I 
108TH CONGRESS 
2D SESSION 
H. R. 4433
To protect the public health by providing the Food and Drug Administration 
with certain authority to regulate tobacco products. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 20, 2004
Mr. TOM DAVIS of Virginia (for himself, Mr. WAXMAN, Mr. PLATTS, and Mr. 
MEEHAN) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To protect the public health by providing the Food and 
Drug Administration with certain authority to regulate 
tobacco products.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Family Smoking Prevention and Tobacco Control Act’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows:
Sec. 1. Short title; table of contents. 
Sec. 2. Findings. 
Sec. 3. Purpose. 
Sec. 4. Scope and effect.
Sec. 5. Severability. 
TITLE I—AUTHORITY OF THE FOOD AND DRUG 
ADMINISTRATION 
Sec. 101. Amendment of Federal food, drug, and cosmetic act. 
Sec. 102. Construction of current regulations. 
Sec. 103. Conforming and other amendments to general provisions. 
TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND 
SMOKE CONSTITUENT DISCLOSURE 
Sec. 201. Cigarette label and advertising warnings. 
Sec. 202. Authority to revise cigarette warning label Statements. 
Sec. 203. State regulation of cigarette advertising and promotion. 
Sec. 204. Smokeless tobacco labels and advertising warnings. 
Sec. 205. Authority to revise smokeless tobacco product warning label State-
ments. 
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the public. 
TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO 
PRODUCTS 
Sec. 301. Labeling, record keeping, records inspection. 
Sec. 302. Study and report.
SEC. 2. FINDINGS. 
The Congress finds the following: 
(1) The use of tobacco products by the Nation’s 
children is a pediatric disease of considerable pro-
portions that results in new generations of tobacco-
dependent children and adults. 
(2) A consensus exists within the scientific and 
medical communities that tobacco products are in-
herently dangerous and cause cancer, heart disease, 
and other serious adverse health effects. 
(3) Nicotine is an addictive drug. 
(4) Virtually all new users of tobacco products 
are under the minimum legal age to purchase such 
products.
tion in youth smoking would also result in approxi-
mately $75,000,000,000 in savings attributable to 
reduced health care costs. 
(15) Advertising, marketing, and promotion of 
tobacco products have been especially directed to at-
tract young persons to use tobacco products and 
these efforts have resulted in increased use of such 
products by youth. Past efforts to oversee these ac-
tivities have not been successful in adequately pre-
venting such increased use. 
(16) In 2001, the tobacco industry spent more 
than $11,000,000,000 to attract new users, retain 
current users, increase current consumption, and 
generate favorable long-term attitudes toward smok-
ing and tobacco use. 
(17) 
Tobacco 
product 
advertising 
often 
misleadingly portrays the use of tobacco as socially 
acceptable and healthful to minors. 
(18) Tobacco product advertising is regularly 
seen by persons under the age of 18, and persons 
under the age of 18 are regularly exposed to tobacco 
product promotional efforts. 
(19) Through advertisements during and spon-
sorship of sporting events, tobacco has become 
strongly associated with sports and has become por-
trayed as an integral part of sports and the healthy 
lifestyle associated with rigorous sporting activity. 
(20) Children are exposed to substantial and 
unavoidable tobacco advertising that leads to favor-
able beliefs about tobacco use, plays a role in leading 
young people to overestimate the prevalence of to-
bacco use, and increases the number of young people 
who begin to use tobacco. 
(21) The use of tobacco products in motion pic-
tures and other mass media glamorizes its use for 
young people and encourages them to use tobacco 
products. 
(22) Tobacco advertising expands the size of 
the tobacco market by increasing consumption of to-
bacco products including tobacco use by young peo-
ple. 
(23) Children are more influenced by tobacco 
advertising than adults, they smoke the most adver-
tised brands. 
(24) Tobacco company documents indicate that 
young people are an important and often crucial seg-
ment of the tobacco market. Children, who tend to 
be more price-sensitive than adults, are influenced 
by advertising and promotion practices that result in 
drastically reduced cigarette prices.
(25) Comprehensive advertising restrictions will 
have a positive effect on the smoking rates of young 
people. 
(26) Restrictions on advertising are necessary 
to prevent unrestricted tobacco advertising from un-
dermining legislation prohibiting access to young 
people and providing for education about tobacco 
use. 
(27) International experience shows that adver-
tising regulations that are stringent and comprehen-
sive have a greater impact on overall tobacco use 
and young people’s use than weaker or less com-
prehensive ones. 
(28) Text only requirements, although not as 
stringent as a ban, will help reduce underage use of 
tobacco products while preserving the informational 
function of advertising. 
(29) It is in the public interest for Congress to 
adopt legislation to address the public health crisis 
created by actions of the tobacco industry. 
(30) The final regulations promulgated by the 
Secretary of Health and Human Services in the Au-
gust 28, 1996, issue of the Federal Register (61 
Fed. Reg. 44615–44618) for inclusion as part 897 
of title 21, Code of Federal Regulations, are con-
sistent with the First Amendment to the United 
States Constitution and with the standards set forth 
in the amendments made by this Act for the regula-
tion of tobacco products by the Food and Drug Ad-
ministration and the restriction on the sale and dis-
tribution, including access to and the advertising 
and promotion of, tobacco products contained in 
such regulations are substantially related to accom-
plishing the public health goals of this Act. 
(31) The regulations described in paragraph 
(30) will directly and materially advance the Federal 
Government’s substantial interest in reducing the 
number of children and adolescents who use ciga-
rettes and smokeless tobacco and in preventing the 
life-threatening health consequences associated with 
tobacco use. An overwhelming majority of Americans 
who use tobacco products begin using such products 
while they are minors and become addicted to the 
nicotine in those products before reaching the age of 
18. Tobacco advertising and promotion plays a cru-
cial role in the decision of these minors to begin 
using tobacco products. Less restrictive and less 
comprehensive approaches have not and will not be 
effective in reducing the problems addressed by such 
regulations. The reasonable restrictions on the ad-
vertising and promotion of tobacco products con-
tained in such regulations will lead to a significant 
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 
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 
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 to-
bacco 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 insuring that state-
ments about modified risk tobacco products are com-
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 approved in advance of mar-
keting, and to require that the evidence relied on to 
support approval of these products is rigorous.
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; 
(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 
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; 
(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. 
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: 
‘‘(nn)(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—
‘‘(A) a product in the form of conventional food 
(including water and chewing gum), a product rep-
resented for use as or for use in a conventional food, 
or a product that is intended for ingestion in cap-
sule, tablet, softgel, or liquid form; or 
‘‘(B) an article that is approved or is regulated 
as a drug by the Food and Drug Administration. 
‘‘(3) The products described in paragraph (2)(A) 
shall be subject to chapter IV or chapter V of this Act 
and the articles described in paragraph (2)(B) shall be 
subject to chapter V of this Act. 
‘‘(4) A tobacco product may not be marketed in com-
bination with any other article or product regulated under 
this Act (including a drug, biologic, food, cosmetics, med-
ical device, or a dietary supplement).’’.
(b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.) is amended—
(1) by redesignating chapter IX as chapter X; 
(2) by redesignating sections 901 through 907 
as sections 1001 through 1007; and 
(3) by inserting after section 803 the following: 
‘‘CHAPTER IX—TOBACCO 
PRODUCTS 
‘‘SEC. 900. DEFINITIONS. 
‘‘In this chapter: 
‘‘(1) ADDITIVE.—The term ‘additive’ means 
any substance the intended use of which results or 
may reasonably be expected to result, directly or in-
directly, in its becoming a component or otherwise 
affecting the characteristic of any tobacco product 
(including any substances intended for use as a fla-
voring, coloring or in producing, manufacturing, 
packing, processing, preparing, treating, packaging, 
transporting, or holding), except that such term does 
not include tobacco or a pesticide chemical residue 
in or on raw tobacco or a pesticide chemical. 
‘‘(2) BRAND.—The term ‘brand’ means a vari-
ety of tobacco product distinguished by the tobacco 
used, tar content, nicotine content, flavoring used,
size, filtration, or packaging, logo, registered trade-
mark or brand name, identifiable pattern of colors, 
or any combination of such attributes. 
‘‘(3) CIGARETTE.—The term ‘cigarette’ has the 
meaning given that term by section 3(1) of the Fed-
eral Cigarette Labeling and Advertising Act (15 
U.S.C. 1332(1)), but also includes tobacco, in any 
form, that is functional in the product, which, be-
cause of its appearance, the type of tobacco used in 
the filler, or its packaging and labeling, is likely to 
be offered to, or purchased by, consumers as a ciga-
rette or as roll-your-own tobacco. 
‘‘(4) CIGARETTE
TOBACCO.—The term ‘ciga-
rette tobacco’ means any product that consists of 
loose tobacco that is intended for use by consumers 
in a cigarette. Unless otherwise stated, the require-
ments for cigarettes shall also apply to cigarette to-
bacco. 
‘‘(5) COMMERCE.—The term ‘commerce’ has 
the meaning given that term by section 3(2) of the 
Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1332(2)). 
‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The 
term ‘counterfeit tobacco product’ means a tobacco 
product (or the container or labeling of such a prod-
uct) that, without authorization, bears the trade-
mark, trade name, or other identifying mark, im-
print or device, or any likeness thereof, of a tobacco 
product listed in a registration under section 
905(i)(1). 
‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as 
regards a tobacco product means any person who 
furthers the distribution of a tobacco product, 
whether domestic or imported, at any point from the 
original place of manufacture to the person who sells 
or distributes the product to individuals for personal 
consumption. Common carriers are not considered 
distributors for purposes of this chapter. 
‘‘(8) ILLICIT TRADE.—The term ‘illicit trade’ 
means any practice or conduct prohibited by law 
which relates to production, shipment, receipt, pos-
session, distribution, sale, or purchase of tobacco 
products including any practice or conduct intended 
to facilitate such activity. 
‘‘(9) INDIAN TRIBE.—The term ‘Indian tribe’ 
has the meaning given such term in section 4(e) of 
the Indian Self Determination and Education Assist-
ance Act (25 U.S.C. 450b(e)). 
‘‘(10) LITTLE CIGAR.—The term ‘little cigar’ 
has the meaning given that term by section 3(7) of
the Federal Cigarette Labeling and Advertising Act 
(15 U.S.C. 1332(7)). 
‘‘(11) NICOTINE.—The term ‘nicotine’ means 
the 
chemical 
substance 
named 
3-(1-Methyl-2-
pyrrolidinyl) pyridine or C[10]H[14]N[2], including 
any salt or complex of nicotine. 
‘‘(12) PACKAGE.—The term ‘package’ means a 
pack, box, carton, or container of any kind or, if no 
other container, any wrapping (including cello-
phane), in which a tobacco product is offered for 
sale, sold, or otherwise distributed to consumers. 
‘‘(13) RETAILER.—The term ‘retailer’ means 
any person who sells tobacco products to individuals 
for personal consumption, or who operates a facility 
where self-service displays of tobacco products are 
permitted. 
‘‘(14) ROLL-YOUR-OWN
TOBACCO.—The term 
‘roll-your-own tobacco’ means any tobacco which, be-
cause of its appearance, type, packaging, or labeling, 
is suitable for use and likely to be offered to, or pur-
chased by, consumers as tobacco for making ciga-
rettes. 
‘‘(15) SMOKE CONSTITUENT.—The term ‘smoke 
constituent’ means any chemical or chemical com-
pound in mainstream or sidestream tobacco smoke
that either transfers from any component of the cig-
arette to the smoke or that is formed by the combus-
tion or heating of tobacco, additives, or other compo-
nent of the tobacco product. 
‘‘(16) 
SMOKELESS
TOBACCO.—The 
term 
‘smokeless tobacco’ means any tobacco product that 
consists of cut, ground, powdered, or leaf tobacco 
and that is intended to be placed in the oral or nasal 
cavity. 
‘‘(17) STATE.—The term ‘State’ means any 
State of the United States and, for purposes of this 
chapter, includes the District of Columbia, the Com-
monwealth of Puerto Rico, Guam, the Virgin Is-
lands, American Samoa, Wake Island, Midway Is-
lands, Kingman Reef, Johnston Atoll, the Northern 
Mariana Islands, and any other trust territory or 
possession of the United States. 
‘‘(18) TOBACCO
PRODUCT
MANUFACTURER.—
Term ‘tobacco product manufacturer’ means any 
person, including any repacker or relabeler, who—
‘‘(A) manufactures, fabricates, assembles, 
processes, or labels a tobacco product; or
‘‘(B) imports a finished cigarette or 
smokeless tobacco product for sale or distribu-
tion in the United States.
‘‘(19) UNITED
STATES.—The term ‘United 
States’ means the 50 States of the United States of 
America and the District of Columbia, the Common-
wealth of Puerto Rico, Guam, the Virgin Islands, 
American Samoa, Wake Island, Midway Islands, 
Kingman Reef, Johnston Atoll, the Northern Mar-
iana Islands, and any other trust territory or posses-
sion of the United States. 
‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Tobacco products shall be regu-
lated by the Secretary under this chapter and shall not 
be subject to the provisions of chapter V, unless—
‘‘(1) such products are intended for use in the 
diagnosis, cure, mitigation, treatment, or prevention 
of 
disease 
(within 
the 
meaning 
of 
section 
201(g)(1)(B) or section 201(h)(2)); or 
‘‘(2) a claim is made for such products under 
section 201(g)(1)(C) or 201(h)(3); 
other than modified risk tobacco products approved 
in accordance with section 911. 
‘‘(b) APPLICABILITY.—This chapter shall apply to all 
tobacco products subject to the regulations referred to in 
section 102 of the Family Smoking Prevention and To-
bacco Control Act, and to any other tobacco products that
the Secretary by regulation deems to be subject to this 
chapter. 
‘‘(c) SCOPE.—
‘‘(1) IN GENERAL.—Nothing in this chapter, or 
any policy issued or regulation promulgated there-
under, or the Family Smoking Prevention and To-
bacco Control Act, shall be construed to affect the 
Secretary’s authority over, or the regulation of, 
products under this Act that are not tobacco prod-
ucts under chapter V or any other chapter. 
‘‘(2) LIMITATION OF AUTHORITY.—
‘‘(A) IN GENERAL.—The provisions of this 
chapter shall not apply to tobacco leaf that is 
not in the possession of a manufacturer of to-
bacco products, or to the producers of tobacco 
leaf, including tobacco growers, tobacco ware-
houses, and tobacco grower cooperatives, nor 
shall any employee of the Food and Drug Ad-
ministration have any authority to enter onto a 
farm owned by a producer of tobacco leaf with-
out the written consent of such producer. 
‘‘(B) EXCEPTION.—Notwithstanding any 
other provision of this subparagraph, if a pro-
ducer of tobacco leaf is also a tobacco product 
manufacturer or controlled by a tobacco prod-
uct manufacturer, the producer shall be subject 
to this chapter in the producer’s capacity as a 
manufacturer. 
‘‘(C) RULE OF CONSTRUCTION.—Nothing 
in this chapter shall be construed to grant the 
Secretary authority to promulgate regulations 
on any matter that involves the production of 
tobacco leaf or a producer thereof, other than 
activities by a manufacturer affecting produc-
tion. 
‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 
‘‘A tobacco product shall be deemed to be adulterated 
if—
‘‘(1) it consists in whole or in part of any filthy, 
putrid, or decomposed substance, or is otherwise 
contaminated by any added poisonous or added dele-
terious substance that may render the product inju-
rious to health; 
‘‘(2) it has been prepared, packed, or held 
under insanitary conditions whereby it may have 
been contaminated with filth, or whereby it may 
have been rendered injurious to health; 
‘‘(3) its package is composed, in whole or in 
part, of any poisonous or deleterious substance 
which may render the contents injurious to health;
‘‘(4) it is, or purports to be or is represented 
as, a tobacco product which is subject to a tobacco 
product standard established under section 907 un-
less such tobacco product is in all respects in con-
formity with such standard; 
‘‘(5)(A) it is required by section 910(a) to have 
premarket approval and does not have an approved 
application in effect; or 
‘‘(B) it is in violation of the order approving 
such an application; 
‘‘(6) the methods used in, or the facilities or 
controls used for, its manufacture, packing or stor-
age are not in conformity with applicable require-
ments under section 906(e)(1) or an applicable con-
dition prescribed by an order under section 
906(e)(2); and 
‘‘(7) it is in violation of section 911.
‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—A tobacco product shall be 
deemed to be misbranded—
‘‘(1) if its labeling is false or misleading in any 
particular; 
‘‘(2) if in package form unless it bears a label 
containing—
‘‘(A) the name and place of business of the 
tobacco product manufacturer, packer, or dis-
tributor; 
‘‘(B) an accurate statement of the quantity 
of the contents in terms of weight, measure, or 
numerical count; 
‘‘(C) an accurate statement of the percent-
age of the tobacco used in the product that is 
domestically grown tobacco and the percentage 
that is foreign grown tobacco; and 
‘‘(D) the statement required under section 
921(a), 
except that under subparagraph (B) reasonable vari-
ations shall be permitted, and exemptions as to 
small packages shall be established, by regulations 
prescribed by the Secretary; 
‘‘(3) if any word, statement, or other informa-
tion required by or under authority of this chapter 
to appear on the label or labeling is not prominently 
placed thereon with such conspicuousness (as com-
pared with other words, statements or designs in the 
labeling) and in such terms as to render it likely to 
be read and understood by the ordinary individual 
under customary conditions of purchase and use;
‘‘(4) if it has an established name, unless its 
label bears, to the exclusion of any other nonpropri-
etary name, its established name prominently print-
ed in type as required by the Secretary by regula-
tion; 
‘‘(5) if the Secretary has issued regulations re-
quiring that its labeling bear adequate directions for 
use, or adequate warnings against use by children, 
that are necessary for the protection of users unless 
its labeling conforms in all respects to such regula-
tions; 
‘‘(6) if it was manufactured, prepared, propa-
gated, compounded, or processed in any State in an 
establishment not duly registered under section 
905(b), 905(c), 905(d), or 905(h), if it was not in-
cluded in a list required by section 905(i), if a notice 
or other information respecting it was not provided 
as required by such section or section 905(j), or if 
it does not bear such symbols from the uniform sys-
tem for identification of tobacco products prescribed 
under section 905(e) as the Secretary by regulation 
requires; 
‘‘(7) if, in the case of any tobacco product dis-
tributed or offered for sale in any State—
‘‘(A) its advertising is false or misleading 
in any particular; or 
‘‘(B) it is sold or distributed in violation of 
regulations prescribed under section 906(d); 
‘‘(8) unless, in the case of any tobacco product 
distributed or offered for sale in any State, the man-
ufacturer, packer, or distributor thereof includes in 
all advertisements and other descriptive printed mat-
ter issued or caused to be issued by the manufac-
turer, packer, or distributor with respect to that to-
bacco product—
‘‘(A) a true statement of the tobacco prod-
uct’s established name as described in para-
graph (4), printed prominently; and 
‘‘(B) a brief statement of—
‘‘(i) the uses of the tobacco product 
and relevant warnings, precautions, side 
effects, and contraindications; and 
‘‘(ii) in the case of specific tobacco 
products made subject to a finding by the 
Secretary after notice and opportunity for 
comment that such action is appropriate to 
protect the public health, a full description 
of the components of such tobacco product 
or the formula showing quantitatively each
ingredient of such tobacco product to the 
extent required in regulations which shall 
be issued by the Secretary after an oppor-
tunity for a hearing; 
‘‘(9) if it is a tobacco product subject to a to-
bacco product standard established under section 
907, unless it bears such labeling as may be pre-
scribed in such tobacco product standard; or 
‘‘(10) if there was a failure or refusal—
‘‘(A) to comply with any requirement pre-
scribed under section 904 or 908; or 
‘‘(B) to furnish any material or informa-
tion required under section 909. 
‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.—
The Secretary may, by regulation, require prior approval 
of statements made on the label of a tobacco product. No 
regulation issued under this subsection may require prior 
approval by the Secretary of the content of any advertise-
ment, except for modified risk tobacco products as pro-
vided in section 911. No advertisement of a tobacco prod-
uct published after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act shall, with 
respect to the language of label statements as prescribed 
under section 4 of the Cigarette Labeling and Advertising 
Act and section 3 of the Comprehensive Smokeless To-
bacco Health Education Act of 1986 or the regulations 
issued under such sections, be subject to the provisions 
of sections 12 through 15 of the Federal Trade Commis-
sion Act (15 U.S.C. 52 through 55). 
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE 
SECRETARY. 
‘‘(a) REQUIREMENT.—Not later than 6 months after 
the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, each tobacco product manufac-
turer or importer, or agents thereof, shall submit to the 
Secretary the following information: 
‘‘(1) A listing of all ingredients, including to-
bacco, substances, compounds, and additives that 
are, as of such date, added by the manufacturer to 
the tobacco, paper, filter, or other part of each to-
bacco product by brand and by quantity in each 
brand and subbrand. 
‘‘(2) A description of the content, delivery, and 
form of nicotine in each tobacco product measured 
in milligrams of nicotine in accordance with regula-
tions promulgated by the Secretary in accordance 
with section 4(a)(4) of the Federal Cigarette Label-
ing and Advertising Act. 
‘‘(3) A listing of all constituents, including 
smoke constituents as applicable, identified by the
Secretary as harmful or potentially harmful to 
health in each tobacco product, and as applicable in 
the smoke of each tobacco product, by brand and by 
quantity in each brand and subbrand. Effective be-
ginning 2 years after the date of enactment of this 
chapter, the manufacturer, importer, or agent shall 
comply with regulations promulgated under section 
916 in reporting information under this paragraph, 
where applicable. 
‘‘(4) All documents developed after the date of 
enactment of the Family Smoking Prevention and 
Tobacco Control Act that relate to health, toxi-
cological, behavioral, or physiologic effects of current 
or future tobacco products, their constituents (in-
cluding smoke constituents), ingredients, compo-
nents, and additives.
‘‘(b) DATA SUBMISSION.—At the request of the Sec-
retary, each tobacco product manufacturer or importer of 
tobacco products, or agents thereof, shall submit the fol-
lowing: 
‘‘(1) Any or all documents (including under-
lying scientific information) relating to research ac-
tivities, and research findings, conducted, supported, 
or possessed by the manufacturer (or agents thereof) 
on the health, toxicological, behavioral, or physio-
logic effects of tobacco products and their constitu-
ents (including smoke constituents), ingredients, 
components, and additives. 
‘‘(2) Any or all documents (including under-
lying scientific information) relating to research ac-
tivities, and research findings, conducted, supported, 
or possessed by the manufacturer (or agents thereof) 
that relate to the issue of whether a reduction in 
risk to health from tobacco products can occur upon 
the employment of technology available or known to 
the manufacturer. 
‘‘(3) Any or all documents (including under-
lying scientific or financial information) relating to 
marketing research involving the use of tobacco 
products or marketing practices and the effective-
ness of such practices used by tobacco manufactur-
ers and distributors. 
An importer of a tobacco product not manufactured in the 
United States shall supply the information required of a 
tobacco product manufacturer under this subsection. 
‘‘(c) TIME FOR SUBMISSION.—
‘‘(1) IN GENERAL.—At least 90 days prior to 
the delivery for introduction into interstate com-
merce of a tobacco product not on the market on the 
date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, the manufacturer of 
such product shall provide the information required 
under subsection (a). 
‘‘(2) DISCLOSURE
OF
ADDITIVE.—If at any 
time a tobacco product manufacturer adds to its to-
bacco products a new tobacco additive or increases 
the quantity of an existing tobacco additive, the 
manufacturer shall, except as provided in paragraph 
(3), at least 90 days prior to such action so advise 
the Secretary in writing. 
‘‘(3) DISCLOSURE OF OTHER ACTIONS.—If at 
any time a tobacco product manufacturer eliminates 
or decreases an existing additive, or adds or in-
creases an additive that has by regulation been des-
ignated by the Secretary as an additive that is not 
a human or animal carcinogen, or otherwise harmful 
to health under intended conditions of use, the man-
ufacturer shall within 60 days of such action so ad-
vise the Secretary in writing. 
‘‘(d) DATA LIST.—
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, and annually 
thereafter, the Secretary shall publish in a format 
that is understandable and not misleading to a lay
person, and place on public display (in a manner de-
termined by the Secretary) the list established under 
subsection (e). 
‘‘(2) CONSUMER
RESEARCH.—The Secretary 
shall conduct periodic consumer research to ensure 
that the list published under paragraph (1) is not 
misleading to lay persons. Not later than 5 years 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary 
shall submit to the appropriate committees of Con-
gress a report on the results of such research, to-
gether with recommendations on whether such publi-
cation should be continued or modified. 
‘‘(e) DATA COLLECTION.—Not later than 12 months 
after the date of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, the Secretary shall es-
tablish a list of harmful and potentially harmful constitu-
ents, including smoke constituents, to health in each to-
bacco product by brand and by quantity in each brand 
and subbrand. The Secretary shall publish a public notice 
requesting the submission by interested persons of sci-
entific and other information concerning the harmful and 
potentially harmful constituents in tobacco products and 
tobacco smoke.
‘‘SEC. 905. ANNUAL REGISTRATION. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) 
MANUFACTURE, 
PREPARATION, 
COMPOUNDING, OR PROCESSING.—The term ‘manu-
facture, preparation, compounding, or processing’ 
shall include repackaging or otherwise changing the 
container, wrapper, or labeling of any tobacco prod-
uct package in furtherance of the distribution of the 
tobacco product from the original place of manufac-
ture to the person who makes final delivery or sale 
to the ultimate consumer or user. 
‘‘(2) NAME.—The term ‘name’ shall include in 
the case of a partnership the name of each partner 
and, in the case of a corporation, the name of each 
corporate officer and director, and the State of in-
corporation. 
‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.—
On or before December 31 of each year every person who 
owns or operates any establishment in any State engaged 
in the manufacture, preparation, compounding, or proc-
essing of a tobacco product or tobacco products shall reg-
ister with the Secretary the name, places of business, and 
all such establishments of that person. 
‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA-
TORS.—Every person upon first engaging in the manufac-
ture, preparation, compounding, or processing of a tobacco
product or tobacco products in any establishment owned 
or operated in any State by that person shall immediately 
register with the Secretary that person’s name, place of 
business, and such establishment. 
‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.—
Every person required to register under subsection (b) or 
(c) shall immediately register with the Secretary any addi-
tional establishment which that person owns or operates 
in any State and in which that person begins the manufac-
ture, preparation, compounding, or processing of a tobacco 
product or tobacco products. 
‘‘(e) UNIFORM
PRODUCT
IDENTIFICATION
SYS-
TEM.—The Secretary may by regulation prescribe a uni-
form system for the identification of tobacco products and 
may require that persons who are required to list such 
tobacco products under subsection (i) shall list such to-
bacco products in accordance with such system. 
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA-
TION.—The Secretary shall make available for inspection, 
to any person so requesting, any registration filed under 
this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB-
LISHMENTS.—Every establishment in any State registered 
with the Secretary under this section shall be subject to 
inspection under section 704, and every such establish-
ment engaged in the manufacture, compounding, or proc-
essing of a tobacco product or tobacco products shall be 
so inspected by 1 or more officers or employees duly des-
ignated by the Secretary at least once in the 2-year period 
beginning with the date of registration of such establish-
ment under this section and at least once in every succes-
sive 2-year period thereafter. 
‘‘(h) FOREIGN
ESTABLISHMENTS
SHALL
REG-
ISTER.—Any establishment within any foreign country en-
gaged in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products, shall 
register under this section under regulations promulgated 
by the Secretary. Such regulations shall require such es-
tablishment to provide the information required by sub-
section (i) of this section and shall include provisions for 
registration of any such establishment upon condition that 
adequate and effective means are available, by arrange-
ment with the government of such foreign country or oth-
erwise, to enable the Secretary to determine from time to 
time whether tobacco products manufactured, prepared, 
compounded, or processed in such establishment, if im-
ported or offered for import into the United States, shall 
be refused admission on any of the grounds set forth in 
section 801(a). 
‘‘(i) REGISTRATION INFORMATION.—
‘‘(1) PRODUCT LIST.—Every person who reg-
isters with the Secretary under subsection (b), (c), 
(d), or (h) shall, at the time of registration under 
any such subsection, file with the Secretary a list of 
all tobacco products which are being manufactured, 
prepared, compounded, or processed by that person 
for commercial distribution and which has not been 
included in any list of tobacco products filed by that 
person with the Secretary under this paragraph or 
paragraph (2) before such time of registration. Such 
list shall be prepared in such form and manner as 
the Secretary may prescribe and shall be accom-
panied by—
‘‘(A) in the case of a tobacco product con-
tained in the applicable list with respect to 
which a tobacco product standard has been es-
tablished under section 907 or which is subject 
to section 910, a reference to the authority for 
the marketing of such tobacco product and a 
copy of all labeling for such tobacco product; 
‘‘(B) in the case of any other tobacco prod-
uct contained in an applicable list, a copy of all 
consumer information and other labeling for 
such tobacco product, a representative sampling 
of advertisements for such tobacco product,
and, upon request made by the Secretary for 
good cause, a copy of all advertisements for a 
particular tobacco product; and 
‘‘(C) if the registrant filing a list has de-
termined that a tobacco product contained in 
such list is not subject to a tobacco product 
standard established under section 907, a brief 
statement of the basis upon which the reg-
istrant made such determination if the Sec-
retary requests such a statement with respect 
to that particular tobacco product. 
‘‘(2) BIANNUAL REPORT OF ANY CHANGE IN 
PRODUCT LIST.—Each person who registers with the 
Secretary under this section shall report to the Sec-
retary once during the month of June of each year 
and once during the month of December of each 
year the following: 
‘‘(A) A list of each tobacco product intro-
duced by the registrant for commercial distribu-
tion which has not been included in any list 
previously filed by that person with the Sec-
retary under this subparagraph or paragraph 
(1). A list under this subparagraph shall list a 
tobacco product by its established name and
shall be accompanied by the other information 
required by paragraph (1). 
‘‘(B) If since the date the registrant last 
made a report under this paragraph that person 
has discontinued the manufacture, preparation, 
compounding, or processing for commercial dis-
tribution of a tobacco product included in a list 
filed under subparagraph (A) or paragraph (1), 
notice of such discontinuance, the date of such 
discontinuance, and the identity of its estab-
lished name. 
‘‘(C) If since the date the registrant re-
ported under subparagraph (B) a notice of dis-
continuance that person has resumed the manu-
facture, preparation, compounding, or proc-
essing for commercial distribution of the to-
bacco product with respect to which such notice 
of discontinuance was reported, notice of such 
resumption, the date of such resumption, the 
identity of such tobacco product by established 
name, and other information required by para-
graph (1), unless the registrant has previously 
reported such resumption to the Secretary 
under this subparagraph.
‘‘(D) Any material change in any informa-
tion previously submitted under this paragraph 
or paragraph (1). 
‘‘(j) REPORT PRECEDING INTRODUCTION OF CER-
TAIN
SUBSTANTIALLY-EQUIVALENT
PRODUCTS
INTO 
INTERSTATE COMMERCE.—
‘‘(1) IN
GENERAL.—Each person who is re-
quired to register under this section and who pro-
poses to begin the introduction or delivery for intro-
duction into interstate commerce for commercial dis-
tribution of a tobacco product intended for human 
use that was not commercially marketed (other than 
for test marketing) in the United States as of June 
1, 2003, shall, at least 90 days prior to making such 
introduction or delivery, report to the Secretary (in 
such form and manner as the Secretary shall pre-
scribe)—
‘‘(A) the basis for such person’s determina-
tion that the tobacco product is substantially 
equivalent, within the meaning of section 910, 
to a tobacco product commercially marketed 
(other than for test marketing) in the United 
States as of June 1, 2003, that is in compliance 
with the requirements of this Act; and
‘‘(B) action taken by such person to com-
ply with the requirements under section 907 
that are applicable to the tobacco product. 
‘‘(2) APPLICATION TO CERTAIN POST JUNE 1, 
2003 PRODUCTS.—A report under this subsection for 
a tobacco product that was first introduced or deliv-
ered for introduction into interstate commerce for 
commercial distribution in the United States after 
June 1, 2003, and prior to the date that is 15 
months after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act shall 
be submitted to the Secretary not later than 15 
months after such date of enactment. 
