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made available, as well as research generated in the 
future, relating to the health and dependency effects 
or safety of tobacco products; 
(7) to continue to permit the sale of tobacco 
products to adults in conjunction with measures to 
ensure that they are not sold or accessible to under-
age purchasers; 
(8) to impose appropriate regulatory controls on 
the tobacco industry; 
(9) to promote cessation to reduce disease risk 
and the social costs associated with tobacco-related 
diseases; and 
(10) to strengthen legislation against illicit 
trade in tobacco products. 
SEC. 4. SCOPE AND EFFECT. 
(a) INTENDED EFFECT.—Nothing in this Act (or an 
amendment made by this Act) shall be construed to— 
(1) establish a precedent with regard to any 
other industry, situation, circumstance, or legal ac-
tion; or 
(2) affect any action pending in Federal, State, 
or Tribal court, or any agreement, consent decree, or 
contract of any kind. 
(b) AGRICULTURAL ACTIVITIES.—The provisions of 
this Act (or an amendment made by this Act) which au-
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thorize the Secretary to take certain actions with regard 
to tobacco and tobacco products shall not be construed to 
affect any authority of the Secretary of Agriculture under 
existing law regarding the growing, cultivation, or curing 
of raw tobacco. 
(c) REVENUE ACTIVITIES.—The provisions of this 
Act (or an amendment made by this Act) which authorize 
the Secretary to take certain actions with regard to to-
bacco products shall not be construed to affect any author-
ity of the Secretary of the Treasury under chapter 52 of 
the Internal Revenue Code of 1986. 
SEC. 5. SEVERABILITY. 
If any provision of this Act, the amendments made 
by this Act, or the application of any provision of this Act 
to any person or circumstance is held to be invalid, the 
remainder of this Act, the amendments made by this Act, 
and the application of the provisions of this Act to any 
other person or circumstance shall not be affected and 
shall continue to be enforced to the fullest extent possible. 
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TITLE I—AUTHORITY OF THE 
FOOD AND DRUG ADMINIS-
TRATION 
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND 
COSMETIC ACT. 
(a) DEFINITION OF TOBACCO PRODUCTS.—Section 
201 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321) is amended by adding at the end the fol-
lowing: 
‘‘(rr)(1) The term ‘tobacco product’ means any prod-
uct made or derived from tobacco that is intended for 
human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials 
other than tobacco used in manufacturing a component, 
part, or accessory of a tobacco product). 
‘‘(2) The term ‘tobacco product’ does not mean an 
article that is a drug under subsection (g)(1), a device 
under subsection (h), or a combination product described 
in section 503(g). 
‘‘(3) The products described in paragraph (2) shall 
be subject to chapter V of this Act. 
‘‘(4) A tobacco product shall not be marketed in com-
bination with any other article or product regulated under 
this Act (including a drug, biologic, food, cosmetic, med-
ical device, or a dietary supplement).’’. 
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(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 910 
as sections 1001 through 1010; and 
(3) by inserting after chapter VIII the fol-
lowing: 
‘‘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 
(including any substances intended for use as a fla-
voring or 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, 
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size, filtration, packaging, logo, registered trade-
mark, brand name, identifiable pattern of colors, or 
any combination of such attributes. 
‘‘(3) CIGARETTE.—The term ‘cigarette’— 
‘‘(A) means a product that— 
‘‘(i) is a tobacco product; and 
‘‘(ii) meets the definition of the term 
‘cigarette’ in section 3(1) of the Federal 
Cigarette Labeling and Advertising Act; 
and 
‘‘(B) includes tobacco, in any form, that is 
functional in the product, which, because 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 
cigarette 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-
ments applicable to cigarettes under this chapter 
shall also apply to cigarette tobacco. 
‘‘(5) COMMERCE.—The term ‘commerce’ has 
the meaning given that term by section 3(2) of the 
Federal Cigarette Labeling and Advertising Act. 
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‘‘(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
COUNTRY.—The term ‘Indian 
country’ has the meaning given such term in section 
1151 of title 18, United States Code. 
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‘‘(10) 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. 
‘‘(11) LITTLE CIGAR.—The term ‘little cigar’ 
means a product that— 
‘‘(A) is a tobacco product; and 
‘‘(B) meets the definition of the term ‘little 
cigar’ in section 3(7) of the Federal Cigarette 
Labeling and Advertising Act. 
