[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Proposed Rules]
[Pages 23142-23207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09491]
[[Page 23141]]
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
[[Page 23142]]
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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, 877-287-1373,
[email protected].
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
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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
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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
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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
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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
[[Page 23147]]
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
[[Page 23148]]
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
[[Page 23149]]
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
[[Page 23150]]
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).
[[Page 23151]]
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
[[Page 23152]]
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
[[Page 23153]]
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
[[Page 23154]]
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
[[Page 23155]]
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
[[Page 23156]]
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
[[Page 23157]]
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
[[Page 23158]]
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
study found that ``[freshmen college] students who used waterpipes and
cigars perceived them as less harmful than regular cigarettes'' (Ref.
119). These findings are consistent with the finding that perceiving
less product harm is associated with product use (id.). Moreover,
research has shown that such false beliefs about product risks can be a
significant predictor of subsequent use behavior (Refs. 120 and 121).
For instance, adolescents with the lowest perceptions of short-term
risks related to smoking were 2.68 times more likely to initiate
smoking (Ref. 121).
In addition, some dissolvable tobacco products have a candy-like
appearance, frequently are sold next to candy, and are packaged to make
them more attractive to children, which can mislead consumers to think
that they are, in fact, candy or somehow safer than other tobacco
products (Refs. 17 and 79). This rule, if finalized, would apply the
same requirements to all dissolvable tobacco products, including those
that do not consist of cut, ground, powdered, or leaf tobacco.
Many consumers believe that e-cigarettes are ``safe'' tobacco
products or are ``safer'' than cigarettes. FDA has not made such a
determination and conclusive research is not available. Several studies
have evaluated consumers' awareness of e-cigarettes and their
perceptions of risk. For example, researchers involved in Wave 8 of the
ITC Four-Country Survey (involving data from the United States, Canada,
Australia, and the United Kingdom) asked all those respondents who were
aware of e-cigarettes to relay their perceptions of the product (Ref.
36). The vast majority of the respondents who were aware of these
products indicated that they believed e-cigarettes were less harmful
than traditional cigarettes, including 65.9 percent of U.S.
respondents--despite, as noted, the absence of a firm body of evidence
to support such beliefs (id.). Two other surveys revealed similar
results: (1) An online survey in which 70.6 percent of individuals
aware of e-cigarettes believed that e-cigarettes were less harmful than
regular cigarettes and (2) a telephone survey in which 84.7 percent of
individuals aware of these products believed they were less harmful
than regular cigarettes (Ref. 23). However, while the use of e-
cigarettes may have prompted some smokers in the ITC Four-Country
Survey to reduce their overall cigarette smoking and to adopt non-daily
cigarette use, users of e-cigarettes were not more likely to quit than
nonusers of e-cigarettes (Ref. 36). Once again, there is not adequate
evidence that e-cigarette use is a safe alternative to conventional
cigarette smoking. See section VII.C.1 regarding the current mixed
evidence about potential short-term reduced smoking benefits from e-
cigarettes. Notably, as discussed in that section, many consumers have
strong, but to date unsubstantiated, beliefs that e-cigarettes are a
safe and effective way for quitting cigarette use, and many consumers
start
[[Page 23159]]
consuming e-cigarettes because of those unsubstantiated beliefs.
Researchers also have expressed concerns that e-cigarettes that deliver
very low levels of nicotine may be effective starter products for non-
tobacco product users (Ref. 101). Such risks could be mitigated by the
establishment of an FDA regulatory approach for these products that
focuses on limiting youth initiation (id.).
2. Mistaken Perception by Adolescents
Nonclinical information, which includes cellular, tissue, and whole
animal-based laboratory studies, both informs and supports clinical
information. Most tobacco-related adverse health effects are long-term
effects, such as COPD and cancer. What can take years or decades to
develop in a human can be studied in nonclinical assays in mere days or
months. In addition, nonclinical studies allow for histopathology,
which yields strong scientific evidence of a biologically based cause
for a clinically detectable symptomology. Through nonclinical studies,
science is able to better control for exposure level of the product
being tested, as well as control for exposure time and to include a
recovery period, during which no exposure to the product can be
controlled. All of these aspects of nonclinical testing enable science
to better make the connection between an outcome, such as a toxicity
endpoint, and the experimental treatment, such as a specific tobacco
product or tobacco constituent. (See, e.g., Ref. 121.)
Non-clinical research has shown that: (1) Alterations to the brain
caused by nicotine may have a lasting effect on the developing brain
(Ref. 55 at 668-676); (2) the rewarding effects of low and moderate
doses of nicotine were enhanced in adolescent animals as compared to
adult animals, while the aversion to high doses of nicotine normally
seen in adult animals were reduced (Ref. 60 at 658-663); (3) these
affects are long lasting, as exposure to nicotine during adolescence
reduced aversion to high doses of nicotine when the animals were tested
as adults; (4) the adolescent brain is differentially sensitive to both
the acute and repeated effects of nicotine relative to the adult brain
(Ref. 76 at 2295); and (5) there are significant differences in
nicotine sensitivity between early and late phases of adolescence (Ref.
60 and 76).
Brain processes that lead to rational decision making continue to
mature through adolescence (Ref. 122 at 69-70). Acquisition of a fully
coordinated and controlled set of executive functions occurs relatively
later in development. As a result, several researchers have found that
young people may not have the ability to rationally consider the risks
and benefits involved with smoking and its long-term effects (Ref. 123
at 259-266). Young people also wrongly perceive that they are
personally at less risk than others who smoke, and youth underestimate
antismoking attitudes of their peers (id.). ``The belief pattern that
emerges from this study and other research is one in which many young
smokers perceive themselves to be at little or no risk from each
cigarette smoked because they expect to stop smoking before any damage
to their health occurs. In reality, a high percentage of young smokers
continue to smoke over a long period of time and are certainly placed
at risk by their habit'' (id.). Because they lack fully capable
executive function, youth seriously underestimate the future costs
associated with an addiction to nicotine (Ref. 55 at 4). Researchers
believe that youth underestimate the risks of smoking because they are
unable to appreciate the nature, severity, and probabilities of
consequences associated with smoking. Youth also fail to understand the
cumulative nature of the risk (Ref. 123 at 259-266). The proportion of
students seeing a great risk associated with being a smoker leveled off
during the past several years, according to recent research results, as
has the proportion of teens saying that they disapprove of smoking or
attach negative connotations to it (Ref. 83). Similarly, the
``Monitoring the Future'' survey identified a ``rebound'' in the rate
of smokeless tobacco product use by high school students, which
previously had declined from the mid-1990s to the early 2000s (id.).
Researchers attributed the ``rebound'' to leveling off perceptions of
harm caused by smokeless tobacco products, increased advertising of
these products, and a proliferation of new types of smoke-free tobacco
products (id.). In addition to systematically misunderstanding their
risks of harm from various tobacco products, youth and young people
also systematically underestimate their vulnerability to becoming
addicted to nicotine and the use of tobacco products, and overestimate
their ability to stop using tobacco products when they choose. See
section VII.C.
D. Use as Starter Products or Dual Use With Other Tobacco Products
A non-cigarette ``tobacco product'' can be a starter product for
new tobacco users before they migrate to cigarettes or other tobacco
products, or for existing users to become dual users. In a 2008 study,
researchers estimated that there were 7.3 million adolescent cigarette
smokers in the United States in 2002 and 2004, and almost half of them
were polytobacco users (users of more than one type of tobacco product)
(Ref. 124). Of the estimated 3.3 million polytobacco users, 1.9 million
used one other tobacco product and 1.4 million used two or more other
products (id.). The 2012 Surgeon General's Report found that ``among
adolescent and young adult tobacco users, concurrent use of cigarettes,
smokeless tobacco, and/or cigars is common'' (Ref. 54 at 209).
According to the 2009 Youth Risk Behavior Surveillance, among high
school males who use tobacco, 13.2 percent smoke cigars (i.e., cigars,
cigarillos, or little cigars) only, 21.2 percent smoke cigars and
cigarettes, and 19.2 percent smoke cigarettes and cigars and also use
smokeless tobacco (Ref. 54 at 155, Figure 3.13).
Significantly, studies of a variety of tobacco products suggest
that some non-cigarette tobacco users may go on to become addicted
cigarette smokers. For example, in one study of male smokeless tobacco
users who were nonsmokers at baseline, 44.8 percent were still
exclusively using smokeless tobacco at the 4-year followup, 25.5
percent had switched to smoking, 14.3 percent continued using smokeless
tobacco but also became smokers, and 15.2 percent were no longer using
any form of tobacco (Ref. 125). Thus, almost 40 percent of the original
smokeless tobacco users had either switched to cigarettes or become
dual users. In contrast, 78.7 percent of males who smoked at baseline
but did not use smokeless tobacco were still smokers 4 years later,
with only 0.8 percent switching to smokeless tobacco, 3.6 percent
continuing to smoke but becoming smokeless tobacco users as well, and
16.9 percent quitting tobacco product use altogether (id.). Similarly,
in a study of smokeless tobacco product use in young adult males,
current smokeless tobacco users were 233 percent more likely to have
initiated smoking at the 1-year followup than nonusers (Ref. 126).
Subjects who reported past smokeless tobacco product use were 227
percent more likely to begin smoking than participants who had never
used smokeless tobacco (id.). It is not yet clear whether users of the
proposed deemed products go on to become addicted to cigarettes, but
experts have expressed concern that e-cigarettes may draw more
consumers to nicotine-containing products (Refs. 101).
Research involving tobacco products that would be covered by this
rule
[[Page 23160]]
reveals similar conclusions. The prevalence of hookah use appears to be
high among youth who have already tried cigarette smoking and is
associated with other tobacco product use behaviors. For example, in
one study involving 951 adolescents, researchers found that those who
had used hookah tobacco in the last 30 days concurrently used multiple
tobacco products including cigarettes (74.7 percent) and cigars,
cigarillos, and/or little cigars (48.1 percent) (Ref. 127). Given that
waterpipe smoking has been found to increase one's risk of nicotine
dependence, this tendency towards dual use is particularly concerning
(Ref. 93). Regular waterpipe smokers evidence similar withdrawal and
craving symptoms as cigarette smokers (Ref. 128). Engagement in
waterpipe tobacco product use among individuals that would otherwise
remain tobacco na[iuml]ve is of great concern, as about half of
waterpipe users are non-current cigarette smokers (Ref. 129). Waterpipe
smoking frequency predicts regular cigarette use 8 months later among
adolescent males (Ref. 130). Among high school non-smokers and
experimental smokers, there was a strong association between age 20/21
smoking and waterpipe use: Previous non-smokers were more likely to
smoke cigarettes if they use waterpipes, suggesting that waterpipe use
may have preceded cigarette use (Ref. 131). College students with
waterpipe experience, but no cigarette use, were more likely to express
intent to try a cigarette soon (Ref. 26).
A cross-sectional health risk survey of approximately 4,500 high
school students revealed that high school-aged cigar smokers are more
susceptible to future cigarette smoking than nonusers. Specifically, in
students who tried cigars (defined as cigars, little cigars, and
cigarillos) first, 14.6 percent used cigarettes only, 12.2 percent used
cigars only, and 43.6 percent used both cigarettes and cigars (Ref.
117).
VI. Proposed Minimum Age and Identification Restrictions
Currently, there are Federal minimum age and identification
requirements for cigarettes and smokeless tobacco prohibiting sales of
these tobacco products to individuals under 18 years of age. This
proposed rule would extend those requirements to all covered tobacco
products in order to curb initiation of other tobacco products among
youth. We note that the definition of ``covered tobacco products''
would depend on the universe of tobacco products that would be covered
this rule. Under Option 1, all cigars would be covered and, therefore,
these additional provisions would apply to all cigars. However, under
Option 2, only a subset of cigars (i.e., ``covered cigars,'' which
would exclude ``premium'' cigars) would be covered by the rule and,
therefore, these additional provisions would apply to only a subset of
cigars. Under section 906(d) of the Tobacco Control Act, the minimum
age and identification restrictions FDA is proposing here are
appropriate for the public health.
A. Effectiveness of Proposed Restrictions and Section 906(d) Standard
The age and identification restrictions that FDA is proposing on
the sale of covered tobacco products meet the requirements of the
section 906(d) standard and are appropriate for the protection of the
public health. The goal of the proposed age restrictions is to reduce
youth initiation of tobacco use, thereby reducing the number of people
who suffer from tobacco-related illnesses and death and the number of
people who are exposed to secondhand smoke.
Currently, not all states have laws preventing the sale of tobacco
products that would be covered by this rule to those under the age of
18. This proposed action to prohibit sales of covered tobacco products
to individuals under 18 years of age at a minimum would be the most
effective way to keep youth from going to another nearby jurisdiction
that sells tobacco products to those under age 18. FDA intends to work
with retailers to emphasize the importance of continued training for
employees so that they will understand both the importance of the
minimum age restriction as well as how to enforce it. The Center for
Substance Abuse Prevention Draft Conference Edition Report on
Responsible Retailing outlines how a ``comprehensive program of
responsible retailing, properly designed and implemented, can
contribute to the elimination of sales of tobacco and other age-
restricted products to minors'' (Ref. 132 at 1) (see Refs. 133 and
134). FDA intends to use an aggressive nationwide enforcement program
for any new Federal program which will, we believe, increase compliance
and deter youth consumption of addictive tobacco products. FDA's
current nationwide tobacco retail inspection enforcement program, which
is implemented through contractual agreements between FDA and state or
local partners, where feasible, will be able to incorporate new
products or policies to provide additional uniformity to the
enforcement of tobacco laws and regulations.
There is clear evidence that actively enforced minimum age
requirements and identification requests in the states are useful in
reducing illegal sales of tobacco to youth (Refs. 135, 136, 137, and
138). A literature review found that every intervention that prevented
the sale of tobacco to minors has been associated with an observed
reduction in tobacco product use by youth (Ref. 138). The author
reviewed more than 400 published articles and 400 government reports
concerning tobacco sales to minors (id.). There were 19 interventions
in which the sale of tobacco to minors was disrupted (id.). In each
case, the intervention was followed by a decline in youth tobacco use.
Contrary to claims that efforts to disrupt the sale of tobacco to
minors are futile because social sources would ``fill the void making
tobacco more available,'' adolescents who purchase tobacco products
``are the primary social sources for other youth'' (id.). The
disruption of commercial distribution to youth ``creates supply
shortages, driving up the cost of tobacco on the street and
discouraging sharing among peers as smokers protect their supply''
(id.). Declines in tobacco product use were seen in rural communities,
suburban communities, across large regions or states, and countrywide.
Moreover, among all the materials reviewed, none demonstrated a
significant reduction in commercial distribution of tobacco to minors
unaccompanied by reductions in the number of youth who use tobacco
(id.). The author concluded that all available evidence indicates that
interventions that successfully disrupt the sale of tobacco to minors
can be expected to reduce the rate of tobacco product use among
adolescents.
Three small, cross-sectional studies have also found reductions in
tobacco product use following decreases in tobacco accessibility (Ref.
133 citing Refs. 134, 139, and 140). For example, the investigators in
one study surveyed more than 600 7th and 8th grade students in
Woodridge, IL, before and approximately 2 years after a local law on
retailer licensing and youth possession of tobacco was passed (Ref.
139). With active enforcement of the law, illegal sales of tobacco to
individuals under 18 years old were reduced from 70 percent of the
sample of retailers surveyed to 5 percent at the end of the 2-year
compliance review period (id.). Experimental smoking among middle
school students studied dropped from 46 percent to 23 percent 2 years
after the law's passage, and
[[Page 23161]]
regular smoking rates dropped from 16 percent to 5 percent (id.).
Similarly, another study examined youth smoking rates and purchase
behaviors in a longitudinal analysis of 12 communities (Ref. 141). Test
purchases were conducted to determine whether merchant compliance with
access restrictions can lead to lower youth smoking rates. Then these
levels of merchant compliance were compared with youth smoking rates.
From 1992 to 1996, frequent smoking increased by 28 percent in the
communities with retailer compliance levels less than 80 percent, but
frequent smoking decreased by 16 percent in the communities with
retailer compliance levels greater than 80 percent (id.).
Moreover, a number of studies have observed at least some
correlation between the enforcement of youth access restrictions and
reduced tobacco product use among youth when enforcement is coupled
with educational campaigns, and FDA has conducted and plans to continue
to conduct various types of public education regarding tobacco
products. For example, in a four-community study in Monterey County,
CA, where sales of tobacco products to individuals under 18 were
prohibited, researchers studied an intervention group (with educational
campaigns for the community and merchants) and a control group. In
communities with the tobacco intervention, the proportion of stores
selling tobacco to individuals under 18 dropped from 75 percent at
baseline to 0 percent after 34 months; while in the control
communities, the proportion of stores selling tobacco to minors only
dropped from 64 percent to 39 percent (Ref. 133). Additionally, 7th
graders in the intervention communities were significantly less likely
to use tobacco over the course of the study (13.1 percent at baseline
vs. 12.6 percent post-test), while 7th graders in the comparison
communities were significantly more likely to use tobacco (15.6 percent
at baseline vs. 18.6 percent post-test) (id.). In communities using
tobacco intervention policies, treatment effects were evident among the
youngest students (7th grade at baseline) but were not sustained at 34
months, and no significant effects were found for 9th and 11th graders
(id.). Based on these data, the authors concluded that there was some
evidence, albeit inconsistent, that reducing tobacco sales to
individuals under 18 lowered tobacco product use among this age group,
and that younger adolescents are more responsive to educational
campaigns for the community and merchants than older adolescents (id.).
Similarly, in a randomized community trial involving 14 Minnesota
communities (7 intervention communities and 7 control communities),
communities that passed a comprehensive youth tobacco access ordinance
showed less pronounced increases in adolescent daily smoking relative
to control communities (Ref. 137). During the intervention period,
there was statewide media attention on youth access to tobacco.
Additionally, during the intervention period, state retailer
associations and the tobacco industry launched statewide campaigns to
educate retailers and their employees about Minnesota tobacco age-of-
sale law and ways to avoid violating it (id.). The authors posited
that, to the extent both intervention and control communities showed
reductions in illegal sales to individuals under 18, the community
mobilization and education portions of the intervention may have played
a role in increasing the perception among students that they would not
be able to purchase tobacco or discouraged them from trying to do so
(id.).
FDA is aware of two studies that question the link between actively
enforced youth access laws and tobacco use. One 2-year controlled study
in six Massachusetts communities (from 1994 to 1996) that examined the
impact of enforcement of youth access restrictions on smoking behaviors
found that despite a significant and continued increase in compliance
by retailers, young people reported little decline in their ability to
purchase tobacco products. The study also found no relationship between
merchant compliance and smoking prevalence (Ref. 142).
In addition, a meta-analysis of previous studies showed no
detectable relationship between the level of merchant compliance with
youth access laws and 30-day or regular smoking prevalence and no
visible evidence of a threshold effect after compliance reached a
certain level (e.g., 80 or 90 percent) (Ref. 143). Although the authors
noted that one limitation of the analysis was the relatively small
number of controlled studies evaluating the effects of youth access
restrictions on teen smoking prevalence, they observed that the
consistency of the results increased their confidence in the study's
conclusions (id.). Researchers speculated that there was no reported
reduction in youth access, despite increased compliance rates by
retailers, either because youth went to other communities that did not
rigorously enforce the minimum age requirement to purchase cigarettes
or tricked retailers into believing that they were older (id.). While
more data and a larger sample size are needed to support this
hypothesis, these researchers did state that FDA regulations setting a
national standard for tobacco sales could have an effect on tobacco
product use nationwide if there were careful monitoring of compliance
(id.).
Several studies discussed potential reasons for the mixed findings
on the impact of youth access laws on youth tobacco use. Researchers
found that when youth access laws exist and are enforced, youth users
of tobacco, particularly beginning users, may resort to social sources
of tobacco (such as friends, parents, or strangers) or to stealing
(either from parents or from tobacco product retailers) (Ref. 141).
This phenomenon may explain why some data show that where decreases in
youth tobacco product use do result from youth access restrictions, the
decreases are concentrated among heavier teen smokers and/or frequent
smokers (Refs. 141 and 144).
Although the literature is mixed on the role compliance and
enforcement plays in the ability of youth access restrictions to affect
youth tobacco use, because the minimum age and identification
requirements FDA is proposing here would be Federal requirements, they
would apply across the entire United States. More uniform enforcement
by FDA working in conjunction with states would minimize youth's
ability to circumvent the current patchwork of youth access
restrictions by attempting to buy tobacco products in jurisdictions
where enforcement may be more lax. At least one study shows that
perceived accessibility to tobacco products contributes to tobacco
initiation and escalation among youth (Ref. 145). Accordingly, FDA
concludes that the proposed minimum age and identification
restrictions, combined with comprehensive and consistent enforcement at
the Federal level and in partnership with states, will decrease the
likelihood of youth smoking initiation and, therefore, are appropriate
for the protection of the public health under section 906(d) of the
FD&C Act.
The proposed minimum age and identification restrictions for
covered tobacco products are reasonable restrictions to curb youth
tobacco product use that would not hamper adult access to these
products. Adults seeking to purchase cigars or other covered tobacco
products would continue to take the same steps as they had in the past
to purchase these products. The only group that would find it more
difficult to purchase these products would be the youth population. In
addition, FDA believes
[[Page 23162]]
that these restrictions are necessary to prevent reinforcement of
existing misperceptions by youth that certain tobacco products--those
for which there are no minimum age or identification requirements--are
safe for their use. The absence of such requirements for covered
tobacco products could give youth a false sense of security about the
safety of those products sold without these restrictions.
Moreover, the proposed rule would simplify retailer compliance with
tobacco access restrictions. This restriction would make all
cigarettes, smokeless tobacco, and covered tobacco products in a
retailer's establishment subject to the same age and identification
requirements. The proposed restrictions would make compliance less
cumbersome for retailers who sell tobacco products in stores throughout
the United States, because they would have a uniform age and
identification requirement to enforce across their stores (rather than
several state and local laws that could result in differing age
restrictions and application to types of tobacco products). Currently,
the state and local age restrictions vary with respect to the types of
tobacco products to which they apply. For example, while Kentucky
prohibits the sale of tobacco products to persons under 18, the
provision does not define ``tobacco product'' in this context and,
therefore, may not cover proposed deemed tobacco products such as pipe
tobacco and e-cigarettes (Ky Rev Stat. Sec. 438.310). Similarly,
Delaware's age restrictions apply to any product that ``contains
tobacco,'' which could be construed to apply less broadly than the
proposed federal restriction that also would apply to products that are
derived from tobacco (Del. Code Ann. tit. 11, Sec. Sec. 1115, 1116).
With a consistent Federal regulation, retailer owners would be able to
more quickly train employees regarding the restriction without needing
to differentiate between a variety of products that contain similar
packaging and many of the same ingredients. Better retailer compliance
and enforcement can make it more difficult for youth to access
dangerous tobacco products, which FDA believes would, in turn, limit
their use of such products.
B. Application to Proposed Vending Machine Restrictions
Section 1140.14(b)(3) of the proposed regulation would ban the sale
of covered tobacco products in vending machines, 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. This restriction is appropriate for the protection of the public
health because it ensures that persons under the age of 18 cannot
purchase covered tobacco products without a retailer having to verify
their age and identification.
Section 1140.16(c) currently prohibits the sale of cigarettes and
smokeless tobacco in vending machines except those located in
facilities where individuals under 18 years of age are not permitted to
enter at any time. The preamble to FDA's 1995 proposed rule regarding
restrictions on youth access to cigarettes and smokeless tobacco
identified numerous studies and surveys showing that significant
percentages of young people are able to purchase cigarettes from
vending machines (60 FR 41314 at 41324-41326, August 11, 1995). Based
on studies demonstrating how easily youth and young adults could
purchase cigarettes from vending machines and surveys of actual
purchasing behavior, the Agency concluded that the provision would
eliminate a primary source of cigarettes for at least 2 percent of 17-
year-old smokers and 22 percent of 13-to-17-year-old smokers (60 FR
41314 at 41324 and 41325; 61 FR at 44396 at 44449).
As with cigarettes and smokeless tobacco, a ban on vending machine
sales in places accessible to individuals under 18 would eliminate an
easy means of access to covered tobacco products, especially for
younger children. In addition, this proposed restriction is an
important adjunct to the proposed minimum age and identification
requirements. Without the proposed restriction on vending machines, use
of vending machines to obtain covered tobacco products would likely
circumvent the proposed minimum age and identification restrictions.
For example, a 2002 review of youth access policies found that although
vending machines and shoplifting represented approximately 5 percent or
less of youth supply, the flow of cigarettes comes from a variety of
sources (Ref. 146). If it becomes more difficult for youth to buy
cigarettes over the counter, greater numbers of youth will purchase
them from vending machines or older peers, or borrow or steal from
parents (id.). Thus, unless vending machines restrictions are part of
this rule, these well-recognized substitution effects could limit the
effectiveness of the minimum age and identification restrictions FDA is
proposing (Refs. 133 and 140).
Furthermore, more recent research confirms that purchases of
cigarettes from vending machines occur regardless of locks, warning
signs, and other physical restrictions. A 2009 German study on youth
access to tobacco vending machines concluded that electronic locking
devices on vending machines were not sufficient to limit youth access
to tobacco. The study also found that youth were able to circumvent the
electronic locking devices and still obtain cigarettes (Ref. 147).
Accordingly, the proposed restriction is designed to prevent youth
access to the vending machines themselves.
According to the most recent data that is currently available,
tobacco product vending machine sales declined sharply in recent
decades, with 2007 sales totaling $46.9 million (Ref. 148). Since 2007
there has been expansive growth in e-cigarette sales (which were
negligible in 2007), and vending machine sales of e-cigarettes are not
prohibited or restricted to any significant extent at the Federal,
state, or local levels. The proposed rule produces public health
benefits to the extent that e-cigarettes, cigars, and other proposed
deemed products are currently being sold through vending machines or
would be in the future.
We also note that FDA's proposed restriction regarding the use of
vending machines is not intended to apply to facilities in which the
retailer ensures that no person under 18 years of age is present. We
believe this limitation is appropriate because this rule would prohibit
access by youth without imposing additional requirements upon retailers
who serve the over 18-year-old population.
VII. Proposed Required Warning Statements
FDA is proposing to require the following health warning on all
covered tobacco products, as well as cigarette tobacco and roll-your-
own tobacco: ``WARNING: This product contains nicotine derived from
tobacco. Nicotine is an addictive chemical.'' We note that the
definition of ``covered tobacco products'' would depend on the universe
of tobacco products that would be covered this rule. Under Option 1,
all cigars would be covered and, therefore, this additional requirement
would apply to all cigars. However, under Option 2, only a subset of
cigars (i.e., ``covered cigars,'' which would exclude ``premium''
cigars) would be covered by the rule and, therefore, this additional
requirement would apply to only a subset of cigars. FDA is proposing a
self-certification option for manufacturers who certify that their
tobacco product does not contain nicotine (and that they have data to
support that assertion). Such a product would be required to
[[Page 23163]]
bear the statement, ``This product is derived from tobacco.''
FDA is proposing that this warning statement be required to appear
on the packages and in the advertisements for all proposed newly
covered tobacco products and other tobacco products for which health
warnings are not otherwise required by Federal law or regulation (i.e.,
cigarette tobacco and roll-your-own tobacco). As discussed in section
V.A, the addictive nature of nicotine in tobacco products is clear.
In 2000, in settlements with the FTC, the seven largest U.S. cigar
manufacturers agreed to include warnings about significant adverse
health risks of cigar use in their advertising and packaging. (See,
e.g., In re Swisher International, Inc., Docket No. C-3964.)
Under the 2000 FTC consent orders, virtually every cigar package
and advertisement is required to clearly and conspicuously display one
of several warnings on a rotating basis, including the following:
Cigar Smoking Can Cause Cancers of the Mouth and Throat,
Even If You Do Not Inhale.
Cigar Smoking Can Cause Lung Cancer and Heart Disease.
Cigars Are Not a Safe Alternative to Cigarettes.
Tobacco Smoke Increases the Risk of Lung Cancer and Heart
Disease, Even in Nonsmokers.
Based on FDA's authority under section 906(d) of the FD&C Act, FDA
is proposing to adopt these four cigar warning statements from the FTC
consent orders--which the vast majority of cigars already use--in
addition to the warning statement regarding addictiveness. These
warning statements will be randomly displayed and distributed on cigar
product packages and rotated in advertisements. For cigars sold
individually that are not packaged, FDA is proposing that the cigar
warnings 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.
If FDA's proposal to deem tobacco products to be subject to its
``tobacco product'' authorities is finalized, FDA and the FTC will
consult to harmonize national requirements for health warnings on cigar
product packages and in advertisements. In addition, under Option 1,
these warning requirements would now apply to all small and large
cigars, not just to those manufactured by the seven companies subject
to the FTC orders.
