image was also one of the five images rated most effective among the
images used in FDA's 36 proposed required warnings in another
submitter's study of the potential effectiveness of the images.
    FDA also received several comments that opposed use of the image
``toe tag,'' with some submitters indicating that consumers, and in
particular minority populations, might not understand what the image of
a toe tag signifies. Some comments stated that the image ``offend[s]
against human dignity'' or is ``too sensational to be effective,''
while it was alternatively stated that the image should be more graphic
or show more suffering. It was also noted in the comments that the
image did not test as well as other images proposed for use with this
warning statement in FDA's research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``healthy/diseased lungs''
for the reasons given in section III.D of this document.
    Lungs full of cigarettes. In FDA's research study, the image
``lungs full of cigarettes'' had significant effects on all the
salience measures (emotional reaction scale, cognitive reaction scale,
and difficult to look at measure) in all three study populations
(adults, young adults, and youth).
    However, as discussed in section III.D of this document, the
selected image, ``healthy/diseased lungs,'' had the numerically largest
effects of the images proposed for use with this warning statement on
all the salience measures in all three study populations.
    Among young adults, the image ``lungs full of cigarettes'' prompted
higher correct recall of the warning statement at baseline and at 1
week follow-up than the text-only control. The required warning
featuring this image also prompted higher correct recall of the image
at baseline and follow-up among adults and youth than some of the other
images proposed for use with this warning statement.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 99) FDA received some comments that supported the use of
the image ``lungs full of cigarettes,'' including comments from
individuals and State and local public health agencies. Some of these
comments indicated that the image is the best choice for use with this
warning statement, while some also noted that

the image is particularly appropriate for use with the warning
statement.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, in one submitter's study, participants rated this image
highly on its ease of comprehension. It also induced relatively greater
worry and feelings of discouragement from wanting to smoke than a text-
only control. However, the image was rated as one of the least
effective of the images proposed by FDA for use with this warning
statement in another submitter's study of the potential effectiveness
of the images.
    FDA also received several comments that opposed use of the image
``lungs full of cigarettes,'' with some submitters indicating that
consumers might not understand the image, and some comments stating
that the image should show the consequences of lung disease on a real
person or on real lungs and suggesting that the proposed image did not
depict health consequences in an understandable, hard-hitting manner.
One comment noted that the secondary message highlighted by the use of
bold face emphasis in this proposed required warning (``I cause
disease''), could be interpreted as blaming smokers for their
addiction, and expressed concern that this could undermine the proposed
required warning's ability to communicate effectively with smokers. One
comment also stated that the image did not show desirable effects on
some measures in FDA's research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``healthy/diseased lungs''
for the reasons given in section III.D of this document.
    Dr. with X-ray. In FDA's research study, the image ``Dr. [doctor]
with X-ray'' had significant effects on the emotional and cognitive
reaction scales in all three study populations (adults, young adults,
and youth). It also had significant effects on the difficult to look at
measure in adults and youth.
    As discussed in section III.D of this document, the selected image,
``healthy/diseased lungs,'' had significant effects on all the salience
measures in all study populations, and had the largest numerical
effects of the images proposed for use with this warning statement on
the salience measures.
    Among young adults, the image ``Dr. with X-ray'' prompted higher
correct recall of the warning statement at baseline and at 1 week
follow-up than the text-only control, as well as higher correct recall
of the warning statement at follow-up among youth and the adult sample
that viewed a hypothetical advertisement featuring this proposed
required warning.
    However, among young adults, as well as among the adult sample who
viewed a hypothetical advertisement featuring this image, ``Dr. with X-
ray'' was negatively associated with beliefs about the health risks of
secondhand smoke exposure to nonsmokers (i.e., participants viewing
this image were less likely to believe that nonsmokers will suffer
health consequences related to secondhand smoke exposure than
participants viewing the text-only control).
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 100) FDA received some comments that supported the use of
the image ``Dr. with X-ray,'' including comments from individuals, a
public health advocacy group, a community organization, and a State
public health agency. These comments noted that the ``Dr. with X-ray''
image is particularly appropriate for use with the warning statement,
or expressed the view that the image is the best choice for use with
this warning statement.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
required warnings. This image was discussed in some of these comments.
Specifically, this image was rated highly on its ease of comprehension
in one submitter's study, but failed to show an effect on other study
measures (worry, discouragement from smoking). The image was one of the
five images rated least effective among the images used in FDA's 36
proposed required warnings in another submitter's study of the
potential effectiveness of the images, and it was also rated as the
least effective of the images proposed by FDA for use with this warning
statement in another submitter's study of the potential effectiveness
of the images.
    FDA also received several comments that opposed use of the image
``Dr. with X-ray,'' with some submitters indicating that the X-ray
shown in the image is unclear and that the image would not be
understood by consumers, and some indicating that it was too vague or
clinical in nature and did not effectively convey the full impact of
lung disease. It was also noted in the comments that the image failed
to show desirable effects on some measures in FDA's research study, and
that it showed negative effects on the beliefs measure among some of
the study participants.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``healthy/diseased lungs''
for the reasons given in section III.D of this document.
4. ``WARNING: Cigarettes Cause Cancer''
    As discussed in section III.D of this document, FDA selected the
image ``cancerous lesion on lip'' for use with the statement,
``WARNING: Cigarettes cause cancer.'' FDA proposed three other images
for use with this statement: ``Deathly ill woman,'' which appears on
pages 29 and 30 of the document ``Proposed Required Warning Images;''
``white cigarette burning,'' which appears on pages 31 and 32 of the
document ``Proposed Required Warning Images;'' and ``red cigarette
burning,'' which appears on pages 35 and 36 of the document ``Proposed
Required Warning Images.''
    Deathly ill woman. The image ``deathly ill woman'' had strong
overall research results in FDA's research study, including significant
effects on all the salience measures (emotional reaction scale,
cognitive reaction scale, and difficult to look at measure) in all
three study populations (adults, young adults, and youth).
    However, overall the selected image, ``cancerous lesion on lip,''
had slightly higher numerical scores on the emotional and cognitive
reaction scales than this image.
    Among adults, the image ``deathly ill woman'' prompted lower
correct recall of the warning statement at baseline and at 1 week
follow-up. However, the image showed some of the largest effect sizes
for image recall (baseline and follow-up) across the images proposed
for use with this warning statement.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 101) FDA received a large number of comments that
supported the use of the image ``deathly ill woman,'' including
comments from individuals, public health advocacy groups, medical
organizations, academics, and State and local public health agencies.
Many of these comments indicated that this image is the best image for
use with this warning statement, with some stating that the image would
communicate effectively to women and other comments approving of the
image's accurate portrayal of the effects cancer can have on personal
appearance.

    Some comments noted that the image showed positive impacts in
research studies conducted by the submitters. Specifically, in one
submitter's study, participants rated this image highly on its ease of
comprehension. It also induced relatively greater worry and feelings of
discouragement from wanting to smoke than a text-only control. The
submitter concludes that this image, along with ``cancerous lesion on
lip,'' was the most effective of the images proposed for use with this
warning statement. The image was also one of the five images rated most
effective among the images used in FDA's 36 proposed required warnings
in another submitter's study of the potential effectiveness of the
images. It was also one of two images rated effective among FDA's 36
proposed color graphic in another submitter's study of the
effectiveness of the images at stopping someone from smoking, and it
was identified by high school students as one of the ``top three''
proposed required warnings in another submitter's study.
    FDA also received comments that opposed the use of the image
``deathly ill woman.'' Some comments noted that the image ``offend[s]
against human dignity,'' while one stated it was ``too sensational to
be effective.'' Conversely, some comments indicated that the image
should show more obvious signs of illness. It was also noted in the
comments that the image did not show desirable effects on all the
measures in FDA's research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``cancerous lesion on lip''
for the reasons given in section III.D of this document.
    White cigarette burning. In FDA's research study, the image ``white
cigarette burning'' had significant effects on the emotional and
cognitive reaction scales in all three study populations (adults, young
adults, and youth). It also had significant effects on the difficult to
look at measure in adults.
    As discussed in section III.D of this document, the selected image,
``cancerous lesion on lip,'' had significant effects on all the
salience measures in all study populations, and showed some of the
numerically largest effects on these measures of all the images
proposed for use with this warning statement.
    Among youth, the image ``white cigarette burning'' prompted higher
correct recall of the warning statement at baseline than the text-only
control.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 102) FDA received some comments that supported the use of
the image ``white cigarette burning,'' including comments from
individuals and from State and local public health agencies. These
comments noted that the ``white cigarette burning'' image is
particularly appropriate for use with the warning statement, or
expressed the submitter's preference that the image be used with this
warning statement.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image was rated highly on its ease of comprehension
in one submitter's study, but failed to show an effect on other study
measures (worry, discouragement from smoking). The image was rated as
the least effective of the images proposed by FDA for use with this
warning statement in another submitter's study of the potential
effectiveness of the images.
    FDA also received several comments that opposed use of the image
``white cigarette burning,'' with some submitters indicating that the
image does not depict the negative health consequences of smoking or
that the image is not appropriately evocative of cancer, and some
noting that the image is unclear and will not be understood by
consumers. Some comments also criticized the design of the image, and
one stated that the image is not presented in color as required by the
Tobacco Control Act. Some comments also noted that this image of a
burning cigarette could trigger cravings in smokers. It was also noted
in the comments that the image failed to show desirable effects on some
measures in FDA's research study. One comment noted that the secondary
message highlighted by the use of bold face emphasis in this proposed
required warning (``I cause cancer'') could be interpreted as blaming
smokers, and expressed concern that this could undermine the proposed
required warning's ability to communicate effectively with smokers.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``cancerous lesion on lip''
for the reasons given in section III.D of this document.
    Red cigarette burning. In FDA's research study, the image ``red
cigarette burning'' had significant effects on all the salience
measures (emotional reaction scale, cognitive reaction scale, and
difficult to look at measure) in all three study populations (adults,
young adults, and youth).
    However, the selected image, ``cancerous lesion on lip,'' generally
had numerically larger effects than this image on the salience
measures.
    Among adults, young adults, and youth, the image ``red cigarette
burning'' prompted lower correct recall of the warning statement at
baseline and at 1 week follow-up. The proposed required warning
featuring this image also prompted relatively lower recall of the image
at baseline and at 1 week follow-up among adults, young adults, and
youth than ``cancerous lesion on lip.''
    Youth viewing the image ``red cigarette burning'' reported being
more likely to be smoking 1 year from now than youth viewing the text-
only control.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 103) FDA received some comments that supported the use of
the image ``red cigarette burning,'' including comments from
individuals, a public health advocacy group, and from State and local
public health agencies. These comments noted that the ``red cigarette
burning'' image is particularly appropriate for use with the warning
statement, or expressed the submitter's preference that the image be
used with this warning statement.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, in one submitter's study, participants rated this image
highly on its ease of comprehension. It also induced relatively greater
worry and feelings of discouragement from wanting to smoke than a text-
only control. In another submitter's study, particular aspects of the
image were evaluated, and the submitter reported that the use of the
color red to accentuate the warning content in ``red cigarette
burning'' was effective. However, the image was rated as one of the
least effective of the images proposed by FDA for use with this warning
statement in another submitter's study of the potential effectiveness
of the images, and the image was rated as one of the five least
effective images used in FDA's 36 proposed required warnings in another
submitter's study of the potential effectiveness of the images.

