Tobacco Products; Required Warnings for Cigarette Packages and Advertisements

Federal RegisterMar 18, 2020

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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.

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,

AskCTPRegulations@fda.hhs.gov.

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,

PRAStaff@fda.hhs.gov.

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.

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.

Cigarette smoking remains the leading cause of preventable disease and death in the United States and is responsible for more than 480,000 deaths per year. Smoking causes more deaths each year than human immunodeficiency virus, illegal drug use, alcohol use, motor vehicle injuries, and firearm-related incidents combined. In issuing the final rule, FDA determined that the public holds misperceptions about the health risks caused by smoking and that textual warning statements focused on less-known health consequences of smoking paired with concordant color graphics will promote greater public understanding of the risks associated with cigarette smoking, especially given that the existing Surgeon General's warnings currently used in the United States go unnoticed and are effectively “invisible.” FDA has determined that the required new cigarette health warnings will advance the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking.

B. Summary of the Major Provisions of the Final Rule

The final rule establishes new required warnings to appear on cigarette packages and in cigarette advertisements. The rule implements a provision of the Tobacco Control Act that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the FCLAA to require each cigarette package and advertisement to bear one of the new required warnings. These new cigarette health warnings consist of textual warning statements accompanied by color graphics, in the form of concordant photorealistic images, depicting the negative health consequences of cigarette smoking. As required by section 4 of the FCLAA, the new cigarette health warnings must appear prominently on packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements.

In addition, as required under the FCLAA, the final rule establishes marketing requirements that include the

random and equal display and distribution of the required warnings for cigarette packages and quarterly rotation of the required warnings for cigarette advertisements. A tobacco product manufacturer, distributor, or retailer is required to submit a plan for the random and equal display and distribution of the required warnings on packages and the quarterly rotation in advertisements for approval by FDA. In addition, each tobacco product manufacturer that is required to randomly and equally display and distribute required warnings on packaging and quarterly rotate required warnings in advertisements, in accordance with an FDA-approved plan, also must maintain a copy of the FDA-approved plan and make the plan available for inspection and copying by officers and employees of FDA.

FDA developed the new cigarette health warnings included in the final rule through a science-based, iterative research process. The required warnings will promote greater public understanding of the negative health consequences of cigarette smoking.

C. Legal Authority

The final rule is being issued in accordance with sections 201 and 202 of the Tobacco Control Act (Pub. L. 111-31), which amend section 4 of the FCLAA (15 U.S.C. 1333). The final rule is also being issued based upon FDA's authorities related to misbranded tobacco products under sections 903 (21 U.S.C. 387c); FDA's authorities related to records and reports under section 909 (21 U.S.C. 387i); and FDA's rulemaking and inspection authorities under sections 701 (21 U.S.C. 371), 704 (21 U.S.C. 374), and 905(g) (21 U.S.C. 387e(g)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

D. Costs and Benefits

This final rule requires that new cigarette health warnings, each comprising a textual warning statement paired with an accompanying color graphic, appear on cigarette packages and in cigarette advertisements. The final rule further requires that, for cigarette packages, these required warnings be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product, and be randomly and equally distributed throughout the United States in accordance with a plan approved by the FDA. The final rule also requires that, for cigarette advertisements, the required warnings be rotated quarterly in alternating sequences in advertisements for each brand of cigarettes in accordance with a plan approved by FDA. The final new cigarette health warnings will promote greater public understanding of the negative health consequences of cigarette smoking by presenting information about the health risks of smoking to smokers and nonsmokers in a format that helps people better understand these consequences. We describe economic benefits qualitatively. The cost of this final rule consists of initial and recurring labeling costs associated with changing cigarette labels to accommodate the new cigarette health warnings, design and operation costs associated with the random and equal display and distribution of the required warnings for cigarette packages and quarterly rotations of the required warnings for cigarette advertisements, advertising-related costs, and costs associated with government administration and enforcement of the rule. We estimate that, at the mean, the present value of the costs of this final rule is about $1.6 billion using a three percent discount rate and roughly $1.2 billion using a seven percent discount rate (2018$). If the information provided by the cigarette health warning on each cigarette package were valued at about $0.01 (for every pack sold annually nationwide), then the benefits that would be generated by the final rule would equal or exceed the estimated annual costs. This per-pack estimate provides one way to estimate the value the public would need to receive from the information provided on the cigarette health warnings in order to break even with the costs of the rule and is equivalent to 0.2 percent of the average cost of a pack of cigarettes, based on a national average cost of $6.27 per pack.

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 © 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.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

Abbreviation/acronym

What it means

APA

Administrative Procedure Act.

CABG

Coronary artery bypass grafting.

CDC

Centers for Disease Control and Prevention.

COPD

Chronic obstructive pulmonary disease.

CVD

Cardiovascular disease.

D.C. Cir.

United States Court of Appeals for the District of Columbia Circuit.

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.

Federal Register.

HHS

U.S. Department of Health and Human Services.

NARA

National Archives and Records Administration.

NIFLA

Nat'l Inst. of Family and Life Advocates.

NSDUH

National Survey on Drug Use and Health.

OMB

Office of Management and Budget.

PAD

Peripheral arterial disease.

PATH

Population Assessment of Tobacco and Health.

PCI

Percutaneous coronary interventions.

PDF

Portable document format.

PMTA

Premarket tobacco product application.

PVD

Peripheral vascular disease.

SAMHSA

Substance Abuse and Mental Health Services Administration.

SES

Socioeconomic status.

TCA statements

Textual warning statements specified in section 4(a)(1) of the FCLAA.

TTB

Alcohol and Tobacco Tax and Trade Bureau.

WHO

World Health Organization.

III. Background

A. Introduction

To help inform consumers of the potential hazards of cigarette smoking, Congress passed the FCLAA that required that a printed text-only warning appear on cigarette packages (Pub. L. 89-92). The 1965 warning requirement was modified by later amendments to the FCLAA, including the Comprehensive Smoking Education Act of 1984 (Pub. L. 98-474), which extended the warning requirement to cigarette advertising and updated the one warning to four warnings, frequently referred to as the Surgeon General's warnings.

The FCLAA has required the inclusion of text-only warnings on cigarette packages and in cigarette advertisements for many years. As discussed in detail in the proposed rule (84 FR 42754, August 16, 2019) (hereinafter referred to as the proposed rule), there is considerable evidence that the Surgeon General's warnings go largely unnoticed and unconsidered by both smokers and nonsmokers (Ref. 1 at p. 291; see also section V of the proposed rule). These warnings, which have not changed in 35 years, have been described as “invisible” (Ref. 2) and fail to convey relevant information in an effective way (Ref. 1 at p. 291). The Surgeon General's warnings also do not include any color graphics.

