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 applicable reg-
ulation 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; 
‘‘(D) on the basis of new information before 
the Secretary with respect to such tobacco prod-
uct, evaluated together with the evidence before 
the Secretary when the application was reviewed, 
that the methods used in, or the facilities and 
controls used for, the manufacture, processing, 
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packing, or installation of such tobacco product 
do not conform with the requirements 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 before 
the Secretary, evaluated together with the evi-
dence before the Secretary when the application 
was reviewed, that the labeling of such tobacco 
product, based on a fair evaluation of all mate-
rial 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 before 
the Secretary, evaluated together with the evi-
dence before the Secretary when such order was 
issued, that such tobacco product is not shown to 
conform in all respects to a tobacco product 
standard which is in effect under section 907, 
compliance with which was a condition 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. 
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‘‘(2) APPEAL.—The holder of an application sub-
ject 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 thereof 
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 or-
dinarily caused by tobacco products on the market, 
the Secretary shall by order temporarily suspend the 
authority of the manufacturer to market the product. 
If the Secretary issues such an order, the Secretary 
shall proceed expeditiously under paragraph (1) to 
withdraw such application. 
‘‘(e) SERVICE OF ORDER.—An order issued by the Sec-
retary 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 appli-
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cant’s last known address in the records of the Sec-
retary. 
‘‘(f) RECORDS.— 
‘‘(1) ADDITIONAL INFORMATION.—In the case of 
any tobacco product for which an order issued pursu-
ant to subsection (c)(1)(A)(i) for an application filed 
under subsection (b) is in effect, the applicant shall 
establish and maintain such records, and make such 
reports to the Secretary, as the Secretary may by reg-
ulation, 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 Sec-
retary to determine, or facilitate a determination of, 
whether there is or may be grounds for withdrawing 
or temporarily suspending such order. 
‘‘(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 ex-
empt tobacco products intended for investigational use from 
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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 re-
duce harm or the risk of tobacco-related disease asso-
ciated with commercially marketed tobacco products. 
‘‘(2) SOLD OR DISTRIBUTED.— 
‘‘(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-related 
disease associated with commercially marketed 
tobacco products’ means a tobacco product— 
‘‘(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 
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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 
‘‘(iii) the tobacco product manufac-
turer of which has taken any action directed 
to consumers through the media or other-
wise, other than by means of the tobacco 
product’s label, labeling, or advertising, 
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 product or its 
smoke may present a lower risk of disease 
or is less harmful than one or more com-
mercially marketed tobacco products, or 
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presents a reduced exposure to, or does not 
contain or is free of, a substance or sub-
stances. 
‘‘(B) 
LIMITATION.—No 
tobacco 
product 
shall be considered to be ‘sold or distributed for 
use to reduce harm or the risk of tobacco-related 
disease associated with commercially marketed 
tobacco products’, except as described in sub-
paragraph (A). 
‘‘(C) SMOKELESS TOBACCO PRODUCT.—No 
smokeless tobacco product shall be considered to 
be ‘sold or distributed for use to reduce harm 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 para-
graph (2)(A)(ii) shall take effect 12 months after the 
date of enactment of the Family Smoking Prevention 
and Tobacco Control Act for those products whose 
label, labeling, or advertising contains the terms de-
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scribed in such paragraph on such date of enactment. 
The effective date shall be with respect to the date of 
manufacture, provided that, in any case, 30 days 
after such effective date, a manufacturer shall not in-
troduce into the domestic commerce of the United 
States any product 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 de-
pendence, including smoking cessation, is not a modified 
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 Secretary 
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 con-
ducted, supported, or possessed by the tobacco product 
manufacturer relating to the effect of the product on 
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tobacco-related diseases and health-related conditions, 
including information both favorable 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 ac-
tually 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 avail-
able (except matters in the application which are trade se-
crets or otherwise confidential, commercial information) 
and shall request comments by interested persons on the in-
formation contained in the application 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 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. 
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