    FDA also received several comments that opposed use of the image
``red cigarette burning,'' with some submitters indicating that the
image does not depict the negative health consequences of smoking or
that the image is not appropriately evocative of cancer. Some comments
also criticized the design of the image, with one stating that it
looked like an image from a cigarette advertisement. Some comments also
noted that this image of a burning cigarette could trigger cravings in
smokers. It was also noted in the comments that the image failed to
show desirable effects on some measures in FDA's research study and
showed some undesirable effects. Some comments also suggested that
other cancers, including bladder cancer, should be added to the cancers
listed in the image.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``cancerous lesion on lip''
for the reasons given in section III.D of this document.
5. ``WARNING: Cigarettes Cause Strokes and Heart Disease''
    As discussed in section III.D of this document, FDA selected the
image ``oxygen mask on man's face'' for use with the statement,
``WARNING: Cigarettes cause strokes and heart disease.'' FDA proposed
three other images for use with this statement: ``hand with oxygen
mask,'' which appears on pages 37 and 38 of the document ``Proposed
Required Warning Images;'' ``red lightning with heart,'' which appears
on pages 41 and 42 of the document ``Proposed Required Warning
Images;'' and ``man in pain with hand on chest,'' which appears on
pages 43 and 44 of the document ``Proposed Required Warning Images.''
    Hand with oxygen mask. In FDA's research study, the image ``hand
with oxygen mask'' had significant effects on all the salience measures
(emotional reaction scale, cognitive reaction scale, and difficult to
look at measure) in all three study populations (adults, young adults,
and youth).
    However, the selected image, ``oxygen mask on man's face,'' also
had significant effects on all the salience measures, and generally had
numerically larger effects than this image on the emotional reaction
scale and the difficult to look at measure.
    Adults viewing the image ``hand with oxygen mask'' reported being
less likely to quit smoking within the next month than adults viewing
the text-only control.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 104) FDA received some comments that supported the use of
the image ``hand with oxygen mask,'' including comments from
individuals, a community organization, and State public health
agencies. These comments noted that the ``hand with oxygen mask'' image
is the best image for use with the warning statement or stated that the
image was appropriate for use with this warning statement.
    As discussed in section III.C of this document, some comments
submitted to the docket described results of research conducted by the
submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image was rated highly on its ease of comprehension
and induced relatively greater worry and led to higher ratings of
feeling discouraged from wanting to smoke than a text-only control in
one submitter's study. However, the image was rated as the least
effective of the images proposed by FDA for use with this warning
statement in another submitter's study of the potential effectiveness
of the images.
    FDA also received several comments that opposed use of the image
``hand with oxygen mask,'' with some submitters indicating that the
image is hard to understand or not appropriately compelling. Some
comments also stated that the image would be more appropriate for use
with a statement about lung-related health consequences (such as COPD).
It was also noted in the comments that the image failed to show
desirable effects on some measures in FDA's research study and showed
some undesirable effects.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``oxygen mask on man's
face'' for the reasons given in section III.D of this document.
    Red lightning with heart. In FDA's research study, the image ``red
lightning with heart'' had significant effects on the emotional and
cognitive reaction scales in all three study populations (adults, young
adults, and youth). The image also had significant effects on the
difficult to look at measure in adults and young adults.
    However, the selected image, ``oxygen mask on man's face,'' had
significant effects on all the salience measures in all the study
populations, and it generally had numerically larger effects than this
image on the salience measures.
    Among adults, young adults, and youth, the image ``red lightning
with heart'' prompted higher correct recall of the warning statement at
1 week follow-up than the text-only control. However, the proposed
required warning featuring this image prompted relatively lower recall
of the image at baseline and at 1 week follow-up among youth than the
selected image, ``oxygen mask on man's face.''
    FDA received several comments on this image, which the Agency has
summarized and responded to in the following paragraphs.
    (Comment 105) FDA received a few comments that supported the use of
the image ``red lightning with heart,'' including comments from State
and local public health agencies, which noted that this image is
appropriate for use with the warning statement.
    As discussed in section III.C of this document, some comments
submitted to the docket described results of research conducted by the
submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image was rated highly on its ease of comprehension
in one submitter's study, but failed to show an effect on other study
measures (worry, discouragement from smoking). The image was rated as
one of the least effective of the images proposed by FDA for use with
this warning statement in another submitter's study of the potential
effectiveness of the images.
    FDA also received several comments that opposed use of the image
``red lightning with heart,'' with some submitters criticizing the
design of the image, which was characterized as too conceptual and not
easily understandable. Some comments also criticized the illustration
style, stating that it does not have the impact a photograph would
have, and would not compel or move viewers, and may inappropriately
appeal to youth without discouraging them from smoking. It was also
noted in the comments that the image failed to show desirable effects
on some measures in FDA's research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``oxygen mask on man's
face'' for the reasons given in section III.D of this document.
    Man in pain with hand on chest. In FDA's research study, the image
``man in pain with hand on chest'' had significant effects on the
emotional reaction scale in all three study populations (adults, young
adults, and youth). The image also had significant effects on the
cognitive reaction scale in young adults and youth, as well as in

adults viewing a hypothetical advertisement containing ``man in pain
with hand on chest.'' The image also had significant effects on the
difficult to look at measure in adults and youth.
    However, the selected image, ``oxygen mask on man's face,'' had
significant effects on all the salience measures in all the study
populations, and had numerically larger effects than this image on the
salience measures.
    Among youth, the image ``man in pain with hand on chest'' prompted
higher correct recall of the warning statement at 1 week follow-up than
the text-only control. However, the proposed required warning featuring
this image prompted relatively lower recall of the image at baseline
among adults than ``oxygen mask on man's face.''
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 106) FDA received several comments that supported the use
of the image ``man in pain with hand on chest,'' including comments
from individuals, public health advocacy groups, a health care
professional, and a State public health agency. Several of these
comments indicated that this image is the best choice for use with this
warning statement, with some comments noting that the image
appropriately shows how painful heart attacks can be.
    As discussed in section III.C of this document, some comments
submitted to the docket described results of research conducted by the
submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, in one submitter's study, participants rated this image
highly on its ease of comprehension. It also induced relatively greater
worry and feelings of discouragement from wanting to smoke than a text-
only control. However, the image was rated as less effective than the
selected image, ``oxygen mask on man's face,'' in another submitter's
study of the potential effectiveness of the images.
    FDA also received several comments that opposed use of the image
``man in pain with hand on chest.'' Some comments indicated that the
image looks like a man with a headache or other ailment rather than a
man suffering from heart disease or a stroke, and a few comments
indicated the man's hand should be closer to his left side (where his
heart is). Some comments stated that the image should feature a younger
person to drive home the message that heart disease and strokes can
affect young smokers as well as older smokers. One comment suggested
that the man shown in the image should be replaced with a man of color.
It was also stated in the comments that the image failed to show large
effects on salience measures or to show desirable effects on other
measures in FDA's research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``oxygen mask on man's
face'' for the reasons given in section III.D of this document.
6. ``WARNING: Smoking During Pregnancy Can Harm Your Baby''
    As discussed in section III.D of this document, FDA selected the
image ``baby in incubator'' for use with the statement, ``WARNING:
Smoking during pregnancy can harm your baby.'' FDA proposed one other
image for use with this statement: ``pacifier & ashtray,'' which
appears on pages 47 and 48 of the document ``Proposed Required Warning
Images.''
    Pacifier & ashtray. In FDA's research study, the image ``pacifier &
ashtray'' had significant effects on the emotional and cognitive
reaction scales in all three study populations (adults, young adults,
and youth). The image also had significant effects on the difficult to
look at measure in adults and youth.
    However, the selected image, ``baby in incubator,'' had significant
effects on all the salience measures in all the study populations, and
had numerically larger effects than this image on all the salience
measures.
    Among young adults, the image ``pacifier & ashtray'' prompted
higher correct recall of the warning statement at baseline and at 1
week follow-up than the text-only control. However, the proposed
required warning featuring this image prompted relatively lower recall
of the image at baseline and at 1 week follow-up among adults, young
adults, and youth than the selected image, ``baby in incubator.''
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 107) FDA received several comments that supported the use
of the image ``pacifier & ashtray,'' including comments from
individuals, public health advocacy groups, and State and local public
health agencies. In general, these comments indicated that this image
is the best choice for use with this warning statement, with some
noting that the image is compelling and powerful.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image was rated highly on its ease of comprehension
compared to a text-only control in one submitter's study, but failed to
show an effect on other study measures (worry, discouragement from
smoking). The image was also rated as the most effective of the images
proposed by FDA for use with this warning statement in another
submitter's study of the potential effectiveness of the images, but an
image used in another country was rated significantly higher than
either of FDA's proposed images in this study (however, as discussed in
section III.A of this document, at this time FDA does not believe it is
necessary or appropriate to use graphic warnings used in other
countries in place of the images developed by FDA).
    FDA also received several comments that opposed use of the image
``pacifier & ashtray,'' with some submitters criticizing the design of
the image, which was characterized as too symbolic and abstract to be
understood, and as lacking in emotional impact. Some comments stated
that the image does not show a health consequence of smoking, and some
indicated the image is not graphic enough. A few comments also noted
that the image would be more appropriate for a warning related to post-
partum secondhand smoke-related risks, rather than a pregnancy warning,
because pacifiers are used post- rather than pre-partum. One comment
stated that the background used for the textual warning statement in
the image looks unprofessional. It was also stated in the comments that
the image failed to show large effects on the salience measures or to
show desirable effects on some other measures in FDA's research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``baby in incubator'' for
the reasons given in section III.D of this document.
7. ``WARNING: Smoking Can Kill You''
    As discussed in section III.D of this document, FDA selected the
image ``man with chest staples'' for use with the statement, ``WARNING:
Smoking can kill you.'' FDA proposed three other images for use with
this statement: ``red coffin with body,'' which appears on pages 51 and
52 of the document ``Proposed Required Warning Images;'' ``man in
casket,'' which appears on pages 53 and 54 of the document ``Proposed
Required Warning Images;'' and ``cigarettes = RIP,'' which appears

