[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Rules and Regulations]
[Pages 15638-15710]
[FR Doc No: 2020-05223]

Vol. 85

Wednesday,

No. 53

March 18, 2020

Part IV

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 1141

Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements; Required Warnings for Cigarette Packages and
Advertisements: Small Entity Compliance Guide; Guidance for Industry;
Availability; Final Rules

Federal Register / Vol. 85 , No. 53 / Wednesday, March 18, 2020 /
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1141

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

Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to establish new cigarette health warnings for
cigarette packages and advertisements. The final rule implements 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 label 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. The final rule specifies the 11 new textual
warning label statements and accompanying color graphics. FDA is taking
this action to promote greater public understanding of the negative
health consequences of cigarette smoking.

DATES: This rule is effective June 18, 2021. The incorporation by
reference of a certain publication listed in the rule is approved by
the Director of the Federal Register as of June 18, 2021.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of the final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    With regard to the final rule: Courtney Smith, 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<EMAIL_ADDRESS>    With regard to the information collection: 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<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction
    B. Incorporation by Reference
IV. Legal Authority
    A. Summary of Legal Authority
    B. Comments Regarding Legal Authority
    C. Comments Regarding First Amendment Considerations
    D. Comments Regarding the Administrative Procedure Act (APA)
V. Need for Rule and FDA Responses to Comments
    A. Cigarette Use in the United States and the Resulting Health
Consequences
    B. Data Concerning Cigarette Health Warnings
VI. FDA's Approach to Developing and Testing Cigarette Health
Warnings Depicting the Negative Health Consequences of Smoking
    A. FDA's Final Consumer Research Study Findings
    B. Responses to Comments Regarding FDA's Approach
VII. FDA's Selection of Cigarette Health Warnings
    A. General Comments on the Proposed Cigarette Health Warnings
    B. Selected Cigarette Health Warnings
    C. Non-Selected Cigarette Health Warnings
VIII. Alternatives
IX. Description of the Final Rule--Part 1141
    A. Overview of the Final Rule
    B. Description of Final Regulations and Comments
X. Comments Regarding Implementation Issues
XI. Effective Dates
XII. Severability
XIII. Economic Analysis of Impacts
XIV. Analysis of Environmental Impact
XV. Paperwork Reduction Act of 1995
XVI. Federalism
XVII. Consultation and Coordination with Indian Tribal Governments
XVIII. References

I. Executive Summary

A. Purpose of the Final Rule

    The final rule establishes new required warnings for cigarette
packages and advertisements. These new cigarette health warnings
consist of textual warning statements accompanied by color graphics
depicting the negative health consequences of cigarette smoking.\1\
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    \1\ For the purposes of discussion throughout this document, FDA
uses the terms ``cigarette health warnings'' to refer to the
required warnings and ``textual warning statements'' to refer to the
textual warning label statements.
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    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 issuing the final
rule, FDA determined that the public holds misperceptions about the
health risks caused by smoking and that textual warning statements
focused on less-known health consequences of smoking paired with
concordant color graphics will 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
go unnoticed and are effectively ``invisible.'' FDA has determined that
the required 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 Final Rule

    The final rule establishes new required warnings to appear on
cigarette packages and in cigarette advertisements. The rule implements
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 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 by section 4 of the FCLAA, the new
cigarette health warnings must 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.
    In addition, as required under the FCLAA, the final rule
establishes marketing requirements that include the

random and equal display and distribution of the required warnings for
cigarette packages and quarterly rotation of the required warnings for
cigarette advertisements. A tobacco product manufacturer, distributor,
or retailer is 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,
each tobacco product manufacturer that is required to randomly and
equally display and distribute required warnings on packaging and
quarterly rotate required warnings in advertisements, in accordance
with an FDA-approved plan, also must maintain a copy of the FDA-
approved plan and make the plan available for inspection and copying by
officers and employees of FDA.
    FDA developed the new cigarette health warnings included in the
final rule through a science-based, iterative research process. The
required warnings will promote greater public understanding of the
negative health consequences of cigarette smoking.

C. Legal Authority

    The final 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). The final 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 and Benefits

    This final rule requires that new cigarette health warnings, each
comprising a textual warning statement paired with an accompanying
color graphic, appear on cigarette packages and in cigarette
advertisements. The final rule further requires that, for cigarette
packages, these required 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 and equally distributed
throughout the United States in accordance with a plan approved by the
FDA. The final rule also requires that, for cigarette advertisements,
the required warnings be rotated quarterly in alternating sequences in
advertisements for each brand of cigarettes in accordance with a plan
approved by FDA. The final new cigarette health warnings will promote
greater public understanding of the negative health consequences of
cigarette smoking by presenting information about the health risks of
smoking to smokers and nonsmokers in a format that helps people better
understand these consequences. We describe economic benefits
qualitatively. The cost of this final 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
the required warnings for cigarette packages and quarterly rotations of
the required warnings for cigarette advertisements, advertising-related
costs, and costs associated with government administration and
enforcement of the rule. We estimate that, at the mean, the present
value of the costs of this final 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 were valued at about
$0.01 (for every pack sold annually nationwide), then the benefits that
would be generated by the final rule would equal or exceed the
estimated annual costs. This per-pack estimate provides one way to
estimate the value the public would need to receive from the
information provided on the cigarette health warnings in order to break
even with the costs of the rule and is equivalent to 0.2 percent of the
average cost of a pack of cigarettes, based on a national average cost
of $6.27 per pack.\2\
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    \2\ FDA's own analyses and calculations are based in part on
data reported by Nielsen through its RMS service for the cigarettes
category for the 11-week period ending March 23, 2019, for the total
United States market and Convenience Stores and Expanded All Outlets
Combined (xAOC) channels. Copyright (copyright) 2018, The Nielsen
Company. The conclusions drawn from the Nielsen data are those of
the FDA and do not reflect the views of Nielsen. Nielsen is not
responsible for and had no role in and was not involved in analyzing
and preparing the results reported herein. Nielsen RMS data consist
of weekly purchase and pricing data generated from participating
retail store point-of-sale systems in all U.S. markets. See http://www.nielsen.com/us/en.html for more information.
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II. Table of Abbreviations/Commonly Used Acronyms in This Document

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       Abbreviation/acronym                     What it means
------------------------------------------------------------------------
APA...............................  Administrative Procedure Act.
CABG..............................  Coronary artery bypass grafting.
CDC...............................  Centers for Disease Control and
                                     Prevention.
COPD..............................  Chronic obstructive pulmonary
                                     disease.
CVD...............................  Cardiovascular disease.
D.C. Cir..........................  United States Court of Appeals for
                                     the District of Columbia Circuit.
EO................................  Executive Order.
EPA...............................  Environmental Protection Agency.
EPS...............................  Encapsulated PostScript.
FCLAA.............................  Federal Cigarette Labeling and
                                     Advertising Act.
FD&C Act..........................  Federal Food, Drug, and Cosmetic
                                     Act.
FDA...............................  Food and Drug Administration or
                                     Agency.
FR................................  Federal Register.
HHS...............................  U.S. Department of Health and Human
                                     Services.
NARA..............................  National Archives and Records
                                     Administration.
NIFLA.............................  Nat'l Inst. of Family and Life
                                     Advocates.
NSDUH.............................  National Survey on Drug Use and
                                     Health.
OMB...............................  Office of Management and Budget.
PAD...............................  Peripheral arterial disease.
PATH..............................  Population Assessment of Tobacco and
                                     Health.
PCI...............................  Percutaneous coronary interventions.
PDF...............................  Portable document format.
PMTA..............................  Premarket tobacco product
                                     application.

PVD...............................  Peripheral vascular disease.
SAMHSA............................  Substance Abuse and Mental Health
                                     Services Administration.
SES...............................  Socioeconomic status.
TCA statements....................  Textual warning statements specified
                                     in section 4(a)(1) of the FCLAA.
TTB...............................  Alcohol and Tobacco Tax and Trade
                                     Bureau.
WHO...............................  World Health Organization.
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III. Background

A. Introduction

    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 the proposed rule (84 FR 42754, August 16, 2019)
(hereinafter referred to as the proposed rule), there is considerable
evidence that the Surgeon General's warnings go largely unnoticed and
unconsidered by both smokers and nonsmokers (Ref. 1 at p. 291; see also
section V of the proposed rule). These warnings, which have not changed
in 35 years, have been described as ``invisible'' (Ref. 2) and fail to
convey relevant information in an effective way (Ref. 1 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).
    As discussed in the proposed rule, the health risks associated with
cigarette smoking are significant. In developing new cigarette health
warnings for the final rule, FDA carefully examined the scientific
literature, including the 2014 Surgeon General's Report (Ref. 3), 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 40 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. 4-10). Through its review of the scientific literature,
as well as the Agency's science-based, iterative research and
development process (see section VI of the proposed rule), FDA
determined that having warning statements focused on less-known health
consequences of smoking accompanied by photorealistic images would
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.
    Therefore, consistent with section 4 of the FCLAA (as amended by
sections 201 and 202 of the Tobacco Control Act), we are finalizing a
set of 11 required warnings, consisting of textual warning statements
accompanied by concordant color graphics depicting the negative health
consequences of smoking, to appear on cigarette packages and in
cigarette advertisements. Specifically, we are replacing part 1141 to
Title 21 of the Code of Federal Regulations (21 CFR part 1141), and the
new part 1141 requires new cigarette health warnings on cigarette
packages and in cigarette advertisements. As required by section 4 of
the FCLAA, the new cigarette health warnings must 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 the preamble to the proposed rule and in the final
rule, FDA has determined that the new required cigarette health
warnings will advance the Government's interest in promoting greater
public understanding of the negative health consequences of cigarette
smoking.
    On August 16, 2019, FDA issued a proposed rule to establish new
required cigarette health warnings for cigarette packages and
advertisements. These proposed cigarette health warnings consisted of a
set of textual warning statements to be accompanied by concordant color
graphics depicting the negative health consequences of smoking. FDA
proposed to take this action to promote greater public understanding of
the negative health consequences of cigarette smoking as directed by
sections 201 and 202 of the Tobacco Control Act (amending section 4 of
the FCLAA). FDA received about 300 comments to the docket for the
proposed rule. Comments were received from cigarette manufacturers,
retailers and retailer organizations, representatives of tribes/tribal
organizations, health professionals and researchers, public health or
other advocacy groups, academics, State and local public health
agencies, medical organizations, individual consumers, and other
submitters. These comments are summarized and responded to in the
relevant sections of this document. Similar comments are grouped
together by the topics discussed or the particular portions of the
proposed rule or codified language to which they refer.
    To make it easier to identify comments and FDA's responses, the
word ``Comment,'' in parenthesis, appears before the comment's
description, and the word ``Response,'' in parenthesis, appears before
FDA's response. Each comment is numbered to help distinguish among
different comments, and the number assigned is purely for
organizational purposes and does not signify value or importance.
Similar comments are grouped together under the same comment number. In
addition to the comments specific to this rulemaking that we address in
the following sections, we received many general comments expressing
support or opposition to the rule and separate

provisions within the rule. These comments express broad policy views
and do not address specific points related to this rulemaking.
Therefore, these general comments do not require a response. The
remaining comments, as well as FDA's responses, are included in this
document.

