[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Proposed Rules]
[Pages 23141-23207]
[FR Doc No: 2014-09491]

Vol. 79

Friday,

No. 80

April 25, 2014

Part IV

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 1100, 1140, and 1143

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

Federal Register / Vol. 79 , No. 80 / Friday, April 25, 2014 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2014-N-0189]
RIN 0910-AG38

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to deem
products meeting the statutory definition of ``tobacco product,''
except accessories of a proposed deemed tobacco product, to be subject
to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act). The Tobacco Control Act provides FDA authority to
regulate cigarettes, cigarette tobacco, roll-your-own tobacco,
smokeless tobacco, and any other tobacco products that the Agency by
regulation deems to be subject to the law. Option 1 of the proposed
rule would extend the Agency's ``tobacco product'' authorities in the
FD&C Act to all other categories of products, except accessories of a
proposed deemed tobacco product, that meet the statutory definition of
``tobacco product'' in the FD&C Act. Option 2 of the proposed rule
would extend the Agency's ``tobacco product'' authorities to all other
categories of products, except premium cigars and the accessories of a
proposed deemed tobacco product, that meet the statutory definition of
``tobacco product'' in the FD&C Act. FDA also is proposing to prohibit
the sale of ``covered tobacco products'' to individuals under the age
of 18 and to require the display of health warnings on cigarette
tobacco, roll-your own tobacco, and covered tobacco product packages
and in advertisements. FDA is taking this action to address the public
health concerns associated with the use of tobacco products.

DATES: Submit either electronic or written comments on the proposed
rule by July 9, 2014. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 (the PRA) by May 27, 2014,
(see the ``Paperwork Reduction Act of 1995'' section).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-0189 and/or Regulatory Information Number (RIN) 0910-AG38, by any of
the following methods, except that comments on information collection
issues under the PRA must be submitted to the Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB) (see the
``Paperwork Reduction Act of 1995'' section).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency
name, Docket No. FDA-2014-N-0189, and RIN 0910-AG38 for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gerie Voss, Office of Regulations,
Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850-3229,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
I. Legal Authority
II. Background for Deeming All Tobacco Products To Be Subject to the
FD&C Act
III. Continuum of Nicotine-Delivering Products
IV. Deeming Tobacco Products To Be Subject to the FD&C Act
    A. Public Health Benefits of Deeming
    B. The Sottera Decision
    C. Options for Premium Cigars and Request for Comments Regarding
Scope
    D. Request for Comments Regarding Regulation of E-Cigarettes
    E. Request for Comments Regarding Components, Parts, and
Accessories
V. Basis for Additional Provisions
    A. Addictive Nature of Products
    B. Health Risks of Products
    C. Consumer Confusion and Misinformation About Certain Covered
Tobacco Products
    D. Use as Starter Products or Dual Use With Other Tobacco
Products
VI. Proposed Minimum Age and Identification Restrictions
    A. Effectiveness of Proposed Restrictions and Section 906(d)
Standard
    B. Application to Proposed Vending Machine Restrictions
VII. Proposed Required Warning Statements
    A. Requiring Health Warnings Is Appropriate for the Protection
of the Public Health
    B. Effectiveness of Warnings
    C. Proposed Addictiveness Warning
    D. Age of Initiation for Cigar Smokers
    E. Proposed Required Warning Statements for Small and Large
Cigars
VIII. Description of the Proposed Rule
    A. Proposed Part 1100--Tobacco Products Subject to FDA Authority
    B. Proposed Changes to Part 1140--Cigarettes, Smokeless Tobacco,
and Covered Tobacco Products
    C. Proposed Part 1143--Required Warning Statements
IX. Paperwork Reduction Act of 1995
    A. Existing Burdens Associated With Tobacco Products Currently
Subject to the FD&C Act (i.e., Cigarettes, Cigarette Tobacco, Roll-
Your-Own Tobacco, and Smokeless Tobacco) With Approved OMB Control
Numbers
    B. Burdens Associated With Tobacco Products Currently Subject to
the FD&C Act But Not Yet Approved by OMB
    C. New Collections of Information That Apply Only to Proposed
Deemed Tobacco Products
X. Executive Order 13132; Federalism
XI. Environmental Impact
XII. Analysis of Impacts: Summary
XIII. Request for Comments
    A. General Information About Submitting Comments
    B. Public Availability of Comments
    C. Information Identifying the Person Submitting the Comment
XIV. References

Executive Summary

Purpose of the Proposed Rule

    Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco were immediately covered by FDA's tobacco product authorities
in chapter IX of the FD&C Act (21 U.S.C. 387 through 387u) when the
Tobacco Control Act went into effect. For other kinds of tobacco
products, FDA has authority to issue regulations to bring

them under the law by ``deeming'' them to be subject to such
authorities. Consistent with the statute, once a tobacco product is
deemed, FDA may put in place ``restrictions on the sale and
distribution of a tobacco product,'' including age-related access
restrictions and advertising and promotion restrictions, if FDA
determines the restrictions are appropriate for the protection of the
public health. The proposed rule has two purposes: (1) To deem products
that meet the definition of ``tobacco product'' under the law except
accessories of a proposed deemed tobacco product and subject them to
the tobacco control authorities in the FD&C Act and (2) to apply
specific provisions that are appropriate for the protection of the
public health to deemed tobacco products. To satisfy these purposes,
FDA is proposing two options (Option 1 and Option 2), which would
provide two alternatives for the scope of the deeming provisions and,
consequently, the application of the additional specific provisions.

Summary of the Major Provisions of the Regulatory Action

    The proposed rule has two main sections: (1) Deeming provisions and
(2) additional provisions to protect public health.
    Deeming Provisions--Option 1 for the proposed rule would deem all
products meeting the statutory definition of ``tobacco product'' except
accessories of a proposed deemed tobacco product to be subject to FDA's
tobacco product authorities under chapter IX of the FD&C Act. FDA
considers accessories of proposed deemed products to be those items
that are not included as part of a finished tobacco product or intended
or expected to be used by consumers in the consumption of a tobacco
product, and we expect that they will not have a significant impact on
the public health. In addition, FDA considers accessories to be those
items that may be used in the storage or personal possession of a
proposed deemed product. Therefore, items such as hookah tongs, bags,
cases, charcoal burners and holders, as well as cigar foil cutters,
humidors, carriers, and lighters would be considered accessories and
would not fall within the scope of this proposed rule. Section 201(rr)
of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control
Act, defines the term ``tobacco product'' to mean ``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).'' \1\ Products that meet the
statutory definition of ``tobacco products'' can include currently
marketed products such as certain dissolvables, gels, hookah tobacco,
electronic cigarettes, cigars, and pipe tobacco. Components and parts
of tobacco products, but not their related accessories, would also be
included in the scope of this proposed rule. Components and parts are
included as part of a finished tobacco product or intended for consumer
use in the consumption of a tobacco product. Components and parts that
would be covered under this proposal include those items sold
separately or as part of kits sold or distributed for consumer use or
further manufacturing or included as part of a finished tobacco
product. Such examples would include air/smoke filters, tubes, papers,
pouches, or flavorings used for any of the proposed deemed tobacco
products (such as flavored hookah charcoals and hookah flavor
enhancers) or cartridges for e-cigarettes. The proposed rule also deems
any future tobacco products that meet the statutory definition of
``tobacco product'' except accessories of such product to be subject to
FDA's authorities under chapter IX of the FD&C Act. For example, FDA
envisions that there could be tobacco products developed in the future
that provide nicotine delivery (e.g., via dermal or buccal absorption),
similar to currently marketed medicinal nicotine products, but which
are not marketed for therapeutic purposes. Such products would be
``tobacco products'' and subject to FDA's chapter IX authorities should
the deeming rule be finalized.
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    \1\ FDA notes that products falling within the FD&C Act's
definition of ``tobacco product'' may not be considered tobacco
products for Federal excise tax purposes (see 26 U.S.C. 5702(c)).
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    FDA is also proposing a second option to deem only a subset of
cigars (i.e., to exclude from the scope of this proposed rule certain
cigars that we refer to as ``premium cigars''). With respect to current
products, while FDA recognizes that all cigars are harmful and
potentially addictive, it has been suggested that different kinds of
cigars may have the potential for varying effects on public health,
based on possible differences in their effects on dual use, youth
initiation and frequency of use by youth and young adults. Accordingly,
FDA is seeking comment on these options to determine whether all cigars
should be subject to deeming and what provisions of the proposed rule
may be appropriate or not appropriate for different kinds of cigars.
    In addition, FDA realizes that there are distinctions in the
hazards presented by various nicotine-delivering products. Some have
advanced views that certain new tobacco products that are
noncombustible (such as e-cigarettes) may be less hazardous than
combustible products given the carcinogens in smoke and the dangers of
secondhand smoke from combustible products. Accordingly, FDA is seeking
comment in this proposed rule as to how e-cigarettes should be
regulated based on the continuum of nicotine-delivering products. We
welcome comment on how to implement the provisions in the FD&C Act with
respect to e-cigarettes. We also welcome any health and behavioral data
about the effects of using e-cigarettes.
    Once finalized, products deemed under this rule will be subject to
the same FD&C Act provisions that cigarettes, roll-your-own tobacco,
and smokeless tobacco are subject to, with respect to the following:
(1) Enforcement action against products determined to be adulterated
and misbranded; (2) required submission of ingredient listing and
reporting of harmful and potentially harmful constituents (HPHCs) for
all tobacco products; (3) required registration and product listing for
all tobacco products; (4) prohibition against use of modified risk
descriptors (e.g., ``light,'' ``low,'' and ``mild'' descriptors) and
claims unless FDA issues an order permitting their use; (5) prohibition
on the distribution of free samples (same as for cigarettes); and (6)
premarket review requirements. These actions would improve the public
health by affording FDA critical information regarding the health risks
of such products, preventing new products from entering the market if
they are not appropriate for the protection of public health or found
substantially equivalent to an identified predicate product, and
reducing the use of misleading claims and descriptors about the
relative risk of tobacco products, which may lead consumers to initiate
tobacco product use or to continue using tobacco when they would
otherwise quit.
    Additional Provisions--In addition to the provisions in the FD&C
Act that would apply automatically if the proposed products are deemed,
FDA has the authority to invoke its other authorities under the Tobacco
Control Act in regulating these products. At this time, under section
906(d) of the FD&C Act (21 U.S.C. 387f(d)), FDA proposes to apply three
additional provisions to covered tobacco products: (1) Requirement for
a minimum age of purchase; (2) health warnings for