on pages 55 and 56 of the document ``Proposed Required Warning
Images.''
    Red coffin with body. In FDA's research study, the image ``red
coffin with body'' had significant effects on all the salience measures
(emotional reaction scale, cognitive reaction scale, and difficult to
look at measure) in adults and youth. It also had a significant effect
on the cognitive reaction scale in young adults.
    However, the selected image, ``man with chest staples,'' had a
significant effect on all the salience measures in all study
populations, and had numerically larger effects than this image on
these measures.
    Among adults, the image ``red coffin with body'' prompted higher
correct recall of the warning statement at baseline than the text-only
control.
    The image also had a significant impact on beliefs about the health
risks of smoking for smokers relative to the text-only control in the
adult sample that viewed a hypothetical advertisement containing the
proposed required warning.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 108) FDA received several comments that supported the use
of the image ``red coffin with body,'' including comments from
individuals and a community organization. Several of these comments
indicated that this image is the best choice for use with this warning
statement, with some approving of the colors used in the image and some
noting that the image gets the message across in a straightforward
manner.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image was rated highly on its ease of comprehension
compared to a text-only control in one submitter's study, but failed to
show an effect on other study measures (worry, discouragement from
smoking). The image was rated as one of the least effective of the
images proposed by FDA for use with this warning statement in another
submitter's study of the potential effectiveness of the images.
    FDA also received several comments that opposed use of the image
``red coffin with body,'' with some submitters stating that the image
is too conceptual and not easily understandable. Several comments
stated that the image is not impactful and is unlikely to be effective,
with some indicating the image would be more effective if it were a
photograph of an actual person. It was also suggested in the comments
that the image style may inappropriately appeal to youth without
discouraging them from smoking. Some comments noted that the image
failed to show desirable effects on some measures in FDA's research
study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``man with chest staples''
for the reasons given in section III.D of this document.
    Man in casket. In FDA's research study, the image ``man in casket''
had significant effects on all the salience measures (emotional
reaction scale, cognitive reaction scale, and difficult to look at
measure) in adults and youth. It also had a significant effect on the
cognitive reaction scale in young adults.
    However, the selected image, ``man with chest staples,'' had
significant effects on all the salience measures, and generally had
numerically larger effects than this image on these measures.
    Among youth, the image ``man in casket'' prompted higher correct
recall of the warning statement at baseline than the text-only control.
However, among young adults, the image ``man in casket'' prompted lower
correct recall of the warning statement at baseline than the text-only
control.
    The image also had a significant impact on beliefs about the health
risks of smoking for smokers relative to the text-only control in the
adult sample that viewed a hypothetical advertisement containing the
proposed required warning.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 109) FDA received several comments that supported the use
of the image ``man in casket,'' including comments from individuals, a
public health advocacy group, and a State public health agency. Several
of these comments indicated that this image is the best choice for use
with this warning statement, with some noting that the image grabs
viewers' attention and clearly depicts death.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, in one submitter's study, participants rated this image
highly on its ease of comprehension. It also induced relatively greater
worry and feelings of discouragement from wanting to smoke than a text-
only control. In another submitter's study, particular aspects of the
image were evaluated, and the proposed required warning containing the
image ``man in casket'' was found to be significantly more effective at
discouraging others from smoking than a text-only statement on the side
of a cigarette package. However, the image was rated as less effective
than the selected image, ``man with chest staples,'' in another
submitter's study of the potential effectiveness of the images.
    FDA also received several comments that opposed use of the image
``man in casket.'' Multiple comments stated the image looks staged
because the man pictured does not look like he is dead or like he
suffered from smoking-related disease. It was also suggested in the
comments that the image may not be understood by all cultures. The
image was also criticized as lacking a clear association to smoking. It
was also noted in the comments that the image failed to show desirable
effects on some measures in FDA's research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``man with chest staples''
for the reasons given in section III.D of this document.
    Cigarettes = RIP. In FDA's research study, the image ``cigarettes =
RIP'' had significant effects on all the salience measures (emotional
reaction scale, cognitive reaction scale, and difficult to look at
measure) in adults and youth. It also had a significant effect on the
emotional and cognitive reaction scales in young adults.
    However, the selected image, ``man with chest staples,'' had
significant effects on all the salience measures in all the study
populations, and generally had numerically larger effects than this
image on these measures.
    Among adults, the image ``cigarettes = RIP'' prompted higher
correct recall of the warning statement at baseline than the text-only
control. However, the proposed required warning featuring this image
prompted relatively lower recall of the image at baseline and at 1 week
follow-up than the selected image, ``man with chest staples.''
    The image had a significant impact on beliefs about the health
risks of smoking for smokers relative to the text-only control in the
adult sample that viewed a hypothetical advertisement containing the
proposed required warning.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.

    (Comment 110) FDA received several comments that supported the use
of the image ``cigarettes = RIP,'' including comments from individuals
and a State public health agency. Several of these comments indicated
that this image is the best choice for use with this warning statement,
with some noting that the image gets the message across in a
straightforward manner, and one stating that the image will get the
attention of youth tobacco users.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image was rated highly on its ease of comprehension
compared to a text-only control in one submitter's study, but failed to
show an effect on other study measures (worry, discouragement from
smoking). The image was rated as the least effective of the images
proposed by FDA for use with this warning statement in another
submitter's study of the potential effectiveness of the images.
    FDA also received several comments that opposed use of the image
``cigarettes = RIP,'' with some submitters stating that the image is
too conceptual or indirect and lacks impact, and will not be effective
in deterring smoking. Several comments expressed concern that
consumers, including individuals from various cultures with limited
English proficiency and children, might not understand what the shapes
of the cigarette package and tombstone represent, or understand the
abbreviation (``RIP'') used in the image. Some comments criticized the
style of the image, with some characterizing it as low quality and
others objecting on the grounds that it downplays the seriousness of
the risk being conveyed and may inappropriately appeal to youth without
discouraging them from smoking. It was also stated in the comments that
the image failed to show large effects on the salience measures or to
show desirable effects on some other measures in FDA's research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``man with chest staples''
for the reasons given in section III.D of this document.
8. ``WARNING: Tobacco Smoke Causes Fatal Lung Disease in Nonsmokers''
    As discussed in section III.D of this document, FDA selected the
image ``woman crying'' for use with the statement, ``WARNING: Tobacco
smoke causes fatal lung disease.'' FDA proposed four other images for
use with this statement: ``graveyard,'' which appears on pages 59 and
60 of the document ``Proposed Required Warning Images;'' ``man smoke at
woman,'' which appears on pages 61 and 62 of the document ``Proposed
Required Warning Images;'' ``woman smoke at man,'' which appears on
pages 63 and 64 of the document ``Proposed Required Warning Images;''
and ``man hands up & smoke,'' which appears on pages 65 and 66 of the
document ``Proposed Required Warning Images.''
    Graveyard. In FDA's research study, the image ``graveyard'' had
significant effects on the emotional reaction scale in all three study
populations (adults, young adults, and youth). The image also had
significant effects on the cognitive reaction scale in young adults and
youth, and on the difficult to look at measure in youth.
    However, the selected image, ``woman crying,'' had significant
effects on the salience measures in all study populations, and it
generally had numerically larger effects than this image on all the
salience measures.
    Among adults and youth, the image ``graveyard'' prompted lower
correct recall of the warning statement at baseline than the text-only
control. Among young adults, the image prompted lower correct recall of
the warning statement at 1 week follow-up than the text-only control.
    The image ``graveyard'' had a significant impact on beliefs about
the health risks of smoking for smokers in young adults.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 111) FDA received several comments that supported the use
of the image ``graveyard,'' including comments from individuals, a
community organization, and a State public health agency. Several of
these comments indicated that this image is the best choice for use
with this warning statement, with some noting that the image gets the
message across in a straightforward manner, and some noting the image
could deter people from starting to smoke.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, in one submitter's study, participants rated this image
highly on its ease of comprehension. It also induced relatively greater
worry and feelings of discouragement from wanting to smoke than a text-
only control. This image was also rated as the most effective of the
images proposed by FDA for use with this warning statement in another
submitter's study of the potential effectiveness of the images,
although an image used in another country was rated more highly than
this image.
    FDA also received several comments that opposed use of the image
``graveyard.'' Some comments indicated that the image would not be
effective, noting that it is easy to disregard or, alternatively, too
sensational to be effective. It was also stated in the comments that
the image did not show large impacts on the emotional reaction scale
and failed to show desirable effects on some other measures in FDA's
research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``woman crying'' for the
reasons given in section III.D of this document.
    Man smoke at woman. In FDA's research study, the image ``man smoke
at woman'' had significant effects on the emotional and cognitive
reaction scales in adults, young adults, and youth. The image also had
significant effects on the difficult to look at measure in youth.
    However, the selected image, ``woman crying,'' had significant
effects on the salience measures in all study populations, and had
numerically larger effects than this image on the emotional reaction
scale and the difficult to look at measure in all study populations.
    The proposed required warning featuring this image prompted
relatively lower recall of the image at baseline and at 1 week follow-
up than the selected image, ``woman crying.''
    The image ``man smoke at woman'' had a significant impact on
beliefs about the health risks of smoking for smokers in young adults.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 112) FDA received several comments that supported the use
of the image ``man smoke at woman,'' including comments from
individuals and State public health agencies. Several of these comments
indicated that this image is the best choice for use with this warning
statement, with some noting that the image would make smokers think
about how their habit may cause others to avoid them. It was also noted
that the image effectively shows how innocent bystanders are affected
by smokers.

    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, in one submitter's study, participants rated this image
highly on its ease of comprehension. It also induced relatively greater
worry and feelings of discouragement from wanting to smoke than a text-
only control. The submitter also concluded that the image was the most
effective of the images proposed for use with this warning statement.
However, the image was rated as one of the less effective images
proposed by FDA for use with this warning statement in another
submitter's study of the potential effectiveness of the images.
    FDA also received several comments that opposed use of the image
``man smoke at woman.'' Some comments indicated that the image is not
realistic, stating that smokers do not blow smoke at their friends. One
comment indicated that the image failed to portray an obvious health
consequence of secondhand smoke, and multiple comments indicated that
the image conveyed a bad message by showing the nonsmoker covering her
nose and mouth, stating that these actions do not protect you from
secondhand smoke. It was also noted in the comments that the image
failed to show desirable effects on some measures in FDA's research
study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``woman crying'' for the
reasons given in section III.D of this document.
    Woman smoke at man. In FDA's research study, the image ``woman
smoke at man'' had significant effects on the emotional reaction scale
in adults, young adults, and youth. The image also had significant
effects on the cognitive reaction scale in young adults and youth, and
on the difficult to look at measure in adults and youth.
    However, the selected image, ``woman crying,'' had significant
effects on the salience measures in all study populations, and it had
numerically larger effects than this image on the emotional reaction
scale and the difficult to look at measure in all study populations.
    Among adults, the image ``woman smoke at man'' prompted higher
correct recall of the warning statement at 1 week follow-up than the
text-only control. However, among young adults, the image prompted
lower correct recall of the warning statement at baseline than the
text-only control. The proposed required warning featuring this image
also prompted relatively lower recall of the image at baseline and at 1
week follow-up than the selected image, ``woman crying.''
    The image ``woman smoke at man'' had a significant impact on young
adult's intentions to quit smoking in the next month compared to the
text-only control.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 113) FDA received several comments that supported the use
of the image ``woman smoke at man,'' including comments from
individuals, a public health advocacy group, a medical organization,
and State and local public health agencies. Several of these comments
indicated that this image is the best choice for use with this warning
statement, with some noting that the image will make smokers think
about how their actions negatively affect social situations.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image was rated highly on its ease of comprehension
compared to a text-only control in one submitter's study but failed to
show an effect on other study measures (worry, discouragement from
smoking). The image was rated as one of the least effective of the
images proposed by FDA for use with this warning statement in another
submitter's study of the potential effectiveness of the images.
    FDA also received several comments that opposed use of the image
``woman smoke at man.'' Some comments indicated that the image would
not be effective, suggesting that it is not impactful and probably
would not stop people from smoking. One comment indicated that the
image fails to portray an obvious health consequence of secondhand
smoke, and another was critical of the actions of the nonsmoker in the
image, noting that covering your nose and mouth does not protect you
from secondhand smoke. It was also stated in the comments that the
image failed to show desirable effects on some measures in FDA's
research study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``woman crying'' for the
reasons given in section III.D of this document.
    Man hands up & smoke. In FDA's research study, the image ``man
hands up & smoke'' had significant effects on the emotional reaction
scale in all study populations (adults, young adults, and youth) and on
the cognitive reaction scale in young adults and youth.
    However, the selected image, ``woman crying,'' had significant
effects on all the salience measures in all study populations, and it
had numerically larger effects than this image on all these measures.
    The proposed required warning featuring the image ``man hands up &
smoke'' also prompted relatively lower correct recall of the image at
baseline and at 1 week follow-up than the selected image, ``woman
crying.''
    FDA received several comments on this image, which the Agency has
summarized and responded to in the following paragraphs.
    (Comment 114) FDA received some comments that supported the use of
the image ``man hands up & smoke,'' including comments from individuals
and a State public health agency. These comments generally indicated
that this image would be the best choice for use with this warning
statement.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image was rated highly on its ease of comprehension
compared to a text-only control in one submitter's study, but it failed
to show an effect on other study measures (worry, discouragement from
smoking). The image was rated as the least effective of the images
proposed by FDA for use with this warning statement in another
submitter's study of the potential effectiveness of the images.
    FDA also received several comments that opposed use of the image
``man hands up & smoke.'' Some comments indicated that the image is
unrealistic in that it looks like the man is in fog or a house fire as
opposed to being affected by secondhand smoke. One comment indicated
that the image does not portray a health consequence of secondhand
smoke; it was also stated in the comments the image is ineffective and
unintentionally humorous. One comment stated that the image failed to
show large effects on salience measures or to show desirable effects on
other measures in FDA's research study and indicated it should not be
selected.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``woman crying'' for the
reasons given in section III.D of this document.

