electronic, layered design files for each required warning, as well as
technical specifications before the final rule is released.
    (Response 82) To assist regulated entities with implementation, we
are providing the electronic, layered design files, as well as
technical specifications, with the final rule. These materials are
available at https://www.fda.gov/cigarette-warning-files.
4. Section 1141.10--Required Warnings
a. Section 1141.10(a) and (b)--Required Warnings
    In proposed Sec.  1141.10(a) and (b), we proposed to establish
required warnings, consisting of one textual warning statement with a
specific color graphic to accompany the textual warning statement,
which must be accurately reproduced from the materials incorporated by
reference in Sec.  1141.5 (proposed Sec.  1141.10(a) and (b)). We
received comments on the required warnings, and we discuss those
comments and our responses in section VII. After reviewing public
comments and weighing additional scientific, legal, and policy
considerations, FDA is removing 2 of the 13 required warnings included
in the proposed rule, and FDA is finalizing Sec.  1141.10(a) and (b)
with 11 required warnings. As described in the preceding paragraphs,
FDA is also making clarifying changes to Sec.  1141.10(b) to make it
more apparent that it is the combination of a textual warning statement
and its accompanying color graphic that we are incorporating by
reference and that must be accurately reproduced in the appropriate
size and format.
b. Section 1141.10(c)--Packages
    We proposed that section 1141.10(c) establish a requirement for
packages making it unlawful for any person to manufacture, package,
sell, offer to sell, distribute, or import for sale or distribution
within the United States any cigarettes unless the package of which
bears a required warning in accordance with section 4 of the FCLAA and
this part. This section requires that: (1) The required warning must
appear directly on the package and must be clearly visible underneath
any cellophane or other clear wrapping; (2) The required warning must
comprise at least the top 50 percent of the front and rear panels;
provided, however, that on cigarette cartons, the required warning must
be located on the left side of the

front and rear panels of the carton and must comprise at least the left
50 percent of these panels; and (3) The required warning must be
positioned such that the text of the required warning and the other
information on that panel of the package have the same orientation. We
received comments on these requirements, including a comment that we
add an additional requirement under Sec.  1141.10(c). After review and
consideration of the comments, FDA is finalizing this subsection
without change.
    (Comment 83) At least one comment suggests that the required
warning on packages be at least 75 percent on the front and rear panels
of the package, similar to the approach of other countries, such as
Canada and Australia. Additionally, multiple other comments support the
provision requiring the warning comprise at least the top 50 percent of
the front and rear panels of cigarette packages, stating that this
ensures that the required warnings are visible to consumers.
    (Response 83) Section 4 of the FCLAA establishes size requirements,
and FDA declines to increase the size of the required warnings. Based
on the FCLAA, Sec.  1141.10(c)(2) states that the required warnings
must comprise at least the top 50 percent of the front and rear panels
of the package and that the required warnings must be located on the
left side of the front and rear panels of cartons and comprise at least
the left 50 percent of these panels.
    (Comment 84) FDA received comments from both industry and public
health organizations suggesting that the front and rear panels could
carry separate warnings (i.e., a different warning on each side). One
comment suggests this could provide more information to consumers, and
other comments support this as a means of providing some flexibility to
manufacturers, given printing and other considerations. Another comment
suggests FDA could require warnings in different languages on the front
and rear panels of the cigarette package or, through a future
rulemaking, FDA could develop two separate images for each warning so
that any given package would feature the same warning text on each side
but a different depiction.
    (Response 84) Section 4(a)(1) of the FCLAA is ambiguous as to
whether it mandates the use of the same required warning on both the
front and rear panels of the individual cigarette package, or allows
two different required warnings to be used, one on the front panel and
the other on the rear panel. At this time, we see no reason to mandate
that the front and rear panels must carry the same required warnings.
Accordingly, the current rulemaking permits manufacturers to use
different required warnings if they wish. This is also consistent with
Congress's intent that all of the required warnings be displayed in the
marketplace at the same time (see section 4(c)(1) and (3) of the
FCLAA). As the comments indicate, additional changes such as those
suggested (e.g., requiring text in different languages, multiple images
for each warning) could be considered in a further rulemaking.
    (Comment 85) FDA received a comment suggesting that a subsection
(4) be added to Sec.  1141.10(c) to help ensure that the required
warnings be unobstructed from view in the retail environment.
    (Response 85) FDA declines to make this change as we anticipate
that this concern will be adequately addressed by other provisions of
the rule, such as Sec.  1141.1(c) and Sec.  1141.1(d). Under Sec.
1141.1(c), a retailer would not be in violation of 1141.10 for
packaging that: (1) Contains a warning; (2) is supplied to the retailer
by a license- or permit-holding tobacco product manufacturer or
distributor; and (3) is not altered by the retailer in a way that is
material to 15 U.S.C. 1333 or proposed part 1141. Under Sec.
1141.1(d), the advertisement requirements apply to a retailer only if
the retailer is responsible for or directs the warnings for
advertising, but this provision does not relieve a retailer of
liability if the retailer displays in a location an advertisement that
does not contain a warning or that contains a warning that has been
altered by the retailer in a way that is material to section 4 of the
FCLAA or the requirements of part 1141. As discussed in the proposed
rule, retailers would be in violation of the FCLAA and part 1141 if
they alter cigarette packaging or advertising in a way that is material
to these requirements. This could, for example, occur if a retailer
obscures or covers the required warning (e.g., blocking with a sticker
or marker), shrinks the warning, or uses a sleeve to cover the warning.
Retailers also would be liable if they display, in a location open to
the public, an advertisement that does not contain a warning.
c. Section 1141.10(d)--Advertisements
    We proposed that Sec.  1141.10(d) establish that it is unlawful for
any manufacturer, distributor, or retailer of cigarettes to advertise
or cause to be advertised within the United States any cigarette unless
each advertisement bears a required warning in accordance with section
4 of the FCLAA and part 1141. The proposed requirements provide, in
part, that: (1) For print advertisements and other advertisements with
a visual component (including, for example, advertisements on signs,
retail displays, internet web pages, digital platforms, mobile
applications, and email correspondence), the required warning must
appear directly on the advertisement; and (2) the required warning must
comprise at least 20 percent of the area of the advertisement in a
conspicuous and prominent format and location at the top of each
advertisement within the trim area, if any.
    In addition, we proposed in Sec.  1141.10(d)(3) that the text in
each required warning must be in the English language, except in the
case of an advertisement that appears in a non-English medium, the text
in the required warning must appear in the predominant language of the
medium whether or not the advertisement is in English, and in the case
of an advertisement that appears in an English language medium but that
is not in English, the text in the required warning must appear in the
same language as that principally used in the advertisement. We also
proposed in Sec.  1141.10(d)(4) and (5) that for English-language and
Spanish-language warnings, each required warning must be obtained from
the electronic files contained in ``Required Cigarette Health
Warnings,'' which would be incorporated by reference at Sec.  1141.5,
and be accurately reproduced as specified in ``Required Cigarette
Health Warnings,'' and for non-English-language warnings, other than
Spanish-language warnings, each required warning must be obtained from
the electronic files contained in ``Required Cigarette Health
Warnings,'' which would be incorporated by reference at Sec.  1141.5,
and be accurately reproduced as specified in ``Required Cigarette
Health Warnings,'' including the substitution and insertion of a true
and accurate translation of the textual warning statement in place of
the English language version. The inserted textual warning statement
must comply with the requirements of section 4 of the FCLAA, including
area and other formatting requirements, and this part.
    In the following paragraphs, we discuss comments on these
provisions. After carefully considering the comments, we are finalizing
these provisions without substantive change; however, as described
earlier in this section, we made clarifications to Sec.  1141.10(d)(4)
and (5) to make it more apparent that it is the combination of a
textual warning statement and its

accompanying color graphic that we are incorporating by reference and
that must be accurately reproduced in the appropriate size and format.
    (Comment 86) Several comments note general support for the
provision requiring that the required warning comprise at least 20
percent of the area of the advertisements stating that it is sufficient
to ensure the required warnings are visible to consumers. FDA also
received a comment requesting that we consider adding price promotions
and coupons to the examples provided in Sec.  1141.10(d) because many
apps, mailers, and pop up ads contain only coupons or price promotions,
like quick response codes.
    (Response 86) FDA agrees with the general support for these
provisions. We note that the list of examples included in this
provision is not intended to be exhaustive, and that the requirements
under part 1141 apply to all forms of cigarette advertising, regardless
of the medium in which it appears. The final rule applies to
advertisements appearing in or on, for example, promotional materials
(point-of-sale and non-point-of-sale), billboards, posters, placards,
published journals, newspapers, magazines, other periodicals,
catalogues, leaflets, brochures, direct mail, shelf-talkers, display
racks, internet web pages, electronic mail correspondence, or be
communicated via mobile telephone, smartphone, microblog, social media
website, or other communication tool; websites, applications, or other
programs that allow for the sharing of audio, video, or photography
files; video and audio promotions; and items not subject to the sale or
distribution restriction in Sec.  [thinsp]1140.34. We agree that the
requirement that the required warning comprise at least 20 percent of
the area of the advertisement in a conspicuous and prominent format and
location at the top of each advertisement within any trim area will
help ensure the warnings are visible to consumers.
    (Comment 87) Some comments address the translation of the textual
warning statements into languages other than Spanish and express
concerns that manufacturers or retailers might undermine the
effectiveness of the required warning by using a language in the
warning that is not appropriate to the audience reading or experiencing
the advertisement. A comment suggests that if FDA does not provide
warning translations in languages other than English and Spanish, then
FDA should review any translated warning before the product can be
advertised. Another comment recommends that FDA provide the translation
of textual warning statements into languages most commonly used, other
than English, to help ensure access to this information as a health
equity measure.
    (Response 87) Although we decline to provide additional
translations, FDA does intend to monitor translations to ensure that
they are accurately reproduced and will take action, as appropriate, to
address any translations that do not meet the requirements of the FCLAA
and the final rule. Under Sec.  1141.10(d)(5) all non-English-language
warnings, other than Spanish-language warnings, must be accurately
reproduced as specified in ``Required Cigarette Health Warnings,
2020,'' including the substitution and insertion of a true and accurate
translation of the textual warning statement in place of the English
language version. If a translation of a textual warning statement is
not a true and accurate translation, as required by Sec.
1141.10(d)(5), the cigarette will be deemed to be misbranded under
section 903(a)(1) or 903(a)(7)(A) of the FD&C Act for failure to bear
one of the required warnings in accordance with section 4 of the FCLAA
and this part.
d. Section 1141.10(e) and (f)--Other Requirements
    In the proposed rule, Sec.  1141.10(e) states that the required
warnings must be indelibly printed on or permanently affixed to the
package or advertisement. Proposed Sec.  1141.10(f) establishes that no
person may manufacture, package, sell, offer for sale, distribute, or
import for sale or distribution within the United States cigarettes
whose packages or advertisements are not in compliance with section 4
of the FCLAA and this part, except as provided by Sec.  1141.10(c) and
(d). We received no comments regarding these specific proposed
provisions and are finalizing Sec.  1141.10(e) and (f) without change.
e. Section 1141.10(g)--Cigarette Plans
    Section Sec.  1141.10(g)(1) proposed that the required warnings for
packages must be randomly displayed in each 12-month period, in as
equal a number of times as is possible on each brand of the product and
be randomly distributed in all areas of the United States in which the
product is marketed in accordance with a plan submitted by the tobacco
product manufacturer, distributor, or retailer to, and approved by,
FDA. In addition, proposed Sec.  1141.10(g)(2) provides that the
required warnings for advertisements must be rotated quarterly in
alternating sequence in advertisements for each brand of cigarettes in
accordance with a plan submitted by the tobacco product manufacturer,
distributer, retailer to, and approved by, FDA. Under proposed Sec.
1141.10(g)(3), FDA will review each plan submitted under this section
and approve it if the plan: (1) Will provide for the equal distribution
and display on packaging and the rotation required in advertising under
this subsection and (2) assures that all of the labels required under
this section will be displayed by the tobacco product manufacturer,
distributor, or retailer at the same time. Under proposed Sec.
1141.10(g)(4) each tobacco product manufacturer required to randomly
and equally display and distribute warnings on packaging or rotate
warnings in advertisements in accordance with an FDA-approved plan
under section 4 of the FCLAA and this part must maintain a copy of such
FDA-approved plan and make it available for inspection and copying by
officers or employees duly designated by the Secretary of Health and
Human Services. The FDA-approved plan must be retained while in effect
and for a period of not less than 4 years from the date it was last in
effect.
    After considering the comments on Sec.  1141.10(g), we are
finalizing this provision without change. We discuss both the comments
and our responses in the following paragraphs.
    (Comment 88) Some comments express general support both for the
rotation requirements to reduce the risk of wear out and overexposure
and for the submission of plans for approval by FDA. These comments
encourage FDA to have in place robust compliance processes to assess
whether manufactures, distributors, and retailers are meeting the
requirements of this rule. Some comments note that ``particular
attention'' be directed toward media and retailers serving people of
color, people with low incomes, and LGBTQ populations.
    (Response 88) We agree that the requirements related to cigarette
plans are important to implementing the requirements of the FCLAA. The
required warnings on packages must be randomly displayed and
distributed in accordance with an FDA-approved plan. Similarly, the
required warnings for advertisements must be rotated quarterly in
alternating sequence in advertisements, in accordance with an FDA-
approved plan. Each tobacco product manufacturer must maintain a copy
of the plan and make it available for inspection and copying by
officers or employees duly designated by the Secretary. A cigarette
will be deemed to be misbranded under section 903(a)(1) or 903(a)(7)(A)
and (8) of the FD&C Act if its package or advertising does not bear one
of the required warnings in