product packages and advertisements (which FDA is also proposing to
apply to cigarette tobacco and roll-your-own tobacco); and (3)
prohibition of vending machine sales, unless the vending machine is
located in a facility where the retailer ensures that individuals under
18 years of age are prohibited from entering at any time. The term
``covered tobacco products'' would be defined as those products deemed
to be subject to the FD&C Act under section 1100.2 of title 21 of the
Code of Federal Regulations (CFR), other than a component or part that
does not contain tobacco or nicotine.
    Request for Public Comment--In addition to seeking comment on the
overall proposed rule, FDA is specifically seeking comment on the
application of the proposed rule to certain products or in certain
circumstances, including the following:
    1. As noted previously, given that different kinds of cigars may
have the potential for varying effects on public health, FDA is
proposing two options for the categories of cigars that would be
covered by this rule. FDA is specifically seeking comment on whether
all cigars should be subject to deeming and what provisions of the
proposed rule may be appropriate or not appropriate for different kinds
of cigars.
    2. FDA is aware that some tobacco products, such as e-cigarettes
and certain cigars, are being marketed with characterizing flavors, and
that these flavors can be especially attractive to youth. The
prohibition against characterizing flavors established in the Tobacco
Control Act applies to cigarettes only. FDA requests comments on the
characteristics or other factors it should consider in determining
whether a particular tobacco product is a ``cigarette'' as defined in
section 900(3) of the FD&C Act and, consequently, subject to the
prohibition against characterizing flavors, despite being labelled as a
little cigar or other non-cigarette tobacco product. FDA is also
seeking research regarding the long-term effects of flavored tobacco
product usage including data as to the likelihood of whether users of
flavored tobacco products initiate cigarette usage and/or become dual
users with cigarettes.
    3. Also as noted in this document, some have advanced views that
certain new tobacco products that are noncombustible (such as e-
cigarettes) may be less hazardous, at least in certain respects, than
combustible products given the carcinogens in smoke and the dangers of
secondhand smoke. FDA also notes the increase in e-cigarette use by
youth and the availability of fruit and candy-flavored e-cigarette
liquid. We do not currently have sufficient data about these products
to determine what effects e-cigarettes have on the public health.
Accordingly, FDA is seeking comment in this proposed rule as to how
such products should be regulated. We particularly request comment on
behavioral data related to co-use of e-cigarettes and more traditional
tobacco products, including data on the effects of e-cigarettes on the
initiation and continuation of use of other tobacco products.
    4. FDA is proposing to deem those products meeting the definition
of ``tobacco product'' in section 201(rr) of the FD&C Act, except the
accessories of proposed deemed tobacco products to be subject to
chapter IX of the FD&C Act. FDA is seeking comment on how its proposal
to exclude accessories from the scope of the deeming rule would impact
the public health. We also ask for comments, including supporting
facts, research, and other evidence, as to whether FDA should define
components and parts of tobacco products and how those items might be
distinguished from accessories of tobacco products.
    5. The statute establishes a ``substantial equivalence'' (SE)
pathway for a new tobacco product to enter the market if it is
substantially equivalent to a ``predicate product,'' meaning a product
commercially marketed in the United States as of February 15, 2007. FDA
is aware of new product category entrants into the market after the
February 15, 2007, reference date and that the SE pathway may not be
available to these newer products. Because this date is written into
the statute, we do not believe that we have the authority to amend it
with respect to e-cigarettes or other products. FDA is proposing to
extend the compliance period for submitting a marketing application
under this pathway to 24 months following the effective date of a final
rule. FDA is also proposing a 24-month compliance period for the
submission of premarket tobacco applications (PMTAs). In addition, we
intend to continue the compliance policy pending review of marketing
applications if those applications are submitted within the 24 months
after the final rule's effective date. FDA is specifically seeking
comment on whether and, if so, how FDA should consider a different
regulatory mechanism for newer proposed deemed tobacco products that
cannot, as a practical matter, use the SE pathway.
    6. FDA recognizes that there may be the potential for varying
levels of harm and negative effects on public health for different
categories of tobacco products. FDA is considering whether it might be
appropriate for the protection of the public health to stagger the
compliance dates for certain provisions for different categories of
products. FDA seeks comment on this issue.
    7. FDA recognizes that some of the proposals in this document might
impose significant costs on certain manufacturers, consistent with
current practice under Federal Trade Commission (FTC) consent decrees
with several large manufacturers, including the requirement to register
and list products and the requirement for cigar manufacturers to
randomly distribute and rotate warning statements on packages and
advertisements, respectively. FDA seeks comment and data on alternative
approaches for manufacturers to satisfy these requirements that would
reduce costs for manufacturers yet would still be appropriate for the
protection of the public health. We request comment on whether and how
we should revise our existing guidance to provide for flexibility in
this area, while still being appropriately protective of the public
health.
    8. Some have advanced views that certain new tobacco products that
are non-combustible (such as e-cigarettes) may be less hazardous, at
least in certain respects, than combustible products given the
carcinogens in smoke and the dangers of secondhand smoke. Nevertheless,
all tobacco products containing nicotine are addictive, and FDA is not
currently aware of any tobacco products that do not contain nicotine.
Thus, FDA is seeking comments, including supporting research, facts,
and other evidence, as to whether all tobacco products should be
required to carry an addiction warning and, if yes, whether different
warnings should be placed on different categories of products.
    9. FDA is not proposing the fifth FTC warning (Tobacco Use
Increases The Risk Of Infertility, Stillbirth And Low Birth Weight),
because although cigarette smoke causes these health effects (and cigar
smoke is similar to cigarette smoke), the Agency is not aware of
studies specifically linking cigars to these reproductive effects. FDA
requests comment on its proposal to require the use of only four of the
five current FTC warnings for cigars.
    10. FDA is proposing that any cigar that is sold in product
packaging bear a health warning that would be randomly displayed and
distributed on cigar product packages and rotated in advertisements. In
addition, FDA is proposing that warnings for cigars sold individually
and not within product

packages all be included on a sign located at the point-of-sale at each
cash register in any retail establishment where such cigars are sold.
FDA requests comment as to whether all cigars sold without product
packaging, including those cigars we refer to as ``premium cigars,''
should be exempt from the warning requirements.
    11. As explained in the Initial Regulatory Flexibility Analysis,
FDA finds that this rule would have a significant economic impact on a
substantial number of small entities. FDA is seeking comments about any
unique challenges faced by small manufacturers of proposed deemed
tobacco products and how they should be addressed.
    12. FDA is also seeking comment on the proposed addictiveness
warning and any potential for consumer confusion, the proposed size of
the health warnings that would be required by this rule, and on the
role that the size of such warnings has in helping to convey consumer
information.
    13. FDA is seeking comment on the relative merits of Option 1
versus Option 2, taking into account what is appropriate for the public
health, including possible benefits to the public health or possible
negative public health consequences of adopting one Option or the
other.
    Effective Dates--The deeming provisions and age restrictions would
be effective 30 days from the date of publication of the final rule.
The proposed health warning requirements would be effective 24 months
after the final rule is issued. In addition, manufacturers could
continue to introduce into domestic commerce existing inventory that
may not contain the warning statements required under the final rule
for an additional 30 days after the health warnings take effect.
    Compliance Dates for PMTAs and SE Reports--As stated previously, we
understand that, for some products, there may not be predicate products
that were on the market as of February 15, 2007, to which to claim
substantial equivalence. This may be particularly true for e-cigarettes
and similar novel products. For this reason, we are proposing that
these manufacturers who cannot use the SE pathway submit PMTAs to FDA
no later than 24 months following the effective date of the final rule.
We are also proposing a 24-month compliance period for the submission
of SE reports. Therefore, FDA does not intend to initiate enforcement
action against products on the market for failing to have made an
appropriate submission until 24 months following the effective date of
the final rule. If a manufacturer submits a PMTA or SE application for
its affected products within the 24-month time frame, FDA does not
intend to initiate action against those products for failing to have a
marketing authorization unless and until such a time as we have
responded to the application.

Costs and Benefits

    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 FD&C Act.
Option 1 also proposes additional provisions that would apply to
proposed deemed products as well as to certain other tobacco products.
The other coproposal, Option 2, is the same as Option 1 except that it
exempts premium cigars. The proposed deeming action directly requires
proposed deemed ``tobacco products'' to comply with the substantive
requirements of chapter IX of the FD&C Act and its implementing
regulations. We expect that asserting our authority over these tobacco
products will enable us to take further regulatory action in the future
as appropriate; those actions will have their own costs and benefits
and would, as is the case with all rulemaking, be subject to notice and
comment.
    The proposed rule would generate some direct benefits by providing
information to consumers about the risks and characteristics of tobacco
products, which may result in consumers reducing their use of cigars
and other tobacco products or engaging in compensatory health
behaviors. Other potential benefits follow from premarket requirements,
which could prevent more harmful products from appearing on the market
and worsening the health effects of tobacco product use. The proposed
rule would impose costs in the form of registration, submission,
labeling, and other requirements; other likely costs are not
quantifiable based on current data. The quantified costs of the
proposed rule are shown in Table 1A.

                                                   Table 1A--Summary of Quantified Costs Over 20 Years
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                                                            Lower bound                     Upper bound     Lower bound                     Upper bound
                                                               (3%)        Primary (3%)        (3%)            (7%)        Primary (7%)        (7%)
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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
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I. Legal Authority

    The Tobacco Control Act was enacted on June 22, 2009, amending the
FD&C Act and providing FDA with the authority to regulate tobacco
products (Pub. L. 111-31). Specifically, section 101(b) of the Tobacco
Control Act amends the FD&C Act by adding a new chapter that provides
FDA with tools to regulate tobacco products. Section 901 of the FD&C
Act (21 U.S.C. 387a), as amended by the Tobacco Control Act, states
that the new chapter in the FD&C Act (Chapter IX--Tobacco Products)
applies ``to all cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco and to any other tobacco products that the
Secretary [of Health and Human Services] by regulation deems to be
subject to this chapter.'' Under the statute, to extend FDA's ``tobacco
product'' authorities to other tobacco products not specifically
enumerated in the statute, FDA must issue a regulation deeming them to
be subject to the FD&C Act. With Option 1 of this proposed rule, FDA is
proposing to deem all products meeting the statutory definition of
``tobacco product'' except accessories of a proposed deemed tobacco
product to be subject to the FD&C Act. Option 2 would propose to deem a
certain subset of cigars, as well as other products meeting the
definition of ``tobacco product,'' but excluding the accessories of a
proposed deemed tobacco product. Section 201(rr) of the FD&C Act, as
amended by the Tobacco Control Act, defines the term ``tobacco
product'' to mean ``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)''
that is not a drug, device, or combination product under the FD&C Act.
This proposed rule would extend FDA's ``tobacco product'' authorities
to products that meet the statutory definition of ``tobacco product''
in section 201(rr) of the FD&C Act (including the components and parts
of a tobacco product), except the accessories of a tobacco product.
    Section 903 of the FD&C Act provides that a tobacco product is
misbranded unless ``the manufacturer, packer, or distributor thereof
includes in all advertisements and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer, or
distributor with respect to that tobacco product--. . . (B) a brief
statement of--(i) the uses of the tobacco product and relevant
warnings, precautions, side effects, and contraindications.'' Under
section 906(d)(1) of the FD&C Act, FDA may require restrictions on the
sale and distribution of a tobacco product, if the Agency determines
that ``such regulation would be appropriate for the protection of the
public health.'' The finding as to whether ``such regulation would be
appropriate for the protection of the public health shall be determined
with respect to the risks and benefits to the population as a whole,
including users and nonusers of the tobacco product, and taking into
account--(A) the increased or decreased likelihood that existing users
of tobacco products will stop using such products; and (B) the
increased or decreased likelihood that those who do not use tobacco
products will start using such products.''
    Based on the available data on the addictiveness of nicotine (as
discussed in section V.A), the known adverse health effects of some of
the products covered by this proposed rule, such as certain cigars and
waterpipes, the likelihood that users of these products could co-use or
migrate to other tobacco products like cigarettes, and the risk that
failure to act will reinforce consumers' existing confusion and
misinformation about these products' safety or lack of harmfulness, FDA
believes that the sale and distribution restrictions the Agency is
proposing--minimum age and identification requirements (including
vending machine requirements) and health warning requirements--meet the
public health standard set forth in section 906(d) of the FD&C Act.
Specifically, FDA has concluded that the restrictions would be
appropriate for the protection of the public health with respect to the
risks and benefits to the population as a whole, including the
increased likelihood that existing users will quit using tobacco
products and the decreased likelihood that new users will initiate
tobacco product use. This determination is made on the basis of several
factors. First, the available data on the addictiveness of nicotine
suggests the adolescent brain is more vulnerable to developing nicotine
dependence than the adult brain, that exposure to substances such as
nicotine can disrupt brain development and have long-term consequences
on executive cognitive function and on the risk of developing a
substance abuse disorder and various mental health problems as an adult
(Ref. 1), and this exposure to nicotine can also have long-term results
on decreasing attention performance and increasing impulsivity which
could promote the maintenance of nicotine use behavior (id.). Second,
some of the products covered by this rule, such as combustible products
like cigars, pipes, and waterpipes, are known causes of adverse health
effects, including certain cancers and heart disease (see section V.B).
Third, there is the potential for users of products covered by this
rule to migrate to cigarettes or other currently regulated products,
and evidence shows extensive co-use. For example, in 2012, 32 percent
of high school tobacco users had smoked cigarettes and cigars in the
past 30 days (Ref. 2). Current cigarette smokers are also more likely
to have been waterpipe and e-cigarette users than non-smokers (Ref. 3).
In 2012, 80.5 percent of current high school e-cigarette users reported
current conventional cigarette smoking (Ref. 4). We believe that if
this rulemaking is finalized, its provisions may lead to a decline in
youth initiation for covered products, such as waterpipes and e-
cigarettes. If use of those products tends to lead to use of
traditional cigarettes, this rule should avert that cigarette usage.
Finally, there is the risk that failure to act will reinforce
consumers' existing confusion and misinformation about these products'
safety or lack of harmfulness.