‘‘(3) EXEMPTIONS.—
‘‘(A) IN GENERAL.—The Secretary may by 
regulation, exempt from the requirements of 
this subsection tobacco products that are modi-
fied by adding or deleting a tobacco additive, or 
increasing or decreasing the quantity of an ex-
isting tobacco additive, if the Secretary deter-
mines that—
‘‘(i) such modification would be a 
minor modification of a tobacco product 
authorized for sale under this Act;
‘‘(ii) a report under this subsection is 
not necessary to ensure that permitting the 
tobacco product to be marketed would be 
appropriate for protection of the public 
health; and 
‘‘(iii) an exemption is otherwise appro-
priate. 
‘‘(B) REGULATIONS.—Not later than 9 
months after the date of enactment of the Fam-
ily Smoking Prevention and Tobacco Control 
Act, the Secretary shall issue regulations to im-
plement this paragraph. 
‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 
OF TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Any requirement established by 
or under section 902, 903, 905, or 909 applicable to a 
tobacco product shall apply to such tobacco product until 
the applicability of the requirement to the tobacco product 
has been changed by action taken under section 907, sec-
tion 910, section 911, or subsection (d) of this section, 
and any requirement established by or under section 902, 
903, 905, or 909 which is inconsistent with a requirement 
imposed on such tobacco product under section 907, sec-
tion 910, section 911, or subsection (d) of this section 
shall not apply to such tobacco product.
‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM-
MENT.—Each notice of proposed rulemaking under section 
907, 908, 909, 910, or 911 or under this section, any 
other notice which is published in the Federal Register 
with respect to any other action taken under any such sec-
tion and which states the reasons for such action, and 
each publication of findings required to be made in con-
nection with rulemaking under any such section shall set 
forth—
‘‘(1) the manner in which interested persons 
may examine data and other information on which 
the notice or findings is based; and 
‘‘(2) the period within which interested persons 
may present their comments on the notice or find-
ings (including the need therefore) orally or in writ-
ing, which period shall be at least 60 days but may 
not exceed 90 days unless the time is extended by 
the Secretary by a notice published in the Federal 
Register stating good cause therefore. 
‘‘(c) LIMITED
CONFIDENTIALITY
OF
INFORMA-
TION.—Any information reported to or otherwise obtained 
by the Secretary or the Secretary’s representative under 
section 903, 904, 907, 908, 909, 910, 911, or 704, or 
under subsection (e) or (f) of this section, which is exempt 
from disclosure under subsection (a) of section 552 of title
5, United States Code, by reason of subsection (b)(4) of 
that section shall be considered confidential and shall not 
be disclosed, except that the information may be disclosed 
to other officers or employees concerned with carrying out 
this chapter, or when relevant in any proceeding under 
this chapter. 
‘‘(d) RESTRICTIONS.—
‘‘(1) IN GENERAL.—The Secretary may by reg-
ulation require restrictions on the sale and distribu-
tion of a tobacco product, including restrictions on 
the access to, and the advertising and promotion of, 
the tobacco product, if the Secretary determines that 
such regulation would be appropriate for the protec-
tion of the public health. The Secretary may by reg-
ulation impose restrictions on the advertising and 
promotion of a tobacco product consistent with and 
to full extent permitted by the first amendment to 
the Constitution. The finding as to whether such 
regulation would be appropriate for the protection of 
the public health shall be determined with respect to 
the risks and benefits to the population as a whole, 
including users and non-users of the tobacco prod-
uct, and taking into account—
‘‘(A) the increased or decreased likelihood 
that existing users of tobacco products will stop 
using such products; and 
‘‘(B) the increased or decreased likelihood 
that those who do not use tobacco products will 
start using such products. 
No such regulation may require that the sale or dis-
tribution of a tobacco product be limited to the writ-
ten or oral authorization of a practitioner licensed 
by law to prescribe medical products. 
‘‘(2) LABEL STATEMENTS.—The label of a to-
bacco product shall bear such appropriate state-
ments of the restrictions required by a regulation 
under subsection (a) as the Secretary may in such 
regulation prescribe. 
‘‘(3) LIMITATIONS.—
‘‘(A) IN GENERAL.—No restrictions under 
paragraph (1) may—
‘‘(i) prohibit the sale of any tobacco 
product in face-to-face transactions by a 
specific category of retail outlets; or 
‘‘(ii) establish a minimum age of sale 
of tobacco products to any person older 
than 18 years of age.
‘‘(B) MATCHBOOKS.—For purposes of any 
regulations issued by the Secretary, matchbooks 
of conventional size containing not more than 
20 paper matches, and which are customarily 
given away for free with the purchase of to-
bacco products shall be considered as adult 
written publications which shall be permitted to 
contain advertising. Notwithstanding the pre-
ceding sentence, if the Secretary finds that such 
treatment of matchbooks is not appropriate for 
the protection of the public health, the Sec-
retary may determine by regulation that match-
books shall not be considered adult written pub-
lications. 
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.—
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO 
CONFORM.—
‘‘(A) IN GENERAL.—The Secretary may, in 
accordance with subparagraph (B), prescribe 
regulations (which may differ based on the type 
of tobacco product involved) requiring that the 
methods used in, and the facilities and controls 
used for, the manufacture, pre-production de-
sign validation (including a process to assess
the performance of a tobacco product), packing 
and storage of a tobacco product, conform to 
current good manufacturing practice, as pre-
scribed in such regulations, to assure that the 
public health is protected and that the tobacco 
product is in compliance with this chapter. 
Good manufacturing practices may include the 
testing of raw tobacco for pesticide chemical 
residues regardless of whether a tolerance for 
such chemical residues has been established. 
‘‘(B) 
REQUIREMENTS.—The 
Secretary 
shall—
‘‘(i) before promulgating any regula-
tion under subparagraph (A), afford the 
Tobacco Products Scientific Advisory Com-
mittee an opportunity to submit rec-
ommendations with respect to the regula-
tion proposed to be promulgated; 
‘‘(ii) before promulgating any regula-
tion under subparagraph (A), afford oppor-
tunity for an oral hearing;
‘‘(iii) provide the advisory committee a 
reasonable time to make its recommenda-
tion with respect to proposed regulations 
under subparagraph (A); and
‘‘(iv) in establishing the effective date 
of a regulation promulgated under this 
subsection, take into account the dif-
ferences in the manner in which the dif-
ferent types of tobacco products have his-
torically been produced, the financial re-
sources of the different tobacco product 
manufacturers, and the state of their exist-
ing manufacturing facilities, and shall pro-
vide for a reasonable period of time for 
such manufacturers to conform to good 
manufacturing practices. 
‘‘(2) EXEMPTIONS; VARIANCES.—
‘‘(A) PETITION.—Any person subject to 
any requirement prescribed under paragraph 
(1) may petition the Secretary for a permanent 
or temporary exemption or variance from such 
requirement. Such a petition shall be submitted 
to the Secretary in such form and manner as 
the Secretary shall prescribe and shall—
‘‘(i) in the case of a petition for an ex-
emption from a requirement, set forth the 
basis for the petitioner’s determination 
that compliance with the requirement is 
not required to assure that the tobacco
product will be in compliance with this 
chapter; 
‘‘(ii) in the case of a petition for a 
variance from a requirement, set forth the 
methods proposed to be used in, and the 
facilities and controls proposed to be used 
for, the manufacture, packing, and storage 
of the tobacco product in lieu of the meth-
ods, facilities, and controls prescribed by 
the requirement; and 
‘‘(iii) contain such other information 
as the Secretary shall prescribe. 
‘‘(B) REFERRAL TO THE TOBACCO PROD-
UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 
Secretary may refer to the Tobacco Products 
Scientific Advisory Committee any petition sub-
mitted under subparagraph (A). The Tobacco 
Products Scientific Advisory Committee shall 
report its recommendations to the Secretary 
with respect to a petition referred to it within 
60 days after the date of the petition’s referral. 
Within 60 days after—
‘‘(i) the date the petition was sub-
mitted to the Secretary under subpara-
graph (A); or
‘‘(ii) the day after the petition was re-
ferred to the Tobacco Products Scientific 
Advisory Committee, 
whichever occurs later, the Secretary shall by 
order either deny the petition or approve it. 
‘‘(C) APPROVAL.—The Secretary may ap-
prove—
‘‘(i) a petition for an exemption for a 
tobacco product from a requirement if the 
Secretary determines that compliance with 
such requirement is not required to assure 
that the tobacco product will be in compli-
ance with this chapter; and 
‘‘(ii) a petition for a variance for a to-
bacco product from a requirement if the 
Secretary determines that the methods to 
be used in, and the facilities and controls 
to be used for, the manufacture, packing, 
and storage of the tobacco product in lieu 
of the methods, controls, and facilities pre-
scribed by the requirement are sufficient to 
assure that the tobacco product will be in 
compliance with this chapter. 
‘‘(D) CONDITIONS.—An order of the Sec-
retary approving a petition for a variance shall
prescribe such conditions respecting the meth-
ods used in, and the facilities and controls used 
for, the manufacture, packing, and storage of 
the tobacco product to be granted the variance 
under the petition as may be necessary to as-
sure that the tobacco product will be in compli-
ance with this chapter. 
‘‘(E) HEARING.—After the issuance of an 
order under subparagraph (B) respecting a pe-
tition, the petitioner shall have an opportunity 
for an informal hearing on such order. 
‘‘(3) COMPLIANCE.—Compliance with require-
ments under this subsection shall not be required be-
fore the period ending 3 years after the date of en-
actment of the Family Smoking Prevention and To-
bacco Control Act. 
‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary 
may enter into contracts for research, testing, and dem-
onstrations respecting tobacco products and may obtain 
tobacco products for research, testing, and demonstration 
purposes without regard to section 3324(a) and (b) of title 
31, United States Code, and section 5 of title 41, United 
States Code. 
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 
‘‘(a) IN GENERAL.—
‘‘(1) SPECIAL RULE FOR CIGARETTES.—A ciga-
rette or any of its component parts (including the 
tobacco, filter, or paper) shall not contain, as a con-
stituent (including a smoke constituent) or additive, 
an artificial or natural flavor (other than tobacco or 
menthol) or an herb or spice, including strawberry, 
grape, orange, clove, cinnamon, pineapple, vanilla, 
coconut, licorice, cocoa, chocolate, cherry, or coffee, 
that is a characterizing flavor of the tobacco product 
or tobacco smoke. Nothing in this subparagraph 
shall be construed to limit the Secretary’s authority 
to take action under this section or other sections of 
this Act applicable to menthol or any artificial or 
natural flavor, herb, or spice not specified in this 
paragraph. 
‘‘(2) REVISION OF TOBACCO PRODUCT STAND-
ARDS.—The Secretary may revise the tobacco prod-
uct standards in paragraph (1) in accordance with 
subsection (b). 
‘‘(3) TOBACCO
PRODUCT
STANDARDS.—The 
Secretary may adopt tobacco product standards in 
addition to those in paragraph (1) if the Secretary 
finds that a tobacco product standard is appropriate 
for the protection of the public health. This finding 
shall be determined with respect to the risks and
benefits to the population as a whole, including 
users and non-users of the tobacco product, and tak-
ing into account—
‘‘(A) the increased or decreased likelihood 
that existing users of tobacco products will stop 
using such products; and 
‘‘(B) the increased or decreased likelihood 
that those who do not use tobacco products will 
start using such products. 
‘‘(4) CONTENT OF TOBACCO PRODUCT STAND-
ARDS.—A tobacco product standard established 
under this section for a tobacco product—
‘‘(A) shall include provisions that are ap-
propriate for the protection of the public health, 
including provisions, where appropriate— 
‘‘(i) for the reduction of nicotine 
yields of the product; 
‘‘(ii) for the reduction or elimination 
of other constituents, including smoke con-
stituents, or harmful components of the 
product; or 
‘‘(iii) relating to any other require-
ment under (B); 
‘‘(B) shall, where appropriate for the pro-
tection of the public health, include—
‘‘(i) provisions respecting the con-
struction, components, ingredients, addi-
tives, constituents, including smoke con-
stituents, and properties of the tobacco 
product; 
‘‘(ii) provisions for the testing (on a 
sample basis or, if necessary, on an indi-
vidual basis) of the tobacco product; 
‘‘(iii) provisions for the measurement 
of the tobacco product characteristics of 
the tobacco product; 
‘‘(iv) provisions requiring that the re-
sults of each or of certain of the tests of 
the tobacco product required to be made 
under clause (ii) show that the tobacco 
product is in conformity with the portions 
of the standard for which the test or tests 
were required; and 
‘‘(v) a provision requiring that the 
sale and distribution of the tobacco prod-
uct be restricted but only to the extent 
that the sale and distribution of a tobacco 
product may be restricted under a regula-
tion under section 906(d); and
‘‘(C) shall, where appropriate, require the 
use and prescribe the form and content of label-
ing for the proper use of the tobacco product.
‘‘(5) PERIODIC
RE-EVALUATION
OF
TOBACCO 
PRODUCT STANDARDS.—The Secretary shall provide 
for periodic evaluation of tobacco product standards 
established under this section to determine whether 
such standards should be changed to reflect new 
medical, scientific, or other technological data. The 
Secretary may provide for testing under paragraph 
(4)(B) by any person. 
‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN-
FORMED
PERSONS.—In carrying out duties under 
this section, the Secretary shall endeavor to—
‘‘(A) use personnel, facilities, and other 
technical support available in other Federal 
agencies; 
‘‘(B) consult with other Federal agencies 
concerned with standard-setting and other na-
tionally or internationally recognized standard-
setting entities; and 
‘‘(C) 
invite 
appropriate 
participation, 
through joint or other conferences, workshops, 
or other means, by informed persons represent-
ative of scientific, professional, industry, agri-
cultural, or consumer organizations who in the 
Secretary’s judgment can make a significant 
contribution. 
‘‘(b) ESTABLISHMENT OF STANDARDS.—
‘‘(1) NOTICE.—
‘‘(A) IN
GENERAL.—The Secretary shall 
publish in the Federal Register a notice of pro-
posed rulemaking for the establishment, amend-
ment, or revocation of any tobacco product 
standard. 
‘‘(B) REQUIREMENTS OF NOTICE.—A no-
tice of proposed rulemaking for the establish-
ment or amendment of a tobacco product stand-
ard for a tobacco product shall—
‘‘(i) set forth a finding with sup-
porting justification that the tobacco prod-
uct standard is appropriate for the protec-
tion of the public health; 
‘‘(ii) set forth proposed findings with 
respect to the risk of illness or injury that 
the tobacco product standard is intended 
to reduce or eliminate; and 
‘‘(iii) invite interested persons to sub-
mit an existing tobacco product standard 
for the tobacco product, including a draft
or proposed tobacco product standard, for 
consideration by the Secretary. 
‘‘(C) STANDARD.—Upon a determination 
by the Secretary that an additive, constituent 
(including smoke constituent), or other compo-
nent of the product that is the subject of the 
proposed tobacco product standard is harmful, 
it shall be the burden of any party challenging 
the proposed standard to prove that the pro-
posed standard will not reduce or eliminate the 
risk of illness or injury. 
‘‘(D) FINDING.—A notice of proposed rule-
making for the revocation of a tobacco product 
standard shall set forth a finding with sup-
porting justification that the tobacco product 
standard is no longer appropriate for the pro-
tection of the public health. 
‘‘(E) CONSIDERATION
BY
SECRETARY.—
The Secretary shall consider all information 
submitted in connection with a proposed stand-
ard, including information concerning the coun-
tervailing effects of the tobacco product stand-
ard on the health of adolescent tobacco users, 
adult tobacco users, or non-tobacco users, such 
as the creation of a significant demand for con-
traband or other tobacco products that do not 
meet the requirements of this chapter and the 
significance of such demand, and shall issue the 
standard if the Secretary determines that the 
standard would be appropriate for the protec-
tion of the public health. 
‘‘(F) COMMENT.—The Secretary shall pro-
vide for a comment period of not less than 60 
days. 
‘‘(2) PROMULGATION.—
‘‘(A) IN GENERAL.—After the expiration of 
the period for comment on a notice of proposed 
rulemaking published under paragraph (1) re-
specting a tobacco product standard and after 
consideration of such comments and any report 
from the Tobacco Products Scientific Advisory 
Committee, the Secretary shall—
‘‘(i) promulgate a regulation estab-
lishing a tobacco product standard and 
publish in the Federal Register findings on 
the matters referred to in paragraph (1); 
or 
‘‘(ii) publish a notice terminating the 
proceeding for the development of the
standard together with the reasons for 
such termination. 
