‘‘(B) an article that is approved or is regulated 
as a drug by the Food and Drug Administration. 
‘‘(3) The products described in paragraph (2)(A) 
shall be subject to chapter IV or chapter V of this Act 
and the articles described in paragraph (2)(B) shall be 
subject to chapter V of this Act. 
‘‘(4) A tobacco product may not be marketed in com-
bination with any other article or product regulated under 
this Act (including a drug, biologic, food, cosmetics, med-
ical device, or a dietary supplement).’’. 
(b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.) is amended— 
(1) by redesignating chapter IX as chapter X; 
(2) by redesignating sections 901 through 907 
as sections 1001 through 1007; and 
(3) by inserting after section 803 the following: 
‘‘CHAPTER IX—TOBACCO PRODUCTS 
‘‘SEC. 900. DEFINITIONS. 
‘‘In this chapter: 
‘‘(1) ADDITIVE.—The term ‘additive’ means 
any substance the intended use of which results or 
may reasonably be expected to result, directly or in-
directly, in its becoming a component or otherwise 
affecting the characteristic of any tobacco product 
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(including any substances intended for use as a fla-
voring, coloring or in producing, manufacturing, 
packing, processing, preparing, treating, packaging, 
transporting, or holding), except that such term does 
not include tobacco or a pesticide chemical residue 
in or on raw tobacco or a pesticide chemical. 
‘‘(2) BRAND.—The term ‘brand’ means a vari-
ety of tobacco product distinguished by the tobacco 
used, tar content, nicotine content, flavoring used, 
size, filtration, or packaging, logo, registered trade-
mark or brand name, identifiable pattern of colors, 
or any combination of such attributes. 
‘‘(3) CIGARETTE.—The term ‘cigarette’ has the 
meaning given that term by section 3(1) of the Fed-
eral Cigarette Labeling and Advertising Act (15 
U.S.C. 1332(1)), but also includes tobacco, in any 
form, that is functional in the product, which, be-
cause of its appearance, the type of tobacco used in 
the filler, or its packaging and labeling, is likely to 
be offered to, or purchased by, consumers as a ciga-
rette or as roll-your-own tobacco. 
‘‘(4) CIGARETTE
TOBACCO.—The term ‘ciga-
rette tobacco’ means any product that consists of 
loose tobacco that is intended for use by consumers 
in a cigarette. Unless otherwise stated, the require-
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ments for cigarettes shall also apply to cigarette to-
bacco. 
‘‘(5) COMMERCE.—The term ‘commerce’ has 
the meaning given that term by section 3(2) of the 
Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1332(2)). 
‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The 
term ‘counterfeit tobacco product’ means a tobacco 
product (or the container or labeling of such a prod-
uct) that, without authorization, bears the trade-
mark, trade name, or other identifying mark, im-
print or device, or any likeness thereof, of a tobacco 
product listed in a registration under section 
905(i)(1). 
‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as 
regards a tobacco product means any person who 
furthers the distribution of a tobacco product, 
whether domestic or imported, at any point from the 
original place of manufacture to the person who sells 
or distributes the product to individuals for personal 
consumption. Common carriers are not considered 
distributors for purposes of this chapter. 
‘‘(8) ILLICIT TRADE.—The term ‘illicit trade’ 
means any practice or conduct prohibited by law 
which relates to production, shipment, receipt, pos-
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session, distribution, sale, or purchase of tobacco 
products including any practice or conduct intended 
to facilitate such activity. 
‘‘(9) INDIAN TRIBE.—The term ‘Indian tribe’ 
has the meaning given such term in section 4(e) of 
the Indian Self Determination and Education Assist-
ance Act (25 U.S.C. 450b(e)). 
‘‘(10) LITTLE CIGAR.—The term ‘little cigar’ 
has the meaning given that term by section 3(7) of 
the Federal Cigarette Labeling and Advertising Act 
(15 U.S.C. 1332(7)). 
‘‘(11) NICOTINE.—The term ‘nicotine’ means 
the 
chemical 
substance 
named 
3-(1–Methyl-2- 
pyrrolidinyl) pyridine or C[10]H[14]N[2], including 
any salt or complex of nicotine. 
‘‘(12) PACKAGE.—The term ‘package’ means a 
pack, box, carton, or container of any kind or, if no 
other container, any wrapping (including cello-
phane), in which a tobacco product is offered for 
sale, sold, or otherwise distributed to consumers. 
‘‘(13) RETAILER.—The term ‘retailer’ means 
any person who sells tobacco products to individuals 
for personal consumption, or who operates a facility 
where self-service displays of tobacco products are 
permitted. 
