In addition, the largest study to date in the EU found that e-cigarette
use was more likely among smokers who had made a quit attempt during
the past year as compared to those who never smoked (Ref. 109).
    Other studies illustrate that current or former smokers have tried
e-cigarettes not intending to quit tobacco use, but instead, because
they are ``Easy to use when I can't smoke'' (Ref. 198) or can be used
in places where conventional tobacco use is not allowed (Ref. 199). FDA
remains committed to supporting long-term population-level research,
such as the PATH Study, that will help elucidate reasons for and
patterns in tobacco initiation, product switching, and dual use across
the spectrum of tobacco products on the U.S. market, including ENDS and
conventional cigarettes.
    (Comment 158) Many comments noted that almost all e-cigarettes
contain nicotine (Ref. 192). This nicotine delivery varies within and
across brands (Refs. 200, 201) and by the user's level of experience
with these products (e.g., Ref. 202). While many comments expressed
minimal concerns about abuse liability of e-cigarettes, believing that
users will eventually switch entirely to e-cigarettes, others expressed
the belief that long-term use of e-cigarettes may lead to addiction in
youth and young adults.
    (Response) FDA shares similar concerns that youth may initiate
tobacco use with ENDS, become addicted, and then dual use or move on to
traditional tobacco products. FDA discussed available data regarding
dual and polytobacco use in the NPRM and is unaware of long-term
studies finding that dual or polytobacco users eventually switch to
using just one tobacco product (79 FR 23142 at 23159 and 23160).
However, findings from a recent study of 694 participants aged 16 to 26
years old suggest that youth e-cigarette users might transition to

smoking traditional cigarettes (Ref. 203). Therefore, FDA remains
concerned that youth may use one of the newly deemed products, whether
it be an ENDS or any other tobacco product, and dual use with other
tobacco products in the future.
    (Comment 159) Some comments urged FDA to evaluate e-cigarettes
based on their scientific merit and contribution to public health. At
least one comment felt that certain researchers in the tobacco field
were biased based on their connections to public health advocates or
what the comment refers to as ``big tobacco companies.'' Some comments
stated that FDA only considered journal articles when it should have
considered other available information.
    (Response) FDA uses the best evidence available from peer reviewed
journals and other reputable sources to support this rule and fulfill
our public health mandate. In the context of rulemaking, FDA follows
the requirements of Executive Orders 12866 and 13563 by basing its
decisions ``on the best reasonably obtainable scientific, technical,
economic and other information.'' As stated in the NPRM, we will
continue to fund research to help us determine the public health
impacts of ENDS. Long-term studies are not available to conclude that
ENDS are a proven cessation product or to establish what effect e-
cigarettes have on users who might otherwise quit but instead engage in
dual use of ENDS and other tobacco products (79 FR 23142 at 23152).

I. Applicability of Section 901

    In the preamble to the NPRM, FDA stated that the rule applies to
all products that meet the definition of ``tobacco product'' under
section 201(rr) of the FD&C Act and any future products that meet the
definition. FDA stated that e-cigarettes meet the definition of
``tobacco product.''
    (Comment 160) Many comments seeking to exclude e-cigarette products
from the scope of the deeming rule stated that Congress only meant for
FDA to regulate products with the greatest threat (i.e., cigarettes and
smokeless tobacco products). They stated that regulating all tobacco
products as strictly as cigarettes are regulated is not warranted and
that the rigid application of the Tobacco Control Act is not consistent
with public health objectives.
    (Response) FDA disagrees. Congress gave FDA immediate authority
over certain tobacco products (i.e., cigarettes, smokeless tobacco,
cigarette tobacco, and roll-your-own tobacco) and the authority to deem
other products (including ENDS and other products that meet the
statutory definition of ``tobacco product''). All tobacco products,
regardless of the category of products, pose a health risk. Further, at
this time, only some of the restrictions in part 1140 (which, prior to
the rule, applied only to cigarettes and smokeless tobacco) will apply
to the newly deemed products. Specifically, while the minimum age and
identification, vending machine, and free sample provisions will apply
to the newly deemed products, additional provisions in part 1140
(including minimum pack size and restrictions on self-service displays,
sale and distribution of nontobacco items, and sponsorship of events)
will not apply to the newly deemed products at this time.
    (Comment 161) Many comments expressed concern that Congress did not
wish to effectively ban e-cigarettes (as they claimed would occur as a
result of deeming these products), because such a ban violates section
907(d)(3) of the FD&C Act. They stated that if Congress wanted to ban
them, they would have done so under their drug authority.
    (Response) FDA is not banning any category of tobacco product by
issuing this final deeming rule.
    (Comment 162) Many comments claimed that Congress did not intend
for FDA to strictly apply the Tobacco Control Act requirements to all
newly deemed products, especially those that do not contain tobacco
leaf. They believed because e-liquids do not contain tobacco leaf, such
products should be regulated differently than cigarettes and
traditional smokeless tobacco products.
    (Response) With this rule, FDA is deeming all products that meet
the definition of ``tobacco product,'' including e-liquids, to be
subject to the tobacco product authorities in chapter IX of the FD&C
Act, to address the public health concerns associated with them. The
FD&C Act does not include any requirement that a product contain
``tobacco leaf'' to meet the definition of ``tobacco product'' and be
deemed under this final rule. As stated previously, FDA is not
requiring that ENDS and the other newly deemed products comply with all
of the requirements of part 1140 at this time.
    (Comment 163) Some comments suggested that we need more
toxicological, epidemiological, and behavioral studies before deeming
e-cigarettes under section 901. Other comments stated that FDA must
regulate e-cigarettes despite not having the level of scientific
evidence that is available for most conventional tobacco products.
    (Response) FDA continues to research and fund studies regarding
ENDS initiation, use (including transitions to other tobacco products
and multiple use), perceptions, dependence, and toxicity (Ref. 195).
FDA also has been conducting a series of public workshops to obtain
additional information on e-cigarettes and their impact on public
health (79 FR 55815). These workshops are not necessary to inform this
deeming rule; however, they may inform FDA's development of future
rules impacting ENDS. Any additional regulations regarding ENDS will be
subject to the requirements of the APA.
    (Comment 164) Some comments sought clarification as to FDA's
authority over e-liquids that do not contain nicotine or other
chemicals derived from tobacco plants and those e-liquids that contain
nicotine derived from a nontobacco source (e.g., eggplants or
tomatoes). Others claimed that FDA does not have regulatory authority
over e-cigarettes that are refillable and do not contain nicotine, but
does have authority over e-liquids if the liquid contains nicotine.
Yet, some said that e-liquids used in e-cigarettes should have an
entirely new classification, because use of the words ``tobacco
product'' in marketing materials would cause undue confusion for
consumers.
    (Response) As stated in section 201(rr) of the FD&C Act, the
definition of ``tobacco product'' includes any product made or derived
from tobacco, including any component, part, or accessory of a tobacco
product. An e-liquid made or derived from tobacco meets this definition
and, therefore, is subject to FDA's chapter IX authorities. E-liquids
that do not contain nicotine or other substances derived from tobacco
may still be components or parts and, therefore, subject to FDA's
tobacco control authorities, if they are an assembly of materials
intended or reasonably expected to be used with or for the human
consumption of a tobacco product and do not meet the definition of
accessory.
    (Comment 165) Some comments tried to compare pipes and rolling
papers (which are required to smoke tobacco) with e-cigarettes (which
are required to ``vape'' e-liquids), stating that e-cigarettes should
not be regulated. They indicated that, unlike rolling paper which is
``intended for human consumption'' and therefore a tobacco product
component, a pipe is ``non-consumable'' and should not be considered a
tobacco product component. They said that, like pipes, e-cigarettes are
``non-consumable products'' and, therefore, are not

components or parts of tobacco products and not subject to regulation.
They also stated that only the e-liquid is the consumable product and
should be the only part of the e-cigarette subject to regulation.
    (Response) The definition of ``tobacco product'' as set forth in
section 201(rr) of the FD&C Act includes all components, parts, and
accessories of tobacco products (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). FDA interprets components and parts of a tobacco
product to include any assembly of materials intended or reasonably
expected: (1) To alter or affect the tobacco product's performance,
composition, constituents or characteristics; or (2) to be used with or
for the human consumption of a tobacco product. Both e-cigarettes and
pipes meet this definition. Thus, such products are subject to FDA's
chapter IX authorities as a result of this rule.
    (Comment 166) Many comments stated that FDA lacks any type of
meaningful justification for deeming e-cigarettes because e-cigarettes
do not represent the same level of public health threat as cigarettes.
They claimed that FDA has the burden of showing a rational basis for
regulation and that the lack of data showing that these products do not
cause harm cannot serve as a basis for regulating them. In addition,
some comments stated that FDA has no justification for regulating
products simply because they may deliver nicotine. They likened such
authority to imposing onerous regulations on caffeine, another plant-
derived chemical.
    (Response) FDA disagrees. FDA is deeming these products to address
public health concerns (79 FR 23142 at 23148 and 23149). ENDS are
tobacco products. As stated throughout this document, FDA has
determined that deeming all products meeting the statutory definition
of ``tobacco product'' will significantly benefit public health. We
also note that by merely deeming ENDS to be tobacco products, FDA is
not imposing the same level of regulation as is currently imposed on
cigarettes. For example, restrictions on self-service displays, sale
and distribution of nontobacco items, and sponsorship of events will
not apply to ENDS at this time. FDA will consider the health effects of
all products before determining whether to issue additional
regulations.
    (Comment 167) Many comments stated that the NPRM would ban
virtually all of the e-liquid products and premium vaporizers
(including mods, tanks, and open systems) and other components or parts
because manufacturers of such products would not have adequate
resources to comply with the requirements of the law.
    (Response) FDA disagrees. FDA is not banning any tobacco product
under this final rule. Rather, FDA is extending its authority to
regulate such products under section 901 of the FD&C Act. Manufacturers
of ENDS products were on notice that they could be considered FDA-
regulated tobacco products since the enactment of the Tobacco Control
Act and the issuance of the Sottera decision shortly thereafter. See
section VIII.K for additional discussion regarding the Sottera case.
Therefore, FDA disagrees with any comments referring to this rule as
banning any categories of tobacco products.
    (Comment 168) Some comments stated that FDA does not have the
authority to regulate the ingredients that can be used in e-liquids.
    (Response) FDA clarifies that, although it will not be directly
regulating the individual ingredients in e-liquids at this time,
sections 905 and 910 of the FD&C Act give FDA authority to review and
consider ingredients in making determinations on SE reports and PMTAs
(i.e., the Agency will look at ingredients within a specific e-liquid
and determine whether the overall tobacco product meets the statutory
standard for marketing authorization). In addition, section 904
requires manufacturers to submit a listing of all ingredients 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,
and section 915 of the FD&C Act authorizes FDA to issue a regulation to
require that ``tobacco product manufacturers, packagers, or importers
make disclosures relating to the results of the testing of tar and
nicotine through labels or advertising or other appropriate means, and
make disclosures regarding the results of the testing of other
constituents, including smoke constituents, ingredients, or additives,
that the Secretary determines should be disclosed to the public to
protect the public health and will not mislead consumers about the risk
of tobacco-related disease'' (emphasis added).
    (Comment 169) A few comments noted the differences among products
in the ENDS category in contrast to the relatively uniform category of
combusted tobacco products. Given these differences and the rapid cycle
of innovation and product development for ENDS products, they stated
that FDA cannot use the Tobacco Control Act framework to regulate them.
    (Response) FDA agrees that there are many differences among the
products in the ENDS category. However, there are many differences
among combusted tobacco products as well. For example, many cigars are
wrapped in whole tobacco leaf, whereas cigarettes are not. Waterpipe
tobacco is consumed in a manner very different from the consumption of
cigarettes and cigars. The differences among these products do not
affect the Agency's ability to regulate them in accordance with the
requirements of the Tobacco Control Act.

