[Federal Register Volume 84, Number 159 (Friday, August 16, 2019)]
[Proposed Rules]
[Pages 42754-42798]
[FR Doc No: 2019-17481]

Vol. 84

Friday,

No. 159

August 16, 2019

Part IV

Department of Health and Human Services

-----------------------------------------------------------------------

Food and Drug Administration

-----------------------------------------------------------------------

21 CFR Part 1141

Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements; Proposed Rules

Federal Register / Vol. 84 , No. 159 / Friday, August 16, 2019 /
Proposed Rules

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1141

[Docket No. FDA-2019-N-3065]
RIN 0910-AI39

Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a proposed rule to establish new required cigarette health
warnings for cigarette packages and advertisements. The proposed rule
would implement a provision of the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act) that requires FDA to issue
regulations requiring color graphics depicting the negative health
consequences of smoking to accompany new textual warning statements.
The Tobacco Control Act amends the Federal Cigarette Labeling and
Advertising Act (FCLAA) of 1965 to require each cigarette package and
advertisement to bear one of the new required warnings. This proposed
rule, once finalized, would specify the color graphics that must
accompany the new textual warning statements. FDA is proposing to take
this action to promote greater public understanding of the negative
health consequences of cigarette smoking.

DATES: Submit either electronic or written comments on the proposed
rule by October 15, 2019. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by September 16, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 15, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 15, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3065 for ``Tobacco Products; Required Warnings for Cigarette
Packages and Advertisements.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-9-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 to the Office of Management and Budget
(OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>All comments should be identified with the
title, ``Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements.''

FOR FURTHER INFORMATION CONTACT: Courtney Smith or Daniel Gittleson,
Office of Regulations, Center for Tobacco Products, Food and Drug
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    With regard to the information collection: Amber Sanford, Office of
Operations, Food and Drug Administration, Three White Flint North 10A-
12M, 11601 Landsdown St.,

North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs, Benefits, and Informational Effects
Table of Abbreviations/Commonly Used Acronyms in This Document
II. Background
    A. Need for the Regulation
    B. History of the Rulemaking
    C. Incorporation by Reference
III. Legal Authority
IV. Cigarette Use in the United States and the Resulting Health
Consequences
    A. Smoking Prevalence and Initiation in the United States
    B. Negative Health Consequences of Smoking
V. Data Concerning Cigarette Health Warnings
    A. The Current 1984 Surgeon General's Warnings Are Inadequate
    B. Cigarette Health Warnings That Are Noticeable, Lead to
Learning, and Increase Knowledge Will Promote Public Understanding
About the Negative Health Consequences of Smoking
VI. FDA's Process for Developing and Testing the Proposed Cigarette
Health Warnings
    A. Review of the Negative Health Consequences of Cigarette
Smoking
    B. Developing Revised Textual Warning Statements
    C. FDA's Consumer Research Study on Revised Textual Warning
Statements
    D. Developing and Testing Images Depicting the Negative Health
Consequences of Smoking To Accompany the Textual Warning Statements
    E. FDA's Consumer Research Study on New Cigarette Health
Warnings
VII. FDA's Proposed Required Warnings
    A. FDA's Proposed Required Warnings
VIII. First Amendment Considerations
IX. Description of the Proposed Rule
    A. General Provisions (Proposed Subpart A)
    B. Required Warnings for Cigarette Packages and Advertisements
(Proposed Sec.  1141.10)
    C. Misbranding of Cigarettes (Proposed Sec.  1141.12)
X. Proposed Effective Dates
XI. Severability and Other Considerations
XII. Preliminary Economic Analysis of Impacts
XIII. Analysis of Environmental Impact
XIV. Paperwork Reduction Act of 1995
XV. Federalism
XVI. Consultation and Coordination With Indian Tribal Governments
XVII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    This proposed rule would establish new required cigarette health
warnings for cigarette packages and advertisements. These new cigarette
health warnings would consist of textual warning statements accompanied
by color graphics depicting the negative health consequences of
cigarette smoking. The new cigarette health warnings, once finalized,
would appear prominently on cigarette packages and in cigarette
advertisements, occupying the top 50 percent of the area of the front
and rear panels of cigarette packages and at least 20 percent of the
area at the top of cigarette advertisements.
    Cigarette smoking remains the leading cause of preventable disease
and death in the United States and is responsible for more than 480,000
deaths per year. Smoking causes more deaths each year than human
immunodeficiency virus, illegal drug use, alcohol use, motor vehicle
injuries, and firearm-related incidents combined. In developing this
proposed rule, FDA determined that the public holds misperceptions
about the health risks caused by smoking and that warning statements
focused on less-known health consequences of smoking paired with
concordant color graphics would promote greater public understanding of
the risks associated with cigarette smoking, especially given that the
existing Surgeon General's warnings currently used in the United States
have been shown to go unnoticed and be ``invisible.'' For the reasons
discussed in the preamble to this proposed rule, FDA has determined
that the proposed new cigarette health warnings will advance the
Government's interest in promoting greater public understanding of the
negative health consequences of cigarette smoking.

B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule would establish new required warnings to appear
on cigarette packages and in cigarette advertisements. The proposed
rule would implement a provision of the Tobacco Control Act that
requires FDA to issue regulations requiring color graphics depicting
the negative health consequences of smoking to accompany new textual
warning statements. The Tobacco Control Act amends the FCLAA to require
each cigarette package and advertisement to bear one of the new
required warnings. These new cigarette health warnings would consist of
textual warning statements accompanied by color graphics, in the form
of concordant photorealistic images, depicting the negative health
consequences of cigarette smoking. As required under the FCLAA, the new
cigarette health warnings, once finalized, would appear prominently on
cigarette packages and in cigarette advertisements, occupying the top
50 percent of the area of the front and rear panels of cigarette
packages and at least 20 percent of the area at the top of cigarette
advertisements.
    In addition, as required under the FCLAA, the proposed rule would
establish marketing requirements that would include the random display
and distribution of the required warnings for cigarette packages and
quarterly rotations of the required warnings for cigarette
advertisements. A tobacco product manufacturer, distributor, or
retailer would be required to submit a plan for the random and equal
display and distribution of the required warnings on packages and the
quarterly rotation in advertisements for approval by FDA. In addition,
the proposed rule would require each tobacco product manufacturer
required to randomly and equally display and distribute warnings on
packaging or quarterly rotate warnings on advertisements in accordance
with an FDA-approved plan, to maintain a copy of the FDA-approved plan,
and to make the plan available for inspection and copying by officers
and employees of FDA.
    FDA developed the new cigarette health warnings included in this
proposed rule through a science-based, iterative research process. The
proposed warnings are intended to promote greater public understanding
of the negative health consequences of cigarette smoking.

C. Legal Authority

    This proposed rule is being issued in accordance with sections 201
and 202 of the Tobacco Control Act (Pub. L. 111-31), which amend
section 4 of the FCLAA (15 U.S.C. 1333). This proposed rule is also
being issued based upon FDA's authorities related to misbranded tobacco
products under sections 903 (21 U.S.C. 387c); FDA's authorities related
to records and reports under section 909 (21 U.S.C. 387i); and FDA's
rulemaking and inspection authorities under sections 701 (21 U.S.C.
371), 704 (21 U.S.C. 374), and 905(g) (21 U.S.C. 387e(g)) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act).

D. Costs, Benefits, and Informational Effects

    The proposed new cigarette health warnings would promote greater
public understanding of the negative health consequences of cigarette
smoking by presenting information about the health risks of smoking to
smokers and nonsmokers in a format that helps

people better understand these consequences. Despite the informational
effects of this proposed rule, there is a high level of uncertainty
around quantitative economic benefits at this time, so we describe them
qualitatively. The cost of this proposed rule consists of initial and
recurring labeling costs associated with changing cigarette labels to
accommodate the new cigarette health warnings, design and operation
costs associated with the random and equal display and distribution of
required cigarette health warnings for cigarette packages and quarterly
rotations of the required warnings for cigarette advertisements,
advertising-related costs, and costs associated with government
administration and enforcement of the rule. We estimate that, at the
mean, the present value of the costs of this proposed rule is about
$1.6 billion using a three percent discount rate and roughly $1.2
billion using a seven percent discount rate (2018$). If the information
provided by the cigarette health warning on each cigarette package was
valued at about $0.01 (for every pack sold annually nationwide), then
the benefits that would be generated by the proposed rule would equal
or exceed the estimated annual costs.

     Table of Abbreviations/Commonly Used Acronyms in This Document
------------------------------------------------------------------------
          Abbreviation/acronym                    What it means
------------------------------------------------------------------------
CDC....................................  Centers for Disease Control and
                                          Prevention.
COPD...................................  Chronic Obstructive Pulmonary
                                          Disease.
D.C. Cir...............................  United States Court of Appeals
                                          for the District of Columbia
                                          Circuit.
EO.....................................  Executive Order.
EPA....................................  Environmental Protection
                                          Agency.
FCLAA..................................  Federal Cigarette Labeling and
                                          Advertising Act.
FD&C Act...............................  Federal Food, Drug, and
                                          Cosmetic Act.
FDA....................................  Food and Drug Administration.
FTC....................................  Federal Trade Commission.
IOM....................................  Institute of Medicine.
ITC-4..................................  International Tobacco Control
                                          Four Country Survey.
NARA...................................  National Archives and Records
                                          Administration.
OFR....................................  Office of the Federal Register.
OMB....................................  Office of Management and
                                          Budget.
PAD....................................  Peripheral arterial disease.
PDF....................................  Portable document format.
PVD....................................  Peripheral vascular disease.
SES....................................  Socioeconomic status.
SIDS...................................  Sudden infant death syndrome.
TCA statements.........................  Textual warning statements
                                          specified in section 4(1) of
                                          the FCLAA.
TTB....................................  Alcohol and Tobacco Tax and
                                          Trade Bureau.
WHO....................................  World Health Organization.
------------------------------------------------------------------------

II. Background

A. Need for the Regulation

    To help inform consumers of the potential hazards of cigarette
smoking, Congress passed the FCLAA that required that a printed text-
only warning appear on cigarette packages (Pub. L. 89-92). The 1965
warning requirement was modified by later amendments to the FCLAA,
including the Comprehensive Smoking Education Act of 1984 (Pub. L. 98-
474), which extended the warning requirement to cigarette advertising
and updated the one warning to four warnings, frequently referred to as
the Surgeon General's warnings.
    The FCLAA has required the inclusion of text-only warnings on
cigarette packages and in cigarette advertisements for many years. As
discussed in detail in section V.A, there is considerable evidence that
the Surgeon General's warnings go largely unnoticed and unconsidered by
both smokers and nonsmokers. These warnings, which have not changed in
nearly 35 years, have been described as ``invisible'' (Ref. 1) and fail
to convey relevant information in an effective way (Ref. 2 at p. 291).
The Surgeon General's warnings also do not include any color graphics.
    In 2009, in enacting the Tobacco Control Act, Congress further
amended the FCLAA and directed FDA to issue new cigarette health
warnings that would include a graphic component depicting the negative
health consequences of smoking to accompany the new textual warnings
(section 201 of the Tobacco Control Act). In enacting this legislation,
Congress also provided that FDA may adjust the warnings if FDA found
that such a change would promote greater public understanding of the
risks associated with the use of tobacco products (section 202 of the
Tobacco Control Act).
    Approximately 34.3 million U.S. adults smoke cigarettes (defined as
smoking at least 100 cigarettes during their lifetime and now smoking
cigarettes every day or some days) and nearly 1.4 million U.S. youth
(aged 12-17 years) smoke cigarettes (defined as past 30-day use) (Refs.
5 and 6). Results from the 2017 National Survey on Drug Use and Health
demonstrate that, on average, each day in the United States, about
2,000 youth under age 18 smoke their first cigarette, and 320 youth
become daily cigarette smokers (Ref. 7).
    The health risks associated with cigarette smoking are significant.
Cigarette smoking is the leading cause of preventable disease and death
in the United States and is responsible for more than 480,000 deaths
per year (Ref. 8). Smoking causes more deaths each year than human
immunodeficiency virus, illegal drug use, alcohol use, motor vehicle
injuries, and firearm-related incidents combined (Refs. 9 and 10). Over
16 million Americans alive today live with disease caused by smoking
cigarettes (Ref. 8). In addition to lung cancer, heart disease, and
chronic obstructive pulmonary disease (COPD), smoking also causes
numerous other serious health conditions that are less-known effects of
smoking and exposure to secondhand smoke, including many types of
cancer, premature birth, low birth weight, sudden infant death syndrome
(SIDS), respiratory illnesses, clogged arteries, reduced blood flow,
diabetes, rheumatoid arthritis, and vision conditions such as age-
related macular degeneration and cataracts (Ref. 8).
    In developing this proposed rule, FDA carefully examined the
scientific literature, including the 2014 Surgeon General's Report
(Ref. 8), which identified 11 more health conditions that have been
established to have sufficient evidence to infer a causal link to
cigarette smoking--the highest level of evidence of causal inferences
from the criteria applied in the Surgeon General's Reports. Those
health conditions examined in the 2014 Surgeon General's Report are in
addition to the more than forty unique health consequences already
classified in previous Surgeon General's Reports as being caused by
smoking and exposure to secondhand smoke. Additional findings in the
scientific literature demonstrate that the U.S. public--including youth
and adults, smokers and nonsmokers--holds misperceptions about the
health risks caused by smoking (Refs. 3 and 11-16). Through its review
of the scientific literature, as well as the Agency's science-based,
iterative research and development process (described in sections V and
VI), FDA determined that having warning statements focused on less-
known health consequences of smoking accompanied by photorealistic

