42754 Federal Register / Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules

DEPARTMENT OF HEALTH AND Electronic Submissions information you claim to be confidential HUMAN SERVICES Submit electronic comments in the with a heading or cover note that states following way: ‘‘THIS DOCUMENT CONTAINS Food and Drug Administration • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The https://www.regulations.gov. Follow the Agency will review this copy, including 21 CFR Part 1141 instructions for submitting comments. the claimed confidential information, in Comments submitted electronically, its consideration of comments. The [Docket No. FDA–2019–N–3065] including attachments, to https:// second copy, which will have the www.regulations.gov will be posted to claimed confidential information RIN 0910–AI39 the docket unchanged. Because your redacted/blacked out, will be available comment will be made public, you are for public viewing and posted on Tobacco Products; Required Warnings solely responsible for ensuring that your https://www.regulations.gov. Submit for Cigarette Packages and comment does not include any both copies to the Dockets Management Advertisements confidential information that you or a Staff. If you do not wish your name and third party may not wish to be posted, contact information to be made publicly AGENCY: Food and Drug Administration, such as medical information, your or available, you can provide this HHS. anyone else’s Social Security number, or information on the cover sheet and not in the body of your comments and you ACTION: Proposed rule. confidential business information, such as a manufacturing process. Please note must identify this information as SUMMARY: The Food and Drug that if you include your name, contact ‘‘confidential.’’ Any information marked Administration (FDA, the Agency, or information, or other information that as ‘‘confidential’’ will not be disclosed we) is issuing a proposed rule to identifies you in the body of your except in accordance with 21 CFR 10.20 establish new required cigarette health comments, that information will be and other applicable disclosure law. For warnings for cigarette packages and posted on https://www.regulations.gov. more information about FDA’s posting advertisements. The proposed rule • If you want to submit a comment of comments to public dockets, see 80 would implement a provision of the with confidential information that you FR 56469, September 18, 2015, or access Family Smoking Prevention and do not wish to be made available to the the information at: http://www.gpo.gov/ Tobacco Control Act (Tobacco Control public submit the comment as a written/ fdsys/pkg/FR-2015-9-18/pdf/2015- Act) that requires FDA to issue paper submission and in the manner 23389.pdf. regulations requiring color graphics detailed (see ‘‘Written/Paper Docket: For access to the docket to depicting the negative health Submissions’’ and ‘‘Instructions.’’) read background documents or the consequences of smoking to accompany electronic and written/paper comments Written/Paper Submissions new textual warning statements. The received, go to https:// Tobacco Control Act amends the Submit written/paper submissions as www.regulations.gov and insert the Federal Cigarette Labeling and follows: docket number, found in brackets in the Advertising Act (FCLAA) of 1965 to • Mail/Hand Delivery/Courier (for heading of this document, into the require each cigarette package and written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts advertisement to bear one of the new Management Staff (HFA–305), Food and and/or go to the Dockets Management required warnings. This proposed rule, Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, once finalized, would specify the color Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. graphics that must accompany the new • For written/paper comments Submit comments on information textual warning statements. FDA is submitted to the Dockets Management collection issues under the Paperwork proposing to take this action to promote Staff, FDA will post your comment, as Reduction Act of 1995 to the Office of greater public understanding of the well as any attachments, except for Management and Budget (OMB) in the negative health consequences of information submitted, marked and following ways: cigarette smoking. identified, as confidential, if submitted • Fax to the Office of Information and as detailed in ‘‘Instructions.’’ DATES: Regulatory Affairs, OMB, Attn: FDA Submit either electronic or Instructions: All submissions received written comments on the proposed rule Desk Officer, FAX: 202–395–7285, or must include the Docket No. FDA– email to [email protected]. by October 15, 2019. Submit comments 2019–N–3065 for ‘‘Tobacco Products; on information collection issues under All comments should be identified with Required Warnings for Cigarette the title, ‘‘Tobacco Products; Required the Paperwork Reduction Act of 1995 by Packages and Advertisements.’’ September 16, 2019. Warnings for Cigarette Packages and Received comments, those filed in a Advertisements.’’ ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be as follows. Please note that late, placed in the docket and, except for FOR FURTHER INFORMATION CONTACT: untimely filed comments will not be those submitted as ‘‘Confidential Courtney Smith or Daniel Gittleson, considered. Electronic comments must Submissions,’’ publicly viewable at Office of Regulations, Center for be submitted on or before October 15, https://www.regulations.gov or at the Tobacco Products, Food and Drug 2019. The https://www.regulations.gov Dockets Management Staff between 9 Administration, Document Control electronic filing system will accept a.m. and 4 p.m., Monday through Center, Bldg. 71, Rm. G335, 10903 New comments until 11:59 p.m. Eastern Time Friday. Hampshire Ave., Silver Spring, MD at the end of October 15, 2019. • Confidential Submissions—To 20993–0002, 877–287–1373, email: Comments received by mail/hand submit a comment with confidential [email protected]. delivery/courier (for written/paper information that you do not wish to be With regard to the information submissions) will be considered timely made publicly available, submit your collection: Amber Sanford, Office of if they are postmarked or the delivery comments only as a written/paper Operations, Food and Drug service acceptance receipt is on or submission. You should submit two Administration, Three White Flint before that date. copies total. One copy will include the North 10A–12M, 11601 Landsdown St.,

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North Bethesda, MD 20852, PRAStaff@ for cigarette packages and cigarette health warnings, once fda.hhs.gov. advertisements. These new cigarette finalized, would appear prominently on SUPPLEMENTARY INFORMATION: health warnings would consist of cigarette packages and in cigarette textual warning statements advertisements, occupying the top 50 Table of Contents accompanied by color graphics percent of the area of the front and rear I. Executive Summary depicting the negative health panels of cigarette packages and at least A. Purpose of the Proposed Rule consequences of cigarette smoking. The 20 percent of the area at the top of B. Summary of the Major Provisions of the new cigarette health warnings, once cigarette advertisements. Proposed Rule finalized, would appear prominently on In addition, as required under the C. Legal Authority cigarette packages and in cigarette FCLAA, the proposed rule would D. Costs, Benefits, and Informational establish marketing requirements that Effects advertisements, occupying the top 50 Table of Abbreviations/Commonly Used percent of the area of the front and rear would include the random display and Acronyms in This Document panels of cigarette packages and at least distribution of the required warnings for II. Background 20 percent of the area at the top of cigarette packages and quarterly A. Need for the Regulation cigarette advertisements. rotations of the required warnings for B. History of the Rulemaking Cigarette smoking remains the leading cigarette advertisements. A tobacco C. Incorporation by Reference cause of preventable disease and death product manufacturer, distributor, or III. Legal Authority in the United States and is responsible retailer would be required to submit a IV. Cigarette Use in the United States and the for more than 480,000 deaths per year. plan for the random and equal display Resulting Health Consequences Smoking causes more deaths each year and distribution of the required A. Smoking Prevalence and Initiation in the United States than human immunodeficiency virus, warnings on packages and the quarterly B. Negative Health Consequences of illegal drug use, alcohol use, motor rotation in advertisements for approval Smoking vehicle injuries, and firearm-related by FDA. In addition, the proposed rule V. Data Concerning Cigarette Health incidents combined. In developing this would require each tobacco product Warnings proposed rule, FDA determined that the manufacturer required to randomly and A. The Current 1984 Surgeon General’s public holds misperceptions about the equally display and distribute warnings Warnings Are Inadequate health risks caused by smoking and that on packaging or quarterly rotate B. Cigarette Health Warnings That Are warning statements focused on less- warnings on advertisements in Noticeable, Lead to Learning, and Increase Knowledge Will Promote Public known health consequences of smoking accordance with an FDA-approved plan, Understanding About the Negative paired with concordant color graphics to maintain a copy of the FDA-approved Health Consequences of Smoking would promote greater public plan, and to make the plan available for VI. FDA’s Process for Developing and Testing understanding of the risks associated inspection and copying by officers and the Proposed Cigarette Health Warnings with cigarette smoking, especially given employees of FDA. A. Review of the Negative Health that the existing Surgeon General’s FDA developed the new cigarette Consequences of Cigarette Smoking warnings currently used in the United health warnings included in this B. Developing Revised Textual Warning States have been shown to go unnoticed proposed rule through a science-based, Statements and be ‘‘invisible.’’ For the reasons iterative research process. The proposed C. FDA’s Consumer Research Study on Revised Textual Warning Statements discussed in the preamble to this warnings are intended to promote D. Developing and Testing Images proposed rule, FDA has determined that greater public understanding of the Depicting the Negative Health the proposed new cigarette health negative health consequences of Consequences of Smoking To warnings will advance the cigarette smoking. Accompany the Textual Warning Government’s interest in promoting Statements greater public understanding of the C. Legal Authority E. FDA’s Consumer Research Study on negative health consequences of This proposed rule is being issued in New Cigarette Health Warnings cigarette smoking. accordance with sections 201 and 202 of VII. FDA’s Proposed Required Warnings the Tobacco Control Act (Pub. L. 111– A. FDA’s Proposed Required Warnings B. Summary of the Major Provisions of 31), which amend section 4 of the VIII. First Amendment Considerations the Proposed Rule IX. Description of the Proposed Rule FCLAA (15 U.S.C. 1333). This proposed A. General Provisions (Proposed Subpart This proposed rule would establish rule is also being issued based upon A) new required warnings to appear on FDA’s authorities related to misbranded B. Required Warnings for Cigarette cigarette packages and in cigarette tobacco products under sections 903 (21 Packages and Advertisements (Proposed advertisements. The proposed rule U.S.C. 387c); FDA’s authorities related § 1141.10) would implement a provision of the to records and reports under section 909 C. Misbranding of Cigarettes (Proposed Tobacco Control Act that requires FDA (21 U.S.C. 387i); and FDA’s rulemaking § 1141.12) to issue regulations requiring color and inspection authorities under X. Proposed Effective Dates graphics depicting the negative health sections 701 (21 U.S.C. 371), 704 (21 XI. Severability and Other Considerations consequences of smoking to accompany XII. Preliminary Economic Analysis of U.S.C. 374), and 905(g) (21 U.S.C. Impacts new textual warning statements. The 387e(g)) of the Federal Food, Drug, and XIII. Analysis of Environmental Impact Tobacco Control Act amends the Cosmetic Act (FD&C Act). XIV. Paperwork Reduction Act of 1995 FCLAA to require each cigarette package XV. Federalism and advertisement to bear one of the D. Costs, Benefits, and Informational XVI. Consultation and Coordination With new required warnings. These new Effects Indian Tribal Governments cigarette health warnings would consist The proposed new cigarette health XVII. References of textual warning statements warnings would promote greater public I. Executive Summary accompanied by color graphics, in the understanding of the negative health form of concordant photorealistic consequences of cigarette smoking by A. Purpose of the Proposed Rule images, depicting the negative health presenting information about the health This proposed rule would establish consequences of cigarette smoking. As risks of smoking to smokers and new required cigarette health warnings required under the FCLAA, the new nonsmokers in a format that helps

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people better understand these TABLE OF ABBREVIATIONS/COMMONLY nearly 1.4 million U.S. youth (aged 12– consequences. Despite the informational USED ACRONYMS IN THIS DOCU- 17 years) smoke cigarettes (defined as effects of this proposed rule, there is a MENT—Continued past 30-day use) (Refs. 5 and 6). Results high level of uncertainty around from the 2017 National Survey on Drug quantitative economic benefits at this Abbreviation/ Use and Health demonstrate that, on time, so we describe them qualitatively. acronym What it means average, each day in the United States, The cost of this proposed rule consists about 2,000 youth under age 18 smoke of initial and recurring labeling costs TCA state- Textual warning statements their first cigarette, and 320 youth associated with changing cigarette labels ments. specified in section 4(1) of become daily cigarette smokers (Ref. 7). the FCLAA. to accommodate the new cigarette The health risks associated with TTB ...... Alcohol and Tobacco Tax cigarette smoking are significant. health warnings, design and operation and Trade Bureau. costs associated with the random and WHO ...... World Health Organization. Cigarette smoking is the leading cause of equal display and distribution of preventable disease and death in the United States and is responsible for required cigarette health warnings for II. Background cigarette packages and quarterly more than 480,000 deaths per year (Ref. rotations of the required warnings for A. Need for the Regulation 8). Smoking causes more deaths each cigarette advertisements, advertising- To help inform consumers of the year than human immunodeficiency related costs, and costs associated with potential hazards of cigarette smoking, virus, illegal drug use, alcohol use, government administration and Congress passed the FCLAA that motor vehicle injuries, and firearm- enforcement of the rule. We estimate required that a printed text-only related incidents combined (Refs. 9 and that, at the mean, the present value of warning appear on cigarette packages 10). Over 16 million Americans alive today live with disease caused by the costs of this proposed rule is about (Pub. L. 89–92). The 1965 warning smoking cigarettes (Ref. 8). In addition $1.6 billion using a three percent requirement was modified by later to lung cancer, heart disease, and discount rate and roughly $1.2 billion amendments to the FCLAA, including chronic obstructive pulmonary disease using a seven percent discount rate the Comprehensive Smoking Education (COPD), smoking also causes numerous (2018$). If the information provided by Act of 1984 (Pub. L. 98–474), which other serious health conditions that are the cigarette health warning on each extended the warning requirement to less-known effects of smoking and cigarette package was valued at about cigarette advertising and updated the exposure to secondhand smoke, $0.01 (for every pack sold annually one warning to four warnings, including many types of cancer, nationwide), then the benefits that frequently referred to as the Surgeon would be generated by the proposed premature birth, low birth weight, General’s warnings. sudden infant death syndrome (SIDS), rule would equal or exceed the The FCLAA has required the estimated annual costs. respiratory illnesses, clogged arteries, inclusion of text-only warnings on reduced blood flow, diabetes, cigarette packages and in cigarette TABLE OF ABBREVIATIONS/COMMONLY rheumatoid arthritis, and vision advertisements for many years. As conditions such as age-related macular USED ACRONYMS IN THIS DOCUMENT discussed in detail in section V.A, there degeneration and cataracts (Ref. 8). is considerable evidence that the In developing this proposed rule, FDA Abbreviation/ Surgeon General’s warnings go largely acronym What it means carefully examined the scientific unnoticed and unconsidered by both literature, including the 2014 Surgeon CDC ...... Centers for Disease Control smokers and nonsmokers. These General’s Report (Ref. 8), which and Prevention. warnings, which have not changed in identified 11 more health conditions COPD ...... Chronic Obstructive Pul- nearly 35 years, have been described as that have been established to have monary Disease. ‘‘invisible’’ (Ref. 1) and fail to convey sufficient evidence to infer a causal link D.C. Cir ...... United States Court of Ap- relevant information in an effective way to cigarette smoking—the highest level peals for the District of (Ref. 2 at p. 291). The Surgeon General’s of evidence of causal inferences from Columbia Circuit. warnings also do not include any color EO ...... Executive Order. the criteria applied in the Surgeon EPA ...... Environmental Protection graphics. General’s Reports. Those health Agency. In 2009, in enacting the Tobacco conditions examined in the 2014 FCLAA ...... Federal Cigarette Labeling Control Act, Congress further amended Surgeon General’s Report are in and Advertising Act. the FCLAA and directed FDA to issue addition to the more than forty unique FD&C Act ...... Federal Food, Drug, and new cigarette health warnings that health consequences already classified Cosmetic Act. would include a graphic component in previous Surgeon General’s Reports FDA ...... Food and Drug Administra- depicting the negative health as being caused by smoking and tion. consequences of smoking to accompany exposure to secondhand smoke. FTC ...... Federal Trade Commission. the new textual warnings (section 201 of IOM ...... Institute of Medicine. Additional findings in the scientific ITC–4 ...... International Tobacco Con- the Tobacco Control Act). In enacting literature demonstrate that the U.S. trol Four Country Survey. this legislation, Congress also provided public—including youth and adults, NARA ...... National Archives and that FDA may adjust the warnings if smokers and nonsmokers—holds Records Administration. FDA found that such a change would misperceptions about the health risks OFR ...... Office of the Federal Reg- promote greater public understanding of caused by smoking (Refs. 3 and 11–16). ister. the risks associated with the use of Through its review of the scientific OMB ...... Office of Management and tobacco products (section 202 of the literature, as well as the Agency’s Budget. Tobacco Control Act). science-based, iterative research and PAD ...... Peripheral arterial disease. PDF ...... Portable document format. Approximately 34.3 million U.S. development process (described in PVD ...... Peripheral vascular disease. adults smoke cigarettes (defined as sections V and VI), FDA determined that SES ...... Socioeconomic status. smoking at least 100 cigarettes during having warning statements focused on SIDS ...... Sudden infant death syn- their lifetime and now smoking less-known health consequences of drome. cigarettes every day or some days) and smoking accompanied by photorealistic

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images can promote greater public denied the Government’s petition for website). Any material incorporated by understanding of the risks associated panel rehearing and rehearing en banc, reference must meet the Office of the with cigarette smoking, especially given and the Government decided not to seek Federal Register’s (OFR) requirements the unnoticed and ‘‘invisible’’ 1984 further review of the Court’s ruling. In for incorporating material by reference Surgeon General’s warnings currently a letter to Congress on March 15, 2013, (5 U.S.C 552(a) and 1 CFR part 51). the U.S. Attorney General reported used in the United States (see section III. Legal Authority V.A). FDA’s intention to undertake research to Therefore, consistent with section 4 of support a new rulemaking consistent The Tobacco Control Act was enacted the FCLAA (as amended by sections 201 with the Tobacco Control Act (Ref. 17). on June 22, 2009, amending the FD&C and 202 of the Tobacco Control Act), we Central to FDA’s work since that time Act and providing FDA with the are proposing a set of textual warning has been evaluating how to address the authority to regulate the manufacture, label statements, to be accompanied by D.C. Circuit’s critiques of the prior rule marketing, and distribution of tobacco concordant color graphics depicting the and carefully considering how to products to protect the public health negative health consequences of develop a research plan and rulemaking and to reduce tobacco use by minors. smoking, to appear on cigarette process that will provide a robust record Section 201 of the Tobacco Control Act packages and in cigarette for a new cigarette health warnings rule. amends section 4 of the FCLAA to advertisements. Specifically, we are Through extensive legal, scientific, and require that nine new health warning proposing to replace part 1141 to Title regulatory analyses, FDA developed a statements appear on cigarette packages 21 of the Code of Federal Regulations science-based, iterative research process and in cigarette advertisements and (21 CFR part 1141), and the new part for developing new cigarette health directs FDA to ‘‘issue regulations that 1141 would require new cigarette health warnings to put forth in this proposed require color graphics depicting the warnings 1 on cigarette packages and in rule that would advance the negative health consequences of cigarette advertisements. These new Government’s substantial interest in smoking’’ to accompany the nine new cigarette health warnings would consist promoting greater public understanding health warning statements. Under of up to 13 textual warning label of the negative health consequences of section 201 of the Tobacco Control Act, statements accompanied by color smoking. Because these cigarette health FDA may adjust the type size, text, and graphics depicting the negative health warnings, as shown through the robust format of the cigarette health warnings consequences of smoking. As required scientific evidence described in detail in as FDA determines appropriate so that both the color graphics and the by section 4 of the FCLAA, the new sections VI–VII, are factual and accompanying textual warning label cigarette health warnings would appear accurate, advance the substantial statements are clear, conspicuous, and prominently on packages and in Government interest in promoting legible and appear within the specified advertisements, occupying the top 50 greater public understanding of the negative health consequences of area (15 U.S.C. 1333(d)). percent of the area of the front and rear Section 202(b) of the Tobacco Control panels of cigarette packages and at least smoking, and are not unduly burdensome, FDA believes the warnings Act also amends section 4 of the FCLAA 20 percent of the area at the top of to add a new subsection 2 that permits cigarette advertisements. would pass a First Amendment analysis under Zauderer v. Office of Disciplinary FDA to, after providing notice and an As described in section VII, FDA has opportunity for the public to comment, determined that the proposed new Counsel, 471 U.S. 626 (1985) (or, if applied, Central Hudson Gas & Elec. adjust the format, type size, color cigarette health warnings will advance Corp. v. Pub. Serv. Comm’n, 447 U.S. graphics, and text of any of the label the Government’s interest in promoting 557 (1980)). After reviewing public requirements, or establish the format, greater public understanding of the comments and weighing additional type size, and text of any other negative health consequences of scientific, legal, and policy disclosures required under the FD&C cigarette smoking. considerations, FDA intends to finalize Act, if such a change would promote B. History of the Rulemaking some or all of the 13 cigarette health greater public understanding of the risks warnings proposed in this rule. associated with the use of tobacco In the Federal Register of June 22, products. Such adjustments, including 2011 (76 FR 36628), FDA issued a final C. Incorporation by Reference adjustments to the text of some of the rule entitled ‘‘Required Warnings for FDA is proposing to incorporate by warning statements and to the number Cigarette Packages and reference certain material entitled of proposed required warnings, are Advertisements,’’ which specified nine ‘‘Required Cigarette Health Warnings.’’ included as part of this proposed rule. images to accompany the nine textual We have included an electronic portable These requirements are supplemented warning statements for cigarettes set out document format (PDF) file, containing by the FD&C Act’s misbranding in the Tobacco Control Act. The final the proposed required warnings, as a provisions, which require that product rule was challenged in court, and on reference in the docket (Ref. 18). Any labeling and advertising include August 24, 2012, the United States final rule would provide information on required warnings. For example, a Court of Appeals of the District of how to obtain the final electronic, tobacco product is deemed misbranded Columbia vacated the rule and layered design files for each required under section 903(a)(1) or (a)(7)(A) of remanded the matter to the Agency. R.J. warning, as well as technical the FD&C Act if its labeling or Reynolds Tobacco Co. v. Food & Drug specifications to help regulated entities advertising is false or misleading in any Administration, 696 F.3d 1205 (D.C. Cir. appropriately select, crop, and scale the 2012), overruled on other grounds by warnings to ensure the required 2 Section 201(a) of the Tobacco Control Act Am. Meat Inst. v. U.S. Dep’t of Agric., warnings are accurately reproduced amends section 4 of the FCLAA to add a new 760 F.3d 18, 22–23 (D.C. Cir. 2014) (en subsection (d), ‘‘Graphic Label Statements,’’ which across various sizes and shapes of is codified at 15 U.S.C. 1333(d). Section 202(b) of banc). On December 5, 2012, the Court cigarette packages and cigarette the Tobacco Control Act amends section 4 of the advertisements. FDA would also FCLAA to also add a new subsection (d), ‘‘Change 1 For the purposes of discussion throughout this in Required Statements,’’ which is also codified at document, FDA uses the term ‘‘cigarette health provide instructions for how to access 15 U.S.C. 1333(d). Both provisions of the Tobacco warnings’’ to refer to the required warnings we are this material (e.g., via download through Control Act are correctly codified as ‘‘15 U.S.C. proposing. FDA’s website or a file transfer protocol 1333(d).’’

