Tobacco Products; Required Warnings for Cigarette Packages and Advertisements

 
CONTENT
Federal Register, Volume 84 Issue 159 (Friday, August 16, 2019)
[Federal Register Volume 84, Number 159 (Friday, August 16, 2019)]
[Proposed Rules]
[Pages 42754-42798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17481]
[[Page 42753]]
Vol. 84
Friday,
No. 159
August 16, 2019
Part IV
Department of Health and Human Services
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Food and Drug Administration
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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
[[Page 42754]]
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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.
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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: 202-395-7285, or email to
[email protected]. 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, 877-287-1373, email:
[email protected].
    With regard to the information collection: Amber Sanford, Office of
Operations, Food and Drug Administration, Three White Flint North 10A-
12M, 11601 Landsdown St.,
[[Page 42755]]
North Bethesda, MD 20852, [email protected].
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
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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
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          Abbreviation/acronym                    What it means
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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.
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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
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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.
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    \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.
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    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.
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    \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
[[Page 42758]]
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
[[Page 42759]]
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).
[[Page 42760]]
    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
[[Page 42761]]
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
[[Page 42762]]
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
[[Page 42763]]
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
[[Page 42764]]
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.
[[Page 42765]]
    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
[[Page 42766]]
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).
[[Page 42767]]
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).
[[Page 42768]]

                                            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
[[Page 42769]]
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
[[Page 42770]]
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
concepts from further consideration, and inform a future quantitative
consumer research study (see section VI.E).
    FDA used a photorealistic illustration format for the images rather
than photographs, because this format best allowed depicting specific
features of the health conditions as described by the textual warning
statements. The photorealistic illustration format also facilitated
providing factually accurate images that depict common presentations of
the health conditions in a realistic and objective format devoid of
non-essential elements. Using photorealistic images allowed further
editing and refinements for clarity and ease of understanding
throughout the research and development process for new cigarette
health warnings. A certified medical illustrator developed high
quality, medically accurate, photorealistic images in close
collaboration with FDA staff. After the photorealistic images were
created, FDA paired each textual warning statement (the 9 TCA
statements and the 15 revised statements tested in the first
quantitative consumer research study) with a concordant image for
further testing.
    To do this further testing, FDA evaluated the photorealistic images
through a series of 20 qualitative focus groups with adolescent
smokers, adolescents at risk for starting smoking, and adult smokers
(OMB control number 0910-0796, ``Qualitative Study on Consumer
Perceptions of Cigarettes Health Warning Images''). The focus groups
examined what factual information the images conveyed to participants
about the negative health consequences of cigarette smoking in the
absence of a paired textual warning statement, as well as how
concordant participants considered the images to be when paired with
potential textual warning statements (both TCA
[[Page 42771]]
statements and the revised statements). Based on feedback received in
these focus groups, FDA further refined some images for additional
clarity and eliminated other images that were not well understood or
where potential confusion could not be resolved through additional
revisions. FDA then completed final pairings of textual warning
statements and concordant photorealistic images for testing in the
final quantitative consumer research study.
    As noted earlier (see section VI.C), FDA selected a total of 15
textual warning statements for further testing. However, two of the
textual warning statements (fatal lung disease in nonsmokers, COPD)
shared similar concordant images (diseased lungs). To preserve the
option of potentially requiring both warning statements but without
using two similar images, FDA paired an additional concordant image
that tested well in the qualitative focus groups (man with oxygen tank)
with the COPD warning statement for further testing. Therefore, FDA
prepared a total of 16 statement-and-image pairings to test in the
final quantitative consumer research study.
E. FDA's Consumer Research Study on New Cigarette Health Warnings
    Once FDA examined opportunities to promote greater public
understanding of the risks associated with cigarette smoking, developed
potential revised statements to address gaps in public understanding,
tested the revised statements in a consumer research study, and
developed concordant photorealistic images that depict the negative
health consequences of smoking, the Agency prepared a set of 16
cigarette health warnings (statements paired with their concordant
photorealistic images) to be tested in a final consumer research study.
The purpose of the final research study was to assess the extent to
which any of the cigarette health warnings, developed through FDA's
science-based, iterative research process, increase understanding of
the negative health consequences of cigarette smoking. For warnings to
be considered for this proposed rule, FDA decided that a warning tested
in this final consumer research study must demonstrate statistically
significant improvements, as compared to the control condition, on both
the two outcomes of ``new information'' and ``self-reported learning''
(more discussion about the study design, including the control and
outcomes follows).
1. Study Design
    FDA's final research study on new cigarette health warnings was a
three-session internet-based consumer research study using an online
research panel (OMB control number 0910-0866, ``Experimental Study of
Cigarette Warnings''). The study included 9,760 participants,
including: (1) Adolescents (aged 13-17 years) who were current smokers
and those at risk for starting smoking; (2) younger adults (aged 18-24
years) who were current smokers and nonsmokers; and (3) older-adults
(aged 25 years and older) who were current smokers and nonsmokers.
Study participants in all age groups were assigned to a condition that
determined which warnings they viewed during the study. Participants in
the control condition viewed one of the four current Surgeon General's
cigarette warnings. Participants in each of the treatment conditions
viewed one of 16 of the new cigarette health warnings (i.e., text-image
pairings) FDA developed through the process described in sections VI.B-
D. Table 2 provides a list of the 16 textual warning statements (paired
with images) that FDA evaluated in this study.
   Table 2--Text of Cigarette Health Warnings Tested in FDA's Consumer
                             Research Study
------------------------------------------------------------------------
                               Statements
-------------------------------------------------------------------------
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.
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. [paired
 with an image of diseased lungs]
WARNING: Smoking causes COPD, a lung disease that can be fatal. [paired
 with an image of man with oxygen tank]
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.
------------------------------------------------------------------------
    All participants viewed their assigned warnings on both a mock
three-dimensional cigarette package that could be rotated on screen and
as part of a mock full-page magazine cigarette advertisement in either
their current (e.g., on the side of the package for the Surgeon
General's warnings) or proposed (e.g., on the top 50 percent of the
front and rear panel of the package for the new cigarette health
warnings) size and location.
    The study took place over three sessions over more than two weeks
for each respondent. During the first session, participants answered
baseline questions about their beliefs about the negative health
consequences of cigarette smoking. Next, they viewed their assigned
warning on both the mock cigarette package and in the mock cigarette
advertisement and answered questions assessing the following outcomes:
     Whether the warning was new information to participants
(``new information);
     Whether participants learned something from the warning
(``self-reported learning'');
     Whether the warning made participants think about the
health risks of smoking (``thinking about risks'');
     Whether the warning was perceived to be informative
(``perceived informativeness'');
[[Page 42772]]
     Whether the warning was perceived to be understandable
(``perceived understandability'');
     Whether the warning was perceived to be a fact or opinion
(``perceived factualness'');
     Whether participants reported beliefs linking smoking and
each of the health consequences presented in the warning (``health
beliefs'');
     Whether the warning was perceived to help participants
understand the negative health effects of smoking (``perceived
helpfulness understanding health effects'');
     Whether the warning grabbed their attention
(``attention''); and
     Whether the warning was recalled (``recall'').
    Approximately 1 day later, during the second session, participants
viewed their assigned warning again and answered questions assessing
their beliefs about the negative health consequences of cigarette
smoking. Approximately 14 days after the second session, during the
third session (i.e., a delayed post-test), participants answered
questions about their beliefs about the negative health consequences of
cigarette smoking as well as questions assessing recall of the warning
they viewed.
    More details about the study methodology, including the sample size
calculation and analysis plan, can be found in the study report, which
we have included in this docket (Ref. 153).\9\
---------------------------------------------------------------------------
    \9\ As with the first consumer research study, 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 results of the final consumer research study allowed FDA to
draw important conclusions that provide a basis for the cigarette
health warnings included in this proposed rule. Overall, relative to
the average of the Surgeon General's warnings, most of the new
cigarette health warnings were reported to be new information; resulted
in greater self-reported learning; led to thinking about risks; were
higher on perceived informativeness, perceived understandability, and
perceived helpfulness understanding health effects; increased agreement
with accurate health beliefs over time; attracted attention; and were
recalled.
    As discussed above (see section VI.C.3), FDA determined that the
outcomes ``new information'' and ``self-reported learning'' are
predictive for the task of identifying which of the cigarette health
warnings increase understanding of the negative health consequences of
cigarette smoking. Participants were significantly more likely,
relative to the control condition (i.e., the Surgeon General's
warnings), to report that, for 13 of the 16 cigarette health warnings
tested (except for the warnings related to addiction, smoking can kill,
and quitting smoking), the new cigarette health warnings provided new
information and resulted in greater self-reported learning (see Ref.
153, Table 4-1, ``Summary of Results'').
    More details about the full study results can be found in the study
report, which we have included in this docket (Ref. 153).
3. How Study Findings Were Used
    Because the purpose of this final quantitative consumer research
study was to identify which of the cigarette health warnings increase
understanding of the negative health consequences of cigarette smoking,
the study was not designed to put the cigarette health warnings in a
rank order or compare individual results of one cigarette health
warning to another. FDA evaluated the research results for each
individual cigarette health warning to determine which warnings to
include in this proposed rule.
    FDA is including in this proposed rule only the warnings that
demonstrate statistically significant improvements, as compared to the
control condition (i.e., the Surgeon General's warnings), on both the
outcomes of ``new information'' and ``self-reported learning'' (i.e.,
knowledge gain). Following review of the findings of the final
quantitative consumer research study, FDA is proposing 13 cigarette
health warnings that use the following 12 statements:
     WARNING: Tobacco smoke can harm your children.
     WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
     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. [paired with two images] \10\
---------------------------------------------------------------------------
    \10\ As discussed in section VI.D, FDA paired two concordant
images (i.e., diseased lungs, man with oxygen tank) with the COPD
warning statement for final testing. Both text and image pairings
demonstrated statistically significant improvements, as compared to
the control condition (i.e., the Surgeon General's warnings), on
both the outcomes of ``new information'' and ``self-reported
learning'' (i.e., knowledge gain).
---------------------------------------------------------------------------
     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.
    The cigarette health warnings using the following three statements
did not demonstrate statistically significant improvements, as compared
to the control condition, on the outcomes of ``new information'' and
``self-reported learning'' and therefore are not included as part of
this proposed rule:
     WARNING: Cigarettes are addictive.
     WARNING: Smoking can kill you.
     WARNING: Quitting smoking now greatly reduces serious
risks to your health.
VII. FDA's Proposed Required Warnings
    The initial section 4(d) of the FCLAA, as amended by section 201 of
the Tobacco Control Act, directs FDA to issue ``regulations that
require color graphics depicting the negative health consequences of
smoking'' to accompany the textual warning statements specified in
section 4(a)(1) of the FCLAA. A second section 4(d) of the FCLAA, as
created by section 202(b) of the Tobacco Control Act, permits FDA,
through notice and comment rulemaking, to adjust the format, type size,
color graphics, and text of any of the label requirements if such a
change would promote greater public understanding of the risks
associated with the use of tobacco products. FDA interprets these
provisions of the FCLAA to permit a rulemaking that establishes new
cigarette health warnings and at the same time adjusts the text and
color graphic requirements, including the number of required warnings,
so long as the adjustments promote greater public understanding of the
risks of the use of tobacco products.
    As described in section VI.B, 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 would promote greater public understanding of the risks
associated with cigarette smoking. The empirical results
[[Page 42773]]
demonstrate sufficient scientific support to adjust the textual warning
statements. Also, as described in section VI.D, FDA carefully developed
and tested concordant color graphics, in the form of photorealistic
images, depicting the negative health consequences of smoking to
accompany each of the textual warning statements included in this
proposed rule. Based on the results of FDA's research, we intend to
finalize some or all of the 13 new cigarette health warnings proposed
in this rule. We invite comment on how many warnings should be selected
for the final rule and whether fewer than, more than, or exactly nine
warnings would advance the Government's interest in promoting greater
public understanding of the negative health consequences of smoking.
    The 13 proposed warnings, each of which consists of a textual
warning statement paired with a concordant photorealistic image
depicting the negative health consequences of smoking, are available in
an electronic PDF in this docket (Ref. 18). For the final rule, the
required warnings will be contained in a document entitled ``Required
Cigarette Health Warnings,'' as is further discussed in section II.C.
    These proposed required warnings, as shown through the robust
scientific evidence described in detail in sections V and VI and in the
remainder of this section, are factual and accurate, advance the
Government's interest, and are not unduly burdensome (see section VIII
for a more detailed discussion). In determining which proposed
cigarette health warnings will be required in the final rule, FDA will
consider public comments submitted to this docket, full research
results from our final quantitative consumer research study (including
peer reviewer comments), scientific literature, and other
considerations as discussed in this proposal.
A. FDA's Proposed Required Warnings
    As discussed above, we assessed whether the new cigarette health
warnings, developed through FDA's science-based, iterative research
process, will advance the Government's interest in promoting greater
public understanding of the negative health consequences of cigarette
smoking. Based on available data and information available to us at
this time, including results from FDA's final consumer research study
(see section VI for a full description of the final consumer research
study) (Ref. 153), we identified 13 cigarette health warnings for this
proposed rule.
    Each of the proposed warnings described in this section
demonstrated statistically significant higher levels of providing new
information and self-reported learning when compared to the control
condition (i.e., the Surgeon General's warnings) (Ref. 153). While the
final consumer research study was designed to measure a range of
outcomes related to consumer understanding, as an initial matter, FDA
is including in this proposed rule only the warnings that demonstrate
statistically significant improvements, as compared to the control
condition (i.e., the Surgeon General's warnings), on both the outcomes
of ``new information'' and ``self-reported learning'' (i.e., knowledge
gain). As described above, the scientific literature demonstrates that
these two outcomes are predictive for the task of assessing which of
the new cigarette health warnings increase understanding of the risks
associated with cigarette smoking. Other study outcomes provide
additional, useful information and are reflected in the study report
(Ref. 153).
    FDA solicits comment on the individual cigarette health warnings
included in this proposal, and we ask that comments provide data and
factual information that would help us to further consider which
proposed warnings to include in the final rule or whether such warnings
should be altered, consistent with the Government's interest, and how.
For additional consideration, the following subsections provide
relevant scientific support for each of the proposed required warnings.