images can promote greater public understanding of the risks associated
with cigarette smoking, especially given the unnoticed and
``invisible'' 1984 Surgeon General's warnings currently used in the
United States (see section V.A).
    Therefore, consistent with section 4 of the FCLAA (as amended by
sections 201 and 202 of the Tobacco Control Act), we are proposing a
set of textual warning label statements, to be accompanied by
concordant color graphics depicting the negative health consequences of
smoking, to appear on cigarette packages and in cigarette
advertisements. Specifically, we are proposing to replace part 1141 to
Title 21 of the Code of Federal Regulations (21 CFR part 1141), and the
new part 1141 would require new cigarette health warnings \1\ on
cigarette packages and in cigarette advertisements. These new cigarette
health warnings would consist of up to 13 textual warning label
statements accompanied by color graphics depicting the negative health
consequences of smoking. As required by section 4 of the FCLAA, the new
cigarette health warnings would appear prominently on packages and in
advertisements, occupying the top 50 percent of the area of the front
and rear panels of cigarette packages and at least 20 percent of the
area at the top of cigarette advertisements.
---------------------------------------------------------------------------

    \1\ For the purposes of discussion throughout this document, FDA
uses the term ``cigarette health warnings'' to refer to the required
warnings we are proposing.
---------------------------------------------------------------------------

    As described in section VII, FDA has determined that the proposed
new cigarette health warnings will advance the Government's interest in
promoting greater public understanding of the negative health
consequences of cigarette smoking.

B. History of the Rulemaking

    In the Federal Register of June 22, 2011 (76 FR 36628), FDA issued
a final rule entitled ``Required Warnings for Cigarette Packages and
Advertisements,'' which specified nine images to accompany the nine
textual warning statements for cigarettes set out in the Tobacco
Control Act. The final rule was challenged in court, and on August 24,
2012, the United States Court of Appeals of the District of Columbia
vacated the rule and remanded the matter to the Agency. R.J. Reynolds
Tobacco Co. v. Food & Drug Administration, 696 F.3d 1205 (D.C. Cir.
2012), overruled on other grounds by Am. Meat Inst. v. U.S. Dep't of
Agric., 760 F.3d 18, 22-23 (D.C. Cir. 2014) (en banc). On December 5,
2012, the Court denied the Government's petition for panel rehearing
and rehearing en banc, and the Government decided not to seek further
review of the Court's ruling. In a letter to Congress on March 15,
2013, the U.S. Attorney General reported FDA's intention to undertake
research to support a new rulemaking consistent with the Tobacco
Control Act (Ref. 17).
    Central to FDA's work since that time has been evaluating how to
address the D.C. Circuit's critiques of the prior rule and carefully
considering how to develop a research plan and rulemaking process that
will provide a robust record for a new cigarette health warnings rule.
Through extensive legal, scientific, and regulatory analyses, FDA
developed a science-based, iterative research process for developing
new cigarette health warnings to put forth in this proposed rule that
would advance the Government's substantial interest in promoting
greater public understanding of the negative health consequences of
smoking. Because these cigarette health warnings, as shown through the
robust scientific evidence described in detail in sections VI-VII, are
factual and accurate, advance the substantial Government interest in
promoting greater public understanding of the negative health
consequences of smoking, and are not unduly burdensome, FDA believes
the warnings would pass a First Amendment analysis under Zauderer v.
Office of Disciplinary Counsel, 471 U.S. 626 (1985) (or, if applied,
Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n, 447 U.S. 557
(1980)). After reviewing public comments and weighing additional
scientific, legal, and policy considerations, FDA intends to finalize
some or all of the 13 cigarette health warnings proposed in this rule.

C. Incorporation by Reference

    FDA is proposing to incorporate by reference certain material
entitled ``Required Cigarette Health Warnings.'' We have included an
electronic portable document format (PDF) file, containing the proposed
required warnings, as a reference in the docket (Ref. 18). Any final
rule would provide information on how to obtain the final electronic,
layered design files for each required warning, as well as technical
specifications to help regulated entities appropriately select, crop,
and scale the warnings to ensure the required warnings are accurately
reproduced across various sizes and shapes of cigarette packages and
cigarette advertisements. FDA would also provide instructions for how
to access this material (e.g., via download through FDA's website or a
file transfer protocol website). Any material incorporated by reference
must meet the Office of the Federal Register's (OFR) requirements for
incorporating material by reference (5 U.S.C 552(a) and 1 CFR part 51).

III. Legal Authority

    The Tobacco Control Act was enacted on June 22, 2009, amending the
FD&C Act and providing FDA with the authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect
the public health and to reduce tobacco use by minors. Section 201 of
the Tobacco Control Act amends section 4 of the FCLAA to require that
nine new health warning statements appear on cigarette packages and in
cigarette advertisements and directs FDA to ``issue regulations that
require color graphics depicting the negative health consequences of
smoking'' to accompany the nine new health warning statements. Under
section 201 of the Tobacco Control Act, FDA may adjust the type size,
text, and format of the cigarette health warnings as FDA determines
appropriate so that both the color graphics and the accompanying
textual warning label statements are clear, conspicuous, and legible
and appear within the specified area (15 U.S.C. 1333(d)).
    Section 202(b) of the Tobacco Control Act also amends section 4 of
the FCLAA to add a new subsection \2\ that permits FDA to, after
providing notice and an opportunity for the public to comment, adjust
the format, type size, color graphics, and text of any of the label
requirements, or establish the format, type size, and text of any other
disclosures required under the FD&C Act, if such a change would promote
greater public understanding of the risks associated with the use of
tobacco products. Such adjustments, including adjustments to the text
of some of the warning statements and to the number of proposed
required warnings, are included as part of this proposed rule.
---------------------------------------------------------------------------

    \2\ Section 201(a) of the Tobacco Control Act amends section 4
of the FCLAA to add a new subsection (d), ``Graphic Label
Statements,'' which is codified at 15 U.S.C. 1333(d). Section 202(b)
of the Tobacco Control Act amends section 4 of the FCLAA to also add
a new subsection (d), ``Change in Required Statements,'' which is
also codified at 15 U.S.C. 1333(d). Both provisions of the Tobacco
Control Act are correctly codified as ``15 U.S.C. 1333(d).''
---------------------------------------------------------------------------

    These requirements are supplemented by the FD&C Act's misbranding
provisions, which require that product labeling and advertising include
required warnings. For example, a tobacco product is deemed misbranded
under section 903(a)(1) or (a)(7)(A) of the FD&C Act if its labeling or
advertising is false or misleading in any

particular. Under section 201(n) of the FD&C Act (21 U.S.C. 321(n)), in
determining whether labeling or advertising is misleading, FDA
considers, among other things, the failure to reveal material facts
concerning the consequences that may result from the customary or usual
use of the product. Similarly, under section 903(a)(8)(B) of the FD&C
Act, a tobacco product is deemed misbranded unless the manufacturer,
packer, or distributor includes in all advertisements and other
descriptive printed matter, which FDA interprets as including packages,
a brief statement of, among other things, the relevant warnings. Under
section 701(a) of the FD&C Act, FDA has authority to issue regulations
for the efficient enforcement of the FD&C Act, and sections 704 and
905(g) provide FDA with general inspection authority.
    Section 909 of the FD&C Act authorizes FDA to require tobacco
product manufacturers to establish and maintain records, make reports,
and provide such information as the Agency may by regulation reasonably
require to ensure that a tobacco product is not adulterated or
misbranded and to otherwise protect public health.

IV. Cigarette Use in the United States and the Resulting Health
Consequences

    Cigarette smoking is the leading cause of preventable disease and
death in the United States and is responsible for more than 480,000
deaths per year (Ref. 8). Smoking causes more deaths each year than
human immunodeficiency virus (HIV), illegal drug use, alcohol use,
motor vehicle injuries, and firearm-related incidents combined (Refs. 9
and 10). In addition to lung cancer, heart disease, and COPD, smoking
also causes numerous other serious health conditions, including many
types of cancer, premature birth, low birth weight, SIDS, respiratory
illnesses, clogged arteries, reduced blood flow, diabetes, rheumatoid
arthritis, and vision conditions such as age-related macular
degeneration and cataracts (Ref. 8).

A. Smoking Prevalence and Initiation in the United States

    Approximately 34.3 million U.S. adults and nearly 1.4 million U.S.
youth (aged 12-17 years) smoke cigarettes (Refs. 5 and 6). Over 16
million Americans alive today live with disease caused by smoking
cigarettes (Ref. 8). Results from the 2017 National Survey on Drug Use
and Health demonstrate that, on average, each day in the United States,
about 2,000 youth under age 18 smoke their first cigarette, and 320
youth become daily cigarette smokers (Ref. 7).
    Cigarettes remain the most commonly used tobacco product in the
United States among adults, and a substantial percentage of U.S. adults
are cigarette smokers (Ref. 5). Although cigarette smoking prevalence
has generally declined over the past several decades, results from the
2017 National Health Interview Survey indicate that approximately 34.3
million U.S. adults (or 14.0 percent of the U.S. adult population) are
current cigarette smokers (Ref. 5). Among these adult smokers, the vast
majority--75 percent, or approximately 25.7 million people--smoke every
day. Smoking prevalence remains higher than the national average among
certain demographic subgroups of the adult population. For example,
among adults with differing levels of education, the highest prevalence
rates have been observed in adults with lower education levels. Data
indicate that 36.8 percent of adults with a General Education
Development (GED) certificate and 23.1 percent of adults with less than
a high school diploma were current smokers in 2017, compared with 7.1
percent of adults with a college degree and 4.1 percent of adults with
a graduate degree (Ref. 5).
    The National Youth Tobacco Survey is a nationally representative
survey of U.S. students attending public and private schools in grades
6 through 12. The 2018 National Youth Tobacco Survey data showed that
past 30-day smoking prevalence among high school students was 8.1
percent, representing 1.2 million young people, of which 23.1 percent
were frequent smokers (defined as cigarette use on 20 or more of the
past 30 days) (Ref. 6). The data also showed that past 30-day
prevalence among middle school students was 1.8 percent, representing
200,000 youth, of which 19.7 percent were frequent smokers (Ref. 6).
These youth who have smoked in the past 30 days are at particular risk
of becoming nicotine dependent through smoking. In one study, 22
percent of 7th grade students who had initiated occasional smoking
reported a symptom of nicotine dependence within 4 weeks after starting
to smoke at least once per month (Ref. 19). Among 60 students with
symptoms of nicotine dependence, 62 percent reported experiencing their
first symptom before smoking daily or began smoking daily only upon
experiencing their first symptom (Ref. 19). An analysis of the 2012
National Youth Tobacco Survey found that a substantial proportion of
adolescents that use tobacco report symptoms of nicotine dependence,
even with low levels of use (Ref. 20). Among adolescents who reported
only smoking cigarettes, 42.6 percent reported having strong cravings
to smoke, a symptom of nicotine dependence, in the past 30 days (Ref.
20).

