section.
    As explained in section III.A of this document, we considered the
comments submitted to the docket as we determined which color graphic
images to require to accompany the nine textual warning statements in
the final rule. We did not simply count the number of comments received
supporting or opposing the use of a particular image as a way to
measure the relative effectiveness of our proposed images or of images
recommended by comments, but rather evaluated the substantive input
contained in the comments to help inform our decisions in selecting or
not selecting a particular image and to obtain other relevant
information related to research on the images. Many of the comments
contained information about the submitter's personal opinions, beliefs,
and attitudes related to various images. While this information is
helpful in understanding how people might interpret various images and
in raising issues for further exploration, this type of qualitative
information is not as useful as quantitative assessments of the
relative effectiveness of the 36 proposed required warnings at
conveying information about the negative health consequences of
smoking, such as the assessment provided in FDA's research study.
    Furthermore, as described in more detail in the comment summaries
and responses in sections III.D and III.E of this document, some of the
information contained in comments that criticized or opposed the use of
various proposed images suggested that the images evoked negative
emotional reactions in the viewer. The research literature,

however, suggests that warnings that evoke these reactions can increase
the likelihood smokers will reduce their smoking, make an attempt to
quit, or quit altogether (Ref. 44).
1. Comments Submitting Research on FDA's Proposed Required Warnings
    We received several comments, including comments from academics, a
nonprofit organization, and a prevention specialist, that described the
results of scientific investigations that the submitters had conducted
to examine the potential effectiveness of FDA's proposed required
warnings on various outcomes. We address that research and our
responses to these comments in the comment summaries and responses in
this section. The information contained in these comments about
particular proposed required warnings is also discussed as applicable
in sections III.D and III.E of this document.
    As is discussed in the summaries in this section, the nine required
warnings we have selected for use on cigarette packages and in
cigarette advertisements generally performed well in the studies
discussed in these comments. These comments indicate that the findings
from our own research study are robust, as they have generally been
confirmed under the various different study designs utilized in the
research discussed in these comments.
    However, in contrast to our own research study, we did not have
access to the raw data or to all the statistical analyses for the
studies discussed in these comments. In addition, the design of some of
these studies did not allow for an assessment of the relative
effectiveness of FDA's 36 proposed required warnings. This limited the
utility of the information provided in the submissions.
    Thus, while we carefully considered the information provided in
these submissions, the results of our own study were more helpful in
making research-based selection choices.
    (Comment 44) One study was submitted by a group from a medical
institution and by a collaborating academic who has conducted research
on graphic health warnings. Participants were recruited from an
Internet panel of adults, young adults, and youth. The report for the
study states that it was intended to assess the potential effectiveness
of FDA's 36 proposed required warnings. Among other things,
participants were asked to provide certain demographic information as
well as information concerning their smoking status and attitudes and
beliefs about smoking. In addition, the study tested nine ``sets'' of
warnings, one for each of the textual warning statements required by
the Tobacco Control Act. Each set included each of the proposed
required warnings published with the proposed rule for use with the
specific textual warning statement as well as at least one alternative
warning. Each participant was randomly assigned to view and rate two
sets of health warnings.
    Warnings within each set were first rated individually on a scale
of 1 to 10 and then participants were asked to rank order the entire
set for perceived effectiveness for discouraging smoking. The comment
presented the rating and ranking scores for the health warnings. The
comment also presented preliminary statistical analyses for the overall
ranking scores; statistical data were not presented for individual
ratings for the individual measures assessed. The comment concludes
that preliminary results from the study show that warnings that were
more explicit about the health risks of smoking were rated as being
more effective among both adults and youth. The academic who conducted
the study similarly concluded that health warnings that were more
explicit and that elicited greater emotional reactions were rated as
being most effective, and the researcher recommended that FDA select
certain graphic warnings that received high rating and ranking scores
in the study (including required warnings proposed by FDA as well as
graphic warnings that have been used in other countries).
    (Response) The results of this study are generally consistent with
the results of the scientific literature and the study sponsored by
FDA. This study shows that the existing cigarette warnings are not
salient among either adults or youth. Among other responses, 50.3
percent of adults responded that they never or rarely noticed the
health warnings on cigarette packs, while 23.7 percent stated that they
often or very often noticed the warnings. Among youth, 63.3 percent
responded that they never or rarely noticed the health warnings on
cigarette packs, while 12.9 percent stated that they often or very
often noticed the warning. The graphic warnings selected for inclusion
in the final regulation generally performed relatively well in both
this study and in FDA's research study. It is difficult to assess the
results of this study more specifically without additional information
concerning the study protocol, methods, and statistical analyses.
    (Comment 45) A study was submitted by a researcher with expertise
in risk perceptions and decisionmaking. Participants were young adult
college students, including smokers, nonsmokers, and ``vulnerable''
nonsmokers. The study assessed emotional reactions, risk perceptions,
and smoking aversion. Participants were randomized into four
conditions, with each viewing 18 graphic warnings. Two conditions
viewed graphic warnings being used in other countries, one condition
viewed 18 graphic warnings published with the proposed rule, and the
fourth condition viewed the proposed FDA graphic warnings plus three
graphic warnings from other jurisdictions. According to the comment,
warnings ``that were perceived as more graphic, more intense, less
good, and more fearful produced more thoughts about not wanting to
smoke.'' The comment concludes that, compared to the viewed warnings
being used in other countries, the FDA proposed required warnings did
not maximize thoughts of health risk perceptions or smoking aversion,
although the differences between the warnings from other jurisdictions
and FDA's proposed required warnings were marginal.
    (Response) The nine required warnings that we have selected
performed relatively well in this study. Many performed as well as the
warnings from other jurisdictions and some performed better. It is
difficult to assess the results of this study more specifically,
however, without additional information concerning the study protocol,
methods, and statistical analyses.
    (Comment 46) A study was submitted by a group of behavioral
scientists whose research focuses on cognitive, emotional, and imagery
processes that influence how people respond to messages about health
risks. Their experimental study evaluated the 36 proposed required
warnings published with the proposed rule. Participants were young
adults ages 18 to 25, and included smokers and nonsmokers. Each
participant viewed 18 of the 36 proposed required warnings and was
asked to rate each on the following measures: Perceived comprehension,
worry about the health risks of smoking, and the extent to which the
warning discouraged the participant from wanting to smoke a cigarette.
The comment states that the study provides strong support that most of
the graphic warnings proposed by FDA are perceived by young adult
smokers as easy to understand, as enhancing worry about the health
risks of smoking, and as discouraging young adult smokers from wanting
to smoke. The comment states that the results of the study are
consistent with the growing body of

evidence showing that, compared to text-only warnings, graphic warnings
can evoke stronger emotional responses and reduce motivations to smoke.
    (Response) The nine required warnings that we have selected
performed relatively well in this study. It is difficult to assess the
results of this study more specifically without additional information
concerning the study protocol, methods, and statistical analyses.
    (Comment 47) A study was submitted by two researchers at a
university-based public policy center. The comment states that the
study, of young adult and adult smokers, was conducted to assess
limitations of the FDA study and to identify ways to increase the
impact of the warnings. The study used the same online survey firm as
that used in the FDA study, although respondents who participated in
the FDA study were not eligible to participate in this study. The study
was limited to four of the nine warning statements required by the
Tobacco Control Act. The graphic warnings assessed for each of these
four statements included some of the proposed FDA warnings, these same
proposed warnings with additional text or color added, and some graphic
warnings used in Canada. Graphic warnings were compared against a text-
only control warning that appeared on the side of a cigarette pack. The
study used two indices to assess efficacy. The first assessment was
perceived effectiveness in discouraging someone from smoking. For the
second assessment, participants were asked to imagine themselves
smoking a cigarette and then to report how good or bad they would feel
smoking a cigarette. The comment states that in three of the four
warning messages required by the Tobacco Control Act, a single exposure
to a large graphic warning was more effective in creating immediate
negative emotional associations with the act of smoking than exposure
to the text-only warning. The comment states that the study did not
show that the single exposure affected immediate plans to quit smoking;
the authors of the comment note that a brief test following a single
exposure is unlikely to detect this effect, and that they would expect
quit intentions to increase through repeated exposures to the warnings.
    (Response) The proposed required warnings published by FDA and
included in this study performed relatively well in this study. It is
difficult to assess the results of this study more specifically without
additional information concerning the study and the statistical
analyses.
    (Comment 48) An organization of high school students submitted the
results of a study they conducted to assess the efficacy of the 36
proposed required warnings published with the proposed rule.
Organization members recruited participants from their high schools and
communities. Each participant viewed 18 of the proposed required
warnings and was asked to rate each warning for perceived effectiveness
in stopping someone from smoking. Findings were reported as arithmetic
means and modes. The comment concludes that study respondents generally
believed that the most effective images were the more graphic images.
    (Response) We note that the nine required warnings we selected
generally rated highly in this study.
    (Comment 49) One comment contained the results of a study conducted
by two individuals among college students at a U.S. university. In this
study, 63 college students, apparently including both smokers and
nonsmokers, were shown the 36 proposed required warnings and asked to
rate them on a scale of 1 to 7 on their perceived effectiveness in
helping smokers' intent to quit. According to the comment, certain
demographic information also was obtained from participants. The
comment identifies the five proposed required warnings that were ranked
as being the most effective warnings and the five proposed required
warnings that were ranked as being the least effective. According to
the comment, demographic factors did not affect the rating scores. The
only factor identified as having an impact on rating was smoking
status, with participants who had a history of smoking more likely to
rate the graphic warnings as being effective than subjects who did not
have any history of smoking.
    In another comment, submitted by a self-identified prevention
specialist from a U.S. public school district, 1,339 high school
students viewed the 36 proposed required warnings and were asked
``which image would change your mind about smoking.'' The comment
identified the ``top three'' proposed required warnings.
    (Response) We note that the proposed required warnings chosen as
``most effective'' include some of the nine required warnings we
selected. Neither of these comments included sufficient information or
data with which to further assess the results or conclusions.
2. Other Comments
    FDA also received a number of other comments that discussed the
proposed required warnings generally or highlighted issues that applied
to some or all of the proposed required warnings. These comments are
summarized and responded to in the following paragraphs.
    (Comment 50) Many comments stated that graphic health warnings that
elicit strong emotional responses are most effective in communicating
the negative health consequences of smoking and in encouraging smoking
cessation and discouraging smoking initiation. Most of these comments
recommended that FDA select the warnings that evoke the strongest
emotional responses. Some of these comments cited graphic warnings used
in other countries or international research showing that images that
trigger emotional responses promote greater awareness and better
recollection of the health risks of smoking. Some of these comments
also stated that warnings that trigger these responses retain their
effectiveness longer. Some of these comments recommended that FDA
select graphic warnings that portray graphically disturbing images or
images that evoke fear or disgust.
    (Response) We agree that eliciting strong emotional responses helps
communicate health information. The overall body of scientific
literature indicates that health warnings that evoke strong emotional
reactions enhance an individual's ability to process the warning
information. This leads to increased knowledge and thoughts about the
health risks of smoking and the extent to which an individual could
personally experience a smoking-related disease, which can in turn
motivate positive behaviors. For example, the literature suggests that
risk information is most readily communicated by messages that arouse
emotional reactions (see Ref. 45), and that smokers who report greater
negative emotional reactions in response to cigarette warnings are
significantly more likely to have read and thought about the warnings
and more likely to reduce the amount they smoke and to quit or make an
attempt to quit (Ref. 44). The research literature also suggests that
warnings that generate an immediate emotional response from viewers
confer negative affect to smoking cues and undermine the appeal and
attractiveness of smoking (Ref. 45 and Ref. 40 at pp. 37-38). In FDA's
study, eight of the nine selected required warnings elicited strong
emotional reactions across all target audiences. As is further
discussed in section III.D of this document, the ninth selected
required warning, which, unlike the other eight required warnings,
contains a warning statement that is framed in a positive manner, also