    1. WARNING: Tobacco smoke can harm your children.
    This proposed warning consists of the TCA statement ``WARNING:
Tobacco smoke can harm your children'' paired with a concordant,
factually accurate, photorealistic image depicting a negative health
consequence of secondhand smoke exposure in children. The image shows
the head and shoulders of a young boy (aged 8-10 years) wearing a
hospital gown and receiving a nebulizer treatment for chronic asthma
resulting from secondhand smoke exposure.
    Since 2004, several Surgeon General's Reports have confirmed the
causal link between exposure to secondhand smoke and several negative
health consequences in children, including middle ear disease,
respiratory symptoms, impaired lung function, lower respiratory
illness, and SIDS (Refs. 8, 154, and 155). The 2006 Surgeon General's
Report stated that the evidence is sufficient to conclude--the highest
level of evidence of causal inferences from the criteria applied in the
Surgeon General's Reports--that secondhand smoke exposure from parental
smoking causes the following negative health effects: Lower respiratory
illness in infants and children; middle ear disease in children,
including acute and recurrent otitis media and chronic middle ear
effusion; cough, phlegm, wheeze, and breathlessness among children of
school age, and ever having asthma among children of school age; the
onset of wheeze illnesses in early childhood; persistent adverse
effects on lung function across childhood; and a lower level of lung
function during childhood (Ref. 155). More recently published studies
on the topic support the Surgeon General's Reports' conclusion that
parental secondhand smoke influences child health, particularly
respiratory health (Refs. 156-158).
    2. WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
    This proposed warning consists of the TCA statement ``WARNING:
Tobacco smoke causes fatal lung disease in nonsmokers'' paired with a
concordant, factually accurate, photorealistic image depicting fatal
lung disease. The image shows gloved hands holding a pair of diseased
lungs containing cancerous lesions from chronic secondhand smoke
exposure.
    The 1986 and subsequent Surgeon General's Reports have confirmed
the causal link between secondhand smoke exposure and lung cancer, a
fatal lung disease, among nonsmokers (Refs.155 and 159). The conclusion
in the 2006 Surgeon General's Report extends to all secondhand smoke
exposure, regardless of location of exposure (e.g., at home, at work,
in other settings); the combined evidence from multiple studies
indicates a 20 to 30 percent increase in the risk of lung cancer from
secondhand smoke exposure associated with living with a smoker (Ref.
155). For example, a meta-analysis of 43 studies, including studies
conducted in both the United States and outside of the United States,
found that the relative risk of lung cancer among nonsmoking women who
live with partners who smoke (i.e., the risk of the lung cancer among
nonsmokers living with smokers compared to nonsmokers not living with
smokers) was 1.29 (Ref. 160). This means that nonsmoking women who live
with partners who smoke have 1.29 times higher risk of lung cancer
compared to nonsmoking women who live with partners who do not smoke.
Recent studies support and extend these conclusions (Refs. 161-164). In
addition to the many lung cancer deaths caused directly by smoking,
researchers
[[Page 42774]]
estimate that another 5 percent of all lung cancer deaths, or 7,300
deaths annually (as measured in 2006), can be attributed to secondhand
smoke exposure (Ref. 165).
    3. WARNING: Smoking causes head and neck cancer.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes head and neck cancer'' paired with
a concordant, factually accurate, photorealistic image depicting neck
cancer. The image shows the head and neck of a woman (aged 50-60 years)
who has neck cancer caused by cigarette smoking. The woman has a
visible tumor protruding from the right side her neck just below her
jawline.
    Common head and neck cancers include mouth, nose, pharynx, and
larynx. Since 1979, Surgeon General's Report have recognized that
smoking causes head and neck cancers, and the 2004 Surgeon General's
Report stated that the evidence is sufficient to infer a causal
relationship--the highest level of evidence of causal inferences from
the criteria applied in the Surgeon General's Reports--between smoking
and cancers of the oral cavity, pharynx, and larynx (Ref. 154),
building on the strong conclusions of causality from previous reports.
The magnitude of this relationship is substantial--male and female
smokers who currently smoke and have smoked only cigarettes experience
10- and 5-fold higher risk of head and neck cancers than lifetime
nonsmokers, respectively. The 2004 Surgeon General's Report summarized
clinical studies showing that premalignant lesions in the mouth and
throat are most commonly found in areas that have direct contact with
tobacco or smoke and that quitting smoking causes most premalignant
lesions to regress and reduces oral and pharyngeal cancer incidence and
mortality (Ref. 154). In 2015, there were 44,430 new cases of cancer of
the oral cavity and pharynx and 12,292 new cases of cancer of the
larynx (Ref. 166). There were approximately 14,000 deaths from head and
neck cancer in 2016 (approximately 10,000 from cancer of the lip, oral
cavity, and pharynx, and approximately 3,900 from cancer of the larynx)
(Ref. 166). Most head and neck cancers are attributable to smoking,
with almost 70 percent of lip, oral cavity, pharynx, and larynx cancer
deaths from 2000 to 2004 attributable to smoking, representing 7,900
deaths a year (Ref. 30).
    4. WARNING: Smoking causes bladder cancer, which can lead to bloody
urine.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes bladder cancer, which can lead to
bloody urine'' paired with a concordant, factually accurate,
photorealistic image depicting bloody urine. The image shows a gloved
hand holding a urine specimen cup containing bloody urine resulting
from bladder cancer caused by cigarette smoking.
    The association between smoking and bladder cancer has been noted
since the first Surgeon General's Report in 1964, and a causal
conclusion was reported in the 1990 report (Refs. 183 and 219). The
2014 Surgeon General's Report again confirmed that the evidence is
sufficient to infer a causal relationship--the highest level of
evidence of causal inferences from the criteria applied in the Surgeon
General's Reports--between cigarette smoking and bladder cancer (Ref.
8). Recent research illustrates that even smoking a few cigarettes per
day is associated with an increased risk of bladder cancer (Ref. 167)
and that low intensity/long duration smoking is particularly associated
with increased bladder cancer risk (Ref. 168). In most cases, blood in
the urine (called hematuria) is the first visible sign of bladder
cancer (Ref. 169), although there are other causes of hematuria. The
number of cases of bladder cancer related to smoking is considerable.
There were 73,000 bladder cancer cases in the United States in 2015 and
16,650 deaths from bladder cancer in 2017 (Ref. 166). According to the
American Cancer Society, 1 in 27 men and 1 in 89 women will develop
bladder cancer during their lifetime (Ref. 170). The Centers for
Disease Control and Prevention (CDC) has estimated that 40 percent of
bladder cancer deaths in 2000 through 2004 were attributable to
smoking, representing almost 5,000 deaths a year (Ref. 30).
    5. WARNING: Smoking during pregnancy stunts fetal growth.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking during pregnancy stunts fetal growth''
paired with a concordant, factually accurate, photorealistic image
depicting a negative health consequence of smoking during pregnancy: An
infant with low birth weight resulting from stunted fetal growth. The
image shows a newborn infant on a medical scale, and the digital
display on the scale reads four pounds.
    The 2004 Surgeon General's Report concluded for the first time that
the evidence was sufficient to infer a causal relationship--the highest
level of evidence of causal inferences based on the criteria applied in
the Surgeon General's Reports--between maternal smoking and fetal
growth restriction and preterm delivery (Ref. 154). The 2004 Surgeon
General's Report summarized many studies that found a consistent and
strong relationship between smoking and reduced birth weight as well as
a strong dose-response relationship between smoking intensity and birth
weight, and the 2010 Surgeon General's Report cited additional studies
further supporting that conclusion (Ref. 171). New studies published
since 2014 further support the causal relation between smoking and
restricted fetal growth (Refs. 172-175).
    In the United States, around eight percent of newborns have low
birth weight each year (Ref. 176). The CDC reported that low birth
weight was twice as common among smoking mothers compared to nonsmoking
mothers in Ohio in a 6-month period in 1989, with 20 percent of cases
of low birth weight among infants during the same period due to
maternal smoking (Ref. 177). Low birth weight was almost 60 percent
more common among mothers who smoked during pregnancy than mothers who
did not in a study in Massachusetts in 1998 (Ref. 32). The California
EPA estimated 24,500 cases of low birth weight due to maternal exposure
to environmental tobacco smoke (i.e., secondhand smoking) in the United
States per year (Ref. 34).
    6. WARNING: Smoking can cause heart disease and strokes by clogging
arteries.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking can cause heart disease and strokes by
clogging arteries'' paired with a concordant, factually accurate,
photorealistic image depicting a patient who recently underwent heart
surgery to treat heart disease caused by smoking. The image shows the
chest of a man (aged 60-70 years) wearing an open hospital gown. The
man has a large, recently-sutured incision running down the middle of
his chest and is undergoing post-operative monitoring.
    Surgeon General's Reports since the 1970s have concluded that
smoking is causally related to heart disease and stroke (Refs. 154 and
178). The 2014 Surgeon General's Report summarized the evidence and
focused on new insights into causal mechanisms gained since the earlier
report (Ref. 8). Coronary heart disease--often simply called heart
disease--is a disorder of the blood vessels of the heart that can lead
to a heart attack. A heart attack happens when an artery becomes
blocked, preventing oxygen and nutrients from getting to the heart.
Stroke occurs when blood supply to part of the brain is interrupted or
reduced, depriving brain
[[Page 42775]]
tissue of oxygen and nutrients (Ref. 179). Atherosclerosis, or clogged
arteries, is a disease in which plaque builds up inside the arteries
that carry oxygen-rich blood to the heart and other parts of the body
and can lead to heart attack and stroke through thrombosis, or blockage
of the arteries (Refs. 8 and 179). Most coronary heart disease involves
atherosclerosis, or clogged arteries. The 2004 Surgeon General's Report
concluded that evidence from several different populations, multiple
age groups, and both genders is sufficient to conclude that there is a
causal relationship--the highest level of evidence of causal inferences
from the criteria applied in the Surgeon General's Reports--between
smoking and atherosclerosis and related health conditions such as heart
disease and stroke (Ref. 154). Across many studies over time, a clear
dose-response relationship has been established with smoking more
cigarettes and smoking for a longer time linked to greater risk of
heart disease and stroke. More recent evidence demonstrates that even a
very low frequency of smoking (i.e., even as few as one cigarette per
day) has a measurable increase in the risk for cardiovascular disease
(Ref. 180). The 2004 Surgeon General's Report further concluded that
the evidence is sufficient to infer a causal relationship--the highest
level of evidence of causal inferences from the criteria applied in the
Surgeon General's Reports--between smoking and subclinical (or very
early signs of) atherosclerosis (Ref. 154).
    The public health burden of heart disease and stroke is
considerable. It has been estimated that, in the United States, over 2
million people have had a heart attack during their lifetime and over 1
million have had a stroke during their lifetime due to smoking (Ref.
21). The mortality burden is also substantial. There are approximately
635,000 deaths from heart disease and 140,000 deaths from stroke in the
United States each year (Ref. 181). Recent data showed that the
mortality risk (i.e., the risk of dying) for current smokers compared
to never smokers from heart disease was 2.50 times greater for men and
2.86 times greater for women. The risk of having a stroke was 1.92
times greater for men and 2.10 times greater for women who were current
smokers compared to never smokers (Ref. 182). The proportion of all
deaths from heart attack and stroke due to active smoking is notable--
24.1 percent for heart disease deaths and 11.3 percent for stroke
deaths. This represents approximately 100,000 deaths from heart attack
due to smoking, and 15,000 stroke deaths due to smoking (Ref. 8).
    7. WARNING: Smoking causes COPD, a lung disease that can be fatal.
[image of diseased lungs]
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes COPD, a lung disease that can be
fatal'' paired with a concordant, factually accurate, photorealistic
image depicting COPD. The image shows gloved hands holding a pair of
diseased, darkened lungs removed from a smoker with COPD. Because a
similar image of diseased lungs was paired with the TCA statement
regarding fatal lung disease in nonsmokers, FDA paired this revised
statement with two different images for final testing (see next
subsection).
    Chronic obstructive pulmonary disease (COPD) includes the diseases
emphysema and chronic bronchitis. The 1964 Surgeon General's Report
concluded that smoking is a primary cause of chronic bronchitis, and
subsequent reports summarized additional evidence to conclude, in the
2004 Surgeon General's Report, at the highest level of evidence of
causal inferences from the criteria applied in the Surgeon General's
Reports, that the evidence is sufficient to infer a causal relationship
between active smoking and COPD morbidity and mortality (Refs. 154,
183, and 184). The 2014 Surgeon General's Report reinforced and
extended this evidence to discuss the relationship between smoking and
COPD mortality (Ref. 8). The 2014 Surgeon General's Report concluded
that the evidence is sufficient to infer--once again, the highest level
of evidence of causal inferences from the criteria applied in the
Surgeon General's Reports--that smoking is in fact the dominant cause
of COPD in the United States (Ref. 8). The report also concluded that
smoking causes all elements of COPD, including emphysema and damage to
the airways of the lung (Ref. 8).
    The public health burden of COPD is substantial. The National
Heart, Lung, Blood Institute estimates that there are 12 million U.S.
adults currently living who have been diagnosed with COPD and another
12 million who have COPD but have not yet been diagnosed (Ref. 185). It
has also been estimated that approximately 7.5 million people currently
living with COPD (whether diagnosed or undiagnosed) have the disease
because of smoking (Ref. 21). The mortality risk from COPD for current
smokers compared to never smokers was 25.61 times higher for men and
22.35 times higher for women, according to 50-year trends published in
the New England Journal of Medicine (Ref. 182). There are about 128,000
COPD deaths in the United States each year, of which 101,000 (79
percent) are attributable to smoking (Ref. 8).
    8. WARNING: Smoking causes COPD, a lung disease that can be fatal.
[image of man with oxygen tank]
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes COPD, a lung disease that can be
fatal'' paired with a concordant, factually accurate, photorealistic
image depicting a man receiving oxygen support because he has COPD
caused by cigarette smoking. The image shows the head and neck of a man
(aged 50-60 years) who has a nasal canula under his nose supplying
oxygen; the oxygen tank can be seen behind his left shoulder. Because,
based on the findings from previous qualitative testing (see section
VI.D), both this warning statement and the TCA statement regarding
fatal lung disease in nonsmokers were paired with similar images of
diseased lungs (see previous subsection), FDA decided to pair this
revised statement with an additional concordant image for testing in
the final quantitative consumer research study.
    As explained in the previous subsection (``7. WARNING: Smoking
causes COPD, a lung disease that can be fatal. [image of diseased
lungs]''), COPD includes the diseases emphysema and chronic bronchitis.
