liquids, even though the comments stated that most consumers are not
adept at handling or mixing chemicals. These ``do-it-yourself
manufacturers,'' as the comments referred to them, would increase
health risks, because more individuals possessing pure nicotine could
lead to more accidental poisonings and the possibility of overdoses.
Comments pointed to a survey from an e-cigarette forum which stated
that ``[a]bout 79 percent of respondents said they would 'look to the
black market' if products they use 'were banned tomorrow,' while 14
percent said they would return to smoking analog cigarettes'' (e.g.,
Ref. 44).
    Comments also expressed concern that regulation will increase
prices of the newly deemed tobacco products and consumers will turn to
an illicit market to obtain products for lower prices. For example,
they stated that some markets for cigarettes (e.g., New York)
experience smuggling rates of beyond 50 percent, as consumers seek
products for lower costs. These comments expected a similar result to
occur after the deeming rule becomes effective (see Ref. 45).
    Further, they stated that this illicit market would cause
additional problems like stifling innovation for regulated companies,
because companies operating in the illicit market would not be
complying with costly regulations and would be able to take advantage
of innovations elsewhere in the world. They theorized that this illicit
market would favor very small domestic producers over existing medium-
sized domestic manufacturers with better quality control and safety
mechanisms.
    In addition to concerns about e-cigarettes, comments expressed
concerns about the potential for illicit markets for other newly deemed
products. For example, they stated that a final deeming regulation
(without an exemption for premium cigars) would exacerbate the black
market that already exists for premium Cuban cigars. The comments also
noted that those involved in the waterpipe tobacco industry already
operate more informally (e.g., without local regulation) and,
therefore, the deeming regulation would cause more business to be
transacted in illicit markets. They also expressed concern about the
development of a flourishing illicit market if flavors were not
permitted in the deemed products.
    (Response) FDA understands these concerns, but believes that this
rule will not increase current illicit practices or create new illicit
markets, because FDA is not banning any tobacco product with this
deeming rule. Even if some illicit trade were to develop in an attempt
to evade the requirements of this rule, FDA does not believe it would
result in a volume sufficient to outweigh the public health benefits of
the rule. FDA authority over the newly deemed tobacco products will
give it means to determine which products are legally on the market and
which are counterfeit or otherwise illegally marketed. The Tobacco
Control Act gives the Agency these and other authorities, such as
section 920 of the FD&C Act (21 U.S.C. 387t), to help address illicit
tobacco products.
    In addition, FDA recently commissioned a report from the National
Research Council and Institute of Medicine Panel to help us better
understand and consider all aspects of illicit tobacco markets (Ref.
46). This report focused mainly on combustible products, especially
cigarettes, as they are the subject of most illicit tobacco trade. The
relevance of those findings to an assessment of the potential for
illicit trade in tobacco products more generally in the United States,
such as ENDS products, is open to question. Overall, illicit trade in
cigarettes is under 10 percent. It is not clear if illicit trade in any
of the newly deemed products will be greater or less than that observed
for cigarettes. Evidence from Canada shows the development of an
illicit market in ENDS products in that particular context where the
government currently regulates all nicotine-containing electronic
smoking products as medical devices under the Food and Drugs Act,
regardless of the products' health claims.\12\ Canada does, however,
have a legal market for the sale of non-nicotine containing ENDS
products. Despite the fact that Health Canada has not approved any
nicotine-containing ENDS products for sale or importation in the
country a 2015 e-cigarette usage study (Ref. 48) showed usage rates
among Canadian populations that were similar to those among U.S.
populations.
---------------------------------------------------------------------------

    \12\ ENDS and e-liquids that do not contain nicotine can be
legally sold in Canada. Health Canada issued a Notice in 2009
regarding electronic cigarette products that contain nicotine (Ref.
47).
---------------------------------------------------------------------------

    Despite the potential for some illicit ENDS market activity to
occur, FDA emphasizes that the presence of an illicit market does not
affect its legal authority to regulate such products and that there is
evidence that many ENDS manufacturers will likely submit premarket
applications in the United States.
    Moreover, as stated previously, FDA expects that the public health
benefits that likely will accrue as a result of this final rule will be
greater than the negative effects that could result if there were an
increase in illicit markets. This final deeming rule will afford FDA
additional tools to reduce the number of illnesses and premature deaths
associated with tobacco product use. For example, FDA will be able to
obtain critical information regarding the health risks of newly deemed
tobacco products, including information derived from ingredient listing
submissions and reporting of HPHCs required under the FD&C Act. FDA
will also receive information on the location and number of
manufacturing establishments, which will allow the Agency to establish
effective compliance programs. In addition, because of this rule, FDA
will be able to take enforcement action against manufacturers of newly
deemed products who make unsubstantiated MRTP claims or false or
misleading claims about their products, thus allowing for better-
informed consumers and helping to prevent the use of misleading
campaigns targeted to youth populations. It will also prevent from
entering the market new products that are not appropriate for the
protection of public health, are not substantially equivalent to a
valid predicate product, or are not exempt from SE. Finally, the newly
deemed tobacco products may be subject to future regulations that FDA
determines are appropriate.
    FDA believes that this rule will not stifle innovation but could,
instead, encourage it. The greater regulatory certainty created by the
premarket review process may encourage companies to invest in creating
potentially beneficial novel products, with greater confidence that
improved products will not be competing against equally novel, but more
dangerous, products. For example, a company may be more willing to
invest the additional resources needed to ensure that its product is
designed and manufactured with appropriate methods and controls.

The PMTA pathway will incentivize development of tobacco products that
pose less risk to human health by limiting market access by riskier
competitor products. Furthermore, since the ``appropriate for the
protection of the public health'' standard involves comparison to the
general tobacco product market, FDA believes that, over time, the
premarket authorities will move the market toward less risky tobacco
products.

C. Policy for Certain Regulatory Requirements for All Manufacturers of
Newly Deemed Products

    FDA received many comments expressing concern regarding the
regulatory and financial burdens associated with certain automatic
provisions that will apply to newly deemed products once this rule
becomes effective. In response to comments, FDA has considered
instances in which the Agency has implemented compliance policies for
currently regulated products. Accordingly, the Agency is announcing the
following compliance policy with respect to newly deemed products. As
with any such policy, the Agency will review and revise this policy as
appropriate. If FDA were to change this policy, the Agency would
provide notice to affected entities.
1. Substantial Equivalence
    As provided in guidance for currently regulated products
(``Demonstrating the Substantial Equivalence of a New Tobacco Product:
Responses to Frequently Asked Questions (Edition 2)'' (80 FR 53810,
September 8, 2015)), FDA does not intend to enforce against
manufacturers who make tobacco blending changes without a marketing
authorization if the tobacco blending changes are intended to address
the natural variation of tobacco (e.g., due to variation in growing
conditions) in order to maintain a consistent product. However, FDA
does intend to enforce the premarket authorization requirements for
tobacco blending changes that are intended to alter the chemical or
perception properties of the new product (e.g., nicotine level, pH,
smoothness, harshness).
    FDA does not intend to take enforcement action for at least 30
calendar days from the date the not substantially equivalent (NSE)
order issues for those products that are in a retailer's current
inventory at a specific retail location on the date FDA issues the NSE
order. This policy extends only to tobacco products that are already in
a retail store that offers the products for sale directly to adult
consumers.
    FDA has provided guidance (``Demonstrating the Substantial
Equivalence of a New Tobacco Product: Responses to Frequently Asked
Questions (Edition 2)'') on currently regulated tobacco products
stating that a change in supplier, where the new supplier is used for
the same ingredient, additive, component, part, or material, with
identical specifications, would not render a new tobacco product. This
guidance also will apply to newly deemed products.
2. Reporting of HPHCs
    FDA intends to issue 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. 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 guidance is
issued well in advance of that time. At this time, FDA also does not
intend to enforce this requirement in relation to manufacturers of
components and parts used for incorporation into finished tobacco
products. In the future, we intend to evaluate if there are additional
constituents that are present in newly deemed products and should be
included in the HPHC list for reporting. FDA also intends to issue
guidance to further refine the list of reportable HPHCs based on
product class.
3. Tobacco Health Document Submission
    Although section 904(a)(4) sets out an ongoing requirement to
submit tobacco health documents developed after June 22, 2009 (the date
of enactment of the Tobacco Control Act), FDA generally does not intend
to enforce the requirement with respect to all such documents at this
time, so long as a specified set of documents is submitted by the
effective date plus 6 months. FDA intends to publish additional
guidance that specifies the scope of such health documents within three
to six months of the publication date of this final rule, with
sufficient advance time for manufacturers and importers to prepare
their submissions.
    FDA does intend to collect other tobacco health documents developed
after June 22, 2009, but before doing so the Agency will publish
additional guidance specifying the timing of subsequent submissions.
Note that, despite this compliance policy with respect to timeliness of
submissions, manufacturers and importers are still to preserve all
tobacco health documents developed after June 22, 2009, for future
submissions to FDA. Failure to submit tobacco health documents
developed after June 22, 2009, because of a failure to preserve them
after publication of this rule will constitute a violation of section
904(a)(4).
4. Compliance Policy for Components and Parts
    As discussed in section VI.B, at this time FDA does not intend to
enforce certain requirements for components and parts of newly deemed
products that are sold or distributed for further manufacturing into
finished tobacco products.

D. Compliance Policy Regarding Certain Provisions and Small-Scale
Tobacco Product Manufacturers

    In the NPRM, FDA requested comment on the ability of smaller
manufacturers of newly deemed tobacco products to fully comply with the
requirements of the FD&C Act and how FDA might be able to address those
concerns. Considering the comments and FDA's finite enforcement
resources, the Agency's view is that those resources may not be best
used in immediately enforcing the provisions of this rule against
certain manufacturers that are small-scale tobacco product
manufacturers and that fail to comply with certain requirements of the
FD&C Act. Therefore, FDA generally intends to grant small-scale tobacco
manufacturers additional time to respond to SE deficiency letters and
to not bring enforcement action against those small-scale tobacco
product manufacturers who submit ingredient listings within 12 months
of the effective date of this rule, and is granting small-scale tobacco
product manufacturers an additional six-month compliance period for the
tobacco health document submission