‘‘(12) 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. 
‘‘(13) 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. 
‘‘(14) RETAILER.—The term ‘retailer’ means 
any person, government, or entity 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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‘‘(15) ROLL-YOUR-OWN
TOBACCO.—The term 
‘roll-your-own tobacco’ means any tobacco product 
which, because of its appearance, type, packaging, or 
labeling, is suitable for use and likely to be offered 
to, or purchased by, consumers as tobacco for mak-
ing cigarettes. 
‘‘(16) SMALL
TOBACCO
PRODUCT
MANUFAC-
TURER.—The term ‘small tobacco product manufac-
turer’ means a tobacco product manufacturer that 
employs fewer than 350 employees. For purposes of 
determining the number of employees of a manufac-
turer under the preceding sentence, the employees of 
a manufacturer are deemed to include the employees 
of each entity that controls, is controlled by, or is 
under common control with such manufacturer. 
‘‘(17) 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. 
‘‘(18) 
SMOKELESS
TOBACCO.—The 
term 
‘smokeless tobacco’ means any tobacco product that 
consists of cut, ground, powdered, or leaf tobacco 
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and that is intended to be placed in the oral or nasal 
cavity. 
‘‘(19) STATE; TERRITORY.—The terms ‘State’ 
and ‘Territory’ shall have the meanings given to 
such terms in section 201. 
‘‘(20) TOBACCO
PRODUCT
MANUFACTURER.— 
The 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 tobacco product 
for sale or distribution in the United States. 
‘‘(21) TOBACCO WAREHOUSE.— 
‘‘(A) Subject to subparagraphs (B) and 
(C), the term ‘tobacco warehouse’ includes any 
person— 
‘‘(i) who— 
‘‘(I) removes foreign material 
from tobacco leaf through nothing 
other than a mechanical process; 
‘‘(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; 
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‘‘(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’ ex-
cludes 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 sub-
paragraph is appropriate for the protection of 
the public health. 
‘‘(22) UNITED
STATES.—The term ‘United 
States’ means the 50 States of the United States of 
America and the District of Columbia, the Common-
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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, including 
modified risk tobacco products for which an order has 
been issued in accordance with section 911, shall be regu-
lated 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, roll-your-own 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 Preven-
tion and Tobacco Control Act, shall be construed to 
affect, expand, or limit the Secretary’s authority 
over (including the authority to determine whether 
products may be regulated), or the regulation of, 
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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 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 
under a contract with a tobacco product manu-
facturer and who is not otherwise engaged in 
the manufacturing process. 
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‘‘(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. 
‘‘(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 the Family 
Smoking Prevention and Tobacco Control Act, the Sec-
retary shall establish within the Food and Drug Adminis-
tration the Center for Tobacco Products, which shall re-
port 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. 
‘‘(f) OFFICE TO ASSIST SMALL TOBACCO PRODUCT 
MANUFACTURERS.—The Secretary shall establish within 
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the Food and Drug Administration an identifiable office 
to provide technical and other nonfinancial assistance to 
small tobacco product manufacturers to assist them in 
complying 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 
appropriate. 
‘‘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) the manufacturer or importer of the to-
bacco product fails to pay a user fee assessed to 
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such manufacturer 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 
product standard established under section 907 un-
less such tobacco product is in all respects in con-
formity with such standard; 
‘‘(6)(A) it is required by section 910(a) to have 
premarket review and does not have an order in ef-
fect 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 
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 
‘‘(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 
domestically 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 
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 
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under section 4 of the Federal Cigarette Labeling and Ad-
vertising Act and section 3 of the Comprehensive Smoke-
less Tobacco Health Education Act of 1986 or the regula-
tions issued under such sections, be subject to the provi-
sions of sections 12 through 15 of the Federal Trade Com-
mission Act. 
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE 
SECRETARY. 
‘‘(a) REQUIREMENT.—Each tobacco product manu-
facturer or importer, or agents thereof, shall submit to 
the Secretary the following information: 
‘‘(1) Not later than 6 months after the date of 
enactment of the Family Smoking Prevention and 
Tobacco Control Act, a listing of all ingredients, in-
cluding tobacco, substances, compounds, and addi-
tives that are, as of such date, added by the manu-
facturer to the tobacco, paper, filter, or other part 
of each tobacco 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(e) of the Federal Cigarette Labeling 
and Advertising Act. 