B. Incorporation by Reference

    FDA is incorporating by reference ``Required Cigarette Health
Warnings, 2020,'' which was approved by the Office of the Federal
Register. You may obtain a free copy of the material from FDA's
website, located at https://www.fda.gov/cigarette-warning-files; the
Docket at https://www.regulations.gov; or from the Food and Drug
Administration, Center for Tobacco Products, Document Control Center,
Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, email<EMAIL_ADDRESS>    The material incorporated by reference, entitled ``Required
Cigarette Health Warnings, 2020,'' includes the required warnings
(comprising a textual warning statement, as specified in Sec.
1141.10(a), and its accompanying color graphic) in different layouts
based on the size and aspect ratio of the display area where the
required warning must appear (i.e., on cigarette packages, in cigarette
advertisements). We have included an electronic portable document
format (PDF) file containing all the required warnings as a reference
in the docket for the final rule (Ref. 11). FDA is also making this
material available on its website at https://www.fda.gov/cigarette-warning-files.
    FDA recognizes that adaptations to the required warnings may be
needed to avoid technical implementation issues due to the varying
features, formats, and sizes of cigarette packages and advertisements.
To help prevent distortion of the image and text and to minimize the
need for adaptation, FDA has created electronic, layered design files,
built as Encapsulated PostScript (.eps) files, in different formats and
aspect ratios designed to fit packaging and advertising of various
shapes and sizes. FDA is not requiring the use of these .eps files, but
rather we are providing the files as a resource to assist regulated
entities implement part 1141. In addition to the material incorporated
by reference and the .eps files, FDA is making available a technical
specifications document that includes information on how to access,
select, use, and adapt the appropriate .eps file based on the size and
aspect ratio of the display area where the required warning must
appear. These .eps files and technical specifications are also
available on FDA's website at https://www.fda.gov/cigarette-warning-files.

IV. Legal Authority

A. Summary of Legal Authority

    As set forth in the preamble to the proposed rule, the Tobacco
Control Act amends the FD&C Act and provides 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 the
Secretary of the Department of Health and Human Services \3\ to ``issue
regulations that require color graphics depicting the negative health
consequences of smoking'' to accompany the nine new health warning
statements. Congress also provided that the provision requiring the new
health warning statements would not become effective until after the
graphic label rulemaking was completed. Under section 201 of the
Tobacco Control Act, in a subsection entitled ``Graphic Label
Statements,'' 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 statements are
clear, conspicuous, and legible and appear within the specified area
(15 U.S.C. 1333(d)).
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    \3\ The Secretary has delegated this authority to FDA. For the
purposes of discussion throughout this document, FDA uses ``FDA''
when discussing this authority.
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    Section 202(b) of the Tobacco Control Act, in a subsection entitled
``Change in Required Statements,'' also amends section 4 of the FCLAA
to add a new subsection that permits FDA, through a rulemaking, 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 (15 U.S.C. 1333(d)).\4\ Such adjustments,
including adjustments to the text of some of the warning statements and
to the number of required warnings, were included as part of the
proposed rule.
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    \4\ 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).'' To
reduce confusion, this document refers to them, respectively, as
section 201 and section 202(b).
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    These requirements are supplemented by the FD&C Act's misbranding
provisions, which require that product labeling and advertising include
required warnings (section 903). 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.
    While FDA did not receive comments on many of these authorities,
FDA did receive comments regarding our authority to require more than
nine warning label statements and to adjust the text, as well as
comments related to the Administrative Procedure Act (APA) and the
constitutionality of the required warnings. These comments are
summarized and responded to in the following paragraphs. Multiple
comments are often summarized together for convenience. Comment numbers
are assigned to facilitate later reference; they do not indicate
importance or the sequence in which comments were received.

B. Comments Regarding Legal Authority

    (Comment 1) FDA received several comments, including comments from
cigarette manufacturers and a retail organization, disputing FDA's
authority to adjust the text of the warning label statements, to
propose textual warning statements other than the nine warnings
included in section 201 of the Tobacco Control Act (amending section 4
of the FCLAA), and to require more than nine warning label statements.
These comments argue that section 202(b) only permits FDA to adjust the
format and type size for the label statement, which does not include
rewriting and replacing the Tobacco Control Act warning label
statements. Instead, FDA should have proposed warnings that used only
the text statements that Congress set out in section 201 of the Tobacco
Control Act.
    (Response 1) FDA disagrees with these comments. When Congress
passed the Tobacco Control Act, Congress also amended the FCLAA to give
the Secretary more specific authority to

adjust and revise required cigarette warnings. This new authority
includes two separate provisions authorizing FDA to revise aspects of
the warning statements:
     Section 201 of the Tobacco Control Act, which provides
that the Secretary ``may adjust the type size, text and format of the
label statements specified in [FCLAA] subsections 4(a)(2) and 4(b)(2)
as the Secretary determines appropriate so that both the graphics and
accompanying label statements are clear, conspicuous, legible and
appear within the specified area;'' and
     Section 202(b), which permits the Secretary, through a
rulemaking, to ``adjust the format, type size, color graphics, and text
of any of the label requirements . . . if the Secretary finds that such
a change would promote greater public understanding of the risks
associated with the use of tobacco products.'' (Emphasis added.)
    It is significant that section 201 cross-references subsections
(a)(2) and (b)(2); subsection (a)(2) addresses ``Placement; typography;
etc.'' for the ``label statement[s] required by paragraph [(a)(1)]''
for package labels, and subsection (b)(2) addresses the ``Typography,
etc.'' of the ``label statement[s] required by subsection (a)'' for
cigarette advertising. Thus, the adjustments authorized by section 201
focus on placement, typography, clarity, conspicuousness, and
legibility--changes that go to the visual presentation of cigarette
warnings. By contrast, section 202(b) gives the Secretary broader
authority to ``adjust the format, type, size, color graphics, and text
of any of the label requirements'' (emphasis added). Section 202(b)'s
reference to ``label requirements'' is also significant; at minimum, it
refers to and sweeps in the entirety of FCLAA subsection 4(a), which is
entitled ``Label Requirements.'' Also importantly, section 202(b)
allows its more sweeping adjustments only upon a finding that ``such a
change would promote greater public understanding of the risks'' of
smoking.
    The adjustments permitted by section 202(b) therefore differ from
those permitted by section 201 in that:
    (1) section 202(b) authorizes adjustments to ``any of the label
requirements'' of FCLAA subsection 4(a), rather than just adjustments
to the ``type size, text and format'' specified in FCLAA subsection
4(a)(2) (governing the placement, typography, etc., of the ``label
statements'' on package labels) and (4)(b)(2) (governing the
typography, etc., of the ``label statements'' in cigarette
advertising);
    (2) the relevant finding relates to promoting the public's
understanding of the risks associated with the use of tobacco products
rather than the visual clarity of the label statements; and
    (3) section 202(b) explicitly requires rulemaking under 5 U.S.C.
553 for the adjustments it authorizes, while section 201 does not.
    We therefore disagree with comments that argue that, under section
202(b), FDA may only adjust the typographic look of the warnings' text,
not their substance. That assertion conflicts with the plain meaning of
``text,'' which, as comments concede, refers to both ``words and
form,'' not merely the latter. The interpretation is also inconsistent
with the difference in the predicate findings required for adjustments
under sections 201 and 202(b): Visual clarity versus improving public
understanding of risks. If Congress had meant section 202(b) to limit
FDA to making adjustments to improve visual clarity, it would not have
included a predicate finding that relates to the warnings' substance.
Congress further indicated its intent to allow more substantive changes
under section 202(b) by explicitly requiring rulemaking under 5 U.S.C.
553, while adjustments under section 201 are allowed simply upon the
Secretary's determination.
    Some comments argue that the term ``adjust'' precludes changes that
would better be described by the term ``edit'' or ``revise.'' FDA
disagrees. First, the title of section 202 of the Tobacco Control Act
is ``Authority to Revise Cigarette Warning Label Statements'' (emphasis
added). That title reflects Congress's intent to authorize FDA to
revise the warning statements themselves, not merely make typographical
changes. Second, section 202(b) includes the authority to adjust not
only the text of the warnings but also non-textual items like
``format,'' ``type size,'' and ``color graphics''--``edit'' or
``revise'' would not as clearly encompass the types of changes
associated with those items. It is therefore likely that Congress chose
the term ``adjust'' as an umbrella term best suited to include the
variety of changes authorized under section 202(b) of the Tobacco
Control Act.
    FDA also disagrees with the comments that asserted that Congress
did not authorize FDA to adjust the number of warnings. As discussed
below, it is far from clear that the number of warnings is in fact a
statutory requirement. But even if it were, the statutory language does
not speak directly to this issue, and FDA reasonably construes the
statute to allow it to adjust the number of warnings. Section 202(b) of
the Tobacco Control Act authorizes FDA to adjust the ``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--not just to adjust the ``types size, text and format of the
label statements'' specified in subsections governing ``placement,
typography, etc.'' so that both the graphics and the accompanying label
statements are clear, conspicuous, legible, and appear within the
specified area, as section 201 does (emphasis added).
    As amended by the Tobacco Control Act, subsection 4(a) of the
FCLAA, which identifies the ``label requirements'' that may be adjusted
under section 202(b), does not provide a requirement as to how many
warnings there must be. Nothing in the head of subsection 4(a)(1)
refers to ``9 labels''; rather, it refers to ``one of the following
labels.'' In addition, section 202(a) of the Tobacco Control Act amends
the FCLAA's preemption provision, subsection 5(a) of the FCLAA, to
provide that, ``Except to the extent the Secretary requires additional
or different statements on any cigarette package by a regulation, . . .
no statement relating to smoking and health, other than the statement
required by section 4 of [the FCLAA, now amended by the Tobacco Control
Act], shall be required on any cigarette package.'' FCLAA subsection
5(a), as amended by Tobacco Control Act section 202(a) (codified at 15
U.S.C. 1334(a)) (emphasis added). The reference to ``additional''
statements indicates that Congress did not consider nine warnings to be
a fixed statutory requirement. In any event, by authorizing adjustments
to the ``text of any of the label requirements,'' section 202(b)
plainly contemplates that FDA may adjust the ``text'' of the label
requirements within paragraph (1) of subsection 4(a) of the FCLAA
(which is entitled ``Label Requirements''), precisely as this final
rule does.
    Even if FCLAA subsection 4(a)(1) required ``one of the following 9
labels,'' and not just ``one of the following labels,'' as it actually
does, such a numeric requirement would still be among the FCLAA ``label
requirements'' subject to being adjusted under section 202(b) of the
Tobacco Control Act. FDA has determined that all 11 warnings that are
part of this final rule will promote greater public understanding of
the risks of cigarette smoking. FDA therefore may adjust the number of
warnings through this rulemaking conducted under 5 U.S.C. 553.
    (Comment 2) One comment states that FDA does not have the authority
to