accordance with section 4 of the FCLAA and this part. We further
discuss the importance of enforcing these requirements in later
paragraphs of this section (see section IX.B.6).
    (Comment 89) Two comments raise concerns related to satisfying the
``random and equal'' requirement of proposed Sec.  1141.10(g) for 13
different warnings without significant changes to packaging production.
These comments note that because 13 is both a prime and odd number,
printing 13 different warnings equally is incompatible with industry-
wide printing practices. One comment suggests that FDA either require a
random and equal distribution of 12 or 9 warnings or random but unequal
display of 13 warnings. The other comment proposes that FDA require 9
different warnings and provide greater flexibility for the random and
equal requirement because of printing method variation across the
industry.
    (Response 89) FDA is requiring 11 warnings, which we appreciate is
also a prime and odd number and thus may present similar issues. We
address some of these issues in section X. In addition, by permitting
the front and rear panels to carry different warnings, the rule may
mitigate some of these issues by giving manufacturers flexibility in
how they meet the requirements of the rule. We also note that the FCLAA
provides that the required warnings be ``randomly displayed in each 12-
month period, in as equal a number of times as is possible on each
brand of the product,'' which we believe provides for some flexibility
in the meaning of ``equal,'' as defined below. Manufacturers with
concerns about complying with this requirement should promptly reach
out to FDA to discuss their approach for reasonably achieving the
random and equal display and distribution of the required warnings, in
as equal a number of times as is possible, and any other specific
concerns or circumstances regarding this requirement. We encourage
manufacturers to submit their cigarette plan to FDA as soon as possible
so that we can discuss these concerns and consider proposals with
manufacturers in a timely manner. FDA intends to issue a final guidance
document with additional information and recommendations that may be
helpful in preparing these plans, which, when issued, may be found at
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
    (Comment 90) Comments also raised concerns about satisfying the
``random and equal'' requirement within the 12-month period prescribed
by proposed Sec.  1141.10(g)(1), which states each required warning
would be required to be randomly displayed in each 12-month period, in
as equal a number of times as is possible on each brand of the product.
These comments asked for clarification of the phrase ``as is possible''
and asked for flexibility in achieving ``equal distribution.'' At least
two comments suggest a deviation allowance of 4 percent (or larger).
These comments also note the difficulty of achieving equal distribution
within the 12-month period specified and asked for a longer period in
which to achieve equal distribution, suggesting that achieving the
random and equal requirement within the 12-month period would be
particularly challenging for products with low annual volume sales.
    (Response 90) We recognize and understand the difficulties in
achieving the random and equal display requirement within a 12-month
period given the number of required warnings and agree that some level
of deviation is appropriate particularly given the language of the
FCLAA, which includes the phrase ``as equal a number of times as is
possible.'' The cigarette plan for packaging should include a
discussion of how the requirements are to be implemented based on the
specific manufacturing processes and distribution procedures to ensure
random display, in as equal a number of times as is possible, in each
12-month period on each brand of the product. Manufacturers with
concerns about complying with this requirement for their products
should promptly reach out to FDA to discuss their approach and proposal
for reasonably achieving the random and equal display and distribution
of the required warnings, in as equal a number of times as is possible,
and any other specific concerns or circumstances regarding this
requirement. We encourage manufacturers to submit their cigarette plan
to FDA as soon as possible so that we can discuss these concerns and
consider proposals with manufacturers in a timely manner. Additionally,
FDA intends to issue a final guidance document with additional
information and recommendations that may be helpful in preparing these
plans, which, when issued, may be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
    (Comment 91) One comment requests that FDA accept in digital files
(i.e., electronic art) the representative samples of packages and
advertisements with each of the required warnings submitted with
cigarette plans as FDA does for biannual tobacco product listing
submissions. The comment notes that this would allow plans to be
prepared quickly without the expense of engraving cylinders and
obtaining proofs for each brand style. The comment also notes that the
submission of physical packages would also be time-consuming, whereas
the use of digital files would allow companies to more quickly respond
without the time and expense of re-engraving cylinders.
    (Response 91) FDA agrees that it is acceptable to voluntarily
submit representative advertisements and packaging as digital files
(i.e., electronic art) along with other information that the
manufacturer elects to submit with the cigarette plan to ensure that it
is complete. The information submitted should describe a plan to
achieve the random and equal display and distribution of the required
warnings on packages and the quarterly rotation of the required
warnings in advertisements. As discussed in the section IX of the
proposed rule, FDA is only requesting that the cigarette plan include
representative samples of packages and advertisements with each of the
required warnings. The samples are to place the cigarette plan in
context and facilitate FDA's review of the plan. FDA's review of a
cigarette plan is only for the purpose of determining compliance with
the statutory and regulatory criteria for approval of a cigarette plan,
as set forth in section 4(c)(3) of the FCLAA and proposed Sec.
1141.10(g)(3). Approval of a cigarette plan does not represent a
determination by FDA that any specific package or advertisement
complies with any of the other requirements under section 4 of the
FCLAA and part 1141, or any other requirements under the FD&C Act and
its implementing regulations. Additionally, FDA intends to issue a
final guidance document with additional information and recommendations
that may be helpful in preparing these plans, which, when issued, may
be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
    (Comment 92) FDA also received at least one comment requesting FDA
clarify in the final rule that retailers are not required to submit
plans for random and equal display of the required warnings for
packages and quarterly rotation of the required warnings in
advertisements. The comment notes that requiring retailers to submit a
plan exceeds FDA's authority, would unduly burden retailers, and is not
achievable as retailers have no control over which heath warning is
displayed as they receive the cigarette packages that they sell, and
often the advertisements they use, from tobacco product manufacturers
and distributors.

    (Response 92) With respect to the concerns related to retailers,
Sec.  1141.1(c) and (d) explain when a retailer is not in violation of
the FCLAA and Sec.  1141.10. Under Sec.  1141.1(c), retailers typically
would not be required to submit a cigarette plan for packaging, as long
as the cigarette packaging: (1) Contains a warning; (2) is supplied to
the retailer by a license- or permit-holding tobacco product
manufacturer or distributor; and (3) is not altered by the retailer in
a way that is material to 15 U.S.C. 1333 or part 1141 (see Sec.
1141.1(c)). We believe most, if not all, retailers would fall under
this scenario. Retailers who are also manufacturers will be subject to
both the requirements for retailers and manufacturers, as applicable.
Retailers that are responsible for or direct the warnings for
advertising will be required to submit a cigarette plan for advertising
and would be subject to the advertisement requirements set forth in
Sec.  1141.10(d). We note, however, this provision will not relieve a
retailer of liability if the retailer displays in a location open to
the public an advertisement that does not contain a warning or that
contains a warning that has been altered by the retailer in a way that
is material to section 4 of the FCLAA or the requirements of this
proposed part.
    We discuss these provisions in more detail in the section IX of the
proposed rule. In general, based on FDA's experience reviewing plans
for other tobacco products, we believe it is likely that for domestic
products only one cigarette plan will be submitted for each brand and
that the brand's manufacturer will submit this plan because, in most
instances, the brand's manufacturer is the entity best able to ensure
that a plan meets the relevant requirements. The brand's manufacturer
is also typically the entity responsible, either directly or through a
contractor or other agent, for placing or directing the placement of
the required warnings on the brand's cigarette packages and for
directing distribution. For cigarettes that are imported, the importer
(included in the definition of manufacturer) usually directs
distribution of the packages after they are imported. Therefore, for
imported cigarettes, the importer is likely best-positioned to submit
the plan. To further aid in the understanding of the cigarette plan
requirements, FDA intends to issue a final guidance document with
additional information and recommendations that may be helpful in
preparing these plans, which, when issued, may be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
5. Section 1141.12--Misbranding of Cigarettes
    Under proposed Sec.  1141.12 a cigarette would be deemed to be
misbranded under section 903(a)(1) of the FD&C Act if its package does
not bear one of the required warnings and will be deemed to be
misbranded under section 903(a)(7)(A) of the FD&C Act if its
advertising does not bear one of the required warnings in accordance
with section 4 of the FCLAA and this part. In addition, under proposed
Sec.  1141.12(b) a cigarette advertisement and other descriptive
printed matter issued or caused to be issued by the manufacturer,
packer, or distributor would be deemed to include a brief statement of
relevant warnings for the purposes of section 903(a)(8) of the FD&C Act
if it bears one of the required warnings in accordance with section 4
of the FCLAA and this part. A cigarette distributed or offered for sale
in any State shall be deemed to be misbranded under section 903(a)(8)
of the FD&C Act unless the manufacturer, packer, or distributor
includes in all advertisements and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer, or
distributor with respect to the cigarette one of the required warnings
in accordance with section 4 of the FCLAA and this part. We received no
comment regarding proposed Sec.  1141.12, and we are finalizing this
section without change.
6. Other Comments--Compliance
    (Comment 93) FDA received some general comments related to
enforcement of the rule. These comments encourage FDA to ensure
enforcement of the required warnings on packages and advertisements
particularly in neighborhoods of low SES. The comments suggest that
surveillance and fines may improve compliance. Other comments recommend
that FDA be mindful of vendors who, although illegal, might sell
merchandise such as from their backpacks.
    (Response 93) FDA agrees that enforcing warning requirements is
important. FDA conducts routine monitoring and surveillance of the
manufacturing, marketing, sales, distribution, labeling, advertising
and other promotional activities of regulated tobacco products for
compliance with applicable provisions of the FD&C Act. FDA has a range
of tools to help ensure compliance with tobacco product regulations.
Failure to comply with the FCLAA, FD&C Act, or their implementing
regulations may result in FDA initiating action, including, but not
limited to, warning letters, civil money penalties, no-tobacco-sale
orders, seizures, injunction, or criminal prosecution. Additionally,
misbranded tobacco products offered for import into the United States
are subject to detention and refusal of admission.
    (Comment 94) Another comment also suggests that FDA require
manufacturers to submit inventory information, including information on
levels of inventory and when it is expected to be sold, as a means of
distinguishing cigarette packages sold from existing inventory from
inventory manufactured after the effective date. The comment recommends
FDA ask for information on how to read date codes to help the Agency
better understand which manufacturers may not be complying with the
rule.
    (Response 94) FDA declines to adopt these suggestions as section
201(b) of the Tobacco Control Act imposes a requirement that, beginning
30 days after the effective date of the final rule, manufacturers would
not be permitted to introduce into domestic commerce any cigarette
packages that do not contain the required warnings, irrespective of the
date of manufacture. FDA believes this requirement addresses the
concern related to ensuring compliance with the required warnings.

