1114.27(a)(1), it may slow down the substantive review process.
    iv. Tobacco ingredients. Section 1114.7(i)(1)(iv) requires
information regarding tobacco ingredients, including:
     The type(s) of tobacco (e.g., Bright, Burley,
reconstituted). This information is important to determining the public
health impact of the products because different types of tobacco have
different constituent profiles. In the proposed rule, we also included
a requirement to specify the grade(s) of the tobacco and we have
removed this due to the general lack of standardized grading systems.
     the quantity, with the unit of measure (including ranges
or means, and acceptance limits), of each tobacco ingredient in the new
tobacco product reported as mass per gram of tobacco for nonportioned
tobacco products and as mass per portion for portioned tobacco products
(with any specification variation, if applicable);
     the specification(s) of tobacco used for the new tobacco
product (with any specification variation, if applicable); and
     a description of any genetic engineering that impacts
characteristics of the tobacco product, such as the constituent
profile.
    Additionally, FDA recommends a PMTA contain any other information
about tobacco ingredients to fully characterize the new tobacco
product, as applicable, such as country of origin, which can reflect
different constituent levels (Ref. 41). While failure to include other
information about tobacco ingredients to fully characterize the tobacco
product would not serve as the basis for FDA refusing to accept or file
an application under Sec.  1114.27(a)(1), it may slow down the
substantive review process. If the new tobacco product does not contain
tobacco (e.g., rolling paper or tipping paper), this section of the
application must specifically state that the product does not contain
tobacco.
    FDA requires in Sec.  1114.7(i)(1) that ingredient quantities be
reported as mass per gram of tobacco for nonportioned tobacco products
and as mass per portion for portioned tobacco products. These specific
measurements provide consistent, complete information that allows FDA
to understand the ingredient quantities. In contrast, if ingredient
quantities were reported as percentages, FDA would have to make
assumptions about the denominator used to calculate the percentage. For
example, if xylitol were reported as 10 percent of a portioned moist
snuff, FDA would not able to determine if xylitol was 10 percent of the
mass of the tobacco filler or of the entire product (containing filler,
paper, etc.). For more information on uniquely

identifying components, ingredients, and additives and reporting their
quantities, please refer to FDA's guidance for industry entitled
``Listing of Ingredients in Tobacco Products.''
    v. Constituents. Section 1114.7(i)(1)(v) requires a full statement
of the constituents, including HPHCs and other constituents, contained
within, or emitted from (including its smoke or aerosol), the product,
including any reaction products from leaching or aging. FDA considers
constituents to be properties of the new tobacco product, a full
statement of which is required to be in a PMTA by section 910(b)(1)(B)
of the FD&C Act. The constituents contained within, and delivered from,
the product can be detected through constituent testing on the product.
The constituent testing should reflect the various conditions under
which consumers may use the product (e.g., light use, typical use, and
heavy use) and the types of products that consumers are likely to use
in conjunction with the product. For example, an open (refillable) e-
cigarette should be tested with a variety of e-liquids that consumers
are likely to consume using the e-cigarette. The reports of constituent
testing must be conducted in the manner required by, and include all
information that is specified in, Sec.  1114.7(i)(1)(v), including the
full test data.
    FDA published an initial list of the constituents that it has
identified as HPHCs in the Federal Register of April 3, 2012, which it
intends to update periodically by providing the public with notice and
the opportunity to submit comments. FDA recently proposed the addition
of 19 constituents to the established list of HPHCs.\20\
---------------------------------------------------------------------------

    \20\ 84 FR 38032 (August 5, 2019).
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    The constituent testing data FDA requires for all products include:
     The constituent names in alphabetical order;
     the common name(s);
     the CAS number;
     the mean quantity and variance with unit of measure;
     the number of samples and measurement replicates for each
sample. As stated in Sec.  1114.7(i)(4)(iv), the testing must be
conducted using a sufficient sample size and number of replicates to
substantiate the results of the type of testing conducted;
     a description of method procedure, method validation
information, and rationale for selecting each test method (as required
by Sec.  1114.7(i)(4)(v));
     the name and location of the testing laboratory or
laboratories and documentation showing that the laboratory or
laboratories is (or are) accredited by a nationally or internationally
recognized external accreditation organization (as required by Sec.
1114.7(i)(4)(i));
     the length of time between dates of manufacture and
date(s) of testing (as required by Sec.  1114.7(i)(4)(ii));
     storage conditions of the tobacco product before it was
tested. It is important for FDA to understand the storage conditions
before testing because they could affect the quantity of volatile
organic compounds or promote microbial growth in the tobacco product
(as required by Sec.  1114.7(i)(4)(iii));
     reports of constituent testing that include test
protocols, any deviation(s) from the test protocols, quantitative
acceptance (pass/fail) criteria, line data, and a summary of the
results, for each applicable parameter (as required by Sec.
1114.7(i)(4)(vi)); and
     complete descriptions of any smoking or aerosol generating
regimens used for analytical testing that are not standardized or
widely accepted by the scientific community, if applicable (as required
by Sec.  1114.7(i)(4)(vii)).
    Multiple comments provided feedback or requested clarification
related to these provisions, as discussed below.
    (Comment 39) One comment requested additional clarification
regarding the HPHCs for which an applicant must conduct testing when
submitting a PMTA for an ENDS. The comment noted the proposed addition
of 19 constituents to the established list of HPHCs and sought further
information regarding what must be submitted in a PMTA.
    (Response 39) The rule requires each applicant to submit
information regarding all constituents contained in and emitted from
the product, which could include both constituents that are contained
within the established list of HPHCs and those that are not on the
list. FDA's recommendations regarding constituents in an ENDS for which
a prospective applicant might want to consider testing, as appropriate
for its specific product, are discussed elsewhere in this document (see
Response 35).
    (Comment 40) One comment stated that while consideration of the
constituents on FDA's list of HPHCs is important, FDA should not give
it undue emphasis because there are other toxins in tobacco products
that are not on this list. The comment stated an application's exposure
assessment should cover the full range of exposures generated by the
new product and that FDA should revise the rule to clearly state that
evidence of biological and clinical effects of the product will be
given more weight than measures of exposure.
    Another comment stated that the definitions of the terms
``constituent'' and ``HPHC'' are so broad that the requirement in Sec.
1114.7(i)(1)(v) to report all constituents contained within or emitted
from the product could be difficult for applicants. The comment stated
that there are practical constraints on the number, capacity, and
capability of laboratories equipped to conduct the testing. The comment
also expressed concern that FDA could potentially refuse to file an
application in which an applicant omitted a constituent. The comment
suggested that FDA revise the rule so that an application would be
required to contain only information for ``relevant'' constituents and
HPHCs, rather than all constituents. Specifically, the comment
recommended that the inclusion of constituent and HPHC information
should be based on a comprehensive risk assessment of the particular
product.
    (Response 40) FDA declines to make revisions in response to these
comments. An application is not required to contain testing for all
HPHCs on the initial list; rather, it must contain testing for HPHCs
that are contained within and can be delivered by the type of product
and contain a description of why the HPHCs that were tested are
appropriate for the type of product. FDA declines to limit the scope of
the constituents that must be reported in a PMTA to only those that an
applicant considers to be relevant because it may impair FDA's ability
to determine the health risks of a new tobacco product. As discussed in
the rule, the constituents contained within and delivered from a
tobacco product directly relate to its health risks. The HPHC list can
be helpful to applicants in preparing a description of why the HPHCs
for which it tested are appropriate for the product type, including,
where appropriate, why an applicant did not test for certain HPHCs. For
example, a PMTA for a smokeless tobacco product would not be required
to contain testing results for HPHCs that are a byproduct of combustion
(e.g., carbon monoxide) where the product does not contain or deliver
such constituents. However, a PMTA for an inhaled tobacco product that
an applicant claims aerosolizes a substance but does not combust it,
such as an e-cigarette or heated tobacco product, should provide
evidence, such as testing for HPHCs that result from complete or
incomplete combustion, to demonstrate that the product is not
combusted. For recommendations on constituent testing

for ENDS products, please see the ENDS PMTA Guidance.
    Additionally, FDA declines to revise the rule to assign weight to
different types of evidence. Finding that there is a showing that
permitting the marketing of a new tobacco product would be APPH is a
complex determination that must be made with respect to risks and
benefits to the population as a whole, considering the likelihood of
changes in tobacco product use behavior (including initiation and
cessation) caused by the marketing of the new tobacco product. When
determining whether the marketing of a particular new tobacco product
would be APPH, FDA will evaluate the factors in light of available
information regarding the existing tobacco product market, tobacco use
behaviors, and the associated health risks at the time of review.
    (Comment 41) One comment requested FDA provide greater detail
regarding the ranges of constituents that would be acceptable in a
PMTA.
    (Response 41) FDA does not set limits for what constitutes
acceptable ranges for constituents as a part of this rulemaking. FDA's
APPH determination will include a consideration of constituent levels
and their resulting health risks; however, FDA must also consider of a
variety of information related to health risk and tobacco product use
behaviors. FDA recommends that applicants take all the necessary steps
in controlling and mitigating any circumstances that may affect the
constituent yields generated from a new tobacco product as this may
impact the risks and benefits associated with the new tobacco product
on the population health as a whole, when compared to other products on
the market.
    (Comment 42) One comment stated the final rule must provide greater
detail regarding the appropriate validated methodologies or regimens
required for testing.
    (Response 42) As discussed in Sec.  1114.7(i)(1)(v), for combusted
or inhaled tobacco products, constituent smoke or aerosol yields from
the new product must be determined using intense and nonintense smoking
or aerosol-generating regimens, where established. Two smoking or
aerosol-generating regimens are required, where established, to
understand the way that constituent yields delivered by a tobacco
product can change over a range of different smoking conditions. If
constituent yields were only reported from a single smoking or aerosol-
generating regimen, FDA would have limited and potentially misleading
information about constituent yields produced by a given tobacco
product. Many studies demonstrate that different smoking regimens
result in different constituent yields from the same product (Refs. 42
and 43). By requiring both an intense and a nonintense smoking or
aerosol generating regimen, where established, FDA will have a better
understanding of quantities of each constituent that may be produced by
the tobacco product when used under different conditions. If no intense
and nonintense smoking or aerosol-generating regimens (e.g.,
International Organization for Standardization (ISO) and Health Canada
Intense (HCI) regimens for cigarettes, Cooperation Centre for
Scientific Research Relative to Tobacco (CORESTA) regimens for cigars)
have been established and an applicant must use an alternative regimen,
an applicant should provide an explanation as to why the alternative
regimen provides comparable results. For ENDS products, for example,
where intense and nonintense regimens may have not been established,
the application must contain an explanation of why the alternative
regimen provides comparable results to the intense and nonintense
regimens.
    (Comment 43) One comment stated that manufacturers of premium
cigars should not be required to submit information regarding HPHCs and
other constituents. The comment stated that not only is there a lack of
testing standards, the variability inherent in premium cigars would
render the results of any constituent testing worthless for assessing a
product.
    (Response 43) As stated in Sec.  1114.1(d) and described in section
VII.A., this rule does not apply to ``premium'' cigars. To the extent
this comment is applicable to products other than ``premium'' cigars,
such as large cigars that do not meet the definition of ``premium''
cigar, FDA disagrees with this comment. Each applicant that submits a
PMTA is required by Sec.  1114.7(i)(1)(v) to conduct constituent
testing and submit the results as part of their application.
Understanding the constituents contained within and emitted from a
tobacco product is a crucial component of being able to determine its
health effects, which is why FDA will refuse to accept a PMTA (under
Sec.  1114.27(a)(1)), as appropriate, where it lacks constituent
testing information required by Sec.  1114.7(i)(1)(v). Where a
product's ingredients have natural variability that could affect
constituent testing results, FDA recommends an applicant submit
scientific evidence justifying why the results reflect the natural
variability of the ingredients in the new tobacco product. This
evidence could include items such as scientific literature establishing
the variability of the product, information related to international or
national testing standards, or data from an investigation with
sufficient sample size to demonstrate attributes affecting variability
of the test results (e.g., weight, smoke efficiency, crop year to crop
year, region to region). Additionally, CORESTA \21\ have established
and published methods on how to generate cigar smoke to quantitatively
compare HPHCs found in cigar smoke.
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    \21\ CORESTA standards that applicants might consider include
CORESTA Reference Method (CRM) 46: Atmosphere for Conditioning and
Testing Cigars of all Sizes and Shapes; CRM 47: Cigars--Sampling;
CRM 64: Routine Analytical Cigar-Smoking Machine--Specifications,
Definitions and Standard Conditions; CRM 65: Determination of Total
and Nicotine-Free Dry Particulate Matter using a Routine Analytical
Cigar-Smoking Machine--Determination of Total Particulate Matter and
Preparation for Water and Nicotine Measurements; CRM 66:
Determination of Nicotine in the Mainstream Smoke of Cigars by Gas
Chromatographic Analysis; CRM 67: Determination of Water in the
Mainstream Smoke of Cigars by Gas Chromatographic Analysis; CRM 68:
Determination of Carbon Monoxide in the Mainstream Smoke of Cigars
by Non-Dispersive Infrared Analysis.
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    vi. Container closure system. Section 1114.7(i)(1)(vi) requires
that the application contain a description of the container closure
system for the new tobacco product, if applicable, including
information describing how the container closure system protects and
preserves the product from damage during transport, environmental
contaminants, and leaching and migration of constituents into the new
tobacco product. The description must also contain information
describing design features developed to prevent the risk of accidental
exposure, if any (e.g., child resistant packaging for e-liquids). These
descriptions are important to FDA's review of the product because they
help demonstrate that the product used by consumers is in the same
condition as that described in the application and manufactured by the
applicant and provide information regarding whether the container
closure system has any features that could prevent accidental exposure.
    Additionally, evidence demonstrates that the container closure
system used can change the characteristics of the product. For example,
substances within the packaging materials can affect product moisture
(e.g., when the manufacturer changes the container closure system of a
moist snuff from plastic to fiberboard), which can affect microbial
stability and TSNA formation during storage (Ref. 44). Another example
is when menthol or other

