[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]
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Vol. 85
Wednesday,
No. 53
March 18, 2020
Part IV
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 1141
Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements; Required Warnings for Cigarette Packages and
Advertisements: Small Entity Compliance Guide; Guidance for Industry;
Availability; Final Rules
Federal Register / Vol. 85 , No. 53 / Wednesday, March 18, 2020 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1141
[Docket No. FDA-2019-N-3065]
RIN 0910-AI39
Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to establish new cigarette health warnings for
cigarette packages and advertisements. The final rule implements a
provision of the Family Smoking Prevention and Tobacco Control Act
(Tobacco Control Act) that requires FDA to issue regulations requiring
color graphics depicting the negative health consequences of smoking to
accompany new textual warning label statements. The Tobacco Control Act
amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of
1965 to require each cigarette package and advertisement to bear one of
the new required warnings. The final rule specifies the 11 new textual
warning label statements and accompanying color graphics. FDA is taking
this action to promote greater public understanding of the negative
health consequences of cigarette smoking.
DATES: This rule is effective June 18, 2021. The incorporation by
reference of a certain publication listed in the rule is approved by
the Director of the Federal Register as of June 18, 2021.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of the final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
With regard to the final rule: Courtney Smith, Office of
Regulations, Center for Tobacco Products, Food and Drug Administration,
Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, [email 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
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random and equal display and distribution of the required warnings for
cigarette packages and quarterly rotation of the required warnings for
cigarette advertisements. A tobacco product manufacturer, distributor,
or retailer is required to submit a plan for the random and equal
display and distribution of the required warnings on packages and the
quarterly rotation in advertisements for approval by FDA. In addition,
each tobacco product manufacturer that is required to randomly and
equally display and distribute required warnings on packaging and
quarterly rotate required warnings in advertisements, in accordance
with an FDA-approved plan, also must maintain a copy of the FDA-
approved plan and make the plan available for inspection and copying by
officers and employees of FDA.
FDA developed the new cigarette health warnings included in the
final rule through a science-based, iterative research process. The
required warnings will promote greater public understanding of the
negative health consequences of cigarette smoking.
C. Legal Authority
The final rule is being issued in accordance with sections 201 and
202 of the Tobacco Control Act (Pub. L. 111-31), which amend section 4
of the FCLAA (15 U.S.C. 1333). The final rule is also being issued
based upon FDA's authorities related to misbranded tobacco products
under sections 903 (21 U.S.C. 387c); FDA's authorities related to
records and reports under section 909 (21 U.S.C. 387i); and FDA's
rulemaking and inspection authorities under sections 701 (21 U.S.C.
371), 704 (21 U.S.C. 374), and 905(g) (21 U.S.C. 387e(g)) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
D. Costs and Benefits
This final rule requires that new cigarette health warnings, each
comprising a textual warning statement paired with an accompanying
color graphic, appear on cigarette packages and in cigarette
advertisements. The final rule further requires that, for cigarette
packages, these required warnings be randomly displayed in each 12-
month period, in as equal a number of times as is possible on each
brand of the product, and be randomly and equally distributed
throughout the United States in accordance with a plan approved by the
FDA. The final rule also requires that, for cigarette advertisements,
the required warnings be rotated quarterly in alternating sequences in
advertisements for each brand of cigarettes in accordance with a plan
approved by FDA. The final new cigarette health warnings will promote
greater public understanding of the negative health consequences of
cigarette smoking by presenting information about the health risks of
smoking to smokers and nonsmokers in a format that helps people better
understand these consequences. We describe economic benefits
qualitatively. The cost of this final rule consists of initial and
recurring labeling costs associated with changing cigarette labels to
accommodate the new cigarette health warnings, design and operation
costs associated with the random and equal display and distribution of
the required warnings for cigarette packages and quarterly rotations of
the required warnings for cigarette advertisements, advertising-related
costs, and costs associated with government administration and
enforcement of the rule. We estimate that, at the mean, the present
value of the costs of this final rule is about $1.6 billion using a
three percent discount rate and roughly $1.2 billion using a seven
percent discount rate (2018$). If the information provided by the
cigarette health warning on each cigarette package were valued at about
$0.01 (for every pack sold annually nationwide), then the benefits that
would be generated by the final rule would equal or exceed the
estimated annual costs. This per-pack estimate provides one way to
estimate the value the public would need to receive from the
information provided on the cigarette health warnings in order to break
even with the costs of the rule and is equivalent to 0.2 percent of the
average cost of a pack of cigarettes, based on a national average cost
of $6.27 per pack.\2\
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\2\ FDA's own analyses and calculations are based in part on
data reported by Nielsen through its RMS service for the cigarettes
category for the 11-week period ending March 23, 2019, for the total
United States market and Convenience Stores and Expanded All Outlets
Combined (xAOC) channels. Copyright (copyright) 2018, The Nielsen
Company. The conclusions drawn from the Nielsen data are those of
the FDA and do not reflect the views of Nielsen. Nielsen is not
responsible for and had no role in and was not involved in analyzing
and preparing the results reported herein. Nielsen RMS data consist
of weekly purchase and pricing data generated from participating
retail store point-of-sale systems in all U.S. markets. See http://www.nielsen.com/us/en.html for more information.