X. Comments Regarding Implementation Issues

    Some comments raise questions related to implementing the
requirements of the final rule. We describe and address those comments
in the following paragraphs.
    (Comment 95) FDA received comments objecting to the proposed rule
as based on a fundamental misunderstanding of the processes used to
print the vast majority of cigarette packaging in the United States,
which one comment states is a gravure process using engraved cylinders.
These comments state the rule would place significant and unnecessary
burdens on industry because the requirement of random and equal display
and distribution is infeasible.
    (Response 95) We disagree that the rule is based on a fundamental
misunderstanding of the processes used to print the vast majority of
cigarette packaging in the United States. We respond to this particular
concern in more detail in the Final Regulatory Impact Analysis that is
issuing with the final rule (Ref. 16), but we note generally that
(contrary to the

comment's suggestion) FDA's Labeling Cost Model does assume that 95
percent of cigarette UPCs will be printed using the gravure method.
    In addition, we recognize and understand that achieving conformity
with the narrowest possible reading of the random and equal display
requirement within a 12-month period would pose some difficulties, and
we agree that allowing some level of deviation is appropriate
particularly given the language of the FCLAA, which includes the phrase
``as equal a number of times as is possible.'' As we discuss in section
IX, the cigarette plan for packaging should include a discussion of how
the requirements are to be implemented based on the specific
manufacturing processes and distribution procedures to ensure random
display, in as equal a number of times as is possible, in each 12-month
period on each brand of the product. Manufacturers with concerns about
complying with this requirement for their products should promptly
reach out to FDA to discuss their approach and proposal for reasonably
achieving the random and equal display and distribution of the required
warnings, in as equal a number of times as is possible, and any other
specific concerns or circumstances regarding this requirement. We
encourage manufacturers to submit their cigarette plan to FDA as soon
as possible so that we can discuss these concerns and consider
proposals with manufacturers in a timely manner. Additionally, FDA
intends to issue a final guidance document with additional information
and recommendations that may be helpful in preparing these plans,
which, when issued, may be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
    (Comment 96) One comment requests ``Printer's Proofs'' for each
required warning to facilitate consistent reproduction of the color
images. The comment notes that manufacturers use different ink
application techniques and substrates, which could result in altered
appearances of the warnings on packs.
    (Response 96) FDA intends to provide Printer's Proofs upon request.
Regulated entities can request a set of SWOP or GRACoL Printer's Proofs
for the required warnings (each set will contain a total of 22 proofs:
The 11 required warnings with black text on white backgrounds and the
11 required warnings with white text on black backgrounds). Requests
can be submitted by email (cigarettewarningfiles@fda.hhs.gov), phone
(1-877-CTP-1373) or regular mail (Food and Drug Administration, Center
for Tobacco Products, Document Control Center, Building 71, Room G335,
ATTN: Office of Health Communication and Education, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002).
    (Comment 97) One comment discusses a challenge with accurately
reproducing the required warnings on a variety of cigarette package
shapes and sizes. The company asked that FDA provide specific direction
for permissible adjustments to the required warnings and that FDA
tolerate minor variances in how the warnings appear on cigarette
packaging.
    (Response 97) As discussed in section IX.B.3, we are providing the
required warnings in a variety of sizes and formats as incorporated by
reference materials. In addition, we are providing electronic, layered
design files in an .eps format, which manufacturers may use in
developing their packaging and labeling, as well as technical
specifications to selecting, using, and adapting these files. These
documents will provide extensive information and help manufacturers
accurately reproduce the required warnings for different packages
shapes and sizes.
    (Comment 98) One comment requests that FDA clarify how
manufacturers should incorporate the required warnings on packs with
hinged lids. The comment states that the content of warnings printed on
the hinged lids can shift up or down by about 1 mm at the point where
the lid meets the front of the pack due to normal variations in
production of the packaging. These comments recommend that FDA design
the warnings with all text located either above or below the hinged
lid, allow for minor variations in how the required warnings appear on
cigarette packs due to this manufacturing variability, or provide font
suitcases and instructions for use that allow manufacturers to flow
text freely within a designated text area to ensure that the text is
not interrupted.
    (Response 98) To ensure that the warning is clear and legible on
hinged lid packages, FDA is allowing for minor variations in how the
required warnings appear. Manufacturers can separate two lines of text
within the textual warning statement such that the line at the location
where the lid is to open cuts across the background space between two
lines rather than through a line of text. This will help ensure that
the textual warning statement is not severed when the package is opened
and is clear, conspicuous, and legible in accordance with section 4 of
the FCLAA. We note that product packages with hinged lids are widely
prevalent in countries that already require pictorial cigarette
warnings and, based on that experience, we conclude that this new
provision should provide companies with flexibility for displaying the
warnings on packages with hinged lids.
    (Comment 99) One comment requests that FDA allow manufacturers to
position warnings below soft pack closures. The comment explains that
the top of a cigarette soft pack is folded down and held down by an
adhesive closure that is applied after the packages have been printed.
Without any accommodation, that closure would obstruct a portion of the
required warnings. The comment notes that in FDA's 2011 rulemaking, the
Agency permitted manufacturers to ``adapt the warnings on 'soft pack'
style packaging by moving the warning below the closure'' (76 FR at
36691), but the comment asserts that the 0.375 inch boundary that FDA
previously contemplated is too small to ensure there is enough adhesive
for the package to remain closed while accounting for standard printing
variations. Instead, the comment requests that FDA should allow the
closure to extend up to 0.482 inches from the top of the edge of the
package.
    (Response 99) FDA disagrees. As in 2011, we recognize the
technological difficulty of incorporating the required warnings on
``soft pack'' style packaging. Given the paramount need to incorporate
the warning without obstructing any of the elements of the warning
(i.e., the image and the textual warning statement), a company may
adapt the warnings on ``soft pack'' style packaging by moving the
warning below the closure. Because of the importance of maintaining the
integrity of the required warning (e.g., not distorting the image or
text), an adaptation of 0.375 inches may be acceptable only when it is
not technologically feasible to incorporate the required warnings on
``soft pack'' style packaging without the need to adapt the required
warning and the required warning after the adaptation is still
accurately reproduced (e.g., the required warning is not distorted).
Anything in excess of 0.375 inches may begin to distort the required
warning and likely would not be in compliance with the requirements of
the FCLAA and part 1141. We strongly encourage manufacturers to reach
out to us to discuss these issues.
    Under this approach, companies using ``soft pack'' style packaging
could move only the upper boundary of the display area of the warning
so that it runs along a line that is parallel to and not more than
0.375 inches from the top edge of the package. The companies may
compress the vertical size of the

image and then shift it down (so that it stays within the top 50
percent of the package), but companies who do this must ensure that, to
the extent the required warning must be adapted to fit the dimensions
of the warning area below the closure, the proportions of the required
warning must be maintained. In addition, the closure and the portion of
the packaging that appears between the top edge of the package and the
upper boundary of the display area of the required warning must be
either solid black or solid white. This will allow companies to
continue to produce ``soft pack'' style packaging with closures at the
top center of the pack without obstructing the required warning.
However, if we determine that it would be technologically feasible to
incorporate the required warnings on ``soft pack'' style packaging
without the need to adapt the warning in this way, we plan to notify
the regulated companies and the public of this conclusion and give
regulated companies a reasonable amount of time to modify their
packaging before any regulatory action is taken under this rule.
    (Comment 100) Some comments request clarifications on implementing
the advertising requirements when the advertisement is what they call
``small'' or digital. For example, one comment notes that the proposed
rule does not provide clarification regarding the display of warnings
in digital advertisements. The comment asks that FDA evaluate existing
digital platforms and provide specific direction on how to display the
required warnings based on specific devices and software prior to
finalizing the final rule. Another comment notes challenges related to
displaying the warnings on small advertisements in a way that is not
illegible or distorted. This comment suggests that FDA exempt small
advertisements from the warning requirements or revise the minimum font
requirements and use an appropriate image specifically designed for
small formats.
    (Response 100) Although FDA acknowledges that implementing the
requirements for certain small advertisements and some digital
advertisements may present specific challenges in certain cases, we
decline to exempt small advertisements. In both the case of digital
advertisements or small advertisements, FDA invites manufacturers to
raise the specific implementation issue they have as part of the
submission of the plan under Sec.  1141.10(g) to facilitate a solution
that reflects the requirements and is also technically feasible for the
manufacturer or other responsible entity.

XI. Effective Dates

    In the proposed rule, FDA proposed that the required warnings for
packages and advertisement become effective 15 months after the date
the final rule publishes in the Federal Register, consistent with the
language of section 201(b) of the Tobacco Control Act. FDA also
proposed an effective date for the submission of plans under Sec.
1141.10(g) of no later than 5 months after the final rule publishes in
the Federal Register. Section 201(b) of the Tobacco Control Act
provides that, beginning 30 days after the effective date, a
manufacturer must not introduce into domestic commerce of the United
States any product, irrespective of the date of manufacture, that is
not in conformance with section 4 of the FCLAA, as amended by the
Tobacco Control Act. As provided by section 201(b) of the Tobacco
Control Act, after the 30-day period, manufacturers would not be
permitted to introduce into domestic commerce any cigarette packages
that do not contain the required warnings, irrespective of the date of
manufacture. In the proposed rule, we also requested comments regarding
ways to differentiate cigarette packages sold from existing inventory
from those that were manufactured after the effective date.
    We received comments on both of these proposed effective dates, as
well as the 30-day period. Following consideration of the comments as
described below, the final rule continues to include an effective date
of 15 months from the date the final rule publishes in the Federal
Register, as required by section 201(b) of the Tobacco Control Act.
However, after further consideration, we are no longer including a 5-
month effective date for the submission of cigarette plans to FDA. The
FCLAA and Sec.  1141.10(g) require manufacturers to submit plans for
the display and distribution of required warnings on cigarettes
packages and the rotation of required warnings on cigarette advertising
and to obtain FDA approval of their plans before products required to
bear such warnings enter the market. Therefore, we strongly encourage
entities to submit cigarette plans as soon as possible after
publication of this final rule, and in any event within 5 months after
the publication of this final rule. In addition, as directed by section
201(b) of the Tobacco Control Act, after the 30-day period,
manufacturers will not be permitted to introduce into domestic commerce
any cigarette packages that do not contain the required warnings,
irrespective of the date of manufacture.
    (Comment 101) Some comments identify a challenge with complying
with the implementation deadline of 15 months after publication of the
final rule. These comments note that once the final rule is published
it will take time to redesign packaging to include the new required
warnings, submit plans to FDA for review, work with printers to develop
printing processes to print the new required warnings in accord with
their approved plans, and then print new packs. These comments request
an extension of the 15-month deadline, that FDA toll (i.e., pause) the
deadline during the Agency's review of the rotational plans, or both,
or that FDA use enforcement discretion to allow companies greater than
15 months to come into compliance. A comment suggests FDA is obligated
to determine the length of time it will take manufacturers to engrave
cylinders and print labels and provide a sufficient amount of time to
comply with the rule. This comment notes that the number of cylinders
that need to be engraved will depend on the number of required
warnings, which could result in thousands of cylinders, that there are
two main printing companies used by the industry, that manufacturers
may need additional time to redesign their labels to use fewer colors,
and lastly, that manufacturers cannot get a head start because of
uncertainty around the rule surviving constitutional challenge or being
subject to severability. One comment requests that FDA clarify that
``distributors and retailers can continue to distribute and sell for an
unlimited sell-through period products manufactured before the
effective date and introduced into commerce by the manufacturer within
30 days of the effective date.'' This comment asserts that small
tobacco product manufacturers cannot afford the hardship of product
returns by distributors and retailers who may be uncertain of their
ability to sell products that do not bear the required warnings.
    Other comments encourage the Agency to maintain the proposed rule's
timelines for implementation (e.g., submitting cigarette plans no later
than 5 months after publication of the final rule and implementing the
warnings no later than 15 months after publication of the final rule)
as they are reasonable and consistent with the FCLAA, especially given
the time that has elapsed since the issuance of the initial rule in
2011 and that the public has been deprived of the benefits of the
required warnings for almost a decade due to FDA's slow response in
proposing this rule. These

comments note that industry has been on notice of the required warnings
since the enactment of the Tobacco Control Act and manufacturers have
implemented pictorial cigarette warnings in more than 100 other
countries.
    (Response 101) We agree with the comments that suggest we maintain
the proposed 15-month deadline for the effective date of the required
warnings, consistent with the Tobacco Control Act. Consistent with the
statute, we believe it is also important to maintain the 30-day period
after which products may not be introduced into domestic commerce by
the manufacturer, and we disagree that further clarification of this is
necessary. Although we acknowledge that there may be some challenges as
industry moves to implement these requirements, FDA intends to assist
manufacturers, distributors, and retailers, as applicable, with
specific questions and concerns regarding these requirements.
Manufacturers with concerns about complying with this requirement for
their products should reach out to FDA to discuss their approach and
proposal for reasonably achieving the random and equal display and
distribution of the required warnings, in as equal a number of times as
is possible, and any other specific concerns or circumstances regarding
compliance with the warning requirements.
    Section 201(a) of the Tobacco Control Act requires manufacturers to
submit plans for the display and distribution of required warnings on
cigarettes packages and the rotation of required warnings on cigarette
advertising, and to obtain FDA approval of their plans before products
required to bear such warnings enter the market. Therefore, for
products that will be on the market as of the effective date of the
required warnings, manufacturers must submit, and FDA must approve,
their plans ahead of the required warnings' effective date. FDA
strongly encourages entities to submit cigarette plans as soon as
possible after publication of this final rule, and in any event within
five months after publication of this final rule. Doing so will benefit
regulated industry, based on the comments the Agency received regarding
the time firms may need to work with printers to implement the required
warnings as outlined in their approved plans. Early submission will
facilitate timely FDA review prior to the effective date of the
required warnings, encourage dialogue with entities regarding any
implementation concerns, and provide time to consider proposals by
entities in a timely manner. Given the initial high volume of original
submissions FDA may receive and based on our experience with review of
plans for required warnings on other tobacco products, our best
estimate is that it will take up to 6 months for the Agency to review
those original submissions. FDA will ensure that its review of
cigarette plans will be completed no later than 6 months after receipt
of an adequate plan from persons who work in good faith with FDA to
complete its review (e.g., persons should work diligently with FDA and
be responsive by submitting any requested information in a timely
manner). If there is a higher volume of submissions received than
currently expected, for those entities who submit an adequate plan
within 5 months of publication of this final rule and who work in good
faith with FDA to complete its review, FDA intends to ensure that
entities are not delayed or prevented from distributing cigarette
packages or advertising their products due to the Agency's not having
approved their plans by the effective date of the final rule. In
addition, FDA intends to issue a final guidance document that is
intended to assist entities with developing their cigarette plans,
which, when issued, may be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.

