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was approved, that the labeling of such tobacco
product, based on a fair evaluation of all mate-
rial 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 before
the Secretary, evaluated together with the evi-
dence before the Secretary when the application
was approved, that such tobacco product is not
shown to conform in all respects to a tobacco
product standard which is in effect under section
907, compliance with which was a condition to
approval of the application, and that there is a
lack of adequate information to justify the devi-
ation from such standard.
‘‘(2) APPEAL.—The holder of an application sub-
ject 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 withdrawal,
obtain review thereof in accordance with subsection
(e).
‘‘(3) TEMPORARY
SUSPENSION.—If, after pro-
viding an opportunity for an informal hearing, the
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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 products 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 expeditiously under
paragraph (1) to withdraw such application.
‘‘(e) SERVICE OF ORDER.—An order issued by the Sec-
retary 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 appli-
cant’s last known address in the records of the Sec-
retary.
‘‘(f) RECORDS.—
‘‘(1) ADDITIONAL INFORMATION.—In the case of
any tobacco product for which an approval of an ap-
plication 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
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such application, prescribe on the basis of a finding
that such records and reports are necessary in order
to enable the Secretary to determine, or facilitate a
determination of, whether there is or may be grounds
for withdrawing or temporarily suspending such ap-
proval.
‘‘(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 ex-
empt 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:
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‘‘(1) MODIFIED RISK TOBACCO PRODUCT.—The
term ‘modified risk tobacco product’ means any to-
bacco product that is sold or distributed for use to re-
duce harm or the risk of tobacco-related disease asso-
ciated with commercially marketed tobacco products.
‘‘(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-related
disease associated with commercially marketed
tobacco products’ means a tobacco product—
‘‘(A) 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
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‘‘(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 directed
to consumers through the media or other-
wise, other than by means of the tobacco
product’s label, labeling or advertising, after
the date of enactment of the Family Smok-
ing Prevention and Tobacco Control Act, re-
specting the product that would be reason-
ably expected to result in consumers believ-
ing that the tobacco product or its smoke
may present a lower risk of disease or is
less harmful than one or more commercially
marketed tobacco products, or presents a re-
duced 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-related
disease associated with commercially marketed
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tobacco products’, except as described in sub-
paragraph (A).
‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product
that is intended to be used for the treatment of tobacco de-
pendence, 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 Secretary
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 con-
ducted, supported, or possessed by the tobacco product
manufacturer relating to the effect of the product on
tobacco related diseases and health-related conditions,
including information both favorable 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 ac-
tually use the tobacco product; and
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‘‘(7) such other information as the Secretary
may require.
‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall make
the application described in subsection (d) publicly avail-
able (except matters in the application which are trade se-
crets or otherwise confidential, commercial information)
and shall request comments by interested persons on the in-
formation contained in the application and on the label,
labeling, and advertising accompanying such application.
‘‘(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 pro-
vided in paragraph (2), the Secretary shall approve
an application for a modified risk tobacco product
filed under this section only if the Secretary deter-
mines that the applicant has demonstrated that such
product, as it is actually used by consumers, will—
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‘‘(A) significantly reduce harm and the risk
of tobacco-related disease to individual tobacco
users; and
‘‘(B) 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 products.
‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.—
‘‘(A) IN GENERAL.—The Secretary may ap-
prove an application for a tobacco product that
has not been approved as a modified risk tobacco
product pursuant to paragraph (1) if the Sec-
retary 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 subsection (b)(2)
is limited to an explicit or implicit rep-
resentation that such tobacco product or its
smoke contains or is free of a substance or
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contains a reduced level of a substance, or
presents a reduced exposure 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 standards
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 subpara-
graph (A) the Secretary must also find that the
applicant has demonstrated that—
‘‘(i) the magnitude of the overall reduc-
tions in exposure to the substance or sub-
stances which are the subject of the applica-
tion is substantial, such substance or sub-
stances are harmful, and the product as ac-
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tually used exposes consumers to the speci-
fied reduced level of the substance or sub-
stances;
‘‘(ii) the product as actually used by
consumers will not expose them to higher
levels of other harmful substances compared
to the similar types of tobacco products then
on the market unless such increases are
minimal and the anticipated overall impact
of use of the product remains a substantial
and measurable reduction in overall mor-
bidity and mortality among individual to-
bacco 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
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‘‘(iv) approval of the application is ex-
pected to 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 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 Sec-
retary that the requirements of this para-
graph 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 post-market
surveillance and studies and to submit to
the Secretary the results of such surveillance
and studies to determine the impact of the
application approval on consumer percep-
tion, behavior, and health and to enable the
Secretary to review the accuracy of the de-
terminations upon which the approval was
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based in accordance with a protocol ap-
proved by the Secretary.