9. ``WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to
Your Health''
    As discussed in section III.D of this document, FDA selected the
image ``man I Quit t-shirt'' for use with the statement, ``WARNING:
Quitting smoking now greatly reduces serious risks to your health.''
FDA proposed two other images for use with this statement: ``cigarettes
in toilet bowl,'' which appears on pages 69 and 70 of the document
``Proposed Required Warning Images;'' and ``woman blowing bubble,''
which appears on pages 71 and 72 of the document ``Proposed Required
Warning Images.''
    Cigarettes in toilet bowl. In FDA's research study, the image
``cigarettes in toilet bowl'' had significant effects on the emotional
reaction scale in adults and young adults and significant effect on the
cognitive reaction scale in all study populations (adults, young
adults, and youth).
    Among youth, the image ``cigarettes in toilet bowl'' prompted
higher correct recall of the warning statement at 1 week follow-up than
the text-only control. However, the proposed required warning featuring
this image prompted relatively lower recall of the image at baseline
and at 1 week follow-up than the selected image, ``man I Quit t-
shirt.''
    The image ``cigarettes in toilet bowl'' had a significant impact on
beliefs about the health risks of smoking for smokers in young adults.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 115) FDA received some comments that supported the use of
the image ``cigarettes in toilet bowl,'' including comments from
individuals, a community organization, and a local public health
agency. Some comments noted that this image is the best choice for use
with this warning statement, and it was also noted in the comments that
the image is effective because it creates an association between
cigarettes and other undesirable things that belong in a toilet bowl.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image failed to show any significant effects in one
submitter's study on measures of ease of comprehension, worry, and
feeling discouraged from smoking compared to a text-only control. In
addition, the image was rated as less effective than the selected
image, ``man I Quit t-shirt,'' in another submitter's study of the
potential effectiveness of the images.
    FDA also received several comments that opposed use of the image
``cigarettes in toilet bowl.'' These comments noted that the image is
not clear or does not convey a health consequence of smoking. It was
also noted that the image is not easily understood, or alternatively,
that it is banal. Multiple comments expressed concern about what is
shown in the image, stating that it recommends a bad or unhealthy
action (i.e., flushing cigarettes down a toilet, which the comments
stated could clog the toilet and pollute the environment). Some
comments also stated that the statement was difficult to read in the
``cigarettes in toilet bowl'' image. It was also stated in the comments
that the image did not show large effects on the emotional and
cognitive reaction scales in FDA's research study and failed to show
desirable effects on other measures.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``man I Quit t-shirt'' for
the reasons given in section III.D of this document.
    Woman blowing bubble. In FDA's research study, the image ``woman
blowing bubble'' had a significant effect on the cognitive reaction
scale in youth.
    The image ``woman blowing bubble'' had a negative impact on youth
beliefs about the health risks of smoking for smokers and for
nonsmokers (i.e., youth who viewed this image were less likely to
believe that smokers will suffer negative health consequences or that
nonsmokers exposed to secondhand smoke will suffer negative health
consequences than youth who viewed the text-only control). Furthermore,
the adult sample that viewed a hypothetical advertisement containing
the proposed required warning reported that they were less likely to
quit smoking in the next 30 days compared to adults who viewed the
text-only control.
    (Comment 116) FDA received some comments that supported the use of
the image ``woman blowing bubble,'' including comments from
individuals, a public health advocacy group, and a State public health
agency. Multiple comments noted that the image appropriately shows how
quitting smoking allows for a better lung capacity or noted that it
effectively conveys the idea that there are beneficial effects of
quitting.
    As discussed in section III.C of this document, some comments
submitted to the docket described the results of research conducted by
the submitters to examine the potential effectiveness of FDA's proposed
images. This image was discussed in some of these comments.
Specifically, this image led to lower levels of worry and lower reports
of feeling discouraged from smoking relative to a text-only control in
one submitter's study. In addition, the image was rated as the least
effective of the images proposed by FDA for use with this warning
statement in another submitter's study of the potential effectiveness
of the images.
    FDA also received several comments that opposed use of the image
``woman blowing bubble.'' Multiple comments stated that the image is
confusing and is not appropriately compelling and would not be
effective in encouraging smokers to quit. Some comments indicated that
the image does not effectively convey the message contained in the
warning statement, and some noted that the image is banal or,
alternatively, too positive. Multiple comments also stated the image is
hard to understand, and that smokers may not comprehend the association
between the image and the warning statement. It was also stated that
the image would inappropriately appeal to youth without discouraging
them from smoking, and that the image is inappropriate because it is
sexually suggestive. It was also noted in the comments that the image
showed negative results on some measures in FDA's research study, and
failed to show desirable effects on other measures.
    (Response) We are not selecting this image for use in a required
warning and have instead selected the image ``man I Quit t-shirt'' for
the reasons given in section III.D of this document.
10. Image for Advertisements With a Small Surface Area
    As discussed in section III.D of this document, FDA selected the
image which appears on page 75 of the document entitled ``Proposed
Required Warning Images'' for use with the textual warning statements
solely in advertisements with a small surface area (defined as less
than 12 square inches). We also proposed one other image for use with
this statement, which appears on page 74 of the document entitled
``Proposed Required Warning Images.''
    The proposed image on page 74 depicts a burning cigarette enclosed
by a red circle with a red bar across the image. We did not receive any
comments on either of the proposed images.
    As explained in section III.D of this document, we have selected
the image of a black exclamation mark enclosed within a red equilateral
triangle for use

in advertisements with a small surface area because we have concluded
that the common purpose of this image, to denote a warning of a threat
to health or of a hazard which could result in personal injury, makes
it the most appropriate for use in the required warning context.

IV. Comments Regarding Textual Warning Statements

A. Changes to Textual Warning Statements

    As we explained in the proposed rule, section 202(b) of the Tobacco
Control Act, amending section 4 of FCLAA (15 U.S.C. 1333), gives us the
authority to adjust the format, type size, color graphics, and text of
any of the required warning statements if such a change ``would promote
greater public understanding of the risks associated with the use of
tobacco products.'' In addition, under section 4(d) of FCLAA, FDA may
adjust the type size, text, and format of the warning statements as the
Agency determines appropriate ``so that both the graphics and the
accompanying label statements are clear, conspicuous, legible and
appear within the specified area.'' Such adjustments, including
adjustments to the text and format of some of the warning statements,
were included with some of the proposed warnings (75 FR 69524 at
69534). We did not receive comments about these adjustments. Two of the
warning statements we have selected for this final rule are presented
in all uppercase letters, as they were in the proposal. In addition,
one of the proposed required warnings, ``baby in incubator,'' was
presented without the signal word ``WARNING.'' The research literature
on graphic health warnings indicates that signal words, such as
``Warning,'' have been found to enhance the noticeability of safety
warnings and convey the degree of risk (see Ref. 40 at p. 33). In the
final rule, we are thus not removing the word ``WARNING'' from this
required warning, such that the text in this required warning is the
same as the text presented in section 201 of the Tobacco Control Act
(``WARNING: Smoking during pregnancy can harm your baby'').
    Moreover, section 906(d) of the FD&C Act (21 U.S.C. 387f(d))
authorizes FDA to issue regulations restricting the sale or
distribution of cigarettes and other tobacco products. As is discussed
in more detail in section V.B.6 of this document, a reference to a
cessation resource has been included in the final required warnings.
    Although we did not receive any comments about the adjustments we
made to the text of some of the warning statements in the 36 proposed
required warnings, we received numerous comments requesting other
changes to the textual statements for the new required warnings,
including requests to strengthen the text, to add additional
information to the text or to otherwise modify the text of the warnings
statements. We also received requests to substitute alternative warning
statements for some or all of the textual statements and to expand the
warning statements by adding additional statements regarding smoking-
related risks. The comments, and our responses, are summarized in the
following paragraphs. We also received numerous comments about our
proposal to include a reference to a cessation resource in the required
warnings; these comments and our responses are summarized in section
V.B.6 of this document.
    (Comment 117) Several comments suggested that some of the textual
warning statements should be changed to include language asserted to be
stronger and more direct. For example, multiple comments suggested that
the statement, ``WARNING: Tobacco smoke can harm your children,''
should be reworded to be more assertive, for example, to state
``Tobacco smoke harms your children.'' One comment referenced the
conclusion from the 2010 Surgeon General's report that there is no
risk-free level of exposure to secondhand smoke as support for this
modification (Ref. 37). Similarly, multiple comments recommended that
FDA change the warning statement, ``WARNING: Smoking during pregnancy
can harm your baby,'' to be more strongly worded. For instance,
comments suggested this statement could instead be worded as ``WARNING:
Smoking during pregnancy harms your baby'' or ``WARNING: Smoking when
pregnant harms your baby'' or ``WARNING: Smoking harms your baby'' or
``WARNING: Smoking harms the fetus and babies.'' Multiple comments also
suggested the warning statement ``WARNING: Smoking can kill you''
should not be worded in a conditional manner. One comment suggested
that the text could instead state ``Smoking kills.''
    Similarly, FDA received a number of comments suggesting other
modifications that individuals, public health advocacy groups, health
care professionals, community organizations, and other groups believed
would augment the nine statements. For example, one comment from a
public health advocacy group suggested that the statement ``Cigarettes
are addictive'' be modified to state ``Cigarettes are HIGHLY
addictive,'' while another comment suggested the statement read
``Cigarettes are addictive and shorten your life.'' Similarly, a
comment from a health care professional suggested the warning should
state ``Cigarettes are addictive and deadly.'' Another comment from a
nonprofit foundation suggested that the statement ``Cigarettes cause
strokes and heart disease'' be modified to state ``Cigarettes cause
strokes, heart disease, and amputations.''
    (Response) Section 202(b) of the Tobacco Control Act gives FDA the
authority to change the textual warning statements if such a change
would promote greater public understanding of the health risks
associated with smoking. However, at this point, we decline to make the
recommended changes. We are adopting the nine textual statements
mandated by Congress in section 4(a)(1) of FCLAA. The nine new textual
warning statements objectively communicate some of the major health
risks associated with smoking in an effective manner. The new textual
statements represent a significant improvement over the current set of
warnings in that they are specific, unambiguous, and succinctly
describe documented outcomes of cigarette use and exposure. We conclude
that these nine new statements will effectively convey the major health
risks of smoking, which will help discourage nonsmokers from initiating
cigarette use, and encourage current smokers to consider cessation,
particularly when combined with graphic images depicting the negative
health consequences of smoking.
    However, we intend to monitor the effects of these required
warnings once they are put into use. We will conduct research and keep
abreast of scientific developments regarding the efficacy of various
required warnings and the types and elements of various warnings that
improve efficacy. Such research will help inform us regarding whether
to propose changes to the textual warning statements, such as by using
stronger or more direct language, in a future rulemaking.
    (Comment 118) Many comments recommended that FDA include additional
textual information to give further context for the health warnings.
For example, comments requested that FDA add information such as
research statistics, factual testimonials, or other explanatory text to
further enhance the effectiveness of the new required warnings. Several
of the comments suggested specific text for particular warning
statements; for example, one comment suggested the warning

