decrease in the number of minors using and becom-
ing addicted to those products. 
(32) The regulations described in paragraph 
(30) impose no more extensive restrictions on com-
munication by tobacco manufacturers and sellers 
than are necessary to reduce the number of children 
and adolescents who use cigarettes and smokeless to-
bacco and to prevent the life-threatening health con-
sequences associated with tobacco use. Such regula-
tions are narrowly tailored to restrict those adver-
tising and promotional practices which are most like-
ly to be seen or heard by youth and most likely to 
entice them into tobacco use, while affording tobacco 
manufacturers and sellers ample opportunity to con-
vey information about their products to adult con-
sumers. 
(33) Tobacco dependence is a chronic disease, 
one that typically requires repeated interventions to 
achieve long-term or permanent abstinence. 
(34) Because the only known safe alternative to 
smoking is cessation, interventions should target all 
smokers to help them quit completely. 
(35) Tobacco products have been used to facili-
tate and finance criminal activities both domestically 
and internationally. Illicit trade of tobacco products 
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has been linked to organized crime and terrorist 
groups. 
(36) It is essential that the Food and Drug Ad-
ministration review products sold or distributed for 
use to reduce risks or exposures associated with to-
bacco products and that it be empowered to review 
any advertising and labeling for such products. It is 
also essential that manufacturers, prior to marketing 
such products, be required to demonstrate that such 
products will meet a series of rigorous criteria, and 
will benefit the health of the population as a whole, 
taking into account both users of tobacco products 
and persons who do not currently use tobacco prod-
ucts. 
(37) Unless tobacco products that purport to 
reduce the risks to the public of tobacco use actually 
reduce such risks, those products can cause substan-
tial harm to the public health to the extent that the 
individuals, who would otherwise not consume to-
bacco products or would consume such products less, 
use tobacco products purporting to reduce risk. 
Those who use products sold or distributed as modi-
fied risk products that do not in fact reduce risk, 
rather than quitting or reducing their use of tobacco 
products, have a substantially increased likelihood of 
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suffering disability and premature death. The costs 
to society of the widespread use of products sold or 
distributed as modified risk products that do not in 
fact reduce risk or that increase risk include thou-
sands of unnecessary deaths and injuries and huge 
costs to our health care system. 
(38) As the National Cancer Institute has 
found, many smokers mistakenly believe that ‘‘low 
tar’’ and ‘‘light’’ cigarettes cause fewer health prob-
lems than other cigarettes. As the National Cancer 
Institute has also found, mistaken beliefs about the 
health consequences of smoking ‘‘low tar’’ and 
‘‘light’’ cigarettes can reduce the motivation to quit 
smoking entirely and thereby lead to disease and 
death. 
(39) Recent studies have demonstrated that 
there has been no reduction in risk on a population- 
wide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes, 
and such products may actually increase the risk of 
tobacco use. 
(40) The dangers of products sold or distrib-
uted as modified risk tobacco products that do not 
in fact reduce risk are so high that there is a com-
pelling governmental interest in ensuring that state-
ments about modified risk tobacco products are com-
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plete, accurate, and relate to the overall disease risk 
of the product. 
(41) As the Federal Trade Commission has 
found, consumers have misinterpreted advertise-
ments in which one product is claimed to be less 
harmful than a comparable product, even in the 
presence of disclosures and advisories intended to 
provide clarification. 
(42) Permitting manufacturers to make unsub-
stantiated statements concerning modified risk to-
bacco products, whether express or implied, even if 
accompanied by disclaimers would be detrimental to 
the public health. 
(43) The only way to effectively protect the 
public health from the dangers of unsubstantiated 
modified risk tobacco products is to empower the 
Food and Drug Administration to require that prod-
ucts that tobacco manufacturers sold or distributed 
for risk reduction be reviewed in advance of mar-
keting, and to require that the evidence relied on to 
support claims be fully verified. 
(44) The Food and Drug Administration is a 
regulatory agency with the scientific expertise to 
identify harmful substances in products to which 
consumers are exposed, to design standards to limit 
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exposure to those substances, to evaluate scientific 
studies supporting claims about the safety of prod-
ucts, and to evaluate the impact of labels, labeling, 
and advertising on consumer behavior in order to re-
duce the risk of harm and promote understanding of 
the impact of the product on health. In connection 
with its mandate to promote health and reduce the 
risk of harm, the Food and Drug Administration 
routinely makes decisions about whether and how 
products may be marketed in the United States. 
