Initial plans

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Electronic Submissions

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.

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.

SUMMARY:

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.

DATES:

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.

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ADDRESSES:

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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

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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/201523389.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 oira_submission@omb.eop.gov.
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:
AskCTPRegulations@fda.hhs.gov.
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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Federal Register / Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules
North Bethesda, MD 20852, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:

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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
§ 1141.10)
C. Misbranding of Cigarettes (Proposed
§ 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

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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 lessknown 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

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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, advertisingrelated costs, and costs associated with
government administration and
enforcement of the rule. We estimate
that, at the mean, the present value of
the costs of this proposed rule is about
$1.6 billion using a three percent
discount rate and roughly $1.2 billion
using a seven percent discount rate
(2018$). If the information provided by
the cigarette health warning on each
cigarette package was valued at about
$0.01 (for every pack sold annually
nationwide), then the benefits that
would be generated by the proposed
rule would equal or exceed the
estimated annual costs.

TABLE OF ABBREVIATIONS/COMMONLY
USED ACRONYMS IN THIS DOCUMENT
Abbreviation/
acronym

What it means

CDC ...............

Centers for Disease Control
and Prevention.
Chronic Obstructive Pulmonary Disease.
United States Court of Appeals for the District of
Columbia Circuit.
Executive Order.
Environmental Protection
Agency.
Federal Cigarette Labeling
and Advertising Act.
Federal Food, Drug, and
Cosmetic Act.
Food and Drug Administration.
Federal Trade Commission.
Institute of Medicine.
International Tobacco Control Four Country Survey.
National Archives and
Records Administration.
Office of the Federal Register.
Office of Management and
Budget.
Peripheral arterial disease.
Portable document format.
Peripheral vascular disease.
Socioeconomic status.
Sudden infant death syndrome.

COPD .............
D.C. Cir ..........
EO ..................
EPA ................
FCLAA ...........
FD&C Act .......
FDA ................
FTC ................
IOM ................
ITC–4 .............

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NARA .............
OFR ...............
OMB ...............
PAD ................
PDF ................
PVD ................
SES ................
SIDS ...............

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TABLE OF ABBREVIATIONS/COMMONLY nearly 1.4 million U.S. youth (aged 12–
USED ACRONYMS IN THIS DOCU- 17 years) smoke cigarettes (defined as
past 30-day use) (Refs. 5 and 6). Results
MENT—Continued
Abbreviation/
acronym

What it means

TCA statements.

Textual warning statements
specified in section 4(1) of
the FCLAA.
Alcohol and Tobacco Tax
and Trade Bureau.
World Health Organization.

TTB ................
WHO ..............

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

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

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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
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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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

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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.
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
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).’’

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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 firearmrelated 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).

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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

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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

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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

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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

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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

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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 nonprominent 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).

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

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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).

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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

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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

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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 onethird (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

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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 smokingrelated 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

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

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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

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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

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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 preimplementation 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

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warning as well as aiding
comprehension and understanding of
the information contained in the
message warning. In a United Statesbased 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

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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 nonCanadian 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

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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 smokingrelated 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

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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 lessknown 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.

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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 metaanalysis 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

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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.

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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

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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

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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

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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.

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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’’).

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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

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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, agerelated 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 nonU.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).

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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.
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

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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.

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TABLE 1—TCA AND REVISED STATEMENTS STUDIED IN FDA’S CONSUMER RESEARCH STUDY
TCA statements (short name)

Revised statements (short name)

WARNING: Cigarettes are addictive (addictive).
WARNING: Tobacco smoke can harm your children (harm children).
WARNING: Cigarettes cause fatal lung disease (fatal lung disease in
smokers).
WARNING: Cigarettes cause cancer (unspecified cancer).
WARNING: Cigarettes cause strokes and heart disease (strokes and
heart disease).
WARNING: Smoking during pregnancy can harm your baby (harm your
baby).
WARNING: Smoking can kill you (kill you).
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers
(fatal lung disease in nonsmokers).
WARNING: Quitting smoking now greatly reduces serious risks to your
health (quit now).

WARNING: Smoking causes mouth and throat cancer (mouth and
throat cancer).
WARNING: Smoking causes head and neck cancer (head and neck
cancer).
WARNING: Smoking causes bladder cancer, which can lead to bloody
urine (bladder cancer).
WARNING: Smoking during pregnancy causes premature birth (premature birth).
WARNING: Smoking during pregnancy stunts fetal growth (stunts fetal
growth).
WARNING: Smoking during pregnancy causes premature 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).