The 1964 Surgeon General's Report concluded that smoking is a primary
cause of chronic bronchitis, and subsequent reports summarized
additional evidence to conclude, in the 2004 Surgeon General's Report,
at the highest level of evidence of causal inferences from the criteria
applied in the Surgeon General's Reports, that the evidence is
sufficient to infer a causal relationship between active smoking and
COPD morbidity and mortality (Refs. 154, 183, and 184). The 2014
Surgeon General's Report reinforced and extended this evidence to
discuss the relationship between smoking and COPD mortality (Ref. 8).
The 2014 Surgeon General's Report concluded that the evidence is
sufficient to infer--once again, the highest level of evidence of
causal inferences from the criteria applied in the Surgeon General's
Reports--that smoking is in fact the dominant cause of COPD in the
United States (Ref. 8). The report also concluded that smoking causes
all elements of COPD, including emphysema and damage to the airways of
the lung (Ref. 8).
    The public health burden of COPD is substantial. The National
Heart, Lung, Blood Institute estimates that there are
[[Page 42776]]
12 million U.S. adults currently living who have been diagnosed with
COPD and another 12 million who have COPD but have not yet been
diagnosed (Ref. 185). It has also been estimated that approximately 7.5
million people currently living with COPD (whether diagnosed or
undiagnosed) have the disease because of smoking (Ref. 21). The
mortality risk from COPD for current smokers compared to never smokers
was 25.61 times higher for men and 22.35 times higher for women,
according to 50-year trends published in the New England Journal of
Medicine (Ref. 182). There are about 128,000 COPD deaths in the United
States each year, of which 101,000 (79 percent) are attributable to
smoking (Ref. 8).
    9. WARNING: Smoking reduces blood flow, which can cause erectile
dysfunction.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking reduces blood flow, which can cause
erectile dysfunction'' paired with a concordant, factually accurate,
photorealistic image depicting a man who is experiencing erectile
dysfunction caused by smoking. The image shows a man (aged 50-60 years)
sitting on the edge of a bed and leaning forward, with one elbow
resting on each knee. The man's head is tilted down, with his forehead
pressed into the knuckles of his right hand. Behind him on the bed, his
female partner looks off in another direction.
    The 2014 Surgeon General's Report concluded, for the first time,
that the evidence is sufficient to infer a causal relationship--the
highest level of evidence of causal inferences from the criteria
applied in the Surgeon General's Reports--between smoking and erectile
dysfunction (Ref. 8). This conclusion is supported by the consistency
of the strength of the association across numerous studies that
evaluated rates of erectile dysfunction among smokers. For example, a
recent meta-analysis of studies that included 50,360 participants found
that smoking more cigarettes and smoking for a longer time were
associated with increased erectile dysfunction risk (Ref. 186).
    Erectile dysfunction is likely under-reported in epidemiological
studies; therefore, the effect estimates observed in studies are likely
an underestimate. However, given that limitation of being under-
reported in studies, at least 20 percent of all men have some degree of
erectile dysfunction (Ref. 187). Among men between the ages of 40 and
70 years, approximately 50 percent have some degree of erectile
dysfunction (Ref. 187). Smokers have been found to have a 40 percent
increased risk of erectile dysfunction in studies such as the Health
Professionals Follow-up Study and the Olmsted County Study of Urinary
Symptoms and Health Status (Refs. 27 and 28).
    10. WARNING: Smoking reduces blood flow to the limbs, which can
require amputation.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking reduces blood flow to the limbs, which can
require amputation'' paired with a concordant, factually accurate,
photorealistic image depicting the feet of a person who had several
toes amputated due to tissue damage resulting from peripheral vascular
disease caused by cigarette smoking.
    Peripheral arterial disease (PAD), also known as peripheral
vascular disease (PVD), is a condition in which narrowed arteries
reduce blood flow to the limbs, especially the legs. Plaque is made up
of fat, cholesterol, calcium, fibrous tissue, and other substances in
the blood. Over time, plaque can harden and narrow the arteries. This
limits the flow of oxygen-rich blood to organs and other parts of the
body. PAD/PVD usually affects the arteries in the legs (Ref. 188).
Complications of PAD/PVD occur because of decreased or absent blood
flow and may include amputation or loss of limb due to tissue not
getting enough oxygen from blood and dying. The 1983 Surgeon General's
Report entitled ``The Health Consequences of Smoking: Cardiovascular
Disease'' summarized evidence regarding smoking and PAD/PVD and
concluded that cigarette smoking is the most powerful risk factor
predisposing to this condition and that smoking cessation plays an
important role in its medical and surgical management (Ref. 189). Since
that time, other Surgeon General's Reports have extended this evidence
base, through the 2014 report (Ref. 8).
    The population health burden of PAD/PVD is substantial. Overall
prevalence of PAD/PVD was found to be 13.5 percent in 2012 in the
Atherosclerosis Risk in Communities study, a multi-site, biracial,
prospective cohort study investigating the causes and clinical effects
of atherosclerosis in four U.S. communities (Ref. 190). A meta-analysis
of studies of PAD/PVD and smoking found that the risk of the condition
was 2.71 times greater for current smokers and 1.67 times greater for
former smokers compared to never smokers (Ref. 26). In its summary of a
recent prospective analysis using the Women's Health Study, which
evaluated the relationships of smoking and smoking cessation with PAD/
PVD, the 2014 Surgeon General's Report showed that risk estimates have
increased over time (Ref. 8). Results from that study found higher
risks than those in the meta-analysis; compared to never smokers, the
risk of PAD/PVD in the Women's Health Study was 3.16 times greater for
former smokers, 11.94 times greater for current smokers reporting less
than 15 cigarettes per day, and 21.08 times greater for current smokers
reporting 15 or more cigarettes per day (Ref. 191).
    One estimate from a review of the scientific literature suggests
that there are between 160,000 and 180,000 amputations due to PAD/PVD
annually in the United States, and, among people with critical limb
ischemia (i.e., a severe blockage of the arteries that greatly reduces
blood flow due to PAD/PVD), 25 percent have amputations each year (Ref.
192). Another article estimates that ``over 90% of all limb amputations
in the Western world occur as a direct or indirect consequence'' of
PAD/PVD (Ref. 193).
    11. WARNING: Smoking causes type 2 diabetes, which raises blood
sugar.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes type 2 diabetes, which raises blood
sugar'' paired with a concordant, factually accurate, photorealistic
image depicting a personal glucometer device being used to measure the
blood glucose level of a person with type 2 diabetes caused by
cigarette smoking. The digital display reading of 175 mg/dL and a
notation on the glucometer indicate a high blood sugar level.
    The 2014 Surgeon General's Report concluded, for the first time,
that: (1) The evidence is sufficient to infer--the highest level of
evidence of causal inferences from the criteria applied in the Surgeon
General's Reports--that cigarette smoking is a cause of type 2
diabetes; (2) the risk of developing diabetes is 30 to 40 percent
higher for active smokers than nonsmokers; and (3) there is a
relationship between increased number of cigarettes smoked and
increased risk of developing diabetes (Ref. 8). Across the 25 studies
included in the 2014 Surgeon General's Report updated summary, the
associations were strong and consistent and were found in many
subgroups, and these results have been replicated in many different
study populations and study locations.
    The public health burden of smoking and diabetes is substantial.
The prevalence of diabetes among U.S. adults was estimated to be 12.1
percent in 2005 through 2010 National Health and Nutrition Examination
Survey data (Ref. 194). A meta-analysis of studies
[[Page 42777]]
found the risk of type 2 diabetes to be 44 percent greater among
current smokers and 23 percent greater among former smokers compared to
never smokers (Ref. 25). Smoking has been estimated to cause 9,000 of
the 70,810 deaths (12.7 percent) due to diabetes in the United States
each year (Ref. 8).
    12. WARNING: Smoking causes age-related macular degeneration, which
can lead to blindness.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes age-related macular degeneration,
which can lead to blindness'' paired with a concordant, factually
accurate, photorealistic image depicting a closeup of an older man
(aged 65 years or older) who has age-related macular degeneration
caused by cigarette smoking. The man is receiving an injection in his
right eye to prevent additional vessel growth.
    Macular degeneration is an incurable eye disease that causes
blindness. The 2014 Surgeon General's Report on cigarette smoking
concluded, for the first time, that the evidence is sufficient to infer
a causal relationship--the highest level of evidence of causal
inferences from the criteria applied in the Surgeon General's Reports--
between cigarette smoking and the two major types of advanced age-
related macular degeneration (Ref. 8). The association is found across
a range of populations and through various study designs. The
prevalence of any macular degeneration among U.S. adults aged 40 years
and older was estimated to be 6.5 percent (Ref. 216). A meta-analysis
found that current smokers were approximately twice as likely (relative
risks for cohort studies of 2.06 and for case-control studies of 2.38),
as never smokers to have macular degeneration (Ref. 23).
    13. WARNING: Smoking causes cataracts, which can lead to blindness.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes cataracts, which can lead to
blindness'' paired with a concordant, factually accurate,
photorealistic image depicting a closeup of the face of a man (aged 65
years or older) who has a cataract caused by cigarette smoking. The
man's right pupil is covered by a large cataract.
    A cataract is a clouding of the lens in the eye that affects
vision. Without treatment, the area of clouding of the lens can
increase and eventually leads to blindness. The 2004 Surgeon General's
Report on cigarette smoking concluded that the evidence is sufficient
to infer a causal relationship--the highest level of evidence of causal
inferences from the criteria applied in the Surgeon General's Reports--
between smoking and nuclear cataracts (Ref. 154). A nuclear cataract is
one of the three types of cataracts and refers to the location of the
clouding in the lens of the eye. The epidemiologic studies examined in
the 2004 Surgeon General's Report found generally consistent
associations between smoking and nuclear cataracts, with most studies
reporting that smoking doubled or tripled the relative risk of nuclear
cataracts; in addition, a dose-response relationship was observed as
risk increased with the number of cigarettes smoked (Ref. 154). Data
for other types of cataracts were less strong, and these subtypes are
also less common in the population (Ref. 154). Authors have continued
to identify smoking as a major causal risk factor in the development
and progression of cataracts (Refs. 195-197). Studies of smoking
cessation and risk of cataracts has affirmed that risk decreases, but
is not equivalent to never smokers, upon elimination of the exposures
of tobacco smoke (Ref. 198).
    Prevalence of cataracts among U.S. adults aged 40 years and older
in 2010 was estimated to be 17.1 percent by the National Eye Institute
(Ref. 199). By age 75, more than half of non-Hispanic whites have
cataracts (Ref. 199). A meta-analysis found that the risk of cataracts
was about 50 percent higher for current smokers and 20 percent to 60
percent higher for former smokers compared to never smokers (Ref. 24).
VIII. First Amendment Considerations
    The Government may, consistent with the First Amendment, require
the disclosure of factual information in commercial marketing where the
disclosure is justified by a Government interest and does not unduly
burden protected speech. Zauderer v. Office of Disciplinary Counsel;
Nat'l Inst. of Family and Life Advocates v. Becerra, 138 S. Ct. 2361,
2372 (2018). The proposed new cigarette health warnings, including
their images, fully satisfy those requirements.
    The proposed warnings are factual and accurate. As described in
greater detail in section VI.A above, ``Review of the Negative Health
Consequences of Cigarette Smoking,'' in developing the new warnings,
FDA relied on the 2014 Surgeon General's Report, entitled ``The Health
Consequences of Smoking: 50 Years of Progress'' (Ref. 8), in addition
to previous reports of the Surgeon General and other scientific
literature, which together present a robust body of evidence
documenting the health consequences from both active smoking and
exposure to secondhand smoke across a range of diseases and organ
systems. In particular, Surgeon General's Reports provide definitive
syntheses of the available evidence on smoking and health (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 IARC (Refs. 200 and 212).
Because of the rigor and consistent application of these causal
standards, the Surgeon General's Reports are the preeminent authority
for determinations of conditions caused by cigarette smoking and by
exposure to secondhand smoke. Every smoking-related condition in every
warning statement that FDA tested is supported at the very highest
level of evidence of causal inferences from the criteria applied in the
Surgeon General's Reports.
    Based upon this research and upon the substantial scientific
literature on the significant gaps and misperceptions in public
understanding of the negative health consequences of smoking (see
section V.A.3 above, ``There Remain Significant Gaps in Public
Understanding About the Negative Health Consequences of Cigarette
Smoking''), FDA developed initial versions of revised statements for
further review, testing, and refinement. These initial revised
statements were further reviewed by FDA internal epidemiological
experts to confirm that the health conditions under consideration were
causally linked to cigarette smoking or exposure to secondhand smoke.
    In parallel with FDA's work to develop and test revised warning
statements, the Agency also undertook an iterative, research-based
approach to develop and test color graphics depicting the negative
health consequences of cigarette smoking to accompany the statements.
As discussed in section VI.D above (``Developing and Testing Images
Depicting the Negative Health Consequences of Smoking to Accompany the
Textual Warning Statements''), FDA used a photorealistic illustration
format for the images because this format best allowed FDA to ensure
that the final images would be fully concordant with the ultimate
textual statements addressing the same health conditions. The
photorealistic illustration format also facilitated providing factually
accurate images that depict common presentations of the health
conditions in a realistic and objective format devoid of non-essential
elements.
    FDA also carefully considered the D.C. Circuit Court findings
regarding the
[[Page 42778]]
Agency's 2010-2011 cigarette warning rule, including the court's
statements criticizing the images as having been designed ``to evoke an
emotional response'' with ``inflammatory images and the provocatively-
named hotline.'' R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d at 1216
(D.C. Cir. 2012). The court further found that some of the images
``could be misinterpreted by consumers'' and some did ``not convey any
warning information at all.'' Id. (emphasis omitted) (``For example,
the images of a woman crying, a small child, and the man wearing a T-
shirt emblazoned with the words 'I QUIT' do not offer any information
about the health effects of smoking.''). As discussed below, FDA's
science-based, iterative research process to develop and select the
current proposed cigarette health warnings thoroughly addresses any
such criticisms.
    To ensure that all proposed warnings are unambiguous, are unlikely
to be misinterpreted or misunderstood by consumers, and do convey
warning information, FDA repeatedly tested potential text statements,
potential images, and potential pairings of statements with images. To
assess the 9 statements set out in the TCA and the 17 potential revised
statements that were under consideration at the start of its consumer
research, FDA conducted 16 qualitative focus groups with adolescent
smokers, adolescents at risk for starting smoking, and adult smokers.
