Tobacco Products; Required Warnings for Cigarette Packages and Advertisements, 15638-15710 [2020-05223]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Rules and Regulations]
[Pages 15638-15710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05223]



[[Page 15637]]

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

[[Page 15638]]


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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 protected].
    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 protected].

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

[[Page 15639]]

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 https://www.nielsen.com/us/en.html for more information.
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II. Table of Abbreviations/Commonly Used Acronyms in This Document

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

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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

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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 protected].
    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

[[Page 15642]]

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

[[Page 15643]]

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).

[[Page 15644]]

    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

[[Page 15645]]

(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

[[Page 15646]]

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

[[Page 15647]]

``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

[[Page 15648]]

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

[[Page 15649]]

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

[[Page 15650]]

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

[[Page 15651]]

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

[[Page 15652]]

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

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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

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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 
findings from FDA's PATH, the Gallup Poll, and the National Survey on 
Drug Use and Health (NSDUH) that show high proportions of respondents 
indicating awareness that smoking cigarettes is generally harmful to 
one's health. Additionally, the comment submits an analysis of PATH 
data from adult respondents that describes perception measures of 
smoking-related health effects and associations with current smoking 
status. The comment also cites

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published studies and draws the conclusions that the U.S. population 
has high levels of knowledge regarding general and specific smoking-
related health effects, the public overestimates the risks of smoking, 
and the proposed cigarette health warnings would be ineffective at 
increasing consumer understanding of the negative consequences of 
smoking.
    (Response 26) FDA disagrees with the view that the public already 
has a strong understanding of the health consequences of smoking. 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 many of the negative health consequences of smoking 
(see also section VI.A of the proposed rule, 84 FR at 42766-67, citing 
research studies finding that consumers are largely unaware of the 
negative health consequences of cigarette smoking not mentioned in 
current warnings, as well as more specific information about the 
negative health effects and their mechanisms). Moreover, and 
importantly, the published scientific literature indicates that 
consumers do not understand the wide range of illnesses caused by 
smoking. As discussed in section V.B.2 and VI.D of the proposed rule, 
84 FR at 42763-64, 42770, pictorial cigarette warnings have been 
demonstrated to address these gaps in public understanding about the 
negative health consequences of smoking by conveying new information in 
a large and prominent format that will attract attention, be noticed, 
prompt consumers to think about the risks of smoking, and be 
remembered.
    The data that the comment cites on general awareness of the harms 
of smoking in FDA's ongoing PATH study, the Gallup Poll, and NSDUH are 
not relevant to this rulemaking. The goal of the required warnings is 
not to increase perceptions of general harm of smoking as measured by 
questions in these surveys, such as ``How harmful do you think 
cigarettes are to health?'' or ``Do you think smoking is harmful to 
you?'' Rather, the goal is to promote greater public understanding of 
the negative health consequences of smoking as conveyed in the required 
warnings, which address specific health consequences rather than health 
consequences in the abstract.
    The statement also describes an analysis of the publicly available 
PATH data from Wave 1 (2013-2014), Wave 2 (2014-2015), and Wave 3 
(2015-2016). The comment's analysis attempts to examine perception 
measures of the specific health harms of smoking referenced in the 
required warnings. We have concerns with the analysis presented in the 
comment of PATH data for specific health outcomes. Significant 
limitations include a lack of description of the methods and 
statistical approach, which make it unclear how perceptions/awareness 
across the three waves used in the analysis were calculated and whether 
the longitudinal data were properly weighted. In addition, there is a 
lack of data from youth (younger than 18), for whom these questions 
were not assessed, which may potentially bias the results as younger 
people may be less informed about the range of health consequences 
caused by smoking.
    Beyond concerns with the analytic approach, there are important 
limitations in the analysis's attempt to extrapolate from PATH survey 
items to the required warning topics. Many of the items used do not 
align well with the topic covered in the proposed warnings. For 
example, the specific smoking-related health effect found in the PATH 
item ``Based on what you know or believe, does smoking cause . . . 
[h]arm to fetuses (or unborn children) during pregnancy from second-
hand smoke?'' is purportedly aligned with the statement ``WARNING: 
Smoking during pregnancy stunts fetal growth.'' Similarly, the specific 
smoking-related health effect found in the PATH item ``Based on what 
you know or believe, does smoking cause . . . [l]ung disease such as 
emphysema in smokers?'' is purportedly aligned with the textual 
statement ``WARNING: Smoking causes COPD, a lung disease that can be 
fatal.'' Although these PATH items may assess general awareness of 
related health conditions, they do not have sufficient specificity to 
draw conclusions about the required warnings and the particular health 
conditions on which they are focused. Even for items that more directly 
relate to the textual warning statements such as the one found for 
bladder cancer (``WARNING: Smoking causes bladder cancer, which can 
lead to bloody urine''), the PATH item ``Based on what you know or 
believe, does smoking cause . . . [b]ladder cancer in smokers?'' does 
not fully capture all information found in the required warning, such 
as the symptoms of bladder cancer in this example. More importantly, 
the PATH items do not capture information that is conveyed in the image 
depicting the negative health outcome, but rather only focus on one 
element of the warnings: The textual warning statement.
    Even setting all those serious limitations aside, the evidence 
presented in the comment based on PATH data still show that there are 
significant opportunities to further promote greater public 
understanding of the risks associated with cigarette smoking through 
the required warnings. For example, even according to the comment's own 
analysis of PATH data, awareness among adults that smoking causes 
blindness (an incomplete measure of understanding that smoking causes 
cataracts, which can lead to blindness), was less than 50 percent, and 
awareness among adults that smoking causes bladder cancer was less than 
60 percent. Additionally, simply being aware that smoking causes a 
specific health condition is not the same as understanding. As 
described in section V of the proposed rule (see the first paragraph of 
this response), understanding the negative health harms of smoking is 
multifaceted and comprises many processes involving attention, reading, 
knowledge, thinking about the risks, learning, information processing, 
and recall.
    A more appropriate test of understanding that smoking causes the 
specific health conditions in the required warnings is FDA's final 
quantitative consumer research study (Ref. 17), which examined those 
specific outcomes among youth and adults and used study questions that 
were specific to the warnings being tested. As outlined in section VII, 
the individual required warnings provided new information to between 
35.7 and 88.7 percent of participants in the study, and the required 
warnings were all perceived to be more helpful in understanding 
negative health effects than the current 1984 Surgeon General's 
warnings.
    The comment also concludes that the public overestimates the risk 
of smoking, citing data from an academic researcher (Refs. 36 and 37). 
However, that research reports on surveys that were paid for and 
commissioned by tobacco-industry law firms in 1985, 1997, and 1998 for 
use in defending the tobacco industry against litigation and has been 
criticized on methodological and other grounds in the public health and 
psychology scientific literature (Ref. 38; see also, e.g., Refs. 39 and 
40).
2. Cigarette Health Warnings That Are Noticeable, Lead to Learning, and 
Increase Knowledge Will Promote Greater Public Understanding About the 
Negative Health Consequences of Smoking
    The process of getting individuals to understand a message is a 
multifaceted process, as individuals must first attend to the message 
(i.e., notice and be made aware of the message), and then they

[[Page 15656]]

must process the information in the message (i.e., acquire knowledge of 
and learn that information) (Ref. 41). As FDA discussed in the proposed 
rule, a large body of scientific evidence demonstrates that large, 
pictorial cigarette warnings, such as those required in the final rule, 
promote greater public understanding about the health consequences of 
smoking as they: (1) Increase the noticeability of the warning's 
message, resulting in increased consumer attention to, reading, and 
recall of the message; and (2) increase knowledge, learning, 
information processing of, and thinking about the negative health 
consequences of smoking. Pictorial cigarette warnings address gaps in 
public understanding of the negative health consequences of smoking as 
the visual depictions of smoking-related disease in the warnings 
reinforce what is in the text of the warnings while also providing new 
information beyond what is in the text (Ref. 42; see also Ref. 43). As 
described in section V.B.2.c of the proposed rule, pictorial cigarette 
warnings can increase understanding of the negative health consequences 
of smoking across diverse populations while also benefitting 
subpopulations that have disparities in knowledge about the negative 
health consequences of smoking. Given the widespread implementation of 
large pictorial cigarette warnings on cigarette packages in over 100 
countries around the world, real world experience from those countries 
support these conclusions. FDA received many comments on the 
effectiveness of large pictorial cigarette warnings in increasing 
public understanding of the health harms of smoking. Those comments, 
and FDA's responses, are summarized below.
    (Comment 27) Multiple comments agree that the evidence conclusively 
shows that cigarette health warnings that combine images and text are 
more effective than text-only warnings at increasing knowledge and 
public understanding of the health effects of smoking. One comment, 
citing the 2012 Surgeon General's Report (Ref. 33), states that 
``health warnings on cigarette packages are a direct, cost-effective 
means of communicating information on health risks of smoking to 
consumers'' and that such warnings increase knowledge about the harms 
of tobacco use. One comment notes that the scientific evidence shows 
that cigarette health warnings increase attention, noticeability, 
recall, information processing, and understanding of the warnings. The 
comment also states that visual depictions of smoking-related disease 
in pictorial cigarette warnings provide new information beyond what is 
found in the text of the warnings by helping to reinforce and also 
depict and explain the health effect in the text. The comment cites a 
2008 report by the World Health Organization (WHO) (Ref. 44), which 
concluded that health warnings on tobacco packages increase smokers' 
awareness of their risk by use of pictures that depict the harms of 
smoking. Another comment notes that cigarette health warnings that 
combine images and text increase understanding of the risks of smoking 
by increasing attention, objective knowledge about risks, self-reported 
learning, and thinking about the risks of smoking.
    (Response 27) FDA agrees that the scientific evidence shows that 
pictorial cigarette health warnings are more effective than text-only 
warnings at increasing knowledge and public understanding of the 
negative health consequences of smoking. As described in section V.B. 
of the proposed rule, a robust body of scientific literature shows that 
cigarette health warnings that combine images and text promote public 
understanding of the negative consequences of smoking. For example, 
research shows that compared to text-only cigarette warnings, pictorial 
cigarette warnings are more likely to be noticed (Refs. 45-57); to be 
read, looked at closely, and recalled (Refs. 48 and 58); to lead to 
higher knowledge gain and learning (Refs. 59 and 60); and to lead to 
thinking about the message content (Ref. 61).
    (Comment 28) A comment cites a published meta-analysis (Ref. 61) of 
37 studies across 16 countries that summarizes much of the current 
evidence base describing how cigarette health warnings that combine 
images and text outperform text-only warnings on outcomes such as 
attracting and holding attention and stronger cognitive reactions such 
as perceived credibility and thinking about the risks.
    (Response 28) FDA appreciates the submission of this important and 
comprehensive research. This meta-analysis was included in the proposed 
rule as Ref. 50 and was discussed, along with other supportive 
information about the ability of pictorial cigarette warnings to 
improve understanding, in section V.B.2.b of the proposed rule in a 
subsection entitled ``Pictorial cigarette warnings increase information 
processing and learning of new information about the negative health 
consequences of smoking.''
    (Comment 29) One comment from a large international tobacco 
research program provides an analysis of natural experiment data 
collected from 13 countries assessing real-world changes in adult 
smokers' knowledge of the health conditions--that focus on the same 
health conditions as those included in the proposed required warnings--
before and after implementation of pictorial cigarette warnings in 
those countries. The comment's analysis indicates that, in all 
countries, there was generally no change in smokers' knowledge of 
already well-known health effects following implementation of pictorial 
cigarette warnings but that pictorial cigarette warnings can lead to 
further increases in knowledge of health effects for which awareness 
levels are already quite high. The analysis also indicated that 
pictorial cigarette warnings significantly improved awareness of less-
known health effects and that pictorial cigarette warnings that are 
large and appeared on both the front and back of cigarette packs were 
more effective for increasing health knowledge. In addition, the 
comment estimates that, after the introduction of the proposed warnings 
in the United States, an additional 3.84 million smokers would know/be 
aware that smoking causes gangrene, an additional 5.22 million smokers 
would know/be aware that smoking causes blindness, an additional 3.22 
million smokers would know/be aware that smoking causes impotence, and 
an additional 5.90 million smokers would know/be aware that smoking 
causes bladder cancer.
    (Response 29) FDA appreciates the submission of this analysis of 
real-world data on the impact of the introduction of pictorial 
cigarette health warnings on smokers' knowledge of the negative health 
consequences of smoking. We agree that, once implemented, the required 
warnings will have a positive impact on the public's understanding of 
the negative health consequences of smoking. Indeed, in section V of 
the proposed rule, we discussed data (see, e.g., Refs. 4, 45, 46, 61, 
and 62) regarding how cigarette health warnings can inform the public 
and lead to improvements in health knowledge by, in part, increasing 
noticeability of the warnings and attention paid to the warnings, and 
that the current 1984 Surgeon General's warnings are rarely noticed or 
read.
    The results submitted do have some limitations that are common to 
real-world natural experiments, such as differences in the demographics 
of smokers between the countries studied and the United States. There 
are also some differences between the warnings in the countries studied 
and the final required warnings in the United States

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in terms of the size of the warnings (ranging between 30 and 90 percent 
of the pack) and placement of the warnings (i.e., on front and back of 
packs or just one side). Additionally, the measures used in the 
comment's submitted study do not match the exact wording or exact 
health consequences depicted in the proposed required warnings (e.g., 
secondhand smoke causes asthma in children versus tobacco smoke can 
harm your children). Finally, this study only includes adult smokers, 
so it cannot account for the potential improvements in understanding of 
the negative health consequences of smoking among other nonsmoking 
adults or among youth.
    Although there are limitations to applying evaluation findings from 
other countries to the United States, the evidence submitted by the 
comments addresses many of these limitations with its longitudinal 
cohort design and robust number of countries included in the analysis 
and as such provides a useful framework to understand the anticipated 
effect of the required warnings.
    (Comment 30) A comment asserts that FDA failed to adequately 
address contrary evidence indicating that graphic warnings do not 
meaningfully influence consumer knowledge regarding the health 
consequences of smoking. The comment states that FDA ignores findings 
from U.S.-based studies that demonstrate little or no contribution of 
added color graphics to textual warning messages (Refs. 63-67).
    (Response 30) In section V.B.2.a of the proposed rule, we 
acknowledge a small number of U.S.-based studies that failed to find 
that the specific pictorial cigarette warnings tested in those studies 
had an effect on increasing study participants' agreement with correct 
health beliefs about the negative effects of smoking. As we discussed 
in the proposed rule, the failure to find an effect 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, such as the nine 
warning statements set forth by Congress in the Tobacco Control Act 
that focus on better-known health consequences of smoking. Some of the 
comments cited recently published studies, and we have since completed 
review of those studies. One study (Ref. 66) compared participants who 
viewed pictorial cigarette warnings, based on the nine TCA statements, 
to those who viewed the text-only versions of the warnings. The study 
found that the pictorial cigarette warnings using the nine TCA 
statements did not promote greater public understanding when compared 
to text-only warnings, which is consistent with previous findings (Ref. 
68). These findings are also consistent with FDA's first quantitative 
consumer research study, which showed that, generally, relatively few 
study participants reported the nine TCA statements to be new 
information (Ref. 12), and further support FDA's decision to develop 
and test new textual warning statements beyond the nine statements in 
the Tobacco Control Act. Finally, the comment cites additional studies 
that focus on the effect of pictorial cigarette warnings on emotional 
reactions or behavioral outcomes (e.g., implicit or explicit negative 
evaluations) (Ref. 67), cigarette purchasing behavior (Ref. 65), quit 
intentions and quit attempts (Ref. 63), and smoking behaviors (Ref. 
64), each of which is beyond the scope of this rulemaking. The purpose 
of the final rule is to promote greater public understanding of the 
negative health consequences of smoking.
    (Comment 31) One comment questions FDA's use of existing published 
scientific studies from outside of the United States, which it 
considers unreliable scientific evidence to support the rule.
    (Response 31) FDA disagrees that published scientific studies from 
outside the United States are, by definition, unreliable scientific 
evidence to support the final rule. The consistency of findings on the 
effectiveness of pictorial cigarette warnings across countries supports 
both the scientific validity and reliability of the effect of pictorial 
cigarette warnings, irrespective of country-specific contexts. In 
section V.B of the proposed rule, FDA discusses studies that 
demonstrate how pictorial cigarette warnings promote greater 
understanding about the health consequences of smoking. Some of the 
cited literature includes studies conducted outside of the United 
States. These international data are appropriate because they provide 
empirical support for the role of pictorial cigarette warnings in 
generally promoting understanding of the negative health consequences 
of smoking, especially as some of those studies test the effect of the 
actual implementation of pictorial cigarette warnings at the national 
level, which is not currently possible to study in the United States. 
Like those international studies, U.S.-based studies support the 
conclusion that pictorial cigarette warnings promote greater 
understanding of the negative health consequences of smoking. 
Accordingly, this body of scientific literature further confirms the 
findings from FDA's own consumer research studies demonstrating that 
the required warnings will promote greater public understanding.
    (Comment 32) Some comments mention public education campaigns as an 
alternative to requiring cigarette manufacturers to display cigarette 
health warnings on their packaging and in their advertising. One 
comment states that FDA did not consider the potential for enhanced 
public education campaigns as a less burdensome approach to advance its 
objective and promote consumer understanding. Another comment states 
that ``there is also strong evidence that an FDA-run public-education 
campaign would be significantly more effective than the proposed 
graphic warnings'' and that such campaigns have several advantages over 
graphic warnings.
    (Response 32) FDA and others have been actively engaged in a 
variety of public education campaigns related to cigarette and other 
tobacco product use, and these campaigns have made positive 
contributions to educating the public. However, given the enormity of 
the public health consequences of cigarette smoking in the United 
States, and the large and diverse sectors of society affected by 
cigarette smoking, Congress correctly concluded that this channel for 
communications was not by itself sufficient. Accordingly, in enacting 
the Tobacco Control Act, Congress amended section 4 of the FCLAA and 
directed FDA to issue new cigarette health warnings that include color 
graphics depicting the negative health consequences of smoking to 
accompany new textual warning statements (section 201 of the Tobacco 
Control Act, which amends section 4 of the FCLAA). Furthermore, 
research shows that cigarette packages and advertisements can serve as 
important channels for communicating health information to broad 
audiences that include both smokers and nonsmokers (Refs. 43 and 45). 
Daily smokers, who in 2016 averaged 14.1 cigarettes per day, are 
potentially exposed to the warnings on packages over 5,100 times per 
year, and, because these packages are often visible to individuals 
other than the person carrying the package, warnings on those packages 
are potentially viewed by many others, including nonsmokers (Refs. 43 
and 69). Also, smokers and nonsmokers, including adolescents, 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. FDA agrees that there is an important role for other 
educational

[[Page 15658]]

efforts to inform smokers and nonsmokers about the negative health 
consequences of smoking; however, while such efforts complement the 
required warnings, they are not, by themselves, an effective 
alternative.

VI. FDA's Approach to Developing and Testing Cigarette Health Warnings 
Depicting the Negative Health Consequences of Smoking

    As explained in the proposed rule, FDA undertook a rigorous 
science-based, iterative research process to developing and testing 
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. Part of this iterative process included 
considering whether to revise the nine TCA statements to promote 
greater public understanding of the risks associated with cigarette 
smoking. FDA determined there was sufficient support to propose 
adjusting the text of the TCA statements, as authorized by section 4(d) 
of the FCLAA (as amended by section 202(b) of the Tobacco Control Act). 
The process also included undertaking two large consumer research 
studies, the second of which built on the findings from the first.
    The first quantitative study was a large (2,505 participants) 
consumer research study to assess which, if any, of 15 revised warning 
statements would promote greater public understanding of the risks 
associated with cigarette smoking as compared to the 9 TCA statements 
(OMB control number 0910-0848). In this first quantitative consumer 
research study, each of the 9 revised textual warning statements that 
are included in this final rule demonstrated statistically significant 
higher levels on the two key measures (i.e., ``new information'' and 
``self-reported learning'') that are predictive for the task of 
identifying whether a revised warning statement will promote greater 
public understanding of the risks associated with cigarette smoking. 
The second, final quantitative study was a large (9,760 participants) 
consumer research study to test 16 text-and-image pairings against the 
current Surgeon General's warnings (OMB control number 0910-0866). We 
discuss the results of the final consumer research study in this 
section.
    Both quantitative consumer research studies are described in detail 
in the proposed rule, along with the other steps that informed FDA's 
selection of the cigarette health warnings. The proposed rule also 
included as references the draft study reports for each quantitative 
study, and these reports describe the studies and present the results 
of the analyses from the studies. At the time the proposed rule 
published, the reports were undergoing peer review, and these studies 
have since completed peer review and are available in the docket for 
this final rule (Refs. 12 and 17).

A. FDA's Final Consumer Research Study Findings

    FDA's final large quantitative consumer research study strongly 
supports the Agency's determination that the final required warnings 
will promote greater public understanding of the negative health 
consequences of cigarette smoking. The 11 final required warnings 
outperformed the current 1984 Surgeon General's warnings on the two 
outcomes FDA determined are 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 improvement in nearly all 
other measures of understanding when compared to the Surgeon General's 
warnings.
    Prior to conducting the study, FDA's study design specified that, 
to be considered for regulatory action, individual warnings would have 
to demonstrate statistically significant improvements, as compared to 
the current Surgeon General's warnings (which were used as the control 
condition), on both of two specific outcome measures: ``new 
information'' and ``self-reported learning'' (Ref. 204). The completed 
research results show that all 11 final required warnings surpassed the 
Surgeon General's warnings on both of these outcome measures. In 
addition, as the final study report demonstrates, all 11 of the final 
required warnings also surpassed the Surgeon General's warnings on six 
other measures; beyond the ``new information'' and ``self-reported 
learning'' outcome measures, all 11 final required warnings also led to 
more thinking about risks; were higher on perceived informativeness, 
perceived understandability, and perceived helpfulness understanding 
health effects; attracted more attention; and were better recalled 
(Ref. 17).
1. Study Design
    As described in section VI.E of the proposed rule, 84 FR at 42771-
72, the purpose of FDA's final quantitative consumer research study 
(OMB control number 0910-0866) was to assess the extent to which any of 
the 16 tested cigarette health warnings, developed through FDA's 
science-based, iterative research process, increase understanding of 
the negative health consequences of cigarette smoking. More details 
about the full study results can be found in the final peer-reviewed 
study report, which we have included in this docket (Ref. 17). Because 
the purpose of this final quantitative consumer research study was to 
identify which of the 16 tested cigarette health warnings increase 
understanding of the negative health consequences of cigarette smoking, 
the study was not designed to put the tested cigarette health warnings 
in a rank order or compare individual results of one cigarette health 
warning to another. FDA evaluated the research results for each 
individual tested cigarette health warning to determine which warnings 
to include in the proposed rule. In doing so, FDA rejected 3 of the 16 
warnings that were tested because they did not outperform the current 
Surgeon General's warnings on both the ``new information'' and ``self-
reported learning'' outcome measures that FDA determined are predictive 
of improved understanding. In finalizing the rule, FDA continued to 
review and evaluate the research results and has narrowed the 13 
previously proposed warnings even further, down to the 11 final 
required warnings. Section VII provides the individual results from the 
final consumer research study for each of the 11 final required 
warnings, as well as for the 2 proposed warnings that were not selected 
for the final rule. We note that the study was not designed, nor 
statistically powered, to examine effects for various groups by age 
(i.e., adolescent, young adult, older adults) or smoking status (i.e., 
nonsmokers, smokers). Results are presented for the overall sample for 
all 10 outcome measures:
     Whether the warning was new information to participants 
(``new information'');
     Whether participants learned something from the warning 
(``self-reported learning'');
     Whether the warning made participants think about the 
health risks of smoking (``thinking about risks'');
     Whether the warning was perceived to be informative 
(``perceived informativeness'');
     Whether the warning was perceived to be understandable 
(``perceived understandability'');

[[Page 15659]]

     Whether the warning was perceived to be a fact or opinion 
(``perceived factualness'');
     Whether participants reported beliefs linking smoking and 
each of the health consequences presented in the warning (``health 
beliefs'');
     Whether the warning was perceived to help participants 
understand the negative health effects of smoking (``perceived 
helpfulness understanding health effects'');
     Whether the warning grabbed their attention 
(``attention''); and
     Whether the warning was recalled (``recall'').
    Prior to conducting the study, FDA conducted a power analysis, 
which is a test to ensure that the overall sample size would adequately 
detect study effects should they exist. The power analysis allowed FDA 
to determine the optimal sample size and allocation of the sample 
across the study conditions, which informed the study sample. FDA 
expected it to be harder to find effects on the ``health belief'' 
outcome measure than on the other measures (including the ``new 
information'' and ``self-reported learning'' measures that FDA 
specified as predictive of improved understanding), and therefore 
powered the study on the estimated ``health belief'' effect size in 
order to ensure sufficient robustness to detect statistically 
significant differences. In particular, for the overall sample size, 
FDA calculated power to detect a statistically significant difference 
in the change in a health belief from Sessions 1 to 2 between the 
treatment and the control groups.
2. Use of FDA's Final Consumer Research Study Results in the Selection 
of Required Warnings
    As discussed in section VII of the proposed rule, we identified 13 
cigarette health warnings for the proposed rule. All proposed warnings 
were factual and accurate, advanced the Government's interest, were not 
unduly burdensome, and demonstrated statistically significant higher 
levels of providing new information and self-reported learning when 
compared to the control condition (i.e., the Surgeon General's 
warnings) (Ref. 17). We stated that we intended to finalize some or all 
of the 13 proposed warnings and that, in determining which proposed 
warnings would be required in the final rule, FDA would consider public 
comments submitted to this docket, full research results from our final 
quantitative consumer research study (including peer reviewer 
comments), the scientific literature, and other considerations.
    Since the publication of the proposed rule, FDA has continued to 
review and evaluate this study's results. Those results, discussed in 
more detail in section VII, strongly support our determination that the 
final required warnings will improve understanding of the negative 
health consequences of smoking. All 11 of the final required warnings 
demonstrated statistically significant improvements over the current 
Surgeon General's warnings (the control condition in the study) on 
these 8 outcomes: New information, self-reported learning, thinking 
about the health risks of smoking, perceived informativeness, perceived 
understandability, perceived helpfulness understanding health effects, 
attention, and recall (see Ref. 17 for more information about the 
study).
    As described in section V.B of the proposed rule, understanding is 
multifaceted and composed of multiple processes. Consumer perceptions 
that a warning provides new information and can contribute to self-
reported learning are necessary precursors to message comprehension and 
learning (Refs. 61, 206, and 207). An important first step in promoting 
public understanding of health risks is therefore to raise public 
awareness of those risks, particularly if the risks are not commonly 
known (Refs. 209 and 210). FDA determined that, to be considered for 
the final rule, a tested warning would need to demonstrate 
statistically significantly better performance than the control (the 
current Surgeon General's warnings) on these two ``new information'' 
and ``self-reported learning'' outcome measures as predictive for 
promoting understanding of the risks associated with cigarette smoking.
    Other outcome measures were ``perceived informativeness,'' 
``perceived understandability,'' ``perceived factualness,'' and 
``perceived helpfulness in understanding health effects.'' These 
measures capture study participants' reactions to and judgment of a 
message (Ref. 61). In turn, an individual's judgment of a warning is 
linked to increased likelihood that the warning is understood (Refs. 
208 and 211).
    The ``health beliefs'' and ``thinking about risks'' outcome 
measures capture study participants' ability to process and think about 
the information in a message, which subsequently leads to knowledge 
acquisition and learning (Ref. 206). Warnings that promote accurate 
health beliefs and thinking about the health risks of smoking are more 
likely to lead to understanding about the negative health consequences 
of smoking compared to warnings that fail to promote these indicators.
    Two other outcome measures, ``attention'' and ``recall,'' capture 
study participants' attention to a warning and their ability to 
recognize or recall the warning (Refs. 61 and 206). A warning that is 
noticed and attracts sufficient attention for information to be encoded 
and recalled increases the likelihood of understanding the warning 
compared to a warning that does not attract attention (Refs. 34, 207, 
and 208).
    As noted above, all 11 final required warnings outperformed the 
current Surgeon General's warnings on 8 of the 10 outcome measures, 
including the two that FDA determined were predictive of improved 
understanding (i.e., ``new information'' and ``self-reported 
learning''). On the ``health beliefs'' outcome, nearly all (9 of 11) of 
the final required warnings also demonstrated statistically significant 
improvements over the Surgeon General's warnings between Session 1 of 
the study and Session 2, approximately 1 to 2 days later, and many (7 
of 11) of the required warnings also demonstrated statistically 
significant improvements over the Surgeon General's warnings on changes 
in health beliefs between Session 1 of the study and Session 3, 
approximately 17 days later. As noted in section VI.C.3 of the proposed 
rule, 84 FR at 42769, health beliefs may be unlikely to change with 
limited exposures, as was seen in FDA's first quantitative consumer 
research study (see Ref. 12). In FDA's final consumer research study, 
which had just two brief exposures to the tested warnings over 2 days, 
measurable changes in health beliefs were not expected (see, e.g., 
Refs. 205 and 206). That FDA's final consumer research study found 
changes in health beliefs between Sessions 1 and 2 for 9 of the 11 
final required warnings, and that those changes persisted for an 
additional 2 weeks for 7 of the 11 final required warnings, 
demonstrates that even with two brief exposures, the cigarette health 
warnings influenced participants' beliefs about the negative health 
consequences of smoking.
    On one of the 10 outcomes in our final consumer research study, 
``perceived factualness,'' the cigarette health warnings did not 
reliably outperform the current Surgeon General's warnings. All tested 
warnings (both the 16 tested cigarette health warnings and the 4 
current Surgeon General's warnings, which served as the control 
condition) were rated as factual by the vast majority of participants. 
Four of the final required warnings, however, were not perceived as 
factual to a degree that was statistically

[[Page 15660]]

significantly more or less than the Surgeon General's warnings. The 
remaining required warnings were perceived as factual statistically 
significantly less than the Surgeon General's warnings. Such a finding 
is common in pre-implementation studies that test warnings about health 
effects for which there are low levels of consumer awareness (Refs. 4, 
43, and 78). As explained in the responses to comments later in this 
section (see section VI.B.2), individuals presented with new 
information may view it with skepticism and even consider the new 
information less factual than information they have seen before (Refs. 
70-77).
    Beyond looking at statistical significance, FDA also considered the 
strength and consistency of the findings across all outcomes. Although 
we found some variation in the effect of each of the tested required 
warnings on some study outcomes, this is to be expected as there was a 
diverse representation of health topics across the warnings. In 
addition, as mentioned above and in the proposed rule, differing levels 
of baseline knowledge among participants about the various health 
conditions would contribute to the variation found in the effects 
across the required warnings.
    In any event, the consistent pattern of findings for each 
individual required warning and across all the required warnings is 
highly supportive. For example, we assessed participants' ability to 
recall the warning they had previously been exposed to in the study. 
Participants viewed four warnings in random order, one of which they 
had previously been shown; thus, participants had a one in four (25 
percent) random chance of correctly guessing the warning they had 
previously been shown. Participants who were shown one of the 4 Surgeon 
General's warnings recalled which warning they were shown at levels 
very similar to what they would achieve through chance guessing (25.7 
percent recall). By contrast, the tested cigarette health warnings were 
recalled substantially more, with recall ranging from 49.4 to 73.9 
percent, depending on the specific required warning.
    Although not conducted with a nationally representative sample, 
which prevents direct extrapolation of the study findings to the U.S. 
population, the size and consistency of the effects found in our final 
consumer research study demonstrate that the required warnings will 
promote greater public understanding of the negative health 
consequences of smoking.

