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conduct such surveillance and if such protocol will 
result in collection of the data or other information 
designated by the Secretary as necessary to protect 
the public health. 
‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Sec-
retary, after an opportunity for an informal hearing, shall 
withdraw an order under subsection (g) if the Secretary 
determines that— 
‘‘(1) the applicant, based on new information, 
can no longer make the demonstrations required 
under subsection (g), or the Secretary can no longer 
make the determinations required under subsection 
(g); 
‘‘(2) the application failed to include material 
information or included any untrue statement of ma-
terial fact; 
‘‘(3) any explicit or implicit representation that 
the product reduces risk or exposure is no longer 
valid, including if— 
‘‘(A) a tobacco product standard is estab-
lished pursuant to section 907; 
‘‘(B) an action is taken that affects the 
risks presented by other commercially marketed 
tobacco products that were compared to the 
product that is the subject of the application; or 
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‘‘(C) any postmarket surveillance or stud-
ies reveal that the order 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 subsection (i); or 
‘‘(5) the applicant failed to meet a condition 
imposed under subsection (h). 
‘‘(k) CHAPTER IV OR V.—A product for which the 
Secretary has issued an order pursuant to subsection (g) 
shall not be subject to chapter IV or V. 
‘‘(l) IMPLEMENTING REGULATIONS OR GUIDANCE.— 
‘‘(1) SCIENTIFIC EVIDENCE.—Not later than 2 
years after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act, the 
Secretary shall issue regulations or guidance (or any 
combination thereof) on the scientific evidence re-
quired for assessment and ongoing review of modi-
fied risk tobacco products. Such regulations or guid-
ance shall— 
‘‘(A) to the extent that adequate scientific 
evidence exists, establish minimum standards 
for scientific studies needed prior to issuing an 
order under subsection (g) to show that a sub-
stantial reduction in morbidity or mortality 
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among individual tobacco users occurs for prod-
ucts described in subsection (g)(1) or is reason-
ably likely for products described in subsection 
(g)(2); 
‘‘(B) include validated biomarkers, inter-
mediate clinical endpoints, and other feasible 
outcome measures, as appropriate; 
‘‘(C) establish minimum standards for 
postmarket studies, that shall include regular 
and long-term assessments of health outcomes 
and mortality, intermediate clinical endpoints, 
consumer perception of harm reduction, and the 
impact on quitting behavior and new use of to-
bacco products, as appropriate; 
‘‘(D) establish minimum standards for re-
quired postmarket surveillance, including ongo-
ing assessments of consumer perception; 
‘‘(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; and 
‘‘(F) establish a reasonable timetable for 
the Secretary to review an application under 
this section. 
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‘‘(2) CONSULTATION.—The regulations or guid-
ance issued under paragraph (1) shall be developed 
in consultation with the Institute of Medicine, and 
with the input of other appropriate scientific and 
medical experts, on the design and conduct of such 
studies and surveillance. 
‘‘(3) REVISION.—The regulations or guidance 
under paragraph (1) shall be revised on a regular 
basis as new scientific information becomes avail-
able. 
‘‘(4) NEW
TOBACCO
PRODUCTS.—Not later 
than 2 years after the date of enactment of the 
Family Smoking Prevention and Tobacco Control 
Act, the Secretary shall issue a regulation or guid-
ance that permits the filing of a single application 
for any tobacco product that is a new tobacco prod-
uct under section 910 and which the applicant seeks 
to commercially market under this section. 
‘‘(m) DISTRIBUTORS.—Except as provided in this 
section, no distributor may take any action, after the date 
of enactment of the Family Smoking Prevention and To-
bacco Control Act, with respect to a tobacco product that 
would reasonably be expected to result in consumers be-
lieving that the tobacco product or its smoke may present 
a lower risk of disease or is less harmful than one or more 
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HR 1108 RFS 
commercially marketed tobacco products, or presents a re-
duced exposure to, or does not contain or is free of, a sub-
stance or substances. 
‘‘SEC. 912. JUDICIAL REVIEW. 
‘‘(a) RIGHT TO REVIEW.— 
‘‘(1) IN
GENERAL.—Not later than 30 days 
after— 
‘‘(A) the promulgation of a regulation 
under section 907 establishing, amending, or 
revoking a tobacco product standard; or 
‘‘(B) a denial of an application under sec-
tion 910(c), 
any person adversely affected by such regulation or 
denial may file a petition for judicial review of such 
regulation or denial with the United States Court of 
Appeals for the District of Columbia or for the cir-
cuit in which such person resides or has their prin-
cipal place of business. 
