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

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

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

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

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

``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

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

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

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

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

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

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.
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                          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

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:

                                   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

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,

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:

                               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''