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Appendix A
Section 911 of the
Family Smoking Prevention and
Tobacco Control Act of 2009
21 USC 387k. ‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
“(a) In General- No person may introduce or deliver for introduction
into interstate commerce any modified 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 tobacco product that is sold or dis -
tributed for use to reduce harm or the risk of tobacco-related disease
associated with commercially marketed tobacco products.
“(2) SOLD OR DISTRIBUTED-
“(A) IN GENERAL- With respect to a tobacco 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 other
commercially marketed tobacco products;
“(II) the tobacco product or its smoke contains a reduced
level of a substance or presents a reduced exposure to a
substance; or
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248 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
“(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 descrip-
tors ‘light’, ‘mild’, or ‘low’ or similar descriptors; or
“(iii) the tobacco product manufacturer of which has taken any
action directed to consumers through the media or otherwise,
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 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-
related disease associated with commercially marketed 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 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 products
whose label, labeling, or advertising contains the terms described 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, beginning 30 days after such effective date, a manufacturer
shall not introduce into the domestic 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 ces-
sation, is not a modified risk tobacco product under this section if it has
been approved as a drug or device by the Food and Drug Administra-
tion and is subject to the requirements of chapter V.
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249
APPENDIX A
“(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 adver-
tising 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 scientific 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-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 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, commer-
cial information) and shall request comments by interested persons on
the information 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 Advi-
sory 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 section, issue an order that a modified risk
product may be commercially marketed only if the Secretary deter-
mines 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 tobacco users; and
“(B) benefit the health of the population as a whole taking into
account both users of tobacco products and persons who do not
currently use tobacco products.
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250 STUDIES ON MODIFIED RISK 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 com-
mercially marketed under paragraph (1) if the Secretary makes
the findings required under this paragraph and determines 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 modi-
fied risk tobacco product under subsection (b) is limited to an
explicit or implicit 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 available and, using the best
available scientific methods, cannot be made available without
conducting long-term epidemiological studies for an applica -
tion to meet the standards set forth in paragraph (1); and
“(iv) the scientific evidence that is available without conduct-
ing long-term epidemiological studies demonstrates that a
measurable and substantial reduction in morbidity or mor-
tality among individual tobacco users is reasonably likely in
subsequent studies.
“(B) ADDITIONAL FINDINGS REQUIRED- To issue an order
under subparagraph (A) the Secretary must also find that the
applicant has demonstrated that--
“(i) the magnitude of the overall reductions in exposure to the
substance or substances which are the subject of the applica-
tion 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 compared to
the similar types of tobacco products then on the market unless
such increases are minimal and the reasonably likely overall
impact of use of the product remains a substantial and mea-
surable reduction in overall morbidity and mortality among
individual tobacco users;
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251
APPENDIX A
“(iii) testing of actual consumer perception shows that, as the
applicant proposes to label and market the product, consumers
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 demonstrated to present less of a
risk of disease than 1 or more other commercially 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 products and persons
who do not currently use tobacco products.
“(C) CONDITIONS OF MARKETING-
“(i) IN GENERAL- Applications subject 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 consumer perception,
behavior, and health and to enable the Secretary to review
the accuracy of the determinations upon which the order was
based in accordance with a protocol approved by the Secretary.
“(iii) ANNUAL SUBMISSION- The results of such postmarket
surveillance and studies described in clause (ii) shall be sub -
mitted annually.
“(3) BASIS- The determinations under paragraphs (1) and (2) shall
be based on--
“(A) the scientific evidence submitted by the applicant; and
“(B) scientific evidence and other information that is made avail-
able to the Secretary.
“(4) BENEFIT TO HEALTH OF INDIVIDUALS AND OF POPULA-
TION AS A WHOLE- In making the determinations under para-
graphs (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 prod-
ucts will switch to the tobacco product that is the subject of the
application;
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252 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
“(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 Secretary 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 under-
stand 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 products.
“(2) COMPARATIVE CLAIMS-
“(A) IN GENERAL- The Secretary may require for the market-
ing of a product under this subsection that a claim comparing
a tobacco product to 1 or more other commercially marketed
tobacco products shall compare the tobacco product to a commer-
cially marketed tobacco 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 established regular tobacco product).