In 2009, in enacting the Tobacco Control Act, Congress further amended the FCLAA and directed FDA to issue new cigarette health warnings that would include a graphic component depicting the negative health consequences of smoking to accompany the new textual warnings (section 201 of the Tobacco Control Act). In enacting this legislation, Congress also provided that FDA may adjust the warnings if FDA found that such a change would promote greater public understanding of the risks associated with the use of tobacco products (section 202 of the Tobacco Control Act).

As discussed in the proposed rule, the health risks associated with cigarette smoking are significant. In developing new cigarette health warnings for the final rule, FDA carefully examined the scientific literature, including the 2014 Surgeon General's Report (Ref. 3), which identified 11 more health conditions that have been established to have sufficient evidence to infer a causal link to cigarette smoking—the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports. Those health conditions examined in the 2014 Surgeon General's Report are in addition to the more than 40 unique health consequences already classified in previous Surgeon General's Reports as being caused by smoking and exposure to secondhand smoke. Additional findings in the scientific literature demonstrate that the U.S. public—including youth and adults, smokers and nonsmokers—holds misperceptions about the health risks caused by smoking (Refs. 4-10). Through its review of the scientific literature, as well as the Agency's science-based, iterative research and development process (see section VI of the proposed rule), FDA determined that having warning statements focused on less-known health consequences of smoking accompanied by photorealistic images would promote greater public understanding of the risks associated with cigarette smoking, especially given the unnoticed and “invisible” 1984 Surgeon General's warnings currently used in the United States.

Therefore, consistent with section 4 of the FCLAA (as amended by sections 201 and 202 of the Tobacco Control Act), we are finalizing a set of 11 required warnings, consisting of textual warning statements accompanied by concordant color graphics depicting the negative health consequences of smoking, to appear on cigarette packages and in cigarette advertisements. Specifically, we are replacing part 1141 to Title 21 of the Code of Federal Regulations (21 CFR part 1141), and the new part 1141 requires new cigarette health warnings on cigarette packages and in cigarette advertisements. As required by section 4 of the FCLAA, the new cigarette health warnings must appear prominently on packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements.

As described in the preamble to the proposed rule and in the final rule, FDA has determined that the new required cigarette health warnings will advance the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking.

On August 16, 2019, FDA issued a proposed rule to establish new required cigarette health warnings for cigarette packages and advertisements. These proposed cigarette health warnings consisted of a set of textual warning statements to be accompanied by concordant color graphics depicting the negative health consequences of smoking. FDA proposed to take this action to promote greater public understanding of the negative health consequences of cigarette smoking as directed by sections 201 and 202 of the Tobacco Control Act (amending section 4 of the FCLAA). FDA received about 300 comments to the docket for the proposed rule. Comments were received from cigarette manufacturers, retailers and retailer organizations, representatives of tribes/tribal organizations, health professionals and researchers, public health or other advocacy groups, academics, State and local public health agencies, medical organizations, individual consumers, and other submitters. These comments are summarized and responded to in the relevant sections of this document. Similar comments are grouped together by the topics discussed or the particular portions of the proposed rule or codified language to which they refer.

To make it easier to identify comments and FDA's responses, the word “Comment,” in parenthesis, appears before the comment's description, and the word “Response,” in parenthesis, appears before FDA's response. Each comment is numbered to help distinguish among different comments, and the number assigned is purely for organizational purposes and does not signify value or importance. Similar comments are grouped together under the same comment number. In addition to the comments specific to this rulemaking that we address in the following sections, we received many general comments expressing support or opposition to the rule and separate

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

B. Incorporation by Reference

FDA is incorporating by reference “Required Cigarette Health Warnings, 2020,” which was approved by the Office of the Federal Register. You may obtain a free copy of the material from FDA's website, located at

https://www.fda.gov/cigarette-warning-files;

the Docket at

https://www.regulations.gov;

or from the Food and Drug Administration, Center for Tobacco Products, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, email:

cigarettewarningfiles@fda.hhs.gov.

The material incorporated by reference, entitled “Required Cigarette Health Warnings, 2020,” includes the required warnings (comprising a textual warning statement, as specified in § 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

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)).

The Secretary has delegated this authority to FDA. For the purposes of discussion throughout this document, FDA uses “FDA” when discussing this authority.

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)).

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.

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).

These requirements are supplemented by the FD&C Act's misbranding provisions, which require that product labeling and advertising include required warnings (section 903). Under section 701(a) of the FD&C Act, FDA has authority to issue regulations for the efficient enforcement of the FD&C Act, and sections 704 and 905(g) provide FDA with general inspection authority.

Section 909 of the FD&C Act authorizes FDA to require tobacco product manufacturers to establish and maintain records, make reports, and provide such information as the Agency may by regulation reasonably require to ensure that a tobacco product is not adulterated or misbranded and to otherwise protect public health.

While FDA did not receive comments on many of these authorities, FDA did receive comments regarding our authority to require more than nine warning label statements and to adjust the text, as well as comments related to the Administrative Procedure Act (APA) and the constitutionality of the required warnings. These comments are summarized and responded to in the following paragraphs. Multiple comments are often summarized together for convenience. Comment numbers are assigned to facilitate later reference; they do not indicate importance or the sequence in which comments were received.

B. Comments Regarding Legal Authority

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

(Response 1) FDA disagrees with these comments. When Congress passed the Tobacco Control Act, Congress also amended the FCLAA to give the Secretary more specific authority to

adjust and revise required cigarette warnings. This new authority includes two separate provisions authorizing FDA to revise aspects of the warning statements:

• Section 201 of the Tobacco Control Act, which provides that the Secretary “may adjust the type size, text and format of the label statements

specified in [FCLAA] subsections 4(a)(2) and 4(b)(2)

as the Secretary determines appropriate so that both the graphics and accompanying label statements are clear, conspicuous, legible and appear within the specified area;” and

• Section 202(b), which permits the Secretary, through a rulemaking, to “adjust the format, type size, color graphics, and text of any of the label requirements . . . if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of tobacco products.” (Emphasis added.)

It is significant that section 201 cross-references subsections (a)(2) and (b)(2); subsection (a)(2) addresses “Placement; typography; etc.” for the “label statement[s] required by paragraph [(a)(1)]” for package labels, and subsection (b)(2) addresses the “Typography, etc.” of the “label statement[s] required by subsection (a)” for cigarette advertising. Thus, the adjustments authorized by section 201 focus on placement, typography, clarity, conspicuousness, and legibility—changes that go to the visual presentation of cigarette warnings. By contrast, section 202(b) gives the Secretary broader authority to “adjust the format, type, size, color graphics, and text of any of the label

requirements”

(emphasis added). Section 202(b)'s reference to “label requirements” is also significant; at minimum, it refers to and sweeps in the entirety of FCLAA subsection 4(a), which is entitled “Label Requirements.” Also importantly, section 202(b) allows its more sweeping adjustments only upon a finding that “such a change would promote greater public understanding of the risks” of smoking.