II. Background for Deeming All Tobacco Products To Be Subject to the
FD&C Act

    Adolescence is the peak time for tobacco product use initiation and
experimentation (Ref. 5). In recent years, new types of tobacco
products, sometimes referred to as ``novel tobacco products,'' have
become an increasing concern to public health due, in part, to their
appeal to youth and young adults. Currently, non-regulated tobacco
products come in many forms, including electronic cigarettes, nicotine
gels, and certain dissolvable tobacco products (i.e., those dissolvable
products that do not currently meet the definition of ``smokeless
tobacco'' in section 900(18) of the FD&C Act (21 U.S.C. 387(18))
because they do not contain cut, ground, powdered, or leaf tobacco and
instead contain nicotine extracted from tobacco). These products are
widely available. Electronic cigarettes (or e-cigarettes), for example,
are widely available in retail outlets such as kiosks in shopping malls
and on the Internet and their online popularity has surpassed that of
snus and nicotine replacement therapies which have been on the market
far longer than e-cigarettes (Refs. 6 and 7).
    Additionally, young adults often mistakenly think non-cigarette
tobacco products are safe alternatives to cigarettes (Ref. 8). Research
has shown that youth are also particularly vulnerable to the appeal of
novel tobacco products (Refs. 9, 10, 11, and 12). Because of their
addictiveness and the marketing and sale of these products (and their
subsequent use by youth), some non-cigarette tobacco products can
introduce youth into a lifetime of addicted tobacco product use and
related harms, including premature death (Refs. 13, 14, 15, and 16).
    Further, many of the products proposed to be covered by this rule
are offered in fruit and candy flavors, such as chocolate and grape
flavors, making them especially attractive to children and young
adults. For example, from 2010 to 2012, one cigar company introduced
grape, white grape, and blueberry flavors to its line of little cigars
and cigarillos (Ref. 17). In 2012, a manufacturer of nicotine solutions
for e-cigarettes introduced Mint Mocha and Spiced Apple Cider flavors
for their e-cigarette solutions (id.).
    The first nationally representative study (derived from more than
4,000 young adults aged 18 to 34) to examine the prevalence of the use
of flavored tobacco products following the 2009 FDA flavor ban in
cigarettes found that 20 percent of tobacco users in the study
currently use a flavored tobacco product (Ref.17). The most common
flavored products include flavored pipe tobacco, little cigars, and
hookah tobacco (id.). Research has shown that flavored product use is
higher among 18-to-24-year-olds than 25-to-34-year-olds, and that sugar
preference is strongest among youth and young adults and declines with
age (id.). Such findings indicate that flavored product use may
influence tobacco-use patterns in young adulthood, a critical period
when

lifelong patterns of tobacco use are often established (Ref. 17 citing
Ref. 18). See section V.A for further discussion regarding the impact
of nicotine on youth and young adults. See also section V.B for a
description of health risks associated with the proposed deemed tobacco
products. Given this initial data regarding the increased prevalence of
flavored tobacco products following the 2009 flavored cigarette ban,
FDA seeks comments, data, and research regarding the following:
     Aside from this proposed rule, what additional actions, if
any, should FDA take to address the sale of candy and/or fruit-flavored
tobacco products to children and young adults? For example, what data
should FDA request manufacturers submit in new tobacco product
applications to establish that flavorants either do not raise different
questions of public health, in the case of SE reports, or are
appropriate for the protection of public health in the case of
premarket tobacco product applications?
     What is the likelihood that individuals who engage in
flavored tobacco product use will initiate cigarette use and/or become
dual users with cigarettes?
     The prohibition against characterizing flavors established
in the Tobacco Control Act applies to cigarettes only. Consequently,
when this regulation is finalized and other tobacco products are deemed
subject to FDA's tobacco product authority, the statutory prohibition
against characterizing flavors will not apply automatically to those
products. However, once they are deemed, FDA may establish a product
standard prohibiting flavors in those products. FDA requests
information and data that would support establishing such a standard.
    FDA is concerned that manufacturers may be labeling, packaging, or
otherwise representing tobacco products that are, in fact, cigarettes
to be little cigars, cigarillos, or similar products in order to evade
the prohibition against characterizing flavors in cigarettes. FDA
requests comments on the characteristics or other factors it should
consider in determining whether a particular tobacco product is a
``cigarette'' as defined in section 900(3) of the FD&C Act and,
consequently, subject to the prohibition against characterizing
flavors, despite being labelled as a little cigar or other non-
cigarette tobacco product.
    Moreover, efforts to improve public health by reducing the
prevalence of cigarette smoking may be undermined by tobacco users
switching to other tobacco products. The scientific evidence remains as
yet unclear what the public health impact will be from products such as
e-cigarettes. More youth who report they would never have used a
tobacco product are experimenting with e-cigarettes (Ref. 4, 18); the
number of cigarette smokers who actually quit tobacco product use with
e-cigarettes is low (Ref. 19); current cigarette users experimenting
with e-cigarettes have become dual users (id.)--with unknown health
impacts. Although the health consequences of e-cigarettes are not well
understood because of their relatively new entrance into the market,
the health concerns and addictive properties of other tobacco products
have been widely recognized in Surgeon General Reports and scientific
literature.
    When similar products are taxed or regulated differently,
substitutions across products occur. For example, industry documents
indicate that tobacco firms have been aware of disparities in the legal
treatment of cigarettes and cigars and have made efforts to develop
small cigars that cigarette smokers would smoke (Refs. 20 and 21).
Sales of small cigars quadrupled in the early 1970s, when cigars were
taxed at a much lower rate than cigarettes and cigarette (but not small
cigar) advertisements were banned from television and radio (Ref.
21).\2\
---------------------------------------------------------------------------

    \2\ FDA notes that taxation falls under the jurisdiction of the
U.S. Department of Treasury/Alcohol and Tobacco Tax and Trade Bureau
(TTB) and that neither FDA's act of ``deeming'' nor any other FDA
regulations directly affect the taxation of any tobacco product.
---------------------------------------------------------------------------

    This substitution is evidenced in the recent trends regarding
cigarette consumption compared to the use of other combustible tobacco
products (e.g., small and large cigars, pipe tobacco, and roll-your-own
tobacco). For example, the Centers for Disease Control and Prevention
(CDC) reported a 32.8 percent decrease in cigarette consumption between
2000 and 2011, while the consumption of non-cigarette combustible
products increased from 15.2 billion ``cigarette equivalents'' (i.e.,
small cigars and large cigars, and per-cigarette equivalents for pipe
tobacco and roll-your-own tobacco) to 33.8 billion--a 123.1 percent
increase over the same time period (Ref. 22). Pipe tobacco consumption
during this period increased 482.1 percent, and consumption of large
cigars increased 233.1 percent (id.). This research suggests that
recent changes in consumption of non-cigarette combustible products,
particularly increases in large cigar and pipe tobacco use, are
associated with a decline in cigarette consumption, and indicate that
certain cigarette smokers may switch to non-cigarette combustible
products (id. at 567). While researchers posited that this change in
prevalence rates is likely due to the lower taxes (and ultimately lower
cost to the consumer) (id. at 566), the lack of regulation over certain
tobacco products may be a contributing factor. Without a common
regulatory framework, tobacco firms can exploit differences in
regulatory requirements to drive consumers to different product
markets.

III. Continuum of Nicotine-Delivering Products

    There are public health questions and concerns about currently
unregulated tobacco products. Nevertheless, there are distinctions in
the hazards presented by various nicotine-delivering products. Some
have advanced views that certain new non-combustible tobacco products
(such as e-cigarettes) may be less hazardous, at least in certain
respects, than combustible products given the carcinogens in smoke and
the dangers of secondhand smoke. To the extent that certain products
are shown to be less harmful, they could help reduce the overall death
and disease toll from tobacco product use at a population level in the
United States. This is a function of the existence of a continuum of
nicotine-delivering products that pose differing levels of risk to the
individual.
    Cigarette smoking is the major contributor to the death and disease
attributable to tobacco use. The challenge for FDA, in considering
currently regulated products and any additional products that would be
deemed to be subject to the FD&C Act, is that regulatory policy under
the Tobacco Control Act must account for the net public health impacts
at the population level. This includes impacts on initiation,
cessation, and an evaluation of product harm.
    Emerging technologies such as the e-cigarette may have the
potential to reduce the death and disease toll from overall tobacco
product use depending on who uses the products and how they are used.
If such products result in minimal initiation by children and
adolescents while significant numbers of smokers quit, then there is a
potential for the net impact at the population level to be positive.
If, on the other hand, there is significant initiation by young people,
minimal quitting, or significant dual use of combustible and non-
combustible products, then the public health impact could be negative.
    FDA is aware that some e-cigarettes (as well as other products that
would be

deemed under this proposed rule) are being marketed with flavors that
may be attractive to young people. FDA asks for comments, data, and
research to determine whether the Agency's evaluation of the relative
risk or potential for harm reduction of such a product should be
different in the presence of flavors in these products, especially if
there is evidence that these flavors make the products more attractive
to children. Because e-cigarettes are not currently subject to FDA
jurisdiction (unless they are marketed for therapeutic purposes), FDA
currently lacks the authority to collect vital information about these
products. Deeming these products would permit us to collect information
about their ingredients to ensure that other potentially harmful
constituents are not present. Deeming would also allow us to collect
information regarding health and behavioral effects of these products.

IV. Deeming Tobacco Products To Be Subject to the FD&C Act

    At this time, based on the statute, cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco are subject to the self-
executing provisions in the Tobacco Control Act, including: (1) General
controls (e.g., registration, product listing, ingredient listing, user
fees for certain products, and adulteration and misbranding provisions)
and (2) premarket review requirements for certain products. See, e.g.,
sections 902 (adulteration provisions), 903 (misbranding provisions),
904 (ingredient listing), 905 (registration and product listing), 910
(premarket review for ``new'' ``tobacco products''), 911 (premarket
review for ``modified risk tobacco products''), and 919 (user fees) of
the FD&C Act (21 U.S.C. 387b, 387c, 387d, 387e, 387j, 387k, and 387s).
This proposed rule would apply these FD&C Act provisions that are
currently applicable to cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco to other tobacco products meeting the
statutory definition of tobacco product. Option 1 would apply this
proposed rule to all products meeting the statutory definition of
``tobacco product,'' except accessories of a proposed deemed tobacco
product, to be subject to the FD&C Act. Option 2 would propose to deem
a certain subset of cigars (not including premium cigars), as well as
other products meeting the definition of ``tobacco product,'' but
excluding the accessories of a proposed deemed tobacco product. These
two options, as well as FDA's definition of a ``covered cigar,'' are
further discussed in section IV.C. FDA requests comments, data, and
research as to which option should be utilized for the scope of this
rule and, if Option 2 is selected as the scope of the final rule, the
appropriateness of the definition of ``covered cigar.''

A. Public Health Benefits of Deeming

    Deeming ``tobacco products'' (except accessories) to be subject to
the FD&C Act would result in significant benefits for the public
health. Once deemed, tobacco products become subject to the FD&C Act
and its implementing regulations, affording FDA additional tools to use
to reduce the number of illnesses and premature deaths associated with
the use of tobacco products. For example, it would provide FDA with
critical information regarding the health risks of the proposed deemed
tobacco products including information derived from ingredient listing
submissions and reporting of hazardous and potentially hazardous
constituents required under the FD&C Act. Deeming would provide FDA
with information on the location and number of regulated entities and
allow the Agency to establish effective compliance programs. Deeming
also would help to correct consumer misperceptions, due to variations
in the regulatory status of tobacco products, that tobacco products not
currently regulated by FDA are safe alternatives to currently regulated
tobacco products (see section V.C). In addition, it would reduce the
use of misleading claims on the products to allow for better-informed
decision-making by consumers and would prohibit these products from
being targeted to youth populations. It would prevent new products from
entering the market that are not appropriate for the protection of
public health or are not substantially equivalent to a predicate
product already on the market. Newly deemed tobacco products also may
be subject to future regulations if FDA determines that such regulation
would be appropriate for the protection of the public health (section
906(d) of the FD&C Act).
    The following public health benefits would result directly from the
deeming provisions of this proposed rule:
     Adulteration and misbranding prohibited for all tobacco
products (section 902 and 903 of the FD&C Act): Applying sections 902
and 903 of the FD&C Act would ensure that every tobacco product meets
the same basic requirements and ensure that the labeling of such
products is not false or misleading. FDA would be able to take
enforcement action against any tobacco products that did not meet these
basic standards. For example, if a product was produced in insanitary
conditions or was contaminated, or if its labeling contained a
misleading claim, it would be subject to FDA enforcement action,
including seizure or injunction.
     Requirement for ingredient listing and reporting of HPHCs
for all tobacco products (section 904 of the FD&C Act): Under this
requirement, manufacturers and importers of all tobacco products would
provide ingredient listings and reporting of HPHCs to FDA. FDA would be
able to take enforcement action with respect to those tobacco products
for which an ingredient listing or report of HPHCs was not provided.
Ingredient listings and reports of HPHCs would assist FDA in better
understanding the contents of regulated products and their health
consequences. That information would assist FDA in assessing potential
health risks and determining if future regulations to address the
health risks posed by particular products are warranted. However, FDA
recognizes that it could be difficult for manufacturers of certain
proposed deemed products (e.g., small businesses) to fulfill these
requirements. Accordingly, FDA requests comments as to whether smaller
manufacturers may be unable to satisfy these requirements and how FDA
might be able to address those manufacturers' concerns.
     Requirement for registration and product listing (section
905 of the FD&C Act): With application of this requirement, FDA would
require registration of all tobacco product manufacturing
establishments and product listings for all tobacco products. FDA would
be able to conduct more efficient inspections and bring enforcement
action, if necessary, against a tobacco firm not in compliance with the
requirements of the Tobacco Control Act. While this requirement would
provide FDA with critical information, the Agency also recognizes that
it could be costly for certain manufacturers of proposed deemed
products. Therefore, FDA requests comment and data on possible ways to
implement this requirement (e.g., delaying compliance with this
provision) that would reduce costs for manufacturers yet still be
appropriate for the protection of public health.
     Review of premarket applications and SE reports (section
905 and 910 of the FD&C Act): With the SE pathway, FDA can evaluate
whether a new product raises different questions of public health
compared to its predicate product. Through the premarket application
pathway, FDA could authorize the introduction of products into the
market where appropriate for