B. Responses to Comments Regarding FDA's Approach

    FDA received numerous comments in the docket related to its 
approach to developing and testing new cigarette health warnings 
depicting the negative health consequences of smoking, which we 
summarize and respond to in the following paragraphs.
1. Overall Iterative Research Process
    (Comment 33) Several comments support FDA's science-based, 
iterative research process, stating that it shows that the research was 
strong and demonstrates that the proposed required warnings will lead 
to greater public understanding of the health harms of smoking and that 
the proposed rule is well supported and justified. Comments note the 
comprehensive list of scientific references used to provide robust 
evidence for the support of cigarette health warnings in promoting 
understanding as well as the set of qualitative and quantitative 
consumer studies that FDA conducted. However, some comments object to 
the research and development process, for example, stating that FDA 
``has not developed record evidence which supports the choice made,'' 
and that the proposed rule ``constitutes regulation on the basis of 
speculation, conjecture, or supposition--based on either: (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.''
    (Response 33) We disagree with the comments that suggest the rule 
is based on speculation, conjecture, and supposition. As described in 
detail in the proposed rule, and as many comments recognize, the rule 
is the result of a science-based, iterative research process across all 
phases of research and development of the required warnings that would 
advance the Government's substantial interest in promoting greater 
public understanding of the negative health consequences of smoking. In 
addition, contrary to the suggestion of at least one comment, the 
Government's interest in this rule is not to reduce smoking rates, but 
rather it is to promote greater public understanding of the negative 
health consequences of smoking. We discuss the Government's interest 
for the final rule in detail at section IV.C.1.
    (Comment 34) One comment, from an internationally recognized expert 
in developing and testing cigarette health warnings who submitted on 
behalf of a public health group, summarizes and evaluates FDA's process 
for developing and testing the proposed required warnings, the 
regulatory objectives of the proposed rule, and the proposed rule's 
potential burden on industry. The comment ultimately concludes that 
FDA's regulatory objectives are clearly articulated and appropriate; 
FDA has engaged in a comprehensive and rigorous research process to 
develop and test the proposed required warnings; findings from FDA's 
studies highlight substantial gaps in existing health knowledge among 
consumers; the current 1984 Surgeon General's warnings on cigarette 
packages and in cigarette advertisements fall well below minimum 
international standards; findings from FDA's studies reinforce the 
importance of using graphic images to communicate the health effects of 
smoking; the design of the proposed required warnings is consistent 
with the scientific literature on effective design principles; the size 
of the warnings is appropriate and necessary to achieve FDA's 
objectives; and the proposed required warnings do not ``unduly'' 
restrict manufacturers' ability to convey other information on packages 
or advertisements. The comment further states that the findings from 
FDA's consumer research studies are highly consistent with the 
extensive evidence from ``post-implementation'' studies that have 
assessed the impact of pictorial cigarette warnings in other countries. 
The comment also considers the potential limitations that FDA 
identified with the studies, such as the use of an online survey and 
the decision made about the appropriate comparison group, and concludes 
that these potential limitations do not prevent the findings from 
providing strong support for the proposed warnings.
    (Response 34) FDA agrees with this supportive comment that the 
research and development process was rigorous and adhered to best 
practices for the conduct and reporting of the studies and that the 
potential limitations we identified do not prevent the study findings 
from providing strong support for the proposed required warnings. We 
also agree that the studies and other scientific analysis in the 
proposed rule strongly support both the need for the rule as well as 
the ability of the rule as designed to meet the Government's 
objectives.
    (Comment 35) At least one comment objects that FDA provided no 
evidence in the proposed rule to support why the Agency selected 
particular color graphics to illustrate the textual warning statements, 
including whether it considered alternative graphics to illustrate the 
same concepts or why it chose the selected photorealistic illustrations 
over others that could have

[[Page 15661]]

depicted the same health conditions described in the textual warning 
statements.
    (Response 35) As described in detail in section VI.D of the 
proposed rule, FDA undertook an iterative, research-based approach to 
develop color graphics depicting the negative health consequences of 
cigarette smoking to accompany the textual warning statements. This 
process required considering findings from health communication science 
research regarding best practices for helping the public better 
understand health risk information and testing potential text 
statements, potential images, and potential pairings of text statements 
with images to ensure that the final required cigarette health warnings 
are unambiguous, are unlikely to be misinterpreted or misunderstood by 
consumers, and do convey factually accurate information.
    Research indicates that multiple factors influence whether a 
specific type of visual depiction (such as an image compared to a bar 
chart or graph) ultimately aids or impedes message comprehension, 
including the level of concordance between the text and accompanying 
visual depiction (e.g., using an image of an eye to depict the word 
``eye''); the level of cognitive effort required to understand the 
information (e.g., using a stacked bar chart to depict multiple data 
comparisons requires greater cognitive effort); and the type of 
communication channel used to deliver the message (e.g., information 
presented by a doctor as part of a conversation with a patient, versus 
information presented in a mass media campaign) (Refs. 79-89). For 
example, in comparison to bar charts or graphs, visual depictions in 
the form of illustrations or photographs are more likely to aid 
comprehension when used for mass-communication purposes because these 
types of visual depictions are more easily made congruent (i.e., the 
type of visual is appropriate for the message) and concordant, and they 
require less numerical proficiency and cognitive effort to understand 
the information (Refs. 81, 82, 86, and 87).
    Based on our review of the literature, the cigarette health warning 
message content, and the communication channel, FDA determined that 
textual warning statements paired with factually accurate, concordant 
photographs or photorealistic images of specific health conditions, 
presented in a realistic and objective format, would be most likely to 
advance the Government's interest in promoting greater public 
understanding of the negative health consequences of cigarette smoking. 
FDA ultimately used a photorealistic illustration format for the images 
because this format best allowed FDA to ensure that the final images 
would be fully concordant with the ultimate textual statements 
addressing the same health conditions. The photorealistic illustration 
format also facilitated providing factually accurate images that depict 
common presentations of the health conditions in a realistic and 
objective format devoid of non-essential elements.
    In terms of determining what to depict in the photorealistic 
illustrations, FDA consulted the medical literature and internal Agency 
medical experts to identify common, visual presentations of each health 
condition described by the textual warning statements. FDA then 
developed a larger set of potential warning images, which were 
subsequently refined and reduced, including with feedback from various 
qualitative focus groups and interviews, to the set of 16 text-and-
image pairings that were included in the second large quantitative 
consumer research study.
2. Quantitative Studies
    (Comment 36) One comment suggests that FDA's two quantitative 
consumer research studies were not credible because they did not go 
through a peer review process.
    (Response 36) We disagree with this comment. As stated in the 
proposed rule, we placed in the docket for public comment two study 
reports that described FDA's quantitative consumer research studies and 
presented the results of the analyses from the studies. In developing 
this final rule, we considered comments on those study reports. In 
addition, as discussed in the proposed rule, both studies were also 
undergoing a peer review process, which is now complete. The peer 
reviewers included six experts in behavioral science (psychology, 
public health behavior, tobacco control/tobacco regulatory science, and 
health communication). The peer reviewers concluded that the studies 
were strong and that ``both studies are very well done in terms of 
design and data analysis'' and ``appropriate to address the study's 
purpose.'' Peer reviewers provided comments to improve the clarity of 
the study reports and provide additional details. The external peer 
review report is available on FDA's ``Completed Peer Reviews'' website 
at https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews. Following 
consideration of the peer review comments, FDA updated the study 
reports accordingly, including adding clarifying details about the 
studies' procedure and analysis, but none of these updates to either 
study report changes the results, findings, or conclusions of either 
study, nor do any of the updates affect FDA's decisions that relied in 
part on these studies. The final peer-reviewed study reports are 
included in the docket to this final rule (Refs. 12 and 17).
    (Comment 37) One comment asserts that FDA's two quantitative 
consumer research studies suffered from study design flaws and are 
inherently biased. The comment states that both studies compare new, 
more specific information in the proposed required warnings to the more 
general statements contained in the nine TCA statements and in the four 
Surgeon General's warnings. The comment argues that comparing highly 
detailed statements to more general statements may artificially inflate 
study participants' self-reported measures of learnings or new 
information by conflating specificity and length of the new statements 
with knowledge. Another comment, however, states that new knowledge 
among participants in the experimental conditions of FDA's studies is a 
logical and reasonable consequence of the potential real-world 
implications of displaying specific versus general health effects. 
Additionally, this comment states that information about specific 
health effects typically conveys more information and may produce more 
specific health knowledge, which is consistent with FDA's study 
findings that indicate that participants who were shown the revised 
textual warning statements and new cigarette health warnings reported 
greater scores in ``new information'' and ``self-reported learning'' 
when compared to the control participants.
    (Response 37) FDA disagrees with the comment that the two 
quantitative studies suffer from design flaws and are inherently 
biased. Rather, as pointed out by other comments, the study design 
yields valid findings that exposure to the specific information 
contained in the required warnings promotes greater understanding of 
the negative consequences of smoking when compared to the broad 
statements contained in the warnings to which they are compared.
    (Comment 38) Other comments object that FDA has not demonstrated 
that the required warnings will promote public understanding of the 
negative health consequences of smoking due to the limitations of the 
study measures ``new information'' and ``self-reported learning.'' One 
comment asserts that these study measures do not reflect increased 
learning and understanding

[[Page 15662]]

and that FDA fails to demonstrate how these measures can reflect 
understanding via mentally processing, reflecting on, and thinking 
about the harms of smoking.
    (Response 38) FDA disagrees with the comment that relying on the 
measures of ``new information'' and ``self-reported learning'' prevent 
scientific support for the required warnings in advancing the 
Government's purpose of promoting public understanding of the negative 
health consequences of smoking. As described in section V.B of the 
proposed rule, 84 FR at 42762-65, FDA undertook an in-depth review of 
the scientific literature to determine that cigarette health warnings 
that provide new information and lead to learning promote understanding 
about the negative health consequences of smoking. In addition, as also 
described in V.B of the proposed rule, 84 FR at 42762-65, understanding 
is multifaceted and composed of several processes such as attention, 
acquiring new information, learning, knowledge, thinking about the 
message (i.e., cognitive elaboration), and recall. FDA's final consumer 
research study supports the effectiveness of the required warnings in 
promoting understanding across these various measures, as the study's 
findings indicate that, overall and relative to the average of the 
Surgeon General's warnings (i.e., the control condition), all of the 
new required warnings were reported to be ``new information'' and 
resulted in greater ``self-reported learning.'' Because the required 
warnings outperformed the Surgeon General's warnings on ``new 
information'' and ``self-reported learning''--the two outcome measures 
that FDA specified as predictive of improved understanding--as well as 
six other measures of understanding (i.e., thinking about health risks 
of smoking, attention to the warnings, perceived informativeness, 
perceived understandability, perceived helpfulness in understanding 
health effects, recall), the study results demonstrate that the 
required warnings will promote greater public understanding of the 
negative health consequences of smoking.
    (Comment 39) Some comments assert that FDA's ``new information'' 
and ``self-reported learning'' measures are susceptible to social 
desirability bias (i.e., that participants respond in a way they think 
they ``should'' respond rather than their actual responses). However, 
another comment finds the measures used in FDA's consumer research 
studies were ``appropriate to address the research questions and have 
been adapted from previous research to the extent possible,'' were 
standardized across conditions and respondent subgroups, and where 
scales were created, there was sufficient rationale and details on the 
construction and analysis of the scales.
    (Response 39) FDA disagrees that the ``new information'' and 
``self-reported learning'' outcome measures in its consumer research 
studies are susceptible to social desirability bias, and we instead 
agree with the comment that the measures were appropriate to address 
the research conditions. As explained in the proposed rule and in the 
consumer research study final reports (Refs. 12 and 17), FDA reviewed 
the existing scientific literature on methods, design issues, and 
outcome measures used in other studies seeking to improve consumer 
knowledge and to correct misperceptions about the health risks of 
cigarette smoking. As we noted in the supporting statement for the 
information collection requests approved by the Office of Management 
and Budget (OMB), the measures used in both studies were drawn from 
previously used and/or validated instruments to ensure that instruments 
are not ambiguous, burdensome, or confusing (OMB control numbers 0910-
0848 and 0910-0866). Finally, because of the experimental design of 
these studies and randomization of participants to conditions, any 
potential social desirability bias in participants' responses would be 
equally distributed among the conditions (including the control 
condition) thus minimizing any impact of any potential bias on the 
results.
    (Comment 40) One comment states that FDA's final consumer research 
study failed to show that cigarette health warnings promote 
understanding due to health beliefs scores measured at Sessions 2 and 
3. The comment claims that five of the warnings reduced respondents' 
knowledge about relevant health risks, and seven of the remaining eight 
warnings saw sharp decreases in knowledge gains between Sessions 2 and 
3. Another comment acknowledges the challenges with changing health 
beliefs in study interventions with limited stimuli exposure and 
shorter study duration.
    (Response 40) We disagree with the comment that concluded that our 
final consumer research study fails to show that the proposed required 
warnings promote understanding. Overall, the failure to detect 
differences in some of the outcomes assessed in the final quantitative 
consumer research study should be interpreted within the context of its 
experimental design, which collected data on 10 different measures. FDA 
is appropriately prioritizing the outcomes that provide the best 
assessment of initial reactions (``new information'' and ``self-
reported learning'') over more ``delayed'' outcomes that are unlikely 
to change after only brief exposure to a warning (``health beliefs''). 
In any event, findings from the study indicate that the required 
warnings promote gains in health beliefs, as 11 of the 13 proposed 
required warnings (and 9 of the 11 final required warnings) showed 
greater gains in health beliefs between Sessions 1 and 2 than the 
Surgeon General's warnings, and, even though the study was not powered 
to detect changes between Sessions 1 and 3 on this measure, 7 of the 13 
proposed required warnings (and 7 of the 11 final required warnings) 
did so. In general, health beliefs may be unlikely to change with 
limited exposures, as was seen in FDA's first quantitative consumer 
research study, which measured outcomes based on a single exposure. For 
FDA's final quantitative consumer research study, which only included 
two exposures, significant changes in health beliefs were not expected 
(see, e.g., Refs. 205 and 206). That the final study found 
statistically significant changes in health beliefs between Sessions 1 
and 2 for nearly all of the final required warnings, and that such 
changes persisted for an additional 2 weeks for 7 of them even though 
the study was not powered to find such changes by Session 3, 
demonstrates that even with limited exposure, the warnings influenced 
participants' beliefs about the negative health consequences of 
smoking.
    Moreover, the conclusions made by the comment are inaccurate and 
misrepresent the study findings. For example, FDA is unable to find in 
the report or to replicate the values provided by the comment that 
purportedly show reductions in study participants' knowledge about 
health risks. FDA is similarly unable to replicate the comment's 
precise calculations regarding decreases in health beliefs scores 
between Sessions 2 and 3. In addition, as acknowledged by the other 
comment, there are challenges with changing health beliefs in study 
interventions with limited stimuli exposure and shorter study duration.
    (Comment 41) A few comments state that FDA's consumer research 
studies fail to support the proposed required warnings, because there 
were instances where FDA's warnings did not improve certain outcomes 
measured such as ``perceived believability'' or ``perceived 
factualness.'' Another comment, however, observes that the inverse

[[Page 15663]]

association between the ``novelty'' of a health warning and its 
believability is a common finding in pre-implementation studies that 
test warnings for health effects for which consumers have low levels of 
awareness, citing supporting studies, and notes that the inverse 
association between novelty and credibility reflects the normal 
cognitive process that occurs when individuals integrate new 
information into their existing belief system. This comment notes that 
these findings from FDA's studies showing lower levels of perceived 
believability or perceived factualness should not be generalized beyond 
the pre-implementation settings as research shows that cigarette health 
warnings implemented on packages are perceived as highly credible and 
that the believability of new health warnings increase over time.
    (Response 41) FDA disagrees with the comments that suggest the 
studies fail to support the proposed required warnings because there 
were no effects for a small number of outcomes measured, e.g., 
``perceived factualness.'' 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; this finding was acknowledged by the comment speaking to the 
inverse association between ``novelty'' or newness of a health warning 
and its believability. When presented with new information, individuals 
may rely on certain common mental heuristics to aid judgment and 
decision making, though reliance on these heuristics can sometimes lead 
to judgment errors or biases (Refs. 70-77). Participants in FDA's 
consumer research studies may have relied on these types of heuristics 
to make judgments about the ``perceived factualness'' of the warnings 
tested in the study based in some measure on the ``novelty'' or newness 
of the new cigarette health warnings versus the familiarity of the 
current 1984 Surgeon General's warnings. As discussed in section V.A of 
the proposed rule, the Surgeon General's warnings have been displayed 
on cigarette packages for more than 35 years and are part of many 
smokers' previously held beliefs, further supporting the need to convey 
new information to the public that is not known about the health 
consequences of smoking. It is also important to emphasize that 
perceived factualness as measured in FDA's final consumer research 
study was assessed with an item telling participants, ``Next, we would 
like to know whether you think this warning is an opinion or a fact. 
Opinions are judgments or feelings that cannot be proven true or false. 
Facts are statements that can be proven true or false,'' and then 
asking participants, ``Would you say that this warning is opinion or 
fact?'' This outcome measure has nothing to do with the actual factual 
accuracy of the content of cigarette health warning (see earlier in 
this section for more discussion on our final consumer research study; 
Ref. 17). FDA unequivocally found that each of the warning statements 
is factual and uncontroversial, based on extensive scientific evidence.
    (Comment 42) One comment suggests that FDA fails to address the 
potential for the cigarette health warnings to ``backfire'' (e.g., will 
be avoided) and that ``highly graphic'' warnings may lower levels of 
recall compared to warnings with less graphic content.
    (Response 42) FDA did not design the required warnings to evoke 
negative emotions. Rather, through the Agency's science-based, 
iterative research process, the required warnings were designed to be 
factually accurate, to make the textual statements and accompanying 
images depicting the specific health conditions concordant, and to 
present the information in a realistic and objective format (see 
section VII.B for further discussion of the required warnings). We 
disagree that the required warnings will lead to low levels of recall 
of the content in the warnings. To the contrary, findings from FDA's 
final consumer research study show that, relative to individuals who 
viewed the Surgeon General's warnings (i.e., the control condition), 
individuals who viewed a cigarette health warning were much more likely 
to accurately recall the warning they saw.
    (Comment 43) Some comments question FDA's use of non-nationally 
representative samples in its consumer research studies, suggesting 
that this limits the usefulness of the studies. Another comment, 
however, states that ``many non-probability based samples can provide a 
diverse, heterogeneous sample'' (citing Refs. 90 and 91) and 
``[a]lthough participants in a commercial panel may differ from the 
general population, the sociodemographic profile of the FDA study 
sample indicates considerable diversity based on sex, education, race/
ethnicity, and income level.'' In addition, this comment notes that 
generally, non-probability samples are acceptable for randomized 
trials, such as the FDA experiments. This comment concludes that 
overall, the study sampling designs and recruitment from both studies 
are appropriate for the study objectives and the analysis plan.
    (Response 43) We disagree with the comments that suggest that the 
non-nationally representative samples used in our consumer research 
studies limit the usefulness of the studies in demonstrating that the 
required warnings will promote greater public understanding of the 
negative health consequences of smoking. We do agree, however, with the 
other comment that states that an experimental design does not require 
a nationally representative sample to demonstrate a valid and reliable 
effect. FDA set specific recruitment targets for the number of study 
participants in each age group and tobacco-use category to be recruited 
into the study population to ensure that the study results would be 
potentially applicable to multiple age and tobacco user groups. With 
respect to the study samples for Studies 1 and 2, the large 
heterogeneous samples allowed FDA to test outcomes across a range of 
individuals, thus strengthening the conclusions and applicability of 
the study findings, and were appropriate for the objectives of FDA's 
consumer research. Further, the tests of the specific textual warning 
statements in FDA's first quantitative consumer research study and the 
cigarette health warnings (i.e., text plus image) in FDA's final 
quantitative consumer research study represent some of the largest 
experimental studies on cigarette warnings conducted to date.
    (Comment 44) Another comment asserts that FDA's final consumer 
research study is flawed because FDA did not incorporate the 
commenter's suggestions regarding demographic and other factors in its 
comment submitted related to FDA's information collection request for 
this study. However, another comment supports FDA's study design and 
implementation stating that the research undertaken by FDA to inform 
the selection of health warnings was ``comprehensive and demonstrates a 
high level of scientific rigour.''
    (Response 44) We disagree with the comments that suggest that the 
final consumer research study is flawed. While FDA considered the 
comments received on the information collection request for the study 
(OMB control number 0910-0866), including those submitted by the 
commenter, we did not adopt those suggestions (e.g., using a nationally 
representative sample, changing specific study questions, changing the 
design to better mimic real-world conditions) as they were not 
necessary for the purpose of the study. FDA agrees with the comment 
that states that FDA's research was comprehensive and demonstrated a 
high level of scientific rigor due to the careful

[[Page 15664]]

consideration of the study design, methods, selection of measures, 
sampling strategy, and analysis.
    (Comment 45) Some comments state that the final consumer research 
study suffered from methodological flaws, such as a small sample size, 
selection bias, a lack of meaningful pretesting, and a failure to mimic 
real-world conditions.
    (Response 45) FDA disagrees with the criticism that our final 
consumer research study suffered from those methodological flaws. 
Regarding the sample size of 9,760 participants, prior to conducting 
the study, FDA conducted a power analysis, which we discuss in section 
VI.A.1.
    Regarding the potential risk for selection bias in the final 
consumer research study, as stated elsewhere, FDA made efforts to 
ensure that the demographics of participants in the study population 
were diverse. Participants' demographic characteristics are reported in 
the final study report (Ref. 17).
    With regard to meaningful pretesting, the measures used in the 
final consumer research study are well-established and/or pulled from 
validated instruments for communication and social science research 
focused on general health warnings or cigarette warnings, specifically. 
FDA reviewed studies assessing warnings for consumer products 
(including tobacco and cigarette health warnings), which informed the 
selection of the items in the proposed study.
    The health belief items assess knowledge of the specific content in 
the warning statements. The language and wording used in these items 
were derived from the specific language used in the warning statements, 
which underwent formative, qualitative testing with adult current 
smokers, adolescent current smokers, and adolescents susceptible to 
cigarette smoking (OMB control number 0910-0674, ``Qualitative Study on 
Cigarettes and Smoking: Knowledge, Beliefs, and Misperceptions,'' which 
assessed reactions and understanding of the draft warning statements; 
and OMB control number 0910-0796, ``Qualitative Study on Consumer 
Perceptions of Cigarettes Health Warning Images,'' which assessed 
reactions and understanding of the draft warning statements that were 
paired with images). In addition, FDA evaluated the performance of 
questionnaire items and draft warning statements in its first large 
quantitative consumer research study (OMB control number 0910-0848). 
The findings from the aforementioned quantitative and qualitative 
studies informed the development of warning statements, revisions to 
those statements, the questions used to assess beliefs about the health 
condition included in the warnings, and the selection of measures for 
FDA's final consumer research study. In addition, the final consumer 
research study pretested the programmed questionnaire to assess 
potential programming issues that might have affected the quality of 
the data.
    Finally, the final consumer research study was designed to increase 
the external validity of the study where possible. For example, the 
procedures for the study provided two exposures to the warnings (to 
better reflect frequent exposure in real-world conditions) and used a 
longer followup time than many similar studies to assess potential 
longer-term and enduring influence of cigarette health warnings to 
better approximate conditions once the warnings are implemented. In 
addition, as part of the online study, participants were able to rotate 
a digital mockup of a cigarette package on the screen to permit viewing 
all sides of the cigarette package (as opposed to viewing a static 
image) to better approximate real-world conditions. Participants also 
viewed the cigarette health warning in both formats (i.e., on packages 
and in advertisements), which provided an appropriate presentation of 
the real-world display of the warnings for smokers and nonsmokers once 
the required warnings are implemented.
    (Comment 46) One comment objects that, because FDA's final consumer 
research study tested the new textual warning statements and concordant 
photorealistic illustrations in combination, there is no basis to think 
that the ``supposed improvements'' are attributable in any way to the 
graphic components of the proposed required warnings, rather than to 
the new text.
    (Response 46) We disagree with the comment's objection that 
``improvements'' need to be measured separately. The purpose of the 
final consumer research study was to determine if new cigarette health 
warnings (including both text and images) would improve understanding 
of the negative health consequences of smoking, which the research 
findings do support, and is consistent with the Congress's direction 
that FDA issue regulations that require color graphics depicting the 
negative health consequences of smoking to accompany the textual 
warning statements. The final consumer research study's use of the 
current 1984 Surgeon General's warnings as the comparison is 
appropriate, because it allowed for investigation of the potential 
effect of implementing new cigarette health warnings compared to the 
current state of warnings for cigarette packages and advertisements in 
the United States. Additionally, as noted in section V.B.1 of the 
proposed rule, and in other comments submitted to the docket, the 
scientific evidence shows that larger cigarette health warnings 
containing text paired with images are more effective than text-only 
warnings at increasing knowledge and public understanding of the health 
effects of smoking (Refs. 4, 45-48, 54, 55, 57, 59, 61, 62, and 92-94).
    (Comment 47) At least one comment states that FDA's final consumer 
research study fails to isolate the effect, if any, of the size and 
location of the warnings. The comment asserts that FDA failed to 
address evidence indicating that its size requirements for packaging 
and advertising do not advance consumer understanding. In contrast, 
multiple comments state that the size and location of the required 
warnings are appropriate and necessary to achieve FDA's objectives. 
These comments note that smaller, less prominent warnings on cigarette 
packages and in cigarette advertisements would be less effective in 
promoting greater public understanding of the negative health 
consequences of smoking. Moreover, one comment explains that ``key to 
the effectiveness'' of pictorial cigarette warnings is their size 
(taking up at least 50 percent or more of the cigarette package), text 
that clearly describes the health effects of smoking accompanied by a 
color graphic that demonstrates such negative health consequences, and 
placement on the front of cigarette packages. Another comment states 
that ``[t]he scientific evidence conclusively shows that graphic health 
warnings are more effective than text-only warnings at increasing 
knowledge and public understanding of the health effects of smoking,'' 
and that ``[r]esearch also shows that size plays a key role in the 
effectiveness of graphic warnings--larger graphic health warnings are 
more effective. Warnings must be large enough to be easily noticed and 
read, and should be as large as possible.'' Similarly, another comment 
gives evidence to support the necessity of the warnings in their 
required size and location, explaining that ``[t]he size of a health 
warning has an important influence on its ability to communicate health 
information.'' This comment also explains that the size is necessary to 
include important detail depicting the negative health consequences of 
smoking, something research on health

[[Page 15665]]

warnings on cigarettes and other consumer products has demonstrated 
consumers seek, and which increases comprehension.
    Additionally, another comment from a group of health psychologists 
tested the impact of the proposed required warnings in their proposed 
size and location as compared to warnings using only the proposed 
textual warning statements without an image. That study reported that, 
compared to the text-only warnings, FDA's proposed required warnings 
rated higher on perceived new knowledge and understandability, 
providing further empirical support for the size of the required 
warnings. In addition, a comment submitted by another group of 
academics described an analysis of a longitudinal cohort survey data 
from 13 (non-U.S.) countries to assess changes in adult smokers' 
knowledge of the health effects of cigarettes before and after 
implementation of pictorial cigarette warnings. Pictorial cigarette 
warning size requirements and placement on the front and back of 
packages varied by country. Analysis provided by the comments concluded 
that pictorial cigarette warnings that are large and appeared on both 
the front and back of cigarette packs were more effective for 
increasing health knowledge.
    (Response 47) We agree with the comments stating that the size and 
location of the required warnings on cigarette packages and in 
cigarette advertisements are appropriate and necessary to advance the 
Government's interest of promoting greater public understanding of the 
negative health consequences of smoking, and that the communicative 
value of the size and location requirements also are amply supported by 
evidence (see previous comment response for additional references to 
this body of scientific literature). Moreover, as required by section 4 
of the FCLAA, as amended by the Tobacco Control Act, the required 
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 more fully in section V.A of the 
proposed rule, the existing Surgeon General's warnings have been shown 
to go unnoticed or to fail to convey relevant information regarding the 
health risks of smoking, resulting in significant portions of the 
population that misunderstand or underestimate the health risks of 
smoking. The new size and location of the required warnings, as 
specified by statute, are needed to increase the noticeability of the 
required warnings in order to promote greater public understanding of 
the negative health consequences of smoking. The remaining 50 percent 
of the principal panels of product packages and the remaining 80 
percent of product advertisements provide ample space for 
manufacturers' speech.
    (Comment 48) One comment asserts that FDA failed to meaningfully 
address the differential effect the proposed required warnings may have 
on specific subpopulations. The comment states that failure to consider 
subgroup differences in the consumer studies can potentially impact the 
effectiveness of cigarette health warnings. The comment also cites 
research purportedly showing that cigarette health warnings lead to 
unintended responses among vulnerable subpopulations. Other comments, 
however, provide general support for the potential impact of the 
required warnings on socially disadvantaged groups who may possess 
lower knowledge of the health risks of smoking due to lower health 
literacy and limited access to information about the hazards of 
smoking. These comments state that cigarette health warnings, paired 
with images, depicting the harms of smoking increase the accessibility 
of warnings and may help to reduce disparities in health knowledge 
about the harms of smoking among these disadvantaged groups.
    (Response 48) The purpose of FDA's two large quantitative consumer 
research studies was to assess whether new cigarette health warnings 
promote consumer understanding of the negative health consequences of 
smoking, not to understand the broad effects of the warnings on 
different populations. Although participants with various demographic 
and tobacco use statuses were included in the consumer research 
studies, the studies were not designed to examine differences in 
outcomes by those subgroups. The primary analyses focused on whether 
new cigarette health warnings increase understanding of the negative 
health consequences of smoking in the overall sample, and the findings 
support that conclusion. In exploratory subgroup analyses, findings 
were similar across subgroups, demonstrating the robustness of these 
findings.
    Regarding the comment's summary of the results of scientific 
studies that showed a number of differential effects cigarette health 
warnings may have on subpopulations that vary by demographic or tobacco 
use statuses, none of these studies examined whether cigarette health 
warnings have effects on understanding of the negative health 
consequences of smoking. Rather, these studies examined other outcomes, 
including emotional reactions to the warnings, effects on intentions to 
quit smoking and quit attempts, and whether the warnings deter 
cigarette purchase, among others. Those outcomes, however, are not 
aligned with the Government's interest in this rule, which is to 
promote greater public understanding of the negative health 
consequences of smoking. None of the scientific studies referred to in 
the comment provide direct evidence suggesting that cigarette health 
warnings have differential effects on consumer understanding of the 
negative health consequences of smoking among vulnerable 
subpopulations. On the contrary, as described in section V.B.2.c of the 
proposed rule, scientific evidence suggests that pictorial cigarette 
warnings increase understanding of the health consequences of smoking 
across diverse settings and countries and are effective for diverse 
populations (Refs. 15, 45, 50, and 94-99), likely reducing disparities 
found in consumer understanding about the harms of smoking for some 
populations such as those with lower health literacy. For example, a 
study of U.S. consumers found that pictorial cigarette warnings were 
considered to be more attention-grabbing and more credible compared to 
text-only warnings; these effects were consistently observed across all 
subgroups, including racial/ethnic minorities, those with lower levels 
of education, and those with lower SES (Ref. 100). We agree with the 
general comments supporting the importance of the proposed required 
warnings and that they may help reduce disparities in health knowledge.
    (Comment 49) Some comments assert that pictorial cigarette warnings 
do not promote greater understanding of the negative consequences of 
smoking. One comment cites research studies and asserts that these 
studies conclude that graphic warnings do not change people's beliefs 
about the harms of smoking.
    (Response 49) FDA disagrees that pictorial cigarette warnings do 
not promote greater understanding of the negative health consequences 
of smoking. There is a substantial body of evidence to support their 
effectiveness. As explained in section V.B of the proposed rule, to 
understand a message, individuals must first attend to the message 
(i.e., notice and be made aware of the message), and then they must 
process the information in the message (i.e., acquire knowledge of and 
learn that information) (Ref. 41). These processes contribute to 
engagement with

[[Page 15666]]

the message and lead to understanding. The important role of attention 
in message storing and processing is well supported by research (see, 
e.g., Ref. 101). Studies demonstrate that increasing notice of and 
attention to the information in a cigarette health warning promotes 
understanding of the message. Data from the International Tobacco 
Control Four Country Survey showed that noticing health warnings on 
cigarette packages was associated with increased knowledge about the 
health consequences of smoking (Ref. 4). Smokers who reported noticing 
the cigarette health warnings were more likely to report believing that 
smoking causes the specific health consequences contained in the 
warnings, compared to those who did not notice the warnings.
    The results of FDA's final consumer research study, outlined in 
more detail earlier in this section, also strongly support that 
pictorial cigarette warnings, including the final required warnings, 
improve understanding of the negative health consequences of smoking. 
Across almost all outcomes measured in the study, the cigarette health 
warnings demonstrated statistically significant improvements over the 
Surgeon General's warnings (i.e., the control condition in this study). 
This was true for all required warnings across the outcomes of new 
information, self-reported learning, thinking about the risks, 
perceived informativeness, perceived understandability, perceived 
helpfulness in understanding health effects, attention, and recall (see 
Ref. 17). All but 2 of the final required warnings (``harms children'' 
and ``COPD'' paired with an image of a man with an oxygen tank) also 
demonstrated statistically significant improvements over the Surgeon 
General's warnings on changes in health beliefs between Sessions 1 and 
2; and 7 of the final required warnings also demonstrated statistically 
significant improvements over the Surgeon General's warnings on changes 
in health beliefs between Sessions 1 and 3, approximately 17 days 
later. As noted in section VI.C.3 of the proposed rule, health beliefs 
may be unlikely to change with limited exposures, as was seen in FDA's 
first quantitative consumer research study (see Ref. 12), which 
measured outcomes based on a single exposure. For FDA's final 
quantitative consumer research study, which only included two 
exposures, statistically significant changes in health beliefs also 
were not expected. That the final study found statistically significant 
changes in health beliefs between Sessions 1 and 2 for most warnings 
tested, and that such changes persisted for an additional 2 weeks for 7 
of the warnings, demonstrates that even with limited exposure, the 
warnings still influenced study participants' beliefs about the 
negative health consequences of smoking. Another comment states, 
``[t]he high threshold for changing health beliefs after brief exposure 
to a health warning makes the findings of [FDA's final quantitative 
consumer research study] all the more remarkable: brief exposure to a 
graphic warning led to greater changes in health beliefs after 1-2 days 
for 11 out of 16 warnings, and for 7 out of 16 warnings at two-week 
follow up.''
    Finally, the comments cite studies that they assert show that 
pictorial cigarette warnings do not change people's beliefs about the 
harms of smoking. FDA has already acknowledged some of these studies in 
the proposed rule (see, e.g., Refs. 47, 102, and 103), and, as 
previously discussed, we believe that the failure for the pictorial 
cigarette warnings tested in those studies to impact health beliefs is 
partly (but not entirely) due to the high preexisting knowledge of the 
particular smoking harms found in the warnings used in those studies 
(e.g., many people are aware that smoking causes lung cancer). In 
addition, one comment cites a study (Ref. 104) that compared 
``aversive'' images of health effects of smoking to ``relatively mild'' 
images (e.g., wrinkled apple) to examine visual attention to the 
warnings, attitudes toward smoking, and quit intentions. That study 
focused on intentionally aversive images and measured attitudes and 
behavior, neither of which align with the design of FDA's images, the 
outcomes measured in FDA's consumer research study, or this rule. In 
part because the required warnings communicate some of the less-known 
and less-understood health harms of smoking, the required warnings are 
unlike those considered in the studies and will promote greater 
understanding. This view is supported by the findings of the final 
quantitative consumer study.
3. Qualitative Studies
    (Comment 50) FDA received several comments addressing the 
qualitative studies.\5\ Some comments suggest that the qualitative 
studies ``raise further questions about whether the proposed graphic 
health warnings will effectively improve public understanding of the 
health consequences of smoking.'' These comments also suggest that the 
qualitative study reports ``reinforce [the] position that the proposed 
warnings violate the First Amendment because . . . they appeal to 
viewers' emotions rather than conveying factual information and 
restrict far more speech than necessary.'' The comments point, in part, 
to certain statements from individual participants in the qualitative 
studies as evidence that the proposed required warnings being 
considered by FDA were confusing and misleading, and further argue 
that, by electing not to make the changes suggested by these individual 
commenters, FDA improperly ignored this evidence. The comments also 
point to individual statements regarding the scope of the warnings and 
argue that FDA ignored evidence that the proposed required warnings 
were broader than necessary. The comments also suggest that FDA failed 
to consider whether the proposed required warnings would remedy a real-
world harm. The comments also suggest that FDA violated the APA by not 
making the qualitative study reports available when the proposed rule 
first issued and by providing only 15 days for public comment on these 
materials.
---------------------------------------------------------------------------

    \5\ As discussed in section IV, the Agency supplemented the 
docket with qualitative study information and reopened the comment 
period for an additional 15 days (84 FR 60966).
---------------------------------------------------------------------------

    Other comments state that FDA's use of qualitative studies and 
related data was appropriate, noting that a key principle of 
qualitative research is that the analysis must look for patterns across 
responses, rather than rely on any one statement. One comment 
highlights that a potential pitfall with qualitative studies is to 
place ``too much emphasis on a single quote or comment that sparks 
interest,'' noting FDA avoided this by basing its decisions on the body 
of findings across the studies. Another comment notes that the 
qualitative studies outline the iterative, science-based process 
undertaken by FDA in which the findings from the qualitative studies 
were used to inform the development and refinement of the warnings 
tested in subsequent quantitative studies.
    (Response 50) We agree that our use of qualitative studies was 
appropriate. As we discussed in the proposed rule and earlier in this 
section, FDA conducted various qualitative focus groups and interviews 
to test and refine the textual warning statements and images and to 
obtain feedback on which pairings of textual warning statements and 
images should be selected for further study. These qualitative studies 
are based on small sample sizes, are not nationally representative, and 
do not yield data that can be generalized. The intent behind conducting 
these qualitative studies was primarily to

[[Page 15667]]

explore and inform subsequent research. We disagree that a 
determination to not make every change suggested by individual 
qualitative study participants--which, in some cases, may have rendered 
the required warnings factually inaccurate--concedes that FDA ``ignored 
evidence that the proposed warnings were confusing and misleading.'' 
FDA did not originally include the qualitative study reports in the 
docket as the rulemaking itself did not directly rely on these studies. 
However, because the qualitative studies were used to inform further 
research and development, namely, the quantitative consumer research 
studies, FDA has made these additional materials available as well. We 
addressed the APA concern earlier in this document (see section 
IV.D.4). And, as we discuss in detail in sections IV and VII, we 
disagree that the required warnings violate the First Amendment.