‘‘(iii) ANNUAL
SUBMISSION.—The re-
sults of such post-market surveillance and
studies described in clause (ii) shall be sub-
mitted 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 deter-
minations under paragraphs (1) and (2), the Sec-
retary 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 ap-
plication;
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‘‘(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 sub-
mitted by interested persons.
‘‘(h) ADDITIONAL CONDITIONS FOR APPROVAL.—
‘‘(1) MODIFIED RISK PRODUCTS.—The Secretary
shall require for the approval of an application under
this section that any advertising or labeling con-
cerning modified risk products enable the public to
comprehend the information concerning modified risk
and to understand the relative significance of such in-
formation in the context of total health and in rela-
tion to all of the diseases and health-related condi-
tions 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 tobacco
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‘‘(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 Sec-
retary 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 require
that an applicant, whose application has been ap-
proved under this subsection, comply with require-
ments relating to advertising and promotion of the to-
bacco product.
‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.—
‘‘(1) IN GENERAL.—The Secretary shall require
that an applicant under subsection (g)(1) conduct
post market 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 deter-
minations upon which the approval was based, and
to provide information that the Secretary determines
is otherwise necessary regarding the use or health
risks involving the tobacco product. The results of
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post-market surveillance and studies shall be sub-
mitted 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 approval of
the Secretary, a protocol for the required surveillance.
The Secretary, within 60 days of the receipt of such
protocol, shall determine if the principal investigator
proposed to be used in the surveillance has sufficient
qualifications and experience to conduct such surveil-
lance and if such protocol will result in collection of
the data or other information designated by the Sec-
retary 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);
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‘‘(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 to-
bacco products that were compared to the prod-
uct that is the subject of the application; or
‘‘(C) any postmarket surveillance or studies
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 im-
posed 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.—
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‘‘(1) SCIENTIFIC EVIDENCE.—Not later than 2
years after the date of enactment of the Family Smok-
ing Prevention and Tobacco Control Act, the Sec-
retary shall issue regulations or guidance (or any
combination thereof) on the scientific evidence re-
quired for assessment and ongoing review of modified
risk tobacco products. Such regulations or guidance
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 like-
ly;
‘‘(B) include validated biomarkers, inter-
mediate clinical endpoints, and other feasible
outcome measures, as appropriate;
‘‘(C) establish minimum standards for post
market studies, that shall include regular and
long-term assessments of health outcomes and
mortality, intermediate clinical endpoints, con-
sumer perception of harm reduction, and the im-
pact on quitting behavior and new use of tobacco
products, as appropriate;
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‘‘(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 available.
‘‘(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 guidance that
permits the filing of a single application for any to-
bacco product that is a new tobacco product under
section 910 and for which the applicant seeks ap-
proval as a modified risk tobacco product under this
section.
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‘‘(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 harmful than
one or more commercially marketed tobacco products, or
presents a reduced exposure to, or does not contain 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 re-
voking 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 circuit
in which such person resides or has their principal
place of business.
‘‘(2) REQUIREMENTS.—
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‘‘(A) COPY OF PETITION.—A copy of the pe-
tition filed under paragraph (1) shall be trans-
mitted 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 sec-
tion, 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;
‘‘(iii) proceedings of any panel or ad-
visory committee with respect to such regu-
lation or order;
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‘‘(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 regulation
or order, as being relevant to such regula-
tion or order.
‘‘(b) STANDARD OF REVIEW.—Upon the filing of the
petition under subsection (a) for judicial review of a regula-
tion 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 relief, in-
cluding interim relief, as provided for in such chapter. A
regulation or denial described in subsection (a) shall be re-
viewed 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 cer-
tification, as provided in section 1254 of title 28, United
States Code.
