# Tobacco Product Standard for Menthol in Cigarettes > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2022-08994 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** May 4, 2022 - **Citation:** 87 FR 26454 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1162 [Docket No. FDA-2021-N-1349] RIN 0910-AI60 Tobacco Product Standard for Menthol in Cigarettes AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes. Tobacco use is the leading preventable cause of death and disease in the United States. Menthol's flavor and sensory effects increase appeal and make menthol cigarettes easier to use, particularly among youth and young adults. There are over 18.5 million menthol cigarette smokers ages 12 and older in the United States. This proposed product standard would reduce the appeal of cigarettes, particularly to youth and young adults, and thereby decrease the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking. In addition, the proposed tobacco product standard would improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation. FDA is taking this action to reduce the tobacco-related death and disease associated with menthol cigarette use. The proposed standard also is expected to reduce tobacco-related health disparities and advance health equity. DATES: Submit either electronic or written comments on the proposed rule by July 5, 2022. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 5, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions: All submissions received must include the Docket No. FDA-2021-N-1349 for “Tobacco Product Standard for Menthol in Cigarettes.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. FOR FURTHER INFORMATION CONTACT: Beth Buckler or Eric Mandle, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, CTPRegulations@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Commonly Used Acronyms in This Document III. Background A. Need for the Regulation B. Relevant Regulatory History of Menthol Cigarettes C. Legal Authority D. FDA's Consideration of Health Equity IV. Menthol Cigarette Use Is Common, Addictive, and Harmful A. Background B. Menthol Smoking Is Widespread and Disproportionately Impacts Youth, Young Adults, and Other Vulnerable Populations in the United States C. Menthol in Cigarettes Increases Smoking Initiation, Increases Progression to Regular Use, and Contributes to Nicotine Dependence D. Menthol in Cigarettes Makes Quitting Smoking More Difficult E. Menthol Cigarettes Are Marketed Disproportionately in Underserved Communities and to Vulnerable Populations V. Determination That the Standard Is Appropriate for the Protection of the Public Health A. The Likelihood That Nonusers Would Start Using Cigarettes B. The Likelihood That Existing Menthol Cigarette Users Would Reduce Cigarette Consumption or Stop Cigarette Smoking C. Benefits and Risks to the Population as a Whole D. Conclusion VI. Additional Considerations and Requests for Comments A. Section 907 of the FD&C Act B. Request for Comments on the Potential Racial and Social Justice Implications of the Proposed Product Standard VII. Description of the Proposed Rule A. Scope (Proposed § 1162.1) B. Definitions (Proposed § 1162.3) C. Prohibition on Use of Menthol as a Characterizing Flavor in Cigarettes (Proposed § 1162.5) VIII. Proposed Effective Date IX. Preliminary Economic Analysis of Impacts A. Introduction B. Summary of Costs and Benefits X. Analysis of Environmental Impact XI. Paperwork Reduction Act of 1995 XII. Federalism XIII. Consultation and Coordination With Indian Tribal Governments XIV. References I. Executive Summary A. Purpose of the Proposed Rule FDA is proposing a tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes. In developing this proposed rule, FDA carefully considered the scientific evidence and complex policy issues related to menthol cigarettes. As described in the preamble of this rule, FDA has conducted multiple scientific reviews related to menthol cigarettes, issued two advance notices of proposed rulemaking (ANPRMs) to solicit data and information about menthol cigarettes, considered a citizen petition requesting that FDA ban menthol as a characterizing flavor in cigarettes, and sponsored research on a variety of menthol-related topics. Each year, 480,000 people die prematurely from a smoking-attributable disease, making tobacco use the leading cause of preventable death and disease in the United States. In 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) banned characterizing flavors in cigarettes, other than tobacco or menthol, based on their appeal to youth, in order to reduce the number of children and adolescents who smoke cigarettes. As a result, menthol cigarettes are the only cigarettes with a characterizing flavor still marketed in the United States. In 2019, there were more than 18.5 million current smokers of menthol cigarettes ages 12 and older in the United States. Although menthol cigarette smoking is widespread in the United States, menthol cigarettes are used at a particularly high rate by youth, young adults, and certain other vulnerable populations such as African American and other racial and ethnic groups. Menthol is a flavor compound added to cigarettes, which produces a minty taste and cooling sensation when inhaled. Menthol's flavor and sensory effects reduce the harshness of cigarette smoking and make it easier for new users, particularly youth and young adults, to continue experimenting and progress to regular use. In addition, data show that menthol cigarettes contribute to greater nicotine dependence in youth and young adults than non-menthol cigarettes. By prohibiting menthol as a characterizing flavor in cigarettes, this proposed product standard would reduce the appeal of cigarettes, particularly to youth and young adults, who are more likely to try a menthol cigarette as their first cigarette than a non-menthol cigarette. And because almost all daily smokers started smoking before the age of 25, it would thereby decrease the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking. By prohibiting menthol as a characterizing flavor in cigarettes, FDA expects a significant reduction in the likelihood of youth and young adult initiation and progression to regular cigarette smoking, which is expected to prevent future cigarette-related disease and death. In addition, the proposed tobacco product standard would improve the health and reduce the mortality risk of current menthol cigarette smokers by substantially decreasing cigarette consumption and increasing the likelihood of cessation. Published modeling studies have estimated a 15.1 percent reduction in smoking prevalence within 40 years if menthol cigarettes were no longer available in the United States. These studies also estimate that 324,000 to 654,000 smoking attributable deaths overall (92,000 to 238,000 among African Americans) would be avoided within 40 years. FDA expects the public health benefit of this rule to be particularly pronounced among vulnerable populations, including youth and young adults, as well as Black smokers, who have the highest prevalence of menthol cigarette smoking and experience a disproportionate burden of the related harms. For the reasons discussed in the preamble of this proposed rule, FDA finds that the proposed tobacco product standard would be appropriate for the protection of the public health. Additionally, this proposed product standard is expected to substantially decrease tobacco-related health disparities and to advance health equity across population groups. B. Summary of the Major Provisions of the Proposed Rule The proposed rule would prohibit the use of menthol as a characterizing flavor in cigarettes and cigarette components and parts, including those that are sold separately to consumers. Specifically, the rule would provide that a cigarette or any of its components or parts (including the tobacco, filter, wrapper, or paper, as applicable) shall not contain, as a constituent (including a smoke constituent) or additive, menthol that is a characterizing flavor of the tobacco product or tobacco smoke. Under the proposed rule, no person may manufacture, distribute, sell, or offer for distribution or sale, within the United States a cigarette or cigarette component or part that is not in compliance with the product standard. Among the factors that FDA believes are relevant in determining whether a cigarette has a characterizing flavor are: • The presence and amount of artificial or natural flavor additives, compounds, constituents, or ingredients, or any other flavoring ingredient in a tobacco product, including its components or parts; • The multisensory experience ( i.e., taste, aroma, and cooling or burning sensations in the mouth and throat) of a flavor during use of a tobacco product, including its components or parts; • Flavor representations (including descriptors), either explicit or implicit, in or on the labeling (including packaging) or advertising of tobacco products; and • Any other means that impart flavor or represent that the tobacco products has a characterizing flavor. FDA is proposing that any final rule that may issue based on this proposed rule become effective 1 year after the date of publication of the final rule. Therefore, after the effective date, no person may manufacture, sell, or offer for sale or distribution within the United States a cigarette