XII. Severability

    Consistent with section 5 of the Tobacco Control Act, FDA intends
for the various requirements established by this rulemaking to be
severable. Section 5 of the Tobacco Control Act states that, if any
provision of a regulation issued under the Tobacco Control Act is held
to be invalid, the remainder of the regulation ``shall not be affected
and shall continue to be enforced to the fullest extent possible.''
(Section 5 of the Tobacco Control Act is codified at 21 U.S.C. 387
note.) FDA has concluded that the individual aspects of this rule are
workable on their own and should go forward in the event that some are
invalidated. As discussed below, FDA has determined that severability
both is consistent with Congressional intent and would best advance the
Government's interest in promoting greater public understanding of the
negative health consequences of cigarette smoking.
    The rule is sound in its entirety and should be upheld in full.
However, in a circumstance where some but not all of the rule's
provisions are invalidated, FDA's intent is for the other provisions to
go into effect. A key question to determining severability is whether
the remaining portions of a regulation ``could function sensibly
without the stricken provision.'' MD/DC/DE Broadcasters Ass'n v.
F.C.C., 236 F.3d 13, 22 (D.C. Cir. 2001). Here, FDA has considered each
provision independently and concluded that the individual portions of
this rule are workable on their own.
    In the event that some portions of the rule are stricken, FDA has
concluded that each other portion of the rule would ``function
sensibly'' on its own and should go into effect. As the proposed rule
indicated, if a court were to invalidate some of the cigarette health
warnings (i.e., text-and-image pairings), but some of the pairings
remained valid, FDA intends that the remaining required warnings would
go into effect. As another example, if a court were to invalidate some
but not all of the images within the cigarette health warnings, FDA
intends that those images would be severed and the corresponding
textual warning statements would go into effect without the invalidated
images, along with the remaining cigarette health warnings that pair a
textual warning statement with an image. As a third example, if a court
were to invalidate all of the images within the cigarette health
warnings, FDA intends for the invalidated images to be severed and all
the warnings to go into effect with only their textual warning
statements.
    Among other things, FDA has considered the statute's rotation and
distribution requirements in reaching its conclusion that all portions
of the rule can function sensibly and should take effect if any
portions are invalidated. In the event that any warnings specified in
this final rule do not go into effect, the requirements for warnings to
be randomly and equally displayed and distributed on packages and
quarterly rotated in advertisements will be applied to the remaining
warnings, such as remaining text-and-image pairings or textual warning
statements without images.
    FDA's intent for any invalidated portions of the rule to be severed
also advances Congress's intent to replace the stale 1984 Surgeon
General's warnings and to promote greater public understanding of the
negative health consequences of cigarette smoking, since the remaining
warnings could go into effect much earlier than could any different
warnings implemented by other, subsequent means, such as further Agency
rulemaking.
    Several comments made remarks supporting or opposing the
severability of the rule's provisions.
    (Comment 102) One comment objects to any severing of the rulemaking
because it asserts that FDA did not

justify each permutation presented in the proposed rule, and severing
the rulemaking would deny interested parties sufficient notice to
participate in a meaningful notice and comment process. The comment
suggests that section 5 of the Tobacco Control Act does not mandate
severing the rulemaking in this situation. In addition, one comment
states that because the Tobacco Control Act mandates that the textual
warning statements must be accompanied by color graphics, FDA does not
have the discretion to implement the textual warning statements only.
This comment asserts that FDA is not authorized to change the placement
of the warnings or reduce the statutory 50 percent size requirement.
Another comment stated that implementation of only portions of the
regulation would not be workable from a practical standpoint of
rotating, distributing, and displaying the required warnings on
cigarette packages and advertisements.
    In contrast, other comments support severability, arguing that
should any portion of the rule be invalidated, considering other parts
severable and workable is consistent with section 5 of the Tobacco
Control Act and Congressional intent. Some comments specifically
recommend that should a court invalidate any portion or block the
images, the remaining portions should go into effect, as they would
promote greater public understanding of the negative health
consequences of cigarette smoking. Some comments suggest that
severability is appropriate, but FDA should further explain its
rationale to ensure judicial consideration of severability, if
necessary, to prevent vacation of the entire rule should a court find
any portion objectionable. One comment addresses the various scenarios
FDA set out in the proposed rule with suggestions of how FDA should
proceed in each case. That comment suggests that, if a court blocks the
images, FDA should proceed with implementing the textual warning
statements and, even if the size of the warnings is reduced, FDA should
prioritize maintaining the warning at the top of the pack because of
the importance of visibility of the warning.
    (Response 102) FDA agrees with comments asserting that, if a
portion of this rule is invalidated, severability would be appropriate.
Case law supports that conclusion, including case law regarding the
severability of statutory provisions. The Supreme Court in Alaska
Airlines, Inc. v. Brock, 480 U.S. 678 (1987), set forth the test for
severability of statutory provisions, emphasizing that ``a court should
refrain from invalidating more of the statute than is necessary.'' Id.
at 684 (brackets omitted). There are two prongs to the examination.
First, a court should evaluate whether ``the Legislature would [] have
enacted those provisions which are within its power, independently of
that which is not,'' i.e., ``whether the statute will function in a
manner consistent with the intent of Congress'' if it is stripped of
its unconstitutional provisions. Id. at 684, 685. Then, the reviewing
court will consider whether ``what is left is fully operative as a
law,'' or if instead ``the balance of the legislation is incapable of
functioning independently.'' Id. at 684 (quotation marks omitted).
    The same test is used to determine whether the invalid portion of a
statute or the invalid portion of a regulation may be severed from the
rest. See United States v. Smith, 945 F.3d 729, 738 (2d Cir. 2019)
(citing decisions addressing statutory severability for the standard to
determine regulatory severability). ``Whether the offending portion of
a regulation is severable depends upon the intent of the agency and
upon whether the remainder of the regulation could function sensibly
without the stricken provision.'' MD/DC/DE Broadcasters Ass'n v.
F.C.C., 236 F.3d 13, 22 (D.C. Cir. 2001). See also K-Mart Corp. v.
Cartier, 486 U.S. 281, 294 (1988) (severing a portion of a Customs
Service regulation as being in conflict with the statute).
    As noted, FDA intends for every portion of this rule to be
severable and has concluded that, if some but not all portions of the
rule were invalidated, remaining portions could and should function
sensibly on their own. FDA's conclusion is informed by Congress's
express intent. FDA agrees with the comments that section 5 of the
Tobacco Control Act, entitled ``Severability,'' expressly signals
Congress's intent for regulations issued under the statute to be
severable and for any remaining portion to be legally enforceable
should any portion be found invalid. Section 5 provides in relevant
part that ``[i]f any . . . of the regulations promulgated under this
division . . . is held to be invalid, the remainder . . . shall not be
affected and shall continue to be enforced to the fullest extent
possible.'' The inclusion of section 5 in the Tobacco Control Act
creates a presumption that Congress intended for any invalid portion of
a regulation issued under the statute to be severable from the
remainder. Alaska Airlines, 480 U.S. at 686 (same, for statutes;
holding that when Congress explicitly provides for severance by
including a severability clause in a statute, there is ``a presumption
that Congress did not intend the validity of the statute in question to
depend on the validity of the constitutionally offensive provision'').
Here, taking into consideration this statutory provision and Congress's
stated goals in requiring these warnings, FDA is explicitly stating its
intent that the portions of this regulation be interpreted as
severable. Therefore, the courts can say without any doubt, and all the
more strongly ``without any substantial doubt[,] that the agency would
have adopted the severed portion on its own.'' Am. Petroleum Inst. v.
Envtl. Prot. Agency, 862 F.3d 50, 71 (D.C. Cir. 2017) (quotation marks
omitted), modified on other grounds, 883 F.3d 918 (D.C. Cir. 2018).
    The second prong of a severability analysis is whether the
remaining portions of a statute or regulation remain workable on their
own. In this case, they do. The different text-and-image pairings and
the different textual warning statements can be and are intended to be
incorporated into the label of a package or an advertisement on an
individual basis and therefore ``operate entirely independently of one
another.'' Davis Cty. Solid Waste Mgmt. v. U.S. E.P.A., 108 F.3d 1454,
1459 (D.C. Cir. 1997) (internal citation omitted). Because the Agency
intends as many of the warnings to go forward as possible, and because
the regulation will function even if some of the text-and-image
pairings or the images are invalidated, any provisions of this rule
that may be invalidated are properly severable.
    With respect to the comment asserting that FDA lacks the discretion
to implement the warning requirements with textual warning statements
only or with other deviations from the statutory mandate, FDA notes
that the question of severability is distinct from that of the
Congressional directive to issue a warning regulation in the first
instance. The situation that is the subject of this ``Severability''
section--i.e., the circumstance where a court has disagreed with FDA's
conclusions as to the legality of some but not all provisions of the
rule--raises different questions from those addressed in the comment.
Contrary to what the comment states, FDA is not asserting, and does not
need to assert, that it has the authority to promulgate a rule under
section 15 U.S.C. 1333 that deviates from the requirements of section
1333. Instead, FDA here is asserting, and need only assert, that in the
event that a court invalidates certain provisions of this rule but not
others, FDA intends the

remaining provisions to go into effect on their own.
    To the extent that the comment questions FDA's authority to oversee
implementation of text-only warnings in the event of a court decision
invalidating the images but upholding the rest of the rule, FDA
disagrees. The comment asserts that, because the Tobacco Control Act
directs FDA to issue color graphics to accompany the textual warning
statements, FDA is without authority to implement the remaining
portions of a rule if a court invalidates the color graphics but not
the textual statements. FDA disagrees with any interpretation of the
statute that would compel this result. Again, the question here relates
only to severability and to what details of the regulation are
preserved in the case where some provisions do not survive. The statute
provides that FDA ``shall issue regulations that require color graphics
depicting the negative health consequences of smoking to accompany the
label statements specified in subsection (a)(1)'' (section 201(a) of
the Tobacco Control Act). But this language does not dictate that, if
some of the text-and-image pairings, images, or textual warning
statements were invalidated by a court while other pairings, images, or
statements were not invalidated, the result would be to invalidate all
of the rule's requirements. For the reasons described above, in the
event that some provisions of this rule are invalidated, the statute
compels, FDA intends, and courts should recognize as workable the
preservation of all remaining portions.
    FDA disagrees with comments that suggest that stating its
intentions for severability fails to provide the public with adequate
notice of the portions of the rule that would take effect if any others
are severed and prevents meaningful public comment. The public has had
the opportunity to comment on the entire proposal, as well as each
required textual warning statement and each required text-and-image
pairing, and thus all portions that may take effect if other portions
are severed.
    FDA also disagrees with comments suggesting that, if, for example,
a court struck down any or all of the images but upheld the textual
warning statements, the remaining unsevered portions of the rule would
not be consistent with the intent of Congress. While it is clear that
in section 201 of the Tobacco Control Act Congress intended for color
graphics to accompany textual warning statements, and while the
affirmative proposal of a regulation by FDA under section 201 requiring
only textual warnings would not effectuate that specific intent, this
analysis does not answer the question of severability, i.e., of what
provisions of a regulation should survive in the event that a court
strikes down some but not all provisions of this rulemaking replacing
the Surgeon General's warnings with new text-and-image pairings. Here,
Congress's intent surely supports preservation. It was clearly the
intent of Congress by passing the Tobacco Control Act to replace the
stale 1984 Surgeon General's warnings and to increase the size and
update the placement of new required cigarette warnings, as well as to
require color graphics. In the event that a court determines that a
rule is valid with respect to the new textual warning statements but is
not valid with respect to other aspects, including the color graphics,
implementation of those other aspects would be consistent with
Congress's intent to strengthen cigarette warnings.
    Likewise, FDA disagrees with comments that it would be unworkable
for warnings containing only textual warning statements or only text-
and-image pairings that were not invalidated to take effect. FDA is
aware of no technical, practical, or other impediment to implementation
of individual provisions of this rule without the others. Thus, in the
context of the question of severability, FDA concludes that the
implementation of warnings containing only textual warning statements
would be workable (i.e., if all of the images are struck down), as
would the implementation of a smaller number of required warnings
(i.e., if some of the text-and-image pairings were found to be invalid
and were severed, leaving fewer total pairings or a mixture of warnings
that included both text-only and text-and-image pairings). FDA notes
that comments do not provide details about why or how the
implementation of portions of the regulation would not be workable.
However, if companies have specific questions, FDA is ready to work
with them regarding implementation issues.