FDA's proposal that these cigar warnings be randomly distributed on
packages and rotated in advertisements is consistent with the
requirements established by Congress in the Tobacco Control Act for
statutorily covered products. Section 4 of the Federal Cigarette
Labeling and Advertising Act and section 204 of the Tobacco Control Act
require the random distribution and rotation of warnings for cigarettes
and smokeless tobacco products, respectively. Therefore, FDA is not
proposing to treat cigars differently from currently regulated tobacco
products. Further, rotation of warning labels already occurs under the
FTC consent decrees. The WHO also has recognized the need to rotate
health warnings for tobacco products. In the WHO's Framework Convention
on Tobacco Control (FCTC),\4\ an evidence-based treaty that provides a
regulatory strategy for addressing the serious negative impacts of
tobacco products, calls for warnings that are rotating, ``large, clear,
visible and legible.'' (WHO FCTC article 11.1(b).) However, FDA
recognizes that the random distribution of warning statements on cigar
product packages and the rotation of statements on advertisements can
result in significant costs for cigar manufacturers. Therefore, FDA
requests comments on other possible methods (e.g., randomly assigning
warning statements per individual cigar or Universal Product Code) to
ensure that the warnings have a maximum public health impact by
reaching as many individuals as possible yet do not grow stale from
overuse. FDA requests comments and data showing that such alternative
methods would still achieve FDA's public health goals yet would reduce
costs for cigar manufacturers.
---------------------------------------------------------------------------
\4\ There are 168 signatories to the WHO's Framework Convention
on Tobacco Control as of August 2010. At this time, the United
States is a signatory but has not ratified this treaty.
---------------------------------------------------------------------------
In the following sections, we discuss the bases for the proposed
warning statements. We discuss how FDA's proposed health warning
statements and the exercise of authority in this area meet the
requirements for implementing a restriction regarding the sale and
distribution of a tobacco product under section 906(d) of the FD&C Act.
We also explain the importance of including the proposed health
warnings on small and large cigars given the scientific evidence
regarding the serious adverse health risks associated with cigar use,
the age of initiation of cigar use, and the increasing popularity of
cigars among youth (in particular, small cigars), as well as the fact
that many of these products already display most of these warnings. In
addition, we explain that these warning statements, as well as the
proposed additional warning for covered tobacco products (and cigarette
tobacco and roll-your-own tobacco), will effectively communicate to
consumers the addictive nature of the nicotine in these products. FDA
believes that consumers should clearly understand and appreciate the
dangers of tobacco use. Greater awareness and understanding of the
dangerous health effects of tobacco product use will help consumers
better understand the potential consequences of their purchase and use
of tobacco products.
A. Requiring Health Warnings Is Appropriate for the Protection of the
Public Health
The purpose of health warnings is to help current and potential
tobacco users understand and appreciate the serious adverse health
consequences associated with tobacco product use and the addictive
nature of tobacco products. Adolescents do not accurately understand
the health risks associated with smoking, and smokers tend to
underestimate the risk of harm (Ref. 149). FDA believes it is
reasonable to apply this notion of imperfect smoking-related knowledge
to other forms of tobacco product use as well. Given the dangers
associated with continued use of tobacco products, FDA believes it is
critical to include a warning on all such products to help consumers
better understand and appreciate the addictive nature of these
products.
For more than 45 years, Congress has required textual health
warnings for cigarettes on product packages. Warnings in cigarette
advertising have been required since the FTC issued its 1972 consent
orders and since 1984 by statute. (See in re Lorillard et al., 80 FTC
455 (1972); Comprehensive Smoking Education Act, Pub. L. 98-474
(1984).) For almost 25 years, Congress has required textual health
warnings for smokeless tobacco packages and advertisements. The FCTC
also requires health warnings on tobacco product packages (article 11)
and in tobacco product advertising (article 13). The 2000 consent
orders between seven cigar manufacturers and the FTC required health
warnings for cigar packages and advertisements. Thus, requiring health
warnings on all tobacco products subject to the FD&C Act is consistent
with existing laws, practices, and international standards.
The health warnings that FDA is proposing, which concern risks
associated with the use of tobacco products, are clearly material with
respect to the consequences that may result from the use of those
products. For all covered tobacco products (as
[[Page 23164]]
well as cigarette tobacco and roll-your-own tobacco) that contain
nicotine, the proposed regulation would require a warning about the
addictive nature of nicotine in the product. For small and large
cigars, the warnings also convey information about health consequences,
including certain cancers, cardiovascular disease, and effects on
others exposed to secondhand smoke. It is important for consumers who
are making purchasing decisions to understand that, unlike most other
consumer products, once tobacco product use is initiated, it can be
very difficult to stop using the product.
Consumers also may be unaware of the presence and addictive nature
of nicotine in all of these products, as they can be the first tobacco
product that a young person uses before progressing to cigarette
smoking or use of other tobacco products, as discussed in section V. In
addition, once a user becomes addicted, he or she likely would increase
use and, therefore, increase his or her risk of suffering from other
negative health effects given the dose-response relationship associated
with many of these products (Ref. 49). Therefore, the warnings FDA is
proposing would provide highly material information that all consumers
should know about the consequences of using tobacco products. Failure
to disclose material facts about tobacco products, such as the presence
and addictive nature of the nicotine in the products, is likely to
mislead consumers. See In re Lorillard, et al., 80 FTC 455 (1972)
(consent order resolving charges that failure to disclose statutory
health warning for cigarettes in cigarette advertising was deceptive
and unfair). See also In re Swisher International, Inc., Docket No. C-
3964; In re Havatampa, Inc., Docket No C-3965; In re Consolidated Cigar
Corp., Docket No. C-3966; In re General Cigar Holdings, Inc., Docket
No. C-3967; In re John Middleton, Inc., Docket No. C-3968; In re Lane
Limited, Docket No., C-3969; In re Swedish Match North America, Inc.,
Docket No. C-3970 (consent orders resolving allegations that failure to
disclose the adverse health consequences of cigar use was deceptive and
unfair).
The proposed requirements to include health warnings on tobacco
product packages and in advertisements also would satisfy the standard
in section 906(d) of the FD&C Act, which allows the Agency to issue a
regulation to require restrictions on the sale or distribution of a
tobacco product, if the regulation ``would be appropriate for the
protection of the public health.'' According to the statute, the
determination as to whether a regulation would be appropriate for the
public health must be based on the risks and benefits to the population
as a whole (including tobacco users and nonusers) and taking into
account how the regulation could impact the likelihood of existing
users stopping use of the product and the likelihood of new users
starting to use the product (section 906(d)(1)(A) and (B) of the FD&C
Act).
The public health benefits to both users and nonusers from this
regulation would be significant. As discussed in sections V.B and
VII.E, there is substantial evidence that certain tobacco products
within the scope of this regulation cause serious diseases and death
and that secondhand smoke causes deadly diseases in nonsmokers. The
addictive nature of tobacco products also has been well-documented (see
section V.A). These proposed warnings would help ensure that youth and
young adults, who may be more susceptible to the addictiveness of
nicotine, have a greater awareness of the dangers associated with these
products before they might become addicted. As discussed in section
VII.B, researchers have found that tobacco health warnings on product
packages and in advertisements can effectively provide this important
health information to consumers. FDA believes that the proposed
warnings would help both users and nonusers better understand and
appreciate these dangers.
B. Effectiveness of Warnings
The use of tobacco packages to help consumers better understand and
appreciate tobacco-related health risks has a number of advantages. The
frequency of exposure is high. In addition, package warnings are
delivered both at the time of tobacco product use and at the point of
purchase. Thus, the messages are delivered to tobacco users at the most
important times--when they are considering using or purchasing the
tobacco product. The messages on packages also help the public at
large, including potential tobacco users, better understand and
appreciate the health and addictiveness risks of using the products
(Ref. 56). Requiring health warnings in advertisements similarly is an
important means of helping consumers better understand and appreciate
the health consequences of tobacco use. (See In re Lorillard et al., 80
FTC 455 (1972); Federal Cigarette Labeling and Advertising Act (FCLAA),
15 U.S.C. 1331 et seq.; Comprehensive Smokeless Tobacco Health
Education Act of 1986 (CSTHEA), 15 U.S.C. 4402 et seq.)
For the communication to be effectively understood and appreciated,
consumers must notice and pay attention to the warning. As discussed at
length in this section, the size, placement, and other design features
of the warning play a role in the effective communication of the
underlying message. As discussed in sections VIII.C.2 and VIII.C.3, the
proposed regulation would require that the health warning statements
comprise 30 percent of the area of the two principal display panels of
the package to help ensure that consumers notice and process the
critical information conveyed in the required warning statements. The
IOM, Congress, and Article 11 of the FCTC recognize the importance of
having the warnings cover at least 30 percent of the area of the
principal display panels, and users are more likely to recall warnings
that are in a larger size and that appear on the front/major surfaces
of the tobacco package (Ref. 58; 15 U.S.C. 4402(b); FCTC article 11).
Because the warnings would be required to appear on 30 percent of the
two principal display panels (which includes the front of the package),
FDA believes that the proposed warnings will be effective in helping
consumers better understand and appreciate critical information. We are
proposing a 30-percent size requirement for product packages to be
consistent with Congress' size requirements for similar text-only
warnings for smokeless tobacco under CSTHEA (15 U.S.C. 4402(a)(2)(A)),
rather than the 50-percent size requirement that Congress chose for
graphic warnings on cigarette packages. We invite comment on the
appropriateness of this size requirement.
In addition, because a large font size increases the impact and
legibility of the warning, FDA is proposing that the warning statement
on packages and advertisements appear in the maximum font size that
would fit into the warning area. Given the variety of packaging sizes
for the tobacco products at issue in this regulation, it is not
feasible to specify a single font size for all products within the
scope of this regulation. Therefore, FDA is proposing that the font be
as large as possible to ensure that the required warning statement will
be noticed by consumers regardless of the package size. Research has
shown that using the largest possible lettering can increase warning
effectiveness and increasing font size aids communication (Ref. 150).
Similarly, the proposed requirement that the warnings appear in black
text on a white background or
[[Page 23165]]
white text on a black background will improve the legibility and
noticeability of the warnings (Refs. 58 and 150).
The format requirements that FDA is proposing are similar to those
included in a 2001 European Union Directive, which have been shown to
increase the effectiveness of health warnings. European Union (EU)
Directive (2001/37/EC) requires that tobacco warnings in all member
countries meet certain minimum standards that are similar to those that
FDA is proposing (i.e., EU required health warnings comprise 30 percent
of the area on the front of package and 40 percent on the back of the
package; black Helvetica bold type on a white background; warnings to
occupy the greatest possible proportion of the warning area set aside
for the text required; messages centered in the warning area and
surrounded by a black border of 3 to 4 millimeters (mm) in width).
Prior to the 2001 Directive, warnings in most European Union countries
were very small and general. In one study conducted for the European
Commission, a majority of respondents considered the Directive's new
warning format more effective and more credible than the previous
format (Ref. 151). A study of Spanish university students also
concluded that text warnings based on the Directive significantly
increased perceptions of the risk of tobacco products (Ref. 152).
Additionally, in a study of similar warnings in the United Kingdom,
smokers indicated that their awareness of the warnings increased along
with thoughts about the health risks of smoking (Ref. 153).
FDA believes that the fundamental similarities between cigarettes
and smokeless tobacco and other tobacco products allow for the
application of data regarding the effectiveness of cigarette and
smokeless tobacco warnings to warnings for other tobacco products.
Research dating back to the late 1980s has found that small warning
labels for cigarettes and small warning labels for smokeless tobacco
products alike were rarely noticed and suffered from low rates of
recall among youth (Refs. 154, 155, and 156). For example, in one eye-
tracking study, adolescents were asked to view five cigarette ads that
included a health warning (Ref. 155). The average viewing time of the
health warning was only 8 percent of the total time spent viewing the
ads, and participants subsequently demonstrated a low recall of the
warnings (id.). Similarly, a study of health warnings on oral snuff and
chewing tobacco pouches revealed that fewer than half of the subjects
recalled seeing the warnings and approximately one-third of those who
saw the warnings recalled the content (Ref. 156). These studies were
all based on the small warning sizes then required by United States
law. As discussed above, the Tobacco Control Act requires substantially
larger warnings for cigarettes and smokeless tobacco products, and this
proposed rule, if finalized, would require similarly sized warnings for
other tobacco products. Warning size clearly matters, as recall
increases significantly with font size (Ref. 156 at ii61). In a study
of recall of health warnings in smokeless tobacco ads, conducted with
895 young males, 63 percent of participants recalled a high contrast
warning in 10-point font; doubling the warning size to a 20-point font
increased recall from 63 percent to 76 percent representing a 20-
percent improvement in recall (Ref. 156 at ii61-ii62). Research on
cigarette-package warnings confirms that larger warnings are better
noticed and more likely to be recalled (Ref. 54 at 810; ref. 58 at App.
C-3; ref. 150). These studies support FDA's belief that requiring that
the proposed warnings appear in the maximum font size will improve
their noticeability.
The content of the proposed messages also indicates that they
should help consumers understand and appreciate the relevant health
risks. In a qualitative study conducted for Health Canada, researchers
tested text-only smokeless product health messages, some of which are
similar to FDA's proposed health warnings for cigars. One of the tested
Canadian messages (This product causes mouth diseases) generally was
considered to be a low-impact message, which participants felt was not
a deterrent but merely a reminder (Ref. 159 at 11). However, FDA's
proposed message (adopting the existing FTC warning language) regarding
mouth diseases is more specific and alerts consumers that not only do
small and large cigars cause ``mouth diseases,'' they also cause cancer
of both the mouth and the throat. As the IOM explained with respect to
cigarette warnings, specific unambiguous warnings are more likely to be
noticed and less likely to be discounted than vague warnings (Ref. 58
at App C-3).
Another Canadian tested message (Use of this product can cause
cancer) is similar to three of FDA's proposed warning messages. Most
respondents in the Canadian study considered this message to be
credible, although some found that the message was ``too vague to be
effective'' (Ref. 159 at 12). However, FDA's proposed health warnings,
adopting the existing FTC language, are more specific than the Canadian
message (referring to specific types of cancers, noting the risk of
mouth and throat cancers even for those that do not inhale, and
alerting users that the smoke released from their product can even
cause cancer in nonsmokers) (Ref. 58). FDA believes, therefore, that
the proposed warnings will be effective in helping current and
potential smokers understand and appreciate the adverse health
consequences related to cigar smoking.
Researchers have studied the relationship between substance use and
memory for health warnings on cigarettes, smokeless tobacco, and
alcohol. For smokeless tobacco, researchers confirmed a statistically
significant correlation between use and recognition memory for the
product's health warnings (Ref. 157 at 147).
Although there has not yet been extensive research regarding the
effectiveness of health warnings on tobacco products other than
cigarettes (Refs. 155, 156, 157, 158), existing studies support the use
of these messages. Canada's text-only health warning messages for
chewing tobacco and oral snuff packages (similar to the ones FDA is
proposing to apply to cigars) were issued in 2000 (Ref. 159), which the
qualitative study described above found to be effective at educating
consumers about the dangers associated with their use. In the instances
where consumers believed the messages were ineffective, FDA is
proposing messages that differ significantly from the Canadian messages
in that they provide additional, specific health information for
consumers.
FDA intends to conduct research and keep abreast of scientific
developments regarding the efficacy of the final health warnings and
the ways in which their efficacy could be improved. We will use the
results of our monitoring and such research to help determine whether
any of the warning statements (if finalized) should be revised in a
future rulemaking. Under Option 2, these warning label requirements
would only apply to covered cigars and not to premium cigars.
C. Proposed Addictiveness Warning
To FDA's knowledge, all tobacco products currently on the market
contain nicotine (Ref. 49 at 12). 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). Nicotine is psychoactive and can serve as
a ``reinforcer'' to motivate tobacco-seeking and tobacco-using behavior
(Ref. 49 at 7). The patterns of nicotine
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use are regular and compulsive, and a withdrawal syndrome usually
accompanies tobacco abstinence (Ref. 49 at 13). Tolerance develops to
nicotine such that repeated use results in diminished effects and can
be accompanied by increased intake (Ref. 49 at 13). The pharmacologic
and behavioral processes that determine tobacco addiction are similar
to those that determine addiction to other drugs (Ref. 49 at ii).
Leading national and international organizations, including WHO, the
American Psychiatric Association (APA), the American Cancer Society,
and the American Academy of Addiction Psychiatry, have recognized
chronic tobacco product use as a drug addiction (Ref. 49 at iii). WHO
and APA do not use identical definitions of ``addiction''; however,
they have in common several criteria for establishing a drug as
addicting--such as the fact that the user's behavior is largely
controlled by a psychoactive substance; the drug is reinforcing and the
user can develop a tolerance to it; and withdrawal can occur following
abstinence--and nicotine meets all these criteria (Ref. 49 at iv). See
section V.A for additional information regarding the addictiveness of
tobacco products.
Accordingly, FDA proposes to help consumers better understand and
appreciate the addictiveness of tobacco product use by adding warnings
on packages and in advertisements for all covered tobacco products and
those products not already requiring a health warning under Federal law
or regulation (i.e., cigarette tobacco and roll-your-own tobacco). FDA
proposes that such warning would state: ``This product contains
nicotine derived from tobacco. Nicotine is an addictive chemical.''
1. Consumer Perceptions Regarding Addictiveness of Tobacco Products
This warning is particularly important given consumers' erroneous
and unsubstantiated beliefs that tobacco products other than cigarettes
are either less addictive than cigarettes or are not addictive at all.
For example, in a survey of high school students, 46.3 percent of
participants--83.3 percent of whom were waterpipe users--believed their
product was less addictive and safer than cigarettes (Ref. 90 at 3, 4)
(also citing several additional studies where young adult waterpipe
users reported that their tobacco product was less addictive). Also, in
a qualitative study prepared for Health Canada consisting of smokeless
tobacco, cigars, and pipe users between the ages of 16 and 60 plus,
most large cigar smokers thought that their product was less addictive
than cigarettes or not addictive at all because they smoked for
pleasure or did not smoke daily (Ref. 158 at 1, 40). Small cigar
smokers in this study were split as to whether they believed their
product of choice was addictive (Ref. 158 at 41). While most chewing
tobacco and snuff users tended to believe these products were as
addictive as cigarettes, some believed their chew was not addictive
because the taste was such a turnoff (id.). Not only do these studies
further indicate the need for a warning statement to ensure that
consumers recognize that nicotine is addictive, but they also indicate
that broader education regarding the addictiveness of tobacco products
also may be necessary given that consumers in the Canadian study
incorrectly believed an individual could not be addicted to a product
that he or she ``disliked'' or did not use every day (id.).
FDA also believes that this warning is necessary to reduce youths'
widely held but erroneous belief that certain tobacco products--those
for which there currently are no warnings regarding addictiveness--are
safe for their use (Ref. 51). Youth believe that they will be able to
stop using tobacco whenever they want to do so (id.). However, because
of the addictiveness of nicotine, they often have great difficulty
doing so. Thus, addiction warnings are particularly important for
youth. Health warnings are currently required for cigarettes and
smokeless tobacco under the Tobacco Control Act. The absence of a
health warning requirement for other tobacco products could reinforce
the existing false sense of security that youth have about the safety
of those products.
Further, many consumers believe that the use of e-cigarettes will
help them quit smoking, even though this has not been proven by long-
term studies of significant numbers of e-cigarette users, and some
consumers forego proven cessation methods due to those unsubstantiated
beliefs. For example, in the ITC Four-Country Survey, 75.4 percent of
respondents indicated that they used e-cigarettes to help them reduce
their smoking and 85.1 percent reported using e-cigarettes to help them
quit smoking (Ref. 36). In a survey of current and former smokers, 80
percent of respondents reported that they used e-cigarettes to help
them reduce the number of cigarettes they use and 65 percent stated
they used e-cigarettes to try to quit using cigarettes (id.). Section
IV.D discusses the possible reduced usage of cigarettes that may be
associated with e-cigarettes and the limitation of existing studies. We
do not currently have sufficient data about these products to determine
what effects e-cigarettes have on the public health.
2. Alternative Statement for Products Without Nicotine
The products for which FDA is proposing health warnings under this
rule all contain nicotine. FDA is not aware of any currently marketed
tobacco product that does not contain nicotine. However, in the event
that such products are developed, FDA proposes that manufacturers of
such products submit a certification of that fact (and the fact that
they have the data to support this assertion) to FDA. Products for
which such a certification has been submitted would not contain any
warning that would clearly indicate that it is a tobacco product.
Accordingly, FDA is proposing that such products include the following
alternative statement on their product packages and in their
advertisements: ``This product is derived from tobacco.'' FDA believes
it is important to alert consumers and retailers as to which items are
tobacco products. Even if a tobacco product does not contain nicotine,
it can still contain other addictive chemicals (like anabasine or
nornicotine, discussed in the preamble) or dangerous toxicants.
Therefore, FDA believes consumers should be aware that the product is,
in fact, a tobacco product. In addition, the statement would alert
consumers as to which products would require identification for
purchase and increase retailer awareness of the products for which they
must verify the age of consumers. FDA requests comments on this
alternative statement.
3. Request for Comments Regarding Addictiveness Warning for Certain
Categories of Tobacco Products
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 tobacco products
that are non-combustible (such as e-cigarettes) may be less hazardous
than combustible products, given the carcinogens in smoke and the
dangers of secondhand smoke. Thus, FDA is seeking comments, including
supporting research, facts, and other evidence, as to whether all
tobacco products should be required to carry the proposed addictiveness
warning and if different warnings should be placed on different
categories of products.
In addition, we note that this requirement would apply to products
that are derived from tobacco, and not
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just products that themselves contain tobacco, based on the definition
of ``tobacco product'' in section 201(rr) of the FD&C Act. As a result,
FDA recognizes that the use of the words ``tobacco product'' in the
warning might be thought to have the potential to confuse consumers.
Accordingly, FDA request comments, including supporting facts,
research, and other evidence regarding the following questions:
Do the words ``tobacco product'' in this proposed warning
have the potential to cause confusion for consumers? If so, what are
the product types where such a warning could potentially confuse
consumers?
If there are concerns about the use of the word ``tobacco
product,'' what other language should FDA consider utilizing in this
proposed warning?
Would such other proposed language still have the ability
to notify consumers that certain products (especially those that look
like candy) are, in fact, tobacco products and potentially harmful and/
or addictive?
D. Age of Initiation for Cigar Smokers
FDA's proposed warning statements are intended to educate both
youth and adults regarding the dangerous effects of cigar smoking in
order to provide consumers with the information to better understand
the potential consequences of their decisions, and in the case of
youth, to prevent youths from initiating use. There is a common
misconception that young people do not smoke cigars, and it is
therefore unnecessary to warn them of the dangers of cigar smoking
(Ref. 28 at 13). However, as discussed in this document, data show that
a substantial number of young people smoke cigars (defined as cigars,
little cigars, and cigarillos). Each day in the United States, more
than 3,000 youth under age 18 smoke their first cigar (Ref. 81). In
addition, young people who use both cigars and cigarettes are more
likely to be frequent users of both products (Ref. 117 at 647).
Therefore, the proposed warnings are necessary to alert young people to
the dangers of initiating cigar use, as well as to help current cigar
smokers better understand and appreciate the health risks of using
cigars.
Young adults appear to be particularly interested in cigarillos, as
opposed to large cigars. The close resemblance of small cigars and many
cigarillos to cigarettes have led consumers, particularly children and
young adults, to substitute them for cigarettes (Ref. 160). Researchers
assessing studies designed to measure cigar use have found significant
increases in reported cigar prevalence when they reproduced the studies
but added examples of little cigar and cigarillo brands, indicating
consumer confusion between little cigars and cigarillos on one hand,
and cigarettes on the other, as well as indicating consumer
substitution of little cigars and cigarillos for cigarettes. For
example, researchers re-administered the Youth Risk Behavior Survey to
six Midwestern high schools and included a popular little cigar brand
name to the item measuring cigar use (Ref. 65). When the survey was
initially administered, the local rates of cigar and cigarette use were
consistent with national rates (id.). However, when the cigar item was
modified to include a little cigar brand-specific example, the
percentage of high school students reporting cigar use nearly doubled--
jumping from 12.9 percent to 20.7 percent (Ref. 65). Likewise,
researchers assessing data from the 2009 Virginia Youth Tobacco Survey
found that 57.3 percent of respondents who used a popular brand of
little cigars and cigarillos erroneously reported no general cigar use
(Ref. 66). These findings are consistent with focus group data for
2001, where researchers found that respondents generally (but wrongly)
did not think inexpensive cigarillos or little cigars were ``cigars,''
and where the rate of self-reported cigar use increased by 37.5 percent
once the definition of cigar was clarified (Ref. 161). Moreover, in a
secondary analysis of cigar use by persons aged 18 to 25 from the
National Survey on Drug Use and Health (2002-2008), researchers
determined that the top five cigar brands most frequently smoked by
current cigar users include little cigars or cigarillos (Ref. 162).
Research also shows that youth may be initiating cigar use as much
as cigarette use. The National Survey on Drug Use and Health found that
of the more than 2.9 million people aged 12 and above who first used
cigars of any type in 2010, nearly 1.1 million (or approximately 37
percent) were under the age of 18 at initiation (Ref. 82). (This
amounts to nearly 3,000 youths initiating cigar use every day.) By
comparison, of the nearly 2.4 million people aged 12 and above who
first used cigarettes in 2010, 1.4 million (or approximately 58.3
percent) were under the age of 18 at initiation (Ref. 82). (This
amounts to 3,800 youths initiating cigarette use each day.) A 2009
study found similar results, reporting that approximately 14 percent of
high school students had smoked cigars at least 1 day during the
previous 30-day period, compared with 19.5 percent who had smoked
cigarettes at least 1 day during the same period (Ref. 167 at 10, 12).
The Office of Inspector General of the Department of Health and
Human Services (HHS) also published figures in 1999 regarding the
patterns of cigar use. According to their survey, 76 percent of high
school and junior high teens knew other teens about their age who
smoked cigars (Ref. 35 at 4). While most teens' first exposure to
tobacco was with cigarettes, 22 percent of students in this survey
tried cigars first (Ref. 35 at 6). This is of particular concern given
that young people who start as cigar-only users are more susceptible to
becoming future cigarette users than other youth (id.). This report
also notes that manufactured cigars (i.e., most types of small cigars
and cigarillos) are most commonly used by teens due to their ease of
purchase, low cost, sweetened flavors, and pleasant aromas (Ref. 35 at
ii). More recent surveys have confirmed the popularity of small cigars
and cigarillos is due at least in part to the availability of a wide
variety of flavors (Ref. 162 citing Ref. 163; Ref. 164; Ref. 165).
Young consumers appear to view little cigars and cigarillos as being
less expensive and more convenient than large and premium cigars,
contributing to their popularity (Ref. 160).
In addition, according to the 2001 National Household Survey on
Drug Abuse, the number of younger children initiating cigar use is
beginning to exceed the number of young adults initiating cigar use,
further highlighting the importance of health warnings. From 1965 until
1996, there were more cigar initiates among 18- to 25-year olds than
among 12- to 17-year olds (Ref. 166). Yet, from 1997 to 2000, the
number of new cigars users in the 12- to 17-year old group exceeded the
18- to 25-year-old initiates (id.).
In some states, cigar smoking among youth may be even more popular
than cigarette smoking. For example, the 2009 Youth Risk Behavior
Surveillance study found that 18 percent of high school boys in
Massachusetts were cigarette smokers and 22 percent were cigar smokers
(Ref. 167 at 66, 72). Similarly, an Ohio survey of 4,335 students
showed cigars to be the most popular tobacco product among high school
students (Ref. 11 at 647). (See also Ref. 164.) These data indicate
that small and large cigars are no longer an ``alternative'' to
cigarette use, but rather they are the most popular tobacco product for
many young people.
E. Proposed Required Warning Statements for Small and Large Cigars
FDA is proposing five health warning statements for use on all
cigar packages
[[Page 23168]]
and in all cigar advertisements. Under Option 1, all cigars would be
required to display these health warning statements. Under Option 2,
only a subset of cigars (i.e., those defined as ``covered cigars,''
which would exclude ``premium'' cigars) would be required to display
these warning statements. The first four warnings (discussed in this
document) are identical to four of the warnings included in the seven
consent orders that the FTC entered into with the largest mass
marketers of cigars. (See, e.g., In re Swisher International, Inc.,
Docket No. C-3964.) FDA is not proposing the fifth FTC warning (Tobacco
Use Increases The Risk Of Infertility, Stillbirth And Low Birth
Weight), because although cigarette smoking has been shown to cause
these health effects and cigar smoke is similar, 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.
1. WARNING: Cigar Smoking Can Cause Cancers of the Mouth and Throat,
Even if You Do Not Inhale
The NCI's Monograph No. 9 provides a comprehensive, peer-reviewed
analysis of the trends in cigar smoking and potential public health
consequences. NCI identified a dose-response relationship for cigar
smoking and oral, laryngeal, pharyngeal, and esophageal cancers,
finding an increased risk of these diseases with greater numbers of
cigars smoked per day and deeper inhalation (Ref. 28 at 120-130). Cigar
smoking can cause cancers of the mouth and throat even for smokers who
do not inhale (id.). As a result, cigar smokers who do not inhale have
disease risks higher than those who have never smoked (Ref. 28 at ii).
FDA believes that a warning regarding these potential health
consequences is necessary because of consumers' widely held, but
erroneous, belief that cigars are safe products if users do not inhale
the smoke (id.).