or any of its components or parts that is not in compliance with part 1162. This regulation does not include a prohibition on individual consumer possession or use, and FDA cannot and will not enforce against individual consumers for possession or use of menthol cigarettes. FDA's enforcement will only address manufacturers, distributors, wholesalers, importers, and retailers. State and local law enforcement agencies do not independently enforce the Federal Food, Drug and Cosmetic Act (FD&C Act). These entities do not and cannot take enforcement actions against any violation of chapter IX of the Act or this regulation on FDA's behalf. We recognize concerns about how State and local law enforcement agencies enforce their own laws in a manner that may impact equity and community safety and seek comment on how FDA can best make clear the respective roles of FDA and State and local law enforcement. C. Legal Authority Section 907 of the FD&C Act (21 U.S.C. 387g) prohibited characterizing flavors, other than menthol and tobacco, in cigarettes. Section 907 expressly preserved FDA's ability to prohibit menthol as an exercise of FDA's authorities to revise or issue tobacco product standards, including provisions that would require the reduction or elimination of a constituent (including a smoke constituent), or harmful component of tobacco products; and provisions respecting the construction, components, ingredients, additives, constituents (including smoke constituents), and properties of the tobacco product (section 907(a)(2), (a)(3), (a)(4)(A)(ii), and (a)(4)(B)(i) of the FD&C Act). FDA's authorities related to the sale and distribution of tobacco products are established under sections 907(a)(4)(B)(v) and 906(d) (21 U.S.C. 387f(d)) of the FD&C Act. D. Costs and Benefits The quantified benefits of this proposed rule come from lower smoking-attributable mortality in the U.S. population due to diminished exposure to tobacco smoke for both users and nonusers of cigarettes. The costs of this proposed rule are those to firms to comply with the rule, to consumers impacted by the rule, and to the government to enforce this product standard. In addition to benefits and costs, this rule will cause transfers from State governments, Federal Government, and firms to consumers in the form of reduced revenue and tax revenue. We estimate that the annualized benefits over a 40-year time horizon will equal $220 billion at a 7 percent discount rate, with a low estimate of $102 billion and a high estimate of $334 billion, and $232 billion at a 3 percent discount rate, with a low estimate of $108 billion and a high estimate of $353 billion. Over a 40-year time horizon, we estimate that the annualized costs will equal $307 million at a 7 percent discount rate, with a low estimate of $16 million and a high estimate of $601 million, and $291 million at a 3 percent discount rate, with a low estimate of $9 million and a high estimate of $573 million. II. Table of Abbreviations/Commonly Used Acronyms in This Document Abbreviation/acronym What it means Addiction Review Scientific Review of the Effects of Menthol in Cigarettes on Tobacco Addiction: 1980-2021. ANPRM Advance notice of proposed rulemaking. CARDIA Coronary Artery Risk Development in Young Adults. CFR Code of Federal Regulations. CPS II Cancer Prevention Study II. CTP FDA's Center for Tobacco Products. EE Expert Elicitation. ENDS Electronic Nicotine Delivery Systems. E.O. Executive order. FD&C Act Federal Food, Drug, and Cosmetic Act. FDA Food and Drug Administration. FR Federal Register. FTC Federal Trade Commission. HHS U.S. Department of Health and Human Services. HTP Heated Tobacco Product. IOM Institute of Medicine. LGBTQ+ Lesbian, gay, bisexual, transgender, or queer. Nav Guide Navigation Guide Systematic Review Methodology. NCI National Cancer Institute. NHANES National Health and Nutrition Examination Survey. NHIS National Health Interview Survey. NRC National Research Council. NSDUH National Survey on Drug Use and Health. NYC New York City. NYAHS National Young Adult Health Survey. NYTS National Youth Tobacco Survey. PATH Population Assessment of Tobacco and Health. PRIA Preliminary Regulatory Impact Analysis. RYO Roll-your-own. SAVM Smoking and Vaping Model. SGR Surgeon General Report. SIDS Sudden infant death syndrome. Tobacco Control Act Family Smoking Prevention and Tobacco Control Act. TPSAC Tobacco Product Scientific Advisory Committee. TUS-CPS Tobacco Use Supplement to the Current Population Survey. YRBS Youth Risk Behavior Survey. III. Background A. Need for the Regulation FDA is proposing to prohibit menthol as a characterizing flavor in cigarettes. Cigarette smoking is the leading cause of preventable death and disease in the United States and is responsible for more than 480,000 premature deaths per year (Ref. 1). Menthol is a flavor compound that is added to cigarettes, which produces a minty taste and cooling sensation when inhaled (Ref. 2). These sensory properties contribute to smoker perceptions that menthol cigarettes are easier to inhale, are less irritating, have a better taste, are smoother and more refreshing than non-menthol cigarettes (Refs. 3-5). Menthol's flavor and sensory effects reduce the harshness of cigarette smoking among new users and facilitate experimentation and progression to regular smoking of menthol cigarettes, particularly among youth and young adults (Refs. 6-7, 5, 8). As a result, the brain is repeatedly exposed to nicotine and susceptible to nicotine addiction (Ref. 9). In addition to its flavor and sensory effects, menthol contributes to a greater risk of nicotine dependence by enhancing the addictive effects of nicotine in the brain by affecting mechanisms involved in nicotine addiction (Refs. 10-13). Clinical data show that menthol cigarette smokers have higher levels of brain nicotinic receptors compared to non-menthol smokers (Ref. 14). Studies demonstrate that menthol, like nicotine, binds to nicotinic receptors in the brain (Refs. 15 and 16), and menthol alone can increase the number of nicotinic receptors in the brain (Refs. 10 and 11). Evidence demonstrates that the combined effects of menthol and nicotine in the brain are associated with behaviors indicative of greater addiction to nicotine compared to nicotine alone (Refs. 10 and 12). Youth and young adults are particularly susceptible to becoming addicted to nicotine. Due to its ongoing development, the adolescent brain, which continues to develop until about age 25, is more vulnerable to nicotine's effects than the adult brain (Refs. 17-19). The combined effects of nicotine and menthol in the developing brain make youth who smoke menthol cigarettes particularly vulnerable to the effects of menthol on nicotine dependence. Data from multiple studies across different populations and time periods demonstrate that menthol cigarettes contribute to greater nicotine dependence in youth and young adults 1 than non-menthol cigarettes (Refs. 20-28). Menthol is a significant contributor to experimentation and progression to regular cigarette smoking among this population (Refs. 25, 29-31, 8). This is of particular concern since the vast majority of smoking initiation occurs during adolescence (Refs. 32, 8, 31, 33) and youth and young adults are more likely to try a menthol cigarette as their first cigarette than a non-menthol cigarette (Refs. 8, 31, and 33). 1 Though age ranges for youth and young adults vary across studies, in general, “youth” or “adolescent” encompasses those 11-17 years of age, while those who are 18-25 years old are considered “young adults” (even though, developmentally, the period between 18-20 years of age is often labeled late adolescence); those 26 years of age or older are considered “adults” or “older adults” (Ref. 32). In addition to the impacts on progression to regular use and dependence, menthol contributes to reduced cessation success, particularly among Black smokers 2 (Refs. 34-41) (see section IV.D of this document). A number of nationally representative studies among young adult and adult smokers show that menthol in cigarettes contributes to reduced cessation success (Refs. 34-35, 42, 36-38, 40, 43). Among Black smokers, this effect is consistent across large nationally representative studies, smaller clinical studies of smokers, reviews of the menthol and cessation literature, and meta-analyses, which examined outcomes from multiple menthol and cessation studies. Although findings among smokers in the general population produce more mixed results than findings specific to Black smokers, the strongest studies on the general population support an effect of menthol on reduced cessation. For example, two recent studies using data from the nationally representative longitudinal Population Assessment of Tobacco and Health (PATH) study found that menthol is associated with reduced smoking cessation across multiple years of followup (Refs. 40 and 43). 