‘‘(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.
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‘‘(e) REGULATIONS AND ORDERS MUST RECITE BASIS
IN RECORD.—To facilitate judicial review, a regulation 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 pro-
vided in this chapter, nothing in this chapter shall be
construed as limiting or diminishing the authority of
the Federal Trade Commission to enforce the laws
under its jurisdiction with respect to the advertising,
sale, or distribution of tobacco products.
‘‘(2) ENFORCEMENT.—Any advertising that vio-
lates this chapter or a provision of the regulations re-
ferred to in section 1112 of the Family Smoking Pre-
vention and Tobacco Control Act, is an unfair or de-
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ceptive act or practice under section 5(a) of the Fed-
eral Trade Commission Act (15 U.S.C. 45(a)) and
shall be considered a violation of a rule promulgated
under section 18 of that Act (15 U.S.C. 57a).
‘‘(b) COORDINATION.—With respect to the requirements
of section 4 of the Federal Cigarette Labeling and Adver-
tising Act (15 U.S.C. 1333) and section 3 of the Comprehen-
sive 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,
any rule under this chapter that is subject to section 801.
This section and section 801 do not apply to the regulations
referred to in section 1112 of the Family Smoking Preven-
tion and Tobacco Control Act.
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‘‘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 promul-
gated under subsection (a) shall require testing and report-
ing of tobacco product constituents, ingredients, and addi-
tives, 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 importers make dis-
closures relating to the results of the testing of tar and nico-
tine through labels or advertising or other appropriate
means, and make disclosures regarding the results 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 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 tobacco
product constituents, including smoke constituents.
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‘‘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 con-
strued to limit the authority of a Federal agency (in-
cluding the Armed Forces), a State or political sub-
division of a State, or the government of an Indian
tribe to enact, adopt, promulgate, and enforce any
law, rule, regulation, or other measure with respect to
tobacco products that is in addition to, or more strin-
gent than, requirements established under this chap-
ter, including a law, rule, regulation, or other meas-
ure relating to or prohibiting the sale, distribution,
possession, exposure to, access to, advertising and pro-
motion of, or use of tobacco products by individuals
of any age, information reporting to the State, or
measures relating to fire safety standards for tobacco
products. No provision of this 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
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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 tobacco
product standards, premarket approval, adulter-
ation, misbranding, labeling, registration, good
manufacturing standards, or reduced risk prod-
ucts.
‘‘(B) EXCEPTION.—Subparagraph (A) does
not apply to requirements relating to the sale,
distribution, possession, information reporting 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 dis-
closed to a State under subparagraph (A) that is
exempt from disclosure under section 554(b)(4)
of title 5, United States Code, 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 af-
fect any action or the liability of any person under the
product liability law of any State.
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‘‘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 a 11-
member advisory committee, to be known as the ‘Tobacco
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 appropriately
diversified professional backgrounds. The com-
mittee shall be composed of—
‘‘(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;
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‘‘(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 members
of the committee appointed under clauses (iv)
and (v) of subparagraph (A) shall serve as con-
sultants 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
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.
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‘‘(c) DUTIES.—The Tobacco Products Scientific Advi-
sory Committee shall provide advice, information, and rec-
ommendations to the Secretary—
‘‘(1) as provided in this chapter;
‘‘(2) on the effects of the alteration of the nicotine
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 requested
by the Secretary.
‘‘(d) COMPENSATION; SUPPORT; FACA.—
‘‘(1) COMPENSATION AND TRAVEL.—Members of
the Advisory Committee who are not officers or em-
ployees of the United States, while attending con-
ferences or meetings of the committee or otherwise en-
gaged in its business, shall be entitled to receive com-
pensation at rates to be fixed by the Secretary, which
may not exceed the daily equivalent of the rate in ef-
fect 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 member may be allowed travel
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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 Secretary
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 main-
tain a transcript of any proceeding of the panel or com-
mittee. Each such panel and committee shall delete from
any transcript made under this subsection information
which is exempt from disclosure under section 552(b) of title
5, United States Code.
‘‘SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DE-
PENDENCE.