‘‘(B) EFFECTIVE DATE.—A regulation es-
tablishing a tobacco product standard shall set 
forth the date or dates upon which the standard 
shall take effect, but no such regulation may 
take effect before 1 year after the date of its 
publication unless the Secretary determines 
that an earlier effective date is necessary for 
the protection of the public health. Such date or 
dates shall be established so as to minimize, 
consistent with the public health, economic loss 
to, and disruption or dislocation of, domestic 
and international trade. 
‘‘(3) POWER
RESERVED
TO
CONGRESS.—Be-
cause of the importance of a decision of the Sec-
retary to issue a regulation establishing a tobacco 
product standard—
‘‘(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, 
Congress expressly reserves to itself such power.
‘‘(4) AMENDMENT; REVOCATION.—
‘‘(A) AUTHORITY.—The Secretary, upon 
the Secretary’s own initiative or upon petition 
of an interested person may by a regulation, 
promulgated in accordance with the require-
ments of paragraphs (1) and (2)(B), 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) REFERENCE TO ADVISORY COMMITTEE.—
The Secretary may—
‘‘(A) on the Secretary’s own initiative, 
refer a proposed regulation for the establish-
ment, amendment, or revocation of a tobacco 
product standard; or 
‘‘(B) upon the request of an interested per-
son which demonstrates good cause for referral 
and which is made before the expiration of the
period for submission of comments on such pro-
posed regulation, 
refer such proposed regulation to the Tobacco Products 
Scientific Advisory Committee, for a report and rec-
ommendation with respect to any matter involved in the 
proposed regulation which requires the exercise of sci-
entific judgment. If a proposed regulation is referred 
under this paragraph to the Tobacco Products Scientific 
Advisory Committee, the Secretary shall provide the advi-
sory committee with the data and information on which 
such proposed regulation is based. The Tobacco Products 
Scientific Advisory Committee shall, within 60 days after 
the referral of a proposed regulation and after inde-
pendent study of the data and information furnished to 
it by the Secretary and other data and information before 
it, submit to the Secretary a report and recommendation 
respecting such regulation, together with all underlying 
data and information and a statement of the reason or 
basis for the recommendation. A copy of such report and 
recommendation shall be made public by the Secretary. 
‘‘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. 
‘‘(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-
termines that inadequate grounds exist to support 
the actions required by the order, the Secretary shall 
vacate the order. 
‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE-
CALL.—
‘‘(A) IN GENERAL.—If, after providing an 
opportunity for an informal hearing under 
paragraph (1), the Secretary determines that
the order should be amended to include a recall 
of the tobacco product with respect to which the 
order was issued, the Secretary shall, except as 
provided in subparagraph (B), amend the order 
to require a recall. The Secretary shall specify 
a timetable in which the tobacco product recall 
will occur and shall require periodic reports to 
the Secretary describing the progress of the re-
call. 
‘‘(B) NOTICE.—An amended order under 
subparagraph (A)—
‘‘(i) shall not include recall of a to-
bacco product from individuals; and 
‘‘(ii) shall provide for notice to per-
sons subject to the risks associated with 
the use of such tobacco product. 
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) of this section.
‘‘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-
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 
‘‘(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 
‘‘(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 June 
1, 2003; or 
‘‘(B) any modification (including a change 
in design, any component, any part, or any con-
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 June 
1, 2003. 
‘‘(2) PREMARKET APPROVAL REQUIRED.—
‘‘(A) NEW
PRODUCTS.—Approval under 
this section of an application for premarket ap-
proval for any new tobacco product is required 
unless—
‘‘(i) the manufacturer has submitted a 
report under section 905(j); and 
‘‘(ii) the Secretary 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 June 1, 
2003; and 
‘‘(II)(aa) is in compliance with 
the requirements of this Act; or 
‘‘(bb) is exempt from the require-
ments of section 905(j) pursuant to a 
regulation 
issued 
under 
section 
905(j)(3). 
‘‘(B) APPLICATION
TO
CERTAIN
POST 
JUNE
1, 2003
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 June 1, 2003, and 
prior to the date that is 15 months after
the date of enactment of the Family Smok-
ing Prevention and Tobacco Control Act; 
and 
‘‘(ii) for which a report was submitted 
under section 905(j) within such 15-month 
period, until the Secretary issues an order 
that the tobacco product is not substan-
tially equivalent. 
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.—
‘‘(A) IN
GENERAL.—In this section and 
section 905(j), the terms ‘substantially equiva-
lent’ or ‘substantial equivalence’ mean, with re-
spect to the tobacco product being compared to 
the predicate tobacco product, that the Sec-
retary by order has found that the tobacco 
product—
‘‘(i) has the same characteristics as 
the predicate tobacco product; or 
‘‘(ii) has different characteristics and 
the information submitted contains infor-
mation, including clinical data if deemed 
necessary by the Secretary, that dem-
onstrates that it is not appropriate to reg-
ulate the product under this section be-
cause the product does not raise different 
questions of public health. 
‘‘(B) 
CHARACTERISTICS.—In 
subpara-
graph (A), the term ‘characteristics’ means the 
materials, 
ingredients, 
design, 
composition, 
heating source, or other features of a tobacco 
product. 
‘‘(C) LIMITATION.—A tobacco product may 
not be found to be substantially equivalent to a 
predicate tobacco product that has been re-
moved from the market at the initiative of the 
Secretary or that has been determined by a ju-
dicial order to be misbranded or adulterated. 
‘‘(4) HEALTH INFORMATION.—
‘‘(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 for premarket 
approval 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-
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 
‘‘(G) such other information relevant to 
the subject matter of the application as the Sec-
retary may require. 
‘‘(2) REFERENCE 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 approval of the application, together with all un-
derlying data and the reasons or basis for the rec-
ommendation. 
‘‘(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 para-
graph (2) of such subsection, shall—
‘‘(i) issue an order approving the ap-
plication if the Secretary finds that none of 
the grounds for denying approval specified 
in paragraph (2) of this subsection applies; 
or 
‘‘(ii) deny approval of the application 
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 approving an application 
for a tobacco product may require as a condi-
tion to such approval 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
APPROVAL.—The Secretary 
shall deny approval of an application for a tobacco 
product if, upon the basis of the information sub-
mitted to the Secretary as part of the application 
and any 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, compli-
ance with which is a condition to approval of 
the application, 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 
place such application in approvable form (which 
measures may include further research by the appli-
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 approval of a 
tobacco product 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-
perts qualified by training and experience to 
evaluate the tobacco product. 
‘‘(B) OTHER EVIDENCE.—If the Secretary 
determines that there exists valid scientific evi-
dence (other than evidence derived from inves-
tigations described in subparagraph (A)) which 
is sufficient to evaluate the tobacco product the 
Secretary may authorize that the determination
for purposes of paragraph (2)(A) be made on 
the basis of such evidence. 
‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.—
‘‘(1) IN GENERAL.—The Secretary shall, upon 
obtaining, where appropriate, advice on scientific 
matters from an advisory committee, and after due 
notice and opportunity for informal hearing to the 
holder of an approved application for a tobacco 
product, issue an order withdrawing approval of the 
application if the Secretary finds—
‘‘(A) that the continued marketing of such 
tobacco product no longer is appropriate for the 
protection of the public health; 
‘‘(B) that the application contained or was 
accompanied by an untrue statement of a mate-
rial fact; 
‘‘(C) that the applicant—
‘‘(i) has failed to establish a system 
for maintaining records, or has repeatedly 
or deliberately failed to maintain records 
or to make reports, required by an applica-
ble regulation under section 909; 
‘‘(ii) has refused to permit access to, 
or copying or verification of, such records 
as required by section 704; or
‘‘(iii) has not complied with the re-
quirements of section 905; 
‘‘(D) on the basis of new information be-
fore the Secretary with respect to such tobacco 
product, evaluated together with the evidence 
before the Secretary when the application was 
approved, that the methods used in, or the fa-
cilities and controls used for, the manufacture, 
processing, packing, or installation of such to-
bacco product do not conform with the require-
ments of section 906(e) and were not brought 
into conformity with such requirements within a 
reasonable time after receipt of written notice 
from the Secretary of nonconformity; 
‘‘(E) on the basis of new information be-
fore the Secretary, evaluated together with the 
evidence before the Secretary when the applica-
tion was approved, that the labeling of such to-
bacco product, based on a fair evaluation of all 
material facts, is false or misleading in any par-
ticular and was not corrected within a reason-
able time after receipt of written notice from 
the Secretary of such fact; or 
‘‘(F) on the basis of new information be-
fore the Secretary, evaluated together with the
evidence before the Secretary when the applica-
tion was approved, that such tobacco product is 
not shown to conform in all respects to a to-
bacco product standard which is in effect under 
section 907, compliance with which was a con-
dition to approval of the application, and that 
there is a lack of adequate information to jus-
tify the deviation from such standard. 
‘‘(2) APPEAL.—The holder of an application 
subject to an order issued under paragraph (1) with-
drawing approval of the application may, by petition 
filed on or before the 30th day after the date upon 
which such holder receives notice of such with-
drawal, obtain review thereof in accordance with 
subsection (e). 
‘‘(3) TEMPORARY SUSPENSION.—If, after pro-
viding an opportunity for an informal hearing, the 
Secretary determines there is reasonable probability 
that the continuation of distribution of a tobacco 
product under an approved application would cause 
serious, adverse health consequences or death, that 
is greater than ordinarily caused by tobacco prod-
ucts on the market, the Secretary shall by order 
temporarily suspend the approval of the application 
approved under this section. If the Secretary issues
such an order, the Secretary shall proceed expedi-
tiously under paragraph (1) to withdraw such appli-
cation. 
‘‘(e) SERVICE OF ORDER.—An order issued by the 
Secretary under this section shall be served— 
‘‘(1) in person by any officer or employee of the 
department designated by the Secretary; or 
‘‘(2) by mailing the order by registered mail or 
certified mail addressed to the applicant at the ap-
plicant’s last known address in the records of the 
Secretary. 
‘‘(f) RECORDS.—
‘‘(1) ADDITIONAL INFORMATION.—In the case 
of any tobacco product for which an approval of an 
application filed under subsection (b) is in effect, the 
applicant shall establish and maintain such records, 
and make such reports to the Secretary, as the Sec-
retary may by regulation, or by order with respect 
to such application, prescribe on the basis of a find-
ing that such records and reports are necessary in 
order to enable the Secretary to determine, or facili-
tate a determination of, whether there is or may be 
grounds for withdrawing or temporarily suspending 
such approval.
‘‘(2) ACCESS TO RECORDS.—Each person re-
quired under this section to maintain records, and 
each person in charge or custody thereof, shall, upon 
request of an officer or employee designated by the 
Secretary, permit such officer or employee at all rea-
sonable times to have access to and copy and verify 
such records. 
‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP-
TION FOR INVESTIGATIONAL USE.—The Secretary may 
exempt tobacco products intended for investigational use 
from the provisions of this chapter under such conditions 
as the Secretary may by regulation prescribe. 
‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—No person may introduce or de-
liver for introduction into interstate commerce any modi-
fied risk tobacco product unless approval of an application 
filed pursuant to subsection (d) is effective with respect 
to such product. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) MODIFIED RISK TOBACCO PRODUCT.—The 
term ‘modified risk tobacco product’ means any to-
bacco product that is sold or distributed for use to 
reduce harm or the risk of tobacco-related disease 
associated with commercially marketed tobacco prod-
ucts.
‘‘(2) SOLD OR DISTRIBUTED.—
‘‘(A) IN GENERAL.—With respect to a to-
bacco product, the term ‘sold or distributed for 
use to reduce harm or the risk of tobacco-re-
lated disease associated with commercially mar-
keted tobacco products’ means a tobacco prod-
uct—
‘‘(i) the label, labeling, or advertising 
of which represents explicitly or implicitly 
that—
‘‘(I) the tobacco product presents 
a lower risk of tobacco-related disease 
or is less harmful than one or more 
other commercially marketed tobacco 
products; 
‘‘(II) the tobacco product or its 
smoke contains a reduced level of a 
substance or presents a reduced expo-
sure to a substance; or 
‘‘(III) the tobacco product or its 
smoke does not contain or is free of a 
substance; 
‘‘(ii) the label, labeling, or advertising 
of which uses the descriptors ‘light’, ‘mild’, 
or ‘low’ or similar descriptors; or
‘‘(iii) the tobacco product manufac-
turer of which has taken any action di-
rected to consumers through the media or 
otherwise, other than by means of the to-
bacco product’s label, labeling or adver-
tising, after the date of enactment of the 
Family Smoking Prevention and Tobacco 
Control Act, respecting the product that 
would be reasonably expected to result in 
consumers believing that the tobacco prod-
uct or its smoke may present a lower risk 
of disease or is less harmful than one or 
more commercially marketed tobacco prod-
ucts, or presents a reduced exposure to, or 
does not contain or is free of, a substance 
or substances. 
‘‘(B) LIMITATION.—No tobacco product 
shall be considered to be ‘sold or distributed for 
use to reduce harm or the risk of tobacco-re-
lated disease associated with commercially mar-
keted tobacco products’, except as described in 
subparagraph (A). 
‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product 
that is intended to be used for the treatment of tobacco 
dependence, including smoking cessation, is not a modified
risk tobacco product under this section and is subject to 
the requirements of chapter V. 
‘‘(d) FILING.—Any person may file with the Sec-
retary an application for a modified risk tobacco product. 
Such application shall include—
‘‘(1) a description of the proposed product and 
any proposed advertising and labeling; 
‘‘(2) the conditions for using the product; 
‘‘(3) the formulation of the product; 
‘‘(4) sample product labels and labeling; 
‘‘(5) all documents (including underlying sci-
entific information) relating to research findings 
conducted, supported, or possessed by the tobacco 
product manufacturer relating to the effect of the 
product on tobacco related diseases and health-re-
lated conditions, including information both favor-
able and unfavorable to the ability of the product to 
reduce risk or exposure and relating to human 
health; 
‘‘(6) data and information on how consumers 
actually use the tobacco product; and 
‘‘(7) such other information as the Secretary 
may require. 
‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall 
make the application described in subsection (d) publicly
available (except matters in the application which are 
trade secrets or otherwise confidential, commercial infor-
mation) and shall request comments by interested persons 
on the information contained in the application and on the 
label, labeling, and advertising accompanying such appli-
cation. 
‘‘(f) ADVISORY COMMITTEE.—
‘‘(1) IN GENERAL.—The Secretary shall refer to 
an advisory committee any application submitted 
under this subsection. 
‘‘(2) RECOMMENDATIONS.—Not later than 60 
days after the date an application is referred to an 
advisory committee under paragraph (1), the advi-
sory committee shall report its recommendations on 
the application to the Secretary. 
‘‘(g) APPROVAL.—
‘‘(1) MODIFIED
RISK
PRODUCTS.—Except as 
provided in paragraph (2), the Secretary shall ap-
prove an application for a modified risk tobacco 
product filed under this section only if the Secretary 
determines that the applicant has demonstrated that 
such product, as it is actually used by consumers, 
will—
‘‘(A) significantly reduce harm and the 
risk of tobacco-related disease to individual to-
bacco users; and 
‘‘(B) benefit the health of the population 
as a whole taking into account both users of to-
bacco products and persons who do not cur-
rently use tobacco products. 
‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.—
‘‘(A) IN
GENERAL.—The Secretary may 
approve an application for a tobacco product 
that has not been approved as a modified risk 
tobacco product pursuant to paragraph (1) if 
the Secretary makes the findings required 
under this paragraph and determines that the 
applicant has demonstrated that—
‘‘(i) the approval of the application 
would be appropriate to promote the public 
health; 
‘‘(ii) any aspect of the label, labeling, 
and advertising for such product that 
would cause the tobacco product to be a 
modified risk tobacco product under sub-
section (b)(2) is limited to an explicit or 
implicit representation that such tobacco 
product or its smoke contains or is free of
a substance or contains a reduced level of 
a substance, or presents a reduced expo-
sure to a substance in tobacco smoke; 
‘‘(iii) scientific evidence is not avail-
able and, using the best available scientific 
methods, cannot be made available without 
conducting long-term epidemiological stud-
ies for an application to meet the stand-
ards set forth in paragraph (1); and 
‘‘(iv) the scientific evidence that is 
available without conducting long-term epi-
demiological studies demonstrates that a 
measurable and substantial reduction in 
morbidity or mortality among individual 
tobacco users is anticipated in subsequent 
studies. 