(45) The Federal Trade Commission was cre-
ated to protect consumers from unfair or deceptive 
acts or practices, and to regulate unfair methods of 
competition. Its focus is on those marketplace prac-
tices that deceive or mislead consumers, and those 
that give some competitors an unfair advantage. Its 
mission is to regulate activities in the marketplace. 
Neither the Federal Trade Commission nor any 
other Federal agency except the Food and Drug Ad-
ministration possesses the scientific expertise needed 
to implement effectively all provisions of the Family 
Smoking Prevention and Tobacco Control Act. 
(46) If manufacturers state or imply in commu-
nications directed to consumers through the media 
or through a label, labeling, or advertising, that a to-
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bacco product is approved or inspected by the Food 
and Drug Administration or complies with Food and 
Drug Administration standards, consumers are like-
ly to be confused and misled. Depending upon the 
particular language used and its context, such a 
statement could result in consumers being misled 
into believing that the product is endorsed by the 
Food and Drug Administration for use or in con-
sumers being misled about the harmfulness of the 
product because of such regulation, inspection, ap-
proval, or compliance. 
(47) In August 2006 a United States district 
court judge found that the major United States cig-
arette companies continue to target and market to 
youth. USA v. Philip Morris, USA, Inc., et al. (Civil 
Action No. 99–2496 (GK), August 17, 2006). 
(48) In August 2006 a United States district 
court judge found that the major United States cig-
arette companies dramatically increased their adver-
tising and promotional spending in ways that en-
courage youth to start smoking subsequent to the 
signing of the Master Settlement Agreement in 
1998. USA v. Philip Morris, USA, Inc., et al. (Civil 
Action No. 99–2496 (GK), August 17, 2006). 
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(49) In August 2006 a United States district 
court judge found that the major United States cig-
arette companies have designed their cigarettes to 
precisely control nicotine delivery levels and provide 
doses of nicotine sufficient to create and sustain ad-
diction while also concealing much of their nicotine- 
related research. USA v. Philip Morris, USA, Inc., 
et al. (Civil Action No. 99–2496 (GK), August 17, 
2006). 
SEC. 3. PURPOSE. 
The purposes of this Act are— 
(1) to provide authority to the Food and Drug 
Administration to regulate tobacco products under 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.), by recognizing it as the primary 
Federal regulatory authority with respect to the 
manufacture, marketing, and distribution of tobacco 
products as provided for in this Act; 
(2) to ensure that the Food and Drug Adminis-
tration has the authority to address issues of par-
ticular concern to public health officials, especially 
the use of tobacco by young people and dependence 
on tobacco; 
(3) to authorize the Food and Drug Adminis-
tration to set national standards controlling the 
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manufacture of tobacco products and the identity, 
public disclosure, and amount of ingredients used in 
such products; 
(4) to provide new and flexible enforcement au-
thority to ensure that there is effective oversight of 
the tobacco industry’s efforts to develop, introduce, 
and promote less harmful tobacco products; 
(5) to vest the Food and Drug Administration 
with the authority to regulate the levels of tar, nico-
tine, and other harmful components of tobacco prod-
ucts; 
(6) in order to ensure that consumers are better 
informed, to require tobacco product manufacturers 
to disclose research which has not previously been 
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; 
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(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-
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-
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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. 
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). 
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‘‘(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).’’. 
(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 
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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, 
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 
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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. 
‘‘(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 
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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. 
‘‘(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. 
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‘‘(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. 
‘‘(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. 
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‘‘(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 
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.— 
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‘‘(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; 
‘‘(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 
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‘‘(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-
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. 
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‘‘(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, 
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 
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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. 