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particular. Under section 201(n) of the youth become daily cigarette smokers adolescents who reported only smoking FD&C Act (21 U.S.C. 321(n)), in (Ref. 7). cigarettes, 42.6 percent reported having determining whether labeling or Cigarettes remain the most commonly strong cravings to smoke, a symptom of advertising is misleading, FDA used tobacco product in the United nicotine dependence, in the past 30 considers, among other things, the States among adults, and a substantial days (Ref. 20). failure to reveal material facts percentage of U.S. adults are cigarette smokers (Ref. 5). Although cigarette B. Negative Health Consequences of concerning the consequences that may Smoking result from the customary or usual use smoking prevalence has generally of the product. Similarly, under section declined over the past several decades, Cigarette smoking remains the leading 903(a)(8)(B) of the FD&C Act, a tobacco results from the 2017 National Health cause of preventable disease and death product is deemed misbranded unless Interview Survey indicate that in the United States. The 2014 Surgeon the manufacturer, packer, or distributor approximately 34.3 million U.S. adults General’s Report found that cigarette includes in all advertisements and other (or 14.0 percent of the U.S. adult smoking was responsible for an average descriptive printed matter, which FDA population) are current cigarette of over 480,000 premature deaths in the interprets as including packages, a brief smokers (Ref. 5). Among these adult United States each year from 2005 to statement of, among other things, the smokers, the vast majority—75 percent, 2009, of which almost 440,000 occurred relevant warnings. Under section 701(a) or approximately 25.7 million people— because of active smoking (Ref. 8). The of the FD&C Act, FDA has authority to smoke every day. Smoking prevalence report also found that cigarette smoking issue regulations for the efficient remains higher than the national was directly responsible for 163,700 enforcement of the FD&C Act, and average among certain demographic deaths from cancer, 160,600 deaths from sections 704 and 905(g) provide FDA subgroups of the adult population. For circulatory conditions, and 113,100 with general inspection authority. example, among adults with differing deaths from pulmonary diseases each year. As a consequence of secondhand Section 909 of the FD&C Act levels of education, the highest smoke exposure, there were an authorizes FDA to require tobacco prevalence rates have been observed in adults with lower education levels. Data additional 7,330 deaths from lung product manufacturers to establish and indicate that 36.8 percent of adults with cancer and 33,950 deaths from coronary maintain records, make reports, and a General Education Development (GED) heart disease annually. Cigarette provide such information as the Agency certificate and 23.1 percent of adults smoking therefore accounted for 87 may by regulation reasonably require to with less than a high school diploma percent of deaths from lung cancer, 79 ensure that a tobacco product is not were current smokers in 2017, percent of deaths from COPD, and 32 adulterated or misbranded and to compared with 7.1 percent of adults percent of deaths from coronary heart otherwise protect public health. with a college degree and 4.1 percent of disease in the United States from 2005 IV. Cigarette Use in the United States adults with a graduate degree (Ref. 5). to 2009. and the Resulting Health Consequences The National Youth Tobacco Survey It has also been estimated that is a nationally representative survey of approximately 14 million U.S. adults Cigarette smoking is the leading cause U.S. students attending public and had serious medical conditions of preventable disease and death in the private schools in grades 6 through 12. attributable to cigarette smoking in 2009 United States and is responsible for The 2018 National Youth Tobacco (Ref. 21). COPD accounted for the more than 480,000 deaths per year (Ref. Survey data showed that past 30-day largest number of these conditions with 8). Smoking causes more deaths each smoking prevalence among high school an estimated 7.5 million Americans year than human immunodeficiency students was 8.1 percent, representing living with this condition because of virus (HIV), illegal drug use, alcohol 1.2 million young people, of which 23.1 smoking. Other serious conditions for use, motor vehicle injuries, and firearm- percent were frequent smokers (defined which smoking-attributable morbidity related incidents combined (Refs. 9 and as cigarette use on 20 or more of the past was estimated included heart attack (2.3 10). In addition to lung cancer, heart 30 days) (Ref. 6). The data also showed million cases), cancer (1.3 million disease, and COPD, smoking also causes that past 30-day prevalence among cases), and stroke (1.2 million cases) numerous other serious health middle school students was 1.8 percent, (Ref. 21). Because individuals can live conditions, including many types of representing 200,000 youth, of which for many years with some of these cancer, premature birth, low birth 19.7 percent were frequent smokers health conditions and, in some cases, weight, SIDS, respiratory illnesses, (Ref. 6). These youth who have smoked smoking-attributable health conditions clogged arteries, reduced blood flow, in the past 30 days are at particular risk can develop after a smoker has stopped diabetes, rheumatoid arthritis, and of becoming nicotine dependent smoking (e.g., lung cancer) (e.g., Ref. vision conditions such as age-related through smoking. In one study, 22 22), the morbidity burden from cigarette macular degeneration and cataracts (Ref. percent of 7th grade students who had smoking is expected to remain high. 8). initiated occasional smoking reported a Cigarette smoking also causes many other health conditions; however, the A. Smoking Prevalence and Initiation in symptom of nicotine dependence within link between smoking and these the United States 4 weeks after starting to smoke at least once per month (Ref. 19). Among 60 conditions is less known to the public. Approximately 34.3 million U.S. students with symptoms of nicotine For example, a meta-analysis found that adults and nearly 1.4 million U.S. youth dependence, 62 percent reported current smokers are twice as likely as (aged 12–17 years) smoke cigarettes experiencing their first symptom before never smokers to have age-related (Refs. 5 and 6). Over 16 million smoking daily or began smoking daily macular degeneration (Ref. 23), a Americans alive today live with disease only upon experiencing their first degenerative condition of the tissues of caused by smoking cigarettes (Ref. 8). symptom (Ref. 19). An analysis of the the retina. Current smokers have also Results from the 2017 National Survey 2012 National Youth Tobacco Survey been found to have approximately 50 on Drug Use and Health demonstrate found that a substantial proportion of percent higher risk of age-related that, on average, each day in the United adolescents that use tobacco report cataracts than never smokers according States, about 2,000 youth under age 18 symptoms of nicotine dependence, even to meta-analysis (Ref. 24). Cigarette smoke their first cigarette, and 320 with low levels of use (Ref. 20). Among smokers have an increased risk of

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numerous circulatory and metabolic secondhand smoke include middle ear in-store cigarette advertisements are conditions. Another meta-analysis disease, respiratory symptoms, impaired typically located in areas of a store that found that smokers have approximately lung function, lower respiratory illness, are seen by a majority of consumers, 45 percent higher risk of diabetes than and SIDS, and it is estimated that 400 such as near the checkout counter, and nonsmokers (Ref. 25). It is estimated infants die from SIDS due to exposure provide significant opportunities for that 1.8 million Americans have to secondhand smoke each year (Ref. 8). communicating with smokers and diabetes due to smoking (Ref. 21) and nonsmokers (Refs. 44–47). The V. Data Concerning Cigarette Health that 9,000 Americans die of diabetes inclusion of health warnings on Warnings due to smoking each year (Ref. 8). cigarette packages and in Current smokers are nearly three times A. The Current 1984 Surgeon General’s advertisements therefore can provide a as likely as never smokers to have Warnings Are Inadequate critical opportunity to help smokers and peripheral arterial disease, a condition As described in this section, cigarette nonsmokers of all ages better that can lead to amputation of limbs warnings in the United States have not understand the negative health (Ref. 26). Male smokers have been found changed in nearly 35 years, and the size consequences of smoking. Prominent to be 40 to 50 percent more likely to and location of the warnings have not displays of such warnings are more have erectile dysfunction due to changed in more than 50 years. The likely to be noticed and to impact diminished blood flow than nonsmokers unchanged content of these health learning and knowledge than non- (Refs. 27 and 28). Smokers also have warnings, as well as their small size and prominent displays (Refs. 3, 4, 39, 48– increased risk of many types of cancer, lack of an image, severely impairs their 50). The World Health Organization’s beyond lung cancer. For example, ability to convey relevant information (WHO) Framework Convention on current smokers have been found to about the negative health consequences Tobacco Control has also recommended have almost four times the risk of of cigarette smoking in an effective way large pictorial cigarette warnings on bladder cancer as never smokers (Ref. (Ref. 2). Research has repeatedly tobacco products as a way to increase 29), and it has been estimated that illustrated that the current 1984 public awareness about the negative smoking is responsible for 5,000 bladder warnings used in the United States health effects of tobacco use (Ref. 51). cancer deaths in the United States each frequently go unnoticed or fail to Given the extreme risks cigarette year (Ref. 30). Smoking has also been convey relevant information regarding smoking poses to the public health, new established to cause cancers of the head health risks (Ref. 4). Moreover, although warnings, as described in detail below and neck, such as oral cancer. The many members of the U.S. public and as included in this proposed rule, American Cancer Society’s Cancer possess some general knowledge of the are critical to promote greater public Prevention Study II found elevated harms of smoking, substantial gaps in understanding of the negative health relative risks (i.e., the risk of the knowledge remain, and smokers have consequences of cigarette smoking. conditions among smokers compared to misinformation regarding cigarettes and 1. The Current 1984 Surgeon General’s nonsmokers) for current smoking of 10.9 the negative health effects of smoking Warnings Have Not Changed in Nearly for males and 5.1 for females for lip, oral (Refs. 36 and 37). 35 Years cavity, and pharyngeal cancers (i.e., Cigarette packages and advertisements male smokers have 10.9 times higher can serve as an important channel for In response to the Surgeon General’s risk of developing these cancers than communicating health information to first major report on smoking and health male nonsmokers, and female smokers broad audiences that include both in 1964, Congress passed the FCLAA to have 5.1 times higher risk of developing smokers and nonsmokers. Daily require warning labels on all cigarette these cancers than female nonsmokers) smokers, who in 2016 averaged 14.1 packages. The text-only warning was and 14.6 for males and 13.0 for females cigarettes per day, are potentially written in small print and located on for laryngeal cancer (Ref. 31). These exposed to the warnings on packages one of the side panels of each cigarette increased risks result in approximately over 5,100 times per year, and, because package. It stated ‘‘CAUTION: Cigarette 4,900 deaths from lip, oral, and these packages are not always concealed Smoking May Be Hazardous to Your pharyngeal cancers and 3,000 deaths and are often visible to those other than Health.’’ This language appeared on all from laryngeal cancer from smoking in the person carrying the package, cigarette packages sold from January 1, the United States each year (Ref. 30). warnings on those packages are 1966, through October 31, 1970. In Secondhand smoke exposure also potentially viewed by many others, 1969, Congress passed the Public Health increases disease risks, especially including nonsmokers (Refs. 38 and 40). Cigarette Smoking Act (Pub. L. 91–222), among infants and children. For Smokers and nonsmokers, including which slightly modified the warning example, secondhand smoke exposure adolescents, also are frequently exposed statement on cigarette packages, but did has been found to be causally linked to to cigarette advertising appearing in a not require any warnings in cigarette stroke, lung cancer, and other disease in range of marketing channels, including advertisements. The new warning adults and lower respiratory illness in print and digital media, outdoor language, ‘‘Warning: The Surgeon children (Ref. 8). Additionally, maternal locations, and in and around retail General Has Determined That Cigarette smoking (i.e., smoking while pregnant) establishments where tobacco products Smoking Is Dangerous to Health’’, has been found to be associated with are sold (Refs. 42 and 43). The appeared on cigarette packages sold in low birth weight (Ref. 32) and fetal importance of cigarette advertising is the United States from November 1, growth restriction (Ref. 33). The reflected in cigarette companies’ 1970, through October 11, 1985. In California Environmental Protection substantial annual expenditures for 1972, the Federal Trade Commission Agency (EPA) has estimated that there cigarette advertising and promotion in (FTC) issued consent orders requiring are 24,500 cases of low birth weight due the United States, which totaled $1.3 six major cigarette manufacturers and to maternal exposure to secondhand billion in 2017 (not including the price distributors to include in all of their smoke (referred to as ‘‘environmental discounts paid to cigarette retailers and cigarette advertisements a clear and tobacco smoke’’) in the United States wholesalers to help lower the price of conspicuous disclosure of the same per year (Ref. 34). Other health cigarettes to consumers) (Ref. 41). Retail warning required to be on packages (Ref. consequences in children exposed to displays of cigarette packages and other 35).

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In 1981, the FTC issued a report to processing models describe how As discussed in the following Congress that concluded that the information is gathered from the senses paragraphs, researchers have also found cigarette health warnings had little and is stored and processed in the brain that the current 1984 Surgeon General’s effect on public awareness and attitudes (Ref. 111). Message processing is warnings are largely unnoticed and toward smoking. The FTC report stated important to learning and unconsidered by both smokers and that the existing warning likely was understanding. Once an individual nonsmokers. This is in accord with the ineffective because it: (1) Was notices a warning, he or she mentally findings of a major report on tobacco overexposed and worn out; (2) lacked stores the information found in the policy in the United States by the novelty; (3) was too abstract; and (4) warning and gives meaning to that Institute of Medicine (IOM) in 2007, lacked personal relevance (Ref. 52). information (Ref. 112). The individual which stated that the 1984 warnings on Subsequently, Congress again mentally processes the information and U.S. cigarette packages are both modified cigarette warnings by enacting builds on it, which helps them better ‘‘unnoticed and stale’’ (Ref. 2 at p. 291). the Comprehensive Smoking Education recall and remember the information Similar conclusions were drawn in a Act of 1984 (Pub. L. 98–474), which (Refs. 43 and 113). How much the study with a nationally representative required the following four rotational information is mentally processed, sample of middle and high school health warnings on packages and reflected on, and thought about impacts students in the United States in 2012. advertisements: 3 how well the information is learned and Less than half (46.9 percent) of students • Surgeon General’s Warning: understood (Ref. 114). who saw a cigarette package with the Smoking Causes Lung Cancer, Heart Attracting and maintaining attention Surgeon General’s warning reported Disease, Emphysema, and May is an important step in how seeing the warning ‘‘most of the time’’ Complicate Pregnancy. or ‘‘always’’ (Ref. 58). • communications, such as warning Surgeon General’s Warning: labels, can inform the public (Refs. 53 Noticeability of the Surgeon General’s Quitting Smoking Now Greatly Reduces and 54). Findings from the International warnings is also low for adults. Findings Serious Risks to Your Health. • Tobacco Control Four Country Survey from the ITC–4 published in 2007 found Surgeon General’s Warning: (ITC–4) found that self-reports of that only 30 percent of U.S. adult Smoking by Pregnant Women May noticing the health warnings on smokers noticed the warning ‘‘often’’ or Result in Fetal Injury, Premature Birth cigarette packages were positively ‘‘very often’’ (Ref. 4). Even if people and Low Birth Weight. associated with health knowledge notice the warnings, less than 20 • Surgeon General’s Warning: among adults across the four countries percent of smokers in the United States Cigarette Smoke Contains Carbon studied, including the United States report reading the warning text ‘‘often’’ Monoxide. (Ref. 3). However, eye-tracking studies, or ‘‘very often’’ (Ref. 4). Moreover, In addition, the law established the which assess attention to visual stimuli, additional findings from the ITC–4 location and format for these warnings have documented low levels of attention found that less than half (46.7 percent) and mandated that they be rotated to the current Surgeon General’s of U.S. respondents considered cigarette quarterly. Despite an FTC warnings in both adults and packages as a source of information on recommendation to change the size and adolescents, meaning that they do not the negative health effects of smoking shape of warnings, Congress retained attract attention (Refs. 55 and 56). One compared to 84.3 percent of the size and rectangular format of study of adolescents viewing tobacco respondents in Canada, where pictorial previous warnings (Ref. 218 at pp. 11, advertisements found that the average health warnings are required (Ref. 3). A 12, 24, and 25; see also Ref. 52). As viewing time of the Surgeon General’s study in 2009 found that 60 percent of implemented, for example, this means warnings amounted to only 8 percent of U.S. adult smokers said they ‘‘never’’ or the Surgeon General’s warnings have the total advertisement viewing time; ‘‘rarely’’ noticed warnings labels on continued to be printed in small type on nearly half (43.6 percent) of adolescents cigarette packages in the past month one side panel of cigarette packages did not look at the warnings at all; and (Ref. 59). More recently, an analysis of from October 12, 1985, to the present. Nearly 35 years have passed since about one-third (36.7 percent) did not the Population Assessment of Tobacco these changes and a substantial body of look at the warning long enough to read and Health Study, an ongoing, research shows that the current 1984 any of its words (Ref. 55). In that study, nationally representative, longitudinal Surgeon General’s warnings do not adolescents were unable to recall the cohort study of adults and youth in the effectively promote greater public content of the current Surgeon General’s United States, found that the current understanding of the negative health warnings or to correctly recognize the health warnings on cigarette packages consequences of smoking and that there warnings from a list, indicating that the often go unnoticed (Refs. 60 and 61). In are better approaches to cigarette health current warnings are likely ineffective the most recent publicly available data warnings. among adolescents (Ref. 55). Similarly, (data collected from late 2016 through a study of middle school students who the end of 2017), nearly three-quarters 2. The Current 1984 Surgeon General’s viewed tobacco advertisements with the (73.5 percent) of the U.S. population, Warnings Do Not Effectively Inform the Surgeon General’s warnings found the including both youth and adults, Public Because They Do Not Attract total amount of time spent focusing on indicated they ‘‘never’’ or ‘‘rarely’’ Attention, Are Not Remembered, and Do the warning statement averaged slightly noticed the health warnings on cigarette Not Prompt Thoughts About the Risks of less than one second (Ref. 56). Similar packages in the past 30 days (Ref. 61) Smoking evidence that the Surgeon General’s (data available at https:// Pictorial cigarette warnings that warnings do not attract attention was www.icpsr.umich.edu/icpsrweb/ increase message processing will aid found with a sample of adult smokers in NAHDAP/studies/36231). Among U.S. consumer understanding of the negative 2011 who were instructed to look at a youth and adults who have noticed health consequences of smoking. tobacco advertisement with a warning cigarette health warnings in the past 30 Cognitive theories and information for 30 seconds, and of that time days, 52.0 percent of youth and 53.5 participants spent an average of only 2.8 percent of adults responded that they 3 Slightly different health warnings were required seconds looking at the Surgeon ‘‘never’’ or ‘‘rarely’’ read or looked on outdoor billboard advertisements. General’s warning specifically (Ref. 57). closely at the warnings in the past 30

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days (i.e., do not attract attention) (Ref. understand its contents are to ask cause of cancer (Refs. 36 and 37). 61). whether the message makes them think Additionally, a quarter of the sample Other data support that adolescents about the message’s substantive did not know that smoking was still also do not see or read, and do not information—showing an even deeper dangerous to health even without remember, the current 1984 Surgeon understanding of the information being inhaling (Refs. 36 and 37). Another General’s warnings on cigarette communicated. These measures, often study of 776 adult and adolescent packages and advertisements. A study of termed ‘‘cognitive elaboration,’’ are smokers and nonsmokers asked ninth-grade students found that nearly well-validated and often used in studies participants what illnesses are caused one-third (27.8 percent) reported never of cigarette health warnings (See, e.g., by smoking (Ref. 15). Whereas the seeing warning labels on cigarettes and Refs. 80 and 84). Research demonstrates majority of respondents identified lung nearly half (46.1 percent) could not that the current 1984 Surgeon General’s cancer as a smoking-related lung correctly identify the location of the warnings do not prompt thoughts about disease, only half mentioned warnings on the package (Ref. 62). the risks of smoking, and they are also emphysema (Ref. 15). A much smaller Similar data suggest that people also perceived to be ineffective at making proportion identified cardiovascular failed to notice or read the current 1984 people think about those risks. Less disease (Ref. 15). Very few (3 to 7 Surgeon General’s warnings prior to the than 40 percent of U.S. adult smokers in percent) named any other smoking- 1999 Master Settlement Agreement, the ITC–4 reported that the Surgeon related cancer (besides lung, mouth, when cigarette advertising was common General’s warnings make them think throat, or gum cancer), such as on outdoor billboards. One study of about the health risk of smoking, a level pancreatic, cervical, bladder, or kidney adults found that drivers could read the that was consistent between 2002 and cancer (Ref. 15). Very few mentioned entire warning message on only 5 2005 (Ref. 4). In a study in Buffalo, NY, negative cardiovascular effects, such as percent of highway billboard 62 percent of adult smokers reported hypertension, atherosclerosis, advertisements and were only able to that the Surgeon General’s warning aneurisms, or stroke, as smoking-related fully read the health warning on 18 of labels made them think ‘‘a little’’ or ‘‘not illnesses. In addition, people the 39 street billboards examined in the at all’’ about the health risks of smoking underestimated the percent of people study (Ref. 63). All these results indicate (Ref. 59). Participants in a randomized diagnosed with lung cancer who would that the current warnings are not clinical trial with smokers in California die from the condition (Ref. 15). appropriately conspicuous in and North Carolina reported that the Findings from another study indicate advertisements compared to the rest of Surgeon General’s warnings made them that approximately one-third of U.S. the advertising message, as discussed in think about the warning message only a adult smokers believe that cigarettes more detail below. little (an average of 2.3 on a scale of 1 have not been proven to cause cancer Not only do the current Surgeon to 5) and made them think about the (Ref. 211). General’s warnings not attract attention, harms of smoking only somewhat (an Many studies show that the public but they also are not remembered—and average of 2.9 on a scale of 1 to 5) (Ref. has limited understanding of other remembering is a key component to 65). That study also found that the smoking-related health consequences long-term understanding of the Surgeon General’s warnings were information beyond surface-level perceived as not impactful (Ref. 65). such as impotence (Refs. 3, 12, 13, and noticing of the information presented. Health communication research has 67; U.S. studies); stroke (Refs. 15 and Viewing time of U.S. cigarette warnings found that adolescents also report that 67; U.S. studies); gangrene (Ref. 12; U.S. is positively associated with recall (Refs. the current 1984 U.S. cigarette warnings study); vision impairment/blindness 55 and 56). Studies have documented do not prompt thoughts about the health (Refs. 11, 119, and 201; non-U.S. low recall of warning statements for risks of smoking. Among a nationally studies); emphysema and chronic both adults and adolescents. In a study representative sample of U.S. middle bronchitis (Ref. 11; non-U.S. study); conducted with 13- to 17-year-olds who and high school students who reported other cancers outside of lung cancer, viewed five tobacco advertisements seeing a cigarette package, less than one- such as bladder cancer (Refs. 11, 13, 15, containing Surgeon General’s warnings, third (30.4 percent) reported that and 67; both U.S. and non-U.S. studies); only 19 percent were able to recall the cigarette warning labels made them the effects of secondhand smoke on general theme of the warning statement think about health risks ‘‘a lot’’ (Ref. 58). nonsmoker adults and children (Ref. 16; (Ref. 55). In another study, only between This proportion is even lower for non-U.S. study); and impacts on 20 and 53 percent of high school adolescent current smokers, as only 13.8 reproductive health and pregnancy students could correctly recall each of percent reported that warnings made (Refs. 13 and 67; U.S. studies). Studies the four Surgeon General’s warnings them think ‘‘a lot’’ about health risks in the United States have also even when they were provided with the (Ref. 58). documented that people are largely actual wording, and some incorrectly unaware of the health risks of smoking recalled having seen a warning that was 3. There Remain Significant Gaps in specific to women, including infertility not being used at the time (Ref. 62). Public Understanding About the (Refs. 13, 14, and 67), osteoporosis, Similarly, low levels of recall were Negative Health Consequences of early menopause, spontaneous abortion, found in a study with high school Cigarette Smoking ectopic pregnancy, and cervical cancer students who viewed tobacco Consumers suffer from a pervasive (Ref. 14 and 67). Research findings also advertisements containing Surgeon lack of knowledge about and show gaps in public understanding of General’s warnings. Although most understanding of the negative health the negative health effects of smoking students (79 percent) reported seeing a consequences of smoking. A nationally during pregnancy. For example, one warning, very few (15 percent) reported representative survey of 1,046 adult focus group study conducted in four the warning statement’s concept and smokers found widespread U.S. cities with current smoking women even fewer (6 percent) correctly misperceptions regarding cigarettes and ages 18 to 30 years found that reported its exact message (Ref. 64). the negative health effects of smoking participants had low to moderate Beyond being noticed and being (Refs. 36 and 37). Thirty-three percent of awareness of smoking outcomes related remembered, additional measures of adult smokers in the sample did not to pregnancy (Ref. 68). These findings how well a message helps people know that cigarettes were a proven suggest that the public does not

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understand the complete range of students found that participants who Malaysian pictorial cigarette warnings illnesses caused by smoking, indicating viewed pictorial cigarette warnings with in 2009, there was a significant increase gaps in public understanding of the full color spent more time looking at the in the percentage of smokers who negative health consequences of warning compared to participants who reported noticing the health warnings smoking. either viewed black and white pictorial often or very often (54.4 percent pre- warnings or text-only warnings (Ref. implementation compared to 67 percent B. Cigarette Health Warnings That Are 77). post-implementation) (Ref. 83). Another Noticeable, Lead to Learning, and Communication theory and research study in the United States surveyed a Increase Knowledge Will Promote Public explain the message characteristics that sample of adolescents who had a parent, Understanding About the Negative impact how an individual is exposed to, guardian, or other household member Health Consequences of Smoking attends to, comprehends, and who participated in a randomized To understand a message, individuals understands the content of the message controlled trial in which a single must first attend to the message (i.e., (Refs. 43, 78, and 79). Messaging that pictorial or text-only warning was notice and be made aware of the includes vivid features (e.g., images) displayed on the parent’s cigarette message), and then they must process increases attention to as well as package for 4 weeks (Ref. 94). The the information in the message (i.e., cognitive elaboration (or thinking about) pictorial cigarette warnings drew greater acquire knowledge of and learn that and processing of the message, which attention among adolescents in the information) (Ref. 70). When introduced leads to increased message study, and adolescents more accurately in other countries, pictorial cigarette comprehension (Ref. 80). Messages that recalled the pictorial cigarette warning. warnings have been shown to increase include vivid features, such as images, In addition, the pictorial cigarette understanding of the negative health are easier to imagine and are more warning was recognized from a list of consequences of smoking (Refs. 3, 4, 39, engaging compared to messages that do warnings more than the text-only and 48). The following section describes not include vivid features. An online cigarette warning. studies that demonstrate how pictorial experiment with 2,156 adults that Studies demonstrate that increasing cigarette warnings promote greater examined varying levels and notice of and attention to the public understanding about the health combinations of vivid features (i.e., information in a cigarette health consequences of smoking as they: (1) testimonial images, identifying warning promotes understanding of the Increase the noticeability of the information, nontestimonial explanatory message. Data from the ITC–4 showed warning’s messages; (2) increase statements, testimonial explanatory that noticing health warnings on knowledge and learning of the negative statements, and contextual information) cigarette packages was associated with health consequences of smoking; and (3) found that increasing the number of increased knowledge about the health benefit subpopulations that have vivid features of cigarette warnings consequences of smoking (Ref. 3). disparities in knowledge about the increased engagement with the message Smokers who reported noticing the negative health consequences of (Ref. 81). cigarette health warnings were more smoking. These studies incorporate a. Pictorial cigarette warnings likely to report believing that smoking measures that evaluate the impact of increase attention to warning messages, causes the specific health consequences tobacco health warnings on which leads to increased understanding contained in the warnings, compared to understanding, many of which were of the negative health consequences of those who did not notice the warnings. drawn from the WHO’s International smoking. Once individuals notice and attend to Agency for Research on Cancer Research supports the role of pictorial the warning, they are able to store and handbook on the methods for evaluating cigarette warnings in increasing process the information in the warning tobacco control policies (Ref. 71). attention to and noticeability of that can be recalled later; these warnings about the harms of smoking. processes contribute to engagement with 1. Cigarette Health Warnings That Are More noticeable pictorial cigarette the message and lead to understanding. Noticeable Will Lead to Increased warnings are more effective in The important role of attention in Attention to the Warning Message communicating the harms of smoking message storing and processing is well To promote understanding of the compared to text-only cigarette supported by research (see, e.g., Ref. 54). content of a warning message, warnings in other countries as well as For example, a study with smokers individuals must first notice the in experimental studies conducted in found that the frequency of noticing a warning and must be made aware of the the United States (Refs. 3, 49, 50, 82, cigarette health warning was associated information contained in that warning and 83). Pictorial cigarette warnings with frequency of thinking about the (Refs. 53 and 54). In the scientific result in higher noticeability of and dangers of smoking (Ref. 95). In literature on consumer warnings, attention to the warning message addition, studies conducted in the features that increase the noticeability of compared to text-only cigarette United States with youth and adults the warning label (also known as vivid warnings (Refs. 4, 48, 72, 77, 82–94). have shown that longer time spent features, such as images) increase the One study using data from ITC-Canada looking at a cigarette health warning likelihood that people will see and pay and ITC-Mexico assessed smokers’ was associated with greater recall of the attention to the warning message (Refs. reactions to cigarette health warnings information found on the warning (Refs. 73 and 74). Physical features (e.g., use (Ref. 48). During the study period, 56, 57, and 217), indicating that of pictures or color) that make a message Mexico had text-only cigarette warnings attention to a cigarette health warning more noticeable increase attraction and while Canada had pictorial cigarette leads to storing of the warning content attention to the message (Ref. 75). A warnings. Compared to adult smokers in and later recall of that information. meta-analysis found that warnings, not Mexico, Canadian adult smokers b. Pictorial cigarette warnings specific to cigarette warnings, that reported greater levels of noticing the increase the likelihood that consumers include such features were more likely warning label and thinking about the will read, recall, and understand the to attract attention than warnings harms of smoking. Another ITC study warnings. without these features (Ref. 76). One assessed noticing warnings in a sample Research supports the role of pictorial experiment among a sample of U.S. of Chinese and Malaysian adult smokers cigarette warnings in increasing reading adult smokers and middle school (Ref. 83). After introduction of the new of and closely looking at the message

