‘‘(D) shall require tobacco products con-
taining foreign-grown tobacco to meet the same 
standards applicable to tobacco products con-
taining domestically grown tobacco. 
‘‘(5) PERIODIC
REEVALUATION
OF
TOBACCO 
PRODUCT STANDARDS.—The Secretary shall provide 
for periodic evaluation of tobacco product standards 
established under this section to determine whether 
such standards should be changed to reflect new 
medical, scientific, or other technological data. The 
Secretary may provide for testing under paragraph 
(4)(B) by any person. 
‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN-
FORMED
PERSONS.—In carrying out duties under 
this section, the Secretary shall endeavor to— 
‘‘(A) use personnel, facilities, and other 
technical support available in other Federal 
agencies; 
‘‘(B) consult with other Federal agencies 
concerned with standard setting and other na-
tionally or internationally recognized standard- 
setting entities; and 
‘‘(C) 
invite 
appropriate 
participation, 
through joint or other conferences, workshops, 
or other means, by informed persons represent-
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ative of scientific, professional, industry, agri-
cultural, or consumer organizations who in the 
Secretary’s judgment can make a significant 
contribution. 
‘‘(b) CONSIDERATIONS BY SECRETARY.— 
‘‘(1) TECHNICAL
ACHIEVABILITY.—The Sec-
retary shall consider information submitted in con-
nection with a proposed standard regarding the tech-
nical achievability of compliance with such standard. 
‘‘(2) OTHER CONSIDERATIONS.—The Secretary 
shall consider all other information submitted in 
connection with a proposed standard, including in-
formation concerning the countervailing effects of 
the tobacco product standard on the health of ado-
lescent tobacco users, adult tobacco users, or non-
tobacco users, such as the creation of a significant 
demand for contraband or other tobacco products 
that do not meet the requirements of this chapter 
and the significance of such demand. 
‘‘(c) PROPOSED STANDARDS.— 
‘‘(1) IN GENERAL.—The Secretary shall publish 
in the Federal Register a notice of proposed rule-
making for the establishment, amendment, or rev-
ocation of any tobacco product standard. 
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‘‘(2) REQUIREMENTS OF NOTICE.—A notice of 
proposed rulemaking for the establishment or 
amendment of a tobacco product standard for a to-
bacco product shall— 
‘‘(A) set forth a finding with supporting 
justification that the tobacco product standard 
is appropriate for the protection of the public 
health; 
‘‘(B) invite interested persons to submit a 
draft or proposed tobacco product standard for 
consideration by the Secretary; 
‘‘(C) invite interested persons to submit 
comments on structuring the standard so that 
it does not advantage foreign-grown tobacco 
over domestically grown tobacco; and 
‘‘(D) invite the Secretary of Agriculture to 
provide any information or analysis which the 
Secretary of Agriculture believes is relevant to 
the proposed tobacco product standard. 
‘‘(3) FINDING.—A notice of proposed rule-
making for the revocation of a tobacco product 
standard shall set forth a finding with supporting 
justification that the tobacco product standard is no 
longer appropriate for the protection of the public 
health. 
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‘‘(4) COMMENT.—The Secretary shall provide 
for a comment period of not less than 60 days. 
‘‘(d) PROMULGATION.— 
‘‘(1) IN GENERAL.—After the expiration of the 
period for comment on a notice of proposed rule-
making published under subsection (c) respecting a 
tobacco product standard and after consideration of 
comments submitted under subsections (b) and (c) 
and any report from the Tobacco Products Scientific 
Advisory Committee, the Secretary shall— 
‘‘(A) if the Secretary determines that the 
standard would be appropriate for the protec-
tion of the public health, promulgate a regula-
tion establishing a tobacco product standard 
and publish in the Federal Register findings on 
the matters referred to in subsection (c); or 
‘‘(B) publish a notice terminating the pro-
ceeding for the development of the standard to-
gether with the reasons for such termination. 
‘‘(2) EFFECTIVE
DATE.—A regulation estab-
lishing a tobacco product standard shall set forth 
the date or dates upon which the standard shall take 
effect, but no such regulation may take effect before 
1 year after the date of its publication unless the 
Secretary determines that an earlier effective date is 
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necessary for the protection of the public health. 