XIII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order (E.O.) 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility
Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). E.O.s 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
E.O. 13771 requires that the costs associated with significant new
regulations ``shall, to the extent permitted by law, be offset by the
elimination of existing costs associated with at least two prior
regulations.'' We believe that this final rule is an economically
significant regulatory action as defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We estimate that for a small manufacturer or importer who
would be affected by this final rule, initial costs could represent
between 2.3 and 42 percent of their annual receipts and recurring costs
could represent from 0.1 to 2.7 percent of their annual receipts.
Hence, we find that the final rule will have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This final rule will
result in an expenditure in any year that meets or exceeds this amount.
    This final rule requires that one of 11 new cigarette health
warnings, each comprising a textual warning statement paired with an
accompanying color graphic, in the form of a photorealistic image,
appear on cigarette packages and in cigarette advertisements. The final
rule further requires that, for cigarette packages, the required
warnings be randomly displayed in each 12-month period, in as equal a
number of times as is possible on each brand of the product and be
randomly distributed throughout the United States in accordance with a
plan approved by FDA. The final rule also requires that, for cigarette
advertisements, the required warnings must be rotated quarterly in
alternating sequence in advertisements for each brand of cigarettes in
accordance with a plan approved by FDA.
    Pictorial cigarette health warnings promote greater public
understanding about the negative health consequences of smoking as they
increase the noticeability of the warning's message,

increase knowledge and learning about the negative health consequences
of smoking, and benefit diverse populations that have disparities in
knowledge about the negative health consequences of smoking. We do not
predict the size of these benefits at this time. We discuss the
informational effects qualitatively.
    The costs of this final rule consist of initial and recurring
labeling costs associated with changing cigarette labels to accommodate
the new cigarette health warnings, design and operation costs
associated with the random and equal display and distribution of the
required warnings for cigarette packages and quarterly rotations of the
required warnings for cigarette advertisements, advertising-related
costs, and costs associated with government administration and
enforcement of the rule. Using a 20-year time horizon, we estimate that
the present value of the costs of this final rule ranges from $1.5
billion to $1.7 billion, with a mean estimate of $1.6 billion, using a
three percent discount rate, and ranges from $1.1 billion to $1.3
billion, with a mean estimate of $1.2 billion, using a seven percent
discount rate (2018$). Annualized costs, which are presented below in
Table 1, range from $100 million per year to $114 million per year,
with a mean estimate of $107 million per year, using a three percent
discount rate, and range from $107 million per year to $122 million per
year, with a mean estimate of $114 million per year, using a seven
percent discount rate (2018$).
    Because it is not possible to compare benefits and costs directly
when the benefits are not quantified, we employ a break-even approach.
If the information provided by the cigarette health warning on each
cigarette package were valued at about $0.01 (for every pack sold
annually nationwide), then the benefits that would be generated by the
final rule would equal or exceed the estimated annual costs.

                    Table 1--Summary of the Informational Effects and Costs of the Final Rule
                                             [In millions of 2018$]
----------------------------------------------------------------------------------------------------------------
                                                                            Units
                                                               ------------------------------
            Category               Primary     Low      High              Discount   Period          Notes
                                  estimate  estimate  estimate    Year       rate    covered
                                                                 dollars     (%)     (years)
----------------------------------------------------------------------------------------------------------------
Informational Effects...........  Pictorial cigarette health warnings promote greater public understanding about
                                  the negative health consequences of smoking as they increase the noticeability
                                  of the warning's message, increase knowledge and learning of the negative
                                  health consequences of smoking, and help reduce disparities in knowledge about
                                  the negative health consequences of smoking across diverse populations. If the
                                  information provided by the cigarette health warning on each cigarette package
                                  was valued at about $0.01 (for every pack sold annually nationwide), then the
                                  benefits that would be generated by the final rule would equal or exceed the
                                  estimated annual costs.
                                 -------------------------------------------------------------------------------
Costs:
    Annualized Monetized            $114.4    $106.6    $122.2      2018         7        20  Effective date of
     $millions/year.                 106.7     100.0     113.5      2018         3        20   15 months from
                                                                                date of
                                                                                publication of
                                                                                final rule.
----------------------------------------------------------------------------------------------------------------

    In line with E.O. 13771, in Table 2 we estimate present and
annualized values of costs and cost savings over an infinite time
horizon. With a seven percent discount rate, discounted relative to
year 2016, the estimated annualized net costs equal $73 million in 2016
dollars over an infinite horizon. Based on these costs, this final rule
is considered a regulatory action under E.O. 13771.

                    Table 2--E.O. 13771 Summary Table
          [In millions of 2016$, over an infinite time horizon]
------------------------------------------------------------------------
                                                                Primary
                            Item                               estimate
                                                                 (7%)
------------------------------------------------------------------------
Present Value of Costs......................................    $1,046.0
Present Value of Cost Savings...............................         0.0
Present Value of Net Costs..................................     1,046.0
Annualized Costs............................................        73.2
Annualized Cost Savings.....................................         0.0
Annualized Net Costs........................................        73.2
------------------------------------------------------------------------
Note: Effective date is 15 months from date of publication of final
  rule.

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 16) and at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

XIV. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Additionally, the action is not
anticipated to pose serious harm to the environment and to adversely
affect a species or the critical habitat of a species as stipulated
under 21 CFR 25.21(b). Therefore, neither an environmental assessment
nor an environmental impact statement is required.

XV. Paperwork Reduction Act of 1995

    The final rule contains information collection requirements that
are subject

to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521) (PRA). The title, description, and respondent description of
the information collection provisions are shown in the following
paragraphs with an estimate of the annual reporting and recordkeeping
burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    Title: Required Warnings for Cigarette Packages and Advertisements.
    Description: The requirement for submission of plans for cigarette
packages and advertisements, and the specific marketing requirements
relating to the random and equal display and distribution of required
warnings on cigarette packaging and quarterly rotation of required
warnings in alternating sequence in cigarette product advertising,
appear in Sec.  1141.10(g). A record of the FDA-approved plan must also
be established and maintained.
    Description of Respondents: The respondents to this collection of
information are manufacturers, distributors, and certain retailers of
cigarettes who will be required to submit plans for cigarette packages
and advertisements to FDA.
    As required by section 3506(c)(2)(B) of the PRA, FDA provided an
opportunity for public comment on the information collection
requirements of the proposed rule that published in the Federal
Register of August 16, 2019 (84 FR 42754). No PRA-related comments were
received.
    FDA requests that each cigarette plan cover both packaging and
advertising as applicable. The tobacco product manufacturer,
distributor, or retailer should demonstrate how they plan to achieve
the random display in each 12-month period, in as equal a number of
times as is possible on each brand of the product, and random
distribution in all areas of the United States of the required warnings
on packages and the quarterly rotation in advertisements. Required
warnings for cigarettes must be randomly displayed, in as equal a
number of times as is possible, and randomly distributed on packages,
and rotated quarterly in advertisements, in accordance with an FDA-
approved plan.
    FDA strongly encourages entities to submit their cigarette plans as
soon as possible after publication of this final rule, and in any event
within 5 months after publication of this final rule. Packages and
advertisements of cigarettes are required to bear the required warnings
beginning 15 months after the date of publication of the final rule.
FDA intends to request an amendment to a plan under review if FDA needs
clarification of information in the plan or other additional
information to determine whether it could approve the plan. Any such
amendments would likely increase the overall review time.
    After FDA approval of an initial plan, a supplement to the approved
plan should be submitted to FDA and approved before making changes to
the random and equal display or distribution of required warnings on
packages or the quarterly rotation of required warnings in
advertisements. For a new brand, a new plan or a supplement to an FDA-
approved plan is required to be submitted and approved before
distributing packages and advertisements for that new brand.
    However, in lieu of a supplement to an FDA-approved plan for a new
brand, manufacturers may reference in their initial plan all brands in
their product listing(s) under section 905(i) of the FD&C Act and
incorporate any new brands into their approved plan, so long as no
other changes are made to the plan. For retailer-generated advertising,
retailers may list ``all brands'' in their plan, which would cover
future brands, so long as the plan provides for the same schedule for
quarterly rotation of the required warnings for all brands.
    FDA allows electronic submissions, via FDA's Electronic Submissions
Gateway, and written submissions. FDA strongly encourages electronic
submission to facilitate efficiency and timeliness of submission and
processing.
    For each brand of cigarettes, the plan for packaging should explain
how: Each of the required warnings will be randomly displayed during
each 12-month period on each brand; each of the required warnings will
be displayed in as equal a number of times as possible on each brand of
the product; and product packages will be randomly and equally
distributed in all areas of the United States in which the product is
marketed. FDA expects that a plan for random and equal display and
distribution of required warnings on packages will ordinarily be based
on the date of manufacture or shipment of the product. For each
cigarette brand, the plan for advertising should explain how the
required warnings will be rotated quarterly in advertisements and how
the quarterly rotations will occur in alternating sequence. Among other
things, the plan should specify the initial rotation timeframe on which
quarterly rotation is based and, if the rotation timeframe varies for
different types/forms of advertising, specify the different quarterly
timeframes associated with the different types/forms of advertising,
and describe the quarterly schedule for rotating each of the required
warnings for each cigarette brand. FDA would not consider a plan that
merely restated the regulatory requirements to be sufficiently detailed
to enable FDA to approve the plan.
    FDA's review of a plan would only be for determining compliance
with the regulatory criteria for approval of a plan, as set forth in
Sec.  1141.10(g)(1) and (2). FDA requests that plans submitted for
review include representative samples of packages and advertisements
with each of the required warnings. Such samples would place the plan
in context and, therefore, facilitate FDA's review of the plan, not a
review of the content of the package labels and advertisements.
Approval of a plan does not represent a determination by FDA that any
package or advertisement complies with any of the other requirements
regarding the placement, font type, size, and color of the warnings
found in section 4 of the FCLAA and part 1141, or any other
requirements under the FD&C Act and its implementing regulations.
    FDA intends to communicate the approval of a plan with a letter to
the submitter. After FDA approval of an initial plan, a supplement to
the approved plan would need to be submitted to FDA for review and
approved before making changes to the display or distribution of
required warnings on packages or the rotation of required warnings in
advertisements. For a new brand, a new plan or a supplement to an
approved plan would need to be submitted and approved before displaying
or distributing packages and advertisements for that new brand.
    However, in lieu of a supplement to an approved plan for a new
brand, manufacturers may reference in their initial plan ``all brands''
in their product listing(s) under section 905(i) of the FD&C Act and
incorporate any new brands into their approved plan, so long as no
other changes are made to the plan. For retailer-generated advertising,
retailers may list ``all brands'' in their plan, which would cover
future brands, so long as the plan provides for the same schedule for
quarterly rotation of the required warnings for all brands.

                                Table 3--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          Type of plan               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Initial Plans...................              59               1              59             150           8,850
Supplements.....................              30               1              30              75           2,250
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          11,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates are based on FDA's experience with information
collections for other tobacco product plans (i.e., OMB control numbers
0910-0671 (smokeless tobacco products) and 0910-0768 (cigars)) and 2017
Treasury Alcohol and Tobacco Tax and Trade Bureau (TTB) data.
    As discussed in the Final Regulatory Impact Analysis (see section
XIII; Ref. 16), based on 2017 TTB data, FDA estimates 59 entities will
be affected by the rule. We estimate these 59 entities will submit a
one-time initial plan, and it will take an average of 150 hours per
respondent to prepare and submit a plan for packaging and advertising
for a total of 8,850 hours. We estimate that about half of respondents
will submit a supplement. If a supplement to an approved plan is
submitted, FDA estimates it will take half the time per response. We
estimate receiving 30 supplements at 75 hours per response for a total
of 2,250 hours. FDA estimates that the total hours for submitting
initial plans and supplements will be 11,100.
    Section 1141.10(g)(4) would establish that each tobacco product
manufacturer required to randomly and equally display and distribute
required warnings on packaging or quarterly rotate required warnings in
advertisements in accordance with an FDA-approved plan under section 4
of the FCLAA and this part must maintain a copy of the FDA-approved
plan (approved under Sec.  1141.10(g)(3)). This copy (or record) of
such FDA-approved plan must be available for inspection and copying by
officers or employees of FDA. This subsection would require that the
record(s) be retained while in effect and for a period of not less than
4 years from the date of FDA's approval of the plan.

                                                   Table 4--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of      Number of records     Total annual      Average burden
                       Plan records                          recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records..................................................                 59                1.5                 89                  3                267
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................                267
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that 59 recordkeepers will keep a total of about 89
records at 3 hours per record for a total of 267 hours. As stated
previously, these estimates are based on FDA's experience with
information collections for other tobacco product plans (i.e., OMB
control numbers 0910-0671 and 0910-0768). Based on our estimates for
the submission of initial plans and supplements (that all respondents
will submit initial plans and about half of respondents will submit
supplements), we estimate that each recordkeeper will keep an average
of 1.5 records.
    FDA estimates that the total burden for this information collection
is 11,367 hours (11,100 reporting hours + 267 recordkeeping hours).
    FDA believes that the required warnings for cigarette packages and
cigarette advertisements in Sec.  1141.10 are not subject to review by
OMB under the PRA because they do not constitute a ``collection of
information'' under that statute (44 U.S.C. 3501-3521). Rather, these
labeling statements are a ``public disclosure'' of information
originally supplied by the Federal Government to the recipient for the
purpose of ``disclosure to the public'' (5 CFR 1320.3(c)(2)).
    The information collection provisions in the final rule have been
submitted to OMB for review as required by section 3507(d) of the PRA.
    Before the effective date of the final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in the
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

XVI. Federalism

    We have analyzed the final rule in accordance with the principles
set forth in E.O. 13132. We have determined that the rule does not
contain policies that have substantial direct effects on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. Accordingly, we conclude that the rule does not contain
policies that have federalism implications as defined in the E.O. and,
consequently, a federalism summary impact statement is not required.

XVII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required. We received two
comments related to tribal consultation and we respond to those
comments in the following paragraphs.