ingredients are applied to the inner foil of a cigarette package to
become incorporated into the consumed product (Ref. 1). The container
closure system may also be intended or reasonably expected to affect
the characteristics of a tobacco product by impacting the rate of
leaching into, and ultimately, the amount of substances found in, the
consumable tobacco product. In fact, it has been demonstrated that
compounds in the container closure system may diffuse into snuff and
affect its characteristics (Ref. 2). Thus, for example, packaging
material that affects the characteristics of a tobacco product by
impacting the moisture level or shelf life of a tobacco product is a
container closure system (e.g., a plastic container compared to a metal
container of smokeless tobacco) because a difference in tobacco
moisture is reasonably expected to affect microbial growth in the
product, extraction efficiency, and total exposure to nicotine or the
carcinogens NNN or NNK. For additional examples of container closure
systems, see the ENDS PMTA Guidance.
    vii. Statement of tobacco blending, reconstitution, and
manipulation. Finally, the rule requires a PMTA to contain a full
statement of the tobacco blending, reconstitution, or manipulation,
where applicable. This may include manufacturer specifications, and
tobacco types, and quantities. This information is important because it
helps FDA understand the characteristics of the tobacco product.
Information on tobacco types and quantities used by an applicant (where
applicable) will help FDA understand the composition of tobacco used,
which can provide important information since the tobacco types and
quantities may impact the tobacco chemistry (e.g., the nicotine
content) and, thereby, the chemical composition of the tobacco product
(Ref. 45).
    b. Other properties. Section 1114.7(i)(2) describes additional
parts of FDA's interpretation of the requirement in section
910(b)(1)(B) of the FD&C Act to provide a full statement of the product
properties and, together with FDA's authority under section
910(b)(1)(G), requires the applicant to provide a full description of
the properties of the tobacco product that includes:
    i. Product dimensions and construction. The product dimensions and
the overall construction of the product using a diagram or schematic
drawing that clearly depicts the finished product and its components
with dimensions, operating parameters, and materials. Under the
definition of finished tobacco product (which includes all components
and parts, sealed in final packaging), the dimensions and schematic
drawings are required to include the final packaging. The diagram or
schematic is an annotated graphical representation that will help FDA
understand the applicant's nomenclature, how the components and parts
function together, and the overall principles of operation of the
finished tobacco product.
    ii. Design parameters and test data. All design parameters of the
product and test data, specifying nominal values or the explicit range
of values as well as the design tolerance (i.e., upper and lower range
limits), where appropriate. Changes in design parameters can change the
health impact of the tobacco product by affecting the level of
constituents that reach the user or nonuser and are also necessary to
fully characterize a tobacco product. Given the potential health
impacts associated with changes in design parameters as well as the
importance of design parameters in fully characterizing a product, the
PMTA review process does not simply note or link these parameters to
the product and any associated constituents. Instead, during PMTA
review, FDA evaluates how products are manufactured, and the controls
put in place during production. For the PMTA pathway, FDA reviews
whether each design parameter meets its specification through test
data, determining whether each parameter is adequately controlled via
documented processes, determining whether safeguards are in place
against hazards and foreseeable misuse, and assessing how the applicant
deals with nonconforming products. FDA believes it is necessary to
review sufficient information to ensure that products marketed under
the PMTA pathway have the necessary manufacturing and control processes
in place. Tables 1 through 22 in Sec.  1114.7(i)(2)(ii)(B) provide the
parameters that are required for different categories of tobacco
products. As part of the full description of the properties of the
tobacco product, the rule also requires, as included in the tables, a
quantitative description of the performance criteria, including test
protocols, test data, and a summary of the results, for each applicable
design parameter and manufacturing step. The test data is a required
part of the PMTA to demonstrate the product consistently meets the
nominal values or range of values as well as the design tolerance.
While test data is a required part of the PMTA, FDA does not require
test data for all the parameters for which it requires target and
range. For example, for parameters that are observational (e.g., number
of waterpipe holes), FDA would not seek test data on that parameter.
Also, some design parameters are machine settings (e.g., tobacco cut
size), calculated (e.g., denier per filament (DPF)), provided by
suppliers (e.g., certificate of analysis for base paper porosity), or
can be extrapolated from other design parameter test data (e.g., filter
pressure drop test data is more informative than filter length test
data). Test data would not be needed for such parameters. In addition,
in tables 1 through 22, FDA has clarified alternative terminology for
``porosity'' understanding that applicants may refer to this term as
``permeability'' for several design parameters as well as adding units
of measure for several design parameters. The design parameters, their
importance to understanding their impact on public health, and methods
for applicants to provide this information are described below.
    One way an applicant can provide the information needed for a
product's required design parameters is with a Manufacturing Data Sheet
Specification (MDSS) document. The MDSS is a document typically
maintained by manufacturers, describing all the parameters that are
controlled by the manufacturer during manufacture of their tobacco
products. There will be cases where the design parameters on the MDSS
will not directly translate into one of the product-specific design
parameters in section 1114.7(i)(2)(ii). In these cases, additional
information would need to be submitted to provide the complete
characterization necessary. There may also be instances (e.g., for
novel tobacco products in one of the categories described in table 1 to
Sec.  1114.7(c)(3)(iii)) where one or more of the required design
parameters do not apply to the tobacco product described in the PMTA.
In these instances, an applicant must justify why the required design
parameter does not apply or how an alternative design parameter(s)
would satisfy one or more of the required design parameters. Similarly,
for test data, an applicant must justify why the required test data
does not apply or how alternative test data should be considered by FDA
in lieu of the required test data. Further, there may be instances
where the tobacco product may not fit into any of the categories
described in table 1 to Sec.  1114.7(c)(3)(iii). In these instances,
the applicant must provide design parameters that would fully
characterize their product. Additionally, if there are

design parameters beyond what FDA is requiring that would characterize
the tobacco product, applicants should provide those to aid in FDA's
scientific review. While failure to include additional design
parameters to fully characterize the tobacco product beyond what FDA is
requiring under this rule would not serve as the basis for FDA refusing
to accept or file an application under Sec.  1114.27(a)(1), it may slow
down the substantive review process.
    Applicants should also state whether the ranges or tolerances
associated with each design parameter correspond to product or process
controls, and what actions the applicant takes when test data falls
outside of these specified ranges. As an example of product and process
controls, a smokeless tobacco product may have set design parameters
(also known as product specifications) for pH and oven volatiles (OV).
The applicant may establish process controls for the fermentation
process by setting lower and upper temperature and humidity limits for
specified time durations. At the end of the fermentation process, a
sample may be tested to verify that the tobacco product meets the
established pH and OV design parameter limits. For any design
parameters that are provided that are not included in the tables to
Sec.  1114.7(i)(2)(ii)(B), applicants must provide test data or process
information to demonstrate that these parameters or their associated
processes are adequately controlled.
    Table 1 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for cigarettes. In this final rule we have revised
table 1 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
These changes include: (1) Removal of the proposed requirement for
applicants to provide cigarette draw resistance, as FDA determined that
requiring this parameter was unnecessary and not as informative as
pressure drop as draw resistance could be modified by the user by
puffing more or less intensely; (2) removal of cigarette paper base
paper basis weight and tipping paper basis weight, as they are not as
informative as other design parameters, such as cigarette paper base
paper porosity; (3) removal of plug wrap parameters, as the effects of
plug wrap are not as informative as cigarette paper parameters; (4)
removal of cigarette mass, paper width, filter diameter, tipping paper
width, and tobacco rod length, as these parameters can be either
calculated from other required design parameters or are not as
informative as other required parameters; (5) removal of filter mass
and filter tow crimp index, as these parameters have less of an impact
on the filter efficiency than other required design parameters that
will affect the smoke constituents that are exposed to users and
nonusers; (6) removal of filter ventilation position of holes, filter
ventilation number of holes, and filter ventilation number of rows as
filter ventilation, which is still required, is affected by these
parameters; (7) the inclusion of filter efficiency as an alternative to
DPF, total denier, or filter density, if available, as these parameter
have a direct effect on filter efficiency and vice versa; (8) the
option to provide cigarette diameter as an alternative to cigarette
circumference as FDA is able to calculate the necessary information
based on either one; and (9) the option for the applicant to provide
cigarette paper band diffusivity in lieu of cigarette paper band
porosity, if applicable (also described as permeability). FDA has
clarified terminology for cigarette paper band porosity, as applicants
may refer to this term as permeability, and also provided an
alternative to providing cigarette paper band porosity or
permeability--band diffusivity, while not preferred, is an acceptable
alternative if it is currently not part of an applicant's practice to
specify cigarette paper band porosity. While there are minor
differences (porosity is more relevant during active puffing, whereas
diffusivity is more relevant during smoldering), the addition of
diffusivity as an alternative parameter allows flexibility to
applicants who do not directly measure porosity or permeability (see
Ref. 46).
    Additionally, FDA has revised certain proposed parameters for test
data, which includes: (1) Removal of puff count as this was duplicative
of information that an applicant would submit with smoke constituent
data since puff count is determined in a smoking machine using either
the ISO or HCI smoking regimen or other applicable regimen; (2) removal
of cigarette draw resistance, as explained above; (3) removal of
cigarette mass, cigarette paper base paper and tipping paper basis
weight, as explained above; (4) removal of plug wrap parameters, as
explained above; (5) removal of tipping paper width and tipping paper
perforation, as explained above; (6) removal of tipping paper length
and width, tobacco rod length, cigarette paper length and width,
cigarette length, cigarette diameter, cigarette paper band width,
cigarette paper band space, filter diameter and length as these are
measured parameters, that are not needed as test data; (7) removal of
filter tow crimping index and filter mass, as explained above. The
finalized parameters listed in table 1 to Sec.  1114.7(i)(2)(ii)(B) are
a necessary part of the application because they are needed to fully
characterize the product and changes in these parameters may affect the
cigarette's impact on the public health, as described below:
     Cigarette length may alter tobacco biomarker levels (Ref.
47);
     cigarette circumference or diameter may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 48); puff count
can directly affect smoke constituent yields (Ref. 49);
     tobacco filler mass may affect smoke constituent yields
(Ref. 50);
     tobacco rod density may modify burn properties and smoke
constituent yields (Refs. 51 and 52);
     tobacco cut size alters the size of the tobacco pieces,
which may result in more particulate matter (Ref. 53);
     tobacco moisture may affect puff count (Ref. 54);
     cigarette paper base paper basis weight may affect puff
count and smoke constituent yields (Ref. 55);
     cigarette paper base paper porosity or permeability may
affect smoke constituent yields (Ref. 55);
     cigarette paper band porosity or permeability may affect
smoke constituent yields because band porosity allows for the overall
assessment of the weighted change in air flow through the cigarette
paper during active puffing (Ref. 56);
     cigarette paper band diffusivity may affect smoke
constituent yields because it mimics air flow during smoldering (Ref.
57);
     cigarette paper band width may affect ventilation and, in
turn, smoke constituent yields (Ref. 58);
     cigarette paper band space may affect ignition propensity
and, in turn, puff count (Ref. 59);
     filter efficiency may affect smoke constituent yields
(Ref. 58);
     filter DPF, total denier, filter density, and filter
length may affect filter efficiency and, in turn, smoke constituent
yields (Ref. 60);
     filter pressure drop may affect smoke constituent yields
(Ref. 61);
     tipping paper, including length, may affect smoke
constituent yields (Ref. 62); and
     filter ventilation may affect smoke constituent yields
(Ref. 48).
    Table 2 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for