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warning as well as aiding and concluded that health warnings significantly more likely to report that comprehension and understanding of increased correct knowledge about the smoking causes blindness compared to the information contained in the negative health effects caused by smokers in countries where there were message warning. In a United States- smoking (Ref. 39). That review no cigarette health warnings about based experimental study, repeated concluded that pictorial cigarette blindness (Canada, the United Kingdom, viewing of warning labels is associated warnings are significantly more likely to and the United States) (Ref. 103). After with increased recognition and memory draw attention, result in greater the introduction of the blindness of the content of the label (Ref. 96). processing, and improve memory of the warning, Australian smokers were Research on recorded eye movement health warning (Ref. 39). Summarizing dramatically more likely than before to during reading of a warning label these effects among smokers, the report knowing that smoking causes provides support for the link between National Cancer Institute concluded in blindness (62 compared to 49 percent) reading and comprehension of the its Tobacco Control Monograph 21 that (Ref. 103). Another study assessing warning (Ref. 97). Measures of viewing large pictorial health warnings on smokers’ beliefs about the health effects duration (e.g., how long the eyes are tobacco packages are effective in of smoking in South Australian smokers fixed on specific words in the warning) increasing smokers’ knowledge (Ref. found that, post-implementation of are associated with how much 66). pictorial cigarette warnings, participants participants are processing and can later Visual depictions of smoking-related reported more health beliefs about recall that information (Refs. 56, 97, and disease in pictorial cigarette warnings smoking-related negative health effects, 98). help address gaps in public such as blindness/eye damage, stroke, Many studies support the finding that understanding of the negative health harm to unborn babies, mouth cancer, cigarette health warnings with vivid consequences of smoking by providing throat cancer, blocked arteries, as features (e.g., images) are read and new information beyond what is in the compared to their health beliefs when looked at more closely compared to text of the warnings through reinforcing previous text-only warnings were those without these features (Refs. 83, and helping to depict and explain the required (Ref. 105). 86, 92; non-U.S. studies). One study of Research supports that exposure to health effect described in the text (Ref. U.S. adult smokers showed that viewing pictorial cigarette warnings leads to 101; see also Ref. 39 at p. 330). Many a pictorial cigarette warning led to knowledge gains about the harms of studies have shown that exposure to higher reported reading or looking smoking among adolescents, whereas, as pictorial cigarette warnings promotes closely at the warning, label memory discussed earlier, the current 1984 and recall, and perceived label knowledge of the negative health effects Surgeon General’s warnings do not. A credibility compared to text-only of smoking (Refs. 3, 48, and 102–107). report of Canadian warnings indicated cigarette warnings (Ref. 85). Another For example, a study using data from that pictorial cigarette warnings study of U.S. adult smokers showed that ITC-Canada and ITC-Mexico assessed improved knowledge of specific participants who had a pictorial smokers’ reactions to cigarette health negative health effects of smoking cigarette warning put on their packs warnings (Ref. 48). During the study among adolescents (e.g., increased reported looking at the label more often period, Mexico had text-only cigarette knowledge of bladder cancer, impotence and correctly recalled the label’s warnings while Canada had pictorial in men, mouth cancer, gum or mouth contents more often than those with cigarette warnings. Compared to disease, reduced growth in babies packs that had a text-only warning on smokers in Mexico, Canadian smokers during pregnancy, and strokes) (Ref. them (Ref. 99). A study in Australia had higher levels of knowledge about 108). One study that surveyed found that students reported more smoking-related health outcomes, such Australian students in grades 8 through frequent reading and attending to the as stroke, impotence, and mouth cancer. 12 found increases in the proportion of pictorial cigarette warnings after they Another study using ITC–4 data showed students who recognized the smoking- were introduced, as compared to when that Canadian smokers were almost related effects of mouth cancer and text-only warnings were displayed (Ref. three times more likely than non- peripheral vascular disease after the 100). Canadian smokers to accurately believe introduction of new pictorial cigarette that smoking causes impotence; during warnings on those topics (Ref. 100). 2. Pictorial Cigarette Warnings Can the time of the study, Canada was the Another study examined the effects of Address Gaps in Public Understanding only country to require pictorial viewing health warnings on beliefs About the Negative Health cigarette warnings and the only country about the specific negative health effects Consequences of Smoking that had a warning about impotence of smoking among adult smokers and a. Pictorial cigarette warnings (Ref. 3). Another study surveyed adult adolescents (aged 16 to 18 years). For increase knowledge and accurate health male smokers to assess changes in both adults and adolescents, exposure to beliefs by addressing gaps in public awareness of health risks from smoking pictorial cigarette warnings that understanding about the negative health after Malaysia implemented new highlighted specific health topics led to consequences of smoking. pictorial cigarette warnings (Ref. 102). increases in correct beliefs about Pictorial cigarette warnings increase Findings showed that knowledge of smoking causing the specific health consumer knowledge of the harmful health risks across 13 different health topic in the warning. For some topics effects of smoking, which promotes conditions was greater after pictorial (e.g., smoking causes strokes, smoking greater public understanding of the cigarette warnings were introduced in causes impotence), increases in correct negative health consequences of Malaysia (Ref. 102). In March 2007, health beliefs were only found in smoking. Numerous non-U.S. studies Australia became the first country to adolescents and not adults (Ref. 106). support the role of pictorial cigarette implement pictorial cigarette warning There are a small number of recent warnings in promoting knowledge gains on cigarette packages with the message studies conducted in the United States in cigarette-related health risks after that smoking causes blindness. ITC data that failed to find an effect of pictorial implementation of those warnings (Refs. from adult smokers were analyzed cigarette warnings on increasing health 3, 39, 48, 49, 100, 102–107, 202, and assessing knowledge that smoking beliefs about the negative effects of 203). One review examined health causes blindness (Ref. 103). Findings smoking (Refs. 77, 84, 109, and 110). warning messages on tobacco products indicated that Australian smokers were The failure in those studies to find an

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association between exposure to One way to process information found showed that approximately 6 years after pictorial cigarette warnings and in a health message includes thinking the introduction of pictorial cigarette increased health beliefs may be partly or about the message’s content. Research warnings in Canada, more than 90 fully attributable to the fact that, as (from both U.S. and international percent of Canadian youth agreed that previously described, the public already studies) has demonstrated that pictorial the pictorial cigarette warnings had has a high pre-existing level of cigarette warnings lead to increased provided them with important and knowledge of the specific health thinking (i.e., ‘‘cognitive elaboration’’) accurate information about the negative consequences described in the warnings about the content of the warning (Refs. health effects of smoking cigarettes (Ref. tested in those studies, some of which 49, 83, 84, 86, 87, 100, 102, 104, and 108). Pictorial cigarette warnings can included warning statements set forth 115). For example, one study of U.S. also serve as effective sources of by Congress in the Tobacco Control Act. adult smokers found that participants information for youth with smoking For example, a few studies have found who were exposed to pictorial cigarette parents. One study interviewed increases in knowledge only of less- warnings processed the information in adolescents whose parents received known conditions (e.g., blindness) but deeper ways, such as thinking about pictorial warnings on their cigarette not of more well-known negative health their own health problems (e.g., packages as part of a randomized effects (e.g., lung cancer) (Refs. 12 and diabetes) in the context of smoking (Ref. clinical trial (Ref. 117). When asked 105). Notably, the increases in health 99). Participants assigned to view about the pictorial cigarette warnings, beliefs from pictorial warnings were pictorial cigarette warnings had more adolescents described how the warnings greatest for negative health effects that accurate recall and were better able to caught their attention. While many started with lower levels of prior beliefs describe the content of the warning already reported believing that smoking about that health condition, such as compared to those assigned to view the was dangerous before seeing the gangrene and stroke (Ref. 12). This text-only warnings (Ref. 99). A meta- warnings, viewing the warnings suggests that the impact of cigarette analysis of experimental studies strengthened and reinforced beliefs warnings on knowledge is greatest for conducted in twenty countries about the negative health consequences topics that are not well known to the compared pictorial cigarette warnings to of smoking. public. text-only cigarette warnings (Ref. 50). In the health communication In summary, pictorial cigarette Compared to text-only warnings, scientific literature, messages that are warnings that convey the risk of specific pictorial cigarette warnings elicited accompanied by images closely linked negative health effects from smoking more thinking about the message to the message content (i.e., concordant) can increase beliefs and knowledge content (Ref. 50). Another study had are shown to increase the likelihood about the health consequences of U.S. adolescent and adult participants that consumers will comprehend the smoking, particularly for negative health view one of nine pictorial cigarette message (Ref. 118). Because of this, effects that are less known. warnings (Ref. 116). Exposure to b. Pictorial cigarette warnings pictorial cigarette warnings increase pictorial cigarette warnings caused understandability and learning of the increase information processing and individuals to think about family learning of new information about the message. After implementation of members who smoke or how smoking Australia’s pictorial cigarette warnings, negative health consequences of could hurt the health of family members focus group research findings concluded smoking. (Ref. 116). that images depicting the health Pictorial cigarette warnings that ii. Pictorial cigarette warnings lead to increase message processing will aid exposure to and learning of new consequences of smoking provided new consumer understanding of the negative information about the negative information beyond what was contained health consequences of smoking. consequences of smoking to smokers in the text through providing a visual Cognitive theories and information and nonsmokers. explanation of the negative health processing models describe how Health warnings on cigarette packages effects noted in the text (Ref. 101). For information is gathered from the senses can serve as prominent sources of health example, very few participants were and is stored and processed in the brain information for both smokers and aware that smoking caused peripheral (Ref. 111). Message processing is nonsmokers (Ref. 2). Daily smokers in vascular disease, and having an image of important to learning and the United States, who in 2016 averaged peripheral vascular disease provided a understanding. Once an individual 14.1 cigarettes per day, are potentially visual explanation of the effects of the notices a warning, he or she mentally exposed to the pictorial cigarette disease, which led to learning of the stores the information found in the warnings on packages over 5,100 times consequences of smoking (Ref. 101). warning and gives meaning to that per year, and, because these packages Studies in other countries have shown information (Ref. 112). The individual are not always concealed and are often that participants tend to rate pictorial mentally processes the information and visible to those other than the person cigarette warnings as being more builds on it, which helps them better carrying the package, information found informative than text-only warnings recall and remember the information on those packages are potentially (Refs. 119 and 120). A study with U.S. (Refs. 43 and 113). How much the viewed by many others, including young adult smokers and nonsmokers information is mentally processed, nonsmokers (Refs. 38–40). Indeed, a evaluated the effect of pictorial cigarette reflected on, and thought about impacts review of tobacco health warning warnings on learning (Ref. 121). how well the information is learned and studies in more than 13 countries, Findings showed that participants rated understood (Ref. 114). Health warnings including the United States, concluded pictorial cigarette warnings higher in are therefore frequently assessed by that pictorial warnings are an important increasing personal understanding of looking to how noticeable they are; how source of health information for smokers the health consequences of smoking and well remembered their content is; and as well as nonsmokers (Ref. 39). leading to learning new information how much they prompt individuals to Pictorial cigarette warnings have also compared to text-only warnings. think about their content. been shown to be effective in c. Pictorial cigarette warnings can i. Pictorial cigarette warnings lead to communicating the health consequences increase understanding of the negative increased thinking about the harms of of smoking to youth (Refs. 94 and 100). health consequences of smoking across smoking. A report prepared for Health Canada diverse populations.

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Research has shown that being a the negative health effects of smoking of those risks, particularly if the risks member of a group with lower (Ref. 136). are not commonly known (Refs. 130 and socioeconomic status (SES), as Pictorial cigarette warnings are likely 131) (see section V.B). Measuring measured by income and education to help reduce disparities among whether information is new helps levels, is associated with having lower disadvantaged groups in consumer identify opportunities to improve knowledge of the negative health understanding about the harms of understanding through increased consequences of smoking; most smokers smoking. One study examined awareness. Additionally, in the United States are in this group perceptions of pictorial cigarette communication science research has (Refs. 5, 123, and 124). One study found warnings among low-income adult found that people are more likely to pay that knowledge about the negative smokers using in-depth interviews (Ref. attention to information that is new, and health effects of smoking was lower 126). Some participants reported that attention plays a vital role in message among older respondents, those with the image in the pictorial cigarette comprehension and learning (Ref. 128). lower educational attainment, and those warning influenced their perceptions of As described in detail in this section, from racial or ethnic minority groups smoking-related conditions because FDA undertook a science-based, (Ref. 123). Some subpopulations, such they contained new information and iterative research and development as specific racial or ethnic minority portrayed long-term health outcomes process to consider whether revisions to groups (e.g., American Indian/Alaskan (e.g., diminished quality of life, the textual warning statements specified Natives), those with a lower level of irreparable physical damage, death) in section 4(1) of the FCLAA (‘‘TCA education, and those experiencing (Ref. 126). statements’’) would promote greater Research has shown that pictorial serious psychological distress (Ref. 5), public understanding of the risks cigarette warnings increase are disproportionately represented in associated with smoking and then to understanding of the health lower SES subgroups, which have lower develop and test paired concordant access to health information and are consequences of smoking across diverse settings and countries (Refs. 4, 87, 102, color graphics to accompany the textual more likely to smoke cigarettes (Refs. 5, warning statements. As part of this 204, and 205). Having a lower SES is 119, and 206–210). These findings demonstrate that pictorial cigarette process, FDA examined the nine TCA also associated with lower health statements to consider whether to revise literacy compared to those with higher warnings are effective for diverse those statements to promote greater SES (Ref. 125). populations that differ in cultural, public understanding of the risks One study compared data from higher racial, ethnic, and socioeconomic and lower income adult smokers who backgrounds. One large study that associated with cigarette smoking (see participated in the ITC–4 and found that randomized 3,371 adult smokers to view sections VI.A–C), which included a higher income smokers had 71 percent, either pictorial cigarette warnings or review of the risks associated with 34 percent, and 83 percent higher odds text-only warnings found that cigarette smoking and a focus on of reporting knowledge that smoking participants who viewed the pictorial negative health effects that are less causes heart disease, stroke, and lung warnings had rated the warnings as known, less understood, or about which cancer, respectively (Ref. 124). being significantly more noticeable and the public holds misperceptions. After However, another study found that, more credible compared to participants considering this information, FDA among nonsmoking Canadian who viewed the text-only warnings (Ref. developed initial versions of revised adolescents, having less spending 127). No statistically significant textual warning statements (‘‘revised money was associated with lower interactions were found between these statements’’). Based on FDA’s careful knowledge of the negative health effects results and race/ethnicity, education, or review of the scientific literature on the of smoking but that disparities in income, which suggests that the health risks associated with cigarette knowledge were not as strong in pictorial warnings had consistently smoking, evaluation of the public’s adolescent smokers as they were in greater noticeability and credibility general awareness and knowledge of other studies with adults (Ref. 11). across all the study subpopulations than those health risks, and assessment of the In addition, smokers with less the text-only warnings (Ref. 127). Other Agency’s own consumer research on education may be less likely to notice research suggests that among lower SES potential revised warning statements, and recall health information in groups, pictorial cigarette warnings may FDA determined there is sufficient cigarette warnings (Refs. 69 and 72). In lead to stronger effects in noticing the support to propose adjusting some of its 2007 report, the IOM expressed warning and thinking about smoking the text of the TCA statements, as concern about the ability of consumers risks compared to those in higher SES authorized by section 4(d) of the FCLAA with less education to recall the groups because of the added benefits of (as amended by section 202(b) of the information included in text-based the information contained in the Tobacco Control Act). While developing messages (Ref. 2). The IOM (Ref. 2) cited pictorial warning (Refs. 72 and 206). the revised statements, FDA worked in a study of Canadian smokers’ Collectively, the evidence demonstrates parallel to develop color graphics, in the knowledge about the country’s prior that pictorial cigarette warnings are form of photorealistic images, depicting warning requirements, which, like the effective across diverse populations and the negative health consequences of current 1984 Surgeon General’s settings and likely will help reduce cigarette smoking to accompany the warnings, only contained four textual disparities found in consumer statements (section 4(d) of the FCLAA; warning statements. In that study, understanding about the harms of see section VI.D). Once FDA determined compared to women with higher smoking. there was sufficient support to propose educational attainment, comparatively adjusting the text of the required fewer women with lower educational VI. FDA’s Process for Developing and warnings, identified textual warning attainment were aware of messages that Testing the Proposed Cigarette Health statements for further testing, and warn of the harmful effects of smoking Warnings developed photorealistic images to on life expectancy, heart disease, or Findings from the scientific literature accompany those statements, we paired pregnancy (Ref. 69). A study of pregnant indicate that an important first step in textual warning statements with women found that those with lower promoting public understanding of concordant images to assess which reading levels had less knowledge about health risks is to raise public awareness statement-and-image pairings should be

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considered for this proposed rule. FDA FDA considered the evidence prevention of the disease’’ (Ref. 154, p. selected 16 statement-and-image presented in Surgeon General’s Reports 18). pairings to test in a final quantitative to identify all negative health Since the first Surgeon General’s consumer research study. Results of this consequences that are causally linked to Report published in 1964, evidence of study (described in section VI.E), along cigarette smoking and exposure to the negative health consequences of with FDA’s formative research, review secondhand smoke, including negative cigarette smoking and secondhand of the scientific literature, and internal health consequences causally linked to smoke has expanded dramatically. For scientific and public health cigarette smoking since the passing of example, the 2014 Surgeon General’s communications expertise, informed the Tobacco Control Act in 2009. Report, entitled ‘‘The Health FDA’s selection of the 13 cigarette Surgeon General’s Reports provide Consequences of Smoking: 50 Years of health warnings in this proposed rule. definitive syntheses of the available Progress’’ (Ref. 8), presented a robust The following subsections describe each evidence on smoking and health and body of scientific evidence documenting of these steps in more detail. use such evidence to reach conclusions the health consequences from both The Agency invites comment on the on causality that have public health smoking and exposure to secondhand warnings proposed in this rule, implications (Ref. 8, p. 3). Surgeon smoke across a range of diseases and including its proposed revisions to the General’s Reports classify the strength of organ systems. In particular, the 2014 textual warning statements and its causal inferences in a four-level Surgeon General’s Report added eleven proposed photorealistic images. Given hierarchy based upon work of the IOM diseases to the long list of diseases the degree of public and stakeholder (now the National Academy of causally linked to cigarette smoking: interest in this area, and the legal Medicine) and the International Agency Liver cancer, colorectal cancer, age- complexities involved, FDA also seeks for Research on Cancer (IARC) (Refs. related macular degeneration, orofacial proposals for alternative text and images 200 and 212): clefts from maternal smoking during pregnancy, tuberculosis, stroke (for you believe would advance the • Evidence is sufficient to infer a adults), diabetes, erectile dysfunction, Government’s interest in promoting causal relationship. ectopic pregnancy, rheumatoid arthritis, greater public understanding of the • Evidence is suggestive but not and impaired immune function (Ref. 8, negative health consequences of sufficient to infer a causal relationship. pp. 4–5). The health conditions smoking. If proposing alternative text • Evidence is inadequate to infer the established to be causally linked to and images to those in this proposed presence or absence of a causal cigarette smoking in the 2014 Surgeon rule, please provide scientific relationship (which encompasses General’s Report are in addition to the information supporting that the evidence that is sparse, of poor quality, more than 40 unique health alternative text and images would, in or conflicting). consequences of cigarette smoking and fact, promote greater public • Evidence is suggestive of no causal exposure to secondhand smoke understanding of the negative health relationship (Refs. 154 at p. 18, 8 at pp. determined by earlier studies (Ref. 8). consequences of smoking. Proposals for 3, 52, and 53). FDA determined that some of the alternative images should accompany These standardized determinations health conditions newly identified in either one of FDA’s proposed textual consider factors such as the consistency the 2014 Surgeon General’s Report warning statements or an alternative of results; the strength of the association represented an opportunity to educate textual warning statement you are between smoking and specific health the public about negative health proposing. effects; specificity; temporality; consequences of cigarette smoking that coherence, plausibility, and analogy; A. Review of the Negative Health are subject to particularly low biologic gradient (dose-response Consequences of Cigarette Smoking awareness and understanding. evidence); and natural experiments (Ref. Historically, the large majority of public In determining whether FDA should, 154 at pp. 21–23). The rigor and health messaging about the health risks as authorized by section 4(d) of the consistent application of these causal associated with cigarette smoking has FCLAA, adjust the format, type size, standards has rendered Surgeon focused on a small subset of health color graphics, and text of any of the General’s Reports the preeminent source conditions, notably lung cancer and label requirements to promote greater regarding whether cigarette smoking addiction. The current Surgeon public understanding of the risks and exposure to secondhand smoke are General’s warnings for cigarette associated with the use of tobacco causally related to specific negative packages and advertisements, which products, FDA reviewed the scientific health consequences. Throughout this have not been updated for nearly 35 literature as well as available nationally proposed rule, and in the context of the years despite increasing evidence of representative data on current consumer word ‘‘cause’’ or ‘‘causes’’ used in the additional, serious negative health knowledge and misperceptions about textual warning statements included effects of cigarette smoking, only the health risks of smoking. Despite the therein, FDA relied on the four-level include warnings on a limited number current 1984 Surgeon General’s classification provided in the Surgeon of health conditions (i.e., lung cancer, warnings on cigarette packages and in General’s Reports. Further, the negative heart disease, emphysema, pregnancy cigarette advertisements, the literature health consequences addressed in this complications, and general risks to demonstrates that substantial proposed rule’s warnings are all rated at health) (see section V for additional proportions of U.S. smokers hold the highest level, meaning that the discussion of the current Surgeon misperceptions about the health risks proposed warnings’ use of ‘‘cause’’ and General’s warnings). Both U.S. and non- associated with cigarette smoking, ‘‘causes’’ is uniformly based upon the U.S. studies have found that consumers particularly regarding cancer, heart strongest possible level of scientific are largely unaware of the negative disease, and other health conditions. inference: ‘‘Evidence is sufficient to health consequences of cigarette For more discussion, see section V.A.3 infer a causal relationship’’ (Ref. 8 at p. smoking not mentioned in current (‘‘There Remain Significant Gaps in 3). A causal relationship supported at warnings as well as more specific Public Understanding About the this level expresses ‘‘[t]he judgment that information about the negative health Negative Health Consequences of smoking causes a particular disease’’ effects and their mechanisms (Refs. 3, Cigarette Smoking’’). and ‘‘has immediate implications for 11, 13–16, 67, 145, and 213–215).

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Additionally, and as discussed in and adult smokers (OMB control control number 0910–0848, section V, the current Surgeon General’s number 0910–0674, ‘‘Qualitative Study ‘‘Experimental Study on Warning warnings often go unnoticed and are not on Cigarettes and Smoking: Knowledge, Statements for Cigarette Graphic Health effective at informing the public of the Beliefs, and Misperceptions’’), FDA Warnings’’). A secondary goal of this health risks associated with cigarette gathered additional input on consumers’ study was to inform the selection of smoking. awareness of the negative health health conditions and specific consequences of cigarette smoking and statements that, when paired with color B. Developing Revised Textual Warning assessed initial consumer responses to graphics depicting the health conditions Statements 17 revised statements 4 and the nine described in the warning statements, After FDA’s initial review of the TCA statements. These focus groups would form new cigarette health scientific literature on cigarette provided FDA with qualitative feedback warnings for further testing. smoking-related consumer knowledge on consumers’ comprehension of each 1. Study Design and misperceptions, as well as its statement, the believability of the epidemiological reviews of the causally content of each statement (e.g., that FDA’s study on revised textual linked health conditions identified in smoking causes the health condition warning statements had two phases, the recent Surgeon General’s Reports noted), if that health condition was new both of which were completed during a and scientific literature, we evaluated information to participants, and other single online session. The study sample whether revising some or all of the TCA feedback about the statement and how comprised 2,505 participants. This statements to focus on negative health to make it more understandable or included adolescents (aged 13 to 17 effects that are less-known or less convey the intended message more years), half of whom were current understood by consumers would clearly. Generally, participants reported smokers and the rest of whom had never promote greater public understanding of the initial revised statements presented smoked but were at risk for starting the risks associated with cigarette new information more than the TCA smoking; younger adult (aged 18 to 24 smoking. FDA developed initial statements. FDA considered this years) current smokers; and older adult versions of revised statements for information in identifying 15 revised (aged 25 years and older) current further review, testing, and refinement. statements 5 for further quantitative (see smokers. Study participants in all age These initial revised statements were section VI.C) and qualitative (see section groups were randomly assigned to a reviewed by FDA internal VI.D) testing. condition that determined which epidemiological experts to ensure that warning statements they viewed during the health conditions under C. FDA’s Consumer Research Study on the study. Participants in the control consideration were causally linked to Revised Textual Warning Statements condition viewed the nine TCA cigarette smoking or exposure to FDA next conducted a large statements. Participants in each of the secondhand smoke, and that these quantitative consumer research study to treatment conditions viewed one of 15 smoking-attributed conditions were not assess which, if any, of the revised revised warnings statements plus 8 TCA rare. warning statements would promote warning statements. Table 1 provides a Through a series of 16 qualitative greater public understanding of the risks list of the 9 TCA statements and 15 focus groups with adolescent smokers, associated with cigarette smoking as revised warning statements that FDA adolescents at risk for starting smoking, compared to the TCA statements (OMB evaluated in this study.

TABLE 1—TCA AND REVISED STATEMENTS STUDIED IN FDA’S CONSUMER RESEARCH STUDY

TCA statements (short name) Revised statements (short name)

WARNING: Cigarettes are addictive (addictive). WARNING: Smoking causes mouth and throat cancer (mouth and WARNING: Tobacco smoke can harm your children (harm children). throat cancer). WARNING: Cigarettes cause fatal lung disease (fatal lung disease in WARNING: Smoking causes head and neck cancer (head and neck smokers). cancer). WARNING: Cigarettes cause cancer (unspecified cancer). WARNING: Smoking causes bladder cancer, which can lead to bloody WARNING: Cigarettes cause strokes and heart disease (strokes and urine (bladder cancer). heart disease). WARNING: Smoking during pregnancy causes premature birth (pre- WARNING: Smoking during pregnancy can harm your baby (harm your mature birth). baby). WARNING: Smoking during pregnancy stunts fetal growth (stunts fetal WARNING: Smoking can kill you (kill you). growth). WARNING: Tobacco smoke causes fatal lung disease in nonsmokers WARNING: Smoking during pregnancy causes premature birth and low (fatal lung disease in nonsmokers). birth weight (low birth weight). WARNING: Quitting smoking now greatly reduces serious risks to your WARNING: Secondhand smoke causes respiratory illnesses in chil- health (quit now). dren, like pneumonia (pneumonia). WARNING: Smoking can cause heart disease and strokes by clogging arteries (clogged arteries). WARNING: Smoking causes COPD, a lung disease that can be fatal (COPD). WARNING: Smoking causes serious lung diseases like emphysema and chronic bronchitis (emphysema and chronic bronchitis).