    (Comment 103) One comment objects to the rulemaking as a product of
a court order rather than of deliberatively reasoned decision making,
suggesting that due to the expedited schedule and lack of meaningful
tribal consultation, the effectiveness of the rule in promoting public
health and its disproportionate effect on tribal communities has not
been fully considered. The comment notes that, because the tribe relies
in part on tobacco revenues to fund basic governmental services, the
rule threatens to have an outsized effect on tribal manufacturers and
requests that meaningful tribal consultation occur prior to finalizing
the rule to discuss the impact and cost incurred by tribal governments.
    (Response 103) FDA agrees that collaboration and consultation with
federally recognized tribal governments, per the FDA Tribal
Consultation Policy and E.O. 13175, is important. FDA engages with
tribal stakeholders, including tribal government leaders, tribal health
leaders, and public health professionals, about the implementation and
enforcement of the Tobacco Control Act and related regulations by
various methods (e.g., ``Dear Tribal Leader'' letters, All Tribes'
Calls, formal and informal consultations as well as face-to-face
meetings). We also encourage tribes to stay informed about developments
related to tobacco products through our website (https://www.fda.gov/TobaccoProducts).
    We disagree that the tribal consultation for the proposed rule was
inadequate. There were several opportunities for tribes to engage with
FDA about the proposed rule, including the impact and costs of the
proposed rule on tribal manufacturers, which was considered as part of
the Preliminary Regulatory Impact Analysis (https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm). In
a ``Dear Tribal Leader'' letter dated August 15, 2019, FDA initiated
consultation with federally recognized Indian tribes on the proposed
rule and invited tribes to participate in an All Tribes' Call on
September 19, 2019. The purpose of the call was to provide an overview
of the proposed rule, answer questions, and hear tribal comments on the
proposed rule. We provided contact information in the letter and during
the call to help ensure that there was a mechanism to address any
further questions. We also encouraged tribes to submit written comments
on the proposed rule and supporting documents such as the Preliminary
Regulatory Impact Analysis.
    (Comment 104) One comment supports the rule as a means to increase
understanding of the negative health consequences of smoking and
encourages FDA to ensure that these efforts reach American Indian/
Alaska Native populations, which have the highest rates of cigarette
smoking (Ref. 26) but lack understanding of the scope of the negative
health consequences of smoking. The comment suggests that FDA partner
with Urban Indian Health organizations to achieve the goals of this and
any future goals, not as a substitute for tribal consultation but as a
means to reach a target population.
    (Response 104) We agree that the rule will promote greater public
understanding of the negative health consequences of smoking. We note
that in addition to this important rulemaking, FDA is developing other
outreach with American Indian/Alaska Native partners.

XVIII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

* 1. IOM of the National Academies. Ending the Tobacco Problem: A
Blueprint for the Nation. R. J. Bonnie, K. Stratton, R. B. Wallace
(Eds.). Washington, DC: The National Academies Press, 2007.
Available at http://www.nationalacademies.org/hmd/Reports/2007/Ending-the-Tobacco-Problem-A-Blueprint-for-the-Nation.aspx.
* 2. U.S. Congress. House. Committee on Energy and Commerce,
Subcommittee on Health. H.R. 1108, Family Smoking Prevention and
Tobacco Control Act: Hearing Before the House Subcommittee on Health
of the Committee on Energy and Commerce. Testimony of Richard
Bonnie. 110th Cong., 1st sess., October 3, 2007.
* 3. U.S. Department of Health and Human Services (HHS). The Health
Consequences of Smoking--50 Years of Progress: A Report of the
Surgeon General. Atlanta, GA: HHS, CDC, National Center for Chronic
Disease Prevention and Health Promotion, Office on Smoking and
Health, 2014.
4. Hammond, D., G.T. Fong, A. McNeill, et al. ``Effectiveness of
Cigarette Warning Labels in Informing Smokers About the Risks of
Smoking: Findings from the International Tobacco Control (ITC) Four
Country Survey.'' Tobacco Control, 15(Suppl. 3): iii19-iii25, 2006.
Available at https://doi.org/10.1136/tc.2005.012294.
5. Elton-Marshall, T., R. Wijesingha, R.D. Kennedy, et al.
``Disparities in Knowledge About the Health Effects of Smoking Among
Adolescents Following the Release of New Pictorial Health Warning
Labels.'' Preventative Medicine, 111:358-365, 2018. Available at
https://doi.org/10.1016/j.ypmed.2017.11.025.
6. Mutti, S., D. Hammond, J.L. Reid, et al. ``The Efficacy of
Cigarette Warning Labels on Health Beliefs in the United States and
Mexico,'' Journal of Health Communication, 18(10):1180-1192, 2013.
Available at https://doi.org/10.1080/10810730.2013.778368.
7. Oncken, C., S. McKee, S. Krishnan-Sarin, et al. ``Knowledge and
Perceived Risk of Smoking-Related Conditions: A Survey of Cigarette
Smokers.'' Preventative Medicine, 40(6):779-784, 2005. Available at
https://doi.org/10.1016/j.ypmed.2004.09.024.
8. Roth, L.K. and H.S. Taylor. ``Risks of Smoking to Reproductive
Health: Assessment of Women's Knowledge.'' American Journal of
Obstetrics and Gynecology, 184(5):934-939, 2001. Available at
https://doi.org/10.1067/mob.2001.112103.
9. Weinstein, N., Slovic, P., Waters, E., and G. Gibson. ``Public
Understanding of the Illnesses Caused by Cigarette Smoking,''
Nicotine and Tobacco Research, 6(2):349-355, 2004. Available at
https://doi.org/10.1080/14622200410001676459.
10. Yang, Y., J.J. Wang, C.X. Wang, et al. ``Awareness of Tobacco-
Related Health Hazards Among Adults in China.'' Biomedical and
Environmental Sciences, 23(6):437-444, 2010. Available at https://doi.org/10.1016/S0895-3988(11)60004-4.
* 11. FDA. ``Required Cigarette Health Warnings, 2020.'' (See 21 CFR
1141.5)
* 12. FDA. Experimental Study on Warning Statements for Cigarette
Graphic Health Warnings: Study Report. January 2020.
* 13. Pomeranz, J.L. ``No Need to Break New Ground: A Response to
the Supreme Court's Threat to Overhaul the Commercial Speech
Doctrine.'' Loyola of Los Angeles Law Review, 45(2): 389-434 (2012).
Available at https://digitalcommons.lmu.edu/llr/vol45/iss2/2.
* 14. U.S. Congress. House. Committee on Energy and Commerce. Family
Smoking Prevention and Tobacco Control Act (H.R. 1256). House Report
Number 111-58, Part 1. 111th Cong., 1st sess., March 26, 2009.
15. Hammond, D., G.T. Fong, R. Borland, et al. ``Text and Graphic
Warnings on Cigarette Packages: Findings from the International
Tobacco Control Four Country Study.'' American Journal of

Preventive Medicine, 32(3):202-209, 2007. Available at https://doi.org/10.1016/j.amepre.2006.11.011.
* 16. FDA. ``Final Regulatory Impact Analysis; Final Regulatory
Flexibility Analysis; Unfunded Mandates Reform Act Analysis,
Required Warnings for Cigarette Packages and Advertisements; Final
Rule.'' 2020.
* 17. FDA. Experimental Study of Cigarette Warnings: Study Report.
January 2020.
* 18. Wang, T.W., K. Asman, A.S. Gentzke, et al. ``Tobacco Product
Use Among Adults--United States, 2017.'' Morbidity and Mortality
Weekly Report, 67(44):1225-1232, 2018. Available at https://doi.org/10.15585/mmwr.mm6744a2.
* 19. Creamer, M.R., T.W. Wang, S. Babb, et al. ``Tobacco Product
Use and Cessation Indicators Among Adults--United States, 2018.''
Morbidity and Mortality Weekly Report, 68(45):1013-1019, 2019.
Available at http://dx.doi.org/10.15585/mmwr.mm6845a2.
20. Cullen, K.A., A.S. Gentzke, M.D. Sawde, et al. ``e-Cigarette Use
Among Youth in the United States, 2019.'' JAMA, E1-E9, 2019.
Available at https://doi.org/10.1001/jama.2019.18387.
* 21. Wang T.W., A.S. Gentzke, M.R. Creamer, et al. ``Tobacco
Product Use and Associated Factors Among Middle and High School
Students--United States, 2019.'' Morbidity and Mortality Weekly
Report, 68(12):1-22, 2019. Available at https://dx.doi.org/10.15585/mmwr.ss6812a1.
* 22. Substance Abuse and Mental Health Services Administration
(SAMHSA). Key Substance Use and Mental Health Indicators in the
United States: Results from the 2018 National Survey on Drug Use and
Health: Detailed Tables. HHS Publication No. PEP19-5068, NSDUH
Series H-54. Rockville, MD: HHS, SAMHSA, Center for Behavioral
Health Statistics and Quality, 2019. Available at https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf.
* 23. Murphy, S.L., J. Xu, K.D. Kochanek, et al. ``Deaths: Final
Data for 2015.'' National Vital Statistics Reports, 66(6):1-75,
2017. Available at https://www.cdc.gov/nchs/data/nvsr/nvsr66/nvsr66_06.pdf.
24. Mokdad, A.H., J.S. Marks, D.F. Stroup, and J.L. Gerberding.
``Actual Causes of Death in the United States, 2000.'' Journal of
the American Medical Association, 291(10):1238-1245, 2004. Available
at https://doi.org/10.1001/jama.291.10.1238.
* 25. CDC. ``Tobacco-Related Disparities.'' CDC.gov. Last reviewed
November 25, 2019. www.cdc.gov/tobacco/disparities/index.htm.
* 26. HHS. Tobacco Use Among U.S. Racial/Ethnic Minority Groups--
African Americans, American Indians and Alaska Natives, Asian
Americans and Pacific Islanders, and Hispanics: A Report of the
Surgeon General. Atlanta, GA: HHS, CDC, National Center for Chronic
Disease Prevention and Health Promotion, Office on Smoking and
Health, 1998.
* 27. Ogden, C.L., T.H. Fakhouri, M.D. Carroll, et al. ``Prevalence
of Obesity Among Adults, by Household Income and Education--United
States, 2011-2014.'' Morbidity and Mortality Weekly Report,
66(50):1369-1373, 2017. Available at https://doi.org/10.15585/mmwr.mm6650a1.
28. Espey, D.K., M.A. Jim, N. Cobb, et al. ``Leading Causes of Death
and All-Cause Mortality in American Indians and Alaska Natives.''
American Journal of Public Health, 104(S3):S303-S311, 2014.
Available at https://doi.org/10.2105/AJPH.2013.301798.
29. Finney Rutten, L.J., E.M. Augustson, R.P. Moser, et al.
``Smoking Knowledge and Behavior in the United States:
Sociodemographic, Smoking Status, and Geographic Patterns.''
Nicotine & Tobacco Research, 10(10):1559-1570, 2008. Available at
https://doi.org/10.1080/14622200802325873.
30. Siahpush, M., A. McNeill, D. Hammond, et al. ``Socioeconomic and
Country Variations in Knowledge of Health Risks of Tobacco Smoking
and Toxic Constituents of Smoke: Results from the 2002 International
Tobacco Control (ITC) Four Country Survey.'' Tobacco Control,
15(Suppl. 3):iii65-iii70, 2006. Available at https://doi.org/10.1136/tc.2005.013276.
* 31. Jamal, A., E. Phillips, A.S. Gentzke, et al. ``Current
Cigarette Smoking Among Adults--United States, 2016.'' Morbidity and
Mortality Weekly Report, 67:53-59, 2018. Available at https://doi.org/10.15585/mmwr.mm6702a1.
32. Wakefield, M., C. Morley, J.K. Horan, et al. ``The Cigarette
Pack as Image: New Evidence from Tobacco Industry Documents.''
Tobacco Control, 11:i73-i80, 2002. Available at https://doi.org/10.1136/tc.11.suppl_1.i73.
* 33. HHS. Preventing Tobacco Use Among Youth and Young Adults: A
Report of the Surgeon General. Atlanta, GA: HHS, CDC, National
Center for Chronic Disease Prevention and Health Promotion, Office
on Smoking and Health, 2012.
* 34. Davis, R.M., E.A. Gilpin, B. Loken, et al. (Eds.). The Role of
Media in Promoting and Reducing Tobacco Use. Tobacco Control
Monograph No. 19, NIH Publication Number 07-6242. Bethesda, MD: HHS,
National Institutes of Health, National Cancer Institute, 2008.
* 35. WHO. WHO Report on the Global Tobacco Epidemic, 2019: Offer
Help to Quit Tobacco Use. Geneva, Switzerland: WHO Geneva, 2019.
Available at https://apps.who.int/iris/bitstream/handle/10665/326043/9789241516204-eng.pdf?ua=1.
36. Viscusi, W.K. ``Do Smokers Underestimate Risks?'' Journal of
Political Economy, 98(6):1253-1269, 1990. Available at
www.jstor.org/stable/2937757.
37. Viscusi, W.K. and J.K. Hakes. ``Risk Beliefs and Smoking
Behavior.'' Economic Inquiry, 46(1):45-59, 2008. Available at
https://doi.org/10.1111/j.1465-7295.2007.00079.x.
38. United States v. Philip Morris U.S.A. Inc., No. 99-cv-2496
(D.D.C. Apr. 6, 2005) (Trial Tr. 17923-17931) (cross-examination of
W. Kip Viscusi). Available at https://www.industrydocuments.ucsf.edu/tobacco/docs/#id=gzhf0028.
39. Slovic, P. ``Rejoinder: The Perils of Viscusi's Analyses of
Smoking Risk Perceptions.'' Journal of Behavioral Decision Making,
13(2):273-276, 2000. Available at https://doi.org/10.1002/
(SICI)1099-0771(200004/06)13:2%3C273::AID-BDM338%3E3.0.CO;2-G.
40. Slovic, P. ``Cigarette Smokers: Rational Actors or Rational
Fools?'' In Smoking: Risk, Perception, and Policy, P. Slovic (Ed.),
97-124. Thousand Oaks, CA: Sage Publications, 2001. Available at
http://dx.doi.org/10.4135/9781452232652.n6.
41. Krugman, D.M., R.J. Fox, and P.M. Fischer ``Do Cigarette
Warnings Warn? Understanding What It Will Take to Develop More
Effective Warnings.'' Journal of Health Communication, 4(2):95-104,
1999. Available at https://doi.org/10.1080/108107399126986.
42. Elliott & Shanahan Research. Developmental Research for New
Australian Health Warnings on Tobacco Products Stage 1. Report
prepared for The Population Health Division, Department of Health
and Ageing. Commonwealth of Australia, September 2002.
43. Hammond, D. ``Health Warning Messages on Tobacco Products: A
Review.'' Tobacco Control, 20(5):327-337, 2011. Available at https://doi.org/10.1136/tc.2010.037630.
44. WHO. WHO Report on the Global Tobacco Epidemic, 2008: The MPOWER
Package. Geneva, Switzerland: WHO Geneva, 2008. Available at https://apps.who.int/iris/bitstream/handle/10665/43818/9789241596282_eng.pdf?sequence=1.
45. Borland, R., N. Wilson, G.T. Fong, et al. ``Impact of Graphic
and Text Warnings on Cigarette Packs: Findings from Four Countries
over Five Years.'' Tobacco Control, 18(5):358-364, 2009. Available
at https://doi.org/10.1136/tc.2008.028043.
46. Elton-Marshall, T., S.S. Xu, G. Meng, et al. ``The Lower
Effectiveness of Text-Only Health Warnings in China Compared to
Pictorial Health Warnings in Malaysia.'' Tobacco Control, 24:iv6-
iv13, 2015. Available at https://doi.org/10.1136/tobaccocontrol-2015-052616.
47. Brewer, N.T., H. Parada, Jr., M.G. Hall, et al. ``Understanding
Why Pictorial Cigarette Pack Warnings Increase Quit Attempts.''
Annals of Behavioral Medicine, 53(3):232-243, 2018. Available at
https://doi.org/10.1093/abm/kay032.
* 48. Evans, A.T., E. Peters, A.A. Strasser, et al. ``Graphic
Warning Labels Elicit Affective and Thoughtful Responses from
Smokers: Results of a Randomized

