‘‘(II) humidifies tobacco leaf with 
nothing other than potable water in the 
form of steam or mist; or 
‘‘(III) de-stems, dries, and packs 
tobacco leaf for storage and shipment; 
‘‘(ii) who performs no other actions 
with respect to tobacco leaf; and 
‘‘(iii) who provides to any manufac-
turer to whom the person sells tobacco all 
information related to the person’s actions 
described in clause (i) that is necessary for 
compliance with this Act. 
‘‘(B) The term ‘tobacco warehouse’ excludes 
any person who— 
‘‘(i) reconstitutes tobacco leaf; 
‘‘(ii) is a manufacturer, distributor, or 
retailer of a tobacco product; or 
‘‘(iii) applies any chemical, additive, 
or substance to the tobacco leaf other than 
potable water in the form of steam or mist. 
‘‘(C) The definition of the term ‘tobacco 
warehouse’ in subparagraph (A) shall not apply 
to the extent to which the Secretary determines, 
through rulemaking, that regulation under this 
chapter of the actions described in such subpara-
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graph is appropriate for the protection of the 
public health. 
‘‘(21) 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 Mariana 
Islands, and any other trust territory or possession of 
the United States. 
‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS. 
‘‘(a) IN
GENERAL.—Tobacco products, including 
modified risk tobacco products for which an order has been 
issued in accordance with section 911, shall be regulated 
by the Secretary under this chapter and shall not be subject 
to the provisions of chapter V. 
‘‘(b) APPLICABILITY.—This chapter shall apply to all 
cigarettes, cigarette tobacco, and smokeless tobacco 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 in sections 101(a), 102, or 103 of title I, 
title II, or title III of the Family Smoking Prevention 
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and Tobacco Control Act, shall be construed to affect, 
expand, or limit the Secretary’s authority over (in-
cluding the authority to determine whether products 
may be regulated), or the regulation of, products 
under this Act that are not tobacco products 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 tobacco 
products, or to the producers of tobacco leaf, in-
cluding tobacco growers, tobacco warehouses, and 
tobacco grower cooperatives, nor shall any em-
ployee of the Food and Drug Administration 
have any authority to enter onto a farm owned 
by a producer of tobacco leaf without the written 
consent of such producer. 
‘‘(B) EXCEPTION.—Notwithstanding sub-
paragraph (A), if a producer of tobacco leaf is 
also a tobacco product manufacturer or con-
trolled by a tobacco product manufacturer, the 
producer shall be subject to this chapter in the 
producer’s capacity as a manufacturer. The ex-
ception in this subparagraph shall not apply to 
a producer of tobacco leaf who grows tobacco 
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under a contract with a tobacco product manu-
facturer and who is not otherwise engaged in the 
manufacturing process. 
‘‘(C) RULE OF CONSTRUCTION.—Nothing in 
this chapter shall be construed to grant the Sec-
retary authority to promulgate regulations on 
any matter that involves the production of to-
bacco leaf or a producer thereof, other than ac-
tivities by a manufacturer affecting production. 
‘‘(d) RULEMAKING PROCEDURES.—Each rulemaking 
under this chapter shall be in accordance with chapter 5 
of title 5, United States Code. This subsection shall not be 
construed to affect the rulemaking provisions of section 
102(a) of the Family Smoking Prevention and Tobacco 
Control Act. 
‘‘(e) CENTER FOR TOBACCO PRODUCTS.—Not later 
than 90 days after the date of enactment of this chapter, 
the Secretary shall establish within the Food and Drug Ad-
ministration the Center for Tobacco Products, which shall 
report to the Commissioner of Food and Drugs in the same 
manner as the other agency centers within the Food and 
Drug Administration. The Center shall be responsible for 
the implementation of this chapter and related matters as-
signed by the Commissioner. 
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‘‘(f) OFFICE TO ASSIST SMALL TOBACCO PRODUCT 
MANUFACTURERS.—The Secretary shall establish within 
the Food and Drug Administration an identifiable office 
to provide technical and other nonfinancial assistance to 
small tobacco product manufacturers to assist them in com-
plying with the requirements of this Act. 
‘‘(g) CONSULTATION PRIOR TO RULEMAKING.—Prior 
to promulgating rules under this chapter, the Secretary 
shall endeavor to consult with other Federal agencies as ap-
propriate. 