2 Throughout the preamble of this proposed rule, FDA uses both the terms “Black” and “African American.” The term “African American” is used to describe or refer to a person of African ancestral origins or who identifies as African American. “Black” is used to broadly describe or refer to a person who identifies with that term. Though both of these terms may overlap, they are distinct concepts ( e.g., a Black person may not identify as African American). As a result, FDA relies on the specific term used by researchers when citing to specific studies. FDA uses the term “Black” when not citing to a specific study. In 2019, there were more than 18.5 million current smokers of menthol cigarettes ages 12 and older in the United States (Ref. 44). Data show that menthol cigarettes are used at a particularly high rate by youth (aged 12-17), young adults (aged 18-25), and other vulnerable populations 3 such as African American and other racial and ethnic groups (Ref. 44). Prohibiting menthol as a characterizing flavor in cigarettes would help to decrease the nicotine addiction resulting from menthol cigarette use, and thereby, decrease disease and death. 3 Throughout the preamble of this proposed rule, the term “vulnerable populations” refers to groups that are susceptible to tobacco product risk and harm due to disproportionate rates of tobacco product initiation, use, burden of tobacco-related diseases, or decreased cessation. Examples of vulnerable populations include those with lower household income and educational attainment, certain racial or ethnic populations, individuals who identify as LGBTQ+, underserved rural populations, those pregnant or trying to become pregnant, those in the military or veterans, or those with behavioral health conditions or substance use disorders. In 2009, the Tobacco Control Act established the “Special Rule for Cigarettes” (section 907(a)(1)(A) of the FD&C Act (Special Rule for Cigarettes). 4 The Special Rule for Cigarettes banned characterizing flavors in cigarettes, other than tobacco or menthol, based on their appeal to youth, in order to reduce the number of children and adolescents who smoke cigarettes (see H.R. Rep. No. 111-58, pt. 1, at 37 (2009)). As a result, menthol cigarettes are the only cigarettes with a characterizing flavor still marketed in the United States. 4 Section 907(a)(1)(A) of the FD&C Act states that beginning 3 months after the date of enactment of the Tobacco Control Act, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. Nothing in this subparagraph (section 907(a)(1)(A) of the Tobacco Control Act) shall be construed to limit the Secretary of HHS's authority to take action under this section or other sections of this Act applicable to menthol or any artificial or natural flavor, herb, or spice not specified in this section. In establishing the Special Rule for Cigarettes, Congress noted that, “[g]iven the number of open questions related to menthol cigarettes, the legislation authorizes the Secretary to ban or modify the use of menthol in cigarettes based on scientific evidence” (H.R. Rep. No. 111-58, pt. 1, at 39 (2009)). Specifically, the Tobacco Control Act authorizes FDA to adopt or revise product standards where FDA determines that such standard is appropriate for the protection of the public health (section 907(a)(2) and (3) of the FD&C Act). After careful consideration of the scientific evidence, FDA is proposing to prohibit the use of menthol as a characterizing flavor in cigarettes in order to reduce the death and disease caused by cigarette use. For the reasons described in the preamble of this rule, FDA finds that this product standard would be appropriate for the protection of the public health because it would prohibit menthol cigarettes, which will reduce initiation rates of smoking cigarettes, particularly for youth and young adults, and thereby decrease the likelihood that nonusers of cigarettes who experiment with these tobacco products would progress to regular cigarette smoking. Additionally, the proposed tobacco product standard is anticipated to improve the health of current smokers of menthol cigarettes by decreasing cigarette consumption and increasing the likelihood of cessation among this population. Published modeling studies have estimated that 324,000 to 654,000 smoking attributable deaths would be avoided by the year 2060 if menthol cigarettes were no longer available in the United States (Refs. 45 and 46). These figures significantly understate the public-health benefits because they undercount lives saved of youth and young adults who, as the result of the menthol ban, do not begin to smoke. Beyond averted deaths, societal benefits would include reduced smoking-related morbidity and health disparities, diminished exposure to secondhand smoke among non-smokers, decreased potential years of life lost, decreased disability, and improved quality of life among former smokers. FDA expects the public health benefit of this rule to be particularly pronounced among vulnerable populations, including youth and young adults, as well as Black smokers, who have the highest prevalence of menthol cigarette smoking and experience a disproportionate burden of the related harms. This proposed product standard is also expected to substantially decrease tobacco-related health disparities and to advance health equity across population groups. Tobacco-related health disparities are the differences observed in population groups regarding: The patterns ( e.g., initiation, dual or polyuse, cessation), prevention, and treatment of tobacco use; the risk, incidence, morbidity, mortality, and burden of tobacco-related illness; and in capacity and infrastructure ( e.g., political systems, educational institutions), access to resources ( e.g., health services and programs), and environmental secondhand smoke exposure (Refs. 47-49). Tobacco-related health disparities affect those who have systematically experienced greater obstacles to health based on group membership due to the inequitable distribution of social, political, economic, and environmental resources (Refs. 50, 49, and 51). Health equity is the attainment of the highest level of health for all people (Ref. 51). It is achieved by equally valuing all individuals regardless of group membership; removing social, economic, and institutional obstacles to health; and addressing historical and contemporary injustices (Refs. 51-53). The advancement of health equity is integral to the reduction and elimination of tobacco-related health disparities, which result from denied opportunity and access to economic, political, and social participation (Refs. 49 and 54). Despite significant declines in cigarette smoking since 1964, “very large disparities in tobacco use remain across groups defined by race, ethnicity, educational level, and socioeconomic status and across regions of the country” (Ref. 1). Menthol cigarettes contribute to these disparities in cigarette use (Refs. 55-56, 21-24, 57-59) and the resulting disparities in health outcomes (Refs. 60-63, 50, 49). Members of underserved communities, 5 such as African American and other racial and ethnic populations, individuals who identify as LGBTQ+, pregnant persons, those with lower household income or educational attainment, and individuals with behavioral health disorders are more likely to report smoking menthol cigarettes than other population groups (Refs. 64-67, 55, 57-59, 68-69, 44, 70-71). Due to this increased prevalence of menthol cigarette smoking, members of underserved communities bear a disproportionate burden of tobacco-related morbidity and mortality (see section V.C of this document). This proposed product standard is anticipated to promote better public health outcomes across population groups. 5 As defined by Executive Order (E.O.) 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” (86 FR 7009, January 25, 2021) the term “underserved communities” refers to populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life. In the context of tobacco products and tobacco-related health disparities, such communities may include populations disproportionately impacted by marketing and promotion targeted on the basis of such shared characteristics. B. Relevant Regulatory History of Menthol Cigarettes In its implementation of the Tobacco Control Act over the past several years, FDA has engaged in close study and careful consideration of the scientific evidence and complex policy issues related to menthol cigarettes. FDA has conducted multiple scientific reviews related to menthol cigarettes, issued two ANPRMs to solicit data and information about menthol cigarettes, considered a citizen petition requesting that FDA ban menthol as a characterizing flavor in cigarettes, and sponsored research on a variety of menthol-related topics through contracts and interagency agreements with Federal partners, including the National Institutes of Health (NIH). 6 Among other things, FDA has considered the comments and information received in response to the scientific reviews, ANPRMs, and citizen petition in developing this proposed rule. 6 Information on specific projects supported by FDA is available at https://www.fda.gov/tobacco-products/tobacco-science-research/research (search “menthol” or “flavors”). 1. Scientific Reviews In March 2010, FDA's Tobacco Product Scientific Advisory Committee (TPSAC) undertook a review of the available evidence concerning menthol cigarettes and solicited and received input from many public commenters, including researchers, tobacco industry representatives, consultants to the tobacco industry, and public health experts. As required by section 907(e) of the FD&C Act, on March 23, 2011, TPSAC submitted its report and recommendation to the Secretary of HHS on the impact of the use of menthol in cigarettes on the public health, including use among children, African Americans, Hispanics, and other racial and ethnic populations (Ref. 72). 