statement related to addiction be accompanied by the following
explanatory text: ``Studies have shown that tobacco can be harder to
quit than heroin or cocaine.'' Other comments suggested that the
statement ``WARNING: Cigarettes cause cancer'' be modified to add
explanatory text about specific cancers caused by cigarettes, including
cancers of the mouth, throat, esophagus, lungs, kidney, bladder,
pancreas, stomach, cervix, and bone marrow. Another comment suggested
that the statement ``Cigarettes cause strokes and heart disease'' be
accompanied by explanatory text stating ``Cigarette smoking doubles
your chances of strokes and can cause heart attacks'' and that the
statement ``Cigarettes cause fatal lung disease'' be accompanied by
explanatory text stating that ``Every cigarette you smoke increases
your chances of dying from lung disease.'' In addition, the comment
suggested that the statement ``Tobacco smoke causes fatal lung disease
in nonsmokers'' be accompanied by explanatory text stating ``You're not
the only one smoking cigarettes. The smoke is not just inhaled by
smokers, it becomes second-hand smoke, which contains more than 50
cancer agents.'' Another comment suggested adding information to the
required warnings that state alternatives to smoking, such as exercise
and healthy eating.
    (Response) We decline to make such changes at this time. As stated
previously, the nine new textual warning statements mandated by
Congress in section 4(a)(1) of FCLAA objectively communicate some of
the major health risks associated with smoking in an effective manner.
In addition, research has shown that warning statements that are short
and to the point and that are presented in larger fonts sizes are
likely to be more effective (Ref. 40 at p. 33). If the additional
requested information were added to the required warnings, the
resulting warning statements would be longer, and the font size of the
warning statements would likely decrease in order for the information
to fit within the specified area. This could undercut the effectiveness
of the warnings (see, e.g., Ref. 57). If research later indicates that
adding such information to the new required warnings will promote a
greater understanding of the risks associated with smoking, we will
consider making these changes using our authority under section 202(b)
of the Tobacco Control Act.
    (Comment 119) One comment suggested that the warning statements
that reference ``tobacco smoke'' should be modified to instead
reference ``cigarette smoke'' to apply more directly to the target
audience.
    (Response) We disagree that this change is warranted. The
statements in section 4(a)(1) of FCLAA, including those that reference
``tobacco smoke,'' are scientifically accurate, and we do not believe
that consumers will fail to understand that the warning statements
referencing ``tobacco smoke'' apply to the products on which they
appear (i.e., cigarettes), which are tobacco products.
    (Comment 120) FDA received a number of comments suggesting that
some of the negative health effects that are the subject of individual
warning statements be replaced with other warnings. For example, one
comment from a medical organization suggested that the statement
``WARNING: Tobacco smoke causes fatal lung disease in nonsmokers''
should instead focus on heart attacks, stating that the magnitude of
fatal heart disease caused by secondhand smoke exposure is greater than
the magnitude of fatal lung disease caused by secondhand smoke
exposure. One comment from an individual suggested that FDA use other
warnings about the health harms of smoking instead of the warning about
addiction.
    Another comment suggested that there should be fewer warnings
regarding the health risks of secondhand smoke to babies and children
and more warnings directed at young teens and pre-teens. One comment
stated that the warnings about smoking during pregnancy and about the
harms of tobacco smoke to children are only relevant to those who are
pregnant or who have children and suggested that these warnings are
thus less impactful than the other warning statements.
    However, other comments stated that the warnings about the risks of
smoking during pregnancy and about the health risks of secondhand smoke
to children address important health issues, will help make smokers
aware that they are harming innocent people around them, and will help
smokers appreciate the severity and magnitude of some of the lesser-
known risks of smoking. One comment from an individual noted that
secondhand smoke kills an estimated 45,000 nonsmokers who live with
smokers from heart disease each year, as well as increasing the risk of
SIDS, acute respiratory infections, ear problems, and severe asthma in
children, and causing respiratory symptoms and slowing lung growth in
children.
    (Response) We decline to amend the warning statements as suggested
by the comments. As stated previously, the nine textual statements
provided by Congress in section 4(a)(1) of FCLAA appropriately
communicate important health risks of smoking. Furthermore, we disagree
with the suggestion that there should be fewer warnings about the
health risks of smoking during pregnancy and of secondhand smoke to
children. These warnings comprise two of the nine warning statements,
and we agree with the comments indicating that these warnings
communicate information about important health issues and will help
smokers understand some of the significant health harms caused by
cigarettes. In addition, while these warnings may be especially
impactful with parents and expectant parents, using a variety of
messages, including messages that may particularly impact certain
audiences, will strengthen the overall impact of the required warnings
(Ref. 40 at pp. 7-8).
    Similarly, we disagree with the suggestion that the warning about
addiction should be replaced by a warning about other health hazards.
As discussed in the preamble to the proposed rule (75 FR 69524 at 69528
through 69529), the magnitude of public health harm caused by
cigarettes is inextricably linked to the addictive nature of these
products (Ref. 16 at p. 14 and Ref. 3 at p. xi), and many people,
particularly adolescents, have a poor understanding of how difficult it
is to quit smoking due to the addictive nature of cigarettes (Ref. 3 at
p. 91). Thus, we conclude this is an important and appropriate health
warning.
    (Comment 121) One comment suggested that graphic health warnings on
cigarette packages and advertisements should have one broad warning
that states: ``Cigarette smoking may cause cancer, death, and other
serious life-threatening health hazards.'' Another comment suggested
one broad warning that states: ``Smoking Can Kill You.''
    (Response) We disagree. We are not aware of any scientific evidence
that one broad warning statement would be more effective in
communicating the multitude of health risks to smokers and nonsmokers
in all age categories than the nine specific textual warnings specified
in section 4(a) of FCLAA.
    As noted in the proposed rule, evidence shows that warnings about
specific health risks, such as cancer, heart disease, and stroke, are
more effective than general warnings (75 FR 69524 at 69533 through
69534). Utilizing a single broad statement like the ones proposed in
the comments would also fail to communicate important information about
the detrimental effects associated with secondhand smoke--and messages
about secondhand smoke have been effective in moving smokers to
consider

the health risks associating with smoking (75 FR 69524 at 69534). For
example, the new set of warnings includes the following statement:
``WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.''
This important warning would be lost if we chose to use just one of the
suggested broad warning statements. In addition, one of the new
required warnings clearly notifies smokers that if they quit smoking,
they can greatly reduce serious risks to their health. Again, that
important message would be lost if we were to use just one of the
suggested broad statements.
    (Comment 122) One comment stated that the ninth warning statement
provided by Congress in the Tobacco Control Act, ``WARNING: Quitting
smoking now greatly reduces serious risks to your health,'' should
appear on all packages after one of the other eight warning statements.
    (Response) We disagree that such a change is warranted. As
discussed in section V.B.6 of this document, we have included a
reference to a cessation resource in the required warnings, which we
conclude is more appropriate than including the ninth warning statement
in all the required warnings.
    (Comment 123) Many comments suggested that FDA add additional
warning statements to state that cigarette smoking may increase the
risk of other diseases such as bladder cancer, impotence, blindness, or
COPD. One comment stated that medical studies have shown that women who
smoke a pack of cigarettes a day double the risk of orofacial cleft
birth defects in their children, and suggested that a warning be added
to include this risk and pictures of children with this birth defect
(citing, e.g., Ref. 58). One comment also suggested that the required
warnings indicate that smoking may increase the risk of breast cancer.
Another comment suggested including messages about short-term effects
of smoking, such as nutritional deficiencies.
    (Response) We decline to add additional warning statements, as
suggested in these comments. At this point, we have determined the nine
textual statements mandated by Congress in section 4(a)(1) of FCLAA
appropriately communicate major health risks of smoking. As stated
previously, we intend to monitor the effects of these required warnings
once they are put into use. We will conduct research and keep abreast
of scientific developments regarding the efficacy of various required
warnings and the types and elements of various warnings that improve
efficacy. We intend to use the results of our monitoring and such
research to determine whether changes should be made to the nine
textual statements in a future rulemaking. We recognize that cigarettes
cause negative health consequences in both smokers and nonsmokers
beyond those addressed in the nine warning statements provided by
Congress, and will take this into account in making future
determinations as to whether the textual statements should be revised
by rulemaking.
    (Comment 124) A few comments also suggested that when FDA initiates
a new rulemaking to establish its next set of graphic warnings, the
Agency should consider adding health warnings that refer to other
smoking-related diseases that are not specifically mentioned in this
first set of required warnings.
    (Response) We intend to periodically review the required warnings
to assess their effectiveness and determine whether the warnings are
suffering from wear out. During this review, we intend to examine the
scientific literature and possibly conduct our own research to
determine if additional textual warnings about the scientifically
documented negative health consequences of smoking are appropriate.
    (Comment 125) One comment suggested that FDA utilize different
warnings with featured messages targeted to specific audiences based on
their different attitudes and beliefs. As an example, this comment
pointed to the Canadian health warning directed at young males, which
stresses that tobacco can make the smoker impotent (Ref. 55).
    (Response) We conclude that the nine textual statements required by
Congress in section 4(a)(1) of FCLAA are appropriate. In addition, we
have selected color graphics to accompany the new warning statements
that use a variety of different fonts, typography, and layouts; depict
a variety of human subjects; and use a variety of styles, including
photographic and graphic illustrations. The required warnings will
reach a wide variety of audiences including youth, young adult, and
adult smokers and nonsmokers. For information on FDA's selection of
images, see section III of this document.
    As previously stated, we intend to monitor the effects of these
required warnings once they are put into use. If our monitoring finds
that the messages are not reaching an appropriately broad population
and that targeted messages would be more effective, we will consider
revising the textual statements in a future rulemaking.
    (Comment 126) One comment suggested that FDA require a standard
pack size and shape, which would help to ensure the readability of
warnings.
    (Response) We do not believe it is necessary to adopt a standard
pack size and shape. We have taken steps to ensure that the required
warnings will be conspicuous and legible on cigarette packages and in
advertisements.