showed significant effects on the emotional reaction scale in one study
population. Given the manner in which this ninth warning is framed, it
is not expected to arouse the same level of response on the emotional
reaction scale used in FDA's research study as the other eight warning
messages (see section III.D of this document).
    Some of the required warnings we selected include images that may
be more emotionally disturbing to certain individuals than others. As
we discussed in the preamble to the proposed rule, the use of health
warnings with disturbing tonal qualities appears to be effective (75 FR
69524 at 69534). But research also indicates that other types of
graphic images, including some that individuals do not find frightening
or disturbing, can also be effective in communicating the health risks
of smoking (Id.). The set of nine graphic warnings we selected includes
a balanced set of images in order to reach the broadest target audience
of smokers and potential smokers.
    (Comment 51) Some comments raised concerns about the quality of the
proposed required warnings published by FDA. Some believed that the
proposed required warnings were weaker than those used in other
countries, and thus, would be less impactful than those in use in other
countries. A few comments said the images were overdone and insulting,
and a few indicated that the submitters believed that the visuals were
poorly crafted.
    (Response) We disagree with these comments. We have chosen a
balanced set of images for use with the required warnings, and these
warnings are generally consistent with the graphic health warnings used
in other countries. The results from our research study and the overall
body of scientific literature on graphic warnings provide a strong
basis for concluding that the nine selected required warnings will
effectively communicate the negative health risks of smoking to smokers
and potential smokers.
    (Comment 52) Some comments raised concerns that the proposed
required warnings were too explicit and too visually disturbing. Some
of these comments raised concerns that the images were too disturbing
for children to see, and others indicated that nonsmokers should not
have to be subjected to ``gross'' images when they go into retail
establishments. Two comments raised concerns that images that showed
humans in distress or human remains were disrespectful and degrading.
One comment stated that the proposed warnings crossed the line and were
an effort to manipulate people to stop smoking or not to start.
    (Response) We disagree. The set of nine required warnings we
selected include a balanced set of images. Some individuals may find
certain images more visually disturbing than others. The images are not
intended to shock or disturb, but rather to effectively educate and
inform smokers and potential smokers about the serious health
consequences of smoking. Each of the nine graphic warnings communicates
negative health consequences of smoking that are well-documented in the
scientific literature. By appropriately conveying the serious health
consequences in a truthful, forthright manner, the images contain
information that may disturb some viewers because the severe, life-
threatening and sometimes disfiguring health effects of smoking are
disturbing. The overall body of scientific evidence indicates that
larger, graphic health warnings will effectively communicate these
risks. We do not agree that these warnings are disrespectful or
degrading.
    (Comment 53) A number of comments advocated for the selection of a
set of images that could communicate with the diverse U.S. population,
and emphasized the importance of human diversity in the images, in part
to help ensure the images reach people of low socioeconomic status that
are more likely to be smokers and/or to have lower literacy. The
comments stated that graphic health warnings are an especially
important communication tool for these population groups. A few
comments also raised concerns that not enough of the 36 proposed
required warnings depicted younger people, and indicated this could
reduce their impact among youth.
    (Response) We agree that it is important to select a set of images
that can communicate with the diverse U.S. population. As discussed in
section III.A of this document, we considered the need for diversity
when making image selections, and the images selected include a
diversity of human images (e.g., race, gender, age), as well as a
diversity of styles (e.g., photographic versus illustrative) and
themes. This is consistent with the evidence base for graphic health
warnings from countries that have already implemented such warnings
(see Ref. 40 at p. 46 and Ref. 11).
    (Comment 54) A number of comments raised concerns that some of the
proposed graphic warnings included graphic illustration or ``cartoon-
style'' images. Some of these comments stated that these warnings might
trivialize the serious health risks of smoking or diminish the
importance of the warnings, with some asserting that this style is
contradictory to the serious messages being conveyed. One comment
believed that these warnings would soften the message, while another
believed the graphic illustration warnings were ``harsh.'' Some
comments stated that these warnings would negatively affect the
believability of the warnings and would not be taken seriously by
youth. One comment expressed concern that the graphic illustration
style images might resonate with youth, but would not be effective with
young adults or adults. It was also noted in the comments that the
images presented in this style may inadvertently suggest approval of
tobacco use to low-literacy populations that do not comprehend the
accompanying textual statement, and that these images could allow
smokers to deny the health consequences that are presented. Another
comment stated that the research suggests ``cartoon-style'' images and
overly conceptual images are easily dismissed by smokers.
    (Response) We disagree with the contention that the use of graphic
illustration style images is categorically inappropriate. One of the
required warnings we selected is presented in this style. As discussed
in section III.B of this document, our research study shows that the
selected required warnings, including the required warning that
includes a graphic illustration style image, showed strong effects in
terms of emotional reaction scale, cognitive reaction scale (including
believability), and the ``difficult to look at'' measure. Given these
results, we concluded that the graphic illustration style can be an
effective style for communicating the negative health risks of smoking,
including to a diverse range of viewers. In addition, it is important
to include a variety of different styles in the final set of warnings.
As discussed in the preamble to the proposed rule, a varied set of
warnings is consistent with the scientific literature, facilitates
better targeting of specific groups whose interests may vary, and has
been shown to be effective in delaying or counteracting wear out of the
warnings (75 FR 69524 at 69534).
    (Comment 55) A number of comments advocated that FDA select only
required warnings with photographic images. Some of these comments
stated that the use of photographic images was important to
realistically portray the negative health consequences of smoking and
to provide a real-life quality to the warnings. One comment stated that
photographic images were needed to ensure that smokers and

potential smokers understood that the depicted health consequence could
really happen and to provide a more physical connection. One comment
stated that photographic images would be more engaging and remembered
than images presented in other styles. One comment stated that warnings
with abstract imagery that require individuals to ``connect the dots''
and draw inferences present an unnecessary and counterproductive hurdle
for viewers, and are unlikely to have an effect on smokers.
    (Response) We agree that graphic warnings with photographic images
can effectively communicate the negative health consequences of
smoking, and most of the required warnings we selected include
photographic images. The existing scientific literature, the experience
of other countries, and the results of our research study show that
graphic warnings using photographic images can effectively communicate
the negative health consequences of smoking. At the same time, we do
not agree that photographic images are the only style of imagery
capable of effectively communicating these health risks. A balanced set
of warnings with a variety of image styles is more likely to
effectively reach a broad group of target audiences, and we note that
graphic warnings used in many other countries include a mix of imagery,
including photographic and other styles.
    (Comment 56) Some comments stated that graphic warnings will not be
effective in deterring smoking. One comment stated that smokers already
know the health risks of smoking and are very brand loyal, so graphic
images will not affect their smoking decisions. Another comment stated
that youth will not be deterred by pictures and the graphic warnings
could instead make smoking more enticing to youth. One comment stated
that smokers are addicted to cigarettes and ``flashy'' pictures will
not stop them from smoking but instead will only encourage them to
cover the pictures. On the other hand, other comments concluded that
graphic health warnings are likely to affect smoking decisions. One
comment stated that graphic warnings will deter initiation, and another
stated that the warnings will lead to a decrease in cigarette sales.
One comment stated that graphic warnings will reach people who
otherwise would not read text-only warnings.
    (Response) As previously discussed, we concluded that large graphic
warnings are effective in conveying the health risks of smoking,
influencing consumer awareness and knowledge of those risks and having
an impact on smoking intentions. We disagree with comments stating that
required warnings will not be effective. We have determined that the
set of required warnings we have selected will effectively convey the
negative health consequences of smoking, which will help discourage
nonsmokers, including children and adolescents, from starting to smoke
cigarettes, and help encourage current smokers to consider cessation to
greatly reduce the serious risks that smoking poses to their health.
    (Comment 57) Several comments stated that images that depict
realistic suffering caused by tobacco use are more effective in
promoting cessation than images that portray death.
    (Response) We agree that graphic warnings that depict the realistic
suffering caused by tobacco use can be effective at communicating the
negative health consequences of smoking, and some of the required
warnings we selected include such images. At the same time, we do not
agree that such images are the only images capable of effectively
communicating the negative health consequences of smoking. A balanced
set of warnings with a variety of image themes is most likely to
maximize the effectiveness of the selected required warnings among a
broad group of target audiences, and notes that graphic warnings used
in many other countries include a mix of imagery. As discussed in the
preamble to the proposed rule, the existing research indicates that the
use of a variety of health warnings broadens the reach of the warnings,
and is effective in counteracting overexposure and delaying wear out of
the warnings (75 FR 69524 at 69534).
    (Comment 58) One comment stated that most of the proposed images
are illustrations rather than graphic warnings, in that they are
meaningful only to people who are already aware of the information in
the accompanying textual warning.
    (Response) Consistent with the requirements of section 201 of the
Tobacco Control Act, we have developed color graphic images that depict
the negative health consequences of smoking to accompany the nine new
warning statements provided by Congress in the Tobacco Control Act. The
graphic health warnings, referred to as ``required warnings'' in the
NPRM and in this final rule, consist of the combination of each textual
warning statement and the accompanying color graphic image we selected
for use with each statement. The submitter of this comment seems to
misunderstand how the images are to be used; they were not developed to
serve as stand-alone warning messages, but rather to accompany textual
warning statements. Although we disagree with the contention in this
comment that the images are only meaningful in conjunction with the
information in the accompanying textual warning, the images are
required to be presented at all times with this accompanying
information.

D. Selected Images

    This section discusses the nine color graphic images that we
selected for use with the textual warning statements set forth in
section 201 of the Tobacco Control Act and the factors that influenced
each selection decision, including the results from our research study,
the substantive comments received in the docket, the relevant
scientific literature, and any other considerations weighed, such as
the diversity a particular image contributes to the overall set of
required warnings.
    The document entitled ``Proposed Required Warning Images'' that was
included in the docket for the proposed rule displayed each of the 36
proposed required warnings (consisting of the proposed images and
accompanying warning statements) on two consecutive pages, with one
display showing the warning statement accompanying the image in black
text on a white background and one display showing it in white text on
a black background. The images are referred to in this section by the
pages on which they appear in the ``Proposed Required Warning Images''
document and by the descriptive names used for each image in the study
report (Ref. 49) summarizing the results of our research study.
    In this section's discussion of the results from our research study
for each selected image, the endpoints that the images showed a
statistically significant effect on in one or more of the study
populations (adult smokers aged 25 or older, young adult smokers aged
18 to 24, and youth who currently smoke or who are susceptible to
smoking aged 13 to 17) are described. This discussion also notes the
level of significance of the effects by providing p-values: (p<0.05),
(p<0.01), and (p<0.001). The p-value is reflective of the percent
chance the finding could have happened by coincidence. For example, for
a finding that is significant at 0.1 percent (p<0.001), there is less
than one chance in a thousand that the finding happened by coincidence.
The full description of our research study and the analyses are
contained in the study report (Ref. 49, study report) that was placed
in the docket for the proposed rule.