``The data clearly establish cigar smoking as a cause of oral
cancer'' (Ref. 28 at 127). Regular cigar smokers who have never smoked
cigarettes, including those who do not inhale, experience significantly
elevated risks for oral, laryngeal, pharyngeal, and esophageal cancers
(Ref. 28 at ii and Ref. 62 at 738). While former cigarette smokers who
currently smoke cigars are more likely to inhale deeply than cigar
smokers who never smoked cigarettes, ``the mouth and oral cavity are
exposed to the carcinogens in smoke whether the smoke is inhaled or
not'' (Ref. 28 at 120). In addition, cigar smokers, including those who
do not inhale, have a similar risk of mouth and throat cancer as do
cigarette smokers, with an overall risk 7 to 10 times higher than for
those who have never smoked (Ref. 28 at 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).
Likewise, NCI researchers found that the data taken as a whole support
cigar smoking as a cause of laryngeal cancer, noting that the relative
risk for those who smoke five or more cigars per day or who inhale
moderately or deeply approaches the risk for cigarette smokers (Ref. 28
at 130).
The data also establish cigar smoking as a cause of esophageal
cancer (id.). Cigar smokers, regardless of whether they inhale, receive
a high smoke exposure to the mouth and tongue, and the esophagus is
exposed to the carcinogens of tobacco smoke, which collect on the
mouth's surface and are swallowed with saliva (id.). The risk of
esophageal cancer is several times higher among cigar smokers than
among those who have never smoked, and the relative risk of occurrence
is similar to that for cigarette smokers (id.).
Several multinational research studies also have noted that cigar
smoking can cause oral cancers and other cancers, even for those who do
not inhale. For example, the European Prospective Investigation into
Cancer and Nutrition (EPIC) examined the effects on cancer incidence
for exclusive cigar smokers, and for cigar smoking in combination with
cigarettes, on 102,395 men from Denmark, Germany, Spain, Sweden, and
the United Kingdom (Ref. 168 at 2402). According to the EPIC study
findings, exclusive cigar smokers who did not inhale had approximately
a two-fold higher risk of lung, upper aerodigestive tract (which
includes oral cavity, pharynx, larynx, and esophagus), and bladder
cancers combined, compared to those who never smoked, and this risk was
six- or seven-fold higher in cigar smokers who inhaled (Ref. 168 at
2405). This increased risk was smallest for smokers who had quit both
cigarettes and cigars in the past and intermediate for those who
switched to only cigars, demonstrating the additional risk associated
with cigar smoking per se (Ref. 168 at 2409). Researchers confirmed a
carcinogenic effect from cigar smoking for upper aerodigestive tract
cancers and found that the risk of these hazards increased with
increased duration of smoking over the smoker's lifespan, increased
intensity per episode, and increased degree of smoke inhalation per
episode (id.).
Similarly, the WHO International Agency for Research on Cancer
(IARC) published a monograph evaluating the carcinogenic risk to humans
from tobacco smoke and involuntary smoke exposure. The IARC explained:
``Cigar and/or pipe smoking is strongly related to cancers of the oral
cavity, oropharynx, hypopharynx, larynx, and oesophagus, the magnitude
of risk being similar to that from cigarette smoking. These risks
increase with the amount of cigar . . . smoking and with the
combination of alcohol and tobacco consumption'' (Ref. 169 at 1184).
2. WARNING: Cigar Smoking Can Cause Lung Cancer and Heart Disease
As discussed in this section, research has shown that cigar smoking
can cause lung cancer and heart disease. Yet, national survey data
found that while 46.6 percent of cigar smokers believe smoking is a
high-risk behavior for developing cancer, they exhibit an ``optimistic
bias'' in estimates of their own risk of developing cancer over 20
years--only 8.7 percent consider themselves to be at high risk (Ref. 30
at 737). FDA believes this proposed warning is necessary to help both
consumers who may be considering smoking cigars and current smokers
better understand and internalize these potential (and critical) health
consequences.
a. Lung Cancer
The evidence clearly establishes that cigar smoking can cause lung
cancer, but the rate of risk varies (Ref. 28 at 119-120 and Ref. 169 at
1180). Like the dose-response relationship apparent from cigar smoking
and mouth and throat cancers, the risk of dying from lung cancer
increases as the number of cigars smoked per day and the depth of
inhalation increase (Ref. 28 at 119-120). Overall lung cancer risk for
cigar smokers also may be similar to the risk for cigarette smokers
once the rates are adjusted for differences in inhalation levels and
quantity of cigars smoked daily (Ref. 28 at 120). For example, cigar
smokers smoking five or more cigars daily with moderate inhalation have
lung cancer risks similar to pack-a-day cigarette smokers (Ref. 28 at
119).
Former cigarette smokers who currently smoke cigars are more likely
to inhale deeply than cigar smokers who have never smoked cigarettes,
increasing their lung cancer risk (Ref. 28 at 155). Cigarette smokers
who switch to smoking only cigars have lung cancer risks that are lower
than continuing cigarette smokers, but these risks appear to be
substantially greater than for
[[Page 23169]]
individuals who have quit smoking altogether (Ref. 28 at 120, 155).
Likewise, in an analysis of the data from the Cancer Prevention
Study II (a large, long-term study of 1.2 million men and women),
researchers found that the risk of lung cancer mortality was
approximately 5 times higher for men who were current smokers of only
cigars at the start of the 12-year followup study period, compared with
men who never smoked (Ref. 170 at 334). This risk was higher for men
who smoked 3 or more cigars per day, who reported inhaling cigar smoke,
or who had smoked cigars for 25 years or more (id.). Notably, even
cigar smokers who reported that they did not inhale were approximately
three times more likely to die from lung cancer than those who never
smoked (id.).
b. Heart Disease
Researchers have identified a pattern of elevated rates of coronary
heart disease and aortic aneurysm among cigar smokers who smoke heavily
or inhale deeply. Evidence from the Cancer Prevention Study, Surgeon
General's reports, and international studies further substantiate the
need to provide clear warnings to consumers of the risk of heart
disease associated with smoking cigars.
The Cancer Prevention Study I (CPS I), which studied nearly 1
million men and women in 25 states, found evidence that the rate of
coronary heart disease increases with an increase in the numbers of
cigars smoked and greater depth of inhalation (Ref. 28 at 144-145).
Researchers also identified a significantly elevated risk of developing
coronary heart disease in those who smoked five or more cigars per day
and exhibited moderate and deep inhalation (id.). Data from CPS I also
suggested that cigar smokers are at an increased risk for aortic
aneurysm, experiencing a risk rate approaching the rate observed for
cigarette smokers (Ref. 28 at 151-152).
Researchers analyzing data from the Cancer Prevention Study II (CPS
II) also examined death rates due to coronary heart disease related to
cigar smoking. The 1999 analysis looked at approximately 7,000 current
cigar smokers, 7,000 former cigar smokers, and 113,000 men who had
never regularly smoked tobacco to determine the risk of heart disease
for cigar smokers (Ref. 30 at 739). Among men younger than 75 years
old, current cigar smokers experienced a coronary heart disease death
rate about one-third higher than those who had never smoked (id.).
In the 2010 Surgeon General's report on smoking hazards, titled
``How Tobacco Smoke Causes Disease,'' the Surgeon General found that
for older adult cigar smokers, particularly those who smoke more than
one cigar per day or inhale the smoke, the risk of heart disease is
moderately higher than that for nonsmokers (Ref. 50 at 362). Among the
studies relied upon by the Surgeon General was a study published in the
New England Journal of Medicine involving 17,774 men (1,546 who smoked
cigars and 16,228 who did not) ages 30 to 85 at baseline (from 1964
through 1973), who reported that they had never smoked cigarettes and
did not currently smoke a pipe (Ref. 33 at 1773). The researchers
determined that cigar smoking was associated with a moderate, but
significant, increase in the risk of coronary heart disease (Ref. 33 at
1778-1779).
International researchers have reached similar conclusions
regarding the impact of cigar smoking on the risk of developing heart
disease. For example, in a study of more than 12,000 Danish people aged
30 and over, which looked at the risk of first acute myocardial
infarction, researchers found highly significant effects related to the
number of cigars used per day and the depth of inhalation of smoke
(Ref. 28 at 143). Another Danish study found the highest rates of
myocardial infarction for smokers of cheroots (a type of cigar) at the
rate of six or more per day, with a relative risk of more than four
times the risk for those who had never smoked (Ref. 28 at 142).
3. WARNING: Cigars Are Not a Safe Alternative to Cigarettes
Many consumers wrongly believe that cigars are a safe alternative
to cigarettes. As discussed in section V.C, research suggests that
youth perceive cigars in a more positive light than cigarettes and
believe they are less harmful (Refs. 35 and 116). In addition, some
cigar smokers believe that cigars are a safe alternative to cigarettes
(Ref. 117). However, the dangers from cigar smoking are similar in
nature and magnitude to the adverse health effects associated with
cigarette smoking. FDA is proposing this health warning to dispel
consumers' widespread, but false, belief that cigars are a safe
alternative to cigarettes.
The tobacco smoke from both cigars and cigarettes is carcinogenic
to humans, and the toxicants in cigar smoke may be even more dangerous
than those in cigarette smoke (Ref. 28). The smoke from both tobacco
products is formed largely from the incomplete combustion of tobacco,
resulting in cigar smoke being composed of the same toxic and
carcinogenic constituents as are in cigarette smoke (Ref. 28 at 3). In
addition, the lower porosity of cigar wrappers results in more carbon
monoxide per gram of tobacco burned than with cigarettes, and the
higher nitrate content of cigar tobacco causes higher concentrations of
nitrogen oxides, carcinogenic N-nitrosamines and ammonia (id.). When
bioassayed in animals (i.e., tested in animals to determine its
potency), the tar of cigar smoke has been found to be more carcinogenic
than the tar in cigarette smoke (id.). Data on cigarette smoking and
disease risk are more extensive than the data available for cigars;
however, given the similarities between the composition of cigar and
cigarette smoke, it is reasonable to assume that most of the diseases
caused by inhalation of tobacco smoke from cigarettes can be caused by
inhalation of tobacco smoke from cigars (Ref. 28 at 113). Therefore,
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).
The mortality rates for cigar smokers also illustrate that cigars
are not a safe alternative to cigarettes. The overall mortality rates
for cigar smokers are higher than rates for those who have never
smoked, although they may be generally lower than the rates observed
for cigarette smokers (Ref. 28 at 112). In addition, the overall
mortality rates for those who inhale approach those rates for cigarette
smokers (Ref. 28 at 110-112). Further, although data on the risk for
those who switch from smoking cigarettes to only cigars are limited,
the existing data suggest that the risk of developing lung cancer for
persons who switch from cigarettes to cigars is substantially higher
than the risk for cigarette smokers who stop smoking all tobacco
products (Ref. 28 at 120). While those who smoke only cigars seem to
have a lower risk of cardiovascular disease than cigarette smokers,
cigarette smokers who switch to cigars often inhale the smoke and thus
are less likely to experience the lower risk of cardiovascular disease
(Refs. 170 and 28 at 145).
4. WARNING: Tobacco Smoke Increases the Risk of Lung Cancer and Heart
Disease, Even in Nonsmokers
In section VII.E.2, we explain the risk of lung cancer and heart
disease associated with cigar smoke and the need to warn consumers
about these
[[Page 23170]]
potential health consequences. Extensive data also exists regarding the
dangers of involuntary exposure to tobacco smoke, including cigar
smoke. Accordingly, FDA proposes to require a warning on cigar packages
and in advertisements to help cigar smokers and potential smokers
understand and appreciate that all tobacco smoke increases the risk of
lung cancer and heart disease for nonsmokers.
It is well established that secondhand smoke causes premature death
and disease in youth and in adults who do not smoke (see, e.g., Ref.
171 at 11 and Ref. 172 at 83, 104). Adult exposure to secondhand smoke
has immediate adverse effects on the cardiovascular system and can lead
to lung cancer and coronary heart disease (Ref. 171 at 445, 532).
Tobacco smoke contains over 4,000 compounds, and there are more than 50
carcinogens in sidestream and mainstream smoke generated from cigars
(Ref. 28 at 96 and Ref. 171). Mainstream cigar smoke is the smoke that
one draws into his or her mouth from the butt end or mouthpiece of a
cigar; whereas sidestream cigar smoke is the smoke emitted from the
burning cone of a cigar during the interval between puffs (Ref. 28 at
65). The Surgeon General recently reiterated that cigar smoke contains
the same toxic substances as cigarette smoke, with varying
concentrations of these constituents found in different types and sizes
of cigars (Ref. 171 at 362 and Ref. 28 at 17-18). Even though tobacco
users (on average) smoke more cigarettes than cigars, the overall level
of toxicants in secondhand smoke from cigars actually is quantitatively
higher than it is in the secondhand smoke produced from cigarettes
(Ref. 28 at 79). Cigars also produce much higher levels of many indoor
pollutants than do cigarettes (Ref. 28 at iii). The smoke from one
cigar can take 5 hours to dissipate, exposing household members to a
considerable involuntary health risk (Ref. 28 at 163).
a. Lung Cancer and Secondhand Smoke
More than 50 carcinogens have been identified in sidestream and
secondhand smoke (Ref. 171). Cigar smoke ``tar'' appears to be at least
as carcinogenic as cigarette smoke ``tar'' (id.). Exposure of
nonsmokers to secondhand smoke has been shown to cause a significant
increase in urinary levels of metabolites of tobacco-specific
nitrosamines, a carcinogen that specifically links exposure to
secondhand smoke with an increased risk for lung cancer (Ref. 171 at
65). All cigars 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). Cigar smoke also
produces measurable amounts of lead and cadmium (Ref. 28 at 75-76).
Little cigars with filter tips and regular cigars contain higher levels
of certain nitrosamines in sidestream smoke than do filtered tip
cigarettes (Ref. 28 at 81).
The Surgeon General recently reiterated that there was considerable
evidence that certain nitrosamines are major factors in the development
of lung cancer (Ref. 171 at 30). According to the Surgeon General, the
evidence was sufficient to infer a causal relationship between
secondhand smoke exposure and lung cancer among lifetime nonsmokers
(Ref. 171 at 434). Individuals living with smokers had a 20 to 30
percent increase in risk of developing lung cancer from secondhand
exposure (Ref. 171 at 445). Although the data to demonstrate a similar
causal relationship is not available, FDA believes it is reasonable to
expect that cigar smoke would produce similar effects, given that data
from the NCI cigar monograph showed that some carcinogens determined to
cause lung cancer are present at higher levels in cigar smoke than in
cigarette smoke and at comparable levels of other carcinogens linked to
lung cancer (Ref. 28 at 76-93).
b. Heart Disease and Secondhand Smoke
The proposed health warning statement indicating that tobacco smoke
can cause heart disease is thoroughly supported by the evidence
reiterated in reports from the Surgeon General (as discussed in section
VII.E.2). FDA believes it is reasonable to expect that this finding
would produce similar effects with respect to secondhand cigar smoke
exposure based on the similar smoke profiles for cigars and cigarettes,
the risk of coronary heart disease associated with active cigar
smoking, and the low levels of toxicant exposure that can cause
coronary heart disease (Ref. 171).
In a 2006 report regarding the health effects of exposure to
secondhand smoke, the Surgeon General concluded that exposure of adults
to secondhand smoke had immediate adverse effects on the cardiovascular
system and caused coronary heart disease (Ref. 171 at 11). Secondhand
smoke increased the risk of coronary heart disease nearly as much as
active heavy smoking. In fact, the estimated increase in risk of
coronary heart disease from exposure to secondhand smoke was 25 to 30
percent above that of unexposed persons (Ref. 171 at 519 and Ref. 83 at
532). Based on these data, the Surgeon General concluded that ``the
evidence is sufficient to infer a causal relationship between exposure
to secondhand smoke and increased risks of coronary heart disease
morbidity and mortality among both men and women'' (Ref. 171 at 15).
The IOM agreed, concluding that there is a causal relationship between
secondhand smoke exposure and cardiovascular disease, as well as a
causal relationship between secondhand smoke exposure and acute
myocardial infarction (Ref. 172 at 219).
Even a relatively brief exposure to secondhand tobacco smoke can
lead to heart disease, as some studies have demonstrated. The IOM found
there is compelling circumstantial evidence that a relatively brief
exposure to secondhand smoke can bring about an acute coronary event
(Ref. 172 at 220).
Given that the effects of secondhand smoke on coronary heart
disease are linked to the combustion of tobacco itself, FDA concludes
that exposure to secondhand cigar smoke can cause the same or similarly
dangerous effects as exposure to secondhand cigarette smoke.
VIII. Description of the Proposed Rule
A. Proposed Part 1100--Tobacco Products Subject to FDA Authority
The proposed rule would add new part 1100 that would describe the
scope of FDA's authority over tobacco products, the requirements that
would apply to tobacco products, applicable definitions, and the
effective date of the rule.
1. Proposed Sec. 1100.1--Scope
Section 201(rr) of the FD&C Act defines the term ``tobacco
product,'' in part, as any product ``made or derived from tobacco''
that is not a ``drug,'' ``device,'' or combination product under the
FD&C Act. The Tobacco Control Act permitted FDA to use the ``tobacco
product'' authorities in the FD&C Act to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco automatically
(``This chapter shall apply to all cigarettes, cigarette tobacco, roll-
your-own tobacco, and smokeless tobacco'' (section 901 of the FD&C
Act)). Therefore, the provisions of the FD&C Act applicable to
``tobacco products'' currently apply only to those products.
Section 901 of the FD&C Act provides that the Secretary of HHS, and
by delegation FDA, has the authority to ``deem'' any other tobacco
products to be subject to the FD&C Act. FDA is exercising this
authority and is
[[Page 23171]]
proposing, in Option 1 for proposed Sec. 1100.1 of this rule, to deem
all products meeting the definition of ``tobacco product,'' as defined
in section 201(rr) of the FD&C Act except accessories of a proposed
deemed tobacco product, to be subject to the FD&C Act. Because the
statutory definition of ``tobacco product'' includes ``any component,
part, or accessory'' and FDA has chosen to exclude ``accessory'' from
the scope of the deeming regulation at this time, the provisions of the
FD&C Act related to ``tobacco product'' also would apply to only the
components and parts of the proposed deemed tobacco products.
To date, FDA has issued and finalized one such implementing
regulation: ``Exemptions From Substantial Equivalence Requirements''
(76 FR 38961, July 5, 2011). Therefore, if this rule is finalized, the
requirements in those regulations would apply to proposed deemed
tobacco products. Proposed deemed tobacco products also would be
covered by the ``Amendments to General Regulations of the Food and Drug
Administration'' rule that became effective on April 14, 2011 (76 FR
12563, March 8, 2011), and the ``Further Amendments to General
Regulations of the Food and Drug Administration to Incorporate Tobacco
Products'' rule that became effective on April 2, 2012 (77 FR 5171,
February 2, 2012) (conforming amendment regulations). Any entity that
manufactures, distributes, imports, or sells the proposed deemed
products is invited to comment on the substantial equivalence and
conforming amendment regulations. In addition, FDA will review existing
guidance documents to determine whether they need to be revised in
light of this rulemaking.
2. Proposed Sec. 1100.2--Requirements
Option 1 for proposed Sec. 1100.2 would state that cigarettes,
cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and all
other tobacco products, as defined in section 201(rr) of the FD&C Act
except the accessories of such other tobacco products, are subject to
the FD&C Act and its implementing regulations. As previously explained,
FDA currently has authority to regulate cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco with the regulatory tools
provided in the FD&C Act. If this proposed rule is finalized, all other
tobacco products that meet the statutory definition, in addition to
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco, and including the components and parts but not accessories of
such other tobacco products, would be subject to the FD&C Act and its
implementing regulations. Option 2 would limit the type of cigars that
would be subject to the FD&C Act and its implementing regulations. For
Option 2, only those cigars the meet the definition of ``covered
cigar'' would be subject to the FD&C Act and its implementing
regulations. FDA is requesting comments as to whether it is appropriate
to deem premium cigars and how non-combustible novel products like e-
cigarettes should be regulated. (See sections IV.C and IV.D.)
3. Proposed Sec. 1100.3--Definitions
Option 1 for proposed Sec. 1100.3 would include one definition
that would apply to this part.
The definition in proposed Sec. 1100.3 is a restatement of the
statutory definition of ``tobacco product'' found in section 201(rr) of
the FD&C Act. FDA proposes to restate the definition of ``tobacco
product'' in two parts: (1) Tobacco product means any product made or
derived from tobacco that is intended for human consumption, including
any component, part, or accessory of a tobacco product (excluding raw
materials other than tobacco used in manufacturing a component, part,
or accessory of a tobacco product) and (2) tobacco product does not
mean an article that is a drug, device, or combination product as those
terms are defined in the FD&C Act. We are repeating the statutory
definition of ``tobacco product'' in this proposed rule for easy
reference for readers of this regulation.
Option 2 for this section would, in addition to defining ``tobacco
product,'' add definitions for ``cigar'' and ``covered cigar.'' A
``cigar'' would be defined as a tobacco product that also meets two
requirements: (1) It is not a cigarette and (2) it is a roll of tobacco
wrapped in leaf tobacco or any substance containing tobacco. This
definition was used in the seven consent orders that the FTC entered
into with the largest mass marketers of cigars. (See, e.g., In re
Swisher International, Inc., Docket No. C-3964.) ``Covered cigar''
would mean any cigar (as defined in Sec. 1100.3), but excluding any
cigar that meets the following requirements: (1) It is wrapped in whole
tobacco leaf; (2) it contains a 100 percent leaf tobacco binder; (3) it
contains primarily long filler tobacco; (4) it is made by combining
manually the wrapper, filler, and binder; (5) it does not have a
filter, tip or non-tobacco mouthpiece and the cap (or crown) of the
cigar is added by hand; (6) it 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) it does
not have a characterizing flavor other than tobacco; and (8) it weighs
more than 6 pounds per 1000. FDA is proposing this definition to limit
the scope of cigars covered under Option 2 by excluding ``premium''
cigars. As discussed earlier, FDA is soliciting comment on how this
proposed rule should apply to cigars.
4. Proposed Effective Date
The requirements in the FD&C Act that currently apply to
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco became effective: (1) On the date of enactment of the Tobacco
Control Act (i.e., June 22, 2009) (referred to in this document as the
automatic provisions), (2) on deadlines based on or calculated from the
date of enactment of the Tobacco Control Act, or (3) upon issuance of a
guidance and/or rulemaking specified by the Tobacco Control Act.
Likewise, FDA is proposing that the effective date of parts 1100
and 1140 be the date of publication of a final rule (if this proposed
rule is finalized) plus 30 days. All of the statutory provisions found
in the FD&C Act that currently are in effect for cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco, or will be in
effect as of 30 days after the date of publication of the final rule,
would apply to proposed deemed tobacco products as a matter of law on
this effective date. Provisions that have not yet become effective as
of the date of publication of the final rule, but rather will become
effective when FDA issues a regulation or guidance, would not yet be in
effect for proposed deemed tobacco products (e.g., regulations
implementing section 915(a) of the FD&C Act for testing, reporting, and
disclosure of tobacco product constituents, ingredients, and additives,
including smoke constituents, by brand and subbrand). These provisions
would apply to all tobacco products subject to the FD&C Act (but not to
accessories of a tobacco product) only when the regulation or guidance
required by the statute is issued.
The final rule publication date plus 30 days was chosen as the
proposed effective date to comply with 5 U.S.C. 553(d) (i.e., the
Administrative Procedure Act requires that a substantive rule provide a
30-day period before its effective date) and to be consistent with the
Tobacco Control Act. Many of the requirements in the FD&C Act became
effective on the date that the Tobacco Control Act was
[[Page 23172]]
enacted, such as sections 902 (adulterated tobacco products), 903
(misbranded tobacco products), and 904(b) (ability of FDA to request
the submission of certain documents from tobacco product manufacturers
or importers). See section VIII.A.1 where we discuss the effect of this
rule on implementing regulations and guidance documents that FDA has
already issued that pertain to ``tobacco products.''
5. Proposed Compliance Dates for Certain Provisions
As described in VIII.A.4, not all of the requirements in the FD&C
Act became effective on the date of enactment of the Tobacco Control
Act. The effective date of some requirements are based on or calculated
from the date of enactment of the Tobacco Control Act, and some
requirements become effective only upon issuance of a guidance and/or
regulation specified by the Tobacco Control Act. For example, section
904(a)(1) of the FD&C Act requires each tobacco manufacturer to submit
an ingredient listing to FDA ``not later than 6 months after the date
of enactment'' of the Tobacco Control Act.
To avoid confusion, and to provide time for firms to comply with
provisions that require labeling changes or information submissions to
the Agency, FDA is proposing compliance timeframes for certain
provisions. For consistency and fairness, FDA is generally using the
existing dates found in the Tobacco Control Act as a guide for
determining the timeframe for compliance with these provisions. Table
1B of this document lists certain provisions that would be applicable
to proposed deemed tobacco products and the dates on which FDA proposes
to start enforcing compliance with those provisions. FDA is seeking
comment on the proposed compliance dates for the provisions listed in
table 1B.
Table 1B--Compliance Dates for Various Provisions
----------------------------------------------------------------------------------------------------------------
FD&C Act citation Provision Compliance date
----------------------------------------------------------------------------------------------------------------
903(a)(2)............................... A tobacco product shall be deemed 24 months after the
misbranded if in package form unless it issuance of the final
bears a label containing--. regulation.
(A) the name and place of business of the
tobacco product manufacturer, packer, or
distributor;
(B) an accurate statement of the quantity
of the contents in terms of weight,
measure, or numerical count;
(C) an accurate statement of the
percentage of the tobacco used in the
product that is domestically grown
tobacco and the percentage that is
foreign grown tobacco; and
(D) the statement required under section
920(a), except that under subparagraph
(B) reasonable variations shall be
permitted, and exemptions as to small
packages shall be established, by
regulations prescribed by the Secretary.
903(a)(3)............................... A tobacco product is misbranded--if any Effective date of part
word, statement, or other information 1100 PLUS 1 year.
required by or under authority of this
chapter to appear on the label or
labeling is not prominently placed
thereon with such conspicuousness (as
compared with other words, statements, or
designs in the labeling) and in such
terms as to render it likely to be read
and understood by the ordinary individual
under customary conditions of purchase
and use.
903(a)(4)............................... A tobacco product is misbranded--(4) if it Effective date of part
has an established name, unless its label 1100 PLUS 1 year.
bears, to the exclusion of any other
nonproprietary name, its established name
prominently printed in type as required
by the Secretary by regulation.
903(a)(8)............................... A tobacco product is misbranded--(8) Effective date of part
unless, in the case of any tobacco 1100 PLUS 1 year.
product distributed or offered for sale
in any State, 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--(A) a true statement of the
tobacco product's established name as
described in paragraph (4), printed
prominently; and (B) a brief statement
of--(i) the uses of the tobacco product
and relevant warnings, precautions, side
effects, and contraindications; and (ii)
in the case of specific tobacco products
made subject to a finding by the
Secretary after notice and opportunity
for comment that such action is
appropriate to protect the public health,
a full description of the components of
such tobacco product or the formula
showing quantitatively each ingredient of
such tobacco product to the extent
required in regulations which shall be
issued by the Secretary after an
opportunity for a hearing.
904(a)(1) and 904(c)(1)................. (a)(1) REQUIREMENT.--Each tobacco product Effective date of part
manufacturer or importer, or agents 1100 PLUS 6 months
thereof, shall submit to the Secretary (products on the market
the following information: (1) Not later as of the effective date)
than 6 months after the date of enactment or 90 days before
of the Family Smoking Prevention and delivery for introduction
Tobacco Control Act, a listing of all into interstate commerce
ingredients, including tobacco, (products entering the
substances, compounds, and additives that market after the
are, as of such date, added by the effective date).
manufacturer to the tobacco, paper,
filter, or other part of each tobacco
product by brand and by quantity in each
brand and subbrand.
(c) TIME FOR SUBMISSION.--................
(1) IN GENERAL.--At least 90 days prior to
the delivery for introduction into
interstate commerce of a tobacco product
not on the market on the date of
enactment of the Family Smoking
Prevention and Tobacco Control Act, the
manufacturer of such product shall
provide the information required under
subsection (a)..
[[Page 23173]]
904(a)(3)............................... REQUIREMENT.--Each tobacco product Effective date of part
manufacturer or importer, or agents 1100 PLUS 3 years.
thereof, shall submit to the Secretary
the following information: (3) Beginning
3 years after the date of enactment of
the Family Smoking Prevention and Tobacco
Control Act, a listing of all
constituents, including smoke
constituents as applicable, identified by
the Secretary as harmful or potentially
harmful to health in each tobacco
product, and as applicable in the smoke
of each tobacco product, by brand and by
quantity in each brand and subbrand.
904(a)(4)............................... REQUIREMENT.--Each tobacco product Effective date of part
manufacturer or importer, or agents 1100 PLUS 6 months
thereof, shall submit to the Secretary (current manufacturers)
the following information: (4) Beginning or 90 days prior to
6 months after the date of enactment of delivery for introduction
the Family Smoking Prevention and Tobacco into interstate commerce
Control Act, all documents developed (new manufacturers).
after such date of enactment that relate
to health, toxicological, behavioral, or
physiologic effects of current or future
tobacco products, their constituents
(including smoke constituents),
ingredients, components, and additives.