As discussed in section VI.B above (``Developing Revised Textual
Warning Statements''), these focus groups provided qualitative feedback
on consumers' comprehension of each potential statement; the
believability of each statement's content (e.g., that smoking causes
the health condition noted); whether the relationship between smoking
and the relevant health conditions was new information for them; and
other feedback to make the statement more understandable or convey the
intended message more clearly.
    This qualitative consumer focus group feedback informed FDA's
selection and refinement of the warning statements for the next phase
of research, a large (2,505 participant) quantitative consumer research
study that tested potential statements on their own, without images.
See details in section VI.C above (``FDA's Consumer Research Study on
Revised Textual Warning Statements'') and in the study results included
in this docket (Ref. 129). Obviating any potential concern that the
proposed new warnings would ``not convey any warning information at
all,'' Reynolds, 696 F.3d at 1216, FDA used the results of this
quantitative research, especially ``self-reported learning'' and ``new
information'' outcomes, to identify the warning statements, to be
paired with accompanying concordant photorealistic images, for testing
in the final quantitative consumer research study.
    FDA's rigorous process for developing the proposed images likewise
obviates any potential concerns of the kind raised in Reynolds that
they might ``not offer any information about the health effects of
smoking'' or be discordant from the text statements with which they are
paired. Id. FDA used different development and research processes to
select and study the images in this rule than it did for the 2010-2011
rulemaking. As discussed above, two of FDA's criteria for images
require them to be factually accurate and to be concordant with the
textual warning statements on the same health condition. FDA sought
repeated consumer feedback to ensure that its proposed images meet
these criteria, including 53 indepth individual interviews with
adolescents and adults, and later on, 20 qualitative focus groups with
adolescent smokers, adolescents at risk for starting smoking, and adult
smokers. Based on feedback received in these focus groups, FDA further
refined some images for additional clarity and identified and
eliminated images that were not well understood or where potential
confusion could not be resolved through additional revisions. See
details in section VI.D above (``Developing and Testing Images
Depicting the Negative Health Consequences of Smoking to Accompany the
Textual Warning Statements''). The Agency took careful and deliberate
steps to develop and test images that are unambiguous and unlikely to
be misinterpreted or misunderstood by consumers. Presenting the health
condition in an objective format devoid of non-essential elements
ensures that the focus of the image remains on the smoking-related
health condition. The process FDA engaged in to develop and study the
warnings was far more extensive than could be completed in the short
timeframe for the prior rule.
    The proposed warnings are clearly justified by the Government's
interest in promoting greater public understanding of the negative
health consequences of cigarette smoking. As the Supreme Court has
recognized, ``tobacco products are dangerous to health when used in the
manner prescribed.'' FDA v. Brown & Williamson Tobacco Corp., 529 U.S.
120, 135 (2000). Indeed, as discussed above, cigarette smoking remains
the leading cause of preventable disease and death in the United
States. Given the magnitude of this public health problem from
cigarette smoking, in the Tobacco Control Act Congress required nine
new health warning statements appear on cigarette packages and in
cigarette advertisements; directed FDA to develop color graphics
``depicting the negative health consequences of smoking'' to accompany
the warning statements; and provided that FDA may adjust the warnings
to ``promote greater public understanding of the risks associated with
the use of tobacco products'' (sections 201 and 202 of the Tobacco
Control Act). In reviewing and upholding the Tobacco Control Act's new
warning requirements, the Sixth Circuit concluded that ``[t]here can be
no doubt that the government has a significant interest in . . .
warning the general public about the harms associated with the use of
tobacco products.'' Disc. Tobacco City & Lottery, Inc. v. U.S., 674
F.3d 509, 519 (6th Cir. 2012).
    FDA's research and review of the scientific literature has
confirmed that many smokers and nonsmokers hold misperceptions about
the health risks associated with cigarette smoking, even among the
health conditions most commonly focused on in health warnings and
public health education campaigns. And studies have shown that
consumers are largely unaware of many of the negative health
consequences of cigarette smoking not mentioned in the current 1984
warnings (see section V.A.3 above, ``There Remain Significant Gaps in
Public Understanding About the Negative Health Consequences of
Cigarette Smoking''). Accordingly, the proposed rule is justified by
the Government's substantial interest in informing consumers regarding
the negative health consequences of smoking.
    Furthermore, the proposed warnings do not unduly burden protected
speech. As the Sixth Circuit held, the Tobacco Control Act's warning
requirement for cigarettes is not unduly burdensome because a
manufacturer has the ability to convey other information of its
choosing in the remaining space available. Disc. Tobacco City &
Lottery, Inc. v. U.S., at 530-31. By statute, the required warnings for
cigarette packages must comprise the top 50 percent of the front and
rear panels, and for advertisements at least 20 percent of the area at
the top of the advertisement. The Sixth Circuit found that ``ample
evidence support[s] the size requirements for the new warnings'' and
``that the remaining portions of their packaging'' are sufficient for
the
[[Page 42779]]
companies ``to place their brand names, logos or other information.''
Id. at 531, 567. See also Spirit Airlines, Inc. v. United States Dep't
of Transp., 687 F.3d 403, 414 (D.C. Cir. 2012) (requirement for
airlines to make total price the most prominent cost figure does not
significantly burden airlines' ability to advertise). The scientific
literature strongly supports that larger warnings, such as those of the
size proposed in this rule, are necessary to ensure that consumers
notice, attend to, and read the messages conveyed by the warnings,
which leads to improved understanding of the specific health
consequences that are the subject of those warnings (Refs. 3 and 4).
See discussions above in, e.g., section V.A (``The Current 1984 Surgeon
General's Warnings Are Inadequate''); section V.B.2.a (``Pictorial
cigarette warnings increase knowledge and accurate health beliefs by
addressing gaps in public understanding about the negative health
consequences of smoking''). Accordingly, the proposed warnings are
constitutional under Zauderer.
    Although Zauderer provides the appropriate framework for review,
the rule also satisfies the elements of the test for commercial speech
articulated in Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n.
Under that test, agencies can regulate speech where the regulation
advances a substantial Government interest and the regulation is no
more extensive than necessary. This standard does not require the
Government to employ ``the least restrictive means'' of regulation or
to achieve a perfect fit between means and ends. Board of Trustees v.
Fox, 492 U.S. 469, 480 (1989). Instead, it is sufficient that the
Government achieve a ``reasonable'' fit by adopting regulations ``in
proportion to the interest served.'' Id.
    As discussed above, the Government's interest in informing the
public and correcting misperceptions about the risks of cigarette
smoking is undeniably substantial. See Disc. Tobacco City & Lottery,
Inc., 674 F.3d at 519. The proposed warnings directly and materially
advance the Government's interest by helping consumers understand the
negative health consequences associated with cigarette smoking. As
discussed above, the current 1984 warnings on cigarettes are virtually
invisible and ineffective (see section V.A above, ``The Current 1984
Surgeon General's Warnings Are Inadequate''). FDA has developed new
warnings with new information, in the form of text paired with
concordant images, to promote greater public understanding of the
negative health consequences of smoking. FDA's extensive qualitative
and quantitative consumer research--on potential statements, potential
images, and potential pairings of statements and images--amply
demonstrate that the proposed cigarette health warnings do in fact
promote better understanding by the public of the negative health
effects of smoking. All 13 of the proposed cigarette health warnings
statistically significantly outperformed the control condition (i.e.,
the current 1984 Surgeon General's warnings) on the dimensions of ``new
information'' and ``self-reported learning.'' See discussion above in
sections VI.B (``Developing Revised Textual Warning Statements'')
through VI.E (``FDA's Consumer Research Study on New Cigarette Health
Warnings''), and the consumer research study reports, which we have
included in the docket (Refs. 129 and 153). The warnings selected for
this proposal will advance the Government's interest.
    Finally, the regulation is appropriately tailored to achieve that
result. The warnings relate to the dangers of smoking cigarettes and
will be required on all cigarette packages and advertisements, so there
is nothing over- or underinclusive in the rule's scope. As the Sixth
Circuit held, the size of the warnings is justified by the ample data
demonstrating that larger warnings ``materially affect consumers'
awareness of the health consequences of smoking,'' Disc. Tobacco City &
Lottery, Inc., 674 F.3d at 530, and there is sufficient remaining room
for the manufacturers' speech.
    Accordingly, the proposed rule is constitutionally permissible
under the First Amendment.
IX. Description of the Proposed Rule
    Section 4 of the FCLAA, as amended by sections 201 and 202 of the
Tobacco Control Act, directs FDA to issue regulations requiring color
graphics depicting the negative health consequences of smoking to
accompany textual warning label statements, and permits FDA to 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. This proposed rule would replace part 1141 in Title
21 of the Code of Federal Regulations to implement these FCLAA
requirements. As described in detail in sections VI-VII, the proposed
required warnings are intended to promote greater public understanding
of the negative health consequences of cigarette smoking. We are
seeking comments on these proposed provisions; if you have comments on
specific provisions, we request that you identify the specific
provisions in your comments.
A. General Provisions (Proposed Subpart A)
1. Scope (Proposed Sec.  1141.1)
    As directed by section 4 of the FCLAA, proposed Sec.  1141.1(a)
would explain that proposed part 1141 sets forth the requirements for
the display of required warnings on packages and in advertisements
cigarettes (proposed Sec.  1141.3 includes a definition of cigarette).
These requirements would be applicable to manufacturers, distributors,
and retailers except as described in this proposed section. Retailers
who are also manufacturers would be subject to both the requirements
for retailers and manufacturers, as applicable.
    Proposed Sec.  1141.1(b) provides that the requirements of this
proposed part would not apply to manufacturers or distributors of
cigarettes that do not manufacture, package, or import cigarettes for
sale or distribution within the United States. This proposed subsection
is consistent with section 4(a)(3) of the FCLAA. Manufacturers and
distributors are defined in proposed Sec.  1141.3.
    In addition, retailers would not be in violation of the
requirements of section 4 of the FCLAA and this proposed part for
cigarette packaging that: (1) Contains a warning; (2) is supplied to
the retailer by a license- or permit-holding tobacco product
manufacturer or distributor; and (3) is not altered by the retailer in
a way that is material to 15 U.S.C. 1333 or proposed part 1141 (see
proposed Sec.  1141.1(c)). We believe most, if not all, retailers would
fall under this scenario.\11\ This proposed subsection is consistent
with section 4(a)(4) of the FCLAA. However, this proposed subsection
would require that a retailer ensure that all cigarette packages they
display or sell contain a warning that is unobscured by stickers,
sleeves, or other materials on the packages, for example.
---------------------------------------------------------------------------
    \11\ We note that manufacturers who are also retailers would be
subject to the proposed requirements as manufacturers.
---------------------------------------------------------------------------
    Under proposed Sec.  1141.1(d), the advertisement requirements in
proposed Sec.  1141.10 would apply to a retailer only if the retailer
is responsible for or directs the warnings for advertising.
Importantly, this provision would not relieve a retailer of liability
if the retailer displays in a location open to the public an
advertisement that does
[[Page 42780]]
not contain a warning or that contains a warning that has been altered
by the retailer in a way that is material to section 4 of the FCLAA or
the requirements of this proposed part.
    Retailers would be in violation of the FCLAA and this proposed part
if they alter cigarette packaging or advertising in a way that is
material to the requirements of section 4 of the FCLAA or proposed part
1141, for example, by obscuring or covering up the warning (e.g.,
blocking with a sticker or marker), shrinking the warning, or using a
sleeve to cover the warning. Retailers also would be liable if they
display, in a location open to the public, an advertisement that does
not contain a warning (proposed Sec.  1141.1(d)).
2. Definitions (Proposed Sec.  1141.3)
    Proposed Sec.  1141.3 provides the definitions for the terms used
in the proposed rule. Proposed Sec.  1141.3 sets forth the meaning of
terms as they apply to proposed subparts A and B of part 1141. Proposed
Sec.  1141.3 includes the following definitions from the FCLAA (15
U.S.C. 1332):
     Cigarette. As defined in section 3(1) of the FCLAA, the
term ``cigarette'' means: (1) Any roll of tobacco wrapped in paper or
in any substance not containing tobacco and (2) any roll of tobacco
wrapped in any substance containing tobacco which, because of its
appearance, the type of tobacco used in the filler, or its packaging
and labeling, is likely to be offered to, or purchased by, consumers as
a cigarette described in paragraph (1) of this definition.
     Commerce. As defined in section 3(2) of the FCLAA,
``commerce'' means--
    [cir] Commerce between any State, the District of Columbia, the
Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa,
Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any
place outside thereof;
    [cir] Commerce between points in any State, the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands,
American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston
Island, but through any place outside thereof; or
    [cir] Commerce wholly within the District of Columbia, Guam, the
Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman
Reef, or Johnston Island.
     Package or packaging. As defined in section 3(4) of the
FCLAA, ``package'' means a pack, box, carton, or container of any kind
in which cigarettes are offered for sale, sold, or otherwise
distributed to consumers. The proposed rule would use ``packaging''
interchangeably with package.
     Person. As defined in section 3(5) of the FCLAA,
``person'' means an individual, partnership, corporation, or any other
business or legal entity.
     United States. As defined in section 3(3) of the FCLAA,
``United States,'' when used in a geographical sense, includes the
several States, the District of Columbia, the Commonwealth of Puerto
Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway
Islands, Kingman Reef, and Johnston Island. The term ``State'' includes
any political division of any State.
    In addition, FDA proposes the following definitions:
     Distributor. FDA proposes to define ``distributor'' as any
person who furthers the distribution of cigarettes, whether domestic or
imported, at any point from the original place of manufacture to the
person who sells or distributes the product to individuals for personal
consumption. Common carriers are not considered distributors for the
purposes of this proposed part.
    This proposed definition of distributor would be consistent with
the definition of distributor in section 900(7) (21 U.S.C. 387(7)) of
the FD&C Act. FDA believes using this definition would help ensure
consistent understanding of the scope of distributor across tobacco
product regulations issued by FDA. For example, Sec.  1140.3 (21 CFR
1140.3) uses a definition of distributor that is the same as this
proposed definition except that Sec.  1140.3 uses ``tobacco product''
instead of ``cigarette.''
     Front panel and rear panel. FDA proposes to define ``front
panel'' and ``rear panel'' to mean the two largest sides or surfaces of
the package.