B. Negative Health Consequences of Smoking

    Cigarette smoking remains the leading cause of preventable disease
and death in the United States. The 2014 Surgeon General's Report found
that cigarette smoking was responsible for an average of over 480,000
premature deaths in the United States each year from 2005 to 2009, of
which almost 440,000 occurred because of active smoking (Ref. 8). The
report also found that cigarette smoking was directly responsible for
163,700 deaths from cancer, 160,600 deaths from circulatory conditions,
and 113,100 deaths from pulmonary diseases each year. As a consequence
of secondhand smoke exposure, there were an additional 7,330 deaths
from lung cancer and 33,950 deaths from coronary heart disease
annually. Cigarette smoking therefore accounted for 87 percent of
deaths from lung cancer, 79 percent of deaths from COPD, and 32 percent
of deaths from coronary heart disease in the United States from 2005 to
2009.
    It has also been estimated that approximately 14 million U.S.
adults had serious medical conditions attributable to cigarette smoking
in 2009 (Ref. 21). COPD accounted for the largest number of these
conditions with an estimated 7.5 million Americans living with this
condition because of smoking. Other serious conditions for which
smoking-attributable morbidity was estimated included heart attack (2.3
million cases), cancer (1.3 million cases), and stroke (1.2 million
cases) (Ref. 21). Because individuals can live for many years with some
of these health conditions and, in some cases, smoking-attributable
health conditions can develop after a smoker has stopped smoking (e.g.,
lung cancer) (e.g., Ref. 22), the morbidity burden from cigarette
smoking is expected to remain high.
    Cigarette smoking also causes many other health conditions;
however, the link between smoking and these conditions is less known to
the public. For example, a meta-analysis found that current smokers are
twice as likely as never smokers to have age-related macular
degeneration (Ref. 23), a degenerative condition of the tissues of the
retina. Current smokers have also been found to have approximately 50
percent higher risk of age-related cataracts than never smokers
according to meta-analysis (Ref. 24). Cigarette smokers have an
increased risk of

numerous circulatory and metabolic conditions. Another meta-analysis
found that smokers have approximately 45 percent higher risk of
diabetes than nonsmokers (Ref. 25). It is estimated that 1.8 million
Americans have diabetes due to smoking (Ref. 21) and that 9,000
Americans die of diabetes due to smoking each year (Ref. 8). Current
smokers are nearly three times as likely as never smokers to have
peripheral arterial disease, a condition that can lead to amputation of
limbs (Ref. 26). Male smokers have been found to be 40 to 50 percent
more likely to have erectile dysfunction due to diminished blood flow
than nonsmokers (Refs. 27 and 28). Smokers also have increased risk of
many types of cancer, beyond lung cancer. For example, current smokers
have been found to have almost four times the risk of bladder cancer as
never smokers (Ref. 29), and it has been estimated that smoking is
responsible for 5,000 bladder cancer deaths in the United States each
year (Ref. 30). Smoking has also been established to cause cancers of
the head and neck, such as oral cancer. The American Cancer Society's
Cancer Prevention Study II found elevated relative risks (i.e., the
risk of the conditions among smokers compared to nonsmokers) for
current smoking of 10.9 for males and 5.1 for females for lip, oral
cavity, and pharyngeal cancers (i.e., male smokers have 10.9 times
higher risk of developing these cancers than male nonsmokers, and
female smokers have 5.1 times higher risk of developing these cancers
than female nonsmokers) and 14.6 for males and 13.0 for females for
laryngeal cancer (Ref. 31). These increased risks result in
approximately 4,900 deaths from lip, oral, and pharyngeal cancers and
3,000 deaths from laryngeal cancer from smoking in the United States
each year (Ref. 30).
    Secondhand smoke exposure also increases disease risks, especially
among infants and children. For example, secondhand smoke exposure has
been found to be causally linked to stroke, lung cancer, and other
disease in adults and lower respiratory illness in children (Ref. 8).
Additionally, maternal smoking (i.e., smoking while pregnant) has been
found to be associated with low birth weight (Ref. 32) and fetal growth
restriction (Ref. 33). The California Environmental Protection Agency
(EPA) has estimated that there are 24,500 cases of low birth weight due
to maternal exposure to secondhand smoke (referred to as
``environmental tobacco smoke'') in the United States per year (Ref.
34). Other health consequences in children exposed to secondhand smoke
include middle ear disease, respiratory symptoms, impaired lung
function, lower respiratory illness, and SIDS, and it is estimated that
400 infants die from SIDS due to exposure to secondhand smoke each year
(Ref. 8).

V. Data Concerning Cigarette Health Warnings

A. The Current 1984 Surgeon General's Warnings Are Inadequate

    As described in this section, cigarette warnings in the United
States have not changed in nearly 35 years, and the size and location
of the warnings have not changed in more than 50 years. The unchanged
content of these health warnings, as well as their small size and lack
of an image, severely impairs their ability to convey relevant
information about the negative health consequences of cigarette smoking
in an effective way (Ref. 2). Research has repeatedly illustrated that
the current 1984 warnings used in the United States frequently go
unnoticed or fail to convey relevant information regarding health risks
(Ref. 4). Moreover, although many members of the U.S. public possess
some general knowledge of the harms of smoking, substantial gaps in
knowledge remain, and smokers have misinformation regarding cigarettes
and the negative health effects of smoking (Refs. 36 and 37).
    Cigarette packages and advertisements can serve as an important
channel for communicating health information to broad audiences that
include both smokers and nonsmokers. Daily smokers, who in 2016
averaged 14.1 cigarettes per day, are potentially exposed to the
warnings on packages over 5,100 times per year, and, because these
packages are not always concealed and are often visible to those other
than the person carrying the package, warnings on those packages are
potentially viewed by many others, including nonsmokers (Refs. 38 and
40). Smokers and nonsmokers, including adolescents, also are frequently
exposed to cigarette advertising appearing in a range of marketing
channels, including print and digital media, outdoor locations, and in
and around retail establishments where tobacco products are sold (Refs.
42 and 43). The importance of cigarette advertising is reflected in
cigarette companies' substantial annual expenditures for cigarette
advertising and promotion in the United States, which totaled $1.3
billion in 2017 (not including the price discounts paid to cigarette
retailers and wholesalers to help lower the price of cigarettes to
consumers) (Ref. 41). Retail displays of cigarette packages and other
in-store cigarette advertisements are typically located in areas of a
store that are seen by a majority of consumers, such as near the
checkout counter, and provide significant opportunities for
communicating with smokers and nonsmokers (Refs. 44-47). The inclusion
of health warnings on cigarette packages and in advertisements
therefore can provide a critical opportunity to help smokers and
nonsmokers of all ages better understand the negative health
consequences of smoking. Prominent displays of such warnings are more
likely to be noticed and to impact learning and knowledge than non-
prominent displays (Refs. 3, 4, 39, 48-50). The World Health
Organization's (WHO) Framework Convention on Tobacco Control has also
recommended large pictorial cigarette warnings on tobacco products as a
way to increase public awareness about the negative health effects of
tobacco use (Ref. 51). Given the extreme risks cigarette smoking poses
to the public health, new warnings, as described in detail below and as
included in this proposed rule, are critical to promote greater public
understanding of the negative health consequences of cigarette smoking.
1. The Current 1984 Surgeon General's Warnings Have Not Changed in
Nearly 35 Years
    In response to the Surgeon General's first major report on smoking
and health in 1964, Congress passed the FCLAA to require warning labels
on all cigarette packages. The text-only warning was written in small
print and located on one of the side panels of each cigarette package.
It stated ``CAUTION: Cigarette Smoking May Be Hazardous to Your
Health.'' This language appeared on all cigarette packages sold from
January 1, 1966, through October 31, 1970. In 1969, Congress passed the
Public Health Cigarette Smoking Act (Pub. L. 91-222), which slightly
modified the warning statement on cigarette packages, but did not
require any warnings in cigarette advertisements. The new warning
language, ``Warning: The Surgeon General Has Determined That Cigarette
Smoking Is Dangerous to Health'', appeared on cigarette packages sold
in the United States from November 1, 1970, through October 11, 1985.
In 1972, the Federal Trade Commission (FTC) issued consent orders
requiring six major cigarette manufacturers and distributors to include
in all of their cigarette advertisements a clear and conspicuous
disclosure of the same warning required to be on packages (Ref. 35).

    In 1981, the FTC issued a report to Congress that concluded that
the cigarette health warnings had little effect on public awareness and
attitudes toward smoking. The FTC report stated that the existing
warning likely was ineffective because it: (1) Was overexposed and worn
out; (2) lacked novelty; (3) was too abstract; and (4) lacked personal
relevance (Ref. 52).
    Subsequently, Congress again modified cigarette warnings by
enacting the Comprehensive Smoking Education Act of 1984 (Pub. L. 98-
474), which required the following four rotational health warnings on
packages and advertisements: \3\
---------------------------------------------------------------------------

    \3\ Slightly different health warnings were required on outdoor
billboard advertisements.
---------------------------------------------------------------------------