4 FDA developed multiple revised versions of the following 4 TCA statements: WARNING: described in these 4 statements are better-known some TCA statements, developed no revised version Cigarettes are addictive; WARNING: Smoking can health consequences of smoking and that revised for others, and also developed statements for which kill you; WARNING: Tobacco smoke causes fatal statements on these conditions likely would not there is no TCA statement focused on that health lung disease in nonsmokers; and WARNING: promote greater public understanding of the Quitting smoking now greatly reduces serious risks condition. negative health consequences of smoking more than to your health. FDA made this determination based 5 The 15 revised statements FDA refined for on focus group feedback and findings from the either the relevant TCA statements themselves or further testing did not include revised versions of scientific literature suggesting the health conditions new statements on different health conditions.

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TABLE 1—TCA AND REVISED STATEMENTS STUDIED IN FDA’S CONSUMER RESEARCH STUDY—Continued

TCA statements (short name) Revised statements (short name)

WARNING: Smoking reduces blood flow, which can cause erectile dys- function (erectile dysfunction). WARNING: Smoking reduces blood flow to the limbs, which can re- quire amputation (amputation). WARNING: Smoking causes type 2 diabetes, which raises blood sugar (diabetes). WARNING: Smoking causes age-related macular degeneration, which can lead to blindness (macular degeneration). WARNING: Smoking causes cataracts, which can lead to blindness (cataracts).

In Phase 1 of the study, all consequences in the warning statement content’’ statements (e.g., blindness, participants viewed nine warning (‘‘health beliefs’’). diabetes) reported that the ‘‘new statements, one at a time, presented in In Phase 2 of the study, all content’’ statements were new random order. Participants in the participants viewed nine warning information to them. When a specific control condition viewed the nine TCA statements presented at the same time. health condition was covered by both a statements. Participants in the treatment Participants assigned to the control revised and TCA statement (e.g., condition viewed 8 TCA statements condition viewed the nine TCA warning cancer), the revised statement was new plus 1 of 15 revised statements, for a statements again. Participants assigned information to more participants than total of 9 statements. Revised statements to the treatment conditions viewed one the TCA statement. that did not have a TCA counterpart of several different combinations of nine At the level of the individual warning (e.g., the diabetes statement) are called revised warning statements. After statement, 10 of the 15 revised ‘‘new content’’ statements for short. viewing the nine warning statements, all statements tested demonstrated Each revised statement either was participants answered questions about presented in place of a more general their beliefs about the link between statistically significant higher levels of TCA statement on the same or similar smoking and each of the health both ‘‘new information’’ and ‘‘self- health condition (e.g., a revised consequences presented in the warning reported learning’’ when compared to a statement on head and neck cancer statements they viewed (‘‘Health TCA statement (see Ref. 129, Table 4– replaced the TCA unspecified cancer beliefs’’). 1, ‘‘Summary of Significant Results’’). statement) or, for ‘‘new content’’ More details about the study Those 10 revised statements focused on statements, was presented in place of a methodology can be found in the study the following negative health effects of randomly selected TCA statement (e.g., report, which we have included in this cigarette smoking: Age-related macular a revised statement on diabetes was docket (Ref. 129).6 degeneration, cataracts, type 2 diabetes, peripheral vascular disease presented in place of the TCA statement 2. Study Findings on fatal lung disease in smokers). After (amputation), bladder cancer, erectile viewing each individual warning The outcomes ‘‘new information’’ and dysfunction, head and neck cancer, statement, participants answered ‘‘self-reported learning’’ provide useful heart disease and stroke (clogged questions about that statement before data for determining whether a revised arteries), stunted fetal growth, and viewing and answering questions about warning statement would promote COPD. greater understanding than a TCA the next assigned statement. The study There were two revised statements statement of the risks associated with evaluated the following outcomes: that had statistically significant higher • cigarette smoking, as described below. Whether the warning statement was levels of ‘‘new information’’ but not In general, relatively few participants new information to participants (‘‘new ‘‘self-reported learning,’’ both of which reported that the content of the TCA information’’) (i.e., participants reported focused on pregnancy-related health statements was new information; more that they had not previously heard of consequences (premature birth; low participants reported that the revised that specific health effect from cigarette birth weight). For two revised statements were new information than smoking); statements (emphysema and chronic • Whether participants learned did participants who viewed the TCA bronchitis; pneumonia), participants something from the warning statement statements on the same health had statistically significant higher levels (‘‘self-reported learning’’); conditions; and most participants • Whether the warning statement reported that the ‘‘new content’’ of ‘‘self-reported learning’’ but not ‘‘new made participants think about the statements were new information. For information.’’ For one revised statement health risks of smoking (‘‘thinking about example, fewer than 24 percent of (mouth and throat cancer), participants risks’’); participants reported that the TCA did not have statistically significant • Whether the warning statement was statements were new information to higher levels of either of these two believable (‘‘believable’’); them,7 whereas more than 66 percent of outcomes. Of the five revised warning • Whether the warning statement was participants who viewed the ‘‘new statements that lacked statistically informative (‘‘informativeness’’) (i.e., significant higher outcomes for both participants reported that the warning 6 FDA will conduct a peer review of this ‘‘new information’’ and ‘‘self-reported was informative to them); consumer research study. FDA’s peer review plans learning’’, four focused on a health • Whether the warning statement was are available online at https://www.fda.gov/science- condition for which another revised perceived to be a fact or an opinion research/science-and-research-special-topics/peer- statement had statistically significant review-scientific-information-and-assessments. (‘‘factuality’’); and 7 higher levels of both ‘‘new information’’ • There was one exception: The TCA statement Whether participants reported ‘‘Fatal lung disease in nonsmokers’’ was new and ‘‘self-reported learning’’ (e.g., beliefs linking smoking and the health information to 41.9 percent of participants. premature birth versus stunts fetal

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growth); only the revised warning FDA evaluated the research results for • WARNING: Quitting smoking now statement on pneumonia did not. each individual warning statement to greatly reduces serious risks to your More details about the full study determine which statements would health. results can be found in the study report, move on for further testing. Based on Additionally, FDA selected the which we have included in this docket this analysis, a total of 10 revised following 10 revised or ‘‘new content’’ (Ref. 129). statements and 5 TCA statements were statements for the final quantitative selected for such further testing. As consumer research study (see section 3. How Study Findings Were Used discussed above, at the level of the VI.E for a discussion of that study): FDA determined that the scientific individual warning statement, 10 of the • WARNING: Smoking causes head literature demonstrates that the 15 revised warning statements tested and neck cancer. outcomes ‘‘new information’’ and ‘‘self- demonstrated statistically significant • WARNING: Smoking causes reported learning’’ are predictive for the higher levels of both ‘‘new information’’ bladder cancer, which can lead to task of identifying which, if any, of the and ‘‘self-reported learning’’ when bloody urine. • revised warning statements would compared to a TCA warning statement. WARNING: Smoking during promote greater public understanding of FDA selected those 10 revised pregnancy stunts fetal growth. • the risks associated with cigarette statements for further testing in the final WARNING: Smoking can cause smoking as compared to a TCA consumer research study discussed heart disease and strokes by clogging statement. Communication science arteries. below. Of the five revised warning • research shows that an important first statements that did not have statistically WARNING: Smoking causes COPD, a lung disease that can be fatal. step in promoting public understanding significant higher outcomes for both • of health risks is to raise public ‘‘new information’’ and ‘‘self-reported WARNING: Smoking reduces blood awareness of those risks, particularly if learning,’’ four focused on a health flow, which can cause erectile the risks are not commonly known condition for which another revised dysfunction. • WARNING: Smoking reduces blood (Refs. 130 and 131) (see section V.B). statement did have statistically flow to the limbs, which can require Measuring whether information is new significant higher levels for both ‘‘new amputation. helps identify opportunities to improve information’’ and ‘‘self-reported • WARNING: Smoking causes type 2 understanding through increased learning’’; only the revised statement on awareness. Additionally, diabetes, which raises blood sugar. harms of secondhand smoke exposure • WARNING: Smoking causes age- communication science research has in children (pneumonia) did not. related macular degeneration, which found that people are more likely to pay Because there was not another revised can lead to blindness. attention to information that is new, and statement on harms of secondhand • WARNING: Smoking causes attention plays a vital role in message smoke exposure in children, FDA cataracts, which can lead to blindness. comprehension and learning (Ref. 128). selected the TCA statement on the same Therefore, ‘‘new information’’ and ‘‘self- health condition (harm children) for D. Developing and Testing Images reported learning’’ are often linked and further testing in the final quantitative Depicting the Negative Health are both predictive of improved consumer research study. Consequences of Smoking To understanding. Other study outcomes, Additionally, as described above, Accompany the Textual Warning such as ‘‘thinking about the risks’’ and FDA did not test a revised warning Statements ‘‘health beliefs,’’ were unlikely to statement for four TCA statements Section 4(d) of the FCLAA, as change with a single brief exposure to (addictive, kill you, fatal lung disease in amended by section 201(a) of the the text-only statements—as was nonsmokers, quit now; see table 1 for Tobacco Control Act, directs FDA to provided in this first quantitative full statements). Although these TCA issue regulations that require color consumer research study—and therefore statements were new information to graphics depicting the negative health were not considered predictive of relatively few participants and self- consequences of smoking to accompany improved understanding in the way the reported learning was low, FDA textual warning statements on cigarette ‘‘new information’’ and ‘‘self-reported determined that it would provide a packages and in cigarette learning’’ measures were. better basis for decision-making to advertisements. In parallel with FDA’s Because the purpose of this first pursue additional data on these four efforts to develop and test revised quantitative consumer research study TCA statements, and thus included warning statements, the Agency also was to determine which, if any, revised them for further testing. undertook an iterative, research-based warning statements promote greater Based on the Agency’s analysis of the approach to develop color graphics public understanding of the risks research results and evaluation of other depicting the negative health associated with cigarette smoking (as considerations as just described, FDA consequences of cigarette smoking to per section 4(d) of the FCLAA) when selected a total of 15 textual warning accompany those statements. This compared to a TCA warning statement, statements for further testing. FDA process required considering how to the study was not designed to put the selected the following five TCA help promote greater public revised statements in a rank order or statements for the final quantitative understanding of the negative health compare individual results of one consumer research study: consequences of cigarette smoking given • revised statement to another. Rather, WARNING: Cigarettes are addictive. that the general public comprises • FDA interpreted the presence of a WARNING: Tobacco smoke can individuals with many varied statistically significant finding in a harm your children. backgrounds, knowledge, beliefs, and positive direction as support for a • WARNING: Smoking can kill you. • abilities to read and understand health revised warning statement over its WARNING: Tobacco smoke causes information. According to National comparator TCA statement.8 fatal lung disease in nonsmokers. Assessment of Adult Literacy estimates, about 12 percent of U.S. adults have 8 Five of the 15 revised statements were ‘‘new selected TCA statement on a different health proficient health literacy (i.e., the ability content’’ statements, without a comparator TCA condition, which may have resulted in larger effects statement on the same health condition. Those five for these ‘‘new content’’ statements as compared to to access, understand, and use health revised statements were compared to a randomly the effects for the remaining 10 revised statements. information and services (Refs. 125 and

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132). Among the remaining adults, 53 152). For example, some types of visual image concepts clear (in terms of percent have intermediate health depiction, such as bar charts and recognizing what was being depicted in literacy, 22 percent have basic health graphs, are better suited to certain the image), attention-grabbing, worth literacy, and 14 percent have below communication purposes such as remembering, credible, and relevant, basic health literacy (Ref. 125). depicting comparisons (bar charts) or and whether the concepts provided any Individuals with basic or below basic conveying numerical information new information. The interviews found health literacy are more likely to be (graphs) (Refs. 142 and 152). When used that some image concepts were very cigarette smokers (Refs. 133–135) and to communicate health risk information clear, while others were less are more likely to have limited to the public, bar charts and graphs are understood. When there were multiple knowledge about the negative health often misperceived, especially when not image concepts on the same or similar consequences of smoking (Refs. 136 and accompanied by further instruction on health conditions, participants reacted 137). National surveys also indicate that how to read and interpret the similarly to those concepts. Overall, the about half of the U.S. adult population information (Refs. 140, 141, 149, and majority of participants found the image has only very basic or below basic 151). Bar charts and graphs also require concepts to be credible and rated most quantitative skills, and only 9 percent of a higher degree of numerical proficiency of the concepts as medium to high in U.S. adults scored in the highest and cognitive effort to promote terms of image clarity. FDA used the numeracy levels (i.e., the ability to consumer understanding than do other feedback from these qualitative understand and use numbers, including types of visual depiction, such as interviews to further refine the initial the ability to read and interpret data illustrations and photographs. In image concepts, eliminate some image presented in tables, graphs, and bar comparison, illustrations, photographs, concepts from further consideration, charts) (Refs. 138 and 139). and other pictorial visual depictions are and inform a future quantitative To determine the best way to visually more likely to aid comprehension when consumer research study (see section depict the negative health consequences used for mass-communication purposes VI.E). FDA used a photorealistic illustration of cigarette smoking to promote greater as these types of visual depictions are format for the images rather than understanding among such a diverse more easily made congruent (i.e., the type of visual is appropriate for the photographs, because this format best population, FDA considered findings message) and concordant, and they allowed depicting specific features of from health communication science require less numerical proficiency and the health conditions as described by research regarding best practices for cognitive effort to understand the the textual warning statements. The helping the public better understand information (Refs. 141, 142, 149, and photorealistic illustration format also health risk information. As described in 150). Therefore, based on this review of facilitated providing factually accurate section V.B, it is well established in the the literature, the proposed cigarette images that depict common scientific literature that vivid features health warning message content, and presentations of the health conditions in (e.g., images) increase noticeability of the communication channel, FDA a realistic and objective format devoid and attention to textual health risk determined that textual warning of non-essential elements. Using information (e.g., cigarette health statements paired with factually photorealistic images allowed further warnings) and increase comprehension, accurate, concordant photographs or editing and refinements for clarity and understanding, and recall of health photorealistic images of specific health ease of understanding throughout the messages (Refs. 43, 50, 75, 78–81, 118, conditions, presented in a realistic and research and development process for and 140–145). Research also indicates objective format, would be most likely new cigarette health warnings. A that visual depictions of textual health to advance the Government’s interest in certified medical illustrator developed risk information are especially promoting greater public understanding high quality, medically accurate, beneficial in aiding comprehension and of the negative health consequences of photorealistic images in close understanding among subpopulations cigarette smoking. collaboration with FDA staff. After the that have lower health literacy and FDA then undertook a rigorous photorealistic images were created, FDA numeracy skills (Refs. 118, 144, and multistep process to develop, test, and paired each textual warning statement 146–148), including greater disparities refine images that: (1) Are factually (the 9 TCA statements and the 15 in knowledge about the negative health accurate; (2) depict common visual revised statements tested in the first consequences of smoking (Ref. 69). presentations of the health conditions quantitative consumer research study) However, multiple factors influence (intended to aid understanding by with a concordant image for further whether a specific type of visual building on existing consumer health testing. depiction (such as an image compared knowledge and experiences) and/or To do this further testing, FDA to a bar chart or graph) ultimately aids show disease states and symptoms as evaluated the photorealistic images or impedes message comprehension, they are typically experienced; (3) through a series of 20 qualitative focus including the level of concordance present the health conditions in a groups with adolescent smokers, between the text and accompanying realistic and objective format that is adolescents at risk for starting smoking, visual depiction (e.g., using an image of devoid of non-essential elements; and and adult smokers (OMB control an eye to depict the word ‘‘eye’’); the (4) are concordant with the statements number 0910–0796, ‘‘Qualitative Study level of cognitive effort required to on the same health conditions. on Consumer Perceptions of Cigarettes understand the information (e.g., using After developing initial image Health Warning Images’’). The focus a stacked bar chart to depict multiple concepts, FDA used information groups examined what factual data comparisons requires greater gathered through a series of 53 indepth information the images conveyed to cognitive effort); and the type of individual interviews with adolescents participants about the negative health communication channel used to deliver and adults (OMB control number 0910– consequences of cigarette smoking in the message (e.g., information presented 0796, ‘‘Qualitative Study of Perceptions the absence of a paired textual warning by a doctor as part of a conversation and Knowledge of Visually Depicted statement, as well as how concordant with a patient, versus information Health Conditions’’) to further refine the participants considered the images to be presented in a mass media campaign) concepts. FDA evaluated the extent to when paired with potential textual (Refs. 118, 140–143, 146, 147, and 149– which participants found the initial warning statements (both TCA

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statements and the revised statements). E. FDA’s Consumer Research Study on study design, including the control and Based on feedback received in these New Cigarette Health Warnings outcomes follows). focus groups, FDA further refined some 1. Study Design images for additional clarity and Once FDA examined opportunities to eliminated other images that were not promote greater public understanding of FDA’s final research study on new well understood or where potential the risks associated with cigarette cigarette health warnings was a three- smoking, developed potential revised confusion could not be resolved through session internet-based consumer statements to address gaps in public additional revisions. FDA then research study using an online research understanding, tested the revised completed final pairings of textual panel (OMB control number 0910–0866, statements in a consumer research ‘‘Experimental Study of Cigarette warning statements and concordant study, and developed concordant Warnings’’). The study included 9,760 photorealistic images for testing in the photorealistic images that depict the participants, including: (1) Adolescents final quantitative consumer research negative health consequences of (aged 13–17 years) who were current study. smoking, the Agency prepared a set of smokers and those at risk for starting As noted earlier (see section VI.C), 16 cigarette health warnings (statements smoking; (2) younger adults (aged 18–24 FDA selected a total of 15 textual paired with their concordant years) who were current smokers and warning statements for further testing. photorealistic images) to be tested in a nonsmokers; and (3) older-adults (aged However, two of the textual warning final consumer research study. The 25 years and older) who were current statements (fatal lung disease in purpose of the final research study was smokers and nonsmokers. Study nonsmokers, COPD) shared similar to assess the extent to which any of the participants in all age groups were concordant images (diseased lungs). To cigarette health warnings, developed assigned to a condition that determined preserve the option of potentially through FDA’s science-based, iterative which warnings they viewed during the requiring both warning statements but research process, increase study. Participants in the control without using two similar images, FDA understanding of the negative health condition viewed one of the four current paired an additional concordant image consequences of cigarette smoking. For Surgeon General’s cigarette warnings. that tested well in the qualitative focus warnings to be considered for this Participants in each of the treatment groups (man with oxygen tank) with the proposed rule, FDA decided that a conditions viewed one of 16 of the new COPD warning statement for further warning tested in this final consumer cigarette health warnings (i.e., text- research study must demonstrate image pairings) FDA developed through testing. Therefore, FDA prepared a total statistically significant improvements, the process described in sections VI.B– of 16 statement-and-image pairings to as compared to the control condition, on D. Table 2 provides a list of the 16 test in the final quantitative consumer both the two outcomes of ‘‘new textual warning statements (paired with research study. information’’ and ‘‘self-reported images) that FDA evaluated in this learning’’ (more discussion about the study.

TABLE 2—TEXT OF CIGARETTE HEALTH WARNINGS TESTED IN FDA’S CONSUMER RESEARCH STUDY

Statements

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

All participants viewed their assigned The study took place over three • Whether the warning was new warnings on both a mock three- sessions over more than two weeks for information to participants (‘‘new dimensional cigarette package that each respondent. During the first information); could be rotated on screen and as part session, participants answered baseline • Whether participants learned of a mock full-page magazine cigarette questions about their beliefs about the something from the warning (‘‘self- advertisement in either their current negative health consequences of reported learning’’); (e.g., on the side of the package for the cigarette smoking. Next, they viewed • Whether the warning made Surgeon General’s warnings) or their assigned warning on both the participants think about the health risks proposed (e.g., on the top 50 percent of mock cigarette package and in the mock of smoking (‘‘thinking about risks’’); the front and rear panel of the package cigarette advertisement and answered • for the new cigarette health warnings) questions assessing the following Whether the warning was perceived size and location. outcomes: to be informative (‘‘perceived informativeness’’);

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• Whether the warning was perceived of the negative health consequences of • WARNING: Smoking reduces blood to be understandable (‘‘perceived cigarette smoking. Participants were flow, which can cause erectile understandability’’); significantly more likely, relative to the dysfunction. • Whether the warning was perceived control condition (i.e., the Surgeon • WARNING: Smoking reduces blood to be a fact or opinion (‘‘perceived General’s warnings), to report that, for flow to the limbs, which can require factualness’’); 13 of the 16 cigarette health warnings amputation. • Whether participants reported tested (except for the warnings related • WARNING: Smoking causes type 2 beliefs linking smoking and each of the to addiction, smoking can kill, and diabetes, which raises blood sugar. health consequences presented in the quitting smoking), the new cigarette • WARNING: Smoking causes age- warning (‘‘health beliefs’’); health warnings provided new related macular degeneration, which • Whether the warning was perceived information and resulted in greater self- can lead to blindness. to help participants understand the reported learning (see Ref. 153, Table 4– • WARNING: Smoking causes negative health effects of smoking 1, ‘‘Summary of Results’’). cataracts, which can lead to blindness. (‘‘perceived helpfulness understanding More details about the full study The cigarette health warnings using health effects’’); results can be found in the study report, the following three statements did not • Whether the warning grabbed their which we have included in this docket demonstrate statistically significant attention (‘‘attention’’); and (Ref. 153). improvements, as compared to the • Whether the warning was recalled control condition, on the outcomes of (‘‘recall’’). 3. How Study Findings Were Used ‘‘new information’’ and ‘‘self-reported Approximately 1 day later, during the Because the purpose of this final learning’’ and therefore are not included second session, participants viewed quantitative consumer research study as part of this proposed rule: their assigned warning again and was to identify which of the cigarette • WARNING: Cigarettes are addictive. answered questions assessing their health warnings increase understanding • WARNING: Smoking can kill you. beliefs about the negative health of the negative health consequences of • WARNING: Quitting smoking now consequences of cigarette smoking. cigarette smoking, the study was not greatly reduces serious risks to your Approximately 14 days after the second designed to put the cigarette health health. session, during the third session (i.e., a warnings in a rank order or compare VII. FDA’s Proposed Required delayed post-test), participants individual results of one cigarette health Warnings answered questions about their beliefs warning to another. FDA evaluated the about the negative health consequences research results for each individual The initial section 4(d) of the FCLAA, of cigarette smoking as well as questions cigarette health warning to determine as amended by section 201 of the assessing recall of the warning they which warnings to include in this Tobacco Control Act, directs FDA to viewed. proposed rule. issue ‘‘regulations that require color More details about the study FDA is including in this proposed graphics depicting the negative health methodology, including the sample size rule only the warnings that demonstrate consequences of smoking’’ to calculation and analysis plan, can be statistically significant improvements, accompany the textual warning found in the study report, which we as compared to the control condition statements specified in section 4(a)(1) of have included in this docket (Ref. 153).9 (i.e., the Surgeon General’s warnings), the FCLAA. A second section 4(d) of the 2. Study Findings on both the outcomes of ‘‘new FCLAA, as created by section 202(b) of information’’ and ‘‘self-reported the Tobacco Control Act, permits FDA, The results of the final consumer learning’’ (i.e., knowledge gain). through notice and comment research study allowed FDA to draw Following review of the findings of the rulemaking, to adjust the format, type important conclusions that provide a final quantitative consumer research size, color graphics, and text of any of basis for the cigarette health warnings study, FDA is proposing 13 cigarette the label requirements if such a change included in this proposed rule. Overall, health warnings that use the following would promote greater public relative to the average of the Surgeon 12 statements: understanding of the risks associated General’s warnings, most of the new • WARNING: Tobacco smoke can with the use of tobacco products. FDA cigarette health warnings were reported harm your children. interprets these provisions of the to be new information; resulted in • WARNING: Tobacco smoke causes FCLAA to permit a rulemaking that greater self-reported learning; led to fatal lung disease in nonsmokers. establishes new cigarette health thinking about risks; were higher on • WARNING: Smoking causes head warnings and at the same time adjusts perceived informativeness, perceived and neck cancer. the text and color graphic requirements, understandability, and perceived • WARNING: Smoking causes including the number of required helpfulness understanding health bladder cancer, which can lead to warnings, so long as the adjustments effects; increased agreement with bloody urine. promote greater public understanding of • accurate health beliefs over time; WARNING: Smoking during the risks of the use of tobacco products. attracted attention; and were recalled. pregnancy stunts fetal growth. As described in section VI.B, FDA • As discussed above (see section WARNING: Smoking can cause undertook a science-based, iterative VI.C.3), FDA determined that the heart disease and strokes by clogging research and development process to outcomes ‘‘new information’’ and ‘‘self- arteries. • consider whether revisions to the reported learning’’ are predictive for the WARNING: Smoking causes COPD, textual warning statements specified in task of identifying which of the cigarette a lung disease that can be fatal. [paired section 4(1) of the FCLAA would 10 health warnings increase understanding with two images] promote greater public understanding of the risks associated with cigarette 9 As with the first consumer research study, FDA 10 As discussed in section VI.D, FDA paired two will conduct a peer review of this consumer concordant images (i.e., diseased lungs, man with smoking. The empirical results research study. FDA’s peer review plans are oxygen tank) with the COPD warning statement for available online at https://www.fda.gov/science- final testing. Both text and image pairings condition (i.e., the Surgeon General’s warnings), on research/science-and-research-special-topics/peer- demonstrated statistically significant both the outcomes of ‘‘new information’’ and ‘‘self- review-scientific-information-and-assessments. improvements, as compared to the control reported learning’’ (i.e., knowledge gain).