requirements. As with any such policy, FDA will review and revise these
policies as appropriate. If FDA were to change these policies, FDA
would do so consistent with its Good Guidance Practices regulations.
    For purposes of this compliance policy, FDA generally considers a
``small-scale tobacco product manufacturer'' to be a manufacturer of
any regulated tobacco product that employs 150 or fewer full-time
equivalent employees and has annual total revenues of $5,000,000 or
less. FDA considers a manufacturer to include each entity that it
controls, is controlled by, or is under common control with. To help
make FDA's individual enforcement decisions more efficient, a
manufacturer may voluntarily submit information regarding all relevant
factors, including information regarding employment and revenues.
Interested manufacturers may contact CTP's call center at 1-877-CTP-
1373 for questions regarding this compliance policy. We note that FDA's
thinking regarding ``small-scale tobacco product manufacturer'' differs
from the definition of ``small tobacco product manufacturer'' in
section 900(16) of the FD&C Act.
    FDA notes that our thinking regarding what a ``small-scale tobacco
product manufacturer'' is for purposes of this policy is designed to
align with the nature of the specific relief provided. That is, the
relief provided (as described throughout this document) relates
generally to requirements for entities to compile or report
information. These activities may require an investment of employee
time and/or financial resources that is more challenging for the
smallest entities to achieve. For these reasons, the threshold takes
note of both employee resources (FTEs) and financial resources (annual
revenues), ensuring that those entities with the most limited human and
financial resources are uniquely considered in FDA's decisions about
enforcement of these provisions, precisely because the provisions may
require resources not as readily available to these entities. Further,
as stated elsewhere in this document, in formulating its thinking, FDA
has considered all available data on employment, revenues, production
volume and other details of operation for current manufacturers of
newly deemed products. In addition, FDA notes that its current approach
reflects a careful review of the potentially unique interests of the
smallest tobacco product manufacturers as considered in light of the
Agency's statutory obligations regarding the protection of public
health.
1. SE Extension Requests (Section 905(j))
    Although information adequate to make submissions should be
available to all manufacturers, we expect small manufacturers to have
more difficulty in putting this information together in an SE Report.
FDA presently intends, for the first 30 months following the effective
date of this rule, to grant extensions to small-scale tobacco product
manufacturers for SE reports that need additional time to respond to SE
deficiency letters. Extensions are not automatically granted. Requests
will be considered on a case-by-case basis. Any extensions granted are
likely to be limited in time--for example, where a manufacturer
normally might have 90 days to respond to a deficiency letter, FDA
will, for small-scale tobacco product manufacturers, grant an
additional 30 days for such a response. FDA encourages all small-scale
tobacco product manufacturers, especially those with limited or no
experience with the SE pathway, to submit SE reports as early as
possible. FDA is not instituting a similar policy for extension
requests related to PMTAs (nor is it providing additional time for
small-scale tobacco product manufacturers to prepare PMTAs) given the
already-extended compliance period for PMTAs, which provides an
additional 6 months to submit a PMTA, discussed in section V.A.
2. Tobacco Health Document Submissions (Section 904(a)(4))
    To address concerns of small-scale tobacco product manufacturers
regarding the submission of certain health documents, and in
recognition of FDA's current enforcement priorities, FDA, for an
additional 6 months following the end of the generally applicable
compliance period, intends not to bring enforcement action against
those small-scale tobacco product manufacturers who submit the required
information.
3. Ingredient Listing Submissions (Section 904(a)(1))
    FDA understands concerns that small-scale tobacco product
manufacturers may need additional time to comply with section
904(a)(1)'s requirement that manufacturers submit ingredient lists. FDA
presently intends not to bring enforcement action against those small-
scale tobacco product manufacturers who submit section 904(a)(1)'s
required information within 12 months of the effective date of this
final rule.
4. Assistance With Marketing Applications
    As with manufacturers in general, these small-scale tobacco
manufacturers will also benefit from additional assistance with their
marketing applications, including the designation of a Regulatory
Health Project Manager so that they have a single point of contact in
CTP's OS for questions about their marketing applications. They will
also have access to an appeals process in the event that FDA denies
their marketing applications (of which one small business has already
taken advantage). Staff from CTP's OCE also will assist small-scale
tobacco product manufacturers with identifying the types of documents
that may be used to establish that their predicate products were on the
market on February 15, 2007. This may include several calls or
correspondence with the manufacturer as it submits different documents
to the Agency.
5. Assistance in Navigating Other Regulatory Requirements
    CTP's OCE will continue to assist small-scale tobacco product
manufacturers in submitting rotational warning plans for FDA approval.
These plans provide the firm's plan for how the required warnings will
be displayed on the packaging and advertising for their product, as
required by 21 CFR 1143.5. This may include several calls or
correspondence with the small business as it seeks approval from the
Agency.
    CTP also has a system to assist small businesses in navigating the
regulatory requirements of FDA. For example, the Center has a Call
Center that triages all calls received from regulated industry. The
Center's Office of Small Business responds to hundreds of calls, emails
and correspondences from small businesses every year to assist them in
answering their specific questions on how to comply with the law.

V. Premarket Review Requirements and Compliance Policy

    Section 910 of the FD&C Act requires FDA authorization in order to
market a new tobacco product. As described elsewhere, the FD&C Act
contains three pathways for obtaining premarket authorization: SE
exemptions, SE reports, and PMTAs.
    Tobacco products that were on the market on February 15, 2007, are
grandfathered and do not require premarket authorization. However, as
described throughout this preamble, these products are subject to the
other requirements of the statute.

A. Compliance Policy for Premarket Review Requirements

    In the NPRM, FDA contemplated a compliance period of 24 months
following the effective date for submitting a premarket application (SE
exemption request, SE report, or PMTA), with a continued compliance
period pending review of those applications (79 FR 23142 at 23144). In
essence, the products would remain on the market during this indefinite
compliance period until the agency rendered a decision on an
application or the application was withdrawn.
    Agency compliance/enforcement policies are not subject to the
requirements that govern notice-and-comment rulemaking. Prof'ls &
Patients for Customized Care v. Shalala, 56 F.3d 592 (5th Cir. 1995) (a
compliance policy guide is not a substantive rule and not subject to
APA's notice-and-comment rulemaking); Takhar v. Kessler, 76 F.3d 995,
1002 (9th Cir. 1996) (FDA compliance policy guides were not required to
go through notice-and-comment procedures). But because the relevant
time periods are of obvious interest, FDA laid out its anticipated
compliance policy in the NPRM, and for similar reasons, is announcing
its revised compliance policy here in the preamble to the final rule,
rather than in a separate guidance document.
    FDA has considered the comments and data submitted in response to
the compliance policy in the NPRM. Some comments expressed concern
about the extended availability of newly deemed, new tobacco products
without scientific review. Others provided additional data regarding
youth and young adult use of flavored tobacco products. In addition,
others comments discussed the potential public health benefits from the
availability of certain flavored newly deemed products (as discussed in
section VIII.F). Taking the diverse comments on these issues, as well
as the uncertainty regarding the positive or negative impact on public
health from products like ENDS, into account, FDA has decided to
implement the compliance policy with staggered initial compliance
periods based on the expected complexity of the applications, followed
by continued compliance periods for FDA review, such that our
enforcement discretion will end twelve months after each initial
compliance period. Under the policy described here for the staggered
compliance periods, and while FDA is conducting its review of marketing
applications during the continued compliance period, the Agency does
not intend to take enforcement action against products remaining on the
market for failure to have a premarket authorization order.
    The compliance periods are staggered to improve efficiency for both
FDA and regulated entities given that the time it takes to prepare
premarket applications is dependent upon the type of application and
complexity of the product. FDA intends to act as expeditiously as
possible with respect to all new applications, while ensuring that
statutory standards are met. Further, if at the time of the conclusion
of the continued compliance period, the applicant has provided the
needed information and review of a pending marketing application has
made substantial progress toward completion, FDA may consider, on a
case-by-case basis, whether to defer enforcement of the premarket
authorization requirements for a reasonable time period.
    FDA's revised compliance policy for premarket review aims to
balance the public health concerns raised in the comments, allow the
Agency to more efficiently manage the flow of incoming applications,
and encourage high-quality premarket submissions from applicants.
    In accordance with the Tobacco Control Act (sections 905 and 910 of
the FD&C Act), a new tobacco product may be legally marketed only if
FDA has authorized its marketing under one of the three premarket
pathways described throughout this document. As a result of the
compliance policy being announced, we expect that manufacturers of
certain newly deemed, new tobacco products will continue to market
their products without FDA authorization for certain time periods.
1. FDA's Revised Compliance Policy Is Informed by Comments Submitted in
Response to the NPRM
    FDA received many comments responding to its detailed requests for
comment on possible compliance approaches. 79 FR at 23175-77. Some
comments expressed concern that the compliance policy for premarket
review described in the NPRM would permit the continued marketing of
tobacco products that have not been reviewed under the public health
standards of the Tobacco Control Act. For example, comments jointly
submitted by 24 health and medical organizations stated that the
contemplated 24-month compliance period and indefinite period of
continued marketing during FDA's review included in the NPRM would
prolong the public's exposure to products that contain nicotine, a
highly addictive substance, and that do not meet the statutory standard
for the grant of a marketing order (Comment No. FDA-2014-N-0189-
79772.).
    They also stated that this approach would allow manufacturers to
continue to market the newly deemed products in ways that appeal to
youth and to manipulate the content of these products in uncontrolled
ways for an indefinite period (id.). They urged FDA to forego its
contemplated compliance policy unless proper precautions are taken to
limit the time period these products are allowed to remain on the
market pending FDA review and authorization. In addition, they
expressed concern that manufacturers, knowing that submission of an
application will permit them to market products for years, have
incentive to submit numerous applications (regardless of how incomplete
or deficient the applications).
    A network of tobacco control policy and legal specialists also
expressed concern regarding the effect of continued marketing of new
tobacco products that have not been reviewed under the applicable
public health standards of the Tobacco Control Act (Comment No. FDA-
2014-N-0189-81044). This organization noted the thousands of
provisional SE reports submitted in the last five days before the
statutory deadline, where such applications pending FDA review are
``being used as placeholders that will allow the tobacco industry to
continue to introduce new products at will, rather than following the
proper legal procedures established by the Tobacco Control Act.'' They
proposed a staggered timeline to submit applications under the three
marketing pathways and a definite time period in which FDA would no
longer exercise enforcement discretion with respect to premarket review
of these products, noting that such an approach would incentivize
industry to generate high-quality, complete applications within the
initial compliance period.
    In addition, two large organizations dedicated to the health of
youth and young adults urged FDA not to implement a compliance period
of any length for products sold in characterizing flavors other than
tobacco or any covered tobacco products that use marketing practices
known to appeal to children and youth (Comment No. FDA-2014-N-0189-
67268; Comment No. FDA-2014-N-0189-79413.). Ranking minority members of
the Energy and Commerce Committee, Health Subcommittee, and Oversight
and Investigations Subcommittee, U.S. House of Representatives also
called for a more protective compliance period than the one
contemplated in the

NPRM, arguing that the proposed compliance period ``puts the nation's
youth at risk'' (Comment No. FDA-2014-N-0189-80119). These comments,
among others, all stressed the attractiveness of these newly deemed
tobacco products to youth and young adults and the need for a more
restrictive compliance policy to ensure that FDA limits the continued
marketing of new tobacco products that have not been reviewed under the
public health standards of the Tobacco Control Act.
    Further, in response to FDA's requests for comments and data in the
NPRM, numerous comments included data, research, and personal stories
regarding the impact of candy and fruit flavors in tobacco products,
including their appeal to youth and young adults, youth perceptions of
flavored tobacco products, and their potential effect on transition
from combusted tobacco product use (particularly, comments noted, in
the case of adults using flavored ENDS to attempt to switch completely
away from cigarette smoking). In addition, many comments urged FDA to
take immediate action regarding flavored tobacco products as a result
of increasing prevalence of flavored product use, and new data show
continued growth in youth and young adult usage of flavored tobacco
products.
    In deciding upon a compliance policy to announce with this final
rule, FDA considered all these comments and sought to balance the
Agency's concern about the continued marketing of new tobacco products
that have not been reviewed by FDA, the potential harmful impact of
flavored tobacco products on youth, and the possibility that some of
those products are playing a role in helping some tobacco users
transition away from what is likely the most harmful form of nicotine
delivery for an individual user, combusted tobacco products. FDA
considered adopting the compliance policy as described in the preamble
to the NPRM or a compliance policy that would provide different
compliance periods for flavored and non-flavored tobacco products. FDA
also considered providing different compliance periods for different
product categories. For example, certain industry comments urged FDA to
stagger compliance dates for different product categories, to delay
compliance until FDA publishes a final guidance for each product
category and to provide ENDS manufacturers a lengthier compliance
period based on where they purport to fit within the risk continuum for
nicotine-delivering products (e.g., Comment No. FDA-2014-N-0189-81859;
Comment No. FDA-2014-N-0189-10852).
    In response to these comments, we note that nicotine use in any
form is of particular concern for youth and pregnant women. On the
other hand, some evidence suggests that ENDS may potentially promote
transition away from combusted tobacco use among some current users and
it is possible that there could be a public health benefit. See also
section III.F for additional discussion of premarket pathways and the
continuum of nicotine-delivering products. Based on currently available
scientific evidence, this revised compliance policy strikes an
appropriate balance among various, often competing, considerations.
2. FDA Is Announcing a Revised Compliance Policy With Staggered
Timeframes and Continued Compliance Periods
    In the interest of public health and taking into account the fact
that there are products already on the market that will now be subject
to premarket review, and in light of the considerations discussed in
section 1 above, we have established the following compliance policy
for newly deemed tobacco products. For those newly deemed products that
were on the market on the effective date of this final rule, but that
were not on the market on February 15, 2007, FDA is providing two
compliance periods: One for submission and FDA receipt of applications
and one for obtaining premarket authorization. Although such products
are subject to the premarket review requirements of the FD&C Act, FDA
does not intend to initiate enforcement action for failure to have
premarket authorization during the respective compliance periods.
    The compliance period for submission and FDA receipt of
applications for newly deemed tobacco products under the three
premarket pathways is as follows:

    SE Exemption Requests--12 months from the effective date of this
final rule
    SE Reports--18 months from the effective date of this final rule
    PMTAs--24 months from the effective date of this final rule

    FDA is adopting the staggered timelines in this policy to account
for the possibility that applicants may need additional time to gather
information for certain premarket submissions that may require
additional data. For example, if a manufacturer plans to submit an SE
Exemption Request, the firm may only need to identify the product,
provide certification statements, and gather scientific information on
the additive change itself and any supporting information demonstrating
that the change to the product is minor and an SE Report is not
necessary. This is less information than that likely required for a
PMTA. We expect this policy will also create a more manageable flow of
premarket applications for newly deemed products. FDA expects that this
staggering of deadlines also will benefit regulated industry, since it
will allow for greater efficiency of FDA review and incentivize higher
quality applications, which will reduce review times for all products.
New products for which no application has been submitted by 24 months
from the effective date of this rule will no longer be subject to this
compliance policy and will be subject to enforcement.
    Unless FDA has issued an order denying or refusing to accept the
submission, products for which timely premarket submissions have been
submitted will be subject to a continued compliance period for 12
months after the initial compliance period described previously. For
such products, FDA does not intend to initiate enforcement for failure
to have premarket authorization during this continued compliance
period, which is as follows:
    SE Exemption Requests--24 months from the effective date of this
final rule (12 months after the compliance period for submission of
such requests)
    SE Reports--30 months from the effective date of this final rule
(12 months after the compliance period for submission of such reports)
    PMTAs--36 months from the effective date of this final rule (12
months after the compliance period for submission of such
requests).\13\
---------------------------------------------------------------------------

    \13\ In addition, we note that any new tobacco product that was
not on the market on the effective date of the rule (i.e., 90 days
after the publication date) is not covered by this compliance policy
and will be subject to enforcement if marketed without authorization
after the effective date.
---------------------------------------------------------------------------

    Once the continued compliance period ends, new tobacco products on
the market without authorization will be subject to enforcement. FDA
will act as expeditiously as possible with respect to all new
applications, while ensuring that statutory standards are met. FDA
expects that this revised compliance policy will encourage the
submission of high quality applications. By providing a date in which
the continued compliance period ends, manufacturers will have an
incentive to submit a complete application and respond substantively
and expeditiously to questions raised during the review process instead
of an incomplete or deficient application just to stay on the market
indefinitely. This staggered

compliance policy also will provide FDA with a more manageable flow of
incoming applications to be reviewed, allowing the agency to more
quickly make decisions on applications.
    FDA believes the staggered compliance periods will be sufficient
for manufacturers to provide high quality applications. To help provide
clarity regarding submission requirements for marketing applications,
FDA has issued several guidance documents, and is finalizing other
guidance documents, regarding the evidence needed for SE reports,
including FDA draft guidance entitled ``Substantial Equivalence
Reports: Manufacturer Requests for Extensions or to Change the
Predicate Tobacco Product'' (79 FR 41292, July 15, 2014), and FDA
guidance entitled ``Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007,''
among others. FDA also has issued a draft guidance entitled
``Applications for Premarket Review of New Tobacco Products'' (76 FR
60055, September 28, 2011). In addition, elsewhere in this issue of the
Federal Register, FDA has made available draft guidance, which when
final will describe FDA's current thinking on some appropriate means of
addressing the premarket authorization requirements for newly deemed
ENDS products. If FDA determines that additional guidance is necessary
to help manufacturers prepare marketing applications, FDA will issue
additional guidance and publish a notice of availability in the Federal
Register.
    Further, if at the time of the conclusion of the continued
compliance period, the applicant has provided the needed information
and review of a pending marketing application has made substantial
progress toward completion, FDA may consider, on a case-by-case basis,
whether to defer enforcement of the premarket authorization
requirements for a reasonable time period.

B. Responses to Comments Regarding Compliance Periods for Premarket
Review Requirements

    (Comment 60) FDA received many comments suggesting that we change
the proposed compliance period for submitting marketing applications.
Some comments suggested that the compliance period should be 24 months
from the date FDA either announces its intent to no longer exercise
enforcement discretion regarding premarket requirements or issues
product-specific guidance on the preparation of PMTAs and the
submission of HPHC testing results. They suggested that the issuance of
the guidance documents be based upon the continuum of risk presented by
nicotine-delivering products. Other comments suggested that we extend
the PMTA compliance period to 5 years following the effective date of
the final rule to give manufacturers sufficient time to complete the
required testing.
    (Response) FDA has already published for public comment draft
guidance for industry regarding the submission of PMTAs, which when
final will represent FDA's current thinking on this topic. In addition,
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. FDA is
committed to helping industry better understand the tobacco product
premarket review process and will continue to hold public Webinars and
meetings with industry. FDA has also published guidance on meetings
with industry, and FDA has had many productive meetings to address
companies' specific questions on the development of tobacco products.
As FDA reviews product applications for currently regulated and newly
deemed categories of products, we intend to identify topics for which
rulemaking or more product specific guidance is appropriate.
    Moreover, along with finalizing this rule, FDA is setting forth an
initial 2-year compliance period for the submission of a PMTA for newly
deemed, new tobacco products, followed by a continued compliance period
of up to 12 months for FDA to review the application. FDA believes that
this will give sufficient time for manufacturers of such products to
prepare high quality applications, and for FDA to review new
applications as expeditiously as possible, while ensuring that the
statutory standards are met. FDA's compliance policy is further
described in section V.A of.
    (Comment 61) Comments were split as to whether the NPRM's
contemplated premarket review compliance timeframes (i.e., 24 months
for manufacturers to submit and for FDA to receive a marketing
application) should apply to manufacturers of newly deemed products.
While many industry comments sought additional time to comply with
these requirements, many other comments suggested that the reason
Congress delayed application of certain requirements to the currently
regulated products (e.g., cigarettes and smokeless tobacco) was to
account for the creation, staffing, and training for a new FDA center.
In addition, they stated that manufacturers of the newly deemed
products cannot argue that they did not have adequate notice that they
would need to comply with premarket requirements given that the Unified
Agenda entry for the deeming proposal published on July 7, 2011, and
was continually updated in subsequent Unified Agenda entries. They
argued that establishing similar timeframes for the newly deemed
products only benefits industry and is detrimental to the public
health.
    (Response) FDA has considered these comments and concludes that the
staggered compliance periods included with this final rule are
sufficient to allow manufacturers of previously unregulated tobacco
products to submit applications without unduly delaying compliance. As
stated elsewhere in this document, FDA has taken several steps to
provide helpful feedback to industry to encourage more complete,
streamlined submissions and reviews, including: (1) Encouraging
teleconferences between the assigned regulatory health project manager
and the applicant; (2) streamlining the SE report review process by
modifying the preliminary review so that it focuses only on
administrative issues and allowing submission deficiencies to be
communicated to the applicant more quickly; (3) providing information
on FDA's Web site about the three pathways available to market products
(including SE) and developing public Webinars to explain the Agency's
processes; and (4) publishing guidance documents. FDA intends to act as
expeditiously as possible with respect to all new applications,
ensuring that statutory standards are met.
    (Comment 62) One comment suggested FDA allow for submission of a
confidential e-cigarette product report in order to satisfy premarket
review requirements. Similarly, another comment encouraged FDA to
establish a ``Tobacco Product Master File'' (TPMF) system similar to
the Agency's Drug Master File (DMF) and Food Additive Master File
(FAMF) systems to allow for e-cigarette/personal vaporizer and e-liquid
suppliers to submit confidential product information (including
information on formulations, facilities, processes, and articles used
in the manufacturing, processing, packaging, and storing of ingredients
used).
    (Response) FDA does allow for the submission and use of information
to be incorporated by reference similar to master file programs for
other FDA-regulated products. In addition, elsewhere in this issue of
the Federal Register, FDA has made available a final guidance to
provide information on how

to establish and reference a TPMF. TPMFs are expected to 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.
    Such a system would be especially helpful in the area of newly
deemed tobacco products. 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 note that, at
present, FDA understands that, based on publically available
information, 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 nature of the
marketplace, FDA expects that the master file system will be widely
appealing and widely utilized by the ENDS industry.
    (Comment 63) At least one comment stated that FDA should prioritize
review of applications for products currently on the market over those
seeking to enter the market and that FDA should establish clear review
deadlines. Another comment suggested that priority should be given to
those products whose marketing is unlikely to be seen by youth or is
limited to existing adult users of the product.
    (Response) During the initial implementation of the Tobacco Control
Act, FDA received a large number of applications for currently marketed
tobacco products. For these provisional products being reviewed through
the SE pathway, in order to appropriately prioritize review, FDA
performed a public health impact evaluation of the product's potential
to raise different questions of public health. Currently marketed
products with the highest potential to raise different questions of
public health were placed in the tier to be reviewed first. If
appropriate, FDA may consider using a prioritization method for newly
deemed products.
    FDA understands the value of establishing timelines for review of
applications. For products not on the market on the effective date, FDA
intends to establish review performance goals in the future as it did
with currently regulated products.
    (Comment 64) Some comments suggested that FDA continue to employ
measures to ensure that completed SE reports and PMTAs are submitted as
expeditiously as possible during the compliance period. They noted that
FDA currently employs a ``refuse-to-accept'' policy for SE applications
that allows FDA to make a threshold determination as to whether an SE
application is sufficiently complete for the Agency to review. They
stated that this policy will help to ensure that manufacturers of the
newly deemed products do not try to unduly extend the time that
products are marketed without FDA review of their applications.
    (Response) FDA agrees. FDA plans to take all reasonable measures to
ensure that applications are reviewed in a timely manner. FDA intends
to continue employing its ``refuse-to-accept'' policy for SE Reports
and other marketing applications (including SE Exemption Requests and
PMTAs).
    (Comment 65) Many comments suggested that FDA should develop a
product category specific framework for submission of PMTAs in light of
the large number of products for which PMTAs will be required, the size
and cost of PMTAs, and FDA's available resources. The comments
suggested that the compliance period should be based on the date FDA
issues a category specific guidance document. The comments stated that,
without category specific guidance, the PMTA process will effectively
eliminate certain tobacco product categories, including the premium
cigar industry. These comments asserted that it was Congress' intent to
treat categories of tobacco products differently, as shown by the
provisions banning flavored cigarettes, providing special
considerations regarding menthol, establishing MRTP provisions, and
creating baseline standards under sections 910 and 907.
    (Response) As stated previously, the statute specifies the
premarket pathways for tobacco products. Congress subjected all new
tobacco products to the same premarket review requirements in sections
905 and 910. FDA has taken many steps to reduce and prevent backlogs of
marketing applications pending FDA review and intends to act as
expeditiously as possible with respect to all new applications, while
ensuring that statutory standards are met. 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. FDA may issue additional category specific
guidance as appropriate. FDA is committed to helping industry better
understand the tobacco product premarket review process and will
continue to hold public Webinars and meetings with industry. In the
category of cigars, and for premium cigars in particular, we expect
that some products will remain on the market due to their status as
grandfathered products, and that others will be able to make use of the
SE pathway.
    (Comment 66) While many comments stated that they needed additional
time to comply with premarketing requirements, many other comments
stated that the contemplated 2-year compliance period was too long. For
example, comments jointly submitted by 24 health and medical
organizations stating that the contemplated 24-month compliance period
included in the NPRM would prolong the public's exposure to products
that contain nicotine, a highly addictive substance, and that, in their
view, do not meet the statutory standard for the grant of a marketing
order (Comment No. FDA-2014-N-0189-79772.). They stated that it would
allow manufacturers to continue to market the newly deemed products in
ways that appeal to youth and to manipulate the content of these
products in uncontrolled ways for an indefinite period (id.). These
comments also argued that a 2-year compliance period will result in
large numbers of adolescents experimenting with newly deemed products
and becoming established e-cigarette users or users of other tobacco
products. Some suggested that FDA reduce the compliance period to 6
months or 12 months and others suggested different compliance periods
for SE reports, SE exemption requests, and PMTAs. One comment stated
that FDA's burden estimates show that the PMTA process should take 18
months, so the compliance period should not extend beyond 18 months.
Alternatively, other comments stated that there should not be any
compliance period for products because the PMTA process was created to
provide a higher scrutiny of review for new products with unknown
health risks and a compliance period is contrary to this purpose. They
also stated that a compliance period would allow the industry to flood
the market place with products and manufacturers would not have an
incentive to quickly develop high-quality applications. In addition,
some comments suggested that FDA should not provide a compliance period
for combusted products, such as pipe tobacco or cigars, because there
is no parallel provision in the current statute for such products.
    Some comments also suggested that manufacturers that sell flavored
tobacco products or that market tobacco