     Surgeon General's Warning: Smoking Causes Lung Cancer,
Heart Disease, Emphysema, and May Complicate Pregnancy.
     Surgeon General's Warning: Quitting Smoking Now Greatly
Reduces Serious Risks to Your Health.
     Surgeon General's Warning: Smoking by Pregnant Women May
Result in Fetal Injury, Premature Birth and Low Birth Weight.
     Surgeon General's Warning: Cigarette Smoke Contains Carbon
Monoxide.
    In addition, the law established the location and format for these
warnings and mandated that they be rotated quarterly. Despite an FTC
recommendation to change the size and shape of warnings, Congress
retained the size and rectangular format of previous warnings (Ref. 218
at pp. 11, 12, 24, and 25; see also Ref. 52). As implemented, for
example, this means the Surgeon General's warnings have continued to be
printed in small type on one side panel of cigarette packages from
October 12, 1985, to the present.
    Nearly 35 years have passed since these changes and a substantial
body of research shows that the current 1984 Surgeon General's warnings
do not effectively promote greater public understanding of the negative
health consequences of smoking and that there are better approaches to
cigarette health warnings.
2. The Current 1984 Surgeon General's Warnings Do Not Effectively
Inform the Public Because They Do Not Attract Attention, Are Not
Remembered, and Do Not Prompt Thoughts About the Risks of Smoking
    Pictorial cigarette warnings that increase message processing will
aid consumer understanding of the negative health consequences of
smoking. Cognitive theories and information processing models describe
how information is gathered from the senses and is stored and processed
in the brain (Ref. 111). Message processing is important to learning
and understanding. Once an individual notices a warning, he or she
mentally stores the information found in the warning and gives meaning
to that information (Ref. 112). The individual mentally processes the
information and builds on it, which helps them better recall and
remember the information (Refs. 43 and 113). How much the information
is mentally processed, reflected on, and thought about impacts how well
the information is learned and understood (Ref. 114).
    Attracting and maintaining attention is an important step in how
communications, such as warning labels, can inform the public (Refs. 53
and 54). Findings from the International Tobacco Control Four Country
Survey (ITC-4) found that self-reports of noticing the health warnings
on cigarette packages were positively associated with health knowledge
among adults across the four countries studied, including the United
States (Ref. 3). However, eye-tracking studies, which assess attention
to visual stimuli, have documented low levels of attention to the
current Surgeon General's warnings in both adults and adolescents,
meaning that they do not attract attention (Refs. 55 and 56). One study
of adolescents viewing tobacco advertisements found that the average
viewing time of the Surgeon General's warnings amounted to only 8
percent of the total advertisement viewing time; nearly half (43.6
percent) of adolescents did not look at the warnings at all; and about
one-third (36.7 percent) did not look at the warning long enough to
read any of its words (Ref. 55). In that study, adolescents were unable
to recall the content of the current Surgeon General's warnings or to
correctly recognize the warnings from a list, indicating that the
current warnings are likely ineffective among adolescents (Ref. 55).
Similarly, a study of middle school students who viewed tobacco
advertisements with the Surgeon General's warnings found the total
amount of time spent focusing on the warning statement averaged
slightly less than one second (Ref. 56). Similar evidence that the
Surgeon General's warnings do not attract attention was found with a
sample of adult smokers in 2011 who were instructed to look at a
tobacco advertisement with a warning for 30 seconds, and of that time
participants spent an average of only 2.8 seconds looking at the
Surgeon General's warning specifically (Ref. 57).
    As discussed in the following paragraphs, researchers have also
found that the current 1984 Surgeon General's warnings are largely
unnoticed and unconsidered by both smokers and nonsmokers. This is in
accord with the findings of a major report on tobacco policy in the
United States by the Institute of Medicine (IOM) in 2007, which stated
that the 1984 warnings on U.S. cigarette packages are both ``unnoticed
and stale'' (Ref. 2 at p. 291). Similar conclusions were drawn in a
study with a nationally representative sample of middle and high school
students in the United States in 2012. Less than half (46.9 percent) of
students who saw a cigarette package with the Surgeon General's warning
reported seeing the warning ``most of the time'' or ``always'' (Ref.
58).
    Noticeability of the Surgeon General's warnings is also low for
adults. Findings from the ITC-4 published in 2007 found that only 30
percent of U.S. adult smokers noticed the warning ``often'' or ``very
often'' (Ref. 4). Even if people notice the warnings, less than 20
percent of smokers in the United States report reading the warning text
``often'' or ``very often'' (Ref. 4). Moreover, additional findings
from the ITC-4 found that less than half (46.7 percent) of U.S.
respondents considered cigarette packages as a source of information on
the negative health effects of smoking compared to 84.3 percent of
respondents in Canada, where pictorial health warnings are required
(Ref. 3). A study in 2009 found that 60 percent of U.S. adult smokers
said they ``never'' or ``rarely'' noticed warnings labels on cigarette
packages in the past month (Ref. 59). More recently, an analysis of the
Population Assessment of Tobacco and Health Study, an ongoing,
nationally representative, longitudinal cohort study of adults and
youth in the United States, found that the current health warnings on
cigarette packages often go unnoticed (Refs. 60 and 61). In the most
recent publicly available data (data collected from late 2016 through
the end of 2017), nearly three-quarters (73.5 percent) of the U.S.
population, including both youth and adults, indicated they ``never''
or ``rarely'' noticed the health warnings on cigarette packages in the
past 30 days (Ref. 61) (data available at https://www.icpsr.umich.edu/icpsrweb/NAHDAP/studies/36231). Among U.S. youth and adults who have
noticed cigarette health warnings in the past 30 days, 52.0 percent of
youth and 53.5 percent of adults responded that they ``never'' or
``rarely'' read or looked closely at the warnings in the past 30

days (i.e., do not attract attention) (Ref. 61).
    Other data support that adolescents also do not see or read, and do
not remember, the current 1984 Surgeon General's warnings on cigarette
packages and advertisements. A study of ninth-grade students found that
nearly one-third (27.8 percent) reported never seeing warning labels on
cigarettes and nearly half (46.1 percent) could not correctly identify
the location of the warnings on the package (Ref. 62).
    Similar data suggest that people also failed to notice or read the
current 1984 Surgeon General's warnings prior to the 1999 Master
Settlement Agreement, when cigarette advertising was common on outdoor
billboards. One study of adults found that drivers could read the
entire warning message on only 5 percent of highway billboard
advertisements and were only able to fully read the health warning on
18 of the 39 street billboards examined in the study (Ref. 63). All
these results indicate that the current warnings are not appropriately
conspicuous in advertisements compared to the rest of the advertising
message, as discussed in more detail below.
    Not only do the current Surgeon General's warnings not attract
attention, but they also are not remembered--and remembering is a key
component to long-term understanding of the information beyond surface-
level noticing of the information presented. Viewing time of U.S.
cigarette warnings is positively associated with recall (Refs. 55 and
56). Studies have documented low recall of warning statements for both
adults and adolescents. In a study conducted with 13- to 17-year-olds
who viewed five tobacco advertisements containing Surgeon General's
warnings, only 19 percent were able to recall the general theme of the
warning statement (Ref. 55). In another study, only between 20 and 53
percent of high school students could correctly recall each of the four
Surgeon General's warnings even when they were provided with the actual
wording, and some incorrectly recalled having seen a warning that was
not being used at the time (Ref. 62). Similarly, low levels of recall
were found in a study with high school students who viewed tobacco
advertisements containing Surgeon General's warnings. Although most
students (79 percent) reported seeing a warning, very few (15 percent)
reported the warning statement's concept and even fewer (6 percent)
correctly reported its exact message (Ref. 64).
    Beyond being noticed and being remembered, additional measures of
how well a message helps people understand its contents are to ask
whether the message makes them think about the message's substantive
information--showing an even deeper understanding of the information
being communicated. These measures, often termed ``cognitive
elaboration,'' are well-validated and often used in studies of
cigarette health warnings (See, e.g., Refs. 80 and 84). Research
demonstrates that the current 1984 Surgeon General's warnings do not
prompt thoughts about the risks of smoking, and they are also perceived
to be ineffective at making people think about those risks. Less than
40 percent of U.S. adult smokers in the ITC-4 reported that the Surgeon
General's warnings make them think about the health risk of smoking, a
level that was consistent between 2002 and 2005 (Ref. 4). In a study in
Buffalo, NY, 62 percent of adult smokers reported that the Surgeon
General's warning labels made them think ``a little'' or ``not at all''
about the health risks of smoking (Ref. 59). Participants in a
randomized clinical trial with smokers in California and North Carolina
reported that the Surgeon General's warnings made them think about the
warning message only a little (an average of 2.3 on a scale of 1 to 5)
and made them think about the harms of smoking only somewhat (an
average of 2.9 on a scale of 1 to 5) (Ref. 65). That study also found
that the Surgeon General's warnings were perceived as not impactful
(Ref. 65).
    Health communication research has found that adolescents also
report that the current 1984 U.S. cigarette warnings do not prompt
thoughts about the health risks of smoking. Among a nationally
representative sample of U.S. middle and high school students who
reported seeing a cigarette package, less than one-third (30.4 percent)
reported that cigarette warning labels made them think about health
risks ``a lot'' (Ref. 58). This proportion is even lower for adolescent
current smokers, as only 13.8 percent reported that warnings made them
think ``a lot'' about health risks (Ref. 58).
3. There Remain Significant Gaps in Public Understanding About the
Negative Health Consequences of Cigarette Smoking
    Consumers suffer from a pervasive lack of knowledge about and
understanding of the negative health consequences of smoking. A
nationally representative survey of 1,046 adult smokers found
widespread misperceptions regarding cigarettes and the negative health
effects of smoking (Refs. 36 and 37). Thirty-three percent of adult
smokers in the sample did not know that cigarettes were a proven cause
of cancer (Refs. 36 and 37). Additionally, a quarter of the sample did
not know that smoking was still dangerous to health even without
inhaling (Refs. 36 and 37). Another study of 776 adult and adolescent
smokers and nonsmokers asked participants what illnesses are caused by
smoking (Ref. 15). Whereas the majority of respondents identified lung
cancer as a smoking-related lung disease, only half mentioned emphysema
(Ref. 15). A much smaller proportion identified cardiovascular disease
(Ref. 15). Very few (3 to 7 percent) named any other smoking-related
cancer (besides lung, mouth, throat, or gum cancer), such as
pancreatic, cervical, bladder, or kidney cancer (Ref. 15). Very few
mentioned negative cardiovascular effects, such as hypertension,
atherosclerosis, aneurisms, or stroke, as smoking-related illnesses. In
addition, people underestimated the percent of people diagnosed with
lung cancer who would die from the condition (Ref. 15). Findings from
another study indicate that approximately one-third of U.S. adult
smokers believe that cigarettes have not been proven to cause cancer
(Ref. 211).
    Many studies show that the public has limited understanding of
other smoking-related health consequences such as impotence (Refs. 3,
12, 13, and 67; U.S. studies); stroke (Refs. 15 and 67; U.S. studies);
gangrene (Ref. 12; U.S. study); vision impairment/blindness (Refs. 11,
119, and 201; non-U.S. studies); emphysema and chronic bronchitis (Ref.
11; non-U.S. study); other cancers outside of lung cancer, such as
bladder cancer (Refs. 11, 13, 15, and 67; both U.S. and non-U.S.
studies); the effects of secondhand smoke on nonsmoker adults and
children (Ref. 16; non-U.S. study); and impacts on reproductive health
and pregnancy (Refs. 13 and 67; U.S. studies). Studies in the United
States have also documented that people are largely unaware of the
health risks of smoking specific to women, including infertility (Refs.
13, 14, and 67), osteoporosis, early menopause, spontaneous abortion,
ectopic pregnancy, and cervical cancer (Ref. 14 and 67). Research
findings also show gaps in public understanding of the negative health
effects of smoking during pregnancy. For example, one focus group study
conducted in four U.S. cities with current smoking women ages 18 to 30
years found that participants had low to moderate awareness of smoking
outcomes related to pregnancy (Ref. 68). These findings suggest that
the public does not

understand the complete range of illnesses caused by smoking,
indicating gaps in public understanding of the negative health
consequences of smoking.

B. Cigarette Health Warnings That Are Noticeable, Lead to Learning, and
Increase Knowledge Will Promote Public Understanding About the Negative
Health Consequences of Smoking