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demonstrate sufficient scientific support Each of the proposed warnings inferences from the criteria applied in to adjust the textual warning statements. described in this section demonstrated the Surgeon General’s Reports—that Also, as described in section VI.D, FDA statistically significant higher levels of secondhand smoke exposure from carefully developed and tested providing new information and self- parental smoking causes the following concordant color graphics, in the form reported learning when compared to the negative health effects: Lower of photorealistic images, depicting the control condition (i.e., the Surgeon respiratory illness in infants and negative health consequences of General’s warnings) (Ref. 153). While children; middle ear disease in children, smoking to accompany each of the the final consumer research study was including acute and recurrent otitis textual warning statements included in designed to measure a range of media and chronic middle ear effusion; this proposed rule. Based on the results outcomes related to consumer cough, phlegm, wheeze, and of FDA’s research, we intend to finalize understanding, as an initial matter, FDA breathlessness among children of school some or all of the 13 new cigarette is including in this proposed rule only age, and ever having asthma among health warnings proposed in this rule. the warnings that demonstrate children of school age; the onset of We invite comment on how many statistically significant improvements, wheeze illnesses in early childhood; warnings should be selected for the final as compared to the control condition persistent adverse effects on lung rule and whether fewer than, more than, (i.e., the Surgeon General’s warnings), function across childhood; and a lower or exactly nine warnings would advance on both the outcomes of ‘‘new level of lung function during childhood the Government’s interest in promoting information’’ and ‘‘self-reported (Ref. 155). More recently published greater public understanding of the learning’’ (i.e., knowledge gain). As studies on the topic support the Surgeon negative health consequences of described above, the scientific literature General’s Reports’ conclusion that smoking. demonstrates that these two outcomes parental secondhand smoke influences The 13 proposed warnings, each of are predictive for the task of assessing child health, particularly respiratory which consists of a textual warning which of the new cigarette health health (Refs. 156–158). statement paired with a concordant warnings increase understanding of the 2. WARNING: Tobacco smoke causes photorealistic image depicting the risks associated with cigarette smoking. fatal lung disease in nonsmokers. This proposed warning consists of the negative health consequences of Other study outcomes provide TCA statement ‘‘WARNING: Tobacco smoking, are available in an electronic additional, useful information and are smoke causes fatal lung disease in PDF in this docket (Ref. 18). For the reflected in the study report (Ref. 153). FDA solicits comment on the nonsmokers’’ paired with a concordant, final rule, the required warnings will be individual cigarette health warnings factually accurate, photorealistic image contained in a document entitled included in this proposal, and we ask depicting fatal lung disease. The image ‘‘Required Cigarette Health Warnings,’’ that comments provide data and factual shows gloved hands holding a pair of as is further discussed in section II.C. information that would help us to diseased lungs containing cancerous These proposed required warnings, as further consider which proposed lesions from chronic secondhand smoke shown through the robust scientific warnings to include in the final rule or exposure. evidence described in detail in sections whether such warnings should be The 1986 and subsequent Surgeon V and VI and in the remainder of this altered, consistent with the General’s Reports have confirmed the section, are factual and accurate, Government’s interest, and how. For causal link between secondhand smoke advance the Government’s interest, and additional consideration, the following exposure and lung cancer, a fatal lung are not unduly burdensome (see section subsections provide relevant scientific disease, among nonsmokers (Refs.155 VIII for a more detailed discussion). In support for each of the proposed and 159). The conclusion in the 2006 determining which proposed cigarette required warnings. Surgeon General’s Report extends to all health warnings will be required in the 1. WARNING: Tobacco smoke can secondhand smoke exposure, regardless final rule, FDA will consider public harm your children. of location of exposure (e.g., at home, at comments submitted to this docket, full This proposed warning consists of the work, in other settings); the combined research results from our final TCA statement ‘‘WARNING: Tobacco evidence from multiple studies quantitative consumer research study smoke can harm your children’’ paired indicates a 20 to 30 percent increase in (including peer reviewer comments), with a concordant, factually accurate, the risk of lung cancer from secondhand scientific literature, and other photorealistic image depicting a smoke exposure associated with living considerations as discussed in this negative health consequence of with a smoker (Ref. 155). For example, proposal. secondhand smoke exposure in a meta-analysis of 43 studies, including A. FDA’s Proposed Required Warnings children. The image shows the head and studies conducted in both the United shoulders of a young boy (aged 8–10 States and outside of the United States, As discussed above, we assessed years) wearing a hospital gown and found that the relative risk of lung whether the new cigarette health receiving a nebulizer treatment for cancer among nonsmoking women who warnings, developed through FDA’s chronic asthma resulting from live with partners who smoke (i.e., the science-based, iterative research secondhand smoke exposure. risk of the lung cancer among process, will advance the Government’s Since 2004, several Surgeon General’s nonsmokers living with smokers interest in promoting greater public Reports have confirmed the causal link compared to nonsmokers not living with understanding of the negative health between exposure to secondhand smoke smokers) was 1.29 (Ref. 160). This consequences of cigarette smoking. and several negative health means that nonsmoking women who Based on available data and information consequences in children, including live with partners who smoke have 1.29 available to us at this time, including middle ear disease, respiratory times higher risk of lung cancer results from FDA’s final consumer symptoms, impaired lung function, compared to nonsmoking women who research study (see section VI for a full lower respiratory illness, and SIDS live with partners who do not smoke. description of the final consumer (Refs. 8, 154, and 155). The 2006 Recent studies support and extend these research study) (Ref. 153), we identified Surgeon General’s Report stated that the conclusions (Refs. 161–164). In addition 13 cigarette health warnings for this evidence is sufficient to conclude—the to the many lung cancer deaths caused proposed rule. highest level of evidence of causal directly by smoking, researchers

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estimate that another 5 percent of all ‘‘WARNING: Smoking causes bladder preterm delivery (Ref. 154). The 2004 lung cancer deaths, or 7,300 deaths cancer, which can lead to bloody urine’’ Surgeon General’s Report summarized annually (as measured in 2006), can be paired with a concordant, factually many studies that found a consistent attributed to secondhand smoke accurate, photorealistic image depicting and strong relationship between exposure (Ref. 165). bloody urine. The image shows a gloved smoking and reduced birth weight as 3. WARNING: Smoking causes head hand holding a urine specimen cup well as a strong dose-response and neck cancer. containing bloody urine resulting from relationship between smoking intensity This proposed warning consists of the bladder cancer caused by cigarette and birth weight, and the 2010 Surgeon revised textual warning statement smoking. General’s Report cited additional ‘‘WARNING: Smoking causes head and The association between smoking and studies further supporting that neck cancer’’ paired with a concordant, bladder cancer has been noted since the conclusion (Ref. 171). New studies factually accurate, photorealistic image first Surgeon General’s Report in 1964, published since 2014 further support depicting neck cancer. The image shows and a causal conclusion was reported in the causal relation between smoking the head and neck of a woman (aged 50– the 1990 report (Refs. 183 and 219). The and restricted fetal growth (Refs. 172– 60 years) who has neck cancer caused 2014 Surgeon General’s Report again 175). by cigarette smoking. The woman has a confirmed that the evidence is sufficient In the United States, around eight visible tumor protruding from the right to infer a causal relationship—the percent of newborns have low birth side her neck just below her jawline. highest level of evidence of causal weight each year (Ref. 176). The CDC Common head and neck cancers inferences from the criteria applied in reported that low birth weight was twice include mouth, nose, pharynx, and the Surgeon General’s Reports—between as common among smoking mothers larynx. Since 1979, Surgeon General’s cigarette smoking and bladder cancer compared to nonsmoking mothers in Report have recognized that smoking (Ref. 8). Recent research illustrates that Ohio in a 6-month period in 1989, with causes head and neck cancers, and the even smoking a few cigarettes per day 20 percent of cases of low birth weight 2004 Surgeon General’s Report stated is associated with an increased risk of among infants during the same period that the evidence is sufficient to infer a bladder cancer (Ref. 167) and that low due to maternal smoking (Ref. 177). Low causal relationship—the highest level of intensity/long duration smoking is birth weight was almost 60 percent evidence of causal inferences from the particularly associated with increased more common among mothers who criteria applied in the Surgeon General’s bladder cancer risk (Ref. 168). In most smoked during pregnancy than mothers Reports—between smoking and cancers cases, blood in the urine (called who did not in a study in Massachusetts of the oral cavity, pharynx, and larynx hematuria) is the first visible sign of in 1998 (Ref. 32). The California EPA (Ref. 154), building on the strong bladder cancer (Ref. 169), although there estimated 24,500 cases of low birth conclusions of causality from previous are other causes of hematuria. The weight due to maternal exposure to reports. The magnitude of this number of cases of bladder cancer environmental tobacco smoke (i.e., relationship is substantial—male and related to smoking is considerable. secondhand smoking) in the United female smokers who currently smoke There were 73,000 bladder cancer cases States per year (Ref. 34). and have smoked only cigarettes in the United States in 2015 and 16,650 6. WARNING: Smoking can cause experience 10- and 5-fold higher risk of deaths from bladder cancer in 2017 (Ref. heart disease and strokes by clogging head and neck cancers than lifetime 166). According to the American Cancer arteries. nonsmokers, respectively. The 2004 Society, 1 in 27 men and 1 in 89 women This proposed warning consists of the Surgeon General’s Report summarized will develop bladder cancer during their revised textual warning statement clinical studies showing that lifetime (Ref. 170). The Centers for ‘‘WARNING: Smoking can cause heart premalignant lesions in the mouth and Disease Control and Prevention (CDC) disease and strokes by clogging arteries’’ throat are most commonly found in has estimated that 40 percent of bladder paired with a concordant, factually areas that have direct contact with cancer deaths in 2000 through 2004 accurate, photorealistic image depicting tobacco or smoke and that quitting were attributable to smoking, a patient who recently underwent heart smoking causes most premalignant representing almost 5,000 deaths a year surgery to treat heart disease caused by lesions to regress and reduces oral and (Ref. 30). smoking. The image shows the chest of pharyngeal cancer incidence and 5. WARNING: Smoking during a man (aged 60–70 years) wearing an mortality (Ref. 154). In 2015, there were pregnancy stunts fetal growth. open hospital gown. The man has a 44,430 new cases of cancer of the oral This proposed warning consists of the large, recently-sutured incision running cavity and pharynx and 12,292 new revised textual warning statement down the middle of his chest and is cases of cancer of the larynx (Ref. 166). ‘‘WARNING: Smoking during pregnancy undergoing post-operative monitoring. There were approximately 14,000 stunts fetal growth’’ paired with a Surgeon General’s Reports since the deaths from head and neck cancer in concordant, factually accurate, 1970s have concluded that smoking is 2016 (approximately 10,000 from cancer photorealistic image depicting a causally related to heart disease and of the lip, oral cavity, and pharynx, and negative health consequence of smoking stroke (Refs. 154 and 178). The 2014 approximately 3,900 from cancer of the during pregnancy: An infant with low Surgeon General’s Report summarized larynx) (Ref. 166). Most head and neck birth weight resulting from stunted fetal the evidence and focused on new cancers are attributable to smoking, with growth. The image shows a newborn insights into causal mechanisms gained almost 70 percent of lip, oral cavity, infant on a medical scale, and the digital since the earlier report (Ref. 8). pharynx, and larynx cancer deaths from display on the scale reads four pounds. Coronary heart disease—often simply 2000 to 2004 attributable to smoking, The 2004 Surgeon General’s Report called heart disease—is a disorder of the representing 7,900 deaths a year (Ref. concluded for the first time that the blood vessels of the heart that can lead 30). evidence was sufficient to infer a causal to a heart attack. A heart attack happens 4. WARNING: Smoking causes relationship—the highest level of when an artery becomes blocked, bladder cancer, which can lead to evidence of causal inferences based on preventing oxygen and nutrients from bloody urine. the criteria applied in the Surgeon getting to the heart. Stroke occurs when This proposed warning consists of the General’s Reports—between maternal blood supply to part of the brain is revised textual warning statement smoking and fetal growth restriction and interrupted or reduced, depriving brain

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tissue of oxygen and nutrients (Ref. heart attack due to smoking, and 15,000 the New England Journal of Medicine 179). Atherosclerosis, or clogged stroke deaths due to smoking (Ref. 8). (Ref. 182). There are about 128,000 arteries, is a disease in which plaque 7. WARNING: Smoking causes COPD, COPD deaths in the United States each builds up inside the arteries that carry a lung disease that can be fatal. [image year, of which 101,000 (79 percent) are oxygen-rich blood to the heart and other of diseased lungs] attributable to smoking (Ref. 8). parts of the body and can lead to heart This proposed warning consists of the 8. WARNING: Smoking causes COPD, attack and stroke through thrombosis, or revised textual warning statement a lung disease that can be fatal. [image blockage of the arteries (Refs. 8 and ‘‘WARNING: Smoking causes COPD, a of man with oxygen tank] 179). Most coronary heart disease lung disease that can be fatal’’ paired This proposed warning consists of the involves atherosclerosis, or clogged with a concordant, factually accurate, revised textual warning statement photorealistic image depicting COPD. ‘‘WARNING: Smoking causes COPD, a arteries. The 2004 Surgeon General’s The image shows gloved hands holding lung disease that can be fatal’’ paired Report concluded that evidence from a pair of diseased, darkened lungs with a concordant, factually accurate, several different populations, multiple removed from a smoker with COPD. photorealistic image depicting a man age groups, and both genders is Because a similar image of diseased receiving oxygen support because he sufficient to conclude that there is a lungs was paired with the TCA has COPD caused by cigarette smoking. causal relationship—the highest level of statement regarding fatal lung disease in The image shows the head and neck of evidence of causal inferences from the nonsmokers, FDA paired this revised a man (aged 50–60 years) who has a criteria applied in the Surgeon General’s statement with two different images for nasal canula under his nose supplying Reports—between smoking and final testing (see next subsection). oxygen; the oxygen tank can be seen atherosclerosis and related health Chronic obstructive pulmonary behind his left shoulder. Because, based conditions such as heart disease and disease (COPD) includes the diseases on the findings from previous stroke (Ref. 154). Across many studies emphysema and chronic bronchitis. The qualitative testing (see section VI.D), over time, a clear dose-response 1964 Surgeon General’s Report both this warning statement and the relationship has been established with concluded that smoking is a primary TCA statement regarding fatal lung smoking more cigarettes and smoking cause of chronic bronchitis, and disease in nonsmokers were paired with for a longer time linked to greater risk subsequent reports summarized similar images of diseased lungs (see of heart disease and stroke. More recent additional evidence to conclude, in the previous subsection), FDA decided to evidence demonstrates that even a very 2004 Surgeon General’s Report, at the pair this revised statement with an low frequency of smoking (i.e., even as highest level of evidence of causal additional concordant image for testing few as one cigarette per day) has a inferences from the criteria applied in in the final quantitative consumer measurable increase in the risk for the Surgeon General’s Reports, that the research study. cardiovascular disease (Ref. 180). The evidence is sufficient to infer a causal As explained in the previous 2004 Surgeon General’s Report further relationship between active smoking subsection (‘‘7. WARNING: Smoking concluded that the evidence is sufficient and COPD morbidity and mortality causes COPD, a lung disease that can be to infer a causal relationship—the (Refs. 154, 183, and 184). The 2014 fatal. [image of diseased lungs]’’), COPD highest level of evidence of causal Surgeon General’s Report reinforced and includes the diseases emphysema and inferences from the criteria applied in extended this evidence to discuss the chronic bronchitis. The 1964 Surgeon the Surgeon General’s Reports—between relationship between smoking and General’s Report concluded that smoking and subclinical (or very early COPD mortality (Ref. 8). The 2014 smoking is a primary cause of chronic signs of) atherosclerosis (Ref. 154). Surgeon General’s Report concluded bronchitis, and subsequent reports that the evidence is sufficient to infer— summarized additional evidence to The public health burden of heart once again, the highest level of evidence conclude, in the 2004 Surgeon General’s disease and stroke is considerable. It has of causal inferences from the criteria Report, at the highest level of evidence been estimated that, in the United applied in the Surgeon General’s of causal inferences from the criteria States, over 2 million people have had Reports—that smoking is in fact the applied in the Surgeon General’s a heart attack during their lifetime and dominant cause of COPD in the United Reports, that the evidence is sufficient over 1 million have had a stroke during States (Ref. 8). The report also to infer a causal relationship between their lifetime due to smoking (Ref. 21). concluded that smoking causes all active smoking and COPD morbidity The mortality burden is also substantial. elements of COPD, including and mortality (Refs. 154, 183, and 184). There are approximately 635,000 deaths emphysema and damage to the airways The 2014 Surgeon General’s Report from heart disease and 140,000 deaths of the lung (Ref. 8). reinforced and extended this evidence from stroke in the United States each The public health burden of COPD is to discuss the relationship between year (Ref. 181). Recent data showed that substantial. The National Heart, Lung, smoking and COPD mortality (Ref. 8). the mortality risk (i.e., the risk of dying) Blood Institute estimates that there are The 2014 Surgeon General’s Report for current smokers compared to never 12 million U.S. adults currently living concluded that the evidence is sufficient smokers from heart disease was 2.50 who have been diagnosed with COPD to infer—once again, the highest level of times greater for men and 2.86 times and another 12 million who have COPD evidence of causal inferences from the greater for women. The risk of having a but have not yet been diagnosed (Ref. criteria applied in the Surgeon General’s stroke was 1.92 times greater for men 185). It has also been estimated that Reports—that smoking is in fact the and 2.10 times greater for women who approximately 7.5 million people dominant cause of COPD in the United were current smokers compared to currently living with COPD (whether States (Ref. 8). The report also never smokers (Ref. 182). The diagnosed or undiagnosed) have the concluded that smoking causes all proportion of all deaths from heart disease because of smoking (Ref. 21). elements of COPD, including attack and stroke due to active smoking The mortality risk from COPD for emphysema and damage to the airways is notable—24.1 percent for heart current smokers compared to never of the lung (Ref. 8). disease deaths and 11.3 percent for smokers was 25.61 times higher for men The public health burden of COPD is stroke deaths. This represents and 22.35 times higher for women, substantial. The National Heart, Lung, approximately 100,000 deaths from according to 50-year trends published in Blood Institute estimates that there are

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12 million U.S. adults currently living dysfunction in studies such as the showed that risk estimates have who have been diagnosed with COPD Health Professionals Follow-up Study increased over time (Ref. 8). Results and another 12 million who have COPD and the Olmsted County Study of from that study found higher risks than but have not yet been diagnosed (Ref. Urinary Symptoms and Health Status those in the meta-analysis; compared to 185). It has also been estimated that (Refs. 27 and 28). never smokers, the risk of PAD/PVD in approximately 7.5 million people 10. WARNING: Smoking reduces the Women’s Health Study was 3.16 currently living with COPD (whether blood flow to the limbs, which can times greater for former smokers, 11.94 diagnosed or undiagnosed) have the require amputation. times greater for current smokers disease because of smoking (Ref. 21). This proposed warning consists of the reporting less than 15 cigarettes per day, The mortality risk from COPD for revised textual warning statement and 21.08 times greater for current current smokers compared to never ‘‘WARNING: Smoking reduces blood smokers reporting 15 or more cigarettes smokers was 25.61 times higher for men flow to the limbs, which can require per day (Ref. 191). and 22.35 times higher for women, amputation’’ paired with a concordant, One estimate from a review of the according to 50-year trends published in factually accurate, photorealistic image scientific literature suggests that there the New England Journal of Medicine depicting the feet of a person who had are between 160,000 and 180,000 (Ref. 182). There are about 128,000 several toes amputated due to tissue amputations due to PAD/PVD annually COPD deaths in the United States each damage resulting from peripheral in the United States, and, among people year, of which 101,000 (79 percent) are vascular disease caused by cigarette with critical limb ischemia (i.e., a severe attributable to smoking (Ref. 8). smoking. blockage of the arteries that greatly 9. WARNING: Smoking reduces blood Peripheral arterial disease (PAD), also reduces blood flow due to PAD/PVD), flow, which can cause erectile known as peripheral vascular disease 25 percent have amputations each year dysfunction. (PVD), is a condition in which narrowed (Ref. 192). Another article estimates that This proposed warning consists of the arteries reduce blood flow to the limbs, ‘‘over 90% of all limb amputations in revised textual warning statement especially the legs. Plaque is made up the Western world occur as a direct or ‘‘WARNING: Smoking reduces blood of fat, cholesterol, calcium, fibrous indirect consequence’’ of PAD/PVD flow, which can cause erectile tissue, and other substances in the (Ref. 193). dysfunction’’ paired with a concordant, blood. Over time, plaque can harden 11. WARNING: Smoking causes type factually accurate, photorealistic image and narrow the arteries. This limits the 2 diabetes, which raises blood sugar. depicting a man who is experiencing flow of oxygen-rich blood to organs and This proposed warning consists of the erectile dysfunction caused by smoking. other parts of the body. PAD/PVD revised textual warning statement The image shows a man (aged 50–60 usually affects the arteries in the legs ‘‘WARNING: Smoking causes type 2 years) sitting on the edge of a bed and (Ref. 188). Complications of PAD/PVD diabetes, which raises blood sugar’’ leaning forward, with one elbow resting occur because of decreased or absent paired with a concordant, factually on each knee. The man’s head is tilted blood flow and may include amputation accurate, photorealistic image depicting down, with his forehead pressed into or loss of limb due to tissue not getting a personal glucometer device being used the knuckles of his right hand. Behind enough oxygen from blood and dying. to measure the blood glucose level of a him on the bed, his female partner looks The 1983 Surgeon General’s Report person with type 2 diabetes caused by off in another direction. entitled ‘‘The Health Consequences of cigarette smoking. The digital display The 2014 Surgeon General’s Report Smoking: Cardiovascular Disease’’ reading of 175 mg/dL and a notation on concluded, for the first time, that the summarized evidence regarding the glucometer indicate a high blood evidence is sufficient to infer a causal smoking and PAD/PVD and concluded sugar level. relationship—the highest level of that cigarette smoking is the most The 2014 Surgeon General’s Report evidence of causal inferences from the powerful risk factor predisposing to this concluded, for the first time, that: (1) criteria applied in the Surgeon General’s condition and that smoking cessation The evidence is sufficient to infer—the Reports—between smoking and erectile plays an important role in its medical highest level of evidence of causal dysfunction (Ref. 8). This conclusion is and surgical management (Ref. 189). inferences from the criteria applied in supported by the consistency of the Since that time, other Surgeon General’s the Surgeon General’s Reports—that strength of the association across Reports have extended this evidence cigarette smoking is a cause of type 2 numerous studies that evaluated rates of base, through the 2014 report (Ref. 8). diabetes; (2) the risk of developing erectile dysfunction among smokers. For The population health burden of diabetes is 30 to 40 percent higher for example, a recent meta-analysis of PAD/PVD is substantial. Overall active smokers than nonsmokers; and studies that included 50,360 prevalence of PAD/PVD was found to be (3) there is a relationship between participants found that smoking more 13.5 percent in 2012 in the increased number of cigarettes smoked cigarettes and smoking for a longer time Atherosclerosis Risk in Communities and increased risk of developing were associated with increased erectile study, a multi-site, biracial, prospective diabetes (Ref. 8). Across the 25 studies dysfunction risk (Ref. 186). cohort study investigating the causes included in the 2014 Surgeon General’s Erectile dysfunction is likely under- and clinical effects of atherosclerosis in Report updated summary, the reported in epidemiological studies; four U.S. communities (Ref. 190). A associations were strong and consistent therefore, the effect estimates observed meta-analysis of studies of PAD/PVD and were found in many subgroups, and in studies are likely an underestimate. and smoking found that the risk of the these results have been replicated in However, given that limitation of being condition was 2.71 times greater for many different study populations and under-reported in studies, at least 20 current smokers and 1.67 times greater study locations. percent of all men have some degree of for former smokers compared to never The public health burden of smoking erectile dysfunction (Ref. 187). Among smokers (Ref. 26). In its summary of a and diabetes is substantial. The men between the ages of 40 and 70 recent prospective analysis using the prevalence of diabetes among U.S. years, approximately 50 percent have Women’s Health Study, which adults was estimated to be 12.1 percent some degree of erectile dysfunction (Ref. evaluated the relationships of smoking in 2005 through 2010 National Health 187). Smokers have been found to have and smoking cessation with PAD/PVD, and Nutrition Examination Survey data a 40 percent increased risk of erectile the 2014 Surgeon General’s Report (Ref. 194). A meta-analysis of studies

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found the risk of type 2 diabetes to be the Surgeon General’s Reports—between across a range of diseases and organ 44 percent greater among current smoking and nuclear cataracts (Ref. systems. In particular, Surgeon smokers and 23 percent greater among 154). A nuclear cataract is one of the General’s Reports provide definitive former smokers compared to never three types of cataracts and refers to the syntheses of the available evidence on smokers (Ref. 25). Smoking has been location of the clouding in the lens of smoking and health (Ref. 8, p. 3). estimated to cause 9,000 of the 70,810 the eye. The epidemiologic studies Surgeon General’s Reports classify the deaths (12.7 percent) due to diabetes in examined in the 2004 Surgeon General’s strength of causal inferences in a four- the United States each year (Ref. 8). Report found generally consistent level hierarchy based upon work of the 12. WARNING: Smoking causes age- associations between smoking and IOM (now the National Academy of related macular degeneration, which nuclear cataracts, with most studies Medicine) and the IARC (Refs. 200 and can lead to blindness. reporting that smoking doubled or 212). Because of the rigor and consistent This proposed warning consists of the tripled the relative risk of nuclear application of these causal standards, revised textual warning statement cataracts; in addition, a dose-response the Surgeon General’s Reports are the ‘‘WARNING: Smoking causes age- relationship was observed as risk preeminent authority for determinations related macular degeneration, which increased with the number of cigarettes of conditions caused by cigarette can lead to blindness’’ paired with a smoked (Ref. 154). Data for other types smoking and by exposure to concordant, factually accurate, of cataracts were less strong, and these secondhand smoke. Every smoking- photorealistic image depicting a closeup subtypes are also less common in the related condition in every warning of an older man (aged 65 years or older) population (Ref. 154). Authors have statement that FDA tested is supported who has age-related macular continued to identify smoking as a at the very highest level of evidence of degeneration caused by cigarette major causal risk factor in the causal inferences from the criteria smoking. The man is receiving an development and progression of applied in the Surgeon General’s injection in his right eye to prevent cataracts (Refs. 195–197). Studies of Reports. additional vessel growth. smoking cessation and risk of cataracts Based upon this research and upon Macular degeneration is an incurable has affirmed that risk decreases, but is the substantial scientific literature on eye disease that causes blindness. The not equivalent to never smokers, upon the significant gaps and misperceptions 2014 Surgeon General’s Report on elimination of the exposures of tobacco in public understanding of the negative cigarette smoking concluded, for the smoke (Ref. 198). health consequences of smoking (see first time, that the evidence is sufficient Prevalence of cataracts among U.S. section V.A.3 above, ‘‘There Remain to infer a causal relationship—the adults aged 40 years and older in 2010 Significant Gaps in Public highest level of evidence of causal was estimated to be 17.1 percent by the Understanding About the Negative inferences from the criteria applied in National Eye Institute (Ref. 199). By age Health Consequences of Cigarette the Surgeon General’s Reports—between 75, more than half of non-Hispanic Smoking’’), FDA developed initial cigarette smoking and the two major whites have cataracts (Ref. 199). A meta- versions of revised statements for types of advanced age-related macular analysis found that the risk of cataracts further review, testing, and refinement. degeneration (Ref. 8). The association is was about 50 percent higher for current These initial revised statements were found across a range of populations and smokers and 20 percent to 60 percent further reviewed by FDA internal through various study designs. The higher for former smokers compared to epidemiological experts to confirm that prevalence of any macular degeneration never smokers (Ref. 24). the health conditions under among U.S. adults aged 40 years and consideration were causally linked to VIII. First Amendment Considerations older was estimated to be 6.5 percent cigarette smoking or exposure to (Ref. 216). A meta-analysis found that The Government may, consistent with secondhand smoke. current smokers were approximately the First Amendment, require the In parallel with FDA’s work to twice as likely (relative risks for cohort disclosure of factual information in develop and test revised warning studies of 2.06 and for case-control commercial marketing where the statements, the Agency also undertook studies of 2.38), as never smokers to disclosure is justified by a Government an iterative, research-based approach to have macular degeneration (Ref. 23). interest and does not unduly burden develop and test color graphics 13. WARNING: Smoking causes protected speech. Zauderer v. Office of depicting the negative health cataracts, which can lead to blindness. Disciplinary Counsel; Nat’l Inst. of consequences of cigarette smoking to This proposed warning consists of the Family and Life Advocates v. Becerra, accompany the statements. As discussed revised textual warning statement 138 S. Ct. 2361, 2372 (2018). The in section VI.D above (‘‘Developing and ‘‘WARNING: Smoking causes cataracts, proposed new cigarette health warnings, Testing Images Depicting the Negative which can lead to blindness’’ paired including their images, fully satisfy Health Consequences of Smoking to with a concordant, factually accurate, those requirements. Accompany the Textual Warning photorealistic image depicting a closeup The proposed warnings are factual Statements’’), FDA used a photorealistic of the face of a man (aged 65 years or and accurate. As described in greater illustration format for the images older) who has a cataract caused by detail in section VI.A above, ‘‘Review of because this format best allowed FDA to cigarette smoking. The man’s right pupil the Negative Health Consequences of ensure that the final images would be is covered by a large cataract. Cigarette Smoking,’’ in developing the fully concordant with the ultimate A cataract is a clouding of the lens in new warnings, FDA relied on the 2014 textual statements addressing the same the eye that affects vision. Without Surgeon General’s Report, entitled ‘‘The health conditions. The photorealistic treatment, the area of clouding of the Health Consequences of Smoking: 50 illustration format also facilitated lens can increase and eventually leads Years of Progress’’ (Ref. 8), in addition providing factually accurate images that to blindness. The 2004 Surgeon to previous reports of the Surgeon depict common presentations of the General’s Report on cigarette smoking General and other scientific literature, health conditions in a realistic and concluded that the evidence is sufficient which together present a robust body of objective format devoid of non-essential to infer a causal relationship—the evidence documenting the health elements. highest level of evidence of causal consequences from both active smoking FDA also carefully considered the inferences from the criteria applied in and exposure to secondhand smoke D.C. Circuit Court findings regarding the