VII. FDA's Selection of Cigarette Health Warnings

    This section discusses the 11 required warnings and the factors 
that influenced each selection decision, including the results from 
FDA's final quantitative consumer research study, the substantive 
comments submitted to the docket, the relevant scientific literature, 
and other legal and policy considerations weighed, such as how well the 
warnings depict the negative health consequences of smoking.
    When we issued the proposed rule, we proposed 13 cigarette health 
warnings, each comprising a textual warning statement paired with a 
concordant photorealistic image depicting the negative health 
consequences of smoking. The 13 proposed required warnings were made 
available as electronic files in PDF format and displayed in the 
document entitled ``Proposed Required Cigarette Health Warnings--PDF 
Files, August 2019,'' which was included in the docket for the proposed 
rule. Consistent with section 4 of the FCLAA, two versions of each of 
the 13 proposed required warnings were developed--one displaying the 
textual warning statement in black font on a white background, and one 
displaying the textual warning statement in white font on a black 
background.
    In order to determine which of the proposed cigarette health 
warnings to require in the final rule, we considered a number of 
factors, including the results from our final consumer research study 
(Ref. 17; see section VI.A for a general description of the study 
results). We carefully examined the research results for the 13 
proposed required warnings on all the different study outcomes, and we 
provide a discussion of those outcomes for each of the required 
warnings later in this section. As discussed elsewhere in this 
preamble, based on the results of our consumer research studies, and 
the existing scientific literature on cigarette health warnings, we 
conclude that the 11 final required warnings will advance the 
Government's interest of promoting greater public understanding of the 
negative health consequences of smoking.
    We also considered the substantive public comments received in the 
docket related to FDA's approach to developing and testing new 
cigarette health warnings, including the results of our consumer 
research studies. We considered comments received in the docket that 
suggested that we use other text or images in the required warnings; 
however, as discussed in more detail in the comment summaries below and 
in section VIII, we selected the required warnings from the set of 
cigarette health warnings we developed, tested, and proposed. Our 
consumer research studies, among other information, indicate that these 
required warnings will promote greater public understanding of the 
negative health consequences of smoking. As explained in the comment 
responses throughout this section, the comments submitted to the docket 
did not persuade us that other textual warning statements or images had 
sufficient support to demonstrate they would advance the Government's 
interest in promoting greater public understanding of the negative 
health consequences of smoking.

A. General Comments on the Proposed Cigarette Health Warnings

    FDA received several comments on the 13 proposed required warnings. 
Some comments discuss the 13 proposed required warnings generally, and 
we have summarized and responded to these comments in this section. The 
comments relating to each individual proposed required warning are 
discussed in sections VII.B and VII.C.
    We considered the comments submitted to the docket as we determined 
which cigarette health warnings to require in the final rule. We 
evaluated the substantive input contained in the comments to help 
inform our decisions in selecting or not selecting a proposed cigarette 
health warning. Many of the comments contain information about the 
submitter's personal opinions related to various proposed warnings. 
While this information is helpful in understanding how some individuals 
might interpret various warnings and in raising issues for further 
exploration, this type of qualitative information is not as useful as 
quantitative assessments of the outcome measures related to increasing 
understanding, such as the evaluation provided in FDA's final consumer 
research study (Ref. 17).
    In addition, we received a number of comments regarding our 
consumer research studies; these comments are summarized in section VI.
1. Comments Submitting Research on FDA's Proposed Required Warnings
    We received some comments that described the results of scientific 
investigations that the submitters had conducted to evaluate the 13 
proposed required warnings on various outcomes. We address that 
research and our responses to these comments in the comment summaries 
and responses below.
    (Comment 51) One comment, representing a group of academic 
researchers, provides information on an experimental study conducted to 
evaluate responses to the 13 proposed required warnings in comparison 
to text-only equivalents among a convenience sample of 412 U.S. adult 
cigarette smokers, dual e-cigarette users and smokers, and nonusers of 
e-cigarettes and cigarettes. The reported findings include that: (1) 
Most of the proposed cigarette health warnings enhanced 
understandability, perceived new knowledge, worry, and discouragement 
to smoke relative to text-only warnings; (2) the proposed cigarette 
health warnings varied in their relative impact in eliciting perceived 
new knowledge, worry, and discouragement to smoke compared to text-only 
versions; and (3) effects of the proposed cigarette health warnings 
were generally stronger for nonusers and dual users (i.e., those who 
both smoke cigarettes and use e-cigarettes) than for smokers, which the 
comments state were generally consistent with their previous work with 
young adults (Ref. 105). The comments conclude that these results are 
consistent with prior work on cigarette health warnings suggesting that 
such warnings enhance knowledge about the harms of smoking and evoke 
reactions that are associated with quitting smoking.
    (Response 51) FDA appreciates the submission of this study using 
FDA's proposed required health warnings that demonstrates additional 
support for the ability of the proposed required warnings to enhance 
public understanding of the negative health

[[Page 15668]]

consequences of smoking as compared to text-only versions of the 
warnings. We note that one outcome included in the study referred to as 
``perceived new knowledge'' is very similar to the outcome used in 
FDA's consumer research study referred to a ``self-reported learning'' 
and shows similarly strong effects on that outcome as in FDA's study. 
In addition, perceived new knowledge was the strongest effect of all 
the outcomes in the study, including worry and discouragement to use 
cigarettes. Overall, the study's conclusions are supported by the data 
presented, but there are some minor limitations in the design and 
measures that may limit generalizability to prior work and the general 
U.S. population. In addition, FDA notes that an assessment of emotional 
responses or behavioral study outcomes is not aligned with the final 
rule, whose purpose is to promote greater public understanding of the 
negative health consequences of smoking.
    (Comment 52) Another comment from a cigarette manufacturer includes 
the findings of a web-based panel, created using a convenience sample, 
stating that the study serves as evidence that the required warnings 
were designed to evoke emotional negative reactions; were meant to 
convey an ideological anti-smoking message; and were not the less-
restrictive alternative, as the study's findings purportedly show that 
textual warnings would be at least as effective as pictorial cigarette 
warnings. In the study, adult participants were randomly assigned into 
one of six conditions that varied in format, size, and location (e.g., 
a text-plus-image warning on the top 50 percent of the package, a text-
only warning on the top 20 percent of the package, a text-plus-image 
warning on the side of the package). Participants were shown a random 
selection of 5 of FDA's 13 proposed required warnings. Afterward, 
participants completed measures assessing agreement with the warning, 
if they had previously heard about the health effects described in the 
warning, if they thought the warnings were communicating that they 
should or should not use or purchase the product, and what message the 
warnings communicated. The comment's study found that, for warnings in 
the proposed size and location (top 50 percent of the front and rear 
panels of the package), between 18.9 and 65.1 percent of participants 
had not previously heard about the health condition in the warnings; 
the vast majority of participants (greater than 76.0 percent) agreed 
with the warning statements; and that many of the results were not 
different depending on the size and placement of the warnings on 
packages. The comment notes that the data show that many smokers in 
this study indicated that the warnings convey a message that they 
should not smoke (74 percent) or purchase the product (71 percent). The 
comment also reports that many smokers in this study believed the 
warnings are trying to make people feel disgusted (68 percent), shock 
people (85 percent), and make people feel distress (70 percent).
    (Response 52) We appreciate the value of additional research on the 
potential impact of FDA's proposed required warnings, but we note that 
many of the outcomes assessed in this study relate to behavior and are 
not aligned with the final rule, whose purpose is to promote greater 
public understanding of the negative health consequences of smoking. 
The study also suffers from numerous limitations on the conclusions 
that can be drawn about the ability of the required warnings to promote 
public understanding of the negative health consequences of cigarette 
smoking. The limitations include that it is unclear whether each set of 
five warnings viewed by each participant was displayed in the same 
format size and location, which prevents us from drawing conclusions 
about the impact of size, location, and specific required cigarette 
warnings on outcomes relevant to understanding. Other limitations 
include a lack of information provided regarding sample recruitment; 
total sample size; study drop-out and attrition; and limited 
information about the sample characteristics beyond age and current 
smoking status. Although the comment states that the demographics of 
the sample were drawn to reflect the U.S. population, there is no 
discussion of whether the data were weighted to the U.S. population or 
whether the attempt to match the U.S. population was successful. While 
the comment includes a description of the study with some descriptive 
measures (e.g., an appendix to the study includes the proportions), 
there is no information provided regarding confidence intervals or 
standard error; therefore, we are unable to determine the accuracy of 
the study's results (Refs. 106 and 107). Further, no information was 
provided as to whether there was adequate power to detect statistically 
significant differences between groups. It is unclear whether the null 
findings found for the effect of warnings compared to warnings with 
different formats is attributed to an actual lack of an effect of the 
cigarette health warnings or a lack of sufficient power to detect such 
effects (Refs. 108-110). Responses to one question only present results 
for 384 of the unknown total number of participants without providing 
information on participants who did not have an opinion on the 
question. The comment also did not provide information about the 
tobacco use status (e.g., never user, former user) of half of the 
sample, which limits the applicability of any findings. Details were 
not provided about the control condition, there was no image provided 
of the stimuli used in that condition, and no data were provided 
comparing the control condition to experimental conditions. Of 
particular concern, it is not clear if survey items were drawn from 
previously validated or previously used surveys, which would lend 
credibility to the items used and reduce the potential for measurement 
error.
2. Other Comments
    FDA received a number of other comments that discuss the proposed 
required warnings generally or highlighted issues that applied to some 
or all of the proposed required warnings. These comments are summarized 
and responded to below.
    (Comment 53) Numerous comments express strong support for the 
proposed required warnings stating, in part, that each of the required 
warnings convey factual information. Comments support the 13 proposed 
warnings, stating that the proposed warnings cover a wide range of 
highly prevalent health conditions and that the health conditions are 
supported by a broad consensus of scientific research and Surgeon 
General's Reports. Other comments state that the images effectively 
capture attention without provoking an emotional response and the 
textual warning messages are brief, accurate, and clearly link to the 
visual image.
    Some comments express support for the use of strong causal language 
such as ``causes,'' providing supporting scientific evidence in the 
required warnings, with one comment submitting a published scientific 
study of 1,413 adults in the United States (Ref. 111). One of these 
comments, which was submitted by a group of research scientists, 
confirms that the characteristics of FDA's proposed warnings suggest 
they will be effective. This comment states that FDA's proposed 
required warnings followed design principles and best practices in 
warning development that enhance their effectiveness, as follows: The 
warnings include human faces or diseased body parts (which, the comment 
notes, studies show are more effective than

[[Page 15669]]

other types of images); the warnings have a high degree of congruency 
(which, the comment notes, studies show increase recall and attention); 
the warnings use strong causal language; and that the warnings are 
concise, making the warning text easier to read and understand. Another 
comment from a group of scientific researchers emphasizes that the 
proposed warnings generally appear to contain congruent image and 
textual components (i.e., both the image and the textual warning 
statement convey the same message), noting this format (congruent 
warning labels) is likely to be an effective means for increasing 
knowledge of the risks conveyed by the warnings.
    (Response 53) We agree with these comments. As we describe in 
sections VI and VII of the proposed rule and in this section, these 
cigarette health warnings, as shown through robust scientific evidence, 
are factual and accurate and advance the substantial Government 
interest in promoting greater public understanding of the negative 
health consequences of smoking. FDA agrees that simple phrasing and the 
use of strong causal language in the textual warning statements is 
justified both by the strength of the epidemiological evidence and 
communication best practices.
    (Comment 54) Two comments criticize nearly all the proposed 
required warnings for not identifying, conveying, or measuring 
perceptions of the baseline risk for the health conditions in the 
proposed required warnings. They also suggest that the absolute risk of 
these conditions for smokers is small and that the warnings do not 
convey the marginal or dose-response risk of these conditions caused by 
smoking, but instead misleadingly imply that the health outcomes are 
solely caused by smoking. The comments also state that certain warnings 
are misleading because they emphasize one negative health consequence 
rather than others with worse survival rates.
    (Response 54) As described in section VII of the proposed rule, the 
burden of the health conditions focused on in the required warnings is 
substantial, and all of these health conditions are causally linked to 
smoking through substantial scientific evidence as summarized in 
various reports of the Surgeon General. Contrary to the comments' 
assertion, nothing in the warning text or image conveys that smoking is 
the only causal factor (i.e., a necessary condition), nor have the 
comments provided any evidence to support that point. However, for many 
of the required warnings, smoking is one of the strongest, if not the 
strongest, causal factors. For example, cigarette smoking has 
repeatedly been identified as the most important risk factor for 
bladder cancer (Refs. 112-114). The National Heart, Lung, and Blood 
Institute of the National Institutes of Health states that smoking is a 
major risk factor for heart disease (Ref. 115), and the Centers for 
Disease Control and Prevention (CDC) states that smoking is one of the 
three key risk factors for heart disease (Ref. 116). FDA strongly 
disagrees that lack of communication about multifactorial causes of a 
disease in any way means that warnings that accurately state that 
smoking causes a negative health consequence are misleading.
    The comment is correct that the marginal risk of disease 
attributable to smoking is not communicated as part of the warnings and 
thus that information is not assessed in FDA's consumer research 
studies. As stated in the documents related to collecting the 
quantitative information in FDA's consumer research studies (OMB 
control numbers 0910-0848 and 0910-0866) and section VI of the proposed 
rule, FDA's goal in the consumer research studies was to assess 
knowledge and understanding of a negative health outcome caused by 
cigarette smoking, not to educate the public about the absolute, 
relative, or dose-response risk conveyed by smoking. Thus, the outcomes 
included in FDA's consumer research studies were not intended to assess 
the absolute or relative level of perception of such risks, but rather 
investigated the effect that viewing the textual warning statements or 
proposed required warnings had on increasing understanding of the 
negative health consequences of cigarette smoking.
    (Comment 55) One comment states that some of the proposed required 
warnings do not convey any relevant information beyond the content 
found in the TCA statements. In one example highlighted, the comment 
states that the required warning ``WARNING: Smoking can cause heart 
disease and strokes by clogging arteries'' conveys the exact same 
information as the TCA statement ``WARNING: Cigarettes cause strokes 
and heart disease,'' asserting that granular information about disease 
mechanism does not promote understanding about the health risks of 
smoking. In another example, the comment argues that the required 
warning ``WARNING: Smoking causes head and neck cancer'' conveys the 
same information as the TCA statement ``WARNING: Cigarettes cause 
cancer.''
    (Response 55) FDA disagrees with both comments that some of the 
required warnings do not convey any relevant information beyond the 
content found in the TCA statements and with the conclusion that 
information about disease mechanism does not affect the public's 
understanding of the risks of smoking. For example, the required 
warning ``WARNING: Smoking can cause heart disease and strokes by 
clogging arteries'' conveys important information relevant to numerous 
smoking health harms: smoking causes heart disease; smoking causes 
strokes; smoking causes clogged arteries; and smoking causes heart 
disease and strokes by clogging arteries. Accordingly, all components 
of the required warnings, including the information related to the 
disease mechanism, increases public understanding of the negative 
consequences of smoking.
    FDA also disagrees with the conclusion that providing additional 
information relevant to the disease (e.g., ``WARNING: Smoking causes 
head and neck cancer'') does not improve consumer understanding above 
related TCA statements (e.g., ``WARNING: Smoking causes cancer''). The 
heterogenous term ``cancer'' refers to a collection of related yet 
unique diseases. In this example, the required warning would promote 
understanding of the causal link between smoking and two different and 
specific cancers: Head and neck. As discussed in section V.A.3 of the 
proposed rule, the U.S. public is generally aware of the effects of 
smoking on lung cancer in smokers, while research demonstrates that the 
public has limited understanding of the effect of smoking on cancers 
outside of lung cancer. Finally, results of FDA's consumer research 
studies support that consumers both understand the required warnings 
and learn new information from them specifically because of the 
specificity of the warning used.
    (Comment 56) Some comments suggest that FDA strengthen the images 
by making them ``less glamourous,'' more ``gross,'' or more 
``shocking'' to be more in line with pictorial cigarette warnings used 
in other countries. One comment highlights existing research 
demonstrating that pictorial cigarette warnings that include ``graphic, 
fear-arousing depictions of the impact of smoking on the body or those 
that use testimonial are associated with increases in motivation to 
quit smoking, thinking about health risks, and engaging in cessation 
behavior'' (Ref. 117). Another comment suggested that use of a 
testimonial or image similar to ``Christine'' from CDC's ``Tips from 
Former Smokers'' campaign would likely evoke a much stronger emotional

[[Page 15670]]

response. Other comments address levels of arousal, with one comment 
recommending FDA drop warnings containing images with ``less arousing 
images [as they] will not support lasting knowledge of the associated 
health effects.'' One comment states that the images in the proposed 
required warnings are ``adequately arousing,'' citing research that 
shows that arousal in cigarette health warnings ``acts as information 
itself, a motivator, and an enhancer of information'' (Ref. 118) and 
that ``arousal is important for the long-term memory of the information 
the FDA wishes to convey'' (Ref. 119). Some comments, however, object 
that FDA designed the new cigarette health warnings to evoke a negative 
emotional response and that ``forcing'' consumers to look at the 
proposed required warnings ``evokes feelings of fear, shame, and 
disgust, and conveys the ideological message that people should not 
smoke.'' These comments also object that the proposed required warnings 
are not purely factual.
    (Response 56) FDA disagrees that the images should be made more 
``gross'' or ``shocking,'' and we also disagree that FDA designed the 
required warnings to evoke an emotional response. The images were not 
designed to evoke negative emotions such as fear, shame, and disgust, 
but rather to promote greater public understanding of the negative 
health consequences of cigarette smoking. As detailed in section VI.D 
of the proposed rule, FDA undertook a rigorous multistep process to 
develop, test, and refine images that: (1) Are factually accurate; (2) 
depict common visual presentations of the health conditions (intended 
to aid understanding by building on existing consumer health knowledge 
and experiences) and/or show disease states and symptoms as they are 
typically experienced; (3) present the health conditions in a realistic 
and objective format that is devoid of non-essential elements; and (4) 
are concordant with the accompanying text statements on the same health 
conditions. The images are not intended to evoke negative emotions such 
as fear, shame, and disgust, but rather to promote greater public 
understanding of the negative health consequences of cigarette smoking. 
Each of the 11 required warnings in the final rule depicts a negative 
health consequence of smoking that is well documented in the scientific 
literature. To be sure, some viewers may experience the information 
contained in the images--which appropriately convey the serious health 
consequences in a factually accurate, realistic manner--as concerning; 
but to the extent this occurs, it will be because the severe, life-
threatening and sometimes disfiguring health effects of smoking are 
indeed concerning.

B. Selected Cigarette Health Warnings

    This section discusses the 11 required warnings and the factors 
that influenced each selection decision, including the results from 
FDA's consumer research studies, relevant scientific literature, the 
substantive comments received to the docket, and other legal and policy 
considerations weighed. Based on these considerations, FDA has 
determined that the 11 required warnings included in the final rule 
will advance the Government's interest in promoting greater public 
understanding of the negative health consequences of cigarette smoking. 
As discussed in section VI.A of the proposed rule, the causal link 
between cigarette smoking and the negative health consequences depicted 
in each required warning is rated at the highest level of the four-
level classification provided in the Surgeon General's Reports.
    As described in section VI of the proposed rule, FDA undertook a 
science-based, iterative research and development process to develop, 
test, and refine new cigarette health warnings that will advance the 
Government's interest in promoting greater public understanding of the 
negative health consequences of cigarette smoking. This careful, 
science-based process resulted in the 11 required warnings that are the 
subject of the final rule. First, FDA undertook research to consider 
whether revisions to the textual warning statements specified in 
section 4(a)(1) of the FCLAA would promote greater public understanding 
of the risks associated with cigarette smoking. The empirical results 
demonstrate sufficient scientific support to adjust the textual warning 
statements (Ref. 12). Second, FDA carefully developed and tested 
concordant color graphics, in the form of photorealistic images, 
depicting the negative health consequences of smoking to accompany each 
of the textual warning statements. In FDA's final consumer research 
study, full cigarette health warnings--consisting of a textual warning 
statement paired with a concordant photorealistic image depicting the 
negative health consequence in the statement--were evaluated to assess 
the extent to which any of the warnings increase understanding of the 
negative health consequences of cigarette smoking. For warnings to be 
considered for the proposed rule, FDA decided that a warning tested in 
the final consumer research study must demonstrate statistically 
significant improvements, as compared to the control condition (i.e., 
the Surgeon General's warnings), on both the two outcomes of ``new 
information'' and ``self-reported learning.''
    In the proposed rule, we stated that, after considering the full 
results of FDA's research, the relevant scientific literature, public 
comments submitted to the docket, and other legal and policy 
considerations, FDA intended to finalize some or all of the 13 proposed 
cigarette health warnings. Based on the empirical results of FDA's 
research program, as well as our consideration of each of the factors 
discussed in this section, FDA is including the following 11 required 
warnings in the final rule. Because these required warnings, as shown 
through the robust scientific evidence described in detail in sections 
VI and VII of the proposed rule, are factual and accurate, advance the 
Government's interest in promoting greater public understanding of the 
negative health consequences of cigarette smoking, and are not unduly 
burdensome (see section IV.B for a more detailed discussion), FDA 
believes the required warnings are consistent with the First Amendment, 
regardless of the standard of scrutiny (e.g., Zauderer or Central 
Hudson) under which they are reviewed.
    The required warnings, each of which consists of a textual warning 
statement paired with a concordant photorealistic image depicting the 
negative health consequences of smoking, are contained in a document 
entitled ``Required Cigarette Health Warnings, 2020'' (Ref. 11), as is 
further discussed in section III.B.
    With regard to the photorealistic images contained in the required 
warnings, and as described in section VI.D of the proposed rule, FDA 
undertook a rigorous multistep process to develop, test, and refine 
images that: (1) Are factually accurate; (2) depict common visual 
presentations of the health conditions (intended to aid understanding 
by building on existing consumer health knowledge and experiences) and/
or show disease states and symptoms as they are typically experienced; 
(3) present the health conditions in a realistic and objective format 
that is devoid of non-essential elements; and (4) are concordant with 
the accompanying text statements on the same health conditions.
    FDA considered many different factors when developing the warning 
images, including current public understanding and gaps in knowledge of 
the negative health consequences of

[[Page 15671]]

cigarette smoking; the varied levels of health literacy and numeracy 
among the U.S. population; findings from communication science research 
regarding the types of visual depictions that are most appropriate for 
communicating health risk information to lay audiences; general best 
practices for developing mass communication efforts; the Agency's 
statutory requirements for cigarette health warnings under section 4 of 
the FCLAA (as amended by sections 201 and 202 of the Tobacco Control 
Act); and the practical implications of visually depicting the negative 
health consequences of cigarette smoking in the form of warnings on 
cigarette packages and in advertisements.
    As a form of mass communication, cigarette health warnings must 
feature messages that are appropriate for the target audience, 
communication channel, and public health goals. In section VI of the 
proposed rule, we described the process for developing and testing the 
required cigarette warnings in detail, outlining the health 
communication science research findings we considered when determining 
how best to help promote greater public understanding of the negative 
health consequences of cigarette smoking. For example, the American 
public is a diverse population comprising individuals with many varied 
backgrounds, knowledge, beliefs, and abilities to read and understand 
health information. In fact, national surveys indicate that only about 
12 percent of U.S. adults have proficient health literacy (i.e., the 
ability to access, understand, and use health information and services) 
and fewer than 10 percent have proficient numeracy levels (i.e., the 
ability to understand and use numbers, including the ability to read 
and interpret data presented in tables, graphs, and bar charts (Refs. 
120-123). Considering these differences in health literacy and numeracy 
levels, as well as additional factors such as the limited amount of 
space for additional explanatory text and graphics and the constraints 
of a one-way communication channel, attempting to convey complex 
information such as quantitative risk measures would be incongruent 
with the Government's interest of increasing public understanding of 
the negative health consequences of cigarette smoking. Instead, best 
practices for health risk communication state that simple, clear, and 
direct messages are best understood, especially for those with low 
health literacy and numeracy.
    Further, given the need to visually depict the content of the 
required warning's textual warning statements with concordant, 
factually accurate color graphics that promote greater understanding of 
the health consequences as described by the text, the majority of 
images appropriately depict external symptoms and disease states. FDA 
hired a certified medical illustrator to develop--in close 
collaboration with FDA staff--the high-quality, factual, medically 
accurate, photorealistic images. As explained in section VI.D of the 
proposed rule, FDA determined that photorealistic illustrations would 
be the most appropriate visual depiction format because this format 
best allowed depicting specific features of the health conditions as 
described by the textual warning statements. The photorealistic 
illustration format also facilitated providing factually accurate 
images that depict common presentations of the health conditions in a 
realistic and objective format devoid of non-essential elements. Using 
photorealistic images also allowed further editing and refinements for 
clarity and ease of understanding throughout the science-based, 
iterative research and development process for new cigarette health 
warnings.
    The photorealistic images in these required warnings present the 
health conditions in a realistic and objective format, do not contain 
additional unnecessary details, and do not contain any elements 
intended to evoke a negative emotional response. Because these warnings 
are designed to educate the public about the very real, serious, and 
sometimes deadly outcomes of cigarette smoking, the factually accurate 
content may evoke subjective, emotional responses among some consumers 
based on their personal history and personality characteristics. See 
section IV.C.2.b for a discussion of comments on this topic.
    In this section's discussion of the results from our final consumer 
research study for each required warning, a study effect with an 
associated p-value below 0.05 (or p<0.05) is considered to be a 
``statistically significant'' effect. A p-value is reflective of the 
probability that a study finding could have happened by chance. For 
example, a p-value of 0.04 means that if there was no true study 
effect, the observed finding would still be obtained in 4 percent of 
studies due to chance. Having a predetermined cut off at p<0.05 is a 
commonly used level to conclude the effect has a very low likelihood of 
being due to chance. In our analyses, we also use additional 
statistical controls (Refs. 124 and 125) to account for the number of 
different statistical tests computed across all warnings for all 
outcomes. With an increased number of statistical tests performed, more 
findings could happen by chance alone. Controlling for this helps to 
produce estimates of statistical significance that are more 
conservative and produce higher confidence in the results. The full 
description of our final consumer research study and the analyses are 
contained in the final, peer-reviewed study report (Ref. 17).
    We describe each of the required warnings next, along with a 
summary of comments received and FDA's responses.
1. ``WARNING: Tobacco smoke can harm your children.''
    This required warning consists of the TCA statement ``WARNING: 
Tobacco smoke can harm your children'' paired with a concordant, 
factually accurate, photorealistic image depicting a negative health 
consequence of secondhand smoke exposure in children. The image shows 
the head and shoulders of a young boy (aged 8-10 years) wearing a 
hospital gown and receiving a nebulizer treatment for chronic asthma 
resulting from secondhand smoke exposure.
    In FDA's final consumer research study, this warning was reported 
to be new information by 40.7 percent of participants who viewed it. In 
section VI of the proposed rule, we explained that the two outcomes of 
``new information'' and ``self-reported learning'' are predictive of 
whether new cigarette health warnings increase understanding of the 
risks associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 61.6 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (83.1 percent) perceived the warning to be 
factual, a result that was not statistically different from the Surgeon 
General's warnings. Despite the strong results on nearly all

[[Page 15672]]

other measures includes in the study, this warning did not show 
statistically significant improvements in health beliefs either between 
Sessions 1 and 2 or between Sessions 1 and 3 over the changes in 
participants who viewed the Surgeon General's warnings, which is not 
surprising given the relatively brief exposure to the warning. Full 
details of the results for this warning in FDA's final consumer 
research study are available in the study's final report (Ref. 17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 57) Multiple comments support the inclusion of this 
warning in the final rule, with one comment emphasizing the importance 
of messages that reinforce the causal link between secondhand smoke 
exposure and negative health outcomes in children (e.g., impaired lung 
function, asthma and respiratory illnesses, sudden infant death 
syndrome, other preventable childhood illnesses).
    (Response 57) We agree that this cigarette health warning is 
important, focuses on a serious health risk of smoking, and will 
promote greater public understanding of the negative health 
consequences of smoking.
    (Comment 58) Some comments object to this warning because they 
assert it is inaccurate and misleading in a number of respects. One 
comment questions the epidemiological evidence used to support this 
warning, stating that the evidence does not support the causal 
relationship between parental secondhand smoke and either ``chronic 
asthma'' or asthma attacks in children ``requiring nebulizer 
treatment.'' Another comment states that the image does not convey 
purely factual information because ``[n]o reasonable consumer would be 
able to determine from the image'' that the child depicted has chronic 
asthma from secondhand smoke exposure or is receiving a nebulizer 
treatment. Rather, the comment states that the child's appearance and 
the mask over the child's face ``suggest only that the child is 
experiencing a medical emergency that requires receipt of oxygen.'' 
Some comments assert that the proposed warning is ``ambiguous,'' 
because it appears to depict the administration of oxygen following an 
asthma attack, and is an ``exaggerated'' or ``worst case scenario'' 
treatment for an asthma attack, because it is uncommon for a child with 
an asthma attack to require oxygen or to be hospitalized. One comment 
states that the text and image are not concordant, because the general 
description of a child suffering harm is not clarified by the picture, 
and the ``ambiguity regarding the harm at issue adds to the fear and 
confusion a consumer would experience when viewing the warnings.'' 
Finally, one comment states that the proposed warning ``seeks to 
advance FDA's anti-smoking message'' by evoking an emotional response 
in consumers, because adults viewing the image would be ``horrified at 
the thought of inflicting such harm on their children.''
    (Response 58) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in section 
VI of the proposed rule, FDA undertook a rigorous, multistep process to 
develop, test, and refine the textual warning statement, accompanying 
image, and the overall warning.
    The textual warning statement ``WARNING: Tobacco smoke can harm 
your children'' is factually accurate. Tobacco smoke exposure in 
children is causally linked to numerous negative health consequences, 
including several respiratory illnesses (Refs. 3 and 126). As stated in 
section VII.A.1 of the proposed rule, the 2006 Surgeon General's Report 
on the health effects of involuntary exposure to tobacco smoke 
concludes that ``the evidence is sufficient to infer a causal 
relationship between secondhand smoke exposure from parental smoking 
and lower respiratory illnesses in infants and children''; ``the 
evidence is sufficient to infer a causal relationship between parental 
smoking and cough, phlegm, wheeze, and breathlessness among children of 
school age''; ``the evidence is sufficient to infer a causal 
relationship between parental smoking and ever having asthma among 
children of school age''; and ``the evidence is sufficient to infer a 
causal relationship between secondhand smoke exposure from parental 
smoking and the onset of wheeze illnesses in early childhood'' (Ref. 
126). The report also concludes that ``the evidence is sufficient to 
infer a causal relationship between maternal smoking during pregnancy 
and persistent adverse effects on lung function across childhood'' and 
``the evidence is sufficient to infer a causal relationship between 
exposure to secondhand smoke after birth and a lower level of lung 
function during childhood.'' As noted in the proposed rule, more recent 
studies also support these same conclusions (see, e.g., Ref. 127).
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. The child has features consistent with chronic asthma 
(e.g., ``allergic shiners'' under the eyes), is wearing a hospital 
gown, and is holding a nebulizer mask. Tobacco smoke exposure can cause 
children who already have asthma to experience more frequent and severe 
asthma attacks (Ref. 126). A retrospective review of hospital-based 
data examining secondhand smoke exposure and asthma severity among 
children with asthma presenting to the pediatric emergency department 
(PED) showed more severe presentation and greater resource utilization 
in the PED for secondhand smoke-exposed children (Ref. 128). 
Additionally, a systematic review found that children with asthma and 
secondhand smoke exposure are nearly twice as likely to be hospitalized 
with asthma exacerbations compared to children with asthma but without 
secondhand smoke exposure (Ref. 129). Further, acute asthma 
exacerbations can be severe and may necessitate treatment, including 
nebulizer treatment, in an emergency department or an inpatient 
setting. Therefore, this image depicts a factually accurate, common 
visual presentation of the health condition and shows the disease state 
as it is typically experienced.
    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. The textual warning statement 
explains that tobacco smoke can harm children. The accompanying 
concordant and factually accurate image depicts a child who has been 
harmed by tobacco smoke exposure. As stated in the preceding paragraph, 
it is not rare or atypical for children with chronic asthma resulting 
from secondhand smoke exposure to receive nebulizer treatments in 
either an emergency department or inpatient setting. Because the 
required warning contains the textual warning statement and image 
paired together, the image aids in understanding the negative health 
consequence that is the focus of the textual warning statement, and 
vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image presents the health condition 
in a realistic and objective format, does not contain additional 
unnecessary details (e.g., hospital room setting, other medical 
equipment), and does not contain any elements intended to evoke a 
negative emotional response.
    2. ``WARNING: Tobacco smoke causes fatal lung disease in 
Nonsmokers.''
    This required warning consists of the TCA statement ``WARNING: 
Tobacco smoke causes fatal lung disease in nonsmokers'' paired with a 
concordant, factually accurate, photorealistic image