    To understand a message, individuals must first attend to the
message (i.e., notice and be made aware of the message), and then they
must process the information in the message (i.e., acquire knowledge of
and learn that information) (Ref. 70). When introduced in other
countries, pictorial cigarette warnings have been shown to increase
understanding of the negative health consequences of smoking (Refs. 3,
4, 39, and 48). The following section describes studies that
demonstrate how pictorial cigarette warnings promote greater public
understanding about the health consequences of smoking as they: (1)
Increase the noticeability of the warning's messages; (2) increase
knowledge and learning of the negative health consequences of smoking;
and (3) benefit subpopulations that have disparities in knowledge about
the negative health consequences of smoking. These studies incorporate
measures that evaluate the impact of tobacco health warnings on
understanding, many of which were drawn from the WHO's International
Agency for Research on Cancer handbook on the methods for evaluating
tobacco control policies (Ref. 71).
1. Cigarette Health Warnings That Are Noticeable Will Lead to Increased
Attention to the Warning Message
    To promote understanding of the content of a warning message,
individuals must first notice the warning and must be made aware of the
information contained in that warning (Refs. 53 and 54). In the
scientific literature on consumer warnings, features that increase the
noticeability of the warning label (also known as vivid features, such
as images) increase the likelihood that people will see and pay
attention to the warning message (Refs. 73 and 74). Physical features
(e.g., use of pictures or color) that make a message more noticeable
increase attraction and attention to the message (Ref. 75). A meta-
analysis found that warnings, not specific to cigarette warnings, that
include such features were more likely to attract attention than
warnings without these features (Ref. 76). One experiment among a
sample of U.S. adult smokers and middle school students found that
participants who viewed pictorial cigarette warnings with full color
spent more time looking at the warning compared to participants who
either viewed black and white pictorial warnings or text-only warnings
(Ref. 77).
    Communication theory and research explain the message
characteristics that impact how an individual is exposed to, attends
to, comprehends, and understands the content of the message (Refs. 43,
78, and 79). Messaging that includes vivid features (e.g., images)
increases attention to as well as cognitive elaboration (or thinking
about) and processing of the message, which leads to increased message
comprehension (Ref. 80). Messages that include vivid features, such as
images, are easier to imagine and are more engaging compared to
messages that do not include vivid features. An online experiment with
2,156 adults that examined varying levels and combinations of vivid
features (i.e., testimonial images, identifying information,
nontestimonial explanatory statements, testimonial explanatory
statements, and contextual information) found that increasing the
number of vivid features of cigarette warnings increased engagement
with the message (Ref. 81).
    a. Pictorial cigarette warnings increase attention to warning
messages, which leads to increased understanding of the negative health
consequences of smoking.
    Research supports the role of pictorial cigarette warnings in
increasing attention to and noticeability of warnings about the harms
of smoking. More noticeable pictorial cigarette warnings are more
effective in communicating the harms of smoking compared to text-only
cigarette warnings in other countries as well as in experimental
studies conducted in the United States (Refs. 3, 49, 50, 82, and 83).
Pictorial cigarette warnings result in higher noticeability of and
attention to the warning message compared to text-only cigarette
warnings (Refs. 4, 48, 72, 77, 82-94). One study using data from ITC-
Canada and ITC-Mexico assessed smokers' reactions to cigarette health
warnings (Ref. 48). During the study period, Mexico had text-only
cigarette warnings while Canada had pictorial cigarette warnings.
Compared to adult smokers in Mexico, Canadian adult smokers reported
greater levels of noticing the warning label and thinking about the
harms of smoking. Another ITC study assessed noticing warnings in a
sample of Chinese and Malaysian adult smokers (Ref. 83). After
introduction of the new Malaysian pictorial cigarette warnings in 2009,
there was a significant increase in the percentage of smokers who
reported noticing the health warnings often or very often (54.4 percent
pre-implementation compared to 67 percent post-implementation) (Ref.
83). Another study in the United States surveyed a sample of
adolescents who had a parent, guardian, or other household member who
participated in a randomized controlled trial in which a single
pictorial or text-only warning was displayed on the parent's cigarette
package for 4 weeks (Ref. 94). The pictorial cigarette warnings drew
greater attention among adolescents in the study, and adolescents more
accurately recalled the pictorial cigarette warning. In addition, the
pictorial cigarette warning was recognized from a list of warnings more
than the text-only cigarette warning.
    Studies demonstrate that increasing notice of and attention to the
information in a cigarette health warning promotes understanding of the
message. Data from the ITC-4 showed that noticing health warnings on
cigarette packages was associated with increased knowledge about the
health consequences of smoking (Ref. 3). Smokers who reported noticing
the cigarette health warnings were more likely to report believing that
smoking causes the specific health consequences contained in the
warnings, compared to those who did not notice the warnings.
    Once individuals notice and attend to the warning, they are able to
store and process the information in the warning that can be recalled
later; these processes contribute to engagement with the message and
lead to understanding. The important role of attention in message
storing and processing is well supported by research (see, e.g., Ref.
54). For example, a study with smokers found that the frequency of
noticing a cigarette health warning was associated with frequency of
thinking about the dangers of smoking (Ref. 95). In addition, studies
conducted in the United States with youth and adults have shown that
longer time spent looking at a cigarette health warning was associated
with greater recall of the information found on the warning (Refs. 56,
57, and 217), indicating that attention to a cigarette health warning
leads to storing of the warning content and later recall of that
information.
    b. Pictorial cigarette warnings increase the likelihood that
consumers will read, recall, and understand the warnings.
    Research supports the role of pictorial cigarette warnings in
increasing reading of and closely looking at the message

warning as well as aiding comprehension and understanding of the
information contained in the message warning. In a United States-based
experimental study, repeated viewing of warning labels is associated
with increased recognition and memory of the content of the label (Ref.
96). Research on recorded eye movement during reading of a warning
label provides support for the link between reading and comprehension
of the warning (Ref. 97). Measures of viewing duration (e.g., how long
the eyes are fixed on specific words in the warning) are associated
with how much participants are processing and can later recall that
information (Refs. 56, 97, and 98).
    Many studies support the finding that cigarette health warnings
with vivid features (e.g., images) are read and looked at more closely
compared to those without these features (Refs. 83, 86, 92; non-U.S.
studies). One study of U.S. adult smokers showed that viewing a
pictorial cigarette warning led to higher reported reading or looking
closely at the warning, label memory and recall, and perceived label
credibility compared to text-only cigarette warnings (Ref. 85). Another
study of U.S. adult smokers showed that participants who had a
pictorial cigarette warning put on their packs reported looking at the
label more often and correctly recalled the label's contents more often
than those with packs that had a text-only warning on them (Ref. 99). A
study in Australia found that students reported more frequent reading
and attending to the pictorial cigarette warnings after they were
introduced, as compared to when text-only warnings were displayed (Ref.
100).
2. Pictorial Cigarette Warnings Can Address Gaps in Public
Understanding About the Negative Health Consequences of Smoking
    a. Pictorial cigarette warnings increase knowledge and accurate
health beliefs by addressing gaps in public understanding about the
negative health consequences of smoking.
    Pictorial cigarette warnings increase consumer knowledge of the
harmful effects of smoking, which promotes greater public understanding
of the negative health consequences of smoking. Numerous non-U.S.
studies support the role of pictorial cigarette warnings in promoting
knowledge gains in cigarette-related health risks after implementation
of those warnings (Refs. 3, 39, 48, 49, 100, 102-107, 202, and 203).
One review examined health warning messages on tobacco products and
concluded that health warnings increased correct knowledge about the
negative health effects caused by smoking (Ref. 39). That review
concluded that pictorial cigarette warnings are significantly more
likely to draw attention, result in greater processing, and improve
memory of the health warning (Ref. 39). Summarizing these effects among
smokers, the National Cancer Institute concluded in its Tobacco Control
Monograph 21 that large pictorial health warnings on tobacco packages
are effective in increasing smokers' knowledge (Ref. 66).
    Visual depictions of smoking-related disease in pictorial cigarette
warnings help address gaps in public understanding of the negative
health consequences of smoking by providing new information beyond what
is in the text of the warnings through reinforcing and helping to
depict and explain the health effect described in the text (Ref. 101;
see also Ref. 39 at p. 330). Many studies have shown that exposure to
pictorial cigarette warnings promotes knowledge of the negative health
effects of smoking (Refs. 3, 48, and 102-107). For example, a study
using data from ITC-Canada and ITC-Mexico assessed smokers' reactions
to cigarette health warnings (Ref. 48). During the study period, Mexico
had text-only cigarette warnings while Canada had pictorial cigarette
warnings. Compared to smokers in Mexico, Canadian smokers had higher
levels of knowledge about smoking-related health outcomes, such as
stroke, impotence, and mouth cancer. Another study using ITC-4 data
showed that Canadian smokers were almost three times more likely than
non-Canadian smokers to accurately believe that smoking causes
impotence; during the time of the study, Canada was the only country to
require pictorial cigarette warnings and the only country that had a
warning about impotence (Ref. 3). Another study surveyed adult male
smokers to assess changes in awareness of health risks from smoking
after Malaysia implemented new pictorial cigarette warnings (Ref. 102).
Findings showed that knowledge of health risks across 13 different
health conditions was greater after pictorial cigarette warnings were
introduced in Malaysia (Ref. 102). In March 2007, Australia became the
first country to implement pictorial cigarette warning on cigarette
packages with the message that smoking causes blindness. ITC data from
adult smokers were analyzed assessing knowledge that smoking causes
blindness (Ref. 103). Findings indicated that Australian smokers were
significantly more likely to report that smoking causes blindness
compared to smokers in countries where there were no cigarette health
warnings about blindness (Canada, the United Kingdom, and the United
States) (Ref. 103). After the introduction of the blindness warning,
Australian smokers were dramatically more likely than before to report
knowing that smoking causes blindness (62 compared to 49 percent) (Ref.
103). Another study assessing smokers' beliefs about the health effects
of smoking in South Australian smokers found that, post-implementation
of pictorial cigarette warnings, participants reported more health
beliefs about smoking-related negative health effects, such as
blindness/eye damage, stroke, harm to unborn babies, mouth cancer,
throat cancer, blocked arteries, as compared to their health beliefs
when previous text-only warnings were required (Ref. 105).
    Research supports that exposure to pictorial cigarette warnings
leads to knowledge gains about the harms of smoking among adolescents,
whereas, as discussed earlier, the current 1984 Surgeon General's
warnings do not. A report of Canadian warnings indicated that pictorial
cigarette warnings improved knowledge of specific negative health
effects of smoking among adolescents (e.g., increased knowledge of
bladder cancer, impotence in men, mouth cancer, gum or mouth disease,
reduced growth in babies during pregnancy, and strokes) (Ref. 108). One
study that surveyed Australian students in grades 8 through 12 found
increases in the proportion of students who recognized the smoking-
related effects of mouth cancer and peripheral vascular disease after
the introduction of new pictorial cigarette warnings on those topics
(Ref. 100). Another study examined the effects of viewing health
warnings on beliefs about the specific negative health effects of
smoking among adult smokers and adolescents (aged 16 to 18 years). For
both adults and adolescents, exposure to pictorial cigarette warnings
that highlighted specific health topics led to increases in correct
beliefs about smoking causing the specific health topic in the warning.
For some topics (e.g., smoking causes strokes, smoking causes
impotence), increases in correct health beliefs were only found in
adolescents and not adults (Ref. 106).
    There are a small number of recent studies conducted in the United
States that failed to find an effect of pictorial cigarette warnings on
increasing health beliefs about the negative effects of smoking (Refs.
77, 84, 109, and 110). The failure in those studies to find an

