106 
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 
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 
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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 
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. 
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‘‘(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 
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 
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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. 
‘‘(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 
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110 
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 
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— 
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‘‘(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 
‘‘(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). 
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