portioned and nonportioned smokeless tobacco products. We have revised
table 2 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
These changes include: (1) Removal of portion thickness, as it is an
unnecessary parameter because it is the pouch effective area that may
result in an increase of the release level of nicotine, unprotonated
nicotine, and could affect TSNA levels, and the pouch effective area
can be calculated from other required design parameters, i.e., pouch
length and pouch width; (2) removal of pouch material nicotine
dissolution extent, as nicotine dissolution rate provides the nicotine
exposure to the user over time, and therefore was considered redundant
and unnecessary; (3) addition of pouch material thickness as this
parameter influences the release level of nicotine and can affect TSNA
levels; \22\ (4) option to provide tobacco particle size in lieu of
tobacco cut size, as tobacco particle size can impact the use profile
of the product and thereby affect the rate and total delivery of HPHCs
similar to tobacco cut size. FDA has revised certain proposed
parameters for test data, which includes the removal the portion
length, width, portion thickness, and material thickness, as these are
measured design parameters that can be obtained from the supplier of
the portion or pouch, and (5) clarification of requiring certain
parameters ``if applicable'' for portioned product properties. While
these parameters are needed for all portioned smokeless products, not
all portioned products are pouched, so the pouch-specific properties
should only be reported if applicable, and thus FDA has added ``if
applicable'' to pouch material porosity or permeability and pouch
material basis weight.
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    \22\ See, e.g., Gale, N., G. Errington, and K. McAdam, Group
Research & Development, British American Tobacco, ``Effects of
Product Format on Nicotine and TSNA Extraction from Snus Pouches,''
Presentation at the 67th Tobacco Science Research Conference,
Williamsburg, VA, September 15-18, 2013. Available at: https://www.researchgate.net/publication/299854728_Effects_of_Product_Format_on_Nicotine_and_TSNA_Extraction_from_Snus_Pouches.
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    The finalized parameters in table 2 to Sec.  1114.7(i)(2)(ii)(B)
are a necessary part of the applications because they are needed to
fully characterize the product and changes in these parameters may
affect the smokeless tobacco product's impact on public health, as
described below:
     Tobacco cut size may alter the particle surface area and
accessibility of saliva to get to the surfaces of the tobacco, thereby
affecting the amount and rate of constituents released from the product
(Ref. 63);
     tobacco moisture may affect microbial growth in the
product, extraction efficiency, and total exposure to nicotine, NNN,
and NNK (Refs. 3 and 64);
     portion mass may affect user exposure to a tobacco product
and, in turn, HPHCs contained in each portion (Ref. 65);
     portion length may affect the constituents in each portion
(Ref. 65);
     portion width may result in a surface area difference,
which is proportional to the amount and rate of constituents released
from the product (Ref. 66);
     pouch material basis weight, pouch material air
permeability, and pouch material thickness influences the interactions
between the tobacco and oral cavity, thereby potentially affecting the
amount and rate of constituents released from the product (Refs. 67,
141, and 142; \23\) and
---------------------------------------------------------------------------

    \23\ See response 45 for additional information.
---------------------------------------------------------------------------

     nicotine dissolution rate is a function of tobacco cut
size and pouch materials, thereby potentially affecting the amount and
rate of constituents released from the product (Ref. 68).
    Table 3 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco rolling paper products. In this
final rule, we have revised table 3 to Sec.  1114.7(i)(2)(ii)(B) to
help ensure that FDA is able to identify and evaluate each product more
accurately and efficiently. These changes include the option to provide
RYO paper band diffusivity in lieu of RYO paper band porosity (also
described as permeability). FDA has clarified terminology for RYO paper
band porosity, as applicants may refer to this term as permeability,
and also provided an alternative to providing cigarette paper band
porosity or permeability--band diffusivity, while not preferred, is an
acceptable alternative if it is currently not part of an applicant's
practice to specify cigarette paper band porosity. While there are
minor differences (porosity is more relevant during active puffing,
whereas diffusivity is more relevant during smoldering), the addition
of diffusivity as an alternative parameter allows flexibility to
applicants who do not directly measure porosity or permeability (see
Ref. 46). Additionally, FDA has revised certain proposed parameters for
test data, which includes the removal the paper length, width, band
space, and band width as these are measured design parameters that are
not needed as test data.
    The finalized parameters listed in table 3 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes in these
parameters may affect the rolling paper's impact on public health, as
described below:
     RYO paper length and RYO paper width may alter the surface
area that is available for tobacco packing, thereby affecting the smoke
constituent yields (Ref. 61);
     RYO mass per paper may be a result of a surface area or
basis weight difference and, in turn, may affect puff count and smoke
constituent yields (Refs. 55 and 61);
     RYO paper base paper basis weight may affect puff count
and smoke constituent yields (Ref. 55);
     RYO paper base paper porosity may affect smoke constituent
yields (Ref. 55);
     RYO paper band porosity may affect smoke constituent
yields because band porosity allows for the overall assessment of the
weighted change in air flow through the cigarette paper during active
puffing (Ref. 56);
     RYO paper band diffusivity may affect smoke constituent
yields because it mimics air flow during smoldering (Ref. 57);
     RYO paper band width may affect ventilation and, in turn,
smoke constituent yields (Ref. 58); and
     RYO paper band space may affect ignition propensity and,
in turn, puff count (Ref. 59).
    Table 4 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco tubes. We have revised table 4 to
Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify
and evaluate each product more accurately and efficiently. These
changes include the addition of: (1) The option to provide tube
diameter as an alternative to tube circumference, as FDA is able to
calculate the information necessary based on either one and (2) the
option for the applicant to provide tube paper band diffusivity in lieu
of tube paper band porosity or permeability, if applicable. FDA has
clarified terminology for RYO paper band porosity, as applicants may
refer to this term as permeability, and also provided an alternative to
providing cigarette paper band porosity or permeability--band
diffusivity, while not preferred, is an acceptable alternative if it is
currently not part of an applicant's practice to specify cigarette
paper band porosity. While there are minor

differences (porosity is more relevant during active puffing, whereas
diffusivity is more relevant during smoldering), the addition of
diffusivity as an alternative parameter allows flexibility to
applicants who do not directly measure porosity or permeability (see
Ref. 46). FDA has revised certain proposed parameters for test data,
which includes the removal of tube length, tube paper width, tube
circumference, tube paper band width, and tube paper band space, as
these are measured design parameters.
    The finalized parameters listed in table 4 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes in these
parameters may affect the RYO tube's impact on public health, as
described below:
     Tube mass may affect smoke constituent yields (Ref. 50);
     tube length may alter tobacco biomarker levels (Ref. 47);
     tube circumference or diameter may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 48);
     tube paper width may affect smoke constituent yields (Ref.
50);
     tube paper base paper basis weight may affect puff count
and smoke constituent yields (Ref. 55);
     tube paper base paper porosity may affect smoke
constituent yields (Ref. 55);
     tube paper band porosity may affect smoke constituent
yields since band porosity allows for the overall assessment of the
weighted change in air flow through the cigarette paper during active
puffing (Ref. 56);
     tube paper band diffusivity may affect smoke constituent
yields because it mimics air flow during smoldering (Ref. 57);
     tube paper band width may affect ventilation and, in turn,
smoke constituent yields (Ref. 58); and
     tube paper band space may affect ignition propensity and,
in turn, puff count (Ref. 59).
    Table 5 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco filtered tubes. In this final rule
we have revised table 5 to Sec.  1114.7(i)(2)(ii)(B) to help ensure
that FDA is able to identify and evaluate each product more accurately
and efficiently. These changes include: (1) The option to provide tube
diameter as an alternative to tube circumference, as FDA is able to
obtain the information necessary from calculations based on what the
applicant submits; (2) the option for the applicant to provide filter
efficiency as an alternative to DPF, total denier, or filter density
(Ref. 60); (3) the option for the applicant to provide diffusivity in
lieu of paper band porosity or permeability, as described in previous
design parameter sections, is an acceptable alternative if it is
currently not part of an applicant's practice to specify paper band
porosity; (4) removal of filter mass, filter diameter, and filter tow
crimping index as these parameters are considered as not as important
as other parameters such as DPF and total denier, and therefore deemed
unnecessary; (5) removal of plug wrap length, width, basis weight, and
porosity as plug wrap parameters contribute to ventilation; however,
filter ventilation and paper porosity have more of an effect on
ventilation and therefore, plug wrap parameters were considered
unnecessary; (6) removal of tipping paper width, basis weight, and
perforation are considered unnecessary because they have little effect
on the airflow and are not combusted during use; and (7) removal of
filter ventilation position of holes, filter ventilation number of
holes, and filter ventilation number of rows as these parameters are
considered redundant because the filter ventilation is affected by
these parameters. The alternatives (filter efficiency and diffusivity)
are also provided under test data for this product category. Further,
FDA has revised certain parameters for test data that were previously
proposed in the PMTA rule, which include: (1) Removal of the tube mass,
tube length, tube diameter, tube paper length, nonfilter tube length,
tube width, tube paper band width and space, filter length, filter
mass, and filter diameter as these are measured design parameters and
(2) removal of filter tow index, plug wrap length, plug wrap width, and
tipping paper basis weight for reasons described above.
    The finalized parameters listed in table 5 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes in these
parameters may affect the filtered tube's impact on public health, as
described below:
     Tube mass may affect smoke constituent yields (Ref. 50);
     tube length may alter tobacco biomarker levels (Ref. 47);
     tube circumference or diameter may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 48);
     tube paper length directly correlates to non-filter tube
length, which may affect smoke constituent yields (Ref. 50);
     tube paper width may affect smoke constituent yields (Ref.
50);
     tube paper base paper basis weight may affect puff count
and smoke constituent yields (Ref. 55);
     tube paper base paper porosity may affect smoke
constituent yields (Ref. 55);
     tube paper band porosity may affect smoke constituent
yields since band porosity allows for the overall assessment of the
weighted change in air flow through the cigarette paper during active
puffing (Ref. 56);
     tube paper band diffusivity may affect smoke constituent
yields because it mimics air flow during smoldering (Ref. 57);
     tube paper band width may affect ventilation and, in turn,
smoke constituent yields (Ref. 58);
     tube paper band space may affect ignition propensity and,
in turn, puff count (Ref. 59);
     filter efficiency may affect smoke constituent yields
(Ref. 58);
     filter DPF may affect filter efficiency and, in turn,
smoke constituent yields (Ref. 60);
     total denier, filter density, and filter length may affect
filter efficiency and, in turn, smoke constituent yields (Ref. 43);
     filter pressure drop may affect smoke constituent yields
(Ref. 61);
     tipping paper length may affect smoke constituent yields
(Ref. 62); and
     filter ventilation may affect smoke constituent yields
(Ref. 48).
    Table 6 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco. In this final rule, we have
revised table 6 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is
able to identify and evaluate each product more accurately and
efficiently. This change includes the removal of the requirement for
the applicant to provide filler mass as this is provided as part of
unique identification of the tobacco product under Sec.  1114.7(c).
    The finalized parameters listed in table 6 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes in these
parameters may affect the RYO tobacco's impact on public health, as
described below:
     Tobacco cut size alters the size of the tobacco pieces,
which may result in more particulate matter (Ref. 53) and
     tobacco moisture may affect puff count when used with
rolling paper (Ref. 54).
    Table 7 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco paper tips. In this final rule, we
have revised table 7 to

Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify
and evaluate each product more accurately and efficiently. This
includes the replacement of the requirement for the applicant to
provide RYO paper base paper perforation, and instead provide RYO paper
porosity. RYO porosity was found to directly convey the smoke
constituent exposure to users, while paper perforation was less
indicative of the exposure of smoke constituents when accounting for
additional design parameters. FDA has also revised certain parameters
for test data that were proposed previously in the PMTA rule, which
include: (1) Removal of the tip length and width and tip mass as these
are measured design parameters; and (2) replacement of paper
perforation to paper porosity, as described above.
    The finalized parameters listed in table 7 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect the paper tip's impact on public health, as described below:
     RYO paper tip length and RYO paper tip width may alter the
surface area that is available for tobacco packing, thereby affecting
the smoke constituent yields (Ref. 61);
     RYO paper tip mass may be a result of a surface area or
basis weight difference and, in turn, may affect puff count and smoke
constituent yields (Refs. 55 and 61);
     RYO paper base paper basis weight may affect puff count
and smoke constituent yields (Ref. 55);
     RYO paper base paper porosity may affect smoke constituent
yields (Ref. 55); and
     RYO paper tip ventilation may affect smoke constituent
yields (Ref. 48).
    Tables 8 through 12 to Sec.  1114.7(i)(2)(ii)(B) describe the
design parameters and information on performance criteria that must be
contained in a PMTA for products categorized as cigars. Cigarettes
(outside the category of heated tobacco products) and cigars are
similar, as they are both cylinders filled with a blend of processed
tobacco that is generally smoked. Both are generally lit with a fire
source, which burns the tobacco as the user inhales at one end; thus,
they are consumed and deliver nicotine in a similar manner. A main
difference between cigarettes and cigars is that cigars are either
wrapped in a tobacco leaf (wrapper and binder) or a material containing
tobacco, whereas non-HTP cigarettes are wrapped in paper (cigarette
paper) or a material that does not contain tobacco. Additionally,
cigars come in a wider variety of sizes and some types of cigars may be
thicker in diameter and contain more tobacco filler than cigarettes.
Despite these differences, for both types of tobacco products, no
matter the size, air is pulled through the tobacco column, which aids
in tobacco combustion and nicotine delivery. Cigarette paper commonly
has an established porosity (permeability), that is set during
manufacturing, while cigar wrapper properties are based on the tobacco
used as the wrapper. Although cigars and cigarettes are wrapped in
different materials, both cigar wrappers and binders, as well as
cigarette papers, have inherent permeabilities/porosities, which may
affect smoke constituent yields. Cigars may be filtered (containing
filter tow or other materials), unfiltered, or unfiltered with tips
made of wood or plastic, while most cigarettes have filters (containing
filter tow) and do not contain tips. If a cigar does contain a filter,
it will be similar to cigarette filters and contain tow. Based on FDA's
experience with cigarettes under the SE pathway, as well as the
similarities between the two products, FDA has used established design
parameter information from cigarettes to develop some of the design
parameter requirements for cigars. Tables 8 through 12 to Sec.
1114.7(i)(2)(ii)(B) describe in more detail the parameters for each
subcategory of cigars.
    Table 8 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for filtered, sheet-wrapped cigars. In this final
rule we have revised table 8 to Sec.  1114.7(i)(2)(ii)(B) to help
ensure that FDA is able to identify and evaluate each product more
accurately and efficiently. These changes include (1) the addition of
cigar wrapper and binder band space, as these parameters affect smoke
constituents; (2) the addition of cigar minimum and maximum diameter
(mm), as the shape of cigars can differ, with the tips being narrower
than the center of the cigar, affecting the rod density, which in turn
modifies the burn properties and smoke yields; (3) providing applicants
the option to provide oven volatiles as an alternative to tobacco
moisture, as well as the option to provide oven volatiles instead of
moisture, as this provides similar information to FDA \24\ and allows
the applicant flexibility to provide either parameter based on the
specific manufacturing processes they employ; and (4) removing cigar
length, cigar diameter, filter diameter, filter length as requirements
for test data as these are measured design parameters that are not
needed as test data.
---------------------------------------------------------------------------

    \24\ Please note that the term ``moisture,'' has widely varying
and conflicting definitions and terminology in use within the
tobacco industry. It is common for ``moisture'' or ``moisture
content'' to be used to refer to water content of a material but in
relation to the tobacco industry it is necessary to differentiate
between ``moisture'' as water content and ``moisture'' as oven
volatiles. https://www.coresta.org/sites/default/files/technical_documents/main/PTM-CTR_MoistureWaterOvenVolatiles_July2014%282%29.pdf.
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    Additionally, based on FDA's understanding of machine-made cigars
and their similarity to cigarettes, we have also included design
requirements previously recommended in the proposed PMTA rule. These
design parameters include (1) cigar mass, wrapper and binder basis
weight, cigar binder and wrapper length and width, cigar wrapper and
binder band porosity, and cigar wrapper and binder width, as these
design parameters may affect smoke constituent yields and (2) the
option for the applicant to provide filter efficiency, if available, as
an alternative to DPF, total denier, or filter density. We have also
included test data requirements for cigar mass, puff count, wrapper and
binder basis weight, and cigar minimum and maximum diameter for reasons
previously discussed.
    The finalized parameters listed in table 8 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect the cigar's impact on public health, as described below:
     Cigar mass reflects the amount of tobacco in a cigar,
which may affect smoke constituent yields (Ref. 69);
     cigar puff count can directly affect smoke constituent
yields (Ref. 69);
     cigar length and diameter can directly affect the amount
of tobacco that is burned and, in turn, affect smoke constituent yields
(Ref. 70);
     tobacco filler mass may affect smoke constituent yields
(Ref. 71);
     for cigarettes, the cigarette paper basis weight may
affect puff count and smoke constituents (Ref. 71). Similarly, for
cigars, the cigar wrapper and binder basis weight may affect puff count
and smoke constituent yields;
     for cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 71). Similarly, for cigars, the
cigar wrapper and binder length and width may directly influence the
area through which air is permitted to enter the tobacco column, which,
in turn, may affect puff count and smoke constituent yields;
     cigar wrapper porosity may affect smoke constituent yields
(Refs. 72 and 73);

     for cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 51 and 52). Similarly,
for cigars, tobacco rod density may modify burn properties and smoke
constituent yields;
     for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for cigars, the tobacco
moisture may affect puff count (Ref. 54);
     for cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter;
     for cigarettes, the band porosity may affect smoke
constituent yields (Ref. 56). Similarly, for cigars, the band porosity
or permeability may affect smoke constituent yields because band
porosity allows for the overall assessment of the weighted change in
air flow through the cigarette paper during active puffing;
     for cigarettes, the band width may affect smoke yields
(Ref. 58). Similarly, for cigars, the wrapper band width and binder
band width may affect ventilation and, in turn, smoke constituent
yield;
     for cigarettes, the band space may affect puff count (Ref.
59). Similarly, for cigars, the wrapper band space and binder space may
affect ignition propensity and, in turn, puff count;
     for cigarettes, the filter parameters can impact smoke
yields (Ref. 60). Similarly, for cigars, the filter diameter, filter
mass, filter tow crimping index, DPF, total denier, filter density, and
filter length may affect filter efficiency and, in turn, smoke
constituent yields;
     For cigarettes, the filter pressure drop affects smoke
yields (Ref. 61). Similarly, for cigars, the filter pressure drop may
affect smoke constituent yields.
     for cigarettes, tipping paper length may affect smoke
constituent yields (Ref. 62). Similarly, for cigars, the tipping paper,
including width, and basis weight, may affect smoke constituent yields;
and
     ventilation may affect smoke constituent yields (Ref. 69).
    Table 9 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for unfiltered, sheet-wrapped cigars. In this final rule, we
have revised table 9 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that
FDA is able to identify and evaluate each product more accurately and
efficiently. These changes include: (1) The addition of overall
diameter because cigar diameter can directly affect the amount of
tobacco that is burned and, in turn, affect smoke constituent yields;
(2) the removal of cigar tip width (mm); (3) the option for applicants
to provide oven volatiles in lieu of tobacco moisture, as this provides
similar information to FDA \25\ and allows the applicant flexibility to
provide either parameter based on the specific manufacturing processes
they employ. In addition, as compared to the proposed PMTA rule, FDA
has removed certain parameters for test data, including the removal of
cigar length, cigar tip length, cigar tip diameter, and cigar tip
width, as FDA has determined that these parameters are not necessary as
test data. Additionally, based on FDA's understanding of cigars and
their similarity to cigarettes, we have also included all the design
requirements previously recommended in the proposed PMTA rule except
cigar burn rate and cigar draw resistance. We have also included the
following test data: Puff count, tobacco rod density, tobacco cut size,
cigar wrapper and binder basis weight, binder porosity, and cigar tip
mass.
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    \25\ See footnote 21.
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    The finalized parameters listed in table 9 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect the cigar's impact on public health, as described below:
     Cigar mass reflects the amount of tobacco in a cigar,
which may affect smoke constituent yields (Ref. 69);
     cigar puff count can directly affect smoke constituent
yields (Ref. 69);
     cigar length and diameter can directly affect the amount
of tobacco that is burned and, in turn, affect smoke constituent yields
(Ref. 70);
     tobacco filler mass may affect smoke constituent yields
(Ref. 69);
     for cigarettes, the cigarette paper basis weight may
affect puff count and smoke constituents (Ref. 71). Similarly, for
cigars, the cigar wrapper and binder basis weight may affect puff count
and smoke constituent yields;
     for cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 71). Similarly, for cigars, the
cigar wrapper length and width and binder width may directly influence
the area through which air is permitted to enter the tobacco column,
which, in turn, may affect puff count and smoke constituent yields;
     cigar wrapper porosity may affect smoke constituent yields
(Refs. 72 and 73).
     for cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 51 and 52). Similarly,
for cigars, the tobacco rod density may modify burn properties and
smoke constituent yields;
     for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for cigars, the tobacco
moisture may affect puff count;
     for cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter;
     for cigarettes, the band porosity may affect smoke
constituent yields (Ref. 56). Similarly, for cigars, the wrapper and
binder band porosity or permeability may affect smoke constituent
yields because band porosity allows for the overall assessment of the
weighted change in air flow through the cigarette paper during active
puffing;
     for cigarettes, the band width may affect smoke yields
(Ref. 58). Similarly, for cigars, the wrapper and binder band width may
affect ventilation and, in turn, smoke constituent yields;
     for cigarettes, the band space may affect puff count (Ref.
59). Similarly, for cigars, the wrapper and binder band space may
affect ignition propensity and, in turn, puff count; and
     cigar tip dimensions directly influence the overall cigar
draw resistance and in turn, puff count (Ref. 74).
    Table 10 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for leaf-wrapped cigars. In this final rule, we have revised
table 10 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is able
to identify and evaluate each product more accurately and efficiently.
These changes include the option to provide oven volatiles instead of
moisture, as this provides similar information to FDA \26\ and allows
the applicant flexibility to provide either parameter based on the
specific manufacturing processes they employ. FDA has also revised
certain parameters for test data previously discussed in the proposed
PMTA rule. Specifically, FDA has removed cigar length as this is a
measured design parameter for which we do not need test data.
Additionally, based on FDA's understanding of leaf-wrapped cigars and
their similarity to cigarettes, we have included the design
requirements that were previously recommended in the proposed PMTA rule
except cigar draw resistance, wrapper and binder porosity, and cigar
burn rate. We have

also included the following parameters for test data that were
previously recommended in the proposed PMTA rule: Puff count, tobacco
rod density, tobacco filler mass, tobacco cut size, and wrapper and
binder basis weight.
---------------------------------------------------------------------------