the protection of public health and prevent introduction of products
that are detrimental to the public health.
    Implementation of these proposed provisions would allow FDA to
monitor product development and changes and to prevent more harmful or
addictive products from reaching the market. The proposed provisions
would also provide a mechanism through which those products that are
less harmful or addictive could enter the market. The greater
regulatory certainty created by premarket authorizations should help
companies to invest in creating novel products, with greater confidence
that improved products will enter the market without having to compete
against equally novel, but more dangerous products. For example, a
company wishing to invest the additional resources needed to ensure
that its e-cigarette is designed and manufactured with appropriate
methods and controls will be more likely to do so if the product is not
competing against products that are more cheaply and crudely made, yet
appear to be identical to the consumer. FDA, through its authorities to
authorize and deny the introduction of new products, can help reduce
tobacco-related morbidity and mortality. Over time, the employment of
the premarket authorities can spur innovation and help to create a
market where available products are less dangerous when consumed, less
likely to lead to initiation of tobacco use, and/or easier to quit.
    Further, FDA's premarket review of the proposed deemed products
will increase product consistency. For example, FDA's oversight of the
constituents of e-cigarettes cartridges would help to ensure quality
control relative to the chemicals and their quantities being
aerosolized and inhaled. At present, there is significant variability
in the concentration of chemicals amongst products--including
variability between labeled content and concentration and actual
content and concentration. The health consequences of these products
are still largely unknown and the popularity of these products is
growing exponentially (Refs. 23, 24, and 25). Without a regulatory
framework, users who expect consistency in these products may instead
be subject to significant variability in nicotine content among
products, raising potential public health and safety issues.
     Elimination of ``light,'' ``low,'' and ``mild''
descriptors and other unproven modified risk claims (section 911 of the
FD&C Act): Applying this requirement to proposed deemed products would
help reduce consumer confusion and misconceptions about such products.
Congress has concluded that the health dangers of tobacco products
marketed as modified risk tobacco products that ``do not in fact reduce
risk'' are ``so high'' that FDA's premarket review is necessary to
protect public health and ensure that such products will reduce health
risks (section 2(39), (40), and (43) of the Tobacco Control Act). Given
that certain users have initiated and continued using certain tobacco
products rather than others (or quitting entirely) based on unproven
modified risk claims and consumers' unsubstantiated beliefs that some
tobacco products are less hazardous than others, this requirement could
lead to increased cessation and reduced initiation.
     Prohibition of free samples of the proposed deemed
products (section 102 of the Tobacco Control Act): This prohibition
would eliminate a pathway for youth to access tobacco products,
reducing youth initiation and therefore short-term and long-term
morbidity and mortality resulting from these products. The Institute of
Medicine (IOM) has stated that free samples of cigarettes ``encourage
experimentation by minors with a risk free and cost-free way to satisfy
their curiosity'' (Ref. 26). While the IOM was speaking in the context
of cigarettes, the same rationale would apply to the proposed deemed
products. In addition, the United States Court of Appeals for the Sixth
Circuit previously recognized that FDA has provided ``extensive''
evidence that free tobacco samples constitute an ``easily accessible
source'' for youth (Discount Tobacco City & Lottery, Inc. v. United
States, 674 F.3d 509, 541 (6th Cir. 2012) (citing 61 FR 44396 at 44460,
August 28, 1996), cert. denied, 133 S. Ct. 1966 (2013)). FDA requests
comments and data showing the extent to which this restriction would
reduce youth use of the proposed deemed products.
     Authority to propose product standards for proposed deemed
tobacco products (section 907 of the FD&C Act (21 U.S.C. 387g)): If
products meeting the definition of tobacco products are deemed to be
subject to the tobacco authorities in the FD&C Act, FDA would have the
authority to propose product standards that would apply to proposed
deemed tobacco products, if such standards were appropriate for the
protection of public health. For example, FDA could issue a standard
regarding additives, constituents, or other components of a proposed
deemed tobacco product under section 907 of the FD&C Act. This would
help to ensure that tobacco products meet standards that are
appropriate for the protection of the public health.

B. The Sottera Decision

    In 2008 and early 2009, FDA detained several shipments of
electronic cigarettes and their accessories offered for import by
Smoking Everywhere and Sottera, Inc. (doing business as NJOY) and
eventually refused admission into the United States to two of Smoking
Everywhere's shipments on the ground that the products appeared to be
unapproved drug/device combination products. Smoking Everywhere--
subsequently joined by Sottera, Inc.--sued the Agency and argued, among
other things, that the Supreme Court's decision in Food & Drug
Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000)
foreclosed regulation of electronic cigarettes under the drug and
device provisions of the FD&C Act unless the products were intended for
therapeutic use. The district court agreed and issued a preliminary
injunction. (See Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62
(D.D.C. 2010).) The government appealed this decision to the United
States Court of Appeals for the D.C. Circuit.
    On December 7, 2010, the D.C. Circuit affirmed the preliminary
injunction, holding that products meeting the FD&C Act's definition of
``tobacco product,'' including electronic cigarettes, are ``drugs''
and/or ``devices'' under the FD&C Act if they are ``marketed for
therapeutic purposes,'' whereas ``customarily marketed tobacco
products'' are ``tobacco products'' under the Tobacco Control Act. (See
Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir.
2010).) On January 24, 2011, the D.C. Circuit denied the government's
petitions for rehearing and rehearing en banc (by the full court). (See
Sottera, Inc. v. FDA, No. 10-5032 (D.C. Cir. Jan. 24, 2011) (per
curiam).) This case affirms that FDA cannot regulate ``customarily
marketed'' tobacco products, including pipe tobacco, small and large
cigars, e-cigarettes, and hookah tobacco, until a regulation that deems
them to be subject to the FD&C Act is finalized.
    On April 25, 2011, FDA issued a letter to stakeholders announcing
that the government had decided not to seek further review of the
Sottera decision and that it would comply with the jurisdictional lines
established by Sottera (see Ref. 27). The Agency noted that the Tobacco
Control Act places certain ``tobacco products'' (i.e., cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco)
immediately under the general controls

and premarket review requirements of the FD&C Act (see section 901(b)
of the FD&C Act). The Tobacco Control Act also permits FDA, by
regulation, to extend those controls to other categories of ``tobacco
products'' (id.). Further, the stakeholder letter announced FDA's
intention to propose a regulation that would extend the Agency's
``tobacco product'' authorities in the FD&C Act to other categories of
tobacco products that meet the statutory definition of ``tobacco
product'' in section 201(rr) of the FD&C Act.

C. Options for Premium Cigars and Request for Comments Regarding Scope

    As discussed in sections V and VI, although all cigars are harmful
and potentially addictive, it has been suggested that different kinds
of cigars (e.g., small cigars, cigarillos, large cigars, premium
cigars) may have the potential for varying effects on public health, if
there are differences in their effects on youth initiation, the
frequency of their use by youth and young adults, and other factors. In
addition, the proportion of cigar smokers showing clear signs of
dependence remains unknown, and usage patterns indicate that cigar only
use beginning in adulthood is less likely to produce addiction than the
use of cigarettes. Thus, by proposing two options for the scope of this
rule, FDA is seeking comment on whether all cigars should be subject to
deeming and what additional restriction(s) may or may not be
appropriate for different kinds of cigars. In particular, FDA is
seeking comment on the relative merits of Option 1 versus Option 2,
taking into account what is appropriate to protect the public health,
including possible benefits to the public health or possible negative
public health consequences of adopting one Option or the other.
    Under Option 1, the proposed rule would extend FDA's authority to
all products meeting the definition of ``tobacco product,'' except the
accessories of such products. (See section IV.E for more information
regarding FDA's proposal not to include accessories in the scope of
this rule). This scope would include all cigars, including small,
large, and premium cigars. FDA considers a cigar to be 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. (See 26
U.S.C. 5702(a)).
    Under Option 2, the proposed rule would extend FDA's authority to a
subset of cigars (defined as ``covered cigars'') and to other products
meeting the definition of ``tobacco product,'' except the accessories
of such products. In order to define the products that would be subject
to this approach, FDA would propose to define a covered cigar to mean:
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.
    While FDA is proposing this second option to possibly define a
subset of cigars and provide a separate regulatory regime for them, FDA
may determine that it is most appropriate to include elements of both
options in any final rule. For example, FDA may decide to deem all
cigars subject to the tobacco product authorities in Chapter IX of the
FD&C Act but may impose different additional restrictions for a certain
subset of those cigars. We ask for comments, including supporting
facts, research, and other evidence, on the following questions
regarding this issue:
     Is this proposed definition of ``covered cigar''
appropriate to capture those products that, because of how they are
used, may have less of a public health impact than other types of
cigars?
     Should long filler tobacco content be included as one of
required elements of a ``premium'' cigar (excluded from the definition
of a ``covered cigar'')? If so, what percentage of the tobacco
contained in the cigar should be required to be long filler tobacco in
order for the cigar to be considered ``premium''?
     Is it appropriate to include the $10 price point in
differentiating ``premium'' cigars from other cigars? Please provide
any data or information that supports the selection of a $10 price
point or, if you believe a different price point is more appropriate,
that supports the selection of that price point.
     Should a volume/rate restriction (e.g., ``is produced at a
rate of no more than [insert number] units per minute'') be included as
one of required elements of a ``premium'' cigar (excluded from the
definition of a ``covered cigar'')? If we were to include this
restriction, what should the rate be? How would FDA determine
compliance with such a restriction?
     Is it appropriate to include the proposed weight
restriction (6 pounds per 1000 units) in differentiating ``premium''
cigars from other cigars?
     Would a different regulatory scheme for covered cigars, as
defined here, or other category of cigars adequately address the
dangers of tobacco use by adults or the proven dangers associated with
use of cigars (such as increased risk of several cancers even among
those users who do not inhale, and risk associated with lower levels of
use as discussed in section VII)?
     How should the fact that studies indicate that young
adults likely prefer cigarillos, as opposed to traditional large
cigars, affect FDA's decision about whether to regulate ``premium''
cigars?
    Although the Agency is proposing a definition with respect to
Option 2, FDA remains concerned that any attempts to create a subset of
premium cigars that are excluded from regulatory authority might sweep
other cigar products under its umbrella. Therefore, we ask for any
comment as to how FDA could further refine this definition, within the
context of Option 2, to ensure that the exclusion would apply only to
those cigars that, because of how they are used, may have less of a
public health impact than other types of cigars.
1. Option 1: Do Not Restrict Categories of Cigars
    Under Option 1, FDA would not restrict the categories of cigars
that fall under the umbrella of deeming and the additional provisions
proposed here (i.e., minimum age and identification; vending machine
restrictions; and health warning requirements). Therefore, small,
large, and premium cigars would all be subject to FDA's tobacco product
authorities under this option.
    As FDA has explained throughout the rule, all cigars are harmful
and potentially addictive (including small cigars, cigarillos, large
cigars, and premium cigars). Cigar smoking is strongly related to
certain cancers (including oral, esophageal, laryngeal, and lung
cancers), heart disease, and premature death (Refs. 28 and 30). Cigar
smoking can cause cancers of the mouth and throat even for smokers who
do not inhale (Ref. 28 at 120-130). As a result, cigar smokers who do
not inhale have disease risks higher than those who have never smoked,
including a 7 to 10 times higher overall risk of mouth and throat
cancer (Ref. 28 at ii, 125). This similarity in risk is likely due to
the similar doses of tobacco delivered directly to the oral cavity and
esophagus by cigars and cigarettes (Ref. 30 at 738).