products to children should not be afforded any compliance period to
satisfy the premarket review requirements of the FD&C Act (79 FR at
23176). For example, two large organizations dedicated to the health of
youth and young adults urged FDA not to grant a compliance period of
any length for products sold in characterizing flavors other than
tobacco or any covered tobacco products that use marketing practices
known to appeal to children and youth (Comment No. FDA-2014-N-0189-
67268; Comment No. FDA-2014-N-0189-79413.).
    Many comments also stated that manufacturers should not be able to
avail themselves of the compliance period unless they agree to restrict
their marketing to adults. However, some comments expressed concern as
to how such a restriction could be administered in accordance with the
First Amendment. In addition, Ranking minority members of the Energy
and Commerce Committee, Health Subcommittee, and Oversight and
Investigations Subcommittee, U.S. House of Representatives called for a
more protective compliance period than the one contemplated in the
NPRM, arguing that a 24-month compliance period ``puts the nation's
youth at risk'' (Comment No. FDA-2014-N-0189-80119).
    (Response) Once this rule takes effect, it will be illegal to sell
these tobacco products to anyone under the age of 18. This final
deeming rule is foundational, affording FDA with the authority to issue
other regulations restricting sales and distribution, including
advertising and promotion, under section 906(d).
    FDA struck a balance by revising the initial compliance period for
SE exemption requests and SE reports to 12 and 18 months, respectively,
and is setting forth a 2-year compliance period for manufacturers of
newly deemed, new tobacco products to submit (and FDA to receive) a
PMTA. FDA believes that these time periods are sufficient for
manufacturers to prepare high quality applications addressing the
requirements in the statute.
    FDA has given extensive consideration to having different
compliance periods for flavored and non-flavored products. There is
some evidence suggesting that flavored products pose a greater public-
health risk than non-flavored products. FDA understands that the appeal
of flavors and use of flavored tobacco products have an important role
in the initiation and continued use of tobacco products, and in the
health risks associated with use of these products. Many comments and
studies provided data and information regarding youth and young adult
use of flavored tobacco products in recent years. (E.g., Refs. 49, 50,
51, 52, 53, 54, 55, 56). And flavors appear to encourage greater use.
(E.g., Ref. 57; Refs. 58, 59). The availability of appealing flavors is
a commonly cited reason for use of non-combusted products among young
tobacco users. (E.g., Refs. 60, 61)
    However, several considerations weigh against a shorter compliance
period for flavored products. There are potential countervailing health
concerns. At least some flavored combusted products (which are of
particular concern because they are known to present similar risks to
cigarettes and are youth appealing) are likely to be ``grandfathered''
and, therefore, would remain on the market regardless of the compliance
period or enforcement policy for newly deemed, noncombusted flavored
products. And, in any event, comments suggested that the availability
of flavors in non-combusted tobacco products, such as ENDS, are
appealing to current smokers of combusted products and may entice
smokers to consider switching to e-cigarettes. (e.g., Comment No. FDA-
2014-N-0189-75088; Comment No. FDA-2014-N-0189-79096). And FDA is aware
of emerging self-reports from current and former cigarette smokers
supporting this claim. (See Refs. 62, 63.) Section VIII.F below
discusses the preliminary evidence available to date regarding
effectiveness of ENDS to help smokers transition from, or reduce their
consumption of, combusted tobacco products. But at least some think
that flavor variety is very important. (See, e.g., Ref. 63). More
research, especially longitudinal research, is needed to understand how
flavoring impacts tobacco use over time (Ref. 64).
    Finally, as with other tobacco products that will be regulated
under this rule, FDA is cognizant of the transition that will be
required for regulated entities. Several comments expressed concern
that even the proposed 24-month compliance period was not sufficient to
submit complete applications for all of their products. For example,
one comment noted that most of the e-cigarette market ``are small and
medium-sized businesses owned and operated by individuals and families
[and] most, if not all of these smaller enterprises lack the resources
to tackle such a high administrative burden'' associated with
submitting multiple PMTAs within the time period (Comment No. FDA-2014-
N-0189-80496). Several comments also expressed concern that the 24-
month proposed compliance period would benefit larger companies with
more resources to complete product applications at the expense of small
and mid-size companies (e.g., Comment No. FDA-2014-N-0189-76162). FDA
notes that a shorter period would have an even greater impact on these
businesses.
    In light of these considerations, FDA believes that a two-year
compliance period for flavored products, as with other tobacco
products, represents the exercise of its enforcement discretion in a
way that strikes an appropriate balance between providing industry time
to transition and protecting the public health. Over time, FDA expects
to see additional data on the role of certain flavored products in
supporting reduction in or abstinence from the use of combusted
products, as well as further data on the role of flavored products in
youth initiation, use, and dual use. Such data will help inform FDA's
regulation of, and product standards for, these and other tobacco
products.
    In developing this compliance period, FDA balanced three important
public health considerations: Concern about the extended availability
of newly deemed, new tobacco products without scientific review;
concern about flavored products' youth appeal; and preliminary data
that some individuals may potentially use such products to transition
away from combusted tobacco use. Taking these factors into account, and
based on currently available scientific evidence, FDA determined that
the compliance periods described in Section V.A. strikes an appropriate
balance to protect public health. FDA is establishing staggered
compliance periods based on the expected complexity of the applications
and continued compliance periods for FDA review such that our exercise
of enforcement discretion will end twelve months after each initial
compliance period. In addition, FDA is announcing that it intends in
the future to issue a proposed product standard that would, if
finalized, eliminate characterizing flavors in all cigars including
cigarillos and little cigars.
    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. FDA
recognizes that flavored e-liquids are especially attractive to youth
and young adults. Attractiveness to youth and young adults is an
important factor in evaluating whether the marketing of a product is

appropriate for the protection of the public health. Manufacturers
should provide information on possible toxicity, addictiveness, and
appeal of flavored tobacco products with their premarket review
applications.

VI. Components, Parts, and Accessories

    In the preamble to the NPRM, we asked for comments, including
supporting facts, research, and other evidence, regarding FDA's
proposal to include components and parts of the newly deemed products
(but not accessories) under the scope of this rule. We also asked for
comments as to whether FDA should define components and parts of
tobacco products and how those items might be distinguished from
accessories (79 FR 23142 at 23152 and 23153). After reviewing the
comments, FDA is finalizing this rule to include components and parts
of the newly deemed products (but excluding accessories of such
products) within the scope of this rule. FDA is also explaining its
current compliance policy with respect to components and parts and
certain requirements that will become effective with this deeming rule.

A. Definitions

    In response to comments, FDA is including definitions of
``accessory'' and ``component or part'' in parts 1100, 1140, and 1143.
As stated in this final rule, an ``accessory'' means any product that
is intended or reasonably expected to be used with or for the human
consumption of a tobacco product; does not contain tobacco and is not
made or derived from tobacco; and meets either of the following:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product, or
    (2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product but (i) solely controls moisture and/or temperature of a stored
product; or (ii) solely provides an external heat source to initiate
but not maintain combustion of a tobacco product.
    FDA has structured paragraph (2)(ii) to ensure that coils and
charcoal are not encompassed by the definition of ``accessory.''
    ``Composition,'' as used in this definition, means the manner in
which the materials, including, for example, ingredients, additives,
and biological organisms, are arranged and integrated. Examples of
accessories are ashtrays, spittoons, hookah tongs, cigar clips and
stands, and pipe pouches, because they do not contain tobacco and are
not derived from tobacco and do not affect or alter the performance,
composition, constituents, or characteristics of a tobacco product.
Accessory examples also include humidors that solely control the
moisture and/or temperature of a stored product and a burner that
solely provides an external heat source to initiate but not maintain
combustion of a tobacco product. As stated in the NPRM, accessories of
newly deemed products are not deemed with this final rule.
    In addition, FDA is defining ``component or part'' to mean any
software or 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. The definition excludes
anything that is an accessory of a tobacco product.
    We note that the term ``material'' means an assembly of
ingredients, including additives. Materials are assembled to form
components and parts. For example, material could be considered the
glue or paper pulp for a cigarette where the paper pulp includes
multiple ingredients (e.g., multiple types of tobacco, water, and
flavors) assembled into the paper (or pulp depending on the water
content). A material could be considered the plastic in the mouthpiece
of an ENDS containing multiple ingredients and additives assembled
together to create a product.
    In determining whether software or an assembly of materials might
be ``intended or reasonably expected'' to alter or affect the tobacco
product's performance, composition, constituents, or characteristics or
to be used with or for the human consumption of a tobacco product (and,
therefore, whether it is a component or part), FDA is not bound by the
manufacturer or distributor's subjective claims of intent. Rather, FDA
can consider the totality of the circumstances, including direct and
circumstantial objective evidence, which encompasses a variety of
factors such as circumstances surrounding the distribution of the
product or the context in which it is sold (see, e.g., 21 CFR 201.128
(drugs), 21 CFR 801.4 (devices); see also U.S. v. Travia, 180 F.Supp.2d
115, 119 (D.D.C. 2001)) and sales data.
    Some examples of materials intended or reasonably expected to be
used with or for the human consumption of a tobacco product are:
     Atomizers and cartomizers used with ENDS;
     water filtration base additives (including those which are
flavored) used with waterpipe tobacco; and
     pouches or flavorings used with any of the newly deemed
products (whether or not the pouch or flavoring contains nicotine or
tobacco).
    Some examples of materials intended or reasonably expected to alter
or affect the tobacco product's performance, composition, constituents,
or characteristics are:
     The cellophane wrapping or plastic tube for a single
cigar;
     a plastic bag or tin holding loose pipe tobacco; and
     a glass or plastic vial container of e-liquid.