[[Page 15673]]

depicting fatal lung disease. The image shows gloved hands holding a 
pair of diseased lungs containing cancerous lesions from chronic 
secondhand smoke exposure.
    In FDA's final consumer research study, this warning was reported 
to be new information by 41.9 percent of participants who viewed it. In 
section VI of the proposed rule, we explained that the two outcomes of 
``new information'' and ``self-reported learning'' are predictive of 
whether new cigarette health warnings increase understanding of the 
risks associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 66.7 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (77.5 percent) perceived the warning to be 
factual, a result that was statistically significantly lower than the 
control condition. Participants who viewed this warning showed 
statistically significant improvements in their health beliefs between 
both Sessions 1 and 2 and Sessions 1 and 3 as compared to the changes 
in participants who viewed the Surgeon General's warnings. Full details 
of the results for this warning in FDA's final consumer research study 
are available in the study's final report (Ref. 17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 59) Some comments object to this warning because they 
assert it is inaccurate and misleading. For example, one comment states 
the image does not convey purely factual information because it does 
not clarify the types of lung disease nonsmokers may experience, and it 
is not clear that a layperson would understand that the lungs are 
diseased and contain cancerous lesions.
    Some comments also state that the illustration does not accurately 
depict the lungs of ``the rare never smoker who suffers from fatal lung 
disease due to secondhand smoke'' and that the lungs ``do not look like 
a non-smoker's lungs'' due to the amount of pigmentation and the 
appearance of the lesions on the lungs (i.e., because such lesions 
would not appear on the surface of the lung and it would be unusual to 
have three separate lesions of the size depicted). The comments also 
suggest that FDA acknowledges in the proposed rule that the lung 
depicted is similar to the lungs of a smoker with COPD.
    Another comment suggests that the warning is misleading because it 
emphasizes a condition that is less prevalent than other smoking-
attributable health conditions. This comment also suggests that the 
proposed warning ``seeks to advance FDA's anti-smoking message'' by 
evoking an emotional response in consumers because the image of 
``blood-covered hands holding bloody diseased lungs from a deceased 
individual is intended to shock and disturb viewers with its goriness 
or to generate fear about the prospect of death and having one's lungs 
removed postmortem.''
    (Response 59) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in the 
proposed rule, FDA undertook a rigorous, multistep process to develop, 
test, and refine the textual warning statement, accompanying image, and 
the overall warning.
    The textual warning statement ``WARNING: Tobacco smoke causes fatal 
lung disease in nonsmokers'' is factually accurate. As stated in the 
proposed rule, the 1986 and subsequent Surgeon General's Reports have 
confirmed the causal link between secondhand smoke exposure and lung 
cancer, a fatal lung disease, among nonsmokers (Refs. 126 and 130). The 
conclusion in the 2006 Surgeon General's Report extends this conclusion 
to all secondhand smoke exposure, regardless of location of exposure 
(e.g., at home, at work, in other settings); the combined evidence from 
multiple studies indicates a 20 to 30 percent increase in the risk of 
lung cancer from secondhand smoke exposure associated with living with 
a smoker (Ref. 126). For example, a meta-analysis of 43 studies, 
including studies conducted both in the United States and outside of 
the United States, found that the relative risk of lung cancer among 
nonsmoking women who live with partners who smoke (i.e., the risk of 
the lung cancer among nonsmokers living with smokers compared to 
nonsmokers not living with smokers) was 1.29 (Ref. 131). This means 
that nonsmoking women who live with partners who smoke have 1.29 times 
higher risk of lung cancer compared to nonsmoking women who live with 
partners who do not smoke. Recent studies support and extend these 
conclusions (Refs. 132-135).
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. The lungs are clearly postmortem, as they have been 
removed from the patient's body, and the cancerous lesions and 
discoloration caused by vascular congestion (i.e., blood in the lower 
lungs causing a darker coloration) are consistent with the appearance 
of postmortem lungs in a nonsmoking patient with fatal lung disease.
    Tobacco smoke is carcinogenic. Unlike lung cancer in smokers, lung 
cancer in nonsmokers targets the distal airways (Ref. 136) and is more 
likely to appear as depicted in the warning (i.e., discolored or 
darkened in the lower lungs). In comparison, postmortem lungs of a 
smoker would typically have a darker, almost black, coloration in the 
medial lungs (i.e., middle of the lungs, facing the chest) as well as 
other visible features that are not depicted in this image of a 
nonsmoker's diseased lungs. Therefore, this image depicts a factually 
accurate, common visual presentation of the health condition and shows 
the disease state as it is typically experienced.
    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. The textual warning statement 
explains that tobacco smoke can cause fatal lung disease in nonsmokers. 
The accompanying concordant and factually accurate image appropriately 
depicts the postmortem lungs of a nonsmoker with fatal lung disease. 
Because the required warning contains the textual warning statement and 
image paired together, the image aids in understanding the negative 
health consequence that is the focus of the textual warning statement, 
and vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image presents the health condition 
in a realistic and objective format, does not contain additional 
unnecessary details (e.g., surgical tools used to remove the lungs, 
background setting), and does not contain any elements intended to 
evoke a negative emotional response.
    3. ``WARNING: Smoking causes head and neck cancer.''

[[Page 15674]]

    This required warning consists of the textual warning statement 
``WARNING: Smoking causes head and neck cancer'' paired with a 
concordant, factually accurate, photorealistic image depicting neck 
cancer. The image shows the head and neck of a woman (aged 50-60 years) 
who has neck cancer caused by cigarette smoking. The woman has a 
visible tumor protruding from the right side of her neck just below her 
jawline.
    In FDA's final consumer research study, this warning was reported 
to be new information by 80.9 percent of participants who viewed it. In 
the proposed rule, we explained that the two outcomes of ``new 
information'' and ``self-reported learning'' are predictive of whether 
new cigarette health warnings increase understanding of the risks 
associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 58.1 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (71.6 percent) perceived the warning to be 
factual, a result that was statistically significantly lower than the 
control condition (see section VI for a fuller discussion of the 
``perceived factualness'' outcome). Participants who viewed this 
warning showed statistically significant improvements in their health 
beliefs between both Sessions 1 and 2 and Sessions 1 and 3 as compared 
to the changes in participants who viewed the Surgeon General's 
warnings. Full details of the results for this warning in FDA's final 
consumer research study are available in the study's final report (Ref. 
17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 60) Some comments object to this proposed warning because 
they assert it is inaccurate and misleading in a number of respects. 
For example, one comment asserts that the image depicts an 
``exceedingly rare'' outcome in terms of tumor size and quotes another 
comment that states the image implies that ``a cancerous mass of that 
size could arise quickly enough that a reasonable person would not have 
had an opportunity to seek treatment before this point.'' Another 
comment states that on its own, the image does not convey purely 
factual information, because it is not obvious whether the growth is a 
tumor or something else. One comment states the proposed warning 
``seeks to advance FDA's anti-smoking message'' by evoking an emotional 
response in consumers because ``the image of a woman with a large tumor 
protruding from her neck is disturbing and unsightly and is clearly 
designed to provoke disgust or discomfort at the sight of the image, 
fear at the prospect of experiencing the same uncomfortable medical 
condition, or both.''
    Many other comments support the inclusion of this warning in the 
final rule. One comment supporting the inclusion of the warning states 
that an estimated 53,000 new cases of cancers of the oral cavity and 
pharynx, which are types of head and neck cancer, will be diagnosed in 
2019 and over 10,000 people will die from those cancers this year and 
that tobacco use is a major risk factor for these cancers (Ref. 137). 
Another comment provided a summary of the 1964 through 2010 Surgeon 
General's Reports as demonstrating strong evidence for the association 
between smoking and head and neck cancer.
    (Response 60) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in the 
proposed rule, FDA undertook a rigorous, multistep process to develop, 
test, and refine the textual warning statement, accompanying image, and 
the overall warning.
    The textual warning statement ``WARNING: Smoking causes head and 
neck cancer'' is factually accurate. As many comments note, there is 
strong scientific support for the causal link between smoking and head 
and neck cancer. For example, and as described in the proposed rule 
(see section VII.A.3 of the proposed rule), the 2004 Surgeon General's 
Report stated that the evidence is sufficient to infer a causal 
relationship--the highest level of evidence of causal inferences from 
the criteria applied in the Surgeon General's Reports--between smoking 
and cancers of the oral cavity, pharynx, and larynx (Ref. 138), 
building on the strong conclusions of causality from previous reports. 
A more recent study (Ref. 139), submitted in a comment, that pooled 
data from 23 studies, found that those who smoked >0 to 3 cigarettes 
per day had 52 percent increased odds of head and neck cancer compared 
to never smokers. Those who smoked >3 to 5 cigarettes per day had 2.01 
to 2.74 times the odds of head and neck cancer as compared to never 
smokers.
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. The location (i.e., on the neck, under the jawline) and 
appearance of the tumor in a woman of the age pictured (50-60 years) is 
suggestive of a cervical lymph node metastasis (i.e., cancer in a lymph 
node) (Refs. 140 and 141). Cancers of the head and neck commonly 
metastasize to the cervical lymph nodes; therefore, the image is 
entirely consistent with a diagnosis of head and neck cancer (Ref. 
142). Moreover, the image is very similar to other images easily found 
depicting the same health condition (Ref. 140 at Figure 3 and Ref. 143 
at Figure 1a). Although some comments assert this image is misleading 
because ``there would be other signs of the cancer before the patient 
would develop a metastasis of the size and presentation in the proposed 
graphic,'' this assertion is not accurate as not all patients with 
cervical lymph node metastases have other symptoms. It is not unusual 
for cervical lymph node metastasis to be the first symptom of head and 
neck carcinoma that causes the patient to seek treatment (Ref. 144 at 
Chapter 9).
    Some comments also claim that the image is misleading because it 
suggests that ``a cancerous mass of that size could arise quickly 
enough that a reasonable person would not have had an opportunity to 
seek treatment before this point.'' Despite experiencing early symptoms 
for head and neck cancer, some individuals may not be able to seek 
early cancer screening and detection, resulting in diagnosis only when 
the disease has become advanced. Factors such as lack of health 
insurance coverage, lack of financial resources, lack of 
transportation, and lack of cancer knowledge serve as barriers to 
cancer screening, resulting in late-stage diagnosis for head and neck 
cancer (Refs. 143 and 146). As a result, it is not unusual for patients 
from underserved communities to present at advanced stages for head and 
neck cancer as depicted in the warning's image (Ref. 143 at Figure 1a 
and Ref. 147). Therefore, this image depicts a factually accurate, 
common visual presentation of the health condition.

[[Page 15675]]

    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. The textual warning statement 
explains that smoking causes head and neck cancer. The accompanying 
concordant and factually accurate image depicts the head and neck of 
woman (aged 50-60 years) who has a cancerous growth protruding from her 
neck below her jawline. Because the required warning contains the 
textual warning statement and image paired together, the image aids in 
understanding the negative health consequence that is the focus of the 
textual warning statement, and vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image presents the health condition 
in a realistic and objective format, does not contain additional 
unnecessary details (e.g., background setting), and does not contain 
any elements intended to evoke a negative emotional response.
    4. ``WARNING: Smoking causes bladder cancer, which can lead to 
bloody urine.''
    This required warning consists of the textual warning statement 
``WARNING: Smoking causes bladder cancer, which can lead to bloody 
urine'' paired with a concordant, factually accurate, photorealistic 
image depicting bloody urine. The image shows a gloved hand holding a 
urine specimen cup containing bloody urine resulting from bladder 
cancer caused by cigarette smoking.
    In FDA's final consumer research study, this warning was reported 
to be new information by 87.2 percent of participants who viewed it. In 
the proposed rule, we explained that the two outcomes of ``new 
information'' and ``self-reported learning'' are predictive of whether 
new cigarette health warnings increase understanding of the risks 
associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 57.8 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (66.0 percent) perceived the warning to be 
factual, a result that was statistically significantly lower than the 
control condition (see section VI for a fuller discussion of the 
``perceived factualness'' outcome). Participants who viewed this 
warning showed statistically significant improvements in their health 
beliefs between both Sessions 1 and 2 and Sessions 1 and 3 as compared 
to the changes in participants who viewed the Surgeon General's 
warnings. Full details of the results for this warning in FDA's final 
consumer research study are available in the study's final report (Ref. 
17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 61) Some comments object to this proposed warning because 
they assert it is inaccurate and misleading. For example, one comment 
states that the proposed warning is misleading because it suggests that 
bloody urine is a more serious health concern than bladder cancer. One 
comment suggests that, on its own, the image does not convey purely 
factual information because a consumer would not be able to determine 
from the image alone that the liquid depicted is bloody urine or bloody 
urine resulting from bladder cancer. This comment also asserts that the 
text and image are not concordant because nothing about the picture 
indicates that bladder cancer is the subject of the warning.
    Some comments suggest that the textual warning statement may be 
misleading and recommend revisions. For example, one comment suggests 
changing ``can'' to ``may'' or adding a disclaimer that ``bladder 
cancer is not the only cause of bloody urine'' and/or ``the absence of 
bloody urine does not mean the absence of bladder cancer.'' Another 
comment suggests that the proposed warning may be misleading because it 
understates the possible negative health consequences and recommends 
that the textual warning statement say, ``Smoking causes bladder 
cancer, which can lead to removal of part or all of the bladder.''
    Other comments suggest changes to the image, such as using a 
different image because the proposed image does not depict a body part 
or a human face. Another comment recommends making the image of the 
urine cup more clear by labeling the cup with words such as ``urine 
sample'' and darkening the color to a red resembling the color of 
blood.
    Finally, one comment states the proposed warning ``seeks to advance 
FDA's anti-smoking message'' by evoking an emotional response in 
consumers because the image ``appears designed to provoke an emotional 
reaction of fear or disgust regarding the nature of the depicted 
liquid.''
    (Response 61) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in the 
proposed rule, FDA undertook a rigorous, multistep process to develop, 
test, and refine the textual warning statement, accompanying image, and 
the overall warning.
    The textual warning statement ``WARNING: Smoking causes bladder 
cancer, which can lead to bloody urine'' is factually accurate, and we 
decline to make changes to the text. As explained in the proposed rule 
(see section VII.A.4 of the proposed rule), smoking is a strong causal 
factor in the development of bladder cancer. Recent research 
illustrates that even smoking a few cigarettes per day is associated 
with an increased risk of bladder cancer (Ref. 148), and the CDC 
estimates that 40 percent of bladder cancer deaths (not bladder cancer 
cases, as one comment asserts) from 2000 through 2004 were attributable 
to smoking, representing almost 5,000 deaths per year (Ref. 149). 
Cigarette smoking has repeatedly been identified as the most important 
risk factor for bladder cancer (Refs. 112-114).
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. As stated in the proposed rule, in most cases, blood in 
the urine (called hematuria) is the first visible sign of bladder 
cancer (Ref. 150). The Mayo Clinic notes that hematuria results in 
urine that can be pink, red, or brown/cola-colored (Ref. 151). The 
current color depicted in the image is factually accurate, and a darker 
red may lead to confusion as to whether the liquid contains only blood 
or bloody urine. We also decline to add a qualifying label to the 
specimen cup that says ``URINE SPECIMEN'' as the specimen cup with a 
gloved hand depicts a routine sampling procedure typical in laboratory 
testing and medical processing of biological samples. Further, the 
image is already paired with a textual warning statement indicating the 
cup contains urine. Therefore, this image depicts a factually accurate, 
common visual presentation of the health condition and shows a symptom 
of the disease state as it is typically experienced.

[[Page 15676]]

    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. We disagree with comments suggesting 
the warning is misleading or ineffective because it understates the 
possible negative health consequences for this health condition; does 
not depict a body part or face; or does not include information not 
directly focused on the specific warning, such as the possibility of 
bladder cancer occurring in the absence of bloody urine or the 
possibility of other nonsmoking-related causes of bloody urine. FDA 
also declines to change the image to be a depiction of a body part, in 
this case a bladder, as research shows that both youth and adults have 
a limited understanding of what a bladder looks like. For example, in 
one pilot study with 168 adolescents, only 7.7 percent could correctly 
label the bladder on a diagram (Ref. 152). This warning is intended to 
promote greater public understanding of bladder cancer caused by 
cigarette smoking. As stated in the preceding paragraph, bloody urine 
is a very common, and, in most cases, the first visible symptom of 
bladder cancer. The textual warning statement explains that smoking 
causes bladder cancer, which can lead to bloody urine. The 
accompanying, concordant, factually accurate image appropriately 
depicts bloody urine consistent with that seen in cases of bladder 
cancer caused by smoking. Because the required warning contains the 
textual warning statement and image paired together, the image aids in 
understanding the negative health consequence that is the focus of the 
textual warning statement, and vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image presents the health condition 
in a realistic and objective format, does not contain additional 
unnecessary details (e.g., background setting), and does not contain 
any elements intended to evoke a negative emotional response.
    5. ``WARNING: Smoking during pregnancy stunts fetal growth.''
    This required warning consists of the textual warning statement 
``WARNING: Smoking during pregnancy stunts fetal growth'' paired with a 
concordant, factually accurate, photorealistic image depicting a 
negative health consequence of smoking during pregnancy: An infant with 
low birth weight resulting from stunted fetal growth. The image shows a 
newborn infant on a medical scale, and the digital display on the scale 
reads four pounds.
    In FDA's final consumer research study, this warning was reported 
to be new information by 40.0 percent of participants who viewed it. In 
the proposed rule, we explained that the two outcomes of ``new 
information'' and ``self-reported learning'' are predictive of whether 
new cigarette health warnings increase understanding of the risks 
associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 66.7 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (83.9 percent) perceived the warning to be 
factual, a result that was not statistically different from the Surgeon 
General's warnings. Participants who viewed this warning showed 
statistically significant improvements in their health beliefs between 
Sessions 1 and 2, but not between Sessions 1 and 3, as compared to the 
changes in participants who viewed the Surgeon General's warnings. Full 
details of the results for this warning in FDA's final consumer 
research study are available in the study's final report (Ref. 17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 62) Some comments object to this proposed warning because 
they assert it is inaccurate and misleading. These comments question 
the accuracy of the visual depiction of the newborn infant, asserting 
that fetal growth and birth weight are not the same; the ``4.00 lbs.'' 
weight displayed in the image represents an extreme example of low 
birth weight due to smoking; the scale's depiction of ``4.00 lbs.'' 
conveys very low birth weight commonly associated with premature birth; 
and FDA has not demonstrated that a birth weight of four pounds is a 
likely outcome of maternal smoking.
    Some comments suggest that the image of an infant on a scale that 
reads ``4.00 lbs.'' may be difficult to see and therefore recommend 
increasing the text size of the weight display to help consumers more 
easily and quickly identify the condition being depicted in the image.
    Other comments raise concerns that the infant in the image appears 
unrealistic and that the low birth weight also relies on viewers/
readers to understand what a healthy weight might be. One comment 
states that the image contains a non-essential element by including the 
infant's apparent ``distress,'' while another comment notes that ``it 
may not be apparent to all that four pounds is underweight, especially 
to those with a lower health literacy or to those who are first-time 
mothers.'' Other comments recommend changing the image to include an 
underweight infant next to an average-sized infant or to feature a 
small infant in an incubator attached to various tubes and lines to 
better communicate the increased risk of low birth weight.
    One comment states the proposed warning ``seeks to advance FDA's 
anti-smoking message'' by evoking an emotional response in consumers 
because the image is ``designed to provoke an instinctive, emotional 
need in adult viewers to comfort the child.''
    (Response 62) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in the 
proposed rule, FDA undertook a rigorous, multistep process to develop, 
test, and refine the textual warning statement, accompanying image, and 
the overall warning.
    The textual warning statement ``WARNING: Smoking during pregnancy 
stunts fetal growth'' is factually accurate. As stated in the proposed 
rule, the 2004 Surgeon General's Report concluded that the evidence was 
sufficient to infer a causal relationship--the highest level of 
evidence of causal inferences based on the criteria applied in the 
Surgeon General's Reports--between maternal smoking and fetal growth 
restriction and preterm delivery (Ref. 138). The 2004 and a subsequent 
Surgeon General's Report summarized many studies that found a 
consistent and strong relationship between smoking and reduced birth 
weight as well as a strong dose-response relationship between smoking 
intensity and birth weight (Refs. 138 and 153). More recent studies 
further support the causal relationship between smoking and restricted 
fetal growth (Refs. 154-157). Further, a recent panel of 57 
international leaders in the field of neonatal growth developed a 
consensus definition of fetal growth restriction using a Delphi method 
(Ref. 158), and both population-

[[Page 15677]]

based and customized percentiles for birth weight were accepted in the 
definition. As such, low birth weight is a strong and important 
indicator of fetal growth restriction.
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. The visual depiction of stunted fetal growth as a newborn 
weighing four pounds on a scale clearly and accurately represents the 
negative health consequence of smoking focused in the textual warning 
statement, since, as described in the preceding paragraph, low birth 
weight is an important indicator of fetal growth restriction (Ref. 
158). FDA disagrees with comments suggesting that four pounds is an 
``extremely'' low birth weight. Epidemiological studies, which show 
that maternal cigarette smoking increases the risk for very low birth 
weight infants, define low birth weight as any weight less than 1,500 
grams (which is equivalent to about 3 pounds, 4 ounces), therefore four 
pounds is not an ``extremely'' low birth weight (Refs. 159 and 160). 
Further, we disagree that the public will not understand that the 
infant is low birth weight because of the ``4.00 lbs.'' display on the 
scale or the infant's appearance. Throughout our iterative process of 
testing and refining this image, even when study participants did not 
know the definition of low birth weight, this image was understood as 
intended. Because the required warning contains the textual warning 
statement and image paired together, the image aids in understanding 
the negative health consequence that is the focus of the textual 
warning statement, and vice versa.
    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. The textual warning statement 
explains that smoking during pregnancy stunts fetal growth. The 
accompanying concordant and factually accurate image depicts a newborn 
infant with low birth weight due to stunted fetal growth resulting from 
maternal smoking. As previously stated, the goal of the required 
warnings is to promote greater public understanding of the negative 
health consequences of smoking by conveying factual information 
regarding the causal association between smoking and specific health 
conditions rather than conveying information about absolute or relative 
risk of these conditions. Similarly, the goal of this specific 
warning's image is not to convey that all babies born with stunted 
fetal growth weigh four pounds, but rather to depict a concordant, 
factually accurate, common visual presentation of the negative health 
consequence of smoking described by the textual warning statement.
    We decline to make changes to the image to depict elements related 
to premature birth, such as placing the infant in an incubator or 
adding tubes. Stunted fetal growth does not necessarily result in 
premature birth, and premature birth is not the subject of this 
required warning. The image depicts a low birth weight infant, not 
necessarily a premature infant who would likely require (and thus be 
depicted with) additional interventions such as an incubator, oxygen, 
feeding tube, and additional monitoring (Ref. 161). This image depicts 
a factually accurate, common visual presentation of the health 
condition of stunted fetal growth and shows the condition as it is 
typically experienced.
    We disagree with the assertion that the image is intended to evoke 
an emotional response. The image presents the health condition (stunted 
fetal growth) in a realistic and objective format, does not contain 
additional unnecessary details (e.g., background setting), and does not 
contain any elements intended to evoke a negative emotional response. 
The inclusion of the weight on the scale further explains that the 
infant has a low birth weight. We also disagree that the infant in the 
image is in apparent ``distress.'' Crying among newborns is common and 
expected in this setting. It is an indicator of healthy lung function 
so much so that it is included in the widely used APGAR scoring used 
one and five minutes after birth (Ref. 162).
    Finally, with regard to comments suggesting that the image's ``4.00 
lbs.'' weight display on the scale may be difficult to see, we agree 
that this important element of the image may be difficult to view in 
certain sizes of cigarette packages or advertisements. As a result, for 
this required warning, we have increased the contrast and size of the 
weight display in the image to improve image clarity.
6. ``WARNING: Smoking can cause heart disease and strokes by clogging 
arteries.''
    This required warning consists of the textual warning statement 
``WARNING: Smoking can cause heart disease and strokes by clogging 
arteries'' paired with a concordant, factually accurate, photorealistic 
image depicting a patient who recently underwent heart surgery to treat 
heart disease caused by smoking. The image shows the chest of a man 
(aged 60-70 years) wearing an open hospital gown. The man has a large, 
recently-sutured incision running down the middle of his chest and is 
undergoing post-operative monitoring.
    In FDA's final consumer research study, this warning was reported 
to be new information by 52.1 percent of participants who viewed it. In 
the proposed rule, we explained that the two outcomes of ``new 
information'' and ``self-reported learning'' are predictive of whether 
new cigarette health warnings increase understanding of the risks 
associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 49.4 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (85.2 percent) perceived the warning to be 
factual, a result that was not statistically different from the Surgeon 
General's warnings. Participants who viewed this warning showed 
statistically significant improvements in their health beliefs between 
Sessions 1 and 2, but not between Sessions 1 and 3 as compared to the 
changes in participants who viewed the Surgeon General's warnings. Full 
details of the results for this warning in FDA's final consumer 
research study are available in the study's final report (Ref. 17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 63) Some comments object to this proposed warning because 
they assert it is inaccurate and misleading. One comment suggests that 
the warning is misleading because it depicts a man who has had recent 
open-heart surgery, presumably coronary artery bypass grafting (CABG), 
and the comment provides data showing that in-patient percutaneous 
coronary interventions (PCIs) are 2.5 times more common than open-heart 
CABG surgery for treating coronary artery disease (Ref. 163). Another 
comment asserts that the image depicts a ``worst case, rather than

[[Page 15678]]

representative scenario.'' One comment states that the textual warning 
statement and image are not concordant because the text indicates that 
smoking can lead to heart disease and strokes, but the image, on its 
own, does not convey that the individual depicted either suffered from 
heart disease or a stroke. Another comment asserts that the warning 
``seeks to advance FDA's anti-smoking message'' by evoking an emotional 
response in consumers because the depiction of a man with a large, 
recently-sutured incision ``is intended to disgust or shock consumers'' 
or ``to make consumers fearful of the prospect of needing to undergo 
major heart surgery and medical monitoring.''
    Other comments support the inclusion of this warning in the final 
rule, emphasizing the strong causal link, based on the conclusions 
drawn from past Surgeon General's Reports, between cigarette smoking 
and heart disease and stroke. The comments also reference a 2018 meta-
analysis of 141 cohort studies that found that smoking approximately 
one cigarette per day carries a much higher risk for developing 
coronary heart disease and stroke than would be expected if the risk 
increased in a linear dose-response relationship (Ref. 164).
    (Response 63) We disagree with comments suggesting that this 
warning is inaccurate or misleading. FDA undertook a rigorous, 
multistep process to develop, test, and refine the textual warning 
statement, accompanying image, and the overall warning.
    The textual warning statement ``WARNING: Smoking can cause heart 
disease and strokes by clogging arteries'' is factually accurate. As 
described in the proposed rule (see section VII.A.6 of the proposed 
rule), coronary heart disease--often simply called heart disease--is a 
disorder of the blood vessels of the heart that can lead to a heart 
attack. Stroke occurs when blood supply to part of the brain is 
interrupted or reduced, depriving brain tissue of oxygen and nutrients 
(Ref. 165). Atherosclerosis, or clogged arteries, is a disease in which 
plaque builds up inside the arteries that carry oxygen-rich blood to 
the heart and other parts of the body and can lead to heart attack and 
stroke through thrombosis, or blockage of the arteries (Refs. 3 and 
165). Most coronary heart disease involves atherosclerosis, or clogged 
arteries. Also as described in the proposed rule, Surgeon General's 
Reports since the 1970s have concluded that smoking is causally related 
to heart disease and stroke (Refs. 138 and 166), and smoking is 
consistently identified as a major risk factor for heart disease and 
stroke (Refs. 35, 115, 116, and 167). Across many studies over time, a 
clear dose-response relationship has been established with smoking more 
cigarettes and smoking for a longer time linked to greater risk of 
heart disease and stroke. More recent evidence demonstrates that even a 
very low frequency of smoking (i.e., even as few as one cigarette per 
day) has a measurable increase in the risk for cardiovascular disease 
(CVD) (Ref. 164).
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. The image shows the chest of a man (aged 60-70 years) 
wearing an open hospital gown. The man has a large, recently-sutured 
incision running down the middle of his chest and is undergoing post-
operative monitoring. As one comment notes, while inpatient discharges 
for CABG surgery have decreased over time, in 2014 there were still 
over 350,000 individuals who underwent the procedure as a consequence 
of coronary artery disease (Ref. 163). The appropriate use criteria and 
decision for treatment approaches is based on many clinical factors, 
with both CABG (as depicted) and PCI commonly used (Ref. 168). 
Therefore, this image depicts a factually accurate, common visual 
presentation of the health condition and shows the disease state as it 
is typically experienced.
    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. The textual warning statement 
explains that smoking can cause heart disease and strokes by clogging 
arteries. The accompanying concordant and factually accurate image 
depicts a patient who received treatment for heart disease caused by 
clogged arteries due to smoking. Because the required warning contains 
the textual warning statement and image paired together, the image aids 
in understanding the negative health consequence that is the focus of 
the textual warning statement, and vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image presents the health condition 
in a realistic and objective format, does not contain additional 
unnecessary details (e.g., background setting), and does not contain 
any elements intended to evoke a negative emotional response.
7. ``WARNING: Smoking causes COPD, a lung disease that can be fatal.'' 
[image of man with oxygen tank]
    This required warning consists of the textual warning statement 
``WARNING: Smoking causes COPD, a lung disease that can be fatal'' 
paired with a concordant, factually accurate, photorealistic image 
depicting a man receiving oxygen support because he has COPD caused by 
cigarette smoking. The image shows the head and neck of a man (aged 50-
60 years) who has a nasal canula under his nose supplying oxygen; the 
oxygen tank can be seen behind his left shoulder.
    In FDA's final consumer research study, this warning was reported 
to be new information by 35.7 percent of participants who viewed it. In 
the proposed rule, we explained that the two outcomes of ``new 
information'' and ``self-reported learning'' are predictive of whether 
new cigarette health warnings increase understanding of the risks 
associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 57.8 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (83.8 percent) perceived the warning to be 
factual, a result that was not statistically different from the Surgeon 
General's warnings. Despite the strong results on nearly all other 
measures included in the study, this warning did not show statistically 
significant improvements in health beliefs between either Sessions 1 
and 2 or between Sessions 1 and 3 over the changes in participants who 
viewed the Surgeon General's warnings, which is not surprising given 
the relatively brief exposure to the warning. Full details of the 
results for this warning are available in FDA's final consumer research 
study are available in the study's final report (Ref. 17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 64) Multiple comments provide data supporting this 
warning, since smoking is the leading cause of COPD. One comment 
emphasizes that a warning depicting COPD--either with an image of a 
diseased lung or the need