In addition, cigar smokers, regardless of whether they inhale, receive
a high smoke exposure to the mouth and tongue. The esophagus is exposed
to the carcinogens of tobacco smoke, which collect on the mouth's
surface and are swallowed with saliva, rendering cigar smoking a cause
of esophageal cancer (Ref. 28 at 130). See section VII.E for further
discussion of the dangerous health risks associated with cigar smoking,
including data regarding risks of additional cancers and disease.
    Cigar tobacco contains nicotine in concentrations similar to those
observed in cigarettes; however, given that most cigars contain more
tobacco, many typically contain greater quantities of nicotine than
cigarettes (Ref. 28 at 81). A large cigar may contain as much tobacco
as a whole pack of cigarettes (Refs. 30 and 31). Nicotine levels in
cigar smoke can be up to 8 times higher than levels in cigarette
smoke--1.7 mg in nonfiltered cigarettes, 1.1 mg in filtered cigarettes,
3.8 mg in little cigars, 9.8 mg in cigars, and 13.3 mg in premium
cigars (Ref. 28 at 67). Even cigar smokers who do not inhale can become
addicted to the product given the absorption of nicotine through the
buccal mucosa (Ref. 28 at 183-184).
    Regardless of whether large cigar and pipe smokers inhale, smoke
particles are deposited into the lungs and stomach area (Ref. 32). All
cigars, regardless of size, produce higher levels of carcinogenic
tobacco-specific nitrosamines per gram in mainstream cigar smoke than
cigarettes produce in mainstream cigarette smoke (Ref. 28 at 75-76). A
large cigar may contain as much tobacco as a whole pack of cigarettes
(Refs. 30 and 31). Cigar smoke also produces measurable amounts of lead
and cadmium (Ref. 28 at 75-76), and the concentrations of some toxic
and carcinogenic compounds are higher in cigar smoke than in cigarettes
(Ref. 33). The National Cancer Institute (NCI) found that ``cigar smoke
is as, or more, toxic and carcinogenic than cigarette smoke; and
differences in disease risks produced by using cigarettes and cigars
relate more to differences in patterns of use, and differences in
inhalation, deposition and retention of cigar smoke than to differences
in smoke composition'' (Ref. 28 at 3).
    Furthermore, a recent analysis of cigar use by young adults (aged
18 to 29) was presented at the meeting of the Society for Research on
Nicotine and Tobacco providing preliminary confirmation that young
adults do use premium cigars. This analysis was derived from data from
the National Adult Tobacco Survey, a nationally representative survey
conducted by the Centers for Disease Control and Prevention (CDC). The
analysis shows that the percentage of young adults reporting current
premium cigar use (15.1 percent) was just as high as the percent
reporting current use of little filtered cigars (11.9 percent) (Ref.
34). Although the patterns of use may be quite different, this analysis
shows that current premium cigar use is being reported by young adults
and that such use is not restricted to older adults. In addition, among
all young adults aged 18 to 29, 2.5 percent reported current use of
premium cigars, compared with 1.7 percent among those aged 30 to 44,
1.2 percent among those aged 45 to 64, and 0.4 percent among those aged
65 and over (id.). Given that this analysis has not yet been included
in a peer reviewed journal, FDA is including this analysis in the
docket and specifically requests comment on it.
    Under this option, FDA is proposing that all cigars be treated in a
similar manner and that they all be deemed to be subject to FDA's
authorities in the FD&C Act as well as the additional provisions
proposed under this rule.
2. Option 2: Restrict Rule to Covered Cigars
    FDA has heard from numerous interested parties, including
manufacturers and retailers of premium cigars, on issues related to how
premium cigars should be regulated. Some have contended that usage
patterns of certain types of cigars (typically known as premium cigars)
can vary dramatically from usage patterns of other cigars. They claim
that the premium cigars category includes cigars that are used on
celebratory occasions only a few times per year. In order to evaluate
this contention and determine the proper scope for this rule, FDA has
attempted to define the category of premium cigars by defining
``covered cigar'' and excluding what might be considered ``premium
cigars'' from that definition. As stated throughout this section, FDA
requests comment on its proposed definition of a ``covered cigar.''
    Although FDA recognizes that all cigars are potentially addictive,
the ability of cigars to deliver nicotine at a level capable of
producing dependence is based on the degree of cigar smoke inhalation,
the rate of oral nicotine absorption, the development of tolerance to
nicotine, the age of initiation, and the duration of exposure (Ref. 28
at 183). The proportion of cigar smokers showing clear signs of
dependence also remains unknown (Ref. 28 at 189). Some members of
industry have noted that these factors suggest that those who smoke
certain types of cigars are not addicted to them.
    In addition, as explained in section VII.D, young adults appear to
be particularly interested in cigarillos, rather than large cigars. It
has been suggested that adolescents are not attracted to large and
premium cigars, because they are offered for sale at a much higher cost
relative to other types of tobacco products and are more difficult to
access (e.g., large and premium cigars are typically sold at
tobacconists' shops versus convenience stores). This is supported by
the study of youth use of cigars by the Office of Inspector General for
the Department of Health and Human Services which states that
``[m]anufactured cigars, rather than premium cigars, are most commonly
used by teens due to their ease of purchase, low cost . . . .'' (Ref.
35). Some industry representatives have stated that there is ``no
evidence to suggest that premium cigar use is increasing among youths''
(FDA-2011-P-0623). They also question whether adolescents use cigars,
citing to the NCI Monograph No. 9, which states that ``[f]ew surveys
have questioned cigar smokers about the quantity and type of cigars
typically consumed'' (Ref. 28).
    The International Premium Cigar and Pipe Retailers Association
(IPCPRA), in its citizen petition seeking to exempt large and premium
cigars from FDA regulation, acknowledged that a premium, hand-rolled
cigar may be a ``tobacco product'' under the Act, but ``there is no
evidence to suggest that it carries anywhere near the public health
risks of a cigarette.'' (FDA-2011-P-0623). Therefore, they claim that
premium cigars are not a public health problem requiring FDA
regulation.
    To support this argument, the IPCPRA notes that NCI has remarked
about the dose-response relationship between the numbers of cigars
smoked and the risk of disease, stating that ``as many as three-
quarters of cigar smokers smoke only occasionally . . . [and t]his
difference in frequency of exposure translates into lower disease].''
(id.). In addition, they note that the health risk tables in NCI's
Monograph No. 9 refer to those who smoke 1-2 cigars per day and,
therefore, the NCI Monograph does not even provide health risk data for
the 75 percent majority of smokers who NCI identifies as ``occasional''
cigar smokers. They also state that ``smokers of 1-2 cigars per day are
at no greater risk statistically . . . for risk of numerous cancers,
coronary heart disease, chronic obstructive pulmonary disease (COPD),
and cerebrovascular disease.'' (FDA-2011-P-0623). Moreover, given the
difference in inhalation patterns

between cigarettes and cigars smokers noted by NCI, the IPCPRA claimed
that the vast majority of premium cigar smokers are occasional users
who do not inhale and, therefore, there would be little public health
benefit if FDA were to regulate premium cigars. FDA requests any
comments, data, and information regarding IPCPRA's analysis of this NCI
data or other data related to disease risk, nicotine addiction, and how
premium cigars are used.

D. Request for Comments Regarding Regulation of E-Cigarettes

    FDA realizes that while all tobacco products are potentially
harmful and potentially addictive, different categories of tobacco
products may have the potential for varying effects on public health.
For example, some have advanced views that certain new non-combustible
tobacco products (such as e-cigarettes) may be less hazardous, at least
in certain respects, than combustible products given the carcinogens in
smoke and the dangers of secondhand smoke.
    FDA is aware of the recent significant increase in the prevalence
of e-cigarette use and continues to research how e-cigarette use is
impacting the public health. In a computer-based mail-in survey of more
than 10,000 U.S. adults, the prevalence of those who had ever used e-
cigarettes (referred to as ``ever use'') quadrupled from 2009 to 2010
(Ref. 25). In 2011, 6.2 percent of all adults and 21.2 percent of
current smokers had ever used e-cigarettes, representing an almost two-
fold increase from 2010 estimates (Ref. 24). Data from Wave 8 of the
International Tobacco Control (ITC) Four-Country Survey (collected from
July 2010 to July 2011) indicated that 20.4 percent of those aware of
e-cigarettes had reported trying the product (Ref. 36).
    The numbers of individuals that have tried e-cigarettes in the
previous 30 days also are indicative of the recent popularity of these
products. An analysis of data from a nationally representative online
study found that 3.4 percent of the general population had ever used e-
cigarettes and 35.9 percent of the group that had used the products had
used them within the previous 30-day period (Ref. 23). In addition,
according to the 2011 and 2012 National Youth Tobacco Survey given to
middle and high school students, e-cigarette use more than doubled,
rising from 3.3 percent to 6.8 percent over these 2 years, including an
increase of concurrent cigarette and e-cigarette use from 0.8 percent
to 1.6 percent--a statistically significant increase (Refs. 4, 37). A
study of 4,444 students from 8 colleges also found that 4.9 percent of
students had ever used e-cigarettes, and 1.5 percent reported use in
the past 30 days (Ref. 38).
    We do not currently have sufficient data about e-cigarettes and
similar products to determine what effects they have on the public
health. Nevertheless, several recent studies of limited numbers of
users suggest that e-cigarettes may have the potential to help smokers,
particularly those who have had limited success with currently approved
cessation programs (Refs. 39, 40, 41, 42, and 43). There is no evidence
to date that e-cigarettes are effective cessation devices. For example,
one trial examining cessation success between e-cigarettes, nicotine
replacement patches, and placebos found that ``[a]chievement of
abstinence was substantially lower than we anticipated.'' (Ref. 19).
This study demonstrated cessation in 21 of 289 smokers (7.3 percent)
versus 17 of 295 (5.8 percent) with nicotine patches. However, none of
these results reached statistical significance (Ref. 19).\3\ In
addition, several large studies appear to raise questions as to whether
e-cigarettes are effective cessation aids in real-world use. In a
nationally representative survey of 1,836 current or recently former
adult smokers, researchers found that, compared with smokers who had
never tried to quit, ever-use of e-cigarettes was not associated with
successful quit attempts, but was associated with unsuccessful quit
attempts (Ref. 44). In another study that analyzed data from 2,758
callers to 6 state tobacco quitlines, e-cigarette users were
significantly less likely to be tobacco abstinent at 7 months than
participants who had never tried e-cigarettes (Ref. 45).
---------------------------------------------------------------------------

    \3\ The observed p-value for cessation with e-cigarettes versus
nicotine patches was p=0.46, and the observed p-value for cessation
with e-cigarettes versus placebo was p=0.44 (Ref. 19).
---------------------------------------------------------------------------

    Some studies on very small numbers of subjects have found that e-
cigarettes may have the potential to help with cessation by delivering
a sufficient nicotine dose, particularly for experienced e-cigarette
users (Refs. 39, 40, 41, 42, 43, and 46). Other studies have suggested
that the sensory aspects associated with e-cigarettes may also have the
potential to provide some short-term smoking reduction benefits. For
example, in the study of 25 smokers utilizing e-cigarettes to address
the short-term potential for smoking reduction, researchers found
promising results but indicated that such ``results are not predictive
of long-term reduction or quitting'' (Ref. 39). This study found that
in smokers who had utilized e-cigarettes for 1 week, 10 puffs from the
e-cigarette over a 4.5-minute period resulted in acute increases in
plasma nicotine and heart rate and a median 55 percent reduction in
craving (id.). In addition, the study noted a considerable individual
variation in smoking topography and found that whether a user can
obtain a sufficient nicotine dose depends on whether he or she is an
experienced user (id.). Even though there is no evidence to date of a
long-term cessation benefit, some researchers believe that e-cigarettes
are at least capable of suppressing the urge to smoke (Ref. 41).
Separately, although this is unrelated to smoking reduction, some
researchers have stated that substituting e-cigarettes for tobacco
cigarettes ``may substantially reduce exposure to tobacco-specific
toxicants'' (Ref. 47).
    Although e-cigarettes may have short-term smoking reduction
benefits, FDA cautions that long-term studies are not available to
conclude that e-cigarettes are a proven cessation product nor to
establish what effects e-cigarettes have in users who might have
otherwise quit, but instead engage in dual use of e-cigarettes and
another tobacco product. There also is very limited information
currently available on the positive and negative subjective effects,
including craving and withdrawal, and the topography of e-cigarettes.
FDA believes it is important to evaluate e-cigarettes based on their
individual characteristics and their influence on behaviors in order to
learn more about the potential benefits and drawbacks of the products.
FDA will continue to analyze the potential benefits and harms of e-
cigarettes, as well as their impact on nonusers and the population
level as a whole, if the deeming rule is finalized. Thus, FDA is
seeking comments, including supporting research, facts, and other
evidence, as to how e-cigarettes should be regulated based on the
continuum of nicotine-delivering products (as discussed in section III)
and the potential benefits associated with e-cigarettes. Without more
data, it is not possible to know the impact of these products either on
reducing usage of cigarettes or in possibly prolonging usage of
cigarettes while continuing to expose users to the harmful carcinogens
in combustible tobacco products (Ref. 23).