    FDA is proposing to include a definition of front and rear panels
because section 4 of the FCLAA, in setting out the placement
requirements for the label statements, provides that each label
statement shall comprise the top 50 percent of the front and rear
panels of the package. This proposed definition would help ensure that
all persons responsible for complying with the FCLAA and this proposed
part identify the sides or surfaces of the cigarette package on which
the required warnings must appear. On almost all cigarette packages,
these two panels are oriented directly opposite from one another and
are the same size.
     Manufacturer. FDA proposes to define ``manufacturer'' as
any person, including any repacker or relabeler, who manufactures,
fabricates, assembles, processes, or labels a finished cigarette
product; or imports any cigarette that is intended for sale or
distribution to consumers in the United States.
     Retailer. FDA proposes to define ``retailer'' as any
person who sells cigarettes to individuals for personal consumption, or
who operates a facility where vending machines or self-service displays
of cigarettes are permitted. This definition would include any person
who sells cigarettes online (e.g., through a website or mobile phone
application).
    The proposed definitions of manufacturer and retailer are similar
to those used in part 1140 (which establishes sale and distribution
restrictions for cigarettes, as well as other tobacco products), but
with some edits to reflect that the scope of this proposed part is
cigarette packaging and advertisements.
3. Incorporation by Reference (Proposed Sec.  1141.5)
    Proposed Sec.  1141.5 would identify the material that FDA proposes
to incorporate by reference in this proposed part, entitled ``Required
Cigarette Health Warnings.'' This section states that FDA is proposing
to incorporate by reference each required warning, consisting of a
textual warning label statement and its accompanying color graphic. Any
final rule would provide information on how to obtain the electronic,
layered design files for each required warning, as well as technical
specifications to help manufacturers appropriately select, crop, and
scale the warnings to ensure the required warnings are accurately
reproduced during implementation across various sizes of cigarette
packaging and cigarette advertisements. This material would be
available for download either through FDA's website or a file transfer
protocol website. For ease of review for this proposed rule, we have
included an electronic PDF file, containing the proposed required
warnings, as a reference in the docket for this proposed rule (Ref.
18).
    As described in section II.C, FDA intends to provide the required
warnings selected for the final rule as electronic, layered design
files and incorporate those by reference. The material incorporated by
reference must meet the OFR's requirements for incorporating material
by reference, and thus the way this material is displayed may be
changed for the final rule to meet such requirements.
    Proposed Sec.  1141.5(a) would identify the material that FDA
proposes to incorporate by reference, ``Required Cigarette Health
Warnings,'' and how to obtain the material from FDA. This material
would include the electronic, layered design files for each required
[[Page 42781]]
warning in a range of sizes and aspect ratios, including the textual
statements in English and Spanish, font files, color spaces, the
accompanying color graphics, and the white and black warning
backgrounds and borders. These layered design files would be
accompanied by technical specifications describing how to use the
layered design files to help manufacturers appropriately select, crop,
and scale the warnings to ensure the required warnings are accurately
reproduced during implementation of the required warnings on cigarette
packages and in cigarette advertisements. Manufacturers, distributors,
and, when applicable, retailers would obtain the required warnings by
downloading the files directly from FDA's website or via a file
transfer protocol website and accurately reproduce them on cigarette
packages and in advertisements as required by section 4 of the FCLAA
and proposed part 1141.
    This proposed section would also explain that the material is
incorporated by reference with the approval of the Director of the
Federal Register and where interested parties may obtain a copy of the
material (1 CFR part 51). Specifically, if the proposed incorporation
by reference is approved by the OFR and incorporated in the final rule,
interested parties would be able to examine the incorporated material
at that National Archives and Records Administration and at FDA's
Dockets Management Staff.
    Proposed Sec.  1141.5(b) would list the source where interested
parties may obtain a copy of the incorporated material, i.e., by
contacting FDA's Center for Tobacco Products at the address listed.
B. Required Warnings for Cigarette Packages and Advertisements
(Proposed Sec.  1141.10)
    To promote greater public understanding of the negative health
consequences of cigarette smoking, proposed Sec.  1141.10 would
establish required warnings for cigarette packages and advertising. The
proposed requirements comply with section 4 of the FCLAA and include a
textual warning label statement (proposed Sec.  1141.10(a)(1)) with an
accompanying color graphic (proposed Sec.  1141.10(a)(2)).
    Proposed Sec.  1141.10(a) would establish that a required warning
must contain both one of the textual warning label statements and a
color graphic to accompany the textual warning label statement. The
textual warning label statements that would be required will be set out
in any final rule. As FDA has described in section VI.D, we have
identified concordant color graphics proposed to accompany each textual
warning label statement. FDA invites comment on the proposed textual
warning statements and accompanying color graphics. 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 that
supports 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. These comments and information
will help inform the required warnings to be included in a final rule.
    Section 4(d) of the FCLAA directs that the required warnings be
clear, conspicuous, and legible. Accordingly, proposed Sec.  1141.10(b)
and (c) are intended to address those FCLAA requirements. Proposed
Sec.  1141.10(b) would require that manufacturers and distributors (and
retailers in the specific circumstances described in proposed Sec.
1141.1(c)) obtain and accurately reproduce the required warning (which
would comprise the combination of the textual warning label statement
and its accompanying color graphic), from the electronic files
contained in the material to be incorporated by reference at proposed
Sec.  1141.5. These entities would be responsible for ensuring that the
required warnings are not distorted, obscured, or otherwise
inaccurately reproduced from the incorporated material when reproduced
for use in differing types of media (e.g., print, digital). For
example, the required warnings would need to be accurately reproduced,
including maintaining text specifications such as font face and size;
using capital letters for the word ``WARNING'' in each statement; and
maintaining the relationship of text to image for each warning. As per
the requirements laid out in section 4 of the FCLAA, the text of the
cigarette health warnings on packages must be black on a white
background, or white on a black background, in a manner that contrasts,
by typography, layout, or color, with all other printed material on the
package.
    Proposed Sec.  1141.10(c) would establish generally that it is
unlawful for any person to manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within the United States
any cigarette unless the package of which bears a required warning (as
described in proposed Sec.  1141.10(a)) in accordance with section 4 of
the FCLAA and this proposed part. This provision would apply to any
package, including a pack, box, carton, or container, all of which are
included in the definition of package in section 3(4) of the FCLAA.
Thus, in the instance of a carton that contains packs of cigarettes,
the carton and each pack would be required to bear a required warning.
This proposed requirement helps to promote public understanding of the
negative health consequences of cigarette smoking by ensuring that all
cigarette packages bear the required warning.
    In addition, proposed Sec.  1141.10(c)(1) would require that the
warning appear directly on the package and be clearly visible
underneath any cellophane or other clear wrapping. This proposed
requirement is intended to ensure that the warning is not obscured in
any way, e.g., any outer wrapping and tear tape would be required to be
clear and otherwise not interfere with the required warning's
visibility. For packages that are soft-sided (i.e., ``soft pack'' style
packaging), the overwrap closure must not obscure the warning, and, for
hinged lid packages, this would mean that no word of the textual
warning statement may be severed when the package is opened.
    Proposed Sec.  1141.10(c)(2) would implement the requirements in
section 4 of the FCLAA that the required warning comprise at least the
top 50 percent of the front and rear panels of the package. For cartons
(which are included in the definition of package), proposed Sec.
1141.10(c)(2) would specify that the required warning be located on the
left side of the front and rear panels of the carton and comprise at
least the left 50 percent of these panels. This proposed requirement is
intended to ensure that when cigarettes are sold in cartons and not as
individual packs, the required warnings are clearly visible,
conspicuous, and legible to consumers as required by the FCLAA. As
described earlier in this section, the required warning would need to
be on the carton and on each pack to ensure compliance with the FCLAA
and this proposed part.
    Proposed Sec.  1141.10(c)(3) would specify that the required
warning be positioned such that the text of the required warning and
other information on that panel of the package have the same
orientation. For example, if the front panel of a cigarette package
contains information, such as the brand
[[Page 42782]]
name of the cigarette, in a left to right orientation, the required
warning could not be placed such that it appears at a right angle to
this text. Rather, the required warning, including the textual warning
label statement, must also appear in a left to right orientation. This
would help ensure that the required warnings on cigarette packages
would be conspicuous and legible to consumers, as required by section 4
of the FCLAA and this proposed part.
    Cigarette advertisements are addressed in proposed Sec.
1141.10(d). This section would establish requirements related to
cigarette advertising, including that it is unlawful for any
manufacturer, distributor, or retailer of cigarettes to advertise or
cause to be advertised within the United States any cigarette unless
each advertisement bears a required warning in accordance with section
4 of the FCLAA and this proposed part. As per the requirements laid out
in section 4 of the FCLAA, the text of the cigarette health warnings in
advertisements must be black if the background is white and white if
the background is black.
    More specifically, for print advertisements and other
advertisements with a visual component, the required warning must
appear directly on the advertisement (proposed Sec.  1141.10(d)(1)).
Advertisements that would be subject to this proposed rule may appear
in or on, for example, promotional materials (point-of-sale or non-
point-of-sale), billboards, posters, placards, published journals,
newspapers, magazines, other periodicals, catalogues, leaflets,
brochures, direct mail, shelf-talkers, display racks, internet web
pages, electronic mail correspondence, and also may include those
communicated via mobile telephone, smartphone, microblog, social media
website, or other communication tool; \12\ websites, applications, or
other programs that allow for the sharing of audio, video, or
photography files; video and audio promotions; and items not subject to
the sale or distribution ban in Sec.  1140.34. Proposed Sec.
1141.10(d)(1) includes some of these examples for reference but neither
the examples in Sec.  1141.10 (d) nor this discussion are intended to
be exhaustive.
---------------------------------------------------------------------------
    \12\ FCLAA prohibits any advertising of cigarettes on radio,
television, or other media regulated by the Federal Communications
Commission.
---------------------------------------------------------------------------
    Proposed Sec.  1141.10(d)(2) would require that the warning
comprise at least 20 percent of the area of the advertisement in a
conspicuous and prominent format and location at the top of each
advertisement, and that no part of the required warning would fall in
the ``trim area'' (i.e., the area of an advertisement that is cut off
as part of the print publishing process). To meet the proposed
requirement, the required warning would need to be in the
advertisement's ``safe area'' (i.e., not in the trim area) and not be
placed in any area of an advertisement that may be cropped or folded
during final publishing. For advertisements in digital media, proposed
Sec.  1141.10(d)(2) would mean that a required warning must be
appropriately scaled in its coding for both standard desktop and mobile
sizes to ensure that the full required warning is visible on the screen
in its entirety (i.e., a user does not need to scroll in any direction
to see any areas of the warning), is located at the top of the screen,
and is displayed at each point of access to such advertisements. These
proposed requirements are consistent with the language of section 4(b)
of the FCLAA, which mandates that the required warning comprise at
least 20 percent of the area of the advertisement and specifies that
the advertisement appear in a conspicuous and prominent format and
location at the top of the advertisement. We recognize that there is a
wide variation in advertisement size and media, and we are requesting
comments and information on how advertisements in different types of
media might comply with these proposed requirements, including comments
on issues related to small-size advertisements, advertisements in
digital media, and non-visual advertisements.
    Proposed Sec.  1141.10(d)(3) would require that the text of the
required warning be in English, with the two exceptions established in
section 3(b) of the FCLAA. First, the text of the required warning
should not be in English when the advertisement appears in a non-
English medium. In that case, the text of the required warning would be
required to appear in the predominant language of the medium regardless
of whether the advertisement is in English (the predominant language is
the primary language used in the non-sponsored content in the
publication). For example, if the predominant language of the medium is
French, but the advertisement is in English, the text of the required
warning would be required to be in French. Second, the text of the
required warning would not need to appear in English when the
advertisement appears in an English language medium but the
advertisement is not in English; in this case, the text of the required
warning would need to appear in the same language as that principally
used in the advertisement. The purpose of the proposed requirement and
the two proposed exceptions in Sec.  1141.10(d)(3) is to help promote
public understanding of the negative health consequences of cigarette
smoking by ensuring that the textual warning label statement component
of the required warning is in the language that is most likely to be
understood by the majority of the public who would view the
advertisement.
    Proposed Sec.  1141.10(d)(4) would state that for English-language
or Spanish-language warnings, each required warning must be obtained
from the electronic files contained in ``Required Cigarette Health
Warnings,'' which would be incorporated by reference (see proposed
Sec.  1141.5). The required warnings would need to be accurately
reproduced as specified in ``Required Cigarette Health Warnings,'' to
help ensure that the required warnings are not distorted or obscured,
and are prominent and legible, consistent with the requirements of the
FCLAA and this proposed part.
    Proposed Sec.  1141.10(d)(5) would require that non-English-
language warnings, other than Spanish-language warnings, be adapted
using the English-language required warnings obtained from the
electronic files contained in ``Required Cigarette Health Warnings,''
which would be incorporated by reference at proposed Sec.  1141.5. As
with the proposed requirement in Sec.  1141.10(d)(4), the required
warnings would be required to be accurately reproduced as specified in
``Required Cigarette Health Warnings,'' but for these warnings this
would also include the substitution and insertion of a true and
accurate translation of the textual warning label statement in place of
the English-language version. The proposed rule would require that the
inserted textual warning label statement comply with all requirements
of section 4 of the FCLAA and this proposed part. The manufacturer,
distributor, or retailer would be required to accurately and
appropriately translate the textual warning label statement into the
appropriate non-English language or the advertisement would be in
violation of the FCLAA and this proposed part. The translated required
warning would also need to meet the area, format, and other
requirements of the FCLAA and this proposed part.
    Proposed Sec.  1141.10(e) would require that the required warnings
be indelibly printed on or permanently affixed to the package or
advertisement. These required warnings, for example, must not be
printed or placed on a label
[[Page 42783]]
affixed to a clear outer wrapper that is likely to be removed to access
the product within the package. This provision is intended to ensure
that the required warnings cannot be easily ripped off, obscured, or
otherwise tampered with, which would undermine the proposed
requirement. For an advertisement in digital media to meet this
proposed requirement, the required warning must remain on the
advertisement at all times and be clear, conspicuous, and legible as
required in section 4 of the FCLAA and this proposed part. Thus, for
example, it would not be enough to display the required warning only
for a period of time in an advertisement in digital media. We invite
comments and information on how advertisements in digital media might
appropriately satisfy this proposed requirement.
