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-
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.
‘‘(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
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
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 102 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
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
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-
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 vari-
ations shall be permitted, and exemptions as to
small packages shall be established, by regulations 
prescribed by the Secretary; 
‘‘(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-
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—
‘‘(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
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-
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-
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
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-
ignated by the Secretary as an additive that is not 
a human or animal carcinogen, or otherwise harmful 
to health under intended conditions of use, the man-
ufacturer shall within 60 days of such action so ad-
vise the Secretary in writing. 
‘‘(d) DATA LIST.—
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, and annually 
thereafter, the Secretary shall publish in a format 
that is understandable and not misleading to a lay 
person, and place on public display (in a manner de-
termined by the Secretary) the list established under 
subsection (e). 
‘‘(2) CONSUMER
RESEARCH.—The Secretary 
shall conduct periodic consumer research to ensure 
that the list published under paragraph (1) is not 
misleading to lay persons. Not later than 5 years 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary 
shall submit to the appropriate committees of Con-
gress a report on the results of such research, to-
gether with recommendations on whether such publi-
cation should be continued or modified.
‘‘(e) DATA COLLECTION.—Not later than 12 months 
after the date of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, the Secretary shall es-
tablish a list of harmful and potentially harmful constitu-
ents, including smoke constituents, to health in each to-
bacco product by brand and by quantity in each brand 
and subbrand. The Secretary shall publish a public notice 
requesting the submission by interested persons of sci-
entific and other information concerning the harmful and 
potentially harmful constituents in tobacco products and 
tobacco smoke. 
‘‘SEC. 905. ANNUAL REGISTRATION. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) 
MANUFACTURE, 
PREPARATION, 
COMPOUNDING, OR PROCESSING.—The term ‘manu-
facture, preparation, compounding, or processing’ 
shall include repackaging or otherwise changing the 
container, wrapper, or labeling of any tobacco prod-
uct package in furtherance of the distribution of the 
tobacco product from the original place of manufac-
ture to the person who makes final delivery or sale 
to the ultimate consumer or user. 
‘‘(2) NAME.—The term ‘name’ shall include in 
the case of a partnership the name of each partner 
and, in the case of a corporation, the name of each
corporate officer and director, and the State of in-
corporation. 
‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.—
On or before December 31 of each year every person who 
owns or operates any establishment in any State engaged 
in the manufacture, preparation, compounding, or proc-
essing of a tobacco product or tobacco products shall reg-
ister with the Secretary the name, places of business, and 
all such establishments of that person. 
‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA-
TORS.—Every person upon first engaging in the manufac-
ture, preparation, compounding, or processing of a tobacco 
product or tobacco products in any establishment owned 
or operated in any State by that person shall immediately 
register with the Secretary that person’s name, place of 
business, and such establishment. 
‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.—
Every person required to register under subsection (b) or 
(c) shall immediately register with the Secretary any addi-
tional establishment which that person owns or operates 
in any State and in which that person begins the manufac-
ture, preparation, compounding, or processing of a tobacco 
product or tobacco products. 
‘‘(e) UNIFORM
PRODUCT
IDENTIFICATION
SYS-
TEM.—The Secretary may by regulation prescribe a uni-
form system for the identification of tobacco products and 
may require that persons who are required to list such 
tobacco products under subsection (i) shall list such to-
bacco products in accordance with such system. 
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA-
TION.—The Secretary shall make available for inspection, 
to any person so requesting, any registration filed under 
this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB-
LISHMENTS.—Every establishment in any State registered 
with the Secretary under this section shall be subject to 
inspection under section 704, and every such establish-
ment engaged in the manufacture, compounding, or proc-
essing of a tobacco product or tobacco products shall be 
so inspected by 1 or more officers or employees duly des-
ignated by the Secretary at least once in the 2-year period 
beginning with the date of registration of such establish-
ment under this section and at least once in every succes-
sive 2-year period thereafter. 
‘‘(h) FOREIGN
ESTABLISHMENTS
SHALL
REG-
ISTER.—Any establishment within any foreign country en-
gaged in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products, shall 
register under this section under regulations promulgated 
by the Secretary. Such regulations shall require such es-
tablishment to provide the information required by sub-
section (i) of this section and shall include provisions for 
registration of any such establishment upon condition that 
adequate and effective means are available, by arrange-
ment with the government of such foreign country or oth-
erwise, to enable the Secretary to determine from time to 
time whether tobacco products manufactured, prepared, 
compounded, or processed in such establishment, if im-
ported or offered for import into the United States, shall 
be refused admission on any of the grounds set forth in 
section 801(a). 