change the textual statements provided in the Tobacco Control Act
without implementing them first.
    (Response 2) FDA disagrees. Under section 202(b), FDA may, through
a rulemaking, adjust the format, type size, color graphics, and text of
any of the label requirements if the Secretary finds that such a change
would promote greater public understanding of the risks associated with
the use of tobacco products. Nothing in the language of section 202(b)
of the Tobacco Control Act requires the Agency to first issue warnings
with the Tobacco Control Act statements, and then wait 15 months or
more for such warnings to be implemented, before the Agency may embark
on an effort to revise the warning statements. What the statute
requires is that revisions to the textual warning statements specified
in section 4(a)(1) of the FCLAA (``TCA statements'') be based on a
finding that such a change would promote greater public understanding
of the risks of smoking. Accordingly, in considering whether to revise
the warnings, FDA designed and undertook a rigorous science-based,
iterative research process specifically to assess whether new textual
warning statements would promote greater public understanding of the
risks associated with tobacco products compared to the warning
statements provided in the Tobacco Control Act. As part of its
research, FDA conducted a large (2,505 participants) quantitative
consumer research study (OMB control number 0910-0848, ``Experimental
Study on Warning Statements for Cigarette Graphic Health Warnings'').
This first consumer research study evaluated new textual warnings
statements compared to the warning statements provided in the Tobacco
Control Act to determine if they would promote greater understanding of
the risks of smoking. More details about the study methodology can be
found in the study report included in the docket (Ref. 12). The results
show that, with respect to the outcomes most predictive for
demonstrating greater understanding of the risks of smoking--``new
information'' and ``self-reported learning''--nearly all tested new
textual warning statements performed significantly better than nearly
all textual warning statements provided by the Tobacco Control Act. The
results of this first consumer research study informed the selection of
textual warning statements that FDA then paired with concordant images
for testing in a final consumer research study (OMB control number
0910-0866, ``Experimental Study of Cigarette Warnings'') (see section
VI for more discussion about FDA's approach to developing and testing
cigarette health warnings). FDA has therefore complied with section
202(b) by including new textual warnings in the final rule only after
finding that they will promote greater public understanding of the
risks associated with smoking as compared to certain textual warnings
in the Tobacco Control Act that are excluded from the final rule.

C. Comments Regarding First Amendment Considerations

    FDA received comments from industry, retailers, public health
organizations and coalitions, state and local governments, academia,
and private citizens related to First Amendment considerations. Several
comments from manufacturers, retail organizations, and private citizens
assert that the required warnings violate the First Amendment of the
United States Constitution under a variety of legal standards. Several
other comments, including from public health organizations and state
and local governments, state that the required warnings comport with
First Amendment requirements.
1. Government's Interest
    (Comment 3) Some comments suggest that the Government's interest in
promoting greater public understanding of the negative health
consequences of cigarette smoking is not substantial, and that, in any
case, FDA's Population Assessment of Tobacco and Health (PATH) data and
public health campaigns undermine that asserted interest. Related
comments suggest that, under the Supreme Court's decision in Nat'l
Inst. of Family and Life Advocates (NIFLA) v. Becerra, 138 S. Ct. 2361
(2018), the Government may not compel ``unjustified disclosures,'' such
as disclosures that fail to address a harm that is potentially real and
not purely hypothetical, or that fail to remedy the harm, e.g., by
telling people things they already know.
    Other comments state that ``communicat[ing] health information to
the public about the negative health effects of cigarettes'' is not the
Government's interest, because the Tobacco Control Act identifies the
Government's interest as reducing the number of youth and adults that
use cigarettes. These comments assert that FDA should not proceed
unless FDA demonstrates the new text and color graphics will reduce
smoking rates. Similarly, other comments assert that, as with the 2011
final rule (76 FR 36628, June 22, 2011), FDA's ``true'' governmental
interest is to reduce smoking and that FDA has not provided any
evidence in support of that interest. Other comments generally support
FDA's interest in promoting greater public understanding of the
negative health consequences as a substantial Government interest that
fully supports the rule.
    (Response 3) FDA agrees with the comments that recognize that
promoting greater public understanding of the negative health
consequences of smoking is a substantial Government interest that fully
supports the rule. Providing relevant, truthful, and non-misleading
information to consumers in ways that promote greater public
understanding provides consumers with a better opportunity to make
informed choices. See, e.g., Greater New Orleans Broad. Ass'n v. United
States, 527 U.S. 173, 184-85 (1999); Ref. 13 at 405 (``Disclosure
requirements are based on the `informational function' of commercial
speech and the accepted understanding that it would be impossible for
consumers to verify such information on their own. As a result, the
U.S. regulatory landscape is replete with commercial disclosure
requirements.'').
    As the Sixth Circuit concluded, ``[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.''
Discount Tobacco City & Lottery, Inc. v. U.S., 674 F.3d 509, 519 (6th
Cir. 2012). Cigarette smoking remains the primary cause of preventable
disease and death in the United States. The magnitude of this public
health crisis is compounded by the gaps in knowledge and misperceptions
held by smokers and nonsmokers about the wide variety of negative
health consequences caused by smoking.
    Moreover, FDA's research confirms that the public continues to hold
misperceptions about the health risks of smoking and is largely unaware
of certain serious conditions caused by smoking (see section V.B; see
also NPRM section V.A.3, 84 FR at 42761-62 (``There Remain Significant
Gaps in Public Understanding About the Negative Health Consequences of
Cigarette Smoking'')). Contrary to some comments' assertions, consumers
suffer from a pervasive lack of knowledge about the negative health
consequences of smoking, as both smokers and nonsmokers do not fully
understand that smoking is causally linked to a wide variety of
diseases and health conditions (see section V.B).

    We disagree with comments that argue the public's knowledge of the
general harms of cigarette smoking undercuts the need for these
required warnings. As clearly demonstrated by the rulemaking record,
both the harms of cigarette smoking thoroughly detailed in years of
Surgeon General's reports, and the widespread public misperceptions
about these harms, are very ``real not purely hypothetical.'' NIFLA,
138 S. Ct. at 2377.
    Congress has long recognized and taken steps to address this
information gap. As far back as 1965 when Congress first passed the
FCLAA, it set forth the policy of a comprehensive warning program on
cigarette packages and advertisements so that ``the public may be
adequately informed'' about the dangers of cigarette smoking. FCLAA
Section 2(1), codified at 15 U.S.C. 1331(1). When Congress amended the
FCLAA with the Tobacco Control Act, it recognized that the current 1984
Surgeon General's warnings had become ``ineffective in providing
adequate warnings about the dangers of tobacco products'' (Ref. 14 at
4). To that end, Congress mandated new cigarette warnings to be
accompanied by color graphics and provided the Secretary with the
authority to adjust such warning label requirements if ``such a change
would promote greater public understanding of the risks associated with
the use of tobacco products'' (section 202(b) of the Tobacco Control
Act).
    Under the framework set out in Zauderer v. Office of Disciplinary
Counsel, 471 U.S. 626 (1985), which FDA believes is applicable here, a
Government interest supporting factual disclosures need not be
substantial. But even if a substantial interest were required, that
standard is easily met for these required warnings. ``[T]here is no
question that [the Government's] interest in ensuring the accuracy of
commercial information in the marketplace is substantial.'' Spirit
Airlines, Inc. v. U.S. Dep't of Transp., 687 F.3d. 403, 415 (D.C. Cir.
2012). That interest is heightened when the information at issue
concerns the health risks inherent in using a product. See Posadas de
Puerto Rico Assocs. v. Tourism Co. of Puerto Rico, 478 U.S. 328, 341
(1986) (``[H]ealth, safety, and welfare constitute a `substantial'
governmental interest''); CTIA-The Wireless Ass'n v. City of Berkeley,
928 F.3d 832, 845 (9th Cir.) (``There is no question that protecting
the health and safety of consumers is a substantial governmental
interest.''), cert. denied, 205 L. Ed. 2d 387 (Dec. 9, 2019). As
discussed in further detail in the preamble to the proposed rule, as
well as in section VII below, the required warnings provide factual and
accurate information about the products that are subject to them. The
disclosure of factual and accurate information promotes greater
consumer understanding about their choices in the marketplace. Because
``tobacco products are dangerous to health when used in the manner
prescribed,'' FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120,
135 (2000), the Government has a substantial interest in requiring
disclosures providing factual and accurate information about the
negative health consequences of such products to promote greater
public, including consumer, understanding.
    FDA also does not agree with comments asserting that the Agency's
one true interest lies in reducing smoking rates. The comments cite to
Congressional findings in the Tobacco Control Act, which indicate that
Congress's purposes for the Tobacco Control Act as a whole include
reducing the use of tobacco by minors in an effort to protect millions
from suffering premature death due to tobacco-induced disease. However,
with respect to the warning requirements for cigarettes, the statute
itself is specific: The required warnings are to ``depict[] the
negative health consequences of smoking'' and any changes to these
label requirements are to ``promote greater public understanding of the
risks associated with the use of tobacco products'' (sections 201 and
202 of the Tobacco Control Act).
2. Zauderer
    In the proposed rule, FDA explained that this rule would be
properly analyzed under the Zauderer standard, under which the
Government may require the disclosure of factual and uncontroversial
information in commercial marketing where the disclosure is justified
by a governmental interest and does not unduly burden protected speech.
FDA received many comments addressing the applicability of the First
Amendment standard set out in Zauderer.
    Some of the comments suggest that the required warnings FDA
proposed cannot be upheld under Zauderer because they are not required
to remediate any misleading commercial speech or disclose information
about the terms under which services are available; do not provide
purely factual and uncontroversial information; and are unjustified,
unduly burdensome, and not reasonably related to a substantial
Government interest. Other comments from public health organizations
and academia support the required warnings as appropriate under the
First Amendment and specifically under Zauderer because these are
mandatory factual disclosures that convey valuable factual information
to consumers.
a. Applicability of Zauderer
    (Comment 4) Some comments argue that the proposed warnings should
not be subject to evaluation under Zauderer because they are not being
issued to address consumer deception.
    (Response 4) FDA disagrees that Zauderer applies only to
disclosures that seek to address consumer deception. The comments to
the contrary highlight the ``preventing deception'' phrase at the end
of this passage in Zauderer: ``we hold that an advertiser's rights are
adequately protected as long as disclosure requirements are reasonably
related to the State's interest in preventing deception of consumers.''
Zauderer, 471 U.S. at 651. But this passage merely references ``the
State's interest'' in the particular case before the Court, which
contended that advertisements without certain disclosures were ``false
or deceptive.'' Id. at 633. The Court made no suggestion that its
analysis was confined to mandatory disclosures that seek to prevent
deception and no others.
    The D.C. Circuit considered and rejected such a limited reading of
Zauderer in American Meat Institute v. U.S. Department of Agriculture,
760 F.3d 18 (D.C. Cir. 2014) (en banc). In American Meat, a Department
of Agriculture regulation implementing a federal statute required
identification of the country of origin on the packaging of meat and
meat products. Id. at 20. Examining the facts and language at issue in
Zauderer and Milavetz, Gallop & Milavetz, PA. v. United States, 559
U.S. 229, 253 (2010), in which the Court repeated the ``preventing
deception'' language, the D.C. Circuit held that Zauderer should not be
read to apply only to cases where Government-compelled speech prevents
or corrects deceptive speech. Id. at 22.
    Other circuits addressing this issue have unanimously agreed. In
2001, the Second Circuit applied Zauderer and upheld a compelled
disclosure supported by a substantial state interest in protecting
human health and environment, ``intertwined with the goal of increasing
consumer awareness of the presence of mercury in a variety of
products,'' even though it was ``not intended to prevent `consumer
confusion or deception' per se.'' National Electrical Manufacturers
Association v. Sorrell, 272 F.3d 104, 115