Such date or dates shall be established so as to min-
imize, consistent with the public health, economic 
loss to, and disruption or dislocation of, domestic 
and international trade. In establishing such effec-
tive date or dates, the Secretary shall consider infor-
mation submitted in connection with a proposed 
product standard by interested parties, including 
manufacturers and tobacco growers, regarding the 
technical achievability of compliance with the stand-
ard, and including information concerning the exist-
ence of patents that make it impossible to comply in 
the timeframe envisioned in the proposed standard. 
If the Secretary determines, based on the Sec-
retary’s evaluation of submitted comments, that a 
product standard can be met only by manufacturers 
requiring substantial changes to the methods of 
farming the domestically grown tobacco used by the 
manufacturer, the effective date of that product 
standard shall be not less than 2 years after the 
date of publication of the final regulation estab-
lishing the standard. 
‘‘(3) LIMITATION ON POWER GRANTED TO THE 
FOOD AND DRUG ADMINISTRATION.—Because of the 
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importance of a decision of the Secretary to issue a 
regulation— 
‘‘(A) banning all cigarettes, all smokeless 
tobacco products, all little cigars, all cigars 
other than little cigars, all pipe tobacco, or all 
roll-your-own tobacco products; or 
‘‘(B) requiring the reduction of nicotine 
yields of a tobacco product to zero, 
the Secretary is prohibited from taking such actions 
under this Act. 
‘‘(4) AMENDMENT; REVOCATION.— 
‘‘(A) AUTHORITY.—The Secretary, upon 
the Secretary’s own initiative or upon petition 
of an interested person, may by a regulation, 
promulgated in accordance with the require-
ments of subsection (c) and paragraph (2), 
amend or revoke a tobacco product standard. 
‘‘(B) EFFECTIVE
DATE.—The Secretary 
may declare a proposed amendment of a to-
bacco product standard to be effective on and 
after its publication in the Federal Register and 
until the effective date of any final action taken 
on such amendment if the Secretary determines 
that making it so effective is in the public inter-
est. 
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such use among African Americans, Hispanics, and 
other racial and ethnic minorities. In its review, the 
Tobacco Products Scientific Advisory Committee 
shall address the considerations listed in subsections 
(a)(3)(B)(i) and (b). 
‘‘(2) REPORT
AND
RECOMMENDATION.—Not 
later than 1 year after its establishment, the To-
bacco Product Scientific Advisory Committee shall 
submit to the Secretary the report and recommenda-
tions required pursuant to paragraph (1). 
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to limit the Sec-
retary’s authority to take action under this section 
or other sections of this Act applicable to menthol. 
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES. 
‘‘(a) NOTIFICATION.—If the Secretary determines 
that— 
‘‘(1) a tobacco product which is introduced or 
delivered for introduction into interstate commerce 
for commercial distribution presents an unreasonable 
risk of substantial harm to the public health; and 
‘‘(2) notification under this subsection is nec-
essary to eliminate the unreasonable risk of such 
harm and no more practicable means is available 
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under the provisions of this chapter (other than this 
section) to eliminate such risk, 
the Secretary may issue such order as may be necessary 
to assure that adequate notification is provided in an ap-
propriate form, by the persons and means best suited 
under the circumstances involved, to all persons who 
should properly receive such notification in order to elimi-
nate such risk. The Secretary may order notification by 
any appropriate means, including public service announce-
ments. Before issuing an order under this subsection, the 
Secretary shall consult with the persons who are to give 
notice under the order. 
‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.— 
Compliance with an order issued under this section shall 
not relieve any person from liability under Federal or 
State law. In awarding damages for economic loss in an 
action brought for the enforcement of any such liability, 
the value to the plaintiff in such action of any remedy 
provided under such order shall be taken into account. 
‘‘(c) RECALL AUTHORITY.— 
‘‘(1) IN GENERAL.—If the Secretary finds that 
there is a reasonable probability that a tobacco prod-
uct contains a manufacturing or other defect not or-
dinarily contained in tobacco products on the market 
that would cause serious, adverse health con-
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sequences or death, the Secretary shall issue an 
order requiring the appropriate person (including 
the manufacturers, importers, distributors, or retail-
ers of the tobacco product) to immediately cease dis-
tribution of such tobacco product. The order shall 
provide the person subject to the order with an op-
portunity for an informal hearing, to be held not 
later than 10 days after the date of the issuance of 
the order, on the actions required by the order and 
on whether the order should be amended to require 
a recall of such tobacco product. If, after providing 
an opportunity for such a hearing, the Secretary de-
termines that inadequate grounds exist to support 
the actions required by the order, the Secretary shall 
vacate the order. 
‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE-
CALL.— 
‘‘(A) IN GENERAL.—If, after providing an 
opportunity for an informal hearing under 
paragraph (1), the Secretary determines that 
the order should be amended to include a recall 
of the tobacco product with respect to which the 
order was issued, the Secretary shall, except as 
provided in subparagraph (B), amend the order 
to require a recall. The Secretary shall specify 
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a timetable in which the tobacco product recall 
will occur and shall require periodic reports to 
the Secretary describing the progress of the re-
call. 
‘‘(B) NOTICE.—An amended order under 
subparagraph (A)— 
‘‘(i) shall not include recall of a to-
bacco product from individuals; and 
‘‘(ii) shall provide for notice to per-
sons subject to the risks associated with 
the use of such tobacco product. 
In providing the notice required by clause (ii), 
the Secretary may use the assistance of retail-
ers and other persons who distributed such to-
bacco product. If a significant number of such 
persons cannot be identified, the Secretary shall 
notify such persons under section 705(b). 
‘‘(3) REMEDY
NOT
EXCLUSIVE.—The remedy 
provided by this subsection shall be in addition to 
remedies provided by subsection (a). 
‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD-
UCTS. 
‘‘(a) IN GENERAL.—Every person who is a tobacco 
product manufacturer or importer of a tobacco product 
shall establish and maintain such records, make such re-
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ports, and provide such information, as the Secretary may 
by regulation reasonably require to assure that such to-
bacco product is not adulterated or misbranded and to 
otherwise protect public health. Regulations prescribed 
under the preceding sentence— 
‘‘(1) may require a tobacco product manufac-
turer or importer to report to the Secretary when-
ever the manufacturer or importer receives or other-
wise becomes aware of information that reasonably 
suggests that one of its marketed tobacco products 
may have caused or contributed to a serious unex-
pected adverse experience associated with the use of 
the product or any significant increase in the fre-
quency of a serious, expected adverse product experi-
ence; 
‘‘(2) shall require reporting of other significant 
adverse tobacco product experiences as determined 
by the Secretary to be necessary to be reported; 
‘‘(3) shall not impose requirements unduly bur-
densome to a tobacco product manufacturer or im-
porter, taking into account the cost of complying 
with such requirements and the need for the protec-
tion of the public health and the implementation of 
this chapter; 
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‘‘(4) when prescribing the procedure for making 
requests for reports or information, shall require 
that each request made under such regulations for 
submission of a report or information to the Sec-
retary state the reason or purpose for such request 
and identify to the fullest extent practicable such re-
port or information; 
‘‘(5) when requiring submission of a report or 
information to the Secretary, shall state the reason 
or purpose for the submission of such report or in-
formation and identify to the fullest extent prac-
ticable such report or information; and 
‘‘(6) may not require that the identity of any 
patient or user be disclosed in records, reports, or 
information required under this subsection unless re-
quired for the medical welfare of an individual, to 
determine risks to public health of a tobacco prod-
uct, or to verify a record, report, or information sub-
mitted under this chapter. 
In prescribing regulations under this subsection, the Sec-
retary shall have due regard for the professional ethics of 
the medical profession and the interests of patients. The 
prohibitions of paragraph (6) continue to apply to records, 
reports, and information concerning any individual who 
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cause the product does not raise different 
questions of public health. 
‘‘(B) 
CHARACTERISTICS.—In 
subpara-
graph (A), the term ‘characteristics’ means the 
materials, 
ingredients, 
design, 
composition, 
heating source, or other features of a tobacco 
product. 
‘‘(C) LIMITATION.—A tobacco product may 
not be found to be substantially equivalent to a 
predicate tobacco product that has been re-
moved from the market at the initiative of the 
Secretary or that has been determined by a ju-
dicial order to be misbranded or adulterated. 