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‘‘(3) Beginning 3 years after the date of enact-
ment of the Family Smoking Prevention and To-
bacco Control Act, a listing of all constituents, in-
cluding 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 
beginning 3 years after such date of enactment, the 
manufacturer, importer, or agent shall comply with 
regulations promulgated under section 915 in re-
porting information under this paragraph, where ap-
plicable. 
‘‘(4) Beginning 6 months after the date of en-
actment of the Family Smoking Prevention and To-
bacco Control Act, all documents developed after 
such date of enactment 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: 
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‘‘(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. 
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‘‘(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.— 
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‘‘(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 24 months 
after the date of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, the Secretary shall es-
tablish, and periodically revise as appropriate, a list of 
harmful and potentially harmful constituents, including 
smoke constituents, to health in each tobacco product by 
brand and by quantity in each brand and subbrand. The 
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Secretary shall publish a public notice requesting the sub-
mission by interested persons of scientific and other infor-
mation 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-
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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-
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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 Feb-
ruary 15, 2007, shall, at least 90 days prior to mak-
ing such introduction or delivery, report to the Sec-
retary (in such form and manner as the Secretary 
shall prescribe)— 
‘‘(A) the basis for such person’s determina-
tion that— 
‘‘(i) the tobacco product is substan-
tially equivalent, within the meaning of 
section 910, to a tobacco product commer-
cially marketed (other than for test mar-
keting) in the United States as of Feb-
ruary 15, 2007, or to a tobacco product 
that the Secretary has previously deter-
mined, pursuant to subsection (a)(3) of 
section 910, is substantially equivalent and 
that is in compliance with the require-
ments 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 
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modifications are covered by exemptions 
granted by the Secretary pursuant to para-
graph (3); 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-FEB-
RUARY 15, 2007, PRODUCTS.—A report under this 
subsection for a tobacco product that was first intro-
duced or delivered 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 
exempt from the requirements of this sub-
section relating to the demonstration that a to-
bacco product is substantially equivalent within 
the meaning of section 910, tobacco products 
that are modified by adding or deleting a to-
bacco additive, or increasing or decreasing the 
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quantity of an existing tobacco additive, if the 
Secretary determines 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 
appropriate for protection of the public 
health; and 
‘‘(iii) an exemption is otherwise appro-
priate. 
‘‘(B) REGULATIONS.—Not later than 15 
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, 
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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 or other noti-
fication 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 section and which states the reasons for 
such action, and each publication of findings required to 
be made in connection 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. 
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‘‘(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 
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the public health shall be determined with respect to 
the risks and benefits to the population as a whole, 
including users and nonusers of the tobacco product, 
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 
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‘‘(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. 
‘‘(4) REMOTE SALES.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) within 18 months after the date 
of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, promul-
gate regulations regarding the sale and 
distribution of tobacco products that occur 
through means other than a direct, face-to- 
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‘‘(A) IN GENERAL.—In applying manufac-
turing restrictions to tobacco, the Secretary 
shall, in accordance with subparagraph (B), 
prescribe regulations (which may differ based 
on the type of tobacco product involved) requir-
ing that the methods used in, and the facilities 
and controls used for, the manufacture, 
preproduction design 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, or hazard analysis and critical control 
point methodology, as prescribed in such regu-
lations to assure that the public health is pro-
tected and that the tobacco product is in com-
pliance with this chapter. Such regulations may 
provide for the testing of raw tobacco for pes-
ticide 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-
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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 Tobacco Products 
Scientific Advisory Committee a reasonable 
time to make its recommendation with re-
spect to proposed regulations under sub-
paragraph (A); 
‘‘(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; and 
‘‘(v) not require any small tobacco 
product manufacturer to comply with a 
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regulation under subparagraph (A) for at 
least 4 years following the effective date 
established by the Secretary for such regu-
lation. 
‘‘(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-
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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— 
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‘‘(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, facilities, and controls 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. 
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‘‘(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 end of the 3-year period following the date 
of enactment of the Family Smoking Prevention and 
Tobacco 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. 