‘‘(i) REGISTRATION INFORMATION.—
‘‘(1) PRODUCT LIST.—Every person who reg-
isters with the Secretary under subsection (b), (c), 
(d), or (h) shall, at the time of registration under 
any such subsection, file with the Secretary a list of 
all tobacco products which are being manufactured, 
prepared, compounded, or processed by that person 
for commercial distribution and which has not been 
included in any list of tobacco products filed by that 
person with the Secretary under this paragraph or 
paragraph (2) before such time of registration. Such 
list shall be prepared in such form and manner as 
the Secretary may prescribe and shall be accom-
panied by—
‘‘(A) in the case of a tobacco product con-
tained in the applicable list with respect to 
which a tobacco product standard has been es-
tablished under section 907 or which is subject 
to section 910, a reference to the authority for 
the marketing of such tobacco product and a 
copy of all labeling for such tobacco product; 
‘‘(B) in the case of any other tobacco prod-
uct contained in an applicable list, a copy of all 
consumer information and other labeling for 
such tobacco product, a representative sampling 
of advertisements for such tobacco product, 
and, upon request made by the Secretary for 
good cause, a copy of all advertisements for a 
particular tobacco product; and 
‘‘(C) if the registrant filing a list has de-
termined that a tobacco product contained in 
such list is not subject to a tobacco product 
standard established under section 907, a brief 
statement of the basis upon which the reg-
istrant made such determination if the Sec-
retary requests such a statement with respect 
to that particular tobacco product. 
‘‘(2) BIANNUAL REPORT OF ANY CHANGE IN 
PRODUCT LIST.—Each person who registers with the
Secretary under this section shall report to the Sec-
retary once during the month of June of each year 
and once during the month of December of each 
year the following: 
‘‘(A) A list of each tobacco product intro-
duced by the registrant for commercial distribu-
tion which has not been included in any list 
previously filed by that person with the Sec-
retary under this subparagraph or paragraph 
(1). A list under this subparagraph shall list a 
tobacco product by its established name and 
shall be accompanied by the other information 
required by paragraph (1). 
‘‘(B) If since the date the registrant last 
made a report under this paragraph that person 
has discontinued the manufacture, preparation, 
compounding, or processing for commercial dis-
tribution of a tobacco product included in a list 
filed under subparagraph (A) or paragraph (1), 
notice of such discontinuance, the date of such 
discontinuance, and the identity of its estab-
lished name. 
‘‘(C) If since the date the registrant re-
ported under subparagraph (B) a notice of dis-
continuance that person has resumed the manu-
facture, preparation, compounding, or proc-
essing for commercial distribution of the to-
bacco product with respect to which such notice 
of discontinuance was reported, notice of such 
resumption, the date of such resumption, the 
identity of such tobacco product by established 
name, and other information required by para-
graph (1), unless the registrant has previously 
reported such resumption to the Secretary 
under this subparagraph. 
‘‘(D) Any material change in any informa-
tion previously submitted under this paragraph 
or paragraph (1). 
‘‘(j) REPORT PRECEDING INTRODUCTION OF CER-
TAIN
SUBSTANTIALLY-EQUIVALENT
PRODUCTS
INTO 
INTERSTATE COMMERCE.—
‘‘(1) IN
GENERAL.—Each person who is re-
quired to register under this section and who pro-
poses to begin the introduction or delivery for intro-
duction into interstate commerce for commercial dis-
tribution of a tobacco product intended for human 
use that was not commercially marketed (other than 
for test marketing) in the United States as of June 
1, 2003, shall, at least 90 days prior to making such 
introduction or delivery, report to the Secretary (in
such form and manner as the Secretary shall pre-
scribe)—
‘‘(A) the basis for such person’s determina-
tion that the tobacco product is substantially 
equivalent, within the meaning of section 910, 
to a tobacco product commercially marketed 
(other than for test marketing) in the United 
States as of June 1, 2003, that is in compliance 
with the requirements of this Act; and 
‘‘(B) action taken by such person to com-
ply with the requirements under section 907 
that are applicable to the tobacco product. 