The adjustments permitted by section 202(b) therefore differ from those permitted by section 201 in that:

(1) section 202(b) authorizes adjustments to “any of the label

requirements”

of FCLAA subsection 4(a), rather than just adjustments to the “type size, text and format” specified in FCLAA subsection 4(a)(2) (governing the placement, typography, etc., of the “label statements” on package labels) and (4)(b)(2) (governing the typography, etc., of the “label statements” in cigarette advertising);

(2) the relevant finding relates to promoting the public's understanding of the risks associated with the use of tobacco products rather than the visual clarity of the label statements; and

(3) section 202(b) explicitly requires rulemaking under 5 U.S.C. 553 for the adjustments it authorizes, while section 201 does not.

We therefore disagree with comments that argue that, under section 202(b), FDA may only adjust the typographic look of the warnings' text, not their substance. That assertion conflicts with the plain meaning of “text,” which, as comments concede, refers to both “words and form,” not merely the latter. The interpretation is also inconsistent with the difference in the predicate findings required for adjustments under sections 201 and 202(b): Visual clarity versus improving public understanding of risks. If Congress had meant section 202(b) to limit FDA to making adjustments to improve visual clarity, it would not have included a predicate finding that relates to the warnings' substance. Congress further indicated its intent to allow more substantive changes under section 202(b) by explicitly requiring rulemaking under 5 U.S.C. 553, while adjustments under section 201 are allowed simply upon the Secretary's determination.

Some comments argue that the term “adjust” precludes changes that would better be described by the term “edit” or “revise.” FDA disagrees. First, the title of section 202 of the Tobacco Control Act is “Authority to

Revise

Cigarette Warning Label Statements” (emphasis added). That title reflects Congress's intent to authorize FDA to revise the warning statements themselves, not merely make typographical changes. Second, section 202(b) includes the authority to adjust not only the text of the warnings but also non-textual items like “format,” “type size,” and “color graphics”—“edit” or “revise” would not as clearly encompass the types of changes associated with those items. It is therefore likely that Congress chose the term “adjust” as an umbrella term best suited to include the variety of changes authorized under section 202(b) of the Tobacco Control Act.

FDA also disagrees with the comments that asserted that Congress did not authorize FDA to adjust the number of warnings. As discussed below, it is far from clear that the number of warnings is in fact a statutory requirement. But even if it were, the statutory language does not speak directly to this issue, and FDA reasonably construes the statute to allow it to adjust the number of warnings. Section 202(b) of the Tobacco Control Act authorizes FDA to adjust the “text of any of the label

requirements”

if such a change would promote greater public understanding of the risks associated with the use of tobacco products—not just to adjust the “types size, text and format of the label

statements”

specified in subsections governing “placement, typography, etc.” so that both the graphics and the accompanying label statements are clear, conspicuous, legible, and appear within the specified area, as section 201 does (emphasis added).

As amended by the Tobacco Control Act, subsection 4(a) of the FCLAA, which identifies the “label requirements” that may be adjusted under section 202(b), does not provide a requirement as to how many warnings there must be. Nothing in the head of subsection 4(a)(1) refers to “9 labels”; rather, it refers to “one of the following labels.” In addition, section 202(a) of the Tobacco Control Act amends the FCLAA's preemption provision, subsection 5(a) of the FCLAA, to provide that, “Except to the extent the Secretary requires

additional

or different statements on any cigarette package by a regulation, . . . no statement relating to smoking and health, other than the statement required by section 4 of [the FCLAA, now amended by the Tobacco Control Act], shall be required on any cigarette package.” FCLAA subsection 5(a), as amended by Tobacco Control Act section 202(a) (codified at 15 U.S.C. 1334(a)) (emphasis added). The reference to “additional” statements indicates that Congress did not consider nine warnings to be a fixed statutory requirement. In any event, by authorizing adjustments to the “text of any of the label requirements,” section 202(b) plainly contemplates that FDA may adjust the “text” of the label requirements within paragraph (1) of subsection 4(a) of the FCLAA (which is entitled “Label Requirements”), precisely as this final rule does.

Even if FCLAA subsection 4(a)(1) required “one of the following 9 labels,” and not just “one of the following labels,” as it actually does, such a numeric requirement would still be among the FCLAA “label requirements” subject to being adjusted under section 202(b) of the Tobacco Control Act. FDA has determined that all 11 warnings that are part of this final rule will promote greater public understanding of the risks of cigarette smoking. FDA therefore may adjust the number of warnings through this rulemaking conducted under 5 U.S.C. 553.

(Comment 2) One comment states that FDA does not have the authority to

change the textual statements provided in the Tobacco Control Act without implementing them first.

(Response 2) FDA disagrees. Under section 202(b), FDA may, through a rulemaking, adjust the format, type size, color graphics, and text of any of the label requirements if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of tobacco products. Nothing in the language of section 202(b) of the Tobacco Control Act requires the Agency to first issue warnings with the Tobacco Control Act statements, and then wait 15 months or more for such warnings to be implemented, before the Agency may embark on an effort to revise the warning statements. What the statute requires is that revisions to the textual warning statements specified in section 4(a)(1) of the FCLAA (“TCA statements”) be based on a finding that such a change would promote greater public understanding of the risks of smoking. Accordingly, in considering whether to revise the warnings, FDA designed and undertook a rigorous science-based, iterative research process specifically to assess whether new textual warning statements would promote greater public understanding of the risks associated with tobacco products compared to the warning statements provided in the Tobacco Control Act. As part of its research, FDA conducted a large (2,505 participants) quantitative consumer research study (OMB control number 0910-0848, “Experimental Study on Warning Statements for Cigarette Graphic Health Warnings”). This first consumer research study evaluated new textual warnings statements compared to the warning statements provided in the Tobacco Control Act to determine if they would promote greater understanding of the risks of smoking. More details about the study methodology can be found in the study report included in the docket (Ref. 12). The results show that, with respect to the outcomes most predictive for demonstrating greater understanding of the risks of smoking—“new information” and “self-reported learning”—nearly all tested new textual warning statements performed significantly better than nearly all textual warning statements provided by the Tobacco Control Act. The results of this first consumer research study informed the selection of textual warning statements that FDA then paired with concordant images for testing in a final consumer research study (OMB control number 0910-0866, “Experimental Study of Cigarette Warnings”) (see section VI for more discussion about FDA's approach to developing and testing cigarette health warnings). FDA has therefore complied with section 202(b) by including new textual warnings in the final rule only after finding that they will promote greater public understanding of the risks associated with smoking as compared to certain textual warnings in the Tobacco Control Act that are excluded from the final rule.

C. Comments Regarding First Amendment Considerations

FDA received comments from industry, retailers, public health organizations and coalitions, state and local governments, academia, and private citizens related to First Amendment considerations. Several comments from manufacturers, retail organizations, and private citizens assert that the required warnings violate the First Amendment of the United States Constitution under a variety of legal standards. Several other comments, including from public health organizations and state and local governments, state that the required warnings comport with First Amendment requirements.