[[Page 15679]]

for oxygen as a result of COPD--would be ``more impactful than a simple 
statement that `nicotine is addictive' or `smoking is dangerous to your 
health.' '' The same comment notes that COPD is the fourth leading 
cause of death, is one of the costliest conditions with respect to 
hospital readmissions, and the medical profession witnesses ``the 
devastating consequences of tobacco use among COPD patients every 
day.''
    (Response 64) We agree that this cigarette health warning is 
important, focuses on a serious health risk of smoking, and will 
promote greater public understanding of the negative health 
consequences of smoking.
    (Comment 65) Some comments object to this warning because they 
assert it is inaccurate and misleading in a number of respects. One 
comment states that the image does not, on its own, convey purely 
factual information because ``[n]o reasonable consumer would be able to 
determine from the image alone that the man depicted suffers from 
COPD.'' Rather, the comment suggests, all the image conveys is that the 
man needs oxygen support. Another comment confirms that long-term 
oxygen therapy, delivered through a nasal canula, as depicted in the 
proposed warning, is one of several treatments for COPD (Ref. 169); 
however, the comment asserts that the proposed warning depicts a 
``worst case scenario'' without discussion of the proportion of smokers 
developing COPD who will require long-term oxygen therapy or home 
oxygen. Finally, one comment states that the proposed warning ``seeks 
to advance FDA's anti-smoking message'' by evoking an emotional 
response in consumers, because the image ``appears designed to make 
consumers fearful of the prospect of needing to rely upon an oxygen 
tank to survive.''
    (Response 65) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in the 
proposed rule, FDA undertook a rigorous, multistep process to develop, 
test, and refine the textual warning statement, accompanying image, and 
the overall warning.
    The textual warning statement ``WARNING: Smoking causes COPD, a 
lung disease that can be fatal'' is factually accurate. As stated in 
the proposed rule, COPD includes the diseases emphysema and chronic 
bronchitis. The 1964 Surgeon General's Report concluded that smoking is 
a primary cause of chronic bronchitis, and subsequent reports 
summarized additional evidence to conclude, in the 2004 Surgeon 
General's Report--at the highest level of evidence of causal inferences 
from the criteria applied in the Surgeon General's Reports--that the 
evidence is sufficient to infer a causal relationship between active 
smoking and COPD morbidity and mortality (Refs. 138, 170, and 171). The 
2014 Surgeon General's Report reinforced and extended this evidence to 
discuss the relationship between smoking and COPD mortality (Ref. 3). 
The 2014 Surgeon General's Report concluded that the evidence is 
sufficient to infer--once again, the highest level of evidence of 
causal inferences from the criteria applied in the Surgeon General's 
Reports--that smoking is in fact the dominant cause of COPD in the 
United States (Ref. 3). The mortality risk from COPD for current 
smokers compared to never smokers was 25.61 times higher for men and 
22.35 times higher for women, according to 50-year trends published in 
the New England Journal of Medicine (Ref. 172). There are about 128,000 
COPD deaths in the United States each year, of which 101,000 (79 
percent) are attributable to smoking (Ref. 3).
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. Oxygen therapy is not rare and is recommended for symptom 
relief and prolonging life, and many patients with COPD can use oxygen 
for several years. Oxygen therapy may be used with patients with COPD 
who have symptoms of both severe and moderate hypoxemia (i.e., 
abnormally low level of oxygen in the blood) to improve survival and 
quality of life (Refs. 173 and 174). Each year, more than 1.5 million 
adults in the United States use supplemental oxygen therapy (Ref. 175), 
including those with COPD. For example, among Medicare beneficiaries 
with COPD in 2010, 40.5 percent received oxygen therapy and 18.5 
percent received sustained oxygen therapy (Ref. 176). Quality of life 
can be improved for adults with COPD through the regular use of long-
term oxygen therapy (Ref. 177). Therefore, this image depicts a 
factually accurate, common visual presentation of the health condition 
and shows the disease state and treatment for the disease as it is 
typically experienced.
    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. The textual warning statement 
explains that smoking causes COPD, a fatal lung disease. Including the 
qualifying clause stating that COPD is a fatal lung disease further 
explains and provides important information of this negative health 
consequence of smoking. The accompanying concordant and factually 
accurate image depicts a man with COPD receiving oxygen treatment. 
Because the required warning contains the textual warning statement and 
image paired together, the image aids in understanding the negative 
health consequence that is the focus of the textual warning statement, 
and vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image presents the health condition 
in a realistic and objective format, does not contain additional 
unnecessary details (e.g., background setting), and does not contain 
any elements intended to evoke a negative emotional response.
    (Comment 66) One comment asserts that FDA has not provided any 
scientific basis for requiring two cigarette health warnings on COPD 
(identical textual warning statements paired with two different images) 
when only one warning was proposed for all other health conditions.
    (Response 66) As noted in the proposed rule (see section VI.B of 
the proposed rule), based on the results of FDA's first consumer 
research study (Ref. 12), FDA selected a total of 15 textual warning 
statements for testing in the final consumer research study (Ref. 17). 
However, when each of the textual warning statements were paired with 
concordant photorealistic images, two of the textual warning statements 
(``WARNING: Tobacco smoke causes fatal lung disease in nonsmokers'' and 
``WARNING: Smoking causes COPD, a lung disease that can be fatal'') 
shared similar concordant images (``diseased lungs''). To preserve the 
option of potentially requiring both textual warning statements but 
without using two similar images, FDA paired an additional concordant 
image (``man with oxygen tank'') with the COPD textual warning 
statement for further testing. Therefore, FDA tested a total of 16 
text-and-image pairings in the final quantitative consumer research 
study. Results from that study show that both images (``diseased 
lungs'' and ``man with oxygen tank''), paired with the same COPD 
textual warning statement, performed well across the outcomes measured, 
indicating that either pairing would advance the Government's interest 
in promoting greater public understanding of the negative health 
consequences of cigarette smoking (Ref. 17). We are therefore 
finalizing this cigarette health warning--and not the COPD warning with 
the image of diseased lungs--to avoid having two identical textual 
warning statements about COPD and to avoid having two

[[Page 15680]]

similar, concordant images of diseased lungs paired with different 
textual warning statements.
8. ``WARNING: Smoking reduces blood flow, which can cause erectile 
dysfunction.''
    This required warning consists of the textual warning statement 
``WARNING: Smoking reduces blood flow, which can cause erectile 
dysfunction'' paired with a concordant, factually accurate, 
photorealistic image depicting a man who is experiencing erectile 
dysfunction caused by smoking. The image shows a man (aged 50-60 years) 
sitting on the edge of a bed and leaning forward, with one elbow 
resting on each knee. The man's head is tilted down, with his forehead 
pressed into the knuckles of his right hand. Behind him on the bed, his 
female partner looks off in another direction.
    In FDA's final consumer research study, this warning was reported 
to be new information by 78.8 percent of participants who viewed it. In 
the proposed rule, we explained that the two outcomes of ``new 
information'' and ``self-reported learning'' are predictive of whether 
new cigarette health warnings increase understanding of the risks 
associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 61.4 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (72.4 percent) perceived the warning to be 
factual, a result that was statistically significantly lower than the 
control condition. Participants who viewed this warning showed 
statistically significant improvements in their health beliefs between 
Sessions 1 and 2, but not between Sessions 1 and 3, as compared to the 
changes in participants who viewed the Surgeon General's warnings. Full 
details of the results for this warning in FDA's final consumer 
research study are available in the study's final report (Ref. 17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 67) Some comments object to this warning because they 
assert it is inaccurate and misleading in a number of respects. One 
comment asserts that the image, on its own, does not convey purely 
factual information, because ``it does not provide any health 
information'' (emphasis added) and ``in no way illuminates how smoking 
could cause erectile dysfunction.'' The comment further states that the 
warning is misleading because it emphasizes a chronic, non-fatal 
condition rather than other conditions with high mortality rates. The 
comment also states that the warning ``focuses on erectile dysfunction 
while omitting mention of more common side effects of low blood flow, 
such as numbness or weakness in the legs.'' Finally, the comment states 
that the proposed warning ``seeks to advance FDA's anti-smoking 
message'' by evoking an emotional response in consumers, because the 
image ``is clearly designed to generate embarrassment and shame in 
viewers regarding the sensitive topic of sexual intimacy.''
    Another comment acknowledges that some health conditions are more 
difficult to depict than others. In the case of this warning, the 
comment explains that, while ``literal depictions'' of the health 
conditions are generally preferable, the use of a more ``symbolic'' 
image is ``justified'' for this health condition and warning.
    (Response 67) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in the 
proposed rule, FDA undertook a rigorous, multistep process to develop, 
test, and refine the textual warning statement, accompanying image, and 
the overall warning.
    The textual warning statement ``WARNING: Smoking reduces blood 
flow, which can cause erectile dysfunction'' is factually accurate. As 
discussed in the proposed rule and in reports of the Surgeon General, 
there is strong support that smoking causes erectile dysfunction. The 
2014 Surgeon General's Report concluded that the evidence is sufficient 
to infer a causal relationship--the highest level of evidence of causal 
inferences from the criteria applied in the Surgeon General's Reports--
between smoking and erectile dysfunction (Ref. 3). A recent meta-
analysis of studies that included 50,360 participants found that 
smoking more cigarettes and smoking for a longer time were associated 
with increased erectile dysfunction risk (Ref. 178). Smokers have been 
found to have a 40 percent increased risk of erectile dysfunction in 
studies such as the Health Professionals Follow-up Study and the 
Olmsted County Study of Urinary Symptoms and Health Status (Refs. 179 
and 180). Erectile dysfunction is likely under-reported in 
epidemiological studies; therefore, the effect estimates observed in 
studies are likely an underestimate. Finally, FDA disagrees with the 
comment suggesting only conditions with high mortality rates will 
directly advance the Government's interest. The substantial public 
health burden of cigarette smoking includes individuals with chronic, 
non-fatal diseases, and the Government has a substantial interest in 
improving public understanding about the negative health consequences 
of smoking that encompass health conditions beyond those with the 
highest mortality rates.
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. The man in the image is aged 50-60 years, which is an 
appropriate age range for men experiencing erectile dysfunction caused 
by cigarette smoking (Ref. 181). Also, as one comment notes, some 
health conditions are more difficult to depict literally and therefore 
depicting the ``situational context'' is justified. In the case of this 
required warning, FDA included additional realistic and contextual 
details (e.g., the man's posture, state of undress, bedroom setting, 
intimate partner) to depict the health condition.
    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. This warning is intended to promote 
greater public understanding that cigarette smoking reduces blood flow 
and can cause erectile dysfunction. The textual statement explains that 
smoking reduces blood flow, which can cause erectile dysfunction, 
thereby describing the mechanism through which smoking can cause this 
health effect. The accompanying concordant and factually accurate image 
depicts a man experiencing erectile dysfunction caused by smoking. 
Because the required warning contains the textual warning statement and 
image paired together, the image aids in understanding the negative 
health consequence that is the focus of the textual warning statement, 
and vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image

[[Page 15681]]

presents the health condition in a realistic and appropriately 
contextual format, does not contain additional unnecessary details 
(e.g., background setting), and does not contain any elements intended 
to evoke a negative emotional response.
9. ``WARNING: Smoking reduces blood flow to the limbs, which can 
require amputation.''
    This required warning consists of the textual warning statement 
``WARNING: Smoking reduces blood flow to the limbs, which can require 
amputation'' paired with a concordant, factually accurate, 
photorealistic image depicting the feet of a person who had several 
toes amputated due to tissue damage resulting from peripheral vascular 
disease (PVD) caused by cigarette smoking.
    In FDA's final consumer research study, this warning was reported 
to be new information by 74.7 percent of participants who viewed it. In 
the proposed rule, we explained that the two outcomes of ``new 
information'' and ``self-reported learning'' are predictive of whether 
new cigarette health warnings increase understanding of the risks 
associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 73.8 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (76.7 percent) perceived the warning to be 
factual, a result that was significantly lower than the control 
condition. Participants who viewed this warning showed statistically 
significant improvements in their health beliefs between both Sessions 
1 and 2 and Sessions 1 and 3 as compared to the changes in participants 
who viewed the Surgeon General's warnings. Full details of the results 
for this warning are available in FDA's final consumer research study 
are available in the study's final report (Ref. 17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 68) Some comments object to this proposed warning because 
they assert it is inaccurate and misleading in a number of respects. 
One comment states that the warning's image does not convey purely 
factual information because ``[n]o reasonable consumer would be able to 
determine from the image alone'' that the individual's amputated toes 
were due to tissue damage from PVD. The comment asserts that ``the text 
gives meaning to a disturbing image, rather than the other way 
around.'' Two comments question the accuracy of the image, asserting 
that it depicts Buerger's disease, ``a condition that could affect, at 
most, one in 1,000 smokers.'' One comment suggests the proposed warning 
is misleading, because ``only a small proportion of patients'' with PVD 
require amputation, and the prevalence of PVD in patients who have no 
symptoms is high.
    Another comment states that the text and image are not concordant 
because ``[n]othing about the picture indicates that the amputation 
resulted from reduced blood flow, let alone that the reduced blood flow 
reflects peripheral vascular disease.'' Instead, the comment claims, 
the ``mismatch'' between the text and the image ``adds to the fear and 
confusion a consumer would experience when viewing the warning.'' 
Finally, the comment states that the proposed warning ``seeks to 
advance FDA's anti-smoking message'' by evoking an emotional response 
in consumers, because the image ``is disturbing and unsightly and is 
clearly designed to provoke either disgust at the sight of the image, 
fear at the prospect of undergoing an amputation, or both.''
    (Response 68) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in the 
proposed rule, FDA undertook a rigorous, multistep process to develop, 
test, and refine the textual warning statement, accompanying image, and 
the overall warning.
    The textual warning statement ``WARNING: Smoking reduces blood flow 
to the limbs, which can require amputation'' is factually accurate. As 
discussed in the proposed rule, smoking is known to affect 
cardiovascular health in a number of ways. Smoking can cause peripheral 
arterial disease (PAD), also known as PVD, a health condition that 
causes arteries to narrow, which limits the flow of oxygen-rich blood 
to organs and other parts of the body, including arteries in the legs 
(Ref. 182). Complications of reduced blood flow to the limbs include 
amputation or loss of limbs due to tissue damage caused by poor oxygen 
supply. Numerous Surgeon General's Reports have summarized the strong 
causal evidence between smoking and PAD/PVD and concluded that 
cigarette smoking is the most powerful risk factor predisposing 
individuals to this condition (Refs. 3 and 183). Moreover, also as 
discussed in the proposed rule (see section VII.A.10 of the proposed 
rule), the population health burden of PAD/PVD is high: overall 
prevalence of PAD/PVD was found to be 13.5 percent in 2012 in the 
Atherosclerosis Risk in Communities study (Ref. 184); a meta-analysis 
found that the risk of the condition was 2.71 times greater for current 
smokers and 1.67 times greater for former smokers compared to never 
smokers (Ref. 185); and the 2014 Surgeon General's Report showed that 
risk estimates have increased over time (Ref. 3).
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. The image shows a complication resulting from this health 
condition, namely, toes that have been amputated due to tissue damage 
caused by reduced blood flow due to PAD/PVD. As discussed in the 
proposed rule, among people with critical limb ischemia (i.e., a severe 
blockage of the arteries that greatly reduces blood flow due to PAD/
PVD), 25 percent have amputations each year (Ref. 186). Another article 
estimates that ``over 90% of all limb amputations in the Western world 
occur as a direct or indirect consequence'' of PAD/PVD (Ref. 187). 
Because the warning's image depicts a person who had several toes 
amputated due to tissue damage resulting from PAD/PVD caused by 
cigarette smoking of undefined etiology, the image is consistent with 
PAD/PVD and is not is specific to Buerger's disease, as one comment 
suggested (see Refs. 188 and 189). Therefore, this image depicts a 
factually accurate, common visual presentation of the outcome of the 
health condition and shows the disease state as it may be experienced.
    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. The textual warning statement 
explains that smoking reduces blood flow to the limbs, which can 
require amputation. The accompanying concordant and factually accurate 
image depicts the feet of a person who has had several toes amputated 
due to tissue damage

[[Page 15682]]

resulting from reduced blood flow to the limbs caused by cigarette 
smoking. Because the required warning contains the textual warning 
statement and image paired together, the image aids in understanding 
the negative health consequence that is the focus of the textual 
warning statement, and vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image presents the health condition 
in a realistic and objective format, does not contain additional 
unnecessary details (e.g., background setting, surgical instruments 
used to remove the toes), and does not contain any elements intended to 
evoke a negative emotional response.
10. ``WARNING: Smoking causes type 2 diabetes, which raises blood 
sugar.''
    This required warning consists of the textual warning statement 
``WARNING: Smoking causes type 2 diabetes, which raises blood sugar'' 
paired with a concordant, factually accurate, photorealistic image 
depicting a personal glucometer device being used to measure the blood 
glucose level of a person with type 2 diabetes caused by cigarette 
smoking. The digital display reading of 175 mg/dL and a notation on the 
glucometer indicate a high blood sugar level.
    In FDA's final consumer research study, this warning was reported 
to be new information by 87.2 percent of participants who viewed it. In 
the proposed rule, we explained that the two outcomes of ``new 
information'' and ``self-reported learning'' are predictive of whether 
new cigarette health warnings increase understanding of the risks 
associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 62.3 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (64.0 percent) perceived the warning to be 
factual, a result that was statistically significantly lower than the 
control condition (see section VI for a fuller discussion of the 
``perceived factualness'' outcome). Participants who viewed this 
warning showed statistically significant improvements in their health 
beliefs between both Sessions 1 and 2 and Sessions 1 and 3 as compared 
to the changes in participants who viewed the Surgeon General's 
warnings. Full details of the results for this warning in FDA's final 
consumer research study are available in the study's final report (Ref. 
17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.
    (Comment 69) Multiple comments support the inclusion of this 
warning in the final rule and provide additional epidemiological and 
other scientific data to support the text and image components, 
including a scientific review that concluded that cigarette smoking 
increases the risk for type 2 diabetes incidence (Ref. 190).
    (Response 69) FDA appreciates the submission of additional 
scientific and other support for the inclusion of this warning focused 
on smoking causing type 2 diabetes. We agree that this cigarette health 
warning is important, focuses on a serious health risk of smoking, and 
will promote greater public understanding of the negative health 
consequences of smoking.
    (Comment 70) Some comments recommend FDA consider modifying the 
textual warning statement language or adding a separate warning related 
to smoking's causal link to type 2 diabetes. For example, suggestions 
from comments include ``Smoking causes type 2 diabetes, which can cause 
kidney disease or failure'' and ``Smokers with diabetes (and people 
with diabetes exposed to secondhand smoke) have a heightened risk of 
CVD, premature death, microvascular complications, and worse glycemic 
control when compared with nonsmokers.'' Some comments recommend that 
the textual warning statement convey the ``gravity'' of the disease or 
the serious complications of potentially greater concern to consumers 
without diagnosed diabetes (e.g., CVD, kidney disease, blindness, 
blurry vision, numbness in the hands and feet, amputation).
    (Response 70) While FDA agrees that there are other serious 
complications resulting from type 2 diabetes, we decline to make the 
suggested changes. The textual warning statement is factually accurate 
and is supported by strong epidemiological evidence that confirms the 
appropriate use of the causal language as written. The phrasing is 
appropriate, accurate, and consistent with the other required warnings, 
and it has performed well in FDA's consumer research studies, both on 
its own (in the first consumer research study) and when paired with a 
concordant photorealistic image (in the final consumer research study). 
The results of our rigorous science-based, iterative research process 
indicate that this warning will advance the Government's interest in 
promoting greater public understanding of the negative health 
consequences of smoking.
    (Comment 71) One comment recommends FDA remove numeric digital 
display readings from the glucometer portion of the image because 
``desired blood glucose targets vary among individuals with diabetes'' 
and including a specific numeric value in the image ``could be 
confusing for people with diabetes.'' The comment raises concern that 
individuals could misconstrue such a value (i.e., 175) as indicative of 
the appropriate glycemic target for their own care. Another comment 
suggests blood sugar levels may be less meaningful to some people.
    (Response 71) FDA declines to make the suggested change. As the 
comment notes, there may be a range of desired blood glucose targets 
for different individuals; however, type 2 diabetes is defined as a 
fasting blood sugar greater than 126 mg/dL (Ref. 191), which is clearly 
and accurately depicted in this image. Further, the required warnings 
are not intended to provide individual diagnostic medical information 
or encourage individuals to seek treatment, but rather to promote 
greater public understanding of the negative health consequences of 
cigarette smoking--in this case, that smoking causes type 2 diabetes, 
which raises blood sugar.
    (Comment 72) A comment from a group of research scientists shares 
findings from a recent study of 443 U.S. adults testing images for a 
sugar-sweetened beverage warning about type 2 diabetes. The comment 
states that an image similar to the one proposed here was the most 
common choice (selected by 34 percent of participants) of an image that 
``best represented'' type 2 diabetes.
    (Response 72) FDA appreciates the submission of this study; 
however, the study does not appear to be published and few details were 
submitted about the study methods or full results.
    (Comment 73) Some comments object to this proposed warning, because 
they assert it is inaccurate and misleading in a number of respects. 
One comment states that the image, on its own, does

[[Page 15683]]

not convey purely factual information, because ``the average consumer 
is unlikely to be aware of the meaning of the `175' reading on the 
glucometer (or even to recognize the device as a glucometer).'' For 
that reason, the comment states that the text and image are not 
concordant because the image ``does not relate to diabetes without 
knowledge of additional information not depicted.'' Another comment 
suggests that the image is not accurate because a blood sugar level of 
175 mg/dL is ``well in excess of the minimal threshold for diabetes.''
    One comment states that the proposed warning ``seeks to advance 
FDA's anti-smoking message'' by evoking an emotional response in 
consumers, because the image ``appears designed to provoke the 
emotional reaction of fear or disgust that many experience when faced 
with the prospect of a medical procedure involving needles and drawing 
blood.'' Moreover, the comment claims that the depiction of blood being 
drawn ``threatens to cause an emotional or fearful reaction in many 
consumers'' and ``is not necessary'' to inform consumers regarding the 
risk of type 2 diabetes.
    (Response 73) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in the 
proposed rule, FDA undertook a rigorous, multistep process to develop, 
test, and refine the textual warning statement, accompanying image, and 
the overall warning.
    The textual warning statement ``WARNING: Smoking causes type 2 
diabetes, which raises blood sugar'' is factually accurate. This 
statement is supported by strong epidemiological evidence that confirms 
the appropriate use of the causal language as written, as other 
comments note. The phrasing is also appropriate, accurate, and 
consistent with the other required warnings. The 2014 Surgeon General's 
Report concluded that: (1) The evidence is sufficient to infer--the 
highest level of evidence of causal inferences from the criteria 
applied in the Surgeon General's Reports--that cigarette smoking is a 
cause of type 2 diabetes; (2) the risk of developing diabetes is 30 to 
40 percent higher for active smokers than nonsmokers; and (3) there is 
a relationship between increased number of cigarettes smoked and 
increased risk of developing diabetes (Ref. 3). Across the 25 studies 
included in the 2014 Surgeon General's Report's updated summary, the 
associations were strong and consistent and were found in many 
subgroups, and these results have been replicated in many different 
study populations and study locations. Moreover, additional scientific 
support for this causal link was submitted in other comments (see, 
e.g., Ref. 190).
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. The image depicts a common action taken by people with 
type 2 diabetes: Glucose monitoring. According to the American Diabetes 
Association, ``[f]or many people with diabetes, glucose monitoring is 
key for the achievement of glycemic targets'' and is ``an integral 
component of effective therapy of patients taking insulin'' (Refs. 192 
and 193). Frequent testing of blood glucose is a reality for people 
with diabetes, and the image of a personal glucometer device being used 
to measure the blood glucose level is a common depiction of diabetes. 
Thus, there is support that an image of routine glucose monitoring is 
representative of type 2 diabetes in other contexts.
    With regard to the numerical display, we disagree that the image 
depicting a blood sugar level of 175 mg/dL is inaccurate. While 
diabetes is defined as a fasting blood sugar greater than 126 mg/dL, 
there are more complex criteria needed for an accurate diagnosis of 
type 2 diabetes (Ref. 194). A glucose level of 175 mg/dL is consistent 
with the American Diabetes Association guidelines, which recommend 
patients target peak post-meal blood glucose levels of <180 mg/dL to 
help lower average glycemic levels and improve glycemic control (Ref. 
192). Therefore, this image depicts a factually accurate, common visual 
presentation of the health condition and shows the disease state as it 
is typically experienced.
    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. The textual warning statement 
explains that smoking can cause type 2 diabetes, which raises blood 
sugar. The accompanying concordant and factually accurate image depicts 
a personal glucometer device being used to measure the blood glucose 
level of a person with type 2 diabetes caused by cigarette smoking. 
Because the required warning contains the textual warning statement and 
image paired together, the image aids in understanding the negative 
health consequence that is the focus of the textual warning statement, 
and vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image presents the health condition 
in a realistic and objective format, does not contain additional 
unnecessary details (e.g., background setting), and does not contain 
any elements intended to evoke a negative emotional response.
11. ``WARNING: Smoking causes cataracts, which can lead to blindness.''
    This required warning consists of the textual warning statement 
``WARNING: Smoking causes cataracts, which can lead to blindness'' 
paired with a concordant, factually accurate, photorealistic image 
depicting a closeup of the face of a man (aged 65 years or older) who 
has a cataract caused by cigarette smoking. The man's right pupil is 
covered by a large cataract.
    In FDA's final consumer research study, this warning was reported 
to be new information by 88.7 percent of participants who viewed it. In 
the proposed rule, we explained that the two outcomes of ``new 
information'' and ``self-reported learning'' are predictive of whether 
new cigarette health warnings increase understanding of the risks 
associated with cigarette smoking. Compared to the average of the 
ratings for the four Surgeon General's warnings (the control condition 
in the study), this warning was statistically significantly (p<0.05, 
after adjusting for age group, smoking status, and multiple 
comparisons) higher on both providing new information and self-reported 
learning. In addition, this warning was statistically significantly 
higher than the Surgeon General's warnings on nearly all other outcomes 
measured. This warning grabbed attention more, resulted in more 
thinking about the risks, and was perceived to be more informative, to 
be more understandable, and to be more helpful in understanding the 
health effects of smoking. The warning was correctly recalled by 53.0 
percent of participants, which was statistically significantly higher 
than the 25.7 percent who recalled the Surgeon General's warnings.
    Most participants (65.5 percent) perceived the warning to be 
factual, a result that was statistically significantly lower than the 
control condition (see section VI for a fuller discussion of the 
``perceived factualness'' outcome). Participants who viewed this 
warning showed statistically significant improvements in their health 
beliefs between both Sessions 1 and 2 and Sessions 1 and 3 as compared 
to the changes in participants who viewed the Surgeon General's 
warnings. Full details of the results for this warning in FDA's final 
consumer research study are available in the study's final report (Ref. 
17).
    We received a number of comments on this warning, which we have 
summarized and responded to below.

[[Page 15684]]

    (Comment 74) Multiple comments strongly support the inclusion of 
this proposed warning in the final rule and provide additional 
epidemiological and other scientific data to support the text and image 
components of this warning.
    (Response 74) FDA agrees with the comments that this cigarette 
health warning is important, focuses on a serious health risk of 
smoking, and will promote greater public understanding of the negative 
health consequences of smoking.
    (Comment 75) Some comments recommend that, since women generally 
have a longer life expectancy than men in the United States and are 
therefore more likely to develop age-related eye problems, FDA should 
consider changing the image to one of a woman with a cataract.
    (Response 75) We decline to make this revision. The warning is 
factually accurate and appropriate for the purpose of this rule, which 
is to promote greater public understanding of the negative health 
consequences of cigarette smoking. It is not feasible, nor is it our 
intention, for a single warning to convey all the information that may 
be related to a particular health condition, such as populations with 
the highest prevalence of a disease, projected incidence rates, 
relative risk, mortality rates, or disparities in affected populations. 
Rather, this required warning presents a factually accurate visual 
depiction of the negative health condition that is concordant with the 
paired textual warning statement.
    (Comment 76) Some comments object to this warning because they 
assert it is inaccurate and misleading in a number of respects. One 
comment states that the image does not convey purely factual 
information, because the image, on its own and without the accompanying 
text, ``simply shows a man with one eye differently colored than the 
other'' and ``[t]here is no reason for a consumer to know that the 
depicted eye-color variation represents `a large cataract.' '' The 
comment further states that the warning emphasizes a chronic, non-fatal 
condition, rather than other conditions with high mortality rates. The 
comment also states that the warning emphasizes a condition (blindness) 
that occurs in only a small minority of cataracts.
    Another comment states that the image is ``not a reasonable 
depiction of persons with cataracts'' because the cataract ``would have 
been treated surgically long before it got to this stage.'' In 
addition, the same comment asserts that the image ``misleadingly'' 
makes the cataract look like a cosmetic problem, ``when in reality, 
`[t]he vast majority of patients who undergo cataract surgery in the 
[United States] have cataracts that are undetectable by the unaided 
human eye.' '' Another comment repeats these objections, and one 
comment notes that cataracts can be treated with ``highly successful 
cataract surgery and do not result in permanent visual loss.''
    One comment asserts that the text and image are not concordant, 
because the text indicates that smoking can lead to blindness ``[y]et 
the picture does not clearly indicate that the individual depicted is 
blind.''
    Finally, one comment states that the proposed warning ``seeks to 
advance FDA's anti-smoking message'' by evoking an emotional response 
in consumers, because the image ``is discomforting and appears designed 
to shock the viewer or generate fear at the prospect of experiencing 
the condition in the image.''
    (Response 76) We disagree with comments suggesting that this 
warning is inaccurate or misleading. As explained at length in the 
proposed rule, FDA undertook a rigorous, multistep process to develop, 
test, and refine the textual warning statement, accompanying image, and 
the overall warning.
    The textual warning statement ``WARNING: Smoking causes cataracts, 
which can lead to blindness'' is factually accurate. As discussed in 
the proposed rule, the 2004 Surgeon General's Report on cigarette 
smoking concluded that the evidence is sufficient to infer a causal 
relationship--the highest level of evidence of causal inferences from 
the criteria applied in the Surgeon General's Reports--between smoking 
and cataracts in the lens of the eye (referred to as nuclear cataracts) 
(Ref. 138). Authors have continued to identify smoking as a major 
causal risk factor in the development and progression of cataracts 
(Refs. 195-197). Studies of smoking cessation and risk of cataracts has 
affirmed that risk decreases, but is not equivalent to never smokers, 
upon elimination of the exposures of tobacco smoke (Ref. 198).
    Additionally, the image in the warning is factually accurate and 
depicts a common visual presentation of this negative health 
consequence. The image depicts a close-up of the face of a man aged 65 
years or older, which is an appropriate age range for this condition. 
As stated in the proposed rule (see section VII.A.13 of the proposed 
rule), prevalence of cataracts among U.S. adults aged 40 years and 
older in 2010 was estimated to be 17.1 percent by the National Eye 
Institute (Ref. 199). A study of people affected by cataracts worldwide 
estimated that in 2010, there were more than 400,000 (range: 240,000 to 
850,000) people with cataracts in North America, of whom 13.0 percent 
(95 percent, CI: 7.8. 19.5) were blind as a result of that cataract 
(Ref. 200).
    FDA disagrees with the comment suggesting that only depictions of 
conditions with high mortality rates will directly advance Government's 
interest. As stated in section V.A, the substantial public health 
burden of cigarette smoking includes individuals with chronic, non-
fatal diseases, and therefore FDA has an opportunity to improve public 
understanding about the negative health consequences of smoking that 
encompass health conditions beyond those with the highest mortality 
rates.
    FDA also disagrees with the comment suggesting that the image is 
not a reasonable depiction because persons would have been treated 
surgically before advancing to the stage depicted. Research has shown 
that individuals from underserved populations may face barriers to 
receiving cataract surgery due to factors such as lack of access to 
medical care, lack of insurance coverage, lack of financial resources, 
and lack of transportation (Refs. 201 and 202). Thus, it is factually 
accurate and not uncommon for individuals to experience advanced 
cataracts as depicted in the image.
    Further, the textual warning statement and image are concordant, 
and the warning is not ambiguous. The textual warning statement 
explains that smoking causes cataracts, which can lead to blindness. 
The accompanying concordant and factually accurate image depicts a man 
with a large cataract caused by smoking. Because the required warning 
contains the textual warning statement and image paired together, the 
image aids in understanding the negative health consequence that is the 
focus of the textual warning statement, and vice versa.
    Finally, we disagree with the assertion that the image is intended 
to evoke an emotional response. The image presents the health condition 
in a realistic and objective format, does not contain additional 
unnecessary details (e.g., background setting), and does not contain 
any elements intended to evoke a negative emotional response.