(2d Cir. 2001) (quoting Zauderer). Accord, CTIA, 928 F.3d at 844 (cert.
denied, 205 L. Ed. 2d 387 (Dec. 9, 2019)) (government interest in
furthering public health and safety is sufficient under Zauderer so
long as it is substantial); Discount Tobacco, 674 F.3d at 556-58
(upholding federally required health warnings on cigarette packaging
and in cigarette advertisements, citing Sorrell); Pharm. Care Mgmt.
Ass'n v. Rowe, 429 F.3d 294, 310 n. 8 (1st Cir. 2005) (noting that the
court had found no cases limiting application of the Zauderer compelled
speech test to prevention or correction of deceptive advertising); cf.
Dwyer v. Cappell, 762 F.3d 275, 281-82 (3d Cir. 2014) (describing but
not relying on Zauderer's preventing-deception criterion). And nothing
in NIFLA calls those precedents into doubt. See Am. Bev. Ass'n v. City
& City of San Francisco, 916 F.3d 749, 756 (9th Cir. 2019) (en banc)
(``NIFLA did not address, and a fortiori did not disapprove, the
circuits' precedents . . ., which have unanimously held that Zauderer
applies outside the context of misleading advertisements.'').
    The required health warnings are in any event intended in part to
correct consumer misperceptions regarding the risks presented by
cigarettes, and thereby ``to dissipate the possibility of consumer
confusion or deception.'' Zauderer, 471 U.S. at 651 (internal quotation
marks omitted). There is a long history of deception concerning
consumer health risks in the cigarette industry. The 2014 Surgeon
General's Report provided a 50-year survey, and the second of its ten
``Major Conclusions'' was that ``[t]he tobacco epidemic was initiated
and has been sustained by the aggressive strategies of the tobacco
industry, which has deliberately misled the public on the risks of
smoking cigarettes'' (Ref. 3 at 7). See also United States v. Philip
Morris USA Inc., 566 F.3d 1095 (D.C. Cir. 2009) (upholding
racketeering, fraud, and conspiracy findings against the nation's major
cigarette companies). Even if the largest players in the industry had
not engaged in half a century of fraud, FDA's extensive evidence
demonstrates that important consumer misperceptions regarding the
nature and degree of the risks presented by these products persist.
Therefore, FDA does not agree that Zauderer scrutiny is inapplicable
here.
    (Comment 5) At least one comment argues that the proposed warnings
should not be subject to evaluation under Zauderer because the Supreme
Court in NIFLA limited Zauderer to cases involving disclosures
regarding the provision of services, not goods.
    (Response 5) FDA does not agree Zauderer is limited to cases
involving the provision of services. The Supreme Court in NIFLA ``d[id]
not question the legality of health and safety warnings long considered
permissible, or purely factual and uncontroversial disclosures about
commercial products.'' 138 S. Ct. at 2376 (emphasis added). While the
question presented in that case concerned Zauderer's application to
services other than those provided by the speaker, id. at 2372, nothing
in the opinion suggests that the Court intended to limit Zauderer's
applicability to services to the exclusion of products.
b. Factual, Accurate, and Uncontroversial
    (Comment 6) FDA received comments addressing the factualness and
accuracy of the required warnings. Under Zauderer, these comments
state, a compelled disclosure must be purely factual, and disclosure
requirements that are intended to evoke an emotional response, shock
the viewer into retaining information, or convey an ideological message
about how consumers should behave do not qualify as purely factual.
Many of these comments referred to the D.C. Circuit's 2012 decision
striking down the pictorial cigarette warnings the Agency issued in
2011, R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012).
These comments generally imply that any pictorial cigarette warning
cannot be factual because the point of the warnings is to force
consumers to look at gruesome images that evoke feelings of shame and
fear and to convey an ideological message turning cigarette packages
and advertisements into mini-billboards for the Government's anti-
smoking position. The comments also specifically suggest that the
required warnings proposed by FDA are not purely factual because they
contain what the commenters consider shocking and inflammatory images.
The comments cite as examples the images of diseased feet with
amputated toes, the head and neck tumor, and the lungs, which the
comments say are intended to convey emotions of fear, shame, and
disgust. The comments also contend that FDA's consumer studies confirm
that the required warnings are not factual because the first
quantitative consumer research study showed that many of the tested
statements were perceived to be less believable than the Tobacco
Control Act's warning statements, and in the final quantitative
consumer study, eight of the proposed warnings were less likely to be
``perceived as factual'' than the Surgeon General's warnings.
    FDA also received comments that the required warnings proposed by
FDA are factual and accurate because the textual statements and
accompanying photorealistic images depicting the health harm described
or the effect of that harm are supported by a broad consensus of
scientific research and U.S. Surgeon General's Reports. The comments
point to FDA's final quantitative consumer research study showing that
the new text warnings, paired with the accompanying images, provide new
information that promotes greater public understanding of the negative
health consequences of smoking. These comments also note that there is
nothing in the administrative record that suggests the color images are
intended to evoke an emotional response instead of illustrating the
factual statements. The comments observe that, to the extent any
information about actual negative health effects of smoking evokes
emotion, that response does not make the information or images any less
factual.
    Some comments also suggest that the warnings do not provide purely
factual and uncontroversial information but instead are misleading
because they ``do not depict conditions as they are typically
experienced by smokers and instead depict procedures or outcomes that
are distinct from or extreme as compared to the written warning.''
Comments state that several of the images ``exaggerate the effects of
the diseases they purport to represent, exaggerate the likelihood of
those diseases caused by smoking, or offer a misleading portrayal of
the treatment of those diseases.'' Other comments suggest that the
required warnings proposed by FDA do not go far enough in visual
depiction or textual statement, which results in misleading
understatements of the negative health consequences of smoking. Some
comments also state that FDA did not develop evidence that the required
warnings convey factual information to consumers in a way that is not
misleading and suggest the studies were not designed to do so. Comments
suggest that the study designs did not evaluate whether any of the
warnings FDA proposed conveyed accurate information, and that, for
example, unlike FDA's draft recommendations with modified risk tobacco
products, FDA failed to evaluate consumer understanding of absolute and
relative risk.
    (Response 6) FDA disagrees with those comments that suggest the
visual depictions are not factual and accurate

based on their assertion that they are designed to evoke an emotional
response, such as disgust, and agrees with those comments that say the
images illustrate the factual and accurate textual statements with
which they are paired. In developing the proposed images, FDA conducted
a science-based, iterative research process to develop, test, and
refine images that were factually accurate; that depicted common visual
presentations of the health conditions and/or showed disease states and
symptoms as they are typically experienced; that presented the health
conditions in a realistic and objective format devoid of non-essential
elements; and that study participants found were concordant with the
statements on the same health conditions. To do this, FDA staff,
including internal medical experts from a range of specialties, worked
closely with a certified medical illustrator to develop high quality,
factually accurate photorealistic images (see section VI of the
proposed rule, 84 FR at 42765-66, 42770-71).
    While there is little guidance from the courts with respect to what
constitutes factual and accurate with respect to images for purposes of
Zauderer scrutiny, some comments have noted that the majority of the
resulting images now being included in the final warnings match up with
examples of potential factual disclosures given by the Sixth Circuit in
Discount Tobacco, 674 F.3d 509. In Discount Tobacco, the Sixth Circuit
provided a non-exhaustive list of the types of images that could pass
muster under Zauderer as factual and uncontroversial accompanying
cigarette warnings. These include, for example, ``a picture or drawing
of the internal anatomy of a person suffering from a smoking-related
medical condition'' (images in the required warnings include a diseased
lung); a ``picture or drawing of a person suffering from a smoking-
related medical condition'' (images in the required warnings include
persons suffering from cataracts, reduced blood flow, heart disease,
erectile dysfunction, respiratory problems, head and neck cancer, and
chronic obstructive pulmonary disease (COPD)); or ``pictures consisting
of text and simple graphic images'' (images in the required warnings
include an underweight baby on a scale, a urine specimen cup, and a
blood glucose monitor). Discount Tobacco, 674 F.3d at 559. As the Sixth
Circuit noted, medical students look at such pictures or drawings to
learn about medical conditions and biological systems because they are
factual. Id. The images included in the warnings reflect precisely that
type of factual content.
    FDA also carefully considered the D.C. Circuit's conclusions
regarding the Agency's 2011 cigarette warning final rule, including the
court's statements criticizing those images as having been designed
``to evoke an emotional response'' with ``inflammatory images and the
provocatively-named hotline.'' R.J. Reynolds, 696 F.3d at 1216
(referencing ``1-800-QUIT-NOW'' hotline). The Court further found that
``many'' of the images ``could be misinterpreted by consumers.'' Id.
(stating that an ``image of a man smoking through a tracheotomy hole
might be misinterpreted as suggesting that such a procedure is a common
consequence of smoking,'' rather than symbolize the addictive nature of
cigarettes, as FDA contended--in other words, consumers might not find
the images concordant with their accompanying text statements). The
D.C. Circuit additionally found that ``many'' of the images did ``not
convey any warning information at all.'' Id. (referencing images of a
woman crying, a small child, and a man wearing a T-shirt emblazoned
with the words ``I QUIT''). FDA has addressed those criticisms in
several ways. FDA used a certified medical illustrator to design images
that depicted common visual presentations of the health conditions and/
or showed disease states and symptoms as they are typically
experienced, and that present the health conditions in a realistic and
objective format devoid of non-essential elements. FDA used different
criteria to select and study the images and warnings for this rule than
it did in the 2011 rulemaking. FDA developed the current warnings by
designing and testing potential images, potential text statements, and
potential pairings of text statements with images multiple times with
different groups of consumers to ensure--and be able to demonstrate--
that they are unambiguous and unlikely to be misinterpreted or
misunderstood (in contrast to Reynolds' concern that consumers might
misunderstand the image of a man smoking through his tracheotomy hole),
and that they do convey warning information (in contrast to Reynolds'
concerns that images of a woman crying, a small child, and a man
wearing an ``I QUIT'' T-shirt provided no information at all).
    Some may argue that, because the warnings will promote greater
public understanding about the very real, serious, and sometimes deadly
outcomes of cigarette smoking, their factually accurate content may
evoke subjective, emotional responses from some consumers based on
their personal history and personality characteristics. In general, the
possibility that factual content may evoke an emotional reaction does
not render the content less factual. In this context, an emotional
reaction on the part of some individuals would not render the warnings
or the health information they convey ``controversial'' or
``inflammatory.'' CTIA, 928 F.3d at 847 (holding that sentence of
mandated disclosure about cell-phone radiation that ``tells consumers
what to do in order to avoid exceeding federal guidelines'' ``may not
be reassuring, but it is hardly inflammatory. It provides in summary
form information that the FCC has concluded that consumers should know
in order to ensure their safety.''). There is no controversy about
whether cigarette smoking causes the negative health consequences that
form the content of the warnings. As discussed more fully in sections
VI and VII, the evidence is clear that it does.
    FDA also disagrees with comments that the warnings constitute a
``mini-billboard'' conveying an anti-smoking position on the part of
the Government. FDA expresses no such viewpoint through these required
health and safety disclosures: there is no ``provocatively-named'' ``1-
800-QUIT-NOW'' hotline, and no man wearing a T-shirt emblazoned with
``I QUIT.'' Even though not implicated by the final warnings here, FDA
disagrees with the suggestion that mandatory cessation messages, such
as the current Surgeon General's warning dating to 1984, ``SURGEON
GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks
to Your Health, Birth, And Low Birth Weight,'' are ineligible for First
Amendment review under Zauderer. Cessation statements, like the Surgeon
General's warning just quoted, that contain factual and uncontroversial
information are appropriately reviewed under the Zauderer standard just
like other factual disclosures.
    FDA also disagrees that its research studies confirm the warnings
are not factual. Rather, through the Agency's science-based, iterative
research process, FDA designed warnings that are factually accurate,
have concordant textual statements and accompanying images depicting
the specific health conditions, and are presented in a realistic and
objective format. All warnings (new cigarette health warnings and the
current Surgeon General's warnings, which served as the control
condition) were perceived as being factual by the vast majority of
participants in the consumer research studies. Importantly, we note
that