The Secretary shall consider—
‘‘(1) at the request of the applicant, designating
nicotine replacement products as fast track research
and approval products within the meaning of section
506;
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‘‘(2) direct the Commissioner to consider approv-
ing 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 country
and have marketing experience in such country.
‘‘SEC. 920. USER FEE.
‘‘(a) ESTABLISHMENT OF QUARTERLY USER FEE.—
The Secretary shall assess a quarterly user fee with respect
to every quarter of each fiscal year commencing fiscal 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
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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 products
under this chapter.
‘‘(c) ASSESSMENT OF USER FEE.—
‘‘(1) AMOUNT OF ASSESSMENT.—Except as pro-
vided in paragraph (4), the total user fees assessed
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 subsection (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 man-
ufacturers shall be equal to an amount that is
the applicable percentage of the total costs of ac-
tivities of the Food and Drug Administration de-
scribed in subsection (b).
‘‘(B) APPLICABLE PERCENTAGE.—For pur-
poses of subparagraph (A) the applicable per-
centage for a fiscal year shall be the following:
‘‘(i) 92.07 percent shall be assessed on
manufacturers and importers of cigarettes;
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‘‘(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 to-
bacco;
‘‘(vi) 0.06 percent shall be assessed on
manufacturers and importers of pipe to-
bacco; and
‘‘(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 subject
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 alloca-
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tion 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 sec-
tion; 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;
‘‘(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 Fed-
eral 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 period
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ending on June 30 of the preceding fiscal
year for which fees are being established; 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 ad-
justed 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 the
amount of the quarterly assessment imposed on such
manufacturer or importer under subsection (f) during
each quarter of each fiscal year. Such notifications
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 notification.
‘‘(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-
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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 manufac-
turers 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.
‘‘(e) DETERMINATION
OF
VOLUME
OF
DOMESTIC
SALES.—
‘‘(1) IN GENERAL.—The calculation of gross do-
mestic volume of a class of tobacco product by a man-
ufacturer or importer, and by all manufacturers and
importers as a group, shall be made by the Secretary
using information provided by manufacturers and
importers pursuant to subsection (f), as well as any
other relevant information provided to or obtained by
the Secretary.
‘‘(2) MEASUREMENT.—For purposes of the cal-
culations under this subsection and the information
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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 number
of little cigars sold;
‘‘(C) in the case of large cigars, the number
of cigars weighing more than 3 pounds per thou-
sand sold; and
‘‘(D) in the case of other classes of tobacco
products, in terms of number of pounds, or frac-
tion thereof, of these products sold.
‘‘(f) MEASUREMENT OF GROSS DOMESTIC VOLUME.—
‘‘(1) IN GENERAL.—Each manufacturer and im-
porter of tobacco products shall submit to the Sec-
retary 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 required to be
filed, with such agency. The returns and forms de-
scribed by this paragraph are those returns and forms
related to the release of tobacco products into domestic
commerce, as defined by section 5702(k) of the Inter-
nal Revenue Code of 1986, and the repayment of the
taxes imposed under chapter 52 of such Code (ATF
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Form 500.24 and United States Customs Form 7501
under currently applicable 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 addi-
tion, such person may be subject to a civil penalty in
an amount not to exceed 2 percent of the value of the
kind of tobacco products manufactured or imported
by such person during the applicable quarter, as de-
termined by the Secretary.
‘‘(h) 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. 1112. 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 Fed-
eral Register an interim final rule regarding ciga-
rettes and smokeless tobacco, which is hereby deemed
to be in compliance with the Administrative Proce-
dures Act and other applicable law.
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(2) CONTENTS OF RULE.—Except as provided in
this subsection, the interim final rule published under
paragraph (1), shall be identical in its provisions to
part 897 of the regulations promulgated by the Sec-
retary 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;
(B) strike Subpart C—Labeling and section
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 Proce-
dures Act, the regulation promulgated pursuant to
this section.
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(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 con-
stitute 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 Secretary
of Health and Human Services or the Food and Drug Ad-
ministration as binding precedent:
(1) The preamble to the proposed rule in the doc-
ument entitled ‘‘Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless Tobacco
Products to Protect Children and Adolescents’’ (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
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Products are Nicotine Delivery Devices Under the
Federal Food, Drug, and Cosmetic Act; Jurisdictional
Determination’’ (61 Fed. Reg. 44619–45318 (August
28, 1996)).