association between exposure to pictorial cigarette warnings and
increased health beliefs may be partly or fully attributable to the
fact that, as previously described, the public already has a high pre-
existing level of knowledge of the specific health consequences
described in the warnings tested in those studies, some of which
included warning statements set forth by Congress in the Tobacco
Control Act. For example, a few studies have found increases in
knowledge only of less-known conditions (e.g., blindness) but not of
more well-known negative health effects (e.g., lung cancer) (Refs. 12
and 105). Notably, the increases in health beliefs from pictorial
warnings were greatest for negative health effects that started with
lower levels of prior beliefs about that health condition, such as
gangrene and stroke (Ref. 12). This suggests that the impact of
cigarette warnings on knowledge is greatest for topics that are not
well known to the public.
    In summary, pictorial cigarette warnings that convey the risk of
specific negative health effects from smoking can increase beliefs and
knowledge about the health consequences of smoking, particularly for
negative health effects that are less known.
    b. Pictorial cigarette warnings increase information processing and
learning of new information about the negative health consequences of
smoking.
    Pictorial cigarette warnings that increase message processing will
aid consumer understanding of the negative health consequences of
smoking. Cognitive theories and information processing models describe
how information is gathered from the senses and is stored and processed
in the brain (Ref. 111). Message processing is important to learning
and understanding. Once an individual notices a warning, he or she
mentally stores the information found in the warning and gives meaning
to that information (Ref. 112). The individual mentally processes the
information and builds on it, which helps them better recall and
remember the information (Refs. 43 and 113). How much the information
is mentally processed, reflected on, and thought about impacts how well
the information is learned and understood (Ref. 114). Health warnings
are therefore frequently assessed by looking to how noticeable they
are; how well remembered their content is; and how much they prompt
individuals to think about their content.
    i. Pictorial cigarette warnings lead to increased thinking about
the harms of smoking.
    One way to process information found in a health message includes
thinking about the message's content. Research (from both U.S. and
international studies) has demonstrated that pictorial cigarette
warnings lead to increased thinking (i.e., ``cognitive elaboration'')
about the content of the warning (Refs. 49, 83, 84, 86, 87, 100, 102,
104, and 115). For example, one study of U.S. adult smokers found that
participants who were exposed to pictorial cigarette warnings processed
the information in deeper ways, such as thinking about their own health
problems (e.g., diabetes) in the context of smoking (Ref. 99).
Participants assigned to view pictorial cigarette warnings had more
accurate recall and were better able to describe the content of the
warning compared to those assigned to view the text-only warnings (Ref.
99). A meta-analysis of experimental studies conducted in twenty
countries compared pictorial cigarette warnings to text-only cigarette
warnings (Ref. 50). Compared to text-only warnings, pictorial cigarette
warnings elicited more thinking about the message content (Ref. 50).
Another study had U.S. adolescent and adult participants view one of
nine pictorial cigarette warnings (Ref. 116). Exposure to pictorial
cigarette warnings caused individuals to think about family members who
smoke or how smoking could hurt the health of family members (Ref.
116).
    ii. Pictorial cigarette warnings lead to exposure to and learning
of new information about the negative consequences of smoking to
smokers and nonsmokers.
    Health warnings on cigarette packages can serve as prominent
sources of health information for both smokers and nonsmokers (Ref. 2).
Daily smokers in the United States, who in 2016 averaged 14.1
cigarettes per day, are potentially exposed to the pictorial cigarette
warnings on packages over 5,100 times per year, and, because these
packages are not always concealed and are often visible to those other
than the person carrying the package, information found on those
packages are potentially viewed by many others, including nonsmokers
(Refs. 38-40). Indeed, a review of tobacco health warning studies in
more than 13 countries, including the United States, concluded that
pictorial warnings are an important source of health information for
smokers as well as nonsmokers (Ref. 39).
    Pictorial cigarette warnings have also been shown to be effective
in communicating the health consequences of smoking to youth (Refs. 94
and 100). A report prepared for Health Canada showed that approximately
6 years after the introduction of pictorial cigarette warnings in
Canada, more than 90 percent of Canadian youth agreed that the
pictorial cigarette warnings had provided them with important and
accurate information about the negative health effects of smoking
cigarettes (Ref. 108). Pictorial cigarette warnings can also serve as
effective sources of information for youth with smoking parents. One
study interviewed adolescents whose parents received pictorial warnings
on their cigarette packages as part of a randomized clinical trial
(Ref. 117). When asked about the pictorial cigarette warnings,
adolescents described how the warnings caught their attention. While
many already reported believing that smoking was dangerous before
seeing the warnings, viewing the warnings strengthened and reinforced
beliefs about the negative health consequences of smoking.
    In the health communication scientific literature, messages that
are accompanied by images closely linked to the message content (i.e.,
concordant) are shown to increase the likelihood that consumers will
comprehend the message (Ref. 118). Because of this, pictorial cigarette
warnings increase understandability and learning of the message. After
implementation of Australia's pictorial cigarette warnings, focus group
research findings concluded that images depicting the health
consequences of smoking provided new information beyond what was
contained in the text through providing a visual explanation of the
negative health effects noted in the text (Ref. 101). For example, very
few participants were aware that smoking caused peripheral vascular
disease, and having an image of peripheral vascular disease provided a
visual explanation of the effects of the disease, which led to learning
of the consequences of smoking (Ref. 101). Studies in other countries
have shown that participants tend to rate pictorial cigarette warnings
as being more informative than text-only warnings (Refs. 119 and 120).
A study with U.S. young adult smokers and nonsmokers evaluated the
effect of pictorial cigarette warnings on learning (Ref. 121). Findings
showed that participants rated pictorial cigarette warnings higher in
increasing personal understanding of the health consequences of smoking
and leading to learning new information compared to text-only warnings.
    c. Pictorial cigarette warnings can increase understanding of the
negative health consequences of smoking across diverse populations.

    Research has shown that being a member of a group with lower
socioeconomic status (SES), as measured by income and education levels,
is associated with having lower knowledge of the negative health
consequences of smoking; most smokers in the United States are in this
group (Refs. 5, 123, and 124). One study found that knowledge about the
negative health effects of smoking was lower among older respondents,
those with lower educational attainment, and those from racial or
ethnic minority groups (Ref. 123). Some subpopulations, such as
specific racial or ethnic minority groups (e.g., American Indian/
Alaskan Natives), those with a lower level of education, and those
experiencing serious psychological distress (Ref. 5), are
disproportionately represented in lower SES subgroups, which have lower
access to health information and are more likely to smoke cigarettes
(Refs. 5, 204, and 205). Having a lower SES is also associated with
lower health literacy compared to those with higher SES (Ref. 125).
    One study compared data from higher and lower income adult smokers
who participated in the ITC-4 and found that higher income smokers had
71 percent, 34 percent, and 83 percent higher odds of reporting
knowledge that smoking causes heart disease, stroke, and lung cancer,
respectively (Ref. 124). However, another study found that, among
nonsmoking Canadian adolescents, having less spending money was
associated with lower knowledge of the negative health effects of
smoking but that disparities in knowledge were not as strong in
adolescent smokers as they were in other studies with adults (Ref. 11).
    In addition, smokers with less education may be less likely to
notice and recall health information in cigarette warnings (Refs. 69
and 72). In its 2007 report, the IOM expressed concern about the
ability of consumers with less education to recall the information
included in text-based messages (Ref. 2). The IOM (Ref. 2) cited a
study of Canadian smokers' knowledge about the country's prior warning
requirements, which, like the current 1984 Surgeon General's warnings,
only contained four textual warning statements. In that study, compared
to women with higher educational attainment, comparatively fewer women
with lower educational attainment were aware of messages that warn of
the harmful effects of smoking on life expectancy, heart disease, or
pregnancy (Ref. 69). A study of pregnant women found that those with
lower reading levels had less knowledge about the negative health
effects of smoking (Ref. 136).
    Pictorial cigarette warnings are likely to help reduce disparities
among disadvantaged groups in consumer understanding about the harms of
smoking. One study examined perceptions of pictorial cigarette warnings
among low-income adult smokers using in-depth interviews (Ref. 126).
Some participants reported that the image in the pictorial cigarette
warning influenced their perceptions of smoking-related conditions
because they contained new information and portrayed long-term health
outcomes (e.g., diminished quality of life, irreparable physical
damage, death) (Ref. 126).
    Research has shown that pictorial cigarette warnings increase
understanding of the health consequences of smoking across diverse
settings and countries (Refs. 4, 87, 102, 119, and 206-210). These
findings demonstrate that pictorial cigarette warnings are effective
for diverse populations that differ in cultural, racial, ethnic, and
socioeconomic backgrounds. One large study that randomized 3,371 adult
smokers to view either pictorial cigarette warnings or text-only
warnings found that participants who viewed the pictorial warnings had
rated the warnings as being significantly more noticeable and more
credible compared to participants who viewed the text-only warnings
(Ref. 127). No statistically significant interactions were found
between these results and race/ethnicity, education, or income, which
suggests that the pictorial warnings had consistently greater
noticeability and credibility across all the study subpopulations than
the text-only warnings (Ref. 127). Other research suggests that among
lower SES groups, pictorial cigarette warnings may lead to stronger
effects in noticing the warning and thinking about smoking risks
compared to those in higher SES groups because of the added benefits of
the information contained in the pictorial warning (Refs. 72 and 206).
Collectively, the evidence demonstrates that pictorial cigarette
warnings are effective across diverse populations and settings and
likely will help reduce disparities found in consumer understanding
about the harms of smoking.

VI. FDA's Process for Developing and Testing the Proposed Cigarette
Health Warnings

    Findings from the scientific literature indicate that an important
first step in promoting public understanding of health risks is to
raise public awareness of those risks, particularly if the risks are
not commonly known (Refs. 130 and 131) (see section V.B). Measuring
whether information is new helps identify opportunities to improve
understanding through increased awareness. Additionally, communication
science research has found that people are more likely to pay attention
to information that is new, and attention plays a vital role in message
comprehension and learning (Ref. 128).
    As described in detail in this section, FDA undertook a science-
based, iterative research and development process to consider whether
revisions to the textual warning statements specified in section 4(1)
of the FCLAA (``TCA statements'') would promote greater public
understanding of the risks associated with smoking and then to develop
and test paired concordant color graphics to accompany the textual
warning statements. As part of this process, FDA examined the nine TCA
statements to consider whether to revise those statements to promote
greater public understanding of the risks associated with cigarette
smoking (see sections VI.A-C), which included a review of the risks
associated with cigarette smoking and a focus on negative health
effects that are less known, less understood, or about which the public
holds misperceptions. After considering this information, FDA developed
initial versions of revised textual warning statements (``revised
statements''). Based on FDA's careful review of the scientific
literature on the health risks associated with cigarette smoking,
evaluation of the public's general awareness and knowledge of those
health risks, and assessment of the Agency's own consumer research on
potential revised warning statements, FDA determined there is
sufficient support to propose adjusting some of the text of the TCA
statements, as authorized by section 4(d) of the FCLAA (as amended by
section 202(b) of the Tobacco Control Act). While developing the
revised statements, FDA worked in parallel to develop color graphics,
in the form of photorealistic images, depicting the negative health
consequences of cigarette smoking to accompany the statements (section
4(d) of the FCLAA; see section VI.D). Once FDA determined there was
sufficient support to propose adjusting the text of the required
warnings, identified textual warning statements for further testing,
and developed photorealistic images to accompany those statements, we
paired textual warning statements with concordant images to assess
which statement-and-image pairings should be

considered for this proposed rule. FDA selected 16 statement-and-image
pairings to test in a final quantitative consumer research study.
Results of this study (described in section VI.E), along with FDA's
formative research, review of the scientific literature, and internal
scientific and public health communications expertise, informed FDA's
selection of the 13 cigarette health warnings in this proposed rule.
The following subsections describe each of these steps in more detail.
    The Agency invites comment on the warnings proposed in this rule,
including its proposed revisions to the textual warning statements and
its proposed photorealistic images. Given the degree of public and
stakeholder interest in this area, and the legal complexities involved,
FDA also seeks proposals for alternative text and images you believe
would advance the Government's interest in promoting greater public
understanding of the negative health consequences of smoking. If
proposing alternative text and images to those in this proposed rule,
please provide scientific information supporting that the alternative
text and images would, in fact, promote greater public understanding of
the negative health consequences of smoking. Proposals for alternative
images should accompany either one of FDA's proposed textual warning
statements or an alternative textual warning statement you are
proposing.