1. Government's Interest

(Comment 3) Some comments suggest that the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking is not substantial, and that, in any case, FDA's Population Assessment of Tobacco and Health (PATH) data and public health campaigns undermine that asserted interest. Related comments suggest that, under the Supreme Court's decision in

Nat'l Inst. of Family and Life Advocates (NIFLA)

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

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.

U.S.,

674 F.3d 509, 519 (6th Cir. 2012). Cigarette smoking remains the primary cause of preventable disease and death in the United States. The magnitude of this public health crisis is compounded by the gaps in knowledge and misperceptions held by smokers and nonsmokers about the wide variety of negative health consequences caused by smoking.

Moreover, FDA's research confirms that the public continues to hold misperceptions about the health risks of smoking and is largely unaware of certain serious conditions caused by smoking (see section V.B; see also NPRM section V.A.3, 84 FR at 42761-62 (“There Remain Significant Gaps in Public Understanding About the Negative Health Consequences of Cigarette Smoking”)). Contrary to some comments' assertions, consumers suffer from a pervasive lack of knowledge about the negative health consequences of smoking, as both smokers and nonsmokers do not fully understand that smoking is causally linked to a wide variety of diseases and health conditions (see section V.B).

We disagree with comments that argue the public's knowledge of the general harms of cigarette smoking undercuts the need for these required warnings. As clearly demonstrated by the rulemaking record, both the harms of cigarette smoking thoroughly detailed in years of Surgeon General's reports, and the widespread public misperceptions about these harms, are very “real not purely hypothetical.”

NIFLA,

138 S. Ct. at 2377.

Congress has long recognized and taken steps to address this information gap. As far back as 1965 when Congress first passed the FCLAA, it set forth the policy of a comprehensive warning program on cigarette packages and advertisements so that “the public may be adequately informed” about the dangers of cigarette smoking. FCLAA Section 2(1), codified at 15 U.S.C. 1331(1). When Congress amended the FCLAA with the Tobacco Control Act, it recognized that the current 1984 Surgeon General's warnings had become “ineffective in providing adequate warnings about the dangers of tobacco products” (Ref. 14 at 4). To that end, Congress mandated new cigarette warnings to be accompanied by color graphics and provided the Secretary with the authority to adjust such warning label requirements if “such a change would promote greater public understanding of the risks associated with the use of tobacco products” (section 202(b) of the Tobacco Control Act).

Under the framework set out in

Zauderer

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.

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.

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

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

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).

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

American Meat Institute

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.

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

Sorrell,

272 F.3d 104, 115

(2d Cir. 2001) (quoting

Zauderer

Accord, CTIA,

928 F.3d at 844 (

cert. denied,

205 L. Ed. 2d 387 (Dec. 9, 2019)) (government interest in furthering public health and safety is sufficient under

Zauderer

so long as it is substantial);

Discount Tobacco,

674 F.3d at 556-58 (upholding federally required health warnings on cigarette packaging and in cigarette advertisements, citing

Sorrell

);

Pharm. Care Mgmt. Ass'n

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

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

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 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.

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.

Fox,

492 U.S. 469, 480 (1989), but the Supreme Court has in any event observed that required factual disclosures are less intrusive from a First Amendment perspective than are restrictions on speech.

Zauderer,

471 U.S. at 651. Because the Government's interest in these warnings is substantial and the regulation is no more extensive than necessary to directly advance that interest, the rule withstands review even under

Central Hudson.

As outlined in the preceding paragraphs of this section of the preamble, the risks associated with cigarette smoking present a significant public health problem, and the Government's interest in promoting greater public understanding of those risks is substantial. The scientific evidence produced by FDA's quantitative consumer research demonstrates that the required warnings in this rule directly advance the Government's interest by outperforming the current Surgeon General's warnings in actually providing “new information” and “self-reported learning,” which promote better understanding by the public about the negative health consequences of smoking, among other measured outcomes. As discussed elsewhere, the warnings are no more extensive than necessary to achieve the Government's interest—they provide factual and accurate representations of the dangers of cigarette smoking and apply to all cigarette packages and advertisements by all manufacturers, distributors, and retailers, so they are not over- or underinclusive in scope, and there is enough room remaining on the rest of the packages and advertisements for manufacturers to convey their messages.

Although some comments assert correctly that public health campaigns can be effective in helping raise general awareness of the health risks of using tobacco products, such campaigns may supplement but are not an adequate alternative to placing warnings directly on cigarette packages and advertisements for purposes of advancing the Government's interest. Congress has long required that cigarette warnings appear on packages and in advertisements. As far back as 1965, the FCLAA set forth the policy of a comprehensive warning program on cigarette packages and advertisements so that “the public may be adequately informed” about the dangers of cigarette smoking. FCLAA Section 2(1), codified at 15 U.S.C. 1331(1). This reflects the recognition that, while voluntary public education campaigns can provide effective targeting and messaging, they do not reach every person who looks at a package of cigarettes or advertisements and do not receive as many impressions as a comprehensive program of cigarette package and cigarette advertisement warnings. Studies demonstrate that pictorial cigarette warnings placed directly on products convey the risks to those who look at packages and advertisements with more immediacy and noticeability (see section VI.B for further discussion). Therefore, FDA disagrees that public education campaigns are adequate alternatives for warnings on packages and advertisements.

Regarding the proposed alternative of text-only warnings, the scientific literature strongly supports that pictorial cigarette warnings promote greater public understanding about the health consequences of smoking as, for example, they: (1) Increase the noticeability of the warning's messages; (2) increase knowledge and learning of the negative health consequences of smoking; and (3) benefit subpopulations that have disparities in knowledge about the negative health consequences of smoking (see section V.B of the proposed rule, 84 FR at 42762-65). When Congress amended the FCLAA with the Tobacco Control Act, it recognized that the current 1984 Surgeon General's text-only warnings had become “ineffective in providing adequate warnings about the dangers of tobacco products” (Ref. 14 at 4). To that end, Congress directed new cigarette warnings to be accompanied by color graphics. FDA's quantitative consumer research studies show that the new required warnings with color graphics promote greater understanding of the

negative health consequences of smoking than the current 1984 Surgeon General's warnings, which served as the control condition. Each of the final required warnings outperformed the Surgeon General's warnings on the two outcomes FDA specified (as described in section VI.E of the proposed rule, 84 FR at 42771-72) as being predictive for promoting understanding of the risks associated with cigarette smoking: “new information” and “self-reported learning.” In addition, the final required warnings also demonstrated statistically significant greater scores in nearly all other measures of understanding when compared to the Surgeon General's warnings (see section VII.B below for a discussion of the study results for each required warning). There is ample scientific evidence that textual warnings accompanied by large color images will directly advance greater public understanding of the negative health consequences of smoking.