7 8 In addition, the nonvoting industry representatives of TPSAC submitted a separate document reflecting the tobacco industry perspective (Ref. 73). 7 Based on evidence available at that time, TPSAC concluded that removing menthol cigarettes from the market would benefit the public health and noted that the statute provides a “variety of mechanisms for FDA to consider, if it concludes that it should pursue this recommendation,” but it offered “no specific suggestions for FDA to follow-up” on its recommendations (Ref. 72 at 225). TPSAC also noted that, although the FD&C Act requires FDA to consider information submitted on potential countervailing effects of any proposed product standard, such as the creation of a black market, the advisory committee was not “constituted to carry out analyses of the potential for and impact of a black market for menthol cigarettes” and did not analyze that issue (Ref. 72). Therefore, “FDA would need to assess the potential for contraband menthol cigarettes as required by the [FD&C] Act.” (Ref. 72). 8 Two tobacco companies challenged the TPSAC menthol report in court, alleging that certain TPSAC members had conflicts of interest that led them to shape the recommendations in a manner that injured the tobacco companies. In 2014, the U.S. District Court for the District of Columbia held that TPSAC members were improperly appointed. Lorillard, Inc. v. FDA, 56 F. Supp. 3d 37 (D.D.C. 2014). The court ordered FDA to reconstitute TPSAC and enjoined FDA from using the TPSAC menthol report. Id. at 57. This holding was vacated by the U.S. Court of Appeals for the D.C. Circuit on the ground that the tobacco companies failed to show any imminent injury from the report. R.J. Reynolds Tobacco Co. v. FDA, 810 F.3d 827, 832 (D.C. Cir. 2016). Because of the pendency of this lawsuit at the time FDA began to develop the Preliminary Evaluation discussed below, FDA did not rely on the findings in the TPSAC menthol report in conducting its independent review of the scientific evidence related to menthol. Similarly, in connection with developing this proposed rule, FDA has reviewed the TPSAC menthol report, as well as the industry perspective document submitted by the non-voting industry representatives on TPSAC, but did not rely directly on any findings or recommendations in the TPSAC menthol report. Although the conclusions reached in the TPSAC menthol report are generally consistent with the determinations reached by FDA in support of this proposed rule, FDA conducted an independent analysis of the scientific evidence, including evidence that has developed since the report issued more than 10 years ago. FDA also notes that it has reviewed but did not rely on an additional analysis that builds on modeling prepared in connection with the TPSAC menthol report. That evidence is discussed in the Evaluation of Potential Impacts. Shortly thereafter, independent of TPSAC's work and report, including the nonvoting industry representatives' report, experts within FDA's Center for Tobacco Products (CTP) conducted an evaluation of the available science related to the impact of the use of menthol in cigarettes on public health. This evaluation is titled “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes” (Preliminary Evaluation) and has been peer reviewed (Ref. 74). FDA evaluated peer-reviewed literature, tobacco industry submissions and other materials provided to TPSAC, secondary data analyses, and CTP's own analyses of relevant large data sets (Ref. 74). The Preliminary Evaluation concluded that menthol in cigarettes is likely associated with increased smoking initiation and progression to regular smoking, increased dependence, and reduced cessation success, particularly among African American smokers (Ref. 74). As the body of evidence has continued to grow, FDA recently undertook an updated robust review of the science on menthol in cigarettes. This review, titled “Scientific Review of the Effects of Menthol in Cigarettes on Tobacco Addiction: 1980-2021” (Ref. 75) (Addiction Review), covers the peer-reviewed, publicly available literature spanning the period from 1980 to April 30, 2021, and focuses on the impact of menthol cigarettes on outcomes related to addiction, including progression to regular use, dependence, and cessation. The Addiction Review has been peer reviewed by independent external experts. Taking into consideration comments from this peer review (Ref. 76), FDA revised the Addiction Review, and the final peer-reviewed document is available in the docket for this proposed rule (Ref. 75). FDA's process for this scientific evaluation is described in detail in the Addiction Review (see Ref. 75). In sum, FDA used several scientific publication databases to retrieve articles published between 1980 and April 30, 2021, and developed a screening process, including eligibility criteria, to identify articles for inclusion in the final review (Ref. 75). FDA scored the individual quality of each study using the “QualSyst” systematic review tool (Ref. 75). For the weight of evidence approach, FDA adapted and used the Navigation Guide Systematic Review Methodology (NavGuide), an integrated Cochrane-style risk of bias analysis and weight of evidence approach (Ref. 75). The NavGuide approach was selected due to the rigor of its systematic review methods ( e.g., specifying explicit study questions, conducting a comprehensive search, rating the quality and strength of the evidence according to consistent criteria). The approach also allowed for combining the results of clinical and nonclinical evidence into a single conclusion about the effects of menthol on the outcomes of interest (Ref. 75). This weight of the evidence approach allowed FDA to assess the quality of the available evidence and determine the role of menthol in cigarettes on the sensory effects of smoking, as well as the impact of menthol in cigarettes on the progression to regular use, dependence, and cessation. The Addiction Review found the totality of evidence from 1980 to 2021 supports that: (1) The sensory effects of menthol are associated with positive subjective smoking experiences, such as those that mask and reduce the harshness of cigarette smoking; these effects facilitate continued smoking, (2) menthol is associated with progression to regular cigarette smoking in youth and young adults, (3) menthol in cigarettes is associated with greater dependence among youth, (4) menthol is likely associated with reduced cessation success among the general population, and (5) menthol in cigarettes is associated with reduced cessation success among African American cigarette smokers (Ref. 75). FDA has considered the Addiction Review conclusions based on weighted scientific evidence in the development of this proposed product standard. In addition, FDA undertook a review of scientific evidence related to the potential impacts of a menthol product standard. This review, titled “Review of Studies Assessing the Potential Impact of Prohibiting Menthol as a Characterizing Flavor in Cigarettes” (Ref. 77) (Evaluation of Potential Impacts), is comprised of three distinct evaluations. Section 1 describes the results of a reproducible, transparent, and documented review of the scientific evaluation literature regarding the tobacco use behaviors of young people, tobacco use behaviors of adults, sales of tobacco products, illicit sales of tobacco products, and user modification of tobacco products (Ref. 77). Section 2 describes the scientific evidence relevant to consumers' product choices and intended use behaviors in response to a hypothetical menthol cigarette ban (Ref. 77). And section 3 summarizes and evaluates modeling studies that quantify the effects of a menthol cigarette ban to inform an assessment of the potential behavioral responses to a menthol product standard (Ref. 77). The Evaluation of Potential Impacts has been peer reviewed by independent external experts. Taking into consideration comments from this peer review (Ref. 76), FDA revised the Evaluation of Potential Impacts, and the final peer-reviewed document is available in the docket for this proposed rule (Ref. 77). As with the Addiction Review, FDA has considered this scientific review in the development of this proposed product standard. 