‘‘(C) based on a fair evaluation of all mate-
rial facts, the proposed labeling is false or mis-
leading in any particular; or 
‘‘(D) such tobacco product is not shown to 
conform in all respects to a tobacco product 
standard in effect under section 907, and there 
is a lack of adequate information to justify the 
deviation from such standard. 
‘‘(3) DENIAL INFORMATION.—Any denial of an 
application shall, insofar as the Secretary determines 
to be practicable, be accompanied by a statement in-
forming the applicant of the measures required to 
remove such application from deniable form (which 
measures may include further research by the appli-
cant in accordance with 1 or more protocols pre-
scribed by the Secretary). 
‘‘(4) BASIS
FOR
FINDING.—For purposes of 
this section, the finding as to whether the marketing 
of a tobacco product for which an application has 
been submitted is appropriate for the protection of 
the public health shall be determined with respect to 
the risks and benefits to the population as a whole, 
including users and nonusers of the tobacco product, 
and taking into account— 
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‘‘(A) the increased or decreased likelihood 
that existing users of tobacco products will stop 
using such products; and 
‘‘(B) the increased or decreased likelihood 
that those who do not use tobacco products will 
start using such products. 
‘‘(5) BASIS FOR ACTION.— 
‘‘(A) INVESTIGATIONS.—For purposes of 
paragraph (2)(A), whether permitting a tobacco 
product to be marketed would be appropriate 
for the protection of the public health shall, 
when appropriate, be determined on the basis of 
well-controlled investigations, which may in-
clude 1 or more clinical investigations by ex-
perts qualified by training and experience to 
evaluate the tobacco product. 
‘‘(B) OTHER EVIDENCE.—If the Secretary 
determines that there exists valid scientific evi-
dence (other than evidence derived from inves-
tigations described in subparagraph (A)) which 
is sufficient to evaluate the tobacco product, the 
Secretary may authorize that the determination 
for purposes of paragraph (2)(A) be made on 
the basis of such evidence. 
‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.— 
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‘‘(1) IN GENERAL.—The Secretary shall, upon 
obtaining, where appropriate, advice on scientific 
matters from the Tobacco Products Scientific Advi-
sory Committee, and after due notice and oppor-
tunity for informal hearing for a tobacco product for 
which an order was issued under subsection 
(c)(1)(A)(i), issue an order withdrawing the order if 
the Secretary finds— 
‘‘(A) that the continued marketing of such 
tobacco product no longer is appropriate for the 
protection of the public health; 
‘‘(B) that the application contained or was 
accompanied by an untrue statement of a mate-
rial fact; 
‘‘(C) that the applicant— 
‘‘(i) has failed to establish a system 
for maintaining records, or has repeatedly 
or deliberately failed to maintain records 
or to make reports, required by an applica-
ble regulation under section 909; 
‘‘(ii) has refused to permit access to, 
or copying or verification of, such records 
as required by section 704; or 
‘‘(iii) has not complied with the re-
quirements of section 905; 
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‘‘(D) on the basis of new information be-
fore the Secretary with respect to such tobacco 
product, evaluated together with the evidence 
before the Secretary when the application was 
reviewed, that the methods used in, or the fa-
cilities and controls used for, the manufacture, 
processing, packing, or installation of such to-
bacco product do not conform with the require-
ments of section 906(e) and were not brought 
into conformity with such requirements within a 
reasonable time after receipt of written notice 
from the Secretary of nonconformity; 
‘‘(E) on the basis of new information be-
fore the Secretary, evaluated together with the 
evidence before the Secretary when the applica-
tion was reviewed, that the labeling of such to-
bacco product, based on a fair evaluation of all 
material facts, is false or misleading in any par-
ticular and was not corrected within a reason-
able time after receipt of written notice from 
the Secretary of such fact; or 
‘‘(F) on the basis of new information be-
fore the Secretary, evaluated together with the 
evidence before the Secretary when such order 
was issued, that such tobacco product is not 
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shown to conform in all respects to a tobacco 
product standard which is in effect under sec-
tion 907, compliance with which was a condi-
tion to the issuance of an order relating to the 
application, and that there is a lack of adequate 
information to justify the deviation from such 
standard. 
‘‘(2) APPEAL.—The holder of an application 
subject to an order issued under paragraph (1) with-
drawing an order issued pursuant to subsection 
(c)(1)(A)(i) may, by petition filed on or before the 
30th day after the date upon which such holder re-
ceives notice of such withdrawal, obtain review there-
of in accordance with section 912. 
‘‘(3) TEMPORARY SUSPENSION.—If, after pro-
viding an opportunity for an informal hearing, the 
Secretary determines there is reasonable probability 
that the continuation of distribution of a tobacco 
product under an order would cause serious, adverse 
health consequences or death, that is greater than 
ordinarily caused by tobacco products on the market, 
the Secretary shall by order temporarily suspend the 
authority of the manufacturer to market the prod-
uct. If the Secretary issues such an order, the Sec-
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retary shall proceed expeditiously under paragraph 
(1) to withdraw such application. 
‘‘(e) SERVICE OF ORDER.—An order issued by the 
Secretary under this section shall be served— 
‘‘(1) in person by any officer or employee of the 
department designated by the Secretary; or 
‘‘(2) by mailing the order by registered mail or 
certified mail addressed to the applicant at the ap-
plicant’s last known address in the records of the 
Secretary. 
‘‘(f) RECORDS.— 
‘‘(1) ADDITIONAL INFORMATION.—In the case 
of any tobacco product for which an order issued 
pursuant to subsection (c)(1)(A)(i) for an applica-
tion filed under subsection (b) is in effect, the appli-
cant shall establish and maintain such records, and 
make such reports to the Secretary, as the Secretary 
may by regulation, or by order with respect to such 
application, prescribe on the basis of a finding that 
such records and reports are necessary in order to 
enable the Secretary to determine, or facilitate a de-
termination of, whether there is or may be grounds 
for withdrawing or temporarily suspending such 
order. 
