CITE
21 USC Sec. 321 01/05/2009
EXPCITE
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
HEAD
Sec. 321. Definitions; generally
STATUTE
For the purposes of this chapter -
(a)(1) The term "State", except as used in the last sentence of
section 372(a) of this title, means any State or Territory of the
United States, the District of Columbia, and the Commonwealth of
Puerto Rico.
(2) The term "Territory" means any Territory or possession of the
United States, including the District of Columbia, and excluding
the Commonwealth of Puerto Rico and the Canal Zone.
(b) The term "interstate commerce" means (1) commerce between any
State or Territory and any place outside thereof, and (2) commerce
within the District of Columbia or within any other Territory not
organized with a legislative body.
(c) The term "Department" means Department of Health and Human
Services.
(d) The term "Secretary" means the Secretary of Health and Human
Services.
(e) The term "person" includes individual, partnership,
corporation, and association.
(f) The term "food" means (1) articles used for food or drink for
man or other animals, (2) chewing gum, and (3) articles used for
components of any such article.
(g)(1) The term "drug" means (A) articles recognized in the
official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, or official National Formulary,
or any supplement to any of them; and (B) articles intended for use
in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals; and (C) articles (other than food)
intended to affect the structure or any function of the body of man
or other animals; and (D) articles intended for use as a component
of any article specified in clause (A), (B), or (C). A food or
dietary supplement 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 solely
because the label or the labeling contains such a claim. A food,
dietary ingredient, or dietary supplement for which a truthful and
not misleading statement is made in accordance with section
343(r)(6) of this title is not a drug under clause (C) solely
because the label or the labeling contains such a statement.
(2) The term "counterfeit drug" means a drug which, or the
container or labeling of which, without authorization, bears the
trademark, trade name, or other identifying mark, imprint, or
device, or any likeness thereof, of a drug manufacturer, processor,
packer, or distributor other than the person or persons who in fact
manufactured, processed, packed, or distributed such drug and which
thereby falsely purports or is represented to be the product of, or
to have been packed or distributed by, such other drug
manufacturer, processor, packer, or distributor.
(h) The term "device" (except when used in paragraph (n) of this
section and in sections 331(i), 343(f), 352(c), and 362(c) of this
title) means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which is -
(1) recognized in the official National Formulary, or the
United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention
of disease, in man or other animals, or
(3) intended to affect the structure or any function of the
body of man or other animals, and
which does not achieve its primary 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 its primary intended purposes.
(i) The term "cosmetic" means (1) articles intended to be rubbed,
poured, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance,
and (2) articles intended for use as a component of any such
articles; except that such term shall not include soap.
(j) The term "official compendium" means the official United
States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the
United States, official National Formulary, or any supplement to
any of them.
(k) The term "label" means a display of written, printed, or
graphic matter upon the immediate container of any article; and a
requirement made by or under authority of this chapter that any
word, statement, or other information appear on the label shall not
be considered to be complied with unless such word, statement, or
other information also appears on the outside container or wrapper,
if any there be, of the retail package of such article, or is
easily legible through the outside container or wrapper.
(l) The term "immediate container" does not include package
liners.
(m) The term "labeling" means all labels and other written,
printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.
(n) If an article is alleged to be misbranded because the
labeling or advertising is misleading, then in determining whether
the labeling or advertising is misleading there shall be taken into
account (among other things) not only representations made or
suggested by statement, word, design, device, or any combination
thereof, but also the extent to which the labeling or advertising
fails to reveal facts material in the light of such representations
or material with respect to consequences which may result from the
use of the article to which the labeling or advertising relates
under the conditions of use prescribed in the labeling or
advertising thereof or under such conditions of use as are
customary or usual.
(o) The representation of a drug, in its labeling, as an
antiseptic shall be considered to be a representation that it is a
germicide, except in the case of a drug purporting to be, or
represented as, an antiseptic for inhibitory use as a wet dressing,
ointment, dusting powder, or such other use as involves prolonged
contact with the body.