    Proposed Sec.  1141.10(f) would provide that no person may
manufacture, package, sell, offer for sale, distribute, or import for
sale or distribution within the United States cigarettes whose packages
or advertisements are not in compliance with section 4 of the FCLAA and
this proposed part, except as provided by proposed Sec. Sec.  1141.1(c)
and 1141.1(d).
    Proposed Sec.  1141.10(g) would establish marketing requirements
applicable to cigarettes. The marketing requirements would include the
random and equal display and distribution of the required warnings for
cigarette packages and quarterly rotation of the required warnings in
advertisements. The marketing requirements would also require
submission of a plan that provides for the random and equal display and
distribution of the required warnings on cigarette packaging and the
quarterly rotation of the required warnings in cigarette advertising,
as described under section 4 of FCLAA and part 1141 (referred to as
``plan''). These proposed requirements would ensure that all of the
required warnings would be displayed by the tobacco product
manufacturer, distributor, or retailer at the same time.
    As described in more detail in the following paragraphs, under
proposed Sec.  1141.10(g)(1), each required warning would be required
to be randomly displayed in each 12-month period, in as equal a number
of times as is possible on each brand of the product and the packages
randomly and equally distributed in all areas of the United States in
which the cigarette is marketed. A manufacturer, distributor, or
retailer would be required to submit a plan for random and equal
display and distribution of the required warnings for packaging to FDA
for approval. In addition, proposed Sec.  1141.10(g)(2) would establish
quarterly rotation requirements for the required warnings in
advertisements. Under this proposed requirement, the required warnings
for advertisements must be rotated quarterly in alternating sequence in
advertisements for each brand of cigarettes in accordance with a plan
approved by FDA. The manufacturer, distributor, or retailer would be
required to submit the plan for quarterly rotation of the required
warnings in advertisements to FDA for approval.
    For efficiency of review, each plan submitted under proposed Sec.
1141.10(g)(1) and (2) should cover both packaging and advertising,
rather than submitting each plan separately, to the extent applicable.
The tobacco product manufacturer, distributor, or retailer should
describe how their plan would achieve the random and equal display and
distribution of the required warnings on packages and the quarterly
rotation of the required warnings in advertisements.
    Under proposed Sec.  1141.10(g)(1), for each brand of cigarettes,
the plan for packaging would explain how each of the required warnings
would be randomly displayed during each 12-month period on each brand;
how each of the warnings would be displayed in as equal a number of
times as possible on each brand of the product; and how product
packages would be randomly and equally distributed in all areas of the
United States in which the product is marketed. FDA expects that a plan
for the random and equal display and distribution of required warnings
on packages would ordinarily be based on the date of manufacture or
shipment of the product.
    For each cigarette brand, the plan for advertising would be
required to explain how the required warnings would be rotated
quarterly in advertisements and how the quarterly rotations would occur
in alternating sequence (proposed Sec.  1141.10(g)(2)). Among other
things, the plan should specify the initial rotation timeframe on which
quarterly rotation is based and, if the rotation timeframe varies for
different types/forms of advertising, specify the different quarterly
timeframes associated with the different types/forms of advertising,
and describe the quarterly schedule for rotating each of the required
warnings for each cigarette brand. FDA would not consider a plan that
merely restated the regulatory requirements to be sufficiently detailed
to enable FDA to approve the plan.
    After FDA approval of an initial plan, a supplement to the approved
plan should be submitted to FDA and approved before making changes to
the random and equal display or distribution of required warning
statements on packages or the quarterly rotation of required warning
statements in advertisements. For a new brand, a new plan or a
supplement to an approved plan would be required to be submitted and
approved before displaying or distributing packages and advertisements
for that new brand.
    However, in lieu of a supplement to an approved plan for a new
brand, manufacturers may reference in their initial plan all brands in
their product listing(s) under section 905(i) of the FD&C Act and
incorporate any new brands into their approved plan, so long as no
other changes are made to the plan. For retailer-generated advertising,
retailers may list ``all brands'' in their plan, which would cover
future brands, so long as the plan provides for the same schedule for
quarterly rotation of the required warning statements for all brands.
    Proposed Sec.  1141.10(g)(3) would explain that FDA would review
each plan submitted. FDA's review of a plan would only be for the
purpose of determining compliance with the regulatory criteria for
approval of a plan, as set forth in proposed Sec.  1141.10(g)(1) and
(2). FDA requests that each plan include representative samples of
packages and advertisements with each of the required warnings. Such
samples would place the plan in context and, therefore, facilitate
FDA's review of the plan, not a review of the content of the package
labels and advertisements. During the course of a review of a plan, FDA
may request an amendment to a plan under review if FDA needs
clarification of information in the plan or other additional
information to determine whether FDA could approve the plan.
    As described in proposed Sec.  1141.10(g)(3), FDA intends to
approve the plan if it would: (1) Provide for the random and equal
distribution and display of the required warnings on packaging and the
quarterly rotation of the required warnings in advertising, as set out
in proposed Sec.  1141.10(g)(1) and (2) and (2) assure that all
required warnings would be displayed by the manufacturer, distributor,
or retailer at the same time. Approval of a plan would not represent a
determination by FDA that any specific package or advertisement
complies with any of the other requirements of the FCLAA and proposed
part 1141, including those regarding the placement, font type, size,
and color of the warnings, or any other requirements under the FD&C Act
and
[[Page 42784]]
its implementing regulations. FDA intends to communicate the approval
of a plan by issuing a letter to the submitter. After FDA approval of a
plan, if a manufacturer, distributor, or retailer intends to make
changes to the approved plan, they should first submit a supplement to
FDA for review and approval. To provide FDA sufficient time to review a
supplement to an approved plan, FDA strongly recommends allowing up to
6 months for FDA to review and approve a supplement. The amount of time
it would take FDA to review a supplement, however, would depend upon
the volume and quality of the submissions.
    Plans, and any amendments or supplements, should be submitted to
FDA's Center for Tobacco Products, Office of Compliance and
Enforcement. FDA intends to allow electronic submissions, via FDA's
Electronic Submissions Gateway (https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm), and written submissions,
directed to: Food and Drug Administration, Center for Tobacco Products,
Office of Compliance and Enforcement, Document Control Center, Bldg.
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
FDA strongly encourages electronic submission to facilitate efficiency
and timeliness of submission and processing.
    Proposed Sec.  1141.10(g)(4) would establish that each manufacturer
required to randomly and equally display and distribute warnings on
packaging or quarterly rotate the required warnings in advertisements
in accordance with an FDA-approved plan under section 4 of the FCLAA
and this proposed part must maintain a copy of the FDA-approved plan
and make it available for inspection and copying by officers or
employees of FDA. The FDA-approved plan must be retained while in
effect and for a period of not less than 4 years from the date it was
last in effect. FDA has selected 4 years as a means to help ensure that
the FDA-approved plan would be available for at least one biennial FDA
inspection under sections 704 and 905(g) of the FD&C Act. Retaining the
FDA-approved plan for 4 years from the date it was last in effect would
allow FDA to evaluate, for example, whether the warnings are randomly
and equally displayed on product packaging during the time period in
which such products are offered for sale to consumers. In addition,
based on FDA's experience with smokeless plans, FDA has observed at
times in conducting inspections that firms, including contract
manufacturers, have not been aware of the FDA-approved plan that they
should be following. Requiring that the FDA-approved plan is retained
for 4 years from the date it was last in effect would help ensure that
FDA has the opportunity to confirm during the course of an inspection
that firms are aware of and following an approved plan.
    As discussed in section X, FDA intends to establish an effective
date for the submission of plans to FDA, by each person subject to
proposed Sec.  1141.10(g). This would require submission of plans no
later than 5 months from the date of publication of any final rule.
Although FDA believes this timeframe would provide sufficient time for
the plan to be submitted to FDA and reviewed by FDA in advance of the
effective date for the required warnings on packages and advertisements
(which, consistent with section 4 of the FCLAA, would be 15 months from
the publication date of any final rule), we encourage the submission of
these plans as soon as possible once the final rule is published.
    We invite comment on these proposed requirements, including whether
and how the number of final required warnings selected would affect the
random and equal display and distribution of the required warnings on
packages and the quarterly rotation of the required warnings in
advertisements.
C. Misbranding of Cigarettes (Proposed Sec.  1141.12)
    Proposed Sec.  1141.12(a) sets out that a cigarette package would
be deemed misbranded under section 903(a)(1) of the FD&C Act if its
package and labeling do not bear one of the required warnings in
accordance with section 4 of the FCLAA and this proposed part. In
addition, proposed Sec.  1141.12(a) would provide that a cigarette
would be deemed misbranded under section 903(a)(7)(A) of the FD&C Act
if its advertising does not bear one of the required warnings in
accordance with section 4 of the FCLAA and this proposed part.
    Proposed Sec.  1141.12(b) would explain that a cigarette
advertisement and other descriptive printed matter issued or caused to
be issued by the manufacturer, packer, or distributer, would be deemed
to include a brief statement of relevant warnings for the purposes of
section 903(a)(8) of the FD&C Act, if it bears one of the required
warnings in accordance with section 4 of the FCLAA and this proposed
part. However, FDA is proposing that a cigarette distributed or offered
for sale in any State would be deemed misbranded under section
903(a)(8) of the FD&C Act unless the manufacturer, packer, or
distributor includes in all advertisements and other descriptive
printed matter issued or caused to be issued by the manufacturer,
packer, or distributor with respect to the cigarette one of the
required warnings in accordance with section 4 of the FCLAA and this
proposed part. Section 201(a)(1) of the FD&C Act (21 U.S.C. 321(a)(1))
defines ``State'' as ``any State or Territory of the United States, the
District of Columbia, and the Commonwealth of Puerto Rico.'' The
warnings required by section 4 of the FCLAA for cigarette advertising
and packages are ``relevant warnings'' with respect to cigarettes as
that phrase is used in section 903 of the FD&C Act. For the purpose of
this proposed provision, ``other descriptive printed matter'' would
include the packages of cigarettes and would be required to bear one of
the required warnings.
X. Proposed Effective Dates
    FDA is proposing that the required warnings for packages and
advertisements (proposed Sec.  1141.10) would become effective 15
months after the date the final rule publishes in the Federal Register.
This proposed effective date is consistent with the language of section
201(b) of the Tobacco Control Act, which contemplates that the
amendments to the FCLAA established by the Tobacco Control Act would
take effect 15 months after the issuance of the regulations set out in
201(a) of the Tobacco Control Act. FDA is also proposing an effective
date for submission of plans under the FCLAA and this proposed part
(Sec.  1141.10(g)) of no later than 5 months after the final rule
publishes in the Federal Register. This would help ensure that FDA has
time to review the plan in advance of the effective date requiring that
packaging and advertising of cigarettes bear the required warnings.
    Thus, cigarette packages that do not comply with the requirements
of any final rule must not be manufactured for sale or distribution in
the United States as of the effective date (i.e., 15 months after the
date the final rule publishes in the Federal Register). Section 201(b)
of the Tobacco Control Act provides that, beginning 30 days after the
effective date, a manufacturer must not introduce into the domestic
commerce of the United States any product, irrespective of the date of
manufacture, that is not in conformance with section 4 of the FCLAA, as
amended by the Tobacco Control Act. As provided by section 201(b),
after the 30-day period, manufacturers would not be permitted
[[Page 42785]]
to introduce into domestic commerce any cigarette packages that do not
contain the required warnings, irrespective of the date of manufacture.
While this statutory limitation applies to only manufacturers, FDA
believes that keeping products without the required warnings under any
final rule on the market for an extended period would not be in the
interest of public health. We request comments regarding ways to
differentiate cigarette packages sold from existing inventory from
those that were manufactured after the effective date.
    In addition, as of 15 months from the publication of any final rule
mandating that cigarette packages and advertisements bear the required
warnings, no tobacco product manufacturer, distributor, or retailer of
cigarettes may advertise or cause to be advertised within the United
States any cigarette product unless the advertising complies with the
final rule.
XI. Severability and Other Considerations
    In accordance with section 5 of the Tobacco Control Act, the
various requirements established by this proposed rule, when finalized,
would be considered severable and the individual provisions of this
rule would be considered workable on their own. Section 5 of the
Tobacco Control Act states that, if any provision of a regulation
issued under the Act is held to be invalid, the remainder of the
regulation ``shall not be affected and shall continue to be enforced to
the fullest extent possible.'' (Section 5 of the Tobacco Control Act is
codified at 21 U.S.C. 387 note.) Consistent with that directive, it is
FDA's intent that the invalidity of any provision of the final rule
shall not affect the validity of any other part of the rule. In the
event any court or other lawful authority were to temporarily or
permanently invalidate, restrain, enjoin, or suspend any provision of
the final rule, FDA intends for the remaining parts to continue to be
valid.
    Each provision of the proposed rule is independently supported by
data and analysis as described or referenced in this preamble and, if
issued separately, would remain a proper exercise of FDA authority
under sections 201 and 202 of the Tobacco Control Act and sections 701,
704, 903, 905(g), and 909 of the FD&C Act, as amended by the Tobacco
Control Act. If a court were to invalidate some but not all of the
images within the cigarette health warnings, the corresponding textual
warning statements would go into effect without the invalidated images,
along with the remaining cigarette health warnings that pair a textual
warning statement with an image. The remaining pairings and the textual
warning statements without images would still be required to be
randomly and equally displayed and distributed on packages and
quarterly rotated in advertisements. This approach would advance the
Government's interest in promoting greater public understanding of the
negative health consequences of smoking.
    In the event that a court were to invalidate all of the images
within the cigarette health warnings, FDA intends for all the warnings
to go into effect with only their textual warning statements, without
the invalidated images. These too would be randomly and equally
displayed and distributed on packages and quarterly rotated in
advertisements as required. FDA believes this approach could serve as
an interim measure to address Congress's intent to replace the stale
Surgeon General's warnings and to promote greater public understanding
of the negative health consequences of smoking while FDA worked to
develop new pictorial warnings.
    If a court were to invalidate some of FDA's revised textual
warnings with their paired images but some remained valid, FDA intends
that the remaining revised textual warning statements and their paired
images would go into effect. Alternatively, FDA might also choose to
require that the textual warning statements specified in section 4(1)
of the FCLAA go into effect without an accompanying image. In
determining the appropriate approach, relevant circumstances could
include whether there were a sufficient number of warnings to be
randomly and equally displayed and distributed on packages and
quarterly rotated in advertisements as required by statute. As
described above, FDA proposes implementing text-only cigarette health
warnings as an interim measure as a means to address Congress's intent
to replace the stale Surgeon General's warnings and to promote greater
understanding of the negative health consequences of smoking while FDA
worked to develop new pictorial warnings.