A. Review of the Negative Health Consequences of Cigarette Smoking

    In determining whether FDA should, as authorized by section 4(d) of
the FCLAA, adjust the format, type size, color graphics, and text of
any of the label requirements to promote greater public understanding
of the risks associated with the use of tobacco products, FDA reviewed
the scientific literature as well as available nationally
representative data on current consumer knowledge and misperceptions
about the health risks of smoking. Despite the current 1984 Surgeon
General's warnings on cigarette packages and in cigarette
advertisements, the literature demonstrates that substantial
proportions of U.S. smokers hold misperceptions about the health risks
associated with cigarette smoking, particularly regarding cancer, heart
disease, and other health conditions. For more discussion, see section
V.A.3 (``There Remain Significant Gaps in Public Understanding About
the Negative Health Consequences of Cigarette Smoking'').
    FDA considered the evidence presented in Surgeon General's Reports
to identify all negative health consequences that are causally linked
to cigarette smoking and exposure to secondhand smoke, including
negative health consequences causally linked to cigarette smoking since
the passing of the Tobacco Control Act in 2009. Surgeon General's
Reports provide definitive syntheses of the available evidence on
smoking and health and use such evidence to reach conclusions on
causality that have public health implications (Ref. 8, p. 3). Surgeon
General's Reports classify the strength of causal inferences in a four-
level hierarchy based upon work of the IOM (now the National Academy of
Medicine) and the International Agency for Research on Cancer (IARC)
(Refs. 200 and 212):
     Evidence is sufficient to infer a causal relationship.
     Evidence is suggestive but not sufficient to infer a
causal relationship.
     Evidence is inadequate to infer the presence or absence of
a causal relationship (which encompasses evidence that is sparse, of
poor quality, or conflicting).
     Evidence is suggestive of no causal relationship (Refs.
154 at p. 18, 8 at pp. 3, 52, and 53).
    These standardized determinations consider factors such as the
consistency of results; the strength of the association between smoking
and specific health effects; specificity; temporality; coherence,
plausibility, and analogy; biologic gradient (dose-response evidence);
and natural experiments (Ref. 154 at pp. 21-23). The rigor and
consistent application of these causal standards has rendered Surgeon
General's Reports the preeminent source regarding whether cigarette
smoking and exposure to secondhand smoke are causally related to
specific negative health consequences. Throughout this proposed rule,
and in the context of the word ``cause'' or ``causes'' used in the
textual warning statements included therein, FDA relied on the four-
level classification provided in the Surgeon General's Reports.
Further, the negative health consequences addressed in this proposed
rule's warnings are all rated at the highest level, meaning that the
proposed warnings' use of ``cause'' and ``causes'' is uniformly based
upon the strongest possible level of scientific inference: ``Evidence
is sufficient to infer a causal relationship'' (Ref. 8 at p. 3). A
causal relationship supported at this level expresses ``[t]he judgment
that smoking causes a particular disease'' and ``has immediate
implications for prevention of the disease'' (Ref. 154, p. 18).
    Since the first Surgeon General's Report published in 1964,
evidence of the negative health consequences of cigarette smoking and
secondhand smoke has expanded dramatically. For example, the 2014
Surgeon General's Report, entitled ``The Health Consequences of
Smoking: 50 Years of Progress'' (Ref. 8), presented a robust body of
scientific evidence documenting the health consequences from both
smoking and exposure to secondhand smoke across a range of diseases and
organ systems. In particular, the 2014 Surgeon General's Report added
eleven diseases to the long list of diseases causally linked to
cigarette smoking: Liver cancer, colorectal cancer, age-related macular
degeneration, orofacial clefts from maternal smoking during pregnancy,
tuberculosis, stroke (for adults), diabetes, erectile dysfunction,
ectopic pregnancy, rheumatoid arthritis, and impaired immune function
(Ref. 8, pp. 4-5). The health conditions established to be causally
linked to cigarette smoking in the 2014 Surgeon General's Report are in
addition to the more than 40 unique health consequences of cigarette
smoking and exposure to secondhand smoke determined by earlier studies
(Ref. 8).
    FDA determined that some of the health conditions newly identified
in the 2014 Surgeon General's Report represented an opportunity to
educate the public about negative health consequences of cigarette
smoking that are subject to particularly low awareness and
understanding. Historically, the large majority of public health
messaging about the health risks associated with cigarette smoking has
focused on a small subset of health conditions, notably lung cancer and
addiction. The current Surgeon General's warnings for cigarette
packages and advertisements, which have not been updated for nearly 35
years despite increasing evidence of additional, serious negative
health effects of cigarette smoking, only include warnings on a limited
number of health conditions (i.e., lung cancer, heart disease,
emphysema, pregnancy complications, and general risks to health) (see
section V for additional discussion of the current Surgeon General's
warnings). Both U.S. and non-U.S. studies have found that consumers are
largely unaware of the negative health consequences of cigarette
smoking not mentioned in current warnings as well as more specific
information about the negative health effects and their mechanisms
(Refs. 3, 11, 13-16, 67, 145, and 213-215).

Additionally, and as discussed in section V, the current Surgeon
General's warnings often go unnoticed and are not effective at
informing the public of the health risks associated with cigarette
smoking.

B. Developing Revised Textual Warning Statements

    After FDA's initial review of the scientific literature on
cigarette smoking-related consumer knowledge and misperceptions, as
well as its epidemiological reviews of the causally linked health
conditions identified in the recent Surgeon General's Reports and
scientific literature, we evaluated whether revising some or all of the
TCA statements to focus on negative health effects that are less-known
or less understood by consumers would promote greater public
understanding of the risks associated with cigarette smoking. FDA
developed initial versions of revised statements for further review,
testing, and refinement. These initial revised statements were reviewed
by FDA internal epidemiological experts to ensure that the health
conditions under consideration were causally linked to cigarette
smoking or exposure to secondhand smoke, and that these smoking-
attributed conditions were not rare.
    Through a series of 16 qualitative focus groups with adolescent
smokers, adolescents at risk for starting smoking, and adult smokers
(OMB control number 0910-0674, ``Qualitative Study on Cigarettes and
Smoking: Knowledge, Beliefs, and Misperceptions''), FDA gathered
additional input on consumers' awareness of the negative health
consequences of cigarette smoking and assessed initial consumer
responses to 17 revised statements \4\ and the nine TCA statements.
These focus groups provided FDA with qualitative feedback on consumers'
comprehension of each statement, the believability of the content of
each statement (e.g., that smoking causes the health condition noted),
if that health condition was new information to participants, and other
feedback about the statement and how to make it more understandable or
convey the intended message more clearly. Generally, participants
reported the initial revised statements presented new information more
than the TCA statements. FDA considered this information in identifying
15 revised statements \5\ for further quantitative (see section VI.C)
and qualitative (see section VI.D) testing.
---------------------------------------------------------------------------

    \4\ FDA developed multiple revised versions of some TCA
statements, developed no revised version for others, and also
developed statements for which there is no TCA statement focused on
that health condition.
    \5\ The 15 revised statements FDA refined for further testing
did not include revised versions of the following 4 TCA statements:
WARNING: Cigarettes are addictive; WARNING: Smoking can kill you;
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers; and
WARNING: Quitting smoking now greatly reduces serious risks to your
health. FDA made this determination based on focus group feedback
and findings from the scientific literature suggesting the health
conditions described in these 4 statements are better-known health
consequences of smoking and that revised statements on these
conditions likely would not promote greater public understanding of
the negative health consequences of smoking more than either the
relevant TCA statements themselves or new statements on different
health conditions.
---------------------------------------------------------------------------

C. FDA's Consumer Research Study on Revised Textual Warning Statements

    FDA next conducted a large quantitative consumer research study to
assess which, if any, of the revised warning statements would promote
greater public understanding of the risks associated with cigarette
smoking as compared to the TCA statements (OMB control number 0910-
0848, ``Experimental Study on Warning Statements for Cigarette Graphic
Health Warnings''). A secondary goal of this study was to inform the
selection of health conditions and specific statements that, when
paired with color graphics depicting the health conditions described in
the warning statements, would form new cigarette health warnings for
further testing.
1. Study Design
    FDA's study on revised textual warning statements had two phases,
both of which were completed during a single online session. The study
sample comprised 2,505 participants. This included adolescents (aged 13
to 17 years), half of whom were current smokers and the rest of whom
had never smoked but were at risk for starting smoking; younger adult
(aged 18 to 24 years) current smokers; and older adult (aged 25 years
and older) current smokers. Study participants in all age groups were
randomly assigned to a condition that determined which warning
statements they viewed during the study. Participants in the control
condition viewed the nine TCA statements. Participants in each of the
treatment conditions viewed one of 15 revised warnings statements plus
8 TCA warning statements. Table 1 provides a list of the 9 TCA
statements and 15 revised warning statements that FDA evaluated in this
study.

 Table 1--TCA and Revised Statements Studied in FDA's Consumer Research
                                  Study
------------------------------------------------------------------------
                                              Revised statements (short
        TCA statements (short name)                     name)
------------------------------------------------------------------------
WARNING: Cigarettes are addictive           WARNING: Smoking causes
 (addictive).                                mouth and throat cancer
WARNING: Tobacco smoke can harm your         (mouth and throat cancer).
 children (harm children).                  WARNING: Smoking causes head
WARNING: Cigarettes cause fatal lung         and neck cancer (head and
 disease (fatal lung disease in smokers).    neck cancer).
WARNING: Cigarettes cause cancer            WARNING: Smoking causes
 (unspecified cancer).                       bladder cancer, which can
WARNING: Cigarettes cause strokes and        lead to bloody urine
 heart disease (strokes and heart            (bladder cancer).
 disease).                                  WARNING: Smoking during
WARNING: Smoking during pregnancy can harm   pregnancy causes premature
 your baby (harm your baby).                 birth (premature birth).
WARNING: Smoking can kill you (kill you).   WARNING: Smoking during
WARNING: Tobacco smoke causes fatal lung     pregnancy stunts fetal
 disease in nonsmokers (fatal lung disease   growth (stunts fetal
 in nonsmokers).                             growth).
WARNING: Quitting smoking now greatly       WARNING: Smoking during
 reduces serious risks to your health        pregnancy causes premature
 (quit now).                                 birth and low birth weight
                                             (low birth weight).
                                            WARNING: Secondhand smoke
                                             causes respiratory
                                             illnesses in children, like
                                             pneumonia (pneumonia).
                                            WARNING: Smoking can cause
                                             heart disease and strokes
                                             by clogging arteries
                                             (clogged arteries).
                                            WARNING: Smoking causes
                                             COPD, a lung disease that
                                             can be fatal (COPD).
                                            WARNING: Smoking causes
                                             serious lung diseases like
                                             emphysema and chronic
                                             bronchitis (emphysema and
                                             chronic bronchitis).

                                            WARNING: Smoking reduces
                                             blood flow, which can cause
                                             erectile dysfunction
                                             (erectile dysfunction).
                                            WARNING: Smoking reduces
                                             blood flow to the limbs,
                                             which can require
                                             amputation (amputation).
                                            WARNING: Smoking causes type
                                             2 diabetes, which raises
                                             blood sugar (diabetes).
                                            WARNING: Smoking causes age-
                                             related macular
                                             degeneration, which can
                                             lead to blindness (macular
                                             degeneration).
                                            WARNING: Smoking causes
                                             cataracts, which can lead
                                             to blindness (cataracts).
------------------------------------------------------------------------

    In Phase 1 of the study, all participants viewed nine warning
statements, one at a time, presented in random order. Participants in
the control condition viewed the nine TCA statements. Participants in
the treatment condition viewed 8 TCA statements plus 1 of 15 revised
statements, for a total of 9 statements. Revised statements that did
not have a TCA counterpart (e.g., the diabetes statement) are called
``new content'' statements for short. Each revised statement either was
presented in place of a more general TCA statement on the same or
similar health condition (e.g., a revised statement on head and neck
cancer replaced the TCA unspecified cancer statement) or, for ``new
content'' statements, was presented in place of a randomly selected TCA
statement (e.g., a revised statement on diabetes was presented in place
of the TCA statement on fatal lung disease in smokers). After viewing
each individual warning statement, participants answered questions
about that statement before viewing and answering questions about the
next assigned statement. The study evaluated the following outcomes:
     Whether the warning statement was new information to
participants (``new information'') (i.e., participants reported that
they had not previously heard of that specific health effect from
cigarette smoking);
     Whether participants learned something from the warning
statement (``self-reported learning'');
     Whether the warning statement made participants think
about the health risks of smoking (``thinking about risks'');
     Whether the warning statement was believable
(``believable'');
     Whether the warning statement was informative
(``informativeness'') (i.e., participants reported that the warning was
informative to them);
     Whether the warning statement was perceived to be a fact
or an opinion (``factuality''); and
     Whether participants reported beliefs linking smoking and
the health consequences in the warning statement (``health beliefs'').
    In Phase 2 of the study, all participants viewed nine warning
statements presented at the same time. Participants assigned to the
control condition viewed the nine TCA warning statements again.
Participants assigned to the treatment conditions viewed one of several
different combinations of nine revised warning statements. After
viewing the nine warning statements, all participants answered
questions about their beliefs about the link between smoking and each
of the health consequences presented in the warning statements they
viewed (``Health beliefs'').
    More details about the study methodology can be found in the study
report, which we have included in this docket (Ref. 129).\6\
---------------------------------------------------------------------------

    \6\ FDA will conduct a peer review of this consumer research
study. FDA's peer review plans are available online at https://www.fda.gov/science-research/science-and-research-special-topics/peer-review-scientific-information-and-assessments.
---------------------------------------------------------------------------