(p) The term "new drug" means -
(1) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of which
is such that such drug is not generally recognized, among experts
qualified by scientific training and experience to evaluate the
safety and effectiveness of drugs, as safe and effective for use
under the conditions prescribed, recommended, or suggested in the
labeling thereof, except that such a drug not so recognized shall
not be deemed to be a "new drug" if at any time prior to June 25,
1938, it was subject to the Food and Drugs Act of June 30, 1906,
as amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of which
is such that such drug, as a result of investigations to
determine its safety and effectiveness for use under such
conditions, has become so recognized, but which has not,
otherwise than in such investigations, been used to a material
extent or for a material time under such conditions.
(q)(1)(A) Except as provided in clause (B), the term "pesticide
chemical" means any substance that is a pesticide within the
meaning of the Federal Insecticide, Fungicide, and Rodenticide Act
[7 U.S.C. 136 et seq.], including all active and inert ingredients
of such pesticide. Notwithstanding any other provision of law, the
term "pesticide" within such meaning includes ethylene oxide and
propylene oxide when such substances are applied on food.
(B) In the case of the use, with respect to food, of a substance
described in clause (A) to prevent, destroy, repel, or mitigate
microorganisms (including bacteria, viruses, fungi, protozoa,
algae, and slime), the following applies for purposes of clause
(A):
(i) The definition in such clause for the term "pesticide
chemical" does not include the substance if the substance is
applied for such use on food, or the substance is included for
such use in water that comes into contact with the food, in the
preparing, packing, or holding of the food for commercial
purposes. The substance is not excluded under this subclause from
such definition if the substance is ethylene oxide or propylene
oxide, and is applied for such use on food. The substance is not
so excluded if the substance is applied for such use on a raw
agricultural commodity, or the substance is included for such use
in water that comes into contact with the commodity, as follows:
(I) The substance is applied in the field.
(II) The substance is applied at a treatment facility where
raw agricultural commodities are the only food treated, and the
treatment is in a manner that does not change the status of the
food as a raw agricultural commodity (including treatment
through washing, waxing, fumigating, and packing such
commodities in such manner).
(III) The substance is applied during the transportation of
such commodity between the field and such a treatment facility.
(ii) The definition in such clause for the term "pesticide
chemical" does not include the substance if the substance is a
food contact substance as defined in section 348(h)(6) of this
title, and any of the following circumstances exist: The
substance is included for such use in an object that has a food
contact surface but is not intended to have an ongoing effect on
any portion of the object; the substance is included for such use
in an object that has a food contact surface and is intended to
have an ongoing effect on a portion of the object but not on the
food contact surface; or the substance is included for such use
in or is applied for such use on food packaging (without regard
to whether the substance is intended to have an ongoing effect on
any portion of the packaging). The food contact substance is not
excluded under this subclause from such definition if any of the
following circumstances exist: The substance is applied for such
use on a semipermanent or permanent food contact surface (other
than being applied on food packaging); or the substance is
included for such use in an object that has a semipermanent or
permanent food contact surface (other than being included in food
packaging) and the substance is intended to have an ongoing
effect on the food contact surface.
With respect to the definition of the term "pesticide" that is
applicable to the Federal Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136 et seq.], this clause does not exclude any
substance from such definition.
(2) The term "pesticide chemical residue" means a residue in or
on raw agricultural commodity or processed food of -
(A) a pesticide chemical; or
(B) any other added substance that is present on or in the
commodity or food primarily as a result of the metabolism or
other degradation of a pesticide chemical.
(3) Notwithstanding subparagraphs (1) and (2), the Administrator
may by regulation except a substance from the definition of
"pesticide chemical" or "pesticide chemical residue" if -
(A) its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natural
causes or to human activities not involving the use of any
substances for a pesticidal purpose in the production, storage,
processing, or transportation of any raw agricultural commodity
or processed food; and
(B) the Administrator, after consultation with the Secretary,
determines that the substance more appropriately should be
regulated under one or more provisions of this chapter other than
sections 342(a)(2)(B) and 346a of this title.