Although these examples are materials that are generally intended to
prevent unintended changes to the characteristics of the tobacco
product, they are also intended or reasonably expected to alter or
affect the performance, composition, constituents, or characteristics
of a tobacco product. For example, these materials often leach
ingredients into the consumed product. As some comments noted, with
ENDS, there is the potential for substances to leach from the
containing vial into the e-liquid and these leachates may be inhaled
when the e-liquids are used as intended, posing additional health risks
for consumers. They often can also impact the moisture level or shelf
life of a tobacco product (e.g., whether a cigar is in a hard pack or
soft pack, and whether pipe tobacco is in a plastic or metal
container). The moisture level of a tobacco product, and changes to
that moisture level, can, for example, significantly impact consumers'
exposure to nicotine and other constituents. In some cases, menthol or
other ingredients may have been applied to these materials in order to
have them become incorporated into the consumed product.
    FDA recognizes that in some circumstances some assemblies of
materials can operate as both an aspect of the package and a component
or part of the tobacco product. In such situations, the Agency is only
examining a distinct subset of packaging materials that function as a
component or part of a tobacco product by having the potential to alter
or affect the tobacco product's performance, composition, constituents,
or characteristics. Packaging materials that do not alter or affect,
and are not reasonably expected to alter or affect, the tobacco
product's performance, composition, constituents, or characteristics
are not components or parts of a tobacco product. For example,

a glass vial containing an e-liquid is a component or part of the
tobacco product, whereas a hard plastic blister pack in which the glass
vial of e-liquid is distributed and sold to consumers is not.
    FDA intends to seek additional public comment and issue a rule or
guidance to provide further clarification on assemblies of materials
that are a ``component or part'' of a tobacco product because they are
intended or reasonably expected to alter or affect the tobacco
product's performance, composition, constituents, or characteristics or
are intended or reasonably expected to be used with or for the human
consumption of a tobacco product.
    Many comments specifically asked for clarification and examples of
which objects used with waterpipe tobacco would be considered
components, parts, and accessories. The following is a nonexhaustive
list of examples of components and parts used with waterpipe tobacco:
Flavor enhancers; hose cooling attachments; water filtration base
additives (including those which are flavored); flavored hookah
charcoals; and bowls, valves, hoses, and heads. The following is a
nonexhaustive list of objects used with waterpipe tobacco that would
likely be considered accessories: Hookah glow balls, foil pokers,
shisha oyster forks, tongs, and bags.
    Many comments also sought clarification and examples as to which
objects used with e-cigarettes would be considered components, parts,
and accessories. The following is a nonexhaustive list of examples of
components and parts of ENDS (including e-cigarettes): Atomizers,
flavors used or intended to be used with ENDS (with or without
nicotine), e-liquid solvents, tanks and tank systems, batteries (with
or without variable voltage), coils, cartomizers, digital display/
lights to adjust settings, clearomisers, and programmable software. The
following is a nonexhaustive list of examples of objects used with e-
cigarettes or other ENDS that would likely be considered accessories:
Screwdrivers and lanyards.
    A summary of comments regarding these issues, and FDA's responses,
is included as follows.
    (Comment 67) Many comments urged FDA to define components, parts,
and accessories (particularly for e-cigarettes) to standardize
enforcement nationally, prevent confusion in the marketplace (including
among retailers), close any potential loopholes to circumvent
compliance, increase transparency, and ensure inspectors are enforcing
regulations, while also taking into account retailers who are making a
good faith effort to comply with the law. Many comments provided
suggested definitions for ``component or part'' and ``accessory.''
Other comments stated that FDA should not define these categories of
products, because it is too difficult to properly define such large
categories of products and any definitions quickly would become
outdated.
    (Response) FDA agrees that definitions of component or part and
accessory would be appropriate and has included definitions consistent
with factors noted in the proposal and consideration of comments.
Although we indicated in the NPRM that accessories are not expected to
be used with or for consumption of a tobacco product, we also indicated
our expectation that accessories will have little impact on the public
health. While the definition of accessory is different than the
description in the NPRM, based on consideration of the comments, it
captures our original intent and the classes of products that the
Agency views as accessories. The definitions of component, part, and
accessory, which are discussed at the beginning of this section VI.A of
the document, are included in Sec. Sec.  1100.3, 1140.3, and 1143.1.
    (Comment 68) Several comments expressed concern about FDA's
statement in the NPRM that the Agency may consider rule revisions if
FDA later decides to extend its regulatory authority to components and
parts of newly deemed tobacco products that do not contain tobacco or
nicotine. They stated that the Tobacco Control Act does not permit FDA
to regulate such objects if they do not employ tobacco as a raw
material.
    (Response) FDA disagrees. To clarify, FDA is finalizing its
proposal to deem all tobacco products, including all components and
parts, but excluding accessories of newly deemed tobacco products, to
be subject to chapter IX of the FD&C Act. However, the additional
restrictions (i.e., minimum age and identification, vending, and health
warnings provisions) only apply to ``covered tobacco products.'' The
health warning provisions apply to ``covered tobacco products,''
cigarette tobacco, and roll-your-own tobacco. The term ``covered
tobacco products'' includes all newly deemed tobacco products except
those components and parts that are not made or derived from tobacco.
    FDA also disagrees that the FD&C Act does not authorize FDA to
regulate products that do not employ tobacco as a raw material. Section
901 of the FD&C Act states that chapter IX of the FD&C Act applies to
all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco and to any other tobacco products that the Secretary of Health
and Human Services by regulation deems to be subject to chapter IX.
Section 201(rr) of the FD&C Act defines ``tobacco product,'' in
relevant part, as any product made or derived from tobacco that is
intended for human consumption, including any component, part, or
accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). Therefore, the statute gives FDA authority to deem
additional tobacco products, including all components, parts, and
accessories, except for raw materials (other than tobacco) that go into
manufacturing of components, parts, or accessories of a tobacco
product. Examples of such raw materials would be unprocessed acacia gum
(taken from a tree and not processed) and minted titanium dioxide (used
for whitening cigarette and tipping paper). In this rule, FDA is not
deeming accessories to be subject to chapter IX and, although it is
deeming all components and parts to be subject to chapter IX, it is not
applying the additional restrictions (i.e., minimum age and
identification, vending, and health warnings provisions) to components
and parts that are not made or derived from tobacco. Nevertheless, if
FDA were to consider extending its authority to accessories or to apply
additional restrictions to components or parts, FDA would do so through
the rulemaking process.
    (Comment 69) A few comments expressed concern that the rule would
create incentives for manufacturers to separate nicotine-containing
components from nonnicotine-containing components to evade regulatory
requirements. They stated that the rule would allow minors to purchase
nicotine delivery systems, as long as they do not contain e-liquids,
and obtain the e-liquids from other sources (e.g., friends, parents,
online).
    (Response) FDA understands these concerns. However, this deeming
rule covers tobacco product components and parts intended or reasonably
expected to be used with or for the human consumption of a tobacco
product. In addition, as stated in Sec.  1140.16, retailers of newly
deemed tobacco products may not sell covered tobacco products (through
any medium, including the Internet) to individuals under 18 years of
age. FDA will continue to actively enforce the minimum age restriction
for

mail order and Internet sales, which will help to reduce youth access
to the nicotine and tobacco containing components, without which they
cannot use the other components of ENDS.
    (Comment 70) Some comments stated that the objects used in or with
an e-cigarette (including batteries, wire, screws, silica) should be
beyond the scope of FDA's authority, because they do not become part of
the tobacco product until they are constructed by the consumer. Others
stated that FDA should regulate these objects given reports regarding
the malfunctioning of certain e-cigarette components (e.g., dangers of
exploding batteries (Ref. 65)) and the fact that the e-liquid cannot be
consumed without each component working in conjunction to deliver
nicotine to the consumer. These comments asked FDA to clarify whether
the Agency will regulate only the nicotine-containing cartridges in a
line of products that includes varying degrees of nicotine including
cartridges advertised as nicotine free if they are intended to be used
with or for the human consumption of a tobacco product.
    (Response) This final deeming rule deems all tobacco products as
they are defined in section 201(rr) of the FD&C Act, except accessories
of newly deemed products, but including components and parts as defined
in this rule. The wires, screws, and silica meet the definition of
component or part, as they are an assembly of materials intended or
reasonably expected to be used with or for the human consumption of a
tobacco product and are not accessories of a tobacco product. FDA also
remains concerned about reports of exploding batteries. Batteries that
are co-packaged with other components or parts of an ENDS (e.g.,
cartridges and tanks) or otherwise intended or reasonably expected to
be used with or for the consumption of ENDS are components or parts and
subject to FDA's tobacco product authorities. However, as noted
elsewhere in this document, for ENDS hardware or delivery system
components or parts, such as batteries, FDA expects that it may be
difficult for manufacturers to obtain premarket authorization for such
products, given the great extent of possible variations in combinations
of hardware components, if all considered and sold separately. Thus,
with respect to such apparatus, FDA expects that manufacturers will be
most successful where authorization is sought for entire delivery
systems, rather than individual components. Elsewhere in this issue of
the Federal Register, FDA also has made available draft guidance, which
when final will represent some appropriate means of addressing the
premarket authorization requirements for newly deemed ENDS products and
will include FDA's current thinking regarding compliance with existing
voluntary standards for ENDS batteries.
    In addition, nicotine-containing cartridges that include varying
degrees of nicotine are components or parts and subject to FDA's
chapter IX authorities because they constitute an assembly of materials
intended or reasonably expected to be used with or for the human
consumption of a tobacco product and do not constitute a tobacco
product accessory. Upon the effective date of this final rule, FDA
intends to regulate the entire line of cartridges (including cartridges
that include varying degrees of nicotine or those that do not contain
nicotine, if they meet the definition of component or part).
    (Comment 71) Several comments urged FDA to include all e-liquids in
the minimum age and identification requirements and vending machine
restrictions in the revised part 1140, including e-liquids that do not
contain nicotine, because they are easily accessible to minors online
and can be mixed with nicotine. In addition, they suggested that FDA
require the proposed addiction warning on all components or parts sold
in conjunction with e-liquid.
    (Response) FDA disagrees. Under this deeming rule, e-cigarettes
that contain nicotine cannot be sold to youth under the age of 18. In
addition, an e-liquid with nicotine is a covered tobacco product and,
therefore, will be required to have a health warning under part 1143.
As previously discussed, an e-liquid without nicotine is a component
(and subject to FDA's tobacco control authorities), if it is intended
or reasonably expected to be used with or for the human consumption of
a tobacco product (e.g., with liquid nicotine) and does not constitute
a tobacco product accessory, but an e-liquid that does not contain
nicotine or tobacco is not required to carry a warning, nor is it
subject to the minimum age and identification requirements and vending
machine restrictions under parts 1140 and 1143 because it is not a
covered tobacco product as defined by this rule. Because components
without nicotine or tobacco are intended to be used with a covered
tobacco product, which contains nicotine or tobacco, FDA believes that
it is appropriate to require only the covered tobacco product to be
subject to the minimum age and vending machine provisions and to carry
the warning. Moreover, if a warning is overused, there is the danger
that it will grow stale.
    (Comment 72) One comment disagreed with what it characterized as
FDA's assertions that tobacco product accessories do not pose a public
health risk or environmental risk and stated that such objects are
harmful to humans and the food chain.
    (Response) FDA wishes to clarify language included in the NPRM
regarding accessories (79 FR 23142 at 23153). FDA did not propose, nor
is it stating in this final rule, that tobacco product accessories do
not pose any public health risk. Instead, we indicated that tobacco
product accessories as defined in the rule likely have less (rather
than ``no'') risk to the overall public health, which we reiterate in
this final rule. FDA is regulating components and parts (and not
accessories) of the newly deemed products, so the Agency can better
focus its resources on those objects with a greater likely impact on
public health. Similarly, FDA did not state that this rule would not
impact the environment. Rather, the environmental analysis included in
the NPRM stated that the impacts of this rule will not have a
significant impact on the human environment according to the standard
imposed by the National Environmental Policy Act, as stated in the
proposed environmental assessment (EA). The final EA and Finding of No
Significant Impact (FONSI) are included in the docket.
    (Comment 73) The comments suggested several different regulatory
approaches for components, parts, and accessories. First, several
comments stated that FDA should weigh the relative risks of these
products and impose the least burdensome requirements necessary to
effectively manage or mitigate those risks. They suggested that FDA
treat these products the way the Agency does with its review of
marketing applications. For example, they noted that FDA's draft and
final guidance documents on PMTAs and SE reports explain that FDA does
not intend to enforce the requirements of either section 910 or 905(j)
of the FD&C Act for components of regulated tobacco products that are
sold or distributed solely for further manufacturing into finished
tobacco products because the Agency anticipates ``receiving relevant
information regarding such new tobacco products in the PMTA submission
for the finished regulated tobacco products'' (citing draft guidance,
``Applications for Premarket Review of New Tobacco Products''). Second,
some comments believed that manufacturers of e-cigarette components and
parts