2. Study Findings
    The outcomes ``new information'' and ``self-reported learning''
provide useful data for determining whether a revised warning statement
would promote greater understanding than a TCA statement of the risks
associated with cigarette smoking, as described below. In general,
relatively few participants reported that the content of the TCA
statements was new information; more participants reported that the
revised statements were new information than did participants who
viewed the TCA statements on the same health conditions; and most
participants reported that the ``new content'' statements were new
information. For example, fewer than 24 percent of participants
reported that the TCA statements were new information to them,\7\
whereas more than 66 percent of participants who viewed the ``new
content'' statements (e.g., blindness, diabetes) reported that the
``new content'' statements were new information to them. When a
specific health condition was covered by both a revised and TCA
statement (e.g., cancer), the revised statement was new information to
more participants than the TCA statement.
---------------------------------------------------------------------------

    \7\ There was one exception: The TCA statement ``Fatal lung
disease in nonsmokers'' was new information to 41.9 percent of
participants.
---------------------------------------------------------------------------

    At the level of the individual warning statement, 10 of the 15
revised statements tested demonstrated statistically significant higher
levels of both ``new information'' and ``self-reported learning'' when
compared to a TCA statement (see Ref. 129, Table 4-1, ``Summary of
Significant Results''). Those 10 revised statements focused on the
following negative health effects of cigarette smoking: Age-related
macular degeneration, cataracts, type 2 diabetes, peripheral vascular
disease (amputation), bladder cancer, erectile dysfunction, head and
neck cancer, heart disease and stroke (clogged arteries), stunted fetal
growth, and COPD.
    There were two revised statements that had statistically
significant higher levels of ``new information'' but not ``self-
reported learning,'' both of which focused on pregnancy-related health
consequences (premature birth; low birth weight). For two revised
statements (emphysema and chronic bronchitis; pneumonia), participants
had statistically significant higher levels of ``self-reported
learning'' but not ``new information.'' For one revised statement
(mouth and throat cancer), participants did not have statistically
significant higher levels of either of these two outcomes. Of the five
revised warning statements that lacked statistically significant higher
outcomes for both ``new information'' and ``self-reported learning'',
four focused on a health condition for which another revised statement
had statistically significant higher levels of both ``new information''
and ``self-reported learning'' (e.g., premature birth versus stunts
fetal

growth); only the revised warning statement on pneumonia did not.
    More details about the full study results can be found in the study
report, which we have included in this docket (Ref. 129).
3. How Study Findings Were Used
    FDA determined that the scientific literature demonstrates that the
outcomes ``new information'' and ``self-reported learning'' are
predictive for the task of identifying which, if any, of the revised
warning statements would promote greater public understanding of the
risks associated with cigarette smoking as compared to a TCA statement.
Communication science research shows that an important first step in
promoting public understanding of health risks is to raise public
awareness of those risks, particularly if the risks are not commonly
known (Refs. 130 and 131) (see section V.B). Measuring whether
information is new helps identify opportunities to improve
understanding through increased awareness. Additionally, communication
science research has found that people are more likely to pay attention
to information that is new, and attention plays a vital role in message
comprehension and learning (Ref. 128). Therefore, ``new information''
and ``self-reported learning'' are often linked and are both predictive
of improved understanding. Other study outcomes, such as ``thinking
about the risks'' and ``health beliefs,'' were unlikely to change with
a single brief exposure to the text-only statements--as was provided in
this first quantitative consumer research study--and therefore were not
considered predictive of improved understanding in the way the ``new
information'' and ``self-reported learning'' measures were.
    Because the purpose of this first quantitative consumer research
study was to determine which, if any, revised warning statements
promote greater public understanding of the risks associated with
cigarette smoking (as per section 4(d) of the FCLAA) when compared to a
TCA warning statement, the study was not designed to put the revised
statements in a rank order or compare individual results of one revised
statement to another. Rather, FDA interpreted the presence of a
statistically significant finding in a positive direction as support
for a revised warning statement over its comparator TCA statement.\8\
---------------------------------------------------------------------------

    \8\ Five of the 15 revised statements were ``new content''
statements, without a comparator TCA statement on the same health
condition. Those five revised statements were compared to a randomly
selected TCA statement on a different health condition, which may
have resulted in larger effects for these ``new content'' statements
as compared to the effects for the remaining 10 revised statements.
---------------------------------------------------------------------------

    FDA evaluated the research results for each individual warning
statement to determine which statements would move on for further
testing. Based on this analysis, a total of 10 revised statements and 5
TCA statements were selected for such further testing. As discussed
above, at the level of the individual warning statement, 10 of the 15
revised warning statements tested demonstrated statistically
significant higher levels of both ``new information'' and ``self-
reported learning'' when compared to a TCA warning statement. FDA
selected those 10 revised statements for further testing in the final
consumer research study discussed below. Of the five revised warning
statements that did not have statistically significant higher outcomes
for both ``new information'' and ``self-reported learning,'' four
focused on a health condition for which another revised statement did
have statistically significant higher levels for both ``new
information'' and ``self-reported learning''; only the revised
statement on harms of secondhand smoke exposure in children (pneumonia)
did not. Because there was not another revised statement on harms of
secondhand smoke exposure in children, FDA selected the TCA statement
on the same health condition (harm children) for further testing in the
final quantitative consumer research study.
    Additionally, as described above, FDA did not test a revised
warning statement for four TCA statements (addictive, kill you, fatal
lung disease in nonsmokers, quit now; see table 1 for full statements).
Although these TCA statements were new information to relatively few
participants and self-reported learning was low, FDA determined that it
would provide a better basis for decision-making to pursue additional
data on these four TCA statements, and thus included them for further
testing.
    Based on the Agency's analysis of the research results and
evaluation of other considerations as just described, FDA selected a
total of 15 textual warning statements for further testing. FDA
selected the following five TCA statements for the final quantitative
consumer research study:
     WARNING: Cigarettes are addictive.
     WARNING: Tobacco smoke can harm your children.
     WARNING: Smoking can kill you.
     WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
     WARNING: Quitting smoking now greatly reduces serious
risks to your health.
    Additionally, FDA selected the following 10 revised or ``new
content'' statements for the final quantitative consumer research study
(see section VI.E for a discussion of that study):
     WARNING: Smoking causes head and neck cancer.
     WARNING: Smoking causes bladder cancer, which can lead to
bloody urine.
     WARNING: Smoking during pregnancy stunts fetal growth.
     WARNING: Smoking can cause heart disease and strokes by
clogging arteries.
     WARNING: Smoking causes COPD, a lung disease that can be
fatal.
     WARNING: Smoking reduces blood flow, which can cause
erectile dysfunction.
     WARNING: Smoking reduces blood flow to the limbs, which
can require amputation.
     WARNING: Smoking causes type 2 diabetes, which raises
blood sugar.
     WARNING: Smoking causes age-related macular degeneration,
which can lead to blindness.
     WARNING: Smoking causes cataracts, which can lead to
blindness.

D. Developing and Testing Images Depicting the Negative Health
Consequences of Smoking To Accompany the Textual Warning Statements

    Section 4(d) of the FCLAA, as amended by section 201(a) of the
Tobacco Control Act, directs FDA to issue regulations that require
color graphics depicting the negative health consequences of smoking to
accompany textual warning statements on cigarette packages and in
cigarette advertisements. In parallel with FDA's efforts to develop and
test revised warning statements, the Agency also undertook an
iterative, research-based approach to develop color graphics depicting
the negative health consequences of cigarette smoking to accompany
those statements. This process required considering how to help promote
greater public understanding of the negative health consequences of
cigarette smoking given that the general public comprises individuals
with many varied backgrounds, knowledge, beliefs, and abilities to read
and understand health information. According to National Assessment of
Adult Literacy estimates, about 12 percent of U.S. adults have
proficient health literacy (i.e., the ability to access, understand,
and use health information and services (Refs. 125 and

132). Among the remaining adults, 53 percent have intermediate health
literacy, 22 percent have basic health literacy, and 14 percent have
below basic health literacy (Ref. 125). Individuals with basic or below
basic health literacy are more likely to be cigarette smokers (Refs.
133-135) and are more likely to have limited knowledge about the
negative health consequences of smoking (Refs. 136 and 137). National
surveys also indicate that about half of the U.S. adult population has
only very basic or below basic quantitative skills, and only 9 percent
of U.S. adults scored in the highest numeracy levels (i.e., the ability
to understand and use numbers, including the ability to read and
interpret data presented in tables, graphs, and bar charts) (Refs. 138
and 139).
    To determine the best way to visually depict the negative health
consequences of cigarette smoking to promote greater understanding
among such a diverse population, FDA considered findings from health
communication science research regarding best practices for helping the
public better understand health risk information. As described in
section V.B, it is well established in the scientific literature that
vivid features (e.g., images) increase noticeability of and attention
to textual health risk information (e.g., cigarette health warnings)
and increase comprehension, understanding, and recall of health
messages (Refs. 43, 50, 75, 78-81, 118, and 140-145). Research also
indicates that visual depictions of textual health risk information are
especially beneficial in aiding comprehension and understanding among
subpopulations that have lower health literacy and numeracy skills
(Refs. 118, 144, and 146-148), including greater disparities in
knowledge about the negative health consequences of smoking (Ref. 69).
However, multiple factors influence whether a specific type of visual
depiction (such as an image compared to a bar chart or graph)
ultimately aids or impedes message comprehension, including the level
of concordance between the text and accompanying visual depiction
(e.g., using an image of an eye to depict the word ``eye''); the level
of cognitive effort required to understand the information (e.g., using
a stacked bar chart to depict multiple data comparisons requires
greater cognitive effort); and the type of communication channel used
to deliver the message (e.g., information presented by a doctor as part
of a conversation with a patient, versus information presented in a
mass media campaign) (Refs. 118, 140-143, 146, 147, and 149-152). For
example, some types of visual depiction, such as bar charts and graphs,
are better suited to certain communication purposes such as depicting
comparisons (bar charts) or conveying numerical information (graphs)
(Refs. 142 and 152). When used to communicate health risk information
to the public, bar charts and graphs are often misperceived, especially
when not accompanied by further instruction on how to read and
interpret the information (Refs. 140, 141, 149, and 151). Bar charts
and graphs also require a higher degree of numerical proficiency and
cognitive effort to promote consumer understanding than do other types
of visual depiction, such as illustrations and photographs. In
comparison, illustrations, photographs, and other pictorial visual
depictions are more likely to aid comprehension when used for mass-
communication purposes as these types of visual depictions are more
easily made congruent (i.e., the type of visual is appropriate for the
message) and concordant, and they require less numerical proficiency
and cognitive effort to understand the information (Refs. 141, 142,
149, and 150). Therefore, based on this review of the literature, the
proposed cigarette health warning message content, and the
communication channel, FDA determined that textual warning statements
paired with factually accurate, concordant photographs or
photorealistic images of specific health conditions, presented in a
realistic and objective format, would be most likely to advance the
Government's interest in promoting greater public understanding of the
negative health consequences of cigarette smoking.
    FDA then undertook a rigorous multistep process to develop, test,
and refine images that: (1) Are factually accurate; (2) depict common
visual presentations of the health conditions (intended to aid
understanding by building on existing consumer health knowledge and
experiences) and/or show disease states and symptoms as they are
typically experienced; (3) present the health conditions in a realistic
and objective format that is devoid of non-essential elements; and (4)
are concordant with the statements on the same health conditions.
    After developing initial image concepts, FDA used information
gathered through a series of 53 indepth individual interviews with
adolescents and adults (OMB control number 0910-0796, ``Qualitative
Study of Perceptions and Knowledge of Visually Depicted Health
Conditions'') to further refine the concepts. FDA evaluated the extent
to which participants found the initial image concepts clear (in terms
of recognizing what was being depicted in the image), attention-
grabbing, worth remembering, credible, and relevant, and whether the
concepts provided any new information. The interviews found that some
image concepts were very clear, while others were less understood. When
there were multiple image concepts on the same or similar health
conditions, participants reacted similarly to those concepts. Overall,
the majority of participants found the image concepts to be credible
and rated most of the concepts as medium to high in terms of image
clarity. FDA used the feedback from these qualitative interviews to
further refine the initial image concepts, eliminate some image