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 
‘‘(a) IN GENERAL.— 
‘‘(1) SPECIAL RULES.— 
‘‘(A) SPECIAL RULE FOR CIGARETTES.— 
Beginning 3 months after the date of enact-
ment of the Family Smoking Prevention and 
Tobacco Control Act, a cigarette or any of its 
component parts (including the tobacco, filter, 
or paper) shall not contain, as a constituent (in-
cluding a smoke constituent) or additive, an ar-
tificial or natural flavor (other than tobacco or 
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menthol) or an herb or spice, including straw-
berry, grape, orange, clove, cinnamon, pine-
apple, vanilla, coconut, licorice, cocoa, chocolate, 
cherry, or coffee, that is a characterizing flavor 
of the tobacco product or tobacco smoke. Noth-
ing 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 nat-
ural flavor, herb, or spice not specified in this 
subparagraph. 
‘‘(B) ADDITIONAL SPECIAL RULE.—Begin-
ning 2 years after the date of enactment of the 
Family Smoking Prevention and Tobacco Con-
trol Act, a tobacco product manufacturer shall 
not use tobacco, including foreign grown to-
bacco, that contains a pesticide chemical res-
idue that is at a level greater than is specified 
by any tolerance applicable under Federal law 
to domestically grown tobacco. 
‘‘(2) REVISION OF TOBACCO PRODUCT STAND-
ARDS.—The Secretary may revise the tobacco prod-
uct standards in paragraph (1) in accordance with 
subsection (c). 
‘‘(3) TOBACCO PRODUCT STANDARDS.— 
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‘‘(A) IN
GENERAL.—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. 
‘‘(B) DETERMINATIONS.— 
‘‘(i) CONSIDERATIONS.—In making a 
finding described in subparagraph (A), the 
Secretary shall consider scientific evidence 
concerning— 
‘‘(I) the risks and benefits to the 
population as a whole, including users 
and nonusers of tobacco products, of 
the proposed standard; 
‘‘(II) the increased or decreased 
likelihood that existing users of to-
bacco products will stop using such 
products; and 
‘‘(III) the increased or decreased 
likelihood that those who do not use 
tobacco products will start using such 
products. 
‘‘(ii) 
ADDITIONAL
CONSIDER-
ATIONS.—In the event that the Secretary 
makes a determination, set forth in a pro-
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posed tobacco product standard in a pro-
posed rule, that it is appropriate for the 
protection of public health to require the 
reduction or elimination of an additive, 
constituent (including a smoke constitu-
ent), or other component of a tobacco 
product because the Secretary has found 
that the additive, constituent, or other 
component is or may be harmful, any 
party objecting to the proposed standard 
on the ground that the proposed standard 
will not reduce or eliminate the risk of ill-
ness or injury may provide for the Sec-
retary’s consideration scientific evidence 
that demonstrates that the proposed stand-
ard will not reduce or eliminate the risk of 
illness or injury. 
‘‘(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 nicotine yields of the product; 
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‘‘(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 subparagraph (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 
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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); 
‘‘(C) shall, where appropriate, require the 
use and prescribe the form and content of label-
ing for the proper use of the tobacco product; 
and 
‘‘(D) shall require tobacco products con-
taining foreign-grown tobacco to meet the same 
standards applicable to tobacco products con-
taining domestically grown tobacco. 
‘‘(5) PERIODIC
REEVALUATION
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. 
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‘‘(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) CONSIDERATIONS BY SECRETARY.— 
‘‘(1) TECHNICAL
ACHIEVABILITY.—The Sec-
retary shall consider information submitted in con-
nection with a proposed standard regarding the tech-
nical achievability of compliance with such standard. 
‘‘(2) OTHER CONSIDERATIONS.—The Secretary 
shall consider all other information submitted in 
connection with a proposed standard, including in-
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formation concerning the countervailing effects of 
the tobacco product standard on the health of ado-
lescent tobacco users, adult tobacco users, or non-
tobacco users, such as the creation of a significant 
demand for contraband or other tobacco products 
that do not meet the requirements of this chapter 
and the significance of such demand. 
‘‘(c) PROPOSED STANDARDS.— 
‘‘(1) IN GENERAL.—The Secretary shall publish 
in the Federal Register a notice of proposed rule-
making for the establishment, amendment, or rev-
ocation of any tobacco product standard. 