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‘‘(14) ROLL-YOUR-OWN
TOBACCO.—The term 
‘roll-your-own tobacco’ means any tobacco which, be-
cause of its appearance, type, packaging, or labeling, 
is suitable for use and likely to be offered to, or pur-
chased by, consumers as tobacco for making ciga-
rettes. 
‘‘(15) SMOKE CONSTITUENT.—The term ‘smoke 
constituent’ means any chemical or chemical com-
pound in mainstream or sidestream tobacco smoke 
that either transfers from any component of the cig-
arette to the smoke or that is formed by the combus-
tion or heating of tobacco, additives, or other compo-
nent of the tobacco product. 
‘‘(16) 
SMOKELESS
TOBACCO.—The 
term 
‘smokeless tobacco’ means any tobacco product that 
consists of cut, ground, powdered, or leaf tobacco 
and that is intended to be placed in the oral or nasal 
cavity. 
‘‘(17) STATE.—The term ‘State’ means any 
State of the United States and, for purposes of this 
chapter, includes the District of Columbia, the Com-
monwealth of Puerto Rico, Guam, the Virgin Is-
lands, American Samoa, Wake Island, Midway Is-
lands, Kingman Reef, Johnston Atoll, the Northern 
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Mariana Islands, and any other trust territory or 
possession of the United States. 
‘‘(18) TOBACCO
PRODUCT
MANUFACTURER.— 
Term ‘tobacco product manufacturer’ means any 
person, including any repacker or relabeler, who— 
‘‘(A) manufactures, fabricates, assembles, 
processes, or labels a tobacco product; or 
‘‘(B) imports a finished cigarette or 
smokeless tobacco product for sale or distribu-
tion in the United States. 
‘‘(19) UNITED
STATES.—The term ‘United 
States’ means the 50 States of the United States of 
America and the District of Columbia, the Common-
wealth of Puerto Rico, Guam, the Virgin Islands, 
American Samoa, Wake Island, Midway Islands, 
Kingman Reef, Johnston Atoll, the Northern Mar-
iana Islands, and any other trust territory or posses-
sion of the United States. 
‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Tobacco products shall be regu-
lated by the Secretary under this chapter and shall not 
be subject to the provisions of chapter V, unless— 
‘‘(1) such products are intended for use in the 
diagnosis, cure, mitigation, treatment, or prevention 
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of 
disease 
(within 
the 
meaning 
of 
section 
201(g)(1)(B) or section 201(h)(2)); or 
‘‘(2) a claim is made for such products under 
section 201(g)(1)(C) or 201(h)(3); 
other than modified risk tobacco products approved 
in accordance with section 911. 
‘‘(b) APPLICABILITY.—This chapter shall apply to all 
tobacco products subject to the regulations referred to in 
section 232 of the Family Smoking Prevention and To-
bacco Control Act, and to any other tobacco products that 
the Secretary by regulation deems to be subject to this 
chapter. 
‘‘(c) SCOPE.— 
‘‘(1) IN GENERAL.—Nothing in this chapter, or 
any policy issued or regulation promulgated there-
under, or the Family Smoking Prevention and To-
bacco Control Act, shall be construed to affect the 
Secretary’s authority over, or the regulation of, 
products under this Act that are not tobacco prod-
ucts under chapter V or any other chapter. 
‘‘(2) LIMITATION OF AUTHORITY.— 
‘‘(A) IN GENERAL.—The provisions of this 
chapter shall not apply to tobacco leaf that is 
not in the possession of a manufacturer of to-
bacco products, or to the producers of tobacco 
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leaf, including tobacco growers, tobacco ware-
houses, and tobacco grower cooperatives, nor 
shall any employee of the Food and Drug Ad-
ministration have any authority to enter onto a 
farm owned by a producer of tobacco leaf with-
out the written consent of such producer. 
‘‘(B) EXCEPTION.—Notwithstanding any 
other provision of this subparagraph, if a pro-
ducer of tobacco leaf is also a tobacco product 
manufacturer or controlled by a tobacco prod-
uct manufacturer, the producer shall be subject 
to this chapter in the producer’s capacity as a 
manufacturer. 
‘‘(C) RULE OF CONSTRUCTION.—Nothing 
in this chapter shall be construed to grant the 
Secretary authority to promulgate regulations 
on any matter that involves the production of 
tobacco leaf or a producer thereof, other than 
activities by a manufacturer affecting produc-
tion. 
‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 
‘‘A tobacco product shall be deemed to be adulterated 
if— 
‘‘(1) it consists in whole or in part of any filthy, 
putrid, or decomposed substance, or is otherwise 
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contaminated by any added poisonous or added dele-
terious substance that may render the product inju-
rious to health; 
‘‘(2) it has been prepared, packed, or held 
under insanitary conditions whereby it may have 
been contaminated with filth, or whereby it may 
have been rendered injurious to health; 
‘‘(3) its package is composed, in whole or in 
part, of any poisonous or deleterious substance 
which may render the contents injurious to health; 
‘‘(4) it is, or purports to be or is represented 
as, a tobacco product which is subject to a tobacco 
product standard established under section 907 un-
less such tobacco product is in all respects in con-
formity with such standard; 
‘‘(5)(A) it is required by section 910(a) to have 
premarket approval and does not have an approved 
application in effect; or 
‘‘(B) it is in violation of the order approving 
such an application; 
‘‘(6) the methods used in, or the facilities or 
controls used for, its manufacture, packing or stor-
age are not in conformity with applicable require-
ments under section 906(e)(1) or an applicable con-
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dition prescribed by an order under section 
906(e)(2); or 
‘‘(7) it is in violation of section 911. 
‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—A tobacco product shall be 
deemed to be misbranded— 
‘‘(1) if its labeling is false or misleading in any 
particular; 
‘‘(2) if in package form unless it bears a label 
containing— 
‘‘(A) the name and place of business of the 
tobacco product manufacturer, packer, or dis-
tributor; 
‘‘(B) an accurate statement of the quantity 
of the contents in terms of weight, measure, or 
numerical count; 
‘‘(C) an accurate statement of the percent-
age of the tobacco used in the product that is 
domestically grown tobacco and the percentage 
that is foreign grown tobacco; and 
‘‘(D) the statement required under section 
921(a), except that under subparagraph (B) 
reasonable variations shall be permitted, and 
exemptions as to small packages shall be estab-
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lished, by regulations prescribed by the Sec-
retary; 
‘‘(3) if any word, statement, or other informa-
tion required by or under authority of this chapter 
to appear on the label or labeling is not prominently 
placed thereon with such conspicuousness (as com-
pared with other words, statements or designs in the 
labeling) and in such terms as to render it likely to 
be read and understood by the ordinary individual 
under customary conditions of purchase and use; 
‘‘(4) if it has an established name, unless its 
label bears, to the exclusion of any other nonpropri-
etary name, its established name prominently print-
ed in type as required by the Secretary by regula-
tion; 
‘‘(5) if the Secretary has issued regulations re-
quiring that its labeling bear adequate directions for 
use, or adequate warnings against use by children, 
that are necessary for the protection of users unless 
its labeling conforms in all respects to such regula-
tions; 
‘‘(6) if it was manufactured, prepared, propa-
gated, compounded, or processed in any State in an 
establishment not duly registered under section 
905(b), 905(c), 905(d), or 905(h), if it was not in-
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cluded in a list required by section 905(i), if a notice 
or other information respecting it was not provided 
as required by such section or section 905(j), or if 
it does not bear such symbols from the uniform sys-
tem for identification of tobacco products prescribed 
under section 905(e) as the Secretary by regulation 
requires; 
‘‘(7) if, in the case of any tobacco product dis-
tributed or offered for sale in any State— 
‘‘(A) its advertising is false or misleading 
in any particular; or 
‘‘(B) it is sold or distributed in violation of 
regulations prescribed under section 906(d); 
‘‘(8) unless, in the case of any tobacco product 
distributed or offered for sale in any State, the man-
ufacturer, packer, or distributor thereof includes in 
all advertisements and other descriptive printed mat-
ter issued or caused to be issued by the manufac-
turer, packer, or distributor with respect to that to-
bacco product— 
‘‘(A) a true statement of the tobacco prod-
uct’s established name as described in para-
graph (4), printed prominently; and 
‘‘(B) a brief statement of— 
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‘‘(i) the uses of the tobacco product 
and relevant warnings, precautions, side 
effects, and contraindications; and 
‘‘(ii) in the case of specific tobacco 
products made subject to a finding by the 
Secretary after notice and opportunity for 
comment that such action is appropriate to 
protect the public health, a full description 
of the components of such tobacco product 
or the formula showing quantitatively each 
ingredient of such tobacco product to the 
extent required in regulations which shall 
be issued by the Secretary after an oppor-
tunity for a hearing; 
‘‘(9) if it is a tobacco product subject to a to-
bacco product standard established under section 
907, unless it bears such labeling as may be pre-
scribed in such tobacco product standard; or 
‘‘(10) if there was a failure or refusal— 
‘‘(A) to comply with any requirement pre-
scribed under section 904 or 908; or 
‘‘(B) to furnish any material or informa-
tion required under section 909. 
‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.— 
The Secretary may, by regulation, require prior approval 
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of statements made on the label of a tobacco product. No 
regulation issued under this subsection may require prior 
approval by the Secretary of the content of any advertise-
ment, except for modified risk tobacco products as pro-
vided in section 911. No advertisement of a tobacco prod-
uct published after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act shall, with 
respect to the language of label statements as prescribed 
under section 4 of the Cigarette Labeling and Advertising 
Act and section 3 of the Comprehensive Smokeless To-
bacco Health Education Act of 1986 or the regulations 
issued under such sections, be subject to the provisions 
of sections 12 through 15 of the Federal Trade Commis-
sion Act (15 U.S.C. 52 through 55). 
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE 
SECRETARY. 
‘‘(a) REQUIREMENT.—Not later than 6 months after 
the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, each tobacco product manufac-
turer or importer, or agents thereof, shall submit to the 
Secretary the following information: 
‘‘(1) A listing of all ingredients, including to-
bacco, substances, compounds, and additives that 
are, as of such date, added by the manufacturer to 
the tobacco, paper, filter, or other part of each to-
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bacco product by brand and by quantity in each 
brand and subbrand. 
‘‘(2) A description of the content, delivery, and 
form of nicotine in each tobacco product measured 
in milligrams of nicotine in accordance with regula-
tions promulgated by the Secretary in accordance 
with section 4(a)(4) of the Federal Cigarette Label-
ing and Advertising Act. 
‘‘(3) A listing of all constituents, including 
smoke constituents as applicable, identified by the 
Secretary as harmful or potentially harmful to 
health in each tobacco product, and as applicable in 
the smoke of each tobacco product, by brand and by 
quantity in each brand and subbrand. Effective be-
ginning 2 years after the date of enactment of this 
chapter, the manufacturer, importer, or agent shall 
comply with regulations promulgated under section 
916 in reporting information under this paragraph, 
where applicable. 
‘‘(4) All documents developed after the date of 
enactment of the Family Smoking Prevention and 
Tobacco Control Act that relate to health, toxi-
cological, behavioral, or physiologic effects of current 
or future tobacco products, their constituents (in-
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cluding smoke constituents), ingredients, compo-
nents, and additives. 
‘‘(b) DATA SUBMISSION.—At the request of the Sec-
retary, each tobacco product manufacturer or importer of 
tobacco products, or agents thereof, shall submit the fol-
lowing: 
‘‘(1) Any or all documents (including under-
lying scientific information) relating to research ac-
tivities, and research findings, conducted, supported, 
or possessed by the manufacturer (or agents thereof) 
on the health, toxicological, behavioral, or physio-
logic effects of tobacco products and their constitu-
ents (including smoke constituents), ingredients, 
components, and additives. 
‘‘(2) Any or all documents (including under-
lying scientific information) relating to research ac-
tivities, and research findings, conducted, supported, 
or possessed by the manufacturer (or agents thereof) 
that relate to the issue of whether a reduction in 
risk to health from tobacco products can occur upon 
the employment of technology available or known to 
the manufacturer. 
‘‘(3) Any or all documents (including under-
lying scientific or financial information) relating to 
marketing research involving the use of tobacco 
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products or marketing practices and the effective-
ness of such practices used by tobacco manufactur-
ers and distributors. 
An importer of a tobacco product not manufactured in the 
United States shall supply the information required of a 
tobacco product manufacturer under this subsection. 
‘‘(c) TIME FOR SUBMISSION.— 
‘‘(1) IN GENERAL.—At least 90 days prior to 
the delivery for introduction into interstate com-
merce of a tobacco product not on the market on the 
date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, the manufacturer of 
such product shall provide the information required 
under subsection (a). 
‘‘(2) DISCLOSURE
OF
ADDITIVE.—If at any 
time a tobacco product manufacturer adds to its to-
bacco products a new tobacco additive or increases 
the quantity of an existing tobacco additive, the 
manufacturer shall, except as provided in paragraph 
(3), at least 90 days prior to such action so advise 
the Secretary in writing. 
‘‘(3) DISCLOSURE OF OTHER ACTIONS.—If at 
any time a tobacco product manufacturer eliminates 
or decreases an existing additive, or adds or in-
creases an additive that has by regulation been des-
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