‘‘(2) APPLICATION TO CERTAIN POST JUNE 1, 
2003 PRODUCTS.—A report under this subsection for 
a tobacco product that was first introduced or deliv-
ered for introduction into interstate commerce for 
commercial distribution in the United States after 
June 1, 2003, and prior to the date that is 15 
months after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act shall 
be submitted to the Secretary not later than 15 
months after such date of enactment. 
‘‘(3) EXEMPTIONS.—
‘‘(A) IN GENERAL.—The Secretary may by 
regulation, exempt from the requirements of
this subsection tobacco products that are modi-
fied by adding or deleting a tobacco additive, or 
increasing or decreasing the quantity of an ex-
isting tobacco additive, if the Secretary deter-
mines that—
‘‘(i) such modification would be a 
minor modification of a tobacco product 
authorized for sale under this Act; 
‘‘(ii) a report under this subsection is 
not necessary to ensure that permitting the 
tobacco product to be marketed would be 
appropriate for protection of the public 
health; and 
‘‘(iii) an exemption is otherwise appro-
priate. 
‘‘(B) REGULATIONS.—Not later than 9 
months after the date of enactment of the Fam-
ily Smoking Prevention and Tobacco Control 
Act, the Secretary shall issue regulations to im-
plement this paragraph. 
‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 
OF TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Any requirement established by 
or under section 902, 903, 905, or 909 applicable to a 
tobacco product shall apply to such tobacco product until
the applicability of the requirement to the tobacco product 
has been changed by action taken under section 907, sec-
tion 910, section 911, or subsection (d) of this section, 
and any requirement established by or under section 902, 
903, 905, or 909 which is inconsistent with a requirement 
imposed on such tobacco product under section 907, sec-
tion 910, section 911, or subsection (d) of this section 
shall not apply to such tobacco product. 
‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM-
MENT.—Each notice of proposed rulemaking under section 
907, 908, 909, 910, or 911 or under this section, any 
other notice which is published in the Federal Register 
with respect to any other action taken under any such sec-
tion and which states the reasons for such action, and 
each publication of findings required to be made in con-
nection with rulemaking under any such section shall set 
forth—
‘‘(1) the manner in which interested persons 
may examine data and other information on which 
the notice or findings is based; and 
‘‘(2) the period within which interested persons 
may present their comments on the notice or find-
ings (including the need therefore) orally or in writ-
ing, which period shall be at least 60 days but may 
not exceed 90 days unless the time is extended by
the Secretary by a notice published in the Federal 
Register stating good cause therefore. 
‘‘(c) LIMITED
CONFIDENTIALITY
OF
INFORMA-
TION.—Any information reported to or otherwise obtained 
by the Secretary or the Secretary’s representative under 
section 903, 904, 907, 908, 909, 910, 911, or 704, or 
under subsection (e) or (f) of this section, which is exempt 
from disclosure under subsection (a) of section 552 of title 
5, United States Code, by reason of subsection (b)(4) of 
that section shall be considered confidential and shall not 
be disclosed, except that the information may be disclosed 
to other officers or employees concerned with carrying out 
this chapter, or when relevant in any proceeding under 
this chapter. 
‘‘(d) RESTRICTIONS.—
‘‘(1) IN GENERAL.—The Secretary may by reg-
ulation require restrictions on the sale and distribu-
tion of a tobacco product, including restrictions on 
the access to, and the advertising and promotion of, 
the tobacco product, if the Secretary determines that 
such regulation would be appropriate for the protec-
tion of the public health. The Secretary may by reg-
ulation impose restrictions on the advertising and 
promotion of a tobacco product consistent with and 
to full extent permitted by the first amendment to
the Constitution. The finding as to whether such 
regulation would be appropriate for the protection of 
the public health shall be determined with respect to 
the risks and benefits to the population as a whole, 
including users and non-users of the tobacco prod-
uct, and taking into account—
‘‘(A) the increased or decreased likelihood 
that existing users of tobacco products will stop 
using such products; and 
‘‘(B) the increased or decreased likelihood 
that those who do not use tobacco products will 
start using such products. 
No such regulation may require that the sale or dis-
tribution of a tobacco product be limited to the writ-
ten or oral authorization of a practitioner licensed 
by law to prescribe medical products. 