``perceived factualness'' is distinct and different from actual factual
accuracy. For example, when individuals are presented with new
information, this new information may be viewed with skepticism and
perceived as less factual than information that is familiar or well-
known. We describe this in detail in section VI. FDA also disagrees
with comments suggesting that the images are not factual because they
are exaggerated, not typical, and therefore misleading (see section VII
for further discussion). FDA disagrees with comments suggesting that
its warnings are misleading because they should and do not take into
account consumer understanding of either the relative risk of
developing certain health conditions from smoking or the absolute risk
of developing such conditions (see section VII.A).
c. Unduly Burdensome
    (Comment 7) FDA received several comments stating that the required
warnings violate the First Amendment because the size and placement
requirements unduly burden speech and are broader than reasonably
necessary. The comments raise concerns that each package must bear a
required warning that will take up the top 50 percent of the package's
front and rear panels and that cigarette advertisements must bear
required warnings that occupy at least the top 20 percent of the
advertisement. The comments note that communications with consumers are
already limited due to bans on television and radio advertisements,
promotional items, sponsoring events, and free samples. As
alternatives, some comments suggest text-only warnings or public
education campaigns.
    Other comments say that the required warnings proposed by FDA do
not unduly burden protected speech, noting that the size of the
warnings on the packages and in advertisements is mandated by the
Tobacco Control Act. One comment states there is no evidence that
pictorial cigarette warnings covering 50 percent or more of the package
have prevented companies from communicating their brand imagery in any
of the over 100 countries that have implemented large health warnings.
This comment notes that the health warnings provide additional
information and do not prevent companies from communicating their
promotional information.
    (Response 7) FDA does not believe the warnings 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 ample opportunity to convey other information of its
choosing in the remainder of the packaging or advertisement. Discount
Tobacco, 674 F.3d 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 companies ``to place their brand names, logos or other
information.'' Id. at 531, 567. See also Spirit Airlines, 687 F.3d at
414 (requirement for airlines to make total price the most prominent
cost figure does not significantly burden airlines' ability to
advertise). FDA also notes that, when the final rule is in effect, the
area of cigarette package and advertising space currently devoted to
the Surgeon General's warnings will be available for companies.
    The Supreme Court's decision in NIFLA is not to the contrary. In
NIFLA, the Court affirmed that, under Zauderer, required disclosures
must ``extend no broader than reasonably necessary.'' 138 S. Ct. at
2377. This does not mean that a particular disclosure must be the least
restrictive means of accomplishing the Government's objective. Here,
FDA has concluded that the scientific literature strongly supports that
larger warnings, such as those of the size required by Congress in the
Tobacco Control Act and now being issued by FDA in this rule, are
necessary to ensure that consumers notice, attend to, and read the
messages conveyed by the warnings, which promotes improved
understanding of the specific health consequences that are the subject
of those warnings (Refs. 4 and 15). Furthermore, the exact size of the
required warnings is not a constitutional issue. In Burson v. Freeman,
504 U.S. 191, 208 (1992), the Supreme Court, having determined that
some restricted solicitation-free zone around a voting area was
necessary to secure the State's compelling interest in fair elections,
considered whether a 100-foot restricted zone was permissible or
sufficiently tailored. The Court found that, although there were
outside limits on how large the restricted zone could be, the
difference between 25 and 100 feet was not ``of a constitutional
dimension.'' Id. at 210-11. Because FDA has shown that the larger
warnings at issue are reasonably necessary to achieve the Government's
interest in promoting greater public understanding of the risks of
smoking, and because manufacturers retain adequate space in which to
undertake their preferred speech, the warnings are not unduly
burdensome.
    (Comment 8) Some comments state that the requirement to place
warnings on the top 50 percent of front and rear panels means that all
cigarette packages will look alike when placed in display cases which
show only the top halves of cigarette packages, and the requirement
will thus inhibit manufacturers' abilities to promote their branded
products.
    (Response 8) As noted elsewhere, and in accordance with the Sixth
Circuit decision in Discount Tobacco, 674 F.3d at 530-31, 567, FDA has
determined that the statutorily-required placement of warnings at the
top 50 percent of front and rear panels of cigarette packages, and the
top 20 percent of advertisements, leaves sufficient room for
manufacturer speech. There is ample room for manufacturers to
distinguish their products from other products using the lower half of
a cigarette package and the remaining 80 percent of advertisements for
brand names, logos, or other information. There is also additional
space on the side panels of cigarette packages due to the removal of
the Surgeon General's warnings. Although one comment expresses concern
that the rule will render cigarette packages indistinguishable from one
another because of certain display cases that show only the top
portions of cigarette packages, there is no requirement that display
cases be configured that way. Moreover, FDA observes that cigarette
display fixtures and cases generally do not display only cigarette
package facings, but commonly feature a large amount of ``header,''
``flipper,'' and other cigarette advertising that is subject only to a
20 percent requirement. The requirements here are distinct from the
disclosure requirements found unconstitutional in NIFLA, which mandated
that the required statement be provided in up to 13 languages, thereby
threating to ``drown out'' the speaker's own message. 138 S. Ct. at
2378. Here, any such concern is obviated because manufacturers retain
50 percent of the front and rear panels of cigarette packages, and 80
percent of advertisements, for their speech.
    (Comment 9) One comment on the RIA suggested that the cigarette
companies' reduced ability to communicate branding and other messages
through their packs may result in lost communication potential.
    (Response 9) We also address the same comment in the Final RIA
(Ref. 16). The Final RIA includes an estimate of the immediate costs of
a requirement

for warnings to use 20 percent of advertising space. But acknowledging
that some economic costs may be associated with a mandatory disclosure
provides very little information for any First Amendment analysis. The
pertinent constitutional question is instead whether the mandatory
disclosure is unduly burdensome and chills protected commercial speech,
or whether manufacturers retain adequate space for their speech. See
Zauderer, 471 U.S. at 651; see also id. at 653 n.15 (finding that
``[t]his case does not provide any factual basis for finding Ohio's
disclosure requirements are unduly burdensome''); cf. id. at 663
(Brennan, J., joined by Marshall, J., concurring in part, concurring in
the judgment in part, and dissenting in part) (concluding that the
majority implicitly acknowledged that a mandatory disclosure, pages
long, of ``detailed fee information that would fill far more space than
the advertisement itself, would chill the publication of protected
commercial speech''). As discussed elsewhere in this rule, FDA
concludes that the remaining 80 percent of advertisements, and the
remaining 50 percent of the principal panel of cigarette packages,
provide adequate space for manufacturers' branding and messaging.
3. Central Hudson and Strict Scrutiny
    (Comment 10) FDA received other comments suggesting that the
required warnings are impermissible speaker-, content-, and viewpoint-
based regulations of speech. These comments assert that the required
warnings FDA proposed would fail under intermediate (Central Hudson)
scrutiny because FDA has not shown that the warnings would materially
and directly advance the substantial Government interest of promoting
greater public understanding of the negative health consequences of
smoking. The comments suggest that the problem the Government seeks to
address is not real because smokers are already aware of the risks of
cigarette smoking. Some comments add that even if the focus is on less-
known risks, FDA has not shown that promoting greater public
understanding of these risks is a substantial interest. Comments
further assert that there would be more narrowly tailored means of
addressing those less-known risks, for example, through public health
campaigns. Conversely, other comments state that the proposed rule
would be constitutional under intermediate scrutiny because FDA has a
substantial interest in ensuring that consumers have accurate, factual
information about the serious health effects of using products that are
offered to them and these required warnings would directly advance that
interest, as shown by FDA's quantitative consumer research (Refs. 12
and 17). Finally, at least one comment suggests the warnings are
subject to strict scrutiny and cannot survive that standard.
    (Response 10) FDA has determined that the warnings also would be
constitutional if reviewed under intermediate scrutiny. Under the test
for restrictions on commercial speech articulated in Central Hudson Gas
& Elec. Corp. v. Pub. Serv. Comm'n, 447 U.S. 557 (1980), agencies can
regulate commercial speech where the regulation directly advances a
substantial Government interest and is not more extensive than
necessary to serve that interest. Central Hudson does not require that
the means chosen by the Government be the least restrictive means
available for addressing an issue, see Boards of Trustees. v. Fox, 492
U.S. 469, 480 (1989), but the Supreme Court has in any event observed
that required factual disclosures are less intrusive from a First
Amendment perspective than are restrictions on speech. Zauderer, 471
U.S. at 651. Because the Government's interest in these warnings is
substantial and the regulation is no more extensive than necessary to
directly advance that interest, the rule withstands review even under
Central Hudson.
    As outlined in the preceding paragraphs of this section of the
preamble, the risks associated with cigarette smoking present a
significant public health problem, and the Government's interest in
promoting greater public understanding of those risks is substantial.
The scientific evidence produced by FDA's quantitative consumer
research demonstrates that the required warnings in this rule directly
advance the Government's interest by outperforming the current Surgeon
General's warnings in actually providing ``new information'' and
``self-reported learning,'' which promote better understanding by the
public about the negative health consequences of smoking, among other
measured outcomes. As discussed elsewhere, the warnings are no more
extensive than necessary to achieve the Government's interest--they
provide factual and accurate representations of the dangers of
cigarette smoking and apply to all cigarette packages and
advertisements by all manufacturers, distributors, and retailers, so
they are not over- or underinclusive in scope, and there is enough room
remaining on the rest of the packages and advertisements for
manufacturers to convey their messages.
    Although some comments assert correctly that public health
campaigns can be effective in helping raise general awareness of the
health risks of using tobacco products, such campaigns may supplement
but are not an adequate alternative to placing warnings directly on
cigarette packages and advertisements for purposes of advancing the
Government's interest. Congress has long required that cigarette
warnings appear on packages and in advertisements. As far back as 1965,
the FCLAA set forth the policy of a comprehensive warning program on
cigarette packages and advertisements so that ``the public may be
adequately informed'' about the dangers of cigarette smoking. FCLAA
Section 2(1), codified at 15 U.S.C. 1331(1). This reflects the
recognition that, while voluntary public education campaigns can
provide effective targeting and messaging, they do not reach every
person who looks at a package of cigarettes or advertisements and do
not receive as many impressions as a comprehensive program of cigarette
package and cigarette advertisement warnings. Studies demonstrate that
pictorial cigarette warnings placed directly on products convey the
risks to those who look at packages and advertisements with more
immediacy and noticeability (see section VI.B for further discussion).
Therefore, FDA disagrees that public education campaigns are adequate
alternatives for warnings on packages and advertisements.
    Regarding the proposed alternative of text-only warnings, the
scientific literature strongly supports that pictorial cigarette
warnings promote greater public understanding about the health
consequences of smoking as, for example, 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 (see section V.B of the
proposed rule, 84 FR at 42762-65). When Congress amended the FCLAA with
the Tobacco Control Act, it recognized that the current 1984 Surgeon
General's text-only warnings had become ``ineffective in providing
adequate warnings about the dangers of tobacco products'' (Ref. 14 at
4). To that end, Congress directed new cigarette warnings to be
accompanied by color graphics. FDA's quantitative consumer research
studies show that the new required warnings with color graphics promote
greater understanding of the