should be required to submit marketing applications given the aerosols
and ``vapors'' that consumers generate when using certain components or
parts. Third, some comments stated that instead of requiring
manufacturers of components and parts to comply with the automatic
requirements for the newly deemed products, FDA should require them to
ensure that all of their components and parts that contain tobacco or
tobacco derivatives are shipped and packaged with labeling that
indicates that they are intended for further manufacture.
    (Response) At this time, FDA intends to limit enforcement of the
premarket review requirements to finished tobacco products. For
purposes of this compliance policy applicable to newly deemed products,
a finished tobacco product refers to a tobacco product, including all
components and parts, sealed in final packaging intended for consumer
use (e.g., filters or filter tubes sold separately to consumers or as
part of kits). FDA does not at this time intend to enforce these
requirements for components and parts of newly deemed products that are
sold or distributed solely for further manufacturing into finished
tobacco products. In addition, FDA does not believe that it is
warranted at this time to require components and parts that contain
tobacco or tobacco derivatives to include labeling that indicates they
are intended for further manufacture.
    (Comment 74) Some comments stated that FDA should regulate all
components, parts, and accessories, as long as they have a foreseeable
impact on the public health. They believed that omitting accessories
from the scope of the deeming rule ignores the clear statutory language
that explicitly defines ``tobacco product'' to include accessories.
    (Response) FDA disagrees. Although Congress included
``accessories'' within the definition of ``tobacco product'' in section
201(rr) of the FD&C Act, it did not explicitly require that FDA include
all components, parts, and accessories within the scope of its rule to
deem additional tobacco products under section 901. Accessories, as
defined in this rule, likely have less risk to the overall public
health, and the benefits to overall public health for deeming
accessories subject to FDA's tobacco product authorities are also
likely less. Therefore, FDA is excluding them from the scope of this
deeming rule.
    (Comment 75) Some comments stated that items also used for purposes
other than for tobacco use (i.e., a lighter or matches that can be used
to light candles) should be classified as accessories and, therefore,
not subject to FDA's chapter IX authorities. For example, batteries
used in advanced personal vaporizers can be found in laptop battery
packs or cordless drill packs. These comments also stated that items
such as lighters and batteries may (or may not) be used in consumption
of a tobacco product or are regulated by the Consumer Product Safety
Act (as are child-resistant lighters) and, therefore, should not be
subject to FDA's tobacco product authorities.
    (Response) FDA agrees that it is not necessary to regulate
batteries that are not intended or reasonably expected to be used with
a tobacco product under its tobacco product authorities. However, it is
important that batteries that are co-packaged with other parts of an
ENDS (e.g., cartridges and tanks) or otherwise intended or reasonably
expected to be used with ENDS are components subject to FDA's tobacco
product authorities. FDA remains concerned about reports of exploding
e-cigarette batteries and finds that regulating them can help address
these problems. Toward that end, 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 compliance with existing voluntary standards
for ENDS batteries.
    (Comment 76) Some comments stated that walk-in humidors for cigars
should not be subject to FDA regulation because they are important to
retailers and allow consumers to browse a retailer's stock and make a
selection.
    (Response) As discussed previously, any item that is intended or
reasonably expected to be used with or for the human consumption of a
newly deemed tobacco product; does not contain tobacco or a tobacco
derivative; and is intended or reasonably expected to affect or
maintain the characteristics of the newly deemed tobacco product but
solely controls moisture and/or temperature of a stored newly deemed
tobacco product, is an accessory and excluded from this deeming rule.
Therefore, unless the humidor is designed to affect the tobacco product
in a manner other than controlling moisture or temperature, such walk-
in cigar humidors are not subject to this rule.
    (Comment 77) A few comments expressed concern that e-cigarette
tanks and cartridges would not be included within the proposed vending
machine restrictions because they do not contain nicotine at the time
of sale. They said that such objects are not standardized and that
their quality, composition, and safety are not regulated and,
therefore, they should be subject to FDA's chapter IX authorities.
    (Response) FDA does not believe it is necessary for tanks and
cartridges that do not contain nicotine or tobacco to be subject to the
vending machine restrictions because they can only be used to consume
tobacco or nicotine derived from tobacco with other products that are
subject to the additional restrictions. However, FDA is aware of the
current lack of regulation or standardization of tanks and cartridges,
which are components and parts that FDA is deeming to be subject to
FDA's chapter IX authorities with this rule. After the effective date
of this final rule, FDA will have authority to issue tobacco product
manufacturing practice regulations under section 906(e) of the FD&C Act
and product standards under section 907 of the FD&C Act to address the
quality, composition, and safety of these components and parts. FDA
also notes that these components and parts will usually be subject to
premarket review, either by themselves, as components and parts
intended for consumer use, or as components and parts of products that
undergo further manufacturing for which the end product will be subject
to premarket review.
    (Comment 78) A few comments expressed concern with FDA's
characterization of objects used during a waterpipe tobacco session
(i.e., the burners, holders, screens, and other objects used with
waterpipe tobacco). They stated that all waterpipe burners and holders
can affect waterpipe tobacco emissions, and noted that foil is heated
to the same extent as charcoal during waterpipe use and, therefore, can
present a burning danger (Ref. 66). In addition, the heating source,
screen (or aluminum foil), and hose can have a significant impact on
passive and active exposure and smoking/puffing behaviors and,
therefore, should be components or parts subject to chapter IX of the
FD&C Act.
    (Response) FDA has included definitions of ``component,'' ``part,''
and ``accessory'' with this final rule to provide additional clarity
regarding the characterization of products used during a waterpipe
session. According to these definitions, the screen (or aluminum foil)
and hoses that are co-packaged with other parts of a hookah or
marketed, advertised, or otherwise intended for use with a hookah are
parts or components and subject to FDA's tobacco product authorities.
However, for example, an external burner or

heating source that is not incorporated into the hookah would be an
accessory, provided that it does not contain tobacco or a tobacco
derivative and solely provides an external heat source to initiate but
not maintain combustion of a tobacco product. The holder also is an
accessory and not subject to chapter IX of the FD&C Act.
    (Comment 79) A few comments suggested that charcoal or wood cinder
used with waterpipe tobacco should be considered a tobacco product and
deemed under this regulation. They explained that combustion of these
products produces toxicants and may emit carcinogens, carbon monoxide,
polycyclic aromatic hydrocarbons, and other cancer causing agents.
    (Response) FDA finds that such products are components or parts;
therefore, they are subject to FDA's chapter IX authorities. They are
an assembly of materials intended or reasonably expected to be used
with or for the human consumption of a tobacco product and are not
accessories. As we have noted throughout this document, an accessory
does not contain tobacco and is not made or derived from tobacco, and
it meets one of the following: (1) Is not intended or reasonably
expected to affect or alter the performance, composition, constituents,
or characteristics of a tobacco product; or (2) is intended or
reasonably expected to affect or maintain the performance, composition,
constituents, or characteristics of a tobacco product but (i) solely
controls moisture and/or temperature of a stored product; or (ii)
solely provides an external heat source to initiate but not maintain
combustion of a tobacco product. Therefore, the charcoal or wood cinder
intended or reasonably expected to be used with or for the human
consumption of waterpipe tobacco are components or parts. Further,
charcoal and wood cinders are not considered accessories given that
they: (1) Do not contain tobacco and are not made or derived from
tobacco; and (2) are intended or reasonably expected to alter the
characteristics of a tobacco product but do not solely control moisture
and/or temperature of a stored product and do not solely provide an
external heat source to initiate but not maintain combustion. Instead,
both charcoal and wood cinder are used to maintain the combustion of
waterpipe tobacco.
    (Comment 80) Many comments asked for clarification as to whether
certain items associated with cigar use should be termed
``accessories,'' including cigar tip cutters, permeable humidor
buttons, removable tips, mouthpieces, removable filters, holders,
lighters, ashtrays, and cases.
    (Response) FDA generally expects cigar tip cutters, permeable
humidor buttons, holders, ashtrays, and cases would be accessories that
are not subject to FDA regulation. In addition, as stated in this
section (discussing the definitions of component or part and
accessory), for the purposes of this regulation, any item that does not
contain tobacco or a tobacco derivative and is not integrated in a
tobacco product, but rather solely provides an external heat source, to
initiate but not maintain combustion of a tobacco product (such as a
lighter) is not subject to this deeming rule. However, removable tips,
mouthpieces, and filters are all intended to be used by adult consumers
in the human consumption of a tobacco and do not meet the definition of
accessory, therefore, are included within the scope of this final rule.
    (Comment 81) A few comments expressed concern that vaporizers sold
separately without nicotine can be modified or ``hacked,'' which
researchers found could increase toxins and other dangerous components,
including formaldehyde (Ref. 67). They stated that online videos show
how to ``hack'' an e-cigarette, including how to change the apparatus
to increase the temperature of the ``vapor.'' Because of these
concerns, they argued that such items should be considered components
and parts and under FDA's jurisdiction.
    (Response) FDA agrees that vaporizers are components or parts of a
tobacco product. These objects are an assembly of materials intended or
reasonably expected to be used with or for the consumption of a tobacco
product and do not constitute tobacco product accessories. Therefore,
they are tobacco product components or parts and subject to FDA's
chapter IX authorities. FDA considers components or parts sold directly
to consumers to be finished tobacco products. A finished tobacco
product refers to a tobacco product, including all components and
parts, sealed in final packaging intended for consumer use (e.g.,
filters or filter tubes sold separately to consumers or as part of
kits). FDA remains concerned about adverse events associated with ENDS
use and finds that regulating them can help address these problems.
Toward that end, 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.
    (Comment 82) One comment requested that flavored rolling papers be
included as a newly deemed tobacco product. Another comment claimed
that flavored papers should not be subject to FDA's tobacco control
authorities, because they do not pose a danger to public health.
    (Response) Rolling papers intended for use with cigarette tobacco
or roll-your-own tobacco are already subject to FDA's tobacco control
authorities under section 901 of the FD&C Act because they are
components of cigarettes and cigarette tobacco. Upon the effective date
of this final rule, rolling papers (including flavored papers) intended
for use with newly deemed tobacco products would be tobacco product
components or parts and subject to FDA's chapter IX authorities.

B. Discussion of Requirements Associated With Components and Parts

    FDA received many inquiries about how the automatic provisions
associated with deeming tobacco products would apply to components and
parts. Components and parts of newly deemed tobacco products are
subject to all of the automatic provisions included in the FD&C Act, as
further discussed as follows.
1. Ingredient Listing (Sections 904(a)(1) and 904(c)); Health Document
Submission (Section 904(a)(4)); and Registration and Product Listing
(Section 905)
    At this time, FDA intends to limit enforcement to finished tobacco
products. A finished tobacco product refers to a tobacco product,
including all components and parts, sealed in final packaging intended
for consumer use (e.g., filters, filter tubes, e-cigarettes, or e-
liquids sold separately to consumers or as part of kits). FDA does not
at this time intend to enforce these requirements for components and
parts of newly deemed products that are sold or distributed solely for
further manufacturing into finished tobacco products.
2. SE Reports and PMTAs (Section 905(j) and 910)
    At this time, FDA intends to limit enforcement to finished tobacco
products. FDA does not at this time intend to enforce these
requirements for components and parts of newly deemed products that are
sold or distributed solely for further manufacturing into finished
tobacco products.
3. Reporting of HPHCs (Section 915)
    At this time, FDA intends to limit enforcement to finished tobacco

products. See section IX for further discussion of ENDS retail
establishments and the responsibilities of upstream manufacturers for
reporting of HPHCs. The Agency is working to determine an appropriate
compliance policy to deal with HPHCs for newly deemed products
(including e-liquids) and is intending to issue guidance with enough
time for manufacturers to report given the 3-year compliance period.

VII. Regulation of Cigars and Selection of Option 1

    As discussed in the preamble to the NPRM (79 FR 23142 at 23150
through 23152), it has been suggested that different kinds of cigars
may have the potential for varying effects on public health.
Accordingly, FDA proposed two options for the categories of cigars to
be subject to this deeming rule. Option 1 proposed to deem all products
meeting the statutory definition of ``tobacco product,'' except
accessories of a proposed deemed tobacco product, to be subject to
FDA's tobacco product authorities under chapter IX of the FD&C Act.
Option 2 proposed to deem all products meeting the statutory definition
of ``tobacco product,'' except accessories of a proposed deemed tobacco
product and a subset of cigars referred to as ``premium cigars'' to be
subject to FDA's tobacco product authorities under chapter IX of the
FD&C Act. FDA notes that individual hand rollers of cigars would be
considered manufacturers under chapter IX of the FD&C Act, and subject
to the same requirements as other tobacco product manufacturers.
    (Comment 83) Some comments that supported Option 1 stated that FDA
should regulate premium cigars, in part, because they meet the
statutory definition of ``tobacco product.''
    (Response) FDA agrees. All cigars, including those referred to as
premium cigars, meet the definition of a ``tobacco product'' under
section 201(rr) of the FD&C Act.
    After thorough review of the comments and the scientific evidence,
FDA has concluded that deeming all cigars, rather than a subset, more
completely protects the public health and therefore has adopted Option
1 in the final rule. FDA has concluded that: (1) All cigars pose
serious negative health risks, (2) the available evidence does not
provide a basis for FDA to conclude that the patterns of premium cigar
use sufficiently reduce the health risks to warrant exclusion, and (3)
premium cigars are used by youth and young adults. The fact that some
premium cigar smokers might smoke such products infrequently or report
that they do not inhale does not negate the adverse health effects of
tobacco smoke or demonstrate that cigars do not cause secondhand smoke-
related disease in others. Therefore, we find there is no appropriate
public health justification to exclude premium cigars from the scope of
the final deeming rule and that it is appropriate to deem them.