‘‘(2) LABEL STATEMENTS.—The label of a to-
bacco product shall bear such appropriate state-
ments of the restrictions required by a regulation 
under subsection (a) as the Secretary may in such 
regulation prescribe. 
‘‘(3) LIMITATIONS.—
‘‘(A) IN GENERAL.—No restrictions under 
paragraph (1) may—
‘‘(i) prohibit the sale of any tobacco 
product in face-to-face transactions by a 
specific category of retail outlets; or 
‘‘(ii) establish a minimum age of sale 
of tobacco products to any person older 
than 18 years of age. 
‘‘(B) MATCHBOOKS.—For purposes of any 
regulations issued by the Secretary, matchbooks 
of conventional size containing not more than 
20 paper matches, and which are customarily 
given away for free with the purchase of to-
bacco products shall be considered as adult 
written publications which shall be permitted to 
contain advertising. Notwithstanding the pre-
ceding sentence, if the Secretary finds that such 
treatment of matchbooks is not appropriate for 
the protection of the public health, the Sec-
retary may determine by regulation that match-
books shall not be considered adult written pub-
lications. 
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.—
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO 
CONFORM.—
‘‘(A) IN GENERAL.—The Secretary may, in 
accordance with subparagraph (B), prescribe 
regulations (which may differ based on the type 
of tobacco product involved) requiring that the 
methods used in, and the facilities and controls 
used for, the manufacture, pre-production de-
sign validation (including a process to assess 
the performance of a tobacco product), packing 
and storage of a tobacco product, conform to 
current good manufacturing practice, as pre-
scribed in such regulations, to assure that the 
public health is protected and that the tobacco 
product is in compliance with this chapter. 
Good manufacturing practices may include the 
testing of raw tobacco for pesticide chemical 
residues regardless of whether a tolerance for 
such chemical residues has been established. 
‘‘(B) 
REQUIREMENTS.—The 
Secretary 
shall—
‘‘(i) before promulgating any regula-
tion under subparagraph (A), afford the 
Tobacco Products Scientific Advisory Com-
mittee an opportunity to submit rec-
ommendations with respect to the regula-
tion proposed to be promulgated;
‘‘(ii) before promulgating any regula-
tion under subparagraph (A), afford oppor-
tunity for an oral hearing; 
‘‘(iii) provide the advisory committee a 
reasonable time to make its recommenda-
tion with respect to proposed regulations 
under subparagraph (A); and 
‘‘(iv) in establishing the effective date 
of a regulation promulgated under this 
subsection, take into account the dif-
ferences in the manner in which the dif-
ferent types of tobacco products have his-
torically been produced, the financial re-
sources of the different tobacco product 
manufacturers, and the state of their exist-
ing manufacturing facilities, and shall pro-
vide for a reasonable period of time for 
such manufacturers to conform to good 
manufacturing practices. 
‘‘(2) EXEMPTIONS; VARIANCES.—
‘‘(A) PETITION.—Any person subject to 
any requirement prescribed under paragraph 
(1) may petition the Secretary for a permanent 
or temporary exemption or variance from such 
requirement. Such a petition shall be submitted
to the Secretary in such form and manner as 
the Secretary shall prescribe and shall—
‘‘(i) in the case of a petition for an ex-
emption from a requirement, set forth the 
basis for the petitioner’s determination 
that compliance with the requirement is 
not required to assure that the tobacco 
product will be in compliance with this 
chapter; 
‘‘(ii) in the case of a petition for a 
variance from a requirement, set forth the 
methods proposed to be used in, and the 
facilities and controls proposed to be used 
for, the manufacture, packing, and storage 
of the tobacco product in lieu of the meth-
ods, facilities, and controls prescribed by 
the requirement; and 
‘‘(iii) contain such other information 
as the Secretary shall prescribe. 
‘‘(B) REFERRAL TO THE TOBACCO PROD-
UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 
Secretary may refer to the Tobacco Products 
Scientific Advisory Committee any petition sub-
mitted under subparagraph (A). The Tobacco 
Products Scientific Advisory Committee shall
report its recommendations to the Secretary 
with respect to a petition referred to it within 
60 days after the date of the petition’s referral. 
