Notes on 21 U.S.C. § 321 : US Code - Notes

Search Notes on 21 U.S.C. § 321 : US Code - Notes

(June 25, 1938, ch. 675, Sec. 201, 52 Stat. 1040; July 22, 1954,
ch. 559, Sec. 1, 68 Stat. 511; Pub. L. 85-929, Sec. 2, Sept. 6,
1958, 72 Stat. 1784; Pub. L. 86-618, title I, Sec. 101, July 12,
1960, 74 Stat. 397; Pub. L. 87-781, title I, Sec. 102(a), title
III, Sec. 307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89-74,
Secs. 3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90-399,
Sec. 102, July 13, 1968, 82 Stat. 351; Pub. L. 90-639, Secs. 1,
4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91-513, title II,
Sec. 701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92-
516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94-278, title
V, Sec. 502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-295,
Sec. 3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95-203,
Sec. 4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96-359, Sec. 3,
Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100-670, title I, Sec.
107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101-535, Sec.
5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101-629, Sec. 16(b),
Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-282, Sec. 6, May 13,
1992, 106 Stat. 161; Pub. L. 102-300, Sec. 6(a), (b), June 16,
1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(1), Oct.
29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 3(b), (dd)(1),
4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103-417, Secs.
3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104-
170, title IV, Sec. 402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105-
115, title I, Secs. 121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111
Stat. 2320, 2325, 2327; Pub. L. 105-324, Sec. 2(a), (c), Oct. 30,
1998, 112 Stat. 3035, 3037; Pub. L. 107-109, Sec. 5(b)(1), Jan. 4,
2002, 115 Stat. 1413; Pub. L. 107-250, title III, Sec. 302(d), Oct.
26, 2002, 116 Stat. 1619; Pub. L. 108-282, title I, Sec. 102(b)(1),
(5)(A), (B), title II, Sec. 203(c)(1), Aug. 2, 2004, 118 Stat. 891,
902, 908.)
REFERENCES IN TEXT
The Food and Drugs Act of June 30, 1906, as amended, referred to
in par. (p)(1), and the Food and Drug Act of June 30, 1906, as
amended, referred to in par. (v)(1), is act June 30, 1906, ch.
3915, 34 Stat. 768, as amended, which was classified to subchapter
I (Sec. 1 et seq.) of chapter 1 of this title, was repealed (except
for section 14a which was transferred to section 372a of this
title) by act June 25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059,
and is covered by this chapter.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred
to in par. (q)(1), is act June 25, 1947, ch. 125, as amended
generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is
classified generally to subchapter II (Sec. 136 et seq.) of chapter
6 of Title 7, Agriculture. For complete classification of this Act
to the Code, see Short Title note set out under section 136 of
Title 7 and Tables.
The Poultry Products Inspection Act, referred to in par. (s)(4),
is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which
is classified generally to chapter 10 (Sec. 451 et seq.) of this
title. For complete classification of this Act to the Code, see
Short Title note set out under section 451 of this title and
Tables.
The Meat Inspection Act of March 4, 1907, as amended and
extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch.
2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81
Stat. 584, which are classified generally to subchapters I to IV
(Sec. 601 et seq.) of chapter 12 of this title. For complete
classification of this Act to the Code, see Short Title note set
out under section 601 of this title and Tables.
Section 101(4) of the Food and Drug Administration Modernization
Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L.
105-115, which is set out as a note under section 379g of this
title.
AMENDMENTS
2004-Par. (u). Pub. L. 108-282, Sec. 102(b)(5)(A), substituted
"360b, 360ccc" for "360b".
Par. (v). Pub. L. 108-282, Sec. 102(b)(5)(B), inserted concluding
provisions.
Pars. (nn) to (pp). Pub. L. 108-282, Sec. 102(b)(1), added pars.
(nn) to (pp).
Par. (qq). Pub. L. 108-282, Sec. 203(c)(1), added par. (qq).
2002 - Par. (kk). Pub. L. 107-109 added par. (kk).