Clinical Trial.'' PLoS One, 10(12):e0142879, 2015. Available at
https://doi.org/10.1371/journal.pone.0142879.
49. Gravely, S., G.T. Fong, P. Driezen, et al. ``The Impact of the
2009/2010 Enhancement of Cigarette Health Warning Labels in Uruguay:
Longitudinal Findings from the International Tobacco Control (ITC)
Uruguay Survey.'' Tobacco Control, 25:89-95, 2014. Available at
https://doi.org/10.1136/tobaccocontrol-2014-051742.
50. Green, A.C., S.C. Kaai, G.T. Fong, et al. ``Investigating the
Effectiveness of Pictorial Health Warnings in Mauritius: Findings
from the ITC Mauritius Survey.'' Nicotine & Tobacco Research,
16(9):1240-1247, 2014. Available at https://doi.org/10.1093/ntr/ntu062.
51. Hitchman, S.C., P. Driezen, C. Logel, et al. ``Changes in
Effectiveness of Cigarette Health Warnings over Time in Canada and
the United States, 2002-2011.'' Nicotine & Tobacco Research,
16(5):536-543, 2013. Available at https://doi.org/10.1093/ntr/ntt196.
52. Li, L., R. Borland, H. Yong, et al. ``Longer Term Impact of
Cigarette Package Warnings in Australia Compared with the United
Kingdom and Canada.'' Health Education Research, 30(1):67-80, 2014.
Available at https://doi.org/10.1093/her/cyu074.
53. Loeber, S., S. Vollstadt-Klein, S. Wilden, et al. ``The Effect
of Pictorial Warnings on Cigarette Packages on Attentional Bias of
Smokers.'' Pharmacology Biochemistry and Behavior, 98(2):292-298,
2011. Available at https://doi.org/10.1016/j.pbb.2011.01.010.
54. Mays, D., S.E. Murphy, A.C. Johnson, et al. ``A Pilot Study of
Research Methods for Determining the Impact of Pictorial Cigarette
Warning Labels Among Smokers.'' Tobacco Induced Diseases, 12:16,
2014. Available at https://doi.org/10.1186/1617-9625-12-16.
55. Nagelhout, G.E., A. Osman, H.H. Yong, et al. ``Was the Media
Campaign that Supported Australia's New Pictorial Cigarette Warning
Labels and Plain Packaging Policy Associated with More Attention to
and Talking About Warning Labels?'' Addictive Behaviors, 49:64-67,
2015. Available at https://doi.org/10.1016/j.addbeh.2015.05.015.
56. Nimbarte, A., F. Aghazadeh, and C. Harvey. ``Comparison of
Current U.S. and Canadian Cigarette Pack Warnings.'' International
Quarterly of Community Health Education, 24(1):3-27, 2005. Available
at https://doi.org/10.2190/9px0-nbg1-0ala-g5yh.
*57. Peebles, K., M.G. Hall, J.K. Pepper, et al. ``Adolescents'
Responses to Pictorial Warnings on Their Parents' Cigarette Packs.''
Journal of Adolescent Health, 59(6):635-641, 2016. Available at
https://doi.org/10.1016/j.jadohealth.2016.07.003.
58. McQueen, A., M.W. Kreuter, S. Boyum, et al. ``Reactions to FDA-
Proposed Graphic Warning Labels Affixed to U.S. Smokers' Cigarette
Packs.'' Nicotine & Tobacco Research, 17(7):784-795, 2015. Available
at https://doi.org/10.1093/ntr/ntu339.
59. Thrasher, J.F., D. Hammond, G.T. Fong, et al. ``Smokers'
Reactions to Cigarette Package Warnings with Graphic Imagery and
with Only Text: A Comparison Between Mexico and Canada.'' Salud
P[uacute]blica de M[eacute]xico, 49(Suppl. 2):S233-S240, 2007.
60. Miller, C.L., P.G. Quester, D.J. Hill, et al. ``Smokers' Recall
of Australian Graphic Cigarette Packet Warnings & Awareness of
Associated Health Effects, 2005-2008.'' BMC Public Health, 11:238,
2011. Available at https://doi.org/10.1186/1471-2458-11-238.
* 61. Noar, S.M., M.G. Hall, D.B. Francis, et al. ``Pictorial
Cigarette Pack Warnings: A Meta-Analysis of Experimental Studies.''
Tobacco Control, 25(3):341-354, 2016. Available at https://doi.org/10.1136/tobaccocontrol-2014-051978.
* 62. Fathelrahman, A.I., L.Li, R. Borland, et al. ``Stronger Pack
Warnings Predict Quitting More than Weaker Ones: Finding from the
ITC Malaysia and Thailand Surveys.'' Tobacco Induced Diseases,
11(1):20, 2013. Available at https://doi.org/10.1186/1617-9625-11-20.
63. Bekalu, M.A., S. Ramanadhan, C.A. Bigman, et al. ``Graphic and
Arousing? Emotional and Cognitive Reactions to Tobacco Graphic
Health Warnings and Associated Quit-Related Outcomes Among Low SEP
Population Groups.'' Health Communication, 34(7):726-734, 2019.
Available at https://doi.org/10.1080/10410236.2018.1434733.
64. Robinson, T.N. and J.D. Killen. ``Do Cigarette Warning Labels
Reduce Smoking? Paradoxical Effects Among Adolescents.'' Archives of
Pediatrics & Adolescent Medicine, 151(3):267-272, 1997. Available at
https://doi.org/10.1001/archpedi.1997.02170400053010.
65. Shadel, W.G., S.C. Martino, C.M. Setodji, et al. ``Do Graphic
Health Warning Labels on Cigarette Packages Deter Purchases at
Point-of-Sale? An Experiment with Adult Smokers.'' Health Education
Research, 34(3):321-331, 2019. Available at https://doi.org/10.1093/her/cyz011.
66. Skurka, C., M. Kalaji, M.C. Dorf, et al. ``Independent or
Synergistic? Effects of Varying Size and Using Pictorial Images in
Tobacco Health Warning Labels.'' Drug and Alcohol Dependence,
198:87-94, 2019. Available at https://doi.org/10.1016/j.drugalcdep.2019.01.034.
* 67. Van Dessel, P., C.T. Smith, and J. De ouwer. ``Graphic
Cigarette Pack Warnings Do Not Produce More Negative Implicit
Evaluations of Smoking Compared to Text Only Warnings.'' PLoS ONE,
13(3):1-15, 2018. Available at https://doi.org/10.1371/journal.pone.0194627.
68. Nonnemaker, J.M., C.J. Choiniere, M.C. Farrelly, et al.
``Reactions to Graphic Health Warnings in the United States.''
Health Education Research, 30(1):46-56, 2015. Available at https://doi.org/10.1093/her/cyu036.
69. White, V., E. Bariola, A. Faulkner, et al. ``Graphic Health
Warnings on Cigarette Packs: How Long Before the Effects on
Adolescents Wear Out?'' Nicotine and Tobacco Research, 17(7):776-
783, 2015. Available at https://doi.org/10.1093/ntr/ntu184.
70. Avery, E.J. ``The Role of Source and the Factors Audiences Rely
on in Evaluating Credibility of Health Information.'' Public
Relations Review, 36(1):81-83, 2010. Available at https://doi.org/10.1016/j.pubrev.2009.10.015.
71. Chaiken, S. ``Heuristic Versus Systematic Information Processing
and the Use of Source Versus Message Cues in Persuasion.'' Journal
of Personality and Social Psychology, 39(5):752-766, 1980.
72. Chen, S., K. Duckworth, and S. Chaiken. ``Motivated Heuristic
and Systematic Processing.'' Psychological Inquiry, 10(1), 44-49,
1999. Available at https://doi.org/10.1207/s15327965pli1001_6.
73. Lodge, M. and C. Taber. ``Three Steps Toward a Theory of
Motivated Political Reasoning.'' In Elements of Reason: Cognition,
Choice, and the Bounds of Rationality. Lupia, A., M.D. McCubbins,
and S.L. Popkin (Eds.), 183-213. Cambridge, UK: Cambridge University
Press, 2000.
74. O'Keefe, D.J. ``Chapter 9: The Elaboration Likelihood Model.''
In The SAGE Handbook of Persuasion: Developments in Theory and
Practice, J.P. Dillard and L. Shen (Eds.), 2nd ed, 137-149. Thousand
Oaks, CA: Sage Publications, 2013. Available at https://doi.org/10.4135/9781452218410.n9.
75. Petty, R.E., J.T. Cacioppo, A.J. Strathman, et al. ``To Think or
Not to Think: Exploring Two Routes to Persuasion.'' In Persuasion:
Psychological Insights and Perspectives, T.C. Brock and M.C. Green
(Eds.), 2nd ed, 81-116. Thousand Oaks, CA: Sage Publications, Inc.,
2005.
76. Tverksy, A. and D. Kahneman. ``Judgement Under Uncertainty:
Heuristics and Biases.'' Science, 185(4157):1124-1131, 1974.
Availabe at https://doi.org/10.1126/science.185.4157.1124.
77. Wu, C. and D.R. Shaffer. ``Susceptibility to Persuasive Appeals
as a Function of Source Credibility and Prior Experience with the
Attitude Object.'' Journal of Personality and Social Psychology,
52(4):677-688, 1987. Available at https://psycnet.apa.org/doi/10.1037/0022-35<IP_ADDRESS>7.
78. Kennedy, R.D., M.M. Spafford, I. Behm, et al. ``Positive Impact
of Australian 'Blindness' Tobacco Warning Labels: Findings from the
ITC Four Country Survey.'' Clinical and Experimental Optometry,
95(6):590-598, 2012. Available at https://doi.org/10.1111/j.1444-0938.2012.00789.x.
79. Houts, P.S., C.C. Doak, L.G. Doak, et al. ``The Role of Pictures
in Improving Health Communication: A Review of Research on
Attention, Comprehension, Recall, and Adherence.'' Patient Education
Counseling, 61(2):173-190, 2006. Available at https://doi.org/10.1016/j.pec.2005.05.004.
80. Lipkus, I.M. and J.G. Hollands. ``The Visual Communication of
Risk.'' Journal