negative health consequences of smoking than the current 1984 Surgeon
General's warnings, which served as the control condition. Each of the
final required warnings outperformed the Surgeon General's warnings on
the two outcomes FDA specified (as described in section VI.E of the
proposed rule, 84 FR at 42771-72) as being predictive for promoting
understanding of the risks associated with cigarette smoking: ``new
information'' and ``self-reported learning.'' In addition, the final
required warnings also demonstrated statistically significant greater
scores in nearly all other measures of understanding when compared to
the Surgeon General's warnings (see section VII.B below for a
discussion of the study results for each required warning). There is
ample scientific evidence that textual warnings accompanied by large
color images will directly advance greater public understanding of the
negative health consequences of smoking.
    We disagree with the comment that suggests that the required
warnings are compelled speech that would be subject to strict scrutiny
as content-based regulation of commercial speech, citing Reed v. Town
of Gilbert, 135 S.Ct. 2218, 2226 (2015), Sorrell v. IMS Health Inc.,
564 U.S. 552 (2011), and NIFLA. The rule is properly reviewed under
Zauderer but would also easily survive scrutiny under Central Hudson.
    In Reed v. Town of Gilbert, the Court applied strict scrutiny to
content-based restrictions on non-commercial speech in public fora.
Reed had nothing to do with commercial speech doctrines, much less with
the type of disclosure required by this final rule, and it has not been
understood to alter the applicability of Central Hudson or Zauderer.
Likewise, Sorrell ``did not mark a fundamental departure from Central
Hudson's four-factor test, and Central Hudson continues to apply'' to
regulations of commercial speech, regardless of whether they are
content based. Retail Digital Network, LLC v. Prieto, 861 F.3d 839, 846
(9th Cir. 2017) (en banc); accord Missouri Broad. Ass'n v. Lacy, 846
F.3d 295, 300 n.5 (8th Cir. 2017). The Supreme Court has never applied
strict scrutiny to regulations of this type, notwithstanding that they
generally apply only to a specific type of commercial activity, and may
thus concern a particular subject. To the contrary, in NIFLA, which
post-dates both Reed and Sorrell, the Court reaffirmed that it did
``not question the legality of health and safety warnings long
considered permissible, or purely factual and uncontroversial
disclosures about commercial products.'' NIFLA, 138 S. Ct. at 2376.
4. Constitutionality of Statutory Requirement
    (Comment 11) Several comments argue that the statutory requirement
for ``graphic'' health warning labels in the Tobacco Control Act itself
violates the First Amendment. Other comments express strong support for
the cigarette health warning label requirement in the Tobacco Control
Act, noting that this provision of the Tobacco Control Act was upheld
in Discount Tobacco, 674 F.3d 509 (6th Cir. 2012).
    (Response 11) Comments addressed to the facial constitutionality of
a statute are generally outside the scope of an agency's rulemaking
authority. Am. Meat Inst., 760 F.3d at 25 (``We do not think the
constitutionality of a statute should bobble up and down at an
administration's discretion.''). The statutory requirement for
cigarette health warning labels was in any event considered in a facial
challenge and upheld by the Sixth Circuit in Discount Tobacco City, and
the Supreme Court denied the manufacturers' petition for a writ of
certiorari (569 U.S. 946 (2013)). For the reasons stated in that
opinion, and for the additional reasons stated in the preceding
paragraphs of this section of the preamble explaining why the final
rule is constitutional, the statutory ``graphic label statement''
requirement is consistent with the First Amendment.

D. Comments Regarding the Administrative Procedure Act (APA)

    FDA received comments on a range of APA issues, including general
objections that the rule is not the result of deliberative and reasoned
decision making and comments that assert FDA failed to support the
Agency's findings, ignored alternative evidence, and failed to provide
an opportunity to meaningfully comment. Several comments generally note
that under the APA courts will set aside a rule if the rule exceeds the
Agency's authority, fails to comply with statutory requirements or
consider alternatives, or if the action is otherwise arbitrary,
capricious, or an abuse of discretion. As discussed in detail in the
following paragraphs, FDA has carefully considered and responded to the
APA issues raised in the comments.
1. Adequacy of the Evidence in Support of the Rule
    (Comment 12) Several comments assert that the proposed rule
violated the APA because under the APA, FDA must engage in ``reasoned
decision-making'' and FDA violated the APA by failing to develop
affirmative ``substantial evidence'' to support the rule or,
alternatively, because FDA relied on evidence that does not support the
rule. Some comments suggest that FDA violated the APA by not developing
a record to support the rule but instead issued the rule based on
``speculation, conjecture, or supposition'' and that FDA based the
proposed rule either on: ``(1) a hypothetical reduction in smoking not
supported by the record, or (2) a hypothetical problem, lack of
consumer awareness of the harms of smoking.''
    More specifically, some comments argue that FDA has failed under
the APA to articulate a rational explanation for the required warnings
included in the proposed rule. Comments said that if FDA's interest is
consumer awareness, then consumers do not need to be informed of the
risks of smoking because there is ample evidence that consumers are
well aware of the health risks of cigarette smoking. Other comments
argue that FDA's research is flawed as it is inherently biased and
fails to account for potential confounding variables and did not
reliably test ``whether study participants actually learn anything
new.'' With respect to FDA's final quantitative consumer research
study, some comments suggest FDA also failed to test whether the
proposed images add any new information above and beyond the new text
and failed to control for the effect of altering the warnings' size and
location. Another comment objects to the final quantitative study as
flawed because FDA failed to incorporate the commenter's suggestions on
demographic and other factors. Some comments state that both
quantitative studies are also flawed as they did not test comprehension
or understanding of the revised textual statements or images and
because they enrolled non-representative participants. These comments
also argue that FDA's quantitative studies fail to support the proposed
required warnings because the study results demonstrate low or no
impact of several tested statements or statement-and-image pairings.
Other comments suggest that FDA inappropriately relied on non-U.S.
studies and on other studies that have design or execution limitations,
including lack of comparative effectiveness data, no measurement of
understanding, and no evaluation of whether the image contributes to
understanding over and above text.
    Other comments suggest that if the rule is based on an interest in
a reduction in smoking, then FDA has provided no evidence, including no
consumer perception and actual use data, that the proposed required