905(b), (c), (d), and (h)............... 905(b)--REGISTRATION BY OWNERS AND If the final rule
OPERATORS.--On or before December 31 of publishes in the second
each year, every person who owns or half of the calendar
operates any establishment in any State year, FDA will designate
engaged in the manufacture, preparation, a date for owners and
compounding, or processing of a tobacco operators to register
product or tobacco products shall that is no later than 6
register with the Secretary the name, months into the
places of business, and all such subsequent calendar year.
establishments of that person. If (The registration date
enactment of the Family Smoking will be specified in a
Prevention and Tobacco Control Act occurs draft guidance for
in the second half of the calendar year, registration.).
the Secretary shall designate a date no The timeframes for
later than 6 months into the subsequent paragraphs (c) and (d)
calendar year by which registration under take effect after the
this subsection shall occur. date specified for (b)
905(c)--REGISTRATION BY NEW OWNERS AND occurs.
OPERATORS.--Every person upon first
engaging in the manufacture, preparation,
compounding, or processing of a tobacco
product or tobacco products in any
establishment owned or operated in any
State by that person shall immediately
register with the Secretary that person's
name, place of business, and such
establishment.
905(d)--REGISTRATION OF ADDED
ESTABLISHMENTS.--Every person required to
register under subsection (b) or (c)
shall immediately register with the
Secretary any additional establishment
which that person owns or operates in any
State and in which that person begins the
manufacture, preparation, compounding, or
processing of a tobacco product or
tobacco products.
905(i)(1)............................... PRODUCT LIST.--Every person who registers Must submit at the time of
with the Secretary under subsection (b), initial registration; see
(c), (d), or (h) shall, at the time of date specified for
registration under any such subsection, 905(b).
file with the Secretary a list of all
tobacco products which are being
manufactured, prepared, compounded, or
processed by that person for commercial
distribution and which have not been
included in any list of tobacco products
filed by that person with the Secretary
under this paragraph or paragraph (2)
before such time of registration. Such
list shall be prepared in such form and
manner as the Secretary may prescribe and
shall be accompanied by--(A) in the case
of a tobacco product contained in the
applicable list with respect to which a
tobacco product standard has been
established under section 907 or which is
subject to section 910, a reference to
the authority for the marketing of such
tobacco product and a copy of all
labeling for such tobacco product;.
(B) in the case of any other tobacco
product contained in an applicable list,
a copy of all consumer information and
other labeling for such tobacco product,
a representative sampling of
advertisements for such tobacco product,
and, upon request made by the Secretary
for good cause, a copy of all
advertisements for a particular tobacco
product; and
(C) if the registrant filing a list has
determined that a tobacco product
contained in such list is not subject to
a tobacco product standard established
under section 907, a brief statement of
the basis upon which the registrant made
such determination if the Secretary
requests such a statement with respect to
that particular tobacco product.
907(a)(1)(B)............................ (B) ADDITIONAL SPECIAL RULE.--Beginning 2 Effective date of part
years after the date of enactment of the 1100 PLUS 2 years.
Family Smoking Prevention and Tobacco
Control Act, a tobacco product
manufacturer shall not use tobacco,
including foreign grown tobacco, that
contains a pesticide chemical residue
that is at a level greater than is
specified by any tolerance applicable
under Federal law to domestically grown
tobacco.
911(b)(2)(A)(i) and (ii)................ 911(a)--IN GENERAL.--No person may Use of ``light,'' ``low,''
introduce or deliver for introduction and ``mild'' descriptors:
into interstate commerce any modified Effective date of part
risk tobacco product unless an order 1100 PLUS 1 year (stop
issued under subsection (g) is effective manufacture); Effective
with respect to such product.. date of part 1100 PLUS 13
911(b)(1)--MODIFIED RISK TOBACCO PRODUCT.-- months (stop
The term 'modified risk tobacco product' distribution).
means any tobacco product that is sold or
distributed for use to reduce harm or the
risk of tobacco-related disease
associated with commercially marketed
tobacco products..
(2) SOLD OR DISTRIBUTED.--
[[Page 23174]]
(A) IN GENERAL.--With respect to a tobacco
product, the term 'sold or distributed
for use to reduce harm or the risk of
tobacco-related disease associated with
commercially marketed tobacco products'
means a tobacco product--
* * *
(ii) the label, labeling, or advertising
of which uses the descriptors light,
mild, or low or similar descriptors; or
* * *
(3) EFFECTIVE DATE.--The provisions of
paragraph (2)(A)(ii) shall take effect 12
months after the date of enactment of the
Family Smoking Prevention and Tobacco
Control Act for those products whose
label, labeling, or advertising contains
the terms described in such paragraph on
such date of enactment. The effective
date shall be with respect to the date of
manufacture, provided that, in any case,
beginning 30 days after such effective
date, a manufacturer shall not introduce
into the domestic commerce of the United
States any product, irrespective of the
date of manufacture, that is not in
conformance with paragraph (2)(A)(ii).
920(a)(1)............................... (1) REQUIREMENT.--Beginning 1 year after 24 months after the
the date of enactment of the Family issuance of the final
Smoking Prevention and Tobacco Control regulation.
Act, the label, packaging, and shipping
containers of tobacco products other than
cigarettes for introduction or delivery
for introduction into interstate commerce
in the United States shall bear the
statement 'Sale only allowed in the
United States'.
----------------------------------------------------------------------------------------------------------------
In most circumstances, the compliance dates FDA is proposing for
the proposed deemed tobacco products are similar to the timeframe in
which cigarettes, cigarette tobacco, roll-your-own tobacco, and
smokeless tobacco manufacturers or importers were required to comply
with the corresponding requirement. For example, the labeling
requirement in section 920(a)(1) of the FD&C Act required the label,
packaging, and shipping containers of tobacco products other than
cigarettes for introduction or delivery for introduction into
interstate commerce in the United States to bear the statement ``sale
only allowed in the United States'' beginning 1 year after the date of
enactment of the Tobacco Control Act. In table 1, the proposed
compliance date for this provision as applied to proposed deemed
tobacco product manufacturers would be 2 years after the effective date
of this rule. FDA is soliciting comments on the proposed compliance
dates in table 1.
6. Proposed Regulatory Approach for Newly Deemed Tobacco Products
FDA also is soliciting comment on what FDA actions or regulatory
approaches, if any, should be taken for proposed deemed tobacco
products that are ``new tobacco products'' under section 910(a)(1) of
the FD&C Act. A new tobacco product means ``any tobacco product
(including those products in test markets) that was not commercially
marketed in the United States as of February 15, 2007; or any
modification (including a change in design, any component, any part, or
any constituent, including a smoke constituent, or in the content,
delivery or form of nicotine, or any other additive or ingredient) of a
tobacco product where the modified product was commercially marketed in
the United States after February 15, 2007'' (section 910(a)(1) of the
FD&C Act). In general, a tobacco product manufacturer has three
pathways for legally marketing a new tobacco product: (1) The
manufacturer obtains an order under section 910(c)(1)(A)(i) (order
after review of a premarket application) before the manufacturer
introduces a new tobacco product into interstate commerce (section 910
of the FD&C Act); (2) the manufacturer obtains an order finding
substantial equivalence under section 910(a)(2)(A) of the FD&C Act
(order after review of a section 905(j) report) before the manufacturer
introduces a new tobacco product into interstate commerce (section 910
of the FD&C Act); and (3) the manufacturer makes a request under Sec.
1107.1 (21 CFR 1107.1) and obtains an exemption from the requirements
related to substantial equivalence.\5\ Tobacco products that were
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007, are not ``new tobacco products''
subject to the premarket requirements, and FDA refers to these products
as ``grandfathered.''
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\5\ See 21 CFR 1107.1(b) for information on requesting an
exemption under section 905(j)(3) of the FD&C Act. Manufacturers who
obtain an exemption must then submit a report under section
905(j)(1)(A)(ii) of the FD&C Act.
---------------------------------------------------------------------------
Based on initial information FDA has gathered and received from
industry, many tobacco products we are proposing to deem that are
currently being sold may not be ``grandfathered'' tobacco products
because many were not commercially marketed or modified until after
February 15, 2007. We understand that this may be particularly true in
the case of e-cigarettes and similar novel products. Moreover, new
products that come on the market in the future would never be
grandfathered tobacco products because they would be coming on the
market after February 15, 2007. We do not believe that we have the
authority to alter or amend this grandfathering date, which is set by
statute. Therefore, FDA believes most proposed deemed tobacco products
would be considered new tobacco products and would be required to
obtain an order from FDA prior to marketing under one of the three
pathways listed in section VIII.A.6. As stated in sections VIII.A.6.c
and VIII.A.6.d, FDA is proposing a 24-month compliance policy for
manufacturers of proposed deemed products to submit marketing
applications. FDA does not intend to initiate enforcement action
against products on the market for failing to have an FDA marketing
authorization until 24 months following the effective date of the final
rule. In addition, as described in section VIII.A.6.c, we intend to
continue that compliance policy pending review of marketing
applications if those applications are submitted within the 24 months
after the final rule's effective
[[Page 23175]]
date. We intend to work with industry to assist them in making
submissions. We expect that our proposed approach, as discussed in this
section, would help minimize disruption while FDA conducts its pre-
market review. Further, we request comment on whether there are ways
that we might provide additional flexibility with respect to PMTAs that
would still be appropriately protective of the public health.
a. Premarket Tobacco Applications
Before a new tobacco product may be introduced or delivered for
introduction into interstate commerce, the manufacturer must obtain an
order from FDA authorizing the marketing of the product (section
910(a)(2) of the FD&C Act). Where a new tobacco product is not
substantially equivalent to a tobacco product commercially marketed in
the United States as of February 15, 2007, or exempt from the
requirement to obtain a substantial equivalence determination, the
manufacturer must submit a premarket tobacco product application under
section 910(b) of the FD&C Act and receive a marketing authorization
order under section 910(c)(1)(A)(i) prior to marketing the product.
Under section 902(6)(A) of the FD&C Act, a tobacco product is deemed
adulterated if it is a new tobacco product and it ``does not have an
order in effect under section 910(c)(1)(A)(i)'' as necessary under
section 910(a) of the FD&C Act.
b. Substantial Equivalence
Substantial equivalence is an alternate to the primary pathway of
submitting a new tobacco product application under section 910(b) of
the FD&C Act. To obtain an substantial equivalence order, a
manufacturer must submit an SE report under section 905(j)(1) of the
FD&C Act and receive a substantial equivalence order under section
910(a)(2).
Section 905(j)(1) of the FD&C Act requires that manufacturers
submit SE reports under section 905(j) at least 90 days before
introducing or delivering for introduction into interstate commerce for
commercial distribution, a tobacco product intended for human use that
was not commercially marketed in the United States as of February 15,
2007. However, section 905(j)(2) of the FD&C Act provides that for
tobacco products that were first introduced to the market between
February 15, 2007, and March 22, 2011, SE reports were due 21 months
from the date of enactment of the Tobacco Control Act (March 22, 2011).
Products that met the requirements of section 905(j)(2) were permitted
to remain on the market pending FDA review of their SE reports
(referred to as ``provisional reports'') unless and until FDA issues an
order finding them not substantially equivalent (section 910(a)(2)(B)
of the FD&C Act). Under section 903(a)(6) of the FD&C Act, a tobacco
product is deemed misbranded ``if a notice or other information
respecting it was not provided as required by such section or section
905(j).''
c. Compliance Policy for Substantial Equivalence (SE) Reports
FDA is considering a compliance approach for proposed deemed
products that is similar to the provisional approach set forth in
sections 905(j)(2) and 910(a)(2)(B) of the FD&C Act. FDA is proposing
the following compliance policy for submission of SE reports for all
proposed deemed products.
------------------------------------------------------------------------
If a new tobacco product meets the FDA intends to enforce the FD&C
following. . . Act as follows. . .
------------------------------------------------------------------------
Is marketed between February 15, 2007, FDA does not intend to initiate
and [effective date of part 1100 plus enforcement action against the
24 months] and the manufacturer product for failing to have an
submits a 905(j) report for the FDA marketing authorization
product by [effective date of part unless and until FDA issues an
1100 plus 24 months]. order denying your substantial
equivalence submission under
910(a)(2). If FDA issues such
an order, FDA intends to
enforce the premarket
authorization requirements
with respect to your product.
Is marketed between February 15, 2007, FDA does not intend to initiate
and [effective date of part 1100 plus enforcement action against the
24 months] and the manufacturer did product for failing to have an
not submit a 905(j) report for the FDA marketing authorization
product by [effective date of part until [effective date of part
1100 plus 24 months] and has not 1100 plus 24 months].
obtained a marketing authorization Thereafter, if no PMTA has
order under section 910(c)(1)(A)(i). been filed, FDA intends to
enforce the premarket
authorization requirements
with respect to the product.
Would be marketed on or after FDA intends to enforce the
[effective date of part 1100 plus 24 premarket authorization
months]. requirements with respect to
the product.
------------------------------------------------------------------------
Therefore, FDA is proposing a compliance period of 24 months after
the effective date of this rule--during which time FDA would not intend
to initiate enforcement against the product on the market for failing
to have a marketing order from FDA. Under FDA's proposal, FDA would not
intend to initiate enforcement action for failure to have a marketing
authorization against proposed deemed tobacco products first introduced
or delivered for introduction into interstate commerce for commercial
distribution after February 15, 2007, and prior to the 905(j) proposed
compliance date (i.e., effective date plus 24 months), provided a
905(j) report is submitted no later than the proposed compliance date,
and FDA has not issued an order finding the tobacco product to be not
substantially equivalent. In these cases, the Agency would not intend
to initiate enforcement action against the tobacco product on the
market for failure to have a marketing authorization unless and until
FDA issues an order that the tobacco product is not substantially
equivalent to the predicate tobacco product (section 910(a)(2)(A) of
the FD&C Act). FDA would consider taking different or additional
actions if it believes particular circumstances warrant them. FDA would
also consider revising its compliance policy should the Agency find
that doing so is warranted, such as to better protect the public
health.
FDA is soliciting data, research, information, and comments on this
proposed approach to compliance for new tobacco products, including
comments on the following questions:
What are the benefits and/or disadvantages of a new product
compliance period longer than the proposed 24-month period?
If you disagree with the proposed 24-month new product
compliance period, provide an alternative compliance date and
supporting information.
FDA is proposing that this compliance approach should be
available to all proposed deemed tobacco products. However, should FDA
take into account other factors, such as the type of product or other
circumstances? Why or why not? If so, what factors or circumstances
would be appropriate? For example, is there a justification for having
the
[[Page 23176]]
compliance policy instead apply to the following circumstances:
[cir] When marketing of the new tobacco product is limited to
existing adult users of the product?
[cir] When marketing of the new tobacco product is unlikely to be
seen or received by youth?
[cir] When the new tobacco product bears certain warnings?
Given the express grandfather date and predicate restriction
provided in the FD&C Act that govern the process for legally marketing
a tobacco product, what are the implications for proposed deemed
tobacco products?
What is the impact on public health that proposed deemed
tobacco products that entered the U.S. market after February 15, 2007,
and have no viable predicate have available only the premarket
application pathway?
Provide examples of proposed deemed tobacco products that
would likely be able to proceed to market via the SE pathway. Describe
the range of predicates that would be available to demonstrate
substantial equivalence.
What other alternative marketing pathways or policy options
should FDA consider if, in fact, no predicate is available?
Are there other legal interpretations of the substantial
equivalence grandfather provision that FDA should consider?
d. Compliance Policy for Premarket Tobacco Product Applications
FDA is not certain that manufacturers would in fact be able to use
the SE pathway for many proposed deemed tobacco products because they
may not be able to identify a viable predicate. Where this is in fact
the case, manufacturers of proposed deemed tobacco products would have
available only the premarket application pathway (section 910(b) of the
FD&C Act). As for 905(j) reports, FDA is considering a compliance
approach for premarket tobacco product applications (PMTAs) that is
similar to the provisional approach set forth in sections 905(j)(2) and
910(a)(2)(B) of the FD&C Act. FDA is proposing the following compliance
policy for submission of all PMTAs for proposed deemed products.
------------------------------------------------------------------------
If a new tobacco product meets the FDA intends to enforce the FD&C
following. . . Act as follows. . .
------------------------------------------------------------------------
Is marketed between February 15, 2007, FDA does not intend to initiate
and [effective date of part 1100 plus enforcement action against the
24 months] and the manufacturer product for failing to have an
submits a PMTA for the product by FDA marketing authorization
[effective date of part 1100 plus 24 unless and until FDA issues an
months]. order denying the PMTA under
910(c). If FDA issues such an
order, FDA intends to enforce
the premarket authorization
requirements with respect to
the product.
Is marketed between February 15, 2007, FDA does not intend to initiate
and [effective date of part 1100 plus enforcement action against the
24 months] and the manufacturer did product for failing to have an
not submit a PMTA for the product by FDA marketing authorization
[effective date of part 1100 plus 24 until [effective date of part
months] and has not obtained a 1100 plus 24 months].
marketing authorization order under Thereafter, FDA intends to
section 910(a)(2). enforce the premarket
authorization requirements
with respect to the product.
Would be marketed on or after FDA intends to enforce the
[effective date of part 1100 plus 24 premarket authorization
months]. requirements with respect to
the product.
------------------------------------------------------------------------
Therefore, as with products that may be eligible for the SE
pathway, FDA is proposing a 24-month compliance period for products
that may only be eligible for the PMTA pathway. Under FDA's proposal,
FDA would not intend to initiate enforcement action for failure to have
a marketing authorization against proposed deemed tobacco products
first introduced or delivered for introduction into interstate commerce
for commercial distribution after February 15, 2007, and prior to the
proposed compliance date (i.e., effective date plus 24 months),
provided a PMTA is submitted no later than the proposed compliance
date, and FDA has not issued an order denying the PMTA. In these cases,
the Agency would not intend to initiate enforcement action against the
tobacco product for failure to have a marketing authorization unless
and until FDA issues an order denying the PMTA under section 910(c) of
the FD&C Act.
FDA is seeking data, research, information, and comments related to
the following:
Should FDA consider a different compliance policy for
proposed deemed tobacco products that cannot, as a practical matter,
use the SE pathway? If so, what should the compliance policy entail and
would it benefit public health? Instead of, or in addition to, such a
policy, should FDA consider ways to expedite the review of some or all
premarket applications for proposed deemed products?
If FDA does establish a compliance policy or an expedited
review process, should the policy or expedited process apply to all
proposed deemed products or only to certain categories of products,
such as based on their relative impact on public health? Why or why
not? For example, FDA could establish factors based on certain
categories of products and their relative impact on public health. FDA
could use these factors in guiding its enforcement policy. Examples of
factors FDA might take into account include whether the product is
``non-combusted;'' contains no tobacco leaf, but contains nicotine,
such as some electronic cigarettes; is nonflavored; or is no or low
nicotine.
What other FDA actions or regulatory approaches, if any,
should FDA consider for proposed deemed tobacco products that are ``new
tobacco products'' under section 910(a)(1) of the FD&C Act and why?
Are there unique challenges faced by small manufacturers
of proposed deemed tobacco products and how should they be addressed?
FDA is collecting information as to how it can streamline
review of new product applications. FDA expects that, in certain
instances, it would be able to determine that a product meets the
requirements of section 910 of the FD&C Act using information that
might be less burdensome for a manufacturer to gather and submit to the
Agency. For example, in some cases, it is possible that an applicant
may not need to conduct any new nonclinical or clinical studies, while
in other cases, such as where there is little to no understanding of a
product's potential impact, several nonclinical and clinical studies
may be required for market authorization. Toward that end, FDA is
seeking comment on whether manufacturers of certain categories of
products (e.g., those that contain fewer or substantially lower levels
of toxicants, consistent with the continuum of nicotine-delivering
products as discussed in section III) could support their applications,
and
[[Page 23177]]
allow FDA to make its required findings under section 910 of the FD&C
Act, with types of information that would be less burdensome to collect
than information needed for other product categories.
Is there anything else FDA should consider to help
expedite the application review for products that have fewer or
substantially lower levels of toxicants that are seeking a marketing
authorization under section 910 of the FD&C Act?
FDA is considering possible additional approaches to address this
issue, including increasing the compliance policy period for SEs or
PMTAs for new tobacco products. FDA would also consider revising its
compliance policy should the Agency find that doing so is warranted,
such as to better protect the public health. In addition, FDA may
choose to implement this approach for only certain categories of
proposed deemed products based on their impact on public health.
We are considering other options as well to best address this issue
in a manner that is appropriate for the protection of the public
health. FDA is seeking data, research, information, and comments on the
previously referenced possible approaches.
e. Request for Comments Regarding Possibility of Staggered Compliance
Dates
Different categories of tobacco products may have the potential for
varying levels of harm and negative effects on public health. As a
result of the potential for differing effects on public health, FDA is
considering whether it might be appropriate to stagger the compliance
dates for certain provisions for different categories of products. For
example, FDA may opt to provide different compliance dates for certain
automatic provisions (e.g., ingredient listing under section 904 of the
FD&C Act, registration and listing under section 905, and hazardous and
potentially hazardous constituent reporting under section 915) based on
the negative public health effects known to be associated with certain
products. In such cases, products with fewer known negative impacts
might have additional time to comply with such provisions when compared
with products with greater negative public health effects. FDA requests
comments, including supporting facts, research, and other evidence,
regarding such an approach.
f. Request for Comments Regarding Requirements for Small Tobacco
Product Manufacturers
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. This proposed rule would
primarily affect domestic tobacco product manufacturers and importers.
A number of small tobacco product manufacturers have expressed concern
about their ability to comply with certain requirements found in the
FD&C Act, such as registration and product listing, ingredient listing,
substantial equivalence, and premarket tobacco product applications.
FDA is seeking comments about any unique challenges faced by small
manufacturers of proposed deemed tobacco products and how they should
be addressed. Specifically, FDA would like comments on the following
options that may help lessen the time and resources needed to comply
with certain requirements:
Extending the compliance period to provide more time to gather
the required information to be included in a regulatory submission
information
[cir] If extending the compliance period would be beneficial, which
provisions should be extended and why? Are there any public health
concerns that would outweigh any delay in compliance dates?
[cir] Are there FD&C Act provisions where an extended compliance
period would not lessen the burden on small businesses?
[cir] If extending the compliance period is appropriate, how much
more time should FDA provide and why?
Staggered compliance dates based on the size of the firm:
Instead of extending compliance periods outright, another option is to
stagger compliance dates based on the size of the manufacturer. Under
this option, compliance with certain provisions would be implemented in
timed stages. For example, the reporting deadlines for registration and
product listing and ingredient listing could be implemented as follows:
------------------------------------------------------------------------
Size of firm Reporting deadline
------------------------------------------------------------------------
Large............................. Compliance date proposed in the
rule.
Medium............................ Compliance date proposed in the rule
plus 1 year.
Small............................. Compliance date proposed in the rule
plus 2 years.
------------------------------------------------------------------------
[cir] Which provisions are appropriate to stagger in this manner
and why? Which provisions should not be staggered in this manner and
why?
[cir] If FDA were to stagger compliance dates based on the size of
the manufacturer, how should FDA define the different sizes of firms?
Instead of a comprehensive approach, should FDA consider the
needs of individual tobacco product firms on a case-by-case basis?
Under this scenario, a firm could request additional time to comply
with certain requirements as the need arises. A tobacco product
manufacturer would need to request additional time well in advance of a
submission deadline and provide FDA with supporting documentation
demonstrating undue hardship in meeting a particular deadline or
requirement.
B. Proposed Changes to Part 1140--Cigarettes, Smokeless Tobacco, and
Covered Tobacco Products
1. Proposed Sec. 1140.1--Scope
The proposed rule would make several amendments to part 1140 in
order to apply certain existing restrictions and access provisions to
additional tobacco products. Currently, part 1140 generally applies to
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco products. Therefore, FDA is proposing to add the phrase ``and
covered tobacco products'' to Sec. 1140.1(a) and (b).
2. Proposed Sec. 1140.2--Purpose
Like the proposed changes to Sec. 1140.1, the proposed rule also
would add ``and covered tobacco products'' to indicate that the purpose
of this part is to establish restrictions on the sale, distribution,
and access to covered tobacco products in addition to those already
established for cigarettes and smokeless tobacco.
3. Proposed Sec. 1140.3--Definitions
The proposed rule would revise or add several definitions that
would apply to part 1140. FDA also proposes to revise the order of the
definitions in Sec. 1140.3 so that they appear alphabetically and to
eliminate the individual paragraph designations.
Proposed Sec. 1140.3 would define ``cigar'' as a tobacco product
that also meets two requirements: (1) It is not a cigarette; and (2) it
is a roll of tobacco wrapped in leaf tobacco or any substance
containing tobacco. This definition was used in the seven consent
orders that the FTC entered into with the largest mass marketers of
cigars. (See, e.g., In re Swisher
[[Page 23178]]
International, Inc., Docket No. C-3964.) As discussed earlier, FDA is
soliciting comment on how this proposed rule should apply to cigars and
is, therefore, also soliciting comment on how to further define
categories of cigars, in particular premium cigars.
In addition, to exclude components and parts of tobacco products
that do not contain tobacco or nicotine from the proposed restrictions
in part 1140, we propose to define a ``covered tobacco product'' as any
tobacco product deemed to be subject to the FD&C Act under Sec.
1100.2, except for components or parts that do not contain tobacco or
nicotine. The meaning of ``covered tobacco product'' would depend on
whether FDA selects Option 1 or Option 2 for any final rule. For
purposes of this part, FDA considers any loose tobacco, including pipe
tobacco, and the nicotine in e-cigarette cartridges to be within the
definition of ``covered tobacco product.'' FDA proposes to treat
covered tobacco products in a manner consistent with FDA's treatment of
cigarettes and smokeless tobacco throughout part 1140. See
``Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco to Protect Children and Adolescents ``(75 FR 13225,
March 19, 2010). In current part 1140, FDA imposes restrictions on
cigarettes and smokeless tobacco, but not on the components, parts, and
accessories of such products. FDA believes that applying the minimum
age and identification restrictions to covered tobacco products only
(and not to the components and parts that do not contain nicotine or
tobacco) would be sufficient to protect the public health, because
youth will not be able to use such components and parts and potentially
suffer the consequences without also obtaining the covered tobacco
product. In the event that FDA determines it is appropriate for the
protection of the public health to extend the restrictions in part 1140
to components and parts that do not contain nicotine or tobacco in the
future, the Agency will issue a new rulemaking and provide notice and
opportunity to comment on such proceeding. FDA seeks comment on this
approach. Further, as stated throughout this document, FDA is not
proposing to cover accessories of proposed deemed products within the
scope of this deeming regulation and, therefore, accessories would not
be subject to the additional restrictions in part 1140.
The proposed rule would add a definition of ``importer,'' which
would mean ``any person who imports any tobacco product that is
intended for sale or distribution to consumers in the United States.''
This definition is based on the definition in 21 CFR 1141.3 (included
with the final rule published in the Federal Register of June 22, 2011
(76 FR 36627)).
The proposed rule also would update the following terms:
``distributor,'' ``manufacturer,'' ``package,'' ``point of sale,'' and
``retailer.'' These revised definitions would ensure that the terms
apply to tobacco products other than just cigarettes and smokeless
tobacco.
The proposed rule would redefine ``retailer'' as ``any person who
sells tobacco products to individuals for personal consumption, or who
operates a facility where vending machines or self-service displays are
permitted under this part.'' The revised definition would ensure that
it applies to tobacco products other than just cigarettes and smokeless
tobacco.
Finally, the proposed rule would add a definition for ``tobacco
product.'' This definition would reiterate the portions of section
201(rr) of the FD&C Act, subsections (rr)(1) and (rr)(2), which
establish the criteria for certain products to meet the definition of
``tobacco product.''
4. Proposed Sec. 1140.10--General Responsibilities of Manufacturers,
Distributors, Importers, and Retailers
In this section, for purposes of clarity, FDA proposes to add ``and
covered tobacco products'' to the existing language. In addition, the
Tobacco Control Act defines ``tobacco product manufacturer'' to include
importers (section 900(20) of the FD&C Act), signaling Congress' intent
for tobacco product importers to be subject to requirements like those
in Sec. 1140.10. Accordingly, FDA is proposing to revise this section
to also cover importers.
This section currently sets forth the requirement for
manufacturers, distributors, and retailers of cigarettes and smokeless
tobacco to comply with the applicable requirements in part 1140. With
this proposed change, proposed Sec. 1140.10 also would provide that
manufacturers, distributors, importers, and retailers are responsible
for ensuring that the covered tobacco products (in addition to
cigarettes and smokeless tobacco) that they manufacture, label,
advertise, package, distribute, import, sell, or otherwise hold for
sale comply with all applicable requirements in part 1140.
5. Proposed Sec. 1140.14--Additional Responsibilities of Retailers
In Sec. 1140.14, FDA proposes to divide the section into
responsibilities for retailers of cigarettes and smokeless tobacco
products and responsibilities for retailers of covered tobacco
products. Proposed new Sec. 1140.14(a)(1) through (a)(5) would cover
retailers of cigarettes and smokeless tobacco; proposed Sec.