of the National Cancer Institute Monographs, 1999(25):149-163, 1999.
Available at https://doi.org/10.1093/oxfordjournals.jncimonographs.a024191.
81. Ancker, J.S., Y. Senathirajah, R. Kukafka, et al. ``Design
Features of Graphs in Health Risk Communication: A Systematic
Review.'' Journal of the American Medical Informatics Association,
13(6):608-618, 2006. Available at https://doi.org/10.1197/jamia.M2115.
* 82. Lipkus, I.M. ``Numeric, Verbal, and Visual Formats of
Conveying Health Risks: Suggested Best Practices and Future
Recommendations.'' Medical Decision Making, 27(5):696-713, 2007.
Available at https://doi.org/10.1177/0272989X07307271.
83. Garcia-Retamero, R. and M. Galesic. ``Who Profits from Visual
Aids: Overcoming Challenges in People's Understanding of Risks.''
Social Science & Medicine, 70(7):1019-1025, 2010. Available at
https://doi.org/10.1016/j.socscimed.2009.11.031.
84. Doak, C.C., L.G. Doak, and J.H. Root (Eds.). Teaching Patients
with Low Literacy Skills, 2nd Ed. Philadelphia, PA: J.B. Lippincott
Co, 1996.
*85. Fischhoff, B., N.T. Brewer, and J.S. Downs (Eds.).
Communicating Risks and Benefits: An Evidence-Based User's Guide.
Silver Spring, MD: HHS, FDA, 2011. Available at https://www.fda.gov/media/81597/download.
86. Sparrow, J.A. ``Graphical Displays in Information Systems: Some
Data Properties Influencing the Effectiveness of Alternative
Forms.'' Behaviour & Information Technology, 8(1):43-56, 1989.
Available at https://doi.org/10.1080/01449298908914537.
87. Schapira, M.M., A.B. Nattinger, and C.A. McHorney. ``Frequency
or Probability? A Qualitative Study of Risk Communication Formats
Used in Health Care.'' Medical Decision Making Journal, 21(6):459-
467, 2001. Available at https://doi.org/10.1177/02729890122062811.
88. Schapira, M.M., A.B. Nattinger, and T.L. McAuliffe. ``The
Influence of Graphic Format on Breast Cancer Risk Communication.''
Journal of Health Communication, 11(6):569-582, 2006. Available at
https://doi.org/10.1080/10810730600829916.
89. Slutsky, D.J. ``The Effective Use of Graphs.'' Journal of Wrist
Surgery, 3(2):67-68, 2014. Available at https://doi.org/10.1055/s-0034-1375704.
90. American Association of Public Opinion Research (AAPOR)
Standards Committee. Report on Online Panels. June 2010. Available
at https://www.aapor.org/Education-Resources/Reports/Report-on-Online-Panels.
91. AAPOR. ``Online Panels.'' AAPOR.org. Accessed December 2, 2019.
https://www.aapor.org/AAPOR_Main/media/MainSiteFiles/Online-Panels.pdf.
92. Thrasher, J.F., V. Villalobos, A. Szklo, et al. ``Assessing the
Impact of Cigarette Package Health Warning Labels: A Cross-Country
Comparison in Brazil, Uruguay and Mexico.'' Salud P[uacute]blica de
M[eacute]xico, 52:S206-S215, 2010. Available at https://doi.org/10.1590/S0036-36342010000800016.
93. White, V., B. Webster, and M. Wakefield. ``Do Graphic Health
Warning Labels Have an Impact on Adolescents' Smoking-Related
Beliefs and Behaviours?'' Addiction, 103(9):1562-1571, 2008.
Available at http://dx.doi.org/10.1111/j.1360-0443.2008.02294.x.
94. Ng, D.H L., S.T.D. Roxburgh, S. Sanjay, et al. ``Awareness of
Smoking Risks and Attitudes Towards Graphic Health Warning Labels on
Cigarette Packs: A Cross-Cultural Study of Two Populations in
Singapore and Scotland.'' Eye, 24(5):864-868, 2010. Available at
https://doi.org/10.1038/eye.2009.208.
95. Fathelrahman, A.I., M. Omar, R. Awang, et al. ``Impact of the
New Malaysian Cigarette Pack Warnings on Smokers' Awareness of
Health Risks and Interest in Quitting Smoking.'' International
Journal of Environmental Research and Public Health, 7(11):4089-
4099, 2010. Available at https://doi.org/10.3390/ijerph7114089.
96. Hammond D., J. Thrasher, J.L. Reid, et al. ``Perceived
Effectiveness of Pictorial Health Warnings Among Mexican Youth and
Adults: A Population-Level Intervention with Potential to Reduce
Tobacco-Related Inequities.'' Cancer Causes & Control, 23(Suppl.
1):57-67, 2012. Available at https://doi.org/10.1007/s10552-012-9902-4.
97. Fathelrahman, A.I., M. Omar, R. Awang, et al. ``Smokers'
Responses Toward Cigarette Pack Warning Labels in Predicting Quit
Intention, Stage of Change, and Self-Efficacy.'' Nicotine & Tobacco
Research, 11(3):248-253, 2009. Available at https://doi.org/10.1093/ntr/ntn029.
98. Ngan, T.T., V.A. Le, N.T. My, et al. ``Changes in Vietnamese
Male Smokers' Reactions Towards New Pictorial Cigarette Pack
Warnings Over Time.'' Asian Pacific Journal of Cancer Prevention,
17(Suppl. 1) 71-78, 2016. Available at https://doi.org/10.7314/apjcp.2016.17.s1.71.
99. Chiosi, J.J., L. Andes, S. Asma, et al. ``Warning About the
Harms of Tobacco Use in 22 Countries: Findings from a Cross-
Sectional Household Survey.'' Tobacco Control, 25(4):393-401, 2016.
Available at https://doi.org/10.1136/tobaccocontrol-2014-052047.
*100. Cantrell J., D.M. Vallone, J.F. Thrasher, et al. ``Impact of
Tobacco-Related Health Warning Labels Across Socioeconomic, Race and
Ethnic Groups: Results from a Randomized Web-Based Experiment.''
PloS One, 8(1):e52206, 2013. Available at https://doi.org/10.1371/journal.pone.0052206.
101. Laughery, K.R. ``Safety Communications: Warnings.'' Applied
Ergonomics, 37(4):467-478, 2006. Available at https://doi.org/10.1016/j.apergo.2006.04.020.
102. Niederdeppe, J., D. Kemp, E. Jesch, et al. ``Using Graphic
Warning Labels to Counter Effects of Social Cues and Brand Imagery
in Cigarette Advertising.'' Health Education Research, 34(1):38-49,
2019. Available at https://doi.org/10.1093/her/cyy039.
103. Skurka, C., D. Kemp, J. Davydova, et al. ``Effects of 30% and
50% Cigarette Pack Graphic Warning Labels on Visual Attention,
Negative Affect, Quit Intentions, and Smoking Susceptibility Among
Disadvantaged Populations in the United States.'' Nicotine Tobacco
Research, 20(7):859-866, 2018. Available at https://doi.org/10.1093/ntr/ntx244.
104. S[uuml]ssenbach, P., S. Niemeier, and S. Glock. ``Effects of
and Attention to Graphic Warning Labels on Cigarette Packages.''
Psychology and Health, 28(10):1192-1206, 2013. Available at https://doi.org/10.1080/08870446.2013.799161.
105. Cameron, L.D., J.K. Pepper, N.T. Brewer. ``Responses of Young
Adults to Graphic Warning Labels for Cigarette Packages.'' Tobacco
Control, 24(e1):e14-e22, 2015. Available at https://doi.org/10.1136/tobaccocontrol-2012-050645.
106. Devine, O. ``The Impact of Ignoring Measurement Error When
Estimating Sample Size for Epidemiologic Studies.'' Evaluation & the
Health Professions, 26(3):315-339, 2003. Available at https://doi.org/10.1177/0163278703255232.
107. McKeown-Eyssen, G.E. and R. Tibshirani. ``Implications of
Measurement Error in Exposure for the Sample Sizes of Case-Control
Studies.'' American Journal of Epidemiology, 139(4):415-421, 1994.
Available at https://doi.org/10.1093/oxfordjournals.aje.a117014.
108. Devane, D., C.M. Begley, and M. Clarke. ``How Many Do I Need?
Basic Principles of Sample Size Estimation.'' Journal of Advanced
Nursing, 47(3):297-302, 2004. Available at https://doi.org/10.1111/j.1365-2648.2004.03093.x.
*109. Hickey, G.L., Grant, S.W., Dunning, J., et al. ``Statistical
Primer: Sample Size and Power Calculations--Why, When and How?''
European Journal of Cardio-Thoracic Surgery, 54(1):4-9, 2018.
Available at https://doi.org/10.1093/ejcts/ezy169.
110. Malone, H.E., H. Nicholl, and I. Coyne. ``Fundamentals of
Estimating Sample Size.'' Nurse Researcher, 23(5):21-25, 2016.
Available at https://doi.org/10.7748/nr.23.5.21.s5.
111. Hall, M.D., A.H. Grummon, O.M. Maynard, et al. ``Causal
Language in Health Warning Labels and US Adults' Perception: A
Randomized Experiment.'' American Journal of Public Health,
109(10):1429-1433, 2019. Available at https://doi.org/10.2105/AJPH.2019.305222.
*112. Leta[scaron]iov[aacute], S., A. Medved'ov[aacute], A.
[Scaron]ov[ccaron][iacute]kov[aacute], et al. ``Bladder Cancer, a
Review of the Environmental Risk Factors.'' Environmental Health,
11(Suppl. 1):S11, 2012. Available at https://doi.org/10.1186/1476-069X-11-S1-S11.
113. Burger, M., J.F.W. Catto, G. Dalbagni, et al. ``Epidemiology
and Risk Factors of Urothelial Bladder Cancer.'' European

Urology, 63(2):234-241, 2013. Available at https://doi.org/10.1016/j.eururo.2012.07.033.
114. Cumberbatch, M.G.K., I. Jubber, P.C. Black, et al.
``Epidemiology of Bladder Cancer: A Systematic Review and
Contemporary Update of Risk Factors in 2018.'' European Urology,
74(6):784-795, 2018. Available at https://doi.org/10.1016/j.eururo.2018.09.001.
*115. National Heart, Lung, and Blood Institute. ``Smoking and Your
Heart.'' Accessed January 28, 2020. https://www.nhlbi.nih.gov/health-topics/smoking-and-your-heart.
*116. CDC. ``Know Your Risk for Heart Disease.'' CDC.gov. Last
reviewed December 9, 2019. Available at https://www.cdc.gov/heartdisease/risk_factors.htm.
117. Bansal-Travers, M., D. Hammond, P. Smith, et al. ``The Impact
of Cigarette Pack Design, Descriptors, and Warning Labels on Risk
Perception in the U.S.'' American Journal of Preventive Medicine,
40(6):674-682, 2011. Available at https://doi.org/10.1016/j.amepre.2011.01.021.
118. Thrasher, J.F., N.T. Brewer, J. Niedereppe, et al. ``Advancing
Tobacco Product Warning Labels Research Methods and Theory: A
Summary of a Grantee Meeting Held by the US National Cancer
Institute.'' Nicotine and Tobacco Research, 21(7):855-862, 2019.
Available at https://dx.doi.org/10.1093%2Fntr%2Fnty017.
119. Peters, E., B. Shoots-Reinhard, A. Shoben, et al. ``Pictorial
Warning Labels and Memory for Cigarette Health-Risk Information Over
Time.'' Annals of Behavioral Medicine, 53(4):358-371, 2019.
Available at https://doi.org/10.1093/abm/kay050.
120. Kutner, M., E. Greenberg, Y. Jin, at al. The Health Literacy of
America's Adults: Results From the 2003 National Assessment of Adult
Literacy. Report Number NCES 2006-483. Washington, DC: U.S.
Department of Education, National Center for Education Statistics,
2006. Available at https://nces.ed.gov/pubs2006/2006483.pdf.
121. IOM. Health Literacy: A Prescription to End Confusion. Nielsen-
Bohlman, L., A.M. Panzer, and D.A. Kindig (Eds.). Washington, DC:
The National Academies Press, 2004. Available at https://doi.org/10.17226/10883.
122. Arnold, C.L., T.C. Davis, H.J. Berkel, et al. ``Smoking Status,
Reading Level, and Knowledge of Tobacco Effects Among Low-Income
Pregnant Women.'' Preventive Medicine, 32(4):313-320, 2001.
Available at https://doi.org/10.1006/pmed.2000.0815.
123. Stewart D.W., C.E. Adams, M.A. Cano, et al. ``Associations
Between Health Literacy and Established Predictors of Smoking
Cessation.'' American Journal of Public Health, 103(7):e43-e49,
2013. Available at https://doi.org/10.2105/AJPH.2012.301062.