Within 60 days after—
‘‘(i) the date the petition was sub-
mitted to the Secretary under subpara-
graph (A); or 
‘‘(ii) the day after the petition was re-
ferred to the Tobacco Products Scientific 
Advisory Committee, 
whichever occurs later, the Secretary shall by 
order either deny the petition or approve it. 
‘‘(C) APPROVAL.—The Secretary may ap-
prove—
‘‘(i) a petition for an exemption for a 
tobacco product from a requirement if the 
Secretary determines that compliance with 
such requirement is not required to assure 
that the tobacco product will be in compli-
ance with this chapter; and 
‘‘(ii) a petition for a variance for a to-
bacco product from a requirement if the 
Secretary determines that the methods to 
be used in, and the facilities and controls 
to be used for, the manufacture, packing,
and storage of the tobacco product in lieu 
of the methods, controls, and facilities pre-
scribed by the requirement are sufficient to 
assure that the tobacco product will be in 
compliance with this chapter. 
‘‘(D) CONDITIONS.—An order of the Sec-
retary approving a petition for a variance shall 
prescribe such conditions respecting the meth-
ods used in, and the facilities and controls used 
for, the manufacture, packing, and storage of 
the tobacco product to be granted the variance 
under the petition as may be necessary to as-
sure that the tobacco product will be in compli-
ance with this chapter. 
‘‘(E) HEARING.—After the issuance of an 
order under subparagraph (B) respecting a pe-
tition, the petitioner shall have an opportunity 
for an informal hearing on such order. 
‘‘(3) COMPLIANCE.—Compliance with require-
ments under this subsection shall not be required be-
fore the period ending 3 years after the date of en-
actment of the Family Smoking Prevention and To-
bacco Control Act. 
‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary 
may enter into contracts for research, testing, and dem-
onstrations respecting tobacco products and may obtain 
tobacco products for research, testing, and demonstration 
purposes without regard to section 3324(a) and (b) of title 
31, United States Code, and section 5 of title 41, United 
States Code. 
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 
‘‘(a) IN GENERAL.—
‘‘(1) SPECIAL RULE FOR CIGARETTES.—A ciga-
rette or any of its component parts (including the 
tobacco, filter, or paper) shall not contain, as a con-
stituent (including a smoke constituent) or additive, 
an artificial or natural flavor (other than tobacco or 
menthol) or an herb or spice, including strawberry, 
grape, orange, clove, cinnamon, pineapple, vanilla, 
coconut, licorice, cocoa, chocolate, cherry, or coffee, 
that is a characterizing flavor of the tobacco product 
or tobacco smoke. Nothing in this subparagraph 
shall be construed to limit the Secretary’s authority 
to take action under this section or other sections of 
this Act applicable to menthol or any artificial or 
natural flavor, herb, or spice not specified in this 
paragraph. 
‘‘(2) REVISION OF TOBACCO PRODUCT STAND-
ARDS.—The Secretary may revise the tobacco prod-
uct standards in paragraph (1) in accordance with 
subsection (b). 
‘‘(3) TOBACCO
PRODUCT
STANDARDS.—The 
Secretary may adopt tobacco product standards in 
addition to those in paragraph (1) if the Secretary 
finds that a tobacco product standard is appropriate 
for the protection of the public health. This finding 
shall be determined with respect to the risks and 
benefits to the population as a whole, including 
users and non-users of the tobacco product, and tak-
ing into account—
‘‘(A) the increased or decreased likelihood 
that existing users of tobacco products will stop 
using such products; and 
‘‘(B) the increased or decreased likelihood 
that those who do not use tobacco products will 
start using such products. 