‘‘(2) REQUIREMENTS OF NOTICE.—A notice of 
proposed rulemaking for the establishment or 
amendment of a tobacco product standard for a to-
bacco product shall— 
‘‘(A) set forth a finding with supporting 
justification that the tobacco product standard 
is appropriate for the protection of the public 
health; 
‘‘(B) invite interested persons to submit a 
draft or proposed tobacco product standard for 
consideration by the Secretary; 
‘‘(C) invite interested persons to submit 
comments on structuring the standard so that 
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If the Secretary determines, based on the Sec-
retary’s evaluation of submitted comments, that a 
product standard can be met only by manufacturers 
requiring substantial changes to the methods of 
farming the domestically grown tobacco used by the 
manufacturer, the effective date of that product 
standard shall be not less than 2 years after the 
date of publication of the final regulation estab-
lishing the standard. 
‘‘(3) LIMITATION ON POWER GRANTED TO THE 
FOOD AND DRUG ADMINISTRATION.—Because of the 
importance of a decision of the Secretary to issue a 
regulation— 
‘‘(A) banning all cigarettes, all smokeless 
tobacco products, all little cigars, all cigars 
other than little cigars, all pipe tobacco, or all 
roll-your-own tobacco products; or 
‘‘(B) requiring the reduction of nicotine 
yields of a tobacco product to zero, 
the Secretary is prohibited from taking such actions 
under this Act. 
‘‘(4) AMENDMENT; REVOCATION.— 
‘‘(A) AUTHORITY.—The Secretary, upon 
the Secretary’s own initiative or upon petition 
of an interested person, may by a regulation, 
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promulgated in accordance with the require-
ments of subsection (c) and paragraph (2), 
amend or revoke a tobacco product standard. 
‘‘(B) EFFECTIVE
DATE.—The Secretary 
may declare a proposed amendment of a to-
bacco product standard to be effective on and 
after its publication in the Federal Register and 
until the effective date of any final action taken 
on such amendment if the Secretary determines 
that making it so effective is in the public inter-
est. 
‘‘(5) REFERRAL TO ADVISORY COMMITTEE.— 
‘‘(A) IN
GENERAL.—The Secretary may 
refer a proposed regulation for the establish-
ment, amendment, or revocation of a tobacco 
product standard to the Tobacco Products Sci-
entific Advisory Committee for a report and 
recommendation with respect to any matter in-
volved in the proposed regulation which requires 
the exercise of scientific judgment. 
‘‘(B) INITIATION OF REFERRAL.—The Sec-
retary may make a referral under this para-
graph— 
‘‘(i) on the Secretary’s own initiative; 
or 
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‘‘(ii) upon the request of an interested 
person that— 
‘‘(I) demonstrates good cause for 
the referral; and 
‘‘(II) is made before the expira-
tion of the period for submission of 
comments on the proposed regulation. 
‘‘(C) PROVISION OF DATA.—If a proposed 
regulation is referred under this paragraph to 
the Tobacco Products Scientific Advisory Com-
mittee, the Secretary shall provide the Advisory 
Committee with the data and information on 
which such proposed regulation is based. 
‘‘(D) REPORT
AND
RECOMMENDATION.— 
The Tobacco Products Scientific Advisory Com-
mittee shall, within 60 days after the referral of 
a proposed regulation under this paragraph and 
after independent study of the data and infor-
mation furnished to it by the Secretary and 
other data and information before it, submit to 
the Secretary a report and recommendation re-
specting such regulation, together with all un-
derlying data and information and a statement 
of the reason or basis for the recommendation. 
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‘‘(E) PUBLIC
AVAILABILITY.—The Sec-
retary shall make a copy of each report and rec-
ommendation under subparagraph (D) publicly 
available. 
‘‘(e) MENTHOL CIGARETTES.— 
‘‘(1) 
REFERRAL; 
CONSIDERATIONS.—Imme-
diately upon the establishment of the Tobacco Prod-
ucts Scientific Advisory Committee under section 
917(a), the Secretary shall refer to the Committee 
for report and recommendation, under section 
917(c)(4), the issue of the impact of the use of men-
thol in cigarettes on the public health, including 
such use among children, African Americans, His-
panics, and other racial and ethnic minorities. In its 
review, the Tobacco Products Scientific Advisory 
Committee shall address the considerations listed in 
subsections (a)(3)(B)(i) and (b). 
‘‘(2) REPORT
AND
RECOMMENDATION.—Not 
later than 1 year after its establishment, the To-
bacco Product Scientific Advisory Committee shall 
submit to the Secretary the report and recommenda-
tions required pursuant to paragraph (1). 