J. Definitions

    Several comments suggested that we add definitions specific to e-
cigarettes and their components and parts. Comments stressed the
importance of defining terms broadly enough to ensure all manufacturers
of the finished products or components and parts of the finished
products are covered by the definitions.
    (Comment 170) Some comments suggested that FDA clearly identify
nomenclature and constituents of ENDS products because ENDS is a much
broader category than e-cigarettes. Similarly, some comments stated
that not defining these products would fail to address the exploding
market of e-cigarettes and their e-cigarette components and parts. They
also stated that an ENDS definition is necessary so State and local
governments can use consistent definitions.
    (Response) FDA agrees that there is an expanding market of tobacco
products that meet the FD&C Act definition of ``tobacco products.''
However, FDA does not believe it is necessary to define individual
categories of tobacco products for purposes of this rule. In fact, by
deeming ``tobacco products'' generally, it will help ensure that novel
and future tobacco products are introduced into the market in an
appropriate and efficient manner. FDA may issue specific definitions at
a later time if it determines that doing so is appropriate.
    (Comment 171) At least one comment recommended that we establish a
definition of ``vapor product'' and define it as ``any noncombustible
tobacco-derived product containing nicotine that employs a heating
element, power source, electronic circuit, or other electronic,
chemical or mechanical means, regardless of shape or size, including
any component thereof, that can be used to produce vapor from nicotine
in a solution or other form.'' The comment stated that

several States have adopted variations of this definition and that it
would provide necessary clarity.
    Likewise, at least one comment suggested that we establish a
definition of ``alternative nicotine product,'' which would be defined
as ``any noncombustible tobacco-derived product containing nicotine
that is intended for human consumption, whether chewed, absorbed,
dissolved or ingested by any other means.'' The comment stated that
several States have adopted variations of this definition and that it
would provide necessary clarity.
    (Response) For the reasons explained previously, FDA finds that it
is not necessary to add these definitions to the codified for this
final rule.
    (Comment 172) A few comments suggested that FDA clarify the
differences between ``liquid nicotine'' and ``e-cigarette liquid (or e-
liquid).'' They noted that, throughout the NPRM, FDA referred to the
liquid component of e-cigarettes as ``e-cigarette liquid,'' which
contains nicotine, flavorings, and other ingredients. However, in a few
instances, FDA referred to ``nicotine solutions'' or ``nicotine
liquids.'' They asked that we clarify the difference to avoid confusion
and unintended coverage under chapter IX of the FD&C Act.
    (Response) FDA agrees that clarification is necessary. Liquid
nicotine does not have flavorings or other ingredients added to it. E-
cigarette liquid (or ``e-liquid'') is a liquid containing nicotine,
flavorings, and/or other ingredients. This final rule regulates e-
liquid and liquid nicotine that is made or derived from tobacco.
    (Comment 173) Some comments requested that FDA refer to ENDS
products as vapor products and use definitions that differentiate
between the products that use combustion and those that use
vaporization. They stated that this distinction is necessary because
the potential harms posed by these products are different and consumers
may believe that vapor products are as dangerous as combusted smoking
products. One comment provided an example as to how to recategorize
tobacco products based on their delivery method and combustion. Another
comment requested that FDA add ``combustion'' to the current definition
of cigarette to differentiate between combusted and vaporized products.
    (Response) For purposes of this deeming regulation, FDA does not
believe it is necessary to distinguish between vapor products and
combusted products. The statutory definition of ``cigarette'' was
established by Congress and describes conventional cigarettes (section
900(3) of the FD&C Act). If FDA finds reason to differentiate between
the combusted and vaporized products for the purpose of future
regulations, FDA will issue a new NPRM to propose such definitions. In
addition, FDA is aware that some e-cigarettes are heated to a high
enough level to cause combustion of the e-liquid.
    (Comment 174) At least one comment suggested that FDA alleviate any
potential confusion between conventional cigarettes and e-cigarettes by
adding a third subsection to the proposed definition of ``cigarette''
to read as follows: `` `Cigarette' (1) Means a product that: (i) Is a
tobacco product and (ii) meets the definition of the term ``cigarette''
in section 3(1) of the Federal Cigarette Labeling and Advertising Act;
(2) includes tobacco, in any form, that is functional in the product,
which, because of its appearance, the type of tobacco used in the
filler, or its packaging and labeling, is likely to be offered to, or
purchased by, consumers as a cigarette or as roll-your-own tobacco; and
(3) does not include a product such as nicotine [or products containing
nicotine] that is derived from tobacco but does not contain tobacco.''
    (Response) FDA finds that this addition to the cigarette definition
is unnecessary to prevent confusion between the two product categories.
The definition of ``cigarette'' in Sec.  1140.3 of this final rule
conforms to the definition in section 900(3) of the FD&C Act.
    (Comment 175) One comment requested that FDA establish one common
name for all vapor products, so the manufacturers, distributers,
importers, and retailers of these products can comply with section
903(a)(4) of the FD&C Act, which requires that the manufacturer include
an established name on the product labeling.
    (Response) At this time, FDA has not established a common
nomenclature for this group of products. FDA will consider these
comments in determining whether future regulatory action is
appropriate.

K. Sottera Decision

    In the NPRM, FDA explained that, as set forth in the Sottera
decision, e-cigarettes that are ``customarily marketed'' are tobacco
products over which the Agency cannot exercise its tobacco product
authority until it finalizes a regulation that deems them to be subject
to chapter IX of the FD&C Act.
    (Comment 176) Some comments provided analysis of the D.C. Circuit's
decision in Sottera, Inc. v. Food and Drug Administration, 627 F.3d 891
(D.C. Cir. 2010), which formed part of the basis for FDA's decision to
deem ``tobacco products'' subject to FDA's tobacco product authorities.
They took issue with FDA's description of the key points of the case,
stating that FDA is misreading the holding of Sottera to conclude that
the court there held that FDA has jurisdiction over e-cigarettes as
tobacco products because that question was not presented in the case.
    (Response) FDA's analysis of the Sottera decision in the proposed
deeming rule (79 FR 23142 at 23149 and 23150) was correct. On December
7, 2010, the D.C. Circuit held that FDA has the authority to regulate
customarily marketed tobacco products under the Tobacco Control Act and
products made or derived from tobacco that are marketed for a
therapeutic purpose under the medical product provisions of the FD&C
Act. (See Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891
(D.C. Cir. 2010).) On January 24, 2011, the D.C. Circuit denied the
government's petitions for rehearing and rehearing en banc (by the full
court). (See Sottera, Inc. v. FDA, No. 10-5032 (D.C. Cir. Jan. 24,
2011) (per curiam).) On April 25, 2011, FDA issued a letter to
stakeholders indicating its intent to deem additional tobacco products,
including e-cigarettes, to be subject to FDA's authorities in chapter
IX of the FD&C Act.
    (Comment 177) A few comments claimed that FDA had attempted to ban
e-cigarettes, the Sottera decision established the legality of e-
cigarettes, and FDA's purported ban was unlawful.
    (Response) FDA disagrees. Prior to the Sottera case, FDA did not
seek to ban e-cigarettes. Instead, FDA had detained several shipments
of e-cigarettes and their accessories offered for import by Smoking
Everywhere and Sottera, Inc. (doing business as NJOY) and eventually
refused admission into the United States to two of Smoking Everywhere's
shipments on the ground that the products appeared to be unapproved
drug/device combination products. FDA did not attempt to categorically
ban e-cigarettes for sale in the United States but, instead, sought to
regulate them under its drug/device authorities.
    (Comment 178) A few comments stated that manufacturers are
marketing e-cigarettes as cessation products and, therefore, they
should be regulated as cessation products.
    (Response) As stated in the D.C. Circuit's decision in Sottera, e-
cigarettes that are customarily marketed tobacco products are subject
to FDA's tobacco product authorities. If an e-cigarette

manufacturer wishes to market its product for a therapeutic purpose,
the company would be subject to FDA's drug/device authorities and must
submit an application to be marketed as a medical product.

IX. Effect of Deeming Rule on Vape Shop Manufacturers

    Some comments requested clarification regarding the regulatory
status of an ENDS retail establishment that sells e-liquids (sometimes
known as a vape shop). Such establishments sell a variety of products
including ENDS, replacement pieces, hardware, custom mixed e-liquids,
and other related accessories.
    If an establishment mixes or prepares e-liquids or creates or
modifies aerosolizing apparatus for direct sale to consumers for use in
ENDS, the establishment fits within the definition of ``tobacco product
manufacturer'' in section 900(20) of the FD&C Act and the combinations
it mixes and/or prepares are new tobacco products within the meaning of
section 910(a)(1). For requirements not covered by the compliance
policy set forth in this section, ENDS retail establishments that meet
the definition of a manufacturer should refer to the compliance periods
in tables 2 and 3. As discussed in the Analysis of Impacts (Ref. 204),
FDA expects that most vape shops will stop mixing e-liquids (and
preparing other new tobacco products) to avoid being ``manufacturers''
under the Tobacco Control Act.
    The definition of ``tobacco product manufacturer'' in section
900(20) includes ``any person, including any repacker or relabeler, who
manufactures, fabricates, assembles, processes, or labels a tobacco
product.'' Additionally, for purposes of section 905, the FD&C Act
defines ``manufacturing, preparation, compounding, or processing'' to
include ``repackaging, or otherwise changing the container, wrapper or
labeling of any tobacco product package from the original place of
manufacture to the person who makes the final delivery or sale to the
ultimate consumer or user.'' Section 910(a)(1) defines a ``new tobacco
product'' as ``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.'' Therefore, establishments engaged in mixing or preparing e-
liquids or creating or modifying aerosolizing apparatus for direct sale
to consumers for use in ENDS are tobacco product manufacturers and,
consequently, are subject to all of the statutory and regulatory
requirements applicable to manufacturers.
    The statute authorizes FDA to regulate the manufacture of all new
products, including those manufactured at the retail level. This is
important to FDA's ability to protect the public health since products
manufactured at the retail level pose many of the same public health
risks as those manufactured upstream and possibly additional risks
related to the lack of standard manufacturing practices and controls.
The introduction of statutory controls and oversight into a
historically unregulated market inevitably will lead to some market
change and consolidation. FDA recognizes that, with the implementation
of this final rule, vape shops that meet the definition of tobacco
product manufacturer may cease engaging in manufacturing activities
rather than comply with requirements for manufacturers under this final
rule. However, FDA notes that such entities will have the option to
continue operating solely as retailers, as some vape shops currently
do. In addition, as noted earlier, FDA believes that this policy (and
the deeming rule as a whole) will not stifle innovation but could,
instead, encourage it. Over time, FDA expects that its premarket review
authorities will spur creative evolution and help to create a market
where available products present a lower risk of user and population
harm, provide a more consistent delivery under varying conditions of
use, are less likely to lead to initiation of tobacco use, and/or are
easier to quit. In recent years, ENDS products have proliferated in the
absence of regulation, in some cases resulting in a lack of quality
control and consistency, consumer confusion and even availability of
acutely toxic products. In this context, we expect that changes in the
market in response to regulation will have significant benefits for
public health and will be a net benefit overall.
    As the ENDS market continues to evolve, it is important that FDA
exercise its authority to oversee all establishments engaged in
manufacturing activities and their products, in order to protect
consumers and to carry out the public health objectives of the Tobacco
Control Act.

A. Premarket Requirements (Sections 905 and 910)

    As stated throughout the document, manufacturers of newly deemed
products that are not grandfathered will be required to obtain
premarket authorization of their products through one of three
pathways--PMTA, SE or SE exemption (sections 905 and 910 of the FD&C
Act). Therefore, ENDS retailers engaged in mixing or preparing e-
liquids or creating or modifying aerosolizing apparatus will be
required to obtain premarket authorization for each non-grandfathered
product that they prepare for sale or distribution to consumers.
However, under the compliance policy laid out in section V.A, FDA does
not intend to enforce, during specified compliance periods, the
premarket review requirements including for ENDS retailers that mix or
prepare the same e-liquids they have been preparing and offering for
sale as of the effective daterule, or that create or modify
aerosolizing apparatus resulting in the same products they have been
creating as of the effective date. An initial compliance period, the
length of which is dependent on the type of application to be
submitted, is intended to provide additional time to prepare and submit
premarket applications. In addition, for the 12 months following this
initial compliance period, FDA intends to continue the compliance
policy and does not intend to enforce the premarket review requirements
if the firm has a pending submission. This means that, during this 12-
month continued compliance period of FDA review, FDA expects that ENDS
retailers of any kind will sell only those products that are (1)
grandfathered; (2) authorized by FDA; or (3) tobacco products for which
the ENDS retailer or another (upstream) manufacturer has submitted a
marketing application/submission to FDA during the initial compliance
period. (For PMTAs, the initial compliance period to submit is 24
months after the final rule effective date.)
    FDA expects that this 12-month continued compliance period of FDA
review will benefit manufacturers and retailers of newly deemed
products, including ENDS retailers, since upstream manufacturers that
submit applications will have a significant incentive to make retailers
aware of their pending applications/submissions. Specifically, we
expect that upstream manufacturer suppliers will inform ENDS retailers
selling their products whether the upstream manufacturer has submitted
a premarket application for such e-liquids and other ENDS products

within the initial compliance period such that the retailers can
benefit from the continued compliance period while FDA reviews such
applications. FDA expects that manufacturers will have an incentive to
make retailers aware of which products are the subject of applications,
which will enable retailers to know whether a marketing application has
been submitted and whether FDA has acted on an application. In
addition, retailers may contact suppliers for relevant product
information. Therefore, after 36 months from the effective date (i.e.,
at the end of the initial compliance period plus 12-month continued
compliance period), FDA expects that all ENDS retailers will sell only
those products that are either grandfathered or for which they have, or
an upstream supplier has, received premarket authorization.