C. Non-Selected Cigarette Health Warnings

    This section discusses the two proposed warnings that FDA is not 
selecting. In the proposed rule, we indicated that we would make these 
decisions following our review of public

[[Page 15685]]

comments and after weighing additional scientific, legal, and policy 
considerations. In the following paragraphs, FDA briefly describes the 
study outcomes for each warning and the comments we received.
1. ``WARNING: Smoking causes COPD, a lung disease that can be fatal 
[image of diseased lungs].''
    As explained in section VI of the proposed rule, FDA included two 
textual warning statements (``WARNING: Tobacco smoke causes fatal lung 
disease in nonsmokers'' and ``WARNING: Smoking causes COPD, a lung 
disease that is fatal'') that were each paired with similar concordant 
images of diseased lungs. The proposed textual warning statement 
(``Warning: Smoking causes COPD, a lung disease that can be fatal'') 
paired with the image of diseased lungs showed strong results in FDA's 
final consumer research study, showing statistically significant higher 
ratings across nearly all outcomes. The warning was perceived to be 
factual by a majority of participants, a result that was not 
statistically different from the Surgeon General's warnings (i.e., the 
control condition). Participants who viewed this warning showed 
improvements in their health beliefs between Sessions 1 and 2, but not 
between Sessions 1 and 3. To avoid having two identical textual warning 
statements about COPD and to avoid having two similar, concordant 
images of diseased lungs paired with different textual warning 
statements, FDA is not finalizing this cigarette health warning. FDA 
concludes that having only one required warning statement on COPD 
reflects the Congressional intent of representing a diverse set of 
health conditions and furthers the Government's interest in promoting 
public understanding of the negative health consequences of smoking. In 
the following paragraphs, FDA briefly describes and responds to the 
comments received on this proposed warning.
    (Comment 77) FDA received numerous comments generally supporting 
all of the proposed warnings, including this proposed warning. FDA 
received some comments supporting both proposed warnings related to 
COPD stating smoking is the number one leading cause of COPD. Other 
comments, however, oppose this proposed warning, stating that the 
proposed rule contains no discussion regarding the relationship between 
smoking and the image in the proposed rule; the warning fails to convey 
the relationship between cigarette use topography and the depicted 
image; and that such lung pigmentation is unlikely to occur except 
after ``many years'' of ``heavy'' smoking. Another comment recommends 
FDA consider using only one of the two similar images of diseased lungs 
because studies show that rotating warnings and using a variety of 
topics and images can improve the effectiveness of warnings.
    (Response 77) Although we disagree with the comments that suggest 
the proposed warning did not adequately convey the relationship between 
cigarette use and the depicted image, we have elected not to finalize 
this warning. As we recognized in section VI of the proposed rule, and 
as at least one comment suggests, it is important that the required 
warnings use a variety of topics and images. As previously noted, FDA 
has determined that including one required warning on COPD is 
consistent with Congressional intent of representing a diverse set of 
conditions and also advances the Government's interest of promoting 
greater public understanding of the negative health consequences of 
smoking.
2. ``WARNING: Smoking causes age-related macular degeneration, which 
can lead to blindness.''
    This proposed textual warning statement on age-related macular 
degeneration (AMD) is paired with an image of an older man (aged 65 
years or older) who is receiving an injection in his right eye to 
prevent additional vessel growth. This proposed textual warning 
statement did well in FDA's final consumer research study, showing 
statistically significant higher ratings across all outcomes except 
perceived factualness. However, FDA is not finalizing this cigarette 
health warning because FDA has determined that having only one required 
warning statement related to blindness reflects the Congressional 
intent of representing a diverse set of health conditions and furthers 
the Government's interest in promoting public understanding of the 
negative health consequences of smoking. In the following paragraphs, 
FDA briefly describes and responds to the comments received on this 
proposed warning.
    (Comment 78) As with the other proposed warnings, this warning 
received general support. Several comments (including from state 
societies of optometric physicians and a national professional medical 
association for optometric medicine) support the warning but recommend 
revisions, including that the image should depict the effects of AMD 
rather than the treatment of the disease, e.g., by using one of the 
commonly cited images produced by the National Eye Institute depicting 
a blurred image of a child (as seen from the vantage point of a person 
with AMD). Some comments also recommend that we change the proposed 
image of a black man with AMD to a Hispanic woman with AMD, citing data 
from the National Eye Institute. Other comments oppose this proposed 
warning, stating that FDA did not assess whether consumers viewing the 
proposed warning understood the absolute risk of macular degeneration 
in general, or among smokers. One comment notes that the depiction of 
treatment of macular degeneration is not accurate as the needle 
depicted is thicker than one that would actually be used to treat 
macular degeneration and would not ordinarily be inserted in the center 
of the eye, as depicted.
    (Response 78) We agree with the comments that generally support the 
inclusion of a cigarette health warning that addresses blindness. 
Although this proposed warning showed strong results in the final 
consumer research study, after considering the comments, we have 
elected not to finalize it. As previously noted, FDA has determined 
that including one required warning on blindness is consistent with 
Congressional intent of representing a diverse set of conditions and 
also advances the Government's interest of promoting greater public 
understanding of the negative health consequences of smoking.

VIII. Alternatives

    In the proposed rule, FDA invited proposals for alternative text 
and images and requested that any proposals include scientific 
information supporting that the proposed alternative would, in fact, 
promote greater public understanding of the negative health 
consequences of smoking. In response, FDA received a number of comments 
suggesting text or image edits, and some suggestions for additional 
required warnings or other changes. As we explain in section VII, we 
are finalizing 11 of the 13 proposed required warnings after reviewing 
all the public comments and weighing additional scientific, legal, and 
policy considerations. We also address in section VII suggestions 
specific to those required warnings. In the following paragraphs, FDA 
summarizes other comments we received that suggest additional required 
warnings or general additions or changes we might consider.
    (Comment 79) FDA received several comments suggesting that the 
required warnings provide additional textual information, such as 
information on tobacco cessation or Quitlines; information on the 
positive outcomes of

[[Page 15686]]

quitting smoking (or warnings using ``gain-framed'' phrasing); or 
information on the harmful effects of menthol. Other comments suggest 
specific warnings FDA should require, in addition to or in place of the 
required warnings proposed by FDA. For example, one comment suggests 
that there be a required warning addressing the dangers of tobacco 
smoke pollution or secondhand smoke, citing information from the CDC 
(Ref. 203). The comment suggests that the warning state, ``WARNING: 
Secondhand smoke can cause heart disease and strokes by clogging 
arteries.'' This comment also suggests adding a warning on breast 
cancer that states, ``WARNING: Smoking can cause breast cancer, 
especially in younger women.'' To target young individuals who are 
image conscious, another comment suggests developing a warning related 
to how smoking will harm appearance, such as ``WARNING: Using this 
product will make you look old and wrinkled. Smoking speeds up the 
aging of skin and causes premature sagging.''
    Other comments recommend including additional image elements to the 
proposed required warnings. For example, one comment suggests use of a 
hazard alert triangle symbol (i.e., a yellow triangle with an 
exclamation point in the middle), or the United Nations Globally 
Harmonized System cancer/chronic health hazard symbol, which is already 
mandated by the Occupational Safety and Health Administration for 
chemicals. This comment recommends displaying one or both of these 
symbols beside the text ``WARNING'' ``both to assist non-English 
speakers and to make the message more noticeable.'' Another comment 
recommends that FDA change the background of the warnings to the same 
yellow used on highway warning signs (e.g., similar to a school zone 
warning sign), suggesting this would increase the warnings' visibility 
and strengthen their effectiveness and would more clearly transmit that 
the required warning is a ``warning.'' One comment suggests FDA adopt a 
regulation requiring plain packaging of cigarettes with warning labels 
to eliminate tobacco packaging as a form of advertising and promotion.
    Several of the comments frame their suggestions as topics for 
future rulemakings, with some comments encouraging FDA to begin the 
process of developing additional cigarette health warnings, in part, as 
a means to address the concerns of wear out, overexposure, or loss of 
effectiveness.
    (Response 79) As we discuss in section VII, after carefully 
reviewing the different suggestions that were made, as well as weighing 
scientific, legal, and policy considerations, FDA is finalizing 11 of 
the 13 warnings that were included in the proposed rule. In general, no 
scientific information was submitted to demonstrate that these 
additional suggested warnings or other suggested changes would improve 
consumer understanding of the negative health consequences of smoking; 
not all the suggested health consequences meet FDA's standard for 
verifying the level of causal inference from the reports of the Surgeon 
General; and some health topics are already covered by the required 
warnings. We also note that although one of the nine Tobacco Control 
Act statements FDA tested in the first consumer research study 
(``WARNING: Quitting smoking now greatly reduces serious risks to your 
health''), is a gain-framed message (i.e., one that focuses on the 
positive outcome of taking an action), this statement is not aligned 
with this rule's approach to promoting greater public understanding of 
the negative health consequences of cigarette smoking because its focus 
is not on understanding of the negative health consequences of smoking. 
FDA also recognizes that several of these comments suggested that their 
recommended warnings could require additional notice and another 
opportunity for public comment.
    We discuss concerns related to wear out (or overexposure) in 
section IX. As explained there, the requirements in Sec.  1141.10(g), 
namely that required warnings on packages be randomly and equally 
displayed and distributed and required warnings in advertisements be 
rotated quarterly in alternating sequence in accordance with an FDA 
approved plan, will help address the concerns of overexposure and loss 
of effectiveness over time. Additionally, FDA has authority under 
section 202(b) of the Tobacco Control Act to conduct future rulemakings 
as needed to address these concerns if such a change would promote 
greater public understanding of the risks associated with the use of 
tobacco products.

IX. Description of the Final Rule--Part 1141

A. Overview of the Final Rule

    In the proposed rule, FDA explained that this rule will replace 
part 1141 in Title 21 of the Code of Federal Regulations. The final 
rule requires new warnings on cigarette packages and advertisements. 
Although the proposed rule included 13 required warnings, following our 
review of the comments on the proposed rule and other considerations, 
as described in section VII, FDA is finalizing 11 required warnings. 
The required warnings comprise 11 textual warning statements each 
accompanied by a color graphic depicting the negative health 
consequences of smoking. FDA also made clarifications related to the 
materials that we are incorporating by reference.
    The final rule is authorized by section 4 of the FCLAA, as amended 
by sections 201 and 202 of the Tobacco Control Act, which directs FDA 
to issue regulations requiring color graphics depicting the negative 
health consequences of smoking to accompany textual warning statements, 
and permits FDA to adjust the format, type size, color graphics, and 
text of any of the label requirements, or establish the format, type 
size, and text of any other disclosures required under the FD&C Act, if 
such a change would promote greater public understanding of the risks 
associated with the use of tobacco products.
    In accordance with section 4 of the FCLAA, the final rule directs 
that a required warning must comprise at least the top 50 percent of 
the front and rear panels of cigarette packages and at least the top 20 
percent of the area of advertisements. The final rule also provides 
that the required warnings in packages must be randomly displayed in 
each 12-month period, in as equal a number of times as is possible on 
each brand of the product and be randomly distributed in all areas of 
the United States in which the product is marketed in accordance with 
an FDA-approved plan. The required warnings for advertisements must be 
rotated quarterly in alternating sequence in advertisements for each 
brand of cigarettes in accordance with an FDA-approved plan. Each 
tobacco product manufacturer must maintain a copy of the plan and make 
it available for inspection and copying by officers or employees duly 
designated by the Secretary. The FDA-approved plan must be retained 
while in effect and the plan must be retained for a period of not less 
than 4 years from the date it was last in effect. The required warnings 
will promote greater public understanding of the negative health 
consequences of cigarette smoking. The following paragraphs briefly 
describe the final rule, as well as the comments FDA received and our 
responses to those comments.

[[Page 15687]]

B. Description of Final Regulations and Comments

1. Section 1141.1--Scope
    This section establishes that the requirements apply to 
manufacturers, distributors, and retailers of cigarettes except as 
described in this section. First, manufacturers or distributors of 
cigarettes that do not manufacture, package, or import cigarettes for 
sale or distribution within the United States would not be subject to 
the rule (proposed Sec.  1141.1(b)). Second, we proposed in Sec.  
1141.1(c) that retailers would not be in violation for cigarette 
packaging that: (1) Contains a warning; (2) is supplied to the retailer 
by a license- or permit-holding tobacco product manufacturer or 
distributor; and (3) is not altered by the retailer in a way that is 
material to 15 U.S.C. 1333 or part 1141. However, this proposed 
subsection would require that a retailer ensure that all cigarette 
packages they display or sell contain a warning that is unobscured by 
stickers, sleeves, or other materials on the packages, for example. 
Third, we proposed that under Sec.  1141.1(d), the advertisement 
requirements in proposed Sec.  1141.10 would apply to a retailer only 
if the retailer is responsible for or directs the warnings for 
advertising. Retailers would be liable if they display, in a location 
open to the public, an advertisement that does not contain a warning 
(proposed Sec.  1141.1(d)). Proposed Sec.  1141.1(d) provided, however, 
that retailers would be in violation of the FCLAA and this proposed 
part if they alter cigarette advertising in a way that is material to 
the requirements, for example, by obscuring or covering up the warning 
(e.g., blocking with a sticker or marker), shrinking the warning, or 
using a sleeve to cover the warning.
    We received some comments suggesting a different scope, and we 
summarize those comments and our responses in the following paragraphs. 
We are finalizing this section without change.
    (Comment 80) Many comments suggest that the rule should apply to 
all nicotine and tobacco products or suggest that FDA implement similar 
warning labels on non-cigarette tobacco products, such as cigars, 
smokeless tobacco, and electronic nicotine device systems, in part, 
because educating the public about the risks of these products would 
also serve a legitimate public interest.
    (Response 80) The FCLAA explicitly applies to cigarettes, and thus 
it is beyond the scope of this rulemaking to address products other 
than cigarettes.
    (Comment 81) FDA received comments suggesting that the rule should 
not apply to heated tobacco sticks and, in particular, the heated 
tobacco product, Heatsticks, used with the IQOS holder. The comments 
state that that the proposed rule did not explain how the warnings, 
images, or factual record apply to non-combustible cigarettes or how 
the required warnings would be accurate and non-misleading applied to 
these products. Although the comments acknowledge that the product 
falls within the FCLAA definition of ``cigarette,'' the comments 
suggest the rule's scope should be limited to combustible cigarettes.
    The comments highlight that FDA's communications indicate not all 
products classified as cigarettes under the FCLAA present the same risk 
profile, such as language that ``the agency found that the aerosol 
produced by the IQOS Tobacco Heating System contains fewer toxic 
chemicals than cigarette smoke, and many of the toxins identified are 
present at lower levels than in cigarette smoke'' (Ref. 145). Thus, the 
comments suggest that applying the required warnings to IQOS and 
Heatsticks would ``undercut [FDA's] important health objectives.''
    One comment argues that any rule that does not exempt Heatsticks 
would violate the APA for three reasons: (1) FDA did not carry its 
burden of showing the evidence supporting the required warnings applies 
to Heatsticks (rather FDA's justifications in the proposed rule apply 
only to traditional, combustible cigarettes); (2) the rule would 
contradict without explanation FDA's conclusions in the marketing order 
for Heatsticks; and (3) applying the rule would violate the First 
Amendment and raise potential concerns under the Takings Clause of the 
Fifth Amendment (thus, violating the APA). The comment states the 
proposed rule provides information and evidence only relating to 
traditional, combustible products and notes that none of the illness or 
conditions have been causally linked to Heatsticks used with the IQOS 
device. The comment also indicates that applying the required warnings 
would depart from FDA's findings in the marketing order and FDA has 
failed to explain the apparent conflict between the order and the rule 
by failing to address FDA's previous conclusions regarding the health 
risks presented by Heatsticks used with the IQOS device.
    The comment also states that applying the rule would violate the 
First Amendment because the required warnings must cover at least the 
top 50 percent of the front and rear panels of packages and 20 percent 
of advertisements, and the marketing order requires that 30 percent of 
the front and rear panels and 20 percent of each advertisement contain 
a nicotine warning, which would result in 80 percent of packages and 40 
percent of advertisements being used for the ``[G]overnment's anti-
smoking message.'' This comment also notes this could raise issues 
under the Takings Clause of the Fifth Amendment.
    Both comments also argue that, because the scope of the rule is 
cigarette smoking, and its goal is to promote greater public 
understanding of the negative health consequences of smoking, applying 
the required warnings to Heatsticks would be misleading as this product 
is a non-combustible product, which produces a nicotine-containing 
aerosol without combustion, and FDA has acknowledged these are 
materially different from combustible cigarettes. Given FDA's finding 
in the premarketing authorization orders that the products are 
appropriate for the public health, the comments suggest that FDA should 
tailor the warnings on Heatsticks to contain accurate and non-
misleading information. The comments do not propose specific language 
for this purpose.
    (Response 81) As these comments note, heated tobacco sticks are 
within the FCLAA's definition of cigarette (section 3(1) of the FCLAA), 
and, as such, are within the scope of the rule. Although IQOS 
Heatsticks may present different considerations from traditional 
cigarettes, FDA does not believe that a broad rule requiring cigarette 
health warnings generally is the appropriate place to address the 
requirements as they apply to one specific product. Rather, FDA intends 
to make product-specific decisions about warnings, including decisions 
about potential product-specific changes to the cigarette health 
warnings required by this rule, when issuing or revising individual 
product marketing orders. There is no conflict or inconsistency between 
the warning regime required by the FCLAA (including its adjustments 
through this or potential future rulemakings under section 202 of the 
Tobacco Control Act) and requirements set by a marketing order, because 
FDA has authority to change the applicability of general warning 
requirements for a specific product via a marketing order. Among other 
relevant provisions, section 202(a) of the Tobacco Control Act 
(amending section 5(a) of the FCLAA) specifically states: ``Except to 
the extent the Secretary requires additional or different statements on 
any cigarette package . . . by an order, by an

[[Page 15688]]

authorization to market a product, or by a condition of marketing a 
product, . . . no statement relating to smoking and health, other than 
the statement required by section 1333 of this title, shall be required 
on any cigarette package'' (emphasis added).
    This approach allows FDA to review the evidence submitted in an 
application, including on the health risks of a specific product, and 
make any appropriate product-specific decisions about warnings based on 
that product-specific evidence. FDA already conducted such an 
evaluation in the context of the IQOS premarket tobacco product 
application (PMTA) marketing authorization order. FDA recognizes that 
the final rule amends the general warning regime for cigarettes and 
that FDA will need to consider the applicability of the new regime to 
the IQOS Heatsticks and revisit the terms of the PMTA order. As stated 
in the PMTA order, ``[w]hen FDA promulgates a final rule with respect 
to health warnings for cigarettes, FDA will reevaluate the conditions 
of marketing with respect to warnings for the products subject to this 
order.''
2. Section 1141.3--Definitions
    Proposed Sec.  1141.3 included definitions for the following terms:

 Cigarette
 Commerce
 Distributor
 Front panel and rear panel
 Manufacturer
 Package or packaging
 Person
 Retailer
 United States

    As discussed in the preceding paragraphs, we received some comments 
regarding the scope of this rulemaking and the definition of 
``cigarette,'' which we addressed in those paragraphs. We received no 
other comments related to these definitions, and we are finalizing this 
section without change.
3. Section 1141.5--Incorporation by Reference
    Proposed Sec.  1141.5 stated that certain material would be 
incorporated by reference into this part with the approval of the 
Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 
51. Proposed Sec.  1141.5 provided that all approved material would be 
available for inspection at the U.S. Food and Drug Administration, the 
National Archives and Records Administration, as well as available from 
the Center for Tobacco Products, FDA. Although we did not receive 
comment on the use of incorporated by reference materials, we did 
receive comments requesting clarifications on the substance of those 
materials. In the following paragraphs, we discuss the comments and our 
responses on this section. After considering the comments, we made 
clarifications to this section and Sec.  1141.10(b) and (d)(4) and (5) 
to more clearly state that the materials we are incorporating include 
the textual warning statement paired with its accompanying color 
graphic. It is this combination that must be accurately reproduced and 
meet the requirements of the FCLAA and part 1141. In addition, as 
described in section VII.B.5, FDA also has increased the contrast and 
size of the display in one image (``WARNING: Smoking during pregnancy 
stunts fetal growth'') to improve image clarity. This change is 
reflected in the material that FDA is incorporating by reference.
    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 PDF file containing 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 .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 materials 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.
    (Comment 82) One comment requests that FDA release final 
electronic, layered design files for each required warning, as well as 
technical specifications before the final rule is released.
    (Response 82) To assist regulated entities with implementation, we 
are providing the electronic, layered design files, as well as 
technical specifications, with the final rule. These materials are 
available at https://www.fda.gov/cigarette-warning-files.
4. Section 1141.10--Required Warnings
a. Section 1141.10(a) and (b)--Required Warnings
    In proposed Sec.  1141.10(a) and (b), we proposed to establish 
required warnings, consisting of one textual warning statement with a 
specific color graphic to accompany the textual warning statement, 
which must be accurately reproduced from the materials incorporated by 
reference in Sec.  1141.5 (proposed Sec.  1141.10(a) and (b)). We 
received comments on the required warnings, and we discuss those 
comments and our responses in section VII. After reviewing public 
comments and weighing additional scientific, legal, and policy 
considerations, FDA is removing 2 of the 13 required warnings included 
in the proposed rule, and FDA is finalizing Sec.  1141.10(a) and (b) 
with 11 required warnings. As described in the preceding paragraphs, 
FDA is also making clarifying changes to Sec.  1141.10(b) to make it 
more apparent that it is the combination of a textual warning statement 
and its accompanying color graphic that we are incorporating by 
reference and that must be accurately reproduced in the appropriate 
size and format.
b. Section 1141.10(c)--Packages
    We proposed that section 1141.10(c) establish a requirement for 
packages making it unlawful for any person to manufacture, package, 
sell, offer to sell, distribute, or import for sale or distribution 
within the United States any cigarettes unless the package of which 
bears a required warning in accordance with section 4 of the FCLAA and 
this part. This section requires that: (1) The required warning must 
appear directly on the package and must be clearly visible underneath 
any cellophane or other clear wrapping; (2) The required warning must 
comprise at least the top 50 percent of the front and rear panels; 
provided, however, that on cigarette cartons, the required warning must 
be located on the left side of the

[[Page 15689]]

front and rear panels of the carton and must comprise at least the left 
50 percent of these panels; and (3) The required warning must be 
positioned such that the text of the required warning and the other 
information on that panel of the package have the same orientation. We 
received comments on these requirements, including a comment that we 
add an additional requirement under Sec.  1141.10(c). After review and 
consideration of the comments, FDA is finalizing this subsection 
without change.
    (Comment 83) At least one comment suggests that the required 
warning on packages be at least 75 percent on the front and rear panels 
of the package, similar to the approach of other countries, such as 
Canada and Australia. Additionally, multiple other comments support the 
provision requiring the warning comprise at least the top 50 percent of 
the front and rear panels of cigarette packages, stating that this 
ensures that the required warnings are visible to consumers.
    (Response 83) Section 4 of the FCLAA establishes size requirements, 
and FDA declines to increase the size of the required warnings. Based 
on the FCLAA, Sec.  1141.10(c)(2) states that the required warnings 
must comprise at least the top 50 percent of the front and rear panels 
of the package and that the required warnings must be located on the 
left side of the front and rear panels of cartons and comprise at least 
the left 50 percent of these panels.
    (Comment 84) FDA received comments from both industry and public 
health organizations suggesting that the front and rear panels could 
carry separate warnings (i.e., a different warning on each side). One 
comment suggests this could provide more information to consumers, and 
other comments support this as a means of providing some flexibility to 
manufacturers, given printing and other considerations. Another comment 
suggests FDA could require warnings in different languages on the front 
and rear panels of the cigarette package or, through a future 
rulemaking, FDA could develop two separate images for each warning so 
that any given package would feature the same warning text on each side 
but a different depiction.
    (Response 84) Section 4(a)(1) of the FCLAA is ambiguous as to 
whether it mandates the use of the same required warning on both the 
front and rear panels of the individual cigarette package, or allows 
two different required warnings to be used, one on the front panel and 
the other on the rear panel. At this time, we see no reason to mandate 
that the front and rear panels must carry the same required warnings. 
Accordingly, the current rulemaking permits manufacturers to use 
different required warnings if they wish. This is also consistent with 
Congress's intent that all of the required warnings be displayed in the 
marketplace at the same time (see section 4(c)(1) and (3) of the 
FCLAA). As the comments indicate, additional changes such as those 
suggested (e.g., requiring text in different languages, multiple images 
for each warning) could be considered in a further rulemaking.
    (Comment 85) FDA received a comment suggesting that a subsection 
(4) be added to Sec.  1141.10(c) to help ensure that the required 
warnings be unobstructed from view in the retail environment.
    (Response 85) FDA declines to make this change as we anticipate 
that this concern will be adequately addressed by other provisions of 
the rule, such as Sec.  1141.1(c) and Sec.  1141.1(d). Under Sec.  
1141.1(c), a retailer would not be in violation of 1141.10 for 
packaging that: (1) Contains a warning; (2) is supplied to the retailer 
by a license- or permit-holding tobacco product manufacturer or 
distributor; and (3) is not altered by the retailer in a way that is 
material to 15 U.S.C. 1333 or proposed part 1141. Under Sec.  
1141.1(d), the advertisement requirements apply to a retailer only if 
the retailer is responsible for or directs the warnings for 
advertising, but this provision does not relieve a retailer of 
liability if the retailer displays in a location an advertisement that 
does not contain a warning or that contains a warning that has been 
altered by the retailer in a way that is material to section 4 of the 
FCLAA or the requirements of part 1141. As discussed in the proposed 
rule, retailers would be in violation of the FCLAA and part 1141 if 
they alter cigarette packaging or advertising in a way that is material 
to these requirements. This could, for example, occur if a retailer 
obscures or covers the required warning (e.g., blocking with a sticker 
or marker), shrinks the warning, or uses a sleeve to cover the warning. 
Retailers also would be liable if they display, in a location open to 
the public, an advertisement that does not contain a warning.
c. Section 1141.10(d)--Advertisements
    We proposed that Sec.  1141.10(d) establish that it is unlawful for 
any manufacturer, distributor, or retailer of cigarettes to advertise 
or cause to be advertised within the United States any cigarette unless 
each advertisement bears a required warning in accordance with section 
4 of the FCLAA and part 1141. The proposed requirements provide, in 
part, that: (1) For print advertisements and other advertisements with 
a visual component (including, for example, advertisements on signs, 
retail displays, internet web pages, digital platforms, mobile 
applications, and email correspondence), the required warning must 
appear directly on the advertisement; and (2) the required warning must 
comprise at least 20 percent of the area of the advertisement in a 
conspicuous and prominent format and location at the top of each 
advertisement within the trim area, if any.
    In addition, we proposed in Sec.  1141.10(d)(3) that the text in 
each required warning must be in the English language, except in the 
case of an advertisement that appears in a non-English medium, the text 
in the required warning must appear in the predominant language of the 
medium whether or not the advertisement is in English, and in the case 
of an advertisement that appears in an English language medium but that 
is not in English, the text in the required warning must appear in the 
same language as that principally used in the advertisement. We also 
proposed in Sec.  1141.10(d)(4) and (5) that for English-language and 
Spanish-language warnings, each required warning must be obtained from 
the electronic files contained in ``Required Cigarette Health 
Warnings,'' which would be incorporated by reference at Sec.  1141.5, 
and be accurately reproduced as specified in ``Required Cigarette 
Health Warnings,'' and for non-English-language warnings, other than 
Spanish-language warnings, each required warning must be obtained from 
the electronic files contained in ``Required Cigarette Health 
Warnings,'' which would be incorporated by reference at Sec.  1141.5, 
and be accurately reproduced as specified in ``Required Cigarette 
Health Warnings,'' including the substitution and insertion of a true 
and accurate translation of the textual warning statement in place of 
the English language version. The inserted textual warning statement 
must comply with the requirements of section 4 of the FCLAA, including 
area and other formatting requirements, and this part.
    In the following paragraphs, we discuss comments on these 
provisions. After carefully considering the comments, we are finalizing 
these provisions without substantive change; however, as described 
earlier in this section, we made clarifications to Sec.  1141.10(d)(4) 
and (5) to make it more apparent that it is the combination of a 
textual warning statement and its

[[Page 15690]]

accompanying color graphic that we are incorporating by reference and 
that must be accurately reproduced in the appropriate size and format.
    (Comment 86) Several comments note general support for the 
provision requiring that the required warning comprise at least 20 
percent of the area of the advertisements stating that it is sufficient 
to ensure the required warnings are visible to consumers. FDA also 
received a comment requesting that we consider adding price promotions 
and coupons to the examples provided in Sec.  1141.10(d) because many 
apps, mailers, and pop up ads contain only coupons or price promotions, 
like quick response codes.
    (Response 86) FDA agrees with the general support for these 
provisions. We note that the list of examples included in this 
provision is not intended to be exhaustive, and that the requirements 
under part 1141 apply to all forms of cigarette advertising, regardless 
of the medium in which it appears. The final rule applies to 
advertisements appearing in or on, for example, promotional materials 
(point-of-sale and non-point-of-sale), billboards, posters, placards, 
published journals, newspapers, magazines, other periodicals, 
catalogues, leaflets, brochures, direct mail, shelf-talkers, display 
racks, internet web pages, electronic mail correspondence, or be 
communicated via mobile telephone, smartphone, microblog, social media 
website, or other communication tool; websites, applications, or other 
programs that allow for the sharing of audio, video, or photography 
files; video and audio promotions; and items not subject to the sale or 
distribution restriction in Sec.  [thinsp]1140.34. We agree that the 
requirement that the required warning comprise at least 20 percent of 
the area of the advertisement in a conspicuous and prominent format and 
location at the top of each advertisement within any trim area will 
help ensure the warnings are visible to consumers.
    (Comment 87) Some comments address the translation of the textual 
warning statements into languages other than Spanish and express 
concerns that manufacturers or retailers might undermine the 
effectiveness of the required warning by using a language in the 
warning that is not appropriate to the audience reading or experiencing 
the advertisement. A comment suggests that if FDA does not provide 
warning translations in languages other than English and Spanish, then 
FDA should review any translated warning before the product can be 
advertised. Another comment recommends that FDA provide the translation 
of textual warning statements into languages most commonly used, other 
than English, to help ensure access to this information as a health 
equity measure.
    (Response 87) Although we decline to provide additional 
translations, FDA does intend to monitor translations to ensure that 
they are accurately reproduced and will take action, as appropriate, to 
address any translations that do not meet the requirements of the FCLAA 
and the final rule. Under Sec.  1141.10(d)(5) all non-English-language 
warnings, other than Spanish-language warnings, must be accurately 
reproduced as specified in ``Required Cigarette Health Warnings, 
2020,'' including the substitution and insertion of a true and accurate 
translation of the textual warning statement in place of the English 
language version. If a translation of a textual warning statement is 
not a true and accurate translation, as required by Sec.  
1141.10(d)(5), the cigarette will be deemed to be misbranded under 
section 903(a)(1) or 903(a)(7)(A) of the FD&C Act for failure to bear 
one of the required warnings in accordance with section 4 of the FCLAA 
and this part.
d. Section 1141.10(e) and (f)--Other Requirements
    In the proposed rule, Sec.  1141.10(e) states that the required 
warnings must be indelibly printed on or permanently affixed to the 
package or advertisement. Proposed Sec.  1141.10(f) establishes that no 
person may manufacture, package, sell, offer for sale, distribute, or 
import for sale or distribution within the United States cigarettes 
whose packages or advertisements are not in compliance with section 4 
of the FCLAA and this part, except as provided by Sec.  1141.10(c) and 
(d). We received no comments regarding these specific proposed 
provisions and are finalizing Sec.  1141.10(e) and (f) without change.
e. Section 1141.10(g)--Cigarette Plans
    Section Sec.  1141.10(g)(1) proposed that the required warnings for 
packages must be randomly displayed in each 12-month period, in as 
equal a number of times as is possible on each brand of the product and 
be randomly distributed in all areas of the United States in which the 
product is marketed in accordance with a plan submitted by the tobacco 
product manufacturer, distributor, or retailer to, and approved by, 
FDA. In addition, proposed Sec.  1141.10(g)(2) provides that the 
required warnings for advertisements must be rotated quarterly in 
alternating sequence in advertisements for each brand of cigarettes in 
accordance with a plan submitted by the tobacco product manufacturer, 
distributer, retailer to, and approved by, FDA. Under proposed Sec.  
1141.10(g)(3), FDA will review each plan submitted under this section 
and approve it if the plan: (1) Will provide for the equal distribution 
and display on packaging and the rotation required in advertising under 
this subsection and (2) assures that all of the labels required under 
this section will be displayed by the tobacco product manufacturer, 
distributor, or retailer at the same time. Under proposed Sec.  
1141.10(g)(4) each tobacco product manufacturer required to randomly 
and equally display and distribute warnings on packaging or rotate 
warnings in advertisements in accordance with an FDA-approved plan 
under section 4 of the FCLAA and this part must maintain a copy of such 
FDA-approved plan and make it available for inspection and copying by 
officers or employees duly designated by the Secretary of Health and 
Human Services. The FDA-approved plan must be retained while in effect 
and for a period of not less than 4 years from the date it was last in 
effect.
    After considering the comments on Sec.  1141.10(g), we are 
finalizing this provision without change. We discuss both the comments 
and our responses in the following paragraphs.
    (Comment 88) Some comments express general support both for the 
rotation requirements to reduce the risk of wear out and overexposure 
and for the submission of plans for approval by FDA. These comments 
encourage FDA to have in place robust compliance processes to assess 
whether manufactures, distributors, and retailers are meeting the 
requirements of this rule. Some comments note that ``particular 
attention'' be directed toward media and retailers serving people of 
color, people with low incomes, and LGBTQ populations.
    (Response 88) We agree that the requirements related to cigarette 
plans are important to implementing the requirements of the FCLAA. The 
required warnings on packages must be randomly displayed and 
distributed in accordance with an FDA-approved plan. Similarly, the 
required warnings for advertisements must be rotated quarterly in 
alternating sequence in advertisements, in accordance with an FDA-
approved plan. Each tobacco product manufacturer must maintain a copy 
of the plan and make it available for inspection and copying by 
officers or employees duly designated by the Secretary. A cigarette 
will be deemed to be misbranded under section 903(a)(1) or 903(a)(7)(A) 
and (8) of the FD&C Act if its package or advertising does not bear one 
of the required warnings in

[[Page 15691]]

accordance with section 4 of the FCLAA and this part. We further 
discuss the importance of enforcing these requirements in later 
paragraphs of this section (see section IX.B.6).
    (Comment 89) Two comments raise concerns related to satisfying the 
``random and equal'' requirement of proposed Sec.  1141.10(g) for 13 
different warnings without significant changes to packaging production. 
These comments note that because 13 is both a prime and odd number, 
printing 13 different warnings equally is incompatible with industry-
wide printing practices. One comment suggests that FDA either require a 
random and equal distribution of 12 or 9 warnings or random but unequal 
display of 13 warnings. The other comment proposes that FDA require 9 
different warnings and provide greater flexibility for the random and 
equal requirement because of printing method variation across the 
industry.
    (Response 89) FDA is requiring 11 warnings, which we appreciate is 
also a prime and odd number and thus may present similar issues. We 
address some of these issues in section X. In addition, by permitting 
the front and rear panels to carry different warnings, the rule may 
mitigate some of these issues by giving manufacturers flexibility in 
how they meet the requirements of the rule. We also note that the FCLAA 
provides that the 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,'' which we believe provides for some flexibility 
in the meaning of ``equal,'' as defined below. Manufacturers with 
concerns about complying with this requirement should promptly reach 
out to FDA to discuss their approach for reasonably achieving the 
random and equal display and distribution of the required warnings, in 
as equal a number of times as is possible, and any other specific 
concerns or circumstances regarding this requirement. We encourage 
manufacturers to submit their cigarette plan to FDA as soon as possible 
so that we can discuss these concerns and consider proposals with 
manufacturers in a timely manner. FDA intends to issue a final guidance 
document with additional information and recommendations that may be 
helpful in preparing these plans, which, when issued, may be found at 
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
    (Comment 90) Comments also raised concerns about satisfying the 
``random and equal'' requirement within the 12-month period prescribed 
by proposed Sec.  1141.10(g)(1), which states each required warning 
would be required to be randomly displayed in each 12-month period, in 
as equal a number of times as is possible on each brand of the product. 
These comments asked for clarification of the phrase ``as is possible'' 
and asked for flexibility in achieving ``equal distribution.'' At least 
two comments suggest a deviation allowance of 4 percent (or larger). 
These comments also note the difficulty of achieving equal distribution 
within the 12-month period specified and asked for a longer period in 
which to achieve equal distribution, suggesting that achieving the 
random and equal requirement within the 12-month period would be 
particularly challenging for products with low annual volume sales.
    (Response 90) We recognize and understand the difficulties in 
achieving the random and equal display requirement within a 12-month 
period given the number of required warnings and agree that some level 
of deviation is appropriate particularly given the language of the 
FCLAA, which includes the phrase ``as equal a number of times as is 
possible.'' The cigarette plan for packaging should include a 
discussion of how the requirements are to be implemented based on the 
specific manufacturing processes and distribution procedures to ensure 
random display, in as equal a number of times as is possible, in each 
12-month period on each brand of the product. Manufacturers with 
concerns about complying with this requirement for their products 
should promptly reach out to FDA to discuss their approach and proposal 
for reasonably achieving the random and equal display and distribution 
of the required warnings, in as equal a number of times as is possible, 
and any other specific concerns or circumstances regarding this 
requirement. We encourage manufacturers to submit their cigarette plan 
to FDA as soon as possible so that we can discuss these concerns and 
consider proposals with manufacturers in a timely manner. Additionally, 
FDA intends to issue a final guidance document with additional 
information and recommendations that may be helpful in preparing these 
plans, which, when issued, may be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
    (Comment 91) One comment requests that FDA accept in digital files 
(i.e., electronic art) the representative samples of packages and 
advertisements with each of the required warnings submitted with 
cigarette plans as FDA does for biannual tobacco product listing 
submissions. The comment notes that this would allow plans to be 
prepared quickly without the expense of engraving cylinders and 
obtaining proofs for each brand style. The comment also notes that the 
submission of physical packages would also be time-consuming, whereas 
the use of digital files would allow companies to more quickly respond 
without the time and expense of re-engraving cylinders.
    (Response 91) FDA agrees that it is acceptable to voluntarily 
submit representative advertisements and packaging as digital files 
(i.e., electronic art) along with other information that the 
manufacturer elects to submit with the cigarette plan to ensure that it 
is complete. The information submitted should describe a plan to 
achieve the random and equal display and distribution of the required 
warnings on packages and the quarterly rotation of the required 
warnings in advertisements. As discussed in the section IX of the 
proposed rule, FDA is only requesting that the cigarette plan include 
representative samples of packages and advertisements with each of the 
required warnings. The samples are to place the cigarette plan in 
context and facilitate FDA's review of the plan. FDA's review of a 
cigarette plan is only for the purpose of determining compliance with 
the statutory and regulatory criteria for approval of a cigarette plan, 
as set forth in section 4(c)(3) of the FCLAA and proposed Sec.  
1141.10(g)(3). Approval of a cigarette plan does not represent a 
determination by FDA that any specific package or advertisement 
complies with any of the other requirements under section 4 of the 
FCLAA and part 1141, or any other requirements under the FD&C Act and 
its implementing regulations. Additionally, FDA intends to issue a 
final guidance document with additional information and recommendations 
that may be helpful in preparing these plans, which, when issued, may 
be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
    (Comment 92) FDA also received at least one comment requesting FDA 
clarify in the final rule that retailers are not required to submit 
plans for random and equal display of the required warnings for 
packages and quarterly rotation of the required warnings in 
advertisements. The comment notes that requiring retailers to submit a 
plan exceeds FDA's authority, would unduly burden retailers, and is not 
achievable as retailers have no control over which heath warning is 
displayed as they receive the cigarette packages that they sell, and 
often the advertisements they use, from tobacco product manufacturers 
and distributors.

