BloodNPRM2006-Attachment C-21USC321

From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC321]

TITLE 21--FOOD AND DRUGS

CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER II--DEFINITIONS

Sec. 321. Definitions; generally

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, 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.

(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.
---------------------------------------------------------------------------
\1\ So in original. Probably should be paragraph ``(v)''.
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(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), 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.

(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.)

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

2002--Pars. (ll), (mm). Pub. L. 107-250 added pars. (ll) and (mm).
Par. (kk). Pub. L. 107-109 added par. (kk).
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 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. (w) 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, 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.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see note set out under section
41 of this title.

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).''

Section Referred to in Other Sections

This section is referred to in sections 343, 343-3, 346a, 346b, 350,
352, 353a, 355, 360b, 379e, 383, 802, 825, 1602 of this title; title 7
section 136; title 15 sections 1454, 1456, 1471, 2052, 2602; title 18
section 1365; title 22 section 7201; title 35 section 156; title 42
sections 274e, 287c-11, 289g-2, 300cc-12, 1396r-8; title 49 section
5702.