   Table 4--Compliance Policy for Premarket Requirements--ENDS Retail
                             Establishments
------------------------------------------------------------------------
                               24-36 months after     Beyond 36 months
 0-24 months after the rule    the rule goes into    after the rule goes
      goes into effect               effect              into effect
------------------------------------------------------------------------
FDA does not intend to        FDA does not intend   The compliance
 enforce premarket             to initiate           period no longer
 authorization requirements    enforcement action    applies, even if
 for e-liquid products that    for e-liquid          the final mixture
 retailers mix and sell        products that         has a pending
 without marketing             retailers mix and     marketing
 authorization, provided       sell where a          submission/
 that final mixture is the     marketing             application. All
 same as a product the         application has       products for which
 retailer was selling or       been submitted and    a marketing
 offered for sale as of the    is still pending      submission/
 effective date.               for the final         application is
                               mixture.              pending are subject
                                                     to enforcement
                                                     action.
------------------------------------------------------------------------

    As stated previously, because products manufactured at the retail
level pose many of the same public health risks as those manufactured
upstream, and possibly additional risks, it is important to enforce the
statutory requirements for all new products, even those currently
manufactured by ENDS retailers.
    In general, the FD&C Act provides three pathways that manufacturers
may use to seek market authorization for a new product: The premarket
tobacco product application pathway, the SE pathway, and the exemption
from SE pathway. FDA anticipates that most manufacturers of e-liquids
and apparatus components/complete delivery systems will seek
authorization through the PMTA pathway. To obtain marketing
authorization under the PMTA pathway, manufacturers are required to
establish, among other things, that permitting their product to be
marketed would be appropriate for the protection of the public health.
In establishing this, manufacturers should take into account, and FDA
will consider, the ways in which the new product is likely to be used.
For example, PMTAs for these products should contain information on
whether the product is likely to be used alone or together with other
legally marketed tobacco products (such as available delivery systems),
as well as the type and range of the other products with which it is
likely to be used.
    While the statutory standard will apply to all products for which a
PMTA is filed, FDA expects that different classes of products may have
differing likelihoods of success in meeting the standard, by virtue of
their expected use. As stated previously, to meet the statutory
standard, PMTAs should contain information on whether a product is
likely to be used alone or together with other legally marketed
products and the public health implications of those likely uses. FDA
has issued a draft guidance on PMTAs for ENDS, published concurrently
with this final rule, which, when finalized, will explain FDA's current
thinking regarding some appropriate means of addressing the premarket
authorization requirements for newly deemed e-liquids and hardware/
apparatus components. FDA intends to act as expeditiously as possible
with respect to all new applications, while ensuring that statutory
standards are met.
    To reduce research burdens and increase efficiency for ENDS retail
establishments that file applications, FDA suggests that ENDS retail
establishments use master files whenever possible. By obtaining
permission from a master file holder, manufacturers could reference
extensive ingredients lists and constituent testing that they otherwise
would be required to perform themselves for marketing authorization. To
facilitate this process, elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a final guidance to
provide information on how to establish and reference a TPMF. This
information will help applicants of newly deemed products prepare
premarket and other regulatory submissions because they can reference
information in TPMFs rather than develop the information on their own.
    Given the anticipated availability and use of master files (as
discussed in a separate, final guidance published concurrent with
Deeming), which allows manufacturers to rely on the data and analysis
submitted to FDA by separate entities, FDA anticipates that
manufacturers will, over time, benefit from significantly increased
efficiencies and reduced costs for complying with the statute. Such a
system prevents and reduces duplication and allows for manufacturer
reliance on confidential or sensitive non-public information while
maintaining its confidentiality, thus saving time and reducing burdens
for multiple manufacturers. Because of the nature of upstream supply of
many components for ENDS products, especially e-liquids, FDA
anticipates that commercial incentives will be sufficient to drive
manufacturer reliance on the system of master files. We also note that
at present, FDA understands that, based on the Agency's review of
publically available information as discussed in section III.C of the
Analysis of Impacts (Ref. 204), the number of entities engaged in
upstream production of liquid nicotine and flavors specifically
developed for use with e-liquids is small, in the range of seven to
thirteen entities (see earlier discussion in response to comment 34).
Given the current marketplace, the master file system is likely to
prove widely appealing and widely utilized by the ENDS industry,
reducing burden significantly.
    In addition, FDA intends to open public dockets for uniquely
identified compounds likely to be used in an e-liquid product, such as
propylene glycol, glycerin, nicotine, colorants, and flavoring agents.
FDA intends to invite stakeholders to submit to the docket information
regarding specific compounds, including data, studies, or other files,
such as data on individual health effects of inhalation exposure,
animal study data examining exposure to varying levels of compounds
within e-liquids, or testing the impact of temperature on changes to
the aerosol constituents. This information could

then be used to help support applications for premarket review, for
example, generating information on HPHCs in ENDS products that is then
submitted as part of a PMTA.

B. Ingredient Listing and HPHC Requirements (Section 904 and 915)

    As of the effective date of this rule, the ingredient listing
requirements of section 904 of the FD&C Act will apply to manufacturers
of the newly deemed products, including ENDS retail establishments that
mix or prepare e-liquids or create or modify aerosolizing apparatus for
sale or distribution. At this time, FDA intends to limit enforcement to
finished tobacco products. FDA does not at this time intend to enforce
these requirements for manufacturers of components and parts of newly
deemed products that are sold or distributed solely for further
manufacturing into finished tobacco products. This means that FDA
generally intends to enforce these requirements with respect to ENDS
retail establishments that mix or prepare e-liquids or create or modify
aerosolizing apparatus for sale or distribution directly to consumers
but not to distributors who sell components for further manufacturing.
However, if the upstream distributor submits an ingredient list for a
particular product, FDA does not intend to enforce the ingredient
listing requirement against an ENDS retailer with respect to that
particular product. We note that FDA also intends to issue a guidance
regarding HPHC reporting under section 904(a)(3), and later a testing
regulation as required by section 915, with enough time for
manufacturers to report given the 3-year compliance period for HPHC
reporting. Section 904 (a)(3) requires the submission of a report
listing all constituents, including smoke constituents, identified as
harmful or potentially harmful (HPHC) by the Secretary. Section 915
requires the testing and reporting of the constituents, ingredients,
and additives the Secretary determines should be tested to protect the
public health. The section 915 testing and reporting requirements apply
only after FDA issues a regulation implementing that section, which it
has not yet done. Until these testing and reporting requirements have
been established, newly deemed tobacco products (and currently
regulated tobacco products) are not subject to the testing and
reporting provisions found under section 915. As noted elsewhere in
this document, FDA does not intend to enforce the reporting
requirements under section 904(a)(3) for newly deemed products before
the close of the 3-year compliance period, even if the HPHC guidance
and the section 915 regulation are issued well in advance of that time.

C. Registration and Product Listing (Section 905)

    Section 905 of the FD&C Act requires every person who owns or
operates an establishment engaged in the ``manufacture, preparation,
compounding, or processing of a tobacco product'' to register its
establishment with FDA and submit a listing of its tobacco products to
the Agency. If an ENDS retail establishment engages in these
activities, section 905 requires the establishment to register and list
its products with FDA in accordance with this section. These
requirements apply under the statute for all distinct products
manufactured, and they enable FDA to assess the landscape of products
manufactured by these entities. If ENDS retail establishments are
mixing or preparing e-liquids or creating or modifying aerosolizing
apparatus for direct sale to consumers, then they will have to list
each e-liquid combination that they sell. It will be the responsibility
of the ENDS retail establishment, as a manufacturer, to determine how
many and which products they plan to manufacture. For shops that
prepare an expansive array of custom mixes, with many gradations of
flavor, nicotine strength or other characteristic, this would mean
identifying, listing, and reporting ingredients for a large number of
distinct products. In reality, however, we expect that such entities
will elect to narrow the list of combinations they sell (with more
limited distinctions in strength and flavor, etc.), since such a
narrowing will allow them to continue providing custom products and a
variety of options while simplifying their reporting. However, since
the time and cost of listing each additional mixture is expected to be
very low, the reduction will not necessarily be significant. In
addition, any narrowing may reflect a reduction in products that are
listed but are not actually sold.

D. Tobacco Health Document Submissions (Section 904)

    Section 904(a)(4) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents
that relate to health, toxicological, behavioral, or physiologic
effects of current or future products, their constituents (including
smoke constituents), ingredients, components, and additives. As
discussed in section IV.D (discussing the compliance policy for small-
scale tobacco product manufacturers), FDA, for an additional 6 months
following the end of the generally applicable compliance period, does
not intend to enforce against those small-scale tobacco product
manufacturers (including ENDS retail establishments) who submit the
required information.

E. Office of Small Business Assistance

    Under section 901(f) of the FD&C Act, one of FDA's initial
activities upon passage of the Tobacco Control Act was to establish the
OSBA within CTP to assist small tobacco product manufacturers and
retailers in complying with the law. FDA recognizes that the issuance
of this final deeming rule, including the clarifying information noting
that ENDS retail establishments are manufacturers subject to this rule,
may result in many additional small tobacco product entities contacting
OSBA for assistance. Accordingly, FDA intends to hire additional OSBA
staff to provide assistance to small tobacco product entities wherever
possible.

X. Regulation of Other Categories of Products

    FDA is finalizing this rule to deem all products that meet the
definition of tobacco product in section 201(rr) of the FD&C Act
(except accessories of newly deemed tobacco products) to be subject to
FDA's tobacco product authorities. In addition, as stated in the NPRM,
any future tobacco product that meets the definition in section 201(rr)
(except accessories of newly deemed tobacco products) will also be
subject to FDA's authorities under chapter IX of the FD&C Act.
Regulation of the newly deemed tobacco products is intended to address
the public health concerns related to these products. A summary of the
comments regarding dissolvables, gels, pipe tobacco, waterpipe tobacco,
other alternative products, and future tobacco products is discussed as
follows. FDA's responses to the comments are also included.

A. Nicotine in Newly Deemed Products

    Comments were split as to the health risks of nicotine and its
impact on adult tobacco product users.
    (Comment 179) Many comments stated that nicotine is addictive, and
all products containing nicotine pose a health threat to youth. Some
also stated that nicotine can have detrimental effects on the
cardiovascular system and promotes lung carcinomas (Refs. 15, 205).
Other comments noted that it is generally accepted that nicotine is not
directly responsible for tobacco-related