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to limit the Sec-
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retary’s authority to take action under this section 
or other sections of this Act applicable to menthol. 
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES. 
‘‘(a) NOTIFICATION.—If the Secretary determines 
that— 
‘‘(1) a tobacco product which is introduced or 
delivered for introduction into interstate commerce 
for commercial distribution presents an unreasonable 
risk of substantial harm to the public health; and 
‘‘(2) notification under this subsection is nec-
essary to eliminate the unreasonable risk of such 
harm and no more practicable means is available 
under the provisions of this chapter (other than this 
section) to eliminate such risk, 
the Secretary may issue such order as may be necessary 
to assure that adequate notification is provided in an ap-
propriate form, by the persons and means best suited 
under the circumstances involved, to all persons who 
should properly receive such notification in order to elimi-
nate such risk. The Secretary may order notification by 
any appropriate means, including public service announce-
ments. Before issuing an order under this subsection, the 
Secretary shall consult with the persons who are to give 
notice under the order. 
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‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.— 
Compliance with an order issued under this section shall 
not relieve any person from liability under Federal or 
State law. In awarding damages for economic loss in an 
action brought for the enforcement of any such liability, 
the value to the plaintiff in such action of any remedy 
provided under such order shall be taken into account. 
‘‘(c) RECALL AUTHORITY.— 
‘‘(1) IN GENERAL.—If the Secretary finds that 
there is a reasonable probability that a tobacco prod-
uct contains a manufacturing or other defect not or-
dinarily contained in tobacco products on the market 
that would cause serious, adverse health con-
sequences or death, the Secretary shall issue an 
order requiring the appropriate person (including 
the manufacturers, importers, distributors, or retail-
ers of the tobacco product) to immediately cease dis-
tribution of such tobacco product. The order shall 
provide the person subject to the order with an op-
portunity for an informal hearing, to be held not 
later than 10 days after the date of the issuance of 
the order, on the actions required by the order and 
on whether the order should be amended to require 
a recall of such tobacco product. If, after providing 
an opportunity for such a hearing, the Secretary de-
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In providing the notice required by clause (ii), 
the Secretary may use the assistance of retail-
ers and other persons who distributed such to-
bacco product. If a significant number of such 
persons cannot be identified, the Secretary shall 
notify such persons under section 705(b). 
‘‘(3) REMEDY
NOT
EXCLUSIVE.—The remedy 
provided by this subsection shall be in addition to 
remedies provided by subsection (a). 
‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD-
UCTS. 
‘‘(a) IN GENERAL.—Every person who is a tobacco 
product manufacturer or importer of a tobacco product 
shall establish and maintain such records, make such re-
ports, and provide such information, as the Secretary may 
by regulation reasonably require to assure that such to-
bacco product is not adulterated or misbranded and to 
otherwise protect public health. Regulations prescribed 
under the preceding sentence— 
‘‘(1) may require a tobacco product manufac-
turer or importer to report to the Secretary when-
ever the manufacturer or importer receives or other-
wise becomes aware of information that reasonably 
suggests that one of its marketed tobacco products 
may have caused or contributed to a serious unex-
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pected adverse experience associated with the use of 
the product or any significant increase in the fre-
quency of a serious, expected adverse product experi-
ence; 
‘‘(2) shall require reporting of other significant 
adverse tobacco product experiences as determined 
by the Secretary to be necessary to be reported; 
‘‘(3) shall not impose requirements unduly bur-
densome to a tobacco product manufacturer or im-
porter, taking into account the cost of complying 
with such requirements and the need for the protec-
tion of the public health and the implementation of 
this chapter; 
‘‘(4) when prescribing the procedure for making 
requests for reports or information, shall require 
that each request made under such regulations for 
submission of a report or information to the Sec-
retary state the reason or purpose for such request 
and identify to the fullest extent practicable such re-
port or information; 
‘‘(5) when requiring submission of a report or 
information to the Secretary, shall state the reason 
or purpose for the submission of such report or in-
formation and identify to the fullest extent prac-
ticable such report or information; and 
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‘‘(6) may not require that the identity of any 
patient or user be disclosed in records, reports, or 
information required under this subsection unless re-
quired for the medical welfare of an individual, to 
determine risks to public health of a tobacco prod-
uct, or to verify a record, report, or information sub-
mitted under this chapter. 