    The required warnings, consisting of the nine color graphic images
we selected and the textual warning statements, are contained in a
document titled ``Cigarette Required Warnings,'' as is further
discussed in section V of this document.
1. ``WARNING: Cigarettes are Addictive''
    We selected the image which appears on pages one and two of the
document ``Proposed Required Warning Images,'' referred to as ``hole in
throat,'' for use with this warning statement.
    In our research study, this image had a significant effect
(p<0.001) on all salience measures (emotional reaction scale, cognitive
reaction scale, and difficult to look at measure) in all three study
populations (adults, young adults, and youth). The image had the
numerically largest effects of the images proposed for use with this
warning statement on the emotional reaction scale and the difficult to
look at measure in all three study populations, as well as on the
cognitive reaction scale in adults. As discussed in section III.B of
this document, these salience impacts are important, as the research
literature suggests that they are likely to be related to behavior
change.
    The image also had a significant impact (p<0.05) on adult \4\
beliefs about the health risks of smoking for smokers, and a
significant impact (p<0.05) on adult beliefs about the health risks of
secondhand smoke exposure for nonsmokers, relative to the text-only
control.
---------------------------------------------------------------------------

    \4\ Throughout this section, the results on individual study
measures discussed for the adult study population are results from
the adult sample viewing the hypothetical cigarette package (as
opposed to the sample viewing the hypothetical advertisement),
unless otherwise noted.
---------------------------------------------------------------------------

    However, young adults viewing the image had significantly lower
statement recall at one week follow-up than those who viewed the text-
only control (55.9 percent versus 74.3 percent), as did adults viewing
a hypothetical advertisement containing the proposed required warning
(64.1 percent versus 87.7 percent). However, recall of the statement
was generally high for the image (ranging from 55.9 percent to 86.3
percent), even where it was significantly lower than for the text-only
control, and we conclude that repetitive viewing of the required
warning is likely to increase recall. As explained in section III.C of
this document, we gave greater weight to outcomes on the salience
measures than to outcomes on the recall measures.
    We received a number of comments on this image, which we have
summarized and responded to in the following paragraphs.
    (Comment 59) FDA received a large number of comments supporting the
use of the image ``hole in throat,'' including comments from
individuals (including former smokers), public health advocacy groups,
academics, State and local public health agencies, and health care
professionals. Many comments stated that this image is the best image
for use with this warning statement. Some comments indicated that the
image was appropriately compelling and effectively communicates the
risks of smoking. Other comments stated that the image will be an
effective deterrent to smoking by making a smoker think twice before
buying cigarettes and/or by making children think twice before starting
to smoke. Several comments also indicated that the image concretely
conveys the health harms of smoking.
    (Response) We selected this image for use with this warning
statement.
    (Comment 60) One comment supported use of this image in part
because of the diversity reflected in the image, and noted that it
could be a Latino smoker or a man of color, which could make it more
relevant than other proposed images with low socioeconomic status
smokers. Another comment noted that the image targets a critical
demographic group by portraying an image of a man.
    (Response) We agree that it is beneficial to have a diverse set of
images that communicates with a wide range of audiences, including
population subgroups with higher smoking prevalence rates. In light of
this, we selected a set of nine required warnings (including the image
``hole in throat,'' which portrays a man of color) that includes a
variety of human images that are broadly representative of the overall
population.
    (Comment 61) As mentioned in section III.C of this document, some
comments submitted to the docket described the results of scientific
investigations that the submitters had conducted to examine the
potential effectiveness of FDA's proposed images on various outcomes.
This image was discussed in some of these comments. For example, 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 concluded that this image was the most effective of the
images proposed for use with this warning statement. Additionally, this
image was one of two images deemed effective in another submitter's
survey of comparative effectiveness of the 36 proposed required
warnings at stopping someone from smoking, and it received the highest
overall rating of the images examined for use with this statement in
another submitter's study of the potential effectiveness of the images.
    (Response) As discussed in section III.C of this document, we
carefully considered the comments submitted to the docket that
described the results of studies conducted by the submitters on our
proposed required warnings. The results summarized in these comments
are generally supportive of our image selection decisions.
    (Comment 62) FDA also received some comments that opposed the use
of the image ``hole in throat.'' One comment noted that the image was
``too gross to be effective,'' while another comment stated that it
``offend[s] against human dignity.'' In addition, one comment stated
that the image would only have a one-time shock value, and another
comment indicated that the image was too vague in nature.
    (Response) We disagree with these comments. The image effectively
and concretely communicates the negative health consequences of
smoking. The image clearly portrays the addictive nature of cigarettes,
depicting a man who is still smoking despite prior evidence (a stoma in
his neck) of surgery for cancer. As discussed, this image had a highly
significant effect (p<0.001) on all salience measures (emotional
reaction scale, cognitive reaction scale, and difficult to look at
measure) in all three study populations (adults, young adults, and
youth). The research literature indicates that images that evoke
emotional reactions can promote greater awareness and better
recollection of the health risks of smoking, and can increase the
likelihood smokers will reduce their smoking, make an attempt to quit,
or quit altogether (Ref. 20, 44, and 45).
    Furthermore, contrary to the assertion that the image will only
have a one-time shock value, the research literature suggests that more
vivid warnings are more likely to retain their salience over time (Ref.
3 at p. C-4 and Ref. 41).
2. ``WARNING: Tobacco Smoke Can Harm Your Children''
    We selected the image which appears on pages 9 and 10 of the
document ``Proposed Required Warning Images,'' referred to as ``smoke
approaching baby,'' for use with this warning statement.
    In our research study, this image had a significant effect
(p<0.001) on all the salience measures (emotional reaction scale,
cognitive reaction scale, and

difficult to look at measure) in the adult and youth samples. In young
adults, the image also had a significant effect on all the salience
measures (emotional reaction scale (p<0.01), cognitive reaction scale
(p<0.001), and difficult to look at measure (p<0.05)).
    The image had a significant effect (p<0.05) on recall of the
warning statement at baseline compared to the control for adults and
youth. The image also had a significant effect (p<0.05) on statement
recall at 1 week follow-up in young adults. The image also showed some
of the largest effect sizes for image recall (at baseline and at 1 week
follow-up) in adults and young adults across the images proposed for
use with this warning statement.
    The image had a statistically significant effect (p<0.05) on youth
intentions to not smoke in the next year, with 71.6 percent of youth
viewing the image reporting that they would not be likely to smoke in
the next year compared to 56.9 percent of youth viewing the text-only
control.
    As is discussed in further detail in section III.E of this
document, three other images proposed for use with this warning
statement, ``smoke at toddler,'' ``girl crying,'' and ``girl in oxygen
mask,'' also 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). While several of the images proposed for use with this
warning statement could effectively convey the negative health
consequences of tobacco smoke exposure for nonsmokers (and in
particular, children), we ultimately considered ``smoke approaching
baby'' to have the strongest overall research results of the images
proposed for use with this warning statement for multiple reasons.
    First, two of the images that also showed significant effects on
all the salience measures across the study populations, ``girl crying''
and ``girl in oxygen mask,'' were negatively associated with beliefs
about the health risks of secondhand smoke exposure for nonsmokers in
the adult sample. In other words, adults who viewed these images were
less likely to believe that nonsmokers will suffer from negative health
effects related to secondhand smoke exposure than adults who viewed the
text-only control.
    As described in section III.B of this document, we determined that
the salience results from our research study are the most meaningful
basis for making distinctions among the images given the design
limitations of the research study, which exposed each participant to
each image only once, and thus may not be able to accurately
distinguish the relative effects of the images on more eventual
outcomes, such as changes in beliefs, as reliably as their effects on
more immediate emotional and cognitive reactions. However, the negative
results observed on the secondhand smoke beliefs measure for the images
``girl crying'' and ``girl in oxygen mask'' were of concern,
particularly given that the subject of the warning statement is the
health risks of secondhand smoke exposure for children. Thus, ``smoke
approaching baby'' was considered a preferable alternative to these two
images.
    Furthermore, ``smoke approaching baby'' was associated with youth
reporting that they would be less likely to be smoking 1 year from now.
    We received a number of comments on this image, which we have
summarized and responded to in the following paragraphs.
    (Comment 63) FDA received several comments supporting the use of
the image ``smoke approaching baby,'' including comments from
individuals, a public health advocacy group, and State and local public
health agencies. Some of these comments indicated that this image is
the best image of the ones proposed for use with this warning
statement. One comment stated that the image will clearly inform
parents that when they smoke in the presence of their children, their
children will also be inhaling toxins, and another comment noted that
the image realistically shows secondhand smoke exposure and health
effects. Some comments noted that the image will deter smoking, with
one comment noting that the depiction of an innocent baby will resonate
with parents and cause them to think about their children's health
before smoking.
    (Response) We selected this image for use with this warning
statement.
    (Comment 64) FDA also received some comments expressing support for
the diversity reflected in the image. One comment stated that the image
will appeal to different age and other demographic groups, while
another comment noted that the child in the image could be African-
American, Hispanic, Latino, Native American, and/or Native Hawaiian or
Pacific Islander, and suggested that the image could resonate with a
variety of important population subgroups. The comment also noted that
Latino parents say the health of their children is a motivating factor
in their decision to quit smoking.
    (Response) It is important to have a diverse set of images that
communicate with a wide range of audiences, including a variety of
population subgroups. In order to ensure that the final set of required
warnings effectively communicates risk information to a diverse range
of audiences, we selected a set of nine required warnings, including
the image ``smoke approaching baby,'' that includes a variety of human
images that are broadly representative of the overall population.
    (Comment 65) As mentioned in section III.C of this document, some
comments submitted to the docket described the results of scientific
investigations that the submitters had conducted to examine the
potential effectiveness of FDA's proposed images on various outcomes.
This image was discussed in some of these comments. For example, it was
rated highly on its ease of comprehension and induced relatively
greater worry and feelings of discouragement from wanting to smoke than
a text-only control in one submitter's study.
    (Response) As discussed in section III.C of this document, we
carefully considered the comments submitted to the docket that
described the results of studies conducted by the submitters on our
proposed required warnings. The results summarized in these comments
are generally supportive of our image selection decisions.
    (Comment 66) FDA also received some comments critical of the image
``smoke approaching baby.'' These comments suggested that the child
does not appear to be suffering harms to his health and/or looks too
healthy. One of these comments also stated that the image was
associated with youth reporting that they would be more likely to be
smoking 1 year from now, and advised against its use.
    (Response) We do not agree that the image does not depict the
health hazards of secondhand smoke. Graphic depictions of the visible
effects of disease are not the only way of communicating the health
risks of secondhand smoke for children (see Ref. 11), some of which
(such as impaired lung growth), are not necessarily externally visible
in a photograph of a child exposed to secondhand smoke. Furthermore, it
is important to keep in mind that the image is not used in isolation,
but accompanies the textual warning statement, which provides
additional context for what is shown. As evidenced by the significant
effects the image had on the salience measures compared to the text-
only control across the populations participating in FDA's research
study, the required warning depicts the health consequences of