(r) The term "raw agricultural commodity" means any food in its
raw or natural state, including all fruits that are washed,
colored, or otherwise treated in their unpeeled natural form prior
to marketing.
(s) The term "food additive" means any substance the intended use
of which results or may reasonably be expected to result, directly
or indirectly, in its becoming a component or otherwise affecting
the characteristics of any food (including any substance intended
for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food; and
including any source of radiation intended for any such use), if
such substance is not generally recognized, among experts qualified
by scientific training and experience to evaluate its safety, as
having been adequately shown through scientific procedures (or, in
the case of a substance used in food prior to January 1, 1958,
through either scientific procedures or experience based on common
use in food) to be safe under the conditions of its intended use;
except that such term does not include -
(1) a pesticide chemical residue in or on a raw agricultural
commodity or processed food; or
(2) a pesticide chemical; or
(3) a color additive; or
(4) any substance used in accordance with a sanction or
approval granted prior to September 6, 1958, pursuant to this
chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et
seq.] or the Meat Inspection Act of March 4, 1907, as amended and
extended [21 U.S.C. 601 et seq.];
(5) a new animal drug; or
(6) an ingredient described in paragraph (ff) in, or intended
for use in, a dietary supplement.
(t)(1) The term "color additive" means a material which -
(A) is a dye, pigment, or other substance made by a process of
synthesis or similar artifice, or extracted, isolated, or
otherwise derived, with or without intermediate or final change
of identity, from a vegetable, animal, mineral, or other source,
and
(B) when added or applied to a food, drug, or cosmetic, or to
the human body or any part thereof, is capable (alone or through
reaction with other substance) of imparting color thereto;
except that such term does not include any material which the
Secretary, by regulation, determines is used (or intended to be
used) solely for a purpose or purposes other than coloring.
(2) The term "color" includes black, white, and intermediate
grays.
(3) Nothing in subparagraph (1) of this paragraph shall be
construed to apply to any pesticide chemical, soil or plant
nutrient, or other agricultural chemical solely because of its
effect in aiding, retarding, or otherwise affecting, directly or
indirectly, the growth or other natural physiological processes of
produce of the soil and thereby affecting its color, whether before
or after harvest.
(u) The term "safe" as used in paragraph (s) of this section and
in sections 348, 360b, 360ccc, and 379e of this title, has
reference to the health of man or animal.
(v) The term "new animal drug" means any drug intended for use
for animals other than man, including any drug intended for use in
animal feed but not including such animal feed, -
(1) the composition of which is such that such drug is not
generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness
of animal drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in the labeling
thereof; except that such a drug not so recognized shall not be
deemed to be a "new animal drug" if at any time prior to June 25,
1938, it was subject to the Food and Drug Act of June 30, 1906,
as amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or
(2) the composition of which is such that such drug, as a
result of investigations to determine its safety and
effectiveness for use under such conditions, has become so
recognized but which has not, otherwise than in such
investigations, been used to a material extent or for a material
time under such conditions.
Provided that any drug intended for minor use or use in a minor
species that is not the subject of a final regulation published by
the Secretary through notice and comment rulemaking finding that
the criteria of paragraphs (1) and (2) have not been met (or that
the exception to the criterion in paragraph (1) has been met) is a
new animal drug.
(w) The term "animal feed", as used in paragraph (w) (!1) of this
section, in section 360b of this title, and in provisions of this
chapter referring to such paragraph or section, means an article
which is intended for use for food for animals other than man and
which is intended for use as a substantial source of nutrients in
the diet of the animal, and is not limited to a mixture intended to
be the sole ration of the animal.
(x) The term "informal hearing" means a hearing which is not
subject to section 554, 556, or 557 of title 5 and which provides
for the following:
(1) The presiding officer in the hearing shall be designated by
the Secretary from officers and employees of the Department who
have not participated in any action of the Secretary which is the
subject of the hearing and who are not directly responsible to an
officer or employee of the Department who has participated in any
such action.
(2) Each party to the hearing shall have the right at all times
to be advised and accompanied by an attorney.
