(76 FR 22903). This draft guidance provides information on how a
manufacturer may demonstrate that a tobacco product was commercially
marketed in the United States as of February 15, 2007, and is,
therefore, a grandfathered product not subject to premarket review. The
draft guidance recommends that the manufacturer provide evidence that
may include, among other things, dated copies of advertisements, dated
catalog pages, dated promotional material, and dated bills of lading.
FDA recommends that the manufacturer submit as much information as
possible to demonstrate that the tobacco product was commercially
marketed in the United States as of February 15, 2007. FDA has not yet
finalized this draft guidance.
    The estimate for the number of hours in the existing collection is
FDA's estimate of how long it might take one to review, gather, and
submit dated information if making a request for an Agency
determination.
    FDA estimates the annual burden for the information collection as a
result of this proposed rule as follows:

                                 Table 8--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                  respondent \2\                      hours)
----------------------------------------------------------------------------------------------------------------
Cigars--2 Largest Manufacturers.               2              25              50              10             500
Other Cigar Manufacturers                    341             2.8             947              10           9,470
 (excluding 2 largest
 manufacturers and including
 large and small cigars, and
 importers).....................
Pipe Tobacco Manufacturers                   121             1.7             204              10           2,040
 (Including Importers)..........
Other Tobacco, E-Cigarettes, and             140             1.5             210              10           2,100
 Nicotine Product Manufacturers.
                                 -------------------------------------------------------------------------------

    Total Hours Establishing      ..............  ..............  ..............  ..............          14,110
     that a Tobacco Product was
     Commercially Marketed in
     the United States as of
     February 15, 2007..........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to
  the nearest tenth.

    FDA is basing the current estimates on the existing collection that
applies to tobacco products currently subject to the FD&C Act.
Annually, 2 large cigar manufacturers each are expected to submit 25
grandfathered product status requests each, for a total of 50
applications. The remaining cigar manufacturers are expected to submit
2.8 reports each annually. The total number of reports expected
annually under sections 905(j)(1)(A)(i) and 910 of the FD&C Act for
cigar manufacturers is 997 annually, which is 71 percent of the total
number of grandfathered product applications expected annually. FDA
also estimates it would take a cigar manufacturer approximately 10
hours to complete and submit for FDA review the evidence required by
this collection of information and estimates that it should take
approximately 9,970 hours annually (50 responses times 10 hours plus
947 responses times 10 hours for each response) for cigar manufacturers
to respond to this collection of information.
    Annually, the number of reports expected to be submitted under
sections 905(j)(1)(A)(i) and 910 of the FD&C Act for pipe tobacco
manufacturers is 1.7 product applications each. FDA estimates it would
take a pipe tobacco manufacturer approximately 10 hours to complete and
submit for FDA review the evidence required by this collection of
information. Therefore, FDA estimates that it should take approximately
2,040 hours annually (204 responses times 10 hours for each response)
for pipe tobacco manufacturers to respond to this collection of
information.
    Annually, other tobacco manufacturers (i.e., excluding cigars and
pipe tobacco) are expected to submit 1.5 grandfathered product
applications each. FDA estimates that it will take these manufacturers
10 hours to complete and submit for FDA review the evidence required by
this collection of information. Therefore, FDA estimates that it should
take approximately 2,100 hours (210 total annual responses times 10
hours for each response) for other manufacturers to respond to this
collection of information.
    The total number of burden hours, therefore, is 14,110 (500 hours +
9,470 hours + 2,040 hours + 2,100 hours). FDA has based these estimates
on information from interactions with firms already subject to the FD&C
Act and comments received regarding the submission of reports
establishing that a tobacco product was commercially marketed in the
United States as of February 15, 2007, from a notice of proposed
information collection that covered tobacco products currently subject
to the FD&C Act (76 FR 22903, April 25, 2011).
2. Applications for Premarket Review of New Tobacco Products
    Description of Respondents: The respondents to this collection of
information are manufacturers who are responsible for creating and
submitting new tobacco product premarket applications and who wish to
obtain an FDA order to allow them to market their product.
    On September 28, 2011, FDA announced the availability of a draft
guidance entitled ``Applications for Premarket Review of New Tobacco
Products'' (76 FR 60055). This guidance, when finalized, will provide
industry with information on how to submit an application for premarket
review of new tobacco products as required by section 910 of the FD&C
Act. Section 910(a)(1) of the FD&C Act requires persons who either
create a new tobacco product that was not commercially marketed in the
United States as of February 15, 2007, or modify a tobacco product in
any way after February 15, 2007, including a change in design, any
component, any part, or any constituent, including a smoke constituent,
or in the content, delivery, or form of nicotine, or any other additive
or ingredient, to submit a premarket tobacco product application and
obtain an order from FDA authorizing the marketing of the product
before the product may be introduced or delivered for introduction into
interstate commerce. This requirement applies unless the product has
been shown to be substantially equivalent to a tobacco product
commercially marketed in the United States as of February 15, 2007, or
is exempt from an SE determination under an issued regulation.
    The draft guidance ``Applications for Premarket Review of New
Tobacco Products'' explains the requirements and provides
recommendations for the contents of an application for premarket review
of a new tobacco product. Contents include a cover letter; an executive
summary; full reports of all investigations of health risks; a full
statement of all components, ingredients, additives, and properties,
and of the principle or principles of operation of such tobacco
product; a full description of methods of manufacturing and processing;
a listing of all manufacturing, packaging, and control sites for the
product; an explanation of how the product complies with applicable
tobacco product standards; samples and components; and proposed
labeling. If an applicant does not submit information on any of the
previously mentioned items, the application should include a statement
indicating which information is not being submitted and an explanation
of why the information is not being submitted.
    FDA also encourages persons who would like to study their new
tobacco product to meet with the Office of Science at the Center for
Tobacco Products (CTP) to discuss their investigational plan prior to
distributing the product for investigational purposes. The request for
a meeting should be sent in writing to the Director of CTP's Office of
Science and should include adequate information for FDA to assess the
potential utility of the meeting and to identify FDA staff necessary to
discuss proposed agenda items. FDA is required to deny a PMTA and issue
an order that the product may not be introduced or delivered for
introduction into interstate commerce under section 910(c)(1)(A)(ii) of
the FD&C Act if FDA finds that:
     The manufacturer has not shown that the product is
appropriate for the protection of the public health,

     the manufacturing methods, facilities, or controls do not
conform to manufacturing regulations issued under section 906(e) of the
FD&C Act,
     the proposed labeling is false or misleading, or
     the manufacturer has not shown that the product complies
with any tobacco product standard in effect under section 907 of the
FD&C Act.
    Under section 902(6)(A) of the FD&C Act, a tobacco product is
deemed adulterated if it is a new tobacco product and does not have an
order in effect under section 910(c)(1)(A)(i) of the FD&C Act. Under
section 301(a) of the FD&C Act (21 U.S.C. 331(a)), the introduction or
delivery for introduction into interstate commerce of any adulterated
tobacco product is a prohibited act. Violations of section 910 of the
FD&C Act are subject to regulatory and enforcement action by FDA,
including, but not limited to, seizure and injunction.
    FDA estimates the annual burden for the information collection as a
result of this proposed rule as follows:

                                 Table 9--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Activity                 Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
                Obtaining an FDA Order Authorizing Marketing of Tobacco Product (the application)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including                 1               1               1           5,000           5,000
 Large, Small, and Importers)...
Pipe Tobacco Manufacturers                     1               1               1           5,000           5,000
 (Including Importers)..........
Other Tobacco, E-Cigarettes, and              25               1              25           5,000         125,000
 Nicotine Product Manufacturers.
                                 -------------------------------------------------------------------------------
    Total Hours Obtaining an FDA  ..............  ..............  ..............  ..............         135,000
     order authorizing marketing
     of tobacco product (the
     application)...............
----------------------------------------------------------------------------------------------------------------
                Request for Meeting with CTP's Office of Science to Discuss Investigational Plan
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including                 1               1               1               4               4
 Large, Small, and Importers)...
Pipe Tobacco Manufacturers                     1               1               1               4               4
 (Including Importers)..........
Other Tobacco, E-Cigarettes, and              25               1              25               4             100
 Nicotine Product Manufacturers.
                                 -------------------------------------------------------------------------------
    Total Hours Request for       ..............  ..............  ..............  ..............             108
     Meeting with CTP's Office
     of Science to Discuss
     Investigational Plan.......
----------------------------------------------------------------------------------------------------------------
                                     Sec.   25.40 Environmental Assessments
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including                 1               1               1              12              12
 Large, Small, and Importers)...
Pipe Tobacco Manufacturers                     1               1               1              12              12
 (Including Importers)..........
Other Tobacco, E-Cigarettes, and              25               1              25              12             300
 Nicotine Product Manufacturers.
                                 -------------------------------------------------------------------------------
    Total Hours Sec.   25.40      ..............  ..............  ..............  ..............             324
     Environmental Assessments..
                                 -------------------------------------------------------------------------------
        Total Hours               ..............  ..............  ..............  ..............        135,432
         ``Applications for
         Premarket Review of New
         Tobacco Products''.....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that it will take each respondent approximately 5,000
hours to obtain an order from FDA allowing the marketing of a new
tobacco product. FDA's estimate includes anticipated burden for the
writing of an application, including intra-company edits and approvals,
of approximately 200 hours. In addition, FDA expects that conducting
the necessary scientific investigations for a new tobacco product
(either in-house or via a third-party consultant) will require, on
average, 4,800 hours. FDA also estimates the number of PMTA
applications that FDA expects to receive annually will be 27 (1 each
from cigar and pipe tobacco manufacturers, and 25 from other tobacco
manufacturers.) Therefore, the total annual burden for submitting PMTA
applications is estimated to be 135,000 hours (27 respondents x 5,000
hours).
    FDA notes that this 5,000 hour burden estimate is consistent with
the burden included in the notice announcing the availability of the
draft guidance ``Applications for Premarket Review of New Tobacco
Products'' (76 FR 60055). We are clarifying here that a PMTA may
require one or more types of studies including chemical analysis,
nonclinical studies, and clinical studies. FDA expects that chemical
and design parameter analysis would include the testing of applicable
HPHCs and nonclinical analysis would include literature synthesis and,
as appropriate, some combination of in vitro or in vivo studies, and
computational analyses. For the clinical study component, one or more
types of studies may be included to address, as needed, perception, use
pattern, or health impact. It is possible that an applicant may not
need to conduct any new nonclinical or clinical studies. We note that
for most applications, FDA does not expect that applicants will include
standardized clinical trials, like those conducted to support drug and
device approvals.
    For tobacco products already on the market at the time of the final
rule,

much of the information required to support a PMTA may be obtained from
previously published research on similar products. Therefore, FDA
expects that a large portion of applications may be reviewed with no or
minimal new nonclinical or clinical studies being conducted to support
an application. In contrast, several nonclinical and clinical studies
may be required for market authorization of a new product for which
there is little to no understanding of its potential impact. The range
of hours involved to compile these two types of applications would be
quite variable.
    FDA anticipates that the 27 potential respondents to this
collection may need to meet with CTP's Office of Science to discuss
their investigational plans. To request this meeting, applicants must
compile and submit information to FDA for meeting approval. FDA
estimates that it will take approximately 4 hours to compile this
information, for a total of 108 hours additional burden (27 respondents
x 4 hours).
    FDA also estimates that the 27 potential respondents will take
approximately 12 hours to prepare and submit an environmental
assessment (for a total of 324 hours) in accordance with the
requirements of section Sec.  25.40, as referenced in Sec.
1107.1(b)(9).
    The total reporting burden is estimated to be 135,432 hours burden
(135,000 hours + 108 hours + 324 hours.). FDA's estimates are based on
the corresponding information collection estimates that apply to
tobacco products currently subject to the FD&C Act and an assumption
that manufacturers would submit applications for the premarket review
of tobacco products.
    FDA requests comments on these estimates and the methodology used
to derive the estimates.