Pars. (ll), (mm). Pub. L. 107-250 added pars. (ll) and (mm).
1998 - Par. (q)(1). Pub. L. 105-324, Sec. 2(a), added subpar. (1)
and struck out former subpar. (1) which read as follows: "The term
'pesticide chemical' means any substance that is a pesticide within
the meaning of the Federal Insecticide, Fungicide, and Rodenticide
Act, including all active and inert ingredients of such pesticide."
Par. (q)(3). Pub. L. 105-324, Sec. 2(c), substituted
"subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in
introductory provisions.
1997 - Par. (aa). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
"or 357" after "section 355(j)".
Par. (dd). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out "357,"
after "section 355,".
Par. (ff)(3)(A). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
", certified as an antibiotic under section 357 of this title,"
before "or licensed as a biologic".
Par. (ii). Pub. L. 105-115, Sec. 121(a), added par. (ii).
Par. (jj). Pub. L. 105-115, Sec. 125(e), added par. (jj).
1996 - Par. (q). Pub. L. 104-170, Sec. 402(a), amended par. (q)
generally. Prior to amendment, par. (q) read as follows: "The term
'pesticide chemical' means any substance which, alone, in chemical
combination or in formulation with one or more other substances, is
'a pesticide' within the meaning of the Federal Insecticide,
Fungicide, and Rodenticide Act as now in force or as hereafter
amended, and which is used in the production, storage, or
transportation of raw agricultural commodities."
Par. (s)(1), (2). Pub. L. 104-170, Sec. 402(b), amended subpars.
(1) and (2) generally. Prior to amendment, subpars. (1) and (2)
read as follows:
"(1) a pesticide chemical in or on a raw agricultural commodity;
or
"(2) a pesticide chemical to the extent that it is intended for
use or is used in the production, storage, or transportation of any
raw agricultural commodity; or".
Pars. (gg), (hh). Pub. L. 104-170, Sec. 402(c), added pars. (gg)
and (hh).
1994 - Par. (g)(1). Pub. L. 103-417, Sec. 10(a), amended last
sentence generally. Prior to amendment, last sentence read as
follows: "A food for which a claim, subject to sections
343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
and 343(r)(5)(D) of this title, is made in accordance with the
requirements of section 343(r) of this title is not a drug under
clause (B) solely because the label or labeling contains such a
claim."
Par. (s)(6). Pub. L. 103-417, Sec. 3(b), added subpar. (6).
Par. (ff). Pub. L. 103-417, Sec. 3(a), added par. (ff).
1993 - Pars. (c), (d). Pub. L. 103-80, Sec. 3(dd)(1), substituted
"Health and Human Services" for "Agriculture".
Par. (h). Pub. L. 103-80, Sec. 4(b), amended directory language
of Pub. L. 102-300, Sec. 6(a)(1). See 1992 amendment note below.
Pars. (v) to (ff). Pub. L. 103-80, Sec. 3(b), redesignated pars.
(w) to (ff) as (v) to (ee), respectively.
1992 - Pars. (c), (d). Pub. L. 102-300, Sec. 6(b)(1), which
directed the substitution of "Health and Human Services" for
"Health, Education, and Welfare", could not be executed because
such words did not appear in the original statutory text. See 1993
Amendment note above and Transfer of Functions notes below.
Par. (h). Pub. L. 102-300, Sec. 6(a)(1), as amended by Pub. L.
103-80, Sec. 4(b), substituted "its primary" for "any of its
principal" in two places in concluding provisions.
Par. (u). Pub. L. 102-571 substituted "379e" for "376".
Par. (y)(1). Pub. L. 102-300, Sec. 6(b)(2), struck out "of
Health, Education, and Welfare" after "employees of the
Department".
Pars. (bb) to (ee). Pub. L. 102-282 added pars. (bb) to (ee).
Par. (ff). Pub. L. 102-300, Sec. 6(a)(2), added par. (ff).