A. Health Risks of Premium Cigars

    Researchers estimate that regular cigar smoking was responsible for
approximately 9,000 premature deaths or almost 140,000 years of
potential life lost among adults 35 years or older in 2010 (Ref. 68).
Cigar smoke contains many of the same harmful constituents as cigarette
smoke and may have higher levels of several harmful compounds (Ref. 68,
citing Ref. 69 at 55-104). All cigar smokers have an increased risk of
oral, esophageal, laryngeal, and lung cancer compared to non-tobacco
users (Refs. 35, 69). Among those who report inhaling cigar smoke,
there are significantly elevated levels of many types of cancer and
other adverse health effects, such as increased risk of heart and
pulmonary disease (Refs. 69, 70). Cigar smokers also are at a marked
increase in risk for chronic obstructive pulmonary disease (COPD) and
experience higher mortality risk from COPD than nonsmokers (Refs. 70,
71). In addition, cigar smokers have a higher risk of fatal and
nonfatal stroke than nonsmokers (Ref. 72). All cigars produce
secondhand smoke, which causes negative health effects such as heart
disease and lung cancer in bystanders (Refs. 35, 69).
    Nevertheless, we do note that the 2014 Surgeon General's Report
states that when compared with persons who smoke cigarettes, those who
use cigars exclusively have a lower risk for many smoking-related
diseases (Ref. 9 at 428 citing Ref. 69). Although smoke from cigars
contains the same toxic substances as cigarette smoke, cigar smokers
generally smoke at a lower frequency and tend not to inhale the smoke,
thus reducing (but not eliminating) their exposure to its toxic
substances (id.). Former cigarette smokers are more likely to inhale
cigar smoke than are primary cigar smokers who have never smoked
cigarettes (id.).
    While most studies cited in this section do not explicitly pertain
to premium cigars, the bulk of the established data on the health
effects of cigar smoking is based on smokers of traditional, large
cigars and, therefore, is applicable to the toxicity of premium cigars
given that they share the same characteristics and are generally smoked
in similar ways.
    While exposure to higher levels of cigar smoke for a longer period
of time increases the adverse health risks due to cigar smoking (just
as it does for cigarettes), the Surgeon General has stated that no
amount of smoking is safe (Ref. 2). Further, there are no data
indicating that premium cigar users are not susceptible to health
risks, as discussed in section VII.C. FDA's responses to comments on
the health risks of premium cigars are included in the following
paragraphs.
    (Comment 84) Proponents of Option 1 stated there is no public
health justification for exempting premium cigars and that deeming
premium cigars will benefit the public health immediately through the
automatic and additional provisions and the imposition of future
product standards. They also stated that exempting premium cigars would
have a negative impact on the public health.
    (Response) FDA agrees. As stated in the NPRM, there will be many
public health benefits associated with deeming tobacco products
(including products referred to as premium cigars). For example, the
adulteration and misbranding provisions in sections 902 and 903 of the
FD&C Act, as applied to the newly deemed products, will protect
consumers because FDA will be able to take enforcement action against
any non-compliant tobacco product, such as a product with false or
misleading labeling or advertising. In addition, ingredient listings
and reports of HPHCs under sections 904 and 915 of the FD&C Act will
assist FDA in better understanding the contents of regulated products.
That information would assist FDA in assessing potential health risks
and determining if future regulations to address the health risks posed
by particular products are warranted. With application of the section
905 registration and listing requirements, FDA will be able to conduct
biennial inspections of tobacco product manufacturers. Further,
implementation of the premarket review provisions of sections 905, 910,
and 911 of the FD&C Act will allow FDA to monitor product development
and changes and to prevent more harmful or addictive products from
reaching the market. Moreover, there were no data provided to support
the premise that there are different patterns of use of premium cigars
and that these patterns result in lower health risks.
    (Comment 85) Some comments argued that exempting premium cigars
from deeming would set a dangerous precedent that it is appropriate for
FDA not to regulate certain tobacco products by virtue of their
potential for varying

effects on public health. An exemption could mislead consumers to
believe that premium cigars are safe, which contradicts the available
evidence that all cigars are harmful and potentially addictive. In
addition, the current population of premium cigar users would be left
unprotected, potentially decreasing the likelihood that they would
quit, and leading more youth and young adults to initiate use of
premium cigars or substitute products.
    (Response) FDA agrees with these comments. Accordingly, FDA has
selected Option 1 deeming all cigars, rather than a subset, for the
scope of this final rule.
    (Comment 86) Many comments that supported Option 2 argued that
premium cigars do not present a public health threat significant enough
to warrant regulation and that no evidence was presented that
regulation of premium cigars would substantially improve the public
health. These comments stated that premium cigars represent a small
portion of the tobacco product and cigar markets (annual premium cigar
estimate in the United States of 300 million units compared to nearly
14 billion total cigar units and nearly 300 billion cigarettes) (Ref.
73), and there is no evidence that premium cigars have the same health
consequences or habitual use patterns as other tobacco products. They
generally relied on two studies, Funck-Brentano et al. and Turner et
al., to claim that premium cigars deliver little nicotine to users, by
inhalation or oral absorption (Refs. 74, 75). They also claimed that
cigars do not significantly elevate the risk of addiction or death
(Refs. 76, 77) and stated that, in some studies, there were a very
small number of cancer cases or deaths among cigar smokers (Refs. 78,
79). They also noted the nonsignificant odds ratios for those consuming
1 to 2 cigars per day (Refs. 69, 79) and for the risk of lung cancer
and ``tobacco-related cancers'' among exclusive cigar smokers (Ref.
80).
    (Response) FDA disagrees with these claims and finds that the cited
studies or critiques are not persuasive. Regarding the claim that
premium cigars deliver little nicotine to users, the Turner study (Ref.
75) was a study of only 10 male hospital workers conducted more than 30
years ago. The findings of the Turner study, based on carboxyhemoglobin
and plasma nicotine levels, suggested that former cigarette smokers who
occasionally smoked cigars or regularly smoked pipes had greater cigar
smoke inhalation and absorption than primary cigar and pipe smokers
(i.e., those who never smoked cigarettes). This study also reported
that average plasma nicotine concentrations among primary cigar and
pipe smokers were somewhat elevated 60 minutes into a cigar smoking
session compared with levels measured after smoking abstinence (Ref.
75). Notwithstanding the small sample size, the study results still
demonstrate that cigars deliver nicotine to users.
    Similarly, the Funck-Brentano et al. study (Ref. 74) assessed
biomarkers of tobacco exposure and toxicity in a small sample of cigar
(corona-sized or larger cigar) or pipe smokers (n = 30), cigarette
smokers (n = 28), and nontobacco users (n = 30), making this small
biomarker study less persuasive. In fact, the study authors state:
``These results should not be seen as a justification for the smoking
of pipes and cigars, which are clearly associated with clinically
significant health hazards. We emphasize that we cannot determine
whether our results are explained by the type of tobacco smoked or by
the different inhalation pattern in pipe/cigar smokers and cigarette
smokers.''
    A recent analysis of biomarkers of tobacco exposure among cigar
smokers used data from the 1999-2012 National Health and Nutrition
Examination Survey, a nationally representative survey (Ref. 81). The
sample included more than 220 primary cigar (i.e., current cigar/never
cigarette) smokers and more than 180 secondary cigar (i.e., current
cigar/former cigarette) smokers (id.). The researchers found that serum
cotinine concentrations among primary (and secondary) cigar smokers
were substantially higher than in nontobacco users in crude and
adjusted analyses (id.). In addition, adjusted analyses showed that
concentrations of NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol),
blood cadmium, and lead were also higher among primary (and secondary)
cigar smokers compared with nontobacco users (id.). Therefore, not only
were the cited studies unpersuasive, but this robust and recent
analysis contradicts those studies.
    In addition, FDA did not find persuasive studies cited in comments
for the proposition that cigars do not significantly elevate the risk
of addiction or death. To support this proposition, comments relied in
part on a study (Ref. 76) in which a panel scored the worldwide
harmfulness of 12 nicotine products using a multicriteria decision
analysis approach. Although cigarettes ranked higher than either little
cigars and other cigars on an aggregate harm score, the study found
cigar smoking does result in morbidity, mortality, and dependence.
    The other study used to support the proposition that cigars are not
a significant public health threat (Ref. 77) found a significant
association between primary cigar or pipe smokers and lung cancer
mortality risk, which refutes the claim that cigar use does not
significantly elevate the risk of death. In addition, this study found
an association between COPD mortality risk and secondary cigar or pipe
smoking (but not for primary cigar and pipe smoking). Also, contrary to
the assertions of commenters, a recent systematic review of cigar
smoking and mortality summarized the results of 22 published studies
from 16 different prospective cohorts and found that primary cigar
smoking was associated with increased risk of mortality from all
causes, several types of cancers, coronary heart disease, and aortic
aneurysm (Ref. 82). Mortality risks were greater with increasing number
of cigars smoked per day and self-reported level of inhalation,
however, primary cigar smokers reporting no inhalation still had highly
elevated mortality risks for oral, esophageal, and laryngeal cancers
(id.). In addition, a recent study estimated that in 2010 more than
9,000 premature deaths annually were attributable to regular cigar
smoking (i.e., those who reported smoking cigars on at least 15 of the
past 30 days) (Ref. 68).
    Moreover, FDA reviewed a study by Boffetta et al. (Ref. 78), which
commenters relied upon to claim that a very small number of cancer
cases existed among cigar smokers and, therefore, premium cigars should
not be regulated. The Boffetta et al. study (id.) used a case-control
design to assess the association between lung cancer risk and cigar
smoking. The authors determined that the overall association between
primary cigar or cigarillo smokers and lung cancer was significant and
found significant associations in all but one area (id.). For all other
estimates, the results were statistically significant. We also note
that, despite the relatively small number of cancer cases in this
study, it is only one part of a larger body of evidence that
demonstrates the increased risk of serious adverse health effects
associated with cigar smoking (Refs. 35, 69, 70, 71, 72, 77, 79, 83).
    (Comment 87) Some comments stated cigar smokers are not at risk of
becoming addicted to tobacco products based on their use of cigars.
Other comments stated that certain attributes of premium cigars
increase the likelihood for nicotine dependence, including their size,
the amount of tobacco (and, therefore, nicotine) in the cigar, and the
longer amount of time that it takes to smoke the cigar.