C. New Collections of Information That Applies Only to Proposed Deemed
Tobacco Products

1. Exemption From the Required Warning Statement Requirement
    Description of Respondents: Respondents are manufacturers and other
persons who, to obtain an exemption from the required warning statement
requirement, would be required to certify to FDA that their product
does not contain nicotine, that the company has data to support that
assertion, and, therefore, the product does not warrant the proposed
addictiveness warning.
    This proposed rule contains a new information collection that
pertains to an exemption process related to the requirement to include
the warning statement in proposed Sec.  1143.3(a)(1). Proposed Sec.
1143.3(c) would provide an exemption to the manufacturer of a product
that otherwise would be required to include the warning statement in
proposed Sec.  1143.3(a)(1) on its packages and in its advertisements
(i.e., ``WARNING: This product contains nicotine derived from tobacco.
Nicotine is an addictive chemical.''). To obtain this exemption, a
manufacturer would be required to certify to FDA that its product does
not contain nicotine, that the company has data to support that
assertion, and, therefore, the product does not warrant the proposed
addictiveness warning. For any product that obtains this exemption, the
proposed section requires that the product bear the message: ``This is
product derived from tobacco.'' The parties that package and label such
products would share responsibility for ensuring that this alternative
statement is included on product packages and in advertisements. While
FDA is not aware of any currently marketed tobacco products that do not
contain nicotine, the proposed rule would permit companies to obtain an
exemption from this warning requirement in the event that such tobacco
products are developed in the future.
    FDA estimates the annual burden for the information collection as a
result of this proposed rule as follows:

                                 Table 10--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Activity                 Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
Certification Statement.........               1               1               1              20              20
----------------------------------------------------------------------------------------------------------------
    Total Exemptions From the     ..............  ..............  ..............  ..............             20
     Required Warning Statement
     Requirement................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated average burden per response is based on information
collection estimates that apply to tobacco products currently subject
to the FD&C Act. While very few certifications are expected for tobacco
products that do not contain nicotine, FDA estimates that the number of
certification submissions could rise if the Agency decides in the
future to address not only nicotine, but any other addictive
substances.
    The estimated hours listed in the burden table for certification
submissions reflect the time needed to test the product for nicotine
and preparation and submission of the self-certification request. FDA
expects that these types of certifications will be very rare and
estimates that the Agency will receive on average one submission per
year.
    FDA notes that the labeling statements in proposed Sec. Sec.
1143.3(a)(1) and 1143.5(a)(1) and the proposed alternative warning
statement in proposed Sec.  1143.3(c) (i.e., ``This product is derived
from tobacco'') do not constitute a ``collection of information'' under
the PRA. Rather, these labeling statements are ``public disclosure'' of
information originally supplied by the Federal Government to the
recipient for the purpose of ``disclosure to the public'' (5 CFR
1320.3(c)(2)).
    The total burden for these new collections of information in this
rulemaking is 629,036 reporting hours (53,659 + 1,000 + 13,755 +
403,968 + 7,092 + 14,110 + 135,432 + 20) and 5,214 recordkeeping hours
for a total of 634,250 burden hours.
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should be
identified with the title ``The Food and Drug Administration Deems
Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic
Act, as Amended by the Family Smoking Prevention and Tobacco Control
Act;

Regulations Restricting the Sale and Distribution of Tobacco Products
and Required Warnings for Tobacco Product Packages and
Advertisements.''
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has
submitted the information collection provisions of this proposed rule
to OMB for review. These requirements will not be effective until FDA
obtains OMB approval. FDA will publish a notice concerning OMB approval
of these requirements in the Federal Register.

X. Executive Order 13132; Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.''
    Section 916(a)(1) of the FD&C Act (21 U.S.C. 387p) expressly
preserves the authority of State, local, and tribal governments to ``to
enact, adopt, promulgate, and enforce any law, rule, regulation, or
other measure with respect to tobacco products that is in addition to,
or more stringent than, requirements established under this chapter [21
U.S.C. 387 et seq.],'' except as expressly preempted by section
916(a)(2) of the FD&C Act. With the exception of the limited category
of regulatory actions preempted by section 916(a)(2), State and local
governments may adopt or continue to enforce all requirements
pertaining to tobacco products that are in addition to, or more
stringent than, the requirements of the Tobacco Control Act and its
implementing regulations, including requirements relating to or
prohibiting the sale and distribution of tobacco products, the
advertising and promotion of tobacco products, and the use of tobacco
products by individuals of any age.
    Section 916(a)(2) of the FD&C Act is an express preemption
provision. Section 916(a)(2)(A) expressly preempts any State or local
requirement ``which is different from, or in addition to, any
requirement under [chapter IX of the FD&C Act] relating to tobacco
product standards, premarket review, adulteration, misbranding,
labeling, registration, good manufacturing standards, or modified risk
products.'' However, section 916(a)(2)(B) of the FD&C Act states that
the express preemption provision in subparagraph (A) ``does not apply
to requirements relating to'' among other things ``the sale,
distribution, possession, information reporting to the State, exposure
to, access to, the advertising and promotion of, or use of, tobacco
products by individuals of any age.''
    Executive Order 13132 requires Agencies to consult, to the extent,
practicable, with State and local officials if the Agency foresees the
possibility of a conflict between State law and Federally protected
interests. FDA has not identified any State or local laws that would be
preempted by these proposed restrictions. Nevertheless, FDA intends to
consult with State and local jurisdictions about the potential impact
this rule could have on their requirements.

XI. Environmental Impact

    The Agency has carefully considered the potential environmental
effects of deeming products to be subject to the FD&C Act and the
proposed age and identification restrictions. FDA has concluded that
the actions will not have a significant impact on the human
environment, and that an environmental impact statement is not
required. The Agency's finding of no significant impact and the
evidence supporting that finding, contained in an environmental
assessment, may be seen in the Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
    The Agency also has determined under 21 CFR 25.30(k) that the
labeling requirement is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required for the proposed health warning
statements.

XII. Analysis of Impacts: Summary

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The agency believes that this proposed rule would be an
economically significant regulatory action as defined by Executive
Order 12866.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. FDA has determined that this proposed rule would
have a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
result in a one-year expenditure that meets or exceeds this amount.
    The proposed rule consists of two coproposals, Option 1 and Option
2. The proposed Option 1 deems all products meeting the statutory
definition of ``tobacco product,'' except accessories of a proposed
deemed tobacco product, to be subject to chapter IX of the Federal
Food, Drug, and Cosmetic Act (FD&C Act). Option 1 proposes additional
provisions that would apply to proposed deemed products as well as to
certain other tobacco products. Once deemed, tobacco products become
subject to the FD&C Act and its implementing regulations. The FD&C Act
requirements that would apply to proposed deemed products include
establishment registration and product listing, ingredient listing,
submissions prior to the introduction of new products, and labeling
requirements. Free samples of proposed deemed tobacco products would
also be prohibited. The additional provisions of this proposed rule
include minimum age and identification requirements, vending machine
restrictions, and required warning statements for packages and
advertisements. Although deeming and the associated ``automatic
provisions'' of the FD&C Act could be implemented on their own, the
additional provisions could not be implemented for proposed deemed
products without deeming.
    While FDA currently has authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco under chapter IX
of the FD&C Act, all additional tobacco products that meet the
statutory definition, except

accessories of those proposed deemed tobacco products, would be subject
to chapter IX of the FD&C Act and its implementing regulations under
the proposed rule. These products would include cigars, pipe tobacco,
hookah tobacco, electronic cigarettes, and other novel tobacco products
such as dissolvable products and gels. Of these products to be deemed,
cigars are the most commonly used.
    The other coproposal, Option 2, is the same as Option 1 except that
it exempts premium cigars. The proposed rule would define premium
cigars as cigars that are wrapped in whole tobacco leaf; contain a 100
percent leaf tobacco binder; contain primarily long filler tobacco; are
made by manually combining the wrapper, filler, and binder; have no
filter, tip, or non-tobacco mouthpiece and are capped by hand; do not
have a characterizing flavor other than tobacco; weigh more than 6
pounds per 1000 units; and sell for $10 or more per cigar.
    The proposed deeming action differs from most public health
regulations in that it is an enabling regulation. In other words, in
addition to directly applying the substantive requirements of chapter
IX of the FD&C Act and its implementing regulations to proposed deemed
tobacco products, it enables FDA to issue further public health
regulations related to such products. We expect that asserting our
authority over these tobacco products will enable us to propose further
regulatory action in the future as appropriate, and those actions will
have their own costs and benefits. Without deeming these products to be
subject to the FD&C Act, FDA would lack the authority to collect vital
ingredient and health information about them. We would also lack the
authority to take regulatory action with respect to them, if we
determined it was appropriate to do so.
    The direct benefits of making each of the proposed deemed tobacco
products subject to the requirements of chapter IX of the FD&C Act are
difficult to quantify without additional data, and we cannot predict
the size of these benefits at this time. Among other effects, new
products would be subject to evaluation to ensure they are appropriate
for public health before they could be marketed, labeling could not
contain misleading statements, and FDA would be made aware of the
ingredients in proposed deemed tobacco products. If, without the
proposed rule, new products would be developed that pose substantially
greater health risks than those already on the market, the premarket
requirements made effective by this proposed rule would prevent such
products from appearing on the market and worsening the health effects
of tobacco product use. The warning statements required by this
proposed rule would provide information to consumers about the risks
and characteristics of tobacco products. Consumers may act on this
information by reducing their use of tobacco products. Consumers may
also act on this information through compensating health behaviors.
These responses would generate benefits associated with improved health
and longevity.
    The proposed rule as a whole would impose costs in the form of
registration, submission, and labeling requirements. The deeming
provision would impose immediate costs because manufacturers and
importers of newly-regulated tobacco products would have to comply with
registration, submission, and labeling requirements. Manufacturers of
proposed deemed products, as well as some manufacturers of currently-
regulated products, would have to comply with the warning label
provisions, including costs for signs with warnings at point-of-sale
for cigars sold singly without packaging. There would also be potential
costs for removing noncompliant point-of-sale advertising and complying
with vending machine restrictions.
    The upfront costs for Option 1 are estimated to range from $74.3 to
$347.0 million, with a primary estimate of $171.1 million, while the
costs in subsequent years are estimated to range from $20.8 to $49.0
million, with a primary estimate of $30.6 million. The primary estimate
for the present value of total quantified costs over 20 years is
approximately $592.0 million at a 3 percent discount rate and $467.6
million at a 7 percent discount rate.
    The upfront costs for Option 2 are estimated to range from $60.5 to
$258.5 million, with a primary estimate of $132.8 million, while the
costs in subsequent years are estimated to range from $17.4 to $38.4
million, with a primary estimate of $25.0 million. The primary estimate
for the present value of total quantified costs over 20 years is
approximately $476.4 million at a 3 percent discount rate and $375.0
million at a 7 percent discount rate.
    The quantified costs of both options for the proposed rule can also
be expressed as annualized values, as shown in Table 11.

                                                   Table 11--Summary of Quantified Costs Over 20 Years
                                                                       [$ million]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Lower bound                     Upper bound     Lower bound                     Upper bound
                                                               (3%)        Primary (3%)        (3%)            (7%)        Primary (7%)        (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value Option 1..................................           365.2           592.0         1,010.1           281.4           467.6           810.2
Present Value Option 2..................................           304.0           476.4           779.2           233.8           375.0           622.6
Annualized Value Option 1...............................            23.8            38.6            65.9            24.8            41.2            71.5
Annualized Value Option 2...............................            19.8            31.1            50.8            20.6            33.1            54.9
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In addition to the benefits and costs of both options for the
proposed rule, we assess the benefits and costs of several alternatives
to the proposed rule, although we note that some may be outside of our
current legal authority: deeming only, but exempt proposed deemed
products from all labeling changes and premarket submission
requirements; enforce premarket requirements only for machine-made
cigars; change the grandfather date for new products to the date of
final regulation; deeming only, but exempt proposed deemed products
from all labeling changes; exempt handmade cigars from labeling
changes; deeming only (no additional provisions); alter the compliance
period for labeling changes.\10\
---------------------------------------------------------------------------

    \10\ We note that not all of these regulatory alternatives are
necessarily legally permissible.
---------------------------------------------------------------------------

    Primary estimates of the costs of the regulatory alternatives
appear as present values and annualized values in Table 12.