1990 - Par. (g)(1). Pub. L. 101-629, Sec. 16(b)(1), struck out ";
but does not include devices or their components, parts, or
accessories" after "clause (A), (B), or (C)".
Pub. L. 101-535 inserted at end "A food for which a claim,
subject to sections 343(r)(1)(B) and 343(r)(3) of this title or
sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in
accordance with the requirements of section 343(r) of this title is
not a drug under clause (B) solely because the label or labeling
contains such a claim."
Par. (h)(3). Pub. L. 101-629, Sec. 16(b)(2), which directed the
amendment of subpar. (3) by substituting "its primary" for "any of
its principal", could not be executed because "any of its
principal" did not appear in subpar. (3).
1988 - Par. (w)(3). Pub. L. 100-670 struck out subpar. (3) which
read as follows: "which drug is composed wholly or partly of any
kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, or bacitracin, or any derivative thereof, except
when there is in effect a published order of the Secretary
declaring such drug not to be a new animal drug on the grounds that
(A) the requirement of certification of batches of such drug, as
provided for in section 360b(n) of this title, is not necessary to
insure that the objectives specified in paragraph (3) thereof are
achieved and (B) that neither subparagraph (1) nor (2) of this
paragraph (w) applies to such drug."
1980 - Par. (aa). Pub. L. 96-359 added par. (aa).
1977 - Par. (z). Pub. L. 95-203 added par. (z).
1976 - Par. (h). Pub. L. 94-295, Sec. 3(a)(1)(A), expanded
definition of "device" to include implements, machines, implants,
in vitro reagents, and other similar or related articles, added
recognition in the National Formulary or the United States
Pharmacopeia, or any supplement to the Formulary or Pharmacopeia,
to the enumeration of conditions under which a device may qualify
for inclusion under this chapter, and inserted requirements that a
device be one which does not achieve any of its principal intended
purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized for
the achievement of any of its principal intended purposes.
Par. (n). Pub. L. 94-278 inserted "or advertising" after
"labeling" wherever appearing.
Par. (y). Pub. L. 94-295, Sec. 3(a)(2), added par. (y).
1972 - Par. (q). Pub. L. 92-516 substituted reference to
pesticide for reference to economic poison.
1970 - Par. (a)(2). Pub. L. 91-513, Sec. 701(g), struck out
reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334,
337, 360, 360a, 372, 373, 374, and 375 of this title as they apply
to depressant or stimulant drugs.
Par. (v). Pub. L. 91-513, Sec. 701(a), struck out par. (v) which
defined "depressant or stimulant drug".
1968 - Par. (a)(2). Pub. L. 90-639, Sec. 4(a), extended
provisions to cover depressant and stimulant drugs, the containers
thereof, and equipment used in manufacturing, compounding, or
processing such drugs, to the Canal Zone.
Par. (p). Pub. L. 90-399, Sec. 102(a), (b), inserted "(except a
new animal drug or an animal feed bearing or containing a new
animal drug)" after "Any drug" in subpars. (1) and (2),
respectively.
Par. (s)(5). Pub. L. 90-399, Sec. 102(c), added subpar. (5).
Par. (u). Pub. L. 90-399, Sec. 102(d), inserted reference to
section 360b of this title.
Par. (v)(3). Pub. L. 90-639, Sec. 1, inserted reference to
lysergic acid diethylamide.
Pars. (w), (x). Pub. L. 90-399, Sec. 102(e), added pars. (w) and
(x).
1965 - Par. (g). Pub. L. 89-74, Sec. 9(b), designated existing
provisions as subpar. (1), redesignated cls. (1) to (4) thereof as
(A) to (D), substituted "(A), (B), or (C)" for "(1), (2), or (3)"
and added subpar. (2).
Par. (v). Pub. L. 89-74, Sec. 3(a), added par. (v).
1962 - Par. (a). Pub. L. 87-781, Sec. 307(a), designated existing
provisions as subpar. (2), inserted "Commonwealth of Puerto Rico
and the", and added subpar. (1).