‘‘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 con-
taminated by any added poisonous or added delete-
rious substance that may render the product injurious 
to health; 
‘‘(2) it has been prepared, packed, or held under 
insanitary conditions whereby it may have been con-
taminated 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; 
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‘‘(4) the manufacturer or importer of the tobacco 
product fails to pay a user fee assessed to such manu-
facturer or importer pursuant to section 919 by the 
date specified in section 919 or by the 30th day after 
final agency action on a resolution of any dispute as 
to the amount of such fee; 
‘‘(5) it is, or purports to be or is represented as, 
a tobacco product which is subject to a tobacco prod-
uct standard established under section 907 unless such 
tobacco product is in all respects in conformity with 
such standard; 
‘‘(6)(A) it is required by section 910(a) to have 
premarket review and does not have an order in effect 
under section 910(c)(1)(A)(i); or 
‘‘(B) it is in violation of an order under section 
910(c)(1)(A); 
‘‘(7) the methods used in, or the facilities or con-
trols used for, its manufacture, packing, or storage 
are not in conformity with applicable requirements 
under section 906(e)(1) or an applicable condition 
prescribed by an order under section 906(e)(2); or 
‘‘(8) it is in violation of section 911. 
‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—A tobacco product shall be deemed 
to be misbranded— 
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‘‘(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 do-
mestically grown tobacco and the percentage that 
is foreign grown tobacco; and 
‘‘(D) the statement required under section 
920(a), 
except that under subparagraph (B) reasonable vari-
ations shall be permitted, and exemptions as to small 
packages shall be established, by regulations pre-
scribed 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 
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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 printed 
in type as required by the Secretary by regulation; 
‘‘(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 regulations; 
‘‘(6) if it was manufactured, prepared, propa-
gated, compounded, or processed in an establishment 
not duly registered under section 905(b), 905(c), 
905(d), or 905(h), if it was not included in a list re-
quired by section 905(i), if a notice or other informa-
tion 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 system for identifica-
tion 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— 
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‘‘(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 manu-
facturer, packer, or distributor thereof includes in all 
advertisements and other descriptive printed matter 
issued or caused to be issued by the manufacturer, 
packer, or distributor with respect to that tobacco 
product— 
‘‘(A) a true statement of the tobacco prod-
uct’s established name as described in paragraph 
(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 in-
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gredient of such tobacco product to the ex-
tent 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 prescribed 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 regu-
lation issued under this subsection may require prior ap-
proval by the Secretary of the content of any advertisement, 
except for modified risk tobacco products as provided in sec-
tion 911. No advertisement of a tobacco product published 
after the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act shall, with respect to the lan-
guage of label statements as prescribed under section 4 of 
the Federal Cigarette Labeling and Advertising Act and sec-
tion 3 of the Comprehensive Smokeless Tobacco Health Edu-
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cation Act of 1986 or the regulations issued under such sec-
tions, be subject to the provisions of sections 12 through 15 
of the Federal Trade Commission Act. 
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE 
SECRETARY. 
‘‘(a) REQUIREMENT.—Each tobacco product manufac-
turer or importer, or agents thereof, shall submit to the Sec-
retary the following information: 
‘‘(1) Not later than 6 months after the date of 
enactment of the Family Smoking Prevention and To-
bacco Control Act, a listing of all ingredients, includ-
ing tobacco, 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 regulations 
promulgated by the Secretary in accordance with sec-
tion 4(e) of the Federal Cigarette Labeling and Adver-
tising Act. 
‘‘(3) Beginning 3 years after the date of enact-
ment of this Act, a listing of all constituents, includ-
ing smoke constituents as applicable, identified by the 
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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 3 years after the date of enactment of this 
chapter, the manufacturer, importer, or agent shall 
comply with regulations promulgated under section 
915 in reporting information under this paragraph, 
where applicable. 
‘‘(4) Beginning 6 months after the date of enact-
ment of the Family Smoking Prevention and Tobacco 
Control Act, all documents developed after the date of 
enactment of the Family Smoking Prevention and To-
bacco Control Act that relate to health, toxicological, 
behavioral, or physiologic effects of current or future 
tobacco products, their constituents (including smoke 
constituents), ingredients, components, 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 underlying 
scientific information) relating to research activities, 
and research findings, conducted, supported, or pos-
sessed by the manufacturer (or agents thereof) on the 
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health, toxicological, behavioral, or physiologic effects 
of tobacco products and their constituents (including 
smoke constituents), ingredients, components, and ad-
ditives. 