                   Table 12--Primary Estimate of Quantified Costs for Regulatory Alternatives
                                 [Present and Annualized Values, $ million] \1\
----------------------------------------------------------------------------------------------------------------
                                                                Present      Present     Annualized   Annualized
                         Alternative                           value (3%)   value (7%)   value (3%)   value (7%)
----------------------------------------------------------------------------------------------------------------
1--Deeming only; exempt from labeling changes and new                10.3          8.3          0.7          0.7
 product submissions........................................
2--Enforce premarket requirements only for machine-made             176.3        156.0         11.5         13.8
 cigars.....................................................
3--Change grandfather date to date of regulation............        422.1        333.0         27.5         29.4
4--Deeming only; exempt from labeling changes...............        475.9        360.8         31.1         31.8
Proposed Rule Option 2: Exempt Premium Cigars from                  476.4        375.0         31.1         33.1
 Regulation.................................................
5--Exempt handmade cigars from labeling changes.............        500.0        384.2         32.6         33.9
6--Deeming only; no additional provisions...................        541.6        425.3         35.3         37.5
7a--36-month compliance period for labeling changes.........        572.3        447.1         37.3         39.4
Proposed Rule Option 1--24-month compliance period for              592.0        467.6         38.6         41.2
 labeling changes...........................................
7b--12-month compliance period for labeling changes.........        646.1        523.2         42.2         46.2
----------------------------------------------------------------------------------------------------------------
\1\ Nonquantified benefits are described in the text.

    The majority of the compliance costs of this proposed rule are
fixed, but a portion of the costs are variable. The costs imposed will
be borne primarily by manufacturers and importers; some of the costs
will be passed on to consumers in the form of higher prices. The
average increase in the price of proposed deemed tobacco products,
however, would be very small relative to current prices.
    In addition to the costs described in Tables 11 and 12, the
proposed rule would lead to private costs in the form of reduced
revenues for firms in affected sectors. Additionally, if excise taxes
on tobacco products remain at current levels, annual tax revenues would
fall with reduced use.
    Domestic tobacco product manufacturers and importers, most of which
are small, would be the entities primarily affected by this rule. In
particular, we expect domestic cigar manufacturers to be affected
because they are more likely than importers to be completely
specialized in a newly regulated product, and the handmade segment of
the cigar market is characterized by a large number of low-volume
products. Even though user fees are a transfer payment and not a
societal cost, they are a cost from the standpoint of the manufacturers
who must pay them. Therefore, user fees are included in the estimated
burden for small domestic cigar manufacturers. For Option 1, the
estimated upfront costs range from $390,000 to $759,000 per domestic
cigar manufacturing establishment, and the average annual costs are
estimated to range from $450,000 to $541,000. Several of the regulatory
alternatives that would reduce costs are analyzed as potential
regulatory relief options for small businesses.
    The full analysis of economic impacts is available in the docket
for this proposed rule (Ref. 193) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
    FDA requests comments on all inputs, methods and results that
appear in the economic analysis.

XIII. Request for Comments

A. General Information About Submitting Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document.

B. Public Availability of Comments

    Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov. As a matter of Agency
practice, FDA generally does not post comments submitted by individuals
in their individual capacity on http://www.regulations.gov. This is
determined by information indicating that the submission is written by
an individual, for example, the comment is identified with the category
``Individual Consumer'' under the field titled ``Category (Required),''
on the ``Your Information'' page on www.regulations.gov. For this
proposed rule, however, FDA will not be following this general
practice. Instead, FDA will post on http://www.regulations.gov comments
to this docket that have been submitted by individuals in their
individual capacity. If you wish to submit any information under a
claim of confidentiality, please refer to 21 CFR 10.20.

C. Information Identifying the Person Submitting the Comment

    Please note that your name, contact information, and other
information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your state/province and country (if
provided), the name of your representative (if any), and the category
identifying you (e.g., individual, consumer, academic, industry). For
written submissions submitted to the Division of Dockets Management,
FDA will post the body of your comments on http://www.regulations.gov,
but you can put your name and/or contact information on a separate
cover sheet and not in the body of your comments.

XIV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and
are available electronically at http://www.regulations.gov. (FDA has
verified all the Web site addresses in this reference section, but FDA
is not responsible for any subsequent changes to the Web sites after
this document publishes in the Federal Register.)

1. Counotte, D. S., A. B. Smit, T. Battij, and S. Spijker,
``Development of the Motivational System During Adolescence, and Its
Sensitivity to Disruption by Nicotine,'' Developmental Cognitive
Neuroscience, 1(4):430-443, 2011.
2. Arrazola, R. A., N. M. Kuiper, and S. R. Dube, ``Patterns of
Current Use of Tobacco Products Among U.S. High School Students for
2000-2012--

Findings From the National Youth Tobacco Survey,'' Journal of
Adolescent Health, 1-7, 2013.
3. Pepper, J. K. and N. T. Brewer, ``Electronic Nicotine Delivery
System (Electronic Cigarette) Awareness, Use, Reactions and Beliefs:
A Systematic Review,'' Tobacco Control, published online November
20, 2013.
4. Corey, C., B. Wang, S. E. Johnson, B. Apelberg, et al., ``Notes
From the Field: Electronic Cigarette Use Among Middle and High
School Students--United States, 2011-2012,'' MMWR Morbidity and
Mortality Weekly Report, 62(35):729-730, 2013.
5. Centers for Disease Control and Prevention, ``Tobacco Use Among
Middle and High School Students--United States, 2000-2009,''
Morbidity and Mortality Weekly Report, 59(33), 2010.
6. Goniewicz, M. L., T. Kuma, M. Gawron, et al., ``Nicotine Levels
in Electronic Cigarettes,'' Nicotine & Tobacco Research, doi:
10.10193/ntr/nts103 (Advance access published April 22, 2013).
7. Ayers, J. W., K. M. Ribisl, and J. S. Brownstein, ``Tracking the
Rise in Popularity of Electronic Nicotine Delivery Systems
(Electronic Cigarettes) Using Search Query Surveillance,'' American
Journal of Preventive Medicine, 40(4):448-453, 2011.
8. Richter, P. A., L. L. Pederson, and M. M. O'Hegarty, ``Young
Adult Smoker Risk Perceptions of Traditional Cigarettes and
Nontraditional Tobacco Products,'' American Journal of Health
Behavior, 30(3):302-312, 2006.
9. Cobb, C., K. D. Ward, W. Maziak, et al., ``Waterpipe Tobacco
Smoking: An Emerging Health Crisis in the United States,'' American
Journal of Health Behavior, 34(3):275-285, 2010.
10. Knishkowy, B. and Y. Amitai, ``Water-Pipe (Narghile) Smoking: An
Emerging Health Risk Behavior,'' Pediatrics, 116(1):e113-e119, 2005.
11. Eissenberg, T., K. D. Ward, S. Smith-Simone, et al., ``Waterpipe
Tobacco Smoking on a U.S. College Campus: Prevalence and
Correlates,'' Journal of Adolescent Health, 42(5):526-529, 2008.
12. Romito, L. M., M. K. Saxton, L .L. Coan, et al., ``Retail
Promotions and Perceptions of R.J. Reynolds' Novel Dissolvable
Tobacco in a U.S. Test Market,'' Harm Reduction Journal, 8:10, 2011.
13. Mejia, A. B. and P. M. Ling, ``Tobacco Industry Consumer
Research on Smokeless Tobacco Users and Product Development,''
American Journal of Public Health, 100(1):78-87, 2010.
14. Morrison, M. A., D. M. Krugman, and P. Park, ``Under the Radar:
Smokeless Tobacco Advertising in Magazines With Substantial Youth
Readership,'' American Journal of Public Health, 98(3):543, 2008.
15. Alpert, H. R., H. Koh, and G. N. Connolly, ``Free Nicotine
Content and Strategic Marketing of Moist Snuff Tobacco Products in
the United States: 2000-2006,'' Tobacco Control, 17(5):332, 2008.
16. Tomar, S. L., H. R. Alpert, and G. N. Connolly, ``Patterns of
Dual Use of Cigarettes and Smokeless Tobacco Among U.S. Males:
Findings From National Surveys,'' Tobacco Control, 19(2):104, 2010.
17. Villanti, A. C., A. Richardson, D. M. Vallone, et al.,
``Flavored Tobacco Product Use Among U.S. Young Adults,'' American
Journal of Preventive Medicine, 44(4):388-391, 2013.
18. Johnston, M. L., B. C. Daniel, C. J. Levy, et al., ``Young
Smokers--Prevalence, Trends, Implications, and Related Demographic
Trends,'' Philip Morris USA Research Center; March 31, 1981. Report
No.: Bates No.<PHONE_NUMBER>/0855.
19. Bullen, C., C. Howe, M. Laugesen, et al., ``Electronic
Cigarettes for Smoking Cessation: A Randomized Controlled Trial,''
Lancet, 382(9905):1629-1637, 2013.
20. Delnevo, C. D. and M. Hrywna, ``A Whole `Nother Smoke' or a
Cigarette in Disguise: How RJ Reynolds Reframed the Image of Little
Cigars,'' American Journal of Public Health, 97(8):1368-1375, 2007.
21. Delnevo, C. D., ``Smokers' Choice: What Explains the Steady
Growth of Cigar Use in the U.S.?'' Public Health Reports,
121(2):116-119, 2006.
22. Centers for Disease Control and Prevention, ``Consumption of
Cigarettes and Combustible Tobacco--United States, 2000-2011,''
Morbidity and Mortality Weekly Report, 61: 565-569, (August 3,
2012).
23. Pearson, J. L., A. Richardson, R. S. Niaura, et al., ``e-
Cigarette Awareness, Use, and Harm Perception in U.S. Adults,''
American Journal of Public Health, 102(9):1758-1766, September 2012.
24. King, B. A., S. Alam, G. Promoff, et al., ``Awareness and Ever
Use of Electronic Cigarettes Among U.S. Adults, 2010-2011,''
Nicotine & Tobacco Research, doi:10.1093/ntr/ntt013 (advance access
published February 28, 2013).
25. Regan, A. K., G. Promoff, S. R. Dube, et al., ``Electronic
Nicotine Delivery Systems: Adult Use and Awareness of the `e-
Cigarette' in the USA,'' Tobacco Control, 22:19-23, 2013.
26. Institute of Medicine of the National Academies, ``Growing Up
Tobacco Free: Preventing Nicotine Addiction in Children and
Youths,'' 1994.
27. FDA letter to Stakeholders, available at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm.
28. National Cancer Institute, ``Cigars: Health Effects and
Trends,'' NCI Smoking and Tobacco Control Monograph 9, 1998,
available at http://cancercontrol.cancer.gov/tcrb/monographs/9/m9_complete.PDF.
29. Borawski, E. A., A. Brooks, N. Colabianchi, et al., ``Adult Use
of Cigars, Little Cigars, and Cigarillos in Cuyahoga County, Ohio: A
Cross-Sectional Study,'' Nicotine & Tobacco Research, 12(6):669-673,
2010.
30. Baker, F., S. Ainsworth, J. T. Dye, et al., ``Health Risks
Associated With Cigar Smoking,'' Journal of the American Medical
Association, 284(6):735-740, 2000.
31. American Cancer Society, ``Cigar Smoking,'' Atlanta, GA:
American Cancer Society, 2010; available at http://www.cancer.org/acs/groups/cid/documents/webcontent/002965-pdf.pdf.
32. Rodriguez, J., R. Jiang, W. C. Johnson, et al., ``The
Association of Pipe and Cigar Use With Cotinine Levels, Lung
Function, and Airflow Obstruction,'' Annals of Internal Medicine,
152(4):201-210, 2010.
33. Iribarren, C., I. Tekawa, S. Sidney, et al., ``Effect of Cigar
Smoking on the Risk of Cardiovascular Disease, Chronic Obstructive
Pulmonary Disease, and Cancer in Men,'' The New England Journal of
Medicine, 340(23):1773-1780, 1999.
34. Coleman B. N., C. G. Corey, C. D. Delnevo, et al. ``Use of
Flavored Cigars, Cigarillos, and Little Filtered Cigars: Findings
from the 2012-2013 National Adult Tobacco Survey,'' Presented at
Conference for the Society for Research on Nicotine and Tobacco
(2014).
35. Office of Inspector General, U.S. Department of Health and Human
Services, ``Youth Use of Cigars: Patterns of Use and Perceptions of
Risk,'' OEI-06-98-00030, 1999.
36. Adkinson, S. E., R. J. O'Connor, M. Bansi-Travers, et al.,
``Electronic Nicotine Delivery Systems, International Tobacco
Control Four-Country Survey,'' American Journal of Preventive
Medicine, 44(3):207-215, 2013.
37. Centers for Disease Control and Prevention, ``Tobacco Product
Use Among Middle and High School Students--United States, 2011 and
2012,'' Morbidity and Mortality Weekly Report, 62(45), November 15,
2013; Centers for Disease Control and Prevention, ``Erratum,''
Morbidity and Mortality Weekly Report, 62(46), November 22, 2013.
38. Sutfin, E. L., T. P. McCoy, H. Morrell, et al., ``Electronic
Cigarette Use by College Students,'' Drug and Alcohol Dependence,
131:214-221, 2013.
39. Nides, M. A., S. J. Leischow, M. Bhatter, et al., ``Nicotine
Blood Levels and Short-Term Smoking Reduction With an Electronic
Nicotine Delivery System,'' American Journal of Health Behavior,
38(2):265-274, 2014.
40. Polosa, R., B. Rodu, P. Caponnetto, et al., ``A Fresh Look at
Tobacco Harm Reduction: The Case for the Electronic Cigarette,''
Harm Reduction Journal, 10:19, 2013.
41. Cahn, Z. and M. Siegel, ``Electronic Cigarettes as a Harm
Reduction Strategy for Tobacco Control: A Step Forward or a Repeat
of Past Mistakes?'' Journal of Public Health Policy, 32(1):16-31,
2011.
42. Polosa, R., J. B. Morjaria, P. Caponnetto, et al.,
``Effectiveness and Tolerability of Electronic Cigarette in Real-
Life: A 24-Month Prospective Observational Study,'' Internal and
Emergency Medicine (published online July 20, 2013).
43. Popova, L. and P. M. Ling, ``Alternative Tobacco Product Use and
Smoking