    \26\ See footnote 21.
---------------------------------------------------------------------------

    FDA has also included: (1) The overall diameter as a design
parameter because cigar diameter can directly affect the amount of
tobacco that is burned and, in turn, affect smoke constituent yields
and (2) tobacco cut size as a design parameter as it can alter the size
of tobacco pieces, which may result in more particulate matter.
    The finalized parameters listed in table 10 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect the cigar's impact on public health, as described below:
     Cigar mass reflects the amount of tobacco in a cigar,
which may affect smoke constituent yields (Ref. 69);
     cigar puff count can directly affect smoke constituent
yields (Ref. 69);
     for cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 71). Similarly, for cigars, the
cigar wrapper length and width and binder width may directly influence
the area through which air is permitted to enter the tobacco column,
which, in turn, may affect puff count and smoke constituent yields;
     cigar length and diameter can directly affect the amount
of tobacco that is burned and, in turn, affect smoke constituent yields
(Ref. 70);
     for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for cigars, the tobacco
moisture may affect puff count;
     for cigarettes, the cigarette paper basis weight may
affect puff count and smoke constituents (Ref. 71). Similarly, for
cigars, the cigar wrapper and binder basis weight may affect puff count
and smoke constituent yields;
     for cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 51 and 52). Similarly,
for cigars the tobacco rod density may modify burn properties and smoke
constituent yields; and
     for cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter.
    Table 11 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for cigar tobacco. In this final rule, we have revised table
11 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
These changes include the option to provide oven volatiles instead of
moisture, as this provides similar information to FDA \27\ and allows
the applicant flexibility to provide either parameter based on the
specific manufacturing processes they employ. FDA has also revised
certain proposed parameters for test data, which includes the option to
provide oven volatiles instead of moisture, as described above. In the
proposed rule, we proposed a recommended design parameter for cigar
tobacco, filler mass. Based on FDA's understanding of cigar tobacco, we
have decided not to include filler mass (mg) as a required design
parameter. FDA has concluded that the amount of tobacco added to a
cigar is generally user-dependent and so, the filler mass of the cigar
tobacco as packaged does not have a direct effect on the smoke
constituents.
---------------------------------------------------------------------------

    \27\ See footnote 21.
---------------------------------------------------------------------------

    The finalized parameters listed in table 11 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect its impact on public health, as described below:
     For cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter and
     for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for cigars, the tobacco
moisture may affect puff count.
    Table 12 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a cigar wrapper. In this final rule, we have revised table
12 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
These changes include, for both target specification and test data, the
replacement of cigar maximum and minimum width with wrapper width, as
not all cigar wrappers have a maximum and minimum width; additionally,
in the proposed rule, we discussed recommended design parameters for
cigar wrappers. Based on FDA's understanding of cigar wrappers, and
because cigar wrapper basis weight affects smoke constituents as well
as puff count, we have included cigar wrapper basis weight in the final
rule. For test data that was previously recommended in the proposed
rule, FDA has included cigar wrapper basis weight as a requirement and
replaced cigar minimum and maximum wrapper width with wrapper width for
the reasons discussed previously.
    The finalized parameters listed in table 12 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect its impact on public health, as described below:
     For cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 71). Similarly, for cigars, the
cigar wrapper length and width may directly influence the area through
which air is permitted to enter the tobacco column, which, in turn, may
affect puff count and smoke constituent yields and
     for cigarettes, the cigarette paper basis weight may
affect puff count and smoke constituents (Refs. 71 and 72). Similarly,
for cigars, the cigar wrapper and binder basis weight may affect puff
count and smoke constituent yields.
    Table 13 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a waterpipe. Cigarette tobacco and waterpipe tobacco are
similar, as they are both processed tobacco that is cut, milled, and
sifted before ingredients are added to control for tobacco moisture and
taste. Therefore, tobacco parameters for a cigarette can be
extrapolated to tobacco parameters for a waterpipe. Additionally, the
waterpipe length of the waterpipe stem causes affects the pressure drop
in the waterpipe in a similar way as to the length of the cigarette
filter and filter tow causes a filter pressure drop in a cigarette:
Both determines the amount of suction a smoker needs to apply to the
tobacco product to draw smoke through. Therefore, filter pressure drop
for a cigarette can be extrapolated to the pressure drop of a
waterpipe. The parameters included in table 13 apply to waterpipes
generally. For products that contain a heating source or waterpipe
tobacco, applications should specify information regarding the heating
source and waterpipe tobacco as described in tables 14 and 15.
    In this final rule, we have revised table 13 to Sec.
1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify and
evaluate each product more accurately and efficiently. These changes
include: (1) The removal of number of hoses as the number of hoses can
vary during smoking session and (2) the change in terminology from
``bowl'' to ``base.'' Additionally, in the proposed rule, we
recommended design parameters for waterpipes. Based on FDA's
understanding of waterpipes, we have

required the following design parameters: (1) Hose length, hose
material, and hose internal diameter, which are directly proportional
to air infiltration and affects toxicant yields; (2) stem length and
stem internal diameter, which impacts puffing behavior and toxicant
exposure; (3) pressure drop, which affects smoke constituent yields;
(4) water filter efficiency, which is directly proportional to
mainstream smoke and can increase exposure to HPHCs; and (5) hose air
permeability and heating source type, as theses parameters have a
direct correlation with toxicants and smoke constituents exposed to
users and nonusers. For test data that was previously recommended in
the proposed rule, FDA is requiring all the parameters except foil
length, foil width, and ventilation.
    Further, based on FDA's understanding of waterpipes, we have also
included the following required design parameters: Base diameter, base
volume, base shape, head height, head top diameter, head bottom
diameter, number of holes, head volume, and head material. The shape
and size of the base can affect the pressure drop or difficulty of
pulling air through the waterpipe hose, while the head dimensions
affect how long a smoke session lasts by controlling how much tobacco
can be used during a session. Head dimensions can also affect airflow
beneath and through the tobacco to make heat transfer more effective,
prolonging smoking sessions. FDA has also included the following
required parameter for test data: Head height, head top diameter, head
bottom diameter, and head volume.
    The finalized parameters listed in table 13 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect its impact on public health, as described below:
     Hose dimensions (length and diameter) are directly
proportional to air infiltration and affects toxicant yields (Ref. 75);
     hose material may affect hose permeability, which may
affect smoke constituent yields (Ref. 75);
     stem length influences draw resistance, which can in turn
impact nicotine and other toxicant delivery to the user (Ref. 76);
     stem internal diameter can impact puffing behavior and
toxicant exposure, and in turn, smoke constituent yields (Ref. 76);
     for cigarettes, the pressure drop effect smoke constituent
yields (Ref. 71). For waterpipes the base diameter and base volume
impact how much water the base can hold and how much water the user can
add to the base and the volume of water impacts the pressure drop or
the difficulty of pulling air through the waterpipe hose. Similarly,
for waterpipes, the pressure drop may result in differences in the
difficulty of pulling air through the waterpipe and, in turn, affect
smoke constituent yields (Ref. 71);
     head dimensions affect how long a smoke session lasts by
controlling how much tobacco can be used during a session. Head
dimensions can also affect airflow beneath and through the tobacco to
make heat transfer more effective, prolonging smoking sessions. With a
wider surface area, there is more room for the head to more evenly
distribute heat to the tobacco. A shallower bowl makes tobacco at the
bottom of the head more accessible to heat and allows for heat to be
more evenly distributed to the tobacco. The more holes in the head, the
more airflow, which affects the tobacco temperature. All of this causes
the tobacco to reach different temperatures that affects smoke yields
(Ref. 75);
     water filtering efficiency is directly proportional to
mainstream smoke and can increase exposure to HPHCs (Ref. 77);
     for cigarettes, the filter pressure drop affects smoke
yields (Ref. 71). Similarly, for waterpipes, the pressure drop may
result in differences in the difficulty of pulling air through the
waterpipe and, in turn, affect smoke constituent yields;
     heating source type affects tobacco temperature, which in
turn, may affect smoke constituent yields (Ref. 78); and
     head material could aid in heat transfer, prolonging the
heating of the tobacco and causing the tobacco to reach temperatures
that affect smoke yields.
    Table 14 in Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for waterpipe tobacco. In this final rule, we have revised
table 14 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is able
to identify and evaluate each product more accurately and efficiently.
These changes include the option for the applicant to provide oven
volatiles as an alternative to tobacco filler moisture. We have
provided this alternative because it will allow the applicant to
provide information needed to evaluate the product without conducting
additional testing as this alternative may satisfy these requirements.
Additionally, in the proposed rule, we recommended a design parameter
for waterpipe tobacco, filler mass. Based on FDA's understanding of
waterpipe tobacco, we have decided not to include filler mass as a
required design parameter for waterpipe tobacco. FDA concluded that the
amount of tobacco added during a given smoking session is user-
dependent and so, filler mass of the waterpipe tobacco as packaged does
not have a direct impact on smoke constituents.
    The finalized parameters listed in table 14 to Sec.
1114.7(i)(2)(ii)(B) are necessary to fully characterize the product and
changes may affect its impact on public health as follows:
     For cigarettes, the tobacco cut size may result in more
particulate matter (Refs. 53 and 54). Similarly, for waterpipe tobacco,
the tobacco cut size alters the size of the tobacco pieces, which may
result in more particulate matter. Finer tobacco cut size may result in
a decrease in filling power and in turn, a larger amount of tobacco in
the bowl (Refs. 53 and 54) and
     for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for waterpipe tobacco, the
tobacco moisture may affect puff count. Moisture contributes to packing
density, thus decreasing void volume (Ref. 54).
    Table 15 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a waterpipe heating source. In this final rule, we have
revised table 15 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA
is able to identify and evaluate each product more accurately and
efficiently. These changes include: (1) The removal of heating source
type. As there are multiple types of heating source for waterpipe,
instead of asking for the source type, FDA has changed the terminology
and considered all heating sources as the heating element and (2) the
removal of charcoal temperature and coil temperature range, as
described above, FDA considers all heating sources the heating element;
therefore, the charcoal and coil temperature have been removed and
replaced with ``heating element temperature.'' FDA has also revised the
test data and removed test data for charcoal temperature range and coil
temperature range, for reasons previously described.
    Additionally, in the proposed rule, we recommended design
parameters for waterpipe heating source. Based on FDA's understanding
of waterpipe heating sources, we have included some of these design
parameters, including those related to batteries and power delivery
units (PDU). The finalized parameters listed in table 15 to