[[Page 15692]]

    (Response 92) With respect to the concerns related to retailers, 
Sec.  1141.1(c) and (d) explain when a retailer is not in violation of 
the FCLAA and Sec.  1141.10. Under Sec.  1141.1(c), retailers typically 
would not be required to submit a cigarette plan for packaging, as long 
as the cigarette packaging: (1) Contains a warning; (2) is supplied to 
the retailer by a license- or permit-holding tobacco product 
manufacturer or distributor; and (3) is not altered by the retailer in 
a way that is material to 15 U.S.C. 1333 or part 1141 (see Sec.  
1141.1(c)). We believe most, if not all, retailers would fall under 
this scenario. Retailers who are also manufacturers will be subject to 
both the requirements for retailers and manufacturers, as applicable. 
Retailers that are responsible for or direct the warnings for 
advertising will be required to submit a cigarette plan for advertising 
and would be subject to the advertisement requirements set forth in 
Sec.  1141.10(d). We note, however, this provision will not relieve a 
retailer of liability if the retailer displays in a location open to 
the public an advertisement that does not contain a warning or that 
contains a warning that has been altered by the retailer in a way that 
is material to section 4 of the FCLAA or the requirements of this 
proposed part.
    We discuss these provisions in more detail in the section IX of the 
proposed rule. In general, based on FDA's experience reviewing plans 
for other tobacco products, we believe it is likely that for domestic 
products only one cigarette plan will be submitted for each brand and 
that the brand's manufacturer will submit this plan because, in most 
instances, the brand's manufacturer is the entity best able to ensure 
that a plan meets the relevant requirements. The brand's manufacturer 
is also typically the entity responsible, either directly or through a 
contractor or other agent, for placing or directing the placement of 
the required warnings on the brand's cigarette packages and for 
directing distribution. For cigarettes that are imported, the importer 
(included in the definition of manufacturer) usually directs 
distribution of the packages after they are imported. Therefore, for 
imported cigarettes, the importer is likely best-positioned to submit 
the plan. To further aid in the understanding of the cigarette plan 
requirements, FDA intends to issue a final guidance document with 
additional information and recommendations that may be helpful in 
preparing these plans, which, when issued, may be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
5. Section 1141.12--Misbranding of Cigarettes
    Under proposed Sec.  1141.12 a cigarette would be deemed to be 
misbranded under section 903(a)(1) of the FD&C Act if its package does 
not bear one of the required warnings and will be deemed to be 
misbranded under section 903(a)(7)(A) of the FD&C Act if its 
advertising does not bear one of the required warnings in accordance 
with section 4 of the FCLAA and this part. In addition, under proposed 
Sec.  1141.12(b) a cigarette advertisement and other descriptive 
printed matter issued or caused to be issued by the manufacturer, 
packer, or distributor would be deemed to include a brief statement of 
relevant warnings for the purposes of section 903(a)(8) of the FD&C Act 
if it bears one of the required warnings in accordance with section 4 
of the FCLAA and this part. A cigarette distributed or offered for sale 
in any State shall be deemed to be misbranded under section 903(a)(8) 
of the FD&C Act unless the manufacturer, packer, or distributor 
includes in all advertisements and other descriptive printed matter 
issued or caused to be issued by the manufacturer, packer, or 
distributor with respect to the cigarette one of the required warnings 
in accordance with section 4 of the FCLAA and this part. We received no 
comment regarding proposed Sec.  1141.12, and we are finalizing this 
section without change.
6. Other Comments--Compliance
    (Comment 93) FDA received some general comments related to 
enforcement of the rule. These comments encourage FDA to ensure 
enforcement of the required warnings on packages and advertisements 
particularly in neighborhoods of low SES. The comments suggest that 
surveillance and fines may improve compliance. Other comments recommend 
that FDA be mindful of vendors who, although illegal, might sell 
merchandise such as from their backpacks.
    (Response 93) FDA agrees that enforcing warning requirements is 
important. FDA conducts routine monitoring and surveillance of the 
manufacturing, marketing, sales, distribution, labeling, advertising 
and other promotional activities of regulated tobacco products for 
compliance with applicable provisions of the FD&C Act. FDA has a range 
of tools to help ensure compliance with tobacco product regulations. 
Failure to comply with the FCLAA, FD&C Act, or their implementing 
regulations may result in FDA initiating action, including, but not 
limited to, warning letters, civil money penalties, no-tobacco-sale 
orders, seizures, injunction, or criminal prosecution. Additionally, 
misbranded tobacco products offered for import into the United States 
are subject to detention and refusal of admission.
    (Comment 94) Another comment also suggests that FDA require 
manufacturers to submit inventory information, including information on 
levels of inventory and when it is expected to be sold, as a means of 
distinguishing cigarette packages sold from existing inventory from 
inventory manufactured after the effective date. The comment recommends 
FDA ask for information on how to read date codes to help the Agency 
better understand which manufacturers may not be complying with the 
rule.
    (Response 94) FDA declines to adopt these suggestions as section 
201(b) of the Tobacco Control Act imposes a requirement that, beginning 
30 days after the effective date of the final rule, manufacturers would 
not be permitted to introduce into domestic commerce any cigarette 
packages that do not contain the required warnings, irrespective of the 
date of manufacture. FDA believes this requirement addresses the 
concern related to ensuring compliance with the required warnings.

X. Comments Regarding Implementation Issues

    Some comments raise questions related to implementing the 
requirements of the final rule. We describe and address those comments 
in the following paragraphs.
    (Comment 95) FDA received comments objecting to the proposed rule 
as based on a fundamental misunderstanding of the processes used to 
print the vast majority of cigarette packaging in the United States, 
which one comment states is a gravure process using engraved cylinders. 
These comments state the rule would place significant and unnecessary 
burdens on industry because the requirement of random and equal display 
and distribution is infeasible.
    (Response 95) We disagree that the rule is based on a fundamental 
misunderstanding of the processes used to print the vast majority of 
cigarette packaging in the United States. We respond to this particular 
concern in more detail in the Final Regulatory Impact Analysis that is 
issuing with the final rule (Ref. 16), but we note generally that 
(contrary to the

[[Page 15693]]

comment's suggestion) FDA's Labeling Cost Model does assume that 95 
percent of cigarette UPCs will be printed using the gravure method.
    In addition, we recognize and understand that achieving conformity 
with the narrowest possible reading of the random and equal display 
requirement within a 12-month period would pose some difficulties, and 
we agree that allowing some level of deviation is appropriate 
particularly given the language of the FCLAA, which includes the phrase 
``as equal a number of times as is possible.'' As we discuss in section 
IX, the cigarette plan for packaging should include a discussion of how 
the requirements are to be implemented based on the specific 
manufacturing processes and distribution procedures to ensure random 
display, in as equal a number of times as is possible, in each 12-month 
period on each brand of the product. Manufacturers with concerns about 
complying with this requirement for their products should promptly 
reach out to FDA to discuss their approach and proposal for reasonably 
achieving the random and equal display and distribution of the required 
warnings, in as equal a number of times as is possible, and any other 
specific concerns or circumstances regarding this requirement. We 
encourage manufacturers to submit their cigarette plan to FDA as soon 
as possible so that we can discuss these concerns and consider 
proposals with manufacturers in a timely manner. Additionally, FDA 
intends to issue a final guidance document with additional information 
and recommendations that may be helpful in preparing these plans, 
which, when issued, may be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
    (Comment 96) One comment requests ``Printer's Proofs'' for each 
required warning to facilitate consistent reproduction of the color 
images. The comment notes that manufacturers use different ink 
application techniques and substrates, which could result in altered 
appearances of the warnings on packs.
    (Response 96) FDA intends to provide Printer's Proofs upon request. 
Regulated entities can request a set of SWOP or GRACoL Printer's Proofs 
for the required warnings (each set will contain a total of 22 proofs: 
The 11 required warnings with black text on white backgrounds and the 
11 required warnings with white text on black backgrounds). Requests 
can be submitted by email ([email protected]), phone 
(1-877-CTP-1373) or regular mail (Food and Drug Administration, Center 
for Tobacco Products, Document Control Center, Building 71, Room G335, 
ATTN: Office of Health Communication and Education, 10903 New Hampshire 
Ave., Silver Spring, MD 20993-0002).
    (Comment 97) One comment discusses a challenge with accurately 
reproducing the required warnings on a variety of cigarette package 
shapes and sizes. The company asked that FDA provide specific direction 
for permissible adjustments to the required warnings and that FDA 
tolerate minor variances in how the warnings appear on cigarette 
packaging.
    (Response 97) As discussed in section IX.B.3, we are providing the 
required warnings in a variety of sizes and formats as incorporated by 
reference materials. In addition, we are providing electronic, layered 
design files in an .eps format, which manufacturers may use in 
developing their packaging and labeling, as well as technical 
specifications to selecting, using, and adapting these files. These 
documents will provide extensive information and help manufacturers 
accurately reproduce the required warnings for different packages 
shapes and sizes.
    (Comment 98) One comment requests that FDA clarify how 
manufacturers should incorporate the required warnings on packs with 
hinged lids. The comment states that the content of warnings printed on 
the hinged lids can shift up or down by about 1 mm at the point where 
the lid meets the front of the pack due to normal variations in 
production of the packaging. These comments recommend that FDA design 
the warnings with all text located either above or below the hinged 
lid, allow for minor variations in how the required warnings appear on 
cigarette packs due to this manufacturing variability, or provide font 
suitcases and instructions for use that allow manufacturers to flow 
text freely within a designated text area to ensure that the text is 
not interrupted.
    (Response 98) To ensure that the warning is clear and legible on 
hinged lid packages, FDA is allowing for minor variations in how the 
required warnings appear. Manufacturers can separate two lines of text 
within the textual warning statement such that the line at the location 
where the lid is to open cuts across the background space between two 
lines rather than through a line of text. This will help ensure that 
the textual warning statement is not severed when the package is opened 
and is clear, conspicuous, and legible in accordance with section 4 of 
the FCLAA. We note that product packages with hinged lids are widely 
prevalent in countries that already require pictorial cigarette 
warnings and, based on that experience, we conclude that this new 
provision should provide companies with flexibility for displaying the 
warnings on packages with hinged lids.
    (Comment 99) One comment requests that FDA allow manufacturers to 
position warnings below soft pack closures. The comment explains that 
the top of a cigarette soft pack is folded down and held down by an 
adhesive closure that is applied after the packages have been printed. 
Without any accommodation, that closure would obstruct a portion of the 
required warnings. The comment notes that in FDA's 2011 rulemaking, the 
Agency permitted manufacturers to ``adapt the warnings on 'soft pack' 
style packaging by moving the warning below the closure'' (76 FR at 
36691), but the comment asserts that the 0.375 inch boundary that FDA 
previously contemplated is too small to ensure there is enough adhesive 
for the package to remain closed while accounting for standard printing 
variations. Instead, the comment requests that FDA should allow the 
closure to extend up to 0.482 inches from the top of the edge of the 
package.
    (Response 99) FDA disagrees. As in 2011, we recognize the 
technological difficulty of incorporating the required warnings on 
``soft pack'' style packaging. Given the paramount need to incorporate 
the warning without obstructing any of the elements of the warning 
(i.e., the image and the textual warning statement), a company may 
adapt the warnings on ``soft pack'' style packaging by moving the 
warning below the closure. Because of the importance of maintaining the 
integrity of the required warning (e.g., not distorting the image or 
text), an adaptation of 0.375 inches may be acceptable only when it is 
not technologically feasible to incorporate the required warnings on 
``soft pack'' style packaging without the need to adapt the required 
warning and the required warning after the adaptation is still 
accurately reproduced (e.g., the required warning is not distorted). 
Anything in excess of 0.375 inches may begin to distort the required 
warning and likely would not be in compliance with the requirements of 
the FCLAA and part 1141. We strongly encourage manufacturers to reach 
out to us to discuss these issues.
    Under this approach, companies using ``soft pack'' style packaging 
could move only the upper boundary of the display area of the warning 
so that it runs along a line that is parallel to and not more than 
0.375 inches from the top edge of the package. The companies may 
compress the vertical size of the

[[Page 15694]]

image and then shift it down (so that it stays within the top 50 
percent of the package), but companies who do this must ensure that, to 
the extent the required warning must be adapted to fit the dimensions 
of the warning area below the closure, the proportions of the required 
warning must be maintained. In addition, the closure and the portion of 
the packaging that appears between the top edge of the package and the 
upper boundary of the display area of the required warning must be 
either solid black or solid white. This will allow companies to 
continue to produce ``soft pack'' style packaging with closures at the 
top center of the pack without obstructing the required warning. 
However, if we determine that it would be technologically feasible to 
incorporate the required warnings on ``soft pack'' style packaging 
without the need to adapt the warning in this way, we plan to notify 
the regulated companies and the public of this conclusion and give 
regulated companies a reasonable amount of time to modify their 
packaging before any regulatory action is taken under this rule.
    (Comment 100) Some comments request clarifications on implementing 
the advertising requirements when the advertisement is what they call 
``small'' or digital. For example, one comment notes that the proposed 
rule does not provide clarification regarding the display of warnings 
in digital advertisements. The comment asks that FDA evaluate existing 
digital platforms and provide specific direction on how to display the 
required warnings based on specific devices and software prior to 
finalizing the final rule. Another comment notes challenges related to 
displaying the warnings on small advertisements in a way that is not 
illegible or distorted. This comment suggests that FDA exempt small 
advertisements from the warning requirements or revise the minimum font 
requirements and use an appropriate image specifically designed for 
small formats.
    (Response 100) Although FDA acknowledges that implementing the 
requirements for certain small advertisements and some digital 
advertisements may present specific challenges in certain cases, we 
decline to exempt small advertisements. In both the case of digital 
advertisements or small advertisements, FDA invites manufacturers to 
raise the specific implementation issue they have as part of the 
submission of the plan under Sec.  1141.10(g) to facilitate a solution 
that reflects the requirements and is also technically feasible for the 
manufacturer or other responsible entity.

XI. Effective Dates

    In the proposed rule, FDA proposed that the required warnings for 
packages and advertisement become effective 15 months after the date 
the final rule publishes in the Federal Register, consistent with the 
language of section 201(b) of the Tobacco Control Act. FDA also 
proposed an effective date for the submission of plans under Sec.  
1141.10(g) of no later than 5 months after the final rule publishes in 
the Federal Register. Section 201(b) of the Tobacco Control Act 
provides that, beginning 30 days after the effective date, a 
manufacturer must not introduce into domestic commerce of the United 
States any product, irrespective of the date of manufacture, that is 
not in conformance with section 4 of the FCLAA, as amended by the 
Tobacco Control Act. As provided by section 201(b) of the Tobacco 
Control Act, after the 30-day period, manufacturers would not be 
permitted to introduce into domestic commerce any cigarette packages 
that do not contain the required warnings, irrespective of the date of 
manufacture. In the proposed rule, we also requested comments regarding 
ways to differentiate cigarette packages sold from existing inventory 
from those that were manufactured after the effective date.
    We received comments on both of these proposed effective dates, as 
well as the 30-day period. Following consideration of the comments as 
described below, the final rule continues to include an effective date 
of 15 months from the date the final rule publishes in the Federal 
Register, as required by section 201(b) of the Tobacco Control Act. 
However, after further consideration, we are no longer including a 5-
month effective date for the submission of cigarette plans to FDA. The 
FCLAA and Sec.  1141.10(g) require manufacturers to submit plans for 
the display and distribution of required warnings on cigarettes 
packages and the rotation of required warnings on cigarette advertising 
and to obtain FDA approval of their plans before products required to 
bear such warnings enter the market. Therefore, we strongly encourage 
entities to submit cigarette plans as soon as possible after 
publication of this final rule, and in any event within 5 months after 
the publication of this final rule. In addition, as directed by section 
201(b) of the Tobacco Control Act, after the 30-day period, 
manufacturers will not be permitted to introduce into domestic commerce 
any cigarette packages that do not contain the required warnings, 
irrespective of the date of manufacture.
    (Comment 101) Some comments identify a challenge with complying 
with the implementation deadline of 15 months after publication of the 
final rule. These comments note that once the final rule is published 
it will take time to redesign packaging to include the new required 
warnings, submit plans to FDA for review, work with printers to develop 
printing processes to print the new required warnings in accord with 
their approved plans, and then print new packs. These comments request 
an extension of the 15-month deadline, that FDA toll (i.e., pause) the 
deadline during the Agency's review of the rotational plans, or both, 
or that FDA use enforcement discretion to allow companies greater than 
15 months to come into compliance. A comment suggests FDA is obligated 
to determine the length of time it will take manufacturers to engrave 
cylinders and print labels and provide a sufficient amount of time to 
comply with the rule. This comment notes that the number of cylinders 
that need to be engraved will depend on the number of required 
warnings, which could result in thousands of cylinders, that there are 
two main printing companies used by the industry, that manufacturers 
may need additional time to redesign their labels to use fewer colors, 
and lastly, that manufacturers cannot get a head start because of 
uncertainty around the rule surviving constitutional challenge or being 
subject to severability. One comment requests that FDA clarify that 
``distributors and retailers can continue to distribute and sell for an 
unlimited sell-through period products manufactured before the 
effective date and introduced into commerce by the manufacturer within 
30 days of the effective date.'' This comment asserts that small 
tobacco product manufacturers cannot afford the hardship of product 
returns by distributors and retailers who may be uncertain of their 
ability to sell products that do not bear the required warnings.
    Other comments encourage the Agency to maintain the proposed rule's 
timelines for implementation (e.g., submitting cigarette plans no later 
than 5 months after publication of the final rule and implementing the 
warnings no later than 15 months after publication of the final rule) 
as they are reasonable and consistent with the FCLAA, especially given 
the time that has elapsed since the issuance of the initial rule in 
2011 and that the public has been deprived of the benefits of the 
required warnings for almost a decade due to FDA's slow response in 
proposing this rule. These

[[Page 15695]]

comments note that industry has been on notice of the required warnings 
since the enactment of the Tobacco Control Act and manufacturers have 
implemented pictorial cigarette warnings in more than 100 other 
countries.
    (Response 101) We agree with the comments that suggest we maintain 
the proposed 15-month deadline for the effective date of the required 
warnings, consistent with the Tobacco Control Act. Consistent with the 
statute, we believe it is also important to maintain the 30-day period 
after which products may not be introduced into domestic commerce by 
the manufacturer, and we disagree that further clarification of this is 
necessary. Although we acknowledge that there may be some challenges as 
industry moves to implement these requirements, FDA intends to assist 
manufacturers, distributors, and retailers, as applicable, with 
specific questions and concerns regarding these requirements. 
Manufacturers with concerns about complying with this requirement for 
their products should reach out to FDA to discuss their approach and 
proposal for reasonably achieving the random and equal display and 
distribution of the required warnings, in as equal a number of times as 
is possible, and any other specific concerns or circumstances regarding 
compliance with the warning requirements.
    Section 201(a) of the Tobacco Control Act requires manufacturers to 
submit plans for the display and distribution of required warnings on 
cigarettes packages and the rotation of required warnings on cigarette 
advertising, and to obtain FDA approval of their plans before products 
required to bear such warnings enter the market. Therefore, for 
products that will be on the market as of the effective date of the 
required warnings, manufacturers must submit, and FDA must approve, 
their plans ahead of the required warnings' effective date. FDA 
strongly encourages entities to submit cigarette plans as soon as 
possible after publication of this final rule, and in any event within 
five months after publication of this final rule. Doing so will benefit 
regulated industry, based on the comments the Agency received regarding 
the time firms may need to work with printers to implement the required 
warnings as outlined in their approved plans. Early submission will 
facilitate timely FDA review prior to the effective date of the 
required warnings, encourage dialogue with entities regarding any 
implementation concerns, and provide time to consider proposals by 
entities in a timely manner. Given the initial high volume of original 
submissions FDA may receive and based on our experience with review of 
plans for required warnings on other tobacco products, our best 
estimate is that it will take up to 6 months for the Agency to review 
those original submissions. FDA will ensure that its review of 
cigarette plans will be completed no later than 6 months after receipt 
of an adequate plan from persons who work in good faith with FDA to 
complete its review (e.g., persons should work diligently with FDA and 
be responsive by submitting any requested information in a timely 
manner). If there is a higher volume of submissions received than 
currently expected, for those entities who submit an adequate plan 
within 5 months of publication of this final rule and who work in good 
faith with FDA to complete its review, FDA intends to ensure that 
entities are not delayed or prevented from distributing cigarette 
packages or advertising their products due to the Agency's not having 
approved their plans by the effective date of the final rule. In 
addition, FDA intends to issue a final guidance document that is 
intended to assist entities with developing their cigarette plans, 
which, when issued, may be found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.

XII. Severability

    Consistent with section 5 of the Tobacco Control Act, FDA intends 
for the various requirements established by this rulemaking to be 
severable. Section 5 of the Tobacco Control Act states that, if any 
provision of a regulation issued under the Tobacco Control Act is held 
to be invalid, the remainder of the regulation ``shall not be affected 
and shall continue to be enforced to the fullest extent possible.'' 
(Section 5 of the Tobacco Control Act is codified at 21 U.S.C. 387 
note.) FDA has concluded that the individual aspects of this rule are 
workable on their own and should go forward in the event that some are 
invalidated. As discussed below, FDA has determined that severability 
both is consistent with Congressional intent and would best advance the 
Government's interest in promoting greater public understanding of the 
negative health consequences of cigarette smoking.
    The rule is sound in its entirety and should be upheld in full. 
However, in a circumstance where some but not all of the rule's 
provisions are invalidated, FDA's intent is for the other provisions to 
go into effect. A key question to determining severability is whether 
the remaining portions of a regulation ``could function sensibly 
without the stricken provision.'' MD/DC/DE Broadcasters Ass'n v. 
F.C.C., 236 F.3d 13, 22 (D.C. Cir. 2001). Here, FDA has considered each 
provision independently and concluded that the individual portions of 
this rule are workable on their own.
    In the event that some portions of the rule are stricken, FDA has 
concluded that each other portion of the rule would ``function 
sensibly'' on its own and should go into effect. As the proposed rule 
indicated, if a court were to invalidate some of the cigarette health 
warnings (i.e., text-and-image pairings), but some of the pairings 
remained valid, FDA intends that the remaining required warnings would 
go into effect. As another example, if a court were to invalidate some 
but not all of the images within the cigarette health warnings, FDA 
intends that those images would be severed and the corresponding 
textual warning statements would go into effect without the invalidated 
images, along with the remaining cigarette health warnings that pair a 
textual warning statement with an image. As a third example, if a court 
were to invalidate all of the images within the cigarette health 
warnings, FDA intends for the invalidated images to be severed and all 
the warnings to go into effect with only their textual warning 
statements.
    Among other things, FDA has considered the statute's rotation and 
distribution requirements in reaching its conclusion that all portions 
of the rule can function sensibly and should take effect if any 
portions are invalidated. In the event that any warnings specified in 
this final rule do not go into effect, the requirements for warnings to 
be randomly and equally displayed and distributed on packages and 
quarterly rotated in advertisements will be applied to the remaining 
warnings, such as remaining text-and-image pairings or textual warning 
statements without images.
    FDA's intent for any invalidated portions of the rule to be severed 
also advances Congress's intent to replace the stale 1984 Surgeon 
General's warnings and to promote greater public understanding of the 
negative health consequences of cigarette smoking, since the remaining 
warnings could go into effect much earlier than could any different 
warnings implemented by other, subsequent means, such as further Agency 
rulemaking.
    Several comments made remarks supporting or opposing the 
severability of the rule's provisions.
    (Comment 102) One comment objects to any severing of the rulemaking 
because it asserts that FDA did not

[[Page 15696]]

justify each permutation presented in the proposed rule, and severing 
the rulemaking would deny interested parties sufficient notice to 
participate in a meaningful notice and comment process. The comment 
suggests that section 5 of the Tobacco Control Act does not mandate 
severing the rulemaking in this situation. In addition, one comment 
states that because the Tobacco Control Act mandates that the textual 
warning statements must be accompanied by color graphics, FDA does not 
have the discretion to implement the textual warning statements only. 
This comment asserts that FDA is not authorized to change the placement 
of the warnings or reduce the statutory 50 percent size requirement. 
Another comment stated that implementation of only portions of the 
regulation would not be workable from a practical standpoint of 
rotating, distributing, and displaying the required warnings on 
cigarette packages and advertisements.
    In contrast, other comments support severability, arguing that 
should any portion of the rule be invalidated, considering other parts 
severable and workable is consistent with section 5 of the Tobacco 
Control Act and Congressional intent. Some comments specifically 
recommend that should a court invalidate any portion or block the 
images, the remaining portions should go into effect, as they would 
promote greater public understanding of the negative health 
consequences of cigarette smoking. Some comments suggest that 
severability is appropriate, but FDA should further explain its 
rationale to ensure judicial consideration of severability, if 
necessary, to prevent vacation of the entire rule should a court find 
any portion objectionable. One comment addresses the various scenarios 
FDA set out in the proposed rule with suggestions of how FDA should 
proceed in each case. That comment suggests that, if a court blocks the 
images, FDA should proceed with implementing the textual warning 
statements and, even if the size of the warnings is reduced, FDA should 
prioritize maintaining the warning at the top of the pack because of 
the importance of visibility of the warning.
    (Response 102) FDA agrees with comments asserting that, if a 
portion of this rule is invalidated, severability would be appropriate. 
Case law supports that conclusion, including case law regarding the 
severability of statutory provisions. The Supreme Court in Alaska 
Airlines, Inc. v. Brock, 480 U.S. 678 (1987), set forth the test for 
severability of statutory provisions, emphasizing that ``a court should 
refrain from invalidating more of the statute than is necessary.'' Id. 
at 684 (brackets omitted). There are two prongs to the examination. 
First, a court should evaluate whether ``the Legislature would [] have 
enacted those provisions which are within its power, independently of 
that which is not,'' i.e., ``whether the statute will function in a 
manner consistent with the intent of Congress'' if it is stripped of 
its unconstitutional provisions. Id. at 684, 685. Then, the reviewing 
court will consider whether ``what is left is fully operative as a 
law,'' or if instead ``the balance of the legislation is incapable of 
functioning independently.'' Id. at 684 (quotation marks omitted).
    The same test is used to determine whether the invalid portion of a 
statute or the invalid portion of a regulation may be severed from the 
rest. See United States v. Smith, 945 F.3d 729, 738 (2d Cir. 2019) 
(citing decisions addressing statutory severability for the standard to 
determine regulatory severability). ``Whether the offending portion of 
a regulation is severable depends upon the intent of the agency and 
upon whether the remainder of the regulation could function sensibly 
without the stricken provision.'' MD/DC/DE Broadcasters Ass'n v. 
F.C.C., 236 F.3d 13, 22 (D.C. Cir. 2001). See also K-Mart Corp. v. 
Cartier, 486 U.S. 281, 294 (1988) (severing a portion of a Customs 
Service regulation as being in conflict with the statute).
    As noted, FDA intends for every portion of this rule to be 
severable and has concluded that, if some but not all portions of the 
rule were invalidated, remaining portions could and should function 
sensibly on their own. FDA's conclusion is informed by Congress's 
express intent. FDA agrees with the comments that section 5 of the 
Tobacco Control Act, entitled ``Severability,'' expressly signals 
Congress's intent for regulations issued under the statute to be 
severable and for any remaining portion to be legally enforceable 
should any portion be found invalid. Section 5 provides in relevant 
part that ``[i]f any . . . of the regulations promulgated under this 
division . . . is held to be invalid, the remainder . . . shall not be 
affected and shall continue to be enforced to the fullest extent 
possible.'' The inclusion of section 5 in the Tobacco Control Act 
creates a presumption that Congress intended for any invalid portion of 
a regulation issued under the statute to be severable from the 
remainder. Alaska Airlines, 480 U.S. at 686 (same, for statutes; 
holding that when Congress explicitly provides for severance by 
including a severability clause in a statute, there is ``a presumption 
that Congress did not intend the validity of the statute in question to 
depend on the validity of the constitutionally offensive provision''). 
Here, taking into consideration this statutory provision and Congress's 
stated goals in requiring these warnings, FDA is explicitly stating its 
intent that the portions of this regulation be interpreted as 
severable. Therefore, the courts can say without any doubt, and all the 
more strongly ``without any substantial doubt[,] that the agency would 
have adopted the severed portion on its own.'' Am. Petroleum Inst. v. 
Envtl. Prot. Agency, 862 F.3d 50, 71 (D.C. Cir. 2017) (quotation marks 
omitted), modified on other grounds, 883 F.3d 918 (D.C. Cir. 2018).
    The second prong of a severability analysis is whether the 
remaining portions of a statute or regulation remain workable on their 
own. In this case, they do. The different text-and-image pairings and 
the different textual warning statements can be and are intended to be 
incorporated into the label of a package or an advertisement on an 
individual basis and therefore ``operate entirely independently of one 
another.'' Davis Cty. Solid Waste Mgmt. v. U.S. E.P.A., 108 F.3d 1454, 
1459 (D.C. Cir. 1997) (internal citation omitted). Because the Agency 
intends as many of the warnings to go forward as possible, and because 
the regulation will function even if some of the text-and-image 
pairings or the images are invalidated, any provisions of this rule 
that may be invalidated are properly severable.
    With respect to the comment asserting that FDA lacks the discretion 
to implement the warning requirements with textual warning statements 
only or with other deviations from the statutory mandate, FDA notes 
that the question of severability is distinct from that of the 
Congressional directive to issue a warning regulation in the first 
instance. The situation that is the subject of this ``Severability'' 
section--i.e., the circumstance where a court has disagreed with FDA's 
conclusions as to the legality of some but not all provisions of the 
rule--raises different questions from those addressed in the comment. 
Contrary to what the comment states, FDA is not asserting, and does not 
need to assert, that it has the authority to promulgate a rule under 
section 15 U.S.C. 1333 that deviates from the requirements of section 
1333. Instead, FDA here is asserting, and need only assert, that in the 
event that a court invalidates certain provisions of this rule but not 
others, FDA intends the

[[Page 15697]]

remaining provisions to go into effect on their own.
    To the extent that the comment questions FDA's authority to oversee 
implementation of text-only warnings in the event of a court decision 
invalidating the images but upholding the rest of the rule, FDA 
disagrees. The comment asserts that, because the Tobacco Control Act 
directs FDA to issue color graphics to accompany the textual warning 
statements, FDA is without authority to implement the remaining 
portions of a rule if a court invalidates the color graphics but not 
the textual statements. FDA disagrees with any interpretation of the 
statute that would compel this result. Again, the question here relates 
only to severability and to what details of the regulation are 
preserved in the case where some provisions do not survive. The statute 
provides that FDA ``shall issue regulations that require color graphics 
depicting the negative health consequences of smoking to accompany the 
label statements specified in subsection (a)(1)'' (section 201(a) of 
the Tobacco Control Act). But this language does not dictate that, if 
some of the text-and-image pairings, images, or textual warning 
statements were invalidated by a court while other pairings, images, or 
statements were not invalidated, the result would be to invalidate all 
of the rule's requirements. For the reasons described above, in the 
event that some provisions of this rule are invalidated, the statute 
compels, FDA intends, and courts should recognize as workable the 
preservation of all remaining portions.
    FDA disagrees with comments that suggest that stating its 
intentions for severability fails to provide the public with adequate 
notice of the portions of the rule that would take effect if any others 
are severed and prevents meaningful public comment. The public has had 
the opportunity to comment on the entire proposal, as well as each 
required textual warning statement and each required text-and-image 
pairing, and thus all portions that may take effect if other portions 
are severed.
    FDA also disagrees with comments suggesting that, if, for example, 
a court struck down any or all of the images but upheld the textual 
warning statements, the remaining unsevered portions of the rule would 
not be consistent with the intent of Congress. While it is clear that 
in section 201 of the Tobacco Control Act Congress intended for color 
graphics to accompany textual warning statements, and while the 
affirmative proposal of a regulation by FDA under section 201 requiring 
only textual warnings would not effectuate that specific intent, this 
analysis does not answer the question of severability, i.e., of what 
provisions of a regulation should survive in the event that a court 
strikes down some but not all provisions of this rulemaking replacing 
the Surgeon General's warnings with new text-and-image pairings. Here, 
Congress's intent surely supports preservation. It was clearly the 
intent of Congress by passing the Tobacco Control Act to replace the 
stale 1984 Surgeon General's warnings and to increase the size and 
update the placement of new required cigarette warnings, as well as to 
require color graphics. In the event that a court determines that a 
rule is valid with respect to the new textual warning statements but is 
not valid with respect to other aspects, including the color graphics, 
implementation of those other aspects would be consistent with 
Congress's intent to strengthen cigarette warnings.
    Likewise, FDA disagrees with comments that it would be unworkable 
for warnings containing only textual warning statements or only text-
and-image pairings that were not invalidated to take effect. FDA is 
aware of no technical, practical, or other impediment to implementation 
of individual provisions of this rule without the others. Thus, in the 
context of the question of severability, FDA concludes that the 
implementation of warnings containing only textual warning statements 
would be workable (i.e., if all of the images are struck down), as 
would the implementation of a smaller number of required warnings 
(i.e., if some of the text-and-image pairings were found to be invalid 
and were severed, leaving fewer total pairings or a mixture of warnings 
that included both text-only and text-and-image pairings). FDA notes 
that comments do not provide details about why or how the 
implementation of portions of the regulation would not be workable. 
However, if companies have specific questions, FDA is ready to work 
with them regarding implementation issues.