Cessation: A National Study,'' American Journal of Public Health,
2013 May; 103(5):923-30.
44. Vickerman K. A., et al., ``Use of electronic Cigarettes Among
State Tobacco Cessation Quitline Callers,'' Nicotine & Tobacco
Research, 2013 Oct; 15(10):1787-91.
45. Caponnetto, P., D. Campagna, F. Cibella, et al., ``Efficiency
and Safety of an Electronic Cigarette As Tobacco Cigarettes
Substitute: A Prospective 12-Month Randomized Control Design
Study,'' Public Library of Science one, 8(6): June 2013.
46. Vansickel, A. R. and T. Eissenberg, ``Electronic Cigarettes:
Effective Nicotine After Acute Administration,'' Nicotine & Tobacco
Research, doi: 10.1093/ntr/ntr316 (pub. Feb. 6, 2012).
47. Goniewicz, M. L., J. Knysak, M. Gawron, et al., ``Levels of
Selected Carcinogens and Toxicants in Vapour From Electronic
Cigarettes,'' Tobacco Control (published on March 6, 2013);
available at: http://tobaccocontrol.bmj.com/content/early/2013/03/05/tobaccocontrol-2012-050859.full.pdf+html.
48. NIH State-of-the-Science Conference on ``Tobacco Use:
Prevention, Cessation and Control. Final Panel Statement'', June 12-
14, 2006, available at http://consensus.nih.gov/2006/tobaccostatement.htm# q6.
49. U.S. Department of Health and Human Services, ``The Health
Consequences of Smoking: Nicotine Addiction,'' A Report of the
Surgeon General; 1988, available at http://profiles.nlm.nih.gov/NN/B/B/Z/D/.
50. U.S. Department of Health and Human Services, ``How Tobacco
Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-
Attributable Disease,'' A Report of the Surgeon General, 2010,
available at http://www.ncbi.nlm.nih.gov/books/NBK53017/pdf/TOC.pdf.
51. U.S. Department of Health and Human Services, ``Youth & Tobacco;
Preventing Tobacco Use Among Young People,'' A Report of the Surgeon
General; 1994, available at http://www.surgeongeneral.gov/library/reports/.
52. Substance Abuse and Mental Health Services Administration,
``Results From the 2008 National Survey on Drug Use and Health:
National Findings,'' available at http://www.oas.samhsa.gov/nsduh/2k8nsduh/2k8results.pdf.
53. Prabbhat, J. and F. Chaloupka, ``Curbing the Epidemic:
Governments and the Economics of Tobacco Control,'' The World Bank,
1999, available at http://www.usaid.gov/policy/ads/200/tobacco.pdf.
54. U.S. Department of Health and Human Services, ``Preventing
Tobacco Use Among Youth and Young Adults,'' A Report of the Surgeon
General, 2012.
55. Poorthuis, R. B., N. A. Goriounova, J. J. Couey, et al.,
``Nicotinic Actions on Neuronal Networks for Cognition: General
Principles and Long-Term Consequences,'' Biochemical Pharmacology,
78(7):668-676, 2009.
56. Levin, E. D., S. Lawrence, A. Petro, et al., ``Adolescent vs.
Adult-Onset Nicotine Self-Administration in Male Rats: Duration of
Effect and Differential Nicotinic Receptor Correlates,''
Neurotoxicology and Teratology, 29(4): 458-465, 2007.
57. President's Cancer Panel, ``Promoting Healthy Lifestyles,''
2007.
58. Institute of Medicine of the National Academies, ``Ending the
Tobacco Problem: A Blueprint for the Nation,'' 2007.
59. Barr, R. and D. Pizzagalli, ``A Single Dose of Nicotine Enhances
Reward Responsiveness in Nonsmokers: Implications for Development of
Dependence,'' Biological Psychiatry, 63:1061-1065, 2008.
60. Torres, O. V., H. A. Tejeda, L. A. Natividad, et al., ``Enhanced
Vulnerability to the Rewarding Effects of Nicotine During the
Adolescent Period of Development,'' Pharmacology Biochemistry and
Behavior, 90(4):658-663, 2008.
61. Schochet, T. L., Q. Z. Bremer, M. S. Brownfield, et al., ``The
Dendritically Targeted Protein Dendrin Is Induced by Acute Nicotine
in Cortical Regions of Adolescent Rat Brain,'' European Journal of
Neuroscience, 28(10):1967-1979, 2008.
62. Slotkin, T. A., B. E. Bodwell, I. T. Ryde, et al., ``Adolescent
Nicotine Treatment Changes the Response of Acetylcholine Systems to
Subsequent Nicotine Administration in Adulthood,'' Brain Research
Bulletin, 76(1-2): 152-165, 2008.
63. Rubinstein, M. L., T. L. Luks, A. B. Moscicki, et al.,
``Smoking-Related Cue-Induced Brain Activation in Adolescent Light
Smokers,'' Journal of Adolescent Health, 48(1):7-12, 2011.
64. Fabian, L. A., L. L. Canlass, J. Potts, et al., ``Ad lib Smoking
of Black & Mild Cigarillos and Cigarettes,'' Nicotine & Tobacco
Research, doi: 10.1093/ntr/ntr131 (October 24, 2011).
65. Terchek, J. J., E. M. G. Larkin, M. L. Male, et al., ``Measuring
Cigar Use in Adolescents: Inclusion of a Brand-Specific Item,''
Nicotine & Tobacco Research, 11:842-846, 2009.
66. Nasim, A., M. D. Blank, B. M. Berry, et al., ``Cigar Use
Misreporting Among Youth: Data From the 2009 Youth Tobacco Survey,
Virginia,'' Preventing Chronic Disease, 9:110084, 2012.
67. Griffiths, M. A., T. R. Harmon, et al., ``Hubble Bubble Trouble:
The Need for Education About and Regulation of Hookah Smoking,''
Journal of Public Policy & Marketing, 30(1):119-132, Spring 2011.
68. Mishina, E. V. and A. C. Hoffman, ``Clinical Pharmacology
Research Strategy for Dissolvable Tobacco Products,'' Nicotine &
Tobacco Research, 2013; doi: 10.1093/ntr/ntt182.
69. Washam, C., ``Can Cigarette Alternatives Deliver a Safer Fix?''
Environmental Health Perspectives, 119:a286-a287, 2011.
70. Rainey C. L., P. A. Conder, and J. V. Goodpaster, Chemical
Characterization of Dissolvable Tobacco Products Promoted to Reduce
Harm. Journal of Agricultural and Food Chemistry, 2011; 59:2745-
2751.
71. OED Online. March 2013. Oxford University Press, available at
http://www.oed.com/view/Entry/273643 (accessed: March 20, 2014).
72. Benowitz, N., ``Pharmacologic Aspects of Cigarette Smoking and
Nicotine Addiction,'' The New England Journal of Medicine,
319(20):1318-1330, 1988.
73. Stolerman, I. P. and M. Shoaib, ``The Neurobiology of Tobacco
Addiction,'' Trends in Pharmacological Sciences, 12:467-473, 1991.
74. Watkins, S. S., G. F. Koob, and A. Markou, ``Neural Mechanisms
Underlying Nicotine Addiction: Acute Positive Reinforcement and
Withdrawal,'' Nicotine & Tobacco Research, 2(1):19, 2000.
75. Dani, J. A., D. Ji, and F.M. Zhou, ``Synaptic Plasticity and
Nicotine Addiction,'' Neuron, 31(3):349-352, 2001.
76. Benowitz, N. L., ``Nicotine Addiction,'' The New England Journal
of Medicine, 362(24):2295, 2010.
77. NIDA INFO FACTS, Cigarettes and other Tobacco Products, August
2010, available at http://www.tobaccofreemaine.org/quit_tobacco/documents/NIDAInfoFacts.pdf.
78. Cokkinides, V., P. Bandi, C. McMahon, et al., ``Tobacco Control
in the United States--Recent Progress and Opportunities,'' CA: A
Cancer Journal for Clinicians, 59(6):352-365, 2009.
79. Connolly, G. N., P. Richter, A. Aleguas Jr., et al.,
``Unintentional Child Poisonings Through Ingestion of Conventional
and Novel Tobacco Products,'' Pediatrics, 125:896-899, 2010.
80. Substance Abuse and Mental Health Services Administration.
(2011). Results From the 2010 National Survey on Drug Use and
Health: National Findings. September 2011.
81. ``Results From the 2011 National Survey of Drug Use and Health,
Summary of National Findings''--Table 4.10A--Past Year Initiation of
Substance Use Among Persons Aged 12 or Older Who Initiated Use Prior
to the Age of 18, by Gender: Numbers in Thousands, 2010 and 2011.
NSDUH Series H-44, HHS Publication No. (SMA) 12-4713. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2012.
82. Substance Abuse and Mental Health Services Administration,
``Results From the 2010 National Survey on Drug Use and Health:
Detailed Tables''; available at http://www.samhsa.gov/data/NSDUH/2k10ResultsTables/NSDUHTables2010R/HTM/Sect4peTabs1to16.htm#Tab4.10A.
83. Johnston, L. D., P. M. O'Malley, J. G. Bachman, et al.,
Monitoring the Future National Results on Adolescent Drug Use:
Overview of Key Findings, 2010; Ann Arbor: Institute for Social
Research, The University of Michigan, 2011.
84. Johnston, L. D., P. M. O'Malley, J. G. Bachman, et al.,
``Monitoring the Future,