SEC. 1113. CONFORMING AND OTHER AMENDMENTS TO
GENERAL PROVISIONS.
(a) AMENDMENT OF FEDERAL FOOD, DRUG, AND COS-
METIC ACT.—Except as otherwise expressly provided, when-
ever in this section an amendment is expressed in terms
of an amendment to, or repeal of, a section or other provi-
sion, 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 prod-
uct,’’ after ‘‘device,’’;
(2) in subsection (b), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’;
(3) in subsection (c), by inserting ‘‘tobacco prod-
uct,’’ 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 prod-
uct,’’ after ‘‘device,’’;
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(6) in subsection (h), by inserting ‘‘tobacco prod-
uct,’’ 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 prod-
uct,’’ after ‘‘device,’’;
(9) by striking subsection (p) and inserting the
following:
‘‘(p) The failure to register in accordance with section
510 or 905, the failure to provide any information required
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 condi-
tion 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 section
522 or 913.’’;
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(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:
‘‘(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 designed
to print, imprint, or reproduce the trademark, trade
name, or other identifying mark, imprint, or device
of another or any likeness of any of the foregoing
upon any tobacco product or container or labeling
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thereof so as to render such tobacco product a counter-
feit tobacco product.
‘‘(3) The doing of any act that causes a tobacco
product to be a counterfeit tobacco product, or the sale
or dispensing, or the holding for sale or dispensing,
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 knowl-
edge 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 ORDERS.—
’’;
(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-
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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
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 following:
‘‘A no-tobacco-sale order permanently pro-
hibiting an individual retail outlet from
selling tobacco products shall include provi-
sions that allow the outlet, after a specified
period of time, to request that the Secretary
compromise, modify, or terminate the
order.’’; and
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(C) by adding at the end, the following:
‘‘(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,’’;
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(3) in subsection (g)(1), by inserting ‘‘or tobacco
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 con-
nection 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 ‘‘tobacco
products,’’ after ‘‘devices,’’ each place it appears;
(2) in subsection (a)(1)(B), by inserting ‘‘or to-
bacco product’’ after ‘‘restricted devices’’ each place it
appears; and
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(3) in subsection (b), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’.
(h) SECTION 705.—Section 705(b) (21 U.S.C. 375(b))
is amended by inserting ‘‘tobacco products,’’ after ‘‘de-
vices,’’.
(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 to-
bacco 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 Con-
trol Act, and annually thereafter, the Secretary shall submit
to the Committee on Health, Education, Labor, and Pen-
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sions of the Senate and the Committee on Energy and Com-
merce 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 pur-
suant 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 redesig-
nated by section 101(a)) is amended—
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and
(2) inserting a comma and ‘‘and tobacco prod-
ucts’’ after ‘‘devices’’.
(l) EFFECTIVE DATE FOR NO-TOBACCO-SALE ORDER
AMENDMENTS.—The amendments made by subsection (c),
other than the amendment made by paragraph (2) of such
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subsection, shall take effect upon the issuance of guidance
by the Secretary of Health and Human Services—
(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 sub-
section (c), by identifying the number of violations of
particular requirements over a specified period of
time at a particular retail outlet that constitute a re-
peated 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 outlet,
that outlet will not be considered to have been the 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
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of birth does not constitute a violation of any min-
imum age requirement for the sale of tobacco products
if the retailer has taken effective steps to prevent 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 electronic
scanning device.
CHAPTER 2—TOBACCO PRODUCT WARN-
INGS; CONSTITUENT AND SMOKE CON-
STITUENT DISCLOSURE
SEC. 1121. CIGARETTE LABEL AND ADVERTISING WARN-
INGS.
Section 4 of the Federal Cigarette Labeling and Adver-
tising Act (15 U.S.C. 1333) is amended to read as follows:
‘‘SEC. 4. LABELING.
‘‘(a) LABEL REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any
person to manufacture, package, sell, offer to sell, dis-
tribute, or import for sale or distribution within the
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United States any cigarettes the package of which
fails to bear, in accordance with the requirements of
this section, one of the following labels:
‘WARNING: Cigarettes are addictive’.
