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(20) Children are exposed to substantial and un-
avoidable tobacco advertising that leads to favorable
beliefs about tobacco use, plays a role in leading
young people to overestimate the prevalence of tobacco
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 tobacco
products including tobacco use by young people.
(23) Children are more influenced by tobacco ad-
vertising than adults, they smoke the most advertised
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.
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(26) Restrictions on advertising are necessary to
prevent unrestricted tobacco advertising from under-
mining 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 comprehensive
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 consistent with
the First Amendment to the United States Constitu-
tion and with the standards set forth in the amend-
ments made by this subtitle for the regulation of to-
bacco products by the Food and Drug Administration
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and the restriction on the sale and distribution, in-
cluding access to and the advertising and promotion
of, tobacco products contained in such regulations are
substantially related to accomplishing the public
health goals of this subtitle.
(31) The regulations described in paragraph (30)
will directly and materially advance the Federal Gov-
ernment’s substantial interest in reducing the number
of children and adolescents who use cigarettes and
smokeless tobacco and in preventing the life-threat-
ening health consequences associated with tobacco use.
An overwhelming majority of Americans who use to-
bacco 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 crucial role in the
decision of these minors to begin using tobacco prod-
ucts. Less restrictive and less comprehensive ap-
proaches have not and will not be effective in reduc-
ing the problems addressed by such regulations. The
reasonable restrictions on the advertising and pro-
motion of tobacco products contained in such regula-
tions will lead to a significant decrease in the number
of minors using and becoming addicted to those prod-
ucts.
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(32) The regulations described in paragraph (30)
impose no more extensive restrictions on communica-
tion by tobacco manufacturers and sellers than are
necessary to reduce the number of children and ado-
lescents who use cigarettes and smokeless tobacco and
to prevent the life-threatening health consequences as-
sociated with tobacco use. Such regulations are nar-
rowly tailored to restrict those advertising and pro-
motional practices which are most likely 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 convey information
about their products to adult consumers.
(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.
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(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 re-
duce the risks to the public of tobacco use actually re-
duce such risks, those products can cause substantial
harm to the public health to the extent that the indi-
viduals, who would otherwise not consume tobacco
products or would consume such products less, use to-
bacco products purporting to reduce risk. Those who
use products sold or distributed as modified risk prod-
ucts that do not in fact reduce risk, rather than quit-
ting or reducing their use of tobacco products, have
a substantially increased likelihood of suffering dis-
ability and premature death. The costs to society of
the widespread use of products sold or distributed as
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modified risk products that do not in fact reduce risk
or that increase risk include thousands 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 problems than
other cigarettes. As the National Cancer Institute has
also found, mistaken beliefs about the health con-
sequences of smoking ‘‘low tar’’ and ‘‘light’’ cigarettes
can reduce the motivation to quit smoking entirely
and thereby lead to disease and death.
(39) Recent studies have demonstrated that there
has been no reduction in risk on a population-wide
basis from ‘‘low tar’’ and ‘‘light’’ cigarettes and such
products may actually increase the risk of tobacco
use.
(40) The dangers of products sold or distributed
as modified risk tobacco products that do not in fact
reduce risk are so high that there is a compelling gov-
ernmental interest in insuring that statements about
modified risk tobacco products are complete, accurate,
and relate to the overall disease risk of the product.
(41) As the Federal Trade Commission has
found, consumers have misinterpreted advertisements
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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 clari-
fication.
(42) Permitting manufacturers to make unsub-
stantiated statements concerning modified risk to-
bacco products, whether express or implied, even if ac-
companied by disclaimers would be detrimental to the
public health.
(43) The only way to effectively protect the pub-
lic health from the dangers of unsubstantiated modi-
fied risk tobacco products is to empower the Food and
Drug Administration to require that products that to-
bacco manufacturers sold or distributed for risk re-
duction be approved in advance of marketing, and to
require that the evidence relied on to support ap-
proval of these products is rigorous.
SEC. 1103. PURPOSE.
The purposes of this subtitle 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 reg-
ulatory authority with respect to the manufacture,
marketing, and distribution of tobacco products;
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(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 Administra-
tion to set national standards controlling the manu-
facture 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;
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(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 underage
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. 1104. SCOPE AND EFFECT.