National Results on Adolescent Drug Use, Overview of Key Findings,
2011,'' National Institute on Drug Abuse; available at: http://www.monitoringthefuture.org/pubs/monographs/mtf-overview2011.pdf.
85. Henley, S. J., M. J. Thun, A. Chao, et al., ``Association
Between Exclusive Pipe Smoking and Mortality From Cancer and Other
Diseases,'' Journal of the National Cancer Institute, 96(11):853-
861, 2004.
86. ``Reducing the Health Consequences of Smoking. 25 Years of
Progress.'' A Report of the Surgeon General, DHHS Public No. (CDC)
89-8411. Rockville, MD: U.S. Department of Health and Human
Services, CDC, 1989.
87. Tverdal, A. and K. Bjartveit, ``Health Consequences of Pipe
Versus Cigarette Smoking. Tobacco Control, 20:123-130, 2011.
88. CDC Fact Sheet, ``Smoking and Tobacco Use: Hookahs,'' available
at http://www.cdc.gov/tobacco/data_statistics/fact_sheets/tobacco_industry/hookahs/.
89. Monn, C., P. Kindler, A. Meile, et al., ``Ultrafine Particle
Emissions From Waterpipes,'' Tobacco Control, 16(6):390-393, 2007.
90. Smith, J. R., T. E. Novotny, et al., ``Determinants of Hookah
Use Amongst High School Students,'' Nicotine & Tobacco Research,
doi: 10.1093/ntr/ntr041; 1-8, 2011.
91. Prignot, J., A. J. Sasco, E. Poulet, et al., ``Alternative Forms
of Tobacco Use,'' The International Journal of Tuberculosis and Lung
Disease, 12(7):718-727, 2008.
92. Cobb, C. O., K. Sahmarani, T. Eissenberg, et al., ``Acute
Toxicant Exposure and Cardiac Autonomic Dysfunction From Smoking a
Single Narghile Waterpipe With Tobacco and With a `Healthy' Tobacco-
Free Alternative,'' Toxicology Letters, 212:70-75, 2012.
93. Maziak, W., ``The Global Epidemic of Waterpipe Smoking,''
Addictive Behaviors, 36:1-5, 2011.
94. Akl, E. A., S. Gaddam, S. Gunukula, et al., ``The Effects of
Waterpipe Tobacco Smoking on Health Outcomes: A Systematic Review,''
International Journal of Epidemiology, 39:834-857, 2010.
95. Maziak, W., ``The Waterpipe: An Emerging Global Risk for
Cancer,'' Cancer Epidemiology, 37:1-4, 2013.
96. Sepetdijian, E., A. Shihadeh, and N. A. Saliba, ``Measurement of
16 Polycyclic Aromatic Hydrocarbons in Narghile Waterpipe Tobacco
Smoke,'' Food and Chemical Toxicology, 46:1582-1590, 2008.
97. Schubert, J., J. Hahn, G. Dettbarn, et al., ``Mainstream Smoke
of the Waterpipe: Does This Environmental Matrix Reveal as
Significant Source of Toxic Compounds?'' Toxicology Letters,
205(3):279-284, 2011.
98. Jacob III, P., A. H. Raddaha, D. Dempsey, et al., ``Nicotine,
Carbon Monoxide, and Carcinogen Exposure After a Single Use of a
Water Pipe,'' Cancer Epidemiology, Biomarkers, & Prevention,
20:2345-2353, 2011.
99. American Lung Association, ``Tobacco Policy Trend Alert,''
available at http://www.lungusa2.org/embargo/slati/Trendalert_Waterpipes.pdf. February 2007.
100. Schep, L., R. Slaughter, W. Temple, et al., ``Diethylene Glycol
Poisoning,'' Clinical Toxicology, 47(6):525-535, 2009.
101. Henningfield, J. E. and G. S. Zaatari, ``Electronic Nicotine
Delivery Systems: Emerging Science Foundation for Policy,'' Tobacco
Control, 19:89-90, 2010.
102. FDA, ``Electronic Cigarettes,'' available at: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm.
103. Cobb, N. K. and D. B. Abrams, ``E-Cigarette or Drug Delivery
Device? Regulating Novel Nicotine Products,'' The New England
Journal of Medicine, 365(3):193-195, 2011.
104. Cobb, N. K., M. J. Byron, D. B. Abrams, et al., ``Novel
Nicotine Delivery Systems and Public Health: The Rise of the `E-
Cigarette','' American Journal of Public Health, 100(12):2340-2342,
2010.
105. Williams, M., A. Villarreal, K. Bozhilov, et al., ``Metal and
Silicate Particles Including Nanoparticles Are Present in Electronic
Cigarette Cartomizer Fluid and Aerosol,'' Public Library of Science
one, 8(3):e57987, 2013.
106. Schober, W., et al. ``Use of Electronic Cigarettes (E-
Cigarettes) Impairs Indoor Air Quality and Increases FeNO Levels of
E-Cigarette Consumers,'' International Journal of Hygiene and
Environmental Health (published online 6 December 2013), http://dx.doi.org/10.1016/j.ijheh.2013.11.003.
107. Schripp T., D. Markewitz, E. Uhde, and T. Salthammer, ``Does E-
Cigarette Consumption Cause Passive Vaping?'' Indoor Air, 23(1):25-
31, 2013.]
108. Memorandum from B. J. Westenberger to Michael Levy Re:
Evaluation of E-cigarettes (May 4, 2009), available at: http://www.fda.gov/downloads/drugs/scienceresearch/ucm173250.pdf.
109. Trehy, M. L., W. Ye, M. E. Hadwiger, et al., ``Analysis of
Electronic Cigarette Cartridges, Refill Solutions, and Smoke for
Nicotine and Nicotine Related Impurities,'' Journal of Liquid
Chromatography & Related Technologies, 34:14:, 1442-1458, doi:
10.1080/10826075.2011.572213.
110. Kim, H. and S. Ho-Sang, ``Determination of Tobacco-Specific
Nitrosamines in Replacement Liquids of Electronic Cigarettes by
Liquid Chromatography-Tandem Mass Spectrometry,'' Journal of
Chromatography A, 1291:48-55, 2013.
111. Etter, J., E. Zather, and S. Svensson, ``Analysis of Refill
Liquids for Electronic Cigarettes,'' Addiction, 108:1671-1679, 2013.
112. American Cancer Society. ``Electronic Cigarettes (E-
Cigarettes).'' CA: A Cancer Journal for Clinicians; March 14, 2014;
available at: http://onlinelibrary.wiley.com/doi/10.3322/caac.21228/pdf.
113. American Academy of Pediatrics. ``E-cigarettes Easy to Buy, Can
Hook Kids on Nicotine.'' AAP News Vol. 34, No. 11, Nov. 1, 2013
(doi: 10.1542/aapnews.20133411-24d).
114. J. L. Bolario, ``Candy Flavors Put E-Cigarettes on Kids'
Menu.'' National Public Radio (Feb. 17, 2014); available at: http://www.npr.org/blogs/health/2014/02/17/276558592/candy-flavors-put-e-cigarettes-on-kids-menu.
115. Chatham-Stephens K., R. Law, E. Taylor, et al., ``Notes From
the Field: Calls to Poison Centers for Exposures to Electronic
Cigarettes--United States,'' September 2010-February 2014, Morbidity
and Mortality Weekly Report, April 4, 2014; vol 63(13); 292-293.
116. Malone, R., V. Yerger, and C. Pearson, ``Cigar Risk Perception
in Focus Groups of Urban African American Youth,'' Journal of
Substance Abuse, 13(4):549-561, 2001.
117. Brooks, A., E. M. Gaier Larkin, S. Kishore, et al., ``Cigars,
Cigarettes, and Adolescents,'' American Journal of Health Behavior,
32(6):640-649, 2008.
118. Nyman, A. L., T. M. Taylor, and L. Biener, ``Trends in Cigar
Smoking and Perceptions of Health Risks Among Massachusetts
Adults,'' Tobacco Control, 11 (Suppl. II):ii25-ii29, 2002.
119. Smith, S. Y., B. Curbow, and F. A. Stillman, ``Harm Perception
of Nicotine Products in College Freshmen,'' Nicotine & Tobacco
Research, 9(9):977-982, 2007.
120. Krosnick, J. A., L. Chang, S. J. Sherman, et al., ``The Effects
of Beliefs About the Health Consequences of Cigarette Smoking on
Smoking Onset,'' Journal of Communication, 56:S18-S37, 2006.
121. Song, A. V., H. E. R. Morrell, J .L. Cornell, et al.,
``Perceptions of Smoking-Related Risks and Benefits as Predictors of
Adolescent Smoking Initiation,'' American Journal of Public Health,
99:487-492, 2009.
122. Steinberg, L., ``Cognitive and Affective Development in
Adolescence,'' Trends in Cognitive Sciences, 9(2):69-74, 2005.
123. Slovic, P., ``What Does It Mean to Know a Cumulative Risk?
Adolescents' Perceptions of Short-Term and Long-Term Consequences of
Smoking,'' Journal of Behavioral Decision Making, 13:259-266, 2000.
124. Bombard, J. M., V. J. Rock, L .L. Pederson, et al.,
``Monitoring Polytobacco Use Among Adolescents: Do Cigarette Smokers
Use Other Forms of Tobacco?'' Nicotine & Tobacco Research,
10(11):1581-1589, 2008.
125. Tomar, S. L., ``Is Use of Smokeless Tobacco a Risk Factor for
Cigarette Smoking? The U.S. Experience,'' Nicotine & Tobacco
Research, 5(4):561-569, 2003.
126. Haddock, C. K., M. V. Weg, M. DeBon, et al., ``Evidence That
Smokeless Tobacco Use Is a Gateway for Smoking Initiation in Young
Adult Males,'' Preventive Medicine, 32(3):262-267, 2001.
127. Sterling, K. and R. Mermelstein, ``Examining Hookah Smoking
Among a Cohort of Adolescent Ever Smokers,'' Nicotine & Tobacco
Research, 13:1202-1209, 2011.