XIII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order (E.O.) 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility 
Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4). E.O.s 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
E.O. 13771 requires that the costs associated with significant new 
regulations ``shall, to the extent permitted by law, be offset by the 
elimination of existing costs associated with at least two prior 
regulations.'' We believe that this final rule is an economically 
significant regulatory action as defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. We estimate that for a small manufacturer or importer who 
would be affected by this final rule, initial costs could represent 
between 2.3 and 42 percent of their annual receipts and recurring costs 
could represent from 0.1 to 2.7 percent of their annual receipts. 
Hence, we find that the final rule will have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $154 million, using the most current (2018) Implicit 
Price Deflator for the Gross Domestic Product. This final rule will 
result in an expenditure in any year that meets or exceeds this amount.
    This final rule requires that one of 11 new cigarette health 
warnings, each comprising a textual warning statement paired with an 
accompanying color graphic, in the form of a photorealistic image, 
appear on cigarette packages and in cigarette advertisements. The final 
rule further requires that, for cigarette packages, the 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 distributed throughout the United States in accordance with a 
plan approved by FDA. The final rule also requires that, for cigarette 
advertisements, the required warnings must be rotated quarterly in 
alternating sequence in advertisements for each brand of cigarettes in 
accordance with a plan approved by FDA.
    Pictorial cigarette health warnings promote greater public 
understanding about the negative health consequences of smoking as they 
increase the noticeability of the warning's message,

[[Page 15698]]

increase knowledge and learning about the negative health consequences 
of smoking, and benefit diverse populations that have disparities in 
knowledge about the negative health consequences of smoking. We do not 
predict the size of these benefits at this time. We discuss the 
informational effects qualitatively.
    The costs of this final rule consist 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. Using a 20-year time horizon, we estimate that 
the present value of the costs of this final rule ranges from $1.5 
billion to $1.7 billion, with a mean estimate of $1.6 billion, using a 
three percent discount rate, and ranges from $1.1 billion to $1.3 
billion, with a mean estimate of $1.2 billion, using a seven percent 
discount rate (2018$). Annualized costs, which are presented below in 
Table 1, range from $100 million per year to $114 million per year, 
with a mean estimate of $107 million per year, using a three percent 
discount rate, and range from $107 million per year to $122 million per 
year, with a mean estimate of $114 million per year, using a seven 
percent discount rate (2018$).
    Because it is not possible to compare benefits and costs directly 
when the benefits are not quantified, we employ a break-even approach. 
If the information provided by the cigarette health warning on each 
cigarette package 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.

                    Table 1--Summary of the Informational Effects and Costs of the Final Rule
                                             [In millions of 2018$]
----------------------------------------------------------------------------------------------------------------
                                                                            Units
                                                               ------------------------------
            Category               Primary     Low      High              Discount   Period          Notes
                                  estimate  estimate  estimate    Year       rate    covered
                                                                 dollars     (%)     (years)
----------------------------------------------------------------------------------------------------------------
Informational Effects...........  Pictorial cigarette health warnings promote greater public understanding about
                                  the negative health consequences of smoking as they increase the noticeability
                                  of the warning's message, increase knowledge and learning of the negative
                                  health consequences of smoking, and help reduce disparities in knowledge about
                                  the negative health consequences of smoking across diverse populations. If the
                                  information provided by the cigarette health warning on each cigarette package
                                  was valued at about $0.01 (for every pack sold annually nationwide), then the
                                  benefits that would be generated by the final rule would equal or exceed the
                                  estimated annual costs.
                                 -------------------------------------------------------------------------------
Costs:
    Annualized Monetized            $114.4    $106.6    $122.2      2018         7        20  Effective date of
     $millions/year.                 106.7     100.0     113.5      2018         3        20   15 months from
                                                                                               date of
                                                                                               publication of
                                                                                               final rule.
----------------------------------------------------------------------------------------------------------------

    In line with E.O. 13771, in Table 2 we estimate present and 
annualized values of costs and cost savings over an infinite time 
horizon. With a seven percent discount rate, discounted relative to 
year 2016, the estimated annualized net costs equal $73 million in 2016 
dollars over an infinite horizon. Based on these costs, this final rule 
is considered a regulatory action under E.O. 13771.

                    Table 2--E.O. 13771 Summary Table
          [In millions of 2016$, over an infinite time horizon]
------------------------------------------------------------------------
                                                                Primary
                            Item                               estimate
                                                                 (7%)
------------------------------------------------------------------------
Present Value of Costs......................................    $1,046.0
Present Value of Cost Savings...............................         0.0
Present Value of Net Costs..................................     1,046.0
Annualized Costs............................................        73.2
Annualized Cost Savings.....................................         0.0
Annualized Net Costs........................................        73.2
------------------------------------------------------------------------
Note: Effective date is 15 months from date of publication of final
  rule.

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 16) and at 
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

XIV. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Additionally, the action is not 
anticipated to pose serious harm to the environment and to adversely 
affect a species or the critical habitat of a species as stipulated 
under 21 CFR 25.21(b). Therefore, neither an environmental assessment 
nor an environmental impact statement is required.

XV. Paperwork Reduction Act of 1995

    The final rule contains information collection requirements that 
are subject

[[Page 15699]]

to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521) (PRA). The title, description, and respondent description of 
the information collection provisions are shown in the following 
paragraphs with an estimate of the annual reporting and recordkeeping 
burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Required Warnings for Cigarette Packages and Advertisements.
    Description: The requirement for submission of plans for cigarette 
packages and advertisements, and the specific marketing requirements 
relating to the random and equal display and distribution of required 
warnings on cigarette packaging and quarterly rotation of required 
warnings in alternating sequence in cigarette product advertising, 
appear in Sec.  1141.10(g). A record of the FDA-approved plan must also 
be established and maintained.
    Description of Respondents: The respondents to this collection of 
information are manufacturers, distributors, and certain retailers of 
cigarettes who will be required to submit plans for cigarette packages 
and advertisements to FDA.
    As required by section 3506(c)(2)(B) of the PRA, FDA provided an 
opportunity for public comment on the information collection 
requirements of the proposed rule that published in the Federal 
Register of August 16, 2019 (84 FR 42754). No PRA-related comments were 
received.
    FDA requests that each cigarette plan cover both packaging and 
advertising as applicable. The tobacco product manufacturer, 
distributor, or retailer should demonstrate how they plan to achieve 
the random display in each 12-month period, in as equal a number of 
times as is possible on each brand of the product, and random 
distribution in all areas of the United States of the required warnings 
on packages and the quarterly rotation in advertisements. Required 
warnings for cigarettes must be randomly displayed, in as equal a 
number of times as is possible, and randomly distributed on packages, 
and rotated quarterly in advertisements, in accordance with an FDA-
approved plan.
    FDA strongly encourages entities to submit their cigarette plans as 
soon as possible after publication of this final rule, and in any event 
within 5 months after publication of this final rule. Packages and 
advertisements of cigarettes are required to bear the required warnings 
beginning 15 months after the date of publication of the final rule. 
FDA intends to request an amendment to a plan under review if FDA needs 
clarification of information in the plan or other additional 
information to determine whether it could approve the plan. Any such 
amendments would likely increase the overall review time.
    After FDA approval of an initial plan, a supplement to the approved 
plan should be submitted to FDA and approved before making changes to 
the random and equal display or distribution of required warnings on 
packages or the quarterly rotation of required warnings in 
advertisements. For a new brand, a new plan or a supplement to an FDA-
approved plan is required to be submitted and approved before 
distributing packages and advertisements for that new brand.
    However, in lieu of a supplement to an FDA-approved plan for a new 
brand, manufacturers may reference in their initial plan all brands in 
their product listing(s) under section 905(i) of the FD&C Act and 
incorporate any new brands into their approved plan, so long as no 
other changes are made to the plan. For retailer-generated advertising, 
retailers may list ``all brands'' in their plan, which would cover 
future brands, so long as the plan provides for the same schedule for 
quarterly rotation of the required warnings for all brands.
    FDA allows electronic submissions, via FDA's Electronic Submissions 
Gateway, and written submissions. FDA strongly encourages electronic 
submission to facilitate efficiency and timeliness of submission and 
processing.
    For each brand of cigarettes, the plan for packaging should explain 
how: Each of the required warnings will be randomly displayed during 
each 12-month period on each brand; each of the required warnings will 
be displayed in as equal a number of times as possible on each brand of 
the product; and product packages will be randomly and equally 
distributed in all areas of the United States in which the product is 
marketed. FDA expects that a plan for random and equal display and 
distribution of required warnings on packages will ordinarily be based 
on the date of manufacture or shipment of the product. For each 
cigarette brand, the plan for advertising should explain how the 
required warnings will be rotated quarterly in advertisements and how 
the quarterly rotations will occur in alternating sequence. Among other 
things, the plan should specify the initial rotation timeframe on which 
quarterly rotation is based and, if the rotation timeframe varies for 
different types/forms of advertising, specify the different quarterly 
timeframes associated with the different types/forms of advertising, 
and describe the quarterly schedule for rotating each of the required 
warnings for each cigarette brand. FDA would not consider a plan that 
merely restated the regulatory requirements to be sufficiently detailed 
to enable FDA to approve the plan.
    FDA's review of a plan would only be for determining compliance 
with the regulatory criteria for approval of a plan, as set forth in 
Sec.  1141.10(g)(1) and (2). FDA requests that plans submitted for 
review include representative samples of packages and advertisements 
with each of the required warnings. Such samples would place the plan 
in context and, therefore, facilitate FDA's review of the plan, not a 
review of the content of the package labels and advertisements. 
Approval of a plan does not represent a determination by FDA that any 
package or advertisement complies with any of the other requirements 
regarding the placement, font type, size, and color of the warnings 
found in section 4 of the FCLAA and part 1141, or any other 
requirements under the FD&C Act and its implementing regulations.
    FDA intends to communicate the approval of a plan with a letter to 
the submitter. After FDA approval of an initial plan, a supplement to 
the approved plan would need to be submitted to FDA for review and 
approved before making changes to the display or distribution of 
required warnings on packages or the rotation of required warnings in 
advertisements. For a new brand, a new plan or a supplement to an 
approved plan would need to be submitted and approved before displaying 
or distributing packages and advertisements for that new brand.
    However, in lieu of a supplement to an approved plan for a new 
brand, manufacturers may reference in their initial plan ``all brands'' 
in their product listing(s) under section 905(i) of the FD&C Act and 
incorporate any new brands into their approved plan, so long as no 
other changes are made to the plan. For retailer-generated advertising, 
retailers may list ``all brands'' in their plan, which would cover 
future brands, so long as the plan provides for the same schedule for 
quarterly rotation of the required warnings for all brands.

[[Page 15700]]



                                Table 3--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          Type of plan               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Initial Plans...................              59               1              59             150           8,850
Supplements.....................              30               1              30              75           2,250
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          11,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates are based on FDA's experience with information 
collections for other tobacco product plans (i.e., OMB control numbers 
0910-0671 (smokeless tobacco products) and 0910-0768 (cigars)) and 2017 
Treasury Alcohol and Tobacco Tax and Trade Bureau (TTB) data.
    As discussed in the Final Regulatory Impact Analysis (see section 
XIII; Ref. 16), based on 2017 TTB data, FDA estimates 59 entities will 
be affected by the rule. We estimate these 59 entities will submit a 
one-time initial plan, and it will take an average of 150 hours per 
respondent to prepare and submit a plan for packaging and advertising 
for a total of 8,850 hours. We estimate that about half of respondents 
will submit a supplement. If a supplement to an approved plan is 
submitted, FDA estimates it will take half the time per response. We 
estimate receiving 30 supplements at 75 hours per response for a total 
of 2,250 hours. FDA estimates that the total hours for submitting 
initial plans and supplements will be 11,100.
    Section 1141.10(g)(4) would establish that each tobacco product 
manufacturer required to randomly and equally display and distribute 
required warnings on packaging or quarterly rotate required warnings in 
advertisements in accordance with an FDA-approved plan under section 4 
of the FCLAA and this part must maintain a copy of the FDA-approved 
plan (approved under Sec.  1141.10(g)(3)). This copy (or record) of 
such FDA-approved plan must be available for inspection and copying by 
officers or employees of FDA. This subsection would require that the 
record(s) be retained while in effect and for a period of not less than 
4 years from the date of FDA's approval of the plan.

                                                   Table 4--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of      Number of records     Total annual      Average burden
                       Plan records                          recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records..................................................                 59                1.5                 89                  3                267
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................                267
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that 59 recordkeepers will keep a total of about 89 
records at 3 hours per record for a total of 267 hours. As stated 
previously, these estimates are based on FDA's experience with 
information collections for other tobacco product plans (i.e., OMB 
control numbers 0910-0671 and 0910-0768). Based on our estimates for 
the submission of initial plans and supplements (that all respondents 
will submit initial plans and about half of respondents will submit 
supplements), we estimate that each recordkeeper will keep an average 
of 1.5 records.
    FDA estimates that the total burden for this information collection 
is 11,367 hours (11,100 reporting hours + 267 recordkeeping hours).
    FDA believes that the required warnings for cigarette packages and 
cigarette advertisements in Sec.  1141.10 are not subject to review by 
OMB under the PRA because they do not constitute a ``collection of 
information'' under that statute (44 U.S.C. 3501-3521). Rather, these 
labeling statements are a ``public disclosure'' of information 
originally supplied by the Federal Government to the recipient for the 
purpose of ``disclosure to the public'' (5 CFR 1320.3(c)(2)).
    The information collection provisions in the final rule have been 
submitted to OMB for review as required by section 3507(d) of the PRA.
    Before the effective date of the final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in the 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

XVI. Federalism

    We have analyzed the final rule in accordance with the principles 
set forth in E.O. 13132. We have determined that the rule does not 
contain policies that have substantial direct effects on the States, on 
the relationship between the National Government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government. Accordingly, we conclude that the rule does not contain 
policies that have federalism implications as defined in the E.O. and, 
consequently, a federalism summary impact statement is not required.

XVII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required. We received two 
comments related to tribal consultation and we respond to those 
comments in the following paragraphs.

[[Page 15701]]

    (Comment 103) One comment objects to the rulemaking as a product of 
a court order rather than of deliberatively reasoned decision making, 
suggesting that due to the expedited schedule and lack of meaningful 
tribal consultation, the effectiveness of the rule in promoting public 
health and its disproportionate effect on tribal communities has not 
been fully considered. The comment notes that, because the tribe relies 
in part on tobacco revenues to fund basic governmental services, the 
rule threatens to have an outsized effect on tribal manufacturers and 
requests that meaningful tribal consultation occur prior to finalizing 
the rule to discuss the impact and cost incurred by tribal governments.
    (Response 103) FDA agrees that collaboration and consultation with 
federally recognized tribal governments, per the FDA Tribal 
Consultation Policy and E.O. 13175, is important. FDA engages with 
tribal stakeholders, including tribal government leaders, tribal health 
leaders, and public health professionals, about the implementation and 
enforcement of the Tobacco Control Act and related regulations by 
various methods (e.g., ``Dear Tribal Leader'' letters, All Tribes' 
Calls, formal and informal consultations as well as face-to-face 
meetings). We also encourage tribes to stay informed about developments 
related to tobacco products through our website (https://www.fda.gov/TobaccoProducts).
    We disagree that the tribal consultation for the proposed rule was 
inadequate. There were several opportunities for tribes to engage with 
FDA about the proposed rule, including the impact and costs of the 
proposed rule on tribal manufacturers, which was considered as part of 
the Preliminary Regulatory Impact Analysis (https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm). In 
a ``Dear Tribal Leader'' letter dated August 15, 2019, FDA initiated 
consultation with federally recognized Indian tribes on the proposed 
rule and invited tribes to participate in an All Tribes' Call on 
September 19, 2019. The purpose of the call was to provide an overview 
of the proposed rule, answer questions, and hear tribal comments on the 
proposed rule. We provided contact information in the letter and during 
the call to help ensure that there was a mechanism to address any 
further questions. We also encouraged tribes to submit written comments 
on the proposed rule and supporting documents such as the Preliminary 
Regulatory Impact Analysis.
    (Comment 104) One comment supports the rule as a means to increase 
understanding of the negative health consequences of smoking and 
encourages FDA to ensure that these efforts reach American Indian/
Alaska Native populations, which have the highest rates of cigarette 
smoking (Ref. 26) but lack understanding of the scope of the negative 
health consequences of smoking. The comment suggests that FDA partner 
with Urban Indian Health organizations to achieve the goals of this and 
any future goals, not as a substitute for tribal consultation but as a 
means to reach a target population.
    (Response 104) We agree that the rule will promote greater public 
understanding of the negative health consequences of smoking. We note 
that in addition to this important rulemaking, FDA is developing other 
outreach with American Indian/Alaska Native partners.

XVIII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

* 1. IOM of the National Academies. Ending the Tobacco Problem: A 
Blueprint for the Nation. R. J. Bonnie, K. Stratton, R. B. Wallace 
(Eds.). Washington, DC: The National Academies Press, 2007. 
Available at https://www.nationalacademies.org/hmd/Reports/2007/Ending-the-Tobacco-Problem-A-Blueprint-for-the-Nation.aspx.
* 2. U.S. Congress. House. Committee on Energy and Commerce, 
Subcommittee on Health. H.R. 1108, Family Smoking Prevention and 
Tobacco Control Act: Hearing Before the House Subcommittee on Health 
of the Committee on Energy and Commerce. Testimony of Richard 
Bonnie. 110th Cong., 1st sess., October 3, 2007.
* 3. U.S. Department of Health and Human Services (HHS). The Health 
Consequences of Smoking--50 Years of Progress: A Report of the 
Surgeon General. Atlanta, GA: HHS, CDC, National Center for Chronic 
Disease Prevention and Health Promotion, Office on Smoking and 
Health, 2014.
4. Hammond, D., G.T. Fong, A. McNeill, et al. ``Effectiveness of 
Cigarette Warning Labels in Informing Smokers About the Risks of 
Smoking: Findings from the International Tobacco Control (ITC) Four 
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Available at https://doi.org/10.1111/j.1460-2466.2007.00360.x.

List of Subjects in 21 CFR Part 1141

    Advertising, Incorporation by reference, Labeling, Packaging and 
containers, Tobacco, Smoking.

0
Therefore, under the Federal Cigarette Labeling and Advertising Act, 
the Federal Food, Drug, and Cosmetic Act, and under authority delegated 
to the Commissioner of Food and Drugs, 21 CFR part 1141 is revised to 
read as follows:

PART 1141--REQUIRED WARNINGS FOR CIGARETTE PACKAGES AND 
ADVERTISEMENTS

Subpart A--General Provisions
Sec.
1141.1 Scope.
1141.3 Definitions.
1141.5 Incorporation by reference.
Subpart B--Required Warnings for Cigarette Packages and Advertisements
1141.10 Required warnings.
1141.12 Misbranding of cigarettes.

    Authority:  15 U.S.C. 1333; 21 U.S.C. 371, 374, 387c, 387e, 
387i; Secs. 201 and 202, Pub. L. 111-31, 123 Stat. 1776.

Subpart A--General Provisions


Sec.  1141.1   Scope.

    (a) This part sets forth the requirements for the display of 
required warnings on cigarette packages and in advertisements for 
cigarettes.
    (b) The requirements of this part do not apply to manufacturers or 
distributors of cigarettes that do not manufacture, package, or import 
cigarettes for sale or distribution within the United States.
    (c) A cigarette retailer will not be in violation of Sec.  1141.10 
for packaging that:
    (1) Contains a warning;
    (2) Is supplied to the retailer by a license- or permit-holding 
tobacco product manufacturer, or distributor; and
    (3) Is not altered by the retailer in a way that is material to the 
requirements of section 4 of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1333) or this part.
    (d) Section 1141.10(d) applies to a cigarette retailer only if that 
retailer is responsible for or directs the warnings required under 
Sec.  1141.10 for advertising. However, this paragraph (d) does not 
relieve a retailer of liability if the retailer displays, in a location 
open to the public, an advertisement that does not contain a warning or 
has been altered by the retailer in a way that is material to the 
requirements of section 4 of the Federal Cigarette Labeling and 
Advertising Act or this part.


Sec.  1141.3  Definitions.

    For purposes of this part:
    Cigarette means--
    (1) Any roll of tobacco wrapped in paper or in any substance not 
containing tobacco; and
    (2) Any roll of tobacco wrapped in any substance containing tobacco 
which, because of its appearance, the type of tobacco used in the 
filler, or its packaging and labeling, is likely to be offered to, or 
purchased by, consumers as a cigarette described in paragraph (1) of 
this definition.
    Commerce means:
    (1) Commerce between any State, the District of Columbia, the 
Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, 
Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any 
place outside thereof;
    (2) Commerce between points in any State, the District of Columbia, 
the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American 
Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island, 
but through any place outside thereof; or
    (3) Commerce wholly within the District of Columbia, Guam, the 
Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman 
Reef, or Johnston Island.
    Distributor means any person who furthers the distribution of 
cigarettes, whether domestic or imported, at any point from the 
original place of manufacture to the person who sells or distributes 
the product to individuals for personal consumption. Common carriers 
are not considered distributors for the purposes of this part.
    Front panel and rear panel mean the two largest sides or surfaces 
of the package.
    Manufacturer means any person, including any repacker or relabeler, 
who manufactures, fabricates, assembles, processes, or labels a 
finished cigarette product; or imports any cigarette that is intended 
for sale or distribution to consumers in the United States.
    Package or packaging means a pack, box, carton, or container of any 
kind in which cigarettes are offered for sale, sold, or otherwise 
distributed to consumers.
    Person means an individual, partnership, corporation, or any other 
business or legal entity.
    Retailer means any person who sells cigarettes to individuals for 
personal consumption, or who operates a facility where vending machines 
or self-service displays of cigarettes are permitted.
    United States, when used in a geographical sense, includes the 
several States, the District of Columbia, the Commonwealth of Puerto 
Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway 
Islands, Kingman Reef, and Johnston Island. The term ``State'' includes 
any political division of any State.


Sec.  1141.5   Incorporation by reference.

    (a) Certain material is incorporated by reference into this part 
with the approval of the Director of the Federal Register under 5 
U.S.C. 552(a) and 1 CFR part 51. All approved material is available for 
inspection at U.S. Food and Drug Administration, Division of Dockets 
Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is 
available from the source listed in paragraph (b) of this section. It 
is also available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, email [email protected] or go to 
www.archives.gov/federal-register/cfr/ibr-locations.html.
    (b) Center for Tobacco Products, U.S. Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993; 1-888-463-6332. You 
may also obtain the material at https://www.fda.gov/cigarette-warning-files.
    (1) ``Required Cigarette Health Warnings, 2020'', IBR approved for 
Sec.  1141.10.
    (2) [Reserved]

Subpart B--Required Warnings for Cigarette Packages and 
Advertisements


Sec.  1141.10   Required warnings.

    (a) Required warnings. A required warning must include the 
following:
    (1) One of the following textual warning label statements:
    (i) WARNING: Tobacco smoke can harm your children.
    (ii) WARNING: Tobacco smoke causes fatal lung disease in 
nonsmokers.
    (iii) WARNING: Smoking causes type 2 diabetes, which raises blood 
sugar.
    (iv) WARNING: Smoking reduces blood flow to the limbs, which can 
require amputation.
    (v) WARNING: Smoking causes cataracts, which can lead to blindness.
    (vi) WARNING: Smoking causes bladder cancer, which can lead to 
bloody urine.
    (vii) WARNING: Smoking reduces blood flow, which can cause erectile 
dysfunction.
    (viii) WARNING: Smoking causes head and neck cancer.
    (ix) WARNING: Smoking can cause heart disease and strokes by 
clogging arteries.
    (x) WARNING: Smoking during pregnancy stunts fetal growth.

[[Page 15709]]

    (xi) WARNING: Smoking causes COPD, a lung disease that can be 
fatal.
    (2) A color graphic to accompany the textual warning label 
statement.
    (b) Accurately reproduced. Each required warning, comprising a 
combination of a textual warning label statement and its accompanying 
color graphic, must be accurately reproduced as shown in the materials 
contained in ``Required Cigarette Health Warnings, 2020,'' which is 
incorporated by reference at Sec.  1141.5.
    (c) Packages. It is unlawful for any person to manufacture, 
package, sell, offer to sell, distribute, or import for sale or 
distribution within the United States any cigarettes unless the package 
of which bears a required warning in accordance with section 4 of the 
Federal Cigarette Labeling and Advertising Act and this part.
    (1) The required warning must appear directly on the package and 
must be clearly visible underneath any cellophane or other clear 
wrapping.
    (2) The required warning must comprise at least the top 50 percent 
of the front and rear panels; provided, however, that on cigarette 
cartons, the required warning must be located on the left side of the 
front and rear panels of the carton and must comprise at least the left 
50 percent of these panels.
    (3) The required warning must be positioned such that the text of 
the required warning and the other information on that panel of the 
package have the same orientation.
    (d) Advertisements. It is unlawful for any manufacturer, 
distributor, or retailer of cigarettes to advertise or cause to be 
advertised within the United States any cigarette unless each 
advertisement bears a required warning in accordance with section 4 of 
the Federal Cigarette Labeling and Advertising Act and this part.
    (1) For print advertisements and other advertisements with a visual 
component (including, for example, advertisements on signs, retail 
displays, internet web pages, digital platforms, mobile applications, 
and email correspondence), the required warning must appear directly on 
the advertisement.
    (2) The required warning must comprise at least 20 percent of the 
area of the advertisement in a conspicuous and prominent format and 
location at the top of each advertisement within the trim area, if any.
    (3) The text in each required warning must be in the English 
language, except as follows:
    (i) In the case of an advertisement that appears in a non-English 
medium, the text in the required warning must appear in the predominant 
language of the medium whether or not the advertisement is in English; 
and
    (ii) In the case of an advertisement that appears in an English 
language medium but that is not in English, the text in the required 
warning must appear in the same language as that principally used in 
the advertisement.
    (4) For English-language and Spanish-language warnings, each 
required warning must be accurately reproduced as shown in the 
materials contained in ``Required Cigarette Health Warnings, 2020,'' 
which is incorporated by reference at Sec.  1141.5.
    (5) For non-English-language warnings, other than Spanish-language 
warnings, each required warning must be accurately reproduced as shown 
in the materials contained in ``Required Cigarette Health Warnings, 
2020,'' which is incorporated by reference at Sec.  1141.5, including 
the substitution and insertion of a true and accurate translation of 
the textual warning label statement in place of the English language 
version. The inserted textual warning label statement must comply with 
the requirements of section 4 of the Federal Cigarette Labeling and 
Advertising Act, including area and other formatting requirements, and 
this part.
    (e) Irremovable or permanent warnings. The required warnings must 
be indelibly printed on or permanently affixed to the package or 
advertisement. These warnings, for example, must not be printed or 
placed on a label affixed to a clear outer wrapper that is likely to be 
removed to access the product within the package.
    (f) Sale or distribution. No person may manufacture, package, sell, 
offer for sale, distribute, or import for sale or distribution within 
the United States cigarettes whose packages or advertisements are not 
in compliance with section 4 of the Federal Cigarette Labeling and 
Advertising Act and this part, except as provided by Sec.  1141.1(c) 
and (d).
    (g) Marketing requirements--(1) Random display. The required 
warnings for packages specified in paragraph (a) of this section must 
be randomly displayed in each 12-month period, in as equal a number of 
times as is possible on each brand of the product and be randomly 
distributed in all areas of the United States in which the product is 
marketed in accordance with a plan submitted by the tobacco product 
manufacturer, distributor, or retailer to, and approved by, the Food 
and Drug Administration.
    (2) Rotation. The required warnings for advertisements specified in 
paragraph (a) of this section must be rotated quarterly in alternating 
sequence in advertisements for each brand of cigarettes in accordance 
with a plan submitted by the tobacco product manufacturer, distributer, 
retailer to, and approved by, the Food and Drug Administration.
    (3) Review. The Food and Drug Administration will review each plan 
submitted under this section and approve it if the plan:
    (i) Will provide for the equal distribution and display on 
packaging and the rotation required in advertising under this 
subsection; and
    (ii) Assures that all of the labels required under this section 
will be displayed by the tobacco product manufacturer, distributor, or 
retailer at the same time.
    (4) Record retention. Each tobacco product manufacturer required to 
randomly and equally display and distribute warnings on packaging or 
rotate warnings in advertisements in accordance with an FDA-approved 
plan under section 4 of the Federal Cigarette Labeling and Advertising 
Act and this part must maintain a copy of such FDA-approved plan and 
make it available for inspection and copying by officers or employees 
duly designated by the Secretary of Health and Human Services. The FDA-
approved plan must be retained while in effect and for a period of not 
less than 4 years from the date it was last in effect.


Sec.  1141.12   Misbranding of cigarettes.

    (a) A cigarette will be deemed to be misbranded under section 
903(a)(1) of the Federal Food, Drug, and Cosmetic Act if its package 
does not bear one of the required warnings in accordance with section 4 
of the Federal Cigarette Labeling and Advertising Act and this part. A 
cigarette will be deemed to be misbranded under section 903(a)(7)(A) of 
the Federal Food, Drug, and Cosmetic Act if its advertising does not 
bear one of the required warnings in accordance with section 4 of the 
Federal Cigarette Labeling and Advertising Act and this part.
    (b) A cigarette advertisement and other descriptive printed matter 
issued or caused to be issued by the manufacturer, packer, or 
distributor will be deemed to include a brief statement of relevant 
warnings for the purposes of section 903(a)(8) of the Federal Food, 
Drug, and Cosmetic Act if it bears one of the required warnings in 
accordance with section 4 of the Federal Cigarette Labeling and 
Advertising Act and this part. A cigarette distributed or offered for 
sale in any State shall be deemed to be misbranded under section 
903(a)(8)

[[Page 15710]]

of the Federal Food, Drug, and Cosmetic Act unless the manufacturer, 
packer, or distributor includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to the cigarette one 
of the required warnings in accordance with section 4 of the Federal 
Cigarette Labeling and Advertising Act and this part.

    Dated: March 10, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2020-05223 Filed 3-17-20; 8:45 am]
 BILLING CODE 4164-01-P