2. ANPRMs In July 2013, FDA issued an ANPRM to obtain information related to the potential regulation of menthol in cigarettes, including any data, research, or other information that may inform regulatory actions FDA might take with respect to menthol in cigarettes (78 FR 44484, July 24, 2013) (Menthol ANPRM). FDA sought data and information on a number of complex questions, including whether FDA should consider establishing a tobacco product standard for menthol in menthol cigarettes; if so, what level of menthol would be appropriate for the protection of public health; whether FDA should address menthol in other tobacco products; whether alternatives and substitutes might appear on the market and how those substances might be regulated; whether and how restrictions on advertising and promotion of menthol cigarettes would influence consumer behavior; and whether there was evidence that illicit trade in menthol cigarettes would become a significant problem if menthol cigarettes were banned (78 FR 44484 at 44485). The Menthol ANPRM also requested comment on the Preliminary Evaluation and made available an addendum with articles published since the evaluation was submitted for peer review in 2011 (id.). In July 2017, FDA announced a comprehensive approach to tobacco and nicotine regulation to protect youth and reduce tobacco-related disease and death (Ref. 78). As part of the public dialogue on the comprehensive approach, in March 2018, FDA issued three ANPRMs related to the regulation of nicotine in combustible cigarettes (83 FR 11818, March 16, 2018), flavors (including menthol) in tobacco products (83 FR 12294, March 21, 2018) (Flavors ANPRM), and premium cigars (83 FR 12901, March 26, 2018). In addition, FDA announced the availability of a draft concept paper titled “Illicit Trade in Tobacco Products after Implementation of a Food and Drug Administration Product Standard,” and sought public comment (83 FR 11754, March 16, 2018). This paper analyzes the potential for illicit trade markets to develop in response to a tobacco product standard (Ref. 79 at 2). The Flavors ANPRM requested data and information about the role that flavors play in tobacco products (83 FR 12294). With regard to menthol, FDA requested additional data or information about the role of menthol in cigarettes, including the role menthol plays in: (1) Smoking initiation, (2) the likelihood of smoking cessation in youth, young adults, and adults, (3) the likelihood that menthol smokers would switch to another tobacco product or start dual use with another tobacco product, instead of quitting smoking, if a tobacco product standard prohibited or limited menthol in cigarettes, and (4) the use of tobacco products other than cigarettes ( e.g., electronic nicotine delivery systems (ENDS) and cigars) (83 FR 12294 at 12299). 3. Comments to the ANPRMs While the Menthol ANPRM and the Flavors ANPRM discussed two different potential product standards and a range of product types, both specifically requested public input on the role of menthol in cigarettes. FDA received over 174,000 comments on the Menthol ANPRM, with approximately 165,000 of those comments submitted as part of 41 different organized campaigns. FDA also received over 525,000 comments on the Flavors ANPRM, a large proportion of which were form letters related to 61 different organized campaigns. Some of the issues raised in the comments to the ANPRMs are highlighted below. Comments generally in support of any proposed menthol product standard stated that a product standard would protect the health of smokers and non-smokers, provide current menthol cigarette smokers an incentive to quit smoking, and protect youth, African Americans, and other vulnerable populations from the dangers of menthol cigarettes. FDA received many comments suggesting a specific, nonzero allowable level of menthol in cigarettes; many comments suggested a prohibition on menthol at any level and noted this would be the easiest standard to enforce. Other comments, without specifying a specific level or amount, argued that FDA should determine the nonzero allowable level of menthol in cigarettes. Many others urged FDA to adopt a product standard prohibiting menthol as a characterizing flavor in cigarettes without specifying a specific level or amount. Many of the comments in favor of prohibiting menthol as a characterizing flavor stated that FDA should be responsible for determining the definition of “characterizing flavor” to avoid reliance on industry practices or standards. Regardless of the formulation of a product standard, many comments stated that any menthol product standard is technically achievable and noted the prior ban on other characterizing flavors (other than tobacco and menthol) in cigarettes. Many comments stated that a product standard should apply to menthol (natural or artificial) and any additive, constituent, artificial or natural flavor, component, or insert which conveys menthol or flavoring to cigarettes or cigarette smoke, including through the tobacco or something other than the tobacco itself. These commenters often noted that there are additives beyond natural and synthetic menthol that can create a similar flavor and sensation in cigarettes. FDA also received comments from individuals and members of the tobacco industry generally opposing the establishment of any product standard for menthol cigarettes. These comments generally stated there was insufficient scientific evidence to support a menthol product standard. Industry comments also argued menthol cigarettes do not present a greater health risk when compared to non-menthol cigarettes, arguing that menthol does not increase the risk of disease or increase markers for dependence and addiction. Some comments opposed to a menthol product standard stated it would not be appropriate for the protection of the public health, as a standard would not lead to an increase in cessation and would result in consumers adding menthol to non-menthol cigarettes or the use of illicit or unregulated products. Many comments received from industry noted concern with how FDA would define “characterizing flavors,” arguing that any such definition must use clear and science-based criteria. Some comments argued that, without a definition for “characterizing flavors,” it could be difficult for industry to comply with a menthol product standard. FDA also received comments from industry suggesting that any standard apply only to known natural or synthetic menthol additives currently used in the manufacture of cigarettes, stating that it was not logical for a product standard to apply to unknown additives or additives not currently in use. FDA has reviewed and closely considered the comments to the ANPRMs, as well as additional evidence and information not available at the time of the ANPRMs, in developing this proposed rule. 4. Citizen Petition On April 12, 2013, the Tobacco Control Legal Consortium (now known as the Public Health Law Center) submitted a citizen petition on behalf of themselves, several other public health organizations, and an individual requesting that FDA ban menthol as a characterizing flavor in cigarettes (Ref. 80). FDA issued an interim response in 2013, stating that the Agency had not yet reached a decision on the petition “because it raises significant, complex issues requiring extensive review and analysis by Agency officials” (Ref. 81). In 2020, the African American Tobacco Control Leadership Council and several other public health organizations filed a lawsuit alleging that FDA unreasonably delayed addressing menthol as a characterizing flavor in cigarettes and responding to the citizen petition. Compl., African Am. Tobacco Control Leadership Council v. U.S. Dep't. of Health & Human Servs., No. 20-cv-04012 (N.D. Cal. June 17, 2020), ECF No. 1. Before any action by the court, FDA committed to responding to the petition by a date certain. Subsequently, the U.S. District Court of the Northern District of California held that section 907(a)(5) of the FD&C Act “does not necessarily require that FDA modify the [Special Rule for Cigarettes], but a determination of whether the [Special Rule for Cigarettes] should be modified is required by the statute.” Order Granting in Part and Denying in Part Motion To Dismiss, African Am. Tobacco Control Leadership Council v. U.S. Dep't. of Health & Human Servs., ECF No. 34 at 8 (emphasis in original). On January 14, 2021, the Petitioners submitted a citizen petition supplement pursuant to 21 CFR 10.30(g) to update the administrative record with research developed since 2013 on the impact of menthol in cigarettes. The supplement identified and discussed evidence related to the following topics: Menthol's impact on youth initiation, adult and youth cessation, the impact on non-users of menthol cigarettes caused by secondhand smoke exposure, thirdhand smoke exposure, tobacco waste pollution, the disproportionate impact that menthol has had on several populations ( e.g., African Americans), evaluation data from several jurisdictions that have implemented prohibitions on menthol, technical achievability, and illicit trade (Ref. 82). On April 29, 2021, FDA issued its final response to the citizen petition and included in its response a determination that the Special Rule for Cigarettes should be changed to include menthol (Ref. 83). In its response, FDA stated that it interpreted the petition “as a request that the Agency engage in the rulemaking process by proposing a rule to prohibit menthol as a characterizing flavor in cigarettes.” FDA granted the request, stating it intends to issue a proposed rule to prohibit menthol as a characterizing flavor in cigarettes (Ref. 83). FDA also stated that it intends to work with HHS to enlist and collaborate with other entities at the Federal, Tribal, State, and local levels who provide support to menthol smokers who quit or want to quit as a result of a prohibition of menthol as a characterizing flavor in cigarettes going into effect (Ref. 83). To reach this decision, the Agency considered, among other things, the petition, the January 2021 supplement filed by the Petitioners that updated the administrative record with research developed since 2013 on the impact of menthol cigarettes, and the comments submitted to the petition docket (Ref. 83). C. Legal Authority 1. Product Standard Authority Generally The Tobacco Control Act was enacted on June 22, 2009, amending the FD&C Act and providing FDA with the authority to regulate tobacco products to protect the public health, including reducing tobacco use by youth (Pub. L. 111-31). Section 901 of the FD&C Act (21 U.S.C. 387a) granted FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless tobacco as well as any other tobacco product FDA deemed by regulation. Among the tobacco product authorities provided to FDA is the authority to revise or-adopt tobacco product standards where FDA determines that such standard is appropriate for the protection of the public health (section 907(a)(2) and (3) of the FD&C Act). This includes a tobacco product standard to prohibit the use of menthol as a characterizing flavor. To establish a tobacco product standard, section 907(a)(3)(A) and (B) of the FD&C Act requires that FDA find that the standard is appropriate for the protection of the public health, taking into consideration scientific evidence concerning: • The risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard; • The increased or decreased likelihood that existing users of tobacco products will stop using such products; and • The increased or decreased likelihood that those who do not use tobacco products will start using such products. 