‘‘(B) ADDITIONAL FINDINGS REQUIRED.—
In order to approve an application under sub-
paragraph (A) the Secretary must also find 
that the applicant has demonstrated that—
‘‘(i) the magnitude of the overall re-
ductions in exposure to the substance or 
substances which are the subject of the ap-
plication is substantial, such substance or 
substances are harmful, and the product as
actually used exposes consumers to the 
specified reduced level of the substance or 
substances; 
‘‘(ii) the product as actually used by 
consumers will not expose them to higher 
levels of other harmful substances com-
pared to the similar types of tobacco prod-
ucts then on the market unless such in-
creases are minimal and the anticipated 
overall impact of use of the product re-
mains a substantial and measurable reduc-
tion in overall morbidity and mortality 
among individual tobacco users; 
‘‘(iii) testing of actual consumer per-
ception shows that, as the applicant pro-
poses to label and market the product, con-
sumers will not be misled into believing 
that the product—
‘‘(I) is or has been demonstrated 
to be less harmful; or 
‘‘(II) presents or has been dem-
onstrated to present less of a risk of 
disease than 1 or more other commer-
cially marketed tobacco products; and
‘‘(iv) approval of the application is ex-
pected to benefit the health of the popu-
lation as a whole taking into account both 
users of tobacco products and persons who 
do not currently use tobacco products. 
‘‘(C) CONDITIONS OF APPROVAL.—
‘‘(i) IN
GENERAL.—Applications ap-
proved under this paragraph shall be lim-
ited to a term of not more than 5 years, 
but may be renewed upon a finding by the 
Secretary that the requirements of this 
paragraph continue to be satisfied based 
on the filing of a new application. 
‘‘(ii) AGREEMENTS BY APPLICANT.—
Applications approved under this para-
graph shall be conditioned on the appli-
cant’s agreement to conduct postmarket 
surveillance and studies and to submit to 
the Secretary the results of such surveil-
lance and studies to determine the impact 
of the application approval on consumer 
perception, behavior, and health and to en-
able the Secretary to review the accuracy 
of the determinations upon which the ap-
proval was based in accordance with a pro-
tocol approved by the Secretary. 
‘‘(iii) ANNUAL SUBMISSION.—The re-
sults of such postmarket surveillance and 
studies described in clause (ii) shall be 
submitted annually. 
‘‘(3) BASIS.—The determinations under para-
graphs (1) and (2) shall be based on—
‘‘(A) the scientific evidence submitted by 
the applicant; and 
‘‘(B) scientific evidence and other informa-
tion that is available to the Secretary. 
‘‘(4) BENEFIT
TO
HEALTH
OF
INDIVIDUALS 
AND OF POPULATION AS A WHOLE.—In making the 
determinations under paragraphs (1) and (2), the 
Secretary shall take into account—
‘‘(A) the relative health risks to individuals 
of the tobacco product that is the subject of the 
application; 
‘‘(B) the increased or decreased likelihood 
that existing users of tobacco products who 
would otherwise stop using such products will 
switch to the tobacco product that is the subject 
of the application;
‘‘(C) the increased or decreased likelihood 
that persons who do not use tobacco products 
will start using the tobacco product that is the 
subject of the application; 
‘‘(D) the risks and benefits to persons 
from the use of the tobacco product that is the 
subject of the application as compared to the 
use of products for smoking cessation approved 
under chapter V to treat nicotine dependence; 
and 
‘‘(E) comments, data, and information 
submitted by interested persons. 
‘‘(h) ADDITIONAL CONDITIONS FOR APPROVAL.—
‘‘(1) MODIFIED
RISK
PRODUCTS.—The Sec-
retary shall require for the approval of an applica-
tion under this section that any advertising or label-
ing concerning modified risk products enable the 
public to comprehend the information concerning 
modified risk and to understand the relative signifi-
cance of such information in the context of total 
health and in relation to all of the diseases and 
health-related conditions associated with the use of 
tobacco products. 
‘‘(2) COMPARATIVE CLAIMS.—
‘‘(A) IN GENERAL.—The Secretary may re-
quire for the approval of an application under 
this subsection that a claim comparing a to-
bacco product to 1 or more other commercially 
marketed tobacco products shall compare the 
tobacco product to a commercially marketed to-
bacco product that is representative of that type 
of tobacco product on the market (for example 
the average value of the top 3 brands of an es-
tablished regular tobacco product). 
‘‘(B) QUANTITATIVE
COMPARISONS.—The 
Secretary may also require, for purposes of sub-
paragraph (A), that the percent (or fraction) of 
change and identity of the reference tobacco 
product and a quantitative comparison of the 
amount of the substance claimed to be reduced 
shall be stated in immediate proximity to the 
most prominent claim. 
‘‘(3) LABEL DISCLOSURE.—
‘‘(A) IN GENERAL.—The Secretary may re-
quire the disclosure on the label of other sub-
stances in the tobacco product, or substances 
that may be produced by the consumption of 
that tobacco product, that may affect a disease 
or health-related condition or may increase the
risk of other diseases or health-related condi-
tions associated with the use of tobacco prod-
ucts. 
‘‘(B) CONDITIONS OF USE.—If the condi-
tions of use of the tobacco product may affect 
the risk of the product to human health, the 
Secretary may require the labeling of conditions 
of use. 
‘‘(4) TIME.—The Secretary shall limit an ap-
proval under subsection (g)(1) for a specified period 
of time. 
‘‘(5) ADVERTISING.—The Secretary may re-
quire that an applicant, whose application has been 
approved under this subsection, comply with require-
ments relating to advertising and promotion of the 
tobacco product. 
‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.—
‘‘(1) IN GENERAL.—The Secretary shall require 
that an applicant under subsection (g)(1) conduct 
postmarket surveillance and studies for a tobacco 
product for which an application has been approved 
to determine the impact of the application approval 
on consumer perception, behavior, and health, to en-
able the Secretary to review the accuracy of the de-
terminations upon which the approval was based,
and to provide information that the Secretary deter-
mines is otherwise necessary regarding the use or 
health risks involving the tobacco product. The re-
sults of postmarket surveillance and studies shall be 
submitted to the Secretary on an annual basis. 
‘‘(2) SURVEILLANCE
PROTOCOL.—Each appli-
cant required to conduct a surveillance of a tobacco 
product under paragraph (1) shall, within 30 days 
after receiving notice that the applicant is required 
to conduct such surveillance, submit, for the ap-
proval of the Secretary, a protocol for the required 
surveillance. The Secretary, within 60 days of the 
receipt of such protocol, shall determine if the prin-
cipal investigator proposed to be used in the surveil-
lance has sufficient qualifications and experience to 
conduct such surveillance and if such protocol will 
result in collection of the data or other information 
designated by the Secretary as necessary to protect 
the public health. 
‘‘(j) WITHDRAWAL OF APPROVAL.—The Secretary, 
after an opportunity for an informal hearing, shall with-
draw the approval of an application under this section if 
the Secretary determines that—
‘‘(1) the applicant, based on new information, 
can no longer make the demonstrations required
under subsection (g), or the Secretary can no longer 
make the determinations required under subsection 
(g); 
‘‘(2) the application failed to include material 
information or included any untrue statement of ma-
terial fact; 
‘‘(3) any explicit or implicit representation that 
the product reduces risk or exposure is no longer 
valid, including if—
‘‘(A) a tobacco product standard is estab-
lished pursuant to section 907; 
‘‘(B) an action is taken that affects the 
risks presented by other commercially marketed 
tobacco products that were compared to the 
product that is the subject of the application; or 
‘‘(C) any postmarket surveillance or stud-
ies reveal that the approval of the application is 
no longer consistent with the protection of the 
public health; 
‘‘(4) the applicant failed to conduct or submit 
the postmarket surveillance and studies required 
under subsection (g)(2)(C)(ii) or (i); or 
‘‘(5) the applicant failed to meet a condition 
imposed under subsection (h).
‘‘(k) CHAPTER IV OR V.—A product approved in ac-
cordance with this section shall not be subject to chapter 
IV or V. 
‘‘(l) IMPLEMENTING REGULATIONS OR GUIDANCE.—
‘‘(1) SCIENTIFIC EVIDENCE.—Not later than 2 
years after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act, the 
Secretary shall issue regulations or guidance (or any 
combination thereof) on the scientific evidence re-
quired for assessment and ongoing review of modi-
fied risk tobacco products. Such regulations or guid-
ance shall—
‘‘(A) establish minimum standards for sci-
entific studies needed prior to approval to show 
that a substantial reduction in morbidity or 
mortality among individual tobacco users is 
likely; 
‘‘(B) include validated biomarkers, inter-
mediate clinical endpoints, and other feasible 
outcome measures, as appropriate; 
‘‘(C) establish minimum standards for 
postmarket studies, that shall include regular 
and long-term assessments of health outcomes 
and mortality, intermediate clinical endpoints, 
consumer perception of harm reduction, and the
impact on quitting behavior and new use of to-
bacco products, as appropriate; 
‘‘(D) establish minimum standards for re-
quired postmarket surveillance, including ongo-
ing assessments of consumer perception; and 
‘‘(E) require that data from the required 
studies and surveillance be made available to 
the Secretary prior to the decision on renewal 
of a modified risk tobacco product. 
‘‘(2) CONSULTATION.—The regulations or guid-
ance issued under paragraph (1) shall be developed 
in consultation with the Institute of Medicine, and 
with the input of other appropriate scientific and 
medical experts, on the design and conduct of such 
studies and surveillance. 
‘‘(3) REVISION.—The regulations or guidance 
under paragraph (1) shall be revised on a regular 
basis as new scientific information becomes avail-
able. 
‘‘(4) NEW
TOBACCO
PRODUCTS.—Not later 
than 2 years after the date of enactment of the 
Family Smoking Prevention and Tobacco Control 
Act, the Secretary shall issue a regulation or guid-
ance that permits the filing of a single application 
for any tobacco product that is a new tobacco prod-
100
uct under section 910 and for which the applicant 
seeks approval as a modified risk tobacco product 
under this section. 
‘‘(m) DISTRIBUTORS.—No distributor may take any 
action, after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, with respect to a to-
bacco product that would reasonably be expected to result 
in consumers believing that the tobacco product or its 
smoke may present a lower risk of disease or is less harm-
ful than one or more commercially marketed tobacco prod-
ucts, or presents a reduced exposure to, or does not con-
tain or is free of, a substance or substances. 
‘‘SEC. 912. JUDICIAL REVIEW. 
‘‘(a) RIGHT TO REVIEW.—
‘‘(1) IN
GENERAL.—Not later than 30 days 
after—
‘‘(A) the promulgation of a regulation 
under section 907 establishing, amending, or 
revoking a tobacco product standard; or 
‘‘(B) a denial of an application for ap-
proval under section 910(c), 
any person adversely affected by such regulation or 
denial may file a petition for judicial review of such 
regulation or denial with the United States Court of 
Appeals for the District of Columbia or for the cir-
101
cuit in which such person resides or has their prin-
cipal place of business. 
‘‘(2) REQUIREMENTS.—
‘‘(A) COPY OF PETITION.—A copy of the 
petition filed under paragraph (1) shall be 
transmitted by the clerk of the court involved to 
the Secretary. 
‘‘(B) RECORD OF PROCEEDINGS.—On re-
ceipt of a petition under subparagraph (A), the 
Secretary shall file in the court in which such 
petition was filed—
‘‘(i) the record of the proceedings on 
which the regulation or order was based; 
and 
‘‘(ii) a statement of the reasons for 
the issuance of such a regulation or order. 
‘‘(C) DEFINITION
OF
RECORD.—In this 
section, the term ‘record’ means—
‘‘(i) all notices and other matter pub-
lished in the Federal Register with respect 
to the regulation or order reviewed; 
‘‘(ii) all information submitted to the 
Secretary with respect to such regulation 
or order;
102
‘‘(iii) proceedings of any panel or ad-
visory committee with respect to such reg-
ulation or order; 
‘‘(iv) any hearing held with respect to 
such regulation or order; and 
‘‘(v) any other information identified 
by the Secretary, in the administrative pro-
ceeding held with respect to such regula-
tion or order, as being relevant to such 
regulation or order. 
‘‘(b) STANDARD OF REVIEW.—Upon the filing of the 
petition under subsection (a) for judicial review of a regu-
lation or order, the court shall have jurisdiction to review 
the regulation or order in accordance with chapter 7 of 
title 5, United States Code, and to grant appropriate re-
lief, including interim relief, as provided for in such chap-
ter. A regulation or denial described in subsection (a) shall 
be reviewed in accordance with section 706(2)(A) of title 
5, United States Code. 
‘‘(c) FINALITY OF JUDGMENT.—The judgment of the 
court affirming or setting aside, in whole or in part, any 
regulation or order shall be final, subject to review by the 
Supreme Court of the United States upon certiorari or 
certification, as provided in section 1254 of title 28, 
United States Code.
103
‘‘(d) OTHER REMEDIES.—The remedies provided for 
in this section shall be in addition to, and not in lieu of, 
any other remedies provided by law. 
‘‘(e) REGULATIONS
AND ORDERS MUST RECITE 
BASIS IN RECORD.—To facilitate judicial review, a regula-
tion or order issued under section 906, 907, 908, 909, 
910, or 916 shall contain a statement of the reasons for 
the issuance of such regulation or order in the record of 
the proceedings held in connection with its issuance. 
‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 
‘‘The Secretary shall issue regulations to require that 
retail establishments for which the predominant business 
is the sale of tobacco products comply with any advertising 
restrictions applicable to retail establishments accessible 
to individuals under the age of 18.
‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 
THE FEDERAL TRADE COMMISSION. 
‘‘(a) JURISDICTION.—
‘‘(1) IN
GENERAL.—Except where expressly 
provided in this chapter, nothing in this chapter 
shall be construed as limiting or diminishing the au-
thority of the Federal Trade Commission to enforce 
the laws under its jurisdiction with respect to the 
advertising, sale, or distribution of tobacco products.
104
‘‘(2) ENFORCEMENT.—Any advertising that vio-
lates this chapter or a provision of the regulations 
referred to in section 102 of the Family Smoking 
Prevention and Tobacco Control Act, is an unfair or 
deceptive act or practice under section 5(a) of the 
Federal Trade Commission Act (15 U.S.C. 45(a)) 
and shall be considered a violation of a rule promul-
gated under section 18 of that Act (15 U.S.C. 57a). 
‘‘(b) COORDINATION.—With respect to the require-
ments of section 4 of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1333) and section 3 of the 
Comprehensive Smokeless Tobacco Health Education Act 
of 1986 (15 U.S.C. 4402)—
‘‘(1) the Chairman of the Federal Trade Com-
mission shall coordinate with the Secretary con-
cerning the enforcement of such Act as such enforce-
ment relates to unfair or deceptive acts or practices 
in the advertising of cigarettes or smokeless tobacco; 
and 
‘‘(2) the Secretary shall consult with the Chair-
man of such Commission in revising the label state-
ments and requirements under such sections. 
‘‘SEC. 915. CONGRESSIONAL REVIEW PROVISIONS. 
‘‘In accordance with section 801 of title 5, United 
States Code, Congress shall review, and may disapprove,
105
any rule under this chapter that is subject to section 801. 
This section and section 801 do not apply to the regula-
tions referred to in section 102 of the Family Smoking 
Prevention and Tobacco Control Act. 
‘‘SEC. 916. REGULATION REQUIREMENT. 
‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 
later than 24 months after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, the 
Secretary, acting through the Commissioner of the Food 
and Drug Administration, shall promulgate regulations 
under this Act that meet the requirements of subsection 
(b). 
‘‘(b) CONTENTS OF RULES.—The regulations pro-
mulgated under subsection (a) shall require testing and 
reporting of tobacco product constituents, ingredients, and 
additives, including smoke constituents, by brand and sub-
brand that the Secretary determines should be tested to 
protect the public health. The regulations may require 
that tobacco product manufacturers, packagers, or import-
ers make disclosures relating to the results of the testing 
of tar and nicotine through labels or advertising or other 
appropriate means, and make disclosures regarding the re-
sults of the testing of other constituents, including smoke 
constituents, ingredients, or additives, that the Secretary 
determines should be disclosed to the public to protect the
106
public health and will not mislead consumers about the 
risk of tobacco related disease. 