‘‘(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 
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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 
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— 
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‘‘(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 
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; 
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‘‘(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— 
‘‘(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; 
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‘‘(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 
the labeling) and in such terms as to render it likely 
to be read and understood by the ordinary individual 
under customary conditions of purchase and use; 
‘‘(4) if it has an established name, unless its 
label bears, to the exclusion of any other nonpropri-
etary name, its established name prominently print-
ed in type as required by the Secretary by regula-
tion; 
‘‘(5) if the Secretary has issued regulations re-
quiring that its labeling bear adequate directions for 
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use, or adequate warnings against use by children, 
that are necessary for the protection of users unless 
its labeling conforms in all respects to such regula-
tions; 
‘‘(6) if it was manufactured, prepared, propa-
gated, compounded, or processed in 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 infor-
mation 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— 
‘‘(A) its advertising is false or misleading 
in any particular; or 
‘‘(B) it is sold or distributed in violation of 
regulations prescribed under section 906(d); 
‘‘(8) unless, in the case of any tobacco product 
distributed or offered for sale in any State, the man-
ufacturer, packer, or distributor thereof includes in 
all advertisements and other descriptive printed mat-
ter issued or caused to be issued by the manufac-
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turer, packer, or distributor with respect to that to-
bacco product— 
‘‘(A) a true statement of the tobacco prod-
uct’s established name as described in para-
graph (4), printed prominently; and 
‘‘(B) a brief statement of— 
‘‘(i) the uses of the tobacco product 
and relevant warnings, precautions, side 
effects, and contraindications; and 
‘‘(ii) in the case of specific tobacco 
products made subject to a finding by the 
Secretary after notice and opportunity for 
comment that such action is appropriate to 
protect the public health, a full description 
of the components of such tobacco product 
or the formula showing quantitatively each 
ingredient of such tobacco product to the 
extent required in regulations which shall 
be issued by the Secretary after an oppor-
tunity for a hearing; 
‘‘(9) if it is a tobacco product subject to a to-
bacco product standard established under section 
907, unless it bears such labeling as may be pre-
scribed in such tobacco product standard; or 
‘‘(10) if there was a failure or refusal— 
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‘‘(A) to comply with any requirement pre-
scribed under section 904 or 908; or 
‘‘(B) to furnish any material or informa-
tion required under section 909. 
‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.— 
The Secretary may, by regulation, require prior approval 
of statements made on the label of a tobacco product. No 
regulation issued under this subsection may require prior 
approval by the Secretary of the content of any advertise-
ment, except for modified risk tobacco products as pro-
vided in section 911. No advertisement of a tobacco prod-
uct published after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act shall, with 
respect to the language of label statements as prescribed 
under section 4 of the 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: 
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‘‘(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. 
‘‘(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-
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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: 
‘‘(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, 
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or possessed by the manufacturer (or agents thereof) 
that relate to the issue of whether a reduction in 
risk to health from tobacco products can occur upon 
the employment of technology available or known to 
the manufacturer. 
‘‘(3) Any or all documents (including under-
lying scientific or financial information) relating to 
marketing research involving the use of tobacco 
products or marketing practices and the effective-
ness of such practices used by tobacco manufactur-
ers and distributors. 
An importer of a tobacco product not manufactured in the 
United States shall supply the information required of a 
tobacco product manufacturer under this subsection. 
‘‘(c) TIME FOR SUBMISSION.— 
‘‘(1) IN GENERAL.—At least 90 days prior to 
the delivery for introduction into interstate com-
merce of a tobacco product not on the market on the 
date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, the manufacturer of 
such product shall provide the information required 
under subsection (a). 
‘‘(2) DISCLOSURE
OF
ADDITIVE.—If at any 
time a tobacco product manufacturer adds to its to-
bacco products a new tobacco additive or increases 
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the quantity of an existing tobacco additive, the 
manufacturer shall, except as provided in paragraph 
(3), at least 90 days prior to such action so advise 
the Secretary in writing. 
‘‘(3) DISCLOSURE OF OTHER ACTIONS.—If at 
any time a tobacco product manufacturer eliminates 
or decreases an existing additive, or adds or in-
creases an additive that has by regulation been des-
ignated by the Secretary as an additive that is not 
a human or animal carcinogen, or otherwise harmful 
to health under intended conditions of use, the man-
ufacturer shall within 60 days of such action so ad-
vise the Secretary in writing. 
‘‘(d) DATA LIST.— 
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, and annually 
thereafter, the Secretary shall publish in a format 
that is understandable and not misleading to a lay 
person, and place on public display (in a manner de-
termined by the Secretary) the list established under 
subsection (e). 