2. Authority To Prohibit Menthol as a Characterizing Flavor in Cigarettes The Tobacco Control Act established the Special Rule for Cigarettes that prohibited cigarettes or any of its component parts from containing, as a constituent (including smoke constituent) or additive, an artificial or natural flavor or an herb or spice that is a characterizing flavor of the tobacco product or tobacco smoke (section 907(a)(1)(A) of the FD&C Act). This rule exempted menthol from the prohibition but stated that “nothing in this subparagraph shall be construed to limit the Secretary's authority to take action under this section or other sections of this Act applicable to menthol” (id.). Further, section 907(a)(2) states that FDA “may revise” the Special Rule in accordance with the rulemaking provisions outlined in section 907 of the FD&C Act. Section 907 of the FD&C Act authorizes FDA to issue tobacco product standards that are appropriate for the protection of the public health, including provisions that would require the reduction or elimination of a constituent (including a smoke constituent), or harmful component of tobacco products and provisions respecting the construction, components, ingredients, additives, constituents (including smoke constituents), and properties of the tobacco product (section 907(a)(3), (a)(4)(A)(ii), and (a)(4)(B)(i) of the FD&C Act). This includes the authority to issue a new product standard prohibiting characterizing flavors in tobacco products pursuant to section 907(a)(3) and (4) and to amend or revoke an existing product standard pursuant to section 907(d)(4) of the FD&C Act. Section 907(a)(4)(B)(v) also authorizes FDA to include in a product standard a provision restricting the sale and distribution of a tobacco product to the extent that it may be restricted by a regulation under section 906(d) of the FD&C Act. Similar to section 907(a)(4)(B)(v), section 906(d) of the FD&C Act gives FDA authority to require restrictions on the sale and distribution of tobacco products by regulation if the Agency determines that such regulation would be appropriate for the protection of the public health. Section 701 of the FD&C Act (21 U.S.C. 371) provides FDA with the authority to “promulgate regulations for the efficient enforcement of” the FD&C Act. Pursuant to section 907(a)(2) and (3) and (c) of the FD&C Act, FDA is proposing this tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes, because it would reduce the tobacco-related death and disease associated with menthol cigarette use, and FDA has found the standard to be appropriate for the protection of the public health consistent with section 907(a)(3), (a)(4)(A)(ii), and (a)(4)(B)(i). In addition, this proposed rule would prohibit the distribution, sale, and offer for distribution or sale of cigarettes with menthol as a characterizing flavor. This sale and distribution restriction would also assist FDA in enforcing the standard and would ensure that manufacturers, distributors, and retailers are selling product that complies with the standard. For these reasons, the Agency has found such restriction to be appropriate for the protection of the public health consistent with sections 907(a)(4)(B)(v) and 906(d) of the FD&C Act. FDA's analysis showing that the proposed tobacco product standard is appropriate for the protection of the public health is discussed in section V of this document. D. FDA's Consideration of Health Equity Advancing health equity is a policy priority and an important component of fulfilling FDA's mission to protect and promote public health. FDA and the Federal Government now recognize the advancement of health equity as “both a moral imperative and pragmatic policy,” as E.O. 13995 states. Considerations related to health equity helped inform FDA's decision to prioritize this proposed product standard. In particular, FDA took into account the disproportionate toll menthol cigarettes have taken on certain population subgroups. We note that the expected health benefits of this proposed standard are expected to be greater in these subgroups than in the population more generally. This proposed product standard easily clears the threshold of being appropriate for the protection of the public health, due to the large health benefits from the expected reduced initiation and increased cessation when looking at the population generally. We make this finding even without taking into account the specific expected greater health benefits from this product standard among certain population subgroups. IV. Menthol Cigarette Use Is Common, Addictive, and Harmful A. Background Menthol is a flavor additive widely used in consumer and medicinal products, including cigarettes (Refs. 1 at 782, 84). It is a compound that can be derived from plants or synthetically produced and has a minty taste and cooling properties (Refs. 84 and 2). Menthol is added to cigarettes in a variety of ways ( e.g., sprayed on the cut tobacco during blending; placed in a capsule in the filter) and eventually diffuses throughout the cigarette (Refs. 84-86). Menthol may be present in cigarettes not labeled as menthol cigarettes (Refs. 87, 84-85, 88-89). The first menthol cigarette was marketed in the late 1920s, and the menthol share of the cigarette market has continued to increase since then (Refs. 90-92). Federal Trade Commission (FTC) data on market share of the largest cigarette manufacturers indicate that the menthol cigarette market increased from 16 percent in 1963 to 29 percent in 1979 (Ref. 92). From 1980 to 2009, it remained relatively constant ranging from 25 to 29 percent (Ref. 92) and, from 2010 to 2019, it increased from 31 to 37 percent (Ref. 92). Market trend research evaluating mass retail and convenience store cigarette sales indicates that, from 2011-2015, 31.5 percent of the cigarette market was menthol (Ref. 93). Estimates of cigarette consumption from 2000 to 2018 in the United States show an overall decline of 46 percent in cigarette consumption (435.6 to 235.6 billion), but the decline was greater among non-menthol (52.9 percent; 322.8 billion to 152.0 billion cigarettes) than menthol cigarettes (26.1 percent; 112.8 billion to 83.3 billion cigarettes) (Ref. 94). B. Menthol Smoking Is Widespread and Disproportionately Impacts Youth, Young Adults, and Other Vulnerable Populations in the United States In 2019, there were more than 18.5 million current smokers of menthol cigarettes ages 12 and older in the United States (Ref. 44). Although menthol cigarette smoking is widespread in the United States, menthol cigarettes are used at a particularly high rate among youth, young adults, and other vulnerable populations such as African Americans and other racial and ethnic groups (Ref. 44). In 2019, researchers estimated that approximately 1.15 million U.S. middle and high school students had smoked a cigarette in the prior month based on data from the NYTS, a nationally representative survey (Ref. 95). Of these youth smokers, 46.7 percent reported smoking a menthol cigarette in the prior month, representing an estimated 530,000 youths (Ref. 95). Additionally, data from the 2019 NSDUH estimates that nearly 5.7 million U.S. young adults aged 18-25 years were current smokers, of which 51 percent (2.96 million young adults) smoked menthol cigarettes (Refs. 96 and 44). Using the same 2019 NSDUH data, an additional 39.4 million older adults (aged 26 and older) were current cigarette smokers, of which, 39 percent were current menthol smokers (15.4 million older adults) (Refs. 96 and 44). The disproportionate use of menthol cigarettes by youth and young adult smokers compared to older adults has been consistent over time and across multiple studies with nationally representative populations. A study that examined changes in menthol smoking prevalence among cigarette smokers using NSDUH data from 2004 to 2014 found that the prevalence of past-month menthol smoking between 2008-2010 and 2012-2014 was highest among youth smokers aged 12-17 years (52.5 percent to 53.9 