[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Proposed Rules]
[Pages 23141-23207]
From the Federal Register Online via the Government Printing 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, 
CTPRegulations@fda.hhs.gov.

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

[[Page 23143]]

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

[[Page 23146]]

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

[[Page 23166]]

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

[[Page 23167]]

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.''
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 oira_submission@omb.eop.gov. 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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[[Page 23198]]

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Cigarette Use by College Students,'' Drug and Alcohol Dependence, 
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Pipe Smoking and Cancer Risk in the European Prospective 
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in Men and Risk of Death From Tobacco-Related Cancers,'' Journal of 
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Consequences of Involuntary Exposure to Tobacco Smoke,'' A Report of 
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172. Institute of Medicine, Committee on Secondhand Smoke Exposure 
and Acute Coronary Events, ``Secondhand Smoke Exposure and 
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Addiction,'' Psychopharmacology, 184(3):274-285, 2006.
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Effect of Tobacco Ingredients on Smoke Chemistry. Part I: 
Flavourings and Additives,'' Food and Chemical Toxicology, 42:3-37, 
2004.
175. Gaworski, C., J. D. Heck, M. B. Bennett, et al., ``Toxicologic 
Evaluation of Flavor Ingredients Added to Cigarette Tobacco: Skin 
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Biochemistry, and Behavior, 72(1-2):55-64, 2002.
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Place Preference and Conditioned Place Aversion in Mice,'' 
Pharmacology, Biochemistry, and Behavior, 51(2-3); 457-61, 1995.
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of Tobacco Release [3H]Dopamine From Superfused Rat Striatal 
Slices,'' European Journal of Pharmacology, 276(1-2):195-199, 1995.
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194. Deeming Tobacco Products To Be Subject to the Federal Food, 
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention 
and Tobacco Control Act; Regulations on the Sale and Distribution of 
Tobacco Products and Required Warning Statements for Tobacco 
Products; Proposed Rule: Preliminary Regulatory Impact Analysis, 
Initial Regulatory Flexibility Analysis, and Unfunded Mandates 
Reform Act Analysis; available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

List of Subjects

21 CFR Part 1100

    Smoking, Tobacco.

21 CFR Part 1140

    Advertising, Labeling, Smoking, Tobacco.

21 CFR Part 1143

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

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

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

PART 1100--TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY

Sec.
1100.1 Scope.
1100.2 Requirements.
1100.3 Definitions.

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


Sec.  1100.1  Scope.

Option 1

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

Option 2

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

[[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

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

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

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


Sec.  1140.1  Scope.

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


Sec.  1140.2  Purpose.

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


Sec.  1140.3  Definitions.

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

[[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.
0
7. Revise Sec.  1140.10 to read as follows:


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

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


Sec.  1140.14  Additional responsibilities of retailers.

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

PART 1143--REQUIRED WARNING STATEMENTS

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

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


Sec.  1143.1  Definitions.

Option 1

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

Option 2

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

[[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