Sec.  1114.7(i)(2)(ii)(B) are necessary to fully characterize the
product and changes may affect its impact on public health as follows:
     When combusted, heating sources such as charcoal or wood
cinders expose the user to high yields of toxicants such as carbon
monoxide and polycyclic aromatic hydrocarbons. Therefore, the heating
source mass, density, and temperature may affect smoke constituent
yields (Ref. 78);
     for ENDS, the number of elements affects resistance and
distribution of heat dissipation (Ref. 79). Similarly, for waterpipe
heating source, the number of heating elements can affect resistance
and distribution of heat dissipation;
     for ENDS, the heating element configuration effect affect
toxicant emissions and nicotine delivery (Refs. 80-84). Similarly, for
waterpipe heating source, the eating element configuration may affect
overall heating element resistance, thereby influencing heating element
temperature. The heating element temperature may affect toxicant
emissions and nicotine delivery;
     for ENDS, the heating element diameter may affect toxicant
emissions and nicotine delivery (Refs. 80-84). Similarly, for waterpipe
heating source, the diameter of the heating element affects its
resistance. Heating element resistance may influence heating element
temperature, which in turn affects toxicant emissions and nicotine
delivery;
     for ENDS, an increase in battery capacity (mAh rating) can
increase the number of puffs the e-cigarette can deliver per vaping
session. Longer vaping sessions may lead to greater exposure to
toxicant emissions (Ref. 83). Similarly, for waterpipe heating source
the battery mAh ratings is a measure of the average amount of current
the battery releases over time under normal. Current may influence the
heating element temperature, which in turn affects toxicant emissions
and nicotine delivery. In addition, provides understanding how long a
battery will last and thus the product stability;
     for ENDS, the battery and PDU voltage impacts the amount
of e-liquid consumed, the vapor temperature, and the total emissions of
volatile aldehydes (Ref. 85). Similarly for waterpipe heating sources,
the battery voltage operating range and PDU voltage operating range
(volts) impact the amount of e-liquid consumed, the vapor temperature,
and the total emissions of volatile aldehydes;
     for ENDS, the battery type, battery current operating
range, battery failure safety features, battery conformance to
standards, and PDU current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 58 and 86).
Similarly, for waterpipe heating source, the battery current operating
range is a measure of the current batteries put out to heat the heating
element of the product. The battery should have a normal operating
range as to not overheat the product and cause it to become a hazard to
the user. In addition, this current range has a direct impact on the
heating element, which in turn affects the smoke constituent yields;
     for ENDS, the battery and PDU voltage impacts the amount
of e-liquid consumed, the vapor temperature, and the total emissions of
volatile aldehydes (Ref. 85). Similarly for waterpipe heating source
the PDU voltage operating range impacts the amount of e-liquid
consumed, the vapor temperature, and the total emissions of volatile
aldehydes;
     for ENDS, the battery type, battery current operating
range, battery failure safety features, battery conformance to
standards, and PDU current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 58 and 86).
Similarly for waterpipe heating source, the PDU current operating range
is a measure of the current output to heat the heating element of the
product, which, if not adequately controlled can lead to overheating
the product subsequently may harm the user. In addition, this current
range has a direct impact on the heating element, which in turn affects
the smoke constituent yields; and
     for ENDS, PDU current operating range and wattage range
are necessary for evaluating battery and PDU safety. Risks of e-
cigarette battery explosion, leakage, fire, or overheating are a safety
concern (Refs. 80 and 86). Similarly, for waterpipe heating source the
PDU wattage operating range determines the amount of heat produced. PDU
wattage or wattage operating range may affect the heating element
temperature, thereby affecting toxicant emissions.
    Table 16 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for waterpipe foil. In this final rule, we have revised table
16 to Sec.  1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
Specifically, in the proposed rule, we recommended design parameters
for waterpipe foil. Based on FDA's understanding of waterpipe foil, we
have included the following design parameter requirements: Foil
diameter, foil thickness, number of holes, and diameter of holes. We
have added these parameters because foil parameters affect smoke
constituent yields, and ultimately, the user's exposure to toxicants
and HPHCs. FDA has also revised the required test data to include the
following parameters for the reasons detailed previously: Foil
diameter, foil thickness, and diameter of the holes. Waterpipe foil
length and width were erroneously listed both as required parameters
(in table 16) and as recommended parameters in table 16a. FDA notes
that waterpipe foil length and width are included in the final rule
required parameters.
    The finalized parameters listed in table 16 to Sec.
1114.7(i)(2)(ii)(B) are necessary to fully characterize the product and
changes may affect its impact on public health as follows.
     Waterpipe foil length, diameter, and width are necessary
because they impact the user's puffing behavior and toxicant exposure.
Therefore, the foil dimensions may affect smoke constituent yields
(Ref. 76);
     waterpipe foil thickness influences the distribution of
heat to the tobacco, affecting tobacco temperatures and therefore smoke
constituent yields (Ref. 76); and
     the number and diameter of holes impacts the path of hot
gases through the tobacco mixture, which may affect smoke constituent
yields (Ref. 76).
    Table 17 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a waterpipe head. These parameters are a necessary part of
the application because they are needed to fully characterize the
product and changes may affect the waterpipe head's impact on public
health, as described below:
     Head dimensions (height, top diameter, bottom diameter),
including number of holes, and head volume, affect how long a smoke
session lasts, as well as how much tobacco is used. Head dimensions can
also affect airflow beneath and through the tobacco in the head,
affecting heat transfer to the tobacco. The temperatures reached during
smoking affect smoke yields, and user exposure to these smoke yields
and
     the head material could aid in heat transfer, prolonging
the heating of the tobacco and causing the tobacco to reach
temperatures that affect smoke yields.
    Table 18 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a pipe. The design

parameters described in table 18 to Sec.  1114.7(i)(2)(ii)(B) are a
necessary part of the application because they are needed to fully
characterize the product and changes that may affect the pipe's impact
on public health. In this final rule, we have revised the design
parameters related to pipes to help ensure that FDA is able to identify
and evaluate each product more accurately and efficiently. These
changes include the removal of: Bore minimum diameter, bore maximum
diameter, bit length, and bit diameter. We have removed these
parameters because they were found to be equal to the stem and shank
diameter should be equal to the bore diameter, and in addition, the
length of the bit can vary and have little effect on the user's
exposure to toxicants. FDA has also revised the parameters for test
data to include the removal of: Bore minimum diameter, bore maximum
diameter, bit length, and bit diameter for the reasons described
previously. Additionally, in the proposed rule, we recommended design
parameters for pipes. Based on FDA's understanding of pipes, we have
added design parameters related to the bowl chamber (bowl chamber cover
outer diameter, bowl chamber cover inner diameter, bowl chamber hole
shape, and bowl chamber volume), shank (length and diameter), draught
hole (draught hole diameter, draught hole shape, draught hole location,
and draught hole dimension), screen, airway and pressure drop, and
filter (filter efficiency, pressure drop, and length). These parameters
are a necessary part of the application because they are needed to
fully characterize the product and changes may affect the pipe's impact
on public health, as described below:
     Pipe screens are used in pipes to filter and stop hot
embers and tobacco from traveling up the pipe to the user;
     the bowl chamber inner and outer diameters allow FDA to
calculate the chamber wall thickness. A thicker wall will lead to a
cooler smoke and makes it less likely the user will burn themselves
when holding the chamber. Additionally, the chamber inner diameter will
affect temperature and tobacco capacity, meaning the greater the pipe
surface area, the more leaf can be burned at once, and with increased
temperature, this will affect smoke constituents;
     the bowl chamber hole shape is important to characterize
the pipe as this may affect the airflow and tobacco temperatures, which
in turn affects the burn rate and smoke constituents delivered;
     the bowl chamber volume affects the burn rate and
temperature, which in turn, dictates the smoke constituents delivered
to users.
     the draught hole allows the user to pull air through the
tobacco to their mouth. The diameter of the draught holes affects the
resistance to draw, which can impact nicotine and other toxicant
delivery to the user;
     the draught hole dimensions and geometry may affect the
airflow and oxygen available at the burning tobacco for the chemical
reaction and thus affect smoke constituent yields;
     the draught hole location should enter the bowl directly
centered and at the very bottom of the bowl. The location can affect
airflow and tobacco temperatures, which in turn, affects the burn rate
and smoke constituents delivered;
     the stem of a pipe delivers smoke from the bowl to the
user's mouth. The length of the stem may affect the smoke temperature,
which may affect how the product is consumed, while the diameter of the
stem may affect resistance to draw which can impact nicotine and other
toxicant delivery to the user;
     the shank of a pipe may affect the smoke temperature
(length) and resistance to draw (diameter);
     for cigarettes, the filter pressure drop affects smoke
yields (Ref. 62). Similarly, for pipes, the pressure drop through the
air valve can affect nicotine and other toxicant delivery to the user.
Air flow through an air valve can affect tobacco burn rate and tobacco
temperatures which in turn, may affect smoke constituent delivery to
the user. Some pipes may come with a filter; and
     for cigarettes, filter diameter, DPF, total denier, filter
density, and filter length may affect filter efficiency and, in turn,
smoke constituent yields (Ref. 60). Similarly, for pipes, the filter
efficiency, filter pressure drop, and filter length may affect smoke
constituent yields.
    Table 19 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for pipe tobacco. In this final rule, we have revised table 19
(formerly table 18 in the proposed PMTA rule) to Sec.
1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify and
evaluate each product more accurately and efficiently. These changes
include allowing applicants to provide oven volatiles (%) as an
alternative for tobacco moisture. We have provided these alternatives
because it will allow the applicant to provide information needed to
evaluate the product without conducting additional testing as these
alternatives may satisfy the requirements. Additionally, in the
proposed rule, we recommended design parameters for pipe tobacco. Based
on FDA's understanding of pipe tobacco, we have decided not to include
filler mass (mg) as a design parameter.
    The finalized parameters listed in table 19 to Sec.
1114.7(i)(2)(ii)(B) are required as part of the application because
they are necessary to fully characterize the product and changes may
affect its impact on public health:
     for cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for pipes, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter and
     for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for pipes, the tobacco moisture
or oven volatiles may affect puff count.
    While demonstrating compliance with voluntary standards can provide
information that is important to FDA's review, this alone would neither
fulfill the reporting requirements for battery design parameters under
Sec.  1114.7(i)(2)(ii) nor render further of the battery review
superfluous. As described elsewhere in this section, FDA needs a full
characterization of the tobacco product--including the battery, where
applicable--to complete its review. FDA provides information regarding
the health impacts for each design parameter for products categorized
as ENDS, as discussed elsewhere in this section.
    Table 20 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for an ENDS. In this final rule, we have revised table 20
(formerly table 19 in the proposed PMTA rule) to Sec.
1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify and
evaluate each product more accurately and efficiently. These changes
include (1) the removal of overall atomizer resistance (ohms), wick
ignition temperature, coil temperature cut-off, and coil temperature
range. We have removed these parameters because, current cut-off and
heating element temperature range are now required; as such, the
inclusion of these parameters would be considered redundant. We have
removed wicking ignition because not all wicking materials have an
ignition temperature, nor do all ENDS products have an overall atomizer
resistance; (2) change in language instead of ``coil'' the phrase
``heating element'' is used to include all heating elements that may
not be considered a coil; and (3) the inclusion of ventilation.
Additionally, in the proposed rule, we recommended design parameters
for

