H. R. 1256—43 
‘‘(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 
required for assessment and ongoing review of modified risk 
tobacco products. Such regulations or guidance 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 substantial reduction in morbidity or mortality 
among individual tobacco users occurs for products 
described in subsection (g)(1) or is reasonably likely for 
products described in subsection (g)(2); 
‘‘(B) include validated biomarkers, intermediate clinical 
endpoints, and other feasible outcome measures, as appro-
priate; 
‘‘(C) establish minimum standards for postmarket 
studies, that shall include regular and long-term assess-
ments of health outcomes and mortality, intermediate clin-
ical endpoints, consumer perception of harm reduction, and 
the impact on quitting behavior and new use of tobacco 
products, as appropriate; 
‘‘(D) 
establish 
minimum 
standards 
for 
required 
postmarket surveillance, including ongoing 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. 
‘‘(2) CONSULTATION.—The regulations or guidance issued 
under paragraph (1) shall be developed in consultation with 
the Institute of Medicine, and with the input of other appro-
priate scientific and medical experts, on the design and conduct 
of such studies and surveillance. 
‘‘(3) REVISION.—The regulations or guidance under para-
graph (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 tobacco product that is a new tobacco product 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 Tobacco Control Act, with 
respect to a tobacco 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
H. R. 1256—44 
than one or more commercially marketed tobacco products, or pre-
sents 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 revoking a tobacco product 
standard; or 
‘‘(B) a denial of an application 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.— 
‘‘(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 receipt of a petition 
under subparagraph (A), the Secretary shall file in the 
court in which such petition was filed— 
‘‘(i) the record of the proceedings on which the 
regulation or order was based; and 
‘‘(ii) a statement of the reasons for the issuance 
of such a regulation or order. 
‘‘(C) DEFINITION OF RECORD.—In this section, the term 
‘record’ means— 
‘‘(i) all notices and other matter published 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 advisory com-
mittee with respect to such regulation or order; 
‘‘(iv) any hearing held with respect to such regula-
tion or order; and 
‘‘(v) any other information identified by the Sec-
retary, in the administrative proceeding held with 
respect to such regulation or order, as being relevant 
to such regulation or order. 
‘‘(b) STANDARD
OF REVIEW.—Upon the filing of the petition 
under subsection (a) for judicial review of a regulation 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, including interim relief, as provided 
for in such chapter. 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.
H. R. 1256—45 
‘‘(d) OTHER REMEDIES.—The remedies provided for in this sec-
tion 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 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 provided 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 violates 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 requirements of sec-
tion 4 of the Federal Cigarette Labeling and Advertising Act and 
section 3 of the Comprehensive Smokeless Tobacco Health Edu-
cation Act of 1986— 
‘‘(1) the Chairman of the Federal Trade Commission shall 
coordinate with the Secretary concerning the enforcement of 
such Act as such enforcement relates to unfair or deceptive 
acts or practices in the advertising of cigarettes or smokeless 
tobacco; and 
‘‘(2) the Secretary shall consult with the Chairman of such 
Commission in revising the label statements 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 promulgated under 
subsection (a)— 
‘‘(1) shall require testing and reporting of tobacco product 
constituents, ingredients, and additives, including smoke 
constituents, by brand and subbrand that the Secretary deter-
mines should be tested to protect the public health, provided 
that, for purposes of the testing requirements of this paragraph,
H. R. 1256—46 
tobacco products manufactured and sold by a single tobacco 
product manufacturer that are identical in all respects except 
the labels, packaging design, logo, trade dress, trademark, 
brand name, or any combination thereof, shall be considered 
as a single brand; and 
‘‘(2) may require that tobacco product manufacturers, pack-
agers, or importers make disclosures relating to the results 
of the testing of tar and nicotine through labels or advertising 
or other appropriate means, and make disclosures regarding 
the results of the testing of other constituents, including smoke 
constituents, ingredients, or additives, that the Secretary deter-
mines 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 Secretary shall have the authority under 
this chapter to conduct or to require the testing, reporting, or 
disclosure of tobacco product constituents, including smoke constitu-
ents. 
‘‘(d) SMALL TOBACCO PRODUCT MANUFACTURERS.— 
‘‘(1) FIRST
COMPLIANCE
DATE.—The initial regulations 
promulgated under subsection (a) shall not impose require-
ments 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 manufacturers that are not small 
tobacco product manufacturers. 
‘‘(2) TESTING AND REPORTING INITIAL COMPLIANCE PERIOD.— 
‘‘(A) 4-YEAR PERIOD.—The initial regulations promul-
gated 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 manufac-
turers or the end of the 2-year period following the final 
promulgation of such regulations, as described in para-
graph (1)(A). A small tobacco product manufacturer shall 
be required— 
‘‘(i) to conduct such testing and reporting for 25 
percent of its tobacco products during each year of 
such 4-year period; and 
‘‘(ii) to conduct such testing and reporting for its 
largest-selling tobacco products (as determined by the 
Secretary) before its other tobacco products, or in such 
other order of priority as determined by the Secretary. 
‘‘(B) CASE-BY-CASE DELAY.—Notwithstanding subpara-
graph (A), the Secretary may, on a case-by-case basis, 
delay the date by which an individual small tobacco product 
manufacturer must conduct testing and reporting for its 
tobacco products under this section based upon a showing 
of undue hardship to such manufacturer. 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