‘‘(2) CONSUMER
RESEARCH.—The Secretary 
shall conduct periodic consumer research to ensure 
that the list published under paragraph (1) is not 
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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 
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-
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uct package in furtherance of the distribution of the 
tobacco product from the original place of manufac-
ture to the person who makes final delivery or sale 
to the ultimate consumer or user. 
‘‘(2) NAME.—The term ‘name’ shall include in 
the case of a partnership the name of each partner 
and, in the case of a corporation, the name of each 
corporate officer and director, and the State of in-
corporation. 
‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.— 
On or before December 31 of each year, every person who 
owns or operates any establishment in any State engaged 
in the manufacture, preparation, compounding, or proc-
essing of a tobacco product or tobacco products shall reg-
ister with the Secretary the name, places of business, and 
all such establishments of that person. If enactment of the 
Family Smoking Prevention and Tobacco Control Act oc-
curs in the second half of the calendar year, the Secretary 
shall designate a date no later than 6 months into the 
subsequent 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 
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or operated in any State by that person shall immediately 
register with the Secretary that person’s name, place of 
business, and such establishment. 
‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.— 
Every person required to register under subsection (b) or 
(c) shall immediately register with the Secretary any addi-
tional establishment which that person owns or operates 
in any State and in which that person begins the manufac-
ture, preparation, compounding, or processing of a tobacco 
product or tobacco products. 
‘‘(e) UNIFORM
PRODUCT
IDENTIFICATION
SYS-
TEM.—The Secretary may by regulation prescribe a uni-
form system for the identification of tobacco products and 
may require that persons who are required to list such 
tobacco products under subsection (i) shall list such to-
bacco products in accordance with such system. 
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA-
TION.—The Secretary shall make available for inspection, 
to any person so requesting, any registration filed under 
this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB-
LISHMENTS.—Every establishment registered with the 
Secretary under this section shall be subject to inspection 
under section 704 or subsection (h), and every such estab-
lishment engaged in the manufacture, compounding, or 
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name, and other information required by para-
graph (1), unless the registrant has previously 
reported such resumption to the Secretary 
under this subparagraph. 
‘‘(D) Any material change in any informa-
tion previously submitted under this paragraph 
or paragraph (1). 
‘‘(j) REPORT PRECEDING INTRODUCTION OF CER-
TAIN
SUBSTANTIALLY
EQUIVALENT
PRODUCTS
INTO 
INTERSTATE COMMERCE.— 
‘‘(1) IN
GENERAL.—Each person who is re-
quired to register under this section and who pro-
poses to begin the introduction or delivery for intro-
duction into interstate commerce for commercial dis-
tribution of a tobacco product intended for human 
use that was not commercially marketed (other than 
for test marketing) in the United States as of 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 
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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 
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 
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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 
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. 
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‘‘(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, 
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 
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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. 
‘‘(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.— 
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‘‘(1) IN GENERAL.—The Secretary may by reg-
ulation require restrictions on the sale and distribu-
tion of a tobacco product, including restrictions on 
the access to, and the advertising and promotion of, 
the tobacco product, if the Secretary determines that 
such regulation would be appropriate for the protec-
tion of the public health. The Secretary may by reg-
ulation impose restrictions on the advertising and 
promotion of a tobacco product consistent with and 
to full extent permitted by the first amendment to 
the Constitution. The finding as to whether such 
regulation would be appropriate for the protection of 
the public health shall be determined with respect to 
the risks and benefits to the population as a whole, 
including users and 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-
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report its recommendations to the Secretary 
with respect to a petition referred to it within 
60 days after the date of the petition’s referral. 
Within 60 days after— 
‘‘(i) the date the petition was sub-
mitted to the Secretary under subpara-
graph (A); or 
‘‘(ii) the day after the petition was re-
ferred to the Tobacco Products Scientific 
Advisory Committee, 
whichever occurs later, the Secretary shall by 
order either deny the petition or approve it. 
‘‘(C) APPROVAL.—The Secretary may ap-
prove— 
‘‘(i) a petition for an exemption for a 
tobacco product from a requirement if the 
Secretary determines that compliance with 
such requirement is not required to assure 
that the tobacco product will be in compli-
ance with this chapter; and 
‘‘(ii) a petition for a variance for a to-
bacco product from a requirement if the 
Secretary determines that the methods to 
be used in, and the facilities and controls 
to be used for, the manufacture, packing, 
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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 
‘‘(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-
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