1140.14(b)(1) through (b)(3) would cover retailers of tobacco products
other than cigarettes and smokeless tobacco. Accordingly, the proposed
rule would create new Sec. 1140.14(b)(1), which would prohibit
retailers from selling covered tobacco products (tobacco products other
than cigarettes and smokeless tobacco, which are discussed in proposed
new Sec. 1140.14(a)), to any individual younger than 18 years of age.
This change also would require retailers of covered tobacco products to
verify the purchaser's birth date by reviewing the individual's
photographic identification. However, as noted in proposed Sec.
1140.14(a)(2)(ii), a retailer is not required to verify the age of any
person who is more than 26 years of age. Proposed Sec. 1140.14(b)(3)
would prohibit retailers from using electronic or mechanical devices,
including vending machines, to sell covered tobacco products, except in
locations where the retailer ensures that no person under the age of 18
is permitted. Because the proposed rule would prohibit retailers from
selling covered tobacco products to individuals without verifying that
they are at least 18 years of age, FDA believes it would not be logical
to allow such individuals to purchase such products from vending
machines or other mechanical devices. FDA believes it would not be
practical or feasible for retailers to verify identification prior to
the purchase of covered tobacco products using mechanical devices in
facilities that allow individuals under 18 years of age to enter the
premises.
C. Proposed Part 1143--Required Warning Statements
1. Proposed Sec. 1143.1--Definitions
The proposed rule would add part 1143, which would contain
provisions necessitating the use of ``required warning statements'' for
covered tobacco products, as well as for roll-your-own and cigarette
tobacco, for which health warnings are not already required by Federal
statutes or regulations. Option 1 for proposed section 1143.1 contains
four definitions to aid in the understanding of this part.
First, we propose to define ``covered tobacco product'' for the
purposes of the proposed health warning requirements as 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. As stated
in proposed Sec. 1140.3, the meaning of
[[Page 23179]]
``covered tobacco product'' would depend on whether FDA selects Option
1 or Option 2 for any final rule. In the event that FDA determines that
there is sufficient scientific basis to add additional restrictions to
components and parts that do not contain tobacco or nicotine in the
future, FDA will issue a new rulemaking and provide notice and
opportunity for public comment. Further, as stated throughout this
document, FDA is not proposing to cover accessories of proposed deemed
products within the scope of this deeming regulation and, therefore,
accessories would not be subject to the additional restrictions in part
1143.
Second, we propose to define ``package'' as a ``pack, box, carton,
or container of any kind in which a tobacco product is offered for
sale, sold, or otherwise distributed to consumers.'' This definition is
based on the definition of ``package'' in section 3 of FCLAA, 15 U.S.C.
1332.
Third, we propose to define ``required warning statement'' as a
``textual warning statement required to be on packaging and in
advertisements for cigarette tobacco, roll-your-own tobacco, cigars,
and other covered tobacco products.'' This term refers to the warning
in proposed Sec. 1143.3(a)(1) that would be required on packages and
in advertisements for cigarette tobacco, roll-your-own tobacco, and
covered tobacco products. It also refers to the warnings in proposed
Sec. 1143.5(a)(1) that would be randomly displayed on cigar packages
and rotated quarterly on cigar advertisements.
Fourth, we propose to add a definition for ``roll-your-own
tobacco.'' This definition is identical to the definition of ``roll-
your-own tobacco'' in section 900(15) of the FD&C Act.
In addition to these four definitions, Option 2 would also provide
definitions for ``cigar'' and ``covered cigar'' and they would have the
same meaning as these terms in Option 2 for proposed Sec. 1100.3.
2. Proposed Sec. 1143.3--Required Warning Statement Regarding
Addictiveness of Nicotine
Proposed Sec. 1143.3(a) of the proposed rule would require the use
of a specific warning statement on packages of covered tobacco products
other than cigars, and on packages of roll-your-own and cigarette
tobacco, sold, distributed, or imported for sale within the United
States. This required warning statement would be: ``WARNING: This
product contains nicotine derived from tobacco. Nicotine is an
addictive chemical.'' Specifically, proposed Sec. 1143.3(a)(1) would
state that this requirement applies to cigarette tobacco, roll-your-own
tobacco, and other tobacco products for which health warnings are not
otherwise required by Federal law or regulation. This same warning
statement would also be included as a required warning for cigars in
proposed Sec. 1143.5(a)(1).
``Cigarette tobacco'' is currently defined under Sec. 1140.3(b).
In the proposed rule, and in accordance with the FD&C Act, ``roll-your-
own tobacco'' would be defined in Sec. 1140.3 as ``any tobacco product
which, because of its appearance, type, packaging, or labeling, is
suitable for use and likely to be offered to, or purchased by,
consumers as tobacco for making cigarettes.'' The proposed rule also
would define ``covered tobacco product'' in Sec. 1143.1 as discussed
in section VIII.C.1.
In addition, Sec. 1143.3(a)(1) explains that the requirements of
this subsection would not apply to tobacco products for which health
warnings are already required by law or regulation. Specifically,
health warnings for cigarette packages are already required by section
4(a) of FCLAA (15 U.S.C. 1333(a)). In addition, health warnings for
smokeless tobacco product packages are required by section 3(a) of
CSTHEA (15 U.S.C. 4402(a)).
Proposed Sec. 1143.3(a)(2), like proposed Sec. 1143.5(a)(2),
would require that the required warning statement appear directly on
the package and be clearly visible underneath any cellophane or other
clear wrapping. Thus, any clear outer wrappings on the package would be
required to allow the warning statement to be clearly visible and
easily read by consumers. Proposed Sec. 1143.3(a)(2)(i) through
(a)(2)(v) would give additional explanation as to the size and
placement of the required warning statement to ensure that it is easily
viewed by consumers and would be identical to the requirements of
proposed Sec. 1143.5(a)(2)(i) through (a)(2)(v). For additional
information regarding these requirements, see the analysis in section
VIII.C.2 regarding proposed Sec. 1143.5(a)(2).
Proposed Sec. 1143.3(a)(3) provides the retailer exception,
similar to the one included in proposed Sec. 1143.5(a)(4). Under
proposed Sec. 1143.5(a)(4), to obtain the retailer exception for cigar
packages, the packaging would have to be supplied by a manufacturer,
importer, or distributor who has the required state, local or Alcohol
and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if
applicable. In contrast, under proposed Sec. 1143.3(a)(3), for
retailers to obtain the retailer exception, the packages would not need
to be supplied by a license- or permit-holding manufacturer, importer,
or distributor. These requirements for retailers and the retailer
exemption in proposed Sec. 1143.3(c) are consistent with the
requirements of the FCLAA, 15 U.S.C. 1333 et seq., as modified by
section 201(a) of the Tobacco Control Act. FDA is not including the
``license- or permit-holding'' modifier for covered tobacco products
other than cigars, because not all of these products are currently
under the authority of the TTB. Therefore, manufacturers, importers,
and distributors of such products currently do not need to obtain a
license or permit to manufacture, import, or distribute them.
Proposed Sec. 1143.3(b) requires the use of the warning statement,
``WARNING: This product contains nicotine derived from tobacco.
Nicotine is an addictive chemical.'' on advertisements for all covered
tobacco products and products for which health warnings are not
otherwise required by Federal law or regulation (i.e., cigarette
tobacco and roll-your-own tobacco). For a description of the types of
products that this proposed subsection would cover, see the previous
discussion regarding proposed Sec. 1143.3(a). This provision would
require that manufacturers, packagers, importers, distributors, and
retailers of such products include the required warning statement on
all advertisements for such products within the United States. (See
also section VIII.C.2 for examples of the types of advertisements that
would be covered by this regulation.)
Under proposed Sec. 1143.3(b)(2), the required warning statement
must be located in the upper portion of the area of the advertisement
within the trim area in order to maximize visibility. Proposed
1143.3(b)(2)(i) would require that the warning statement occupy at
least 20 percent of the area of the advertisement, which is the same as
the statutory requirement for press and poster advertisements for
smokeless tobacco products. (See section 3(b)(2)(B) of CSTHEA (15
U.S.C. 4402(b)(2)(B)).) Proposed 1143.3(b)(2)(ii) through (b)(2)(v),
which provide specifications for the required warning statements on
cigar advertisements, would be the same as proposed Sec.
1143.3(a)(2)(ii) through (a)(2)(v), which provide the specifications
for required warnings on cigar packages. Therefore, the description of
proposed Sec. 1143.3(a)(2)(ii) through (a)(2)(v) for cigar packages
also applies to proposed Sec. 1143.3(b)(2)(ii) through (b)(2)(v) for
cigar advertisements.
Proposed Sec. 1143.3(b)(2)(vi) would require that the warning
statement be enclosed by a rectangle that is the same color as the text
of the required warning
[[Page 23180]]
statement. The border of the rectangle would be required to have a
width that is between 3 and 4 mm. The border of the rectangle would be
required to have a width that is between 3 and 4 mm. This border would
allow the warning to be conspicuous among any other text or images in
the advertisement, and the border is the standard size that is used in
many countries and regions, including in the European Community (see,
e.g., 2001/37/EC). Again, FDA would consider the required warning
statement to be conspicuous and legible if the statement is printed in
one to four lines of text, parallel to each other, and there is ample
word and line spacing to allow the statement to be read easily. For
additional information regarding those specifications and why FDA
selected them, please see section VIII.C.2.
Proposed Sec. 1143.3(b)(3) would apply the limited retailer
exception to retailers of covered tobacco products (as well as roll-
your-own and cigarette tobacco), which would be identical to the
retailer exception for cigar advertisements in proposed Sec.
1143.5(b)(3). For additional information regarding the requirements to
meet this exception, see the discussion in section VIII.C.2.
Proposed Sec. 1143.3(c) would provide an exemption to a product
manufacturer that otherwise would be required to include the warning
statement in proposed Sec. 1143.3(a)(1) on its packages and in its
advertisements. To obtain this exemption, the manufacturer would be
required to certify to FDA that its product does not contain nicotine
and that the company has data to support that assertion; therefore, the
product does not warrant the proposed addictiveness warning. For any
product that obtains this exemption, the proposed provision would
require that the product still bear the message: ``This product is
derived from tobacco.'' The parties that package and label such
products would share responsibility for ensuring that this alternative
statement is included on product packages and in advertisements. FDA
believes it is important to alert consumers and retailers as to which
items are tobacco products. Even if a tobacco product does not contain
nicotine, it can still contain other addictive chemicals (like
anabasine or nornicotine, discussed in the preamble) or dangerous
toxicants. Therefore, FDA believes consumers should be aware that the
product is, in fact, a tobacco product. In addition, this statement
would alert consumers as to which products would require identification
for purchase and increase retailer awareness of the products for which
they must verify the age of consumers. While FDA is not aware of any
currently marketed tobacco products that do not contain nicotine, the
proposed rule would permit companies to use this alternative statement
in the event that such tobacco products are developed in the future.
FDA requests comments on this alternative statement.
FDA recognizes that certain tobacco products include constituents,
in addition to nicotine, that may cause addiction. For example, tobacco
products with nicotine removed or with only trace levels of nicotine
may have other addictive constituents. Certain other constituents of
smoke may contribute to sensory qualities of addiction, including
flavorings and other potentially addictive components such as monoamine
oxidase inhibitors (Refs. 173, 174, 175, 176, 177, 178, and 179).
Research also has shown that several constituents found in tobacco
or tobacco smoke (e.g., nornicotine, acetaldehyde, and anabasine) have
the potential to produce dependence and be addictive (``dependence
potential''), as demonstrated by animal research. For example, the
chemical nornicotine has the potential to be addictive in humans.
Nornicotine causes increased dopamine (DA) levels and/or increased
dopaminergic neuronal activity in the midbrain (Refs. 180 and 181).
When released in the midbrain (including the nucleus accumbens and
striatum), DA is widely thought to be involved in the maintenance of
positively reinforced behavior, including feeding and drug taking (Ref.
182). Drugs that cause increased DA in these areas of the brain are
thought to have dependence potential (Ref. 183). In addition,
nornicotine substitutes for nicotine in drug discrimination testing \6\
and maintains self-administration \7\ in animals (Ref. 184).
Acetaldehyde also likely has dependence potential as indicated by
effects on midbrain DA and self-administration studies, along with data
using place conditioning methods (Refs.188, 189, and 190).\8\ Early
data on effect on DA levels suggest that anabasine may also have some
dependence potential (Ref. 192). Given that scientific research
indicates that nicotine is the primary addictive component, FDA has
proposed to include only nicotine in the addictiveness warning.
Nevertheless, FDA requests comment as to whether the proposed
addictiveness warning also should cover other substances that may cause
addiction.
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\6\ Drug discrimination is effective in evaluating shared
central mechanisms of action (Refs. 185, 186, and 187). For example,
stimulant drugs such as caffeine, cocaine, and amphetamine,
partially or fully substitute for nicotine, and vice versa.
\7\ Self-administration procedures allow an animal to perform a
behavior to receive a dose of drug (Ref. 179). Drugs that support
self-administration in animals are thought to have high dependence
potential in humans.
\8\ Place conditioning is a paradigm that evaluates the
rewarding (``place preference'') or aversive (``place avoidance'')
effects of drugs (Ref. 191). Place conditioning with drugs of abuse
such as nicotine, cocaine, amphetamine, morphine, and ethanol
results in preference.
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Manufacturers who submit a false certification to FDA would be
subject to serious penalties. Knowingly and willfully submitting a
false certification would be punishable as a criminal offense under 18
U.S.C. 1001. In addition, a product that did not contain the required
warning statement on its packages or in its advertisements (once the
regulation is finalized) would be misbranded under section 903(a)(1) of
the FD&C Act, as well as other provisions of the Tobacco Control Act
and subject the manufacturer to enforcement action, including civil
money penalties and product seizure. FDA intends to issue guidance
regarding this self-certification process if the regulation is
finalized.
3. Proposed Sec. 1143.5--Required Warning Statements for Cigars
Proposed Sec. 1143.5 of the proposed rule would set forth the
required warning statements for cigars. The proposed definition of
``cigar'' would be defined in Sec. 1140.3 as ``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.'' We are proposing two
options (Option 1 and Option 2) for this section. Option 1 would apply
these requirements to all cigars. Option 2 would apply these
requirements to a subset of cigars (i.e., covered cigars as defined in
Option 2 for proposed Sec. 1143.1). As discussed throughout this
document, FDA seeks comment on the appropriateness of defining
different categories of cigars, the proposed definition of ``covered
cigar,'' and whether certain types of cigars should be subject to a
different regulatory regime.
Proposed Sec. 1143.5 contains the proposed requirements for
packages, advertisements, and marketing. Proposed Sec. 1143.5(a)
contains the proposed requirements for cigar packages only. Proposed
Sec. 1143.5(a)(1) would make it unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or import cigars
without one of the proposed warnings on cigar packages. Four of the
five warnings that would be required to be randomly displayed on
packages would be the
[[Page 23181]]
same as those currently included on certain cigar packages and
advertisements as a result of seven consent orders that the FTC entered
into in 2000 with the largest mass marketers of cigars. (See, e.g., In
re Swisher International, Inc., Docket No. C-3964.) Under Option 1, all
cigars would now be subject to these warning requirements, except the
package requirements for those sold individually and not in product
packages. Option 2 would apply the warning requirements to a subset of
cigars (i.e., covered cigars as defined in Option 2 for section
1143.1). The fifth health warning regarding the addictiveness of
nicotine is the same warning that would be required for covered tobacco
products (as well as cigarette tobacco and roll-your-own tobacco)
included in proposed Sec. 1143.3(a)(1).
Proposed Sec. 1143.5(a)(2) would mandate that the required warning
statements appear directly on the package and be clearly visible
underneath any cellophane or other clear wrapping enclosing the
cigar(s). Thus, any outer wrappings on the package would have to allow
the required warning statement to be clearly visible and easily read by
consumers. Similarly, any other material that is placed on the outside
of packages, such as price information or promotional material (e.g.,
coupons) would not be permitted to be placed over or otherwise obscure
the required warning statement. Paragraphs (a)(2)(i) through (a)(2)(v)
of proposed Sec. 1143.5 would provide additional explanation as to the
size and placement of the required warning statement to ensure that it
is easily viewed by consumers. Proposed Sec. 1143.5(a)(2)(i) would
require that the warning statement be located in a conspicuous and
prominent place on the two principal display panels of the package. For
the warning to be ``conspicuous and prominent,'' it must be in a
location where it is likely to be read and understood by the ordinary
individual under customary conditions of purchase and use. However, FDA
would not consider the required warning statement to be ``conspicuous
and prominent'' if it: (1) Appears or is affixed on the bottom of the
package; (2) is printed or affixed on the tear line; or (3) is printed
or affixed in any other location that would cause the warning to be
obscured, damaged, or destroyed when the package is open. (See 16 CFR
307.6(a) (FTC regulations implementing CSTHEA labeling requirements,
which were rescinded due to FTC's transfer of authority over smokeless
warnings to FDA that was required by the Tobacco Control Act; these
regulations have served as a guide for some of FDA's regulatory
decisions regarding health warnings).)
``Principal display panels'' refers to the two panels of the
package that contain the brand name, logo, and/or selling message for
the product. The principal display panels (PDPs) are those panels that
are most likely to be displayed, presented, shown, or examined under
the normal and customary conditions of display for retail sale and use.
Where the package contains the brand name, logo, and/or selling message
on only one surface of the product package, the second PDP would be the
surface opposite the PDP containing the brand name, logo, and/or
selling message. This term will vary based on the type of packaging
used for the tobacco product.
In addition, proposed Sec. 1143.5(a)(2)(i) would require that the
warning statement comprise at least 30 percent of each of the principal
display panels. We are proposing a 30 percent size requirement for
product packages to be consistent with Congress' size requirements for
similar text-only warnings for smokeless tobacco under CSTHEA (15
U.S.C. 4402(a)(2)(A)), rather than the 50 percent requirements that
Congress chose for graphic warnings on cigarette packages.
Proposed Sec. 1143.5(a)(2)(ii) would require that the warning
statement appear in the maximum font size that would fit into the
warning area. This would ensure that the warning is large enough to be
prominent and clearly visible to consumers. FDA would work with
companies to ensure that the warnings are being printed on the proper
display panels for a particular product.
Proposed Sec. 1143.5(a)(2)(iii) would require that the warning
statement be printed in a conspicuous and legible Helvetica bold or
Arial bold type, which are included in common printing software. This
provision would provide persons printing the required warning
statements on packages with the choice of printing the required warning
statement in black text on a white background, or white text on a black
background, as long as the statement is printed in a manner that
contrasts by typography, layout, or color with all other printed
material on the package. This proposed requirement is consistent with
the requirement for smokeless tobacco product packages included in
section 3(a)(2)(B) of CSTHEA (15 U.S.C. 4402(a)(2)(B)), and the same as
the requirement for cigarette packages under section 4(a)(2) of FCLAA
(15 U.S.C. 1333(a)(2)). FDA would consider the required warning
statement to be conspicuous and legible if the statement is printed in
one to four lines of text, parallel to each other, and there is ample
word and line spacing to allow the statement to be read easily.
Proposed Sec. 1143.5(a)(2)(iv) would require that the warning
statements be capitalized and punctuated as indicated in proposed Sec.
1143.5(a)(1). No person would be permitted to edit the capitalization,
punctuation, or text of the five required warning statements listed in
proposed Sec. 1143.5(a)(1).
Proposed Sec. 1143.5(a)(2)(v) would require that the warning
statement be centered in the warning area. This requirement would help
ensure that the textual statement is conspicuous and legible. This
paragraph also would require that the text of the statement and any
other information on the PDP have the same orientation. Requiring all
text on the PDP of a package to be oriented in the same direction would
help ensure that the warnings are noticed and read by consumers and,
therefore, would be appropriate for the protection of the public
health.
Proposed Sec. 1143.5(a)(3) proposes a different requirement for
cigars sold individually and not in a product package or outer
covering.\9\ FDA is aware that premium cigars, as well as certain other
cigars, are frequently sold to consumers individually and not in
product packaging or an outer covering. Requiring a health warning for
cigars that are not sold to consumers in a product packaging,
therefore, is impractical. Thus, in lieu of such a requirement,
proposed Sec. 1143.5(a)(3) would provide that a person who sells or
distributes cigars individually and without an outer package, would not
be required to comply with the package requirements in proposed Sec.
1143.5(a)(1) and (a)(2), but instead would be required to post the five
required warning statements for cigars (as written in proposed Sec.
1143.5(a)(1)) on a sign which would be posted at the point-of-sale at
each register of any retail establishment that sells individual cigars
that do not contain any product packaging. Retail establishments that
sell such products would be required to prepare these simple black and
white signs in accordance with the
[[Page 23182]]
specifications in proposed Sec. 1143.5(a)(3). Retailers may wish to
place the sign in a sign holder to ensure that the warnings listed on
the sign would be appropriately visible. FDA believes this requirement
will ensure that premium cigar purchasers, as well as purchasers of
other individual cigars, receive the critical health warnings while
allowing persons selling or distributing such cigars to maintain
existing business practices. In addition, any person that manufactures
cigars also must continue to comply with all other packaging and
labeling requirements under the Tobacco Control Act.
---------------------------------------------------------------------------
\9\ In general, pursuant to the Internal Revenue Code at 26
U.S.C. 5751, a tobacco product cannot be sold at retail unless it is
in the package in which the product is removed, upon payment of
Federal excise tax, from the factory or from customs custody.
Section 5751(a)(3) and TTB regulations at 27 CFR 46.166(a) state
that tobacco products may be sold, or offered for sale, at retail
from such packages, provided the products remain in the packages
until removed by the customer or in the presence of the customer.
---------------------------------------------------------------------------
FDA is specifically requesting comments on whether the special rule
in proposed Sec. 1143.5(a)(3) for cigars sold individually would be
effective in helping consumers better appreciate and understand the
relevant health risks or whether there are more effective means for
doing so. For example, would it be feasible for machine-made cigars
that are sold individually to bear the warning on the cigars themselves
or in some other way, and would that be a more effective means of
conveying the warning? In addition, the Agency also seeks comments on
whether there should be different requirements for certain types of
cigars and whether these proposed warning requirements are contrary to
requirements for any cigars covered by the FTC consent decrees. It is
not FDA's intent to allow any cigar that currently bears a warning
pursuant to the FTC consent decrees to no longer be required to do so.
As stated throughout this document, Option 2 for proposed Sec.
1143.5 would apply these requirements to a subset of cigars (defined as
covered cigars). Therefore, under this option, this special rule for
proposed Sec. 1143.5(a)(3) would apply to only those covered cigars
that are sold individually and not in a product package. We note that
those cigars not meeting the definition of ``covered cigars'' would not
be required to provide any warning statements on packages and in
advertisements. FDA requests comment about this special rule.
Like the warning statements required in proposed Sec. 1143.5(a)(1)
and (a)(2), the sign required to be posted at any point of sale where
consumers purchase cigars sold without a product package would have to
be clear, legible, and conspicuous. Therefore, the warning statements
included on the sign must be large enough for consumers to easily read
it. The sign must be posted on or within 3 inches of each cash register
where payment may be made. Therefore, certain retailers would be
required to post multiple signs throughout their establishments. As
stated in proposed Sec. 1143.5(a)(3)(i), the warning statements would
have to be printed in black Helvetica bold or Arial bold type against a
solid white background in at least 17-point type to ensure maximum
visibility. This 17-point type size is consistent with the standard
that Congress required under section 3(a)(2)(B) of CSTHEA (15 U.S.C.
4402(a)(2)(B)), as amended by section 204 of the Tobacco Control Act.
The five individual warning statements must be appropriately spaced on
the 8.5 x 11 inch sign so that each individual warning is conspicuous
and legible. Also, as required in proposed Sec. 1143.5(a)(3)(i), and
like section 3(a)(2)(B) of CSTHEA (15 U.S.C. 4402(a)(2)(B)) for
smokeless products, the warning would be printed so that it contrasts
by typography, layout, or color with all other printed material.
Further, as provided in the proposed required warning statements for
product packages, no person would be permitted to edit the
capitalization, punctuation, or text of the five required warning
statements listed in proposed Sec. 1143.5(a)(1). The requirements in
this paragraph would operate together to ensure that the required
warning statements included at the point-of sale for cigars sold
without a product package could be easily read and understood. If a
retailer offers for sale both cigars sold without a product package and
cigars sold with product packages, the retailer would be required to
post a warning sign in accordance with this paragraph.
Proposed Sec. 1143.5(a)(4) would provide that a cigar retailer
would not be in violation of the regulations if cigar packages
displayed or sold by the retailer do not comply with all the
requirements set forth in the proposed rule, as long as the packages
contain a health warning; are supplied by a manufacturer, importer, or
distributor who has the required state, local, or TTB-issued license or
permit (if applicable); and are not altered by the retailer in a way
that materially affects the display of the required warning statements
on the packages. For example, if a retailer were to tear the warning in
any way or place a sticker or other material over the warning, this
likely would affect the display of the warning statements and this
retailer exemption would not apply. However, if a retailer were to crop
the paper containing the warning statement, but the warning statement
has been unaffected and the size of the warning remains the same (and
the other requirements for this exemption were met), then the retailer
exemption would apply. Thus, cigar manufacturers, distributors, and
importers would have primary responsibility for ensuring that the
warnings on cigar packages comply with the requirements of proposed
Sec. 1143.5, but retailers would have some responsibility as well.
Specifically, retailers would be responsible for ensuring that all
cigar packages they display or sell contain a warning regarding the
health risks associated with smoking cigars. In addition, retailers
could not alter the warning statement in a way that is material to the
requirements of proposed Sec. 1143.5, including by obscuring the
warning (e.g., by placing a sticker or other item on top of it), by
shrinking or severing the warning (in whole or in part), or by
otherwise changing it in a material way. However, retailers would not
be responsible for verifying that the warnings on packages they display
or sell contain the precise wording, capitalization, and punctuation in
the required warning statements listed in proposed Sec. 1143.5(a)(1)
or that they comply with other specifications required in this proposed
subsection. This exception for cigar retailers is the same as the
exception for cigarette retailers in section 4(a)(4) of FCLAA (15
U.S.C. 1333(a)(4)), implemented by Sec. 1141.1(c) of FDA's
regulations, as well as section 3(a)(5) of CSTHEA (15 U.S.C.
4402(a)(5)) for retailers of smokeless products.
Proposed Sec. 1143.5(b) would explain the requirements for
placement of health warnings on cigar advertisements. Specifically,
proposed Sec. 1143.5(b)(1) would require that manufacturers,
packagers, importers, distributors, and retailers include a required
warning statement in all cigar advertisements within the United States,
similar to the existing FTC consent orders with which the major cigar
manufacturers currently comply. Thus, this proposed rule adopts many of
the parameters of the industry/FTC consent orders and current practice
and proposes that all advertisements, regardless of form--which could
include materials such as magazine and newspaper ads, pamphlets,
leaflets, brochures, coupons, catalogues, retail or point-of-sale
displays (including functional items such as clocks or change mats),
posters, billboards, direct mailers, and Internet advertising (e.g.,
Web pages, banner ads, etc.)--would have to contain required warning
statements.
Proposed Sec. 1143.5(b)(2) would require that the required warning
statement be located in the upper portion of the area of the
advertisement within the trim
[[Page 23183]]
area, in order to maximize visibility. Proposed Sec. 1143.5(b)(2)(i)
through (b)(2)(vi) would provide the specifications for such
advertisements, which would be identical to the specifications in
proposed Sec. 1143.3(b)(2)(i) through 1143.3(b)(2)(vi).
Proposed Sec. 1143.5(b)(3), like proposed Sec. 1143.5(a)(4),
would provide that a retailer would not be considered to be in
violation of this provision if it posts an advertisement that does not
comply with all of the proposed requirements, as long as the
advertisement was not created by or on behalf of the cigar retailer and
the retailer is not otherwise responsible for inclusion of the required
warning statements in the advertisement. This section is akin to the
requirement in section 4(c)(4) of FCLAA (15 U.S.C. 1333(4)(c)(4)) and
section 3(b)(3)(D) of CSTHEA (15 U.S.C. 4402(b)(3)(D)), which includes
the same type of exception for retailers displaying cigarette and
smokeless advertisements, respectively. Note that any manufacturer,
packager, distributor, importer, or retailer who is responsible for the
creation of a cigar advertisement would be responsible for complying
with this proposed provision. Proposed Sec. 1143.5(b)(3) also
specifies that this provision would not relieve a retailer of liability
if it publicly displays an advertisement that fails to contain a health
warning or if it materially affects the display of the required warning
statement. Therefore, except when responsible for the creation of an
advertisement or otherwise responsible for the inclusion of the warning
statement, a retailer would not be responsible for ensuring that its
cigar advertisements comply with the specific requirements of proposed
Sec. 1143.5(b)(3). However, retailers would be required to ensure that
their cigar advertisements contain a warning of smoking's risks. They
would also be responsible for complying with other requirements
applicable to cigar retailers, including those in 21 CFR part 1140.
Marketing requirements for cigars are included in proposed Sec.