‘‘(2) Any or all documents (including underlying 
scientific information) relating to research activities, 
and research findings, conducted, supported, or pos-
sessed by the manufacturer (or agents thereof) that re-
late to the issue of whether a reduction in risk to 
health from tobacco products can occur upon the em-
ployment of technology available or known to the 
manufacturer. 
‘‘(3) Any or all documents (including underlying 
scientific or financial information) relating to mar-
keting research involving the use of tobacco products 
or marketing practices and the effectiveness of such 
practices used by tobacco manufacturers and distribu-
tors. 
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 commerce of 
a tobacco product not on the market on the date of 
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enactment of the Family Smoking Prevention and To-
bacco Control Act, the manufacturer of such product 
shall provide the information required under sub-
section (a). 
‘‘(2) DISCLOSURE OF ADDITIVE.—If at any time 
a tobacco product manufacturer adds to its tobacco 
products a new tobacco additive or increases the 
quantity of an existing tobacco additive, the manufac-
turer shall, except as provided in paragraph (3), at 
least 90 days prior to such action so advise the Sec-
retary in writing. 
‘‘(3) DISCLOSURE
OF
OTHER
ACTIONS.—If at 
any time a tobacco product manufacturer eliminates 
or decreases an existing additive, or adds or increases 
an additive that has by regulation been designated 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 manufacturer 
shall within 60 days of such action so advise the Sec-
retary in writing. 
‘‘(d) DATA LIST.— 
‘‘(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, and annually there-
after, the Secretary shall publish in a format that is 
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understandable and not misleading to a lay person, 
and place on public display (in a manner determined 
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, together 
with recommendations on whether such publication 
should be continued or modified. 
‘‘(e) DATA COLLECTION.—Not later than 24 months 
after the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, the Secretary shall establish, 
and periodically revise as appropriate, a list of harmful 
and potentially harmful constituents, including smoke con-
stituents, to health in each tobacco 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 scientific and other information con-
cerning the harmful and potentially harmful constituents 
in tobacco products and tobacco smoke. 
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‘‘SEC. 905. ANNUAL REGISTRATION. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) 
MANUFACTURE, 
PREPARATION, 
COMPOUNDING, 
OR
PROCESSING.—The 
term 
‘manufacture, preparation, compounding, or proc-
essing’ shall include repackaging or otherwise chang-
ing the container, wrapper, or labeling of any tobacco 
product package in furtherance of the distribution of 
the tobacco product from the original place of manu-
facture 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 incor-
poration. 
‘‘(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 register 
with the Secretary the name, places of business, and all such 
establishments of that person. If the enactment of this Act 
occurs in the second half of the calendar year, the Secretary 
shall designate a date no later than 6 months into the subse-
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quent calendar year by which registration pursuant to this 
subsection shall occur. 
‘‘(c) REGISTRATION BY 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 reg-
ister with the Secretary that person’s name, place of busi-
ness, 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 manufacture, 
preparation, compounding, or processing of a tobacco prod-
uct or tobacco products. 
‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYSTEM.— 
The Secretary may by regulation prescribe a uniform sys-
tem for the identification of tobacco products and may re-
quire that persons who are required to list such tobacco 
products under subsection (i) shall list such tobacco prod-
ucts in accordance with such system. 
‘‘(f) PUBLIC ACCESS
TO REGISTRATION INFORMA-
TION.—The Secretary shall make available for inspection, 
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to any person so requesting, any registration filed under 
this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB-
LISHMENTS.—Every establishment registered with the Sec-
retary under this section shall be subject to inspection under 
section 704 or subsection (h), and every such establishment 
engaged in the manufacture, compounding, or processing 
of a tobacco product or tobacco products shall be so in-
spected by 1 or more officers or employees duly designated 
by the Secretary at least once in the 2-year period begin-
ning with the date of registration of such establishment 
under this section and at least once in every successive 2- 
year period thereafter. 