In prescribing regulations under this subsection, the Sec-
retary shall have due regard for the professional ethics of 
the medical profession and the interests of patients. The 
prohibitions of paragraph (6) continue to apply to records, 
reports, and information concerning any individual who 
has been a patient, irrespective of whether or when he 
ceases to be a patient. 
‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), the Secretary shall by regulation require 
a tobacco product manufacturer or importer of a to-
bacco product to report promptly to the Secretary 
any corrective action taken or removal from the 
market of a tobacco product undertaken by such 
manufacturer or importer if the removal or correc-
tion was undertaken— 
‘‘(A) to reduce a risk to health posed by 
the tobacco product; or 
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‘‘(B) to remedy a violation of this chapter 
caused by the tobacco product which may 
present a risk to health. 
A tobacco product manufacturer or importer of a to-
bacco product who undertakes a corrective action or 
removal from the market of a tobacco product which 
is not required to be reported under this subsection 
shall keep a record of such correction or removal. 
‘‘(2) EXCEPTION.—No report of the corrective 
action or removal of a tobacco product may be re-
quired under paragraph (1) if a report of the correc-
tive action or removal is required and has been sub-
mitted under subsection (a). 
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO-
BACCO PRODUCTS. 
‘‘(a) IN GENERAL.— 
‘‘(1) NEW TOBACCO PRODUCT DEFINED.—For 
purposes of this section the term ‘new tobacco prod-
uct’ means— 
‘‘(A) any tobacco product (including those 
products in test markets) that was not commer-
cially marketed in the United States as of Feb-
ruary 15, 2007; or 
‘‘(B) any modification (including a change 
in design, any component, any part, or any con-
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stituent, including a smoke constituent, or in 
the content, delivery or form of nicotine, or any 
other additive or ingredient) of a tobacco prod-
uct where the modified product was commer-
cially marketed in the United States after Feb-
ruary 15, 2007. 
‘‘(2) PREMARKET REVIEW REQUIRED.— 
‘‘(A) NEW
PRODUCTS.—An order under 
subsection (c)(1)(A)(i) for a new tobacco prod-
uct is required unless— 
‘‘(i) the manufacturer has submitted a 
report under section 905(j); and the Sec-
retary has issued an order that the tobacco 
product— 
‘‘(I) is substantially equivalent to 
a tobacco product commercially mar-
keted (other than for test marketing) 
in the United States as of February 
15, 2007; and 
‘‘(II) is in compliance with the 
requirements of this Act; or 
‘‘(ii) the tobacco product is exempt 
from the requirements of section 905(j) 
pursuant to a regulation issued under sec-
tion 905(j)(3). 
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‘‘(B) APPLICATION TO CERTAIN POST-FEB-
RUARY 15, 2007, PRODUCTS.—Subparagraph (A) 
shall not apply to a tobacco product— 
‘‘(i) that was first introduced or deliv-
ered for introduction into interstate com-
merce 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; and 
‘‘(ii) for which a report was submitted 
under section 905(j) within such 21-month 
period, 
except that subparagraph (A) shall apply to the 
tobacco product if the Secretary issues an order 
that the tobacco product is not substantially 
equivalent. 
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 
‘‘(A) IN
GENERAL.—In this section and 
section 905(j), the term ‘substantially equiva-
lent’ or ‘substantial equivalence’ means, with 
respect to the tobacco product being compared 
to the predicate tobacco product, that the Sec-
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‘‘(A) SUMMARY.—As part of a submission 
under section 905(j) respecting a tobacco prod-
uct, the person required to file a premarket no-
tification under such section shall provide an 
adequate summary of any health information 
related to the tobacco product or state that 
such information will be made available upon 
request by any person. 
‘‘(B) REQUIRED INFORMATION.—Any sum-
mary under subparagraph (A) respecting a to-
bacco product shall contain detailed information 
regarding data concerning adverse health ef-
fects and shall be made available to the public 
by the Secretary within 30 days of the issuance 
of a determination that such tobacco product is 
substantially equivalent to another tobacco 
product. 