‘‘(c) AUTHORITY.—The Food and Drug Administra-
tion shall have the authority under this chapter to conduct 
or to require the testing, reporting, or disclosure of to-
bacco product constituents, including smoke constituents. 
‘‘SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY. 
‘‘(a) IN GENERAL.—
‘‘(1) PRESERVATION.—Nothing in this chapter, 
or rules promulgated under this chapter, shall be 
construed to limit the authority of a Federal agency 
(including the Armed Forces), a State or political 
subdivision of a State, or the government of an In-
dian tribe to enact, adopt, promulgate, and enforce 
any law, rule, regulation, or other measure with re-
spect to tobacco products that is in addition to, or 
more stringent than, requirements established under 
this chapter, including a law, rule, regulation, or 
other measure relating to or prohibiting the sale, 
distribution, possession, exposure to, access to, ad-
vertising and promotion of, or use of tobacco prod-
ucts by individuals of any age, information reporting 
to the State, or measures relating to fire safety 
standards for tobacco products. No provision of this
107
chapter shall limit or otherwise affect any State, 
Tribal, or local taxation of tobacco products. 
‘‘(2) PREEMPTION
OF
CERTAIN
STATE
AND 
LOCAL REQUIREMENTS.—
‘‘(A) IN GENERAL.—Except as provided in 
paragraph (1) and subparagraph (B), no State 
or political subdivision of a State may establish 
or continue in effect with respect to a tobacco 
product any requirement which is different 
from, or in addition to, any requirement under 
the provisions of this chapter relating to to-
bacco product standards, premarket approval, 
adulteration, misbranding, labeling, registra-
tion, good manufacturing standards, or modi-
fied risk products. 
‘‘(B) 
EXCEPTION.—Subparagraph 
(A) 
does not apply to requirements relating to the 
sale, distribution, possession, information re-
porting to the State, exposure to, access to, the 
advertising and promotion of, or use of, tobacco 
products by individuals of any age, or relating 
to fire safety standards for tobacco products. 
Information disclosed to a State under subpara-
graph (A) that is exempt from disclosure under 
section 554(b)(4) of title 5, United States Code,
108
shall be treated as trade secret and confidential 
information by the State. 
‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT 
LIABILITY.—No provision of this chapter relating to a to-
bacco product shall be construed to modify or otherwise 
affect any action or the liability of any person under the 
product liability law of any State. 
‘‘SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 
COMMITTEE. 
‘‘(a) ESTABLISHMENT.—Not later than 1 year after 
the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall establish an 
11-member advisory committee, to be known as the ‘To-
bacco Products Scientific Advisory Committee’. 
‘‘(b) MEMBERSHIP.—
‘‘(1) IN GENERAL.—
‘‘(A) MEMBERS.—The Secretary shall ap-
point as members of the Tobacco Products Sci-
entific Advisory Committee individuals who are 
technically qualified by training and experience 
in the medicine, medical ethics, science, or tech-
nology involving the manufacture, evaluation, or 
use of tobacco products, who are of appro-
priately diversified professional backgrounds. 
The committee shall be composed of—
109
‘‘(i) 7 individuals who are physicians, 
dentists, scientists, or health care profes-
sionals practicing in the area of oncology, 
pulmonology, cardiology, toxicology, phar-
macology, addiction, or any other relevant 
specialty; 
‘‘(ii) 1 individual who is an officer or 
employee of a State or local government or 
of the Federal Government; 
‘‘(iii) 1 individual as a representative 
of the general public; 
‘‘(iv) 1 individual as a representative 
of the interests in the tobacco manufac-
turing industry; and 
‘‘(v) 1 individual as a representative 
of the interests of the tobacco growers. 
‘‘(B) NONVOTING
MEMBERS.—The mem-
bers of the committee appointed under clauses 
(iv) and (v) of subparagraph (A) shall serve as 
consultants to those described in clauses (i) 
through (iii) of subparagraph (A) and shall be 
nonvoting representatives. 
‘‘(2) LIMITATION.—The Secretary may not ap-
point to the Advisory Committee any individual who 
is in the regular full-time employ of the Food and
110
Drug Administration or any agency responsible for 
the enforcement of this Act. The Secretary may ap-
point Federal officials as ex officio members. 
‘‘(3) CHAIRPERSON.—The Secretary shall des-
ignate 1 of the members of the Advisory Committee 
to serve as chairperson. 
‘‘(c) DUTIES.—The Tobacco Products Scientific Ad-
visory Committee shall provide advice, information, and 
recommendations to the Secretary—
‘‘(1) as provided in this chapter; 
‘‘(2) on the effects of the alteration of the nico-
tine yields from tobacco products; 
‘‘(3) on whether there is a threshold level below 
which nicotine yields do not produce dependence on 
the tobacco product involved; and 
‘‘(4) on its review of other safety, dependence, 
or health issues relating to tobacco products as re-
quested by the Secretary. 
‘‘(d) COMPENSATION; SUPPORT; FACA.—
‘‘(1) COMPENSATION AND TRAVEL.—Members 
of the Advisory Committee who are not officers or 
employees of the United States, while attending con-
ferences or meetings of the committee or otherwise 
engaged in its business, shall be entitled to receive 
compensation at rates to be fixed by the Secretary,
111
which may not exceed the daily equivalent of the 
rate in effect for level 4 of the Senior Executive 
Schedule under section 5382 of title 5, United 
States Code, for each day (including travel time) 
they are so engaged; and while so serving away from 
their homes or regular places of business each mem-
ber may be allowed travel expenses, including per 
diem in lieu of subsistence, as authorized by section 
5703 of title 5, United States Code, for persons in 
the Government service employed intermittently. 
‘‘(2) ADMINISTRATIVE
SUPPORT.—The Sec-
retary shall furnish the Advisory Committee clerical 
and other assistance. 
‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 
the Federal Advisory Committee Act (5 U.S.C.
App.) does not apply to the Advisory Committee. 
‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM-
MITTEES.—The Advisory Committee shall make and 
maintain a transcript of any proceeding of the panel or 
committee. Each such panel and committee shall delete 
from any transcript made under this subsection informa-
tion which is exempt from disclosure under section 552(b) 
of title 5, United States Code.
112
‘‘SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DE-
PENDENCE. 
‘‘The Secretary shall—
‘‘(1) at the request of the applicant, consider 
designating nicotine replacement products as fast 
track research and approval products within the 
meaning of section 506; 
‘‘(2) direct the Commissioner to consider ap-
proving the extended use of nicotine replacement 
products (such as nicotine patches, nicotine gum, 
and nicotine lozenges) for the treatment of tobacco 
dependence; 
‘‘(3) review and consider the evidence for addi-
tional indications for nicotine replacement products, 
such as for craving relief or relapse prevention; and 
‘‘(4) consider—
‘‘(A) relieving companies of premarket bur-
dens under section 505 if the requirement is re-
dundant considering other nicotine replacement 
therapies already on the market; and 
‘‘(B) time and extent applications for nico-
tine replacement therapies that have been ap-
proved by a regulatory body in a foreign coun-
try and have marketing experience in such 
country.
113
‘‘SEC. 920. USER FEE. 
‘‘(a) ESTABLISHMENT OF QUARTERLY USER FEE.—
The Secretary shall assess a quarterly user fee with re-
spect to every quarter of each fiscal year commencing fis-
cal year 2004, calculated in accordance with this section, 
upon each manufacturer and importer of tobacco products 
subject to this chapter. 
‘‘(b) FUNDING OF FDA REGULATION OF TOBACCO 
PRODUCTS.—The Secretary shall make user fees collected 
pursuant to this section available to pay, in each fiscal 
year, for the costs of the activities of the Food and Drug 
Administration related to the regulation of tobacco prod-
ucts under this chapter. 
‘‘(c) ASSESSMENT OF USER FEE.—
‘‘(1) AMOUNT
OF
ASSESSMENT.—Except as 
provided in paragraph (4), the total user fees as-
sessed each year pursuant to this section shall be 
sufficient, and shall not exceed what is necessary, to 
pay for the costs of the activities described in sub-
section (b) for each fiscal year. 
‘‘(2) ALLOCATION OF ASSESSMENT BY CLASS 
OF TOBACCO PRODUCTS.—
‘‘(A) IN GENERAL.—Subject to paragraph 
(3), the total user fees assessed each fiscal year 
with respect to each class of importers and 
manufacturers shall be equal to an amount that
114
is the applicable percentage of the total costs of 
activities of the Food and Drug Administration 
described in subsection (b). 
‘‘(B) 
APPLICABLE
PERCENTAGE.—For 
purposes of subparagraph (A) the applicable 
percentage for a fiscal year shall be the fol-
lowing: 
‘‘(i) 92.07 percent shall be assessed 
on manufacturers and importers of ciga-
rettes; 
‘‘(ii) 0.05 percent shall be assessed on 
manufacturers and importers of little ci-
gars; 
‘‘(iii) 7.15 percent shall be assessed 
on manufacturers and importers of cigars 
other than little cigars; 
‘‘(iv) 0.43 percent shall be assessed on 
manufacturers and importers of snuff; 
‘‘(v) 0.10 percent shall be assessed on 
manufacturers and importers of chewing 
tobacco; 
‘‘(vi) 0.06 percent shall be assessed on 
manufacturers and importers of pipe to-
bacco; and
115
‘‘(vii) 0.14 percent shall be assessed 
on manufacturers and importers of roll-
your-own tobacco. 
‘‘(3) DISTRIBUTION OF FEE SHARES OF MANU-
FACTURERS AND IMPORTERS EXEMPT FROM USER 
FEE.—Where a class of tobacco products is not sub-
ject to a user fee under this section, the portion of 
the user fee assigned to such class under subsection 
(d)(2) shall be allocated by the Secretary on a pro 
rata basis among the classes of tobacco products 
that are subject to a user fee under this section. 
Such pro rata allocation for each class of tobacco 
products that are subject to a user fee under this 
section shall be the quotient of—
‘‘(A) the sum of the percentages assigned 
to all classes of tobacco products subject to this 
section; divided by 
‘‘(B) the percentage assigned to such class 
under paragraph (2). 
‘‘(4) ANNUAL
LIMIT
ON
ASSESSMENT.—The 
total assessment under this section—
‘‘(A) for fiscal year 2004 shall be 
$85,000,000; 
‘‘(B) for fiscal year 2005 shall be 
$175,000,000;
116
‘‘(C) for fiscal year 2006 shall be 
$300,000,000; and 
‘‘(D) for each subsequent fiscal year, shall 
not exceed the limit on the assessment imposed 
during the previous fiscal year, as adjusted by 
the Secretary (after notice, published in the 
Federal Register) to reflect the greater of—
‘‘(i) the total percentage change that 
occurred in the Consumer Price Index for 
all urban consumers (all items; United 
States city average) for the 12-month pe-
riod ending on June 30 of the preceding 
fiscal year for which fees are being estab-
lished; or 
‘‘(ii) the total percentage change for 
the previous fiscal year in basic pay under 
the General Schedule in accordance with 
section 5332 of title 5, United States 
Code, as adjusted by any locality-based 
comparability payment pursuant to section 
5304 of such title for Federal employees 
stationed in the District of Columbia. 
‘‘(5) TIMING OF USER FEE ASSESSMENT.—The 
Secretary shall notify each manufacturer and im-
porter of tobacco products subject to this section of
117
the amount of the quarterly assessment imposed on 
such manufacturer or importer under subsection (f) 
during each quarter of each fiscal year. Such notifi-
cations shall occur not earlier than 3 months prior 
to the end of the quarter for which such assessment 
is made, and payments of all assessments shall be 
made not later than 60 days after each such notifi-
cation. 
‘‘(d) DETERMINATION OF USER FEE BY COMPANY 
MARKET SHARE.—
‘‘(1) IN GENERAL.—The user fee to be paid by 
each manufacturer or importer of a given class of to-
bacco products shall be determined in each quarter 
by multiplying—
‘‘(A) such manufacturer’s or importer’s 
market share of such class of tobacco products; 
by 
‘‘(B) the portion of the user fee amount 
for the current quarter to be assessed on manu-
facturers and importers of such class of tobacco 
products as determined under subsection (e). 
‘‘(2) NO FEE IN EXCESS OF MARKET SHARE.—
No manufacturer or importer of tobacco products 
shall be required to pay a user fee in excess of the 
market share of such manufacturer or importer.
118
‘‘(e) DETERMINATION
OF VOLUME
OF DOMESTIC 
SALES.—
‘‘(1) IN
GENERAL.—The calculation of gross 
domestic volume of a class of tobacco product by a 
manufacturer or importer, and by all manufacturers 
and importers as a group, shall be made by the Sec-
retary using information provided by manufacturers 
and importers pursuant to subsection (f), as well as 
any other relevant information provided to or ob-
tained by the Secretary. 
‘‘(2) MEASUREMENT.—For purposes of the cal-
culations under this subsection and the information 
provided under subsection (f) by the Secretary, gross 
domestic volume shall be measured by—
‘‘(A) in the case of cigarettes, the number 
of cigarettes sold; 
‘‘(B) in the case of little cigars, the num-
ber of little cigars sold; 
‘‘(C) in the case of large cigars, the num-
ber of cigars weighing more than 3 pounds per 
thousand sold; and 
‘‘(D) in the case of other classes of tobacco 
products, in terms of number of pounds, or 
fraction thereof, of these products sold.
119
‘‘(f) MEASUREMENT
OF GROSS DOMESTIC VOL-
UME.—
‘‘(1) IN
GENERAL.—Each manufacturer and 
importer of tobacco products shall submit to the 
Secretary a certified copy of each of the returns or 
forms described by this paragraph that are required 
to be filed with a Government agency on the same 
date that those returns or forms are filed, or re-
quired to be filed, with such agency. The returns 
and forms described by this paragraph are those re-
turns and forms related to the release of tobacco 
products into domestic commerce, as defined by sec-
tion 5702(k) of the Internal Revenue Code of 1986, 
and the repayment of the taxes imposed under chap-
ter 52 of such Code (ATF Form 500.24 and United 
States Customs Form 7501 under currently applica-
ble regulations). 
‘‘(2) PENALTIES.—Any person that knowingly 
fails to provide information required under this sub-
section or that provides false information under this 
subsection shall be subject to the penalties described 
in section 1003 of title 18, United States Code. In 
addition, such person may be subject to a civil pen-
alty in an amount not to exceed 2 percent of the 
value of the kind of tobacco products manufactured
120
or imported by such person during the applicable 
quarter, as determined by the Secretary. 
‘‘(g) EFFECTIVE DATE.—The user fees prescribed by 
this section shall be assessed in fiscal year 2004, based 
on domestic sales of tobacco products during fiscal year 
2003 and shall be assessed in each fiscal year thereafter.’’. 
SEC. 102. INTERIM FINAL RULE. 
(a) CIGARETTES AND SMOKELESS TOBACCO.—
(1) IN GENERAL.—Not later than 30 days after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall publish in the 
Federal Register an interim final rule regarding 
cigarettes and smokeless tobacco, which is hereby 
deemed to be in compliance with the Administrative 
Procedures Act and other applicable law. 
(2) CONTENTS OF RULE.—Except as provided 
in this subsection, the interim final rule published 
under paragraph (1), shall be identical in its provi-
sions to part 897 of the regulations promulgated by 
the Secretary of Health and Human Services in the 
August 28, 1996, issue of the Federal Register (61 
Fed. Reg., 44615–44618). Such rule shall—
(A) provide for the designation of jurisdic-
tional authority that is in accordance with this 
subsection;
121
(B) strike Subpart C—Labeling and sec-
tion 897.32(c); and 
(C) become effective not later than 1 year 
after the date of enactment of this Act. 
(3) AMENDMENTS TO RULE.—Prior to making 
amendments to the rule published under paragraph 
(1), the Secretary shall promulgate a proposed rule 
in accordance with the Administrative Procedures 
Act. 
(4) RULE OF CONSTRUCTION.—Except as pro-
vided in paragraph (3), nothing in this section shall 
be construed to limit the authority of the Secretary 
to amend, in accordance with the Administrative 
Procedures Act, the regulation promulgated pursu-
ant to this section.