warnings would decrease smoking initiation and increase smoking
cessation.
    (Response 12) FDA disagrees with comments suggesting that the
rationale for and evidentiary basis supporting this rule are
inadequate. Rather, FDA has both documented the need for this rule and
developed a robust record supporting it. As the record demonstrates,
the final cigarette health warnings will promote greater public
understanding of the negative health consequences of smoking.
    The rationale for the rule is clear. Cigarette smoking remains the
leading cause of preventable disease and death in the United States,
yet the public continues to hold misperceptions about the health risks
of smoking and is largely unaware of certain conditions caused by
smoking (see section V for further discussion). We disagree with
comments that argue the public's knowledge of the general harms of
cigarette smoking undercuts the need for these required warnings.
Contrary to some comments' discussion of the PATH data, there remain
large gaps in knowledge about the health effects of smoking, with many
smokers having little awareness of the wide variety of diseases
causally linked to smoking (see section V.B for further discussion). As
discussed in more detail in the First Amendment section, 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.'' Discount
Tobacco, 674 F.3d 509, 519 (6th Cir. 2012).
    FDA also disagrees that the Agency's research fails to support this
rule or that different warning elements should have been tested. FDA
undertook a rigorous science-based, iterative research process to
develop and test cigarette health warnings depicting the negative
health consequences of smoking. FDA's process involved carefully
reviewing the scientific literature on the health risks associated with
cigarette smoking, evaluating the public's general awareness and
knowledge of those health risks, and assessing the Agency's own
consumer research on potential revised warning statements (see section
VI for further discussion). The Agency's findings as a result of this
process showed that the selected pairings of text and pictorial
warnings would promote greater public understanding of the negative
health consequences of cigarette smoking. FDA further disagrees with
comments suggesting that FDA's reliance on other studies in developing
its warnings is inappropriate (see section V.B.2 for further
discussion).
    Accordingly, the proposed rule is justified by the Government's
interest in promoting greater public understanding of the negative
health consequences of smoking. To the extent some comments suggest
that FDA did not prove that the warnings will lead to increased smoking
cessation or decreased initiation, FDA notes that increased smoking
cessation and decreased initiation are not the purpose of this rule.
    (Comment 13) One comment states there is no evidence to support
FDA's proposal to include two different images with the textual warning
statement of ``WARNING: Smoking causes COPD, a lung disease that can be
fatal.''
    (Response 13) FDA is finalizing only one text-and-image pairing for
the textual warning statement, ``WARNING: Smoking causes COPD, a lung
disease that can be fatal.''
2. Consideration of Contrary Scientific Evidence
    (Comment 14) Some comments suggest that FDA did not adequately
consider contrary scientific evidence that undermines the proposed
rule, including evidence showing that graphic warnings are ineffective
in improving consumer comprehension; evidence showing ``shocking
images'' to be less effective; evidence showing that gruesome images
can be seen as exaggerating risks and thus ignored; evidence showing
that ``fear-based'' messages can be ignored or perceived in a defensive
manner; or evidence showing that consumers already understand the
health consequences of smoking. Comments assert that FDA did not
address evidence indicating that the statutory size requirements for
warnings on packages and advertisements do not advance consumer
understanding.
    (Response 14) FDA disagrees with comments suggesting FDA did not
adequately consider contrary scientific evidence. As discussed in
greater detail below, FDA concludes that those studies with findings
contrary to FDA's conclusion regarding images promoting greater
understanding may be partly or fully attributable to the fact that the
public already has a high pre-existing level of knowledge of the
specific health consequences described in the warnings tested in those
studies (see section V.B.2 for further discussion). With respect to the
evidence about the size of the warnings, the proposed required warnings
were tested in the sizes specified by section 4 of the FCLAA. The data
generated from FDA's final quantitative consumer research study
demonstrate that the 11 final required warnings increase understanding
of the negative health consequences of cigarette smoking.
3. Consideration of Alternatives
    (Comment 15) Comments state that FDA did not adequately evaluate
alternatives to the proposed rule, such as refreshing the Surgeon
General's warnings or requiring new, text-only warnings. Other comments
suggest that FDA should evaluate the alternatives of smaller or
differently placed warnings, or the use of ``enhanced public education
campaigns.''
    (Response 15) FDA disagrees with comments suggesting that its
consideration of alternatives was inadequate. FDA considered many
approaches, including text-only warnings or different graphic
approaches, throughout its process. Ultimately, FDA was guided both by
Congress's directive to issue regulations with color graphics to
accompany new textual warnings and, as described more fully in section
VI of the proposed rule, by findings from health communication science
research regarding best practices for communicating health risk
information to the lay public.
    In amending the FCLAA with the Tobacco Control Act, Congress
explicitly recognized that the Surgeon General's text-only warnings had
become ``ineffective in providing adequate warnings about the dangers
of tobacco products'' (Ref. 14 at 4). To that end, Congress mandated
new cigarette textual warning statements to be accompanied by color
graphics. Given this directive, testing text-only warnings would not
have been an optimal use of FDA's resources. FDA did, however, consider
the substantial body of scientific evidence showing that cigarette
textual warning statements better promote public understanding of
health risks when accompanied by color graphics. Furthermore, as
discussed in section VI, FDA's research studies show that the new
warnings with accompanying color graphics promote greater understanding
of the risks of smoking than the controls consisting of the (text-only)
Surgeon General's warnings (see, also, section V of the proposed rule
for a discussion of the literature on the benefits of large pictorial
cigarette health warnings).
    With regard to comments suggesting that FDA should have considered
smaller or differently placed warnings, FDA disagrees. The statute sets
forth the requirements with regard to size and placement of the
warnings, and 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. 4 and 15). The placement of the warnings at
the top 50 percent of the front and rear panels of the packages and at
least the top 20 percent of advertisements will better ensure
noticeability of the warnings. Moreover, the Supreme Court has
recognized that decisions with respect to the constitutionality of a
regulation do not include second-guessing the details of such
regulations. In Burson v. Freeman, 504 U.S. at 210-11, the Court,
having determined that some restricted zone around a voting area was
necessary to secure the State's compelling interest, recognized that
the exact size of that space was not a constitutional question. Rather,
the constitutional question lies in the outer bounds of a regulation;
various permutations within those bounds is a matter for legislators.
    FDA also disagrees with comments that FDA should have pursued
enhanced public education efforts rather than issuing new warnings. As
discussed more fully in the First Amendment section, while public
health campaigns can allow for effective targeting and messaging, they
do not reach every person who looks at a package of cigarettes or
advertisements and do not receive as many impressions as a
comprehensive program of cigarette package and cigarette advertisement
warnings. Studies demonstrate that pictorial cigarette warnings placed
directly on products convey the risks with more immediacy and
noticeability (see section VI.B for further discussion). Accordingly,
new warnings with color graphics for packages and advertisements will
promote greater public understanding of the risks of smoking.
4. Meaningful Opportunity To Comment
    (Comment 16) FDA received comments asserting that the Agency failed
to provide an opportunity to meaningfully comment under the APA because
FDA did not fully disclose the data, methodologies, summaries, and
conclusions relied on to support the proposed rule. Some comments argue
that 60 days is not enough time to comment given the complexity of the
proposed rule and does not provide the public sufficient time to
develop alternative warnings, and one comment requests an extension of
the comment period. The comments note that FDA spent years developing
the proposed rule and emphasized throughout the proposed rule the
complex process the Agency undertook to develop the required warnings.
Some comments suggest FDA made errors due to a court order which, they
contend, forced the Agency to rush through the final stages of
rulemaking or that FDA did not provide sufficient time because the
Agency does not intend to consider alternatives. One comment requests a
response to a Freedom of Information Act request as essential to being
able to meaningfully respond to comments.
    (Response 16) We disagree with these comments. Although the Agency
is under a court order to send the final rule to the Office of the
Federal Register by a specific date, FDA provided a standard 60-day
comment period for the proposed rule and the Agency has thoroughly
reviewed and responded to all public comments and made changes that are
reflected in the final rule based on public input. While the Agency
supplemented the docket with requested background information (84 FR
60966, November 12, 2019), as discussed below these qualitative studies
are not key data relied upon by the Agency to make final decisions
about the proposed and final rules.
    As explained in section VI of the proposed rule, FDA conducted
various qualitative focus groups and interviews (``qualitative
studies'') to test and refine image concepts for the required warnings
and to obtain feedback on which textual statements should be selected
for further study. In general, qualitative research is used to
understand how a research topic is experienced from the perspective of
the study participants. It is typically conducted via indepth
interviews, participant observation, or focus groups to obtain
information about the attitudes, opinions, and behavior of particular
populations. FDA did not include the qualitative study reports in the
docket as the rulemaking itself did not directly rely upon them.
However, because the qualitative studies did inform further FDA
research and development, namely, the quantitative consumer research
studies, FDA subsequently added these materials to the docket and
reopened the comment period for 15 days to allow public input on the
supplemental materials (84 FR 60966).
    The APA does not include a specific procedural requirement for the
length of time an agency must allow for comments. See Phillips
Petroleum Co. v. EPA, 803 F.2d 545, 559 (10th Cir. 1986) (stating
``[t]his opportunity to participate is all that the APA requires'').
FDA's regulations generally require that the Agency provide 60 days for
comment on proposed regulations (21 CFR 10.40(b)(2)). The Commissioner
may shorten or lengthen that time period for ``good cause,'' but in no
event is the time for comment to be less than 10 days. Id. While FDA
regulations permit an extension of comment periods, Sec.
10.40(b)(3)(i), a request to do so ``must discuss the reason comments
could not feasibly be submitted within the time permitted, or that
important new information will shortly be available, or that sound
public policy otherwise supports an extension of the time for
comment.'' Id. When agencies have been challenged on abbreviated
comment periods, courts generally look to whether shorter time frames
were necessitated by deadlines for Agency action. See, e.g., Omnipoint
Corp. v. FCC, 78 F.3d 620, 629-630 (D.C. Cir. 1996) (rejecting a
challenge to a 15-day comment period given a ``congressional mandate
[to act] without administrative or judicial delays'') (internal
quotations and citation omitted); Fla. Power & Light Co. v. United
States, 846 F.2d 765, 772 (D.C. Cir. 1987) (determining that a 15-day
comment period did not violate the APA where the Nuclear Regulatory
Commission was under a Congressionally imposed deadline). Courts
considering whether a public comment period was long enough also look
in particular to whether there is evidence that interested parties did
in fact submit meaningful comments. See, e.g., Fla. Power & Light, 846
F.2d at 772 (finding ``no evidence that petitioners were harmed by the
short comment period,'' where the Commission ``received sixty-one
comments, some of them lengthy, addressing its proposed rule'' and
``[t]hose comments had a measurable effect on the final rule'')
Conference of State Bank Sup'rs v. Office of Thrift Supervision, 792 F.
Supp. 837, 844 (D.D.C. 1992) (rejecting argument that 30-day comment
period was inadequate, ``especially in light of the comments that
[aggrieved plaintiffs] and other interested parties submitted in
response to this proposed rule'') (citing 12 pages of comments in
administrative record).
    Here, the Agency received numerous meaningful comments both in
support of and disagreeing with the proposed rule, totaling thousands
of pages. The Agency has not only taken those public comments into
consideration in issuing this final rule, but also made changes to the
final requirements based on that public feedback, including allowing
cigarette manufacturers to use different required warnings on the front
and rear panels of a cigarette package, and altering the image of the
underweight

baby on a scale to improve image clarity. The initial 60-day period and
supplemental 15-day period for public comment on the notice of proposed
rulemaking provided ample opportunity for public participation in this
rulemaking process, and comments have failed to establish a basis under
Sec.  10.40(b)(3)(i) for any further extensions of time.
5. Requirement of Random and Equal Distribution
    (Comment 17) Comments assert that the random and equal distribution
requirement for cigarette packages as applied to the proposed 13
warnings is arbitrary and capricious under the APA because compliance
is impossible from a printing perspective. Comments urge that FDA must
reduce the number of warnings and provide greater flexibility. These
comments suggest FDA misunderstands the printing processes in the
United States and that industry cannot comply, particularly in the time
allotted. The comments explain the printing process and describe why
requiring the random and equal distribution of thirteen warnings is
``infeasible.''
    (Response 17) FDA is finalizing a set of 11 required warnings. FDA
disagrees that the statute's and the final rule's requirement for
random and equal display and distribution of cigarette package warnings
violates the APA. A standardized number of warnings--11 in this final
rule, reduced from 13 in the proposed rule--gives the industry a known
quantity to implement, and the statute and final rule provides for a
15-month period in which to adjust any printing processes that may
require updating. In addition, as we discuss in our responses to the
comments that describe implementation concerns (see section X), in
preparation for submission of a cigarette plan, FDA encourages
manufacturers to engage with FDA sooner rather than later on specific
issues related to their product (see also section IX.B.4.e).

V. Need for Rule and FDA Responses to Comments

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

1. Smoking Prevalence and Initiation in the United States
    In explaining the need for the proposed rule, we provided
information on smoking prevalence and initiation rates among adults and
children in the United States. As stated in the proposed rule,
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. 18). Although cigarette smoking prevalence has
generally declined over the past several decades, approximately 34.2
million U.S. adults smoke cigarettes, and, among these adult smokers,
the vast majority--74.6 percent, or approximately 25.5 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 36.0 percent of adults with a
General Education Development certificate and 21.8 percent of adults
with less than a high school diploma were current smokers in 2018,
compared with 7.1 percent of adults with a college degree and 3.7
percent of adults with a graduate degree (Ref. 19).
    Despite recent declines in youth smoking rates, the 2019 National
Youth Tobacco Survey data showed that past 30-day smoking prevalence
among high school students was 5.8 percent, representing 860,000 youth,
of which 32.5 percent were frequent smokers (defined as cigarette use
on 20 or more of the past 30 days) (Refs. 20 and 21). The data also
showed that past 30-day prevalence among middle school students was 2.3
percent, representing 270,000 youth (Ref. 20). Results from the 2018
National Survey on Drug Use and Health demonstrate that, on average,
each day in the United States, approximately 1,600 youth ages 12 to 17
smoke their first cigarette, and 170 youth ages 12 to 17 become daily
cigarette smokers (Ref. 22 at Table A.3A).
2. Negative Health Consequences of Smoking
    As described in the proposed rule, the health risks associated with
cigarette smoking are significant. 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 among cigarette
smokers and those exposed to secondhand smoke (Ref. 3). Smoking causes
more deaths each year than human immunodeficiency virus, illegal drug
use, alcohol use, motor vehicle injuries, and firearm-related incidents
combined (Refs. 23 and 24). Over 16 million Americans alive today live
with disease caused by smoking cigarettes (Ref. 3).
    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 (Ref. 3) presented a robust body of scientific
evidence documenting the health consequences from both smoking and
exposure to secondhand smoke across a range of diseases and organ
systems. In particular, the 2014 Surgeon General's Report added eleven
diseases to the long list of diseases causally linked to cigarette
smoking: Liver cancer, colorectal cancer, age-related macular
degeneration, orofacial clefts in newborns from maternal smoking during
pregnancy, tuberculosis, stroke (for adults), diabetes, erectile
dysfunction, ectopic pregnancy, rheumatoid arthritis, and impaired
immune function (Ref. 3 at 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. 3).
    FDA received many comments that were strongly supportive of the
proposed rule, many of which reiterate the negative health consequences
of cigarette smoking described in the proposed rule and stressed the
need for public health measures, such as new cigarette health warnings,
to communicate the latest science to the public. FDA did not receive
comments disputing that cigarette smoking is harmful to human health.
    (Comment 18) Several comments emphasize that, given the substantial
health toll of tobacco use, ``it is difficult to imagine a more
compelling governmental interest than to ensure that the public
understands the health consequences of smoking'' and that health
warnings on cigarettes are one of the most efficient and effective ways
of doing so.
    (Response 18) FDA agrees that the health toll from cigarettes is
substantial and that the required warnings in the final rule will
improve public understanding about the breadth of negative health
consequences caused by smoking. As explained in section V.B of the
proposed rule, the scientific literature demonstrates that cigarette
health warnings that are noticeable, lead to learning, and increase
knowledge will promote greater public understanding of the negative
health consequences of smoking, and FDA's consumer research has
demonstrated that the required warnings will advance this important
governmental interest.
    (Comment 19) A comment (from a public health group and a network of

