pre-market approval process provided
for by the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act, where
there was no evidence that Congress intended the MDA to provide exclusive remedy for tort
claims involving medical devices. Albritton v. ABC Corp., M.D.La.2006, 451 F.Supp.2d 839.
States
18.65
Food and Drug Administration's (FDA) approval of premarket approval application (PMA) for
class III medical device was not specific federal requirement and thus, patient's state law claims
of strict liability, negligent warnings, design, manufacture, and follow-up evaluation, breach of
warranty, and fraud against manufacturer of atrial lead wire for pacemaker were not preempted
by Medical Device Amendments (MDA) to FDCA; neither MDA nor PMA process prescribed
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design specifications, PMA did not impose any "identifiable precondition" applicable to device,
FDA's approval of atrial lead provided no indication of any requirements related to safety or
effectiveness of device, and PMA approval did not impose ascertainable "specific mandate"
rather it represented only FDA's judgment that manufacturer had reasonably assured FDA of
device's safety and effectiveness. Webster v. Pacesetter, Inc., D.D.C.2001, 171 F.Supp.2d 1.
Products Liability
46.1; Sales
427; States
18.15; States
18.65
Action alleging that pharmaceutical company had conspired to commit fraud and to market
unreasonably dangerous drugs were not preempted by Federal Food, Drug, and Cosmetic Act.
Hawkins v. Upjohn Co., E.D.Tex.1994, 890 F.Supp. 609. States
18.65; Products Liability
46.2
Medical Device Amendments to Food, Drug and Cosmetics Act did not preempt state-law causes
of action against manufacturer for injuries caused by alleged defectively designed prosthetic
knee system that was class II medical device, where Food and Drug Administration had not
established specific requirements for particular prosthetic knee system; its class II designation
alone was insufficient to trigger preemption provision. Oliver v. Johnson & Johnson, Inc.,
W.D.Pa.1994, 863 F.Supp. 251. Products Liability
46.1; States
18.65
State tort remedies for injuries caused by DPT vaccine were not preempted by provisions of
Federal Food, Drug, and Cosmetic Act; despite pervasive nature of FDA regulations, provisions
of National Vaccine Act of 1986, was gives claimant option of submitting claim and receiving
compensation on no-fault basis or of filing civil action in state or federal court, manifests
overriding intent to preserve state tort remedies. Foyle By and Through McMillan v. Lederle
Laboratories, E.D.N.C.1987, 674 F.Supp. 530.
Public Health Service Act, Federal Food, Drug and Cosmetic Act, and ensuing regulations
promulgated by Food and Drug Administration did not preempt state tort claims against
diphtheria and tetanus toxoids and pertussis vaccine manufacturers. Martinkovic by Martinkovic
v. Wyeth Laboratories, Inc., N.D.Ill.1987, 669 F.Supp. 212.
Any Massachusetts authority for worldwide notification and recall campaign concerning
allegedly defective intrauterine contraceptive devices was preempted by this chapter. National
Women's Health Network, Inc. v. A. H. Robins Co., Inc., D.C.Mass.1982, 545 F.Supp. 1177.
Fact that practice of medicine is an area traditionally regulated by states does not invalidate those
provisions of this chapter which may at time impinge on some aspect of a doctor's practice.
Pharmaceutical Mfrs. Ass'n v. Food and Drug Administration, D.C.Del.1980, 484 F.Supp. 1179.
Congress has not legislatively expressed any intent to preclude states from entering area of drug
regulation. Pharmaceutical Soc. of State of New York, Inc. v. Lefkowitz, S.D.N.Y.1978, 454
F.Supp. 1175, affirmed 586 F.2d 953.
States are not barred from regulating drug product labeling, but are only limited where labels or
warnings pertain to problems which have already been addressed by federal government.
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Pharmaceutical Soc. of State of New York, Inc. v. Lefkowitz, S.D.N.Y.1978, 454 F.Supp. 1175,
affirmed 586 F.2d 953.
Fact that a state ban of chlorofluorocarbon is permitted by Food and Drug Administration does
not create conflicting preemption problems as regards different state and federal warning
requirements; for preemption purposes, the Food and Drug Administration has not imposed a
current national ban and has permitted states to do so within their geographical boundaries
because such bans are not in conflict with federal policy. Cosmetic, Toiletry and Fragrance
Ass'n., Inc. v. State of Minn., D.C.Minn.1977, 440 F.Supp. 1216, affirmed 575 F.2d 1256.
Although express preemption provisions of federal consumer product labeling legislation, such
as Federal Hazardous Substances Act, section 1261 et seq. of Title 15, and Consumer Product
Safety Act, section 2051 et seq. of Title 15, were not controlling in determining whether
promulgation of chlorofluorocarbon warning requirements under this chapter preempted
adoption of state warning requirements, they weighed heavily in the court's analysis of the
preemption question. Cosmetic, Toiletry and Fragrance Ass'n., Inc. v. State of Minn.,
D.C.Minn.1977, 440 F.Supp. 1216, affirmed 575 F.2d 1256.