(b) LIMITATION ON ADVISORY OPINIONS.—As of the 
date of enactment of this Act, the following documents 
issued by the Food and Drug Administration shall not 
constitute advisory opinions under section 10.85(d)(1) of 
title 21, Code of Federal Regulations, except as they apply 
to tobacco products, and shall not be cited by the Sec-
retary of Health and Human Services or the Food and 
Drug Administration as binding precedent: 
(1) The preamble to the proposed rule in the 
document entitled ‘‘Regulations Restricting the Sale
122
and Distribution of Cigarettes and Smokeless To-
bacco Products to Protect Children and Adoles-
cents’’ (60 Fed. Reg. 41314–41372 (August 11, 
1995)). 
(2) The document entitled ‘‘Nicotine in Ciga-
rettes and Smokeless Tobacco Products is a Drug 
and These Products Are Nicotine Delivery Devices 
Under the Federal Food, Drug, and Cosmetic Act’’ 
(60 Fed. Reg. 41453–41787 (August 11, 1995)).
(3) The preamble to the final rule in the docu-
ment entitled ‘‘Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco to 
Protect Children and Adolescents’’ (61 Fed. Reg. 
44396–44615 (August 28, 1996)). 
(4) The document entitled ‘‘Nicotine in Ciga-
rettes and Smokeless Tobacco is a Drug and These 
Products are Nicotine Delivery Devices Under the 
Federal Food, Drug, and Cosmetic Act; Jurisdic-
tional Determination’’ (61 Fed. Reg. 44619–45318 
(August 28, 1996)). 
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN-
ERAL PROVISIONS. 
(a) AMENDMENT OF FEDERAL FOOD, DRUG, AND 
COSMETIC ACT.—Except as otherwise expressly provided, 
whenever in this section an amendment is expressed in
123
terms of an amendment to, or repeal of, a section or other 
provision, the reference is to a section or other provision 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.). 
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is 
amended—
(1) in subsection (a), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(2) in subsection (b), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(3) in subsection (c), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(4) in subsection (e), by striking ‘‘515(f), or 
519’’ and inserting ‘‘515(f), 519, or 909’’; 
(5) in subsection (g), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(6) in subsection (h), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(7) in subsection (j), by striking ‘‘708, or 721’’ 
and inserting ‘‘708, 721, 904, 905, 906, 907, 908, 
909, or section 921(b)’’; 
(8) in subsection (k), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(9) by striking subsection (p) and inserting the 
following:
124
‘‘(p) The failure to register in accordance with section 
510 or 905, the failure to provide any information re-
quired by section 510(j), 510(k), 905(i), or 905(j), or the 
failure to provide a notice required by section 510(j)(2) 
or 905(i)(2).’’; 
(10) by striking subsection (q)(1) and inserting 
the following: 
‘‘(q)(1) The failure or refusal—
‘‘(A) to comply with any requirement prescribed 
under section 518, 520(g), 903(b)(8), or 908, or 
condition 
prescribed 
under 
section 
903(b)(6)(B)(ii)(II); 
‘‘(B) to furnish any notification or other mate-
rial or information required by or under section 519, 
520(g), 904, 909, or section 921; or 
‘‘(C) to comply with a requirement under sec-
tion 522 or 913.’’; 
(11) in subsection (q)(2), by striking ‘‘device,’’ 
and inserting ‘‘device or tobacco product,’’;
(12) in subsection (r), by inserting ‘‘or tobacco 
product’’ after ‘‘device’’ each time that it appears; 
and 
(13) by adding at the end the following:
125
‘‘(aa) The sale of tobacco products in violation 
of a no-tobacco-sale order issued under section 
303(f). 
‘‘(bb) The introduction or delivery for introduc-
tion into interstate commerce of a tobacco product 
in violation of section 911. 
‘‘(cc)(1) Forging, counterfeiting, simulating, or 
falsely representing, or without proper authority 
using any mark, stamp (including tax stamp), tag, 
label, or other identification device upon any tobacco 
product or container or labeling thereof so as to 
render such tobacco product a counterfeit tobacco 
product. 
‘‘(2) Making, selling, disposing of, or keeping in 
possession, control, or custody, or concealing any 
punch, die, plate, stone, or other item that is de-
signed to print, imprint, or reproduce the trade-
mark, trade name, or other identifying mark, im-
print, or device of another or any likeness of any of 
the foregoing upon any tobacco product or container 
or labeling thereof so as to render such tobacco 
product a counterfeit tobacco product. 
‘‘(3) The doing of any act that causes a tobacco 
product to be a counterfeit tobacco product, or the
126
sale or dispensing, or the holding for sale or dis-
pensing, of a counterfeit tobacco product. 
‘‘(dd) The charitable distribution of tobacco 
products.
‘‘(ee) The failure of a manufacturer or dis-
tributor to notify the Attorney General of their 
knowledge of tobacco products used in illicit trade.’’. 
(c) SECTION 303.—Section 303 (21 U.S.C. 333(f)) 
is amended in subsection (f)—
(1) by striking the subsection heading and in-
serting the following: 
‘‘(f) CIVIL
PENALTIES; NO-TOBACCO-SALE
OR-
DERS.—’’; 
(2) in paragraph (1)(A), by inserting ‘‘or to-
bacco products’’ after ‘‘devices’’; 
(3) by redesignating paragraphs (3), (4), and 
(5) as paragraphs (4), (5), and (6), and inserting 
after paragraph (2) the following: 
‘‘(3) If the Secretary finds that a person has 
committed repeated violations of restrictions promul-
gated under section 906(d) at a particular retail out-
let then the Secretary may impose a no-tobacco-sale 
order on that person prohibiting the sale of tobacco 
products in that outlet. A no-tobacco-sale order may
127
be imposed with a civil penalty under paragraph 
(1).’’; 
(4) in paragraph (4) as so redesignated—
(A) in subparagraph (A)—
(i) by striking ‘‘assessed’’ the first 
time it appears and inserting ‘‘assessed, or 
a no-tobacco-sale order may be imposed,’’; 
and 
(ii) by striking ‘‘penalty’’ and insert-
ing ‘‘penalty, or upon whom a no-tobacco-
order is to be imposed,’’; 
(B) in subparagraph (B)—
(i) by inserting after ‘‘penalty,’’ the 
following: ‘‘or the period to be covered by 
a no-tobacco-sale order,’’; and 
(ii) by adding at the end the fol-
lowing: ‘‘A no-tobacco-sale order perma-
nently prohibiting an individual retail out-
let from selling tobacco products shall in-
clude provisions that allow the outlet, after 
a specified period of time, to request that 
the Secretary compromise, modify, or ter-
minate the order.’’; and 
(C) by adding at the end, the following:
128
‘‘(D) The Secretary may compromise, mod-
ify, or terminate, with or without conditions, 
any no-tobacco-sale order.’’; 
(5) in paragraph (5) as so redesignated—
(A) by striking ‘‘(3)(A)’’ as redesignated, 
and inserting ‘‘(4)(A)’’; 
(B) by inserting ‘‘or the imposition of a 
no-tobacco-sale order’’ after ‘‘penalty’’ the first 
2 places it appears; and 
(C) by striking ‘‘issued.’’ and inserting 
‘‘issued, or on which the no-tobacco-sale order 
was imposed, as the case may be.’’; and 
(6) in paragraph (6), as so redesignated, by 
striking ‘‘paragraph (4)’’ each place it appears and 
inserting ‘‘paragraph (5)’’. 
(d) SECTION 304.—Section 304 (21 U.S.C. 334) is 
amended—
(1) in subsection (a)(2)—
(A) by striking ‘‘and’’ before ‘‘(D)’’; and 
(B) by striking ‘‘device.’’ and inserting the 
following: ‘‘, (E) Any adulterated or misbranded 
tobacco product.’’; 
(2) in subsection (d)(1), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’;
129
(3) in subsection (g)(1), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’ each place it appears; 
and 
(4) in subsection (g)(2)(A), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’ each place it appears. 
(e) SECTION
702.—Section 702(a) (21 U.S.C. 
372(a)) is amended—
(1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and 
(2) by adding at the end thereof the following: 
‘‘(2) For a tobacco product, to the extent feasible, 
the Secretary shall contract with the States in accordance 
with paragraph (1) to carry out inspections of retailers 
in connection with the enforcement of this Act.’’. 
(f) SECTION 703.—Section 703 (21 U.S.C. 373) is 
amended—
(1) by inserting ‘‘tobacco product,’’ after ‘‘de-
vice,’’ each place it appears; and 
(2) by inserting ‘‘tobacco products,’’ after ‘‘de-
vices,’’ each place it appears. 
(g) SECTION 704.—Section 704 (21 U.S.C. 374) is 
amended—
(1) in subsection (a)(1)(A), by inserting ‘‘to-
bacco products,’’ after ‘‘devices,’’ each place it ap-
pears;
130
(2) in subsection (a)(1)(B), by inserting ‘‘or to-
bacco product’’ after ‘‘restricted devices’’ each place 
it appears; and 
(3) in subsection (b), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’. 
(h) SECTION
705.—Section 705(b) (21 U.S.C. 
375(b)) is amended by inserting ‘‘tobacco products,’’ after 
‘‘devices,’’. 
(i) SECTION 709.—Section 709 (21 U.S.C. 379) is 
amended by inserting ‘‘or tobacco product’’ after ‘‘device’’. 
(j) SECTION 801.—Section 801 (21 U.S.C. 381) is 
amended—
(1) in subsection (a)—
(A) by inserting ‘‘tobacco products,’’ after 
‘‘devices,’’ the first time it appears; 
(B) by inserting ‘‘or section 905(j)’’ after 
‘‘section 510’’; and 
(C) by striking ‘‘drugs or devices’’ each 
time it appears and inserting ‘‘drugs, devices, 
or tobacco products’’; 
(2) in subsection (e)(1), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; and 
(3) by adding at the end the following: 
‘‘(p)(1) Not later than 2 years after the date of enact-
ment of the Family Smoking Prevention and Tobacco
131
Control Act, and annually thereafter, the Secretary shall 
submit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives, a report 
regarding—
‘‘(A) the nature, extent, and destination of 
United States tobacco product exports that do not 
conform to tobacco product standards established 
pursuant to this Act; 
‘‘(B) the public health implications of such ex-
ports, including any evidence of a negative public 
health impact; and 
‘‘(C) recommendations or assessments of policy 
alternatives available to Congress and the Executive 
Branch to reduce any negative public health impact 
caused by such exports. 
‘‘(2) The Secretary is authorized to establish appro-
priate information disclosure requirements to carry out 
this subsection.’’. 
(k) SECTION 1003.—Section 1003(d)(2)(C) (as re-
designated by section 101(a)) is amended—
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 
(2) inserting a comma and ‘‘and tobacco prod-
ucts’’ after ‘‘devices’’.
132
(l) 
EFFECTIVE
DATE
FOR
NO-TOBACCO-SALE 
ORDER AMENDMENTS.—The amendments made by sub-
section (c), other than the amendment made by paragraph 
(2) of such subsection, shall take effect upon the issuance 
of guidance by the Secretary of Health and Human Serv-
ices—
(1) defining the term ‘‘repeated violation’’, as 
used in section 303(f) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 333(f)) as amended by 
subsection (c), by identifying the number of viola-
tions of particular requirements over a specified pe-
riod of time at a particular retail outlet that con-
stitute a repeated violation; 
(2) providing for timely and effective notice to 
the retailer of each alleged violation at a particular 
retail outlet and an expedited procedure for the ad-
ministrative appeal of an alleged violation; 
(3) providing that a person may not be charged 
with a violation at a particular retail outlet unless 
the Secretary has provided notice to the retailer of 
all previous violations at that outlet; 
(4) establishing a period of time during which, 
if there are no violations by a particular retail out-
let, that outlet will not considered to have been the
133
site of repeated violations when the next violation 
occurs; and 
(5) providing that good faith reliance on the 
presentation of a false government issued photo-
graphic identification that contains the bearer’s date 
of birth does not constitute a violation of any min-
imum age requirement for the sale of tobacco prod-
ucts if the retailer has taken effective steps to pre-
vent such violations, including—
(A) adopting and enforcing a written policy 
against sales to minors; 
(B) informing its employees of all applica-
ble laws; 
(C) establishing disciplinary sanctions for 
employee noncompliance; and 
(D) requiring its employees to verify age 
by way of photographic identification or elec-
tronic scanning device.
134
TITLE 
II—TOBACCO 
PRODUCT 
WARNINGS; 
CONSTITUENT 
AND 
SMOKE 
CONSTITUENT 
DISCLOSURE 
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 
Section 4 of the Federal Cigarette Labeling and Ad-
vertising Act (15 U.S.C. 1333) is amended to read as fol-
lows: 
‘‘SEC. 4. LABELING. 
‘‘(a) LABEL REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any 
person to manufacture, package, sell, offer to sell, 
distribute, or import for sale or distribution within 
the United States any cigarettes the package of 
which fails to bear, in accordance with the require-
ments of this section, one of the following labels: 
‘WARNING: Cigarettes are addictive’. 
‘WARNING: Tobacco smoke can harm your chil-
dren’. 
‘WARNING: Cigarettes cause fatal lung disease’. 
‘WARNING: Cigarettes cause cancer’. 
‘WARNING: Cigarettes cause strokes and heart dis-
ease’. 
‘WARNING: Smoking during pregnancy can harm 
your baby’.
135
‘WARNING: Smoking can kill you’. 
‘WARNING: Tobacco smoke causes fatal lung dis-
ease in non-smokers’. 
‘WARNING: Quitting smoking now greatly reduces 
serious risks to your health’. 
‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—
‘‘(A) IN GENERAL.—Each label statement 
required by paragraph (1) shall be located in 
the upper portion of the front and rear panels 
of the package, directly on the package under-
neath the cellophane or other clear wrapping. 
Except as provided in subparagraph (B), each 
label statement shall comprise at least the top 
30 percent of the front and rear panels of the 
package. The word ‘WARNING’ shall appear in 
capital letters and all text shall be in con-
spicuous and legible 17-point type, unless the 
text of the label statement would occupy more 
than 70 percent of such area, in which case the 
text may be in a smaller conspicuous and leg-
ible type size, provided that at least 60 percent 
of such area is occupied by required text. The 
text shall be black on a white background, or 
white on a black background, in a manner that 
contrasts, by typography, layout, or color, with
136
all other printed material on the package, in an 
alternating fashion under the plan submitted 
under subsection (b)(4). 
‘‘(B) FLIP-TOP BOXES.—For any cigarette 
brand package manufactured or distributed be-
fore January 1, 2000, which employs a flip-top 
style (if such packaging was used for that 
brand in commerce prior to June 21, 1997), the 
label statement required by paragraph (1) shall 
be located on the flip-top area of the package, 
even if such area is less than 25 percent of the 
area of the front panel. Except as provided in 
this paragraph, the provisions of this subsection 
shall apply to such packages. 
‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU-
TION.—The provisions of this subsection do not 
apply to a tobacco product manufacturer or dis-
tributor of cigarettes which does not manufacture, 
package, or import cigarettes for sale or distribution 
within the United States. 
‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 
of cigarettes shall not be in violation of this sub-
section for packaging that is supplied to the retailer 
by a tobacco product manufacturer, importer, or dis-
tributor and is not altered by the retailer in a way
137
that is material to the requirements of this sub-
section except that this paragraph shall not relieve 
a retailer of liability if the retailer sells or distributes 
tobacco products that are not labeled in accordance 
with this subsection. 
‘‘(b) ADVERTISING REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any 
tobacco product manufacturer, importer, distributor, 
or retailer of cigarettes to advertise or cause to be 
advertised within the United States any cigarette 
unless its advertising bears, in accordance with the 
requirements of this section, one of the labels speci-
fied in subsection (a) of this section. 
‘‘(2) TYPOGRAPHY, ETC.—Each label statement 
required by subsection (a) of this section in cigarette 
advertising shall comply with the standards set forth 
in this paragraph. For press and poster advertise-
ments, each such statement and (where applicable) 
any required statement relating to tar, nicotine, or 
other constituent (including a smoke constituent) 
yield shall comprise at least 20 percent of the area 
of the advertisement and shall appear in a con-
spicuous and prominent format and location at the 
top of each advertisement within the trim area. The 
Secretary may revise the required type sizes in such
138
area in such manner as the Secretary determines ap-
propriate. The word ‘WARNING’ shall appear in 
capital letters, and each label statement shall appear 
in conspicuous and legible type. The text of the label 
statement shall be black if the background is white 
and white if the background is black, under the plan 
submitted under paragraph (4) of this subsection. 