B. Attribution to the Surgeon General

    Section 4(a)(1) of FCLAA contains the nine new textual warning
statements that, when combined with a graphic image, comprise the
required warning. Congress did not include an attribution to the
Surgeon General in the new textual warning statements, as it has done
in past laws on cigarette health warnings. Accordingly, when we issued
our proposed rule and released the 36 proposed required warnings, the
textual warning statements did not include a reference to the Surgeon
General. A number of comments, including those from former Surgeons
General and Commissioned Public Health Service Officers, questioned why
the new health warnings no longer contain any attribution to the
``Surgeon General.'' A summary of the comments and our response
regarding this issue is included in the following paragraphs.
    (Comment 127) The comments noted that, since Surgeon General Luther
Terry's 1964 report highlighting the adverse health effects of tobacco
use, the Office of the Surgeon General has been inextricably linked to
smoking prevention and that the reduction in smoking rates since the
initial report and the advent of the first Surgeon General's warning is
due to the public confidence associated with the Surgeon General's
recommendations. In addition, they claimed that the new warnings would
be less effective without the Surgeon General attribution. Two other
comments also suggested that FDA include ``the federal government
logo'' on the health warnings to communicate that the Department of
Health and Human Services (HHS) endorses the health message. Another
comment from a public health advocacy group suggested that the warning
statements add a reference to FDA and/or the U.S. Government to
legitimize the warnings. In contrast, one comment stated that it did
not support continued use of the Surgeon General attribution, but if
FDA decides to include the attribution, it should be placed on the side
of the package where it does not detract from the new health warnings.
    (Response) We agree with comments highlighting the benefits of the
Surgeon General's work in the area of smoking prevention, but we
decline to add the ``Surgeon General'' attribution to the

required warnings at this time. Congress did not include an attribution
to the Surgeon General as it has done in the past. In addition, there
is inconsistency among the limited scientific literature as to whether
the attribution of health warnings to government sources enhances their
credibility (see, e.g., Refs. 42, 36, 57, and 59). Attribution to a
government resource may increase believability of the information;
however, if the government is generally disliked or mistrusted, a
government source attribution may result in rejection of the health
warning (Ref. 11).
    One 1997 study found that the attribution to a government source,
including the U.S. Surgeon General, did increase the credibility and
viewers' intentions to comply with the warnings for cigarettes (Ref.
57). Similarly, in a study conducted prior to Israel's decision to
require new cigarette warnings on packages, researchers found that
consumers preferred warnings with attribution to a government source or
medical research rather than warnings without attribution (Ref. 59).
    However, in a developmental study assessing appropriate attributes
for new cigarette warnings in Australia, researchers found that the
mention of ``government'' in an attribution reminded smokers that the
government collects tax revenue from cigarettes and led smokers to
challenge the sincerity of the government in issuing cigarette health
warnings (Ref. 48). Similarly, researchers for the European Commission
in the European Union looked at respondents' reactions to three
potential attributions for cigarette warnings: (1) Government/
regulatory bodies; (2) health authorities/cancer charities; and (3)
tobacco industry (Ref. 42). They found smokers did not respond well to
regulatory bodies as a potential source for cigarette warning messages,
believing that government bodies did not care about their smoking
behavior or were motivated by self-interest (Id.).
    Moreover, even though the 1997 study did find benefits associated
with government source attribution, researchers also noted the
potential trade-offs associated with government attribution (Ref. 57).
They noted the surface area restrictions associated with warnings and
that the amount of information that one can give without losing readers
is limited (Id.). They also noted that the addition of attribution
information may require the use of smaller font size, which may impact
legibility and noticeability of the warning (Id.). In fact, as we noted
in the preamble to the proposed rule, the length and font size of the
existing warnings contribute to their ineffectiveness, and larger font
sizes enhance the noticeability of cigarette warnings (75 FR 69524 at
69530 and 69534; Ref. 40 at 30-31). Therefore, given the inconsistency
in the available research and the potential tradeoffs associated with
including a government source attribution in the required warnings, we
conclude that there is insufficient evidence to support addition of an
attribution at this time.
    We will continue to work in partnership with other components
within HHS to educate consumers about the risks of smoking. FDA and
others also will continue to conduct research regarding the efficacy of
required warnings. If such research indicates that adding the Surgeon
General attribution to the cigarette required warnings will improve
their efficacy, we will consider adding a government attribution as
part of a future rulemaking to update the warnings.

C. Foreign Language Translations

    As we explained in the preamble to the proposed rule, consistent
with section 4(b) of FCLAA, proposed Sec.  1141.10(b)(2) would mandate
that the textual component of the required warning appear in the
English language in cigarette advertisements with two exceptions.
First, per proposed Sec.  1141.10(b)(2)(i), if an advertisement appears
in a non-English language publication, the textual portion of the
required warning would need to appear in the predominant language of
the publication. Second, per proposed Sec.  1141.10(b)(2)(ii), if an
advertisement is in an English language publication but the
advertisement itself is presented in a language other than English, the
textual portion of the required warning would need to be presented in
the same foreign language principally used in the advertisement. To
accommodate the potential need for Spanish language translations of the
textual warning statements, we included Spanish translations with the
proposed rule. We received several comments regarding foreign language
translations in advertisements and one comment requesting the use of
foreign language translations on packages. We have summarized and
responded to these comments in the following paragraphs.
    (Comment 128) One comment indicated that the submitter was pleased
to see Spanish translations of the warnings, but asked that FDA
continue to work with as many languages as possible.
    (Response) We understand the importance of ensuring that the
textual portion of the required warnings is translated accurately so
that the message is appropriately communicated to foreign language
speakers. As indicated in the NPRM, we included Spanish language
translations in recognition of the fact that Spanish is the foreign
language most commonly used for cigarette advertisements in the United
States (75 FR 69524 at 69537 through 69538). We also will work with any
advertiser who plans to advertise cigarettes in any non-English
language publication, or who plans to utilize a non-English
advertisement in an English-language publication in accordance with
Sec.  1141.10(b)(2)(ii). Specifically, upon request, we will assist
advertisers in generating a true and accurate translation of the
textual statements for the nine new required warnings for use in
advertisements that are subject to Sec.  1141.10(b)(2).
    (Comment 129) One comment expressed concerns that foreign language
translations sometimes can be ``too literal'' and could inappropriately
impact the meaning of the warning statement.
    (Response) We are sensitive to this concern, and the final rule
requires that any translation of the required warning statements
results in a true and accurate foreign language version of the warning
statements. As stated in the previous response, we will assist any
advertiser who plans to advertise cigarettes with a foreign language
translation of the required warnings.
    (Comment 130) One comment stated that all cigarette advertisements
in predominantly Spanish speaking areas, such as Puerto Rico, and in
Spanish language publications should include warnings in Spanish.
Another comment recommended that the required warnings in
advertisements be in the language of the publication or advertisement.
    (Response) We agree in certain circumstances. As stated in the
proposed rule and required in Sec.  1141.10(b)(2), any advertisement
that appears in a Spanish language publication must present the textual
portion of the required warning in Spanish (see Sec.
1141.10(b)(2)(i)). In addition, for advertisements in English language
publications, if the advertisement itself is presented in Spanish, the
required warning in the advertisement also must be in Spanish (see
Sec.  1141.10(b)(2)(ii)). However, if an English language publication
that includes English language advertisements is sold in predominantly
Spanish speaking areas, the textual component of the required warnings
will still be required to appear in

English, as specified by section 4 of FCLAA.
    We conclude that these requirements will appropriately ensure that
the target audience of any advertisement is able to read and understand
both the promotional content of the advertisement and the important
warning information.
    (Comment 131) One comment requested that the required warnings on
all cigarette packages exported to Puerto Rico and Latin America be in
Spanish.
    (Response) We decline to adopt this request. Section 4(b)(2) of
FCLAA and Sec.  1141.10(b)(2) require translation of required warnings
for certain advertisements only. Neither FCLAA nor the Tobacco Control
Act requires foreign language warnings on cigarette packages sold or
distributed within the United States, including within the Commonwealth
of Puerto Rico. Furthermore, with limited exceptions, FCLAA does not
apply to packages of cigarettes for export from the United States.

V. Description of the Final Rule

A. Overview of the Final Rule

    This final rule adds new part 1141 to Title 21 of the Code of
Federal Regulations, requiring new warnings on cigarette packages and
in cigarette advertisements. These new required warnings consist of the
nine textual warning statements set forth in section 201 of the Tobacco
Control Act accompanied by color graphic images depicting the negative
health consequences of smoking. We have selected nine images, such that
each required warning consists of one of the nine textual warning
statements and an accompanying color graphic.
    As required by section 201 of the Tobacco Control Act, the rule
requires the new warnings to appear prominently on cigarette packages
and in advertisements, occupying at least 50 percent of the area of the
front and rear panels of cigarette packages and the top 20 percent of
the area of advertisements. We also have exercised our authority under
sections 201 and 202 of the Tobacco Control Act, which allow FDA to
adjust the type size, text, and format of the textual warning
statements. For example, under section 4(d) of FCLAA (as amended by
section 201 of the Tobacco Control Act), FDA may adjust the type size,
text, and format as we determine appropriate so that both the textual
warning statements and the accompanying graphics are clear,
conspicuous, legible, and appear within the specified area. Such
adjustments, including adjustments to the type size and the addition of
information regarding a cessation resource, are included for the
required warnings in this final rule. In addition, we are requiring a
reference to 1-800-QUIT-NOW as part of the required warnings in
accordance with section 906(d) of the FD&C Act as appropriate for the
protection of the public health.

B. Description of Final Regulations and Responses to Comments

1. Section 1141.1--Scope
    In the proposed rule, proposed Sec.  1141.1 set forth the scope of
the proposed regulations. In particular, proposed Sec.  1141.1(b)
limited the applicability of the proposed requirements by clarifying
that they would not apply to manufacturers or distributors of
cigarettes that do not manufacture, package, or import cigarettes for
sale or distribution in the United States. Proposed Sec.  1141(c)
described situations where a cigarette retailer would not be in
violation of the proposed rule for displaying or selling cigarette
packages that do not comply with the rule, so long as certain
conditions were met (75 FR 69524 at 69535). We received several
comments regarding the scope of the regulation, which we have
summarized and responded to in the following paragraphs.
    (Comment 132) One comment requested that all imported cigarettes
and tobacco products have required warnings to come into U.S. ports and
be sold in the United States and its territories, including Puerto
Rico.
    (Response) We agree that imported cigarette packages must bear a
required warning in accordance with section 4 of FCLAA and part 1141.
Section 1141.10 provides that it is unlawful for any person to import
for sale or distribution within the United States any cigarettes the
package of which fails to bear one of the required warnings on both the
front and rear panels. Section 1141.3 defines United States to include
specified U.S. territories, including Puerto Rico. In addition, as
explained in section V.B.2 of this document, we are revising the
definition of importer to clarify that the term importer includes any
person who imports any cigarette, regardless of where it was
manufactured. With respect to whether other tobacco products should
have required warnings, we have determined that issue is outside the
scope of this rulemaking.
    (Comment 133) One comment supported the imposition of the required
warnings on all cigarette packages manufactured in the United States,
including all exported cigarette packages. The comment said that it
would be unconscionable for FDA to protect residents in the United
States and not the rest of the world when they are smoking U.S.-made
products. According to this comment, cigarettes that are being exported
are essentially bought in the United States and these products are
under the FDA's jurisdiction.
    (Response) We disagree that it is appropriate to impose a
requirement that cigarettes that are manufactured in the United States
for export bear a required warning. Section 4(a) of FCLAA applies to
cigarettes packages that are ``for sale or distribution within the
United States.'' Section 12 of FCLAA provides:

    Packages of cigarettes manufactured, imported, or packaged (1)
for export from the Unites States or (2) for delivery to a vessel or
aircraft, as supplies, for consumption beyond the jurisdiction of
the internal revenue laws of the Untied States shall be exempt from
the requirements of this Act, but such exemptions shall not apply to
cigarettes manufactured, imported, or packaged for sale or
distribution to members or units of the Armed Forces of the United
States located outside of the United States.