secondhand smoke exposure in a manner that has an impact on both
smokers and potential smokers. Thus, we conclude that the required
warning effectively conveys the message that exposure to tobacco smoke
is harmful for children.
    We also note that the comment stating that the image was associated
with youth reporting that they would be more likely to be smoking 1
year from now is incorrect. In fact, the image had a statistically
significant effect on decreasing youth intentions to smoke (see Ref. 49
at p. 4-4; see also Ref. 50). As stated previously, 71.6 percent of
youth viewing this image reported that they would not be likely to
smoke in the next year, compared to 56.9 percent of youth viewing the
text-only control.
3. ``WARNING: Cigarettes Cause Fatal Lung Disease''
    We selected the image which appears on pages 25 and 26 of the
document ``Proposed Required Warning Images,'' referred to as
``healthy/diseased lungs,'' for use with this warning statement.
    In our research study, this image had a significant effect
(p<0.001) 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). The image
had the numerically largest effects of the images proposed for use with
this warning statement on the salience measures. As discussed in
section III.B of this document, these salience impacts are important,
as the research literature suggests that they are likely to be related
to behavior change.
    The image also showed some of the largest effect sizes for image
recall (at baseline and at 1 week follow-up) in adults and youth across
the images proposed for use with this warning statement.
    We received a number of comments on this image, which we have
summarized and responded to in the following paragraphs.
    (Comment 67) FDA received a large number of comments supporting the
use of the image ``healthy/diseased lungs,'' including comments from
individuals, public health advocacy groups, medical organizations,
academics, State and local public health agencies, and health care
professionals. Many comments indicated that this image is the best
image for use with this warning statement, with one stating that the
image dramatically depicts a health consequence of smoking, and another
noting that it was appropriately gripping and compelling.
    Several comments noted that, based on FDA's research results, this
image is the clear choice among the four images proposed by FDA for use
with this warning statement. Some comments noted that similar images
have been used effectively in other countries that require graphic
health warnings on cigarette packages. One comment noted that this
image could reach a younger audience, and hopefully prevent them from
starting to smoke.
    (Response) We selected this image for use with this warning
statement.
    (Comment 68) As mentioned in section III.C of this document, some
comments submitted to the docket described the results of scientific
investigations that the submitters had conducted to examine the
potential effectiveness of FDA's proposed images on various outcomes.
This image was discussed in some of these comments. For example, 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 concluded that this image was the most effective of the
images proposed for use with this warning statement. Another comment
also submitted research suggesting that this image was the highest
rated for potential effectiveness among the set of images proposed for
use with this warning statement. Another submitter showed that, in a
survey, respondents rated this image as one of the most effective of
the 36 proposed images for encouraging smokers to quit smoking. The
image was also identified in a survey of high school students as one of
the ``top three'' proposed required warnings (out of 36) in another
submitter's study.
    (Response) As discussed in section III.C of this document, we
carefully considered the comments submitted to the docket that
described the results of studies conducted by the submitters on our
proposed required warnings. The results summarized in these comments
are generally supportive of our image selection decisions.
    (Comment 69) FDA also received some comments critical of the image
``healthy/diseased lungs.'' One comment noted that the image was ``too
gross to be effective,'' while several comments expressed the opposite
belief, with some suggesting that the diseased pair of lungs should be
more damaged.
    (Response) The image ``healthy/diseased lungs'' is an appropriate
image that effectively conveys the negative health consequences of
smoking. While, as reflected in the above summary, some comments
expressed a belief that the image of the diseased lung is ``too gross''
and some expressed a belief that the image is too healthy in
appearance, the image effectively evoked emotional and cognitive
reactions in viewers in FDA's research study, which in turn suggests
that the image has the potential to promote greater awareness of the
health risks of smoking and motivate positive behavioral outcomes,
including an increased likelihood that smokers will reduce their
smoking, make an attempt to quit, or quit altogether (Refs. 20, 44, and
45).
4. ``WARNING: Cigarettes Cause Cancer''
    We selected the image which appears on pages 33 and 34 of the
document ``Proposed Required Warning Images,'' referred to as
``cancerous lesion on lip,'' for use with this warning statement.
    In our research study, this image had a significant effect
(p<0.001) 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). The image
had the numerically largest effects of the images proposed for use with
this warning statement on the emotional reaction scale and had the
numerically largest effects on the cognitive reaction scale in young
adults and youth. As discussed in section III.B of this document, these
salience impacts are important, as the research literature suggests
that they are related to behavior change.
    The image also had a significant impact (p<0.05) on beliefs about
the health risks of smoking for smokers, and a significant impact
(p<0.01) on beliefs about the health risks of secondhand smoke exposure
for nonsmokers relative to the text-only control in the adult sample
that viewed a hypothetical advertisement containing the proposed
required warning.
    The image also showed some of the largest effect sizes for image
recall (at baseline and 1 week follow-up) in adults and youth across
the images proposed for use with this warning statement, though it
showed lower correct recall of the warning statement compared to the
control in adults at 1 week follow-up (68.3 percent versus 85.1
percent). However, recall of the statement was generally high at 1 week
follow-up among study participants who viewed this image (ranging from
68.3 percent to 77 percent), and, based on the scientific literature,
we conclude that repetitive viewing of the required warning is likely
to increase recall. As explained in section III.C of this document, we
gave greater weight to

outcomes on the salience measures than to outcomes on the recall
measures.
    As is discussed in further detail in section III.E of this
document, another image proposed for use with this warning statement,
``deathly ill woman,'' also had significant effects on all the salience
measures (emotional reaction scale, cognitive reaction scale, and
difficult to look at measure) in all three samples (adults, young
adults, and youth). While we agree that this image, similar to the
selected image of ``cancerous lesion on lip,'' is a very strong image
that effectively conveys the negative health consequences of smoking,
we ultimately chose ``cancerous lesion on lip'' for use with this
warning statement for several reasons.
    First, ``cancerous lesion on lip'' was the only image among the
images proposed for use with this warning statement that had a positive
impact on beliefs about the health risks of smoking and secondhand
smoke exposure in one of the study samples (adults viewing a
hypothetical advertisement).
    Furthermore, as is stated in several comments (see the following
paragraphs), the selected image, ``cancerous lesion on lip,'' is likely
to have particular relevance for youth. As explained in some of these
comments, the research literature suggests that youth are likely to
relate to and be susceptible to cigarette warnings depicting the
negative short-term impacts of smoking on their personal appearance,
including their lips and teeth (Ref. 53).
    We received a number of comments on this image, which we have
summarized and responded to in the following paragraphs.
    (Comment 70) FDA received a large number of comments supporting the
use of the image ``cancerous lesion on lip,'' including comments from
individuals, public health advocacy groups, a medical organization,
academics, State and local public health agencies, and health care
professionals. Several comments suggested that FDA should use this
image because it has a very high potential to reach consumers and
positively influence their behavior.
    A few comments also specifically addressed the benefits of using an
image that shows the public that cigarettes cause oral cancers, noting
that public awareness of this negative health consequence is low, and
that many smokers and nonsmokers only relate cigarettes to lung cancer
(see also section II.C of this document regarding consumers' lack of
knowledge regarding the health risks of smoking).
    Multiple comments also noted that, based on FDA's research results,
this image was the best choice among the four images proposed for use
with this warning statement, significantly outperforming ``white
cigarette burning'' and ``red cigarette burning,'' and slightly
outperforming ``deathly ill woman.''
    (Response) We selected this image for use with this warning
statement.
    (Comment 71) Several comments noted that the image could be
especially effective with younger audiences and could positively
influence such audiences by illustrating how the health effects caused
by smoking negatively affect their physical appearance. The comments
indicated that adolescents can relate to and will be susceptible to
this message.
    (Response) We agree with these comments. It is important to include
content in the required warnings that is relevant to youth. The image
``cancerous lesion on lip'' has the potential to positively impact
youth behavior, in addition to adult and young adult behavior.
    (Comment 72) As mentioned in section III.C of this document, some
comments submitted to the docket described the results of scientific
investigations that the submitters had conducted to examine the
potential effectiveness of FDA's proposed images on various outcomes.
This image was discussed in some of these comments. For example, 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 concluded that this image, along with ``deathly ill woman,''
was one of the most effective of the images proposed for use with this
warning statement. In addition, this image was rated as the most
effective of the 36 proposed images in another submitter's survey of
comparative effectiveness of the images in helping smokers quit. It was
also the highest rated image among the set of images proposed by FDA
for use with this warning statement in another submitter's study of the
potential effectiveness of the images, and was identified by high
school students as one of the ``top three'' proposed required warnings
(out of 36) in another submitter's study.
    (Response) As discussed in section III.C of this document, we
carefully considered the comments submitted to the docket that
described the results of studies conducted by the submitters on our
proposed required warnings. The results summarized in these comments
are generally supportive of our image selection decisions.
    (Comment 73) FDA also received some comments critical of the image
``cancerous lesion on lip.'' Two comments indicated that the image was
``too gross'' to be effective, while another comment stated that it
borders on the offensive. In contrast, some comments suggested that the
image should be more graphic. Another comment suggested that oral
cancer was an odd choice of cancers to depict in the graphic warning.
    (Response) We disagree with these comments. With respect to the
comments stating that the image was ``too gross'' or that it was
offensive, the research literature indicates that images that evoke
strong emotional reactions can promote greater awareness and better
recollection of the health risks of smoking and can increase the
likelihood smokers will reduce their smoking, make an attempt to quit,
or quit altogether (Refs. 20, 44, and 45).
    With respect to the suggestion that the image is not graphic
enough, as discussed previously, this image had a highly significant
effect (p<0.001) 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), which in
turn suggests that the image has the potential to motivate positive
behavior change (Id.).
    Furthermore, the choice of cancers depicted in the required warning
is appropriate, and will help inform the public that cigarettes cause
oral cancers, and thus increase public awareness of the negative health
consequences of smoking.
5. ``WARNING: Cigarettes Cause Strokes and Heart Disease''
    We selected the image which appears on pages 39 and 40 of the
document ``Proposed Required Warning Images,'' referred to as ``oxygen
mask on man's face,'' for use with this warning statement.
    In our research study, this image had a significant effect
(p<0.001) 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). The image
had the numerically largest effects of the images proposed for use with
this warning statement on the emotional reaction scale and the
difficult to look at measure in all the study populations. These
impacts are important, as the research literature suggests that graphic
warnings that evoke responses of this kind are