The label statements shall be enclosed by a rectan-
gular border that is the same color as the letters 
of the statements and that is the width of the first 
downstroke of the capital ‘W’ of the word ‘WARN-
ING’ in the label statements. The text of such label 
statements shall be in a typeface pro rata to the fol-
lowing requirements: 45-point type for a whole-page 
broadsheet newspaper advertisement; 39-point type 
for a half-page broadsheet newspaper advertisement; 
39-point type for a whole-page tabloid newspaper ad-
vertisement; 27-point type for a half-page tabloid 
newspaper advertisement; 31.5-point type for a dou-
ble page spread magazine or whole-page magazine 
advertisement; 22.5-point type for a 28 centimeter 
by 3 column advertisement; and 15-point type for 
a 20 centimeter by 2 column advertisement. The 
label statements shall be in English, except that in 
the case of—
139 
‘‘(A) an advertisement that appears in a 
newspaper, magazine, periodical, or other publi-
cation that is not in English, the statements 
shall appear in the predominant language of the 
publication; and 
‘‘(B) in the case of any other advertise-
ment that is not in English, the statements 
shall appear in the same language as that prin-
cipally used in the advertisement. 
‘‘(3) 
MATCHBOOKS.—Notwithstanding 
para-
graph (2), for matchbooks (defined as containing not 
more than 20 matches) customarily given away with 
the purchase of tobacco products, each label state-
ment required by subsection (a) may be printed on 
the inside cover of the matchbook. 
‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec-
retary may, through a rulemaking under section 553 
of title 5, United States Code, adjust the format and 
type sizes for the label statements required by this 
section or the text, format, and type sizes of any re-
quired tar, nicotine yield, or other constituent (in-
cluding smoke constituent) disclosures, or to estab-
lish the text, format, and type sizes for any other 
disclosures required under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.). The text
140
of any such label statements or disclosures shall be 
required to appear only within the 20 percent area 
of cigarette advertisements provided by paragraph 
(2) of this subsection. The Secretary shall promul-
gate regulations which provide for adjustments in 
the format and type sizes of any text required to ap-
pear in such area to ensure that the total text re-
quired to appear by law will fit within such area. 
‘‘(5) MARKETING REQUIREMENTS.—
‘‘(A) The label statements specified in sub-
section (a)(1) shall be randomly displayed in 
each 12-month period, in as equal a number of 
times as is possible on each brand of the prod-
uct and be randomly distributed in all areas of 
the United States in which the product is mar-
keted in accordance with a plan submitted by 
the tobacco product manufacturer, importer, 
distributor, or retailer and approved by the Sec-
retary. 
‘‘(B) The label statements specified in sub-
section (a)(1) shall be rotated quarterly in al-
ternating sequence in advertisements for each 
brand of cigarettes in accordance with a plan 
submitted by the tobacco product manufacturer,
141
importer, distributor, or retailer to, and ap-
proved by, the Secretary. 
‘‘(C) The Secretary shall review each plan 
submitted under subparagraph (B) and approve 
it if the plan—
‘‘(i) will provide for the equal distribu-
tion and display on packaging and the ro-
tation required in advertising under this 
subsection; and 
‘‘(ii) assures that all of the labels re-
quired under this section will be displayed 
by the tobacco product manufacturer, im-
porter, distributor, or retailer at the same 
time. 
‘‘(6) APPLICABILITY TO RETAILERS.—This sub-
section applies to a retailer only if that retailer is re-
sponsible for or directs the label statements required 
under this section except that this paragraph shall 
not relieve a retailer of liability if the retailer dis-
plays, in a location open to the public, an advertise-
ment that is not labeled in accordance with the re-
quirements of this subsection.’’.
142
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 
LABEL STATEMENTS. 
Section 4 of the Federal Cigarette Labeling and Ad-
vertising Act (15 U.S.C. 1333), as amended by section 
201, is further amended by adding at the end the fol-
lowing: 
‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec-
retary may, by a rulemaking conducted under section 553 
of title 5, United States Code, adjust the format, type size, 
and text of any of the label requirements, require color 
graphics to accompany the text, increase the required label 
area from 30 percent up to 50 percent of the front and 
rear panels of the package, or establish the format, type 
size, and text of any other disclosures required under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.), if the Secretary finds that such a change would 
promote greater public understanding of the risks associ-
ated with the use of tobacco products.’’. 
SEC. 203. STATE REGULATION OF CIGARETTE ADVER-
TISING AND PROMOTION. 
Section 5 of the Federal Cigarette Labeling and Ad-
vertising Act (15 U.S.C. 1334) is amended by adding at 
the end the following: 
‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 
State or locality may enact statutes and promulgate regu-
lations, based on smoking and health, that take effect
143
after the effective date of the Family Smoking Prevention 
and Tobacco Control Act, imposing specific bans or re-
strictions on the time, place, and manner, but not content, 
of the advertising or promotion of any cigarettes.’’. 
SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 
WARNINGS. 
Section 3 of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (15 U.S.C. 4402) is amend-
ed to read as follows: 
‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 
‘‘(a) GENERAL RULE.— 
‘‘(1) It shall be unlawful for any person to man-
ufacture, package, sell, offer to sell, distribute, or 
import for sale or distribution within the United 
States any smokeless tobacco product unless the 
product package bears, in accordance with the re-
quirements of this Act, one of the following labels: 
‘WARNING: This product can cause mouth cancer’. 
‘WARNING: This product can cause gum disease 
and tooth loss’. 
‘WARNING: This product is not a safe alternative 
to cigarettes’. 
‘WARNING: Smokeless tobacco is addictive’. 
‘‘(2) Each label statement required by para-
graph (1) shall be—
144
‘‘(A) located on the 2 principal display 
panels of the package, and each label statement 
shall comprise at least 30 percent of each such 
display panel; and 
‘‘(B) in 17-point conspicuous and legible 
type and in black text on a white background, 
or white text on a black background, in a man-
ner that contrasts by typography, layout, or 
color, with all other printed material on the 
package, in an alternating fashion under the 
plan submitted under subsection (b)(3), except 
that if the text of a label statement would oc-
cupy more than 70 percent of the area specified 
by subparagraph (A), such text may appear in 
a smaller type size, so long as at least 60 per-
cent of such warning area is occupied by the 
label statement. 
‘‘(3) The label statements required by para-
graph (1) shall be introduced by each tobacco prod-
uct manufacturer, packager, importer, distributor, or 
retailer of smokeless tobacco products concurrently 
into the distribution chain of such products. 
‘‘(4) The provisions of this subsection do not 
apply to a tobacco product manufacturer or dis-
tributor of any smokeless tobacco product that does
145
not manufacture, package, or import smokeless to-
bacco products for sale or distribution within the 
United States. 
‘‘(5) A retailer of smokeless tobacco products 
shall not be in violation of this subsection for pack-
aging that is supplied to the retailer by a tobacco 
products manufacturer, importer, or distributor and 
that is not altered by the retailer unless the retailer 
offers for sale, sells, or distributes a smokeless to-
bacco product that is not labeled in accordance with 
this subsection. 
‘‘(b) REQUIRED LABELS.—
‘‘(1) It shall be unlawful for any tobacco prod-
uct manufacturer, packager, importer, distributor, or 
retailer of smokeless tobacco products to advertise or 
cause to be advertised within the United States any 
smokeless tobacco product unless its advertising 
bears, in accordance with the requirements of this 
section, one of the labels specified in subsection (a). 
‘‘(2) Each label statement required by sub-
section (a) in smokeless tobacco advertising shall 
comply with the standards set forth in this para-
graph. For press and poster advertisements, each 
such statement and (where applicable) any required
146
statement relating to tar, nicotine, or other con-
stituent yield shall—
‘‘(A) comprise at least 20 percent of the 
area of the advertisement, and the warning area 
shall be delineated by a dividing line of con-
trasting color from the advertisement; and 
‘‘(B) the word ‘WARNING’ shall appear in 
capital letters and each label statement shall 
appear in conspicuous and legible type. The text 
of the label statement shall be black on a white 
background, or white on a black background, in 
an alternating fashion under the plan submitted 
under paragraph (3). 
‘‘(3)(A) The label statements specified in sub-
section (a)(1) shall be randomly displayed in each 
12-month period, in as equal a number of times as 
is possible on each brand of the product and be ran-
domly distributed in all areas of the United States 
in which the product is marketed in accordance with 
a plan submitted by the tobacco product manufac-
turer, importer, distributor, or retailer and approved 
by the Secretary. 
‘‘(B) The label statements specified in sub-
section (a)(1) shall be rotated quarterly in alter-
nating sequence in advertisements for each brand of
147
smokeless tobacco product in accordance with a plan 
submitted by the tobacco product manufacturer, im-
porter, distributor, or retailer to, and approved by, 
the Secretary. 
‘‘(C) The Secretary shall review each plan sub-
mitted under subparagraph (B) and approve it if the 
plan—
‘‘(i) will provide for the equal distribution 
and display on packaging and the rotation re-
quired in advertising under this subsection; and 
‘‘(ii) assures that all of the labels required 
under this section will be displayed by the to-
bacco product manufacturer, importer, dis-
tributor, or retailer at the same time. 
‘‘(D) This paragraph applies to a retailer only 
if that retailer is responsible for or directs the label 
statements under this section, unless the retailer dis-
plays in a location open to the public, an advertise-
ment that is not labeled in accordance with the re-
quirements of this subsection. 
‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 
unlawful to advertise smokeless tobacco on any medium 
of electronic communications subject to the jurisdiction of 
the Federal Communications Commission.’’.
148
SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 
PRODUCT WARNING LABEL STATEMENTS. 
Section 3 of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (15 U.S.C. 4402), as 
amended by section 203, is further amended by adding 
at the end the following: 
‘‘(d) AUTHORITY
TO
REVISE
WARNING
LABEL 
STATEMENTS.—The Secretary may, by a rulemaking con-
ducted under section 553 of title 5, United States Code, 
adjust the format, type size, and text of any of the label 
requirements, require color graphics to accompany the 
text, increase the required label area from 30 percent up 
to 50 percent of the front and rear panels of the package, 
or establish the format, type size, and text of any other 
disclosures required under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary 
finds that such a change would promote greater public un-
derstanding of the risks associated with the use of smoke-
less tobacco products.’’. 
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON-
STITUENT DISCLOSURE TO THE PUBLIC. 
Section 4(a) of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1333 (a)), as amended by sec-
tion 201, is further amended by adding at the end the 
following:
149
‘‘(4)(A) The Secretary shall, by a rulemaking 
conducted under section 553 of title 5, United 
States Code, determine (in the Secretary’s sole dis-
cretion) whether cigarette and other tobacco product 
manufacturers shall be required to include in the 
area of each cigarette advertisement specified by 
subsection (b) of this section, or on the package 
label, or both, the tar and nicotine yields of the ad-
vertised or packaged brand. Any such disclosure 
shall be in accordance with the methodology estab-
lished under such regulations, shall conform to the 
type size requirements of subsection (b) of this sec-
tion, and shall appear within the area specified in 
subsection (b) of this section. 
‘‘(B) Any differences between the requirements 
established by the Secretary under subparagraph (A) 
and tar and nicotine yield reporting requirements es-
tablished by the Federal Trade Commission shall be 
resolved by a memorandum of understanding be-
tween the Secretary and the Federal Trade Commis-
sion. 
‘‘(C) In addition to the disclosures required by 
subparagraph (A) of this paragraph, the Secretary 
may, under a rulemaking conducted under section 
553 of title 5, United States Code, prescribe disclo-
150
sure requirements regarding the level of any ciga-
rette or other tobacco product constituent including 
any smoke constituent. Any such disclosure may be 
required if the Secretary determines that disclosure 
would be of benefit to the public health, or otherwise 
would increase consumer awareness of the health 
consequences of the use of tobacco products, except 
that no such prescribed disclosure shall be required 
on the face of any cigarette package or advertise-
ment. Nothing in this section shall prohibit the Sec-
retary from requiring such prescribed disclosure 
through a cigarette or other tobacco product pack-
age or advertisement insert, or by any other means 
under the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.). 
‘‘(D) This paragraph applies to a retailer only 
if that retailer is responsible for or directs the label 
statements required under this section, except that 
this paragraph shall not relieve a retailer of liability 
if the retailer sells or distributes tobacco products 
that are not labeled in accordance with the require-
ments of this subsection.’’.
151
TITLE III—PREVENTION OF IL-
LICIT 
TRADE 
IN 
TOBACCO 
PRODUCTS 
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC-
TION. 
Chapter IX of the Federal Food, Drug, and Cosmetic 
Act, as added by section 101, is further amended by add-
ing at the end the following: 
‘‘SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPEC-
TION. 
‘‘(a) ORIGIN LABELING.—The label, packaging, and 
shipping containers of tobacco products for introduction 
or delivery for introduction into interstate commerce shall 
bear the statement ‘sale only allowed in the United 
States.’
‘‘(b) REGULATIONS CONCERNING RECORDKEEPING 
FOR TRACKING AND TRACING.—
‘‘(1) IN GENERAL.—Not later than 9 months 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary 
shall promulgate regulations regarding the establish-
ment and maintenance of records by any person who 
manufactures, processes, transports, distributes, re-
ceives, packages, holds, exports, or imports tobacco 
products.
152
‘‘(2) INSPECTION.—In promulgating the regula-
tions described in paragraph (1), the Secretary shall 
consider which records are needed for inspection to 
monitor the movement of tobacco products from the 
point of manufacture through distribution to retail 
outlets to assist in investigating potential illicit 
trade, smuggling or counterfeiting of tobacco prod-
ucts. 
‘‘(3) CODES.—The Secretary may require codes 
on the labels of tobacco products or other designs or 
devices for the purpose of tracking or tracing the to-
bacco product through the distribution system. 
‘‘(4) SIZE OF BUSINESS.—The Secretary shall 
take into account the size of a business in promul-
gating regulations under this section. 
‘‘(5) RECORDKEEPING
BY
RETAILERS.—The 
Secretary shall not require any retailer to maintain 
records relating to individual purchasers of tobacco 
products for personal consumption. 
‘‘(c) RECORDS INSPECTION.—If the Secretary has a 
reasonable belief that a tobacco product is part of an illicit 
trade or smuggling or is a counterfeit product, each person 
who manufactures, processes, transports, distributes, re-
ceives, holds, packages, exports, or imports tobacco prod-
ucts shall, at the request of an officer or employee duly
153 
designated by the Secretary, permit such officer or em-
ployee, at reasonable times and within reasonable limits 
and in a reasonable manner, upon the presentation of ap-
propriate credentials and a written notice to such person, 
to have access to and copy all records (including financial 
records) relating to such article that are needed to assist 
the Secretary in investigating potential illicit trade, smug-
gling or counterfeiting of tobacco products. 
‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.—If 
the manufacturer or distributor of a tobacco product has 
knowledge which reasonably supports the conclusion that 
a tobacco product manufactured or distributed by such 
manufacturer or distributor that has left the control of 
such person may be or has been— 
‘‘(A) imported, exported, distributed or of-
fered for sale in interstate commerce by a per-
son without paying duties or taxes required by 
law; or 
‘‘(B) imported, exported, distributed or di-
verted for possible illicit marketing, 
the manufacturer or distributor shall promptly notify the 
Attorney General of such knowledge. 
‘‘(1) KNOWLEDGE DEFINED.—For purposes of 
this subsection, the term ‘knowledge’ as applied to 
a manufacturer or distributor means—
154
‘‘(A) the actual knowledge that the manu-
facturer or distributor had; or 
‘‘(B) the knowledge which a reasonable 
person would have had under like circumstances 
or which would have been obtained upon the ex-
ercise of due care.’’
SEC. 302. STUDY AND REPORT. 
(a) STUDY.—The Comptroller General of the United 
States shall conduct a study of cross-border trade in to-
bacco products to—
(1) collect data on cross-border trade in tobacco 
products, including illicit trade and trade of counter-
feit tobacco products and make recommendations on 
the monitoring of such trade; 
(2) collect data on cross-border advertising (any 
advertising intended to be broadcast, transmitted, or 
distributed from the United States to another coun-
try) of tobacco products and make recommendations 
on how to prevent or eliminate, and what tech-
nologies could help facilitate the elimination of, 
cross-border advertising. 
(b) REPORT.—Not later than 18 months after the 
date of enactment of this Act, the Comptroller General 
of the United States shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and
155
the Committee on Energy and Commerce of the House 
of Representatives a report on the study described in sub-
section (a).
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