Preliminary injunction issued restraining enforcement of M.S.A. § 116.39 requiring that
chlorofluorocarbon warning label be displayed on front panel of pressurized containers; not only
did the court preliminarily conclude that the state legislation was preempted by functionally
oriented approach adopted by Food and Drug Administration but manufacturers would suffer
irreparable harm since cost of compliance might force them to cease selling such products in the
state and duration of warning stage of federal and state chlorofluorocarbon phaseout programs
would be approximately 18 months and only miniscule amount of ozone depletion was involved.
Cosmetic, Toiletry and Fragrance Ass'n., Inc. v. State of Minn., D.C.Minn.1977, 440 F.Supp.
1216, affirmed 575 F.2d 1256.
Food, Drug, and Cosmetic Act (FDCA) did not preempt state law claims, relating to control and
regulation of advertisements by manufacturer of prescription drug paraxetine; Congress did not
intend, when it enacted the FDCA for purposes of protecting public health, to not only decline to
provide private cause of action, but to also eliminate availability of common law state claims. In
re Paxil Litigation, C.D.Cal.2002, 2002 WL 31375497, Unreported. Consumer Protection
36.1; States
18.65
7. Private right of action
Estate of patient who committed suicide while taking manufacturers' antidepressant and
antipsychotic drugs did not have private cause of action in negligence per se under Kansas law
based on alleged violation of FDCA, inasmuch as Congress did not intend to permit private
causes of action to enforce FDCA. Vanderwerf v. SmithKlineBeecham Corp., D.Kan.2006, 414
F.Supp.2d 1023. Products Liability
46.2
State unfair trade practices claims concerning bottling, advertising, promotion, and sale of
particular brand of bottled water did not present a substantial question of federal law, as required
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for federal question jurisdiction, although element of claim was that the water did not meet the
standard of identity for "spring water," which was determined by the Federal Food, Drug and
Cosmetic Act (FDCA); FDCA did not provide a private right of action, and federal interest in
ensuring uniform interpretation of federal statutes and regulations did not require review in
federal court. Savalle v. Nestle Waters North America, Inc., D.Conn.2003, 289 F.Supp.2d 31.
Federal Courts
208
No evidence showed that Congress intended for removal jurisdiction to be available to parties
defending against common law claims, the success of which arguably required consideration of
Federal Food, Drug, and Cosmetic Act (FDCA) or Controlled Substances Act (CSA), as would
support removal of products liability action against drug manufacturers under substantial federal
question and complete preemption doctrines; Acts did not replace entire state products liability
cause of action, and the action sought money damages, rather than to overturn prior Food and
Drug Administration (FDA) decisions regarding drug OxyContin. Little v. Purdue Pharma, L.P.,
S.D.Ohio 2002, 227 F.Supp.2d 838. Removal Of Cases
19(1); Removal Of Cases
25(1)
Food, Drug, and Cosmetic Act (FDCA) did not contain private civil enforcement provisions
encompassing prescription drug users' claims that drug manufacturers promoted off-label uses
and doses of drug while misleading users and others about drug's dangers, as required for
complete preemption to apply to users' claims and create federal jurisdiction supporting removal
of users' state-law class action against manufacturers. McCallister v. Purdue Pharma L.P.,
S.D.W.Va.2001, 164 F.Supp.2d 783.
No private right of action for remedial equitable relief could be implied under this chapter.
National Women's Health Network, Inc. v. A. H. Robins Co., Inc., D.C.Mass.1982, 545 F.Supp.
1177.
This chapter does not create a private right of action. State of Fla. ex rel. Broward County v. Eli
Lilly & Co., S.D.Fla.1971, 329 F.Supp. 364.
Anyone who does business within the reach of this chapter is under an absolute obligation to
comply with the law at all times. U. S. v. Bodine Produce Co., D.C.Ariz.1962, 206 F.Supp. 201.
If this chapter is too broad and needs amending in the public interest to guard against the
possibility of the destruction of wholesome food by the United States, the remedy is to call the
matter to the attention of Congress. U. S. v. 233 Tins, More or Less, Grove Brand*** Whole
Blakemore Strawberries, W.D.Ark.1959, 175 F.Supp. 694.
8. Administration authority
Food, Drug and Cosmetic Act (FDC Act) did not delegate to Food and Drug Administration
(FDA) authority to address packaging of food, drug and dietary supplement products except to
extent necessary to address risks of adulteration. Nutritional Health Alliance v. Food and Drug
Admin., C.A.2 (N.Y.) 2003, 318 F.3d 92.
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21 U.S.C.A. § 301, 21 USCA § 301
Current through P.L. 110-17 approved 04-09-07
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END OF DOCUMENT
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