100 
‘‘(g) MARKETING.— 
‘‘(1) MODIFIED RISK PRODUCTS.—Except as pro-
vided in paragraph (2), the Secretary shall, with re-
spect to an application submitted under this section, 
issue an order that a modified risk product may be 
commercially marketed only if the Secretary deter-
mines that the applicant has demonstrated that such 
product, as it is actually used by consumers, will— 
‘‘(A) significantly reduce harm and the risk 
of tobacco-related disease to individual 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 
issue an order that a tobacco product may be in-
troduced or delivered for introduction into inter-
state commerce, pursuant to an application 
under this section, with respect to a tobacco 
product that may not be commercially marketed 
under paragraph (1) if the Secretary makes the 
findings required under this paragraph and de-
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termines that the applicant has demonstrated 
that— 
‘‘(i) such order 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) is 
limited to an explicit or implicit represen-
tation that such tobacco product or its 
smoke does not contain or is free of a sub-
stance or contains a reduced level of a sub-
stance, 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 
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tobacco users is reasonably likely in subse-
quent studies. 
‘‘(B) ADDITIONAL
FINDINGS
REQUIRED.— 
To issue an order under subparagraph (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-
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 reasonably likely overall 
impact of use of the product remains a sub-
stantial and measurable reduction in over-
all morbidity and mortality among indi-
vidual tobacco users; 
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‘‘(iii) testing of actual consumer per-
ception shows that, as the applicant pro-
poses to label and market the product, con-
sumers will not be misled into believing that 
the product— 
‘‘(I) is or has been demonstrated 
to be less harmful; or 
‘‘(II) presents or has been dem-
onstrated to present less of a risk of 
disease than 1 or more other commer-
cially marketed tobacco products; and 
‘‘(iv) issuance of an order with respect 
to the application is expected 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 to-
bacco products. 
‘‘(C) CONDITIONS OF MARKETING.— 
‘‘(i) IN
GENERAL.—Applications sub-
ject to an order under this paragraph shall 
be limited to a term of not more than 5 
years, but may be renewed upon a finding 
by the Secretary that the requirements of 
this paragraph continue to be satisfied 
based on the filing of a new application. 
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‘‘(ii) AGREEMENTS
BY
APPLICANT.— 
An order under this paragraph shall be con-
ditioned on the applicant’s agreement to 
conduct postmarket surveillance and studies 
and to submit to the Secretary the results of 
such surveillance and studies to determine 
the impact of the order on consumer percep-
tion, behavior, and health and to enable the 
Secretary to review the accuracy of the de-
terminations upon which the order was 
based in accordance with a protocol ap-
proved by the Secretary. 
‘‘(iii) ANNUAL
SUBMISSION.—The re-
sults of such postmarket 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 made available to the Secretary. 
‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS AND 
OF POPULATION AS A WHOLE.—In making the deter-
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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; 
‘‘(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 MARKETING.— 
‘‘(1) MODIFIED RISK PRODUCTS.—The Secretary 
shall require for the marketing of a product under 
this section that any advertising or labeling con-
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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 marketing of a product under this 
subsection that a claim comparing a tobacco 
product to 1 or more other commercially mar-
keted tobacco products shall compare the tobacco 
product to a commercially marketed tobacco 
product that is representative of that type of to-
bacco product on the market (for example the av-
erage value of the top 3 brands of an established 
regular tobacco product). 
‘‘(B) QUANTITATIVE
COMPARISONS.—The 
Secretary may also require, for purposes of sub-
paragraph (A), that the percent (or fraction) of 
change and identity of the reference tobacco 
product and a quantitative comparison of the 
amount of the substance claimed to be reduced 
shall be stated in immediate proximity to the 
most prominent claim. 
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‘‘(3) LABEL DISCLOSURE.— 
‘‘(A) IN GENERAL.—The Secretary may re-
quire the disclosure on the label of other sub-
stances in the tobacco product, or substances that 
may be produced by the consumption of that to-
bacco product, that may affect a disease or 
health-related condition or may increase the risk 
of other diseases or health-related conditions as-
sociated with the use of tobacco products. 
‘‘(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.—An order issued under subsection 
(g)(1) shall be effective for a specified period of time. 
‘‘(5) ADVERTISING.—The Secretary may require, 
with respect to a product for which an applicant ob-
tained an order under subsection (g)(1), that the 
product comply with requirements relating to adver-
tising and promotion of the tobacco product. 
‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.— 
‘‘(1) IN GENERAL.—The Secretary shall require, 
with respect to a product for which an applicant ob-
tained an order under subsection (g)(1), that the ap-
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plicant conduct postmarket surveillance and studies 
for such a tobacco product to determine the impact of 
the order issuance on consumer perception, behavior, 
and health, to enable the Secretary to review the accu-
racy of the determinations upon which the order 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 postmarket 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 AUTHORIZATION.—The Sec-
retary, after an opportunity for an informal hearing, shall 
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withdraw an order under subsection (g) if the Secretary de-
termines 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 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 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 
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‘‘(5) the applicant failed to meet a condition im-
posed under subsection (h). 
‘‘(k) CHAPTER IV OR V.—A product for which the Sec-
retary 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 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) 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 
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); 
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‘‘(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. 
‘‘(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 
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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 which the applicant seeks to commer-
cially market under this section. 
‘‘(m) DISTRIBUTORS.—Except as provided in this sec-
tion, 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 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 sub-
stances. 
‘‘SEC. 912. JUDICIAL REVIEW. 
‘‘(a) RIGHT TO REVIEW.— 
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‘‘(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 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 Circuit 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 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 
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‘‘(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; 
‘‘(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-
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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. 
‘‘(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. 
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116 
‘‘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 102 of the Family Smoking Pre-
vention and Tobacco Control Act, is an unfair or de-
ceptive act or practice under section 5(a) of the Fed-
eral Trade Commission Act and shall be considered a 
violation of a rule promulgated under section 18 of 
that Act. 
‘‘(b) COORDINATION.—With respect to the requirements 
of section 4 of the Federal Cigarette Labeling and Adver-
tising 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 
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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 promul-
gated under subsection (a)— 
‘‘(1) shall require testing and reporting of to-
bacco product constituents, ingredients, and additives, 
including smoke constituents, by brand and subbrand 
that the Secretary determines should be tested to pro-
tect the public health; and 
‘‘(2) may require that tobacco product manufac-
turers, packagers, or importers make disclosures relat-
ing 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 con-
stituents, ingredients, or additives, that the Secretary 
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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 Secretary shall have the au-
thority under this chapter to conduct or to require the test-
ing, reporting, or disclosure of tobacco product constituents, 
including smoke constituents. 
‘‘(d) SMALL TOBACCO PRODUCT MANUFACTURERS.— 
‘‘(1) FIRST COMPLIANCE DATE.—The initial reg-
ulations promulgated under subsection (a) shall not 
impose requirements on small tobacco product manu-
facturers 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 manufac-
turers that are not small tobacco product manu-
facturers. 
‘‘(2) TESTING AND REPORTING INITIAL COMPLI-
ANCE 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 re-
porting for all of its tobacco products. Subject to 
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