128. Primack, B. A., A. Shensa, K. H. Kim, M. V. Carroll, et al.
(2013) ``Waterpipe Smoking Among U.S. University Students,''
Nicotine & Tobacco Research, 15, 29-35.
129. Scragg, R., R. J. Wellman, M. Laugesen, et al., ``Diminished
Autonomy Over Tobacco Can Appear With the First Cigarettes,''
Addictive Behaviors, 33:689-698, 2008.
130. Hampson, S. E., E. Tildesley, J. A. Andrews, et al., ``Smoking
Trajectories Across High School: Sensation Seeking and Hookah Use,''
Nicotine & Tobacco Research, 15(8):1400-1408, 2013.
131. Heinz, A. J., G. E. Giedgowd, N. A. Crane, et al., ``A
Comprehensive Examination of Hookah Smoking in College Students: Use
Patterns and Contexts, Social Norms and Attitudes, Harm Perception,
Psychological Correlates and Co-Occurring Substance Use,'' Addictive
Behaviors, 38:2751-2760, 2013.
132. State Prevention Advancement and Support, Center for Substance
Abuse Prevention, ``Conference Edition Report, Draft Guidance: Best
Practices for Responsible Retailing,'' available at: http://fcpr.fsu.edu/retail/documents/BP_Report_Conference_Edition.pdf.
133. Altman, D. G., A. Y. Wheelis, M. McFarlane, et al., ``The
Relationship Between Tobacco Access and Use Among Adolescents: A
Four Community Study,'' Social Science & Medicine, 48:759-775, 1999.
134. DiFranza, J. R., R. R. Carlson, and R. E. Caisse, ``Reducing
Youth Access to Tobacco,'' Tobacco Control, 1(1):57-58, 1992.
135. Sundh, M. and C. Hagquist, ``Does a Minimum-Age Law for
Purchasing Tobacco Make Any Difference? Swedish Experiences Over 8
Years,'' European Journal of Public Health, 17(2):171-177, 2006.
136. Glanz, K., A. D. Jarrette, E. A. Wilson, et al., ``Reducing
Minors' Access to Tobacco: 8 Years' Experience in Hawaii,''
Preventive Medicine, 44; 55-58, 2007.
137. Forster, J. L., D. M. Murray, M. Wolfson, et al., ``The Effects
of Community Policies to Reduce Youth Access to Tobacco,'' American
Journal of Public Health, 88(8):1193-1198, 1998.
138. DiFranza, J. R., ``Which Interventions Against the Sale of
Tobacco to Minors Can Be Expected to Reduce Smoking?'' Tobacco
Control, 21:436-442, 2012.
139. Jason, L. A., P. Y. Ji, M. D. Anes, et al., ``Active
Enforcement of Cigarette Control Laws in the Prevention of Cigarette
Sales to Minors,'' Journal of the American Medical Association,
266:3159-3161, 1991.
140. Hinds, M. W., ``Impact of a Local Ordinance Banning Tobacco
Sales to Minors,'' Public Health Reports, 107:355-358, 1992.
141. Cummings, K. M., A. Hyland, J. Perla, et al., ``Is the
Prevalence of Youth Smoking Affected by Efforts to Increase Retailer
Compliance With a Minors' Access Law?'' Nicotine & Tobacco Research,
5(4):465-471; 2003.
142. Rigotti, N. A., J. R. DiFranza, Y. Chang, et al., ``The Effect
of Enforcing Tobacco-Sales Laws on Adolescents' Access to Tobacco
and Smoking Behavior,'' The New England Journal of Medicine,
337(15):1044-1051, 1997.
143. Fichtenberg, C. M. and S. A. Glantz, ``Youth Access
Interventions Do Not Affect Youth Smoking,'' Pediatrics,
109(6):1088-1092, 2002.
144. Ross, H., F. J. Chaloupka, and M. Wakefield, ``Youth Smoking
Uptake Progress: Price and Public Policy Effects,'' Eastern Economic
Journal, 32(2):355-367, 2006.
145. Doubeni, C. A., W. Li, H. Fouayzi, et al., ``Perceived
Accessibility as a Predictor of Youth Smoking,'' Annals of Family
Medicine, 6(4):323-330, 2008.
146. Levy, D. T., and K. B. Friend, ``Strategies for Reducing Youth
Access to Tobacco: A Framework for Understanding Empirical Findings
on Youth Access Policies,'' Drugs: Education, Prevention and Policy,
9(3):285-303, 2002.
147. Schneider, S., C. Meyer, S. Yamamoto, et al., ``Implementation
of Electronic Locking Devices for Adolescents at German Tobacco
Vending Machines: Intended and Unintended Changes of Supply and
Demand,'' Tobacco Control, 18: 294-301, 2009.
148. U.S. Census Bureau, ``2007 Economic Census. Retail Trade:
Subject Series: Product Lines Statistics by Kind of Business for the
United States and States: 2007.''
149. Song, A. V., P. Brown, and S. A. Glantz, ``When Health Policy
and Empirical Evidence Collide: The Case of Cigarette Package
Warning Labels and Economic Consumer Surplus,'' American Journal of
Public Health, February 2014, e1-e10, doi:10.2105/AJPH.2013.301737.
150. Elliott & Shanahan Research, ``Literature Review: Evaluation of
the Effectiveness of the Graphic Health Warnings on Tobacco Product
Packaging 2008,'' prepared for Department of Health and Ageing,
Commonwealth of Australia, 2009.
151. European Health Research Partnership and Centre for Tobacco
Control Research, ``Research Into the Labeling of Tobacco Products
in Europe,'' a research report submitted to the European Commission,
December 2002.
151. Portillo, F. and F. Anto[ntilde]anzas, ``Information Disclosure
and Smoking Risk Perceptions: Potential Short-Term Impact on Spanish
Students of the New European Union Directive on Tobacco Products,''
European Journal of Public Health, 12:295-301, 2002.
152. Hammond, D., G. T. Fong, R. Borland, et al., ``Effectiveness of
Cigarette Warning Labels in Information Smokers About the Risks of
Smoking: Findings From the International Tobacco Control (ITC) Four
Country Survey,'' Tobacco Control, 15(Supp III):iii19-iii25, 2006.
153. Fischer, P. M., J. W. Richards Jr, E. J. Berman, and D. M.
Krugman, ``Recall and Eye Tracking Study of Adolescents Viewing
Tobacco Advertisements,'' Journal of the American Medical
Association 1989; 261(1):84-9.
154. D. M. Krugman, R. J. Fox, J. E. Fletcher, et al., ``Do
Adolescents Attend to Warnings in Cigarette Advertising: An Eye-
Tracking Approach,'' Journal of Advertising Research 1994; 34(6):39-
52.
155. R. G. Brubaker and S. K. Mitby. ``Health-Risk Warning Labels on
Smokeless Tobacco Products: Are They Effective?'' Addictive
Behaviors, 1990;15(2):115-118 [PubMed].
156. MacKinnon, D. P. and A. M. Fenaughty, ``Substance Use and
Memory for Health Warning Labels,'' Health Psychology, 12(2):147-
150, 1993.
157. Truitt, L., W. L. Hamilton, P. R. Johnston, et al., ``Recall of
Health Warnings in Smokeless Tobacco Ads,'' Tobacco Control, 11(Supp
II): ii59-63, 2002.
158. Les [Eacute]tudes de March[eacute] Cr[eacute]atec +, ``Health
Warning Messages on Smokeless Tobacco, Cigars, and Pipe Products: A
Qualitative Study With Consumers,'' H4097-02-5029, 2003.
159. Tobacco Products Information Regulations, P.C. 2000-1039, June
21, 2000 (Can.).
160. Kozlowski, L. T., K. M. Dollar, and G. A. Giovino, ``Cigar/
Cigarillo Surveillance: Limitations of the U.S. Department of
Agriculture System,'' American Journal of Preventive Medicine,
34(5):424-426, 2008.
161. Yerger, V., C. Pearson, and R. E. Malone, ``When Is a Cigar Not
a Cigar? African American Youths' Understanding of 'Cigar' Use,''
American Journal of Public Health, 91:316-317, 2001.
162. Cullen, J., P. Mowery, C. Delnevo, et al., ``Seven-Year
Patterns in U.S. Cigar Use Epidemiology Among Young Adults Aged 18-
25 Years: A Focus on Race/Ethnicity and Brand,'' American Journal of
Public Health, 101:1955-1962, 2011.
163. Jolly, D. H., ``Exploring the Use of Little Cigars by Students
at a Historically Black University,'' Preventing Chronic Disease,
5(3):1-9, 2008.
164. American Cancer Society, ``Cancer Facts & Figures 2011,''
Atlanta, GA: American Cancer Society; 2011.
165. Delnevo, C. D., J. Foulds, M. Hrwyna, ``Trading Tobacco: Are
Youths Choosing Cigars Over Cigarettes?'' American Journal of Public
Health, 95(12):2123, 2005.
166. Substance Abuse and Mental Health Services Administration,
Department of Health and Human Services, ``2001 National Household
Survey on Drug Abuse--Trends in Initiation of Substance Abuse,''
available at http://www.oas.samhsa.gov/NHSDA/2k1NHSDA/vol1/Chapter5.htm.
167. Centers for Disease Control and Prevention, ``Youth Risk
Behavior Surveillance--United States, 2009,'' Morbidity and
Mortality Weekly Report, 59(SS-5), 2010.
168. McCormack, V. A., A. Agudo, C. C. Dahm, et al., ``Cigar and
Pipe Smoking and Cancer Risk in the European Prospective
Investigation Into Cancer and Nutrition (EPIC),'' International
Journal of Cancer, 127:2402-2411, 2010.
169. International Agency for Research on Cancer, ``Tobacco Smoke
and

Involuntary Smoking,'' IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans, 83, 2004.
170. Shapiro, J. A., E. J. Jacobs, and M. J. Thun, ``Cigar Smoking
in Men and Risk of Death From Tobacco-Related Cancers,'' Journal of
the National Cancer Institute, 92(4):333-337, 2000.
171. U.S. Department of Health and Human Services, ``The Health
Consequences of Involuntary Exposure to Tobacco Smoke,'' A Report of
the Surgeon General; 2006, available at http://www.ncbi.nlm.nih.gov/books/NBK44324/pdf/TOC.pdf.
172. Institute of Medicine, Committee on Secondhand Smoke Exposure
and Acute Coronary Events, ``Secondhand Smoke Exposure and
Cardiovascular Effects,'' 2010, available at http://www.nap.edu/openbook.php?record_id=12649.
173. Rose, J. E., ``Nicotine and Nonnicotine Factors in Cigarette
Addiction,'' Psychopharmacology, 184(3):274-285, 2006.
174. Baker, R. R., J. R. Pereira da Silva, and G. Smith, ``The
Effect of Tobacco Ingredients on Smoke Chemistry. Part I:
Flavourings and Additives,'' Food and Chemical Toxicology, 42:3-37,
2004.
175. Gaworski, C., J. D. Heck, M. B. Bennett, et al., ``Toxicologic
Evaluation of Flavor Ingredients Added to Cigarette Tobacco: Skin
Painting Bioassay of Cigarette Smoke Condensate in SENCAR Mice,''
Toxicology, 139(1-2):1-17, 1999.
176. Fowler, J., N. D. Volkow, G. J. Wang, et al., ``Inhibition of
Monoamine Oxidase B in the Brains of Smokers,'' Nature,
379(6567):733-736, 1996.
177. Fowler, J. S., N. D. Volkow, G. J. Wang, et al., ``Brain
Monoamine Oxidase A Inhibition in Cigarette Smokers,'' Proceedings
of the National Academy of Sciences, 93(24):14065-14069, 1996.
178. Berlin, I., S. Sa[iuml]d, O. Spreux-Varoquaux, et al., ``A
Reversible Monoamine Oxidase A Inhibitor (Moclobemide) Facilitates
Smoking Cessation and Abstinence in Heavy, Dependent Smokers,''
Clinical Pharmacology and Therapeutics, 58(4):444-452, 1995.
179. George, T. P., J. C. Vessicchio, A. Termine, et al., ``A
Preliminary Placebo-Controlled Trial of Selegiline Hydrochloride for
Smoking Cessation,'' Biological Psychiatry, 53(2):136-143, 2003.
180. Green, T. A., P. A. Crooks, and M. T. Bardo, ``Contributory
Role for Nornicotine in Nicotine Neuropharmacology: Nornicotine-
Evoked Dopamine Overflow From Rat Nucleus Accumbens Slices,''
Biochemical Pharmacology, 62(12):1597-1603, 2001.
181. Dwoskin, L. P., S. T. Buxton, A. L. Jewell, et al., ``S(-)-
Nornicotine Increases Dopamine Release in a Calcium-Dependent Manner
From Superfused Rat Striatal Slices,'' Journal of Neurochemistry,
60(6):2167-2174, 1993.
182. Balfour, D. J., ``The Neurobiology of Tobacco Dependence: A
Preclinical Perspective on the Role of the Dopamine Projections to
the Nucleus Accumbens,'' Nicotine & Tobacco Research, 6(6):899-912,
2004.
183. Deadwyler, S. A., ``Electrophysiological Correlates of Abused
Drugs: Relation to Natural Rewards,'' Annals of the New York Academy
of Sciences, 1187:140-147, 2010.
184. Bardo, M. T., R. A. Bevins, J .E. Klebaur, et al., ``(-)-
Nornicotine Partially Substitutes for (+)-Amphetamine in a Drug
Discrimination Paradigm in Rats,'' Pharmacology, Biochemistry, and
Behavior, 58(4):1083-1087, 1997.
185. Jackson, K. J., M. J. Marks, R. E. Vann, X. Chen, et al.,
``Role of {alpha{time} 5 Nicotinic Acetylcholine Receptors in
Pharmacological and Behavioral Effects of Nicotine in Mice,'' The
Journal of Pharmacology and Experimental Therapeutics, 334(1);137-
46, 2010.
186. Desai, R. I., D. J. Barber, and P. Terry, ``Dopaminergic and
Cholinergic Involvement in the Discriminative Stimulus Effects of
Nicotine and Cocaine in Rats,'' Psychopharmacology, 167(4); 335-43,
2003.
187. Goldberg, S. R., M. E. Risner, I. P. Stolerman, C. Reavill, et
al., ``Nicotine and Some Related Compounds: Effects on Schedule-
Controlled Behaviour and Discriminative Properties in Rats,''
Psychopharmacology, 97(3); 295-302, 1989.
188. Myers, W. D., K. T. Ng, and G. Singer, ``Intravenous Self-
Administration of Acetaldehyde in the Rat as a Function of Schedule,
Food Deprivation and Photoperiod,'' Pharmacology, Biochemistry, and
Behavior, 17(4):807-811, 1982.
189. Amit, Z., Z. W. Brown, and G. E. Rockman, ``Possible
Involvement of Acetaldehyde, Norepinephrine and Their
Tetrahydroisoquinoline Derivatives in the Regulation of Ethanol
Self-Administration,'' Drug and Alcohol Dependence, 2(5-6):495-500,
1977.
190. Rodd-Henricks, Z. A., R. I. Melendez, A. Zaffaroni, et al.,
``The Reinforcing Effects of Acetaldehyde in the Posterior Ventral
Tegmental Area of Alcohol-Preferring Rats,'' Pharmacology,
Biochemistry, and Behavior, 72(1-2):55-64, 2002.
191. Risinger, F. O. and R. A. Oakes, ``Nicotine-Induced Conditioned
Place Preference and Conditioned Place Aversion in Mice,''
Pharmacology, Biochemistry, and Behavior, 51(2-3); 457-61, 1995.
192. Dwoskin, L. P., L. Teng, S. T. Buxton, et al, ``Minor Alkaloids
of Tobacco Release [3H]Dopamine From Superfused Rat Striatal
Slices,'' European Journal of Pharmacology, 276(1-2):195-199, 1995.
193. Perelman's Pocket Cyclopedia of Cigars, 2010; accessed April 3,
2012; available at http://www.cigarcyclopedia.com/images/stories/cigarcyclopedia/10_basics-111409.pdf.
194. Deeming Tobacco Products To Be Subject to the Federal Food,
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention
and Tobacco Control Act; Regulations on the Sale and Distribution of
Tobacco Products and Required Warning Statements for Tobacco
Products; Proposed Rule: Preliminary Regulatory Impact Analysis,
Initial Regulatory Flexibility Analysis, and Unfunded Mandates
Reform Act Analysis; available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

List of Subjects

21 CFR Part 1100

    Smoking, Tobacco.