likely to increase awareness of the health risks of smoking and
increase the likelihood that smokers will reduce their smoking, make an
attempt to quit, or quit altogether (Refs. 20, 44, and 45).
    The image also showed some of the largest effect sizes for image
recall (at baseline and 1 week follow-up) in adults and youth across
the images proposed for use with this warning statement.
    We received a number of comments on this image, which we have
summarized and responded to in the following paragraphs.
    (Comment 74) FDA received a large number of comments supporting the
use of the image ``oxygen mask on man's face,'' including comments from
individuals, medical organizations, public health advocacy groups,
health care professionals, State public health agencies, and academics.
Many of these comments indicated that this image is the best image for
use with this warning statement, while some also noted that the image
will make smokers think twice about continuing to smoke. Some comments
also noted that the image is beneficial in that it will inform the
public of negative consequences of smoking aside from lung disease.
    Some comments also noted that, based on FDA's research results,
this image was the best choice for use with this warning statement,
noting that it elicited the highest scores on the emotional reaction
scale of the images tested for use with this statement in FDA's
research study.
    (Response) We selected this image for use with this warning
statement.
    (Comment 75) As described in section III.C of this document, some
comments submitted to the docket described the results of scientific
investigations that the submitters had conducted to examine the
potential effectiveness of FDA's proposed images on various outcomes.
This image was discussed in some of these comments. For example, 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 concluded that this image was the most effective of the
images proposed for use with this warning statement. In another
submitter's study, this image was the highest-rated of the FDA-proposed
images for use with this warning statement; however, this study also
evaluated two images used with similar warning statements in other
countries (one of open heart surgery, one of a bloody brain), and noted
that they rated higher than FDA's proposed images.
    (Response) As discussed in section III.C of this document, we
carefully considered the comments submitted to the docket that
described the results of studies conducted by the submitters on our
proposed required warnings. The results summarized in these comments
are generally supportive of our image selection decisions.
    (Comment 76) FDA also received some comments critical of the image
``oxygen mask on man's face.'' One comment noted that the image was
``too gross to be effective,'' and one comment stated that the image
should feature a younger person to highlight the fact that heart
attacks and stroke can occur in young smokers as well as in older
smokers.
    (Response) The image ``oxygen mask on man's face'' is an
appropriate image that effectively conveys the negative health
consequences of smoking. We do not agree with the statement that the
image is ``too gross to be effective;'' the image effectively elicited
emotional and cognitive reactions in viewers in our research study,
which in turn suggests that the image has the potential to promote
greater awareness of the health risks of smoking and motivate positive
behavioral outcomes, including an increased likelihood that smokers
will reduce their smoking, make an attempt to quit, or quit altogether
(Refs. 20, 44, and 45).
    While we agree with the statement in the comment that heart disease
and strokes can occur in young smokers as well as in older smokers, the
selected required warning will effectively communicate with a range of
audiences, including consumers of different ages. As described
previously, ``oxygen mask on man's face'' had a significant effect
(p<0.001) on all the salience measures (emotion measures, cognition
measures, and difficult to look at measure) in all three study
populations (adults, young adults, and youth). We considered the
variety and diversity reflected in the images in making selection
decisions, and took into account the importance of selecting a set of
required warnings that includes a diversity of styles (e.g.,
photographic versus illustrative), themes, and human images (e.g.,
race, gender, age). While the person shown in this image is an older
man, some of the images show younger people. Overall, the nine selected
required warnings will effectively communicate to a wide range of
consumers, including both young and older smokers.
6. ``WARNING: Smoking During Pregnancy Can Harm Your Baby''
    We selected the image which appears on pages 45 and 46 of the
document ``Proposed Required Warning Images,'' referred to as ``baby in
incubator,'' for use with this warning statement.
    In our research study, this image had a significant effect
(p<0.001) 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). The image
had the numerically largest effects of the images proposed for use with
this warning statement on the salience measures. As discussed in
section III.B of this document, these salience impacts are important,
as the research literature suggests that they are likely to be related
to behavior change.
    The image had a significant effect (p<0.01) on recall of the
warning statement at baseline compared to the text-only control in
youth. The image also had a significant effect (p<0.05) on statement
recall at follow-up in young adults, and showed the largest effect
sizes for image recall (at baseline and 1 week follow-up) in adults and
youth across the images proposed for use with this warning statement.
    The image had a significant impact (p<0.05) on beliefs about the
health risks of smoking for smokers in adults, although it had a
negative significant impact (p<0.05) on beliefs about the health risks
of smoking for smokers in youth. Thus, the results on this beliefs
measure were mixed for ``baby in incubator.'' However, given the
strength of the effects observed for this image on the salience
measures, the required warning that includes the ``baby in incubator''
image is likely to increase awareness of the health risks of smoking
and increase the likelihood that smokers will reduce their smoking,
make an attempt to quit, or quit altogether (Refs. 20, 44, and 45).
    We received a number of comments on this image, which we have
summarized and responded to in the following paragraphs.
    (Comment 77) FDA received a number of comments supporting the use
of the image ``baby in incubator,'' including comments from
individuals, a community organization, a public health advocacy group,
health care professionals, a State public health agency, and academics.
Several of these comments indicated that this image is the best image
for use with this warning statement, with some noting that the image
effectively shows how smoking during pregnancy can damage a baby's
health. One comment noted that the image could stimulate discussion
about how smoking affects pregnancy among youth.

    One comment also noted that the image ``baby in incubator''
outperformed the other image proposed for use with this warning
statement in FDA's research study on the key criteria that have proven
most meaningful.
    (Response) We selected this image for use with this warning
statement.
    (Comment 78) As described in section III.C of this document, some
comments submitted to the docket described the results of scientific
investigations that the submitters had conducted to examine the
potential effectiveness of FDA's proposed images on various outcomes.
This image was discussed in some of these comments. For example, 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 concluded that this image was the most effective of the
images proposed for use with this warning statement. However, in
another submitter's study, this image was evaluated against images used
in other countries, one of which was very similar in composition to
``baby in incubator'' but which was a photograph rather than a graphic
illustration. In that submitter's study, the photographic image was
rated significantly higher than ``baby in incubator.''
    (Response) As discussed in section III.C of this document, we
carefully considered the comments submitted to the docket that
described the results of studies conducted by the submitters on our
proposed required warnings. The results summarized in these comments
are generally supportive of our image selection decisions.
    (Comment 79) FDA also received a number of comments critical of the
image ``baby in incubator.'' The majority of these comments objected to
the graphic illustration style used for the image, with some submitters
approving of the concept but stating that a photograph would be more
impactful, and some indicating that the style is inappropriate, either
because it downplays the seriousness of the risk described in the
required warning or because it would inappropriately appeal to youth
without discouraging them from smoking.
    Some comments indicated that the lettering style used in the image
was difficult to read, and one comment stated that the results from
FDA's research study for this image, while better than the results for
the other image proposed for use with this warning statement
(``pacifier & ashtray''), were not compelling.
    One comment stated that the image bordered on the offensive.
    (Response) The image ``baby in incubator'' is an appropriate image
that effectively conveys the negative health consequences of smoking.
As discussed in section III.C of this document, we are aware that many
comments received in the docket expressed concern about the use of
graphic illustration style images and expressed a belief that this
style was not strong enough to elicit appropriate reactions. However,
as discussed in section III.C of this document, we disagree with the
contention that the use of graphic illustration style images is
categorically inappropriate. As the results from our research study
demonstrate, the ``baby in incubator'' image effectively elicited
emotional and cognitive reactions, showing a highly significant effect
(p<0.001) on these measures in all study populations, which in turn
suggests that the image has the potential to promote greater awareness
of the health risks of smoking and motivate positive behavioral
outcomes, including an increased likelihood that smokers will reduce
their smoking, make an attempt to quit, or quit altogether (Refs. 20,
44, and 45).
    In addition, based on the study results, we also do not agree that
the image is inappropriately offensive or that our research results for
this image are not compelling. Based on the overall feedback received,
we also disagree that the text in the proposed warning is difficult to
read.
7. ``WARNING: Smoking Can Kill you''
    We selected the image which appears on pages 49 and 50 of the
document ``Proposed Required Warning Images,'' referred to as ``man
with chest staples,'' for use with this warning statement.
    In our research study, this image had a significant effect
(p<0.001) 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). The image
had the numerically largest effects of the images proposed for use with
this warning statement on the salience measures. As discussed in
section III.B of this document, these salience impacts are important,
as the research literature suggests that they are likely to be related
to behavior change.
    The image was also associated with higher intentions to quit
smoking compared to the text-only control (p<0.05) in adults.
    The proposed required warning featuring the ``man with chest
staples'' image showed some of the largest effect sizes for image
recall among the images proposed for this warning statement at baseline
in all study populations and at 1 week follow-up in young adults and
youth.
    Young adults viewing the image had significantly lower recall of
the warning statement than those viewing the text-only control at
baseline (76.2 percent versus 92.3 percent) and 1 week follow-up (78.9
percent versus 91.3 percent). However, recall of the statement was
generally high at baseline and follow-up among study participants who
viewed this image (ranging from 76.2 percent to 90.4 percent), and
repetitive viewing of the required warning is likely to increase
recall. As explained in section III.C of this document, we gave greater
weight to outcomes on the salience measures than to outcomes on the
recall measures.
    We received a number of comments on this image, which we have
summarized and responded to in the following paragraphs.
    (Comment 80) FDA received a large number of comments supporting the
use of the image ``man with chest staples,'' including comments from
individuals (including former smokers), public health advocacy groups,
medical organizations, health care professionals, State and local
public health agencies, and academics. Many of these comments indicated
that this image is the best image for use with this warning statement,
while some also noted that the image is appropriately attention-
grabbing or powerful and that it will make smokers think twice about
continuing to smoke, or help them smoke less. Some comments also noted
that the image is an excellent way of driving home the message that
smoking can kill you. One comment stated that the image is a strong,
solid concept that has been used effectively in other countries that
require graphic health warnings on cigarette packages.
    Some comments stated that, based on FDA's research results, this
image is the best choice for use with this warning statement, noting
that it elicited the highest scores on the emotional reaction scale of
the images tested for use with this statement in FDA's research study,
and had other positive results.
    (Response) We selected this image for use with this warning
statement.
    (Comment 81) As described in section III.C of this document, some
comments submitted to the docket described the results of scientific
investigations that the submitters had conducted to examine the
potential effectiveness of FDA's proposed images on various outcomes.
This image was discussed in some of these comments. For example,