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

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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

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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.

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TABLE 1—TCA AND REVISED STATEMENTS STUDIED IN FDA’S CONSUMER RESEARCH STUDY—Continued
TCA statements (short name)

Revised statements (short name)

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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

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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
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
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/scienceresearch/science-and-research-special-topics/peerreview-scientific-information-and-assessments.
7 There was one exception: The TCA statement
‘‘Fatal lung disease in nonsmokers’’ was new
information to 41.9 percent of participants.

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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.
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 ‘‘selfreported 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

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FDA determined that the scientific
literature demonstrates that the
outcomes ‘‘new information’’ and ‘‘selfreported 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 ‘‘selfreported 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

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 selfreported 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.

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.

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).

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3. How Study Findings Were Used

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• 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 agerelated 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

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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–

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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

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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

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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.

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E. FDA’s Consumer Research Study on
New Cigarette Health Warnings

study design, including the control and
outcomes follows).

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

1. Study Design
FDA’s final research study on new
cigarette health warnings was a threesession 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., textimage 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

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WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:

Cigarettes are addictive.
Tobacco smoke can harm your children.
Smoking can kill you.
Tobacco smoke causes fatal lung disease in nonsmokers.
Quitting smoking now greatly reduces serious risks to your health.
Smoking causes head and neck cancer.
Smoking causes bladder cancer, which can lead to bloody urine.
Smoking during pregnancy stunts fetal growth.
Smoking can cause heart disease and strokes by clogging arteries.
Smoking causes COPD, a lung disease that can be fatal. [paired with an image of diseased lungs]
Smoking causes COPD, a lung disease that can be fatal. [paired with an image of man with oxygen tank]
Smoking reduces blood flow, which can cause erectile dysfunction.
Smoking reduces blood flow to the limbs, which can require amputation.
Smoking causes type 2 diabetes, which raises blood sugar.
Smoking causes age-related macular degeneration, which can lead to blindness.
Smoking causes cataracts, which can lead to blindness.

All participants viewed their assigned
warnings on both a mock threedimensional 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.

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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:

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• Whether the warning was new
information to participants (‘‘new
information);
• Whether participants learned
something from the warning (‘‘selfreported 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’’);

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• 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

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 selfreported 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).

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 ‘‘selfreported learning’’ are predictive for the
task of identifying which of the cigarette
health warnings increase understanding

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

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/scienceresearch/science-and-research-special-topics/peerreview-scientific-information-and-assessments.

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

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• 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 agerelated 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
condition (i.e., the Surgeon General’s warnings), on
both the outcomes of ‘‘new information’’ and ‘‘selfreported learning’’ (i.e., knowledge gain).

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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.

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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.

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Each of the proposed warnings
described in this section demonstrated
statistically significant higher levels of
providing new information and selfreported 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

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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

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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

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‘‘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

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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

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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

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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,
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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

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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 underreported 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

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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,
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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

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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 agerelated macular degeneration, which
can lead to blindness.
This proposed warning consists of the
revised textual warning statement
‘‘WARNING: Smoking causes agerelated 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

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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 metaanalysis 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

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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 fourlevel 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 smokingrelated 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

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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

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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

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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

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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

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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 overor 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

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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 § 1141.1)
As directed by section 4 of the
FCLAA, proposed § 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
§ 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 § 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
§ 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
§ 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.
Under proposed § 1141.1(d), the
advertisement requirements in proposed
§ 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
11 We note that manufacturers who are also
retailers would be subject to the proposed
requirements as manufacturers.

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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 § 1141.1(d)).
2. Definitions (Proposed § 1141.3)
Proposed § 1141.3 provides the
definitions for the terms used in the
proposed rule. Proposed § 1141.3 sets
forth the meaning of terms as they apply
to proposed subparts A and B of part
1141. Proposed § 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—
Æ 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;
Æ 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
Æ 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

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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,
§ 1140.3 (21 CFR 1140.3) uses a
definition of distributor that is the same
as this proposed definition except that
§ 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

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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
§ 1141.5)
Proposed § 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 § 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

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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 § 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
§ 1141.10)
To promote greater public
understanding of the negative health
consequences of cigarette smoking,
proposed § 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
§ 1141.10(a)(1)) with an accompanying
color graphic (proposed § 1141.10(a)(2)).
Proposed § 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

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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 § 1141.10(b) and (c) are
intended to address those FCLAA
requirements. Proposed § 1141.10(b)
would require that manufacturers and
distributors (and retailers in the specific
circumstances described in proposed
§ 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 § 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 § 1141.10(c) would establish
generally that it is unlawful for any

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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 § 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 § 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 § 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 § 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 § 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

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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 § 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 § 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 § 1140.34.
Proposed § 1141.10(d)(1) includes some
of these examples for reference but
neither the examples in § 1141.10 (d)
nor this discussion are intended to be
exhaustive.
Proposed § 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
12 FCLAA prohibits any advertising of cigarettes
on radio, television, or other media regulated by the
Federal Communications Commission.