    FDA invites public comment on the application of the severability
provision in section 5 of the Tobacco Control Act to this rulemaking
and how any severed portions of a final rule would operate, advance the
Government's interest, and address Congress's intent to replace the
stale 1984 Surgeon General's warnings. FDA also seeks comment on
whether additional codified language should be added for any of the
scenarios described in this section.
    FDA further requests public comment, in the event a court were to
invalidate all of the images within the cigarette health warnings or
were to vacate this rule once finalized, as to whether and how FDA
should implement textual warning statements without images as an
interim measure. Additionally, FDA requests comment on whether, in the
event that a court were also to invalidate the size or location of
revised cigarette warnings as directed by Congress (i.e., for packages,
at least the top 50 percent of the front and rear panels of the
packages), it should require that such interim textual warning
statements comprise, for example, at least the top 30 percent of the
front and rear panels of the packages, consistent with warnings for
other categories of tobacco products that are comprised of textual
statements only, while FDA sought to develop new pictorial warnings.
XII. Preliminary Economic Analysis of Impacts
    We have examined the impacts of the proposed rule under Executive
Order (E.O.) 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility
Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). E.O. 13771 requires that the costs associated with significant
new regulations ``shall, to the extent permitted by law, be offset by
the elimination of existing costs associated with at least two prior
regulations.'' We believe that this proposed rule is an economically
significant regulatory action as defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We estimate that for a small manufacturer or importer who
would be affected by this proposed rule, one-time costs could represent
between 2.5 and 35.6 percent of their annual receipts and recurring
costs could represent from 0.4 to 4.4 percent of their annual receipts.
Hence, we find that the proposed rule will have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which
[[Page 42786]]
includes an assessment of anticipated costs and benefits, before
proposing ``any rule that includes any Federal mandate that may result
in the expenditure by State, local, and tribal governments, in the
aggregate, or by the private sector, of $100,000,000 or more (adjusted
annually for inflation) in any one year.'' The current threshold after
adjustment for inflation is $154 million, using the most current (2018)
Implicit Price Deflator for the Gross Domestic Product. This proposed
rule would result in an expenditure in any year that meets or exceeds
this amount.
    This proposed rule would require that one of up to 13 new cigarette
health warnings, each comprising a textual warning statement paired
with an accompanying color graphic image, appear on cigarette packages
and in cigarette advertisements. The proposed rule would further
require that, for cigarette packages, the required cigarette health
warnings be randomly displayed in each 12-month period, in as equal a
number of times as is possible on each brand of the product and be
randomly distributed throughout the United States in accordance with a
plan approved by FDA. The proposed rule would also require that, for
cigarette advertisements, the required cigarette health warnings must
be rotated quarterly in alternating sequence in advertisements for each
brand of cigarettes in accordance with a plan approved by FDA.
    Pictorial cigarette health warnings promote greater public
understanding about the negative health consequences of smoking as they
increase the noticeability of the warning's message, increase knowledge
and learning of the negative health consequences of smoking, and
benefit diverse populations that have disparities in knowledge about
the negative health consequences of smoking.
    The direct economic benefits of providing information on cigarette
health warnings are difficult to quantify, and we do not predict the
size of these benefits at this time. We discuss the informational
effects 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. Using a 20-year time
horizon, we estimate that the present value of the costs of this
proposed rule ranges from $1.3 billion to $1.9 billion, with a mean
estimate of $1.6 billion, using a three percent discount rate, and
ranges from $1.0 billion to $1.5 billion, with a mean estimate of $1.2
billion, using a seven percent discount rate (2018$). Annualized costs,
which are presented below in table 3, range from $88.6 million per year
to $129.7 million per year, with a mean estimate of $107.5 million per
year, using a three percent discount rate, and range from $94.6 million
per year to $139.8 million per year, with a mean estimate of $115.3
million per year, using a seven percent discount rate (2018$).
    Because it is not possible to compare benefits and costs directly
when the benefits are not quantified, we employ a break-even approach.
If the information provided by the cigarette health warning on each
cigarette package was valued at about $0.01 (for every pack sold
annually nationwide), then the benefits that would be generated by the
proposed rule would equal or exceed the estimated annual costs.
                                      Table 3--Summary of the Informational Effects and Costs of the Proposed Rule
                                                                 [in millions of 2018$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Units
                                                     Primary        Low          High    ---------------------------------------------
                                     Category        estimate     estimate     estimate       Year       Discount                            Notes
                                                                                            dollars        rate      Period  covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informational Effects.........  .................    Pictorial cigarette health warnings promote greater public understanding about the negative health
                                                       consequences of smoking as they increase the noticeability of the warning's message, increase
                                                    knowledge and learning of the negative health consequences of smoking and help reduce disparities in
                                                       knowledge about the negative health consequences of smoking across diverse populations. If the
                                                     information provided by the cigarette health warning on each cigarette package was valued at about
                                                     $0.01 (for every pack sold annually nationwide), then the benefits that would be generated by the
                                                                      proposed rule would equal or exceed the estimated annual costs.
                                                  ------------------------------------------------------------------------------------------------------
Costs.........................  Annualized              $115.3        $94.6       $139.8         2018           7%  20 Years.........  Effective date of
                                 Monetized                                                                                              15 months from
                                 $millions/year.                                                                                        date of
                                                                                                                                        publication of
                                                                                                                                        final rule.
                                                         107.5         88.6        129.7         2018           3%  20 Years.........
--------------------------------------------------------------------------------------------------------------------------------------------------------
    In line with E.O. 13771, in table 4 we estimate present and
annualized values of costs and cost savings over an infinite time
horizon. Based on these costs, when finalized this proposed rule would
be considered a regulatory action under E.O. 13771.
[[Page 42787]]
                    Table 4--E.O. 13771 Summary Table
          [in millions of 2016$, over an infinite time horizon]
------------------------------------------------------------------------
                                                                Primary
                             Item                               estimate
                                                                  (7%)
------------------------------------------------------------------------
Present Value of Costs.......................................     $985.8
Present Value of Cost Savings................................          0
Present Value of Net Costs...................................      985.8
Annualized Costs.............................................       69.0
Annualized Cost Savings......................................          0
Annualized Net Costs.........................................       69.0
------------------------------------------------------------------------
Notes: All amounts have been discounted relative to year 2016 from year
  2021, the latter of which is the estimated year in which the proposed
  rule would become effective once finalized. Because of this additional
  discounting step, the present value estimates presented here are in
  all instances lower than the comparable present value estimates
  associated with a 20-year time horizon. Effective date is 15 months
  from date of publication of the final rule.
    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 220) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
XIII. Analysis of Environmental Impact
    The labeling regulation is a class of actions that are ordinarily
categorically excluded under 21 CFR 25.30(k). Additionally, the
proposed action is not anticipated to pose serious harm to the
environment and to adversely affect a species or the critical habitat
of a species as stipulated under 21 CFR 25.21(b). The proposed action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. No extraordinary
circumstances exist that would require a preparation of an
environmental assessment or an environmental impact statement.
XIV. Paperwork Reduction Act of 1995
    This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). A description of these provisions is given in
the Description section immediately below, with an estimate of the
annual reporting and recordkeeping burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Required Warnings for Cigarette Packages and Advertisements
    Description: The requirement for submission of plans for cigarette
packages and advertisements, and the specific marketing requirements
relating to the random and equal display and distribution of required
warning statements on cigarette packaging and quarterly rotation of
required warning statements in alternating sequence in cigarette
product advertising, appear in proposed Sec.  1141.10(d)(5). A record
of the FDA-approved plan must also be established and maintained.
    Description of Respondents: The respondents to this collection of
information are manufacturers, distributors, and certain retailers of
cigarettes who will be required to submit plans for cigarette packages
and advertisements to FDA.
    FDA intends to ask that each plan cover both packaging and
advertising to the extent applicable. The tobacco product manufacturer,
distributor, or retailer should demonstrate how they plan to achieve
the random and equal display and distribution of the required warning
statements on packages and the quarterly rotation in advertisements.
Required warnings for cigarettes must be randomly and equally displayed
and distributed on packages, and rotated quarterly in advertisements,
in accordance with an FDA-approved plan.
    Plans should be submitted to FDA no later than 5 months after the
date of publication of the final rule and before advertising or
commercially marketing a product that is subject to the rule. Packages
and advertisements of cigarettes would be required to bear the required
warnings beginning 15 months after the date of publication of the final
rule. FDA intends to request an amendment to a plan under review if FDA
needs clarification of information in the plan or other additional
information to determine whether it could approve the plan. Any such
amendments would likely increase the overall review time.
    After FDA approval of an initial plan, a supplement to the approved
plan should be submitted to FDA and approved before making changes to
the random and equal display or distribution of required warning
statements on packages or the quarterly rotation of required warning
statements in advertisements. For a new brand, a new plan or a
supplement to an FDA-approved plan would be required to be submitted
and approved before displaying or distributing packages and
advertisements for that new brand.
    However, in lieu of a supplement to an FDA-approved plan for a new
brand, manufacturers may reference in their initial plan all brands in
their product listing(s) under section 905(i) of the FD&C Act and
incorporate any new brands into their approved plan, so long as no
other changes are made to the plan. For retailer-generated advertising,
retailers may list ``all brands'' in their plan, which would cover
future brands, so long as the plan provides for the same schedule for
quarterly rotation of the required warning statements for all brands.
    FDA intends to allow electronic submissions, via FDA's Electronic
Submissions Gateway, and written submissions. FDA strongly encourages
electronic submission to facilitate efficiency and timeliness of
submission and processing.
    For each brand of cigarettes, the plan for packaging should explain
how: Each of the warnings will be randomly displayed during each 12-
month period on each brand; each of the warnings will be displayed in
as equal a number of times as possible on each brand of the product;
and product packages will be randomly and equally distributed in all
areas of the United States in which the product is marketed. FDA
expects that a plan for random and equal display and distribution of
warnings on packages will ordinarily be based on the date of
manufacture or shipment of the product. For each cigarette brand, the
plan for advertising should explain how the required warning statements
will be rotated quarterly in advertisements and how the quarterly
rotations will occur in alternating sequence. Among other things, the
plan should specify the initial rotation timeframe on which quarterly
rotation is based and, if the rotation timeframe varies for different
types/forms of advertising, specify the different quarterly timeframes
associated with the different types/forms of advertising, and describe
the quarterly schedule for rotating each of the required warnings for
each cigarette
[[Page 42788]]
brand. FDA would not consider a plan that merely restated the
regulatory requirements to be sufficiently detailed to enable FDA to
approve the plan.
    FDA's review of a plan would only be for determining compliance
with the regulatory criteria for approval of a plan, as set forth in
proposed Sec.  1140.10(g)(1) and (2). FDA requests that plans submitted
for review include representative samples of packages and
advertisements with each of the required warning statements. Such
samples would place the plan in context and, therefore, facilitate
FDA's review of the plan, not a review of the content of the package
labels and advertisements. Approval of a plan does not represent a
determination by FDA that any package or advertisement complies with
any of the other requirements regarding the placement, font type, size,
and color of the warnings found in section 4 of the FCLAA and proposed
part 1141, or any other requirements under the FD&C Act and its
implementing regulations. FDA intends to communicate the approval of a
plan with a letter to the submitter. After FDA approval of an initial
plan, a supplement to the approved plan would need to be submitted to
FDA for review and approved before making changes to the display or
distribution of required warnings on packages or the rotation of
required warning statements in advertisements. For a new brand, a new
plan or a supplement to an approved plan would need to be submitted and
approved before displaying or distributing packages and advertisements
for that new brand. However, in lieu of a supplement to an approved
plan for a new brand, manufacturers may reference in their initial plan
all brands in their product listing(s) under section 905(i) of the FD&C
Act and incorporate any new brands into their approved plan, so long as
no other changes are made to the plan. For retailer-generated
advertising, retailers may list ``all brands'' in their plan, which
would cover future brands, so long as the plan provides for the same
schedule for quarterly rotation of the required warning statements for
all brands.
                                Table 5--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          Type of plan               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Initial Plans...................              59               1              59             150           8,850
Supplements.....................              30               1              30              75           2,250
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          11,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
    The burden estimates are based on FDA's experience with information
collections for other tobacco product plans (i.e., smokeless OMB
control number 0910-0671 and cigars OMB control number 0910-0768) and
2017 Treasury Alcohol and Tobacco Tax and Trade Bureau (TTB) data.
    As discussed in the preliminary regulatory impact analysis (see
section XII; Ref. 220), based on 2017 TTB data FDA estimates 59
entities will be affected by the rule. We estimate these 59 entities
will submit a one-time initial plan, and it will take an average of 150
hours per respondent to prepare and submit a plan for packaging and
advertising for a total of 8,850 hours. We estimate that about half of
respondents will submit a supplement. If a supplement to an approved
plan is submitted, FDA estimates it will take half the time per
response. We estimate receiving 30 supplements at 75 hours per response
for a total of 2,250 hours. FDA estimates that the total hours for
submitting initial plans and supplements will be 11,100.
    Proposed Sec.  1141.10(g)(4) would establish that 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 under section 4
of the FCLAA and this proposed part must maintain a copy of the FDA-
approved plan (approved under proposed Sec.  1141.10(g)(3)). This copy
(or record) of such FDA-approved plan must be available for inspection
and copying by officers or employees of FDA. This proposed subsection
would require that the record(s) be retained for a period of not less
than 4 years from the date of FDA's approval of the plan.
                               Table 6--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          Plan records               Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Records.........................              59             1.5              89               3             267
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             267
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
    FDA estimates that 59 recordkeepers will keep a total of about 89
records at 2 hours per record for a total of 267 hours. As stated
previously, these estimates are based on FDA's experience with
information collections for other tobacco product plans (i.e.,
smokeless OMB control number 0910-0671 and cigars OMB control number
0910-0768). Based on our estimates for the submission of initial plans
and supplements (that all respondents will submit initial plans and
about half of respondents will submit supplements), we estimate that
each recordkeeper will keep an average of 1.5 records.
    FDA estimates that the total burden for this information collection
is 11,367 hours (11,100 reporting + 267 recordkeeping).