death and disease (Ref. 206) and that the Surgeon General has stated
that it is the toxic substances in tobacco products (not the nicotine)
that cause almost all tobacco-related death and disease (Ref. 9).
    (Response) FDA agrees that nicotine is the primary addictive
substance in tobacco products, as stated in the proposed deeming rule
(79 FR 23142 at 23180). The Surgeon General has long recognized that
nicotine is the primary pharmacologic agent of tobacco that can be
absorbed into the bloodstream and cause addiction (Ref. 1 at 6-9). In
addition, the Surgeon General has stated that addiction to nicotine is
the ``fundamental reason that individuals persist in using tobacco
products, and this persistent use contributes to many diseases'' (Ref.
2 at 105). While nicotine does not directly cause most smoking-related
diseases, addiction to the nicotine in tobacco products sustains
tobacco use, leading to the ingestion of the toxic substances in
combusted tobacco products and tobacco smoke (Ref. 14). However,
nicotine, in low doses, is given in different routes of administration
as nicotine replacement therapies to help consumers to stop smoking,
when approved for such purposes.
    While the inhalation of nicotine (i.e., nicotine without the
products of combustion) is of less risk to overall public health than
the inhalation of nicotine delivered by smoke from combusted tobacco
products, limited data suggests that the pharmacokinetic properties of
inhaled nicotine can be similar to nicotine delivered by combusted
tobacco products. Thus, inhaled nicotine from a non-combustible product
may be as addictive as inhaled nicotine delivered by combusted tobacco
products. Researchers recognize that the effects from nicotine exposure
by inhalation are likely not responsible for the high prevalence of
tobacco-related death and disease in this country (Refs. 10, 11).
Although nicotine has not been shown to cause the chronic disease
associated with tobacco use, the 2014 Surgeon General's report noted
that there are risks associated with nicotine (Ref. 9 at 111). For
example, nicotine at high enough doses has acute toxicity (id.).
Nicotine exposure during fetal development has lasting adverse
consequences for brain development (id.). Nicotine also adversely
affects maternal and fetal health during pregnancy, contributing to
multiple adverse outcomes such as preterm delivery and stillbirth
(id.). Further, data in animal models suggest that nicotine exposure
during adolescence may have lasting adverse consequences for brain
development (id.). Some studies also have found that nicotine can have
detrimental effects on the cardiovascular system and potentially
disrupt the central nervous system (Refs. 14, 15). (See also section
VIII.C discussing the increase in poisoning due to accidental nicotine
ingestion.)
    (Comment 180) FDA received a large number of comments discussing
the addictive nature of nicotine and the impact of nicotine on
adolescents. Several comments stated that research indicates that the
adolescent brain is more vulnerable to nicotine addiction than the
adult brain. The comments noted that researchers have found that,
``most likely owing to its ongoing development, the adolescent brain is
more vulnerable to the effects of nicotine than the adult brain.
Adolescents progress faster to nicotine dependence than adults, find
nicotine more rewarding, underestimate the risks of smoking, and are
more influenced by smoking behavior in their social milieu.'' (Refs.
207, 208). One comment noted that animal research showing the
adolescent brain is particularly vulnerable to nicotine addiction, and
that adolescents are also less susceptible to withdrawal symptoms,
creating an all-reward, no-regret system for psychostimulant use (Refs.
209, 210, 211). Another comment noted that the U.S. Surgeon General has
found that key symptoms of nicotine dependence--such as withdrawal and
tolerance--develop in adolescents following even minimal exposure to
nicotine. Additionally, the comment stated that the Surgeon General's
2012 report cites one study following occasional adolescent smokers
that found that a large proportion experienced at least one symptom of
nicotine dependence upon quitting, even in the first 4 weeks after
initiating monthly smoking (at least two cigarettes within a 2-month
period) (Ref. 49 at 24, citing Ref. 212).
    (Response) FDA agrees that given their developmental stage, and the
fact that brain maturation continues into the mid-twenties, adolescents
and young adults are more uniquely susceptible to biological, social,
and environmental influences to use and become addicted to tobacco
products. If individuals do not start using cigarettes by age 26, they
are unlikely ever to smoke (Ref. 3). Research shows that 87 percent of
established adult smokers began smoking before the age of 18 (Ref. 9).
An analysis by the WHO of studies performed among final-year high
school students in the United States suggests that fewer than two out
of five smokers who believe that they will quit within 5 years actually
do quit. In high-income countries, about 7 out of 10 adult smokers say
they regret initiating smoking and would like to stop (Ref. 213).
    In addition, FDA agrees that there are data suggesting that the
adolescent brain is more vulnerable to developing nicotine dependence
than the adult brain and that there is evidence to suggest that these
brain changes are permanent (Refs. 49, 214). The Surgeon General
reported that ``most people begin to smoke in adolescence and develop
characteristic patterns of nicotine dependence before adulthood'' (Ref.
3). These youth develop physical dependence and experience withdrawal
symptoms when they try to quit smoking (id.). As a result, addiction to
nicotine is often lifelong (Ref. 4). Additionally, youth and young
adults generally ``underestimate the tenacity of nicotine addiction and
overestimate their ability to stop smoking when they choose'' (Ref. 5).
For example, one survey revealed that ``nearly 60 percent of
adolescents believed that they could smoke for a few years and then
quit'' (Ref. 7). Research conducted in animal models have indicated
that exposure to substances such as nicotine can disrupt adolescent
brain development and may have long-term consequences on executive
cognitive function and on the risk of developing a substance abuse
disorder and various mental health problems as an adult (Ref. 8). This
exposure to nicotine can also have long-term results on decreasing
attention performance and increasing impulsivity which could in turn
promote the maintenance of nicotine use behavior (id.).

B. Dissolvables

    FDA noted in the NPRM that it was proposing to deem certain
dissolvable products (i.e., those dissolvable products that do not
currently meet the definition of ``smokeless tobacco'' in section
900(18) of the FD&C Act because they do not contain cut, ground,
powdered, or leaf tobacco and instead contain nicotine extracted from
tobacco). We explained that little evidence is available to ascertain
the pharmacological properties and harmful effects of dissolvable
tobacco products or compare them with FDA-approved nicotine replacement
products or other tobacco products. We also noted that certain
dissolvable smokeless tobacco products, given their candy-like
appearance, have the potential for unintended poisonings. FDA deems
these dissolvable products with this final rule.

    (Comment 181) Comments stated that FDA should not rely on a study
investigating flavored tobacco products in young adults as evidence
that dissolvables are more attractive to children. They indicated that
this study is inapplicable because it only looked at behaviors of
people 18 years or older.
    (Response) The cited study (Ref. 54) assessed the prevalence of
flavored tobacco products (including dissolvables) in individuals 18
and older, which encompasses both young adults and adults. The study
stated that the products' packaging looks like candy packaging and the
products often are sold next to candy. FDA believes that these factors
cause confusion regarding the safety of these novel tobacco products
for adult consumers as well as children (Ref. 215). In addition, this
study cited an additional study that concluded that sugar preference is
greater in youth and young adults (Ref. 53). Accordingly, FDA believes
it was appropriate to cite to this study as evidence supporting FDA's
concerns with certain dissolvable products.
    (Comment 182) Some comments expressed concerns regarding possible
confusion between dissolvable tobacco products and candy and the
possibility of inadvertent poisonings.
    (Response) FDA agrees that the candy-like appearance of some
dissolvable products may result in accidental poisonings. As FDA
discussed in the NPRM, data from 2010 indicates that 13,705 tobacco
product ingestion cases were reported and more than 70 percent of those
cases involved infants under a year old (Ref. 215). Although it is
unclear exactly how many of these cases involved dissolvables,
smokeless tobacco products (in all forms, including dissolvables) were
the second most common tobacco product ingested by children, after
cigarettes (id.).
    (Comment 183) Some comments mentioned that dissolvable tobacco
products may be easily confused with NRTs and, therefore, should be
regulated.
    (Response) The Agency finds that FDA regulation of all dissolvable
products under chapter IX of the FD&C Act will help to alleviate
potential confusion about the safety and use of these products.
Products that contain nicotine derived from tobacco, are intended for
human consumption, and are not marketed for therapeutic purposes, are
subject to FDA's tobacco product authorities under chapter IX of the
FD&C Act.
    (Comment 184) Comments provided unpublished data (Ref. 216)
indicating that dissolvable tobacco products deliver nicotine levels
sufficient to promote and sustain addiction. They also indicated that
dissolvable tobacco products have a higher average pH than other
tobacco products, increasing the amount of absorbable nicotine.
    (Response) FDA acknowledges that information about harmful or
potentially harmful constituents in such products is sparse, but
studies indicate that the level of nicotine in dissolvable products may
differ from cigarettes and may lead to nicotine addiction (Ref. 217).
These studies support the public health need to regulate all
dissolvable tobacco products.
    (Comment 185) Comments stated that dissolvable tobacco products are
safer than other tobacco products and have lower levels of nitrosamines
than snus or snuff and just slightly higher levels than some NRTs (Ref.
218). They also provided information that evaluated plasma nicotine
levels, heart rates, and reduction in cigarette cravings, and found
that the levels in certain dissolvables were similar to the levels in
NRTs (Ref. 219).
    (Response) While a continuum of nicotine-delivering products
exists, deeming all tobacco products will enable the Agency to collect
information about the ingredients and the health and behavioral effects
of these products. These products are ``tobacco products'' with the
potential to addict users and harm children, particularly given their
candy-like appearance, and are subject to FDA's tobacco control
authorities upon the effective date of this final rule. FDA also notes
that NRTs are regulated products and subject to premarket review by
FDA.

C. Gels

    As proposed, FDA is deeming nicotine gels with this final rule.
    (Comment 186) Some comments agreed that nicotine gels should be
subject to FDA's chapter IX authorities under the FD&C Act. In support
of their argument, they provided studies showing that children and
young adults are more susceptible than adults to nicotine poisoning
through the skin (Ref. 220).
    (Response) With this final rule, FDA is finalizing its proposal to
deem all ``tobacco products'' including nicotine gels, which are
absorbed through the skin. In addition to meeting the definition of
``tobacco product,'' nicotine gels can be addictive and lead to use of
other tobacco products that have well-documented risks of tobacco-
related death and disease. Regulating these products also will help,
among other things, to address consumers' unsubstantiated beliefs that
non-cigarette tobacco products are safe alternatives to cigarettes.

D. Pipe Tobacco

    FDA proposed to cover pipe tobacco with this deeming rule. FDA
indicated that pipe tobacco smokers have a risk of tobacco-related
disease similar to the risk of those who inhale cigar smoke or smoke
cigarettes (Ref. 221). The Surgeon General also found that pipe and
cigar smokers experience oral and laryngeal cancer risks similar to
that of cigarette smokers (Ref. 222). FDA is deeming pipe tobacco with
this final rule.
    (Comment 187) A few comments provided suggestions as to how FDA
should define pipe tobacco in this final rule to differentiate it from
roll-your-own tobacco. For example, comments suggested FDA define pipe
tobacco to include the moisture measured at the time of packing, the
amount of reducing sugars, and the fact that it does not use
reconstituted sheet tobacco or expanded leaf tobacco as part of the
blend. Others suggested FDA define the term based on the ``consumer's
reasonable perception of the product'' or include language stating that
it is ``suitable for use and likely to be offered to, or purchased by,
consumers as tobacco to be smoked in a pipe.'' Comments also requested
that FDA enforce against the misuse of pipe tobacco as roll-your-own
tobacco, regardless of whether it defines pipe tobacco, because
mislabeled pipe tobacco already meets the definition of cigarette
tobacco or roll-your-own tobacco.
    (Response) FDA disagrees. The Agency finds that it is not necessary
to define pipe tobacco in this rule. FDA also notes that it has issued
Warning Letters for products bearing the package description of ``pipe
tobacco,'' but that are sold or distributed for use as cigarettes for
the purposes of chapter IX of the FD&C Act due to the fact that,
because of its appearance, the type of tobacco used in the filler, or
its packaging and labeling, it is suitable for use and likely to be
offered to consumers as cigarettes, and/or likely to be purchased by
consumers for making cigarettes or intended for use in cigarettes. FDA
will continue to do so as circumstances warrant.
    (Comment 188) Comments stated that when consumers use pipe tobacco
for its intended use, it does not have the same public health concerns
as other tobacco products. They also stated that pipe tobacco users are
only a small percentage of adults and that only 0.2 percent of minors
indicate that they are dual users of pipe tobacco and cigarettes (Ref.
9). They stated that based on these differences, some of the automatic

deeming provisions should not apply to pipe tobacco. For example, they
claimed premarket review requirements should not apply to pipe tobacco,
because manufacturers make changes to maintain consistent taste for
older populations and not to create ``new'' products.
    Other comments disagreed, citing evidence of the dangers of pipe
tobacco, as discussed in the NPRM (79 FR 23142 at 23156 and 23168).
They also expressed concerns that extended use of pipe tobacco releases
significant amounts of secondhand smoke into the environment.
    (Response) FDA disagrees that pipe smoking is not a public health
issue. As we stated in the NPRM, studies of pipe tobacco smokers have
found that their risk of tobacco-related disease is similar to the risk
in those who inhale cigar smoke or smoke cigarettes (Ref. 221). The
Surgeon General also previously found that pipe and cigar smokers
experience oral and laryngeal cancer risks similar to that of a
cigarette smoker (Ref. 222). While the Surgeon General's report does
indicate that pipe tobacco smokers may have a lower risk of developing
cardiovascular disease than cigarette smokers, pipe tobacco users still
are at risk for these diseases, and those who use both cigarettes and
pipe tobacco may have even higher levels of risk due to their usage
patterns (Ref. 9 at 428). Moreover, researchers have found that when
compared with individuals who have never used tobacco, pipe smokers
have an increased risk of death from cancers of the lung, oropharynx,
esophagus, colorectum, pancreas, and larynx, and from coronary heart
disease, cerebrovascular disease, and COPD (Refs. 32, 221).
    (Comment 189) A few comments expressed concern that retailers who
blend pipe tobacco would be subject to all FD&C Act requirements for
manufacturers, preparers, compounders, or processors of tobacco
products, such as premarket review, and registration and listing. These
comments requested that retailers blending up to either 3,000 pounds or
5,000 pounds of pipe tobacco per year be exempt from the requirements
of the law that apply to manufacturers.
    (Response) All entities that meet the definition of ``tobacco
product manufacturer'' in section 900(20) of the FD&C Act, including
retail establishments that blend pipe tobacco, are subject to and must
comply with all applicable statutory and regulatory requirements for
tobacco product manufacturers.