(3) Before the hearing, each party to the hearing shall be
given reasonable notice of the matters to be considered at the
hearing, including a comprehensive statement of the basis for the
action taken or proposed by the Secretary which is the subject of
the hearing and a general summary of the information which will
be presented by the Secretary at the hearing in support of such
action.
(4) At the hearing the parties to the hearing shall have the
right to hear a full and complete statement of the action of the
Secretary which is the subject of the hearing together with the
information and reasons supporting such action, to conduct
reasonable questioning, and to present any oral or written
information relevant to such action.
(5) The presiding officer in such hearing shall prepare a
written report of the hearing to which shall be attached all
written material presented at the hearing. The participants in
the hearing shall be given the opportunity to review and correct
or supplement the presiding officer's report of the hearing.
(6) The Secretary may require the hearing to be transcribed. A
party to the hearing shall have the right to have the hearing
transcribed at his expense. Any transcription of a hearing shall
be included in the presiding officer's report of the hearing.
(y) The term "saccharin" includes calcium saccharin, sodium
saccharin, and ammonium saccharin.
(z) The term "infant formula" means a food which purports to be
or is represented for special dietary use solely as a food for
infants by reason of its simulation of human milk or its
suitability as a complete or partial substitute for human milk.
(aa) The term "abbreviated drug application" means an application
submitted under section 355(j) of this title for the approval of a
drug that relies on the approved application of another drug with
the same active ingredient to establish safety and efficacy, and -
(1) in the case of section 335a of this title, includes a
supplement to such an application for a different or additional
use of the drug but does not include a supplement to such an
application for other than a different or additional use of the
drug, and
(2) in the case of sections 335b and 335c of this title,
includes any supplement to such an application.
(bb) The term "knowingly" or "knew" means that a person, with
respect to information -
(1) has actual knowledge of the information, or
(2) acts in deliberate ignorance or reckless disregard of the
truth or falsity of the information.
(cc) For purposes of section 335a of this title, the term "high
managerial agent" -
(1) means -
(A) an officer or director of a corporation or an
association,
(B) a partner of a partnership, or
(C) any employee or other agent of a corporation,
association, or partnership,
having duties such that the conduct of such officer, director,
partner, employee, or agent may fairly be assumed to represent
the policy of the corporation, association, or partnership, and
(2) includes persons having management responsibility for -
(A) submissions to the Food and Drug Administration regarding
the development or approval of any drug product,
(B) production, quality assurance, or quality control of any
drug product, or
(C) research and development of any drug product.
(dd) For purposes of sections 335a and 335b of this title, the
term "drug product" means a drug subject to regulation under
section 355, 360b, or 382 of this title or under section 262 of
title 42.
(ee) The term "Commissioner" means the Commissioner of Food and
Drugs.
(ff) The term "dietary supplement" -
(1) means a product (other than tobacco) intended to supplement
the diet that bears or contains one or more of the following
dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet
by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or
combination of any ingredient described in clause (A), (B),
(C), (D), or (E);
(2) means a product that -
(A)(i) is intended for ingestion in a form described in
section 350(c)(1)(B)(i) of this title; or
(ii) complies with section 350(c)(1)(B)(ii) of this title;
(B) is not represented for use as a conventional food or as a
sole item of a meal or the diet; and
(C) is labeled as a dietary supplement; and
(3) does -
(A) include an article that is approved as a new drug under
section 355 of this title or licensed as a biologic under
section 262 of title 42 and was, prior to such approval,
certification, or license, marketed as a dietary supplement or
as a food unless the Secretary has issued a regulation, after
notice and comment, finding that the article, when used as or
in a dietary supplement under the conditions of use and dosages
set forth in the labeling for such dietary supplement, is
unlawful under section 342(f) of this title; and
(B) not include -
(i) an article that is approved as a new drug under section
355 of this title, certified as an antibiotic under section
357 of this title, or licensed as a biologic under section
262 of title 42, or
(ii) an article authorized for investigation as a new drug,
antibiotic, or biological for which substantial clinical
investigations have been instituted and for which the
existence of such investigations has been made public,
which was not before such approval, certification, licensing, or
authorization marketed as a dietary supplement or as a food
unless the Secretary, in the Secretary's discretion, has issued a
regulation, after notice and comment, finding that the article
would be lawful under this chapter.