    FDA believes that the proposed required warnings for cigarette
packages and cigarette advertisements in proposed Sec.  1141.10 are not
subject to
[[Page 42789]]
review by OMB under the PRA because they do not constitute a
``collection of information'' under that statute (44 U.S.C. 3501-3520).
Rather, these labeling statements are a ``public disclosure'' of
information originally supplied by the Federal Government to the
recipient for the purpose of ``disclosure to the public'' (5 CFR
1320.3(c)(2)).
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB or emailed to [email protected]
(see ADDRESSES). All comments should be identified with the title of
the information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this proposed rule to OMB for review. These requirements
will not be effective until FDA obtains OMB approval. FDA will publish
a notice concerning OMB approval of these requirements in the Federal
Register.
XV. Federalism
    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132 and seek input from State
and local officials on potential federalism impacts of the proposed
regulation. Section 4(a) of the Executive Order requires agencies to
``construe . . . a Federal statute to preempt State law only where the
statute contains an express preemption provision or there is some other
clear evidence that the Congress intended preemption of State law, or
where the exercise of State authority conflicts with the exercise of
Federal authority under the Federal statute.'' This rule is being
proposed under section 4 of the FCLAA, as amended by the Tobacco
Control Act, and sections 701, 704, 903, 905(g), and 909 of the FD&C
Act, as amended by the Tobacco Control Act. Federal law includes an
express preemption provision that preempts any requirement, except
pursuant to the Tobacco Control Act, for a ``statement relating to
smoking and health, other than the statement required by section 4 of
[FCLAA], . . . on any cigarette package.'' Section 5(a) of the FCLAA.
It also includes an express preemption provision that preempts any
``requirement or prohibition based on smoking and health . . . imposed
under State law with respect to the advertising or promotion of any
cigarettes the packages of which are labeled in conformity with the
provisions of [FCLAA],'' which includes section 4 of the FCLAA. Section
5(b) of the FCLAA. However, section 5(b) of the FCLAA does not preempt
any State or local statutes and regulations based on smoking and
health, that take effect after June 22, 2009, imposing specific bans or
restrictions on the time, place, and manner, but not content, of the
advertising or promotion of any cigarettes. Section 5(c) of the FCLAA.
    In addition, section 916(a)(2) of the FD&C Act (21 U.S.C. 387p)
expressly preempts any state or local requirement which is different
from, or in addition to, any requirement under Chapter IX of the FD&C
Act relating to, among other things, misbranding and labeling. This
express preemption provision, however, does not apply to requirements
relating to among other things the sale, distribution, access to, or
the advertising and promotion of tobacco products.
XVI. Consultation and Coordination With Indian Tribal Governments
    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.
XVII. References
    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
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*220. Preliminary Regulatory Impact Analysis; Initial Regulatory
Flexibility Analysis; Unfunded Mandates Reform Act Analysis,
Required Warnings for Cigarette Packages and Advertisements;
Proposed Rule.
List of Subjects in 21 CFR Part 1141
    Advertising, Incorporation by reference, Labeling, Packaging and
containers, Tobacco, Smoking.
    Therefore, under the Federal Cigarette Labeling and Advertising
Act, the Federal Food, Drug, and Cosmetic Act, and under authority
delegated to the Commissioner of Food and Drugs, the Food and Drug
Administration proposes to revise 21 CFR part 1141 to read as follows:
PART 1141--REQUIRED WARNINGS FOR CIGARETTE PACKAGES AND
ADVERTISEMENTS
Subpart A--General Provisions
Sec.
1141.1 Scope.
1141.3 Definitions.
1141.5 Incorporation by reference.
Subpart B--Required Warnings for Cigarette Packages and Advertisements
1141.10 Required warnings.
1141.12 Misbranding of cigarettes.
    Authority: 15 U.S.C. 1333; 21 U.S.C. 371, 374, 387c, 387e, 387i;
Secs. 201 and 202, Pub. L. 111-31, 123 Stat. 1776.
Subpart A--General Provisions
Sec.  1141.1  Scope.
    (a) This part sets forth the requirements for the display of
required warnings on cigarette packages and in advertisements for
cigarettes.
    (b) The requirements of this part do not apply to manufacturers or
distributors of cigarettes that do not manufacture, package, or import
cigarettes for sale or distribution within the United States.
    (c) A cigarette retailer will not be in violation of Sec.  1141.10
for packaging that:
    (1) Contains a warning;
    (2) Is supplied to the retailer by a license- or permit-holding
tobacco product manufacturer, or distributor; and
    (3) Is not altered by the retailer in a way that is material to the
requirements of section 4 of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333) or this part.
    (d) Section 1141.10(d) applies to a cigarette retailer only if that
retailer is responsible for or directs the warnings required under
Sec.  1141.10 for advertising. However, this paragraph (d) does not
relieve a retailer of liability if the retailer displays, in a location
open to the public, an advertisement that does not contain a warning or
has been altered by the retailer in a way that is material to the
requirements of section 4 of the Federal Cigarette Labeling and
Advertising Act or this part.
Sec.  1141.3  Definitions.
    For purposes of this part:
    Cigarette means--
    (1) Any roll of tobacco wrapped in paper or in any substance not
containing tobacco; and
    (2) Any roll of tobacco wrapped in any substance containing tobacco
which, because of its appearance, the type of tobacco used in the
filler, or its packaging and labeling, is likely to be offered to, or
purchased by, consumers as a cigarette described in paragraph (1) of
this definition.
    Commerce means:
    (1) Commerce between any State, the District of Columbia, the
Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa,
Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any
place outside thereof;
    (2) Commerce between points in any State, the District of Columbia,
the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American
Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island,
but through any place outside thereof; or
    (3) Commerce wholly within the District of Columbia, Guam, the
Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman
Reef, or Johnston Island.
    Distributor means any person who furthers the distribution of
cigarettes, whether domestic or imported, at any point from the
original place of manufacture to the person who sells or distributes
the product to individuals for personal consumption. Common carriers
are not considered distributors for the purposes of this part.
    Front panel and rear panel mean the two largest sides or surfaces
of the package.
    Manufacturer means any person, including any repacker or relabeler,
who manufactures, fabricates, assembles, processes, or labels a
finished cigarette product; or imports any cigarette that is intended
for sale or distribution to consumers in the United States.
    Package or packaging means a pack, box, carton, or container of any
kind in which cigarettes are offered for sale, sold, or otherwise
distributed to consumers.
    Person means an individual, partnership, corporation, or any other
business or legal entity.
    Retailer means any person who sells cigarettes to individuals for
personal consumption, or who operates a facility where vending machines
or self-service displays of cigarettes are permitted.
    United States, when used in a geographical sense, includes the
several States, the District of Columbia, the Commonwealth of Puerto
Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway
Islands, Kingman Reef, and Johnston Island. The term ``State'' includes
any political division of any State.
Sec.  1141.5  Incorporation by reference.
    (a) Certain material titled ``Required Cigarette Health Warnings,''
appearing in Sec.  1141.10, is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1
[[Page 42797]]
CFR part 51. All approved material is available for inspection at U.S.
Food and Drug Administration, Division of Dockets Management, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available from the
source listed in paragraph (b) of this section. It is also available
for inspection at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
email [email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (b) Center for Tobacco Products, U.S. Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993; 1-888-463-6332.
    (1) ``Required Cigarette Health Warnings''
    (2) [Reserved]
Subpart B--Required Warnings for Cigarette Packages and
Advertisements
Sec.  1141.10  Required warnings.
    (a) A required warning must include the following:
    (1) One of the following textual warning label statements:
    (i) WARNING: Tobacco smoke can harm your children.
    (ii) WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
    (iii) WARNING: Smoking causes age-related macular degeneration,
which can lead to blindness.
    (iv) WARNING: Smoking causes type 2 diabetes, which raises blood
sugar.
    (v) WARNING: Smoking reduces blood flow to the limbs, which can
require amputation.
    (vi) WARNING: Smoking causes cataracts, which can lead to
blindness.
    (vii) WARNING: Smoking causes bladder cancer, which can lead to
bloody urine.
    (viii) WARNING: Smoking reduces blood flow, which can cause
erectile dysfunction.
    (ix) WARNING: Smoking causes head and neck cancer.
    (x) WARNING: Smoking can cause heart disease and strokes by
clogging arteries.
    (xi) WARNING: Smoking during pregnancy stunts fetal growth.
    (xii) WARNING: Smoking causes COPD, a lung disease that can be
fatal.
    (2) A color graphic to accompany the textual warning label
statement.
    (b) Each required warning, comprising a combination of a textual
warning label statement and its accompanying color graphic, must be
obtained and accurately reproduced as specified from the electronic
files contained in ``Required Cigarette Health Warnings,'' which is
incorporated by reference at Sec.  1141.5.
    (c) It is unlawful for any person to manufacture, package, sell,
offer to sell, distribute, or import for sale or distribution within
the United States any cigarettes unless the package of which bears a
required warning in accordance with section 4 of the Federal Cigarette
Labeling and Advertising Act and this part.
    (1) The required warning must appear directly on the package and
must be clearly visible underneath any cellophane or other clear
wrapping.
    (2) The required warning must comprise at least the top 50 percent
of the front and rear panels; provided, however, that on cigarette
cartons, the required warning must be located on the left side of the
front and rear panels of the carton and must comprise at least the left
50 percent of these panels.
    (3) The required warning must be positioned such that the text of
the required warning and the other information on that panel of the
package have the same orientation.
    (d) It is unlawful for any manufacturer, distributor, or retailer
of cigarettes to advertise or cause to be advertised within the United
States any cigarette unless each advertisement bears a required warning
in accordance with section 4 of the Federal Cigarette Labeling and
Advertising Act and this part.
    (1) For print advertisements and other advertisements with a visual
component (including, for example, advertisements on signs, retail
displays, internet web pages, digital platforms, mobile applications,
and email correspondence), the required warning must appear directly on
the advertisement.
    (2) The required warning must comprise at least 20 percent of the
area of the advertisement in a conspicuous and prominent format and
location at the top of each advertisement within the trim area, if any.
    (3) The text in each required warning must be in the English
language, except as follows:
    (i) In the case of an advertisement that appears in a non-English
medium, the text in the required warning must appear in the predominant
language of the medium whether or not the advertisement is in English;
and
    (ii) In the case of an advertisement that appears in an English
language medium but that is not in English, the text in the required
warning must appear in the same language as that principally used in
the advertisement.
    (4) For English-language and Spanish-language warnings, each
required warning must be obtained from the electronic files contained
in ``Required Cigarette Health Warnings,'' which is incorporated by
reference at Sec.  1141.5, and must be accurately reproduced as
specified in ``Required Cigarette Health Warnings.''
    (5) For non-English-language warnings, other than Spanish-language
warnings, each required warning must be obtained from the electronic
files contained in ``Required Cigarette Health Warnings,'' which is
incorporated by reference at Sec.  1141.5, and must be accurately
reproduced as specified in ``Required Cigarette Health Warnings,''
including the substitution and insertion of a true and accurate
translation of the textual warning label statement in place of the
English language version. The inserted textual warning label statement
must comply with the requirements of section 4 of the Federal Cigarette
Labeling and Advertising Act, including area and other formatting
requirements, and this part.
    (e) The required warnings must be indelibly printed on or
permanently affixed to the package or advertisement. These warnings,
for example, must not be printed or placed on a label affixed to a
clear outer wrapper that is likely to be removed to access the product
within the package.
    (f) No person may manufacture, package, sell, offer for sale,
distribute, or import for sale or distribution within the United States
cigarettes whose packages or advertisements are not in compliance with
section 4 of the Federal Cigarette Labeling and Advertising Act and
this part, except as provided by Sec.  1141.1(c) and (d).
    (g)(1) Random display. The required warnings for packages specified
in paragraph (a) of this section must be randomly displayed in each 12-
month period, in as equal a number of times as is possible on each
brand of the product and be randomly distributed in all areas of the
United States in which the product is marketed in accordance with a
plan submitted by the tobacco product manufacturer, distributor, or
retailer to, and approved by, the Food and Drug Administration.
    (2) Rotation. The required warnings for advertisements specified in
paragraph (a) of this section must be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes in accordance
with a plan submitted by the tobacco product manufacturer, distributer,
retailer to, and approved by, the Food and Drug Administration.
    (3) Review. The Food and Drug Administration will review each plan
[[Page 42798]]
submitted under this section and approve it if the plan:
    (i) Will provide for the equal distribution and display on
packaging and the rotation required in advertising under this
subsection; and
    (ii) Assures that all of the labels required under this section
will be displayed by the tobacco product manufacturer, distributor, or
retailer at the same time.
    (4) Record retention. Each tobacco product manufacturer required to
randomly and equally display and distribute warnings on packaging or
rotate warnings in advertisements in accordance with an FDA-approved
plan under section 4 of the Federal Cigarette Labeling and Advertising
Act and this part must maintain a copy of such FDA-approved plan and
make it available for inspection and copying by officers or employees
duly designated by the Secretary of Health and Human Services. The FDA-
approved plan must be retained while in effect and for a period of not
less than 4 years from the date it was last in effect.
Sec.  1141.12  Misbranding of Cigarettes.
    (a) A cigarette will be deemed to be misbranded under section
903(a)(1) of the Federal Food, Drug, and Cosmetic Act if its package
does not bear one of the required warnings in accordance with section 4
of the Federal Cigarette Labeling and Advertising Act and this part. A
cigarette will be deemed to be misbranded under section 903(a)(7)(A) of
the Federal Food, Drug, and Cosmetic Act if its advertising does not
bear one of the required warnings in accordance with section 4 of the
Federal Cigarette Labeling and Advertising Act and this part.
    (b) A cigarette advertisement and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer, or
distributor will be deemed to include a brief statement of relevant
warnings for the purposes of section 903(a)(8) of the Federal Food,
Drug, and Cosmetic Act if it bears one of the required warnings in
accordance with section 4 of the Federal Cigarette Labeling and
Advertising Act and this part. A cigarette distributed or offered for
sale in any State shall be deemed to be misbranded under section
903(a)(8) of the Federal Food, Drug, and Cosmetic Act unless the
manufacturer, packer, or distributor includes in all advertisements and
other descriptive printed matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to the cigarette one
of the required warnings in accordance with section 4 of the Federal
Cigarette Labeling and Advertising Act and this part.
    Dated: July 24, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
    Dated: August 9, 2019.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-17481 Filed 8-15-19; 8:45 am]
BILLING CODE 4164-01-P