percent), followed by young adult smokers aged 18-25 years (43.6 percent to 50 percent), adult smokers aged 26-34 (34.6 percent to 43.9 percent), adult smokers aged 35-49 (30.3 percent to 32.3 percent), and adult smokers aged 50 and older (30.6 percent to 32.9 percent) (Ref. 57). In 2019 NSDUH data, past-month menthol use among cigarette smokers was highest among young adults aged 18-25 years (51 percent), followed by youth aged 12-17 years (48.6 percent) and older adults aged 26 and older (39 percent) (Ref. 44). Results from a study of Wave 2 data from the PATH Study (2014-2015) support these data and indicate age-related differences in past-month menthol cigarette smoking, with a higher proportion of youth aged 12-17 years (46.6 percent) and young adult aged 18-24 years (50 percent) cigarette smokers being menthol smokers compared to older adults aged 25 and older (34.4 percent) (Ref. 97). While data on trends of cigarette smoking from NYTS show a decline in overall cigarette smoking and in menthol cigarette smoking among middle and high school student smokers from 2011 to 2018, nearly half reported smoking menthol cigarettes in 2018 (Ref. 56). African American smokers, regardless of age, are disproportionately more likely to smoke menthol cigarettes than smokers of any other race (Refs. 55-56, 21-24, 57-59, 44), and are also more likely than other racial and ethnic groups to try a menthol cigarette as their first cigarette, regardless of age (Refs. 33, 25, and 31). Findings from 2018 NYTS data show that, among middle and high school students who were current cigarette smokers, 51.4 percent of non-Hispanic Black youth and 50.6 percent of Hispanic youth reported smoking menthol cigarettes, compared to 42.8 percent of non-Hispanic White youth (Ref. 56). Statistically significant differences in this proportion by race and ethnicity have been observed in the NYTS over the 2011-2018 period. While declines in menthol cigarette use from 2011-2018 have been observed among non-Hispanic White youth, declines were not observed among non-Hispanic Black youth or Hispanic youth (Ref. 56). Similarly, among all adults, data from the National Health Interview Survey (NHIS) indicate that cigarette smoking decreased from 20.9 percent in 2005 to 15.1 percent in 2015 (Ref. 70). While there was a significant decrease in the prevalence of menthol cigarette smoking overall (5.3 percent in 2005 to 4.4 percent in 2015), the prevalence of menthol cigarette smoking did not decrease among male smokers, adult smokers aged 25-34, adult smokers aged 55 and older, non-Hispanic Asian smokers, Hispanic smokers, or smokers who had less than a high school education (Ref. 70). Additionally, this study highlights that while the prevalence of all cigarette smoking and menthol smoking, specifically, have decreased over time (2005-2015), the prevalence of menthol smoking in 2015 remained highest among specific groups, such as non-Hispanic Blacks (11.9 percent) (Ref. 70). A systematic literature review of menthol smoking by gender found that female smokers are more likely to smoke menthol cigarettes compared to men (Ref. 98). Additionally, in another study of trends in menthol smoking from 2004 to 2014, the NSDUH data showed that women are significantly more likely to smoke menthol cigarettes than men (Ref. 57). This is consistent with data from the 2019 NSDUH, which indicated that a higher proportion and number of female cigarette smokers smoked menthol (44.8 percent; 9.49 million) than male cigarette smokers (37.1 percent; 9.10 million) (Ref. 44). High levels of menthol cigarette smoking have also been reported in pregnant smokers. An analysis of 2006 to 2015 participant data from two racially and ethnically diverse cohorts of pregnant smokers with lower educational attainment and lower household income indicated high prevalence of menthol use in both cohorts (85 percent and 87 percent) (Ref. 71). Study findings indicate that individuals who identify as lesbian, gay, or bisexual are more likely to report smoking menthol cigarettes compared to those who identify as heterosexual, as well as other disparities related to gender identity or sexual orientation. 9 10 A study examining menthol use by LGBT status found a higher prevalence and a higher likelihood of smoking menthol cigarettes among LGBT smokers compared to heterosexual smokers, and that these differences in use were even greater among LGBT female respondents compared to heterosexual women (Ref. 69). In national data from the 2019 NSDUH, only 6.9 percent of those identifying as straight or heterosexual reported smoking menthol (15.95 million) compared to 14 percent of those identifying as lesbian, gay, or bisexual (2.04 million) (Ref. 44). An analysis of pooled data from the 2015-2019 NSDUH indicate that compared to heterosexual/straight respondents, respondents who identified as gay males, lesbian/gay females, or bisexual females reported higher prevalence of past 30-day smoking (Ref. 99). Additionally, compared to heterosexual/straight respondents, gay males, and bisexual males, findings indicated that lesbian/gay females and bisexual females had higher menthol preference (defined as past 30-day use of menthol cigarettes among those who smoked cigarettes in the past 30-days) (Ref. 99). 9 Throughout the preamble of this proposed rule, FDA uses the terminology cited in the scientific studies. 10 The relevant scientific studies cited herein do not provide data separated by sexual orientation and gender identity. Due to these study limitations, we discuss sexual orientation and gender identity in a combined manner, despite their important distinctions. Study findings show social gradient effects (where higher levels of indicators such as household income are linked to better health outcomes and lower levels are linked to poorer health outcomes) for menthol cigarette use (Refs. 44, 57, and 59). In 2019 NSDUH data, the prevalence of menthol smoking was 13.5 percent among those with a total family income less than $20,000, 8.4 percent between $20,000 and $49,999, 6 percent between $50,000 and $74,999, and 3.6 percent above $75,000 (Ref. 44). In another study of 2012-2014 NSDUH data, among past 30-day smokers, 43.7 percent of smokers with household income less than $30,000 smoked menthol cigarettes compared to 32.1 percent of smokers with household incomes greater than $75,000 (Ref. 57). Additionally, a study using 2018 NSDUH data found that menthol preference among cigarette smokers was 46.8 percent among those living in poverty, 11 42.3 percent among those with income up to two times above the Federal Poverty Threshold, and 35.8 percent among those with income more than two times above the Federal Poverty Threshold (Ref. 59). 11 “Living in poverty” was determined and recoded in the NSDUH public use file based on a person's family income relative to poverty thresholds. The full definition of this variable can be found in the 2019 NSDUH codebook at: https://www.datafiles.samhsa.gov/sites/default/files/field-uploads-protected/studies/NSDUH-2019/NSDUH-2019-datasets/NSDUH-2019-DS0001/NSDUH-2019-DS0001-info/NSDUH-2019-DS0001-info-codebook.pdf. The U.S. Census Bureau assigns a poverty threshold for each combination of family size and number of children in the household. To be at 100 percent of the poverty threshold is equivalent to having a family income that is the same as the poverty threshold. A poverty level less than 100 percent indicates having a family income less than the poverty threshold and therefore defined by the Federal Government as living in poverty. A poverty level greater than 100 percent indicates having a family income greater than the poverty threshold. Menthol cigarette use is also higher among adults with behavioral health conditions or illness (Refs. 44, 100, 68, 59, 101). In 2019 NSDUH data, 17.4 percent of adults age 18 and older who reported past-month serious psychological stress reported past-month menthol smoking compared to only 6.6 percent of those who did not report past month serious psychological distress (Ref. 44). An analysis of young adults (aged 18-30 years) with a serious mental illness who were receiving treatment for smoking cessation, more than half (58 percent) smoked menthol cigarettes (Ref. 101). In national data, a study utilizing 2008/2009 NSDUH data also found that cigarette smokers with mental health symptoms were significantly more likely to smoke menthol cigarettes than smokers who report mild or no mental health symptoms (Ref. 68). Another national study of women aged 18-34 years indicated that menthol smokers had higher odds of reporting anxiety or depression compared to non-menthol smokers (Ref. 100). Lastly, an analysis of young adults (aged 18-30 years) receiving treatment for smoking cessation also found that of those with severe mental illness, more than half (58 percent) smoked menthol cigarettes (Ref. 101). C. Menthol in Cigarettes Increases Smoking Initiation, Increases Progression to Regular Use, and Contributes to Nicotine Dependence 1. Menthol's Flavor and Sensory Properties Make Cigarette Smoking Easier and the Initial Response to Cigarettes More Palatable Menthol is a flavor compound that is added to cigarettes, which produces a minty taste and cooling sensation when inhaled (Ref. 2). As a result of its sensory properties, menthol can reduce irritation (Refs. 102 and 103), reduce