‘‘(b) APPLICATION.— 
‘‘(1) CONTENTS.—An application under this 
section shall contain— 
‘‘(A) full reports of all information, pub-
lished or known to, or which should reasonably 
be known to, the applicant, concerning inves-
tigations which have been made to show the 
health risks of such tobacco product and wheth-
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er such tobacco product presents less risk than 
other tobacco products; 
‘‘(B) a full statement of the components, 
ingredients, additives, and properties, and of 
the principle or principles of operation, of such 
tobacco product; 
‘‘(C) a full description of the methods used 
in, and the facilities and controls used for, the 
manufacture, processing, and, when relevant, 
packing and installation of, such tobacco prod-
uct; 
‘‘(D) an identifying reference to any to-
bacco product standard under section 907 
which would be applicable to any aspect of such 
tobacco product, and either adequate informa-
tion to show that such aspect of such tobacco 
product fully meets such tobacco product stand-
ard or adequate information to justify any devi-
ation from such standard; 
‘‘(E) such samples of such tobacco product 
and of components thereof as the Secretary 
may reasonably require; 
‘‘(F) specimens of the labeling proposed to 
be used for such tobacco product; and 
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‘‘(G) such other information relevant to 
the subject matter of the application as the Sec-
retary may require. 
‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI-
ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 
application meeting the requirements set forth in 
paragraph (1), the Secretary— 
‘‘(A) may, on the Secretary’s own initia-
tive; or 
‘‘(B) may, upon the request of an appli-
cant, 
refer such application to the Tobacco Products Sci-
entific Advisory Committee for reference and for 
submission (within such period as the Secretary may 
establish) of a report and recommendation respect-
ing the application, together with all underlying data 
and the reasons or basis for the recommendation. 
‘‘(c) ACTION ON APPLICATION.— 
‘‘(1) DEADLINE.— 
‘‘(A) IN GENERAL.—As promptly as pos-
sible, but in no event later than 180 days after 
the receipt of an application under subsection 
(b), the Secretary, after considering the report 
and recommendation submitted under sub-
section (b)(2), shall— 
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‘‘(i) issue an order that the new prod-
uct may be introduced or delivered for in-
troduction into interstate commerce if the 
Secretary finds that none of the grounds 
specified in paragraph (2) of this sub-
section applies; or 
‘‘(ii) issue an order that the new prod-
uct may not be introduced or delivered for 
introduction into interstate commerce if 
the Secretary finds (and sets forth the 
basis for such finding as part of or accom-
panying such denial) that 1 or more 
grounds for denial specified in paragraph 
(2) of this subsection apply. 
‘‘(B) RESTRICTIONS
ON
SALE
AND
DIS-
TRIBUTION.—An order under subparagraph 
(A)(i) may require that the sale and distribu-
tion of the tobacco product be restricted but 
only to the extent that the sale and distribution 
of a tobacco product may be restricted under a 
regulation under section 906(d). 
‘‘(2) DENIAL OF APPLICATION.—The Secretary 
shall deny an application submitted under subsection 
(b) if, upon the basis of the information submitted 
to the Secretary as part of the application and any 
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other information before the Secretary with respect 
to such tobacco product, the Secretary finds that— 
‘‘(A) there is a lack of a showing that per-
mitting such tobacco product to be marketed 
would be appropriate for the protection of the 
public health; 
‘‘(B) the methods used in, or the facilities 
or controls used for, the manufacture, proc-
essing, or packing of such tobacco product do 
not conform to the requirements of section 
906(e); 
‘‘(C) based on a fair evaluation of all mate-
rial facts, the proposed labeling is false or mis-
leading in any particular; or 
‘‘(D) such tobacco product is not shown to 
conform in all respects to a tobacco product 
standard in effect under section 907, and there 
is a lack of adequate information to justify the 
deviation from such standard. 
‘‘(3) DENIAL INFORMATION.—Any denial of an 
application shall, insofar as the Secretary determines 
to be practicable, be accompanied by a statement in-
forming the applicant of the measures required to 
remove such application from deniable form (which 
measures may include further research by the appli-
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cant in accordance with 1 or more protocols pre-
scribed by the Secretary). 
‘‘(4) BASIS
FOR
FINDING.—For purposes of 
this section, the finding as to whether the marketing 
of a tobacco product for which an application has 
been submitted is 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 nonusers of the tobacco product, 
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. 
‘‘(5) BASIS FOR ACTION.— 
‘‘(A) INVESTIGATIONS.—For purposes of 
paragraph (2)(A), whether permitting a tobacco 
product to be marketed would be appropriate 
for the protection of the public health shall, 
when appropriate, be determined on the basis of 
well-controlled investigations, which may in-
clude 1 or more clinical investigations by ex-
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