Par. (p)(1). Pub. L. 87-781, Sec. 102(a)(1), inserted "and
effectiveness" after "to evaluate the safety", and "and effective"
after "as safe".
Par. (p)(2). Pub. L. 87-781, Sec. 102(a)(2), inserted "and
effectiveness" after "safety".
1960 - Par. (s). Pub. L. 86-618, Sec. 101(a), excluded color
additives from definition of "food additive".
Par. (t). Pub. L. 86-618, Sec. 101(c), added par. (t). Former
par. (t) redesignated (u).
Par. (u). Pub. L. 86-618, Sec. 101(b), redesignated par. (t) as
(u) and inserted reference to section 376 of this title.
1958 - Pars. (s), (t). Pub. L. 85-929 added pars. (s) and (t).
1954 - Pars. (q), (r). Act July 22, 1954, added pars. (q) and
(r).
EFFECTIVE DATE OF 2004 AMENDMENT
Pub. L. 108-282, title II, Sec. 203(d), Aug. 2, 2004, 118 Stat.
908, provided that: "The amendments made by this section [amending
this section and sections 343 and 343-1 of this title] shall apply
to any food that is labeled on or after January 1, 2006."
EFFECTIVE DATE OF 1997 AMENDMENT
Section 501 of Pub. L. 105-115 provided that: "Except as
otherwise provided in this Act [see Short Title of 1997 Amendment
note set out under section 301 of this title], this Act and the
amendments made by this Act, other than the provisions of and the
amendments made by sections 111, 121, 125, and 307 [enacting
section 355a of this title, amending this section and sections 331,
335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381,
and 382 of this title, section 45C of Title 26, Internal Revenue
Code, section 156 of Title 35, Patents, and section 8126 of Title
38, Veterans' Benefits, repealing sections 356 and 357 of this
title, and enacting provisions set out as notes under sections 351
and 355 of this title], shall take effect 90 days after the date of
enactment of this Act [Nov. 21, 1997]."
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101-535 effective six months after the date
of the promulgation of final regulations to implement section
343(r) of this title, or if such regulations are not promulgated,
the date proposed regulations are to be considered as such final
regulations (Nov. 8, 1992), with exception for persons marketing
food the brand name of which contains a term defined by the
Secretary under section 343(r)(2)(A)(i) of this title, see section
10(a) of Pub. L. 101-535, set out as a note under section 343 of
this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 of this title.
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92-516 effective at the close of Oct. 21,
1972, except if regulations are necessary for the implementation of
any provision that becomes effective on Oct. 21, 1972, and
continuation in effect of subchapter I of chapter 6 of Title 7, and
regulations thereunder, relating to the control of economic
poisons, as in existence prior to Oct. 21, 1972, until superseded
by provisions of Pub. L. 92-516, and regulations thereunder, see
section 4 of Pub. L. 92-516, set out as an Effective Date note
under section 136 of Title 7, Agriculture.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1968 AMENDMENTS; TRANSITIONAL PROVISIONS
Section 6 of Pub. L. 90-639 provided that: "The amendments made
by this Act [amending this section, sections 331, 333, 334, and
360a of this title, and provisions set out as a note under section
289a of Title 42, The Public Health and Welfare] shall apply only
with respect to violations of the Federal Food, Drug, and Cosmetic
Act [this chapter] committed after the date of the enactment of
this Act [Oct. 24, 1968]."
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, except that in the case of a
drug (other than one subject to section 360b(n) of this title)
intended for use in animals other than man which, on Oct. 9, 1962,
was commercially used or sold in the United States, was not a new
drug as defined in par. (p) of this section then in force, and was
not covered by an effective application under section 355 of this
title, the words "effectiveness" and "effective" contained in par.
(v) of this section not applicable to such drug when intended
solely for use under conditions prescribed, recommended, or
suggested in labeling with respect to such drug on that day, see
section 108(a), (b)(3) of Pub. L. 90-399, as amended, set out as an
Effective Date and Transitional Provisions note under section 360b
of this title.