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Agency’s 2010–2011 cigarette warning of this quantitative research, especially leading cause of preventable disease and rule, including the court’s statements ‘‘self-reported learning’’ and ‘‘new death in the United States. Given the criticizing the images as having been information’’ outcomes, to identify the magnitude of this public health problem designed ‘‘to evoke an emotional warning statements, to be paired with from cigarette smoking, in the Tobacco response’’ with ‘‘inflammatory images accompanying concordant Control Act Congress required nine new and the provocatively-named hotline.’’ photorealistic images, for testing in the health warning statements appear on R.J. Reynolds Tobacco Co. v. FDA, 696 final quantitative consumer research cigarette packages and in cigarette F.3d at 1216 (D.C. Cir. 2012). The court study. advertisements; directed FDA to further found that some of the images FDA’s rigorous process for developing develop color graphics ‘‘depicting the ‘‘could be misinterpreted by the proposed images likewise obviates negative health consequences of consumers’’ and some did ‘‘not convey any potential concerns of the kind smoking’’ to accompany the warning any warning information at all.’’ Id. raised in Reynolds that they might ‘‘not statements; and provided that FDA may (emphasis omitted) (‘‘For example, the offer any information about the health adjust the warnings to ‘‘promote greater images of a woman crying, a small effects of smoking’’ or be discordant public understanding of the risks child, and the man wearing a T-shirt from the text statements with which associated with the use of tobacco emblazoned with the words ’I QUIT’ do they are paired. Id. FDA used different products’’ (sections 201 and 202 of the not offer any information about the development and research processes to Tobacco Control Act). In reviewing and health effects of smoking.’’). As select and study the images in this rule upholding the Tobacco Control Act’s discussed below, FDA’s science-based, than it did for the 2010–2011 new warning requirements, the Sixth iterative research process to develop rulemaking. As discussed above, two of Circuit concluded that ‘‘[t]here can be and select the current proposed cigarette FDA’s criteria for images require them no doubt that the government has a health warnings thoroughly addresses to be factually accurate and to be significant interest in . . . warning the any such criticisms. concordant with the textual warning general public about the harms To ensure that all proposed warnings statements on the same health associated with the use of tobacco are unambiguous, are unlikely to be condition. FDA sought repeated products.’’ Disc. Tobacco City & Lottery, misinterpreted or misunderstood by consumer feedback to ensure that its Inc. v. U.S., 674 F.3d 509, 519 (6th Cir. consumers, and do convey warning proposed images meet these criteria, 2012). information, FDA repeatedly tested including 53 indepth individual FDA’s research and review of the potential text statements, potential interviews with adolescents and adults, scientific literature has confirmed that images, and potential pairings of and later on, 20 qualitative focus groups many smokers and nonsmokers hold statements with images. To assess the 9 with adolescent smokers, adolescents at misperceptions about the health risks statements set out in the TCA and the risk for starting smoking, and adult associated with cigarette smoking, even 17 potential revised statements that smokers. Based on feedback received in among the health conditions most were under consideration at the start of these focus groups, FDA further refined commonly focused on in health its consumer research, FDA conducted some images for additional clarity and warnings and public health education 16 qualitative focus groups with identified and eliminated images that campaigns. And studies have shown adolescent smokers, adolescents at risk were not well understood or where that consumers are largely unaware of for starting smoking, and adult smokers. potential confusion could not be many of the negative health As discussed in section VI.B above resolved through additional revisions. consequences of cigarette smoking not (‘‘Developing Revised Textual Warning See details in section VI.D above mentioned in the current 1984 warnings Statements’’), these focus groups (‘‘Developing and Testing Images (see section V.A.3 above, ‘‘There provided qualitative feedback on Depicting the Negative Health Remain Significant Gaps in Public consumers’ comprehension of each Consequences of Smoking to Understanding About the Negative potential statement; the believability of Accompany the Textual Warning Health Consequences of Cigarette each statement’s content (e.g., that Statements’’). The Agency took careful Smoking’’). Accordingly, the proposed smoking causes the health condition and deliberate steps to develop and test rule is justified by the Government’s noted); whether the relationship images that are unambiguous and substantial interest in informing between smoking and the relevant unlikely to be misinterpreted or consumers regarding the negative health health conditions was new information misunderstood by consumers. consequences of smoking. for them; and other feedback to make Presenting the health condition in an Furthermore, the proposed warnings the statement more understandable or objective format devoid of non-essential do not unduly burden protected speech. convey the intended message more elements ensures that the focus of the As the Sixth Circuit held, the Tobacco clearly. image remains on the smoking-related Control Act’s warning requirement for This qualitative consumer focus group health condition. The process FDA cigarettes is not unduly burdensome feedback informed FDA’s selection and engaged in to develop and study the because a manufacturer has the ability refinement of the warning statements for warnings was far more extensive than to convey other information of its the next phase of research, a large (2,505 could be completed in the short choosing in the remaining space participant) quantitative consumer timeframe for the prior rule. available. Disc. Tobacco City & Lottery, research study that tested potential The proposed warnings are clearly Inc. v. U.S., at 530–31. By statute, the statements on their own, without justified by the Government’s interest in required warnings for cigarette packages images. See details in section VI.C above promoting greater public understanding must comprise the top 50 percent of the (‘‘FDA’s Consumer Research Study on of the negative health consequences of front and rear panels, and for Revised Textual Warning Statements’’) cigarette smoking. As the Supreme advertisements at least 20 percent of the and in the study results included in this Court has recognized, ‘‘tobacco products area at the top of the advertisement. The docket (Ref. 129). Obviating any are dangerous to health when used in Sixth Circuit found that ‘‘ample potential concern that the proposed new the manner prescribed.’’ FDA v. Brown evidence support[s] the size warnings would ‘‘not convey any & Williamson Tobacco Corp., 529 U.S. requirements for the new warnings’’ and warning information at all,’’ Reynolds, 120, 135 (2000). Indeed, as discussed ‘‘that the remaining portions of their 696 F.3d at 1216, FDA used the results above, cigarette smoking remains the packaging’’ are sufficient for the

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companies ‘‘to place their brand names, consequences of smoking. FDA’s consequences of cigarette smoking. We logos or other information.’’ Id. at 531, extensive qualitative and quantitative are seeking comments on these 567. See also Spirit Airlines, Inc. v. consumer research—on potential proposed provisions; if you have United States Dep’t of Transp., 687 F.3d statements, potential images, and comments on specific provisions, we 403, 414 (D.C. Cir. 2012) (requirement potential pairings of statements and request that you identify the specific for airlines to make total price the most images—amply demonstrate that the provisions in your comments. prominent cost figure does not proposed cigarette health warnings do A. General Provisions (Proposed significantly burden airlines’ ability to in fact promote better understanding by Subpart A) advertise). The scientific literature the public of the negative health effects strongly supports that larger warnings, of smoking. All 13 of the proposed 1. Scope (Proposed § 1141.1) such as those of the size proposed in cigarette health warnings statistically As directed by section 4 of the this rule, are necessary to ensure that significantly outperformed the control FCLAA, proposed § 1141.1(a) would consumers notice, attend to, and read condition (i.e., the current 1984 Surgeon explain that proposed part 1141 sets the messages conveyed by the warnings, General’s warnings) on the dimensions forth the requirements for the display of which leads to improved understanding of ‘‘new information’’ and ‘‘self-reported required warnings on packages and in of the specific health consequences that learning.’’ See discussion above in advertisements cigarettes (proposed are the subject of those warnings (Refs. sections VI.B (‘‘Developing Revised § 1141.3 includes a definition of 3 and 4). See discussions above in, e.g., Textual Warning Statements’’) through cigarette). These requirements would be section V.A (‘‘The Current 1984 Surgeon VI.E (‘‘FDA’s Consumer Research Study applicable to manufacturers, General’s Warnings Are Inadequate’’); on New Cigarette Health Warnings’’), distributors, and retailers except as section V.B.2.a (‘‘Pictorial cigarette and the consumer research study described in this proposed section. warnings increase knowledge and reports, which we have included in the Retailers who are also manufacturers accurate health beliefs by addressing docket (Refs. 129 and 153). The would be subject to both the gaps in public understanding about the warnings selected for this proposal will requirements for retailers and negative health consequences of advance the Government’s interest. manufacturers, as applicable. smoking’’). Accordingly, the proposed Finally, the regulation is Proposed § 1141.1(b) provides that the warnings are constitutional under appropriately tailored to achieve that requirements of this proposed part Zauderer. result. The warnings relate to the would not apply to manufacturers or Although Zauderer provides the dangers of smoking cigarettes and will distributors of cigarettes that do not appropriate framework for review, the be required on all cigarette packages and manufacture, package, or import rule also satisfies the elements of the advertisements, so there is nothing over- cigarettes for sale or distribution within test for commercial speech articulated or underinclusive in the rule’s scope. As the United States. This proposed in Central Hudson Gas & Elec. Corp. v. the Sixth Circuit held, the size of the subsection is consistent with section Pub. Serv. Comm’n. Under that test, warnings is justified by the ample data 4(a)(3) of the FCLAA. Manufacturers agencies can regulate speech where the demonstrating that larger warnings and distributors are defined in proposed regulation advances a substantial ‘‘materially affect consumers’ awareness § 1141.3. Government interest and the regulation of the health consequences of smoking,’’ In addition, retailers would not be in is no more extensive than necessary. Disc. Tobacco City & Lottery, Inc., 674 violation of the requirements of section This standard does not require the F.3d at 530, and there is sufficient 4 of the FCLAA and this proposed part Government to employ ‘‘the least remaining room for the manufacturers’ for cigarette packaging that: (1) Contains restrictive means’’ of regulation or to speech. a warning; (2) is supplied to the retailer achieve a perfect fit between means and Accordingly, the proposed rule is by a license- or permit-holding tobacco ends. Board of Trustees v. Fox, 492 U.S. constitutionally permissible under the product manufacturer or distributor; 469, 480 (1989). Instead, it is sufficient First Amendment. and (3) is not altered by the retailer in that the Government achieve a IX. Description of the Proposed Rule a way that is material to 15 U.S.C. 1333 ‘‘reasonable’’ fit by adopting regulations or proposed part 1141 (see proposed Section 4 of the FCLAA, as amended ‘‘in proportion to the interest served.’’ § 1141.1(c)). We believe most, if not all, by sections 201 and 202 of the Tobacco Id. retailers would fall under this Control Act, directs FDA to issue As discussed above, the Government’s scenario.11 This proposed subsection is regulations requiring color graphics interest in informing the public and consistent with section 4(a)(4) of the depicting the negative health correcting misperceptions about the FCLAA. However, this proposed consequences of smoking to accompany risks of cigarette smoking is undeniably subsection would require that a retailer textual warning label statements, and substantial. See Disc. Tobacco City & ensure that all cigarette packages they permits FDA to adjust the format, type Lottery, Inc., 674 F.3d at 519. The display or sell contain a warning that is size, color graphics, and text of any of proposed warnings directly and unobscured by stickers, sleeves, or other the label requirements, or establish the materially advance the Government’s materials on the packages, for example. format, type size, and text of any other interest by helping consumers Under proposed § 1141.1(d), the disclosures required under the FD&C understand the negative health advertisement requirements in proposed Act, if such a change would promote consequences associated with cigarette § 1141.10 would apply to a retailer only greater public understanding of the risks smoking. As discussed above, the if the retailer is responsible for or associated with the use of tobacco current 1984 warnings on cigarettes are directs the warnings for advertising. products. This proposed rule would virtually invisible and ineffective (see Importantly, this provision would not replace part 1141 in Title 21 of the Code section V.A above, ‘‘The Current 1984 relieve a retailer of liability if the of Federal Regulations to implement Surgeon General’s Warnings Are retailer displays in a location open to these FCLAA requirements. As Inadequate’’). FDA has developed new the public an advertisement that does warnings with new information, in the described in detail in sections VI–VII, form of text paired with concordant the proposed required warnings are 11 We note that manufacturers who are also images, to promote greater public intended to promote greater public retailers would be subject to the proposed understanding of the negative health understanding of the negative health requirements as manufacturers.

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not contain a warning or that contains rule would use ‘‘packaging’’ intended for sale or distribution to a warning that has been altered by the interchangeably with package. consumers in the United States. retailer in a way that is material to • Person. As defined in section 3(5) of • Retailer. FDA proposes to define section 4 of the FCLAA or the the FCLAA, ‘‘person’’ means an ‘‘retailer’’ as any person who sells requirements of this proposed part. individual, partnership, corporation, or cigarettes to individuals for personal Retailers would be in violation of the any other business or legal entity. consumption, or who operates a facility FCLAA and this proposed part if they • United States. As defined in section where vending machines or self-service alter cigarette packaging or advertising 3(3) of the FCLAA, ‘‘United States,’’ displays of cigarettes are permitted. This in a way that is material to the when used in a geographical sense, definition would include any person requirements of section 4 of the FCLAA includes the several States, the District who sells cigarettes online (e.g., through or proposed part 1141, for example, by of Columbia, the Commonwealth of a website or mobile phone application). obscuring or covering up the warning Puerto Rico, Guam, the Virgin Islands, The proposed definitions of (e.g., blocking with a sticker or marker), American Samoa, Wake Island, Midway manufacturer and retailer are similar to shrinking the warning, or using a sleeve Islands, Kingman Reef, and Johnston those used in part 1140 (which to cover the warning. Retailers also Island. The term ‘‘State’’ includes any establishes sale and distribution would be liable if they display, in a political division of any State. restrictions for cigarettes, as well as location open to the public, an In addition, FDA proposes the other tobacco products), but with some following definitions: edits to reflect that the scope of this advertisement that does not contain a • warning (proposed § 1141.1(d)). Distributor. FDA proposes to define proposed part is cigarette packaging and ‘‘distributor’’ as any person who advertisements. 2. Definitions (Proposed § 1141.3) furthers the distribution of cigarettes, whether domestic or imported, at any 3. Incorporation by Reference (Proposed Proposed § 1141.3 provides the § 1141.5) definitions for the terms used in the point from the original place of proposed rule. Proposed § 1141.3 sets manufacture to the person who sells or Proposed § 1141.5 would identify the forth the meaning of terms as they apply distributes the product to individuals material that FDA proposes to to proposed subparts A and B of part for personal consumption. Common incorporate by reference in this 1141. Proposed § 1141.3 includes the carriers are not considered distributors proposed part, entitled ‘‘Required following definitions from the FCLAA for the purposes of this proposed part. Cigarette Health Warnings.’’ This (15 U.S.C. 1332): This proposed definition of section states that FDA is proposing to • Cigarette. As defined in section 3(1) distributor would be consistent with the incorporate by reference each required of the FCLAA, the term ‘‘cigarette’’ definition of distributor in section warning, consisting of a textual warning means: (1) Any roll of tobacco wrapped 900(7) (21 U.S.C. 387(7)) of the FD&C label statement and its accompanying in paper or in any substance not Act. FDA believes using this definition color graphic. Any final rule would containing tobacco and (2) any roll of would help ensure consistent provide information on how to obtain tobacco wrapped in any substance understanding of the scope of the electronic, layered design files for containing tobacco which, because of its distributor across tobacco product each required warning, as well as appearance, the type of tobacco used in regulations issued by FDA. For example, technical specifications to help the filler, or its packaging and labeling, § 1140.3 (21 CFR 1140.3) uses a manufacturers appropriately select, is likely to be offered to, or purchased definition of distributor that is the same crop, and scale the warnings to ensure by, consumers as a cigarette described as this proposed definition except that the required warnings are accurately in paragraph (1) of this definition. § 1140.3 uses ‘‘tobacco product’’ instead reproduced during implementation • Commerce. As defined in section of ‘‘cigarette.’’ across various sizes of cigarette 3(2) of the FCLAA, ‘‘commerce’’ • Front panel and rear panel. FDA packaging and cigarette advertisements. means— proposes to define ‘‘front panel’’ and This material would be available for Æ Commerce between any State, the ‘‘rear panel’’ to mean the two largest download either through FDA’s website District of Columbia, the sides or surfaces of the package. or a file transfer protocol website. For Commonwealth of Puerto Rico, Guam, FDA is proposing to include a ease of review for this proposed rule, we the Virgin Islands, American Samoa, definition of front and rear panels have included an electronic PDF file, Wake Island, Midway Islands, Kingman because section 4 of the FCLAA, in containing the proposed required Reef, or Johnston Island and any place setting out the placement requirements warnings, as a reference in the docket outside thereof; for the label statements, provides that for this proposed rule (Ref. 18). Æ Commerce between points in any each label statement shall comprise the As described in section II.C, FDA State, the District of Columbia, the top 50 percent of the front and rear intends to provide the required Commonwealth of Puerto Rico, Guam, panels of the package. This proposed warnings selected for the final rule as the Virgin Islands, American Samoa, definition would help ensure that all electronic, layered design files and Wake Island, Midway Islands, Kingman persons responsible for complying with incorporate those by reference. The Reef, or Johnston Island, but through the FCLAA and this proposed part material incorporated by reference must any place outside thereof; or identify the sides or surfaces of the meet the OFR’s requirements for Æ Commerce wholly within the cigarette package on which the required incorporating material by reference, and District of Columbia, Guam, the Virgin warnings must appear. On almost all thus the way this material is displayed Islands, American Samoa, Wake Island, cigarette packages, these two panels are may be changed for the final rule to Midway Island, Kingman Reef, or oriented directly opposite from one meet such requirements. Johnston Island. another and are the same size. Proposed § 1141.5(a) would identify • Package or packaging. As defined • Manufacturer. FDA proposes to the material that FDA proposes to in section 3(4) of the FCLAA, ‘‘package’’ define ‘‘manufacturer’’ as any person, incorporate by reference, ‘‘Required means a pack, box, carton, or container including any repacker or relabeler, who Cigarette Health Warnings,’’ and how to of any kind in which cigarettes are manufactures, fabricates, assembles, obtain the material from FDA. This offered for sale, sold, or otherwise processes, or labels a finished cigarette material would include the electronic, distributed to consumers. The proposed product; or imports any cigarette that is layered design files for each required

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warning in a range of sizes and aspect identified concordant color graphics person to manufacture, package, sell, ratios, including the textual statements proposed to accompany each textual offer to sell, distribute, or import for sale in English and Spanish, font files, color warning label statement. FDA invites or distribution within the United States spaces, the accompanying color comment on the proposed textual any cigarette unless the package of graphics, and the white and black warning statements and accompanying which bears a required warning (as warning backgrounds and borders. color graphics. Given the degree of described in proposed § 1141.10(a)) in These layered design files would be public and stakeholder interest in this accordance with section 4 of the FCLAA accompanied by technical specifications area, and the legal complexities and this proposed part. This provision describing how to use the layered involved, FDA also seeks proposals for would apply to any package, including design files to help manufacturers alternative text and images you believe a pack, box, carton, or container, all of appropriately select, crop, and scale the would advance the Government’s which are included in the definition of warnings to ensure the required interest in promoting greater public package in section 3(4) of the FCLAA. warnings are accurately reproduced understanding of the negative health Thus, in the instance of a carton that during implementation of the required consequences of smoking. If proposing contains packs of cigarettes, the carton warnings on cigarette packages and in alternative text and images to those in and each pack would be required to bear cigarette advertisements. Manufacturers, this proposed rule, please provide a required warning. This proposed distributors, and, when applicable, scientific information that supports that requirement helps to promote public retailers would obtain the required the alternative text and images would, understanding of the negative health warnings by downloading the files in fact, promote greater public consequences of cigarette smoking by directly from FDA’s website or via a file understanding of the negative health ensuring that all cigarette packages bear transfer protocol website and accurately consequences of smoking. Proposals for the required warning. reproduce them on cigarette packages alternative images should accompany In addition, proposed § 1141.10(c)(1) and in advertisements as required by either one of FDA’s proposed textual would require that the warning appear section 4 of the FCLAA and proposed warning statements or an alternative directly on the package and be clearly part 1141. textual warning statement you are visible underneath any cellophane or This proposed section would also proposing. These comments and other clear wrapping. This proposed explain that the material is incorporated information will help inform the requirement is intended to ensure that by reference with the approval of the required warnings to be included in a the warning is not obscured in any way, Director of the Federal Register and final rule. e.g., any outer wrapping and tear tape where interested parties may obtain a Section 4(d) of the FCLAA directs that would be required to be clear and copy of the material (1 CFR part 51). the required warnings be clear, otherwise not interfere with the Specifically, if the proposed conspicuous, and legible. Accordingly, required warning’s visibility. For incorporation by reference is approved proposed § 1141.10(b) and (c) are packages that are soft-sided (i.e., ‘‘soft by the OFR and incorporated in the final intended to address those FCLAA pack’’ style packaging), the overwrap rule, interested parties would be able to requirements. Proposed § 1141.10(b) closure must not obscure the warning, examine the incorporated material at would require that manufacturers and and, for hinged lid packages, this would that National Archives and Records distributors (and retailers in the specific mean that no word of the textual Administration and at FDA’s Dockets circumstances described in proposed warning statement may be severed when Management Staff. § 1141.1(c)) obtain and accurately the package is opened. Proposed § 1141.5(b) would list the reproduce the required warning (which Proposed § 1141.10(c)(2) would source where interested parties may would comprise the combination of the implement the requirements in section obtain a copy of the incorporated textual warning label statement and its 4 of the FCLAA that the required material, i.e., by contacting FDA’s accompanying color graphic), from the warning comprise at least the top 50 Center for Tobacco Products at the electronic files contained in the material percent of the front and rear panels of address listed. to be incorporated by reference at the package. For cartons (which are proposed § 1141.5. These entities would included in the definition of package), B. Required Warnings for Cigarette be responsible for ensuring that the proposed § 1141.10(c)(2) would specify Packages and Advertisements (Proposed required warnings are not distorted, that the required warning be located on § 1141.10) obscured, or otherwise inaccurately the left side of the front and rear panels To promote greater public reproduced from the incorporated of the carton and comprise at least the understanding of the negative health material when reproduced for use in left 50 percent of these panels. This consequences of cigarette smoking, differing types of media (e.g., print, proposed requirement is intended to proposed § 1141.10 would establish digital). For example, the required ensure that when cigarettes are sold in required warnings for cigarette packages warnings would need to be accurately cartons and not as individual packs, the and advertising. The proposed reproduced, including maintaining text required warnings are clearly visible, requirements comply with section 4 of specifications such as font face and size; conspicuous, and legible to consumers the FCLAA and include a textual using capital letters for the word as required by the FCLAA. As described warning label statement (proposed ‘‘WARNING’’ in each statement; and earlier in this section, the required § 1141.10(a)(1)) with an accompanying maintaining the relationship of text to warning would need to be on the carton color graphic (proposed § 1141.10(a)(2)). image for each warning. As per the and on each pack to ensure compliance Proposed § 1141.10(a) would establish requirements laid out in section 4 of the with the FCLAA and this proposed part. that a required warning must contain FCLAA, the text of the cigarette health Proposed § 1141.10(c)(3) would both one of the textual warning label warnings on packages must be black on specify that the required warning be statements and a color graphic to a white background, or white on a black positioned such that the text of the accompany the textual warning label background, in a manner that contrasts, required warning and other information statement. The textual warning label by typography, layout, or color, with all on that panel of the package have the statements that would be required will other printed material on the package. same orientation. For example, if the be set out in any final rule. As FDA has Proposed § 1141.10(c) would establish front panel of a cigarette package described in section VI.D, we have generally that it is unlawful for any contains information, such as the brand