E. Request for Comments Regarding Components, Parts, and Accessories

    FDA asks for comments, including supporting facts, research, and
other evidence, as to whether FDA should define components and parts of
tobacco

products and how those items might be distinguished from accessories of
tobacco products. As stated throughout this document, the FD&C Act
defines ``tobacco product'' to include the components, parts, and
accessories of such tobacco products (section 201(rr) of the FD&C Act).
At this time, FDA is proposing to deem those products meeting the
definition of tobacco product, except the accessories of proposed
deemed products, to be subject to its tobacco control authorities.
Therefore, components and parts of the proposed deemed tobacco products
would fall under the scope of this rule, but accessories would not. We
are proposing to include components and parts within the scope of this
proposed rule, because they are included as part of a finished tobacco
product or intended for consumer use in the consumption of a tobacco
product. However, because accessories are not expected to be used in
the consumption of a tobacco product, we expect that accessories will
have little impact on the public health. FDA is seeking comment on its
proposal to exclude accessories from the scope of the deeming rule.
    FDA believes that components and parts of tobacco products are
those items that are included as part of a finished tobacco product or
intended or expected to be used by consumers in the consumption of a
tobacco product. Components and parts that would be covered under this
proposal include those items sold separately or as part of kits sold or
distributed for consumer use or further manufacturing or included as
part of a finished tobacco product. Such examples would include air/
smoke filters, tubes, papers, pouches, or flavorings used for any of
the proposed deemed tobacco products (such as flavored hookah charcoals
and hookah flavor enhancers) or cartridges for e-cigarettes. In
addition, FDA considers accessories to be those items that are not
included as part of a finished tobacco product or intended or expected
to be used by consumers in the consumption of a tobacco product, but
may be used, for example, in the storage or personal possession of a
proposed deemed product. Therefore, items such as hookah tongs, hookah
bags and cases, hookah charcoal burners and holders, cigar foil
cutters, humidors, or cigar carriers would be considered accessories
and would not fall within the scope of this proposed rule.
    At this time, FDA is not proposing definitions for components,
parts, or accessories. If FDA were to develop definitions of these
categories of products, the definitions likely would include factors
such as whether these items are directly involved in the consumption,
storage, or personal possession of tobacco products. These definitions
also likely would take into account the foreseeable effect on public
health of these items and whether a tobacco product can effectively be
consumed without such items. If you believe FDA should define these
terms, we seek comment on how to define the categories of
``components,'' ``parts,'' and ``accessories.'' We also ask for
comments on whether and how the use of certain components, parts, or
accessories might be used to alter the effects of the tobacco product
on public health, the constituents delivered by the product, or the
potential initiation of new tobacco users.

V. Basis for Additional Provisions

    Substantial research informs the Agency's view that the access
provisions proposed as part of this rule (e.g., age restrictions under
18; prohibition on vending machines) are effective in reducing
initiation of cigarette and smokeless tobacco use, increasing cessation
of cigarette and smokeless tobacco use, and otherwise reducing
cigarette and smokeless tobacco product use among youth and adults. The
research also reflects that health warnings on packages and
advertisements effectively help consumers to understand and appreciate
the health risks of tobacco use. Because historically most tobacco
users in the United States have smoked cigarettes or used smokeless
tobacco (Ref. 28), tobacco product use research and tobacco control
efforts thus far have focused primarily on these products (Ref. 29) and
not on many of the tobacco products, particularly novel products like
certain dissolvables and gels, covered by this proposed rule (Ref. 48).
Research findings regarding the use of cigarettes and smokeless tobacco
products, including research regarding restrictions on those products
that are identical to the restrictions proposed on products subject to
deeming in this rule, also support FDA's proposed action here. FDA's
reliance on these data is appropriate because of the addictive nature
of tobacco products in general and the similar well-documented risks of
several other tobacco products subject to this rule. In addition,
consumer confusion and misinformation, reflected in mistaken beliefs
that non-cigarette tobacco products are safe alternatives to
cigarettes, also support the Agency's determination that the proposed
restrictions are appropriate for the protection of the public health.

A. Addictive Nature of Products

    The Surgeon General has long recognized the addictive nature of
tobacco products due to the presence of highly addictive nicotine that
can be absorbed into the bloodstream (see, e.g., Ref. 49 at 6-9). While
the amount of nicotine delivered and the means through which it is
delivered can either reduce or enhance the nicotine's potential for
abuse and physiological effects (Ref. 50 at 113), nicotine is addictive
(as discussed in section V.A), and FDA believes that all tobacco
products currently available contain nicotine (Ref. 49). The quicker
the delivery, rate of absorption, and attainment of high concentrations
of nicotine, the greater the potential for addiction (Ref. 50 at 113).
At the same time, the ultimate levels of nicotine absorbed into the
blood from tobacco products currently on the market can be similar in
magnitude regardless of the product forms used to deliver nicotine
(Ref. 49). For example, research has shown that oral use of smokeless
tobacco products that do not emit smoke results in ``high venous
concentrations of nicotine equal to those for use of cigarettes'' (Ref.
50 at 113).
1. Impact of Nicotine on Youth and Young Adults
    Adolescence is when most tobacco users begin to develop their
behavior (Ref. 51 at 5, 58, 65-67). If individuals do not start using
cigarettes during childhood or adolescence, they are unlikely ever to
smoke (id.). Research shows that more than 80 percent of established
adult smokers began smoking before the age of 18 (Ref. 52). An analysis
by the World Health Organization (WHO) of studies performed among
final-year high school students in the United States suggests that
fewer than two out of five smokers who believe that they will quit
within 5 years actually do quit. In high-income countries, about 7 out
of 10 adult smokers say they regret initiating smoking and would like
to stop (Ref. 53 at 2). When tobacco product use persists into
adulthood, the risk of long-term, severe health consequences (such as
cancer, heart disease, lung disease, and other serious medical
conditions) increases as duration of use increases (Ref. 50).
    In addition, there are data suggesting that the adolescent brain is
more vulnerable to developing nicotine dependence than the adult brain.
There is also evidence to suggest that these brain changes are
permanent (Refs. 54 and 55). The Surgeon General reported that ``most
people begin to smoke in

adolescence and develop characteristic patterns of nicotine dependence
before adulthood'' (Ref. 51 at 29). These youth develop physical
dependence and experience withdrawal symptoms when they try to quit
smoking (id.). As a result, addiction to nicotine is often lifelong
(Ref. 56). Youth and young adults generally ``underestimate the
tenacity of nicotine addiction and overestimate their ability to stop
smoking when they choose'' (Ref. 57). For example, one survey revealed
that ``nearly 60 percent of adolescents believe that they could smoke
for a few years and then quit'' (Ref. 58).
    Moreover, exposure to substances such as nicotine can disrupt brain
development and have long-term consequences on executive cognitive
function (such as task-switching and planning) and on the risk of
developing a substance abuse disorder and various mental health
problems (particularly affective disorders such as anxiety and
depression) as an adult (Ref. 1). This exposure to nicotine can also
have long-term effects including decreased attention performance and
increased impulsivity, which could promote the maintenance of nicotine
use behavior (id.). Further, the 2010 Surgeon General's report noted
that symptoms of dependence could result from even a limited exposure
to nicotine during adolescence (Ref. 50). Thus, FDA seeks to limit
youth exposure to nicotine and other addictive constituents in tobacco
by proposing restrictions on the age at which individuals can purchase
covered tobacco products. FDA is proposing to prohibit sales of
proposed deemed products to individuals under 18 years of age,
consistent with the current regulatory prohibition on sales of
cigarettes and smokeless tobacco products to individuals under 18 years
of age.
    Nicotine addiction research studies suggest that nicotine increases
sensitivity to rewarding stimuli in the environment, which may
reinforce smoking behavior in vulnerable individuals and contribute to
nicotine addiction (Ref. 59). Researchers have found that adolescent
brains are particularly vulnerable to the rewarding effects of
nicotine, and nicotine exposure during adolescence diminished the
negative effects of high nicotine exposure as an adult (Ref. 60 at
658). Nicotine also may play a role in neurodevelopment in adolescence,
alter future responsiveness to nicotine, and increase brain activation
related to smoking cues (Ref. 61 at 1968, Ref. 62 at 152, and Ref. 63
at 7). Ingredients in tobacco or tobacco smoke other than nicotine may
have reinforcing or synergistic effects of their own (Ref. 50 at 111).
See section VII.C for additional discussion regarding the addictiveness
of nicotine.
2. Nicotine Levels
    Tobacco product users absorb nicotine readily from tobacco smoke
through the lungs and through the mouth or nose for noncombustible
forms of tobacco (Ref. 49 at iii). Nicotine can also be absorbed
through the skin, as evidenced by the use of the nicotine patch for
relieving nicotine withdrawal symptoms. With regular use, nicotine
levels accumulate in the body during the day from the tobacco product
use and then decrease overnight as the body clears the drug (id).
    Nicotine introduced through the lungs is rapidly distributed to the
brain (Ref. 49 at 12). Although somewhat slower, absorption of nicotine
through the oral mucosa and skin is substantial and can produce blood
levels comparable to those achieved through lung absorption. The
effects of nicotine on the central nervous system occur rapidly after
absorption of nicotine from tobacco products (id.). Mild nicotine
intoxication even occurs in first-time smokers (Ref. 49 at 15-16).
Tolerance to the effects of nicotine develops rapidly. The nicotine
level in proposed covered tobacco products varies, both across product
types and brands of the same product type.
    Given the ease with which nicotine can be absorbed into the body,
and the impacts on tobacco users (particularly youth) as described in
section V.A, the nicotine consumption associated with the proposed
deemed products is a primary reason why FDA believes that deeming these
products to be subject to FDA's tobacco product authorities is
necessary and the proposed additional restrictions are appropriate for
the protection of public health. Each of the products described in this
document contains nicotine and, therefore, has the potential to addict
consumers.
a. Nicotine in, and Absorption of Nicotine From, Cigars
    Cigar tobacco contains nicotine in concentrations similar to those
observed in cigarettes; however, given that most cigars contain more
tobacco, many typically contain greater quantities of nicotine than
cigarettes (Ref. 28 at 81). The amount of nicotine in a cigar can range
from the equivalent of a single cigarette to the equivalent of an
entire package of cigarettes, depending on cigar size and the amount of
tobacco incorporated into its components (Refs. 28 at 182 and 30 at
736). A study of 10 cigars selected at random from a cigar retailer
found that the cigars ranged in nicotine concentration from 4.70
milligrams per gram (mg/g) to 22.00 mg/g (Ref. 28 at 183).
    In fact, nicotine levels in cigar smoke can be up to 8 times higher
than levels in cigarette smoke--1.7 mg in nonfiltered cigarettes, 1.1
mg in filtered cigarettes, 3.8 mg in little cigars, 9.8 mg in cigars,
and 13.3 mg in premium cigars (Ref. 28 at 67). Whether cigars deliver
nicotine at a level capable of producing dependence is based on the
degree of cigar smoke inhalation, the rate of oral nicotine absorption,
the development of tolerance to nicotine, the age of initiation, and
the duration of exposure (Ref. 28 at 183). Even cigar smokers who do
not inhale can become addicted to the product given the absorption of
nicotine through the buccal mucosa. The nicotine exposure from inhaling
the smoke from a single cigarillo is similar to exposures from inhaling
smoke from single cigarettes (Ref. 64). The proportion of cigar smokers
showing clear signs of dependence remains unknown (Ref. 28 at 189).
    Nicotine can exist in protonated and free base (or unprotonated)
form; and when in free base form, it is the most addictive and readily
absorbed via respiratory tissues, skin, and the gastrointestinal tract,
which results in the cigar being more addictive and even more difficult
for the user to cease using than the cigar would be if it only
delivered nicotine in the protonated form (Refs. 49 at 593 and 50 at
16). ``The amount of nicotine available as free, unprotonated nicotine
is generally higher in cigars than in cigarettes due to the higher pH
of cigar smoke'' (Ref. 28 at 97). Nicotine absorbed across the buccal
mucosa can provide sustained amounts of ``free base'' nicotine to the
user, which may explain why cigar smokers are less likely to inhale
than cigarette smokers (id.). Thus, a cigar also can deliver nicotine
much like chewing tobacco or oral snuff with nicotine extraction from
the unburned tobacco absorbed directly through the buccal mucosa and
lips (Ref. 28 at 183-184). Researchers have found that some cigar
smokers, particularly those who formerly smoked or currently smoke
cigarettes, were likely to obtain the nicotine by inhaling smoke
directly into the lungs, where it was absorbed as rapidly as cigarette
smoke (Ref. 28 at 186).
    Usage patterns suggest that cigar-only use that begins in adulthood
may be less likely to produce dependence than cigarette smoking, and it
is not likely ``that substantial levels of physical dependence would be
observed in