1143.5(c). Specifically, proposed Sec. 1143.5(c)(1) states that the
required warning statements for cigar packages would be required to be
randomly displayed in each 12-month period, in as equal a number of
times as possible on each brand of cigar. FTC previously defined
``equal number of times as possible'' as permitting deviations of 4
percent or less in a 12-month period and the major cigar manufacturers
agreed and currently comply with this standard, and FDA proposes to
continue to adhere to FTC's definition. For packages, the required
warning statements in proposed Sec. 1143.5(a)(1) also would be
required to be randomly distributed in all areas of the United States
in which the product is marketed. We note that FDA is proposing to
allow manufacturers to continue to introduce into domestic commerce
existing inventory that may not contain the health warnings required
under a final rule for an additional 30 days after the effective date
of any final rule.
This proposed random display and distribution of required warning
statements for cigar packages would be in accordance with a warning
plan submitted by the cigar manufacturer, importer, distributor, or
retailer to, and approved by, FDA. The proposed requirements for random
display and distribution, as well as the submission of a warning plan,
would be similar to those for cigarettes and smokeless tobacco
products, as mandated by section 4(c)(1) of FCLAA (15 U.S.C.
1333(c)(1)) and section 3(a)(3)(A) of CSTHEA (15 U.S.C. 4402(a)(3)(A)),
respectively. For cigars sold individually and without product
packaging, there would be no requirement to rotate and/or randomly
distribute warnings, because all five warnings would be displayed at
the point-of-purchase.
Proposed Sec. 1143.5(c)(2) also would require that the required
warning statements be rotated quarterly in alternating sequence in each
advertisement for each brand of cigar, regardless of whether the cigar
is sold in product packaging. This proposed rotation of warning
statements in cigar advertisements also would be in accordance with an
FDA-approved warning plan.
4. Proposed Sec. 1143.7--Language Requirements for Required Warning
Statements
Consistent with section 4(b) of FCLAA (15 U.S.C. 1333(b)) and
section 3(b) of CSTHEA (15 U.S.C. 4402(b)), proposed Sec. 1143.7 would
require that the warning statement appear in the English language, with
two exceptions. First, under proposed Sec. 1143.7(a), if an
advertisement appears in a non-English language publication, the
required warning statement would need to appear in the predominant
language of the publication. The predominant language is the primary
language used in the nonsponsored content in the publication. For
example, in the case of a newspaper where the nonsponsored content
(e.g., news stories, articles of opinion, and features) is in a foreign
language but the sponsored content (e.g., advertising) is wholly or
partially in English, the predominant language would be the foreign
language used in the nonsponsored content, and the required warning
statement would have to appear in that foreign language. Because such
non-English language publications in the United States are targeted
towards consumers who speak the predominant language of the
publication, this would help ensure that the target audience of
publication is able to read and understand the required warning
statement in the advertisement.
Second, under proposed Sec. 1143.7(b), if an advertisement is in
an English language publication but is presented in a language other
than English, the required warning statement would need to be presented
in the same foreign language principally used in the advertisement.
English language publications in the United States are generally
targeted towards the consumer population as a whole or towards
consumers with a particular interest in the subject matter of the
publication rather than towards consumers who speak a particular
language; however, foreign language advertisements in English-language
publications are targeted towards consumers who speak the foreign
language used in the advertisement. Therefore, requiring foreign
language advertisements in English-language publications to present the
required warning statement in the same language that is used elsewhere
in the advertisement will help ensure that the target audience of the
advertisement is able to read and understand both the promotional
content and the important warning information. These two proposed
exceptions are the same as the exceptions in Sec. 1141.10(b)(2) and
section 4(b)(2) of FCLAA (15 U.S.C. 1333(b)(2)) for the textual portion
of the required warnings in cigarette advertisements, as well as
section 3(b)(G) of CSTHEA (15 U.S.C. 4402(3)(b)(G)) for the required
warning statements in smokeless tobacco advertisements.
5. Proposed Sec. 1143.9--Irremovable or Permanent Required Warning
Statements
Proposed Sec. 1143.9 would require that the required warning
statement be indelibly printed on or permanently affixed to packages
and advertisements. Removable or impermanent warning displays on
packages and in advertisements could become separated from the package
or advertisement and thus would not meet the requirement that they be
conspicuous on the package or advertisement. Removable warnings would
run counter to FDA's purpose of effectively conveying risk information
to
[[Page 23184]]
consumers. For example, if the required warning statement were printed
or stickered on a clear outer wrapper, and this wrapper was meant to be
removed for access to the package (or the tobacco products within the
package), the consumer could access the tobacco product package
numerous times without viewing the warning and receiving the impact of
the critical health message. This same requirement is contained in
Sec. 1141.10(c) regarding health warnings on cigarette packages and in
advertisements.
6. Proposed Sec. 1143.11--Does Not Apply to Foreign Distribution
Proposed Sec. 1143.11 would limit the applicability of the
proposed requirements by clarifying that these requirements would not
apply to manufacturers or distributors of tobacco products that do not
manufacture, package, or import the products for sale or distribution
within the United States.
7. Proposed Sec. 1143.13--Effective Date
This proposed section would provide that part 1143 would take
effect 24 months after the date that the final rule publishes in the
Federal Register. During this time, parties should take whatever steps
they need to plan and implement business operations that will comply
with the final rule. As of the effective date, no manufacturer,
packager, importer, distributor, or retailer would be permitted to
advertise or cause to be advertised within the United States any
tobacco product subject to part 1143 unless the advertising complies
with the final regulation. Also, product packages which do not comply
with the requirements of the final rule must not be manufactured for
sale or distribution in the United States as of the effective date.
Further, a product that is manufactured prior to the effective date
of the final rule that does not have the required warning statements on
its package may not be introduced into commerce in the United States
after 30 days following the effective date. Therefore, 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 effective date of any final
rule. This is consistent with the approach taken in FCLAA (15 U.S.C.
1333(4)(b)), and CSTHEA (15 U.S.C. 4402(3)(b)). After the 30-day
period, manufacturers would not be permitted to introduce into domestic
commerce any product packages that do not contain the health warning
statements required under the final rule, irrespective of the date of
manufacture. While this limitation would apply to manufacturers only,
we note that keeping products without the new warnings on the market
for an extended period of time is not in the interest of public health.
IX. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the OMB under the PRA (44 U.S.C. 3501-3520). A
description of these provisions is given in the Description section
with an estimate of the annual reporting and recordkeeping burden.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Deeming Tobacco Products To Be Subject to the 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
Description: On June 22, 2009, the President signed the Tobacco
Control Act into law. In this proposed rule, the Agency is proposing to
extend FDA's ``tobacco product'' authorities in the FD&C Act to all
other categories of products meeting the statutory definition of
``tobacco product'' in section 201(rr) of the FD&C Act, excluding
accessories of proposed deemed tobacco products. (Two options are
presented in the proposed rule related to what constitutes a covered
tobacco product.) The proposed rule also would prohibit the sale of
covered tobacco products to individuals under the age of 18 and
prohibit the sale of covered tobacco products using the assistance of
any retail-based electronic or mechanical device (such as a vending
machine) except in facilities where the retailer ensures that no person
younger than 18 years of age is present, or permitted to enter, at any
time. This prohibition on sales from electronic or mechanical devices
is not intended to impact the sale of any tobacco product via the
Internet. Lastly, the proposed rule would require specified health
warnings for covered tobacco products (as well as cigarette tobacco and
roll-your-own tobacco) on tobacco product packages and advertisements.
The information collection provisions for which we are seeking
comment in this proposed rule have either: (1) 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; (2) burdens
associated with tobacco products currently subject to the FD&C Act, but
have not yet been approved by OMB; or (3) a new burden that would apply
only to proposed deemed covered tobacco products. The following burden
tables for which we are seeking comment are organized according to
these three categories.
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
The burden estimates found in this section involve existing
collections that have already been approved by OMB and cover tobacco
products that are already subject to the FD&C Act (i.e., cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco). FDA
is making them available for public comment because the collections
have been revised to cover proposed deemed tobacco products. In
developing these new burden estimates for proposed deemed tobacco
products, FDA based the new estimates on the existing collections
already approved by OMB that currently cover cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco. Burden estimates
are based on Option 1.
1. Tobacco Product Establishment Registration and Submission of Certain
Health Information (OMB Control Number 0910-0650)
Description of Respondents: The respondents to this collection of
information are manufacturers, importers, or agents of new and existing
tobacco product establishments regulated by FDA who are required to
register under sections 904 and 905 of
[[Page 23185]]
the FD&C Act. They are persons engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products who
will be registering their product establishments and must file with FDA
a list of all tobacco products being manufactured, prepared,
compounded, or processed by that person for commercial distribution at
the time of registration. They also must submit a listing of all
ingredients whenever additives or the quantities of additives are
changed.
Section 101 of the Tobacco Control Act amended the FD&C Act by
adding sections 905 and 904. Section 905(b) of the FD&C Act requires
that every person who owns or operates any establishment in any State
engaged in the manufacture, preparation, compounding, or processing of
a tobacco product or tobacco products register with FDA the name,
places of business, and all establishments owned or operated by that
person. Section 905(i)(1) of the FD&C Act requires that all registrants
must, at the time of registration, file with FDA a list of all tobacco
products which are being manufactured, prepared, compounded, or
processed by that person for commercial distribution, along with
certain accompanying consumer information, such as all labeling and a
representative sampling of advertisements.
Section 904(a)(1) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit a listing of all
ingredients, including tobacco, substances, compounds, and additives
that are added by the manufacturer to the tobacco, paper, filter, or
other part of each tobacco product by brand and by quantity in each
brand and subbrand. Section 904(c) of the FD&C Act also requires
submission of information whenever additives, or the quantities of
additives, are changed.
FDA issued guidance documents on both (1) ``Registration and
Product Listing for Owners and Operators of Domestic Tobacco Product
Establishments'' (74 FR 58298, November 12, 2009) and (2) ``Listing of
Ingredients in Tobacco Products'' (74 FR 62795, December 1, 2009) to
assist persons making these submissions to FDA under the FD&C Act.
Although electronic submission of registration and product listing
information and ingredient listing information are not required, FDA is
strongly encouraging electronic submission to facilitate efficiency and
timeliness of data management and collection. To that end, FDA designed
the eSubmitter application to streamline the data entry process for
registration and product listing and for ingredient listing. This tool
allows for importation of large quantities of structured data,
attachments of files (e.g., in portable document format (PDFs) and
certain media files), and automatic acknowledgement of FDA's receipt of
submissions. FDA also developed paper forms (Form FDA 3742--
Registration and Listing for Owners and Operators of Domestic Tobacco
Product Establishments and Form FDA 3743--Listing of Ingredients in
Tobacco Products) as alternative submission tools. Both the eSubmitter
application and the paper forms can be accessed at http://www.fda.gov/tobacco.
FDA estimates the additional annual burden for the information
collection as a result of this proposed rule as follows:
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response (in hours) Total hours
respondents respondent \2\ responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Product Establishment Registration (electronic and paper submission)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including Large and 121 1.0 121 3......................................... 363
Small).
Pipe Tobacco Manufacturers.................. 73 1.0 73 3......................................... 219
Other Tobacco, E-Cigarettes, and Nicotine 140 1.0 140 3......................................... 420
Product Manufacturers.
Importers of Cigars (222) and Pipe Tobacco 270 1.0 270 3......................................... 810
(48) Who Are Considered Manufacturers \3\.
-----------------------------------------------------------------------------------------------------------
Total Tobacco Product Establishment .............. .............. .............. .......................................... 1,812
Registration.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Product Listing (electronic and paper submission)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including Large, Small, 343 32.6 11,169 0.75 (45 minutes)......................... 8,377
and Importers).
Pipe Tobacco Manufacturers.................. 73 12.3 901 0.75 (45 minutes)......................... 676
Other Tobacco, E-Cigarettes, and Nicotine 188 8.9 1,675 0.75 (45 minutes)......................... 119
Product Manufacturers.
-----------------------------------------------------------------------------------------------------------
Total Hours Tobacco Product Listing..... .............. .............. .............. .......................................... 10,309
--------------------------------------------------------------------------------------------------------------------------------------------------------
Obtaining a Dun and Bradstreet (DUNS) Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including Large and 121 1.0 121 0.5 (30 minutes).......................... 61
Small).
Pipe Tobacco Manufacturers.................. 73 1.0 73 0.5 (30 minutes).......................... 37
Other Tobacco, E-Cigarettes, and Nicotine 140 1.0 140 0.5 (30 minutes).......................... 70
Product Manufacturers.
Importers of Cigars (222) and Pipe Tobacco 270 1.0 270 0.5 (30 minutes).......................... 135
(48) Who Are Considered Manufacturers.
-----------------------------------------------------------------------------------------------------------
Total Hours Obtaining DUNS Number....... .............. .............. .............. .......................................... 303
-----------------------------------------------------------------------------------------------------------
Total Hours Registration, Product .............. .............. .............. .......................................... 12,424
Listing, and DUNS Number.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 23186]]
Tobacco Product Ingredient Listing (electronic and paper submission)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including Large, Small, 343 32.6 11,169 3......................................... 33,507
and Importers).
Pipe Tobacco Manufacturers.................. 73 12.3 901 3......................................... 2,703
Other Tobacco, E-Cigarettes, and Nicotine 188 8.9 1,675 3......................................... 5,025
Product Manufacturers.
-----------------------------------------------------------------------------------------------------------
Total Hours Tobacco Product Ingredient .............. .............. .............. .......................................... 41,235
Listing.
-----------------------------------------------------------------------------------------------------------
Total Burden Tobacco Product .............. .............. .............. .......................................... 53,659
Establishment Registration and
Submission of Certain Health
Information.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to the nearest tenth.
\3\ Under 21 U.S.C. 387(20), a ``tobacco product manufacturer'' includes any person who ``imports a finished tobacco product for sale or distribution in
the United States.''
Based on aggregate information for 2012 obtained from TTB, FDA
estimates that 194 domestic manufacturers of cigars and pipe tobacco
and 270 importers of cigars and pipe tobacco would be required to
register under section 905 of the FD&C Act. Based on FDA's own
research, FDA estimates another 140 manufacturers of other tobacco
products (non-cigar and non-pipe) would be subject to registration
requirements. FDA estimates that the submission of registration
information required by section 905 of the FD&C Act will take 3 hours
per establishment, with a total of 604 establishments that would be
required to register under this proposed rule, for a total of 1,812
hours (604 x 3).
The estimate for the number of product listing submissions for
cigars is derived by using Perelman's Pocket Cyclopedia of Cigars (Ref.
193). FDA used a count of products offered on a single Web site with a
broad product offering, http://www.pipesandcigars.com/, to derive the
product listing count for pipe tobacco. FDA derives the product listing
estimate for other proposed deemed tobacco products (excluding cigars
and pipe tobacco) using an assumption of 15 percent of the number of
machine-made cigar products and Universal Product Codes (see also Ref.
192, table C4). FDA estimates that the submission of product listing
information required by section 905 of the FD&C Act will take 45
minutes per submission for 13,745 submissions for a total of 10,309
hours.
FDA estimates that obtaining a DUNS number will take 30 minutes.
FDA assumes that all the establishment facilities that would be
required to register under section 905 of the FD&C Act would obtain a
DUNS number, with a total of 604 establishments that would need to
obtain this number. The total burden to obtain a DUNS number is 303
hours.
FDA estimates that the submission of ingredient listing information
as required by section 904 of the FD&C Act will take 3 hours per
tobacco product based on the estimates found in the existing
collection. The Agency estimates that approximately 13,745 ingredient
listings will be submitted based on the methodology used for estimating
the number of product listing submissions described in this section.
The total ingredient listing reporting is 41,235 hours (13,745 x 3).
FDA is soliciting comments on these estimates and the methodology
for estimating the respondent numbers.
2. Tobacco Health Document Submission (OMB Control Number 0910-0654)
Description of Respondents: Respondents to this collection of
information are tobacco product manufacturers, importers, or agents who
will submit all documents developed after June 22, 2009, that relate to
health, toxicological, behavioral, or physiologic effects of current or
future tobacco products to FDA.
Section 904(a)(4) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents
developed after June 22, 2009, that relate to health, toxicological,
behavioral, or physiologic effects of current or future tobacco
products, their constituents (including smoke constituents),
ingredients, components, and additives (herein referred to as ``tobacco
health documents''). Information submissions required under section
904(a)(4) were due to FDA beginning December 22, 2009, for tobacco
products currently subject to the FD&C Act.
FDA is collecting the information submitted under section 904(a)(4)
of the FD&C Act through an electronic portal and through a paper form
(Form FDA 3743) for those individuals who choose not to use the
electronic portal.
FDA estimates the additional annual burden for the information
collection as a result of this proposed rule as follows:
Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 2 4 8 50 400
Large and Small)...............
Pipe Tobacco Manufacturers...... 1 4 4 50 200
[[Page 23187]]
Other Tobacco, E-Cigarettes, and 1 4 4 50 200
Nicotine Product Manufacturers.
Importers of Cigars and Pipe 1 4 4 50 200
Tobacco Who Are Considered
Manufacturers..................
-------------------------------------------------------------------------------
Total Hours Health Document .............. .............. .............. .............. 1,000
Submission.................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that a tobacco health document submission for cigars,
pipe tobacco, other tobacco, and importers of cigars and pipe tobacco
required by section 904(a)(4) of the FD&C Act, will take approximately
50 hours per submission based on the existing collection that applies
to tobacco products currently subject to the FD&C Act and FDA
experience. To derive the number of respondents for this provision, FDA
assumes that very few of the respondents subject to registration
requirements would have health documents to submit. Therefore, the
Agency estimates that approximately five submissions (two for cigar
manufacturers, one for pipe tobacco manufacturers, one for other
tobacco product manufacturers, and one for importers of cigars and pipe
tobacco who are considered manufacturers) will be submitted on an
annual basis. FDA estimates the total number of hours is 1,000 hours (5
submissions multiplied by 4 times per year multiplied by 50 average
burden hours.)
FDA is soliciting comments on these estimates and the methodology
for estimating the respondent numbers.
3. Exemptions From Substantial Equivalence Requirements (OMB Control
Number 0910-0684)
Description of Respondents: Respondents to this collection of
information are manufacturers of proposed deemed tobacco products who
are requesting an exemption from the substantial equivalence
requirements of the FD&C Act.
In a final rule that published on July 5, 2011 (76 FR 38961), FDA
established a pathway for manufacturers to request exemptions from the
substantial equivalence requirements of the Tobacco Control Act (SE
exemptions final rule). The SE exemptions final rule implements section
905(j)(3) of the FD&C Act, under which FDA may exempt tobacco products
that are modified by adding or deleting a tobacco additive, or
increasing or decreasing the quantity of an existing tobacco additive,
if FDA determines that: (1) The modification would be a minor
modification of a tobacco product that can be sold under the FD&C Act,
(2) a report is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health, and (3) an exemption is otherwise appropriate.
The exemption request may be made only by the manufacturer of a
legally marketed tobacco product for a minor modification to that
manufacturer's product and the request (and supporting information)
must be submitted in an electronic format that FDA can process, review,
and archive. In addition, the request and all supporting information
must be legible and in (or translated into) the English language.
An exemption request must be submitted with supporting
documentation and contain:
The manufacturer's address and contact information;
identification of the tobacco product(s);
a detailed explanation of the purpose for the
modification;
a detailed description of the modification; a detailed
explanation of why the modification is a minor modification of a
tobacco product that can be sold under the FD&C Act;
a detailed explanation of why a report under section
905(j)(1)(A)(i) intended to demonstrate substantial equivalence is not
necessary to ensure that permitting the tobacco product to be marketed
would be appropriate for the protection of the public health;
a certification summarizing the supporting evidence and
providing the rationale for why the modification does not increase the
tobacco product's appeal to or use by youth, toxicity, addictiveness,
or abuse liability;
other information justifying an exemption; and
an environmental assessment under part 25 (21 CFR part 25)
prepared in accordance with Sec. 25.40.
The exemption request must contain a certification by a responsible
official summarizing the supporting evidence and providing the
rationale for the official's determination that the modification will
not increase the product's toxicity, addictiveness, or appeal to/use by
youth and include other information justifying an exemption. This
information will enable FDA to determine whether the exemption request
would be appropriate for the protection of the public health. There is
also a procedural mechanism for rescinding an exemption where necessary
to protect the public health. In general, FDA would rescind an
exemption only after providing the manufacturer notice of the proposed
rescission and an opportunity for an informal hearing under part 16 (21
CFR part 16). However, FDA may rescind an exemption prior to notice and
opportunity for a hearing under part 16 if the continuance of the
exemption presents a serious risk to public health. In that case, FDA
would provide the manufacturer an opportunity for a hearing as soon as
possible after the rescission.
FDA reviews the information submitted in support of the request and
determines whether to grant or deny the request based on whether the
criteria specified in the statute are satisfied. If FDA determines that
the information submitted is insufficient to enable it to determine
whether an exemption is appropriate, FDA may request additional
information from the manufacturer. If the manufacturer fails to respond
within the timeframe requested, FDA will consider the exemption request
withdrawn.
FDA estimates the additional annual burden for the information
collection as a result of this proposed rule as follows:
[[Page 23188]]
Table 4--Estimated Annual Reporting Burden
[When manufacturers choose to seek exemption from substantial equivalence] \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR and activity Number of responses per Total annual per response Total hours
respondents respondent \2\ responses (in hours)
----------------------------------------------------------------------------------------------------------------
Sec. 1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 343 0.96 328 12 3,936
Large, Small, and Importers)...
Pipe Tobacco Manufacturers 121 0.58 70 12 840
(Including Importers)..........
Other Tobacco, E-Cigarettes, and 140 0.50 70 12 840
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
Total Hours (Sec. .............. .............. .............. .............. 5,616
1107.1(b)).................
----------------------------------------------------------------------------------------------------------------
Sec. 1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial
Equivalence Request
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 343 0.29 98 3 294
Large, Small, and Importers)...
Pipe Tobacco Manufacturers 121 0.17 21 3 63
(Including Importers)..........
Other Tobacco, E-Cigarettes, and 140 0.15 21 3 63
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
Total Hours (Sec. .............. .............. .............. .............. 420
1107.1(c)).................
----------------------------------------------------------------------------------------------------------------
Sec. 25.40 Preparation of an Environmental Assessment
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 343 0.96 328 12 3,936
Large, Small, and Importers)...
Pipe Tobacco Manufacturers 121 0.58 70 12 840
(Including Importers)..........
Other Tobacco, E-Cigarettes, and 140 0.50 70 12 840
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
Total Hours (Sec. 25.40).. .............. .............. .............. .............. 5,616
----------------------------------------------------------------------------------------------------------------
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product
is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant,
and modifications covered by exemptions granted by Secretary under section 905(j)(3)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 343 1.43 491 3 1,473
Large, Small, and Importers)...
Pipe Tobacco Manufacturers...... 121 0.87 105 3 315
Other Tobacco, E-Cigarettes, and 140 0.75 105 3 315
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
Total Hours (section .............. .............. .............. .............. 2,103
905(j)(1)(A)(ii))..........
-------------------------------------------------------------------------------
Total Hours Exemptions .............. .............. .............. .............. 13,755
From Substantial
Equivalence
Requirements...........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to
the nearest hundredth.
The estimated average burden per response (in hours) is based on
the burdens associated with the existing information collection that
applies to tobacco products currently subject to the FD&C Act (i.e.,
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco). Of an estimated 2,806 new products entering the market
through substantial equivalence exemptions (table 4) and SE reports
(table 5), FDA estimates that 25 percent (701) will enter through
substantial equivalence exemptions. FDA estimates that exemption
requests will be used for an average of 1.5 products each; therefore,
468 requests for exemption (701 products divided by 1.5 requests) will
be submitted annually, and it will take approximately 12 hours to
prepare an exemption request for a total of 5,616 hours (468 x 12
hours).
FDA estimates, based on the existing information collection that
applies to tobacco products currently subject to the FD&C Act, that 30
percent of the initial requests for information (468 x 0.30) will
require additional information in support of the initial exemption
request, and it is expected that it will take an average of 3 hours to
prepare the additional information for a total of 420 hours (468 x 0.30
x 3).
FDA estimates that 604 manufacturers will submit 468 Environmental
Assessments, and each EA is expected to take approximately 12 hours to
prepare and submit one environmental assessment under part 25 in
accordance with the requirements of Sec. 25.40, as referenced in Sec.
1107.1(b)(9) for a total of 5,616 hours (468 x 12).
FDA estimates that 604 respondents will prepare 701 responses (604
x 1.16) and each response will take approximately 3 hours to prepare
the report required by section 905(j)(1)(A)(ii) for a total of 2,103
hours (701 x 1 x 3). This collection of information requires a
manufacturer to submit a report at least 90 days prior to making an
introduction or delivery into interstate commerce for commercial
distribution of a tobacco product. The
[[Page 23189]]
report should contain the manufacturer's basis that the tobacco product
is modified within the meaning of the exemption provision in section
905(j)(3) of the FD&C Act, the modifications are to a product that is
commercially marketed and compliant with the FD&C Act, the
modifications are covered by exemptions granted under section
905(j)(3), and a listing of actions taken to comply with any applicable
requirements of section 907 of the FD&C Act.
FDA's estimates are based on full analysis of economic impacts
(Ref. 194) and information gathered from other FDA-regulated products.
4. Reports Intended To Demonstrate the Substantial Equivalence of a New
Tobacco Product (OMB Control Number 0910-0673)
Description of Respondents: Respondents to this collection of
information are manufacturers of proposed deemed tobacco products who
seek to submit a report to FDA demonstrating substantial equivalence
for tobacco products under section 905(j)(1)(A)(i) of the FD&C Act.
Section 905(j)(1) of the FD&C Act authorizes FDA to establish the
form and manner for the submission of information related to
substantial equivalence. FDA issued guidance intended to assist persons
submitting reports under section 905(j) of the FD&C Act and to explain,
among other things, FDA's interpretation of the statutory sections
related to substantial equivalence (see the guidance for industry and
FDA staff on ``Section 905(j) Reports: Demonstrating Substantial
Equivalence for Tobacco Products'' (76 FR 789, January 6, 2011)).
FDA estimates the additional annual burden for the information
collection as a result of this proposed rule as follows:
Table 5--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent \2\ responses (in hours)
----------------------------------------------------------------------------------------------------------------
Sections 905(j)(1)(A)(i) and 910(a)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 343 4.29 1,472 180 264,960
Large, Small, and Importers)...
Pipe Tobacco Manufacturers 121 2.61 316 180 56,880
(Including Importers)..........
Other Tobacco, E-Cigarettes, and 140 2.26 316 180 56,880
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
Total Hours (sections .............. .............. .............. .............. 378,720
905(j)(1)(A)(i) and 910(a))
----------------------------------------------------------------------------------------------------------------
Sec. 25.40 Environmental Assessments
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 343 4.29 1,472 12 17,664
Large, Small, and Importers)...
Pipe Tobacco Manufacturers 121 2.61 316 12 3,792
(Including Importers)..........
Other Tobacco, E-Cigarettes, and 140 2.26 316 12 3,792
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
Total Environmental .............. .............. .............. .............. 25,248
Assessment.................
-------------------------------------------------------------------------------
Total Hours (``Reports .............. .............. .............. .............. 403,968
Intended to Demonstrate
the Substantial
Equivalence of a New
Tobacco Product'').....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to
the nearest hundredth.
FDA has based these estimates on the full analysis of economic
impacts (Ref. 194) and experience with the existing information
collection that applies to tobacco products currently subject to the
FD&C Act (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco). Of an estimated 2,806 new products entering the
market through substantial equivalence exemptions (table 4) and SE
reports (table 5). FDA estimates that approximately 75 percent of the
products (2,104) will enter the market through SE reporting. Therefore,
FDA estimates that 604 respondents will prepare and submit 2,104
section 905(j)(1)(A)(i) SE reports each year and that it will take a
manufacturer approximately 180 hours per report to prepare the reports
of substantial equivalence for a new tobacco product. Therefore, FDA
estimates the burden for submission of substantial equivalence
information will be 378,720 hours (2,104 responses x 180 hours =
378,720 hours.) In addition, anyone submitting a report of substantial
equivalence is also expected to submit an environmental assessment
report under Sec. 25.40. Six hundred and four respondents are expected
to submit 2,104 reports, and take 12 hours to complete a single report,
for a total of 25,248 burden hours (2,104 reports x 12 hours = 25,248
hours.)
FDA requests comments on these estimates and the methodology used
to estimate the burdens.
5. Electronic Importer's Entry Notice (OMB Control Number 0910-0046)
Description of Respondents: Respondents to this collection of
information are importers of tobacco products offered for import into
the United States whose products meet the same requirements of the
Tobacco Control Act as domestic tobacco products.
With the passage of the Tobacco Control Act, section 801 of the
FD&C Act (21 U.S.C. 381) was amended to add tobacco products to the
inventory of FDA-regulated products. The revised section 801 charges
the Secretary of HHS, through FDA, with the responsibility of assuring
foreign-origin, FDA-regulated foods, drugs, cosmetics, medical devices,
radiological health,
[[Page 23190]]
and tobacco products offered for import into the United States meet the
same requirements of the FD&C Act as do domestic products and the
responsibility for preventing products from entering the country if
they are not in compliance. The discharge of this responsibility
involves close coordination and cooperation between FDA headquarters
and field inspectional personnel and the U.S. Customs and Border
Protection (CBP), as CBP is responsible for enforcing the revenue laws
covering tobacco products. This collection of information in this
section is being used by FDA to review and prevent imported products
from entering the United States if the products do not meet the same
requirements of the FD&C Act as do domestic products.