We disagree with the comment that suggests that the required warnings are compelled speech that would be subject to strict scrutiny as content-based regulation of commercial speech, citing

Reed

Town of Gilbert,

135 S.Ct. 2218, 2226 (2015),

Sorrell

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.

Reed

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

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

Prieto,

861 F.3d 839, 846 (9th Cir. 2017) (en banc); accord

Missouri Broad. Ass'n

Lacy,

846 F.3d 295, 300 n.5 (8th Cir. 2017). The Supreme Court has never applied strict scrutiny to regulations of this type, notwithstanding that they generally apply only to a specific type of commercial activity, and may thus concern a particular subject. To the contrary, in

NIFLA,

which post-dates both

Reed

and

Sorrell,

the Court reaffirmed that it did “not question the legality of health and safety warnings long considered permissible, or purely factual and uncontroversial disclosures about commercial products.”

NIFLA,

138 S. Ct. at 2376.

4. Constitutionality of Statutory Requirement

(Comment 11) Several comments argue that the statutory requirement for “graphic” health warning labels in the Tobacco Control Act itself violates the First Amendment. Other comments express strong support for the cigarette health warning label requirement in the Tobacco Control Act, noting that this provision of the Tobacco Control Act was upheld in

Discount Tobacco,

674 F.3d 509 (6th Cir. 2012).

(Response 11) Comments addressed to the facial constitutionality of a statute are generally outside the scope of an agency's rulemaking authority.

Am. Meat Inst.,

760 F.3d at 25 (“We do not think the constitutionality of a statute should bobble up and down at an administration's discretion.”). The statutory requirement for cigarette health warning labels was in any event considered in a facial challenge and upheld by the Sixth Circuit in

Discount Tobacco City,

and the Supreme Court denied the manufacturers' petition for a writ of certiorari (569 U.S. 946 (2013)). For the reasons stated in that opinion, and for the additional reasons stated in the preceding paragraphs of this section of the preamble explaining why the final rule is constitutional, the statutory “graphic label statement” requirement is consistent with the First Amendment.

D. Comments Regarding the Administrative Procedure Act (APA)

FDA received comments on a range of APA issues, including general objections that the rule is not the result of deliberative and reasoned decision making and comments that assert FDA failed to support the Agency's findings, ignored alternative evidence, and failed to provide an opportunity to meaningfully comment. Several comments generally note that under the APA courts will set aside a rule if the rule exceeds the Agency's authority, fails to comply with statutory requirements or consider alternatives, or if the action is otherwise arbitrary, capricious, or an abuse of discretion. As discussed in detail in the following paragraphs, FDA has carefully considered and responded to the APA issues raised in the comments.

1. Adequacy of the Evidence in Support of the Rule

(Comment 12) Several comments assert that the proposed rule violated the APA because under the APA, FDA must engage in “reasoned decision-making” and FDA violated the APA by failing to develop affirmative “substantial evidence” to support the rule or, alternatively, because FDA relied on evidence that does not support the rule. Some comments suggest that FDA violated the APA by not developing a record to support the rule but instead issued the rule based on “speculation, conjecture, or supposition” and that FDA based the proposed rule either on: “(1) a hypothetical reduction in smoking not supported by the record, or (2) a hypothetical problem, lack of consumer awareness of the harms of smoking.”

More specifically, some comments argue that FDA has failed under the APA to articulate a rational explanation for the required warnings included in the proposed rule. Comments said that if FDA's interest is consumer awareness, then consumers do not need to be informed of the risks of smoking because there is ample evidence that consumers are well aware of the health risks of cigarette smoking. Other comments argue that FDA's research is flawed as it is inherently biased and fails to account for potential confounding variables and did not reliably test “whether study participants actually learn anything new.” With respect to FDA's final quantitative consumer research study, some comments suggest FDA also failed to test whether the proposed images add any new information above and beyond the new text and failed to control for the effect of altering the warnings' size and location. Another comment objects to the final quantitative study as flawed because FDA failed to incorporate the commenter's suggestions on demographic and other factors. Some comments state that both quantitative studies are also flawed as they did not test comprehension or understanding of the revised textual statements or images and because they enrolled non-representative participants. These comments also argue that FDA's quantitative studies fail to support the proposed required warnings because the study results demonstrate low or no impact of several tested statements or statement-and-image pairings. Other comments suggest that FDA inappropriately relied on non-U.S. studies and on other studies that have design or execution limitations, including lack of comparative effectiveness data, no measurement of understanding, and no evaluation of whether the image contributes to understanding over and above text.

Other comments suggest that if the rule is based on an interest in a reduction in smoking, then FDA has provided no evidence, including no consumer perception and actual use data, that the proposed required

warnings would decrease smoking initiation and increase smoking cessation.

(Response 12) FDA disagrees with comments suggesting that the rationale for and evidentiary basis supporting this rule are inadequate. Rather, FDA has both documented the need for this rule and developed a robust record supporting it. As the record demonstrates, the final cigarette health warnings will promote greater public understanding of the negative health consequences of smoking.

The rationale for the rule is clear. Cigarette smoking remains the leading cause of preventable disease and death in the United States, yet the public continues to hold misperceptions about the health risks of smoking and is largely unaware of certain conditions caused by smoking (see section V for further discussion). We disagree with comments that argue the public's knowledge of the general harms of cigarette smoking undercuts the need for these required warnings. Contrary to some comments' discussion of the PATH data, there remain large gaps in knowledge about the health effects of smoking, with many smokers having little awareness of the wide variety of diseases causally linked to smoking (see section V.B for further discussion). As discussed in more detail in the First Amendment section, the Sixth Circuit concluded that “[t]here can be no doubt that the government has a significant interest in . . . warning the general public about the harms associated with the use of tobacco products.”

Discount Tobacco,

674 F.3d 509, 519 (6th Cir. 2012).

FDA also disagrees that the Agency's research fails to support this rule or that different warning elements should have been tested. FDA undertook a rigorous science-based, iterative research process to develop and test cigarette health warnings depicting the negative health consequences of smoking. FDA's process involved carefully reviewing the scientific literature on the health risks associated with cigarette smoking, evaluating the public's general awareness and knowledge of those health risks, and assessing the Agency's own consumer research on potential revised warning statements (see section VI for further discussion). The Agency's findings as a result of this process showed that the selected pairings of text and pictorial warnings would promote greater public understanding of the negative health consequences of cigarette smoking. FDA further disagrees with comments suggesting that FDA's reliance on other studies in developing its warnings is inappropriate (see section V.B.2 for further discussion).

Accordingly, the proposed rule is justified by the Government's interest in promoting greater public understanding of the negative health consequences of smoking. To the extent some comments suggest that FDA did not prove that the warnings will lead to increased smoking cessation or decreased initiation, FDA notes that increased smoking cessation and decreased initiation are not the purpose of this rule.

(Comment 13) One comment states there is no evidence to support FDA's proposal to include two different images with the textual warning statement of “WARNING: Smoking causes COPD, a lung disease that can be fatal.”