(15 U.S.C. 1340). In addition, many other countries impose their own
warning requirements on cigarette packages sold in those countries.
    (Comment 134) One comment requested that FDA exercise enforcement
discretion for retailers and distributors selling cigarettes that do
not bear a specified warning label because retailers do not control the
labeling of the products supplied by manufacturers. The comment claimed
that if a product is provided by a licensed supplier, and not altered
by the distributor, the distributor should likewise be relieved of
liability.
    (Response) FCLAA provides a very limited exemption for retailers
and we do not agree that it is appropriate to broaden the exemption to
distributors. Nor do we agree that it is appropriate to adopt a broad
enforcement discretion policy for retailers and distributors. By
choosing to distribute and sell cigarettes, distributors are under an
obligation to make sure that the products they receive from
manufacturers, importers, and other distributors and subsequently
distribute or sell comply with the law, including checking to see
whether the packages include a required warning on the front and rear
panel. Retailers, however, are not in violation if they display or sell
a cigarette package that includes a health warning, even if it is not
one of the nine required warnings, as long as other

statutory requirements are met (see 15 U.S.C. 1333(a)(4)). The preamble
to the proposed rule made clear that manufacturers, importers, and
distributors have the primary responsibility for ensuring that the
required warnings on cigarette packages comply with all the provisions
of part 1141.
    (Comment 135) One comment expressed concern regarding the exemption
of retailers from an obligation to ensure packages depict required
warnings. This comment claimed that the exemption hampers enforcement,
because an inspector needs to be able to seize noncompliant packaging
at retail.
    (Response) We decline to revise the language of proposed Sec.
1141.1(c). As we explained in the preamble to the proposed rule, the
limited retailer exemption is in accordance with section 4(a)(4) of
FCLAA. The exemption for retailers is limited to situations where the
cigarette package contains a health warning, is supplied to the
retailer by a license- or permit-holding tobacco product manufacturer,
importer, or distributor, and is not altered by the retailer in a way
that is material to the requirements of section 4(a) of FCLAA. We note,
however, that Sec.  1141.1(c) describes situations where a retailer is
not considered in violation of part 1141; this exemption does not apply
to manufacturers, importers, or distributors that provide retailers
with noncompliant cigarette packages. Thus, although a retailer would
not be held liable for selling or offering for sale a cigarette package
that is not in full compliance with the requirements of part 1141, so
long as the retailer fits within the exemption set forth in Sec.
1141.1(c), the manufacturer, importer, or distributor that provided the
noncompliant packages would be liable for violating FCLAA and these
regulations. Furthermore, the misbranding provisions in Sec.  1141.14
apply to the cigarettes themselves. Therefore, if we discover
misbranded cigarette packages in a retail establishment, but the
retailer fits within the exemption set forth in Sec.  1141.1(c), we
could still initiate a seizure action under section 304 of the FD&C Act
(21 U.S.C. 334).
    (Comment 136) One comment requested that FDA revise its 2010
Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco to Protect Children and Adolescents (75 FR 13225,
March 19, 2010) (``reissued 1996 rule'') to ensure that the Agency does
not exceed the scope of the Tobacco Control Act by imposing liability
on retailers and distributors for labeling or advertising in specific
situations. This comment contended that the Tobacco Control Act
provides specific situations in which retailers should not be held
liable for labeling or advertising and those situations are not
recognized in the reissued 1996 rule.
    (Response) Section 201 of the Tobacco Control Act, amending section
4 of FCLAA to require graphic warnings, does contain a specific
exemption for retailers in certain circumstances, and proposed Sec.
1141.1(c) and (d) recognized this exemption. Section 102 of the Tobacco
Control Act required FDA to reissue the 1996 Regulations Restricting
the Sale and Distribution of Cigarettes and Smokeless Tobacco to
Protect Children and Adolescents (61 FR 44396, August 28, 1996) with
certain specified exceptions. We have complied with this requirement
(75 FR 13225). However, section 102 of the Tobacco Control Act did not
specify that the reissued 1996 rule contain an exemption for retailers
or distributors. Consequently, this graphic warning rulemaking did not
propose any revisions to the reissued 1996 rule (currently codified at
21 CFR part 1140).
    (Comment 137) Multiple comments advocated for the placement of
graphic warnings on all tobacco products, including smokeless tobacco
products.
    (Response) We decline to require warnings on other tobacco products
in this rulemaking. In section 4(d) of FCLAA, Congress directed FDA to
issue regulations to require color graphic images to accompany the
warnings statements required by section 4(a)(1) of FCLAA. This section
of FCLAA requires that the statements be included on cigarette
advertisements and cigarette packages. While we may be able to require
warnings on other tobacco products under other authority, such action
is outside the scope of this rulemaking.
2. Section 1141.3--Definitions
    Proposed Sec.  1141.3 included definitions for the following terms:
     Cigarette
     Commerce
     Distributor
     Front panel and rear panel
     Importer
     Manufacturer
     Package
     Person
     Required warning
     Retailer
     United States
We received only a few comments regarding definitions described in the
proposed rule. In light of these comments, we are revising the
definition of ``importer.''
    As explained in the preamble to the proposed rule, proposed Sec.
1141.3 defined ``importer,'' for purposes of part 1141, as any person
who introduces into commerce any cigarette that: (1) Was not
manufactured in the United States and (2) is intended for sale or
distribution to consumers in the United States. Proposed Sec.  1141.3
defined ``retailer'' as any person who sells cigarettes to individuals
for personal consumption, or who operates a facility where vending
machines or self-service displays of cigarettes are permitted (75 FR
69524 at 69536).
    (Comment 138) One comment asked that FDA expand the definition of
importer to include persons who introduce into commerce cigarettes
manufactured in the United States, exported from the United States, and
subsequently imported. According to this comment, legislation in 2000
substantially curtailed this practice, but it is still possible.
    (Response) We agree that any person who introduces into commerce
cigarettes that were imported into the United States, regardless of
where those cigarettes were manufactured, should be considered an
importer. We are revising the definition of importer to clarify this
point.
    (Comment 139) With respect to the definition of retailer, one
comment requested that FDA revise the definition to clarify that
Internet sellers are included in this definition. The comment noted
that it appears the retailer definition is broad enough to cover
Internet sellers, but clarification would avoid any arguments to the
contrary.
    (Response) We have determined that revisions to the definition of
retailer are not needed. The definition is clear that any person,
including an Internet seller, who sells cigarettes to individuals for
personal consumption is a retailer. The comment provided no examples of
possible arguments for why an Internet seller would not meet the
definition of retailer and provided no alternate language for the
definition. It may be possible that an Internet seller would not be
considered a retailer because it is not selling cigarettes to
individuals for personal consumption. In that case, however, the
Internet seller would likely meet the definition of distributor and, if
so, would be responsible for complying with all responsibilities of
distributors under part 1141 and section 4 of FCLAA.
3. Section 1141.10--Required Warnings
    The Tobacco Control Act directs FDA to require that color graphic
images depicting the negative health

consequences of smoking accompany each of the textual warning
statements that must be randomly displayed on cigarette packages (i.e.,
in each 12-month period, all of the different warnings must appear 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) and rotated quarterly in cigarette
advertisements under FCLAA. Accordingly, in proposed Sec.  1141.10, we
proposed that cigarette packages and advertisements contain such a
combination graphic-textual warning.
    Proposed Sec.  1141.10 provided that the warnings required by this
section be obtained from two documents entitled ``Cigarette Required
Warnings--English and Spanish'' and ``Cigarette Required Warnings--
Other Foreign Language Advertisements.'' ``Cigarette Required
Warnings--English and Spanish'' was proposed to contain the required
warnings that must be included on all cigarette packages, and in
cigarette advertisements in which the text of the required warning must
be set forth in the English language or the Spanish language.
``Cigarette Required Warnings--Other Foreign Language Advertisements''
was proposed to contain the electronic files that were to be used to
generate the required warnings for advertisements in which the text of
the required warning must be set forth in a foreign language (other
than Spanish).
    The material that was proposed to be contained in the two documents
entitled ``Cigarette Required Warnings--English and Spanish'' and
``Cigarette Required Warnings--Other Foreign Language Advertisements''
is now contained in a single document entitled ``Cigarette Required
Warnings.'' We have provided this information in a single document
because each of the electronic files for use in advertisements
contained in ``Cigarette Required Warnings'' allows users to select an
English or Spanish textual warning statement or to remove the textual
warning statement and insert a true and accurate foreign language
(other than Spanish) translation of the warning statement into the
file. It is thus unnecessary to provide separate documents with
electronic files for English and Spanish language advertisements and
for advertisements in which the text of the required warning must be
set forth in a foreign language (other than Spanish). Section 1141.10
has been updated to reference this single document, ``Cigarette
Required Warnings,'' rather than the two proposed documents
(``Cigarette Required Warnings--English and Spanish'' and ``Cigarette
Required Warnings--Other Foreign Language Advertisements'').
    Section 1141.10(a) sets forth the requirement specific to cigarette
packages, explaining that the new required warning must comprise at
least the top 50 percent of the front and rear panels of the package,
except for cartons where the warnings shall comprise 50 percent of the
left side of the front and rear panels. This regulation implements
section 4(a)(2) of FCLAA and is in line with the provisions of the
Framework Convention on Tobacco Control (FCTC) (Ref. 60). Section
1141.10(a)(3) specifically provides that the ``required warning shall
appear directly on the package and shall be clearly visible underneath
the cellophane or other clear wrapping.'' Section 1141.10(b) sets forth
the requirements for advertisements, including the requirement that the
warnings comprise at least 20 percent of the area of the
advertisements. Section 1141.10(c) provides that the required warnings
shall be indelibly printed on or permanently affixed to the package or
advertisement. For the final rule, we have deleted the language from
Sec.  1141.10(a)(2) and (b)(3) that specified that the electronic
images must be adapted as necessary to meet the requirements of section
4 of FCLAA and part 1141. As explained in the NPRM (75 FR 69524 at
69536 through 69538), this language was used to indicate that regulated
entities should modify the size of the required warnings to ensure they
are the required size and occupy the required area of the cigarette
package or advertisement. However, Sec.  1141.10(a)(4) and (b)(5) set
forth the size and placement requirements for required warnings on
packages and advertisements, so this language in proposed Sec.
1141.10(a)(2) and (b)(3) was not necessary. In addition, Sec.
1141.10(a)(1) and (b)(1) make clear that the required warnings on
cigarette packages and in cigarette advertisements must be ``in
accordance with section 4 of the Federal Cigarette Labeling and
Advertising Act.''
    We also have made minimal changes to Sec.  1141.10(b)(4), which
used similar language. Specifically, proposed Sec.  1141.10(b)(4)
indicated that the required warnings for foreign language
advertisements (other than Spanish) must be adapted as necessary to
meet the requirements of section 4 of FCLAA and part 1141. For clarity,
we have modified this language to indicate that the textual warning
statement that is inserted into the electronic images must comply with
the requirements of section 4(b)(2) of FCLAA. As explained in the NPRM
(75 FR 69524 at 69538), proposed Sec.  1141.10(b)(4) would have
required regulated entities to obtain color graphics for foreign
language required warnings, other than Spanish language warnings, from
the electronic files contained in ``Cigarette Required Warnings--Other
Foreign Language Advertisements,'' and regulated entities would have to
insert a true and accurate foreign language translation of the textual
warning required by FCLAA into the electronic file to generate the
required warning (as explained previously, these electronic files are
now contained in the document entitled ``Cigarette Required
Warnings''). While the electronic file obtained from ``Cigarette
Required Warnings'' contains some of the elements required by FCLAA
(e.g., a rectangular border to enclose the required warnings and the
color graphic to accompany the label statement), the textual warning
statement that regulated entities insert into the electronic file in
accordance with Sec.  1141.10(b)(4) must comply with the requirements
of section 4(b)(2) of FCLAA. This section provides, among other things,
format specifications related to the textual warning statements in
cigarette advertising, including required type sizes and color
specifications (i.e., the text of the label statement shall be black if
the background is white and white if the background is black), and
requires that the statements appear in conspicuous and legible type.
    In addition, we wish to clarify our intent regarding whether the
same warning statement must appear on both the front and rear panels of
an individual cigarette package. We believe that section 4(a)(1) of
FCLAA is ambiguous as to whether it mandates the use of the same
required warning on both the front and rear panels of an individual
cigarette package or allows two different required warnings to be used,
one on the front panel and the other on the rear panel. We believe that
the latter interpretation is reasonable. It is consistent with
Congress' intent that all of the required warnings, each of which
conveys somewhat different health information, are required to be
displayed in the marketplace at the same time (see section 4(c)(1) and
(c)(3) of FCLAA). While it is possible that two copies of the same
statement on a single package might increase the likelihood of the
warning being noticed and remembered, we also note that different
statements on a single package could lead to greater consumer exposure
as well as delay the wear out of the required warnings. Proposed