E. Waterpipe Tobacco

    The NPRM included waterpipe tobacco as an example of a tobacco
product that would be covered under this deeming rule. We noted
concerns regarding the safety of waterpipe tobacco given the nicotine
and carcinogens in waterpipe tobacco smoke, and the availability of
waterpipe tobacco in a variety of flavors that could be appealing to
youth and young adults. FDA's final rule includes waterpipe tobacco in
the scope of products subject to FDA's tobacco control authorities.
    (Comment 190) One comment requested that FDA clarify whether the
term ``hookah'' refers to the waterpipe or the tobacco used in the
waterpipe.
    (Response) In the NPRM, FDA generally used the term ``hookah'' to
mean waterpipe smoking and ``hookah tobacco'' as the tobacco used in
the waterpipe. Waterpipe smoking may also be referred to by other names
such as shisha or narghile. To alleviate any confusion in this final
rule, FDA has referred to ``waterpipe smoking'' and ``waterpipe
tobacco'' to cover all types of tobacco smoking using a waterpipe.
    (Comment 191) At least one comment expressed concern about the
public health risk of herbal waterpipe tobacco, which they assert has
the same levels of toxicant exposure but without nicotine.
    (Response) FDA's tobacco product authorities under chapter IX of
the FD&C Act do not extend to substances that are not made or derived
from tobacco (like herbal waterpipe tobacco), because they do not meet
the definition of ``tobacco product'' under section 201(rr) of the FD&C
Act.
1. Dual and Polytobacco Use
    (Comment 192) Many comments expressed concern about the growth in
dual and polytobacco use among youth and young adults. For example, the
North Carolina Public Health Association submitted a preliminary
analysis of the 2013 NCYTS, which indicated that 19.1 percent of high
school students reported using two or more tobacco products and that
88.4 percent of high school students who currently are using waterpipe
tobacco reported using at least one other tobacco product. Some
comments noted that dual use of waterpipe tobacco and cigarettes is
more prevalent than exclusive waterpipe tobacco use and that waterpipe
tobacco users typically smoke cigarettes with greater intensity than
nonwaterpipe tobacco users (Ref. 222). In fact, dual use of waterpipe
tobacco and cigarette use is one of the most common tobacco use
profiles found in young adults age 18 to 24 years (e.g., Ref. 223).
    (Response) FDA remains concerned about the potential for dual and
polytobacco use, particularly among youth and young adults. As the
North Carolina research shows, a noncigarette tobacco product (like
waterpipe tobacco) can be the first product used by new tobacco users
and there is concern such users could continue using the initial
product or transition to cigarettes or other tobacco products. There is
also the concern that existing users could become dual users.
Accordingly, it is critical to deem these noncigarette tobacco products
and place restrictions upon them that are appropriate for the
protection of the public health, including age and identification
restrictions to help prevent youth use of these products.
2. Popularity
    (Comment 193) Many comments expressed concern about the growing use
of waterpipe tobacco, particularly among young adults. For example,
they noted that the percentage of young adults aged 18 to 24 who use
waterpipe tobacco (7.8 percent) is significantly higher than adult use
(1.5 percent) (Ref. 224). A few comments suggested that FDA
overestimated this trend.
    (Response) FDA agrees with the many comments that supported
regulation of waterpipe tobacco and noted the increase in use among
young adults. Waterpipe tobacco use continues to increase in
popularity, particularly among college students, with as many as 40
percent reporting ever using waterpipe tobacco and 20 percent reporting
use (i.e., use within the past 30 days) on some college campuses (Refs.
25, 26).
3. Harms
    (Comment 194) Many comments supplemented the data in the NPRM
regarding the dangers of smoking waterpipe tobacco. For example, they
referred to several studies showing significant nicotine, carbon
monoxide, and other carcinogen intake during waterpipe use (e.g., Refs.
225, 226, 227, 228). Further, in studies involving the use of
waterpipes in a hospital research ward, researchers found greater
carbon monoxide exposure and a different pattern of carcinogen exposure
for waterpipe tobacco smokers (when compared to cigarette smokers), and
concluded that exposure to tobacco smoke toxicants during waterpipe use
is similar qualitatively (though not quantitatively) to cigarette smoke
(Refs. 229, 230). Comments concluded that waterpipe users have a
significant risk of smoking-related diseases, but the

magnitude of the risk depends upon the extent of the use.
    (Response) FDA agrees with this assessment and that it supports
finalizing its proposal to include waterpipe tobacco in the scope of
this rule.
    (Comment 195) Many comments included data regarding the increased
cancer risks associated with waterpipe smoking. For example,
researchers identified significant associations between waterpipe
tobacco use and esophageal squamous cell carcinoma and a 6-fold
increase in risk of lung cancer from waterpipe tobacco use (Refs. 231,
232). In addition, the existence of tobacco-related toxicants in
waterpipe tobacco smoke may place users at risk for many of the same
diseases as cigarette smokers, including a risk of lung cancer and
respiratory illness (e.g., Refs. 233, 234, 235, 236). While some
comments maintained that many of these users will use waterpipe tobacco
only once in their lifetime, these products are growing in popularity
with youth and young adults and cause tobacco-related death and
disease.
    Other comments opposed FDA's proposal to regulate waterpipe
tobacco, claiming that the dangers of waterpipe tobacco use are
unsupported, that FDA has not adequately reviewed scientific studies,
and that FDA ignored evidence. They also believed that use of
disposable mouth piece tips would alleviate the risks of spreading
communicable diseases through waterpipe use. In addition, they
indicated that FDA's comparison of a waterpipe smoking session to
smoking a single cigarette is inherently flawed due to the different
patterns of use of these tobacco products.
    (Response) Although it is possible that use of disposable mouth
piece tips could help alleviate the risks of spreading communicable
diseases through waterpipe use, the products nevertheless present a
significant risk of smoking-related diseases. Accordingly, FDA is
finalizing its proposal to include waterpipe tobacco in the scope of
this rule. Further, although the products have different use
topographies, FDA continues to believe that a comparison between the
toxicants emitted during a waterpipe session and cigarette smoking is
valid and indicative of the dangers associated with waterpipe use. In
fact, the WHO study group on tobacco regulation has found that a
waterpipe session can be the equivalent of smoking more than 100
cigarettes (Ref. 237). Moreover, regardless of the number of waterpipe
tobacco users who use waterpipe tobacco for more than 1 day, the
product presents significant health risks and is appropriately included
in the scope of this rule.
4. Addiction
    (Comment 196) Some comments claimed that waterpipe tobacco smokers
do not get addicted and, therefore, there is no need for FDA to
regulate waterpipe tobacco. Others disagreed and claimed that waterpipe
tobacco is addictive. These comments provided extensive data about the
significant health effects (including nicotine and toxicant exposure)
and the highly addictive nature of waterpipe use (e.g., dual use)
(e.g., Ref. 233).
    (Response) Waterpipe tobacco contains nicotine, which is the
primary addictive chemical in tobacco products. Researchers have
observed nicotine dependence characteristics in some users, including
suppressed cravings to smoke and anxiousness (Refs. 238, 239, 240),
with one study showing that waterpipe tobacco use suppressed withdrawal
symptoms just as cigarette smoking suppresses withdrawal symptoms (Ref.
240).
5. Misunderstanding
    (Comment 197) Consumers stated that waterpipe tobacco should be
regulated given its appeal to youth and adolescents' belief that it is
not as harmful as traditional cigarettes. They agreed that a failure to
regulate the proposed deemed products could reinforce consumers'
existing confusion and misinformation about these products. However,
other comments stated that FDA's concerns over youth's misperception of
the safety of certain tobacco products should not be a factor that FDA
should consider in deciding whether to regulate them. They stated that
regulation cannot remedy the fact that certain youth affirmatively
disregard available safety information. Comments noted that waterpipe
tobacco users perceive this product to be much less harmful that
cigarette smoking (Ref. 241), because they mistakenly think that the
water filters out toxicants from the smoke and the fact that waterpipe
tobacco use is frequently exempted from clean indoor air laws.
    (Response) While we continue to believe that alleviating
misperceptions is important, we note that the potential to alleviate
youth's misperception regarding the toxicity of unregulated tobacco
products was only one of many public health benefits associated with
deeming tobacco products, as discussed in the NPRM (79 FR 23142 at
23148 and 23149). Waterpipe smoking carries health risks similar to
smoking cigarettes, and waterpipe smoke contains many of the same
carcinogens and heavy metals as cigarette smoke (79 FR 23142 at 23156
and 23157). In addition, given that waterpipe tobacco smoking sessions
last significantly longer than smoking a cigarette, smoking waterpipe
tobacco could potentially be even more dangerous than smoking a
cigarette (79 FR 23142 at 23156). Consequently, based on the various
impacts on public health, FDA believes regulation of waterpipe tobacco
is important.

F. Additional Novel and Future Tobacco Products

    In the NPRM, FDA proposed to deem additional novel and future
tobacco products if the products meet the definition of ``tobacco
product'' in section 201(rr) of the FD&C Act. FDA is finalizing this
proposal here.
    (Comment 198) Several comments supported deeming all future tobacco
products. One comment requested that the future regulated products
should include products that extend beyond buccal or dermal absorption.
    (Response) Future products that meet the definition of ``tobacco
product'' under section 201(rr) of the FD&C Act, including the
requirement that they be ``intended for human consumption,'' are deemed
subject to FDA's chapter IX authorities as a result of this rule. A
product may be intended for human consumption in a variety of ways,
such as through the lungs or by buccal or dermal absorption. However,
future accessories of newly deemed products are not deemed subject to
chapter IX as a result of this rule.
    (Comment 199) At least one comment cautioned FDA that regulations
for future products should be based on the continuum of risk to ensure
that there is continued innovation to reduce harm.
    (Response) FDA recognizes the existence of a continuum of nicotine-
delivering products and will continue to consider this continuum in
regulating future tobacco products.
    (Comment 202) A few comments stated that FDA should not regulate
products with de minimis amounts of nicotine derived from tobacco that
may be used in cosmetics, food, animal feed, or other products, and for
purposes not related to traditional tobacco use (such as protein).
Additionally, they stated that these types of products should not have
to bear the warning, ``This product is derived from tobacco.''
    (Response) With this final rule, FDA deems all products meeting the
definition of tobacco product, except for accessories of newly deemed
products, to be subject to FDA's authorities under chapter IX of the
FD&C Act.

Determinations about whether particular products meet this definition
would be made on a case-by-case basis. However, animal feed is a
veterinary product and not for human consumption and, therefore, would
not be a tobacco product. Products that contain nicotine derived from
tobacco meet the definition of a tobacco product under the FD&C Act and
are required to bear a health warning on packages and in advertisements
stating: ``WARNING: This product contains nicotine. Nicotine is an
addictive chemical.'' For products that are made or derived from
tobacco (but do not contain nicotine), manufacturers may submit a
certification to FDA and, instead, bear the statement ``This product is
made from tobacco.'' See section XVI.H for additional information
regarding this certification.
    (Comment 203) One comment stated that alternative nicotine
products, such as nicotine toothpicks, have a net positive impact on
the public health because they pose fewer health and safety risks than
conventional cigarettes and could help addicted smokers transition to
less toxic tobacco products. The comment argued that the regulatory
burden for such products should be proportionately reduced.
    (Response) While FDA recognizes the existence of a continuum of
nicotine-delivering products, all tobacco products are addictive and
potentially dangerous and, therefore, should be subject to FDA
regulation. Therefore, FDA is deeming all tobacco products (except
accessories of newly deemed tobacco products) subject to the
requirements of chapter IX of the FD&C Act and requiring certain
additional provisions (i.e., minimum age and identification, vending
machine, and health warnings) for covered tobacco products. FDA will
continue to take this continuum of nicotine-delivering products into
consideration as it contemplates future regulations of the newly deemed
products.