‘‘(h) REGISTRATION BY FOREIGN ESTABLISHMENTS.— 
Any establishment within any foreign country engaged 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 establishment 
to provide the information required by subsection (i) and 
shall include provisions for registration of any such estab-
lishment upon condition that adequate and effective means 
are available, by arrangement with the government of such 
foreign country or otherwise, to enable the Secretary to de-
termine from time to time whether tobacco products manu-
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factured, prepared, compounded, or processed in such estab-
lishment, if imported 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 to-
bacco products which are being manufactured, pre-
pared, compounded, or processed by that person for 
commercial distribution and which have not been in-
cluded 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 accompanied 
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 estab-
lished 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; 
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‘‘(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 par-
ticular tobacco product; and 
‘‘(C) if the registrant filing a list has deter-
mined 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 registrant made such 
determination if the Secretary requests such a 
statement with respect to that particular tobacco 
product. 
‘‘(2) 
CONSULTATION
WITH
RESPECT
TO 
FORMS.—The Secretary shall consult with the Sec-
retary of the Treasury in developing the forms to be 
used for registration under this section to minimize 
the burden on those persons required to register with 
both the Secretary and the Tax and Trade Bureau of 
the Department of the Treasury. 
‘‘(3) BIANNUAL
REPORT
OF
ANY
CHANGE
IN 
PRODUCT LIST.—Each person who registers with the 
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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 pre-
viously filed by that person with the Secretary 
under this subparagraph or paragraph (1). A 
list under this subparagraph shall list a tobacco 
product by its established name and shall be ac-
companied 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 reported 
under subparagraph (B) a notice of discontinu-
ance that person has resumed the manufacture, 
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preparation, compounding, or processing for 
commercial distribution of the tobacco product 
with respect to which such notice of discontinu-
ance was reported, notice of such resumption, the 
date of such resumption, the identity of such to-
bacco product by established name, and other in-
formation required by paragraph (1), unless the 
registrant has previously reported such resump-
tion 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 CERTAIN 
SUBSTANTIALLY
EQUIVALENT
PRODUCTS
INTO
INTER-
STATE COMMERCE.— 
‘‘(1) IN GENERAL.—Each person who is required 
to register under this section and who proposes to 
begin the introduction or delivery for introduction 
into interstate commerce for commercial distribution 
of a tobacco product intended for human use that was 
not commercially marketed (other than for test mar-
keting) in the United States as of February 15, 2007, 
shall, at least 90 days prior to making such introduc-
tion or delivery, report to the Secretary (in such form 
and manner as the Secretary shall prescribe)— 
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‘‘(A) the basis for such person’s determina-
tion that— 
‘‘(i) the tobacco product is substan-
tially equivalent, within the meaning of sec-
tion 910, to a tobacco product commercially 
marketed (other than for test marketing) in 
the United States as of February 15, 2007, 
or to a tobacco product that the Secretary 
has previously determined, pursuant to sub-
section (a)(3) of section 910, is substantially 
equivalent and that is in compliance with 
the requirements of this Act; or 
‘‘(ii) the tobacco product is modified 
within the meaning of paragraph (3), the 
modifications are to a product that is com-
mercially marketed and in compliance with 
the requirements of this Act, and all of the 
modifications are covered by exemptions 
granted by the Secretary pursuant to para-
graph (3); and 
‘‘(B) action taken by such person to comply 
with the requirements under section 907 that are 
applicable to the tobacco product. 
‘‘(2) APPLICATION TO CERTAIN POST-FEBRUARY 
15, 2007, PRODUCTS.—A report under this subsection 
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for a tobacco product that was first introduced or de-
livered for introduction into interstate commerce for 
commercial distribution in the United States after 
February 15, 2007, and prior to the date that is 21 
months after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act shall be 
submitted to the Secretary not later than 21 months 
after such date of enactment. 
‘‘(3) EXEMPTIONS.— 
‘‘(A) IN GENERAL.—The Secretary may ex-
empt from the requirements of this subsection re-
lating to the demonstration that a tobacco prod-
uct is substantially equivalent within the mean-
ing of section 910, tobacco products that are 
modified by adding or deleting a tobacco addi-
tive, or increasing or decreasing the quantity of 
an existing tobacco additive, if the Secretary de-
termines that— 
‘‘(i) such modification would be a 
minor modification of a tobacco product 
that can be sold under this Act; 
‘‘(ii) a report under this subsection is 
not necessary to ensure that permitting the 
tobacco product to be marketed would be ap-
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