EFFECTIVE DATE OF 1965 AMENDMENT
Section 11 of Pub. L. 89-74 provided that: "The foregoing
provisions of this Act [see Short Title of 1965 Amendment note set
out under section 301 of this title] shall take effect on the first
day of the seventh calendar month [Feb. 1, 1966] following the
month in which this Act is enacted [July 15, 1965]; except that (1)
the Secretary shall permit persons, owning or operating any
establishment engaged in manufacturing, preparing, propagating,
compounding, processing, wholesaling, jobbing, or distributing any
depressant or stimulant drug, as referred to in the amendments made
by section 4 of this Act to section 510 of the Federal Food, Drug,
and Cosmetic Act [section 360 of this title], to register their
name, places of business, and establishments, and other information
prescribed by such amendments, with the Secretary prior to such
effective date, and (2) sections 201(v) and 511(g) of the Federal
Food, Drug, and Cosmetic Act, as added by this act [par. (v) of
this section and par. (g) of section 360a of this title], and the
provisions of sections 8 [amending section 372 of this title and
section 1114 of Title 18, Crimes and Criminal Procedure] and 10
[set out as a note under this section] shall take effect upon the
date of enactment of this Act [July 15, 1965]."
EFFECTIVE DATE OF 1962 AMENDMENT
Section 107 of Pub. L. 87-781 provided that:
"(a) Except as otherwise provided in this section, the amendments
made by the foregoing sections of this part A [amending this
section and sections 331, 332, 348, 351 to 353, 355, 357, 379e of
this title, and enacting provisions set out as a note under section
355 of this title] shall take effect on the date of enactment of
this Act [Oct. 10, 1962].
"(b) The amendments made by sections 101, 103, 105, and 106 of
this part A [amending sections 331, 332, 351, 352, 355, and 357 of
this title] shall, with respect to any drug, take effect on the
first day of the seventh calendar month following the month in
which this Act is enacted [Oct. 1962].
"(c)(1) As used in this subsection, the term 'enactment date'
means the date of enactment of this Act; and the term 'basic Act'
means the Federal Food, Drug, and Cosmetic Act [this chapter].
"(2) An application filed pursuant to section 505(b) of the basic
Act [section 355(b) of this title] which was 'effective' within the
meaning of that Act on the day immediately preceding the enactment
date shall be deemed as of the enactment date, to be an application
'approved' by the Secretary within the meaning of the basic Act as
amended by this Act.
"(3) In the case of any drug with respect to which an application
filed under section 505(b) of the basic Act is deemed to be an
approved application on the enactment date by virtue of paragraph
(2) of this subsection -
"(A) the amendments made by this Act to section 201(p), and to
subsections (b) and (d) of section 505, of the basic Act [par.
(p) of this section, and subsecs. (b) and (d) of section 355 of
this title], insofar as such amendments relate to the
effectiveness of drugs, shall not, so long as approval of such
application is not withdrawn or suspended pursuant to section
505(e) of that Act [section 355(e) of this title], apply to such
drug when intended solely for use under conditions prescribed,
recommended, or suggested in labeling covered by such approved
application, but shall apply to any changed use, or conditions of
use, prescribed, recommended, or suggested in its labeling,
including such conditions of use as are the subject of an
amendment or supplement to such application pending on, or filed
after, the enactment date; and
"(B) clause (3) of the first sentence of section 505(e) of the
basic Act, as amended by this Act [section 355(e) of this title],
shall not apply to such drug when intended solely for use under
conditions prescribed, recommended, or suggested in labeling
covered by such approved application (except with respect to such
use, or conditions of use, as are the subject of an amendment or
supplement to such approved application, which amendment or
supplement has been approved after the enactment date under
section 505 of the basic Act as amended by this Act [section 355
of this title]) until whichever of the following first occurs:
(i) the expiration of the two-year period beginning with the
enactment date; (ii) the effective date of an order under section
505(e) of the basic Act [section 355(e) of this title], other
than clause (3) of the first sentence of such section 505(e)
[section 355(e) of this title], withdrawing or suspending the
approval of such application.