XI. Additional Automatic Provisions Applicable to Newly Deemed Products

    In addition to the requirement that non-grandfathered tobacco
products obtain authorization through one of the three marketing
pathways, several provisions in the Tobacco Control Act and its
implementing regulations will automatically apply to the newly deemed
products as of the effective date of this final rule (79 FR 23142 at
23148 and 23149). These provisions include:
    (1) Adulteration and misbranding provisions (sections 902 and 903
of the FD&C Act);
    (2) Ingredient listing and HPHC reporting requirements (sections
904 and 915 of the FD&C Act);
    (3) Registration and product listing requirements (section 905 of
the FD&C Act);
    (4) Prohibition against the use of ``light,'' ``low,'' and ``mild''
descriptors and products with other unauthorized modified risk claims
(section 911 of the FD&C Act); and
    (5) Prohibition of free samples of the proposed deemed products (21
CFR 1140.16(d)).
    Comments regarding these provisions, and FDA's responses to
comments, are as follows.
    (Comment 204) In the proposed deeming rule, FDA noted that it was
taking this action to address the public health concerns associated
with the use of tobacco products. Some comments stated that health
policies based on tobacco use prevention and cessation are not
sufficient to protect the public health.
    (Response) FDA is deeming products that meet the definition of
``tobacco product,'' except accessories of newly deemed tobacco
products, to address the public health concerns with these products. In
the NPRM, FDA included discussion of public health benefits to better
inform the public about the likely results of deeming these tobacco
products. FDA intends to supplement this final rule with regulations as
appropriate to protect the public health.

A. Sections 902 and 903--Adulteration and Misbranding

    In the proposed deeming rule, we explained that the adulteration
and misbranding provisions of sections 902 and 903 of the FD&C Act
would subject all tobacco products to certain basic requirements. For
example, their labeling and advertising cannot be false or misleading,
which will help reduce consumer confusion and misperception. The Agency
can take enforcement action against any tobacco product that did not
meet these basic requirements.
    (Comment 205) A large number of comments discussed the
applicability of sections 902 and 903 of the FD&C Act to the newly
deemed tobacco products. Most comments expressed general support for
applying adulteration and misbranding provisions to the newly deemed
tobacco products. Others supported the application of the provisions
based on concerns that some e-cigarette manufacturers may not be
producing their products in sterile conditions. Several comments
cautioned that the differences between the newly deemed tobacco
products might result in unwarranted restrictions if the provisions are
applied mechanically across all product categories. At least one
comment stated that the adulteration and misbranding provisions should
not apply to e-cigarettes because there is no evidence that
adulteration and misbranding currently occurs with those products or
causes any harm.
    (Response) The adulteration and misbranding provisions of sections
902 and 903 of the FD&C Act will automatically subject all tobacco
products to certain basic requirements. For example, their labeling and
advertising cannot be false or misleading, which will help reduce
consumer confusion and misperception. FDA will be able to take
enforcement action against any tobacco product that does not meet these
basic requirements. For example, if a product is produced in insanitary
conditions or is contaminated, or if its labeling contains a misleading
claim, it will be subject to enforcement action, including seizure and
injunction.

B. Sections 904 and 915--Ingredient Listing and Reporting of HPHCs

    As stated in the NPRM, the newly deemed products will be required
to comply with the ingredient listing and HPHC reporting requirements
of sections 904 and 915 of the FD&C Act. FDA intends to issue a
guidance regarding HPHC reporting, and later a testing and reporting
regulation as required by section 915, with enough time for
manufacturers to report given the 3-year compliance period for HPHC
reporting. As noted elsewhere in this document, FDA does not intend to
enforce the reporting requirements for newly deemed products before the
close of the 3-year compliance period, even if the guidance is issued
well in advance of that time.
    (Comment 206) A couple of comments urged FDA not to require newly
deemed products to comply with the ingredient and HPHC listing
requirements. One comment argued that such reports are useless for
educating consumers, who will invariably use them in an attempt to
determine the relative risk of each product. Another comment claimed
that the HPHC and ingredient listing requirements should be abandoned
because they are not helpful and the cost of producing these reports
would destroy industry.
    (Response) FDA disagrees with these comments. Ingredient and HPHC
reporting assist FDA in better understanding the contents of regulated
products. This information will assist FDA in assessing potential
health risks and determining if future regulations to

address these health risks would be appropriate. The FD&C Act directs
FDA to make certain HPHC information publicly available, but it must do
so in a way that is understandable and not misleading to lay persons.
    (Comment 207) Several comments discussed ingredient and HPHC
listing requirements in the context of small businesses and particular
products. A few comments urged FDA to exempt small businesses that
manufacture e-cigarettes from the HPHC reporting requirement because
the testing would impose a large financial burden on them and would
likely drive them out of business. One comment countered these
arguments, urging FDA to require manufacturers of all products to
comply with the ingredient and HPHC listing requirements and not
provide an exemption for small businesses. The comment argued that the
size of a business does not change a product's potential health impact
and that the health benefits of regulation far exceed the costs.
    Other comments focused on ingredient and HPHC listing requirements
for specific product categories. At least one comment expressed concern
that HPHC testing would disproportionately affect the premium cigar
industry, which has a high number of low-volume products, and requested
that the requirements not apply to small batch or special release
products. One comment claimed that many of the new tobacco products on
the market, such as e-cigarettes, are virtually identical with the
exception of flavoring and nicotine levels and recommended that FDA
allow for these products to be grouped together for the purposes of
HPHC testing.
    (Response) With respect to HPHC testing of similar products, FDA
recognizes that some manufacturers of newly deemed products sell
products in various flavors or with varying levels of nicotine.
Manufacturers of these products will be required to test each variation
for HPHCs, even where the products are otherwise the same. At this
time, there is little known about the constituents of some newly deemed
products. HPHC testing will allow FDA to track the level of HPHCs
across different categories of flavors and by nicotine level. FDA's
compliance policies for the HPHC requirements are described elsewhere
in this document.
    (Comment 208) Several comments stated that FDA should establish
HPHC lists and testing methodology before requiring HPHC testing. One
comment requested that FDA establish an HPHC list and testing
methodology for e-cigarettes in the same manner that it did for
currently regulated tobacco products, including holding public
workshops, requesting and considering Tobacco Products Scientific
Advisory Committee recommendations, publishing draft and final lists in
the Federal Register for public comment, and providing a reasonable
compliance period for e-cigarette manufacturers. A few comments
expressed the opinion that FDA should establish separate lists of HPHCs
for each category of newly deemed tobacco products and not require HPHC
reporting until the lists and corresponding testing methodologies are
created and validated. Other comments stated that because not all
deemed products are likely to have the same HPHCs as currently
regulated products, testing for all of the constituents would be
wasteful.
    (Response) As discussed elsewhere in this document, the compliance
period for HPHC reporting and testing is the effective date of this
rule plus 3 years. FDA intends to issue a guidance regarding HPHC
reporting, and later a testing and reporting regulation as required by
section 915 of the FD&C Act, with enough time for manufacturers to
report given this compliance period. As noted elsewhere in this
document, FDA does not intend to enforce the reporting requirements for
newly deemed products before the close of the 3-year compliance period,
even if the guidance is issued well in advance of that time.
    (Comment 209) Several comments suggested that manufacturers should
be required under section 904 of the FD&C Act to include a statement of
the ingredients and/or nicotine concentration on their product labeling
as a condition of sale. These comments indicated that consumers could
use this information to select e-cigarette liquids with decreasing
nicotine content levels as part of a nicotine replacement therapy to
quit smoking.
    (Response) Sections 915(b) of the FD&C Act and 206 of the Tobacco
Control Act give FDA authority to require the disclosure of nicotine
and certain other information on labeling and by other means. FDA has
not issued regulations for the currently regulated tobacco products and
did not propose this in the proposed deeming rule. FDA will consider
whether it should do so in the future. To the extent the comment is
about ENDS marketed for smoking cessation, such a product would be
subject to FDA's drug/device authorities and not subject to FDA's
tobacco product authorities.
    (Comment 210) Some comments suggested that any HPHC requirement for
cigars should require analysis of HPHCs in the tobacco (rather than the
smoke) in a manner similar to that for hand-rolling tobacco. They
stated that HPHC smoke analysis is neither available nor readily
producible for most cigars. They also stated that smoking regimens
recommended for collecting HPHC data for tobacco smoke were developed
for cigarettes and suggested that cigars are inherently more variable
than cigarettes. Finally, they stated that the cigar smoke test method
recommended by the Centre de Coop[eacute]ration pour les Recherches
Scientifiques Relatives au Tabac in 2005 has produced more variable
data than that obtained using the comparable test method for
cigarettes, making it difficult to compare consistent test results for
cigars.
    (Response) FDA disagrees with the comments. In order to determine
the HPHC deliveries that each cigar provides, it is important that
manufacturers submit HPHC data on smoke yields for cigars. HPHC
quantities in cigar tobacco only would not provide a complete
understanding of the toxicity of each cigar. As stated by the comments,
Centre de Coop[eacute]ration pour les Recherches Scientifiques
Relatives au Tabac (CORESTA) published method 64 in 2005 that describes
a smoking regimen for cigars. It is not clear that the variability in
cigar HPHC yields will be greater than that for cigarette yields.
Variability in HPHC smoke yields is dependent on the smoking regimen,
analytical method, and batch-to-batch consistency in product
composition. Therefore, it is expected that the variability in HPHC
smoke yields from some cigarettes will exceed that for cigars. In any
case, as with cigarettes, it is important to understand the HPHC
deliveries in cigar smoke.

C. Section 905--Registration and Listing

    As stated in the NPRM, manufacturers of the newly deemed products
will be required to comply with section 905(b) of the FD&C Act, which
requires the registration of any establishment engaged in the
manufacture, preparation, compounding, or processing of a tobacco
product. In addition, they must comply with section 905(i) of the FD&C
Act, which requires registrants to submit a list of all tobacco
products that are being manufactured, prepared, compounded, or
processed for commercial distribution. FDA must issue a regulation
before foreign establishments are required to comply with these
requirements.
    (Comment 211) Several comments stated that FDA should apply the
same

requirements to both foreign and domestic manufacturers of tobacco
products, including manufacturers of the newly deemed products. They
expressed concern that FDA has not yet issued a proposed registration
and listing rule and has not provided a timeframe for a final rule that
would apply these requirements to foreign establishments. They also
stated that the absence of registration and listing requirements for
foreign establishments creates incentives for manufacturers of the
newly deemed products to move their facilities overseas.
    (Response) As indicated in the Unified Agenda of Spring 2015 (Ref.
242), FDA plans to issue a proposed registration and listing rule that
would extend these requirements to foreign tobacco product
establishments. In addition, upon the effective date of this final
deeming rule, both foreign and domestic manufacturers will be subject
to, among other things, adulteration and misbranding restrictions
(sections 902 and 903 of the FD&C Act); requirements for ingredient
listing and reporting of HPHCs for all tobacco products (section 904 of
the FD&C Act); and premarket authorization requirements (sections 905
and 910 of the FD&C Act).