‘WARNING: Tobacco smoke can harm your children’.
‘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’.
‘WARNING: Smoking can kill you’.
‘WARNING: Tobacco smoke causes fatal lung disease
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 underneath the
cellophane or other clear wrapping. Except as
provided in subparagraph (B), each label state-
ment shall comprise at least the top 30 percent
of the front and rear panels of the package. The
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word ‘WARNING’ shall appear in capital letters
and all text shall be in conspicuous and legible
17-point type, unless the text of the label state-
ment would occupy more than 70 percent of such
area, in which case the text may be in a smaller
conspicuous and legible 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 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 lo-
cated 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 para-
graph, the provisions of this subsection shall
apply to such packages.
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‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU-
TION.—The provisions of this subsection do not apply
to a tobacco product manufacturer or distributor 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 subsection
for packaging that is supplied to the retailer by a to-
bacco product manufacturer, importer, or distributor
and is not altered by the retailer in a way that is
material to the requirements of this subsection except
that this paragraph shall not relieve a retailer of li-
ability if the retailer sells or distributes tobacco prod-
ucts that are not labeled in accordance with this sub-
section.
‘‘(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 ad-
vertised within the United States any cigarette unless
its advertising bears, in accordance with the require-
ments of this section, one of the labels specified in
subsection (a) of this section.
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‘‘(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 conspicuous
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 area in
such manner as the Secretary determines appropriate.
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 rectangular 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 ‘WARNING’ in the label statements. The
text of such label statements shall be in a typeface pro
rata to the following requirements: 45-point type for
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required by subsection (a) may be printed on the in-
side 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 sec-
tion or the text, format, and type sizes of any re-
quired tar, nicotine yield, or other constituent (in-
cluding smoke constituent) disclosures, or to establish
the text, format, and type sizes for any other disclo-
sures required under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et. seq.). The text 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 sub-
section. The Secretary shall promulgate regulations
which provide for adjustments in the format and type
sizes of any text required to appear in such area to
ensure that the total text required 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 product
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and be randomly distributed in all areas of the
United States in which the product is marketed
in accordance with a plan submitted by the to-
bacco product manufacturer, importer, dis-
tributor, or retailer and approved by the Sec-
retary.
‘‘(B) The label statements specified in sub-
section (a)(1) shall be rotated quarterly in alter-
nating sequence in advertisements for each brand
of cigarettes in accordance with a plan sub-
mitted by the tobacco product manufacturer, im-
porter, distributor, or retailer to, and approved
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.
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‘‘(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.’’.
SEC. 1122. AUTHORITY TO REVISE CIGARETTE WARNING
LABEL STATEMENTS.
Section 4 of the Federal Cigarette Labeling and Adver-
tising Act (15 U.S.C. 1333), as amended by section 1121,
is further amended by adding at the end the following:
‘‘(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 great-
er public understanding of the risks associated with the use
of tobacco products.’’.
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SEC. 1123. STATE REGULATION OF CIGARETTE ADVER-
TISING AND PROMOTION.
Section 5 of the Federal Cigarette Labeling and Adver-
tising 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 regula-
tions, based on smoking and health, that take effect after
the effective date of the Family Smoking Prevention and
Tobacco Control Act, imposing specific bans or restrictions
on the time, place, and manner, but not content, of the ad-
vertising or promotion of any cigarettes.’’.
SEC. 1124. SMOKELESS TOBACCO LABELS AND ADVER-
TISING WARNINGS.
Section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402) is amended
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 im-
port for sale or distribution within the United States
any smokeless tobacco product unless the product
package bears, in accordance with the requirements of
this Act, one of the following labels:
‘WARNING: This product can cause mouth cancer’.
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‘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 paragraph
(1) shall be—
‘‘(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 manner
that contrasts by typography, layout, or color,
with all other printed material on the package,
in an alternating fashion under the plan sub-
mitted under subsection (b)(3), except that if the
text of a label statement would occupy 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 percent of such warning
area is occupied by the label statement.
‘‘(3) The label statements required by paragraph
(1) shall be introduced by each tobacco product manu-