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II. Table of Abbreviations/Commonly Used Acronyms in This Document
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Abbreviation/acronym What it means
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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
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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
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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 http://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
Country Survey.'' Tobacco Control, 15(Suppl. 3): iii19-iii25, 2006.
Available at https://doi.org/10.1136/tc.2005.012294.
5. Elton-Marshall, T., R. Wijesingha, R.D. Kennedy, et al.
``Disparities in Knowledge About the Health Effects of Smoking Among
Adolescents Following the Release of New Pictorial Health Warning
Labels.'' Preventative Medicine, 111:358-365, 2018. Available at
https://doi.org/10.1016/j.ypmed.2017.11.025.
6. Mutti, S., D. Hammond, J.L. Reid, et al. ``The Efficacy of
Cigarette Warning Labels on Health Beliefs in the United States and
Mexico,'' Journal of Health Communication, 18(10):1180-1192, 2013.
Available at https://doi.org/10.1080/10810730.2013.778368.
7. Oncken, C., S. McKee, S. Krishnan-Sarin, et al. ``Knowledge and
Perceived Risk of Smoking-Related Conditions: A Survey of Cigarette
Smokers.'' Preventative Medicine, 40(6):779-784, 2005. Available at
https://doi.org/10.1016/j.ypmed.2004.09.024.
8. Roth, L.K. and H.S. Taylor. ``Risks of Smoking to Reproductive
Health: Assessment of Women's Knowledge.'' American Journal of
Obstetrics and Gynecology, 184(5):934-939, 2001. Available at
https://doi.org/10.1067/mob.2001.112103.
9. Weinstein, N., Slovic, P., Waters, E., and G. Gibson. ``Public
Understanding of the Illnesses Caused by Cigarette Smoking,''
Nicotine and Tobacco Research, 6(2):349-355, 2004. Available at
https://doi.org/10.1080/14622200410001676459.
10. Yang, Y., J.J. Wang, C.X. Wang, et al. ``Awareness of Tobacco-
Related Health Hazards Among Adults in China.'' Biomedical and
Environmental Sciences, 23(6):437-444, 2010. Available at https://doi.org/10.1016/S0895-3988(11)60004-4.
* 11. FDA. ``Required Cigarette Health Warnings, 2020.'' (See 21 CFR
1141.5)
* 12. FDA. Experimental Study on Warning Statements for Cigarette
Graphic Health Warnings: Study Report. January 2020.
* 13. Pomeranz, J.L. ``No Need to Break New Ground: A Response to
the Supreme Court's Threat to Overhaul the Commercial Speech
Doctrine.'' Loyola of Los Angeles Law Review, 45(2): 389-434 (2012).
Available at https://digitalcommons.lmu.edu/llr/vol45/iss2/2.
* 14. U.S. Congress. House. Committee on Energy and Commerce. Family
Smoking Prevention and Tobacco Control Act (H.R. 1256). House Report
Number 111-58, Part 1. 111th Cong., 1st sess., March 26, 2009.
15. Hammond, D., G.T. Fong, R. Borland, et al. ``Text and Graphic
Warnings on Cigarette Packages: Findings from the International
Tobacco Control Four Country Study.'' American Journal of
[[Page 15702]]
Preventive Medicine, 32(3):202-209, 2007. Available at https://doi.org/10.1016/j.amepre.2006.11.011.
* 16. FDA. ``Final Regulatory Impact Analysis; Final Regulatory
Flexibility Analysis; Unfunded Mandates Reform Act Analysis,
Required Warnings for Cigarette Packages and Advertisements; Final
Rule.'' 2020.
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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