D. Section 911--Elimination of Low, Light, and Mild, and Other
Unauthorized Modified Risk Claims

    Section 911 of the FD&C Act is one of the automatic statutory
provisions that will apply to the newly deemed products on the
effective date of this regulation. The purpose of this section is to
prohibit the introduction into interstate commerce of MRTPs, including
products the label, labeling, or advertising of which uses ``low,''
``light,'' or ``mild,'' or other modified risk claims unless FDA issues
an order authorizing their marketing. This requirement will help
consumers better understand and appreciate the health risks of the
newly deemed products. In addition to any applicable premarket review
under section 910 of the FD&C Act, if a manufacturer wishes to sell a
MRTP, the company must submit an MRTP application under section 911 and
receive an FDA order to legally market an MRTP.
    (Comment 212) A number of comments discussed the application of the
MRTP restrictions to the newly deemed products. Several comments
argued, as a general matter, that subjecting the newly deemed products
to section 911 would be an unconstitutional restriction of free speech
because FDA either has no substantial interest that would be advanced
by such restrictions or has not demonstrated that restricting modified
risk claims for these products would advance its substantial interest
in protecting the public health. A couple of comments argued that the
brand names of newly deemed products that contain the descriptor
``low,'' ``light,'' or ``mild'' should be prohibited only where the
descriptors specifically convey a modified risk claim. These comments
stated that where ``low,'' ``light,'' or ``mild'' is used and
understood by consumers to describe something other than a modified
risk (such as the product's taste), restricting the use of a brand name
containing one of these terms would be unconstitutional, arbitrary, and
capricious because the government does not advance any substantial
interest by doing so. Other comments supported the application of
section 911 to all newly deemed tobacco products, with some comments
maintaining that certain e-cigarette companies are currently marketing
their products using unauthorized modified risk claims.
    (Response) FDA disagrees with the suggestion that subjecting the
newly deemed products to section 911 would be an unconstitutional
restriction of free speech. The Sixth Circuit upheld the modified risk
provisions against a First Amendment challenge to the facial validity
of the statute in Discount Tobacco v. FDA, 674 F.3d 509, 531-37 (6th
Cir. 2012). We discuss this issue in depth in section II.B.3.b. FDA has
and will continue to apply section 911 of the FD&C Act consistent with
the First Amendment and will take all relevant facts into account on a
case-by-case basis.
    FDA agrees with comments that supported the application of section
911 to all newly deemed products. Historically, certain users have
initiated and continued using certain tobacco products based on
unauthorized modified risk claims and consumers' unsubstantiated
beliefs about the relative safety of these products. Section 911 will
prevent the use of unsubstantiated modified risk claims, which may
mislead consumers and lead them to initiate tobacco product use or to
continue using tobacco when they would otherwise quit. This will allow
for better-informed consumers and help to prevent the use of misleading
marketing targeted to youth populations.
    (Comment 213) Many comments stated that e-cigarette companies make
direct and indirect health claims in the marketing and promotion of
their products (e.g., by posting customer comments and testimonials on
their Web sites) and that some e-cigarette advertising implies FDA
approval or endorsement (e.g., use of the FDA logo on labels or
statements such as ``made in an FDA-approved facility'') (Ref. 151). As
a result, the comments suggested a number of different actions to curb
these unsubstantiated or misleading claims, including: (1) Prohibiting
direct and implied therapeutic claims that e-cigarettes are effective
cessation products unless there is evidence; (2) using existing
enforcement authority to prohibit therapeutic, health, and cessation
claims unless there is evidence of safety and efficacy; (3) working
with the FTC to prohibit such claims as false advertising until such
time as there is evidence of safety and efficacy; (4) working with the
FTC to introduce or strengthen disclosure rules on the Internet (e.g.,
product reviews) to promote transparency; and (5) prohibiting explicit
or implicit statements that e-cigarettes are approved or endorsed by
FDA.
    (Response) Under section 911 of the FD&C Act, no person may
introduce or deliver for introduction into interstate commerce any MRTP
without an order in effect under section 911(g). Also, a tobacco
product is misbranded if its label, labeling, or advertising is false
or misleading in any particular. Therefore, by deeming ENDS and other
tobacco products, FDA is now authorized to take enforcement action
against manufacturers who sell and distribute products with
unsubstantiated MRTP claims, or false or misleading claims on their
label, labeling, or advertising. Additionally, under section 301(tt) of
the FD&C Act, anyone making explicit or implicit statements that a
product is, among other things, ``approved'' or ``endorsed by FDA'' is
committing a prohibited act. An ENDS product claiming to be an NRT or
otherwise marketed for therapeutic purposes is a drug or device subject
to FDA's regulations and laws for those products. Additionally, the
Agency will consider these comments in the future, and, if FDA
determines that it is appropriate, will issue additional regulations.

E. Section 919--User Fees

    In 2014, FDA issued a final rule regarding user fees for
cigarettes, snuff, chewing tobacco, and roll-your-own tobacco,
including the submission of information needed to calculate and assess
those user fees (79 FR 39302, July 10, 2014). In that final rule, FDA
stated that if it deems cigars or pipe tobacco, FDA would respond to
the NPRM comments regarding user fee provisions for cigars and pipes,
and revise the user fee regulations (79 FR 39302 at 39305).

Accordingly, elsewhere in this issue of the Federal Register, FDA is
issuing a final rule revising the current user fee regulations.
    (Comment 214) Some comments supported applying the user fee
provisions of the Tobacco Control Act to all tobacco products,
explaining that application of user fee provisions to all products is
essential to ensure uniformity and fairness across the regulated
entities. They also noted that section 919(b)(3) of the FD&C Act states
that no manufacturer or importer of tobacco products shall be required
to pay a user fee in excess of the percentage share of such
manufacturer or importer. Accordingly, they argued that FDA cannot
assess user fees based on the continuum of nicotine-delivering
products.
    (Response) Elsewhere in this issue of the Federal Register, FDA is
issuing a final rule regarding user fees for cigars and pipe tobacco,
including the submission of information needed to calculate their user
fee assessments. These comments are addressed in that rule.

F. Tobacco Control Act, Section 102--Prohibition Against Free Samples

    In this final rule, FDA is not modifying the existing restriction
on distributing free samples of tobacco products (21 CFR 1140.16(d)).
As a result, this restriction will prohibit the distribution of free
samples of newly deemed tobacco products, as required by section 102 of
the Tobacco Control Act. See section II.B.3.a for discussion regarding
the constitutionality of this free sample prohibition.
    FDA understands concerns from some retailers about the effect that
a ban on free samples would have on their ability to promote new
products. FDA wishes to clarify that allowing prospective adult buyers
to smell or handle one of the newly deemed products is not considered
distribution of a ``free sample'' as long as the free product is not
actually consumed, in whole or in part, in the retail facility and the
prospective buyer does not leave the facility with a free tobacco
product. For example, affording adult consumers the opportunity to
handle a cigar will give them the ability to feel the resistance of the
cigar's structure and allow them to clearly see the color of the
product, which is an indication of the fermentation period for the
tobacco. Handling the product also will allow users to capture the
aroma of a cigar and the box (if the cigar is sold in a package).
However, if the prospective buyer lights and draws or puffs on the
cigar to keep it lit, or otherwise uses the free cigar or leaves the
retail establishment with a free cigar (partially used or intact
whole), this would constitute a ``free sample'' in violation of the
restriction on free samples mandated by section 102 of the Tobacco
Control Act. We believe that, in most circumstances, other retail
facilities, including ENDS retail establishments, can similarly allow
customers to touch, hold, and smell their products without violating
the free sample ban. We note that nothing in this policy should be
construed to alter or amend the regulation implementing the free sample
ban at Sec.  1140.16.
    (Comment 215) A large number of comments discussed whether FDA
should allow the continued distribution of free samples of the newly
deemed tobacco products. Most comments expressed general support for
the ban on free samples, citing concerns that such samples serve as a
gateway for youth tobacco initiation. Several comments argued that
there is no reason to believe that free samples of pipe tobacco and
premium cigars encourage youth initiation because the samples are
distributed almost exclusively in adult-only retail operations. One
comment claimed that because epidemiological data suggest that the
majority of premium cigar smokers fall into a category where there is
no significant difference in the incidence of disease compared to
never-smokers, banning free samples of premium cigars would have no
corresponding benefit even if it did reduce youth initiation. This
comment also claimed that it would similarly not help prevent youth
access because they assert that, as indicated in a recent SAMHSA
survey, there is no evidence that youth obtain premium cigars at all,
let alone as free samples from retailers.
    Several comments, referring specifically to pipe tobacco, premium
cigars, and e-cigarettes, stated that, in light of the lack of evidence
that youth obtain free samples of their products, banning these
samples, which are a vital part of their industries, would only hurt
sales and small businesses without a corresponding public health
benefit. Comments referring to premium cigars and pipe tobacco stated
that free samples of these products are necessary to entice adult
consumers to purchase what are frequently unique and sometimes
expensive products. Comments on e-cigarettes argued that, because their
products are new, free samples are necessary to convince cigarette
users to switch to them.
    One comment argued that FDA's proposed ban on free samples
impermissibly restricts commercial speech that is protected by the
First Amendment. The comment stated that while the court in Discount
Tobacco City & Lottery v. United States upheld the Tobacco Control
Act's sampling ban on cigarettes, the evidence the court used to uphold
that ban does not support the same ban for the newly deemed tobacco
products. The comment argued that FDA has presented no evidence that
samples of these products lead to youth initiation and, therefore, the
Agency would not be advancing a legitimate government interest with
this ban. Additionally, the comment suggested that even if the ban did
advance a legitimate government interest, FDA could achieve the same
results through less restrictive means, such as by allowing samples in
qualified adult-only facilities, as FDA does with smokeless tobacco.
    (Response) FDA disagrees with the assertions that the proposed ban
on free samples would hurt businesses without corresponding public
health benefits or that this prohibition impermissibly restricts
commercial speech. This prohibition will eliminate a pathway for youth
to access tobacco products, which can help reduce youth initiation and
therefore short-term and long-term morbidity and mortality resulting
from these products. The IOM has stated that free samples of cigarettes
``encourage experimentation by minors with a risk free and cost-free
way to satisfy their curiosity'' (Ref. 30). While the IOM was speaking
in the context of cigarettes, FDA believes that the same rationale
applies to the newly deemed products. In addition, the U.S. Court of
Appeals for the Sixth Circuit held that the free sample ban as applied
to cigarettes does not violate the First Amendment. The court
recognized that FDA has provided ``extensive'' evidence that free
tobacco samples constitute an ``easily accessible source'' for youth
(Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509,
541 (6th Cir. 2012) (citing 61 FR 44396 at 44460, August 28, 1996),
cert. denied sub nom. Am. Snuff Co., LLC v. United States, 133 S. Ct.
1966 (2013)). Moreover, the panel unanimously found that the ban
``embodie[d] a narrow fit between the harm articulated and the
restrictions employed'' (id.). See section II.B.3.a for more detailed
discussion of the constitutionality of the free sample prohibition.
    FDA understands concerns from cigar retailers about the effect that
a ban on free samples would have on their ability to promote new
products. FDA wishes to clarify that allowing prospective adult buyers
to smell or handle a cigar is not considered the distribution of a

``free sample'' as long as the product is not actually consumed, in
whole or in part, in the retail facility and the prospective buyer does
not leave the facility with a free tobacco product. Affording adult
consumers the opportunity to handle the product will give them the
ability to feel the resistance of the cigar's structure, and allow them
to clearly see the color of the product, which is an indication of the
fermentation period for the tobacco. It also will allow users to
capture the aroma of the cigar and the box (if the cigar is sold in a
package). However, if the prospective buyer lights and draws or puffs
on the free cigar or otherwise uses the free cigar or leaves the retail
establishment with a free cigar (partially used or intact whole), this
would constitute a ``free sample'' in violation of the ban on free
samples mandated by section 102 of the Tobacco Control Act. We believe
that, in most circumstances, other retail facilities, including ENDS
retail establishments, can similarly allow customers to touch, hold,
and smell their products without violating the free sample ban.

XII. Requests for Additional Regulations Applicable to Newly Deemed
Products

    In the NPRM, FDA noted that certain provisions would automatically
apply to the newly deemed products and that the Agency was proposing
additional restrictions that also would apply to covered tobacco
products. FDA also noted that after the final rule becomes effective,
the Agency would have the authority to issue additional regulations
applicable to the newly deemed products, including product standards
under section 907 of the FD&C Act. Many stakeholders submitted comments
and data regarding the need for additional requirements and
restrictions for the newly deemed products. Some of these requests
would require a separate NPRM, and they will help inform FDA as it
considers additional regulations for newly deemed products.

A. Ban on Flavored Tobacco Products

    FDA received numerous comments regarding flavored tobacco products,
including comments expressing concerns regarding the impact of flavors
on youth and young adults and preliminary data regarding some
individuals' use of flavored ENDS products to transition away from
combusted tobacco use. FDA's summary of comments and data regarding
flavored tobacco products is included in section V.B of this document.
FDA's responses to comments regarding a possible ban on flavored
tobacco products are included below.
    (Comment 216) Many comments suggested that FDA include a ban on
flavored tobacco products with this final rule. Other comments
suggested that FDA continue to allow the sale of fruit or candy-
flavored e-cigarettes, because they aid cigarette smokers in decreasing
cigarette use and in smoking cessation. These comments generally relied
on a research article that found that most e-cigarette users switched
between flavors on a daily basis or within the day, with former smokers
switching more frequently than current smokers, and that respondents
indicated that flavor variety was ``very important'' in reducing or
quitting smoking (Ref. 62). This survey also noted that almost half of
respondents indicated that a reduction in available flavors would
``increase craving[s] for tobacco cigarettes and would make reducing or
completely substituting smoking less likely'' (id.). Therefore, they
believed that FDA should not sacrifice adults' use of flavored tobacco
products in an attempt to prevent children from using flavored tobacco
products. These comments also noted that flavors are used in other
legally marketed products including nicotine replacement therapies
(NRTs), which are FDA-approved products.
    (Response) FDA is not banning flavored tobacco products with this
final deeming rule. To address concerns with the growing flavored cigar
market and its impact on youth and young adult initiation with tobacco
products, FDA is announcing here that it intends to issue in the future
a proposed product standard that would prohibit characterizing flavors
in all cigars, including cigarillos and little cigars.
    As discussed in section VIII.F of this document, we recognize that
there is evidence that some individual former smokers may now report
using ENDS (Ref. 24). However, the study referred to in the comments
(Ref. 62) examined self-selected research subjects who were recruited
through an e-cigarette Web site. All respondents were either former
smokers (91.2 percent) or current smokers (8.8 percent); both groups
had smoked on average 22 years before beginning to use ENDS. The
article did not consider whether either the self-selection or the
demographic profile of the respondents might affect the applicability
of its results to any larger population. Moreover, the study did not
address the question of whether study participants would have increased
cigarette use if there were no available flavored ENDS or if the
variety of flavored ENDS were limited. If additional evidence emerges
that flavored ENDS make it more likely that smokers switch completely
to ENDS, such evidence submitted as part of a PMTA would help support
that application, as part of the analysis of whether the marketing of
the product is appropriate for the protection of public health.
    Further, new data shows continued growth in youth and young adult
usage of flavored tobacco products. FDA has balanced those concerns
with preliminary data showing that some adults may potentially use
flavored ENDS to transition from combusted tobacco use when developing
the compliance policy for premarket review.
    (Comment 217) Many comments responded to FDA's request for data,
research, and information regarding the characteristics or factors it
should consider in determining whether a particular tobacco product is
a ``cigarette'' as defined in section 900(3) of the FD&C Act and,
consequently, subject to the prohibition against characterizing
flavors, despite being labeled as a little cigar or other noncigarette
tobacco product. Several comments stated that little cigars are being
marketed and used as cigarettes and, therefore, FDA should communicate
that such products are subject to the cigarette flavor ban. Other
comments provided information regarding the differences between
cigarettes and little cigars or other noncigarette tobacco products and
indicated that such products should not be subject to the cigarette
flavor ban.
    (Response) FDA understands and appreciates comments regarding the
role that flavored little cigars, or similar products, might play on
initiation of tobacco product use and dual use. FDA will continue to
determine whether a product is a ``cigarette'' under the FD&C Act and
subject to the statutory flavor ban on a case-by-case basis.
    (Comment 218) One comment stated that section 907(d)(3) of the FD&C
Act, which prohibits FDA from banning certain enumerated tobacco
products, demonstrates that Congress did not intend to grant FDA the
power to ban any tobacco product by any means, including by enacting a
product standard that would be a tantamount ban of newly deemed
products, especially when some of these products present lower risks of
death and disease than the specifically enumerated ones. Some comments
also referred to the difficulty in defining ``characterizing flavor''
in the context of instituting a ban on flavored newly deemed tobacco
products.