‘‘(4) HEALTH INFORMATION.— 
‘‘(A) SUMMARY.—As part of a submission 
under section 905(j) respecting a tobacco prod-
uct, the person required to file a premarket no-
tification under such section shall provide an 
adequate summary of any health information 
related to the tobacco product or state that 
such information will be made available upon 
request by any person. 
‘‘(B) REQUIRED INFORMATION.—Any sum-
mary under subparagraph (A) respecting a to-
bacco product shall contain detailed information 
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regarding data concerning adverse health ef-
fects and shall be made available to the public 
by the Secretary within 30 days of the issuance 
of a determination that such tobacco product is 
substantially equivalent to another tobacco 
product. 
‘‘(b) APPLICATION.— 
‘‘(1) CONTENTS.—An application under this 
section shall contain— 
‘‘(A) full reports of all information, pub-
lished or known to, or which should reasonably 
be known to, the applicant, concerning inves-
tigations which have been made to show the 
health risks of such tobacco product and wheth-
er such tobacco product presents less risk than 
other tobacco products; 
‘‘(B) a full statement of the components, 
ingredients, additives, and properties, and of 
the principle or principles of operation, of such 
tobacco product; 
‘‘(C) a full description of the methods used 
in, and the facilities and controls used for, the 
manufacture, processing, and, when relevant, 
packing and installation of, such tobacco prod-
uct; 
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‘‘(D) an identifying reference to any to-
bacco product standard under section 907 
which would be applicable to any aspect of such 
tobacco product, and either adequate informa-
tion to show that such aspect of such tobacco 
product fully meets such tobacco product stand-
ard or adequate information to justify any devi-
ation from such standard; 
‘‘(E) such samples of such tobacco product 
and of components thereof as the Secretary 
may reasonably require; 
‘‘(F) specimens of the labeling proposed to 
be used for such tobacco product; and 
‘‘(G) such other information relevant to 
the subject matter of the application as the Sec-
retary may require. 
‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI-
ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 
application meeting the requirements set forth in 
paragraph (1), the Secretary— 
‘‘(A) may, on the Secretary’s own initia-
tive; or 
‘‘(B) may, upon the request of an appli-
cant, 
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refer such application to the Tobacco Products Sci-
entific Advisory Committee for reference and for 
submission (within such period as the Secretary may 
establish) of a report and recommendation respect-
ing the application, together with all underlying data 
and the reasons or basis for the recommendation. 
‘‘(c) ACTION ON APPLICATION.— 
‘‘(1) DEADLINE.— 
‘‘(A) IN GENERAL.—As promptly as pos-
sible, but in no event later than 180 days after 
the receipt of an application under subsection 
(b), the Secretary, after considering the report 
and recommendation submitted under sub-
section (b)(2), shall— 
‘‘(i) issue an order that the new prod-
uct may be introduced or delivered for in-
troduction into interstate commerce if the 
Secretary finds that none of the grounds 
specified in paragraph (2) of this sub-
section applies; or 
‘‘(ii) issue an order that the new prod-
uct may not be introduced or delivered for 
introduction into interstate commerce if 
the Secretary finds (and sets forth the 
basis for such finding as part of or accom-
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panying such denial) that 1 or more 
grounds for denial specified in paragraph 
(2) of this subsection apply. 
‘‘(B) RESTRICTIONS
ON
SALE
AND
DIS-
TRIBUTION.—An order under subparagraph 
(A)(i) may require that the sale and distribu-
tion of the tobacco product be restricted but 
only to the extent that the sale and distribution 
of a tobacco product may be restricted under a 
regulation under section 906(d). 
‘‘(2) DENIAL OF APPLICATION.—The Secretary 
shall deny an application submitted under subsection 
(b) if, upon the basis of the information submitted 
to the Secretary as part of the application and any 
other information before the Secretary with respect 
to such tobacco product, the Secretary finds that— 
‘‘(A) there is a lack of a showing that per-
mitting such tobacco product to be marketed 
would be appropriate for the protection of the 
public health; 
‘‘(B) the methods used in, or the facilities 
or controls used for, the manufacture, proc-
essing, or packing of such tobacco product do 
not conform to the requirements of section 
906(e); 
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‘‘(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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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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100 
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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101 
‘‘(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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102 
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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