127 
‘‘(5) all documents (including underlying sci-
entific information) relating to research findings 
conducted, supported, or possessed by the tobacco 
product manufacturer relating to the effect of the 
product on tobacco-related diseases and health-re-
lated conditions, including information both favor-
able and unfavorable to the ability of the product to 
reduce risk or exposure and relating to human 
health; 
‘‘(6) data and information on how consumers 
actually use the tobacco product; and 
‘‘(7) such other information as the Secretary 
may require. 
‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall 
make the application described in subsection (d) publicly 
available (except matters in the application which are 
trade secrets or otherwise confidential, commercial infor-
mation) and shall request comments by interested persons 
on the information contained in the application and on the 
label, labeling, and advertising accompanying such appli-
cation. 
‘‘(f) ADVISORY COMMITTEE.— 
‘‘(1) IN GENERAL.—The Secretary shall refer to 
an advisory committee any application submitted 
under this subsection. 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00127
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
128 
‘‘(2) RECOMMENDATIONS.—Not later than 60 
days after the date an application is referred to an 
advisory committee under paragraph (1), the advi-
sory committee shall report its recommendations on 
the application to the Secretary. 
‘‘(g) APPROVAL.— 
‘‘(1) MODIFIED
RISK
PRODUCTS.—Except as 
provided in paragraph (2), the Secretary shall ap-
prove an application for a modified risk tobacco 
product filed under this section only if the Secretary 
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 to-
bacco users; and 
‘‘(B) benefit the health of the population 
as a whole taking into account both users of to-
bacco products and persons who do not cur-
rently use tobacco products. 
‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— 
‘‘(A) IN
GENERAL.—The Secretary may 
approve an application for a tobacco product 
that has not been approved as a modified risk 
tobacco product pursuant to paragraph (1) if 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00128
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
129 
the Secretary makes the findings required 
under this paragraph and determines that the 
applicant has demonstrated that— 
‘‘(i) the approval of the application 
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 sub-
section (b)(2) is limited to an explicit or 
implicit representation that such tobacco 
product or its smoke contains or is free of 
a substance or contains a reduced level of 
a substance, or presents a reduced expo-
sure 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 stand-
ards set forth in paragraph (1); and 
‘‘(iv) the scientific evidence that is 
available without conducting long-term epi-
demiological studies demonstrates that a 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00129
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
130 
measurable and substantial reduction in 
morbidity or mortality among individual 
tobacco users is anticipated in subsequent 
studies. 
‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 
In order to approve an application under sub-
paragraph (A) the Secretary must also find 
that the applicant has demonstrated that— 
‘‘(i) the magnitude of the overall re-
ductions in exposure to the substance or 
substances which are the subject of the ap-
plication 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 com-
pared to the similar types of tobacco prod-
ucts then on the market unless such in-
creases are minimal and the anticipated 
overall impact of use of the product re-
mains a substantial and measurable reduc-
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00130
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
131 
tion in overall morbidity and mortality 
among individual tobacco users; 
‘‘(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) approval of the application is ex-
pected to benefit the health of the popu-
lation as a whole taking into account both 
users of tobacco products and persons who 
do not currently use tobacco products. 
‘‘(C) CONDITIONS OF APPROVAL.— 
‘‘(i) IN
GENERAL.—Applications ap-
proved under this paragraph shall be lim-
ited to a term of not more than 5 years, 
but may be renewed upon a finding by the 
Secretary that the requirements of this 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00131
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
132 
paragraph continue to be satisfied based 
on the filing of a new application. 
‘‘(ii) AGREEMENTS BY APPLICANT.— 
Applications approved under this para-
graph shall be conditioned on the appli-
cant’s agreement to conduct post-market 
surveillance and studies and to submit to 
the Secretary the results of such surveil-
lance and studies to determine the impact 
of the application approval on consumer 
perception, behavior, and health and to en-
able the Secretary to review the accuracy 
of the determinations upon which the ap-
proval was based in accordance with a pro-
tocol approved by the Secretary. 
‘‘(iii) ANNUAL SUBMISSION.—The re-
sults of such post-market 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 available to the Secretary. 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00132
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
133 
‘‘(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 
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 APPROVAL.— 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00133
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
134 
‘‘(1) MODIFIED
RISK
PRODUCTS.—The Sec-
retary shall require for the approval of an applica-
tion under this section that any advertising or label-
ing concerning modified risk products enable the 
public to comprehend the information concerning 
modified risk and to understand the relative signifi-
cance 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 products. 
‘‘(2) COMPARATIVE CLAIMS.— 
‘‘(A) IN GENERAL.—The Secretary may re-
quire for the approval of an application under 
this subsection that a claim comparing a to-
bacco product to 1 or more other commercially 
marketed tobacco products shall compare the 
tobacco 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 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00134
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
135 
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 
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.—The Secretary shall limit an ap-
proval under subsection (g)(1) for a specified period 
of time. 
‘‘(5) ADVERTISING.—The Secretary may re-
quire that an applicant, whose application has been 
approved under this subsection, comply with require-
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00135
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
136 
ments relating to advertising and promotion of the 
tobacco product. 
‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.— 
‘‘(1) IN GENERAL.—The Secretary shall require 
that an applicant under subsection (g)(1) conduct 
post market surveillance and studies for a tobacco 
product for which an application has been approved 
to determine the impact of the application approval 
on consumer perception, behavior, and health, to en-
able the Secretary to review the accuracy of the de-
terminations upon which the approval was based, 
and to provide information that the Secretary deter-
mines is otherwise necessary regarding the use or 
health risks involving the tobacco product. The re-
sults of post-market surveillance and studies shall be 
submitted 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 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-
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00136
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
137 
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 APPROVAL.—The Secretary, 
after an opportunity for an informal hearing, shall with-
draw the approval of an application under this section 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 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 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00137
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS
138 
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 approval of the application 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 (i); or 
‘‘(5) the applicant failed to meet a condition 
imposed under subsection (h). 
‘‘(k) CHAPTER IV OR V.—A product approved in ac-
cordance with this section 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 re-
quired for assessment and ongoing review of modi-
fied risk tobacco products. Such regulations or guid-
ance shall— 
‘‘(A) establish minimum standards for sci-
entific studies needed prior to approval to show 
VerDate Aug 31 2005 
00:40 Aug 05, 2006
Jkt 049200
PO 00000
Frm 00138
Fmt 6652
Sfmt 6201
E:\BILLS\H5951.IH
H5951
jcorcoran on PROD1PC62 with BILLS