people who rarely smoked on 2 or more consecutive days'' (Ref. 28 at
189-190) (emphasis added). However, studies suggest that cigar use is
underreported by adolescents in part due to misunderstanding of the
definition of ``cigar'' in national surveys (Ref. 65 at 845 and Ref. 66
at 2, 4). For example, when a group of students were re-administered a
national survey but asked whether they had used cigars with the brand
name ``Black and Mild'' in the past 30 days rather than just ``cigars,
little cigars, or cigarillos,'' the percentage of students reporting
cigar use nearly doubled--from 12.9 percent to 20.7 percent. (Ref. 65
at 842). Therefore, adolescents need to be aware that small and large
cigars, like cigarettes, contain nicotine that can cause addiction (see
section V.A for further discussion regarding the effects of nicotine on
adolescent brains).
b. Nicotine in, and Absorption of Nicotine From, E-Cigarettes
    The amount of nicotine in e-cigarettes varies among brands. In a
2012 study, researchers tested the products under conditions in which
e-cigarette users use their products (Ref. 6). They found that ``high
nicotine'' cartridges delivered between 0.5 mg and 15.4 mg of nicotine,
and cartridges labeled ``low'' or ``medium'' delivered between 0.5 mg
and 3.1 mg of nicotine (id.). The efficacy of the nicotine
aerosolization also varied widely--with some e-cigarettes aerosolizing
within a range of 21 to 85 percent of the relative amounts of nicotine
present in the cartridges (id.). As a result, nicotine levels of a
single puff of 70 milliliters may be estimated between 1.7 micrograms
(mcg) and 51.3 mcg (id.). We are also aware that some e-cigarettes
currently being marketed claim to permit users to adjust the level of
nicotine delivery and that some users may attempt to employ this
claimed feature to reduce their nicotine use over time.
c. Nicotine in Hookah Tobacco
    Researchers have found that the nicotine level to which users are
exposed while smoking hookah tobacco is greater than the level from
cigarette smoking and, therefore, that hookah smoking also carries the
potential for addiction (Ref. 67). In a study of frequent hookah
tobacco users, half of the men and a third of the women reported
trying, but failing, to quit smoking hookah tobacco in the past (id.).
The researchers note that ``[h]ookah smoking exposes users to smoke and
may be a gateway to nicotine addiction'' (id.).
d. Nicotine in Dissolvables
    To date, little evidence is available to ascertain the
pharmacological properties and harmful effects of dissolvable tobacco
products or compare them with FDA-approved nicotine replacement
products or other tobacco products (Ref. 68). The dose of unprotonated
nicotine in dissolvable tobacco products can vary widely across product
formulations and brands, as well as the manufacture date, lot, and
batch (id.) Researchers at Indiana University-Purdue University
Indianapolis published the first chemical analysis of dissolvable
tobacco and found that ``dissolvables contain nicotine levels
comparable to those in a single cigarette'' (Ref. 69, citing Ref. 70).
Rapid intake of nicotine leads to the highest blood and brain
concentrations at the lowest doses of nicotine, but oral administration
requires higher doses of nicotine to produce the same toxic effects
(Ref. 70).

B. Health Risks of Products

    The health effects of cigarettes have been well documented (see,
e.g., Refs. 49, 50, and 51). Like cigarettes, many of the tobacco
products proposed to be deemed through this rule have well-documented
adverse health effects. The health risks of some of these proposed
deemed products are discussed in this section. See section VII for
additional rationales for specific proposed health warnings.
    In the ``Findings'' section of the Tobacco Control Act (section 2),
Congress notes that the ``use of tobacco products by the Nation's
children is a pediatric disease of considerable proportions that
results in new generations of tobacco-dependent children and adults''
and that a ``consensus exists within the scientific and medical
communities that tobacco products are inherently dangerous and cause
cancer, heart disease, and other serious adverse health effects.'' In
enacting the Tobacco Control Act, Congress found that providing FDA
with authority to regulate tobacco products, including the advertising
and promotion of such products, would result in significant benefits to
the American public in human and economic terms (section 2(12) of the
Tobacco Control Act). The U.S. Government has a substantial interest in
reducing the number of Americans, particularly youth and young adults,
who use cigarettes and other tobacco products, to prevent the life-
threatening health consequences associated with tobacco product use
(section 2(31) of the Tobacco Control Act). Virtually all new users of
most tobacco products are youth, and a reduction in tobacco product use
by this population alone could significantly reduce tobacco-related
death and disease in the United States (Ref. 51).
    Congress also expressed concern about the addictiveness of these
``inherently dangerous products'' (section 2(2) of the Tobacco Control
Act). In 1988 the Surgeon General found that ``all tobacco products
contain substantial amounts of nicotine'' (Ref. 49). Addictiveness
means ``[t]he state or quality of being addictive; addictedness,
addiction; an instance of this.'' (Ref. 71). Because the covered
tobacco products (i.e., those products deemed to be subject to the FD&C
Act under Sec.  1100.2, other than a component or part that does not
contain tobacco or nicotine) are made or derived from tobacco and
contain nicotine, they are addictive (Refs. 72, 73, 74, 75, and 76).
There are several symptoms that are indicative of addiction to drugs
including nicotine. The primary criteria are highly controlled or
compulsive use, psychoactive effects, and drug-reinforced behavior
(Ref. 50 at 105-106). Additional criteria are stereotypic patterns of
use, despite harmful effects, relapse following abstinence, and
recurrent drug cravings (id.). Dependence-producing drugs often produce
tolerance and physical dependence (id.).
    ``Tobacco use is the leading preventable cause of disease,
disability, and death in the United States'' (Ref. 77). When people do
not use tobacco products, the positive impact on public health is
great. For example, smoking declines in the last half century are
responsible for nearly 40 percent of the reduction in male lung cancer
deaths between 1991 and 2003 (Ref. 78). By extending FDA's ``tobacco
product'' authorities to tobacco products meeting the statutory
definition, FDA would be better able to ensure that the health risks of
these products are effectively communicated to consumers and that youth
do not have access to these products. These steps would increase the
likelihood that existing users will quit using tobacco products, and
decrease the likelihood that new individuals, including youth, will
initiate tobacco product use.
1. Dissolvable Products
    As stated previously, dissolvable products that do not currently
meet the definition of smokeless tobacco under 21 U.S.C. 387(18),
because they do not contain cut, ground, powdered, or leaf tobacco and
instead contain nicotine extracted from tobacco, are not currently
regulated by FDA. This proposed rule

would ensure that all dissolvable products are subject to FDA
regulation.
    The ``Monitoring the Future'' study found that the use of
noncombustible tobacco products (including pouches and dissolvables,
which contain nicotine, tobacco carcinogens, and toxicants) has
increased amongst youth in grades 8, 10, and 12 over the past several
years (Ref. 83). Compared to cigarettes, scientists have found that
dissolvables have a higher proportion of unprotonated nicotine but that
dose can vary widely (Ref. 68). The potential for acquiring nicotine
dependence exists for individuals who initiate tobacco product use with
dissolvable products, but the information about hazardous or potential
hazardous constituents in such products is sparse (id.).
    Certain dissolvable smokeless tobacco products also have the
potential for unintended poisonings given the candy-like appearance of
certain dissolvable tobacco products. Data from 2010 indicates that
13,705 tobacco product ingestion cases were reported and more than 70
percent of those cases involved infants under a year old (Ref. 79).
While it is unclear exactly how many of these cases involved
dissolvables, smokeless tobacco products (in all forms, including
dissolvables) were the second most common tobacco product ingested by
children, after cigarettes (id.).
2. Cigars
    Regardless of whether large cigar and pipe smokers inhale, smoke
particles are deposited into the lung (Ref. 32). A large cigar may
contain as much tobacco as a whole pack of cigarettes (Refs. 30 and
31). In addition, the concentrations of some toxic and carcinogenic
compounds are higher in cigar smoke than in cigarettes, and tobacco
smoke is a major source of fine-particle and carbon monoxide indoor air
pollution (Ref. 33). A smoker's risk of cardiovascular disease is
particularly high for former cigarette smokers who switch to cigars,
because they are more likely to be regular users and to inhale the
smoke (Ref. 28 at 155).
    As discussed further in section VII.E, cigar smoking also is
strongly related to certain cancers (including oral, esophageal,
laryngeal, and lung cancers), heart disease, and premature death (Refs.
28 and 62). Cigar smokers who inhale have a similar risk of death and
disease as cigarette smokers (see, e.g., Ref. 28). Research suggests
that smoking small cigars, in particular, is associated with smoke
inhalation that leads to significant exposure to carbon monoxide and
presumably other toxic components of tobacco smoke, which can lead to
respiratory diseases usually associated with cigarette smoking (Ref.
64).
    Moreover, age of initiation data illustrates the increasing
popularity of cigars, in particular small cigars, and the potential
risks for youth and young adults. According to the 2010 and 2011 data
from the National Survey on Drug Use and Health (NSDUH), 2.95 million
people aged 12 or older initiated cigar use in 2010--1.087 million of
whom where between the ages of 12 and 18. In 2011, 2.8 million
initiated cigar use, of which 1.113 million were between the ages of 12
and 18 (Refs. 6, 80, 81, and 82). The 2010 ``Monitoring the Future''
study showed that 23 percent of 12th graders reported smoking small
cigars in the past year (Ref. 83). While there was a dip in the number
of high school seniors smoking small cigars, that number remained high
at 19.5 percent in 2011 (Ref. 84). Additional discussion of the health
risks associated with cigars is included in section VII.E.
3. Pipe Tobacco
    Studies of pipe smokers illustrate a risk of tobacco-related
disease similar to the risk in those who inhale cigar smoke or smoke
cigarettes (Ref. 85). The Surgeon General previously found that pipe
and cigar smokers experience oral and laryngeal cancer risks similar to
that of a cigarette smoker (Ref. 86). Moreover, when compared with
never having used tobacco, researchers found that pipe smokers have an
increased risk of death from cancers of the lung, oropharynx,
esophagus, colorectum, pancreas, larynx, and from coronary heart
disease, cerebrovascular disease, and COPD (Refs. 32 and 85). Further,
in a Norwegian study involving 16,932 participants, researchers found
that pipe smokers have an elevated risk of premature mortality similar
to that of cigarette smokers who smoke at comparable consumption levels
(Ref. 87). This finding applies to total mortality and mortality for
smoking-related diseases (i.e., ischaemic heart disease, stroke,
cardiovascular disease, and other smoking related cancers), except for
lung cancer where smokers of only cigarettes have the highest mortality
(id.). Notably, even men with the lowest daily consumption of pipe
tobacco (less than three pipefuls per day) were found to have
significantly higher health risks than never users (id.).
4. Waterpipe Smoking
    Waterpipe smoking (also known as hookah, shisha, and narghile) uses
specially made tobacco that comes in different flavors, such as apple,
mint, cherry, chocolate, and licorice (Ref. 88). This type of tobacco
use carries similar health risks as smoking cigarettes with respect to
the large amounts of ultrafine particles emitted during a waterpipe
smoking session (Ref. 89). Waterpipe smoke contains many of the same
carcinogens and heavy metals as cigarette smoke, and because waterpipe
smoking sessions last longer than smoking a cigarette and there is
increased smoke volume, a single session of waterpipe smoking (which
typically lasts 20 to 80 minutes) could potentially be more dangerous
than smoking a cigarette (which typically takes 5 to 7 minutes) (Refs.
90 and 91). When compared to smoking a single cigarette, a meta-
analysis of studies regarding waterpipe use showed that a single
episode of waterpipe use is associated with exposure to 1.7 times the
nicotine, 6.5 times the carbon monoxide, and 46.4 times the tar (Ref.
9). In one study of participants aged 18 to 50 years old, researchers
found that a single waterpipe session leads to measurable transient
dysfunction in cardiac autonomic regulation and suggests an increased
risk of adverse cardiovascular events for hookah users (Ref. 92). When
compared to individuals who do not use waterpipes, researchers also
have found that waterpipe users (as ascertained by analyses in multiple
studies of participants ages 10 to 80) more than double their risk of
lung cancer, respiratory illness, and low birth weight when users are
expectant mothers (Refs. 10, 93, and 94).
    Studies also have demonstrated the presence of high levels of
tobacco-related carcinogens such as certain polycyclic aromatic
hydrocarbons (PAHs) and tobacco-specific nitrosamines (TSNAs) in
waterpipe users, which increase cancer risk in users (Ref. 95 citing
Refs. 96 and 97; and Ref. 98). For example, a study of exposure to
nicotine, carbon monoxide, and carcinogens in subjects who used
waterpipes under controlled conditions found that users had
significantly higher carbon monoxide levels than even cigarette
smokers, which can pose potential health risks especially for people
with cardiovascular and pulmonary diseases (Ref. 98). This study also
found increased urinary levels of TSNAs and PAHs following waterpipe
smoking (id.). In fact, the excretion of all PAH metabolites increased
50 percent following waterpipe smoking, indicating that it is a
significant source of exposure to this class of carcinogens (id.).
Waterpipe use also poses additional public health risks due to shared
mouthpieces and the heated, moist smoke that waterpipes produce. As a