Additionally, these comments suggested that because cigar tobacco is
more alkaline than cigarette tobacco, nicotine may be absorbed into the
blood stream more rapidly, even without inhaling (Refs. 84, 85).
    (Response) FDA agrees that all cigars are potentially addictive. As
discussed in the preamble to the NPRM, a cigar can contain as much
tobacco as a whole pack of cigarettes, and nicotine yields from smoking
a cigar can be up to eight times higher than yields from smoking a
cigarette (79 FR 23142 at 23154). Although the amount of nicotine taken
in by a cigar user depends on various factors like how long the person
smokes the cigar, the number of puffs taken, and the degree of
inhalation, a leading review of the science of cigar smoking concluded
that ``[c]igars are capable of providing high levels of nicotine at a
sufficiently rapid rate to produce clear physiological and
psychological effects that lead to dependence, even if the smoke is not
inhaled'' (Ref. 35). In addition, regardless of whether premium cigar
smokers inhale, buccal absorption of nicotine does occur, and cigar
smokers may also absorb nicotine through the lips due to the alkalinity
of cigar tobacco (Refs. 86, 87). This increased nicotine yield and
absorption increases the risk of nicotine addiction from cigar smoking.
Researchers analyzing data from the NYTS found that although the
percentage of youth reporting various measures of dependence was lower
for cigars than for cigarettes or smokeless tobacco, some youth did
report some measures of cigar addiction (Ref. 88). This study found
that 6.7 percent of middle and high school students who only smoked
cigars also reported strong cravings for a tobacco product during the
past 30 days, and 7.8 percent reported sometimes/often/always feeling
irritable or restless when not using tobacco--which are measures of
dependence (id.) We note that the Surgeon General has found that all
forms of nicotine delivery do not pose an equal risk in establishing or
maintaining nicotine addiction (Ref. 9).
    (Comment 88) Many comments remarked that premium cigars do not pose
the same adverse health effects as cigarettes and other types of cigars
because most studies of cigar health effects do not differentiate
between types of cigars. They claimed this lack of evidence precludes
conclusions about the health effects of premium cigars specifically.
    (Response) The science is clear that cigar use of all types can
lead to negative health effects, as discussed throughout this section
of the document. Thus, the contention that studies are inconclusive
about the health effects of premium cigars because they do not
differentiate between types of cigars is not persuasive.
    All cigar use is harmful and potentially addictive. Cigar smokers
have an increased risk of oral, esophageal, laryngeal, and lung cancer
compared to nonsmokers (Refs. 35, 69). Among those who report inhaling
cigar smoke, there are significantly elevated levels of many types of
cancer and other health effects, such as increased risk of heart and
pulmonary disease (Refs. 69, 70). Cigar smokers also have a marked
increase in risk for COPD and experience higher mortality risk from
COPD than nonsmokers (Refs. 70, 71). In addition, cigar smokers have a
higher risk of fatal and nonfatal stroke than nonsmokers (Ref. 72). All
cigars produce secondhand smoke, which causes negative health effects
such as heart disease and lung cancer in bystanders (Refs. 35, 69).
    We note that the Surgeon General reported in 2014 that,
``[c]ompared with persons who smoke cigarettes, smokers who smoke pipes
or cigars exclusively have a lower risk for many smoking-related
diseases (internal citation omitted). Smoke from pipes and cigars
contains the same toxic substances as cigarette smoke, but those who
use a pipe or cigar usually smoke at a lower frequency; observation
indicates that they tend not to inhale the smoke, thus reducing their
exposure to its toxic substances (internal citations omitted). Evidence
indicates that former cigarette smokers are more likely to inhale pipe
or cigar smoke than are primary pipe and cigar smokers who have never
smoked cigarettes (internal citations omitted)'' (Ref. 9 at 428-429).
However, research indicates that most cigar smokers do inhale some
amount of smoke, even when they do not intend to inhale, and are not
aware of doing so (Refs. 32, 33).
    Finally, FDA specifically sought comment on how the potential
different patterns of use for premium cigars might result in different
or decreased health impacts, but no such evidence was submitted (see
discussion in section VII.C of document).
    (Comment 89) Some comments indicated that many cigar users,
including those who smoke premium cigar brands, are also current or
former cigarette users, increasing their exposure to toxic constituents
and the health risks of using combusted tobacco products (Refs. 89,
90). Additionally, they stated that these users are more likely to
inhale when they use cigars and may smoke more cigars per day,
significantly increasing their health risks (Refs. 33, 91, 92, 93, 94).
    (Response) FDA agrees. Given the adverse health effects of all
cigars, FDA has selected Option 1 deeming all cigars, rather than a
subset, for the scope of this final deeming rule.
    (Comment 90) Some comments raised concerns about dual and polyuse
of cigars and other tobacco products, which is common among both adults
and youth (Refs. 90, 95). For example, in one study, 35.1 percent of
adult premium cigar users, 58.3 percent of cigarillo and other mass
market cigar users (i.e., those reporting their usual cigar did not
have a filter and the usual brand was not premium), and 75.2 percent of
little filtered cigar users also smoked cigarettes (Ref. 90). Some
comments noted that multiple product use is concerning because
polytobacco users are more likely to report symptoms of nicotine
dependence (Ref. 88).
    (Response) As FDA stated in the NPRM, we are concerned about the
use of multiple products, especially combusted tobacco products.

B. Youth and Young Adults Use Premium Cigars

    Proponents of Option 2 have stated that an exemption for premium
cigars is warranted because youth prefer machine-made cigars (as
opposed to hand-rolled) given their low price, flavoring, and easier
availability. However, although youth and young adults have a higher
use of cigarillos and other mass market cigars, studies indicate that
they are also using premium cigars.
    (Comment 91) Many comments cited data showing that among those age
12 and older, past month cigar use decreased slightly from 5.4 percent
in 2002 to 5.2 percent in 2012 after peaking at 5.7 percent in 2004
(Ref. 89 at Figure 4.1). Among youth only (ages 12 to 17), cigar
smoking prevalence declined between 2004 (4.8 percent) and 2012 (2.6
percent) (Ref. 89 at Figure 4.1). Trend data from the National Youth
Risk Behavior Survey also indicate that cigar use among male high
school students, female students, and white, black, and Hispanic
students either declined or remained stable from 1997 to 2011 (Ref. 9).
Additionally, from 1997 to 2013, ``a significant linear decrease
occurred overall in the prevalence of current [youth] cigar use (22.0
percent-12.6 percent)'' (Ref. 96), which was observed from data
collected by the CDC 1997-2013 YRBS (Ref. 29). Accordingly, they
questioned whether FDA should be regulating cigars.

    Other comments included data indicating that youth cigar use has
not declined when compared to use of other tobacco products. They noted
that many youth surveys show youth cigar smoking to be higher than, or
about the same as, cigarette smoking. For example, in 2013, among U.S.
high school males, the prevalence of current (past 30 day) cigar
smoking (16.5 percent) was comparable to current (past 30 day)
cigarette smoking (16.4 percent) (Ref. 96). Additionally, in 21 U.S.
cities that conducted the 2013 YRBS, the prevalence of current cigar
smoking (8.6 percent) was comparable to current cigarette smoking (7.7
percent) among high school students (id.). In 2014, NYTS reported that
among high school Non-Hispanic black students, 8.8 percent reported
smoking cigars in the past 30 days, whereas 4.5 percent reported
smoking cigarettes in the past 30 days (Ref. 22). In addition, among
high school males overall, the prevalence of past 30 day cigar smoking
(10.8 percent) was comparable to past 30 day cigarette smoking (10.6
percent) (id.). Measures of youth use of cigars may underestimate
prevalence due to incorrect self-identification as a non-cigar smoker
and confusion between the various cigar products (Refs. 97, 98, 99).
Accordingly, the comments supported FDA's regulation of all cigars.
    (Response) FDA remains concerned about the use of all tobacco
products, particularly combusted tobacco products like cigars and
cigarettes, and remains most concerned about use by youth and young
adults given their unique susceptibility to the addictiveness of
nicotine. Although supporters of Option 2 relied upon NSDUH data
showing a decline in cigar smoking prevalence among individuals aged 12
to 17 from 2004 to 2012, the NSDUH's questions about ever and past 30-
day use of cigars did not include examples of specific brands. We note
that the Surgeon General's 2014 report states that ``data from the
1997-2011 obtained from the National YRBS indicate that current cigar
use among male high school students declined from 1997-2005 and then
remained stable from 2005-2011. Among female students, current cigar
use declined from 1997-2011.'' (Ref. 9 at 736, internal references
omitted). The 2013 YRBS, a nationally representative survey of 13,000
youths, indicated that cigar use prevalence trends have decreased from
1997-2013 for youth in grades 9 through 12 (22 percent in 1997 to 12.6
percent in 2013) (Ref. 29).
    Evidence suggests that some youth may recognize the brand of cigar
they smoke, but not that it is a ``cigar'' in general terms and,
therefore, may not report their cigar use (Refs. 98, 100). When
examples of brand names were added to the 2012 NYTS, there was a
pronounced increase from 2011 in reported cigar smoking among non-
Hispanic black females (Ref. 100). Among NYTS high school students
overall from 2000 to 2011, there was no change in prevalence of cigar
smoking (Ref. 101). This lack of decline in cigar smoking is a concern
considering cigarette smoking among high school students did
significantly decline over these periods (id.). Among NYTS high school
students overall from 2011 to 2014, there was a decrease in prevalence
of current use of cigars from 11.6 percent to 8.2 percent (Ref. 22).
    (Comment 92) The comments were divided as to whether youth use
premium cigars. Some comments provided data demonstrating youth use of
premium cigars. Others submitted mainly informal industry surveys and
anecdotal evidence illustrating that the majority of premium cigar
users are older adult males who smoke infrequently and often in a
celebratory nature. A few other comments stated that patterns of use
studies are inconclusive, because many studies do not differentiate
between premium cigars and mass-market cigars.
    (Response) Although youth and young adults tend to smoke mass
market cigar brands, they are also using premium cigars. In one study,
researchers used data from the 2010-2011 NSDUH and Nielsen market
scanner data to define a study sample consisting of 6,678 past 30-day
cigar smokers who reported smoking a usual brand of cigars (Ref. 59).
While many youth identified a mass market cigar as the brand they used
most often, this analysis reveals that 3.8 percent of youth aged 12 to
17 and 12.1 percent of young adults aged 18 to 25 also identified
certain premium cigars to be the brand they smoked most often (id.).
Individuals in both cohorts reported at least eight different premium
cigar brands among the brands they used most often, providing evidence
that youth and young adults are smoking premium cigars (id.).
    One study analyzing data from the 2012-2013 National Adult Tobacco
Survey (NATS), with 60,192 participants 18 years and older found that
of those smokers whose type of cigar could be identified based on the
attributes of their usual product (e.g., premium cigar smoker, little
cigar smoker, cigarillo smoker), 19.9 percent were premium cigar
smokers (Ref. 90). More specifically, 15.1 percent of cigar smokers
aged 18 to 29 years old, who identified themselves as smoking every
day, some days, or rarely, indicated the cigar they usually smoked on
those occasions was a premium cigar (id.), which clearly illustrates
that young adults are using premium cigars. Although some comments
questioned the applicability of the NATS data on premium cigar use by
youth and young adults (in part, because the study did not use the
proposed definition of ``premium cigar'' in the NPRM), FDA is not
persuaded. FDA does not believe it is necessary for the definition of
premium cigars in this study to match exactly the definition in the
NPRM in order to draw inferences about the use of different types of
cigar products. These data, along with the NSDUH and Nielsen market
scanner data discussed previously, clearly indicate that youth and
young adults are using premium cigars.
    Some comments stated the previously mentioned studies show only
minimal premium cigar use by minors. By contrast, they relied on Soldz
et al. (Ref. 102), which examined preferred cigar brands based on a
survey of Massachusetts middle and high school students. Although the
study did not include any particular premium cigars among the brands
reported, 16.4 percent of youth cigars users were categorized as
preferring a ``non-listed'' brand which the authors suggested ``may
largely consist of premium cigars.'' The authors based this
determination given the participants' positive association between the
``non-listed'' brands and parental cigar use and the negative
association between the listed cigar brands and parental cigar use.
Consequently, FDA does not believe this study demonstrates that youth
do not use premium cigars. These comments also did not provide
persuasive peer-reviewed evidence indicating that youth and young
adults do not use these products. In addition, comments stating that
youth and adult cigar use studies are not conclusive with regard to
premium cigars because they do not differentiate between cigar types
are not persuasive. Such studies show that youth and young adults smoke
cigars, and other studies that do differentiate between product types,
such as those previously discussed, indicate that youth and young
adults do, in fact, use premium cigars.
    In light of the health risks associated with the use of all types
of cigars, FDA has selected Option 1 and is deeming all cigars,
including premium cigars, in this rule.
    (Comment 93) A few comments disagreed with FDA's characterization
of one study cited in the NPRM (Ref. 103) for the proposition that
young

adults often mistakenly view non-cigarette tobacco products, such as
cigars, as safe alternatives to cigarettes. They noted that most young
adult participants in the study rated shisha, herbal cigarettes, and