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‘‘(2) ACCESS TO RECORDS.—Each person re-
quired under this section to maintain records, and 
each person in charge of custody thereof, shall, upon 
request of an officer or employee designated by the 
Secretary, permit such officer or employee at all rea-
sonable times to have access to and copy and verify 
such records. 
‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP-
TION FOR INVESTIGATIONAL USE.—The Secretary may 
exempt tobacco products intended for investigational use 
from the provisions of this chapter under such conditions 
as the Secretary may by regulation prescribe. 
‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—No person may introduce or de-
liver for introduction into interstate commerce any modi-
fied risk tobacco product unless an order issued pursuant 
to subsection (g) is effective with respect to such product. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) MODIFIED RISK TOBACCO PRODUCT.—The 
term ‘modified risk tobacco product’ means any to-
bacco product that is sold or distributed for use to 
reduce harm or the risk of tobacco-related disease 
associated with commercially marketed tobacco prod-
ucts. 
‘‘(2) SOLD OR DISTRIBUTED.— 
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‘‘(A) IN GENERAL.—With respect to a to-
bacco product, the term ‘sold or distributed for 
use to reduce harm or the risk of tobacco-re-
lated disease associated with commercially mar-
keted tobacco products’ means a tobacco prod-
uct— 
‘‘(i) the label, labeling, or advertising 
of which represents explicitly or implicitly 
that— 
‘‘(I) the tobacco product presents 
a lower risk of tobacco-related disease 
or is less harmful than one or more 
other commercially marketed tobacco 
products; 
‘‘(II) the tobacco product or its 
smoke contains a reduced level of a 
substance or presents a reduced expo-
sure to a substance; or 
‘‘(III) the tobacco product or its 
smoke does not contain or is free of a 
substance; 
‘‘(ii) the label, labeling, or advertising 
of which uses the descriptors ‘light’, ‘mild’, 
or ‘low’ or similar descriptors; or 
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‘‘(iii) the tobacco product manufac-
turer of which has taken any action di-
rected to consumers through the media or 
otherwise, other than by means of the to-
bacco product’s label, labeling, or adver-
tising, after the date of enactment of the 
Family Smoking Prevention and Tobacco 
Control Act, respecting the product that 
would be reasonably expected to result in 
consumers believing that the tobacco prod-
uct or its smoke may present a lower risk 
of disease or is less harmful than one or 
more commercially marketed tobacco prod-
ucts, or presents a reduced exposure to, or 
does not contain or is free of, a substance 
or substances. 
‘‘(B) LIMITATION.—No tobacco product 
shall be considered to be ‘sold or distributed for 
use to reduce harm or the risk of tobacco-re-
lated disease associated with commercially mar-
keted tobacco products’, except as described in 
subparagraph (A). 
‘‘(C) SMOKELESS TOBACCO PRODUCT.—No 
smokeless tobacco product shall be considered 
to be ‘sold or distributed for use to reduce harm 
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100 
or the risk of tobacco-related disease associated 
with commercially marketed tobacco products’ 
solely because its label, labeling, or advertising 
uses the following phrases to describe such 
product and its use: ‘smokeless tobacco’, 
‘smokeless tobacco product’, ‘not consumed by 
smoking’, 
‘does 
not 
produce 
smoke’, 
‘smokefree’, ‘smoke-free’, ‘without smoke’, ‘no 
smoke’, or ‘not smoke’. 
‘‘(3) EFFECTIVE
DATE.—The provisions of 
paragraph (2)(A)(ii) shall take effect 12 months 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act for those prod-
ucts whose label, labeling, or advertising contains 
the terms described in such paragraph on such date 
of enactment. The effective date shall be with re-
spect to the date of manufacture, provided that, in 
any case, beginning 30 days after such effective 
date, a manufacturer shall not introduce into the do-
mestic commerce of the United States any product, 
irrespective of the date of manufacture, that is not 
in conformance with paragraph (2)(A)(ii). 
‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product 
that is intended to be used for the treatment of tobacco 
dependence, including smoking cessation, is not a modified 
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101 
risk tobacco product under this section if it has been ap-
proved as a drug or device by the Food and Drug Adminis-
tration and is subject to the requirements of chapter V. 
‘‘(d) FILING.—Any person may file with the Sec-
retary an application for a modified risk tobacco product. 
Such application shall include— 
‘‘(1) a description of the proposed product and 
any proposed advertising and labeling; 
‘‘(2) the conditions for using the product; 
‘‘(3) the formulation of the product; 
‘‘(4) sample product labels and labeling; 
‘‘(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. 
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102 
‘‘(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 
the Tobacco Products Scientific Advisory Committee 
any application submitted 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 Committee shall 
report its recommendations on the application to the 
Secretary. 
‘‘(g) MARKETING.— 
‘‘(1) MODIFIED
RISK
PRODUCTS.—Except as 
provided in paragraph (2), the Secretary shall, with 
respect to an application submitted under this sec-
tion, issue an order that a modified risk product 
may be commercially marketed only if the Secretary 
determines that the applicant has demonstrated that 
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103 
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 
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 de-
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 
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104 
modified risk tobacco product under sub-
section (b) is limited to an explicit or im-
plicit representation 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 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 
measurable and substantial reduction in 
morbidity or mortality among individual 
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— 
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105 
‘‘(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 reasonably 
likely overall impact of use of the product 
remains a substantial and measurable re-
duction 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 
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106 
‘‘(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. 
‘‘(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-
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107 
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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108 
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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