result, users are at increased risk of contracting communicable
diseases and viruses (Ref. 99).
    Moreover, waterpipe use appears to be increasing among youth in the
United States, further illustrating the potential risks for youth and
young adults (Ref. 90). In 2010, results of the ``Monitoring the
Future'' study showed that 17 percent of 12th graders reported smoking
tobacco in a waterpipe (Ref. 83). The following year, 18.5 percent of
high school seniors reported smoking tobacco in a waterpipe (Ref. 84).
Researchers also studied waterpipe use among 689 students from 3 high
schools in San Diego County. Of the study participants, 26.1 percent
had used hookah and the mean age of initiation was 15.8 years (Ref.
90). Waterpipe users are exposed to tobacco toxicants and thus are at
risk for the same types of harms caused by cigarette smoking and, in
addition, may become cigarette smokers or dual tobacco users (Ref. 88).
5. E-Cigarettes
    We do not currently have sufficient data about e-cigarettes to
determine what effects they have on the public health. Some studies
have revealed the existence of toxicants in both the e-cigarette liquid
and the exhaled aerosol of some e-cigarettes. For example, FDA
previously noted the presence in a certain e-cigarette cartridge of
contaminants such as diethylene glycol (DEG)--a chemical that has
caused poisonings in other consumer products such as acetaminophen and
cough syrup and which FDA has stated ``is toxic to humans'' (Ref. 100,
Ref. 101 citing Refs. 102, 103, and 104). While the presence of DEG in
any product is of great concern, we note that it was found in only 1 of
18 cartridges studied and it was not found at all in another 16 studies
(Ref. 41).
    Further, one study found that toxic chemicals such as formaldehyde
and acetaldehyde were detected in the cartridges as well as the aerosol
from certain e-cigarette nicotine solutions (Ref. 47). Acrolein, which
can cause irritation to the nasal cavity and damage to the lining of
the lungs and may contribute to cardiovascular disease in cigarette
smokers, was also found in the aerosol (id.). While the level of
carcinogenic formaldehyde from the e-cigarette aerosol was somewhat
comparable to the amount received from cigarette smoking, the overall
levels of the toxicants tested in this study were 9 to 450 times lower
than those in cigarette smoke (id.). In another study, a total of 22
chemical elements, some of which can cause adverse health effects in
the respiratory and nervous systems, were identified in e-cigarette
aerosol (Ref. 105). Among those elements were lead, nickel, and
chromium, which are included on the Agency's harmful and potentially
harmful constituents list (id., citing 77 FR 20034, April 3, 2012).
Research published in 2013 reported that under near real-use
conditions, e-cigarettes increased indoor air levels of polycyclic
aromatic hydrocarbons, 1,2-propanediol, 1,2,3-propanetriol, glycerine,
nicotine, fine particles, ultrafine particles, particle number
concentrations, and aluminum. (Refs. 106 and 107).
    Despite the existence of certain toxicants in e-cigarette devices
and the exhaled aerosol, several studies support the notion that the
quantity of toxicants is significantly less than those in tobacco
cigarettes and tobacco smoke and similar to those contained in
recognized nicotine-replacement therapies. For example, researchers
reviewing the result of 16 laboratory analyses of e-cigarettes only
found trace levels of TSNAs, and these were at levels similar to those
in the nicotine patch (Ref. 41). Testing on some devices also has
revealed the existence of TSNAs in cartridge fluid, but generally at
low levels similar to those in nicotine replacement therapies
(Refs.108). Another study, published in 2013, also found cadmium, lead,
and nickel in the e-cigarette aerosol but only in trace levels and
comparable to those levels found in the Nicorette inhaler (Ref. 47).
Two researchers stated in 2011 that the ``preponderance of the
available evidence shows [e-cigarettes] to be much safer than tobacco
cigarettes and comparable in toxicity to conventional nicotine
replacement products'' (Ref. 41). Even if such findings are applicable
to many products, e-cigarette manufacturers may vary in the quality of
production, as discussed in section V.B.5. with respect to
contamination with DEG, and as discussed further with respect to
significant variability in nicotine content, and such variation may be
dangerous. As such, given the existence of toxic chemicals in at least
some e-cigarettes and the fact that most contain nicotine, FDA believes
that its oversight of these products (which would occur if this deeming
ruling becomes final) is appropriate for the protection of the public
health.
    Researchers have identified instances of poor quality control and
significant variability in nicotine content when testing certain e-
cigarette cartridges (Refs. 6, 102, 109, and 110). For example, in one
study, researchers found that actual nicotine amounts differed from
label amounts by more than 20 percent in 9 out of 20 original e-
cigarette cartridges tested, and in 3 out of 15 refill cartridges
tested (Ref. 6). Yet, in another study, researchers theorized that
manufacturing processes may have improved over time, because the
nicotine content in both the original and-refill bottles was close to
what was on the label and the difference between the content and labels
was smaller than was previously reported (Ref. 111). However, it is
unclear whether manufacturing processes have actually improved over
time, because this study was conducted before or at the same time as
studies finding significant variability in nicotine content. This
potential variability in nicotine content could be misleading to
consumers who believe that they are consuming one level of nicotine but
instead may be consuming higher levels in certain instances.
    More recently, some have noted the availability of flavored e-
cigarette liquids and expressed concern about the possibility that
these candy flavors could appeal to youth. E-cigarettes are available
in numerous flavors including vanilla, chocolate, peach schnapps,
bubblegum, and cola (Refs. 112 and 113). Following the release of a
2013 report by CDC noting the increased prevalence of e-cigarette use
in middle school and high school students, students have been quoted in
newspaper articles noting that classmates use e-cigarettes and that
they prefer flavors like gummy bears ``because it tastes really good''
(Ref. 114). If this deeming rule becomes final, FDA would have the
authority to issue regulations to prevent youth access to e-cigarettes
(such as the minimum age and identification provision, which is being
proposed with this rule). FDA asks for comments, data, and research
regarding the following:
     Given the data showing a significant increase in e-
cigarette usage among youth (Ref. 4) and the availability of fruit and
candy-flavored nicotine liquids, what other regulatory actions should
the Agency consider taking with respect to e-cigarettes?
     Does one's use of fruit and candy-flavored nicotine
liquids impact the likelihood that such individual will initiate use of
combustible tobacco products and/or become a dual user with combustible
tobacco products? How should that affect FDA's regulatory decisions
regarding e-cigarettes?
    Another area for concern regarding e-cigarettes is their potential
for acute toxicity. In February 2014, 41.7 percent of the combined
calls to poison control centers for conventional cigarettes and e-
cigarettes were for e-cigarette exposures (Ref. 115). In addition, 51.1

percent of those exposures were for children aged 0 to 5 years (id.).
    Although the public health impact of e-cigarettes is unknown, FDA
believes e-cigarettes that contain nicotine derived from tobacco should
be deemed to be tobacco products in order to obtain product and
ingredient listing information and levels of harmful and potentially
harmful constituents to ensure that users are not exposed to inhaled
chemicals known to be harmful. We also believe that more information is
needed to determine the public health impact of these products.
    Notably, in light of the impact of nicotine on youth (see section
V.A), and given the data on co-use and poly-use of tobacco products by
youth and others (see section V.D), FDA is proposing that tobacco
products in all forms, as defined by statute, not just cigarettes and
smokeless tobacco, be similarly regulated.

C. Consumer Confusion and Misinformation About Certain Covered Tobacco
Products

1. Misinformation About the Harmfulness of Various Tobacco Products
    Despite the addictiveness of nicotine and the documented adverse
health effects of cigarettes, smokeless tobacco, cigars, and hookah
tobacco, studies show that many consumers wrongly view certain tobacco
products, including novel tobacco products, as safe alternatives to
cigarettes and smokeless tobacco. Variations in the regulatory status
of tobacco products may reinforce that mistaken perception.
    Research reflects that many people inaccurately think cigars, as
well as waterpipes and other tobacco products covered by this proposed
rule, are safe alternatives to cigarettes. Indeed, research suggests
that youth perceive cigars in a more positive light than cigarettes and
believe cigars are more natural and less harmful (Refs. 35 and 116);
and some do not realize that cigars contain nicotine (id.). In
addition, in a focus group of African-American youth aged 14 to 18,
researchers found that the participants were not well versed in the
harms caused by smoking cigars (Ref. 116). In fact, the study found
that youth had received very little cigar-specific health education,
reinforcing the importance of alerting consumers about the dangers of
smoking cigars (id.). Likely referring to small cigars, the youth noted
that cigars were easy to obtain, that new brands were targeting youth,
and that the products were prominent in rap videos (id.). Use of cigar
products by youth and young adults is no longer an ``alternative'' to
cigarette use, but rather is now the primary tobacco product of choice
in certain urban and suburban areas (Ref. 117). One study also showed
that adult cigar smokers (including cigarillo smokers) were three times
as likely as non-cigar smokers to believe, mistakenly, that switching
from cigarettes to cigars reduces a smoker's chance of illness (32.3
percent versus 11.2 percent), with former cigarette smokers the most
likely among cigar smokers to believe that cigars are a safer
alternative (47.9 percent) (Ref. 117). See section VII.C.1 for
additional discussion of consumers' confusion and misinformation about
the addictiveness of cigars.
    Such confusion and misinformation about the harmfulness and
addictiveness of cigars are particularly troubling given the increasing
popularity of cigars (in particular, small cigars) among youth,
especially young adult males and teenagers (Ref. 54). The 2010 National
Survey on Drug Use and Health found that over 1 in 10 young adults
(ages 18-25 years old) smokes cigars (Ref. 54 at 146, Table 3.5b). In
2011, 19.5 percent of high school seniors reported using small cigars
in the past year (Ref. 84). The CDC also issued a study in 2012, which
found that total cigarette consumption decreased 32.8 percent from 2000
to 2011, while consumption of loose tobacco and small and large cigars
increased 123.1 percent over the same period (Ref. 22). These data
suggest that certain smokers have switched from cigarettes to other
combustible tobacco products (id.)
    Whereas studies have shown that cigarette and waterpipe smoking
deliver similar nicotine levels, one study showed that 46 percent of
students wrongly believed that hookah is less addictive or safer than
cigarettes, one third of which wrongly believed that hookah had less
nicotine, no nicotine, or was generally less addictive than cigarettes
(Ref. 90). Moreover, findings suggest that mistaken beliefs that
waterpipe smoking is ``safer or less addictive than cigarettes'' are
more prevalent among those who have ever used hookah (78.2 percent)
compared to hookah nonusers (31.6 percent) (id.). Similarly, another