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, it was noted that, based on
respondents' rating and ranking of this image's effectiveness, the
image clearly stands out as the highest rated of the images FDA
proposed for use with this warning statement.
    (Response) As discussed in section III.C of this document, we
carefully considered the comments submitted to the docket that
described the results of studies conducted by the submitters on our
proposed required warnings. The results summarized in these comments
are generally supportive of our image selection decisions.
    (Comment 82) FDA also received some comments critical of the image
``man with chest staples.'' One comment stated that the image was ``too
gross to be effective,'' while another stated the image ``offend[s]
against human dignity.'' A few comments suggested that the person in
the image should look worse (e.g., paler, weaker, thinner, like he had
suffered more), and some comments suggested the person's death should
be more clearly tied to smoking by the image. One comment indicated
that persons unfamiliar with an autopsy may not understand the image.
    (Response) The image ``man with chest staples'' is an appropriate
image that effectively conveys the negative health consequences of
smoking. We do not agree that the image ``is too gross to be
effective'' or that it ``offend[s] against human dignity;'' the image
shows a realistic outcome of the negative health consequences caused by
smoking, and effectively elicited emotional and cognitive reactions in
viewers in our research study. This in turn suggests that the image has
the potential to promote greater awareness of the health risks of
smoking and motivate positive behavioral outcomes, including an
increased likelihood that smokers will reduce their smoking, make an
attempt to quit, or quit altogether (Refs. 20, 44, and 45).
    Viewers will understand that the image shows someone who has died
from a smoking-related cause. Although we agree that not all viewers
will necessarily be familiar with an autopsy scar, it is important to
keep in mind that the image is not used in isolation, but accompanies
the textual warning statement, which provides additional context for
what is shown. The results observed in our research study suggest that
viewers from all age groups understood and reacted to this image in
desirable ways. The figure shown is appropriate; although some of the
negative health consequences of smoking may lead to the effects on
appearance suggested in the comments (e.g., significant disease-related
weight loss), other consequences, such as heart attacks, can kill
smokers without first causing these effects.
8. ``WARNING: Tobacco Smoke Causes Fatal Lung Disease in Nonsmokers''
    We selected the image which appears on pages 57 and 58 of the
document ``Proposed Required Warning Images,'' referred to as ``woman
crying,'' for use with this warning statement.
    In our research study, this image had a significant effect
(p<0.001) on the emotional reaction scale in all three study
populations (adults, young adults, and youth). It also showed
significant effects on the difficult to look at measure in all study
populations (adults (p<0.01), young adults (p<0.001), and youth
(p<0.001)), and significant effects on the cognitive reaction scale in
all study populations (adults (p<0.05), young adults (p<0.001), and
youth (p<0.001)). This image was the only image proposed for use with
this warning statement that showed significant effects on all the
salience measures in our research study.
    The image also had a significant impact (p<0.05) on beliefs about
the health risks of smoking for smokers in young adults.
    The proposed required warning that included this image also showed
the largest effect sizes for image recall (at baseline and 1 week
follow-up) in adults, young adults, and youth across the images
proposed for this warning statement. Youth viewing the image had
significantly lower recall of the warning statement than those viewing
the text-only control at baseline (52.4 percent versus 68.9 percent).
However, recall of the statement was generally high among study
participants who viewed this image, and repetitive viewing of the
required warning is likely to increase recall. As explained in section
III.C of this document, we gave greater weight to outcomes on the
salience measures than to outcomes on the recall measures.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 83) FDA received several comments supporting the use of
the image ``woman crying,'' including comments from individuals
(including former smokers) and public health advocacy groups. Some of
these comments indicated that this image is the best image of the ones
proposed for use with this warning statement. One comment stated that
the image stood out as particularly effective among the proposed
required warnings because it shows the devastating effects secondhand
smoke can have on people who have tried to protect themselves by not
smoking, and indicated that the image will remind smokers that they are
harming their loved ones and others around them as well as themselves.
Others noted that the image sends a powerful message.
    One comment indicated that the image outperformed the other images
proposed for use with this warning statement on the emotional reaction
scale and the difficult to look at measure in FDA's research, and noted
that it appears to be a cut above the other images.
    (Response) We selected this image for use with this warning
statement.
    (Comment 84) One comment approved of the diversity reflected in the
image (which shows an African-American woman).
    (Response) We agree that it is beneficial to have a diverse set of
images that communicate with a wide range of audiences, including a
variety of population subgroups. In order to ensure that the final set
of required warnings effectively communicates risk information to a
diverse range of audiences, we selected a set of nine required
warnings, including the image ``woman crying,'' that includes a variety
of human images that are broadly representative of the overall
population.
    (Comment 85) As described in section III.C of this document, some
comments submitted to the docket described the results of scientific
investigations that the submitters had conducted to examine the
potential effectiveness of FDA's proposed images on various outcomes.
This image was discussed in some of these comments. For example, this
image 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.
    (Response) As discussed in section III.C of this document, we
carefully considered the comments submitted to the docket that
described the results of studies conducted by the submitters on our
proposed required warnings. The results summarized in these comments
are generally supportive of our image selection decisions.
    (Comment 86) FDA also received some comments critical of the image
``woman crying.'' One comment indicated that the image borders on the

offensive, while another stated it is too sensational to be effective.
    Other comments suggested that the image did not directly portray a
health consequence of secondhand smoke, or that the image is not
clearly tied to secondhand smoke. One comment also suggested that the
image should not be used because it did not have an impact on beliefs
about the health harms of secondhand smoke or on quit intentions in
FDA's research study.
    (Response) We disagree with these comments. The image ``woman
crying'' is an appropriate image that effectively conveys the negative
health consequences of smoking. We do not agree that the image is
offensive or too sensational; the image is a realistic portrayal of how
the negative health consequences caused by exposure to secondhand smoke
can affect people. It effectively elicited emotional and cognitive
reactions in those who viewed it in our research study, which in turn
suggests that the image has the potential to promote greater awareness
of the health risks of smoking and motivate positive behavioral
outcomes, including an increased likelihood that smokers will reduce
their smoking, make an attempt to quit, or quit altogether (Refs. 20,
44, and 45).
    We do not agree that the image does not depict a health consequence
of secondhand smoke. Graphic depictions of the visible effects of
disease are not the only way of communicating the health risks of
secondhand smoke exposure (see Ref. 11). The negative health
consequences caused by secondhand smoke exposure, including fatal lung
disease, have many dimensions, including emotional suffering. This
image highlights that dimension. Furthermore, it is important to keep
in mind that the image is not used in isolation, but accompanies the
textual warning statement, which provides additional context for what
is shown. As evidenced by the image's significant impact on the
salience measures across the populations participating in our research
study, the proposed required warning effectively depicts the health
consequences of secondhand smoke exposure, including the suffering
endured by those experiencing these health consequences.
9. ``WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to
Your Health''
    We selected the image which appears on pages 67 and 68 of the
document ``Proposed Required Warning Images,'' referred to as ``man I
Quit t-shirt,'' for use with this warning statement.
    In our research study, the image had a statistically significant
effect on the emotional reaction scale in young adults (p<0.05), and on
the cognitive reaction scale in adults (p<0.05), young adults (p<0.01),
and youth (p<0.001).
    The proposed required warning that included this image also showed
the largest effect sizes for image recall (at baseline and 1 week
follow-up) in adults, young adults, and youth across the images
proposed for this warning statement.
    Although this image, along with the other images proposed for use
with this warning statement, did not elicit the magnitude of reactions
on the salience measures (emotional reaction scale, cognitive reaction
scale, difficult to look at measure) that some of the images proposed
for use with other warning statements did, this is likely a result of
the information being conveyed in the warning statement, which
emphasizes the positive health benefits of quitting smoking. The
content of this required warning is not expected to arouse the same
level of response on some of the salience measures as the other
messages.
    However, the research literature suggests that warnings that focus
on the benefits of quitting are effective at encouraging cessation, and
suggests that positive, self-efficacy messages can be used effectively
as one component of graphic health warnings to increase smokers'
motivations and confidence about quitting (Ref. 40 at pp. 35, 39-41).
The research literature also highlights the importance of including one
or more warnings that provide solutions, such as the ``man I Quit t-
shirt'' required warning, in a set of warnings conveying the negative
health consequences of smoking. Specifically, the literature recommends
that, in addition to communicating the health risks of smoking, some
warnings should also provide information on how to avoid these risks
(i.e., by quitting), in order to optimize the effectiveness of the
overall set of warning messages (see Ref. 48 and Ref. 40 at p. 37).
    As is discussed in further detail in section III.E of this
document, another image proposed for use with this warning statement,
``cigarettes in toilet bowl,'' also had significant effects on the
emotional reaction scale in some study populations and on the cognitive
reaction scale, as well as showing positive effects on other study
measures. While this image, similar to the selected image (``man I Quit
t-shirt''), could be effectively used with this warning statement, we
ultimately selected ``man I Quit t-shirt'' for use with this warning
statement based on a consideration of multiple factors, including the
feedback received in the docket, which is discussed in the comment
summaries in the following paragraphs and in section III.E of this
document.
    Furthermore, as noted in section III.A of this document, in order
to ensure that the final set of required warnings effectively
communicates risk information to a diverse range of audiences, we
selected a set of nine required warnings, including the image ``man I
Quit t-shirt,'' that includes a variety of human images that are
broadly representative of the overall population. The image ``man I
Quit t-shirt'' contributes to the variety seen in the final set of
images by picturing a man who is younger than the men in the other
required warning images. Additionally, as reflected in the comment
summary, the man shown in the image is perceived by many viewers as
strong and ``macho,'' suggesting that the image has the potential to
reach and effectively communicate with a demographic group that has
been heavily targeted by tobacco industry cigarette advertising (see
Ref. 54 at p. 151). The depiction of men as strong, powerful, macho,
rugged, and independent, and the association of these characteristics
with cigarette brands, has long been a prominent theme in tobacco
industry advertising (Id. at p. 151), and targeted marketing efforts by
the tobacco industry have led to greater smoking uptake and lower
cessation rates in targeted subgroups (Id. at p. 211).
    We received a number of comments on this image, which we have
summarized and responded to in the following paragraphs.
    (Comment 87) FDA received a number of comments supporting the use
of the image ``man I Quit t-shirt,'' including comments from
individuals, public health advocacy groups, medical organizations, and
State and local public health agencies. Many of these comments
indicated that this image is the best image of the ones proposed for
use with this warning statement. Several of the comments discussed
specific favorable aspects of the image or potential effects of the
image, including that the image models a positive behavior, is
compelling, and that it will encourage others to quit. Several comments
believed that the image could reach a critical demographic group by
showing a younger, ``cool,'' ``macho'' man and suggesting that it is
manly and/or cool to quit smoking. Some comments also suggested that
the image is positive in that it shows that quitting is a heroic
decision.
    (Response) We selected this image for use with this warning
statement.