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name of the cigarette, in a left to right part of the required warning would fall appear in the same language as that orientation, the required warning could in the ‘‘trim area’’ (i.e., the area of an principally used in the advertisement. not be placed such that it appears at a advertisement that is cut off as part of The purpose of the proposed right angle to this text. Rather, the the print publishing process). To meet requirement and the two proposed required warning, including the textual the proposed requirement, the required exceptions in § 1141.10(d)(3) is to help warning label statement, must also warning would need to be in the promote public understanding of the appear in a left to right orientation. This advertisement’s ‘‘safe area’’ (i.e., not in negative health consequences of would help ensure that the required the trim area) and not be placed in any cigarette smoking by ensuring that the warnings on cigarette packages would area of an advertisement that may be textual warning label statement be conspicuous and legible to cropped or folded during final component of the required warning is in consumers, as required by section 4 of publishing. For advertisements in the language that is most likely to be the FCLAA and this proposed part. digital media, proposed § 1141.10(d)(2) understood by the majority of the public Cigarette advertisements are would mean that a required warning who would view the advertisement. addressed in proposed § 1141.10(d). must be appropriately scaled in its Proposed § 1141.10(d)(4) would state This section would establish coding for both standard desktop and that for English-language or Spanish- requirements related to cigarette mobile sizes to ensure that the full language warnings, each required advertising, including that it is unlawful required warning is visible on the warning must be obtained from the for any manufacturer, distributor, or screen in its entirety (i.e., a user does electronic files contained in ‘‘Required retailer of cigarettes to advertise or not need to scroll in any direction to see Cigarette Health Warnings,’’ which cause to be advertised within the United any areas of the warning), is located at would be incorporated by reference (see States any cigarette unless each the top of the screen, and is displayed proposed § 1141.5). The required advertisement bears a required warning at each point of access to such warnings would need to be accurately in accordance with section 4 of the advertisements. These proposed reproduced as specified in ‘‘Required FCLAA and this proposed part. As per requirements are consistent with the Cigarette Health Warnings,’’ to help the requirements laid out in section 4 of language of section 4(b) of the FCLAA, ensure that the required warnings are the FCLAA, the text of the cigarette which mandates that the required not distorted or obscured, and are health warnings in advertisements must warning comprise at least 20 percent of prominent and legible, consistent with be black if the background is white and the area of the advertisement and the requirements of the FCLAA and this white if the background is black. specifies that the advertisement appear proposed part. More specifically, for print in a conspicuous and prominent format Proposed § 1141.10(d)(5) would advertisements and other and location at the top of the require that non-English-language warnings, other than Spanish-language advertisements with a visual advertisement. We recognize that there warnings, be adapted using the English- component, the required warning must is a wide variation in advertisement size language required warnings obtained appear directly on the advertisement and media, and we are requesting from the electronic files contained in (proposed § 1141.10(d)(1)). comments and information on how ‘‘Required Cigarette Health Warnings,’’ Advertisements that would be subject to advertisements in different types of which would be incorporated by this proposed rule may appear in or on, media might comply with these reference at proposed § 1141.5. As with for example, promotional materials proposed requirements, including the proposed requirement in (point-of-sale or non-point-of-sale), comments on issues related to small- § 1141.10(d)(4), the required warnings billboards, posters, placards, published size advertisements, advertisements in journals, newspapers, magazines, other would be required to be accurately digital media, and non-visual reproduced as specified in ‘‘Required periodicals, catalogues, leaflets, advertisements. brochures, direct mail, shelf-talkers, Cigarette Health Warnings,’’ but for Proposed § 1141.10(d)(3) would display racks, internet web pages, these warnings this would also include require that the text of the required electronic mail correspondence, and the substitution and insertion of a true warning be in English, with the two also may include those communicated and accurate translation of the textual exceptions established in section 3(b) of via mobile telephone, smartphone, warning label statement in place of the the FCLAA. First, the text of the microblog, social media website, or English-language version. The proposed required warning should not be in other communication tool; 12 websites, rule would require that the inserted English when the advertisement appears applications, or other programs that textual warning label statement comply in a non-English medium. In that case, allow for the sharing of audio, video, or with all requirements of section 4 of the the text of the required warning would photography files; video and audio FCLAA and this proposed part. The be required to appear in the promotions; and items not subject to the manufacturer, distributor, or retailer predominant language of the medium sale or distribution ban in § 1140.34. would be required to accurately and regardless of whether the advertisement Proposed § 1141.10(d)(1) includes some appropriately translate the textual is in English (the predominant language of these examples for reference but warning label statement into the is the primary language used in the non- neither the examples in § 1141.10 (d) appropriate non-English language or the sponsored content in the publication). nor this discussion are intended to be advertisement would be in violation of For example, if the predominant the FCLAA and this proposed part. The exhaustive. language of the medium is French, but Proposed § 1141.10(d)(2) would translated required warning would also the advertisement is in English, the text require that the warning comprise at need to meet the area, format, and other of the required warning would be least 20 percent of the area of the requirements of the FCLAA and this required to be in French. Second, the advertisement in a conspicuous and proposed part. text of the required warning would not Proposed § 1141.10(e) would require prominent format and location at the need to appear in English when the that the required warnings be indelibly top of each advertisement, and that no advertisement appears in an English printed on or permanently affixed to the package or advertisement. These 12 FCLAA prohibits any advertising of cigarettes language medium but the advertisement on radio, television, or other media regulated by the is not in English; in this case, the text required warnings, for example, must Federal Communications Commission. of the required warning would need to not be printed or placed on a label

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affixed to a clear outer wrapper that is addition, proposed § 1141.10(g)(2) should be submitted to FDA and likely to be removed to access the would establish quarterly rotation approved before making changes to the product within the package. This requirements for the required warnings random and equal display or provision is intended to ensure that the in advertisements. Under this proposed distribution of required warning required warnings cannot be easily requirement, the required warnings for statements on packages or the quarterly ripped off, obscured, or otherwise advertisements must be rotated rotation of required warning statements tampered with, which would quarterly in alternating sequence in in advertisements. For a new brand, a undermine the proposed requirement. advertisements for each brand of new plan or a supplement to an For an advertisement in digital media to cigarettes in accordance with a plan approved plan would be required to be meet this proposed requirement, the approved by FDA. The manufacturer, submitted and approved before required warning must remain on the distributor, or retailer would be required displaying or distributing packages and advertisement at all times and be clear, to submit the plan for quarterly rotation advertisements for that new brand. conspicuous, and legible as required in of the required warnings in However, in lieu of a supplement to section 4 of the FCLAA and this advertisements to FDA for approval. an approved plan for a new brand, proposed part. Thus, for example, it For efficiency of review, each plan manufacturers may reference in their would not be enough to display the submitted under proposed initial plan all brands in their product required warning only for a period of § 1141.10(g)(1) and (2) should cover listing(s) under section 905(i) of the time in an advertisement in digital both packaging and advertising, rather FD&C Act and incorporate any new media. We invite comments and than submitting each plan separately, to brands into their approved plan, so long information on how advertisements in the extent applicable. The tobacco as no other changes are made to the digital media might appropriately product manufacturer, distributor, or plan. For retailer-generated advertising, satisfy this proposed requirement. retailer should describe how their plan retailers may list ‘‘all brands’’ in their Proposed § 1141.10(f) would provide would achieve the random and equal plan, which would cover future brands, that no person may manufacture, display and distribution of the required so long as the plan provides for the package, sell, offer for sale, distribute, or warnings on packages and the quarterly same schedule for quarterly rotation of import for sale or distribution within rotation of the required warnings in the required warning statements for all the United States cigarettes whose advertisements. brands. packages or advertisements are not in Under proposed § 1141.10(g)(1), for Proposed § 1141.10(g)(3) would compliance with section 4 of the each brand of cigarettes, the plan for explain that FDA would review each FCLAA and this proposed part, except packaging would explain how each of plan submitted. FDA’s review of a plan as provided by proposed §§ 1141.1(c) the required warnings would be would only be for the purpose of and 1141.1(d). randomly displayed during each 12- determining compliance with the Proposed § 1141.10(g) would establish month period on each brand; how each regulatory criteria for approval of a plan, marketing requirements applicable to of the warnings would be displayed in as set forth in proposed § 1141.10(g)(1) cigarettes. The marketing requirements as equal a number of times as possible and (2). FDA requests that each plan would include the random and equal on each brand of the product; and how include representative samples of display and distribution of the required product packages would be randomly packages and advertisements with each warnings for cigarette packages and and equally distributed in all areas of of the required warnings. Such samples quarterly rotation of the required the United States in which the product would place the plan in context and, warnings in advertisements. The is marketed. FDA expects that a plan for therefore, facilitate FDA’s review of the marketing requirements would also the random and equal display and plan, not a review of the content of the require submission of a plan that distribution of required warnings on package labels and advertisements. provides for the random and equal packages would ordinarily be based on During the course of a review of a plan, display and distribution of the required the date of manufacture or shipment of FDA may request an amendment to a warnings on cigarette packaging and the the product. plan under review if FDA needs quarterly rotation of the required For each cigarette brand, the plan for clarification of information in the plan warnings in cigarette advertising, as advertising would be required to or other additional information to described under section 4 of FCLAA explain how the required warnings determine whether FDA could approve and part 1141 (referred to as ‘‘plan’’). would be rotated quarterly in the plan. These proposed requirements would advertisements and how the quarterly As described in proposed ensure that all of the required warnings rotations would occur in alternating § 1141.10(g)(3), FDA intends to approve would be displayed by the tobacco sequence (proposed § 1141.10(g)(2)). the plan if it would: (1) Provide for the product manufacturer, distributor, or Among other things, the plan should random and equal distribution and retailer at the same time. specify the initial rotation timeframe on display of the required warnings on As described in more detail in the which quarterly rotation is based and, if packaging and the quarterly rotation of following paragraphs, under proposed the rotation timeframe varies for the required warnings in advertising, as § 1141.10(g)(1), each required warning different types/forms of advertising, set out in proposed § 1141.10(g)(1) and would be required to be randomly specify the different quarterly (2) and (2) assure that all required displayed in each 12-month period, in timeframes associated with the different warnings would be displayed by the as equal a number of times as is possible types/forms of advertising, and describe manufacturer, distributor, or retailer at on each brand of the product and the the quarterly schedule for rotating each the same time. Approval of a plan packages randomly and equally of the required warnings for each would not represent a determination by distributed in all areas of the United cigarette brand. FDA would not FDA that any specific package or States in which the cigarette is consider a plan that merely restated the advertisement complies with any of the marketed. A manufacturer, distributor, regulatory requirements to be other requirements of the FCLAA and or retailer would be required to submit sufficiently detailed to enable FDA to proposed part 1141, including those a plan for random and equal display and approve the plan. regarding the placement, font type, size, distribution of the required warnings for After FDA approval of an initial plan, and color of the warnings, or any other packaging to FDA for approval. In a supplement to the approved plan requirements under the FD&C Act and

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its implementing regulations. FDA contract manufacturers, have not been misbranded under section 903(a)(8) of intends to communicate the approval of aware of the FDA-approved plan that the FD&C Act unless the manufacturer, a plan by issuing a letter to the they should be following. Requiring that packer, or distributor includes in all submitter. After FDA approval of a plan, the FDA-approved plan is retained for 4 advertisements and other descriptive if a manufacturer, distributor, or retailer years from the date it was last in effect printed matter issued or caused to be intends to make changes to the would help ensure that FDA has the issued by the manufacturer, packer, or approved plan, they should first submit opportunity to confirm during the distributor with respect to the cigarette a supplement to FDA for review and course of an inspection that firms are one of the required warnings in approval. To provide FDA sufficient aware of and following an approved accordance with section 4 of the FCLAA time to review a supplement to an plan. and this proposed part. Section approved plan, FDA strongly As discussed in section X, FDA 201(a)(1) of the FD&C Act (21 U.S.C. recommends allowing up to 6 months intends to establish an effective date for 321(a)(1)) defines ‘‘State’’ as ‘‘any State for FDA to review and approve a the submission of plans to FDA, by each or Territory of the United States, the supplement. The amount of time it person subject to proposed § 1141.10(g). District of Columbia, and the would take FDA to review a This would require submission of plans Commonwealth of Puerto Rico.’’ The supplement, however, would depend no later than 5 months from the date of warnings required by section 4 of the upon the volume and quality of the publication of any final rule. Although FCLAA for cigarette advertising and submissions. FDA believes this timeframe would packages are ‘‘relevant warnings’’ with Plans, and any amendments or provide sufficient time for the plan to be respect to cigarettes as that phrase is supplements, should be submitted to submitted to FDA and reviewed by FDA used in section 903 of the FD&C Act. FDA’s Center for Tobacco Products, in advance of the effective date for the For the purpose of this proposed Office of Compliance and Enforcement. required warnings on packages and provision, ‘‘other descriptive printed FDA intends to allow electronic advertisements (which, consistent with matter’’ would include the packages of submissions, via FDA’s Electronic section 4 of the FCLAA, would be 15 cigarettes and would be required to bear Submissions Gateway (https:// months from the publication date of any one of the required warnings. www.fda.gov/ForIndustry/Electronic final rule), we encourage the submission SubmissionsGateway/default.htm), and of these plans as soon as possible once X. Proposed Effective Dates written submissions, directed to: Food the final rule is published. FDA is proposing that the required and Drug Administration, Center for We invite comment on these proposed warnings for packages and Tobacco Products, Office of Compliance requirements, including whether and advertisements (proposed § 1141.10) and Enforcement, Document Control how the number of final required would become effective 15 months after Center, Bldg. 71, Rm. G335, 10903 New warnings selected would affect the the date the final rule publishes in the Hampshire Ave., Silver Spring, MD random and equal display and Federal Register. This proposed 20993–0002. FDA strongly encourages distribution of the required warnings on effective date is consistent with the electronic submission to facilitate packages and the quarterly rotation of language of section 201(b) of the efficiency and timeliness of submission the required warnings in Tobacco Control Act, which and processing. advertisements. contemplates that the amendments to Proposed § 1141.10(g)(4) would the FCLAA established by the Tobacco C. Misbranding of Cigarettes (Proposed establish that each manufacturer Control Act would take effect 15 months § 1141.12) required to randomly and equally after the issuance of the regulations set display and distribute warnings on Proposed § 1141.12(a) sets out that a out in 201(a) of the Tobacco Control packaging or quarterly rotate the cigarette package would be deemed Act. FDA is also proposing an effective required warnings in advertisements in misbranded under section 903(a)(1) of date for submission of plans under the accordance with an FDA-approved plan the FD&C Act if its package and labeling FCLAA and this proposed part under section 4 of the FCLAA and this do not bear one of the required warnings (§ 1141.10(g)) of no later than 5 months proposed part must maintain a copy of in accordance with section 4 of the after the final rule publishes in the the FDA-approved plan and make it FCLAA and this proposed part. In Federal Register. This would help available for inspection and copying by addition, proposed § 1141.12(a) would ensure that FDA has time to review the officers or employees of FDA. The FDA- provide that a cigarette would be plan in advance of the effective date approved plan must be retained while deemed misbranded under section requiring that packaging and advertising in effect and for a period of not less than 903(a)(7)(A) of the FD&C Act if its of cigarettes bear the required warnings. 4 years from the date it was last in advertising does not bear one of the Thus, cigarette packages that do not effect. FDA has selected 4 years as a required warnings in accordance with comply with the requirements of any means to help ensure that the FDA- section 4 of the FCLAA and this final rule must not be manufactured for approved plan would be available for at proposed part. sale or distribution in the United States least one biennial FDA inspection under Proposed § 1141.12(b) would explain as of the effective date (i.e., 15 months sections 704 and 905(g) of the FD&C that a cigarette advertisement and other after the date the final rule publishes in Act. Retaining the FDA-approved plan descriptive printed matter issued or the Federal Register). Section 201(b) of for 4 years from the date it was last in caused to be issued by the the Tobacco Control Act provides that, effect would allow FDA to evaluate, for manufacturer, packer, or distributer, beginning 30 days after the effective example, whether the warnings are would be deemed to include a brief date, a manufacturer must not introduce randomly and equally displayed on statement of relevant warnings for the into the domestic commerce of the product packaging during the time purposes of section 903(a)(8) of the United States any product, irrespective period in which such products are FD&C Act, if it bears one of the required of the date of manufacture, that is not offered for sale to consumers. In warnings in accordance with section 4 in conformance with section 4 of the addition, based on FDA’s experience of the FCLAA and this proposed part. FCLAA, as amended by the Tobacco with smokeless plans, FDA has However, FDA is proposing that a Control Act. As provided by section observed at times in conducting cigarette distributed or offered for sale 201(b), after the 30-day period, inspections that firms, including in any State would be deemed manufacturers would not be permitted

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to introduce into domestic commerce remaining cigarette health warnings that added for any of the scenarios described any cigarette packages that do not pair a textual warning statement with an in this section. contain the required warnings, image. The remaining pairings and the FDA further requests public comment, irrespective of the date of manufacture. textual warning statements without in the event a court were to invalidate While this statutory limitation applies images would still be required to be all of the images within the cigarette to only manufacturers, FDA believes randomly and equally displayed and health warnings or were to vacate this that keeping products without the distributed on packages and quarterly rule once finalized, as to whether and required warnings under any final rule rotated in advertisements. This how FDA should implement textual on the market for an extended period approach would advance the warning statements without images as would not be in the interest of public Government’s interest in promoting an interim measure. Additionally, FDA health. We request comments regarding greater public understanding of the requests comment on whether, in the ways to differentiate cigarette packages negative health consequences of event that a court were also to invalidate sold from existing inventory from those smoking. the size or location of revised cigarette that were manufactured after the In the event that a court were to warnings as directed by Congress (i.e., effective date. invalidate all of the images within the for packages, at least the top 50 percent In addition, as of 15 months from the cigarette health warnings, FDA intends of the front and rear panels of the publication of any final rule mandating for all the warnings to go into effect packages), it should require that such that cigarette packages and with only their textual warning interim textual warning statements advertisements bear the required statements, without the invalidated comprise, for example, at least the top warnings, no tobacco product images. These too would be randomly 30 percent of the front and rear panels manufacturer, distributor, or retailer of and equally displayed and distributed of the packages, consistent with cigarettes may advertise or cause to be on packages and quarterly rotated in warnings for other categories of tobacco advertised within the United States any advertisements as required. FDA products that are comprised of textual cigarette product unless the advertising believes this approach could serve as an statements only, while FDA sought to complies with the final rule. interim measure to address Congress’s develop new pictorial warnings. XI. Severability and Other intent to replace the stale Surgeon XII. Preliminary Economic Analysis of Considerations General’s warnings and to promote Impacts In accordance with section 5 of the greater public understanding of the We have examined the impacts of the Tobacco Control Act, the various negative health consequences of proposed rule under Executive Order requirements established by this smoking while FDA worked to develop (E.O.) 12866, E.O. 13563, E.O. 13771, proposed rule, when finalized, would be new pictorial warnings. the Regulatory Flexibility Act (5 U.S.C. considered severable and the individual If a court were to invalidate some of 601–612), and the Unfunded Mandates provisions of this rule would be FDA’s revised textual warnings with Reform Act of 1995 (Pub. L. 104–4). considered workable on their own. their paired images but some remained Executive Orders 12866 and 13563 Section 5 of the Tobacco Control Act valid, FDA intends that the remaining direct us to assess all costs and benefits states that, if any provision of a revised textual warning statements and of available regulatory alternatives and, regulation issued under the Act is held their paired images would go into effect. when regulation is necessary, to select to be invalid, the remainder of the Alternatively, FDA might also choose to regulatory approaches that maximize regulation ‘‘shall not be affected and require that the textual warning net benefits (including potential shall continue to be enforced to the statements specified in section 4(1) of economic, environmental, public health fullest extent possible.’’ (Section 5 of the the FCLAA go into effect without an and safety, and other advantages; Tobacco Control Act is codified at 21 accompanying image. In determining distributive impacts; and equity). E.O. U.S.C. 387 note.) Consistent with that the appropriate approach, relevant 13771 requires that the costs associated directive, it is FDA’s intent that the circumstances could include whether with significant new regulations ‘‘shall, invalidity of any provision of the final there were a sufficient number of to the extent permitted by law, be offset rule shall not affect the validity of any warnings to be randomly and equally by the elimination of existing costs other part of the rule. In the event any displayed and distributed on packages associated with at least two prior court or other lawful authority were to and quarterly rotated in advertisements regulations.’’ We believe that this temporarily or permanently invalidate, as required by statute. As described proposed rule is an economically restrain, enjoin, or suspend any above, FDA proposes implementing significant regulatory action as defined provision of the final rule, FDA intends text-only cigarette health warnings as an by E.O. 12866. for the remaining parts to continue to be interim measure as a means to address The Regulatory Flexibility Act valid. Congress’s intent to replace the stale requires us to analyze regulatory options Each provision of the proposed rule is Surgeon General’s warnings and to that would minimize any significant independently supported by data and promote greater understanding of the impact of a rule on small entities. We analysis as described or referenced in negative health consequences of estimate that for a small manufacturer or this preamble and, if issued separately, smoking while FDA worked to develop importer who would be affected by this would remain a proper exercise of FDA new pictorial warnings. proposed rule, one-time costs could authority under sections 201 and 202 of FDA invites public comment on the represent between 2.5 and 35.6 percent the Tobacco Control Act and sections application of the severability provision of their annual receipts and recurring 701, 704, 903, 905(g), and 909 of the in section 5 of the Tobacco Control Act costs could represent from 0.4 to 4.4 FD&C Act, as amended by the Tobacco to this rulemaking and how any severed percent of their annual receipts. Hence, Control Act. If a court were to invalidate portions of a final rule would operate, we find that the proposed rule will have some but not all of the images within advance the Government’s interest, and a significant economic impact on a the cigarette health warnings, the address Congress’s intent to replace the substantial number of small entities. corresponding textual warning stale 1984 Surgeon General’s warnings. The Unfunded Mandates Reform Act statements would go into effect without FDA also seeks comment on whether of 1995 (section 202(a)) requires us to the invalidated images, along with the additional codified language should be prepare a written statement, which

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includes an assessment of anticipated quarterly in alternating sequence in enforcement of the rule. Using a 20-year costs and benefits, before proposing advertisements for each brand of time horizon, we estimate that the ‘‘any rule that includes any Federal cigarettes in accordance with a plan present value of the costs of this mandate that may result in the approved by FDA. proposed rule ranges from $1.3 billion expenditure by State, local, and tribal Pictorial cigarette health warnings to $1.9 billion, with a mean estimate of governments, in the aggregate, or by the promote greater public understanding $1.6 billion, using a three percent private sector, of $100,000,000 or more about the negative health consequences discount rate, and ranges from $1.0 (adjusted annually for inflation) in any of smoking as they increase the billion to $1.5 billion, with a mean one year.’’ The current threshold after noticeability of the warning’s message, estimate of $1.2 billion, using a seven increase knowledge and learning of the adjustment for inflation is $154 million, percent discount rate (2018$). using the most current (2018) Implicit negative health consequences of Annualized costs, which are presented Price Deflator for the Gross Domestic smoking, and benefit diverse below in table 3, range from $88.6 Product. This proposed rule would populations that have disparities in result in an expenditure in any year that knowledge about the negative health million per year to $129.7 million per meets or exceeds this amount. consequences of smoking. year, with a mean estimate of $107.5 This proposed rule would require that The direct economic benefits of million per year, using a three percent one of up to 13 new cigarette health providing information on cigarette discount rate, and range from $94.6 warnings, each comprising a textual health warnings are difficult to quantify, million per year to $139.8 million per warning statement paired with an and we do not predict the size of these year, with a mean estimate of $115.3 accompanying color graphic image, benefits at this time. We discuss the million per year, using a seven percent appear on cigarette packages and in informational effects qualitatively. discount rate (2018$). cigarette advertisements. The proposed The cost of this proposed rule consists Because it is not possible to compare rule would further require that, for of initial and recurring labeling costs benefits and costs directly when the associated with changing cigarette labels cigarette packages, the required cigarette benefits are not quantified, we employ health warnings be randomly displayed to accommodate the new cigarette a break-even approach. If the in each 12-month period, in as equal a health warnings, design and operation information provided by the cigarette number of times as is possible on each costs associated with the random and brand of the product and be randomly equal display and distribution of health warning on each cigarette distributed throughout the United States required cigarette health warnings for package was valued at about $0.01 (for in accordance with a plan approved by cigarette packages and quarterly every pack sold annually nationwide), FDA. The proposed rule would also rotations of the required warnings for then the benefits that would be require that, for cigarette cigarette advertisements, advertising- generated by the proposed rule would advertisements, the required cigarette related costs, and costs associated with equal or exceed the estimated annual health warnings must be rotated government administration and costs.

TABLE 3—SUMMARY OF THE INFORMATIONAL EFFECTS AND COSTS OF THE PROPOSED RULE [in millions of 2018$]

Units Primary Low esti- High esti- Category estimate mate mate Discount Period Notes Year dollars rate covered

Informational ...... Pictorial cigarette health warnings promote greater public understanding about the negative health con- Effects. sequences of smoking as they increase the noticeability of the warning’s message, increase knowledge and learning of the negative health consequences of smoking and help reduce disparities in knowledge about the negative health consequences of smoking across diverse populations. If the information pro- vided by the cigarette health warning on each cigarette package was valued at about $0.01 (for every pack sold annually nationwide), then the benefits that would be generated by the proposed rule would equal or exceed the estimated annual costs.

Costs ...... Annualized $115.3 $94.6 $139.8 2018 7% 20 Years .... Effective date of Monetized 15 months from $millions/year. date of publica- tion of final rule. 107.5 88.6 129.7 2018 3% 20 Years.