"(4) In the case of any drug which, on the day immediately
preceding the enactment date, (A) was commercially used or sold in
the United States, (B) was not a new drug as defined by section
201(p) of the basic Act as then in force [par. (p) of this
section], and (C) was not covered by an effective application under
section 505 of that Act [section 355 of this title], the amendments
to section 201(p) [par. (p) of this section] made by this Act shall
not apply to such drug when intended solely for use under
conditions prescribed, recommended, or suggested in labeling with
respect to such drug on that day."
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE OF 1958 AMENDMENT
Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
6(a) of Pub. L. 85-929, set out as a note under section 342 of this
title.
EFFECTIVE DATE OF 1954 AMENDMENT
For effective date of amendment by act July 22, 1954, see section
5 of that act, set out as a note under section 342 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 102-282
Amendment by Pub. L. 102-282 not to preclude any other civil,
criminal, or administrative remedy provided under Federal or State
law, including any private right of action against any person for
the same action subject to any action or civil penalty under an
amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
282, set out as a note under section 335a of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Amendments by Pub. L. 101-535 not to be construed to alter
authority of Secretary of Health and Human Services and Secretary
of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.), see section 9 of Pub. L. 101-535, set out as a note under
section 343 of this title.
SAVINGS PROVISION
Section 702 of Pub. L. 91-513, as amended by Pub. L. 93-481, Sec.
2, Oct. 26, 1974, 88 Stat. 1455, provided that:
"(a) Prosecutions for any violation of law occurring prior to the
effective date [see Effective Date of 1970 Amendment note above] of
section 701 [repealing section 360a of this title, and amending
sections 321, 331, 333, 334, 360, 372, and 381 of this title,
sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure,
and section 242 of Title 42, The Public Health and Welfare] shall
not be affected by the repeals or amendments made by such section,
or abated by reason thereof.
"(b) Civil seizures or forfeitures and injunctive proceedings
commenced prior to the effective date of section 701 shall not be
affected by the repeals or amendments made by such section, or
abated by reason thereof.
"(c) All administrative proceedings pending before the Bureau of
Narcotics and Dangerous Drugs [now the Drug Enforcement
Administration] on the date of enactment of this Act [Oct. 27,
1970] shall be continued and brought to final determination in
accord with laws and regulations in effect prior to such date of
enactment. Where a drug is finally determined under such
proceedings to be a depressant or stimulant drug, as defined in
section 201(v) of the Federal Food, Drug, and Cosmetic Act [par.
(v) of this section], such drug shall automatically be controlled
under this title [subchapter I of chapter 13 of this title] by the
Attorney General without further proceedings and listed in the
appropriate schedule after he has obtained the recommendation of
the Secretary. Any drug with respect to which such a final
determination has been made prior to the date of enactment of this
Act which is not listed in section 202 [section 812 of this title]
within schedules I through V shall automatically be controlled
under this title [subchapter I of chapter 13 of this title] by the
Attorney General without further proceedings, and be listed in the
appropriate schedule, after he has obtained the recommendations of
the Secretary.
"(d) Notwithstanding subsection (a) of this section or section
1103 [of Pub. L. 91-513, set out as a note under sections 171 to
174 of this title], section 4202 of title 18, United States Code,
shall apply to any individual convicted under any of the laws
repealed by this title or title III [subchapter I or subchapter II
of chapter 13 of this title] without regard to the terms of any
sentence imposed on such individual under such law."
TRANSFER OF FUNCTIONS
Secretary and Department of Health, Education, and Welfare
redesignated Secretary and Department of Health and Human Services
by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
695, which is classified to section 3508(b) of Title 20, Education.
Functions of Secretary of Health, Education, and Welfare [now
Health and Human Services] under Federal Food, Drug, and Cosmetic
Act, to the extent such functions related to administration and
enforcement of the Poison Prevention Packaging Act of 1970 (15
U.S.C. 1471 et seq.), transferred to Consumer Product Safety
Commission by section 2079 of Title 15, Commerce and Trade.