    (Comment 88) As described in section III.C of this document, some
comments submitted to the docket described the results of scientific
investigations that the submitters had conducted to examine the
potential effectiveness of FDA's proposed images on various outcomes.
This image was discussed in some of these comments. In one submitter's
study, the image ``man I Quit T-shirt'' was the highest rated of the
images proposed by FDA for use with this warning statement among
adults. This study also tested a version of the required warning that
had been manipulated to add a quitline number; this version was rated
and ranked as the most effective warning overall among study
participants. In another submitter's study, this image was rated highly
on its ease of comprehension, but led to lower worry relative to a
text-only control (but as the researcher noted, the message in this
warning is reassuring: ``Quitting smoking now greatly reduces serious
risks to your health'').
    (Response) As discussed in section III.C of this document, we
carefully considered the comments submitted to the docket that
described the results of studies conducted by the submitters on our
proposed required warnings. The results summarized in these comments
are generally supportive of our image selection decisions.
    (Comment 89) FDA also received some comments critical of the image
``man I Quit t-shirt.'' Some comments indicated that the image does not
convey a health consequence of smoking, while one indicated that the
text was difficult to read. One comment also noted that the image
failed to show an effect on some measures in FDA's research study, and
another indicated that the image is banal.
    (Response) We disagree with these comments. The image ``man I Quit
t-shirt'' is an appropriate image. Consumers can be educated about the
negative health consequences of smoking in a variety of ways. While the
other required warnings discuss and portray the consequences of
starting or continuing to smoke (which has been shown to be one
effective way to educate consumers), another method of increasing
awareness and knowledge about the negative consequences of a behavior
is to disseminate messages that discuss the positive health benefits of
refraining from a behavior (Ref. 55). Studies attest to the potential
effectiveness of warnings that adopt such an approach (Ref. 40 at p.
35). Accordingly, the warning statement used in this required warning,
``Quitting smoking now greatly reduces serious risks to your health,''
is framed in a positive manner, discussing the health benefits of
ceasing to smoke, and the image is consistent with this text. This
required warning, particularly as part of the overall set of required
warnings, will help educate consumers about the negative health
consequences of smoking and help encourage positive behavior (see Ref.
40 at pp. 35 and 40).
    Based on the overall feedback received and the results from our
research study, we also disagree that the text in the proposed warning
is difficult to read or that the image is banal.
10. Image for Advertisements With a Small Surface Area
    In addition to proposing 36 required warnings for use on cigarette
packages and in cigarette advertisements in the NPRM, we also proposed
two other color graphics for use solely in advertisements with a small
surface area of less than 12 square inches (75 FR 69524 at 69539). As
we explained in the NPRM, these two proposed color graphics differ in
their composition from the other proposed images in that the details of
these two color graphics should be clear, conspicuous, and legible even
when the image is reduced in size to occupy 20 percent of a surface
with an area of less than 12 square inches (75 FR 69524 at 69535). We
proposed that whichever of these options was selected would be used in
combination with one of the nine textual statements only in
advertisements with a small surface area (i.e., less than 12 square
inches). However, as we noted in the NPRM, even an advertisement with a
relatively small surface area would need to be large enough so that the
required graphic and accompanying textual warning statement are clear,
conspicuous, and legible (75 FR 69524 at 69539).
    We 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). This image depicts a black
exclamation mark enclosed within a red equilateral triangle.
    As stated previously, FDA proposed two images for use solely with
the textual warning statements in advertisements with a small surface
area; the selected image described in the previous paragraph and an
image of a burning cigarette enclosed in a red circle with a red bar
across it. We did not receive any comments on either of the proposed
images.
    Versions of both of these images have been used in other contexts.
For example, the image of an exclamation mark enclosed within a
triangle is often used to draw attention to a warning of danger or
hazards that could result in personal injury or a threat to health
(see, e.g., 16 CFR 1211.15, 16 CFR 1407.3; 16 CFR 1500.19; and Ref.
56). The image of a burning cigarette enclosed in a red circle with a
red bar across it is the international ``No Smoking'' symbol (Ref. 56)
and is often used on signs and placards to denote an area where smoking
is prohibited (see, e.g., 14 CFR 23.853, 49 CFR 374.201).
    In light of the other contexts in which the two proposed images are
used, we selected the image of the exclamation mark enclosed within a
red equilateral triangle, as we believe this image is more appropriate
than the other proposed image for use in the required warnings. As
stated, this image is commonly used to draw attention to a warning of
danger which could result in personal injury or a threat to health,
which is consistent with its purpose in cigarette advertisements with a
small surface area. Many consumers have likely been exposed to similar
symbols in other contexts and, as a result, are likely to recognize and
understand that the image is drawing attention to a warning of a threat
to health.

E. Non-Selected Images

    This section discusses the 27 color graphic images that we proposed
but have not selected for use at this time, and the factors that
influenced the decision not to use each image, including the research
results for the images, the comments received in the docket, and the
relevant scientific literature.
    Consistent with the discussion of selected images in section III.D
of this document, the images are referred to in this section by the
pages on which they appear in the ``Proposed Required Warning Images''
document and by the descriptive names used in the study report (Ref.
49, study report) summarizing the results of FDA's research study.
1. ``WARNING: Cigarettes Are Addictive''
    As discussed in section III.D of this document, we selected the
image ``hole in throat'' for use with the statement, ``WARNING:
Cigarettes are addictive.'' We proposed three other images for use with
this statement: ``cigarette injection,'' which appears on pages 3 and 4
of the document ``Proposed Required Warning Images;'' ``red puppet,''
which appears on pages 5 and

6 of the document ``Proposed Required Warning Images;'' and ``woman in
rain,'' which appears on pages 7 and 8 of the document ``Proposed
Required Warning Images.''
    Cigarette Injection. The image ``cigarette injection'' had strong
overall research results in FDA's research study, including significant
effects on the emotional and cognitive reaction scales in all three
study populations and significant effects on the difficult to look at
measure in adults and young adults. It also showed higher correct
recall of the warning statement compared to the control in adults and
young adults at baseline, and was associated with higher intentions to
quit compared to the control for young adults. The image also had a
positive significant impact on adult beliefs about the health risks of
smoking for smokers in adults viewing the hypothetical cigarette
package with the proposed required warning, although it had a negative
significant impact on this same measure in adults viewing the
hypothetical cigarette advertisement featuring this proposed required
warning.
    The image selected for use with this warning statement, ``hole in
throat,'' had numerically larger effects than this image (``cigarette
injection'') on the salience measures (emotional and cognitive reaction
scales, difficult to look at measure) in all three study populations.
As discussed in section III.B of this document, the research literature
suggests that the salience measures used in FDA's study are likely to
be related to behavior change.
    In addition, the selected image, ``hole in throat,'' enhanced the
diversity of the overall set of selected images by helping ensure the
human images broadly represent the U.S. population. Although
``cigarette injection'' offered variety in terms of style in that it
uses a graphic illustration style as opposed to the photographic style
used in most of the selected images, this style is incorporated in the
final set of required warnings with the image used for the warning
statement ``Smoking during pregnancy can harm your baby.''
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 90) FDA received several comments that supported the use
of the image ``cigarette injection,'' including comments from
individuals, public health advocacy groups, and a State public health
agency. Some of the comments stated that the image would be an
effective smoking deterrent. Several of the comments noted that the
image would help smokers understand that, although cigarettes are legal
products, they are just as addictive as illegal drugs like heroin. One
comment indicated that the image would be particularly effective with
underage smokers.
    FDA also received several comments that opposed the use of the
image ``cigarette injection.'' Many of these comments objected to the
graphic illustration style used in the image, with some stating it
would be ineffective or less effective than a photographic image, and
some indicating it would detract from the seriousness of the message
being conveyed. Some comments also expressed concern that the style
would inappropriately appeal to youth without deterring them from
smoking.
    A few comments also objected to the comparison of legal cigarette
products with illegal drugs, with one comment indicating this
downplayed the seriousness of intravenous drug use, and another comment
noting that the analogy of cigarette use to heroin use could cause
consumers to discount the message if they believe that cigarette and
heroin use are not comparable.
    Some comments also stated that the image could be misunderstood or
was too abstract, and one comment stated that the image does not
illustrate adverse health effects.
    One comment noted that the proposed required warning featuring the
``cigarette injection'' image was not rated highly on its ease of
comprehension in a research study the submitter conducted on the 36
proposed required warnings, though it did show a significant effect on
worry and feeling discouraged from wanting to smoke relative to a text-
only control.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``hole in throat'' for the
reasons given in section III.D of this document.
    Red puppet. In FDA's research study, the image ``red puppet'' had
significant effects on the emotional and cognitive reaction scales in
all three study populations. It also showed higher correct recall of
the warning statement compared to the control in young adults at 1 week
follow-up.
    However, the selected image, ``hole in throat,'' had numerically
larger effects than this image on the salience measures (emotional
reaction scale, cognitive reaction scale, difficult to look at measure)
in all three study populations. In addition, looking across the
different measures used in the research study, both the image ``hole in
throat'' and the image ``cigarette injection'' had stronger overall
research results than this image.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 91) FDA received several comments that supported the use
of the image ``red puppet,'' including comments from individuals, a
public health advocacy group, and from State and local public health
agencies. Some of the comments stated that the image is likely to be
effective, and one stated that it would impact underage smokers.
Another noted that it was a clever image.
    FDA also received several comments that opposed the use of the
image ``red puppet.'' Some of these comments stated that the image
style was less effective than a photographic image. One comment
expressed concern that the style would inappropriately appeal to youth
without deterring them from smoking.
    Several comments expressed concern that the image would not be
understood by some consumers, including youth and some racial and
ethnic minorities, who might not understand and identify with the
picture of a marionette, or draw the analogy between the manipulation
suggested by the image of the puppet and addiction.
    A few comments stated the image does not convey a health
consequence of smoking, while one comment stated that the results from
FDA's research study for this image did not support its selection from
among the images proposed for use with this warning statement.
    Three comments noted that the proposed required warning featuring
the ``red puppet'' image was not highly rated in research studies
conducted by the submitters. One comment noted that the image did not
increase worry relative to a text-only label or discourage respondents
from smoking relative to a text-only label in the submitter's study,
while two others noted that the image was ranked as one of the least
effective of the proposed images by respondents in the submitters'
studies.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``hole in throat'' for the
reasons given in section III.D of this document.
    Woman in rain. In FDA's research study, the image ``woman in rain''
had a significant effect on the difficult to look at measure in adults
and young adults. The image also had a significant impact on adult
beliefs about the health risks of smoking for smokers compared to the
control.