21 CFR Part 1140

    Advertising, Labeling, Smoking, Tobacco.

21 CFR Part 1143

    Advertising, Labeling, Packaging and containers, Smoking, Tobacco.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR chapter I be amended as follows:

0
1. Add part 1100 to subchapter K to read as follows:

PART 1100--TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY

Sec.
1100.1 Scope.
1100.2 Requirements.
1100.3 Definitions.

    Authority: 21 U.S.C. 387a(b), 387f(d); Secs. 901(b) and 906(d),
Pub. L. 111-31; 21 CFR 16.1 and 1107.1; 21 CFR 1.1, 1.20, 14.55,
17.1, and 17.2.

Sec.  1100.1  Scope.

Option 1

    In addition to FDA's authority over cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco, FDA deems all other
products meeting the definition of tobacco product under section
201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(rr)), except accessories of such other tobacco products, to be
subject to the Federal Food, Drug, and Cosmetic Act.

Option 2

    In addition to FDA's authority over cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco, FDA deems all other
products meeting the definition of tobacco product under section
201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(rr)), except accessories of such other tobacco products and cigars
that are not within the scope of the covered cigar definition in Sec.
1100.3, to be subject to the Federal Food, Drug, and Cosmetic Act.

Sec.  1100.2  Requirements.

Option 1

    Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless
tobacco, and all other tobacco products, except accessories of such
other tobacco products, are subject to chapter IX of the Federal Food,
Drug, and Cosmetic Act and its implementing regulations. Tobacco
product is defined in section 201(rr) of the Federal Food, Drug, and
Cosmetic Act.

Option 2

    Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless
tobacco, covered cigars, and all other tobacco products, except
accessories of such other tobacco products and cigars that are not
within the scope of the covered cigar definition in Sec.  1100.3, are
subject to chapter IX of the Federal Food, Drug, and Cosmetic Act and
its implementing regulations. Tobacco product is defined in section
201(rr) of the Federal Food, Drug, and Cosmetic Act.

Sec.  1100.3  Definitions.

Option 1

    Tobacco product. As stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part, a tobacco product:
    (1) Means any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product);
and
    (2) Does not mean an article that is a drug defined in section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device defined
in section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a
combination product described in section 503(g) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353(g)).

Option 2

    Cigar means a tobacco product that:
    (1) Is not a cigarette and
    (2) Is a roll of tobacco wrapped in leaf tobacco or any substance
containing tobacco.
    Covered cigar means any cigar as defined in this part, except a
cigar that:
    (1) Is wrapped in whole tobacco leaf;
    (2) Contains a 100 percent leaf tobacco binder;
    (3) Contains primarily long filler tobacco;
    (4) Is made by combining manually the wrapper, filler, and binder;
    (5) Has no filter, tip, or non-tobacco mouthpiece and is capped by
hand;
    (6) Has a retail price (after any discounts or coupons) of no less
than $10 per cigar (adjusted, as necessary, every 2 years, effective
July 1st, to account for any increases in the price of tobacco products
since the last price adjustment,);
    (7) Does not have a characterizing flavor other than tobacco; and
    (8) Weighs more than 6 pounds per 1000 units.
    Tobacco product. As stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part, a tobacco product:
    (1) Means any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product);
and
    (2) Does not mean an article that is a drug defined in section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device defined
in section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a
combination product described in section 503(g) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353(g)).

PART 1140--CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO
PRODUCTS

0
2. The heading for part 1140 is revised to read as shown above.
0
3. The authority citation for 21 CFR part 1140 continues to read as
follows:

    Authority: 21 U.S.C. 301 et seq.; Sec. 102, Pub. L. 111-31.

0
4. Revise Sec.  1140.1 to read as follows:

Sec.  1140.1  Scope.

    (a) This part sets out the restrictions under the Federal Food,
Drug, and Cosmetic Act on the sale, distribution, and use of
cigarettes, smokeless tobacco, and covered tobacco products.
    (b) The failure to comply with any applicable provision in this
part in the sale, distribution, and use of cigarettes, smokeless
tobacco, and covered tobacco products renders the product misbranded
under the Federal Food, Drug, and Cosmetic Act.
    (c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
0
5. Revise Sec.  1140.2 to read as follows:

Sec.  1140.2  Purpose.

    The purpose of this part is to establish restrictions on the sale,
distribution, and use of cigarettes, smokeless tobacco, and covered
tobacco products in order to reduce the number of children and
adolescents who use these products, and to reduce the life-threatening
consequences associated with tobacco use.
0
6. Revise Sec.  1140.3 to read as follows:

Sec.  1140.3  Definitions.

    For the purposes of this part:
    Cigar means a tobacco product that:
    (1) Is not a cigarette and
    (2) Is a roll of tobacco wrapped in leaf tobacco or any substance
containing tobacco.
    Cigarette. (1) Means a product that:
    (i) Is a tobacco product and
    (ii) Meets the definition of the term ``cigarette'' in section 3(1)
of the Federal Cigarette Labeling and Advertising Act; and
    (2) Includes tobacco, in any form, that is functional in the
product, which, because of its appearance, the type of tobacco used in
the filler, or its packaging and labeling, is likely to be offered to,
or purchased by, consumers as a cigarette or as roll-your-own tobacco.
    Cigarette tobacco means any product that consists of loose tobacco
that is intended for use by consumers in a cigarette. Unless otherwise
stated, the requirements applicable to cigarettes under this chapter
also apply to cigarette tobacco.
    Covered tobacco product means any tobacco product deemed to be
subject to the Federal Food, Drug, and Cosmetic Act pursuant to Sec.
1100.2 of this chapter, but excludes any component or part that does
not contain tobacco or nicotine.
    Distributor means any person who furthers the distribution of a
tobacco product, whether domestic or imported, at any point from the
original place of manufacture to the person who sells or distributes
the product to individuals for personal consumption. Common carriers
are not considered distributors for the purposes of this part.
    Importer means any person who imports any tobacco product that is
intended for sale or distribution to consumers in the United States.
    Manufacturer means any person, including any repacker and/or
relabeler, who manufactures, fabricates, assembles, processes, or
labels a finished tobacco product.
    Nicotine means the chemical substance named 3-(1-Methyl-2-
pyrrolidinyl)pyridine or C[10]H[14]N[2], including any salt or complex
of nicotine.
    Package means a pack, box, carton, or container of any kind in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
    Point of sale means any location at which a consumer can purchase
or

otherwise obtain tobacco products for personal consumption.
    Retailer means any person who sells tobacco products to individuals
for personal consumption, or who operates a facility where vending
machines or self-service displays are permitted under this part.
    Smokeless tobacco means any tobacco product that consists of cut,
ground, powdered, or leaf tobacco and that is intended to be placed in
the oral or nasal cavity.
    Tobacco product. As stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(rr)) in relevant part, a tobacco
product:
    (1) Means any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product) and
    (2) Does not mean an article that is a drug defined in section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device defined
in section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a
combination product described in section 503(g) of the Federal Food,
Drug, and Cosmetic Act.
0
7. Revise Sec.  1140.10 to read as follows:

Sec.  1140.10  General responsibilities of manufacturers, distributors,
and retailers.

    Each manufacturer, distributor, importer, and retailer is
responsible for ensuring that the cigarettes, smokeless tobacco, or
covered tobacco products it manufactures, labels, advertises, packages,
distributes, imports, sells, or otherwise holds for sale comply with
all applicable requirements under this part.
0
8. Revise Sec.  1140.14 to read as follows:

Sec.  1140.14  Additional responsibilities of retailers.

    (a) In addition to the other requirements under this part, each
cigarette and smokeless tobacco retailer is responsible for ensuring
that all sales of cigarettes or smokeless tobacco to any person comply
with the following requirements:
    (1) No retailer may sell cigarettes or smokeless tobacco to any
person younger than 18 years of age;
    (2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this
section and in Sec.  1140.16(c)(2)(i), each retailer must verify by
means of photographic identification containing the bearer's date of
birth that no person purchasing the product is younger than 18 years of
age;
    (ii) No such verification is required for any person over the age
of 26;
    (3) Except as otherwise provided in Sec.  1140.16(c)(2)(ii), a
retailer may sell cigarettes or smokeless tobacco only in a direct,
face-to-face exchange without the assistance of any electronic or
mechanical device (such as a vending machine);
    (4) No retailer may break or otherwise open any cigarette or
smokeless tobacco package to sell or distribute individual cigarettes
or a number of unpackaged cigarettes that is smaller than the quantity
in the minimum cigarette package size defined in Sec.  1140.16(b), or
any quantity of cigarette tobacco or smokeless tobacco that is smaller
than the smallest package distributed by the manufacturer for
individual consumer use; and
    (5) Each retailer must ensure that all self-service displays,
advertising, labeling, and other items, that are located in the
retailer's establishment and that do not comply with the requirements
of this part, are removed or are brought into compliance with the
requirements under this part.
    (b) Notwithstanding the requirements in paragraph (a) of this
section and in addition to the other requirements under this part, each
retailer of covered tobacco products is responsible for ensuring that
all sales of such covered tobacco products to any person comply with
the following requirements:
    (1) No retailer may sell covered tobacco products to any person
younger than 18 years of age;
    (2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this
section and in Sec.  1140.16(c)(2)(i), each retailer must verify by
means of photographic identification containing the bearer's date of
birth that no person purchasing the product is younger than 18 years of
age;
    (ii) No such verification is required for any person over the age
of 26; and
    (3) A retailer may not sell covered tobacco products with the
assistance of any electronic or mechanical device (such as a vending
machine), except in facilities where the retailer ensures that no
person younger than 18 years of age is present, or permitted to enter,
at any time.
0
9. Add part 1143 to subchapter K to read as follows:

PART 1143--REQUIRED WARNING STATEMENTS

Sec.
1143.1 Definitions.
1143.3 Required warning statement regarding addictiveness of
nicotine.
1143.5 Required warning statements for cigars.
1143.7 Language requirements for required warning statements.
1143.9 Irremovable or permanent required warning statements.
1143.11 Does not apply to foreign distribution.
1143.13 Effective date.

    Authority: 21 U.S.C. 387a(b), 387f(d); Pub. L. 111-31, 123 Stat.
1776.

Sec.  1143.1  Definitions.

Option 1

    For purposes of this part:
    Covered tobacco product means any tobacco product deemed to be
subject to the Federal Food, Drug, and Cosmetic Act pursuant to Sec.
1100.2 of this chapter, but excludes any component or part of a tobacco
product that does not contain nicotine or tobacco.
    Package means a pack, box, carton, or container of any kind in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
    Required warning statement means a textual warning statement
required to be on packaging and in advertisements for cigarette
tobacco, roll-your-own tobacco, cigars, and other covered tobacco
products.
    Roll-your-own tobacco means any tobacco product which, because of
its appearance, type, packaging, or labeling, is suitable for use and
likely to be offered to, or purchased by, consumers as tobacco for
making cigarettes.

Option 2

    For purposes of this part:
    Cigar means a tobacco product that:
    (1) Is not a cigarette and
    (2) Is a roll of tobacco wrapped in leaf tobacco or any substance
containing tobacco.
    Covered cigar means any cigar as defined in this part, except a
cigar that:
    (1) Is wrapped in whole tobacco leaf;
    (2) Contains a 100 percent leaf tobacco binder;
    (3) Contains primarily long filler tobacco;
    (4) Is made by combining manually the wrapper, filler, and binder;
    (5) Has no filter, tip, or non-tobacco mouthpiece and is capped by
hand;
    (6) Has a retail price (after any discounts or coupons) of no less
than $10 per cigar (adjusted, as necessary, every 2 years, effective
July 1st, to account for any increases in the price of tobacco products
since the last price adjustment);
    (7) Does not have a characterizing flavor other than tobacco; and
    (8) Weighs more than 6 pounds per 1000 units.
    Covered tobacco product means any tobacco product deemed to be
subject to the Federal Food, Drug, and Cosmetic Act pursuant to Sec.
1100.2 of this chapter, but excludes any component or part of

a tobacco product that does not contain nicotine or tobacco.
    Package means a pack, box, carton, or container of any kind in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
    Required warning statement means a textual warning statement
required to be on packaging and in advertisements for cigarette
tobacco, roll-your-own tobacco, covered cigars, and other covered
tobacco products.
    Roll-your-own tobacco means any tobacco product which, because of
its appearance, type, packaging, or labeling, is suitable for use and
likely to be offered to, or purchased by, consumers as tobacco for
making cigarettes.