Functions of Secretary of Health, Education, and Welfare [now
Health and Human Services] under Drug Abuse Control Amendments of
1965 [see Short Title of 1965 Amendment note set out under section
301 of this title] transferred to Attorney General except function
of regulating counterfeiting of those drugs which are not
"depressant or stimulant" drugs, see section 2 of Reorg. Plan No. 1
of 1968, set out in the Appendix to Title 5, Government
Organization and Employees.
Functions of Federal Security Administrator transferred to
Secretary of Health, Education, and Welfare and all agencies of
Federal Security Agency transferred to Department of Health,
Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953,
set out in the Appendix to Title 5, Government Organization and
Employees. Federal Security Agency and office of Administrator
abolished by section 8 of Reorg. Plan No. 1 of 1953.
Food and Drug Administration in Department of Agriculture and its
functions, except those functions relating to administration of
Insecticide Act of 1910 and Naval Stores Act, transferred to
Federal Security Agency, to be administered under direction and
supervision of Federal Security Administrator, by Reorg. Plan No.
IV of 1940, set out in the Appendix to Title 5.
REGULATION OF TOBACCO
Section 422 of Pub. L. 105-115 provided that: "Nothing in this
Act [see Short Title of 1997 Amendment note set out under section
301 of this title] or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health
and Human Services has any authority to regulate any tobacco
product, tobacco ingredient, or tobacco additive. Such authority,
if any, shall be exercised under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] as in effect on the day before
the date of the enactment of this Act [Nov. 21, 1997]."
CONGRESSIONAL FINDINGS RELATING TO PUB. L. 103-417
Section 2 of Pub. L. 103-417 provided that: "Congress finds that -

"(1) improving the health status of United States citizens
ranks at the top of the national priorities of the Federal
Government;
"(2) the importance of nutrition and the benefits of dietary
supplements to health promotion and disease prevention have been
documented increasingly in scientific studies;
"(3)(A) there is a link between the ingestion of certain
nutrients or dietary supplements and the prevention of chronic
diseases such as cancer, heart disease, and osteoporosis; and
"(B) clinical research has shown that several chronic diseases
can be prevented simply with a healthful diet, such as a diet
that is low in fat, saturated fat, cholesterol, and sodium, with
a high proportion of plant-based foods;
"(4) healthful diets may mitigate the need for expensive
medical procedures, such as coronary bypass surgery or
angioplasty;
"(5) preventive health measures, including education, good
nutrition, and appropriate use of safe nutritional supplements
will limit the incidence of chronic diseases, and reduce long-
term health care expenditures;
"(6)(A) promotion of good health and healthy lifestyles
improves and extends lives while reducing health care
expenditures; and
"(B) reduction in health care expenditures is of paramount
importance to the future of the country and the economic well-
being of the country;
"(7) there is a growing need for emphasis on the dissemination
of information linking nutrition and long-term good health;
"(8) consumers should be empowered to make choices about
preventive health care programs based on data from scientific
studies of health benefits related to particular dietary
supplements;
"(9) national surveys have revealed that almost 50 percent of
the 260,000,000 Americans regularly consume dietary supplements
of vitamins, minerals, or herbs as a means of improving their
nutrition;
"(10) studies indicate that consumers are placing increased
reliance on the use of nontraditional health care providers to
avoid the excessive costs of traditional medical services and to
obtain more holistic consideration of their needs;
"(11) the United States will spend over $1,000,000,000,000 on
health care in 1994, which is about 12 percent of the Gross
National Product of the United States, and this amount and
percentage will continue to increase unless significant efforts
are undertaken to reverse the increase;
"(12)(A) the nutritional supplement industry is an integral
part of the economy of the United States;
"(B) the industry consistently projects a positive trade
balance; and
"(C) the estimated 600 dietary supplement manufacturers in the
United States produce approximately 4,000 products, with total
annual sales of such products alone reaching at least
$4,000,000,000;
"(13) although the Federal Government should take swift action
against products that are unsafe or adulterated, the Federal
Government should not take any actions to impose unreasonable
regulatory barriers limiting or slowing the flow of safe products
and accurate information to consumers;
"(14) dietary supplements are safe within a broad range of
intake, and safety problems with the supplements are relatively
rare; and
"(15)(A) legislative action that protects the right of access
of consumers to safe dietary supplements is necessary in order to
promote wellness; and
"(B) a rational Federal framework must be established to
supersede the current ad hoc, patchwork regulatory policy on
dietary supplements."