    Looking across the different measures used in FDA's research study,
this image was relatively less effective than other images proposed for
this warning statement, including the image selected for use in the
required warnings ``hole in throat.''
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 92) FDA received multiple comments that supported the use
of the image ``woman in rain,'' including comments from individuals, a
community organization, and a State public health agency. Some of the
comments stated that the image is likely to be effective, and one
stated that smokers would be able to relate to the image.
    FDA also received a number of comments that opposed the use of the
image ``woman in rain.'' Some of these comments stated that the image
would not be effective and is not emotionally arousing, while some
stated that it shows a very weak harm (i.e., standing in the rain).
Another comment stated that the image makes smoking seem like a normal
behavior.
    Several comments expressed concern that the image would not be
understood by consumers, indicating it was too vague in nature and
requires a high analytical ability to understand.
    Several comments stated the image does not convey a health
consequence of smoking, while three comments stated that the results
from FDA's research study for this image did not support its selection
from among the images proposed for use with this warning statement.
    Two comments noted that the proposed required warning featuring the
``woman in rain'' image was not highly rated in research studies
conducted by the submitters. One comment noted that the image was not
rated highly on its ease of comprehension and did not increase worry
relative to a text-only label or discourage respondents from smoking
relative to a text-only label in the submitter's study, while another
noted that the image was ranked as one of the least effective of the 36
proposed images by respondents in the submitter's study.
    (Response) We did not select this image for use in a required
warning and instead have selected the image ``hole in throat'' for the
reasons given in section III.D of this document.
2. ``WARNING: Tobacco Smoke Can Harm Your Children''
    As discussed in section III.D of this document, we selected the
image ``smoke approaching baby'' for use with the statement, ``WARNING:
Tobacco Smoke Can Harm Your Children.'' FDA proposed five other images
for use with this statement: ``Smoke at toddler,'' which appears on
pages 11 and 12 of the document ``Proposed Required Warning Images;''
``smoke at baby,'' which appears on pages 13 and 14 of the document
``Proposed Required Warning Images;'' ``girl crying,'' which appears on
pages 15 and 16 of the document ``Proposed Required Warning Images;''
``warning in child lettering,'' which appears on pages 17 and 18 of the
document ``Proposed Required Warning Images;'' and ``girl in oxygen
mask,'' which appears on pages 19 and 20 of the document ``Proposed
Required Warning Images.''
    Smoke at toddler. In FDA's research study, the image ``smoke at
toddler'' had significant effects on all the salience measures
(emotional reaction scale, cognitive reaction scale, 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, ``smoke approaching baby,'' also had significant
impacts on all the salience measures in all three study populations,
and also showed significant impacts on recall and behavioral intentions
in some populations.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 93) FDA received a number of comments that supported the
use of the image ``smoke at toddler,'' including comments from
individuals, a medical organization, public health advocacy groups,
academics, and State and local public health agencies. Some of these
comments indicated that the image would cause people to reconsider
smoking due to the harm it can cause to others, especially a child or a
baby.
    Three comments noted that the image showed positive impacts in
research studies conducted by the submitters. Specifically, in one
submitter's study this image had the relatively greatest impact in
discouraging respondents from wanting to smoke of the images proposed
for use with this warning statement. In another submitter's study of
the potential effectiveness of the images, this image received the
highest overall rating of the images proposed for use with this warning
statement. In addition, it was one of the two highest rated images of
the FDA images proposed for use with this warning statement in another
submitter's study.
    FDA also received several comments that opposed use of the image
``smoke at toddler.'' Multiple comments stated that the image would be
perceived as demeaning to smokers by suggesting they blow smoke
directly at their children, and one comment cited the image as an
unreal portrayal. Another comment expressed concern that the image
would prompt denial among smokers, who would interpret the image to
mean that their children are not at risk if they do not blow smoke
directly at them. One comment said the image does not depict a negative
health consequence of smoking, while another comment stated the image
was too positive, in that the child looked too happy. Finally, another
comment stated that other images tested in FDA's research study for use
with this warning statement elicited higher scores on the emotional and
cognitive reaction scales than this image.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``smoke approaching baby''
for the reasons given in section III.D of this document.
    Smoke at baby. In FDA's research study, the image ``smoke at baby''
had significant effects on the emotional and cognitive reaction scales
in all three study populations (adults, young adults, and youth) and
significant effects on the difficult to look at measure in adults and
youth. It also showed higher correct recall of the warning statement
compared to the control in adults and young adults at 1 week follow-up.
    However, as discussed in section III.D of this document, the
selected image, ``smoke approaching baby,'' had significant impacts on
all the salience measures in all three study populations, and also
showed significant impacts on recall and behavioral intentions in some
populations.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 94) FDA received several comments that supported the use
of the image ``smoke at baby,'' including comments from individuals, a
community organization, a medical organization, academics, and a State
public health agency. Some of these comments indicated that the image
would cause people to reconsider smoking due to the harm it can cause
to children, and one comment noted that the image evokes a strong
emotional reaction, clearly communicating that it is wrong to engage in
the behavior portrayed in the image.
    Two comments noted that the image showed positive impacts in
research

studies conducted by the submitters. Specifically, this image had a
significant impact in discouraging respondents from wanting to smoke in
one submitter's study, and it was one of the two highest-rated images
of the FDA images proposed for use with this warning statement in
another submitter's study.
    FDA also received several comments that opposed the use of the
image ``smoke at baby.'' Many of these comments objected to the graphic
illustration style used in the image, with some stating it would be
ineffective or less effective than a photographic image, and some
indicating it would detract from the seriousness of the message being
conveyed. Some comments also expressed concern that the style would
inappropriately appeal to youth without deterring them from smoking.
    Multiple comments stated that the image would be perceived as
demeaning to smokers by suggesting they blow smoke directly at their
children, and one comment cited the image as an unreal portrayal.
Another comment expressed concern that the image would prompt denial
among smokers, who would interpret the image to mean that their
children are not at risk if they do not blow smoke directly at them.
    A couple of comments stated that other images tested in FDA's
research study for use with this warning statement outperformed this
image, with one noting that other images elicited higher scores on the
emotional reaction scale and difficult to look at measure than this
image, and another noting that other images had higher scores on the
quit intentions and recall measures than this image.
    One comment expressed concern that the image could be perceived to
mean that mothers who smoke should not breastfeed their children.
Another comment stated that the text used in the proposed required
warning was difficult to read.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``smoke approaching baby''
for the reasons given in section III.D of this document.
    Girl crying. In FDA's research study, the image ``girl crying'' 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). It also
showed higher correct recall of the warning statement compared to the
control in adults at baseline, and higher correct recall of the warning
statement at 1 week follow-up compared to the text-only control for
adults and young adults. Youth who viewed the image also reported that
they would be significantly less likely to be smoking 1 year from now
compared to youth who viewed the control.
    However, the image had a significant negative impact on adult
beliefs about the health risks of secondhand smoke exposure for
nonsmokers, i.e., adults who viewed the image were less likely to
believe that nonsmokers will suffer from negative health effects due to
secondhand smoke exposure than adults who viewed the text-only control.
    As discussed in section III.D of this document, the selected image,
``smoke approaching baby,'' had significant impacts on all the salience
measures in all three study populations, and also showed significant
impacts on recall and behavioral intentions in some populations. Thus,
while ``girl crying'' showed positive effects on several important
measures in FDA's research study, the selected image was considered to
be a stronger choice, as it also showed positive effects on several
important measures and did not show any negative effects.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 95) FDA received several comments that supported the use
of the image ``girl crying,'' including comments from individuals and
from a State public health agency. Some comments noted that the
submitter found this image to be the most effective of the images
proposed for use with this warning statement, and others noted it would
appropriately elicit negative emotions in viewers.
    FDA also received several comments that opposed use of the image
``girl crying.'' Multiple comments stated that it was not clear why the
girl was crying, and one comment stated that the image does not depict
a health consequence of secondhand smoke exposure. One comment
indicated that the image was too sensational to be effective, and
another comment cited the image as an unreal portrayal, stating that
young children do not know they are being harmed when they are exposed
to smoke and thus would not cry as a result of such exposure, and noted
that this is what makes secondhand smoke exposure so insidious. One
comment indicated that other images tested in FDA's research study for
use with this warning statement had superior overall results to this
image.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``smoke approaching baby''
for the reasons given in section III.D of this document.
    Warning in child lettering. In FDA's research study, the image
``warning in child lettering'' had significant effects on the emotional
and cognitive reaction scales in all three study populations (adults,
young adults, and youth). It also showed higher correct recall of the
warning statement compared to the control in adults and young adults at
baseline, and higher correct recall of the warning statement at 1 week
follow-up compared to the control for adults, young adults, and youth.
However, ``warning in child lettering'' showed lower correct recall of
the image at baseline and follow-up for adults, young adults, and youth
compared to the other images.
    Looking across the different measures used in FDA's research study,
this image was relatively less effective than other images proposed for
use with this warning statement, including the image selected for use
in the required warnings, ``smoke approaching baby.''
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 96) FDA received several comments that supported the use
of the image ``warning in child lettering,'' including comments from
individuals, a public health advocacy group, a medical organization,
and a State public health agency. Some comments felt the use of child's
handwriting in the image would be especially impactful with parents,
and one comment noted that this image would have wide appeal,
resonating with parents of any race or ethnicity.
    FDA also received several comments that opposed use of the image
``warning in child lettering.'' Multiple comments objected to the image
style, indicating that a photographic depiction would be more effective
at deterring people from smoking, with one comment noting that the
image style would be inappropriately appealing to youth without
discouraging them from smoking. One comment indicated that the image
does not depict a negative health consequence of smoking, and another
indicated that the image was not eye-catching.
    Two comments noted that other images proposed for use with this
warning statement had superior overall results compared to this image
in FDA's research study and stated that FDA should not select this
image for use in the required warning. In addition, two comments noted
that the image was not highly rated in research studies conducted by
the submitters. One comment noted that the image was

ranked as the least effective of the 36 proposed images by respondents
in the submitter's study, while another noted that the image was ranked
the lowest by a considerable margin of the images proposed for use with
this warning statement in the submitter's study.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``smoke approaching baby''
for the reasons given in section III.D of this document.
    Girl in oxygen mask. In FDA's research study, the image ``girl in
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 image had a significant negative impact on adult
beliefs about the health risks of secondhand smoke exposure for
nonsmokers, i.e., adults who viewed the image were less likely to
believe that nonsmokers will suffer from negative health effects due to
secondhand smoke exposure than adults who viewed the text-only control.
    As discussed in section III.D of this document, the selected image,
``smoke approaching baby,'' had significant impacts on all the salience
measures in all three study populations, and also showed significant
impacts on recall and behavioral intentions in some populations. Thus,
the selected image was considered to be a stronger choice than ``girl
in oxygen mask,'' as it showed positive effects on several important
measures, but did not show any negative effects.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 97) FDA received a number of comments that supported the
use of the image ``girl in oxygen mask,'' including comments from
individuals, a public health advocacy group, a medical organization, a
health care professional, and a State public health agency, with some
comments noting that the image clearly conveys the message that smoke
exposure can harm children, and powerfully shows the consequences of
smoking.
    FDA also received several comments that opposed use of the image
``girl in oxygen mask.'' Some comments noted that it was unclear that
the person portrayed in the image was a child, and suggested that the
image would be more persuasive if the person shown were younger. One
comment expressed concern that persons of low socioeconomic status
would not understand the image, and a few comments suggested that the
image should show more severe disease or more clear association between
the girl's illness and smoke exposure.
    (Response) We are not selecting this image for use in a required
warning and instead have selected the image ``smoke approaching baby''
for the reasons given in section III.D of this document.
3. ``WARNING: Cigarettes Cause Fatal Lung Disease''
    As discussed in section III.D of this document, FDA selected the
image ``healthy/diseased lungs'' for use with the statement, ``WARNING:
Cigarettes cause fatal lung disease.'' FDA proposed three other images
for use with this statement: ``toe tag,'' which appears on pages 21 and
22 of the document ``Proposed Required Warning Images;'' ``lungs full
of cigarettes,'' which appears on pages 23 and 24 of the document
``Proposed Required Warning Images;'' and ``Dr. [doctor] with X-ray,''
which appears on pages 27 and 28 of the document ``Proposed Required
Warning Images.''
    Toe tag. In FDA's research study, the image ``toe tag'' 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.
    The image ``toe tag'' prompted lower correct recall of the warning
statement than the text-only control at baseline among youth.
    FDA received a number of comments on this image, which the Agency
has summarized and responded to in the following paragraphs.
    (Comment 98) FDA received a number of comments that supported the
use of the image ``toe tag,'' including comments from individuals, a
medical organization, public health advocacy groups, academics, 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. It was also noted that the image effectively communicates
the risks of smoking and would effectively deter smokers.
    Some comments noted that the image showed positive effects in
research studies conducted by the submitters. 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. The