Until October 1995, importers were required to file manual entry on
OMB-approved forms, which were accompanied by related documents.
Information provided by these forms included information such as
country of origin, name of the importing vessel, entry number (assigned
by CBP), port of entry, the port of lading and unlading, value in U.S.
dollars, shipper or manufacturer, importer of record, original
consignee, broker, broker's reference number and CBP house box number,
bill of lading numbers, and location of goods. FDA stopped using these
paper forms effective October 1, 1995, to eliminate duplication of
information and to reduce the paperwork burden both on the import
community and FDA. FDA then developed and implemented an automated
nationwide entry processing system, which enabled FDA to more
efficiently obtain and process the information it requires to fulfill
its regulatory responsibility.
Most of the information FDA requires to carry out its regulatory
responsibilities under section 801 of the FD&C Act is already provided
electronically by filers to CBP. Because CBP relays this data to FDA
using an electronic interface, the majority of data submitted by the
entry filer need be done only once.
FDA estimates the additional annual burden for the information
collection as a result of this proposed rule as follows:
Table 6--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response (in hours) Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importers of Cigars who are Considered 222 159 35,224 0.14 (8\1/2\ minutes)..................... 4,931
Manufacturers.
Importers of Pipe Tobacco Who Are Considered 48 123 5,916 0.14 (8\1/2\ minutes)..................... 828
Manufacturers.
Other Tobacco, E-Cigarettes, and Nicotine 140 68 9,520 0.14 (8\1/2\ minutes)..................... 1,333
Product Manufacturers.
-----------------------------------------------------------------------------------------------------------
Total Hours Importation of Tobacco .............. .............. .............. .......................................... 7,092
Products.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates the burden hours to be 7,092 burden hours (4,931 +
1,295 + 1,333 hours). This reflects the addition of proposed deemed
tobacco products to the list of FDA's regulated products. The original
(nontobacco) hourly burden for this information collection was based on
FDA's estimate of imported tobacco products obtained from the United
States Customs and Border Protection (CBP). When testing the use of
electronic and paper forms, FDA determined that the average time for
completing either electronic or manual entries was the same.
Based on the original data collected by FDA when the importer entry
notice information collection was most recently approved, it is
expected that each respondent will take 0.14 hour (8 \1/2\ minutes) to
respond. The estimated hours per response are expected to remain the
same for tobacco importers.
FDA estimates that there will be no additional costs to provide
import data electronically to FDA, as filers already have equipment and
software in place to enable them to provide data to CBP via the
automated system. Therefore, no additional software or hardware need be
developed or purchased to enable filers to file the FDA data elements
at the same time they file entries electronically with CBP.
6. Further Amendments to General Regulations of the Food and Drug
Administration To Incorporate Tobacco Products (OMB Control Number
0910-0690)
Description of Respondents: Respondents are manufacturers,
distributors, and other persons who export tobacco products not
intended for sale in the United States.
In a rule published on February 2, 2012 (77 FR 5171), FDA amended
certain of its general regulations to include tobacco products, where
appropriate, in light of FDA's authority to regulate these products
under the Tobacco Control Act (conforming amendments rule). The
conforming amendments rule subjects tobacco products to the same
general requirements that apply to other FDA-regulated products, where
appropriate.
The conforming amendments rule amended 21 CFR 1.101(b), among other
sections, to require persons who export human drugs, biologics,
devices, animal drugs, cosmetics, and tobacco products that may not be
sold in the United States to maintain records demonstrating their
compliance with the requirements in section 801(e)(1) of the FD&C Act.
Section 801(e)(1) requires exporters to keep records demonstrating that
the exported product: (1) Meets with the foreign purchaser's
specifications; (2) does not conflict with the laws of the foreign
country; (3) is labeled on the outside of the shipping package that is
intended for export; and (4) is not sold or offered for sale in the
United States. These criteria also could be met by maintaining other
documentation, such as letters from a foreign government agency or
notarized certifications from a responsible company official in the
United States stating that the exported product does not conflict with
the laws of the foreign country.
FDA estimates the annual burden for the information collection as a
result of this proposed rule as follows:
[[Page 23191]]
Table 7--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per record (in Total hours
recordkeepers recordkeeper records hours)
----------------------------------------------------------------------------------------------------------------
21 CFR 1.101(b)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Large and 42 3 126 22 2,772
Small).........................
Pipe Tobacco Manufacturers...... 10 3 30 22 660
Other Tobacco, E-Cigarettes, and 27 3 81 22 1,782
Nicotine Product Manufacturers.
----------------------------------------------------------------------------------------------------------------
Total Further Amendments to .............. .............. .............. .............. 5,214
General Regulations of the Food
and Drug Administrations to
Incorporate Tobacco Products...
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The Agency has estimated the number of respondents and burden hours
associated with the recordkeeping requirements by reviewing Agency
records and using Agency expert resources, and conferring with another
Federal Agency with experience and information regarding tobacco
product exporters. FDA estimates that 79 establishments (half of the
158 estimated total of all tobacco manufacturers listed in the
collection of information approved under OMB control number 0910-0046
who manufacture cigars, pipe tobacco, and other tobacco products) could
be involved in the exporting of all tobacco products annually. Based on
previous recordkeeping estimates for the exporter's reporting burden in
the existing OMB-approved collection of information (OMB control number
0910-0482, ``Export Notification and Recordkeeping Requirements''),
each establishment will maintain an average of three records per year,
and it will take each recordkeeper an average of 22 hours per
recordkeeper to maintain each record. The Agency estimates 5,214 burden
hours will be needed for tobacco product exporters to create and
maintain records demonstrating compliance with section 801(e)(1) of the
FD&C Act (79 recordkeepers x 3 records per year x 22 hours per record =
5,214).
B. Burdens Associated With Tobacco Products Currently Subject to the
FD&C Act But Not Yet Approved by OMB
The information collections described in this section also involve
collections that have been previously made available for public comment
because they involved tobacco products currently subject to the FD&C
Act. However, these information collections have not yet been approved
by OMB. FDA is making them available for public comment again because
we have revised the burdens to include proposed deemed tobacco
products. In developing the burden estimates for proposed deemed
tobacco products, FDA based the estimates on the existing collections
that were previously made available for comment. FDA requests comments
on these estimates and the methodology used to estimate the burdens.
1. Establishing That a Tobacco Product Was Commercially Marketed in the
United States as of February 15, 2007
Description of Respondents: Respondents to this collection of
information are manufacturers of tobacco products who wish to
demonstrate that their tobacco product was commercially marketed in the
United States as of February 15, 2007, and is a grandfathered product
not subject to premarket review.
On April 25, 2011, FDA announced the availability of a draft
guidance document entitled ``Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007''
(76 FR 22903). This draft guidance provides information on how a
manufacturer may demonstrate that a tobacco product was commercially
marketed in the United States as of February 15, 2007, and is,
therefore, a grandfathered product not subject to premarket review. The
draft guidance recommends that the manufacturer provide evidence that
may include, among other things, dated copies of advertisements, dated
catalog pages, dated promotional material, and dated bills of lading.
FDA recommends that the manufacturer submit as much information as
possible to demonstrate that the tobacco product was commercially
marketed in the United States as of February 15, 2007. FDA has not yet
finalized this draft guidance.
The estimate for the number of hours in the existing collection is
FDA's estimate of how long it might take one to review, gather, and
submit dated information if making a request for an Agency
determination.
FDA estimates the annual burden for the information collection as a
result of this proposed rule as follows:
Table 8--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Activity respondents responses per responses response (in Total hours
respondent \2\ hours)
----------------------------------------------------------------------------------------------------------------
Cigars--2 Largest Manufacturers. 2 25 50 10 500
Other Cigar Manufacturers 341 2.8 947 10 9,470
(excluding 2 largest
manufacturers and including
large and small cigars, and
importers).....................
Pipe Tobacco Manufacturers 121 1.7 204 10 2,040
(Including Importers)..........
Other Tobacco, E-Cigarettes, and 140 1.5 210 10 2,100
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
[[Page 23192]]
Total Hours Establishing .............. .............. .............. .............. 14,110
that a Tobacco Product was
Commercially Marketed in
the United States as of
February 15, 2007..........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to
the nearest tenth.
FDA is basing the current estimates on the existing collection that
applies to tobacco products currently subject to the FD&C Act.
Annually, 2 large cigar manufacturers each are expected to submit 25
grandfathered product status requests each, for a total of 50
applications. The remaining cigar manufacturers are expected to submit
2.8 reports each annually. The total number of reports expected
annually under sections 905(j)(1)(A)(i) and 910 of the FD&C Act for
cigar manufacturers is 997 annually, which is 71 percent of the total
number of grandfathered product applications expected annually. FDA
also estimates it would take a cigar manufacturer approximately 10
hours to complete and submit for FDA review the evidence required by
this collection of information and estimates that it should take
approximately 9,970 hours annually (50 responses times 10 hours plus
947 responses times 10 hours for each response) for cigar manufacturers
to respond to this collection of information.
Annually, the number of reports expected to be submitted under
sections 905(j)(1)(A)(i) and 910 of the FD&C Act for pipe tobacco
manufacturers is 1.7 product applications each. FDA estimates it would
take a pipe tobacco manufacturer approximately 10 hours to complete and
submit for FDA review the evidence required by this collection of
information. Therefore, FDA estimates that it should take approximately
2,040 hours annually (204 responses times 10 hours for each response)
for pipe tobacco manufacturers to respond to this collection of
information.
Annually, other tobacco manufacturers (i.e., excluding cigars and
pipe tobacco) are expected to submit 1.5 grandfathered product
applications each. FDA estimates that it will take these manufacturers
10 hours to complete and submit for FDA review the evidence required by
this collection of information. Therefore, FDA estimates that it should
take approximately 2,100 hours (210 total annual responses times 10
hours for each response) for other manufacturers to respond to this
collection of information.
The total number of burden hours, therefore, is 14,110 (500 hours +
9,470 hours + 2,040 hours + 2,100 hours). FDA has based these estimates
on information from interactions with firms already subject to the FD&C
Act and comments received regarding the submission of reports
establishing that a tobacco product was commercially marketed in the
United States as of February 15, 2007, from a notice of proposed
information collection that covered tobacco products currently subject
to the FD&C Act (76 FR 22903, April 25, 2011).
2. Applications for Premarket Review of New Tobacco Products
Description of Respondents: The respondents to this collection of
information are manufacturers who are responsible for creating and
submitting new tobacco product premarket applications and who wish to
obtain an FDA order to allow them to market their product.
On September 28, 2011, FDA announced the availability of a draft
guidance entitled ``Applications for Premarket Review of New Tobacco
Products'' (76 FR 60055). This guidance, when finalized, will provide
industry with information on how to submit an application for premarket
review of new tobacco products as required by section 910 of the FD&C
Act. Section 910(a)(1) of the FD&C Act requires persons who either
create a new tobacco product that was not commercially marketed in the
United States as of February 15, 2007, or modify a tobacco product in
any way after February 15, 2007, including a change in design, any
component, any part, or any constituent, including a smoke constituent,
or in the content, delivery, or form of nicotine, or any other additive
or ingredient, to submit a premarket tobacco product application and
obtain an order from FDA authorizing the marketing of the product
before the product may be introduced or delivered for introduction into
interstate commerce. This requirement applies unless the product has
been shown to be substantially equivalent to a tobacco product
commercially marketed in the United States as of February 15, 2007, or
is exempt from an SE determination under an issued regulation.
The draft guidance ``Applications for Premarket Review of New
Tobacco Products'' explains the requirements and provides
recommendations for the contents of an application for premarket review
of a new tobacco product. Contents include a cover letter; an executive
summary; full reports of all investigations of health risks; a full
statement of all components, ingredients, additives, and properties,
and of the principle or principles of operation of such tobacco
product; a full description of methods of manufacturing and processing;
a listing of all manufacturing, packaging, and control sites for the
product; an explanation of how the product complies with applicable
tobacco product standards; samples and components; and proposed
labeling. If an applicant does not submit information on any of the
previously mentioned items, the application should include a statement
indicating which information is not being submitted and an explanation
of why the information is not being submitted.
FDA also encourages persons who would like to study their new
tobacco product to meet with the Office of Science at the Center for
Tobacco Products (CTP) to discuss their investigational plan prior to
distributing the product for investigational purposes. The request for
a meeting should be sent in writing to the Director of CTP's Office of
Science and should include adequate information for FDA to assess the
potential utility of the meeting and to identify FDA staff necessary to
discuss proposed agenda items. FDA is required to deny a PMTA and issue
an order that the product may not be introduced or delivered for
introduction into interstate commerce under section 910(c)(1)(A)(ii) of
the FD&C Act if FDA finds that:
The manufacturer has not shown that the product is
appropriate for the protection of the public health,
[[Page 23193]]
the manufacturing methods, facilities, or controls do not
conform to manufacturing regulations issued under section 906(e) of the
FD&C Act,
the proposed labeling is false or misleading, or
the manufacturer has not shown that the product complies
with any tobacco product standard in effect under section 907 of the
FD&C Act.
Under section 902(6)(A) of the FD&C Act, a tobacco product is
deemed adulterated if it is a new tobacco product and does not have an
order in effect under section 910(c)(1)(A)(i) of the FD&C Act. Under
section 301(a) of the FD&C Act (21 U.S.C. 331(a)), the introduction or
delivery for introduction into interstate commerce of any adulterated
tobacco product is a prohibited act. Violations of section 910 of the
FD&C Act are subject to regulatory and enforcement action by FDA,
including, but not limited to, seizure and injunction.
FDA estimates the annual burden for the information collection as a
result of this proposed rule as follows:
Table 9--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Obtaining an FDA Order Authorizing Marketing of Tobacco Product (the application)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 1 1 1 5,000 5,000
Large, Small, and Importers)...
Pipe Tobacco Manufacturers 1 1 1 5,000 5,000
(Including Importers)..........
Other Tobacco, E-Cigarettes, and 25 1 25 5,000 125,000
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
Total Hours Obtaining an FDA .............. .............. .............. .............. 135,000
order authorizing marketing
of tobacco product (the
application)...............
----------------------------------------------------------------------------------------------------------------
Request for Meeting with CTP's Office of Science to Discuss Investigational Plan
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 1 1 1 4 4
Large, Small, and Importers)...
Pipe Tobacco Manufacturers 1 1 1 4 4
(Including Importers)..........
Other Tobacco, E-Cigarettes, and 25 1 25 4 100
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
Total Hours Request for .............. .............. .............. .............. 108
Meeting with CTP's Office
of Science to Discuss
Investigational Plan.......
----------------------------------------------------------------------------------------------------------------
Sec. 25.40 Environmental Assessments
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including 1 1 1 12 12
Large, Small, and Importers)...
Pipe Tobacco Manufacturers 1 1 1 12 12
(Including Importers)..........
Other Tobacco, E-Cigarettes, and 25 1 25 12 300
Nicotine Product Manufacturers.
-------------------------------------------------------------------------------
Total Hours Sec. 25.40 .............. .............. .............. .............. 324
Environmental Assessments..
-------------------------------------------------------------------------------
Total Hours .............. .............. .............. .............. 135,432
``Applications for
Premarket Review of New
Tobacco Products''.....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that it will take each respondent approximately 5,000
hours to obtain an order from FDA allowing the marketing of a new
tobacco product. FDA's estimate includes anticipated burden for the
writing of an application, including intra-company edits and approvals,
of approximately 200 hours. In addition, FDA expects that conducting
the necessary scientific investigations for a new tobacco product
(either in-house or via a third-party consultant) will require, on
average, 4,800 hours. FDA also estimates the number of PMTA
applications that FDA expects to receive annually will be 27 (1 each
from cigar and pipe tobacco manufacturers, and 25 from other tobacco
manufacturers.) Therefore, the total annual burden for submitting PMTA
applications is estimated to be 135,000 hours (27 respondents x 5,000
hours).
FDA notes that this 5,000 hour burden estimate is consistent with
the burden included in the notice announcing the availability of the
draft guidance ``Applications for Premarket Review of New Tobacco
Products'' (76 FR 60055). We are clarifying here that a PMTA may
require one or more types of studies including chemical analysis,
nonclinical studies, and clinical studies. FDA expects that chemical
and design parameter analysis would include the testing of applicable
HPHCs and nonclinical analysis would include literature synthesis and,
as appropriate, some combination of in vitro or in vivo studies, and
computational analyses. For the clinical study component, one or more
types of studies may be included to address, as needed, perception, use
pattern, or health impact. It is possible that an applicant may not
need to conduct any new nonclinical or clinical studies. We note that
for most applications, FDA does not expect that applicants will include
standardized clinical trials, like those conducted to support drug and
device approvals.
For tobacco products already on the market at the time of the final
rule,
[[Page 23194]]
much of the information required to support a PMTA may be obtained from
previously published research on similar products. Therefore, FDA
expects that a large portion of applications may be reviewed with no or
minimal new nonclinical or clinical studies being conducted to support
an application. In contrast, several nonclinical and clinical studies
may be required for market authorization of a new product for which
there is little to no understanding of its potential impact. The range
of hours involved to compile these two types of applications would be
quite variable.
FDA anticipates that the 27 potential respondents to this
collection may need to meet with CTP's Office of Science to discuss
their investigational plans. To request this meeting, applicants must
compile and submit information to FDA for meeting approval. FDA
estimates that it will take approximately 4 hours to compile this
information, for a total of 108 hours additional burden (27 respondents
x 4 hours).
FDA also estimates that the 27 potential respondents will take
approximately 12 hours to prepare and submit an environmental
assessment (for a total of 324 hours) in accordance with the
requirements of section Sec. 25.40, as referenced in Sec.
1107.1(b)(9).
The total reporting burden is estimated to be 135,432 hours burden
(135,000 hours + 108 hours + 324 hours.). FDA's estimates are based on
the corresponding information collection estimates that apply to
tobacco products currently subject to the FD&C Act and an assumption
that manufacturers would submit applications for the premarket review
of tobacco products.
FDA requests comments on these estimates and the methodology used
to derive the estimates.
C. New Collections of Information That Applies Only to Proposed Deemed
Tobacco Products
1. Exemption From the Required Warning Statement Requirement
Description of Respondents: Respondents are manufacturers and other
persons who, to obtain an exemption from the required warning statement
requirement, would be required to certify to FDA that their product
does not contain nicotine, that the company has data to support that
assertion, and, therefore, the product does not warrant the proposed
addictiveness warning.
This proposed rule contains a new information collection that
pertains to an exemption process related to the requirement to include
the warning statement in proposed Sec. 1143.3(a)(1). Proposed Sec.
1143.3(c) would provide an exemption to the manufacturer of a product
that otherwise would be required to include the warning statement in
proposed Sec. 1143.3(a)(1) on its packages and in its advertisements
(i.e., ``WARNING: This product contains nicotine derived from tobacco.
Nicotine is an addictive chemical.''). To obtain this exemption, a
manufacturer would be required to certify to FDA that its product does
not contain nicotine, that the company has data to support that
assertion, and, therefore, the product does not warrant the proposed
addictiveness warning. For any product that obtains this exemption, the
proposed section requires that the product bear the message: ``This is
product derived from tobacco.'' The parties that package and label such
products would share responsibility for ensuring that this alternative
statement is included on product packages and in advertisements. While
FDA is not aware of any currently marketed tobacco products that do not
contain nicotine, the proposed rule would permit companies to obtain an
exemption from this warning requirement in the event that such tobacco
products are developed in the future.
FDA estimates the annual burden for the information collection as a
result of this proposed rule as follows:
Table 10--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Certification Statement......... 1 1 1 20 20
----------------------------------------------------------------------------------------------------------------
Total Exemptions From the .............. .............. .............. .............. 20
Required Warning Statement
Requirement................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimated average burden per response is based on information
collection estimates that apply to tobacco products currently subject
to the FD&C Act. While very few certifications are expected for tobacco
products that do not contain nicotine, FDA estimates that the number of
certification submissions could rise if the Agency decides in the
future to address not only nicotine, but any other addictive
substances.
The estimated hours listed in the burden table for certification
submissions reflect the time needed to test the product for nicotine
and preparation and submission of the self-certification request. FDA
expects that these types of certifications will be very rare and
estimates that the Agency will receive on average one submission per
year.
FDA notes that the labeling statements in proposed Sec. Sec.
1143.3(a)(1) and 1143.5(a)(1) and the proposed alternative warning
statement in proposed Sec. 1143.3(c) (i.e., ``This product is derived
from tobacco'') do not constitute a ``collection of information'' under
the PRA. Rather, these labeling statements are ``public disclosure'' of
information originally supplied by the Federal Government to the
recipient for the purpose of ``disclosure to the public'' (5 CFR
1320.3(c)(2)).
The total burden for these new collections of information in this
rulemaking is 629,036 reporting hours (53,659 + 1,000 + 13,755 +
403,968 + 7,092 + 14,110 + 135,432 + 20) and 5,214 recordkeeping hours
for a total of 634,250 burden hours.
To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974,
or emailed to [email protected]. All comments should be
identified with the title ``The Food and Drug Administration Deems
Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic
Act, as Amended by the Family Smoking Prevention and Tobacco Control
Act;
[[Page 23195]]
Regulations Restricting the Sale and Distribution of Tobacco Products
and Required Warnings for Tobacco Product Packages and
Advertisements.''
In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has
submitted the information collection provisions of this proposed rule
to OMB for review. These requirements will not be effective until FDA
obtains OMB approval. FDA will publish a notice concerning OMB approval
of these requirements in the Federal Register.
X. Executive Order 13132; Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.''
Section 916(a)(1) of the FD&C Act (21 U.S.C. 387p) expressly
preserves the authority of State, local, and tribal governments to ``to
enact, adopt, promulgate, and enforce any law, rule, regulation, or
other measure with respect to tobacco products that is in addition to,
or more stringent than, requirements established under this chapter [21
U.S.C. 387 et seq.],'' except as expressly preempted by section
916(a)(2) of the FD&C Act. With the exception of the limited category
of regulatory actions preempted by section 916(a)(2), State and local
governments may adopt or continue to enforce all requirements
pertaining to tobacco products that are in addition to, or more
stringent than, the requirements of the Tobacco Control Act and its
implementing regulations, including requirements relating to or
prohibiting the sale and distribution of tobacco products, the
advertising and promotion of tobacco products, and the use of tobacco
products by individuals of any age.
Section 916(a)(2) of the FD&C Act is an express preemption
provision. Section 916(a)(2)(A) expressly preempts any State or local
requirement ``which is different from, or in addition to, any
requirement under [chapter IX of the FD&C Act] relating to tobacco
product standards, premarket review, adulteration, misbranding,
labeling, registration, good manufacturing standards, or modified risk
products.'' However, section 916(a)(2)(B) of the FD&C Act states that
the express preemption provision in subparagraph (A) ``does not apply
to requirements relating to'' among other things ``the sale,
distribution, possession, information reporting to the State, exposure
to, access to, the advertising and promotion of, or use of, tobacco
products by individuals of any age.''
Executive Order 13132 requires Agencies to consult, to the extent,
practicable, with State and local officials if the Agency foresees the
possibility of a conflict between State law and Federally protected
interests. FDA has not identified any State or local laws that would be
preempted by these proposed restrictions. Nevertheless, FDA intends to
consult with State and local jurisdictions about the potential impact
this rule could have on their requirements.
XI. Environmental Impact
The Agency has carefully considered the potential environmental
effects of deeming products to be subject to the FD&C Act and the
proposed age and identification restrictions. FDA has concluded that
the actions will not have a significant impact on the human
environment, and that an environmental impact statement is not
required. The Agency's finding of no significant impact and the
evidence supporting that finding, contained in an environmental
assessment, may be seen in the Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
The Agency also has determined under 21 CFR 25.30(k) that the
labeling requirement is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required for the proposed health warning
statements.
XII. Analysis of Impacts: Summary
FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The agency believes that this proposed rule would be an
economically significant regulatory action as defined by Executive
Order 12866.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. FDA has determined that this proposed rule would
have a significant economic impact on a substantial number of small
entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
result in a one-year expenditure that meets or exceeds this amount.
The proposed rule consists of two coproposals, Option 1 and Option
2. The proposed Option 1 deems all products meeting the statutory
definition of ``tobacco product,'' except accessories of a proposed
deemed tobacco product, to be subject to chapter IX of the Federal
Food, Drug, and Cosmetic Act (FD&C Act). Option 1 proposes additional
provisions that would apply to proposed deemed products as well as to
certain other tobacco products. Once deemed, tobacco products become
subject to the FD&C Act and its implementing regulations. The FD&C Act
requirements that would apply to proposed deemed products include
establishment registration and product listing, ingredient listing,
submissions prior to the introduction of new products, and labeling
requirements. Free samples of proposed deemed tobacco products would
also be prohibited. The additional provisions of this proposed rule
include minimum age and identification requirements, vending machine
restrictions, and required warning statements for packages and
advertisements. Although deeming and the associated ``automatic
provisions'' of the FD&C Act could be implemented on their own, the
additional provisions could not be implemented for proposed deemed
products without deeming.
While FDA currently has authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco under chapter IX
of the FD&C Act, all additional tobacco products that meet the
statutory definition, except
[[Page 23196]]
accessories of those proposed deemed tobacco products, would be subject
to chapter IX of the FD&C Act and its implementing regulations under
the proposed rule. These products would include cigars, pipe tobacco,
hookah tobacco, electronic cigarettes, and other novel tobacco products
such as dissolvable products and gels. Of these products to be deemed,
cigars are the most commonly used.
The other coproposal, Option 2, is the same as Option 1 except that
it exempts premium cigars. The proposed rule would define premium
cigars as cigars that are wrapped in whole tobacco leaf; contain a 100
percent leaf tobacco binder; contain primarily long filler tobacco; are
made by manually combining the wrapper, filler, and binder; have no
filter, tip, or non-tobacco mouthpiece and are capped by hand; do not
have a characterizing flavor other than tobacco; weigh more than 6
pounds per 1000 units; and sell for $10 or more per cigar.
The proposed deeming action differs from most public health
regulations in that it is an enabling regulation. In other words, in
addition to directly applying the substantive requirements of chapter
IX of the FD&C Act and its implementing regulations to proposed deemed
tobacco products, it enables FDA to issue further public health
regulations related to such products. We expect that asserting our
authority over these tobacco products will enable us to propose further
regulatory action in the future as appropriate, and those actions will
have their own costs and benefits. Without deeming these products to be
subject to the FD&C Act, FDA would lack the authority to collect vital
ingredient and health information about them. We would also lack the
authority to take regulatory action with respect to them, if we
determined it was appropriate to do so.
The direct benefits of making each of the proposed deemed tobacco
products subject to the requirements of chapter IX of the FD&C Act are
difficult to quantify without additional data, and we cannot predict
the size of these benefits at this time. Among other effects, new
products would be subject to evaluation to ensure they are appropriate
for public health before they could be marketed, labeling could not
contain misleading statements, and FDA would be made aware of the
ingredients in proposed deemed tobacco products. If, without the
proposed rule, new products would be developed that pose substantially
greater health risks than those already on the market, the premarket
requirements made effective by this proposed rule would prevent such
products from appearing on the market and worsening the health effects
of tobacco product use. The warning statements required by this
proposed rule would provide information to consumers about the risks
and characteristics of tobacco products. Consumers may act on this
information by reducing their use of tobacco products. Consumers may
also act on this information through compensating health behaviors.
These responses would generate benefits associated with improved health
and longevity.
The proposed rule as a whole would impose costs in the form of
registration, submission, and labeling requirements. The deeming
provision would impose immediate costs because manufacturers and
importers of newly-regulated tobacco products would have to comply with
registration, submission, and labeling requirements. Manufacturers of
proposed deemed products, as well as some manufacturers of currently-
regulated products, would have to comply with the warning label
provisions, including costs for signs with warnings at point-of-sale
for cigars sold singly without packaging. There would also be potential
costs for removing noncompliant point-of-sale advertising and complying
with vending machine restrictions.
The upfront costs for Option 1 are estimated to range from $74.3 to
$347.0 million, with a primary estimate of $171.1 million, while the
costs in subsequent years are estimated to range from $20.8 to $49.0
million, with a primary estimate of $30.6 million. The primary estimate
for the present value of total quantified costs over 20 years is
approximately $592.0 million at a 3 percent discount rate and $467.6
million at a 7 percent discount rate.
The upfront costs for Option 2 are estimated to range from $60.5 to
$258.5 million, with a primary estimate of $132.8 million, while the
costs in subsequent years are estimated to range from $17.4 to $38.4
million, with a primary estimate of $25.0 million. The primary estimate
for the present value of total quantified costs over 20 years is
approximately $476.4 million at a 3 percent discount rate and $375.0
million at a 7 percent discount rate.
The quantified costs of both options for the proposed rule can also
be expressed as annualized values, as shown in Table 11.