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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 § 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 smallsize advertisements, advertisements in
digital media, and non-visual
advertisements.
Proposed § 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 nonsponsored 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

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appear in the same language as that
principally used in the advertisement.
The purpose of the proposed
requirement and the two proposed
exceptions in § 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 § 1141.10(d)(4) would state
that for English-language or Spanishlanguage 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 § 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 § 1141.10(d)(5) would
require that non-English-language
warnings, other than Spanish-language
warnings, be adapted using the Englishlanguage required warnings obtained
from the electronic files contained in
‘‘Required Cigarette Health Warnings,’’
which would be incorporated by
reference at proposed § 1141.5. As with
the proposed requirement in
§ 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 § 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

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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 § 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 §§ 1141.1(c)
and 1141.1(d).
Proposed § 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
§ 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
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addition, proposed § 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
§ 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 § 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 12month 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 § 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,
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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 § 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 § 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
§ 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 § 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

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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/Electronic
SubmissionsGateway/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 § 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 FDAapproved 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 FDAapproved 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

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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 § 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
§ 1141.12)
Proposed § 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 § 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 § 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

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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 § 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
(§ 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

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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

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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
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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

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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, advertisingrelated 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
estimate

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Category

Informational
Effects.

.........................

Costs ...............

Annualized
Monetized
$millions/year.

19:40 Aug 15, 2019

High estimate

Year dollars

Discount
rate

Period
covered

Notes

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.
$115.3

$94.6

$139.8

2018

7%

20 Years ....

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

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Low estimate

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time horizon. Based on these costs,
when finalized this proposed rule

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Effective date of
15 months from
date of publication of final rule.

would be considered a regulatory action
under E.O. 13771.

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TABLE 4—E.O. 13771 SUMMARY
TABLE
[in millions of 2016$, over an infinite time
horizon]
Primary
estimate
(7%)

Item
Present Value of Costs ................
Present Value of Cost Savings ....
Present Value of Net Costs ..........
Annualized Costs ..........................
Annualized Cost Savings .............
Annualized Net Costs ...................

$985.8
0
985.8
69.0
0
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/Reports
ManualsForms/Reports/Economic
Analyses/default.htm.

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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.

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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 § 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

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42787

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 FDAapproved 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

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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 § 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
respondents

Type of plan

Number of
responses per
respondent

Total annual
responses

Average
burden per
response

Total hours

Initial Plans ...........................................................................
Supplements ........................................................................

59
30

1
1

59
30

150
75

8,850
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 § 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 § 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
recordkeepers

Plan records

Total annual
records

Average
burden per
recordkeeping

Total hours

Records ................................................................................

59

1.5

89

3

267

Total ..............................................................................

........................

........................

........................

........................

267

1 There
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Number of
records per
recordkeeper

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

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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.

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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 § 1141.10 are not subject to

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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 oira_submission@
omb.eop.gov (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

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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.
*1. U.S. Congress. House. Committee on
Energy and Commerce, Subcommittee on
Health. H.R. 1108, Family Smoking
Prevention and Tobacco Control Act:
Hearing Before the House Subcommittee
on Health of the Committee on Energy
and Commerce. Testimony of Richard

