H. R. 1256—39 
matters in the application which are trade secrets or otherwise 
confidential, commercial information) and shall request comments 
by interested persons on the information contained in the applica-
tion and on the label, labeling, and advertising accompanying such 
application. 
‘‘(f) ADVISORY COMMITTEE.— 
‘‘(1) IN GENERAL.—The Secretary shall refer to the Tobacco 
Products Scientific Advisory Committee any application sub-
mitted under this section. 
‘‘(2) RECOMMENDATIONS.—Not later than 60 days after the 
date an application is referred to the Tobacco Products Scientific 
Advisory Committee under paragraph (1), the Advisory Com-
mittee shall report its recommendations on the application 
to the Secretary. 
‘‘(g) MARKETING.— 
‘‘(1) MODIFIED RISK PRODUCTS.—Except as provided in para-
graph (2), the Secretary shall, with respect to an application 
submitted under this section, issue an order that a modified 
risk product may be commercially marketed only if the Sec-
retary determines 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 introduced or delivered 
for introduction into interstate 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 determines 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 adver-
tising 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 rep-
resentation that such tobacco product or its smoke 
does not contain or is free of a substance or contains 
a reduced level of a substance, or presents a reduced 
exposure to a substance in tobacco smoke; 
‘‘(iii) scientific evidence is not available and, using 
the best available scientific methods, cannot be made 
available without conducting long-term epidemiological 
studies for an application to meet the standards set 
forth in paragraph (1); and 
‘‘(iv) the scientific evidence that is available with-
out conducting long-term epidemiological studies dem-
onstrates that a measurable and substantial reduction 
in morbidity or mortality among individual tobacco 
users is reasonably likely in subsequent studies.
H. R. 1256—40 
‘‘(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 reductions in expo-
sure to the substance or substances which are the 
subject of the application is substantial, such substance 
or substances are harmful, and the product as actually 
used exposes consumers to the specified reduced level 
of the substance or substances; 
‘‘(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 substantial and meas-
urable reduction in overall morbidity and mortality 
among individual tobacco users; 
‘‘(iii) testing of actual consumer perception shows 
that, as the applicant proposes to label and market 
the product, consumers 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 demonstrated to 
present less of a risk of disease than 1 or more 
other commercially 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 tobacco products. 
‘‘(C) CONDITIONS OF MARKETING.— 
‘‘(i) IN GENERAL.—Applications subject 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. 
‘‘(ii) AGREEMENTS BY APPLICANT.—An order under 
this paragraph shall be conditioned 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 perception, behavior, 
and health and to enable the Secretary to review the 
accuracy of the determinations upon which the order 
was based in accordance with a protocol approved by 
the Secretary. 
‘‘(iii) ANNUAL
SUBMISSION.—The results of such 
postmarket surveillance and studies described in clause 
(ii) shall be submitted annually. 
‘‘(3) BASIS.—The determinations under paragraphs (1) and 
(2) shall be based on— 
‘‘(A) the scientific evidence submitted by the applicant; 
and
H. R. 1256—41 
‘‘(B) scientific evidence and other information that is 
made available to the Secretary. 
‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS AND OF POPU-
LATION
AS
A
WHOLE.—In making the determinations under 
paragraphs (1) and (2), the Secretary 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 application; 
‘‘(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 submitted 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 concerning modified risk products enable 
the public to comprehend the information concerning modified 
risk and to understand the relative significance of such informa-
tion in the context of total health and in relation to all of 
the diseases and health-related conditions associated with the 
use of tobacco products. 
‘‘(2) COMPARATIVE CLAIMS.— 
‘‘(A) IN GENERAL.—The Secretary may require for the 
marketing of a product under this subsection that a claim 
comparing a tobacco product to 1 or more other commer-
cially marketed tobacco products shall compare the tobacco 
product to a commercially marketed tobacco product that 
is representative of that type of tobacco product on the 
market (for example the average value of the top 3 brands 
of an established regular tobacco product). 
‘‘(B) QUANTITATIVE COMPARISONS.—The Secretary may 
also require, for purposes of subparagraph (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. 
‘‘(3) LABEL DISCLOSURE.— 
‘‘(A) IN
GENERAL.—The Secretary may require the 
disclosure on the label of other substances in the tobacco 
product, or substances that may be produced by the 
consumption of that tobacco product, that may affect a 
disease or health-related condition or may increase the 
risk of other diseases or health-related conditions associ-
ated with the use of tobacco products. 
‘‘(B) CONDITIONS OF USE.—If the conditions of use of 
the tobacco product may affect the risk of the product 
to human health, the Secretary may require the labeling 
of conditions of use.
H. R. 1256—42 
‘‘(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 obtained an order 
under subsection (g)(1), that the product comply with require-
ments relating to advertising 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 obtained an order under 
subsection (g)(1), that the applicant conduct postmarket surveil-
lance 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 
accuracy 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 submitted to the Secretary on an annual 
basis. 
‘‘(2) SURVEILLANCE PROTOCOL.—Each applicant 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 surveil-
lance. 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 surveillance and if such protocol 
will result in collection of the data or other information des-
ignated by the Secretary as necessary to protect the public 
health. 
‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Secretary, 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 material 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 established 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 applica-
tion; 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 
‘‘(5) the applicant failed to meet a condition imposed under 
subsection (h).