‘‘(2) REQUIREMENTS.— 
‘‘(A) COPY OF PETITION.—A copy of the 
petition filed under paragraph (1) shall be 
transmitted by the clerk of the court involved to 
the Secretary. 
‘‘(B) RECORD OF PROCEEDINGS.—On re-
ceipt of a petition under subparagraph (A), the 
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Secretary shall file in the court in which such 
petition was filed— 
‘‘(i) the record of the proceedings on 
which the regulation or order was based; 
and 
‘‘(ii) a statement of the reasons for 
the issuance of such a regulation or order. 
‘‘(C) DEFINITION
OF
RECORD.—In this 
section, the term ‘record’ means— 
‘‘(i) all notices and other matter pub-
lished in the Federal Register with respect 
to the regulation or order reviewed; 
‘‘(ii) all information submitted to the 
Secretary with respect to such regulation 
or order; 
‘‘(iii) proceedings of any panel or ad-
visory committee with respect to such reg-
ulation or order; 
‘‘(iv) any hearing held with respect to 
such regulation or order; and 
‘‘(v) any other information identified 
by the Secretary, in the administrative pro-
ceeding held with respect to such regula-
tion or order, as being relevant to such 
regulation or order. 
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‘‘(b) STANDARD OF REVIEW.—Upon the filing of the 
petition under subsection (a) for judicial review of a regu-
lation or order, the court shall have jurisdiction to review 
the regulation or order in accordance with chapter 7 of 
title 5, United States Code, and to grant appropriate re-
lief, including interim relief, as provided for in such chap-
ter. A regulation or denial described in subsection (a) shall 
be reviewed in accordance with section 706(2)(A) of title 
5, United States Code. 
‘‘(c) FINALITY OF JUDGMENT.—The judgment of the 
court affirming or setting aside, in whole or in part, any 
regulation or order shall be final, subject to review by the 
Supreme Court of the United States upon certiorari or 
certification, as provided in section 1254 of title 28, 
United States Code. 
‘‘(d) OTHER REMEDIES.—The remedies provided for 
in this section shall be in addition to, and not in lieu of, 
any other remedies provided by law. 
‘‘(e) REGULATIONS
AND ORDERS MUST RECITE 
BASIS IN RECORD.—To facilitate judicial review, a regula-
tion or order issued under section 906, 907, 908, 909, 
910, or 916 shall contain a statement of the reasons for 
the issuance of such regulation or order in the record of 
the proceedings held in connection with its issuance. 
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HR 1108 RFS 
‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 
‘‘The Secretary shall issue regulations to require that 
retail establishments for which the predominant business 
is the sale of tobacco products comply with any advertising 
restrictions applicable to retail establishments accessible 
to individuals under the age of 18. 
‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 
THE FEDERAL TRADE COMMISSION. 
‘‘(a) JURISDICTION.— 
‘‘(1) IN
GENERAL.—Except where expressly 
provided in this chapter, nothing in this chapter 
shall be construed as limiting or diminishing the au-
thority of the Federal Trade Commission to enforce 
the laws under its jurisdiction with respect to the 
advertising, sale, or distribution of tobacco products. 
‘‘(2) ENFORCEMENT.—Any advertising that vio-
lates this chapter or a provision of the regulations 
referred to in section 102 of the Family Smoking 
Prevention and Tobacco Control Act, is an unfair or 
deceptive act or practice under section 5(a) of the 
Federal Trade Commission Act and shall be consid-
ered a violation of a rule promulgated under section 
18 of that Act. 
‘‘(b) COORDINATION.—With respect to the require-
ments of section 4 of the Federal Cigarette Labeling and 
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HR 1108 RFS 
Advertising Act and section 3 of the Comprehensive 
Smokeless Tobacco Health Education Act of 1986— 
‘‘(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. REGULATION REQUIREMENT. 
‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 
later than 36 months after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall promulgate regulations under this Act that 
meet the requirements of subsection (b). 
‘‘(b) CONTENTS OF RULES.—The regulations pro-
mulgated under subsection (a)— 
‘‘(1) shall require testing and reporting of to-
bacco product constituents, ingredients, and addi-
tives, including smoke constituents, by brand and 
subbrand that the Secretary determines should be 
tested to protect the public health, provided that, for 
purposes of the testing requirements of this para-
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graph, tobacco products manufactured and sold by a 
single tobacco product manufacturer that are iden-
tical in all respects except the labels, packaging de-
sign, logo, trade dress, trademark, brand name, or 
any combination thereof, shall be considered as a 
single brand; and 
‘‘(2) may require that tobacco product manu-
facturers, packagers, or importers make disclosures 
relating to the results of the testing of tar and nico-
tine through labels or advertising or other appro-
priate 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 mis-
lead consumers about the risk of tobacco-related dis-
ease. 