ENDS. Based on FDA's evolving understanding of ENDS products, we have
included the following previously recommended design parameters, as
required: Draw resistance puff count, atomizer tank/cartridge volume,
number of heating elements, heating elements length and diameter,
heating element configuration, battery voltage operating range, battery
current operating range, battery nominal voltage, battery current
rating, battery charging temperature limits, battery discharge
temperature limits, battery end of discharge voltage, battery maximum
charging current, battery maximum discharging current, battery upper
limits charging voltage, PDU voltage operating range, and PDU current
operating range. FDA has also revised the test data to include these
parameters, as these parameters affect the heating element temperature
which in turn effects the smoke constituents exposed to the users and
nonusers.
    The finalized parameters listed in table 20 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect its impact on public health, as described below.
     The air flow rate of the ENDS can affect the coil/heating
element temperature, e-liquid consumption, and aerosol characteristics
such as particle number concentration, count median diameter, and
PM2.5, which impact aerosol exposure (Ref. 87);
     coil/heating element resistance may affect overall heating
element resistance, thereby influencing heating element temperature.
The coil/heating element's resistance, material and the voltage \28\
determine the current flow and heating element temperature. The heating
element temperature and temperature duration may affect toxicant
emissions and nicotine delivery (Refs. 80-84);
---------------------------------------------------------------------------

    \28\ Voltage, current, and resistance are used to ensure the
battery and the ENDS are operating within the ``normal operating
range.'' The battery manufacturer sets the normal range of the
voltage and current. Understanding the resistance allows FDA to
assess whether the coil is drawing more current than the battery is
designed for.
---------------------------------------------------------------------------

     coil/heating element resistance and battery output voltage
determine PDU wattage. PDU wattage determines the amount of heat
produced by the atomizer. PDU wattage or wattage operating range may
affect the heating element temperature, thereby affecting toxicant
emissions and nicotine delivery (Refs. 82 and 84);
     an increase in battery capacity (mAh rating) can increase
the number of puffs the e-cigarette can deliver per vaping session.
Longer vaping sessions may lead to greater exposure to toxicant
emissions (Ref. 83);
     the temperature of the coil/heating element can affect the
chemical and physical characteristics of the aerosol delivered to the
user. An increase in coil/heating element temperature can increase HPHC
levels in the aerosol, therefore, maximum coil/heating element
temperature and temperature control deviation from this maximum coil/
heating element temperature can affect toxicant emissions and nicotine
delivery (Refs. 80-84);
     number of coils/heating element present can affect overall
atomizer resistance and distribution of heat dissipation (Ref. 79);
     the position of the coil/heating element can increase the
possibility of dry puff conditions and subsequent increased toxicant
emissions (Ref. 82);
     atomizer and cartridge components of e-cigarettes may be
heated repeatedly and aerosolized and can contribute to increased
toxicant emissions (Ref. 80);
     puff count can differ depending on other puff topography
(e.g., puff duration and puff flow rate), e-cigarette and atomizer
design, and e-liquid parameters. Puff count can also affect total puff
volume, which in turn can affect total toxicant emissions (Ref. 88). In
addition, information on the puff count of ENDS can help FDA assess the
health risks of the product, including how it compares to other
products;
     e-liquid capacity of the atomizer tank/cartridge can
affect total puff volume, which in turn can affect total toxicant
emissions (Refs. 88 and 89);
     battery/PDU voltage or voltage operating range may affect
the heating element temperature, thereby affecting toxicant emissions
and nicotine delivery (Refs. 81-84);
     battery wattage or wattage operating range may affect the
heating element temperature, thereby affecting toxicant emissions
(Refs. 82 and 84);
     coil/heating element resistance and battery output voltage
determine PDU wattage. PDU wattage determines the amount of heat
produced by the atomizer. PDU wattage or wattage operating range may
affect the heating element temperature, thereby affecting toxicant
emissions (Refs. 82 and 84);
     PDU wattage deviation may influence heating element
temperature, thereby affecting toxicant emissions (Refs. 82 and 84).
     the temperature of the coil/heating element can affect the
chemical and physical characteristics of the aerosol delivered to the
user. An increase in coil/heating element temperature can increase HPHC
levels in the aerosol, therefore, maximum coil/heating element
temperature and temperature control deviation from this maximum coil/
heating element temperature can affect toxicant emissions and nicotine
delivery (Refs. 81-84);
     coil/heating element resistance, number of coils/heating
element, coil/heating element gauge, and coil/heating element
configuration may affect overall heating element resistance, thereby
influencing heating element temperature. The heating element
temperature may affect toxicant emissions and nicotine delivery (Refs.
81-84);
     battery type, battery current operating range, battery
failure safety features, battery conformance to standards, and PDU
current operating range are necessary for evaluating battery and PDU
safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 80 and 86);
     battery power impacts the delivery of nicotine and the
total emissions of volatile aldehydes (Refs. 85 and 90);
     battery and PDU voltage impact the amount of e-liquid
consumed, the vapor temperature, and the total emissions of volatile
aldehydes (Ref. 85);
     the draw resistance of the ENDS impacts the ease of
drawing air into the ENDS to produce aerosol, which can affect nicotine
and other toxicant delivery to the user (Ref. 91). For cigarettes, we
evaluate filter pressure drop since it is more informative than draw
resistance; however, for ENDS, there is no filter pressure drop or
other similar parameter that could be used in place of draw resistance;
     inhaled aerosol temperatures can be damaging or
uncomfortable to users who inhale aerosol above a certain temperature
(Ref. 92); and
     ventilation may affect smoke constituent yields (Ref. 69).
    Table 21 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for an e-liquid. In this final rule, we have revised Table 21
(formerly Table 20 in the proposed PMTA rule) to Sec.
1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify and
evaluate each product more accurately and efficiently. Specifically, we
removed the requirement to provide the e-liquid boiling point as a
required design parameter because the information it would provide is
sufficiently captured by coil temperature and e-liquid composition.
    The finalized parameters listed in table 21 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes

may affect its impact on public health, as described below:
     The e-liquid volume can affect the delivery of nicotine
and other toxicants to the user (Refs. 88 and 89);
     aerosol parameters such as particle number concentration,
count median diameter, and PM2.5 are used to characterize
the amount and size of particles to which the user is exposed.
Epidemiological and clinical studies have shown that exposure to large
amounts of small particles can impair lung function and is correlated
with cardiovascular disease (Refs. 93 and 94);
     e-liquid viscosity impact the proportion of nicotine that
is aerosolized (Ref. 95). Also, the e-liquid viscosity can affect the
electronic cigarette nicotine and other toxicant delivery to the user
(Refs. 79 and 88); and
     the e-liquid volume can affect the delivery of nicotine
and other toxicants to the user (Refs. 88 and 89).
    Table 22 to Sec.  1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for heated tobacco products (HTPs). HTPs currently sold in
global markets can function in ways that are similar to products in
other product categories. For example, some HTPs can function like ENDS
products by aerosolizing e-liquids or using a battery and PDU to power
the product. Other HTPs can contain tobacco filler, like a cigarette or
cigar, but are heated instead of combusted. For these reasons, the
properties of HTPs vary widely, but are comparable to the properties of
other tobacco product categories. As such, based on FDA's experience
with other similarly characterized tobacco products, the information
needed from a design parameter standpoint perspective for HTPs overlaps
with that of products in other categories. The parameters listed in
table 22 to Sec.  1114.7(i)(2)(ii)(B) are a necessary part of the
application because they are needed to fully characterize the product
and changes may affect its impact on public health, as described below:
     For cigarettes, the length, diameter, and mass can affect
smoke constituent yields (Ref. 70). Similarly, for HTPs, dimensions
(mass, length, width, height, and diameter) can directly affect the
amount of tobacco that is heated and, in turn, affect smoke constituent
yields;
     for ENDS products, the draw resistance can affect nicotine
and other toxicant delivery to the user (Ref. 91). Similarly, for HTPs,
the draw resistance can impact the ease of drawing air into the product
to produce aerosol, which can affect smoke constituent yields;
     for ENDS, puff count can affect total toxicants emissions
(Refs. 88). Similarly, for HTPs, the puff count can affect puff volume,
which in turn can affect total toxicant emissions;
     for ENDS, e-liquid capacity of the atomizer tank/cartridge
can affect total toxicant emissions (Refs. 88 and 89). Similarly, for
HTPs, the product volume (capacity of the cartridge) can affect total
puff volume, which in turn can affect total toxicant emissions;
     for ENDS, airflow rate can impact aerosol exposure (Ref.
87). Similarly, for HTPs, the airflow rate allows air to flow from the
heating element to the user's mouth; some products allow the user to
manually change the airflow while others have a minimum airflow that
activates the product;
     for cigars, ventilation may affect smoke constituents
yields. Similarly, for HTPs, ventilation may affect smoke constituent
yields (Ref. 69);
     for ENDS, the battery and PDU voltage may affect the
heating element, thereby affecting toxicant emissions and nicotine
delivery (Refs. 81-84). Similarly, for HTPs, the battery and PDU
voltage impact the amount of e-liquid consumed, the vapor temperature,
and the total emissions of volatile aldehydes (Ref. 85). In addition,
it gives an idea of the temperature users will encounter;
     for ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 60 and 86). Similarly, for
HTPs the temperature sensor is a safety feature that allows the product
power to be cut off to ensure the product does not get too hot, causing
the battery to vent or harm the user;
     for cigarettes, wrapper length and width may affect puff
count and smoke constituents yields (Ref. 71). Similarly, for HTPS
material wrapper length and width may directly influence the area
through which the air is permitted to enter the tobacco column, which,
in turn, may affect puff count and smoke constituent yields (Ref. 71);
     for cigarettes, wrapper basis weight may affect puff count
and smoke constituents (Ref. 71 and 72). Similarly, for HTPs, the
material wrapper basis weight may affect puff count and smoke
constituent yields;
     for cigars, the cigar wrapper porosity may affect smoke
constituent yields (Refs. 72 and 73). Similarly, for HTPs, the material
porosity may affect smoke constituent yields;
     for waterpipe, the heating source may affect smoke
constituent yields. Similarly for HTPs, the heating element source (or
a description of the type or approach) provides information on the type
of heated tobacco product, such as a coil applied to the product;
     for ENDS, the temperature of the heating element can
affect the chemical and physical characteristics of the aerosol
delivered to the user (Refs. 81-84). Similarly for HTPs, the
temperature of the heating element (heating element temperature range,
operational temperature, maximum temperature) can affect the chemical
and physical characteristics of the aerosol delivered to the user. An
increase in heating element temperature can increase HPHC levels in the
aerosol; therefore, maximum heating element temperature and temperature
control deviation from this maximum heating element temperature can
affect toxicant emissions and nicotine delivery;
     for ENDS, the heating element temperature may affect
toxicant emissions and nicotine delivery (Ref. 84). Similarly, for
HTPs, the heating element material can have a direct effect on the heat
transfer to the e-liquid or tobacco, and in turn, affect the smoke
constituent yields;
     for ENDS, the heating element configuration may affect
toxicant emissions and nicotine delivery (Refs. 80-84). Similarly, for
HTPs, the heating element configuration may affect overall heating
element resistance, thereby influencing heating element temperature.
The heating element temperature may affect toxicant emissions and
nicotine delivery;
     for ENDS, the heating element dimensions may affect
toxicant emissions and nicotine delivery (Refs. 80-84). Similarly, for
HTPs, the heating element dimensions such as length influences the
overall surface area, which affects heating element resistance, which
influences the heating element temperature;
     for ENDS, the heating element mass may affect toxicant
emissions and nicotine delivery (Refs. 80-84). Similarly, for HTPs, the
heating element mass influences the power delivery of the battery, and
in turn, the heat applied to the e-liquid or tobacco, which affects the
smoke constituent yields and in turn, affects the smoke constituent
yields;
     for ENDS, the heating element location may affect toxicant
emissions and nicotine delivery (Refs. 80-84). Similarly, for HTPs, the
heating element location can affect nicotine emissions;
     for ENDS, the number of heating elements may influence the
heating element temperature thereby affecting toxicant exposure and
nicotine delivery