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Bonnie. 110th Cong., 1st sess., October 3,
2007.
*2. IOM of the National Academies. Ending
the Tobacco Problem: A Blueprint for the
Nation. R.J. Bonnie, K. Stratton, R.B.
Wallace, Eds. Washington, DC: The
National Academies Press, 2007.
Available at http://
www.nationalacademies.org/hmd/
Reports/2007/Ending-the-TobaccoProblem-A-Blueprint-for-theNation.aspx.
3. Hammond, D., G.T. Fong, A. McNeill, et
al. ‘‘Effectiveness of Cigarette Warning
Labels in Informing Smokers About the
Risks of Smoking: Findings from the
International Tobacco Control (ITC) Four
Country Survey.’’ Tobacco Control,
15(Suppl. 3):iii19–iii25, 2006. Available
at https://doi.org/10.1136/
tc.2005.012294.
4. Hammond, D., G.T. Fong, R. Borland, et al.
‘‘Text and Graphic Warnings on Cigarette
Packages: Findings from the
International Tobacco Control Four
Country Study.’’ American Journal of
Preventive Medicine, 32(3):202–209,
2007. Available at https://doi.org/
10.1016/j.amepre.2006.11.011.
*5. Wang, T.W., K. Asman, A.S. Gentzke, et
al. ‘‘Tobacco Product Use Among
Adults—United States, 2017.’’ Morbidity
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67(44):1225–1232, 2018. Available at
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mmwr.mm6744a2.
*6. Gentzke, A.S., M. Creamer, K.A. Cullen,
et al. ‘‘Vital Signs: Tobacco Product Use
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Morbidity and Mortality Weekly Report,
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Department of Health and Human
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data/sites/default/files/cbhsq-reports/
NSDUHDetailedTabs2017/
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*8. U.S. Department of Health and Human
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on Smoking and Health, 2014.
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‘‘Deaths: Final Data for 2015.’’ National
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and J.L. Gerberding. ‘‘Actual Causes of
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11. Elton-Marshall, T., R. Wijesingha, R.D.
Kennedy, et al. ‘‘Disparities in
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206. Hammond D., J. Thrasher, J.L. Reid, et
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2012. Available at https://doi.org/
10.1007/s10552-012-9902-4.
207. Borland, R., H.H. Yong, N. Wilson, et al.
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et al. ‘‘Smokers’ Responses Toward
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‘‘Changes in Vietnamese Male Smokers’
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apjcp.2016.17.s1.71.
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Chemicals to Humans: Tobacco
Smoking, Vol. 83. Lyon, France: IARC,
1986. Available at https://
monographs.iarc.fr/wp-content/uploads/
2018/06/mono38.pdf.
213. Mutti, S., J.L. Reid, P.C. Gupta, et al.
‘‘Perceived Effectiveness of Text and
Pictorial Health Warnings for Smokeless
Tobacco Packages in Navi Mumbai,
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from an Experimental Study.’’ Tobacco
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tobaccocontrol-2015-052315.
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Niccolai, et al. ‘‘Public Awareness of
Head and Neck Cancers: A CrossSectional Survey.’’ JAMA
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140(7):639–646, 2014. Available at
https://doi.org/10.1001/
jamaoto.2014.867.
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‘‘Perceptions of Blindness Related to
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sj.eye.6701955.
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‘‘Prevalence of Age-Related Macular
Degeneration in the US Population.’’
Archives of Ophthalmology, 129(1):75–
80, 2011. Available at https://doi.org/
10.1001/archophthalmol.2010.318.
217. Krugman, D.M., R.J. Fox, J.E. Fletcher,
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Warnings in Cigarette Advertising? An
Eye-Tracking Approach.’’ Journal of
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Energy and Commerce. Comprehensive
Smoking Education Act (H.R. 3979).
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Cong., 2d sess., August 3, 1984.
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Cessation: A Report of the Surgeon
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Public Health Service, CDC, National
Center for Chronic Disease Prevention
and Health Promotion, Office on
Smoking and Health, 1990.
*220. Preliminary Regulatory Impact
Analysis; Initial Regulatory Flexibility
Analysis; Unfunded Mandates Reform
Act Analysis, Required Warnings for
Cigarette Packages and Advertisements;
Proposed Rule.

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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:

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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
§ 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 § 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 § 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.
§ 1141.3

List of Subjects in 21 CFR Part 1141

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PART 1141—REQUIRED WARNINGS
FOR CIGARETTE PACKAGES AND
ADVERTISEMENTS

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.

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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.
§ 1141.5

Incorporation by reference.

(a) Certain material titled ‘‘Required
Cigarette Health Warnings,’’ appearing
in § 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

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Federal Register / Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules
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 fedreg.legal@nara.gov or go to
https://www.archives.gov/federalregister/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

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§ 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 agerelated 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,’’

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which is incorporated by reference at
§ 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 Spanishlanguage warnings, each required

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warning must be obtained from the
electronic files contained in ‘‘Required
Cigarette Health Warnings,’’ which is
incorporated by reference at § 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 § 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 § 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

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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 FDAapproved 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

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period of not less than 4 years from the
date it was last in effect.
§ 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

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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

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