Sec.  1141.10(a)(1), along with the description of this provision in
the preamble to the proposed rule (75 FR 69524 at 69536), however,
implied that the same required warning must appear on both the front
and the back of the package. Therefore, we are revising Sec.
1141.10(a)(1) to state, ``It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or import * * *
any cigarettes the package of which fails to bear * * * one of the
required warnings on the front and the rear panels.''
    We received comments regarding the format of required warnings on
packages and advertisements, the applicability of the requirements to
cigarette cartons, and the need for the warnings to remain clearly
visible and permanently affixed to packages. A summary of these
comments and our responses is provided in the following paragraphs.
    (Comment 140) Many comments, including those from health
institutions, nonprofit organizations, academics, and consumers, agreed
that the significant enhancements to the cigarette health warnings
required by Sec.  1141.10 will make them considerably more noticeable
and memorable than warnings that currently appear on cigarette packages
and in cigarette advertisements. However, many comments also noted that
the FCTC Article 11 Guidelines urge parties to cover as much of the
principal display areas as possible and that evidence suggests that
warnings larger than 50 percent of the principal display areas may be
even more effective (citing Ref. 41). The comments noted that
researchers also have found that smokers correlate the size of the
warning label to the importance of the message--the larger the message,
the greater magnitude of the risk (citing Ref. 61). Accordingly, these
comments requested that FDA consider increasing the size of the graphic
warnings such that they occupy more than 50 percent of the front and
rear panels of cigarette packages.
    (Response) We decline to revise the 50 percent area requirement at
this time. We have currently determined that this requirement is
sufficient to achieve our goals, and this requirement is consistent
with the specification set forth by Congress in section 4(a)(2) of
FCLAA.
    (Comment 141) A few comments expressed the belief that there was no
adequate justification for the amount of space mandated for the new
required warnings (i.e., 50 percent of the front and back panels of
packages and the top 20 percent of the area of advertisements). One
comment noted that Congress enacted the 50 percent requirement without
committee testimony or other fact-finding as to whether a smaller-sized
warning would be effective. The comments asserted that the current size
and placement of the warnings on cigarette packages and advertising
have contributed to ``complete awareness levels of the dangers of
cigarettes.''
    (Response) We disagree. As we stated in the preamble to the
proposed rule, our assessment of the literature and our experience as a
public health agency supports the requirement that the new warnings
comprise the top 50 percent of the area of each of the front and rear
panels of cigarette packages and the top 20 percent of the area of
cigarette advertisements in the United States (75 FR 69524 at 69533).
For example, researchers have found that larger graphic warnings are
likely to have the greatest impact and that ``larger (label) size means
higher visibility and better ability to compete with other package
elements'' (Ref. 40 at p. 30). Smokers are more likely to recall larger
warnings, and have been found to correlate the size of the warning with
the seriousness of the risk (Ref. 61). One Canadian study found that
smokers judged warnings that covered 80 percent of the package to be
most effective (Ref. 11). In a New Zealand study gauging responses to
different sized graphic health warnings (one sized 50 percent of the
front of the pack, and another sized 30 percent of the front of the
pack), participants strongly preferred the larger sized warning (Ref.
40 at p. 31). Participants felt that the larger sized warning was more
prominent, more likely to stand out from product branding, and that
some of the messages on the front of the pack remained visible when the
pack was open (Id. at p. 30). The 50 percent requirement also is
consistent with the FCTC (i.e., the required warnings should occupy 50
percent or more of the principal display areas of packages), which was
among the substantial evidence considered by Congress when enacting the
Tobacco Control Act (FCTC art. 11.1(b)). ``Congress also informed its
warning requirements by looking at the use of a nearly identical
warning requirement in Canada.'' Commonwealth Brands v. United States,
678 F. Supp. 2d 512, 531 (W.D. Ky. 2010), appeal pending sub nom.,
Discount Tobacco City & Lottery, Inc. v. United States, Nos. 10-5234 &
10-5235 (6th Cir.).
    In addition, as described more fully in section II.C of this
document, the existing warnings have not been effective in
communicating the health risks of smoking, resulting in significant
portions of the population that misunderstand or underestimate the
health risks of smoking. The new size and placement requirements are
needed to increase the salience of cigarette health warnings, which are
now considered ``invisible,'' in order to educate the public about the
health risks of smoking, which in turn, can positively impact smoking
intentions and behaviors (Ref. 3 at p. 291).
    (Comment 142) Some comments suggested that the regulation include a
font size requirement.
    (Response) We note that the proposal included a requirement related
to font size and this is retained in the final rule. The final rule
mandates that the required warnings be accurately reproduced from the
document incorporated by reference entitled ``Cigarette Required
Warnings.'' The required font style and font size already will be
included in the options within the downloadable files that allow the
user to select English and Spanish language warning statements.
    For advertisements in foreign languages other than Spanish,
companies must comply with the font size requirements in section
4(b)(2) of FCLAA and any format requirements included in the document
incorporated by reference (see section V.B.4 of this document). In all
situations, the textual statements must be conspicuous and legible as
required by section 4 of FCLAA.
    (Comment 143) One comment from an industry group took issue with
FDA's authority to require the new graphic warnings on cigarette
cartons, claiming that Congress' intent was to require the new graphic
warnings on individual cigarette packs only, not cartons. The submitter
recommended that FDA expressly exempt cartons from this requirement.
    (Response) We disagree with this comment. FCLAA defines the term
``package'' to mean a ``pack, box, carton, or container of any kind in
which cigarettes are offered for sale, sold, or otherwise distributed
to consumers.'' (section 3(4) of FCLAA (15 U.S.C. 1332(4)) (emphasis
added)). Similarly, section 900(13) of the FD&C Act defines the term
``package'' to mean a ``pack, box, carton, or container of any kind or,
if no other container, any wrapping (including cellophane), in which a
tobacco product is offered for sale, sold, or otherwise distributed to
consumers.'' (21 U.S.C. 387(13) (emphasis added)). Given these
definitions, it is clear that when Congress decided to require graphic
warnings that occupy 50 percent of the front and back panels of
cigarette ``packages,'' it intended for this requirement to apply to
both individual

packs and cartons. Therefore, Sec.  1141.10(a)(4) continues to mandate
that the required warnings must constitute 50 percent of the left side
of the front and rear panels of cigarette cartons.
    (Comment 144) One comment recommended that FDA require the nine new
textual warning statements, included in section 4(a) of FCLAA, to be
displayed in the same manner as the display of the existing warnings,
because that format has contributed to the public being fully informed
about the health risks of smoking.
    (Response) We disagree. First, as explained in section II.C of this
document, the public is not adequately informed about the health risks
of smoking and frequently underestimates those risks. Second, Congress
mandated that the format of the new health warnings change from the
small warning on the side panel of the pack, covering only 4 percent of
the pack, to health warnings that ``comprise the top 50 percent of the
front and rear panels of the package'' and ``at least 20 percent of the
area of the advertisement.'' (15 U.S.C. 1333(a)(2) and (b)(2)). This is
consistent with the FCTC (FCTC art. 11.1(b)). Therefore, we decline to
change the format of the required warnings from that included in the
proposed rule.
    (Comment 145) One comment suggested that the required warnings on
cigarette advertisements cover at least 50 percent of the
advertisement's principal surface and match the advertisement's primary
language.
    (Response) As stated in the preamble to the proposed rule and as
required by section 4 of FCLAA, Sec.  1141.10(b)(5) mandates that the
required warnings comprise at least the top 20 percent of the area of
the advertisement. Section 4 of FCLAA also requires that the warning
statement appear in conspicuous and legible type. At this time, we
conclude these requirements are sufficient to ensure that the required
warnings are appropriately clear, conspicuous, and legible by
consumers.
    Moreover, as stated in the preamble to the proposed rule and as
indicated in section IV.C of this document, while the textual portion
of the required warning in a cigarette advertisement must generally be
in English, if an advertisement is presented in a language other than
English, the textual portion of the required warning must be presented
in the language principally used in the advertisement (see Sec.
1141.10(b)(2)(ii)). Therefore, we have determined that modifications to
the codified text are not necessary.
    (Comment 146) Proposed Sec.  1141.10(a)(5) provided that the
``required warning shall be positioned such that the text of the
required warning and the other information on that panel of the package
have the same orientation.'' One comment expressed concern that this
provision could be problematic if a manufacturer places the brand name
and other information vertically on the front and/or back of the
cigarette package. The comment believed that this provision would
require the warning, or the text of the warning, to appear sideways on
the cigarette package.
    (Response) The intent of this provision is to ensure that the
textual statement in the required warning and other information on the
front and rear panels of the package have the same orientation. As
explained in the NPRM, this will in turn ensure that the warnings are
noticed and read by consumers that are reading the other information
found on the package (75 FR 69524 at 69537). Therefore, in the unusual
circumstance where a manufacturer chooses to place its brand name or
other information such that viewers do not read along the horizontal
axis (i.e., from left to right) to read this information, the
manufacturer must place the required warning in the same orientation.
    (Comment 147) Two comments suggested that the FDA require health
warnings on 100 percent of only the front or the rear panel of the
cigarette package.
    (Response) We disagree. First, section 4(a)(2) of FCLAA
specifically requires that the cigarette health warnings ``comprise the
top 50 percent of the front and rear panels of the package.'' Second,
Article 11 of the FCTC states that the health warnings ``should be 50%
or more of the principal display areas but shall be no less than 30% of