(a) INTENDED EFFECT.—Nothing in this subtitle (or
an amendment made by this subtitle) 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 subtitle (or an amendment made by this subtitle) which
authorize the Secretary to take certain actions with regard
to tobacco and tobacco products shall not be construed to
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affect any authority of the Secretary of Agriculture under
existing law regarding the growing, cultivation, or curing
of raw tobacco.
SEC. 1105. SEVERABILITY.
If any provision of this subtitle, the amendments made
by this subtitle, or the application of any provision of this
subtitle to any person or circumstance is held to be invalid,
the remainder of this subtitle, the amendments made by this
subtitle, and the application of the provisions of this subtitle
to any other person or circumstance shall not be affected
and shall continue to be enforced to the fullest extent pos-
sible.
CHAPTER 1—AUTHORITY OF THE FOOD
AND DRUG ADMINISTRATION
SEC. 1111. 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 following:
‘‘(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 ac-
cessory of a tobacco product (except for raw materials other
than tobacco used in manufacturing a component, part, or
accessory of a tobacco product).
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‘‘(2) The term ‘tobacco product’ does not mean—
‘‘(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 capsule,
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, medical
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:
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‘‘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 indirectly,
in its becoming a component or otherwise affecting
the characteristic of any tobacco product (including
any substances intended for use as a flavoring, color-
ing or in producing, manufacturing, packing, proc-
essing, preparing, treating, packaging, transporting,
or holding), except that such term does not include to-
bacco or a pesticide chemical residue in or on raw to-
bacco or a pesticide chemical.
‘‘(2) BRAND.—The term ‘brand’ means a variety
of tobacco product distinguished by the tobacco used,
tar content, nicotine content, flavoring used, size, fil-
tration, or packaging, logo, registered trademark 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
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form, that is functional in the product, which, because
of its appearance, the type of tobacco used in the
filler, or its packaging and labeling, is likely to be of-
fered to, or purchased by, consumers as a cigarette or
as roll-your-own tobacco.
‘‘(4) CIGARETTE TOBACCO.—The term ‘cigarette
tobacco’ means any product that consists of loose to-
bacco that is intended for use by consumers in a ciga-
rette. Unless otherwise stated, the requirements for
cigarettes shall also apply to cigarette tobacco.
‘‘(5) COMMERCE.—The term ‘commerce’ has the
meaning given that term by section 3(2) of the Fed-
eral 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 trademark,
trade name, or other identifying mark, imprint or de-
vice, or any likeness thereof, of a tobacco product list-
ed in a registration under section 905(i)(1).
‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as
regards a tobacco product means any person who fur-
thers the distribution of a tobacco product, whether
domestic or imported, at any point from the original
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place of manufacture to the person who sells or dis-
tributes the product to individuals for personal con-
sumption. Common carriers are not considered dis-
tributors 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, posses-
sion, distribution, sale, or purchase of tobacco prod-
ucts including any practice or conduct intended to fa-
cilitate such activity.
‘‘(9) INDIAN TRIBE.—The term ‘Indian tribe’ has
the meaning given such term in section 4(e) of the In-
dian Self Determination and Education Assistance
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 cellophane),
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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 per-
mitted.
‘‘(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 cigarettes.
‘‘(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 ciga-
rette to the smoke or that is formed by the combustion
or heating of tobacco, additives, or other component of
the tobacco product.
‘‘(16) SMOKELESS TOBACCO.—The term ‘smoke-
less 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
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chapter, includes the District of Columbia, the Com-
monwealth of Puerto Rico, Guam, the Virgin Islands,
American Samoa, Wake Island, Midway Islands,
Kingman Reef, Johnston Atoll, the Northern Mariana
Islands, and any other trust territory or possession of
the United States.
‘‘(18) TOBACCO
PRODUCT
MANUFACTURER.—
Term ‘tobacco product manufacturer’ means any per-
son, including any repacker or relabeler, who—
‘‘(A) manufactures, fabricates, assembles,
processes, or labels a tobacco product; or
‘‘(B) imports a finished cigarette or smoke-
less tobacco product for sale or distribution 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 Mariana
Islands, and any other trust territory or possession of
the United States.
