[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  

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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.,

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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
------------------------------------------------------------------------
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.
---------------------------------------------------------------------------

    \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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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