Table 11--Summary of Quantified Costs Over 20 Years
[$ million]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lower bound Upper bound Lower bound Upper bound
(3%) Primary (3%) (3%) (7%) Primary (7%) (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value Option 1.................................. 365.2 592.0 1,010.1 281.4 467.6 810.2
Present Value Option 2.................................. 304.0 476.4 779.2 233.8 375.0 622.6
Annualized Value Option 1............................... 23.8 38.6 65.9 24.8 41.2 71.5
Annualized Value Option 2............................... 19.8 31.1 50.8 20.6 33.1 54.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
In addition to the benefits and costs of both options for the
proposed rule, we assess the benefits and costs of several alternatives
to the proposed rule, although we note that some may be outside of our
current legal authority: deeming only, but exempt proposed deemed
products from all labeling changes and premarket submission
requirements; enforce premarket requirements only for machine-made
cigars; change the grandfather date for new products to the date of
final regulation; deeming only, but exempt proposed deemed products
from all labeling changes; exempt handmade cigars from labeling
changes; deeming only (no additional provisions); alter the compliance
period for labeling changes.\10\
---------------------------------------------------------------------------
\10\ We note that not all of these regulatory alternatives are
necessarily legally permissible.
---------------------------------------------------------------------------
Primary estimates of the costs of the regulatory alternatives
appear as present values and annualized values in Table 12.
[[Page 23197]]
Table 12--Primary Estimate of Quantified Costs for Regulatory Alternatives
[Present and Annualized Values, $ million] \1\
----------------------------------------------------------------------------------------------------------------
Present Present Annualized Annualized
Alternative value (3%) value (7%) value (3%) value (7%)
----------------------------------------------------------------------------------------------------------------
1--Deeming only; exempt from labeling changes and new 10.3 8.3 0.7 0.7
product submissions........................................
2--Enforce premarket requirements only for machine-made 176.3 156.0 11.5 13.8
cigars.....................................................
3--Change grandfather date to date of regulation............ 422.1 333.0 27.5 29.4
4--Deeming only; exempt from labeling changes............... 475.9 360.8 31.1 31.8
Proposed Rule Option 2: Exempt Premium Cigars from 476.4 375.0 31.1 33.1
Regulation.................................................
5--Exempt handmade cigars from labeling changes............. 500.0 384.2 32.6 33.9
6--Deeming only; no additional provisions................... 541.6 425.3 35.3 37.5
7a--36-month compliance period for labeling changes......... 572.3 447.1 37.3 39.4
Proposed Rule Option 1--24-month compliance period for 592.0 467.6 38.6 41.2
labeling changes...........................................
7b--12-month compliance period for labeling changes......... 646.1 523.2 42.2 46.2
----------------------------------------------------------------------------------------------------------------
\1\ Nonquantified benefits are described in the text.
The majority of the compliance costs of this proposed rule are
fixed, but a portion of the costs are variable. The costs imposed will
be borne primarily by manufacturers and importers; some of the costs
will be passed on to consumers in the form of higher prices. The
average increase in the price of proposed deemed tobacco products,
however, would be very small relative to current prices.
In addition to the costs described in Tables 11 and 12, the
proposed rule would lead to private costs in the form of reduced
revenues for firms in affected sectors. Additionally, if excise taxes
on tobacco products remain at current levels, annual tax revenues would
fall with reduced use.
Domestic tobacco product manufacturers and importers, most of which
are small, would be the entities primarily affected by this rule. In
particular, we expect domestic cigar manufacturers to be affected
because they are more likely than importers to be completely
specialized in a newly regulated product, and the handmade segment of
the cigar market is characterized by a large number of low-volume
products. Even though user fees are a transfer payment and not a
societal cost, they are a cost from the standpoint of the manufacturers
who must pay them. Therefore, user fees are included in the estimated
burden for small domestic cigar manufacturers. For Option 1, the
estimated upfront costs range from $390,000 to $759,000 per domestic
cigar manufacturing establishment, and the average annual costs are
estimated to range from $450,000 to $541,000. Several of the regulatory
alternatives that would reduce costs are analyzed as potential
regulatory relief options for small businesses.
The full analysis of economic impacts is available in the docket
for this proposed rule (Ref. 193) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
FDA requests comments on all inputs, methods and results that
appear in the economic analysis.
XIII. Request for Comments
A. General Information About Submitting Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document.
B. Public Availability of Comments
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov. As a matter of Agency
practice, FDA generally does not post comments submitted by individuals
in their individual capacity on http://www.regulations.gov. This is
determined by information indicating that the submission is written by
an individual, for example, the comment is identified with the category
``Individual Consumer'' under the field titled ``Category (Required),''
on the ``Your Information'' page on www.regulations.gov. For this
proposed rule, however, FDA will not be following this general
practice. Instead, FDA will post on http://www.regulations.gov comments
to this docket that have been submitted by individuals in their
individual capacity. If you wish to submit any information under a
claim of confidentiality, please refer to 21 CFR 10.20.
C. Information Identifying the Person Submitting the Comment
Please note that your name, contact information, and other
information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your state/province and country (if
provided), the name of your representative (if any), and the category
identifying you (e.g., individual, consumer, academic, industry). For
written submissions submitted to the Division of Dockets Management,
FDA will post the body of your comments on http://www.regulations.gov,
but you can put your name and/or contact information on a separate
cover sheet and not in the body of your comments.
XIV. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and
are available electronically at http://www.regulations.gov. (FDA has
verified all the Web site addresses in this reference section, but FDA
is not responsible for any subsequent changes to the Web sites after
this document publishes in the Federal Register.)
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List of Subjects
21 CFR Part 1100
Smoking, Tobacco.
21 CFR Part 1140
Advertising, Labeling, Smoking, Tobacco.
21 CFR Part 1143
Advertising, Labeling, Packaging and containers, Smoking, Tobacco.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR chapter I be amended as follows:
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1. Add part 1100 to subchapter K to read as follows:
PART 1100--TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY
Sec.
1100.1 Scope.
1100.2 Requirements.
1100.3 Definitions.
Authority: 21 U.S.C. 387a(b), 387f(d); Secs. 901(b) and 906(d),
Pub. L. 111-31; 21 CFR 16.1 and 1107.1; 21 CFR 1.1, 1.20, 14.55,
17.1, and 17.2.
Sec. 1100.1 Scope.
Option 1
In addition to FDA's authority over cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco, FDA deems all other
products meeting the definition of tobacco product under section
201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(rr)), except accessories of such other tobacco products, to be
subject to the Federal Food, Drug, and Cosmetic Act.
Option 2
In addition to FDA's authority over cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco, FDA deems all other
products meeting the definition of tobacco product under section
201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(rr)), except accessories of such other tobacco products and cigars
that are not within the scope of the covered cigar definition in Sec.
1100.3, to be subject to the Federal Food, Drug, and Cosmetic Act.
[[Page 23203]]
Sec. 1100.2 Requirements.
Option 1
Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless
tobacco, and all other tobacco products, except accessories of such
other tobacco products, are subject to chapter IX of the Federal Food,
Drug, and Cosmetic Act and its implementing regulations. Tobacco
product is defined in section 201(rr) of the Federal Food, Drug, and
Cosmetic Act.
Option 2
Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless
tobacco, covered cigars, and all other tobacco products, except
accessories of such other tobacco products and cigars that are not
within the scope of the covered cigar definition in Sec. 1100.3, are
subject to chapter IX of the Federal Food, Drug, and Cosmetic Act and
its implementing regulations. Tobacco product is defined in section
201(rr) of the Federal Food, Drug, and Cosmetic Act.
Sec. 1100.3 Definitions.
Option 1
Tobacco product. As stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part, a tobacco product:
(1) Means any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product);
and
(2) Does not mean an article that is a drug defined in section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device defined
in section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a
combination product described in section 503(g) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353(g)).
Option 2
Cigar means a tobacco product that:
(1) Is not a cigarette and
(2) Is a roll of tobacco wrapped in leaf tobacco or any substance
containing tobacco.
Covered cigar means any cigar as defined in this part, except a
cigar that:
(1) Is wrapped in whole tobacco leaf;
(2) Contains a 100 percent leaf tobacco binder;
(3) Contains primarily long filler tobacco;
(4) Is made by combining manually the wrapper, filler, and binder;
(5) Has no filter, tip, or non-tobacco mouthpiece and is capped by
hand;
(6) Has a retail price (after any discounts or coupons) of no less
than $10 per cigar (adjusted, as necessary, every 2 years, effective
July 1st, to account for any increases in the price of tobacco products
since the last price adjustment,);
(7) Does not have a characterizing flavor other than tobacco; and
(8) Weighs more than 6 pounds per 1000 units.
Tobacco product. As stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part, a tobacco product:
(1) Means any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product);
and
(2) Does not mean an article that is a drug defined in section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device defined
in section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a
combination product described in section 503(g) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353(g)).
PART 1140--CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO
PRODUCTS
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2. The heading for part 1140 is revised to read as shown above.
0
3. The authority citation for 21 CFR part 1140 continues to read as
follows:
Authority: 21 U.S.C. 301 et seq.; Sec. 102, Pub. L. 111-31.
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4. Revise Sec. 1140.1 to read as follows:
Sec. 1140.1 Scope.
(a) This part sets out the restrictions under the Federal Food,
Drug, and Cosmetic Act on the sale, distribution, and use of
cigarettes, smokeless tobacco, and covered tobacco products.
(b) The failure to comply with any applicable provision in this
part in the sale, distribution, and use of cigarettes, smokeless
tobacco, and covered tobacco products renders the product misbranded
under the Federal Food, Drug, and Cosmetic Act.
(c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
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5. Revise Sec. 1140.2 to read as follows:
Sec. 1140.2 Purpose.
The purpose of this part is to establish restrictions on the sale,
distribution, and use of cigarettes, smokeless tobacco, and covered
tobacco products in order to reduce the number of children and
adolescents who use these products, and to reduce the life-threatening
consequences associated with tobacco use.
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6. Revise Sec. 1140.3 to read as follows:
Sec. 1140.3 Definitions.
For the purposes of this part:
Cigar means a tobacco product that:
(1) Is not a cigarette and
(2) Is a roll of tobacco wrapped in leaf tobacco or any substance
containing tobacco.
Cigarette. (1) Means a product that:
(i) Is a tobacco product and
(ii) Meets the definition of the term ``cigarette'' in section 3(1)
of the Federal Cigarette Labeling and Advertising Act; and
(2) Includes tobacco, in any form, that is functional in the
product, which, because of its appearance, the type of tobacco used in
the filler, or its packaging and labeling, is likely to be offered to,
or purchased by, consumers as a cigarette or as roll-your-own tobacco.
Cigarette tobacco means any product that consists of loose tobacco
that is intended for use by consumers in a cigarette. Unless otherwise
stated, the requirements applicable to cigarettes under this chapter
also apply to cigarette tobacco.
Covered tobacco product means any tobacco product deemed to be
subject to the Federal Food, Drug, and Cosmetic Act pursuant to Sec.
1100.2 of this chapter, but excludes any component or part that does
not contain tobacco or nicotine.
Distributor means any person who furthers the distribution of a
tobacco product, whether domestic or imported, at any point from the
original place of manufacture to the person who sells or distributes
the product to individuals for personal consumption. Common carriers
are not considered distributors for the purposes of this part.
Importer means any person who imports any tobacco product that is
intended for sale or distribution to consumers in the United States.
Manufacturer means any person, including any repacker and/or
relabeler, who manufactures, fabricates, assembles, processes, or
labels a finished tobacco product.
Nicotine means the chemical substance named 3-(1-Methyl-2-
pyrrolidinyl)pyridine or C[10]H[14]N[2], including any salt or complex
of nicotine.
Package means a pack, box, carton, or container of any kind in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
Point of sale means any location at which a consumer can purchase
or
[[Page 23204]]
otherwise obtain tobacco products for personal consumption.
Retailer means any person who sells tobacco products to individuals
for personal consumption, or who operates a facility where vending
machines or self-service displays are permitted under this part.
Smokeless tobacco means any tobacco product that consists of cut,
ground, powdered, or leaf tobacco and that is intended to be placed in
the oral or nasal cavity.
Tobacco product. As stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(rr)) in relevant part, a tobacco
product:
(1) Means any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product) and
(2) Does not mean an article that is a drug defined in section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device defined
in section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a
combination product described in section 503(g) of the Federal Food,
Drug, and Cosmetic Act.
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7. Revise Sec. 1140.10 to read as follows:
Sec. 1140.10 General responsibilities of manufacturers, distributors,
and retailers.
Each manufacturer, distributor, importer, and retailer is
responsible for ensuring that the cigarettes, smokeless tobacco, or
covered tobacco products it manufactures, labels, advertises, packages,
distributes, imports, sells, or otherwise holds for sale comply with
all applicable requirements under this part.
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8. Revise Sec. 1140.14 to read as follows:
Sec. 1140.14 Additional responsibilities of retailers.
(a) In addition to the other requirements under this part, each
cigarette and smokeless tobacco retailer is responsible for ensuring
that all sales of cigarettes or smokeless tobacco to any person comply
with the following requirements:
(1) No retailer may sell cigarettes or smokeless tobacco to any
person younger than 18 years of age;
(2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this
section and in Sec. 1140.16(c)(2)(i), each retailer must verify by
means of photographic identification containing the bearer's date of
birth that no person purchasing the product is younger than 18 years of
age;
(ii) No such verification is required for any person over the age
of 26;
(3) Except as otherwise provided in Sec. 1140.16(c)(2)(ii), a
retailer may sell cigarettes or smokeless tobacco only in a direct,
face-to-face exchange without the assistance of any electronic or
mechanical device (such as a vending machine);
(4) No retailer may break or otherwise open any cigarette or
smokeless tobacco package to sell or distribute individual cigarettes
or a number of unpackaged cigarettes that is smaller than the quantity
in the minimum cigarette package size defined in Sec. 1140.16(b), or
any quantity of cigarette tobacco or smokeless tobacco that is smaller
than the smallest package distributed by the manufacturer for
individual consumer use; and
(5) Each retailer must ensure that all self-service displays,
advertising, labeling, and other items, that are located in the
retailer's establishment and that do not comply with the requirements
of this part, are removed or are brought into compliance with the
requirements under this part.
(b) Notwithstanding the requirements in paragraph (a) of this
section and in addition to the other requirements under this part, each
retailer of covered tobacco products is responsible for ensuring that
all sales of such covered tobacco products to any person comply with
the following requirements:
(1) No retailer may sell covered tobacco products to any person
younger than 18 years of age;
(2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this
section and in Sec. 1140.16(c)(2)(i), each retailer must verify by
means of photographic identification containing the bearer's date of
birth that no person purchasing the product is younger than 18 years of
age;
(ii) No such verification is required for any person over the age
of 26; and
(3) A retailer may not sell covered tobacco products with the
assistance of any electronic or mechanical device (such as a vending
machine), except in facilities where the retailer ensures that no
person younger than 18 years of age is present, or permitted to enter,
at any time.
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9. Add part 1143 to subchapter K to read as follows:
PART 1143--REQUIRED WARNING STATEMENTS
Sec.
1143.1 Definitions.
1143.3 Required warning statement regarding addictiveness of
nicotine.
1143.5 Required warning statements for cigars.
1143.7 Language requirements for required warning statements.
1143.9 Irremovable or permanent required warning statements.
1143.11 Does not apply to foreign distribution.
1143.13 Effective date.
Authority: 21 U.S.C. 387a(b), 387f(d); Pub. L. 111-31, 123 Stat.
1776.
Sec. 1143.1 Definitions.
Option 1
For purposes of this part:
Covered tobacco product means any tobacco product deemed to be
subject to the Federal Food, Drug, and Cosmetic Act pursuant to Sec.
1100.2 of this chapter, but excludes any component or part of a tobacco
product that does not contain nicotine or tobacco.
Package means a pack, box, carton, or container of any kind in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
Required warning statement means a textual warning statement
required to be on packaging and in advertisements for cigarette
tobacco, roll-your-own tobacco, cigars, and other covered tobacco
products.
Roll-your-own tobacco means any tobacco product which, because of
its appearance, type, packaging, or labeling, is suitable for use and
likely to be offered to, or purchased by, consumers as tobacco for
making cigarettes.
Option 2
For purposes of this part:
Cigar means a tobacco product that:
(1) Is not a cigarette and
(2) Is a roll of tobacco wrapped in leaf tobacco or any substance
containing tobacco.
Covered cigar means any cigar as defined in this part, except a
cigar that:
(1) Is wrapped in whole tobacco leaf;
(2) Contains a 100 percent leaf tobacco binder;
(3) Contains primarily long filler tobacco;
(4) Is made by combining manually the wrapper, filler, and binder;
(5) Has no filter, tip, or non-tobacco mouthpiece and is capped by
hand;
(6) Has a retail price (after any discounts or coupons) of no less
than $10 per cigar (adjusted, as necessary, every 2 years, effective
July 1st, to account for any increases in the price of tobacco products
since the last price adjustment);
(7) Does not have a characterizing flavor other than tobacco; and
(8) Weighs more than 6 pounds per 1000 units.
Covered tobacco product means any tobacco product deemed to be
subject to the Federal Food, Drug, and Cosmetic Act pursuant to Sec.
1100.2 of this chapter, but excludes any component or part of
[[Page 23205]]
a tobacco product that does not contain nicotine or tobacco.
Package means a pack, box, carton, or container of any kind in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
Required warning statement means a textual warning statement
required to be on packaging and in advertisements for cigarette
tobacco, roll-your-own tobacco, covered cigars, and other covered
tobacco products.
Roll-your-own tobacco means any tobacco product which, because of
its appearance, type, packaging, or labeling, is suitable for use and
likely to be offered to, or purchased by, consumers as tobacco for
making cigarettes.
Sec. 1143.3 Required warning statement regarding addictiveness of
nicotine.
(a) Packages. (1) For cigarette tobacco, roll-your-own tobacco, and
covered tobacco products other than cigars, it is unlawful for any
person to manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States such product
unless the tobacco product bears the following required warning
statement on each product package: ``WARNING: This product contains
nicotine derived from tobacco. Nicotine is an addictive chemical.''
(2) The required warning statement must appear directly on the
package and must be clearly visible underneath any cellophane or other
clear wrapping as follows:
(i) Be located in a conspicuous and prominent place on the two
principal display panels of the package and the warning area must
comprise at least 30 percent of each of the principal display panels;
(ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
(iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the package;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section; and
(v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other information on the principal display panel have
the same orientation.
(3) A retailer of any tobacco product covered by paragraphs (a)(1)
and (2) of this section will not be in violation of this section for
packaging that:
(i) Contains a health warning;
(ii) Is supplied to the retailer by the tobacco product
manufacturer, importer, or distributor, and
(iii) Is not altered by the retailer in a way that is material to
the requirements of this section.
(b) Advertisements. (1) For cigarette tobacco, roll-your-own
tobacco, and covered tobacco products other than cigars, it is unlawful
for any tobacco product manufacturer, packager, importer, distributor,
or retailer of the tobacco product to advertise or cause to be
advertised within the United States any tobacco product unless each
advertisement bears, in accordance with the requirements of this
section, the required warning statement specified in paragraph (a)(1)
of this section.
(2) The required warning statement must appear in the upper portion
of the area of the advertisement within the trim area as follows:
(i) Occupy at least 20 percent of the area of the advertisement;
(ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
(iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the advertisement;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section;
(v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other textual information in the advertisement have
the same orientation; and
(vi) Be surrounded by a rectangular border that is the same color
as the text of the required warning statement and that is not less than
3 millimeters (mm) or more than 4 mm.
(3) This paragraph (b) applies to a retailer only if that retailer
is responsible for or directs the health warning required under the
paragraph. However, this paragraph does not relieve a retailer of
liability if the retailer displays, in a location open to the public,
an advertisement that does not contain a health warning or contains a
health warning that has been altered by the retailer in a way that is
material to the requirements of this section.
(c) Self-certification. A tobacco product that would otherwise be
required to bear the warning in paragraph (a)(1) of this section but
does not contain nicotine is not required to bear the warning in
paragraph (a)(1) of this section on packages or advertisements if the
manufacturer of the tobacco product has submitted to FDA a confirmation
statement certifying to be true and accurate that the product does not
contain nicotine and that the manufacturer has data to support that
assertion. Any product not required to bear the warning in paragraph
(a)(1) of this section must include the following statement ``This
product is derived from tobacco.'' on all packages and advertisements
in accordance with the requirements of this part.
Sec. 1143.5 Required warning statements for cigars.
Option 1
(a) Packages. (1) It is unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States any cigar the package of which
fails to bear one of the following required warning statements on each
product package:
(i) WARNING: Cigar smoking can cause cancers of the mouth and
throat, even if you do not inhale.
(ii) WARNING: Cigar smoking can cause lung cancer and heart
disease.
(iii) WARNING: Cigars are not a safe alternative to cigarettes.
(iv) WARNING: Tobacco smoke increases the risk of lung cancer and
heart disease, even in nonsmokers.
(v) WARNING: This product contains nicotine derived from tobacco.
Nicotine is an addictive chemical.
(2) Each required warning statement must appear directly on the
package and must be clearly visible underneath any cellophane or other
clear wrapping as follows:
(i) Be located in a conspicuous and prominent place on the two
principal display panels of the package and the warning area must
comprise at least 30 percent of each of the principal display panels;
(ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
(iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the package;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section; and
[[Page 23206]]
(v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other information on that principal display panel
have the same orientation.
(3) No person may manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within the United States
any cigar without a required warning statement, except for cigars that
are sold individually and not in a product package. For cigars that are
sold individually and not in a product package, the required warning
statements must be posted at the retailer's point-of-sale in accordance
with the following:
(i) The warnings in paragraph (a) of this section must be placed on
a sign that is a minimum of 8.5 x 11 inches, posted on or within 3
inches of each cash register where payment may be made so that the
sign(s) are unobstructed in their entirety and can be read easily by
each consumer making a purchase;
(ii) The sign must be clear, legible, and conspicuous and be
printed in black Helvetica bold or Arial bold type against a solid
white background in at least 17 point type with appropriate space
between the warning statements
(iii) Be printed in a manner that contrasts by typography, layout,
or color, with all other printed material; and
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section.
(4) A retailer of any cigar covered by paragraphs (a)(1) and (2) of
this section will not be in violation of this section for packaging
that:
(i) Contains a health warning;
(ii) Is supplied to the retailer by a manufacturer, importer, or
distributor who has the required state, local, or Alcohol and Tobacco
Tax and Trade Bureau (TTB)-issued license or permit, if applicable, and
(iii) Is not altered by the retailer in a way that is material to
the requirements of this section.
(b) Advertisements. (1) It is unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of cigars to
advertise or cause to be advertised within the United States any cigar
unless each advertisement bears, in accordance with the requirements of
this section, one of the required warning statements specified in
paragraph (a)(1) of this section.
(2) Each required warning statement must appear in the upper
portion of the area of the advertisement within the trim area as
follows:
(i) Occupy at least 20 percent of the area of the advertisement;
(ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
(iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the advertisement;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section;
(v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other textual information in the advertisement have
the same orientation; and
(vi) Be surrounded by a rectangular border that is the same color
as the text of the required warning statement and that is not less than
3 mm or more than 4 mm.
(3) This paragraph (b) applies to a retailer only if that retailer
is responsible for or directs the warning statements required under the
paragraph. However, this paragraph of this section does not relieve a
retailer of liability if the retailer displays, in a location open to
the public, an advertisement that does not contain a health warning or
contains a health warning that has been altered by the retailer in a
way that is material to the requirements of this section.
(c) Marketing requirements. (1) The warning statements required in
paragraph (a)(1) of this section must be randomly displayed in each 12-
month period, in as equal a number of times as is possible on each
brand of cigar sold in product packaging and be randomly distributed in
all areas of the United States in which the product is marketed in
accordance with a plan submitted by the cigar manufacturer, importer,
distributor, or retailer to, and approved by the Food and Drug
Administration.
(2) The warning statements required in paragraph (a)(1) of this
section must be rotated quarterly in alternating sequence in each
advertisement for each brand of cigar in accordance with a plan
submitted by the cigar manufacturer, importer, distributor, or retailer
to, and approved by the Food and Drug Administration.
Option 2
(a) Packages. (1) It is unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States any covered cigar the package of
which fails to bear one of the following required warning statements on
each product package:
(i) WARNING: Cigar smoking can cause cancers of the mouth and
throat, even if you do not inhale.
(ii) WARNING: Cigar smoking can cause lung cancer and heart
disease.
(iii) WARNING: Cigars are not a safe alternative to cigarettes.
(iv) WARNING: Tobacco smoke increases the risk of lung cancer and
heart disease, even in nonsmokers.
(v) WARNING: This product contains nicotine derived from tobacco.
Nicotine is an addictive chemical.
(2) Each required warning statement must appear directly on the
package and must be clearly visible underneath any cellophane or other
clear wrapping as follows:
(i) Be located in a conspicuous and prominent place on the two
principal display panels of the package and the warning area must
comprise at least 30 percent of each of the principal display panels;
(ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
(iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the package;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section; and
(v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other information on that principal display panel
have the same orientation.
(3) No person may manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within the United States
any covered cigar without a required warning statement, except for
covered cigars that are sold individually and not in a product package.
For covered cigars that are sold individually and not in a product
package, the required warning statements must be posted at the
retailer's point-of-sale in accordance with the following:
(i) The warnings in paragraph (a) of this section must be placed on
a sign that is a minimum of 8.5 x 11 inches, posted on or within 3
inches of each cash register where payment may be made so that the
sign(s) are
[[Page 23207]]
unobstructed in their entirety and can be read easily by each consumer
making a purchase;
(ii) The sign must be clear, legible, and conspicuous and be
printed in black Helvetica bold or Arial bold type against a solid
white background in at least 17 point type with appropriate space
between the warning statements;
(iii) Be printed in a manner that contrasts by typography, layout,
or color, with all other printed material; and
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section.
(4) A retailer of any covered cigar covered by paragraphs (a)(1)
and (2) of this section will not be in violation of this section for
packaging that:
(i) Contains a health warning;
(ii) Is supplied to the retailer by a manufacturer, importer, or
distributor who has the required state, local, or TTB-issued license or
permit, if applicable, and
(iii) Is not altered by the retailer in a way that is material to
the requirements of this section.
(b) Advertisements. (1) It is unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of covered
cigars to advertise or cause to be advertised within the United States
any covered cigar unless each advertisement bears, in accordance with
the requirements of this section, one of the required warning
statements specified in paragraph (a)(1) of this section.
(2) Each required warning statement must appear in the upper
portion of the area of the advertisement within the trim area as
follows:
(i) Occupy at least 20 percent of the area of the advertisement;
(ii) Be printed in a font size that ensures that the text occupies
the greatest possible proportion of the warning area set aside for the
text required;
(iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type and in black text on a white background or white text on a
black background in a manner that contrasts by typography, layout, or
color, with all other printed material on the advertisement;
(iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section;
(v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other textual information in the advertisement have
the same orientation; and
(vi) Be surrounded by a rectangular border that is the same color
as the text of the required warning statement and that is not less than
3 mm or more than 4 mm.
(3) This paragraph (b) applies to a retailer only if that retailer
is responsible for or directs the warning statements required under the
paragraph. However, this paragraph of this section does not relieve a
retailer of liability if the retailer displays, in a location open to
the public, an advertisement that does not contain a health warning or
contains a health warning that has been altered by the retailer in a
way that is material to the requirements of this section.
(c) Marketing requirements. (1) The warning statements required in
paragraph (a)(1) of this section must be randomly displayed in each 12-
month period, in as equal a number of times as is possible on each
applicable brand of covered cigar and be randomly distributed in all
areas of the United States in which the product is marketed in
accordance with a plan submitted by the cigar manufacturer, importer,
distributor, or retailer to, and approved by the Food and Drug
Administration.
(2) The warning statements required in paragraph (a)(1) of this
section must be rotated quarterly in alternating sequence in each
advertisement for each applicable brand of covered cigar in accordance
with a plan submitted by the cigar manufacturer, importer, distributor,
or retailer to, and approved by the Food and Drug Administration.
Sec. 1143.7 Language requirements for required warning statements.
The text in each required warning statement required in Sec.
1143.3 or Sec. 1143.5 must be in the English language, except as
follows:
(a) In the case of an advertisement that appears in a non-English
publication, the text in the required warning statement must appear in
the predominant language of the publication whether or not the
advertisement is in English, and;
(b) In the case of an advertisement that appears in an English
language publication but that is not in English, the text in the
required warning statement must appear in the same language as that
principally used in the advertisement.
Sec. 1143.9 Irremovable or permanent required warning statements.
The required warning statements required by this section must be
indelibly printed on or permanently affixed to the package or
advertisement. These warnings, for example, must not be printed or
placed on a product label affixed to a clear outer wrapper that is
likely to be removed to access the product within the package.
Sec. 1143.11 Does not apply to foreign distribution.
The provisions of this part do not apply to a manufacturer or
distributor of tobacco products that does not manufacture, package, or
import tobacco products for sale or distribution within the United
States.
Sec. 1143.13 Effective date.
This part will take effect 24 months after [date of publication of
final rule]. The effective date will be with respect to the date of
manufacture, provided that, in any case, beginning 30 days after the
effective date, a manufacturer may not introduce into the domestic
commerce of the United States any product, irrespective of the date of
manufacture that is not in conformance with this part.
Dated: April 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09491 Filed 4-24-14; 8:45 am]
BILLING CODE 4160-01-P