state and territorial tobacco prevention and control programs across
the United States) expressed support for FDA to fully implement all of
the warnings in the proposed rule. The comment states the rule is
complementary to the needs and goals of public health agencies and that
the required warnings on cigarette packs and advertisements will
effectively and appropriately support state and territory-based efforts
to educate smoking and nonsmoking consumers.
    (Response 19) FDA agrees that the final rule will complement other
educational efforts that inform smokers and nonsmokers about the
negative health consequences of smoking. As we discuss in section VII,
following consideration of the public comments received in the docket,
as well as based on the results of our consumer research studies,
existing scientific literature on cigarette health warnings, and legal
and policy considerations, FDA is finalizing 11 of the 13 required
warnings.
    (Comment 20) Some comments provide additional information that
smoking disproportionately harms (through both higher prevalence and
tobacco-related death and disease) many marginalized populations,
including African-Americans; American Indians, and Alaskan Natives;
people with low incomes, low educational attainment, and low health
literacy; people who identify as lesbian, gay, bisexual, or
transgender; and people with behavioral health and substance use
conditions (see, e.g., Refs. 25-28).
    (Response 20) FDA agrees that cigarette smoking disparities exist
among specific subpopulations in the United States. As described in
section IV.A of the proposed rule, smoking prevalence is higher in some
subpopulations (e.g., those with lower socioeconomic status (SES)) than
the general U.S. population (Refs. 18, 29, and 30). For the reasons
explained in section V.B.2 of the proposed rule, some subpopulations
experience disparities in knowledge of the health harms of smoking due
to lower health information access and lower health literacy, and the
evidence collectively demonstrates that pictorial cigarette warnings,
such as the required warnings being issued in this final rule, are
effective across diverse populations and settings and will likely help
reduce disparities found in consumer understanding about the harms of
smoking.

B. Data Concerning Cigarette Health Warnings

1. The Current 1984 Surgeon General's Warnings Are Inadequate
    In the preamble to the proposed rule, FDA observed that cigarette
packages and advertisements can serve as important channels for
communicating health information to broad audiences that include both
smokers and nonsmokers. Daily smokers 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, including retail customers,
warnings on those packages are potentially viewed by many others,
including nonsmokers (Refs. 31 and 32). 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. 33 and 34). 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. However, the current 1984 Surgeon
General's warnings have suffered from three critical problems: (1) They
have not changed in more than 35 years and long ago became effectively
stale; (2) they do not effectively promote greater public understanding
of the risks of smoking because they do not attract attention, are not
remembered, and do not prompt thoughts about the risks of smoking; and
(3) they do not address areas where there are significant gaps in
public understanding about the negative health consequences of
cigarette smoking (see section V.A of the proposed rule).
    The proposed rule presented extensive evidence from the scientific
literature regarding how the current 1984 Surgeon General's warnings
are largely unnoticed and unconsidered by both smokers and nonsmokers
(see section V.A.2 of the proposed rule). FDA also provided clear
evidence that consumers suffer from a pervasive lack of knowledge about
and understanding of many of the negative health consequences of
smoking and the current Surgeon General's warnings are inadequate to
address these knowledge gaps.
    We received numerous comments supporting our analysis regarding the
inadequacy of the current 1984 Surgeon General's warnings that appear
on cigarette packages and in cigarette advertisements. FDA also
received many comments regarding the level of consumers' knowledge and
understanding of the health risks of smoking. Several comments stated
that the public is adequately informed about the risks of smoking,
while many other comments explained that consumers lack knowledge about
a wide variety of smoking risks. These comments, and our responses, are
summarized below.
    (Comment 21) A substantial number of comments strongly support the
proposed rule and urge FDA to include all 13 proposed required warnings
in the final rule. These comments cite as support: The more than 35
years since the current 1984 Surgeon General's warning labels were
changed; the conclusion that the current Surgeon General's warnings are
``wholly inadequate'' because they are not noticed and fail to address
many of the health harms of smoking of which the public has little
knowledge; the demonstrated gaps in public awareness and knowledge of
the health risks of tobacco use; the well-established and
``overwhelming'' findings that large pictorial cigarette warnings such
as those included in the proposed rule can effectively promote public
awareness and understanding of the negative health consequences of
smoking through conveying the risks of smoking and secondhand smoke
(Ref. 35); and FDA's scientific evidence and research studies
establishing that the proposed warnings will advance the Government's
interest in promoting greater public understanding of the negative
health consequences of cigarette smoking.
    (Response 21) FDA agrees that there is a strong need for new
cigarette health warnings because, as noted in section V.A of the
proposed rule, the current 1984 Surgeon General's warnings are
inadequate because they do not attract attention, are not noticed, do
not prompt consumers to think about the risks of smoking, are not
remembered, do not address the breadth of negative health consequences
of smoking, and have not been updated in more than 35 years. FDA agrees
that large pictorial cigarette warnings, such as the ones required in
the final rule, will address the noted issues by attracting attention
and focusing on less-known health consequences of smoking to promote
greater public understanding of the negative health consequences of
smoking (see section V.B of the proposed rule and section V.B of the
final rule).
    (Comment 22) Several comments strongly support FDA's aim in issuing

new cigarette health warnings, which is to promote greater public
understanding of the negative health consequences of smoking. One
comment from an academic researcher states that the proposed warnings'
focus on ``novel'' health effects, for which there are lower levels of
public awareness, is an appropriate and effective strategy. Comments
from multiple professional medical associations emphasize that their
medical professional members know first-hand the devastating impact of
tobacco-related death and disease on the patients, including children,
they treat in their clinical practice every day. Many comments from
public health providers and advocacy groups, including those caring for
children, strongly encourage FDA to finalize the proposed rule as
quickly as possible (no later than the federal court deadline) and to
implement the enhanced warning labels without further delay. Another
comment, submitted by an academic researcher, emphasizes that the
proposed rule presents a ``unique opportunity'' to educate consumers on
some of the less-known health effects of tobacco use, including bladder
cancer, erectile dysfunction, and diabetes, stating that ``these health
effects are among those that consumers and the general public in the
U.S. are largely less aware,'' according to research conducted by the
researcher.
    (Response 22) As described in the proposed rule, when developing
the new cigarette health warnings, FDA consulted the epidemiological
literature of causally-linked health conditions as identified in the
Surgeon General's Reports and scientific literature (see sections VI.A
and VII.A of the proposed rule). FDA developed cigarette health
warnings that focus on negative health effects that are less known or
less understood by consumers. FDA agrees that the required warnings,
once implemented, will promote greater public understanding of the
negative health consequences of smoking.
    (Comment 23) A number of comments support FDA's finding that the
current 1984 Surgeon General's warnings are inadequate and not taken
seriously by consumers, public understanding of the health impacts of
smoking is still limited, and large, pictorial cigarette warnings can
increase knowledge of the health harms of smoking. Some comments
discuss the wide range of studies that indicate that the existing
warnings on cigarette packages and in cigarette advertisements are
substantially less effective at communicating the health effects of
smoking than larger pictorial cigarette warnings and are associated
with substantial disparities in health knowledge.
    (Response 23) FDA agrees with these supportive comments that the
current 1984 Surgeon General's warnings on cigarette packages and in
cigarette advertisements are inadequate and ineffective in
communicating the health harms of smoking and that the larger pictorial
warnings required by this rule will be more effective in helping
promote greater public understanding of the negative health
consequences of smoking.
    (Comment 24) A comment asserts that FDA's proposed rule references
some published studies that are older, do not specifically address the
current state of the public's knowledge, or focus on smoking-related
health effects (e.g., cervical cancer, infertility, kidney cancer,
osteoporosis) that are not found in the proposed warnings. The comment
states that none of the studies are directly relevant in showing what
the U.S. population currently knows about the health risks identified
in the proposed required warnings.
    (Response 24) To examine public understanding of the negative
health consequences of smoking within the U.S. population, FDA
conducted qualitative and quantitative consumer research studies that
recruited youth, young adults, older adults, smokers, and nonsmokers in
addition to our review of the existing scientific literature. Our
findings reinforced what is known about public misperceptions of the
health harms of smoking while also addressing gaps that the comment
identifies with updated and relevant scientific support.
    As discussed in section V.A.3 of the proposed rule, 84 FR at 42761-
62, consumers suffer from a pervasive lack of knowledge about and
understanding of the many negative health consequences of smoking, and
importantly, the published literature indicates that consumers do not
understand the wide range of illnesses caused by smoking. Due to these
gaps in public understanding about the negative health consequences of
smoking, as seen in the literature, FDA developed the required warnings
to cover a range of smoking-related health effects (as described in
section VI of the proposed rule) in order to improve public
understanding (see section V.B.2 of the proposed rule, 84 FR at 42763-
65 (``Pictorial Cigarette Warnings Can Address Gaps in Public
Understanding About the Negative Health Consequences of Smoking'')).
Additionally, FDA's rigorous science-based, iterative research and
development process confirmed that there are substantial consumer
knowledge gaps in in the United States and that the required warnings
focusing on the specific health consequences highlighted will meet
FDA's objectives, especially as indicated by outcomes of ``new
information'' and ``self-reported learning'' (see section VI of the
proposed rule and sections VI and VII of this final rule).
    (Comment 25) Several comments discuss the disproportionate burden
of smoking observed for some subgroups (e.g., those with lower SES,
non-English speakers) and state these subgroups also have disparities
in knowledge about the negative harms of smoking. Several comments
state that these subgroups tend to have lower levels of health
literacy, limited access to information about the hazards of smoking,
and tend to benefit the least from textual warnings on smoking harms.
As a result, many comments state that cigarette health warnings with
images depicting the harms of smoking will benefit these subgroups by
effectively communicating the negative consequences of smoking to
diverse populations.
    (Response 25) FDA agrees. As discussed in section V.B.2.c of the
proposed rule, 84 FR at 42764-65, research shows that pictorial
cigarette warnings are effective for diverse populations that differ in
cultural, racial, ethnic, and socioeconomic backgrounds. Pictorial
cigarette warnings are likely to help reduce disparities among
disadvantaged groups in consumer understanding about the harms of
smoking.
    (Comment 26) Two comments argue that individuals in the United
States have substantial exposure to smoking-related information from a
wide array of Federal, State, and other public health sources which
results in high awareness of the negative health effects of smoking,
rendering the proposed cigarette health warnings ineffective in
increasing consumer understanding of the negative health consequences
of smoking and that FDA has failed to address scientific evidence
showing that consumers already understand the health consequences of
smoking. In support of that argument, one comment describes survey