Sec.  1143.3  Required warning statement regarding addictiveness of
nicotine.

    (a) Packages. (1) For cigarette tobacco, roll-your-own tobacco, and
covered tobacco products other than cigars, it is unlawful for any
person to manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States such product
unless the tobacco product bears the following required warning
statement on each product package: ``WARNING: This product contains
nicotine derived from tobacco. Nicotine is an addictive chemical.''
    (2) The required warning statement must appear directly on the
package and must be clearly visible underneath any cellophane or other
clear wrapping as follows:
    (i) Be located in a conspicuous and prominent place on the two
principal display panels of the package and the warning area must
comprise at least 30 percent of each of the principal display panels;
    (ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the package;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section; and
    (v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other information on the principal display panel have
the same orientation.
    (3) A retailer of any tobacco product covered by paragraphs (a)(1)
and (2) of this section will not be in violation of this section for
packaging that:
    (i) Contains a health warning;
    (ii) Is supplied to the retailer by the tobacco product
manufacturer, importer, or distributor, and
    (iii) Is not altered by the retailer in a way that is material to
the requirements of this section.
    (b) Advertisements. (1) For cigarette tobacco, roll-your-own
tobacco, and covered tobacco products other than cigars, it is unlawful
for any tobacco product manufacturer, packager, importer, distributor,
or retailer of the tobacco product to advertise or cause to be
advertised within the United States any tobacco product unless each
advertisement bears, in accordance with the requirements of this
section, the required warning statement specified in paragraph (a)(1)
of this section.
    (2) The required warning statement must appear in the upper portion
of the area of the advertisement within the trim area as follows:
    (i) Occupy at least 20 percent of the area of the advertisement;
    (ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the advertisement;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section;
    (v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other textual information in the advertisement have
the same orientation; and
    (vi) Be surrounded by a rectangular border that is the same color
as the text of the required warning statement and that is not less than
3 millimeters (mm) or more than 4 mm.
    (3) This paragraph (b) applies to a retailer only if that retailer
is responsible for or directs the health warning required under the
paragraph. However, this paragraph does not relieve a retailer of
liability if the retailer displays, in a location open to the public,
an advertisement that does not contain a health warning or contains a
health warning that has been altered by the retailer in a way that is
material to the requirements of this section.
    (c) Self-certification. A tobacco product that would otherwise be
required to bear the warning in paragraph (a)(1) of this section but
does not contain nicotine is not required to bear the warning in
paragraph (a)(1) of this section on packages or advertisements if the
manufacturer of the tobacco product has submitted to FDA a confirmation
statement certifying to be true and accurate that the product does not
contain nicotine and that the manufacturer has data to support that
assertion. Any product not required to bear the warning in paragraph
(a)(1) of this section must include the following statement ``This
product is derived from tobacco.'' on all packages and advertisements
in accordance with the requirements of this part.

Sec.  1143.5  Required warning statements for cigars.

Option 1

    (a) Packages. (1) It is unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States any cigar the package of which
fails to bear one of the following required warning statements on each
product package:
    (i) WARNING: Cigar smoking can cause cancers of the mouth and
throat, even if you do not inhale.
    (ii) WARNING: Cigar smoking can cause lung cancer and heart
disease.
    (iii) WARNING: Cigars are not a safe alternative to cigarettes.
    (iv) WARNING: Tobacco smoke increases the risk of lung cancer and
heart disease, even in nonsmokers.
    (v) WARNING: This product contains nicotine derived from tobacco.
Nicotine is an addictive chemical.
    (2) Each required warning statement must appear directly on the
package and must be clearly visible underneath any cellophane or other
clear wrapping as follows:
    (i) Be located in a conspicuous and prominent place on the two
principal display panels of the package and the warning area must
comprise at least 30 percent of each of the principal display panels;
    (ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the package;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section; and

    (v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other information on that principal display panel
have the same orientation.
    (3) No person may manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within the United States
any cigar without a required warning statement, except for cigars that
are sold individually and not in a product package. For cigars that are
sold individually and not in a product package, the required warning
statements must be posted at the retailer's point-of-sale in accordance
with the following:
    (i) The warnings in paragraph (a) of this section must be placed on
a sign that is a minimum of 8.5 x 11 inches, posted on or within 3
inches of each cash register where payment may be made so that the
sign(s) are unobstructed in their entirety and can be read easily by
each consumer making a purchase;
    (ii) The sign must be clear, legible, and conspicuous and be
printed in black Helvetica bold or Arial bold type against a solid
white background in at least 17 point type with appropriate space
between the warning statements
    (iii) Be printed in a manner that contrasts by typography, layout,
or color, with all other printed material; and
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section.
    (4) A retailer of any cigar covered by paragraphs (a)(1) and (2) of
this section will not be in violation of this section for packaging
that:
    (i) Contains a health warning;
    (ii) Is supplied to the retailer by a manufacturer, importer, or
distributor who has the required state, local, or Alcohol and Tobacco
Tax and Trade Bureau (TTB)-issued license or permit, if applicable, and
    (iii) Is not altered by the retailer in a way that is material to
the requirements of this section.
    (b) Advertisements. (1) It is unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of cigars to
advertise or cause to be advertised within the United States any cigar
unless each advertisement bears, in accordance with the requirements of
this section, one of the required warning statements specified in
paragraph (a)(1) of this section.
    (2) Each required warning statement must appear in the upper
portion of the area of the advertisement within the trim area as
follows:
    (i) Occupy at least 20 percent of the area of the advertisement;
    (ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the advertisement;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section;
    (v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other textual information in the advertisement have
the same orientation; and
    (vi) Be surrounded by a rectangular border that is the same color
as the text of the required warning statement and that is not less than
3 mm or more than 4 mm.
    (3) This paragraph (b) applies to a retailer only if that retailer
is responsible for or directs the warning statements required under the
paragraph. However, this paragraph of this section does not relieve a
retailer of liability if the retailer displays, in a location open to
the public, an advertisement that does not contain a health warning or
contains a health warning that has been altered by the retailer in a
way that is material to the requirements of this section.
    (c) Marketing requirements. (1) The warning statements required in
paragraph (a)(1) of this section must be randomly displayed in each 12-
month period, in as equal a number of times as is possible on each
brand of cigar sold in product packaging and be randomly distributed in
all areas of the United States in which the product is marketed in
accordance with a plan submitted by the cigar manufacturer, importer,
distributor, or retailer to, and approved by the Food and Drug
Administration.
    (2) The warning statements required in paragraph (a)(1) of this
section must be rotated quarterly in alternating sequence in each
advertisement for each brand of cigar in accordance with a plan
submitted by the cigar manufacturer, importer, distributor, or retailer
to, and approved by the Food and Drug Administration.

Option 2

    (a) Packages. (1) It is unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States any covered cigar the package of
which fails to bear one of the following required warning statements on
each product package:
    (i) WARNING: Cigar smoking can cause cancers of the mouth and
throat, even if you do not inhale.
    (ii) WARNING: Cigar smoking can cause lung cancer and heart
disease.
    (iii) WARNING: Cigars are not a safe alternative to cigarettes.
    (iv) WARNING: Tobacco smoke increases the risk of lung cancer and
heart disease, even in nonsmokers.
    (v) WARNING: This product contains nicotine derived from tobacco.
Nicotine is an addictive chemical.
    (2) Each required warning statement must appear directly on the
package and must be clearly visible underneath any cellophane or other
clear wrapping as follows:
    (i) Be located in a conspicuous and prominent place on the two
principal display panels of the package and the warning area must
comprise at least 30 percent of each of the principal display panels;
    (ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the package;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section; and
    (v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other information on that principal display panel
have the same orientation.
    (3) No person may manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within the United States
any covered cigar without a required warning statement, except for
covered cigars that are sold individually and not in a product package.
For covered cigars that are sold individually and not in a product
package, the required warning statements must be posted at the
retailer's point-of-sale in accordance with the following:
    (i) The warnings in paragraph (a) of this section must be placed on
a sign that is a minimum of 8.5 x 11 inches, posted on or within 3
inches of each cash register where payment may be made so that the
sign(s) are

unobstructed in their entirety and can be read easily by each consumer
making a purchase;
    (ii) The sign must be clear, legible, and conspicuous and be
printed in black Helvetica bold or Arial bold type against a solid
white background in at least 17 point type with appropriate space
between the warning statements;
    (iii) Be printed in a manner that contrasts by typography, layout,
or color, with all other printed material; and
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section.
    (4) A retailer of any covered cigar covered by paragraphs (a)(1)
and (2) of this section will not be in violation of this section for
packaging that:
    (i) Contains a health warning;
    (ii) Is supplied to the retailer by a manufacturer, importer, or
distributor who has the required state, local, or TTB-issued license or
permit, if applicable, and
    (iii) Is not altered by the retailer in a way that is material to
the requirements of this section.
    (b) Advertisements. (1) It is unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of covered
cigars to advertise or cause to be advertised within the United States
any covered cigar unless each advertisement bears, in accordance with
the requirements of this section, one of the required warning
statements specified in paragraph (a)(1) of this section.
    (2) Each required warning statement must appear in the upper
portion of the area of the advertisement within the trim area as
follows:
    (i) Occupy at least 20 percent of the area of the advertisement;
    (ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the advertisement;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section;
    (v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other textual information in the advertisement have
the same orientation; and
    (vi) Be surrounded by a rectangular border that is the same color
as the text of the required warning statement and that is not less than
3 mm or more than 4 mm.
    (3) This paragraph (b) applies to a retailer only if that retailer
is responsible for or directs the warning statements required under the
paragraph. However, this paragraph of this section does not relieve a
retailer of liability if the retailer displays, in a location open to
the public, an advertisement that does not contain a health warning or
contains a health warning that has been altered by the retailer in a
way that is material to the requirements of this section.
    (c) Marketing requirements. (1) The warning statements required in
paragraph (a)(1) of this section must be randomly displayed in each 12-
month period, in as equal a number of times as is possible on each
applicable brand of covered cigar and be randomly distributed in all
areas of the United States in which the product is marketed in
accordance with a plan submitted by the cigar manufacturer, importer,
distributor, or retailer to, and approved by the Food and Drug
Administration.
    (2) The warning statements required in paragraph (a)(1) of this
section must be rotated quarterly in alternating sequence in each
advertisement for each applicable brand of covered cigar in accordance
with a plan submitted by the cigar manufacturer, importer, distributor,
or retailer to, and approved by the Food and Drug Administration.

Sec.  1143.7  Language requirements for required warning statements.

    The text in each required warning statement required in Sec.
1143.3 or Sec.  1143.5 must be in the English language, except as
follows:
    (a) In the case of an advertisement that appears in a non-English
publication, the text in the required warning statement must appear in
the predominant language of the publication whether or not the
advertisement is in English, and;
    (b) In the case of an advertisement that appears in an English
language publication but that is not in English, the text in the
required warning statement must appear in the same language as that
principally used in the advertisement.

Sec.  1143.9  Irremovable or permanent required warning statements.

    The required warning statements required by this section must be
indelibly printed on or permanently affixed to the package or
advertisement. These warnings, for example, must not be printed or
placed on a product label affixed to a clear outer wrapper that is
likely to be removed to access the product within the package.

Sec.  1143.11  Does not apply to foreign distribution.

    The provisions of this part do not apply to a manufacturer or
distributor of tobacco products that does not manufacture, package, or
import tobacco products for sale or distribution within the United
States.

Sec.  1143.13  Effective date.

    This part will take effect 24 months after [date of publication of
final rule]. The effective date will be with respect to the date of
manufacture, provided that, in any case, beginning 30 days after the
effective date, a manufacturer may not introduce into the domestic
commerce of the United States any product, irrespective of the date of
manufacture that is not in conformance with this part.

    Dated: April 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09491 Filed 4-24-14; 8:45 am]
BILLING CODE 4160-01-P