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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 prod-
ucts and persons who do not currently use 
tobacco 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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HR 1108 RFS 
‘‘(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 con-
sumer perception, behavior, and health and 
to enable the Secretary to review the accu-
racy of the determinations upon which the 
order was based in accordance with a pro-
tocol approved by the Secretary. 
‘‘(iii) ANNUAL SUBMISSION.—The re-
sults of such postmarket surveillance and 
studies described in clause (ii) shall be 
submitted 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 
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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 Sec-
retary shall require for the marketing of a product 
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HR 1108 RFS 
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 information in the context of total health and 
in relation to all of the diseases and health-related 
conditions associated with the use of tobacco prod-
ucts. 
‘‘(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 to-
bacco product to a commercially marketed to-
bacco 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 es-
tablished 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 
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shall be stated in immediate proximity to the 
most prominent claim. 
‘‘(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 tobacco product, that may affect a disease 
or health-related condition or may increase the 
risk of other diseases or health-related condi-
tions associated with the use of tobacco prod-
ucts. 
‘‘(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 
Secretary 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 re-
quire, with respect to a product for which an appli-
cant obtained an order under subsection (g)(1), that 
the product comply with requirements relating to ad-
vertising and promotion of the tobacco product. 
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HR 1108 RFS 
‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.— 
‘‘(1) IN
GENERAL.—The Secretary shall re-
quire, with respect to a product for which an appli-
cant obtained an order under subsection (g)(1), that 
the applicant conduct postmarket surveillance and 
studies for such a tobacco product to determine the 
impact of the order issuance on consumer percep-
tion, behavior, and health, to enable the Secretary to 
review the accuracy of the determinations upon 
which the order was based, and to provide informa-
tion that the Secretary determines is otherwise nec-
essary regarding the use or health risks involving 
the tobacco product. The results of postmarket sur-
veillance and studies shall be submitted to the Sec-
retary 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 ap-
proval of the Secretary, a protocol for the required 
surveillance. The Secretary, within 60 days of the 
receipt of such protocol, shall determine if the prin-
cipal investigator proposed to be used in the surveil-
lance has sufficient qualifications and experience to 
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