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‘‘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 di-
agnosis, 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 sec-
tion 1112 of the Family Smoking Prevention and Tobacco
Control Act, and to any other tobacco products that the Sec-
retary 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 Sec-
retary’s authority over, or the regulation of, products
under this Act that are not tobacco products under
chapter V or any other chapter.
‘‘(2) LIMITATION OF AUTHORITY.—
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‘‘(A) IN GENERAL.—The provisions of this
chapter shall not apply to tobacco leaf that is not
in the possession of a manufacturer of tobacco
products, or to the producers of tobacco leaf, in-
cluding tobacco growers, tobacco warehouses, and
tobacco grower cooperatives, nor shall any em-
ployee of the Food and Drug Administration
have any authority to enter onto a farm owned
by a producer of tobacco leaf without the written
consent of such producer.
‘‘(B) 
EXCEPTION.—Notwithstanding 
any
other provision of this subparagraph, if a pro-
ducer of tobacco leaf is also a tobacco product
manufacturer or controlled by a tobacco product
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 Sec-
retary authority to promulgate regulations on
any matter that involves the production of to-
bacco leaf or a producer thereof, other than ac-
tivities by a manufacturer affecting production.
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‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS.
‘‘A tobacco product shall be deemed to be adulterated
if—
‘‘(1) it consists in whole or in part of any filthy,
putrid, or decomposed substance, or is otherwise con-
taminated by any added poisonous or added delete-
rious substance that may render the product injurious
to health;
‘‘(2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been con-
taminated with filth, or whereby it may have been
rendered injurious to health;
‘‘(3) its package is composed, in whole or in
part, of any poisonous or deleterious substance which
may render the contents injurious to health;
‘‘(4) it is, or purports to be or is represented as,
a tobacco product which is subject to a tobacco prod-
uct standard established under section 907 unless such
tobacco product is in all respects in conformity with
such standard;
‘‘(5)(A) it is required by section 910(a) to have
premarket approval and does not have an approved
application in effect;
‘‘(B) it is in violation of the order approving
such an application; or
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‘‘(6) the methods used in, or the facilities or con-
trols used for, its manufacture, packing or storage are
not in conformity with applicable requirements under
section 906(e)(1) or an applicable condition pre-
scribed by an order under section 906(e)(2); or
‘‘(7) it is in violation of section 911.
‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—A tobacco product shall be deemed
to be misbranded—
‘‘(1) if its labeling is false or misleading in any
particular;
‘‘(2) if in package form unless it bears a label
containing—
‘‘(A) the name and place of business of the
tobacco product manufacturer, packer, or dis-
tributor;
‘‘(B) an accurate statement of the quantity
of the contents in terms of weight, measure, or
numerical count;
‘‘(C) an accurate statement of the percent-
age of the tobacco used in the product that is do-
mestically grown tobacco and the percentage that
is foreign grown tobacco; and
‘‘(D) the statement required under section
921(a),
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except that under subparagraph (B) reasonable vari-
ations shall be permitted, and exemptions as to small
packages shall be established, by regulations pre-
scribed by the Secretary;
‘‘(3) if any word, statement, or other informa-
tion required by or under authority of this chapter to
appear on the label or labeling is not prominently
placed thereon with such conspicuousness (as com-
pared with other words, statements or designs in the
labeling) and in such terms as to render it likely to
be read and understood by the ordinary individual
under customary conditions of purchase and use;
‘‘(4) if it has an established name, unless its
label bears, to the exclusion of any other nonpropri-
etary name, its established name prominently printed
in type as required by the Secretary by regulation;
‘‘(5) if the Secretary has issued regulations re-
quiring that its labeling bear adequate directions for
use, or adequate warnings against use by children,
that are necessary for the protection of users unless its
labeling conforms in all respects to such regulations;
‘‘(6) if it was manufactured, prepared, propa-
gated, compounded, or processed in any State in an
establishment not duly registered under section
905(b), 905(c), 905(d), or 905(h), if it was not in-
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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 system
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 manu-
facturer, packer, or distributor thereof includes in all
advertisements and other descriptive printed matter
issued or caused to be issued by the manufacturer,
packer, or distributor with respect to that tobacco
product—
‘‘(A) a true statement of the tobacco prod-
uct’s established name as described in paragraph
(4), printed prominently; and
‘‘(B) a brief statement of—
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‘‘(i) the uses of the tobacco product and
relevant warnings, precautions, side effects,
and contraindications; and
‘‘(ii) in the case of specific tobacco
products made subject to a finding by the
Secretary after notice and opportunity for
comment that such action is appropriate to
protect the public health, a full description
of the components of such tobacco product or
the formula showing quantitatively each in-
gredient of such tobacco product to the ex-
tent required in regulations which shall be
issued by the Secretary after an oppor-
tunity for a hearing;
‘‘(9) if it is a tobacco product subject to a to-
bacco product standard established under section 907,
unless it bears such labeling as may be prescribed in
such tobacco product standard; or
‘‘(10) if there was a failure or refusal—
‘‘(A) to comply with any requirement pre-
scribed under section 904 or 908; or
‘‘(B) to furnish any material or informa-
tion required under section 909.
‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.—The
Secretary may, by regulation, require prior approval of
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statements made on the label of a tobacco product. No regu-
lation issued under this subsection may require prior ap-
proval by the Secretary of the content of any advertisement,
except for modified risk tobacco products as provided in sec-
tion 911. No advertisement of a tobacco product published
after the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act shall, with respect to the lan-
guage of label statements as prescribed under section 4 of
the Cigarette Labeling and Advertising Act and section 3
of the Comprehensive Smokeless Tobacco 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 Commission 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 Sec-
retary 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 to-
bacco, paper, filter, or other part of each tobacco
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product by brand and by quantity in each brand and
subbrand.
‘‘(2) A description of the content, delivery, and
form of nicotine in each tobacco product measured in
milligrams of nicotine in accordance with regulations
promulgated by the Secretary in accordance with sec-
tion 4(a)(4) of the Federal Cigarette Labeling 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
915 in reporting information under this paragraph,
where applicable.
‘‘(4) All documents developed after the date of
enactment of the Family Smoking Prevention and To-
bacco Control Act that relate to health, toxicological,
behavioral, or physiologic effects of current or future
tobacco products, their constituents (including smoke
constituents), ingredients, components, and additives.
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practices used by tobacco manufacturers and distribu-
tors.
An importer of a tobacco product not manufactured in the
United States shall supply the information required of a
tobacco product manufacturer under this subsection.
‘‘(c) TIME FOR SUBMISSION.—
‘‘(1) IN GENERAL.—At least 90 days prior to the
delivery for introduction into interstate commerce of
a tobacco product not on the market on the date of
enactment of the Family Smoking Prevention and To-
bacco Control Act, the manufacturer of such product
shall provide the information required under sub-
section (a).
‘‘(2) DISCLOSURE OF ADDITIVE.—If at any time
a tobacco product manufacturer adds to its tobacco
products a new tobacco additive or increases the
quantity of an existing tobacco additive, the manufac-
turer shall, except as provided in paragraph (3), at
least 90 days prior to such action so advise the Sec-
retary in writing.
‘‘(3) DISCLOSURE
OF
OTHER
ACTIONS.—If at
any time a tobacco product manufacturer eliminates
or decreases an existing additive, or adds or increases
an additive that has by regulation been designated by
the Secretary as an additive that is not a human or
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animal carcinogen, or otherwise harmful to health
under intended conditions of use, the manufacturer
shall within 60 days of such action so advise the Sec-
retary in writing.
‘‘(d) DATA LIST.—
‘‘(1) IN GENERAL.—Not later than 3 years after
the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, and annually there-
after, the Secretary shall publish in a format that is
understandable and not misleading to a lay person,
and place on public display (in a manner determined
by the Secretary) the list established under subsection
(e).
‘‘(2) CONSUMER
RESEARCH.—The Secretary
shall conduct periodic consumer research to ensure
that the list published under paragraph (1) is not
misleading to lay persons. Not later than 5 years
after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the Secretary
shall submit to the appropriate committees of Con-
gress a report on the results of such research, together
with recommendations on whether such publication
should be continued or modified.
‘‘(e) DATA COLLECTION.—Not later than 12 months
after the date of enactment of the Family Smoking Preven-
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tion and Tobacco Control Act, the Secretary shall establish
a list of harmful and potentially harmful constituents, in-
cluding smoke constituents, to health in each tobacco prod-
uct by brand and by quantity in each brand and subbrand.