(Ref. 79). Similarly, for HTPs, the number of coils/heating element
present can affect overall resistance and distribution of heat
dissipation;
     for ENDS, the heating element diameter or gauge may affect
toxicant emissions and nicotine delivery (Refs. 80-84). Similarly, for
HTPs, the bigger the diameter of the heating element, the lower its
resistance, and vice versa. Heating element resistance may influence
heating element temperature. The heating element temperature may affect
toxicant emissions and nicotine delivery;
     for ENDS, the heating element resistance may affect
toxicant emissions and nicotine delivery (Refs. 80-84). Similarly, for
HTPs, the heating element resistance may affect overall heating element
resistance, thereby influencing heating element temperature. The
heating element temperature may affect toxicant emissions and nicotine
delivery;
     for cigars, tobacco filler mass may affect smoke
constituent yields (Ref. 69). Similarly, for HTPs, the tobacco filler
mass may affect smoke constituent yields;
     for cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 51 and 52). Similarly,
for HTPs, the tobacco rod density may modify burn properties and smoke
constituent yields;
     for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for HTPs, tobacco moisture or
oven volatiles may affect puff count.
     for cigarettes, tobacco cut size alters the size of the
tobacco pieces, which may result in more particulate matter (Ref. 53).
Similarly, for HTPs, tobacco cut size alters the size of the tobacco
pieces, which may result in more particulate matter (Ref. 53);
     for e-liquids, the e-liquid volume can affect the delivery
of nicotine and other toxicants to the user (Refs. 88 and 89).
Similarly, for HTPs, the e-liquid volume can affect the delivery of
nicotine and other toxicants to the user;
     for e-liquids, the e-liquid viscosity can affect the
electronic cigarette nicotine and other toxicant delivery to the user
(Refs. 79 and 88). Similarly, for HTPs e-liquid viscosity impact the
proportion of nicotine that is aerosolized. The e-liquid viscosity can
affect the nicotine and other toxicant delivery to the user (Refs. 79
and 88);
     for ENDS, an increase in battery capacity (mAh rating) can
increase the number of puffs the e-cigarette can deliver per vaping
session. Longer vaping sessions may lead to greater exposure to
toxicant emissions (Ref. 83). Similarly, for HTPs the battery capacity
is a measure of the charge stored by the battery. The higher the mAh
rating, the higher the capacity of the battery and the longer it will
last between charges. The longer the battery lasts, the more the user
can inhale smoke constituents;
     for ENDS, the battery voltage operating range and PDU
voltage operating range impact the amount of e-liquid consumed, the
vapor temperature, and the total emissions of volatile aldehydes (Ref.
85). Similarly, for HTPs, the battery and PDU voltage operating range
or wattage impact the amount of e-liquid consumed, the vapor
temperature, and the total emissions of volatile aldehydes;
     for ENDS, the battery type, battery current operating
range, battery failure safety features, battery conformance to
standards, and PDU current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 58 and 86).
Similarly, for HTPs, the battery current range gives an indication of
the safe zone for the battery to charge and what is considered its
normal operating region; if the battery levels go beyond the safe zone
while charging, the battery could be damaged, which could cause harm to
the user;
     for ENDS, the battery and PDU voltage impacts the amount
of e-liquid consumed, the vapor temperature, and the total emissions of
volatile aldehydes (Ref. 85). Similarly for HTPs, the battery nominal
voltage indicates how much current the battery can send out to the
heating element. For the same resistance, a higher voltage will send
more current (and more watts) to the heating element and it will
produce more vapor. There is a link between voltage and capacity
because vaping at a higher wattage will produce a higher current and
that will reduce the amount of time you can vape between charges;
     for ENDS, an increase in battery capacity (mAh rating) can
increase the number of puffs the e-cigarette can deliver per vaping
session. Longer vaping sessions may lead to greater exposure to
toxicant emissions (Ref. 83). Similarly, for HTPs, the battery rating
is a measure of the average amount of current the battery releases over
time under normal use. Current may influence the heating element
temperature, which in turn affects toxicant emissions and nicotine
delivery. In addition, battery mAh rating provides an understanding of
how long a battery will last and thus the product stability;
     for ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 58 and 86). Similarly for
HTPs, the battery charging temperature limits gives insight on the safe
range for battery charging temperatures and testing will show if the
software of the battery can keep the battery in the safe zone;
     for ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 58 and 86). Similarly, for
HTPs, battery discharge temperature limits give insight on the safe
range for battery discharging temperatures and testing will show if the
software of the battery can keep the battery in the safe zone;
     for ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 58 and 86). Similarly, for
HTPs, the end of discharge voltage is the level to which the battery
voltage or cell voltage can fall to before affecting the load. This
helps to establish the life cycle of the battery;
     for ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 58 and 86). Similarly, for
HTPs, the battery maximum charging current at which the battery can be
charged continuously is usually defined by the battery manufacturer in
order to prevent excessive charge rates that would damage the battery
or reduce its capacity. Damage to batteries is a hazard to users;
     for ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 58 and 86). Similarly, for
HTPs, the battery maximum discharge current at which the battery can be
discharged continuously is usually defined by the battery manufacturer
in order to prevent excessive discharge rates that would damage the
battery or reduce its capacity. Damage to batteries is a hazard to
users;
     for ENDS, the battery type, failure safety features, and
battery conformance

to standards are necessary for evaluating battery and PDU safety. Risks
of e-cigarette battery explosion, leakage, fire, or overheating are a
safety concern (Refs. 58 and 86). Similarly, for HTPs, the battery
upper limits charging voltage is important to limit the maximum battery
voltage during charging to prevent damage to the battery, which is a
hazard to users;
     for ENDS, battery and PDU voltage can impact the total
emissions of volatile aldehydes (Ref. 85). Similarly, for HTPs, the
battery and PDU voltage impact the amount of e-liquid consumed, the
vapor temperature, and the total emissions of volatile aldehydes (Ref.
85);
     for ENDS, PDU current operating range and wattage range
are necessary for evaluating battery and PDU safety. Risks of e-
cigarette battery explosion, leakage, fire, or overheating are a safety
concern (Refs. 80 and 86). Similarly, for HTPS, PDU current operating
range and wattage operating range may influence the heating element
temperature thereby affecting toxicant emissions;
     for ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 58 and 86). Similarly, for
HTPs, the PDU temperature cutoff is an electrical safety product that
interrupts electric current when heated to a specific temperature to
protect the user;
     for ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 58 and 86). Similarly, for
HTPs, the current cutoff is an electrical cutoff, which is an
electrical safety product that interrupts electric current when a
specific condition is met (i.e., temperature, current, etc.) to protect
the user;
     for ENDS, the battery and PDU current operating range may
influence the toxicant emissions (Refs. 82 and 84). Similarly, for
HTPs, the batteries and PDU should have a normal current operating
range so as to not overheat the product and cause it to become a hazard
to the user. In addition, this current range has a direct impact on the
heating element, which in turn affects the smoke constituent yields;
     inhaled aerosol temperatures can be damaging or
uncomfortable to users who inhale aerosol above a certain temperature;
     for e-liquids, aerosol parameters such as particle number
concentration, count median diameter, and particulate matter
(PM)2.5 are used to characterize the amount and size of
particles to which the user is exposed (Refs. 93 and 94). Similarly,
for HTPs, aerosol parameters such as particle number concentration,
count median diameter, and PM2.5 are used to characterize
the amount and size of particles to which the user is exposed. Clinical
studies have shown that exposure to large amounts of small particles
can impair lung function and is correlated with cardiovascular disease;
     for cigarettes, filter efficiency may affect smoke
constituent yields (Ref. 60). Similarly, for HTPs, filter efficiency
effect smoke constituent yields;
     for cigarettes, filter pressure drop may affect smoke
constituent yields (Ref. 61). Similarly, for HTPs, filter pressure drop
may affect smoke constituent yields; and
     for cigarettes, filter diameter, DPF, total denier, filter
density, and filter length may affect filter efficiency and, in turn,
smoke constituent yields (Ref. 60). Similarly, for the HTPs, the filter
diameter, DPF, total denier, filter density, and filter length, may
affect filter efficiency and, in turn, smoke constituent yields (Ref.
60).
    FDA received comments regarding design parameters and test data, as
required by Sec.  1114.7(i)(2)(ii) and associated tables, as discussed
below.
    (Comment 44) One comment stated that the lists of product design
parameters in Sec.  1114.7(i)(2)(ii) do not reflect the subcategories
of innovative tobacco products or nicotine delivery systems that exist
in some of the product categories and that by requiring all parameters,
FDA would have some applicants generate parameters that are not
relevant to their particular subcategory. The comment suggested that
FDA make the design parameters in these tables recommendations rather
than required parameters.
    (Response 44) FDA declines to make this change to the rule. FDA
believes that design parameters are necessary to fully characterize a
tobacco product and are an important consideration in determining its
health effects. FDA agrees that the required lists of product design
parameters in Sec.  1114.7(i)(2)(ii) are not necessarily reflective of
all subcategories of innovative tobacco products or nicotine delivery
systems. However, table 1 to Sec.  1114.7(c)(3)(iii) includes a list of
tobacco product categories and subcategories, which should help the
applicant to determine whether the rule includes an appropriate
category and subcategory for its new tobacco product and the
corresponding design parameters that must be submitted, where
applicable.
    (Comment 45) One comment stated that FDA should not require testing
for nicotine dissolution in portioned smokeless tobacco because it does
not represent the potential rate or amount of exposure. The comment
also stated that because the pouch material for smokeless tobacco does
not have nicotine, applicants should not be required to provide pouch
material information.
    (Response 45) FDA believes that nicotine dissolution testing is an
effective mechanism for FDA to gain insight into product performance
and relative differences in the likely experience of users. In
addition, changes in pouch materials of portioned smokeless tobacco
products may change the permeability of the pouch and the rate at which
nicotine is released, which can affect the overall performance of the
product, including the rate at which nicotine is released to consumers
(Ref. 67). Additionally, a study using nicotine tablets with different
polymer content shows that nicotine release can be affected by
thickness and pore size of the material that encloses nicotine (Ref.
67). In this study, upon hydration, polymer in tablet formulations
swells, forming a polymer gel layer and effectively acting as a
permeable membrane. The tablets released nicotine at a rate controlled
by swelling of the polymer followed by the diffusion through the
swollen polymer gel layer. Polymer network gel swelling can affect
material layer thickness (Ref. 141) and pore size (Ref. 142) which in
turn can affect diffusion across the layer. Pouch materials are
characterized by basis weight, air permeability, and thickness.
Therefore, pouch material properties such as basis weight, air
permeability and thickness are required to evaluate nicotine release
from pouched smokeless tobacco products. Given the important
information that nicotine dissolution testing and pouch material
provide to FDA's review, FDA declines to remove the requirements for
reporting pouch material information and nicotine dissolution testing
in this PMTA rule.
    (Comment 46) One comment stated that FDA needs to remove the
proposed design parameters for cigars in Sec.  1114.7(i)(2)(ii) from
the rule and reassess its thinking as to the design parameters it
requires and recommends for premarket review for cigars. The comment
stated that the current proposed parameters for each type of cigar
specified do not correspond to the actual design parameters that cigar
manufacturers can or do use or test for

and, therefore, it would be impossible for applicants to provide the
proposed parameters to FDA. The comment recommended that FDA require
the reporting of design parameters only for cigar length, ring gauge,
weight, and filter ventilation.
    (Response 46) FDA declines to remove the design parameters for
cigars. As described below, design parameters are needed to fully
characterize the product and assess its impact on public health.
Because these design parameters are an important component of being
able to determine a product's health effects, FDA may refuse to accept
or refuse to file a PMTA if it lacks design parameters information
required by Sec.  1114.7(i)(2)(ii). To ensure that FDA is able to fully
determine the precise product being reviewed, FDA requires applicants
provide all design parameters specific to the new product tobacco
category. In an event that an applicant is unable to provide a design
parameter listed in Sec.  1114.7(i)(2)(ii) for the new tobacco product,