(Response 13) FDA is finalizing only one text-and-image pairing for the textual warning statement, “WARNING: Smoking causes COPD, a lung disease that can be fatal.”

2. Consideration of Contrary Scientific Evidence

(Comment 14) Some comments suggest that FDA did not adequately consider contrary scientific evidence that undermines the proposed rule, including evidence showing that graphic warnings are ineffective in improving consumer comprehension; evidence showing “shocking images” to be less effective; evidence showing that gruesome images can be seen as exaggerating risks and thus ignored; evidence showing that “fear-based” messages can be ignored or perceived in a defensive manner; or evidence showing that consumers already understand the health consequences of smoking. Comments assert that FDA did not address evidence indicating that the statutory size requirements for warnings on packages and advertisements do not advance consumer understanding.

(Response 14) FDA disagrees with comments suggesting FDA did not adequately consider contrary scientific evidence. As discussed in greater detail below, FDA concludes that those studies with findings contrary to FDA's conclusion regarding images promoting greater understanding may be partly or fully attributable to the fact that the public already has a high pre-existing level of knowledge of the specific health consequences described in the warnings tested in those studies (see section V.B.2 for further discussion). With respect to the evidence about the size of the warnings, the proposed required warnings were tested in the sizes specified by section 4 of the FCLAA. The data generated from FDA's final quantitative consumer research study demonstrate that the 11 final required warnings increase understanding of the negative health consequences of cigarette smoking.

3. Consideration of Alternatives

(Comment 15) Comments state that FDA did not adequately evaluate alternatives to the proposed rule, such as refreshing the Surgeon General's warnings or requiring new, text-only warnings. Other comments suggest that FDA should evaluate the alternatives of smaller or differently placed warnings, or the use of “enhanced public education campaigns.”

(Response 15) FDA disagrees with comments suggesting that its consideration of alternatives was inadequate. FDA considered many approaches, including text-only warnings or different graphic approaches, throughout its process. Ultimately, FDA was guided both by Congress's directive to issue regulations with color graphics to accompany new textual warnings and, as described more fully in section VI of the proposed rule, by findings from health communication science research regarding best practices for communicating health risk information to the lay public.

In amending the FCLAA with the Tobacco Control Act, Congress explicitly recognized that the Surgeon General's text-only warnings had become “ineffective in providing adequate warnings about the dangers of tobacco products” (Ref. 14 at 4). To that end, Congress mandated new cigarette textual warning statements to be accompanied by color graphics. Given this directive, testing text-only warnings would not have been an optimal use of FDA's resources. FDA did, however, consider the substantial body of scientific evidence showing that cigarette textual warning statements better promote public understanding of health risks when accompanied by color graphics. Furthermore, as discussed in section VI, FDA's research studies show that the new warnings with accompanying color graphics promote greater understanding of the risks of smoking than the controls consisting of the (text-only) Surgeon General's warnings (see, also, section V of the proposed rule for a discussion of the literature on the benefits of large pictorial cigarette health warnings).

With regard to comments suggesting that FDA should have considered smaller or differently placed warnings, FDA disagrees. The statute sets forth the requirements with regard to size and placement of the warnings, and the scientific literature strongly supports that larger warnings, such as those of the size proposed in this rule, are

necessary to ensure that consumers notice, attend to, and read the messages conveyed by the warnings, which leads to improved understanding of the specific health consequences that are the subject of those warnings (Refs. 4 and 15). The placement of the warnings at the top 50 percent of the front and rear panels of the packages and at least the top 20 percent of advertisements will better ensure noticeability of the warnings. Moreover, the Supreme Court has recognized that decisions with respect to the constitutionality of a regulation do not include second-guessing the details of such regulations. In

Burson

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.

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, § 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.

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.

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

Office of Thrift Supervision,

792 F. Supp. 837, 844 (D.D.C. 1992) (rejecting argument that 30-day comment period was inadequate, “especially in light of the comments that [aggrieved plaintiffs] and other interested parties submitted in response to this proposed rule”) (citing 12 pages of comments in administrative record).

Here, the Agency received numerous meaningful comments both in support of and disagreeing with the proposed rule, totaling thousands of pages. The Agency has not only taken those public comments into consideration in issuing this final rule, but also made changes to the final requirements based on that public feedback, including allowing cigarette manufacturers to use different required warnings on the front and rear panels of a cigarette package, and altering the image of the underweight

baby on a scale to improve image clarity. The initial 60-day period and supplemental 15-day period for public comment on the notice of proposed rulemaking provided ample opportunity for public participation in this rulemaking process, and comments have failed to establish a basis under § 10.40(b)(3)(i) for any further extensions of time.

5. Requirement of Random and Equal Distribution

(Comment 17) Comments assert that the random and equal distribution requirement for cigarette packages as applied to the proposed 13 warnings is arbitrary and capricious under the APA because compliance is impossible from a printing perspective. Comments urge that FDA must reduce the number of warnings and provide greater flexibility. These comments suggest FDA misunderstands the printing processes in the United States and that industry cannot comply, particularly in the time allotted. The comments explain the printing process and describe why requiring the random and equal distribution of thirteen warnings is “infeasible.”

(Response 17) FDA is finalizing a set of 11 required warnings. FDA disagrees that the statute's and the final rule's requirement for random and equal display and distribution of cigarette package warnings violates the APA. A standardized number of warnings—11 in this final rule, reduced from 13 in the proposed rule—gives the industry a known quantity to implement, and the statute and final rule provides for a 15-month period in which to adjust any printing processes that may require updating. In addition, as we discuss in our responses to the comments that describe implementation concerns (see section X), in preparation for submission of a cigarette plan, FDA encourages manufacturers to engage with FDA sooner rather than later on specific issues related to their product (see also section IX.B.4.e).

V. Need for Rule and FDA Responses to Comments

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

1. Smoking Prevalence and Initiation in the United States

In explaining the need for the proposed rule, we provided information on smoking prevalence and initiation rates among adults and children in the United States. As stated in the proposed rule, cigarettes remain the most commonly used tobacco product in the United States among adults, and a substantial percentage of U.S. adults are cigarette smokers (Ref. 18). Although cigarette smoking prevalence has generally declined over the past several decades, approximately 34.2 million U.S. adults smoke cigarettes, and, among these adult smokers, the vast majority—74.6 percent, or approximately 25.5 million people—smoke every day. Smoking prevalence remains higher than the national average among certain demographic subgroups of the adult population. For example, among adults with differing levels of education, the highest prevalence rates have been observed in adults with lower education levels. Data indicate that 36.0 percent of adults with a General Education Development certificate and 21.8 percent of adults with less than a high school diploma were current smokers in 2018, compared with 7.1 percent of adults with a college degree and 3.7 percent of adults with a graduate degree (Ref. 19).