“(B) QUANTITATIVE COMPARISONS- The Secretary may also
require, for purposes of subparagraph (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 require the disclosure on
the label of other substances in the tobacco product, or substances
that may be produced by the consumption of that tobacco prod-
uct, that may affect a disease or health-related condition or may
increase the risk of other diseases or health-related conditions
associated with the use of tobacco products.
“(B) CONDITIONS OF USE- If the conditions 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.
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253
APPENDIX A
“(5) ADVERTISING- The Secretary may require, with respect to
a product for which an applicant obtained an order under sub-
section (g)(1), that the product comply with requirements relating
to advertising and promotion of the tobacco product.
“(i) Postmarket Surveillance and Studies-
“(1) IN GENERAL- The Secretary shall require, with respect to
a product for which an applicant obtained an order under sub-
section (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 perception, behavior, and health, to
enable the Secretary to review the accuracy of the determinations
upon which the order was based, and to provide information that
the Secretary determines is otherwise necessary regarding the use or
health risks involving the tobacco product. The results of postmarket
surveillance and studies shall be submitted to the Secretary on an
annual basis.
“(2) SURVEILLANCE PROTOCOL- Each applicant required to con-
duct 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 approval of the Secretary,
a protocol for the required surveillance. The Secretary, within 60 days
of the receipt of such protocol, shall determine if the principal inves-
tigator proposed to be used in the surveillance has sufficient quali-
fications 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 Secretary, after an opportunity
for an informal hearing, shall withdraw an order under subsection (g)
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 material 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 established pursuant to sec-
tion 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 studies reveal that the order
is no longer consistent with the protection of the public health;
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254 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
“(4) the applicant failed to conduct or submit the postmarket sur-
veillance and studies required under subsection (g)(2)(C)(ii) or sub-
section (i); or
“(5) the applicant failed to meet a condition imposed under subsec -
tion (h).
“(k) Chapter IV or V- A product for which the Secretary has issued an
order pursuant to subsection (g) 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 com -
bination thereof) on the scientific evidence required for assessment
and ongoing review of modified risk tobacco products. Such regula-
tions or guidance shall--
“(A) to the extent that adequate scientific evidence exists, estab-
lish minimum standards for scientific studies needed prior to
issuing an order under subsection (g) to show that a substantial
reduction in morbidity or mortality among individual tobacco
users occurs for products described in subsection (g)(1) or is rea-
sonably likely for products described in subsection (g)(2);
“(B) include validated biomarkers, intermediate clinical end-
points, and other feasible outcome measures, as appropriate;
“(C) establish minimum standards for postmarket studies, that
shall include regular and long-term assessments of health out-
comes and mortality, intermediate clinical endpoints, consumer
perception of harm reduction, and the impact on quitting behav-
ior and new use of tobacco products, as appropriate;
“(D) establish minimum standards for required postmarket sur-
veillance, including ongoing assessments of consumer perception;
“(E) require that data from the required studies and surveil-
lance be made available to the Secretary prior to the decision on
renewal of a modified risk tobacco product; and
“(F) establish a reasonable timetable for the Secretary to review
an application under this section.
“(2) CONSULTATION- The regulations or guidance issued under
paragraph (1) shall be developed in consultation with the Institute
of Medicine, and with the input of other appropriate scientific and
medical experts, on the design and conduct of such studies and
surveillance.
“(3) REVISION- The regulations or guidance under paragraph (1)
shall be revised on a regular basis as new scientific information
becomes available.
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255
APPENDIX A
“(4) NEW TOBACCO PRODUCTS- Not later than 2 years after the
date of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall issue a regulation or guidance that
permits the filing of a single application for any tobacco product that
is a new tobacco product under section 910 and which the applicant
seeks to commercially market under this section.
“(m) Distributors- Except as provided in this section, no distributor
may take any action, after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, with respect to a tobacco product
that would reasonably be 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 commercially marketed
tobacco products, or presents a reduced exposure to, or does not con -
tain or is free of, a substance or substances.
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