‘‘(c) AUTHORITY.—The Secretary shall have the au-
thority under this chapter to conduct or to require the 
testing, reporting, or disclosure of tobacco product con-
stituents, including smoke constituents. 
‘‘(d) SMALL
TOBACCO
PRODUCT
MANUFACTUR-
ERS.— 
‘‘(1) FIRST
COMPLIANCE
DATE.—The initial 
regulations promulgated under subsection (a) shall 
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not impose requirements on small tobacco product 
manufacturers before the later of— 
‘‘(A) the end of the 2-year period following 
the final promulgation of such regulations; and 
‘‘(B) the initial date set by the Secretary 
for compliance with such regulations by manu-
facturers that are not small tobacco product 
manufacturers. 
‘‘(2) TESTING AND REPORTING INITIAL COM-
PLIANCE PERIOD.— 
‘‘(A) 4-YEAR PERIOD.—The initial regula-
tions promulgated under subsection (a) shall 
give each small tobacco product manufacturer a 
4-year period over which to conduct testing and 
reporting for all of its tobacco products. Subject 
to paragraph (1), the end of the first year of 
such 4-year period shall coincide with the initial 
date of compliance under this section set by the 
Secretary with respect to manufacturers that 
are not small tobacco product manufacturers or 
the end of the 2-year period following the final 
promulgation of such regulations, as described 
in paragraph (1)(A). A small tobacco product 
manufacturer shall be required— 
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‘‘(i) to conduct such testing and re-
porting for 25 percent of its tobacco prod-
ucts during each year of such 4-year pe-
riod; and 
‘‘(ii) to conduct such testing and re-
porting for its largest-selling tobacco prod-
ucts (as determined by the Secretary) be-
fore its other tobacco products, or in such 
other order of priority as determined by 
the Secretary. 
‘‘(B) 
CASE-BY-CASE
DELAY.—Notwith-
standing subparagraph (A), the Secretary may, 
on a case-by-case basis, delay the date by which 
an individual small tobacco product manufac-
turer must conduct testing and reporting for its 
tobacco products under this section based upon 
a showing of undue hardship to such manufac-
turer. Notwithstanding the preceding sentence, 
the Secretary shall not extend the deadline for 
a small tobacco product manufacturer to con-
duct testing and reporting for all of its tobacco 
products beyond a total of 5 years after the ini-
tial date of compliance under this section set by 
the Secretary with respect to manufacturers 
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HR 1108 RFS 
that are not small tobacco product manufactur-
ers. 
‘‘(3) SUBSEQUENT AND ADDITIONAL TESTING 
AND
REPORTING.—The regulations promulgated 
under subsection (a) shall provide that, with respect 
to any subsequent or additional testing and report-
ing of tobacco products required under this section, 
such testing and reporting by a small tobacco prod-
uct manufacturer shall be conducted in accordance 
with the timeframes described in paragraph (2)(A), 
except that, in the case of a new product, or if there 
has been a modification described in section 
910(a)(1)(B) of any product of a small tobacco 
product manufacturer since the last testing and re-
porting required under this section, the Secretary 
shall require that any subsequent or additional test-
ing and reporting be conducted in accordance with 
the same timeframe applicable to manufacturers 
that are not small tobacco product manufacturers. 
‘‘(4) JOINT LABORATORY TESTING SERVICES.— 
The Secretary shall allow any 2 or more small to-
bacco product manufacturers to join together to pur-
chase laboratory testing services required by this 
section on a group basis in order to ensure that such 
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HR 1108 RFS 
manufacturers receive access to, and fair pricing of, 
such testing services. 
‘‘(e) EXTENSIONS FOR LIMITED LABORATORY CA-
PACITY.— 
‘‘(1) IN
GENERAL.—The regulations promul-
gated under subsection (a) shall provide that a small 
tobacco product manufacturer shall not be consid-
ered to be in violation of this section before the 
deadline applicable under paragraphs (3) and (4), 
if— 
‘‘(A) the tobacco products of such manu-
facturer are in compliance with all other re-
quirements of this chapter; and 
‘‘(B) the conditions described in paragraph 
(2) are met. 
‘‘(2) CONDITIONS.—Notwithstanding the re-
quirements of this section, the Secretary may delay 
the date by which a small tobacco product manufac-
turer must be in compliance with the testing and re-
porting required by this section until such time as 
the testing is reported if, not later than 90 days be-
fore the deadline for reporting in accordance with 
this section, a small tobacco product manufacturer 
provides evidence to the Secretary demonstrating 
that— 
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