Despite recent declines in youth smoking rates, the 2019 National Youth Tobacco Survey data showed that past 30-day smoking prevalence among high school students was 5.8 percent, representing 860,000 youth, of which 32.5 percent were frequent smokers (defined as cigarette use on 20 or more of the past 30 days) (Refs. 20 and 21). The data also showed that past 30-day prevalence among middle school students was 2.3 percent, representing 270,000 youth (Ref. 20). Results from the 2018 National Survey on Drug Use and Health demonstrate that, on average, each day in the United States, approximately 1,600 youth ages 12 to 17 smoke their first cigarette, and 170 youth ages 12 to 17 become daily cigarette smokers (Ref. 22 at Table A.3A).

2. Negative Health Consequences of Smoking

As described in the proposed rule, the health risks associated with cigarette smoking are significant. Cigarette smoking remains the leading cause of preventable disease and death in the United States and is responsible for more than 480,000 deaths per year among cigarette smokers and those exposed to secondhand smoke (Ref. 3). Smoking causes more deaths each year than human immunodeficiency virus, illegal drug use, alcohol use, motor vehicle injuries, and firearm-related incidents combined (Refs. 23 and 24). Over 16 million Americans alive today live with disease caused by smoking cigarettes (Ref. 3).

Since the first Surgeon General's Report published in 1964, evidence of the negative health consequences of cigarette smoking and secondhand smoke has expanded dramatically. For example, the 2014 Surgeon General's Report (Ref. 3) presented a robust body of scientific evidence documenting the health consequences from both smoking and exposure to secondhand smoke across a range of diseases and organ systems. In particular, the 2014 Surgeon General's Report added eleven diseases to the long list of diseases causally linked to cigarette smoking: Liver cancer, colorectal cancer, age-related macular degeneration, orofacial clefts in newborns from maternal smoking during pregnancy, tuberculosis, stroke (for adults), diabetes, erectile dysfunction, ectopic pregnancy, rheumatoid arthritis, and impaired immune function (Ref. 3 at pp. 4-5). The health conditions established to be causally linked to cigarette smoking in the 2014 Surgeon General's Report are in addition to the more than 40 unique health consequences of cigarette smoking and exposure to secondhand smoke determined by earlier studies (Ref. 3).

FDA received many comments that were strongly supportive of the proposed rule, many of which reiterate the negative health consequences of cigarette smoking described in the proposed rule and stressed the need for public health measures, such as new cigarette health warnings, to communicate the latest science to the public. FDA did not receive comments disputing that cigarette smoking is harmful to human health.

(Comment 18) Several comments emphasize that, given the substantial health toll of tobacco use, “it is difficult to imagine a more compelling governmental interest than to ensure that the public understands the health consequences of smoking” and that health warnings on cigarettes are one of the most efficient and effective ways of doing so.

(Response 18) FDA agrees that the health toll from cigarettes is substantial and that the required warnings in the final rule will improve public understanding about the breadth of negative health consequences caused by smoking. As explained in section V.B of the proposed rule, the scientific literature demonstrates that cigarette health warnings that are noticeable, lead to learning, and increase knowledge will promote greater public understanding of the negative health consequences of smoking, and FDA's consumer research has demonstrated that the required warnings will advance this important governmental interest.

(Comment 19) A comment (from a public health group and a network of

state and territorial tobacco prevention and control programs across the United States) expressed support for FDA to fully implement all of the warnings in the proposed rule. The comment states the rule is complementary to the needs and goals of public health agencies and that the required warnings on cigarette packs and advertisements will effectively and appropriately support state and territory-based efforts to educate smoking and nonsmoking consumers.

(Response 19) FDA agrees that the final rule will complement other educational efforts that inform smokers and nonsmokers about the negative health consequences of smoking. As we discuss in section VII, following consideration of the public comments received in the docket, as well as based on the results of our consumer research studies, existing scientific literature on cigarette health warnings, and legal and policy considerations, FDA is finalizing 11 of the 13 required warnings.

(Comment 20) Some comments provide additional information that smoking disproportionately harms (through both higher prevalence and tobacco-related death and disease) many marginalized populations, including African-Americans; American Indians, and Alaskan Natives; people with low incomes, low educational attainment, and low health literacy; people who identify as lesbian, gay, bisexual, or transgender; and people with behavioral health and substance use conditions (see,

e.g.,

Refs. 25-28).

(Response 20) FDA agrees that cigarette smoking disparities exist among specific subpopulations in the United States. As described in section IV.A of the proposed rule, smoking prevalence is higher in some subpopulations (

e.g.,

those with lower socioeconomic status (SES)) than the general U.S. population (Refs. 18, 29, and 30). For the reasons explained in section V.B.2 of the proposed rule, some subpopulations experience disparities in knowledge of the health harms of smoking due to lower health information access and lower health literacy, and the evidence collectively demonstrates that pictorial cigarette warnings, such as the required warnings being issued in this final rule, are effective across diverse populations and settings and will likely help reduce disparities found in consumer understanding about the harms of smoking.

B. Data Concerning Cigarette Health Warnings

1. The Current 1984 Surgeon General's Warnings Are Inadequate

In the preamble to the proposed rule, FDA observed that cigarette packages and advertisements can serve as important channels for communicating health information to broad audiences that include both smokers and nonsmokers. Daily smokers are potentially exposed to the warnings on packages over 5,100 times per year, and, because these packages are not always concealed and are often visible to those other than the person carrying the package, including retail customers, warnings on those packages are potentially viewed by many others, including nonsmokers (Refs. 31 and 32). Smokers and nonsmokers, including adolescents, also are frequently exposed to cigarette advertising appearing in a range of marketing channels, including print and digital media, outdoor locations, and in and around retail establishments where tobacco products are sold (Refs. 33 and 34). The inclusion of health warnings on cigarette packages and in advertisements therefore can provide a critical opportunity to help smokers and nonsmokers of all ages better understand the negative health consequences of smoking. However, the current 1984 Surgeon General's warnings have suffered from three critical problems: (1) They have not changed in more than 35 years and long ago became effectively stale; (2) they do not effectively promote greater public understanding of the risks of smoking because they do not attract attention, are not remembered, and do not prompt thoughts about the risks of smoking; and (3) they do not address areas where there are significant gaps in public understanding about the negative health consequences of cigarette smoking (see section V.A of the proposed rule).

The proposed rule presented extensive evidence from the scientific literature regarding how the current 1984 Surgeon General's warnings are largely unnoticed and unconsidered by both smokers and nonsmokers (see section V.A.2 of the proposed rule). FDA also provided clear evidence that consumers suffer from a pervasive lack of knowledge about and understanding of many of the negative health consequences of smoking and the current Surgeon General's warnings are inadequate to address these knowledge gaps.

We received numerous comments supporting our analysis regarding the inadequacy of the current 1984 Surgeon General's warnings that appear on cigarette packages and in cigarette advertisements. FDA also received many comments regarding the level of consumers' knowledge and understanding of the health risks of smoking. Several comments stated that the public is adequately informed about the risks of smoking, while many other comments explained that consumers lack knowledge about a wide variety of smoking risks. These comments, and our responses, are summarized below.