The Secretary shall publish a public notice requesting the
submission by interested persons of scientific and other in-
formation 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 ‘manufac-
ture, preparation, compounding, or processing’ shall
include repackaging or otherwise changing the con-
tainer, wrapper, or labeling of any tobacco product
package in furtherance of the distribution of the to-
bacco product from the original place of manufacture
to the person who makes final delivery or sale to the
ultimate consumer or user.
‘‘(2) NAME.—The term ‘name’ shall include in
the case of a partnership the name of each partner
and, in the case of a corporation, the name of each
corporate officer and director, and the State of incor-
poration.
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‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.—
On or before December 31 of each year every person who
owns or operates any establishment in any State engaged
in the manufacture, preparation, compounding, or proc-
essing of a tobacco product or tobacco products shall register
with the Secretary the name, places of business, and all such
establishments of that person.
‘‘(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 reg-
ister with the Secretary that person’s name, place of busi-
ness, and such establishment.
‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.—
Every person required to register under subsection (b) or
(c) shall immediately register with the Secretary any addi-
tional establishment which that person owns or operates in
any State and in which that person begins the manufacture,
preparation, compounding, or processing of a tobacco prod-
uct or tobacco products.
‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYSTEM.—
The Secretary may by regulation prescribe a uniform sys-
tem for the identification of tobacco products and may re-
quire that persons who are required to list such tobacco
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products under subsection (i) shall list such tobacco prod-
ucts in accordance with such system.
‘‘(f) PUBLIC ACCESS
TO REGISTRATION INFORMA-
TION.—The Secretary shall make available for inspection,
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 in-
spection under section 704, and every such establishment
engaged in the manufacture, compounding, or processing
of a tobacco product or tobacco products shall be so in-
spected by 1 or more officers or employees duly designated
by the Secretary at least once in the 2-year period begin-
ning with the date of registration of such establishment
under this section and at least once in every successive 2-
year period thereafter.
‘‘(h) FOREIGN ESTABLISHMENTS SHALL REGISTER.—
Any establishment within any foreign country engaged in
the manufacture, preparation, compounding, or processing
of a tobacco product or tobacco products, shall register
under this section under regulations promulgated by the
Secretary. Such regulations shall require such establishment
to provide the information required by subsection (i) of this
section and shall include provisions for registration of any
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such establishment upon condition that adequate and effec-
tive means are available, by arrangement with the govern-
ment of such foreign country or otherwise, to enable the Sec-
retary to determine from time to time whether tobacco prod-
ucts manufactured, prepared, compounded, or processed in
such establishment, if imported or offered for import into
the United States, shall be refused admission on any of the
grounds set forth in section 801(a).
‘‘(i) REGISTRATION INFORMATION.—
‘‘(1) PRODUCT
LIST.—Every person who reg-
isters with the Secretary under subsection (b), (c), (d),
or (h) shall, at the time of registration under any
such subsection, file with the Secretary a list of all to-
bacco products which are being manufactured, pre-
pared, compounded, or processed by that person for
commercial distribution and which has not been in-
cluded in any list of tobacco products filed by that
person with the Secretary under this paragraph or
paragraph (2) before such time of registration. Such
list shall be prepared in such form and manner as the
Secretary may prescribe and shall be accompanied
by—
‘‘(A) in the case of a tobacco product con-
tained in the applicable list with respect to
which a tobacco product standard has been estab-
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lished under section 907 or which is subject to
section 910, a reference to the authority for the
marketing of such tobacco product and a copy of
all labeling for such tobacco product;
‘‘(B) in the case of any other tobacco prod-
uct contained in an applicable list, a copy of all
consumer information and other labeling for
such tobacco product, a representative sampling
of advertisements for such tobacco product, and,
upon request made by the Secretary for good
cause, a copy of all advertisements for a par-
ticular tobacco product; and
‘‘(C) if the registrant filing a list has deter-
mined that a tobacco product contained in such
list is not subject to a tobacco product standard
established under section 907, a brief statement
of the basis upon which the registrant made such
determination if the Secretary requests such a
statement with respect to that particular tobacco
product.
‘‘(2) 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