    (Response) If FDA decides to issue a product standard, it will do
so in accordance with section 907 of the FD&C Act. Because FDA is not
banning flavored tobacco products with this final deeming rule, it is
not necessary to consider whether and how to define ``characterizing
flavor.''

B. Additional Access Restrictions

    (Comment 219) Some comments suggested that FDA require face-to-face
sales for all covered tobacco products, as it does for sales of
cigarettes and smokeless tobacco, as provided in Sec.  1140.14(a)(3).
For example, they suggested that FDA ban self-service displays for
newly deemed tobacco products. They expressed concern that treating
cigarettes and smokeless tobacco differently from other tobacco
products would lead to confusion for retailers and complicate retailer
training programs.
    (Response) FDA will continue to monitor this issue and, if it
determines that it is appropriate for the protection of public health
to extend the self-service display prohibition to newly deemed tobacco
products, the Agency will issue a new NPRM in accordance with the APA.
    (Comment 220) Some comments suggested that we simultaneously issue
this final rule with an ANPRM seeking additional information to draft a
proposal that would apply the additional restrictions in part 1140
(e.g., ban on self-service displays, the sale and distribution of
nontobacco items, and the sponsorship of events) to newly deemed
products.
    (Response) FDA is taking this comment under advisement. If FDA
decides to issue such a proposal, the Agency will comply with the
requirements of the APA.
    (Comment 221) A few comments requested that FDA regulate all
dissolvables and other newly deemed products in the same manner it
regulates other tobacco products, including application of all of the
marketing and advertising restrictions in part 1140.
    (Response) At this time, FDA is subjecting newly deemed products to
the automatic requirements and covered tobacco products to the
additional provisions (i.e., age and identification requirements,
vending machine restrictions, and health warning requirements)
discussed in this final rule. However, if FDA later determines that
extending such marketing and advertising restrictions to the newly
deemed products is appropriate and meets the applicable standard in
section 906(d), FDA will comply with the requirements of the APA when
implementing such restrictions.

C. Nicotine Exposure Warnings

    (Comment 222) Many comments expressed concern about the increase in
nicotine poisonings due to accidental ingestion of e-liquids and
offered suggestions to address this issue: (1) Set a maximum nicotine
content level for e-liquids; (2) require the use of child-resistant
containers; (3) require a poison warning on the packaging and point of
sale for liquid-based products; and (4) set a limit on the allowable
speed of flow of the product from its container (e.g., by requiring a
flow-restricting apparatus on the opening of the container or requiring
a rigid container to prevent quick dispensing of product by squeezing
the container).
    (Response) FDA expressed similar concerns about the increase in
nicotine poisonings in the NPRM and section VIII.D. Once this final
rule becomes effective, FDA has authority to issue additional
regulations to address these concerns. In addition, FDA has issued an
ANPRM prior to this deeming rule, seeking comments, data, research, or
other information that may inform regulatory actions FDA might take
with respect to nicotine exposure warnings and the use of child-
resistant packaging. Moreover, elsewhere in this issue of the Federal
Register, FDA has made available draft guidance, which when final will
describe FDA's current thinking regarding some appropriate means of
addressing the premarket authorization requirements for newly deemed
ENDS products, including recommendations for nicotine exposure warnings
and child-resistant packaging that would help to support a showing that
the marketing of a product is appropriate for the protection of the
public health.

XIII. Severability

    This rule is being finalized with several changes from the NPRM.
Specific comments regarding proposed codified language, and FDA's
responses to those comments, are included in section VII.
    In accordance with section 5 of the Tobacco Control Act, FDA
considers and intends the extension of its authorities over all tobacco
products and the various requirements and prohibitions established by
this rule to be severable. It is FDA's interpretation and position that
the invalidity of any provision of this rule shall not affect the
validity of any other part of this rule. In the event any court or
other lawful authority were to temporarily or permanently invalidate,
restrain, enjoin, or suspend any provision of this final rule, FDA
would conclude that the remaining parts continue to be valid. As stated
in section 5 of the Tobacco Control Act, if certain applications of
this rule to persons or circumstances (discussed in the preamble or
otherwise) are held to be invalid, application of such provisions to
any other person or circumstance will not be affected and will continue
to be enforced to the fullest extent possible. Each provision of the
rule is independently supported by data and analysis as described or
referenced in this preamble and, if issued separately, would remain a
proper exercise of FDA authority.

XIV. Description of the Final Rule--Part 1100

    In the NPRM, FDA explained that new part 1100 would describe the
scope of FDA's authority over tobacco products, the requirements that
would apply to tobacco products, applicable definitions, and the
effective date of the rule. We consider and intend the extension of our
authorities over tobacco products and the various requirements and
prohibitions established by this rule to be severable.

A. Section 1100.1--Scope

    FDA selects Option 1 with this final rule, deeming all cigars
(rather than a subset), which has been applied throughout the codified
text for parts 1100, 1140, and 1143. Therefore, this section now states
that in addition to FDA's authority over cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco, FDA deems all other
products meeting the definition of ``tobacco product'' under section
201(rr) of the FD&C Act, except accessories of such other tobacco
products, to be subject to chapter IX of the FD&C Act. The definition
of ``accessory'' is now included in Sec.  1100.3 (as discussed in
section VI.A).

B. Section 1100.2--Requirements

    Because FDA selected Option 1 for the scope of the deeming rule,
Sec.  1100.2 states that cigarettes, cigarette tobacco, roll-your-own
tobacco, smokeless tobacco are subject to chapter IX of the FD&C Act
and its implementing regulations. In addition, this section states that
FDA has deemed all other tobacco products, except accessories of such
other tobacco products, subject to chapter IX of the FD&C Act and its
implementing regulations.

C. Section 1100.3--Definitions

    FDA requested comment on definitions for cigar, covered cigar, and
tobacco product. Because we are

selecting Option 1 deeming all cigars (rather than a subset) with this
final rule, comments regarding the definition of covered cigar are no
longer relevant to this rulemaking. In addition, FDA received many
comments regarding components, parts, and accessories, including how
they should be defined and the application of requirements to these
objects. We have added definitions of ``component or part'' and
``accessory'' to this section. The discussion of this language is
included in section VI.A.

XV. Description of the Final Rule--Part 1140

    Currently, part 1140 generally applies to cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco. FDA proposed
additional provisions to apply to ``covered tobacco products'' (namely,
the requirement to prohibit the sale and distribution of products to
individuals under 18 years of age and the prohibition on vending
machine sales except in adult-only facilities). As stated elsewhere in
this document, ``covered tobacco product'' means any tobacco product
deemed to be subject to the FD&C Act pursuant to Sec.  1100.2, but
excludes any component or part that is not made or derived from
tobacco. FDA is finalizing these requirements without substantive
change. FDA intends to update the current guidance documents for civil
money penalties and frequently asked questions to reflect that
violations of health warning requirements may lead to the issuance of
civil money penalties. We consider and intend the extension of our
authorities over tobacco products and the various requirements and
prohibitions established by this rule to be severable.

A. Section 1140.1--Scope

    The NPRM offered several amendments to part 1140 in order to apply
select existing sale and distribution restrictions, including age,
identification, and vending machine provisions, to address youth access
to the deemed tobacco products. As currently written, part 1140
generally applies to cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco products. Accordingly, FDA is finalizing
this rule to add the phrase ``and covered tobacco products'' to Sec.
1140.1(a) and (b) to ensure the products are subject to select existing
restrictions and access provisions. We also have added language to
Sec.  1140.1(a) to clarify the scope of Sec.  1140.16(d).

B. Section 1140.2--Purpose

    This final rule adds ``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 restrictions in place for cigarettes and smokeless tobacco.
Therefore, the final rule states that retailers of the newly deemed
covered tobacco products may not sell them to individuals under 18
years of age and requires retailers of covered tobacco products to
verify the purchaser's birth date by reviewing the individual's
photographic identification. However, as noted in Sec.
1140.14(b)(2)(ii), a retailer is not required to verify the age of any
person who is more than 26 years of age. In addition, Sec.
1140.14(b)(3) prohibits the sale of covered tobacco products using an
electronic or mechanical device such as a vending machine, unless it is
located in a facility where the retailer ensures that no person younger
than 18 years of age is present, or permitted to enter, at any time.
FDA does not intend for section 1140.14(b)(3) to prohibit the sale of
tobacco products via the Internet, but the sale of covered tobacco
products via any medium, including the Internet, must only be to
persons 18 years of age or older. Therefore, any sale of covered
tobacco products over the Internet must comply with the minimum age and
identification requirements in this rule.

C. Section 1140.3--Definitions

    In the NPRM, we sought comments on definitions of the following
terms: Cigar, cigarette, cigarette tobacco, covered tobacco product,
distributor, importer, nicotine, package, point of sale, retailer,
smokeless tobacco, and tobacco product. FDA received many comments
regarding whether e-liquids and components, parts, and accessories are
tobacco products. FDA also received many comments regarding the need to
define components, parts, and accessories, which resulted in the
addition of definitions of ``component or part'' and ``accessory'' in
Sec.  1140.3. The discussion of this language in included in section
VI.A. Further, we revised the definition of ``package'' to refer to
``package or packaging.'' We also added a definition of ``roll-your-
own'' to provide further clarity to the definition of ``cigarette.''

D. Section 1140.10--General Responsibilities of Manufacturers,
Distributors, and Retailers

    With the selection of Option 1, Sec.  1140.10 now provides that
manufacturers, distributors, importers, and retailers are responsible
for ensuring that the covered tobacco products (in addition to
cigarettes and smokeless tobacco) they manufacture, label, advertise,
package, distribute, import, sell, or otherwise hold for sale comply
with all applicable requirements in part 1140. The revisions to
Sec. Sec.  1140.10 and 1140.14 clarify that the minimum age and
identification requirements and vending machine restrictions apply to
the newly deemed covered tobacco products.
    Previously, Sec.  1140.10 stated that each manufacturer,
distributor, importer, and retailer is responsible for ensuring that
its products comply with all applicable requirements under part 1140.
FDA proposed to add ``and covered tobacco products'' to the existing
language of this section to clarify that the provision also applies to
``covered tobacco products'' as defined in Sec.  1140.3. In addition,
FDA proposed that Sec.  1140.10 cover importers, because 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. FDA is finalizing this section as drafted in the
NPRM.

E. Section 1140.14--Additional Responsibilities of Retailers

    FDA proposed to divide this section into responsibilities for
retailers of cigarettes and smokeless tobacco products and
responsibilities for retailers of covered tobacco products. FDA is
finalizing this section as drafted in the NPRM. Therefore, upon the
effective date of this final rule, Sec.  1140.14(a)(1) through (a)(5)