(Comment 21) A substantial number of comments strongly support the proposed rule and urge FDA to include all 13 proposed required warnings in the final rule. These comments cite as support: The more than 35 years since the current 1984 Surgeon General's warning labels were changed; the conclusion that the current Surgeon General's warnings are “wholly inadequate” because they are not noticed and fail to address many of the health harms of smoking of which the public has little knowledge; the demonstrated gaps in public awareness and knowledge of the health risks of tobacco use; the well-established and “overwhelming” findings that large pictorial cigarette warnings such as those included in the proposed rule can effectively promote public awareness and understanding of the negative health consequences of smoking through conveying the risks of smoking and secondhand smoke (Ref. 35); and FDA's scientific evidence and research studies establishing that the proposed warnings will advance the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking.

(Response 21) FDA agrees that there is a strong need for new cigarette health warnings because, as noted in section V.A of the proposed rule, the current 1984 Surgeon General's warnings are inadequate because they do not attract attention, are not noticed, do not prompt consumers to think about the risks of smoking, are not remembered, do not address the breadth of negative health consequences of smoking, and have not been updated in more than 35 years. FDA agrees that large pictorial cigarette warnings, such as the ones required in the final rule, will address the noted issues by attracting attention and focusing on less-known health consequences of smoking to promote greater public understanding of the negative health consequences of smoking (see section V.B of the proposed rule and section V.B of the final rule).

(Comment 22) Several comments strongly support FDA's aim in issuing

new cigarette health warnings, which is to promote greater public understanding of the negative health consequences of smoking. One comment from an academic researcher states that the proposed warnings' focus on “novel” health effects, for which there are lower levels of public awareness, is an appropriate and effective strategy. Comments from multiple professional medical associations emphasize that their medical professional members know first-hand the devastating impact of tobacco-related death and disease on the patients, including children, they treat in their clinical practice every day. Many comments from public health providers and advocacy groups, including those caring for children, strongly encourage FDA to finalize the proposed rule as quickly as possible (no later than the federal court deadline) and to implement the enhanced warning labels without further delay. Another comment, submitted by an academic researcher, emphasizes that the proposed rule presents a “unique opportunity” to educate consumers on some of the less-known health effects of tobacco use, including bladder cancer, erectile dysfunction, and diabetes, stating that “these health effects are among those that consumers and the general public in the U.S. are largely less aware,” according to research conducted by the researcher.

(Response 22) As described in the proposed rule, when developing the new cigarette health warnings, FDA consulted the epidemiological literature of causally-linked health conditions as identified in the Surgeon General's Reports and scientific literature (see sections VI.A and VII.A of the proposed rule). FDA developed cigarette health warnings that focus on negative health effects that are less known or less understood by consumers. FDA agrees that the required warnings, once implemented, will promote greater public understanding of the negative health consequences of smoking.

(Comment 23) A number of comments support FDA's finding that the current 1984 Surgeon General's warnings are inadequate and not taken seriously by consumers, public understanding of the health impacts of smoking is still limited, and large, pictorial cigarette warnings can increase knowledge of the health harms of smoking. Some comments discuss the wide range of studies that indicate that the existing warnings on cigarette packages and in cigarette advertisements are substantially less effective at communicating the health effects of smoking than larger pictorial cigarette warnings and are associated with substantial disparities in health knowledge.

(Response 23) FDA agrees with these supportive comments that the current 1984 Surgeon General's warnings on cigarette packages and in cigarette advertisements are inadequate and ineffective in communicating the health harms of smoking and that the larger pictorial warnings required by this rule will be more effective in helping promote greater public understanding of the negative health consequences of smoking.

(Comment 24) A comment asserts that FDA's proposed rule references some published studies that are older, do not specifically address the current state of the public's knowledge, or focus on smoking-related health effects (

e.g.,

cervical cancer, infertility, kidney cancer, osteoporosis) that are not found in the proposed warnings. The comment states that none of the studies are directly relevant in showing what the U.S. population currently knows about the health risks identified in the proposed required warnings.

(Response 24) To examine public understanding of the negative health consequences of smoking within the U.S. population, FDA conducted qualitative and quantitative consumer research studies that recruited youth, young adults, older adults, smokers, and nonsmokers in addition to our review of the existing scientific literature. Our findings reinforced what is known about public misperceptions of the health harms of smoking while also addressing gaps that the comment identifies with updated and relevant scientific support.

As discussed in section V.A.3 of the proposed rule, 84 FR at 42761-62, consumers suffer from a pervasive lack of knowledge about and understanding of the many negative health consequences of smoking, and importantly, the published literature indicates that consumers do not understand the wide

range

of illnesses caused by smoking. Due to these gaps in public understanding about the negative health consequences of smoking, as seen in the literature, FDA developed the required warnings to cover a range of smoking-related health effects (as described in section VI of the proposed rule) in order to improve public understanding (see section V.B.2 of the proposed rule, 84 FR at 42763-65 (“Pictorial Cigarette Warnings Can Address Gaps in Public Understanding About the Negative Health Consequences of Smoking”)). Additionally, FDA's rigorous science-based, iterative research and development process confirmed that there are substantial consumer knowledge gaps in in the United States and that the required warnings focusing on the specific health consequences highlighted will meet FDA's objectives, especially as indicated by outcomes of “new information” and “self-reported learning” (see section VI of the proposed rule and sections VI and VII of this final rule).

(Comment 25) Several comments discuss the disproportionate burden of smoking observed for some subgroups (

e.g.,

those with lower SES, non-English speakers) and state these subgroups also have disparities in knowledge about the negative harms of smoking. Several comments state that these subgroups tend to have lower levels of health literacy, limited access to information about the hazards of smoking, and tend to benefit the least from textual warnings on smoking harms. As a result, many comments state that cigarette health warnings with images depicting the harms of smoking will benefit these subgroups by effectively communicating the negative consequences of smoking to diverse populations.

(Response 25) FDA agrees. As discussed in section V.B.2.c of the proposed rule, 84 FR at 42764-65, research shows that pictorial cigarette warnings are effective for diverse populations that differ in cultural, racial, ethnic, and socioeconomic backgrounds. Pictorial cigarette warnings are likely to help reduce disparities among disadvantaged groups in consumer understanding about the harms of smoking.

(Comment 26) Two comments argue that individuals in the United States have substantial exposure to smoking-related information from a wide array of Federal, State, and other public health sources which results in high awareness of the negative health effects of smoking, rendering the proposed cigarette health warnings ineffective in increasing consumer understanding of the negative health consequences of smoking and that FDA has failed to address scientific evidence showing that consumers already understand the health consequences of smoking. In support of that argument, one comment describes survey 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

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

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

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

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”);

• 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

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