‘‘(4) CONTENT OF TOBACCO PRODUCT STAND-
ARDS.—A tobacco product standard established 
under this section for a tobacco product—
‘‘(A) shall include provisions that are ap-
propriate for the protection of the public health, 
including provisions, where appropriate— 
‘‘(i) for the reduction of nicotine 
yields of the product;
‘‘(ii) for the reduction or elimination 
of other constituents, including smoke con-
stituents, or harmful components of the 
product; or 
‘‘(iii) relating to any other require-
ment under (B); 
‘‘(B) shall, where appropriate for the pro-
tection of the public health, include—
‘‘(i) provisions respecting the con-
struction, components, ingredients, addi-
tives, constituents, including smoke con-
stituents, and properties of the tobacco 
product; 
‘‘(ii) provisions for the testing (on a 
sample basis or, if necessary, on an indi-
vidual basis) of the tobacco product; 
‘‘(iii) provisions for the measurement 
of the tobacco product characteristics of 
the tobacco product; 
‘‘(iv) provisions requiring that the re-
sults of each or of certain of the tests of 
the tobacco product required to be made 
under clause (ii) show that the tobacco 
product is in conformity with the portions
of the standard for which the test or tests 
were required; and 
‘‘(v) a provision requiring that the 
sale and distribution of the tobacco prod-
uct be restricted but only to the extent 
that the sale and distribution of a tobacco 
product may be restricted under a regula-
tion under section 906(d); and 
‘‘(C) shall, where appropriate, require the 
use and prescribe the form and content of label-
ing for the proper use of the tobacco product. 
‘‘(5) PERIODIC
RE-EVALUATION
OF
TOBACCO 
PRODUCT STANDARDS.—The Secretary shall provide 
for periodic evaluation of tobacco product standards 
established under this section to determine whether 
such standards should be changed to reflect new 
medical, scientific, or other technological data. The 
Secretary may provide for testing under paragraph 
(4)(B) by any person. 
‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN-
FORMED
PERSONS.—In carrying out duties under 
this section, the Secretary shall endeavor to—
‘‘(A) use personnel, facilities, and other 
technical support available in other Federal 
agencies;
‘‘(B) consult with other Federal agencies 
concerned with standard-setting and other na-
tionally or internationally recognized standard-
setting entities; and 
‘‘(C) 
invite 
appropriate 
participation, 
through joint or other conferences, workshops, 
or other means, by informed persons represent-
ative of scientific, professional, industry, agri-
cultural, or consumer organizations who in the 
Secretary’s judgment can make a significant 
contribution. 
‘‘(b) ESTABLISHMENT OF STANDARDS.—
‘‘(1) NOTICE.—
‘‘(A) IN
GENERAL.—The Secretary shall 
publish in the Federal Register a notice of pro-
posed rulemaking for the establishment, amend-
ment, or revocation of any tobacco product 
standard. 
‘‘(B) REQUIREMENTS OF NOTICE.—A no-
tice of proposed rulemaking for the establish-
ment or amendment of a tobacco product stand-
ard for a tobacco product shall—
‘‘(i) set forth a finding with sup-
porting justification that the tobacco prod-
uct standard is appropriate for the protec-
tion of the public health; 
‘‘(ii) set forth proposed findings with 
respect to the risk of illness or injury that 
the tobacco product standard is intended 
to reduce or eliminate; and 
‘‘(iii) invite interested persons to sub-
mit an existing tobacco product standard 
for the tobacco product, including a draft 
or proposed tobacco product standard, for 
consideration by the Secretary. 
‘‘(C) STANDARD.—Upon a determination 
by the Secretary that an additive, constituent 
(including smoke constituent), or other compo-
nent of the product that is the subject of the 
proposed tobacco product standard is harmful, 
it shall be the burden of any party challenging 
the proposed standard to prove that the pro-
posed standard will not reduce or eliminate the 
risk of illness or injury. 
‘‘(D) FINDING.—A notice of proposed rule-
making for the revocation of a tobacco product 
standard shall set forth a finding with sup-
porting justification that the tobacco product
standard is no longer appropriate for the pro-
tection of the public health. 
‘‘(E) CONSIDERATION
BY
SECRETARY.—
The Secretary shall consider all information 
submitted in connection with a proposed stand-
ard, including information concerning the coun-
tervailing effects of the tobacco product stand-
ard on the health of adolescent tobacco users, 
adult tobacco users, or non-tobacco users, such 
as the creation of a significant demand for con-
traband or other tobacco products that do not 
meet the requirements of this chapter and the 
significance of such demand, and shall issue the 
standard if the Secretary determines that the 
standard would be appropriate for the protec-
tion of the public health. 
‘‘(F) COMMENT.—The Secretary shall pro-
vide for a comment period of not less than 60 
days. 
‘‘(2) PROMULGATION.—
‘‘(A) IN GENERAL.—After the expiration of 
the period for comment on a notice of proposed 
rulemaking published under paragraph (1) re-
specting a tobacco product standard and after 
consideration of such comments and any report