In line with E.O. 13771, in table 4 we time horizon. Based on these costs, would be considered a regulatory action estimate present and annualized values when finalized this proposed rule under E.O. 13771. of costs and cost savings over an infinite

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TABLE 4—E.O. 13771 SUMMARY FDA invites comments on these amendments would likely increase the TABLE topics: (1) Whether the proposed overall review time. After FDA approval of an initial plan, [in millions of 2016$, over an infinite time collection of information is necessary horizon] for the proper performance of FDA’s a supplement to the approved plan functions, including whether the should be submitted to FDA and Primary information will have practical utility; approved before making changes to the Item estimate (2) the accuracy of FDA’s estimate of the random and equal display or (7%) burden of the proposed collection of distribution of required warning information, including the validity of statements on packages or the quarterly Present Value of Costs ...... $985.8 Present Value of Cost Savings .... 0 the methodology and assumptions used; rotation of required warning statements Present Value of Net Costs ...... 985.8 (3) ways to enhance the quality, utility, in advertisements. For a new brand, a Annualized Costs ...... 69.0 and clarity of the information to be new plan or a supplement to an FDA- Annualized Cost Savings ...... 0 collected; and (4) ways to minimize the approved plan would be required to be Annualized Net Costs ...... 69.0 burden of the collection of information submitted and approved before Notes: All amounts have been discounted on respondents, including through the displaying or distributing packages and relative to year 2016 from year 2021, the latter use of automated collection techniques, advertisements for that new brand. of which is the estimated year in which the when appropriate, and other forms of However, in lieu of a supplement to proposed rule would become effective once fi- information technology. an FDA-approved plan for a new brand, nalized. Because of this additional discounting Title: Required Warnings for Cigarette manufacturers may reference in their step, the present value estimates presented here are in all instances lower than the com- Packages and Advertisements initial plan all brands in their product parable present value estimates associated Description: The requirement for listing(s) under section 905(i) of the with a 20-year time horizon. Effective date is submission of plans for cigarette FD&C Act and incorporate any new 15 months from date of publication of the final packages and advertisements, and the brands into their approved plan, so long rule. specific marketing requirements relating as no other changes are made to the We have developed a comprehensive to the random and equal display and plan. For retailer-generated advertising, Preliminary Economic Analysis of distribution of required warning retailers may list ‘‘all brands’’ in their Impacts that assesses the impacts of the statements on cigarette packaging and plan, which would cover future brands, proposed rule. The full preliminary quarterly rotation of required warning so long as the plan provides for the analysis of economic impacts is statements in alternating sequence in same schedule for quarterly rotation of available in the docket for this proposed cigarette product advertising, appear in the required warning statements for all rule (Ref. 220) and at https:// proposed § 1141.10(d)(5). A record of brands. www.fda.gov/AboutFDA/Reports the FDA-approved plan must also be FDA intends to allow electronic ManualsForms/Reports/Economic established and maintained. submissions, via FDA’s Electronic Analyses/default.htm. Description of Respondents: The Submissions Gateway, and written respondents to this collection of submissions. FDA strongly encourages XIII. Analysis of Environmental Impact information are manufacturers, electronic submission to facilitate The labeling regulation is a class of distributors, and certain retailers of efficiency and timeliness of submission actions that are ordinarily categorically cigarettes who will be required to and processing. excluded under 21 CFR 25.30(k). submit plans for cigarette packages and For each brand of cigarettes, the plan Additionally, the proposed action is not advertisements to FDA. for packaging should explain how: Each anticipated to pose serious harm to the FDA intends to ask that each plan of the warnings will be randomly environment and to adversely affect a cover both packaging and advertising to displayed during each 12-month period species or the critical habitat of a the extent applicable. The tobacco on each brand; each of the warnings will species as stipulated under 21 CFR product manufacturer, distributor, or be displayed in as equal a number of 25.21(b). The proposed action is of a retailer should demonstrate how they times as possible on each brand of the type that does not individually or plan to achieve the random and equal product; and product packages will be cumulatively have a significant effect on display and distribution of the required randomly and equally distributed in all the human environment. No warning statements on packages and the areas of the United States in which the extraordinary circumstances exist that quarterly rotation in advertisements. product is marketed. FDA expects that would require a preparation of an Required warnings for cigarettes must a plan for random and equal display and environmental assessment or an be randomly and equally displayed and distribution of warnings on packages environmental impact statement. distributed on packages, and rotated will ordinarily be based on the date of quarterly in advertisements, in manufacture or shipment of the product. XIV. Paperwork Reduction Act of 1995 accordance with an FDA-approved plan. For each cigarette brand, the plan for This proposed rule contains Plans should be submitted to FDA no advertising should explain how the information collection provisions that later than 5 months after the date of required warning statements will be are subject to review by OMB under the publication of the final rule and before rotated quarterly in advertisements and Paperwork Reduction Act of 1995 (44 advertising or commercially marketing a how the quarterly rotations will occur in U.S.C. 3501–3520). A description of product that is subject to the rule. alternating sequence. Among other these provisions is given in the Packages and advertisements of things, the plan should specify the Description section immediately below, cigarettes would be required to bear the initial rotation timeframe on which with an estimate of the annual reporting required warnings beginning 15 months quarterly rotation is based and, if the and recordkeeping burden. Included in after the date of publication of the final rotation timeframe varies for different the estimate is the time for reviewing rule. FDA intends to request an types/forms of advertising, specify the instructions, searching existing data amendment to a plan under review if different quarterly timeframes sources, gathering and maintaining the FDA needs clarification of information associated with the different types/ data needed, and completing and in the plan or other additional forms of advertising, and describe the reviewing each collection of information to determine whether it quarterly schedule for rotating each of information. could approve the plan. Any such the required warnings for each cigarette

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brand. FDA would not consider a plan or advertisement complies with any of approved before displaying or that merely restated the regulatory the other requirements regarding the distributing packages and requirements to be sufficiently detailed placement, font type, size, and color of advertisements for that new brand. to enable FDA to approve the plan. the warnings found in section 4 of the However, in lieu of a supplement to an FDA’s review of a plan would only be FCLAA and proposed part 1141, or any approved plan for a new brand, for determining compliance with the other requirements under the FD&C Act manufacturers may reference in their regulatory criteria for approval of a plan, and its implementing regulations. FDA initial plan all brands in their product as set forth in proposed § 1140.10(g)(1) intends to communicate the approval of listing(s) under section 905(i) of the and (2). FDA requests that plans a plan with a letter to the submitter. FD&C Act and incorporate any new submitted for review include After FDA approval of an initial plan, a brands into their approved plan, so long representative samples of packages and supplement to the approved plan would as no other changes are made to the advertisements with each of the need to be submitted to FDA for review required warning statements. Such and approved before making changes to plan. For retailer-generated advertising, samples would place the plan in context the display or distribution of required retailers may list ‘‘all brands’’ in their and, therefore, facilitate FDA’s review of warnings on packages or the rotation of plan, which would cover future brands, the plan, not a review of the content of required warning statements in so long as the plan provides for the the package labels and advertisements. advertisements. For a new brand, a new same schedule for quarterly rotation of Approval of a plan does not represent a plan or a supplement to an approved the required warning statements for all determination by FDA that any package plan would need to be submitted and brands.

TABLE 5—ESTIMATED ONE-TIME REPORTING BURDEN 1

Number of Average Type of plan Number of responses per Total annual burden per Total hours respondents respondent responses response

Initial Plans ...... 59 1 59 150 8,850 Supplements ...... 30 1 30 75 2,250

Total ...... 11,100 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimates are based on submit a plan for packaging and on packaging or quarterly rotate FDA’s experience with information advertising for a total of 8,850 hours. We warnings on advertisements in collections for other tobacco product estimate that about half of respondents accordance with an FDA-approved plan plans (i.e., smokeless OMB control will submit a supplement. If a under section 4 of the FCLAA and this number 0910–0671 and cigars OMB supplement to an approved plan is proposed part must maintain a copy of control number 0910–0768) and 2017 submitted, FDA estimates it will take the FDA-approved plan (approved Treasury Alcohol and Tobacco Tax and half the time per response. We estimate under proposed § 1141.10(g)(3)). This Trade Bureau (TTB) data. receiving 30 supplements at 75 hours copy (or record) of such FDA-approved As discussed in the preliminary per response for a total of 2,250 hours. plan must be available for inspection regulatory impact analysis (see section FDA estimates that the total hours for and copying by officers or employees of XII; Ref. 220), based on 2017 TTB data submitting initial plans and FDA. This proposed subsection would FDA estimates 59 entities will be supplements will be 11,100. affected by the rule. We estimate these Proposed § 1141.10(g)(4) would require that the record(s) be retained for 59 entities will submit a one-time initial establish that each tobacco product a period of not less than 4 years from plan, and it will take an average of 150 manufacturer required to randomly and the date of FDA’s approval of the plan. hours per respondent to prepare and equally display and distribute warnings

TABLE 6—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Number of Average Plan records Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping

Records ...... 59 1.5 89 3 267

Total ...... 267 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates that 59 recordkeepers cigars OMB control number 0910–0768). FDA estimates that the total burden will keep a total of about 89 records at Based on our estimates for the for this information collection is 11,367 2 hours per record for a total of 267 submission of initial plans and hours (11,100 reporting + 267 hours. As stated previously, these supplements (that all respondents will recordkeeping). estimates are based on FDA’s experience submit initial plans and about half of FDA believes that the proposed with information collections for other respondents will submit supplements), required warnings for cigarette packages tobacco product plans (i.e., smokeless we estimate that each recordkeeper will and cigarette advertisements in OMB control number 0910–0671 and keep an average of 1.5 records. proposed § 1141.10 are not subject to

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review by OMB under the PRA because the FCLAA. Section 5(b) of the FCLAA. Bonnie. 110th Cong., 1st sess., October 3, they do not constitute a ‘‘collection of However, section 5(b) of the FCLAA 2007. information’’ under that statute (44 does not preempt any State or local *2. IOM of the National Academies. Ending U.S.C. 3501–3520). Rather, these the Tobacco Problem: A Blueprint for the statutes and regulations based on Nation. R.J. Bonnie, K. Stratton, R.B. labeling statements are a ‘‘public smoking and health, that take effect after Wallace, Eds. Washington, DC: The disclosure’’ of information originally June 22, 2009, imposing specific bans or National Academies Press, 2007. supplied by the Federal Government to restrictions on the time, place, and Available at http:// the recipient for the purpose of manner, but not content, of the www.nationalacademies.org/hmd/ ‘‘disclosure to the public’’ (5 CFR advertising or promotion of any Reports/2007/Ending-the-Tobacco- 1320.3(c)(2)). cigarettes. Section 5(c) of the FCLAA. Problem-A-Blueprint-for-the- To ensure that comments on In addition, section 916(a)(2) of the Nation.aspx. information collection are received, 3. Hammond, D., G.T. Fong, A. McNeill, et FD&C Act (21 U.S.C. 387p) expressly al. ‘‘Effectiveness of Cigarette Warning OMB recommends that written preempts any state or local requirement Labels in Informing Smokers About the comments be faxed to the Office of which is different from, or in addition Risks of Smoking: Findings from the Information and Regulatory Affairs, to, any requirement under Chapter IX of International Tobacco Control (ITC) Four OMB or emailed to oira_submission@ the FD&C Act relating to, among other Country Survey.’’ Tobacco Control, omb.eop.gov (see ADDRESSES). All things, misbranding and labeling. This 15(Suppl. 3):iii19–iii25, 2006. Available comments should be identified with the express preemption provision, however, at https://doi.org/10.1136/ title of the information collection. does not apply to requirements relating tc.2005.012294. 4. Hammond, D., G.T. Fong, R. Borland, et al. In compliance with the Paperwork to among other things the sale, Reduction Act of 1995 (44 U.S.C. ‘‘Text and Graphic Warnings on Cigarette distribution, access to, or the advertising Packages: Findings from the 3407(d)), the Agency has submitted the and promotion of tobacco products. International Tobacco Control Four information collection provisions of this Country Study.’’ American Journal of proposed rule to OMB for review. These XVI. Consultation and Coordination Preventive Medicine, 32(3):202–209, requirements will not be effective until With Indian Tribal Governments 2007. Available at https://doi.org/ FDA obtains OMB approval. FDA will We have analyzed this proposed rule 10.1016/j.amepre.2006.11.011. publish a notice concerning OMB in accordance with the principles set *5. Wang, T.W., K. Asman, A.S. Gentzke, et approval of these requirements in the forth in Executive Order 13175. We al. ‘‘Tobacco Product Use Among Federal Register. Adults—United States, 2017.’’ Morbidity have tentatively determined that the and Mortality Weekly Report, XV. Federalism rule does not contain policies that 67(44):1225–1232, 2018. Available at would have a substantial direct effect on https://doi.org/10.15585/ We have analyzed this proposed rule one or more Indian Tribes, on the mmwr.mm6744a2. in accordance with the principles set relationship between the Federal *6. Gentzke, A.S., M. Creamer, K.A. Cullen, forth in Executive Order 13132 and seek Government and Indian Tribes, or on et al. ‘‘Vital Signs: Tobacco Product Use input from State and local officials on the distribution of power and Among Middle and High School potential federalism impacts of the responsibilities between the Federal Students—United States, 2011–2018.’’ Morbidity and Mortality Weekly Report, proposed regulation. Section 4(a) of the Government and Indian Tribes. The Executive Order requires agencies to 68(6):157–164, 2019. 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Chemicals to Humans: Tobacco PART 1141—REQUIRED WARNINGS Commerce means: Smoking, Vol. 83. Lyon, France: IARC, FOR CIGARETTE PACKAGES AND (1) Commerce between any State, the 1986. Available at https:// ADVERTISEMENTS District of Columbia, the monographs.iarc.fr/wp-content/uploads/ Commonwealth of Puerto Rico, Guam, 2018/06/mono38.pdf. Subpart A—General Provisions the Virgin Islands, American Samoa, 213. Mutti, S., J.L. Reid, P.C. Gupta, et al. Sec. Wake Island, Midway Islands, Kingman ‘‘Perceived Effectiveness of Text and 1141.1 Scope. Reef, or Johnston Island and any place Pictorial Health Warnings for Smokeless 1141.3 Definitions. outside thereof; Tobacco Packages in Navi Mumbai, 1141.5 Incorporation by reference. (2) Commerce between points in any India, and Dhaka, Bangladesh: Findings Subpart B—Required Warnings for from an Experimental Study.’’ Tobacco State, the District of Columbia, the Cigarette Packages and Advertisements Control, 25(4):437–443, 2016. Available Commonwealth of Puerto Rico, Guam, at https://doi.org/10.1136/ 1141.10 Required warnings. the Virgin Islands, American Samoa, tobaccocontrol-2015-052315. 1141.12 Misbranding of cigarettes. Wake Island, Midway Islands, Kingman 214. Luryi, A.L., W.G. Yarbrough, L.M. Authority: 15 U.S.C. 1333; 21 U.S.C. 371, Reef, or Johnston Island, but through Niccolai, et al. ‘‘Public Awareness of 374, 387c, 387e, 387i; Secs. 201 and 202, any place outside thereof; or Head and Neck Cancers: A Cross- Pub. L. 111–31, 123 Stat. 1776. (3) Commerce wholly within the Sectional Survey.’’ JAMA District of Columbia, Guam, the Virgin Otolaryngology—Head & Neck Surgery, Subpart A—General Provisions Islands, American Samoa, Wake Island, 140(7):639–646, 2014. Available at § 1141.1 Scope. Midway Island, Kingman Reef, or https://doi.org/10.1001/ Johnston Island. jamaoto.2014.867. (a) This part sets forth the Distributor means any person who 215. Bidwell, G., A. Sahu, R. Edwards, et al. requirements for the display of required furthers the distribution of cigarettes, ‘‘Perceptions of Blindness Related to warnings on cigarette packages and in whether domestic or imported, at any advertisements for cigarettes. Smoking: A Hospital-Based Cross- point from the original place of (b) The requirements of this part do Sectional Study.’’ Eye, 19:945–948, 2005. manufacture to the person who sells or Available at https://doi.org/10.1038/ not apply to manufacturers or distributors of cigarettes that do not distributes the product to individuals sj.eye.6701955. for personal consumption. Common 216. Klein, R., C.F. Chou, B. E. K. Klein, et al. manufacture, package, or import carriers are not considered distributors ‘‘Prevalence of Age-Related Macular cigarettes for sale or distribution within Degeneration in the US Population.’’ the United States. for the purposes of this part. Archives of Ophthalmology, 129(1):75– (c) A cigarette retailer will not be in Front panel and rear panel mean the 80, 2011. Available at https://doi.org/ violation of § 1141.10 for packaging that: two largest sides or surfaces of the 10.1001/archophthalmol.2010.318. (1) Contains a warning; package. 217. Krugman, D.M., R.J. Fox, J.E. Fletcher, (2) Is supplied to the retailer by a Manufacturer means any person, et al. ‘‘Do Adolescents Attend to license- or permit-holding tobacco including any repacker or relabeler, who Warnings in Cigarette Advertising? An product manufacturer, or distributor; manufactures, fabricates, assembles, Eye-Tracking Approach.’’ Journal of and processes, or labels a finished cigarette Advertising Research, 34:39–52, 1994. (3) Is not altered by the retailer in a product; or imports any cigarette that is *218. U.S. Congress. House. Committee on way that is material to the requirements intended for sale or distribution to Energy and Commerce. Comprehensive of section 4 of the Federal Cigarette consumers in the United States. Smoking Education Act (H.R. 3979). Labeling and Advertising Act (15 U.S.C. Package or packaging means a pack, House Report Number 98–805. 98th box, carton, or container of any kind in Cong., 2d sess., August 3, 1984. 1333) or this part. (d) Section 1141.10(d) applies to a which cigarettes are offered for sale, *219. HHS. The Health Benefits of Smoking sold, or otherwise distributed to Cessation: A Report of the Surgeon cigarette retailer only if that retailer is General. DHHS Publication Number responsible for or directs the warnings consumers. (CDC) 90–8416. Rockville, MD: HHS, required under § 1141.10 for Person means an individual, Public Health Service, CDC, National advertising. However, this paragraph (d) partnership, corporation, or any other Center for Chronic Disease Prevention does not relieve a retailer of liability if business or legal entity. and Health Promotion, Office on the retailer displays, in a location open Retailer means any person who sells Smoking and Health, 1990. to the public, an advertisement that cigarettes to individuals for personal *220. Preliminary Regulatory Impact does not contain a warning or has been consumption, or who operates a facility Analysis; Initial Regulatory Flexibility altered by the retailer in a way that is where vending machines or self-service Analysis; Unfunded Mandates Reform material to the requirements of section displays of cigarettes are permitted. Act Analysis, Required Warnings for 4 of the Federal Cigarette Labeling and United States, when used in a Cigarette Packages and Advertisements; Advertising Act or this part. geographical sense, includes the several Proposed Rule. States, the District of Columbia, the § 1141.3 Definitions. List of Subjects in 21 CFR Part 1141 Commonwealth of Puerto Rico, Guam, For purposes of this part: the Virgin Islands, American Samoa, Advertising, Incorporation by Cigarette means— Wake Island, Midway Islands, Kingman reference, Labeling, Packaging and (1) Any roll of tobacco wrapped in Reef, and Johnston Island. The term containers, Tobacco, Smoking. paper or in any substance not ‘‘State’’ includes any political division containing tobacco; and of any State. Therefore, under the Federal Cigarette (2) Any roll of tobacco wrapped in Labeling and Advertising Act, the any substance containing tobacco § 1141.5 Incorporation by reference. Federal Food, Drug, and Cosmetic Act, which, because of its appearance, the (a) Certain material titled ‘‘Required and under authority delegated to the type of tobacco used in the filler, or its Cigarette Health Warnings,’’ appearing Commissioner of Food and Drugs, the packaging and labeling, is likely to be in § 1141.10, is incorporated by Food and Drug Administration proposes offered to, or purchased by, consumers reference into this part with the to revise 21 CFR part 1141 to read as as a cigarette described in paragraph (1) approval of the Director of the Federal follows: of this definition. Register under 5 U.S.C. 552(a) and 1

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CFR part 51. All approved material is which is incorporated by reference at warning must be obtained from the available for inspection at U.S. Food § 1141.5. electronic files contained in ‘‘Required and Drug Administration, Division of (c) It is unlawful for any person to Cigarette Health Warnings,’’ which is Dockets Management, 5630 Fishers manufacture, package, sell, offer to sell, incorporated by reference at § 1141.5, Lane, Rm. 1061, Rockville, MD 20852, distribute, or import for sale or and must be accurately reproduced as and is available from the source listed distribution within the United States specified in ‘‘Required Cigarette Health in paragraph (b) of this section. It is also any cigarettes unless the package of Warnings.’’ available for inspection at the National which bears a required warning in (5) For non-English-language Archives and Records Administration accordance with section 4 of the Federal warnings, other than Spanish-language (NARA). For information on the Cigarette Labeling and Advertising Act warnings, each required warning must availability of this material at NARA, and this part. be obtained from the electronic files email [email protected] or go to (1) The required warning must appear contained in ‘‘Required Cigarette Health https://www.archives.gov/federal- directly on the package and must be Warnings,’’ which is incorporated by register/cfr/ibr-locations.html. clearly visible underneath any reference at § 1141.5, and must be (b) Center for Tobacco Products, U.S. cellophane or other clear wrapping. accurately reproduced as specified in Food and Drug Administration, 10903 (2) The required warning must ‘‘Required Cigarette Health Warnings,’’ New Hampshire Ave., Silver Spring, MD comprise at least the top 50 percent of including the substitution and insertion 20993; 1–888–463–6332. the front and rear panels; provided, of a true and accurate translation of the (1) ‘‘Required Cigarette Health however, that on cigarette cartons, the textual warning label statement in place Warnings’’ required warning must be located on the of the English language version. The (2) [Reserved] left side of the front and rear panels of inserted textual warning label statement the carton and must comprise at least must comply with the requirements of Subpart B—Required Warnings for the left 50 percent of these panels. section 4 of the Federal Cigarette Cigarette Packages and (3) The required warning must be Labeling and Advertising Act, including Advertisements positioned such that the text of the area and other formatting requirements, required warning and the other and this part. § 1141.10 Required warnings. information on that panel of the package (a) A required warning must include (e) The required warnings must be have the same orientation. indelibly printed on or permanently the following: (d) It is unlawful for any affixed to the package or advertisement. (1) One of the following textual manufacturer, distributor, or retailer of These warnings, for example, must not warning label statements: cigarettes to advertise or cause to be be printed or placed on a label affixed (i) WARNING: Tobacco smoke can advertised within the United States any to a clear outer wrapper that is likely to harm your children. cigarette unless each advertisement be removed to access the product within (ii) WARNING: Tobacco smoke causes bears a required warning in accordance the package. fatal lung disease in nonsmokers. with section 4 of the Federal Cigarette (f) No person may manufacture, (iii) WARNING: Smoking causes age- Labeling and Advertising Act and this package, sell, offer for sale, distribute, or related macular degeneration, which part. can lead to blindness. (1) For print advertisements and other import for sale or distribution within (iv) WARNING: Smoking causes type advertisements with a visual component the United States cigarettes whose 2 diabetes, which raises blood sugar. (including, for example, advertisements packages or advertisements are not in (v) WARNING: Smoking reduces on signs, retail displays, internet web compliance with section 4 of the blood flow to the limbs, which can pages, digital platforms, mobile Federal Cigarette Labeling and require amputation. applications, and email Advertising Act and this part, except as (vi) WARNING: Smoking causes correspondence), the required warning provided by § 1141.1(c) and (d). cataracts, which can lead to blindness. must appear directly on the (g)(1) Random display. The required (vii) WARNING: Smoking causes advertisement. warnings for packages specified in bladder cancer, which can lead to (2) The required warning must paragraph (a) of this section must be bloody urine. comprise at least 20 percent of the area randomly displayed in each 12-month (viii) WARNING: Smoking reduces of the advertisement in a conspicuous period, in as equal a number of times as blood flow, which can cause erectile and prominent format and location at is possible on each brand of the product dysfunction. the top of each advertisement within the and be randomly distributed in all areas (ix) WARNING: Smoking causes head trim area, if any. of the United States in which the and neck cancer. (3) The text in each required warning product is marketed in accordance with (x) WARNING: Smoking can cause must be in the English language, except a plan submitted by the tobacco product heart disease and strokes by clogging as follows: manufacturer, distributor, or retailer to, arteries. (i) In the case of an advertisement that and approved by, the Food and Drug (xi) WARNING: Smoking during appears in a non-English medium, the Administration. pregnancy stunts fetal growth. text in the required warning must (2) Rotation. The required warnings (xii) WARNING: Smoking causes appear in the predominant language of for advertisements specified in COPD, a lung disease that can be fatal. the medium whether or not the paragraph (a) of this section must be (2) A color graphic to accompany the advertisement is in English; and rotated quarterly in alternating sequence textual warning label statement. (ii) In the case of an advertisement in advertisements for each brand of (b) Each required warning, comprising that appears in an English language cigarettes in accordance with a plan a combination of a textual warning label medium but that is not in English, the submitted by the tobacco product statement and its accompanying color text in the required warning must manufacturer, distributer, retailer to, graphic, must be obtained and appear in the same language as that and approved by, the Food and Drug accurately reproduced as specified from principally used in the advertisement. Administration. the electronic files contained in (4) For English-language and Spanish- (3) Review. The Food and Drug ‘‘Required Cigarette Health Warnings,’’ language warnings, each required Administration will review each plan

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submitted under this section and period of not less than 4 years from the of the required warnings in accordance approve it if the plan: date it was last in effect. with section 4 of the Federal Cigarette Labeling and Advertising Act and this (i) Will provide for the equal § 1141.12 Misbranding of Cigarettes. distribution and display on packaging part. A cigarette distributed or offered and the rotation required in advertising (a) A cigarette will be deemed to be for sale in any State shall be deemed to under this subsection; and misbranded under section 903(a)(1) of be misbranded under section 903(a)(8) the Federal Food, Drug, and Cosmetic of the Federal Food, Drug, and Cosmetic (ii) Assures that all of the labels Act if its package does not bear one of Act unless the manufacturer, packer, or required under this section will be the required warnings in accordance distributor includes in all displayed by the tobacco product with section 4 of the Federal Cigarette advertisements and other descriptive manufacturer, distributor, or retailer at Labeling and Advertising Act and this printed matter issued or caused to be the same time. part. A cigarette will be deemed to be issued by the manufacturer, packer, or (4) Record retention. Each tobacco misbranded under section 903(a)(7)(A) distributor with respect to the cigarette product manufacturer required to of the Federal Food, Drug, and Cosmetic one of the required warnings in randomly and equally display and Act if its advertising does not bear one accordance with section 4 of the Federal distribute warnings on packaging or of the required warnings in accordance Cigarette Labeling and Advertising Act rotate warnings in advertisements in with section 4 of the Federal Cigarette and this part. Labeling and Advertising Act and this accordance with an FDA-approved plan Dated: July 24, 2019. under section 4 of the Federal Cigarette part. Norman E. Sharpless, Labeling and Advertising Act and this (b) A cigarette advertisement and part must maintain a copy of such FDA- other descriptive printed matter issued Acting Commissioner of Food and Drugs. approved plan and make it available for or caused to be issued by the Dated: August 9, 2019. inspection and copying by officers or manufacturer, packer, or distributor will Eric D. Hargan, employees duly designated by the be deemed to include a brief statement Deputy Secretary, Department of Health and Secretary of Health and Human of relevant warnings for the purposes of Human Services. Services. The FDA-approved plan must section 903(a)(8) of the Federal Food, [FR Doc. 2019–17481 Filed 8–15–19; 8:45 am] be retained while in effect and for a Drug, and Cosmetic Act if it bears one BILLING CODE 4164–01–P

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