DISSEMINATION OF INFORMATION REGARDING THE DANGERS OF DRUG ABUSE
Section 5 of Pub. L. 90-639 provided that: "It is the sense of
the Congress that, because of the inadequate knowledge on the part
of the people of the United States of the substantial adverse
effects of misuse of depressant and stimulant drugs, and of other
drugs liable to abuse, on the individual, his family, and the
community, the highest priority should be given to Federal programs
to disseminate information which may be used to educate the public,
particularly young persons, regarding the dangers of drug abuse."
CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY
Section 2 of Pub. L. 89-74 provided that: "The Congress hereby
finds and declares that there is a widespread illicit traffic in
depressant and stimulant drugs moving in or otherwise affecting
interstate commerce; that the use of such drugs, when not under the
supervision of a licensed practitioner, often endangers safety on
the highways (without distinction of interstate and intrastate
traffic thereon) and otherwise has become a threat to the public
health and safety, making additional regulation of such drugs
necessary regardless of the intrastate or interstate origin of such
drugs; that in order to make regulation and protection of
interstate commerce in such drugs effective, regulation of
intrastate commerce is also necessary because, among other things,
such drugs, when held for illicit sale, often do not bear labeling
showing their place of origin and because in the form in which they
are so held or in which they are consumed a determination of their
place of origin is often extremely difficult or impossible; and
that regulation of interstate commerce without the regulation of
intrastate commerce in such drugs, as provided in this Act [see
Short Title of 1965 Amendment note set out under section 301 of
this title], would discriminate against and adversely affect
interstate commerce in such drugs."
EFFECT OF DRUG ABUSE CONTROL AMENDMENTS OF 1965 ON STATE LAWS
Section 10 of Pub. L. 89-74 provided that:
"(a) Nothing in this Act [enacting section 360a of this title,
amending sections 321, 331, 333, 334, 360, and 372 of this title
and section 1114 of Title 18, Crimes and Criminal Procedure, and
enacting provisions set out as notes under sections 321, 352, and
360a of this title] shall be construed as authorizing the
manufacture, compounding, processing, possession, sale, delivery,
or other disposal of any drug in any State in contravention of the
laws of such State.
"(b) No provision of this Act nor any amendment made by it shall
be construed as indicating an intent on the part of the Congress to
occupy the field in which such provision or amendment operates to
the exclusion of any State law on the same subject matter, unless
there is a direct and positive conflict between such provision or
amendment and such State law so that the two cannot be reconciled
or consistently stand together.
"(c) No amendment made by this Act shall be construed to prevent
the enforcement in the courts of any State of any statute of such
State prescribing any criminal penalty for any act made criminal by
any such amendment."
EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS
Section 202 of Pub. L. 87-781 provided that: "Nothing in the
amendments made by this Act [enacting sections 358 to 360, amending
sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e,
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]
to the Federal Food, Drug, and Cosmetic Act [this chapter] shall be
construed as invalidating any provision of State law which would be
valid in the absence of such amendments unless there is a direct
and positive conflict between such amendments and such provision of
State law."
DEFINITIONS
Section 2 of Pub. L. 105-115 provided that: "In this Act [see
Short Title of 1997 Amendment note set out under section 301 of
this title], the terms 'drug', 'device', 'food', and 'dietary
supplement' have the meaning given such terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)."
(!1) So in original. Probably should be paragraph "(v)".