Except for purposes of paragraph (g) and section 350f of this
title, a dietary supplement shall be deemed to be a food within the
meaning of this chapter.
(gg) The term "processed food" means any food other than a raw
agricultural commodity and includes any raw agricultural commodity
that has been subject to processing, such as canning, cooking,
freezing, dehydration, or milling.
(hh) The term "Administrator" means the Administrator of the
United States Environmental Protection Agency.
(ii) The term "compounded positron emission tomography drug" -
(1) means a drug that -
(A) exhibits spontaneous disintegration of unstable nuclei by
the emission of positrons and is used for the purpose of
providing dual photon positron emission tomographic diagnostic
images; and
(B) has been compounded by or on the order of a practitioner
who is licensed by a State to compound or order compounding for
a drug described in subparagraph (A), and is compounded in
accordance with that State's law, for a patient or for
research, teaching, or quality control; and
(2) includes any nonradioactive reagent, reagent kit,
ingredient, nuclide generator, accelerator, target material,
electronic synthesizer, or other apparatus or computer program to
be used in the preparation of such a drug.
(jj) The term "antibiotic drug" means any drug (except drugs for
use in animals other than humans) composed wholly or partly of any
kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, bacitracin, or any other drug intended for human
use containing any quantity of any chemical substance which is
produced by a micro-organism and which has the capacity to inhibit
or destroy micro-organisms in dilute solution (including a
chemically synthesized equivalent of any such substance) or any
derivative thereof.
(kk) Priority supplement. - The term "priority supplement" means
a drug application referred to in section 101(4) of the Food and
Drug Administration Modernization Act of 1997 (111 Stat. 2298).
(ll)(1) The term "single-use device" means a device that is
intended for one use, or on a single patient during a single
procedure.
(2)(A) The term "reprocessed", with respect to a single-use
device, means an original device that has previously been used on a
patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a
patient. The subsequent processing and manufacture of a reprocessed
single-use device shall result in a device that is reprocessed
within the meaning of this definition.
(B) A single-use device that meets the definition under clause
(A) shall be considered a reprocessed device without regard to any
description of the device used by the manufacturer of the device or
other persons, including a description that uses the term
"recycled" rather than the term "reprocessed".
(3) The term "original device" means a new, unused single-use
device.
(mm)(1) The term "critical reprocessed single-use device" means a
reprocessed single-use device that is intended to contact normally
sterile tissue or body spaces during use.
(2) The term "semi-critical reprocessed single-use device" means
a reprocessed single-use device that is intended to contact intact
mucous membranes and not penetrate normally sterile areas of the
body.
(nn) The term "major species" means cattle, horses, swine,
chickens, turkeys, dogs, and cats, except that the Secretary may
add species to this definition by regulation.
(oo) The term "minor species" means animals other than humans
that are not major species.
(pp) The term "minor use" means the intended use of a drug in a
major species for an indication that occurs infrequently and in
only a small number of animals or in limited geographical areas and
in only a small number of animals annually.
(qq) The term "major food allergen" means any of the following:
(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean
shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g.,
almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
(2) A food ingredient that contains protein derived from a food
specified in paragraph (1), except the following:
(A) Any highly refined oil derived from a food specified in
paragraph (1) and any ingredient derived from such highly
refined oil.
(B) A food ingredient that is exempt under paragraph (6) or
(7) of section 343(w) of this title.
SOURCE
(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; Pub. L. 110-85, title X, Sec. 1005(c), Sept. 27, 2007,
121 Stat. 968.)
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
2007 - Par. (ff). Pub. L. 110-85 substituted "paragraph (g) and
section 350f of this title" for "paragraph (g)" in concluding
provisions.
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)."
FOOTNOTE
(!1) So in original. Probably should be paragraph "(v)".