coughing (Refs. 104 and 105), and relieve pain (Ref. 106). For this reason, compared to non-menthol cigarettes, menthol smokers perceive menthol cigarettes as easier to smoke, less irritating, smoother and more refreshing, and having a better taste (Refs. 4-5, 107-108). Such flavor and sensory effects of menthol reduce the harshness of cigarette smoking among new users, facilitating experimentation and regular use, particularly among younger smokers (Refs. 6, 7, and 5). An individual initiates smoking upon first trying a cigarette, even if they take just one or two puffs (Ref. 32). The vast majority of smoking initiation occurs during adolescence (Ref. 32). Initiation can progress to repeated experimentation, where individuals continue to occasionally try cigarettes, but do not smoke every day, and then to smoking regularly (Ref. 32). When an individual first tries a menthol cigarette, the flavor and sensory effects of menthol make initial smoking experiences more palatable. This makes it easier for new users, particularly youth and young adults, to continue experimenting with smoking and progress to regular use. The 2019 NSDUH found that each day, approximately 1,500 youth (under the age of 18 years) and 2,600 young adults (aged 18-25 years) first smoke a cigarette (Ref. 96). Results from Waves 1-4 of the PATH Study (2013-2017) and the Truth Initiative Young Adult Cohort Study show that youth (aged 12-17 years) and young adults (aged 18-24 years) are more likely to try a menthol cigarette as their first cigarette than a non-menthol cigarette (Refs. 8, 31, and 33). A separate cross-sectional analysis of Wave 1 PATH Study data (2013-2014) also found that among ever cigarette smokers ( i.e., those who reported ever trying a cigarette, even one or two puffs), nearly 43 percent of youth (aged 12-17 years) and 45 percent of young adults (aged 18-24 years) reported that the first cigarette they smoked was mentholated, compared to 30 percent of adults (aged 25 years and older) (Ref. 109). Consistent with the evidence that menthol makes cigarettes easier to use and reinforces tobacco use among new users, results from Wave 2 of the PATH Study (2014-2015) indicate that youth (aged 12-17 years) and young adults (aged 18-24 years) who initiate smoking with menthol cigarettes are more likely to report having a pleasant first smoking experience compared to smokers who initiate with non-menthol cigarettes (Ref. 110). Smokers in the study who reported a pleasant first smoking experience were more likely to smoke regularly (Ref. 110). In another study, young adult smokers (aged 18-24 years) reported that the taste of menthol ( e.g., “minty”, “cool”, “refreshing”) made cigarettes “less harsh” and “easier to inhale” than non-menthol cigarettes, and these factors influenced their initial preference for menthol cigarettes (Ref. 5). A study evaluating the sensory experiences of first cigarette use among young adult and adult smokers (aged 18-34 years) also found that fewer menthol smokers reported experiencing nausea during their first smoking experience compared to non-menthol smokers (Ref. 33). Regular menthol smokers also cite the flavor and sensory factors as primary reasons for continuing to smoke menthol cigarettes (Refs. 4, 5, and 111). Evidence from tobacco industry documents indicates that the industry has been adding menthol to cigarettes because of perceptions among new users that menthol cigarettes are less harsh and easier to smoke (Ref. 7). These documents indicate that menthol has traditionally been added to cigarettes as a design feature to attract new youth and young adult smokers (Refs. 7 and 6). For example, a 1987 document from one company states: “Menthol brands have been said to be good starter products because new smokers appear to know that menthol covers up some of the tobacco taste and they already know what menthol tastes like, vis-à-vis candy” (Ref. 112). Additionally, a 1978 document about a traditionally menthol-only cigarette brand states that the brand is “being purchased by Black people (all ages), young adults (usually college age), but the base of our business is the high school student” (Ref. 113). Menthol cigarettes continue to be used disproportionately by youth and new smokers (Ref. 44). These findings support that menthol's flavor and sensory effects make cigarettes easier to smoke by masking the harshness and irritation of tobacco and reducing unpleasant smoking experiences that can deter new users from repeated experimentation. 2. Menthol Enhances Nicotine Addiction in the Brain Menthol enhances the effects of nicotine in the brain by affecting mechanisms involved in nicotine addiction. Nicotine is the primary chemical in tobacco products that causes addiction through its psychoactive and reinforcing effects (Ref. 114). Nicotine addiction occurs as the result of repeated exposure to nicotine, which induces changes in the brain (Refs. 115, 9, and 116). Addiction to nicotine can lead to symptoms of nicotine dependence, which may include tolerance to the effects of nicotine, withdrawal symptoms upon cessation of use, and craving cigarettes (Refs. 9 and 1). Upon inhaling smoke from a burning cigarette, nicotine is absorbed into the lungs and rapidly travels to the brain. Once in the brain, nicotine produces its initial effects by binding to nicotinic receptors, the primary targets for nicotine in the brain, and inducing release of the chemical dopamine (Refs. 115 and 9). Dopamine plays a major role in the pleasurable and reinforcing effects of smoking that promote continued use (Refs. 115 and 9). After repeated exposure to nicotine, nicotinic receptors become less responsive, prompting an increase in the number of brain nicotinic receptors; this process has been implicated in the development of nicotine addiction (Ref. 9). A clinical study that analyzed brain images of adult non-smokers, menthol smokers, and non-menthol smokers found that menthol cigarette smokers have higher levels of brain nicotinic receptors than non-menthol smokers (Ref. 14). Studies in rodents have been used to provide insight into a mechanism for how menthol produces this effect in the brains of smokers. The nicotinic receptor composition, distribution, and function in the rodent brain is comparable to that of humans, and rodents can be trained to perform a variety of behavioral tasks (Refs. 117-119). Therefore, rodents serve as an appropriate model to examine the behavioral effects of nicotine and the effects of nicotine in the brain. Studies demonstrate that menthol, like nicotine, binds to nicotinic receptors in the brain (Refs. 15 and 16), and menthol alone can increase the number of nicotinic receptors in the brain (Refs. 10 and 11). Consistent with clinical findings in menthol smokers (Ref. 14), animal studies also demonstrate that menthol in combination with nicotine increases the number of nicotinic receptors in the brain to a greater extent than nicotine alone (Refs. 10-12). This effect in the brain was accompanied by greater intensity of nicotine withdrawal signs in rodents treated with nicotine and menthol compared to those treated with nicotine alone (Ref. 10). Menthol also enhances nicotine's effects on dopamine in the rodent brain. Animal studies demonstrate that nicotine-induced dopamine release is greater in the presence of menthol (Ref. 13). Additionally, menthol enhances nicotine-induced increases in dopamine cell activity to a greater extent than nicotine alone; these changes were associated with differences in behavioral responses to the rewarding effects of nicotine, where menthol-treated rodents exhibited greater reward for nicotine than those treated with nicotine alone (Ref. 12). These findings demonstrate that menthol's effects on nicotine in the brain are associated with behaviors indicative of greater addiction to nicotine. In combination with menthol's flavor and sensory effects, menthol's interaction with nicotine in the brain plays a role in making it easier to experiment, progress to regular smoking and dependence, and harder to quit smoking. 3. The Adolescent Brain Is Particularly Vulnerable to the Effects of Nicotine Youth and young adults are particularly susceptible to becoming addicted to nicotine. Due to its ongoing development, the adolescent brain, which continues to develop until about age 25, is more vulnerable to nicotine's effects than the adult brain (Refs. 17-19). The 1994, 2012, 2014, and 2020 Surgeon General's Reports on smoking and health note that almost 90 percent of current adult regular smokers initiated smoking before age 18, and 99 percent initiated smoking before the age of 25, which is the approximate age at which the brain has completed development (Refs. 120, 32, 1, 245). Though age ranges for youth and young adults vary across studies, in general, “youth” or “adolescent” encompasses those 11-17 years of age, while those who are 18-25 years old are considered “young adults” (even though, developmentally, the period between 18-20 years of age is often labeled late adolescence); those 26 years of age or older are considered “adults” (Ref. 32). Studies in adolescent and adult rodents show that adolescents are more sensitive to the rewarding and reinforcing effects of nicotine than adults (Refs. 121-124). In particular, animal studies highlight that early adolescence is a critical period for vulnerability to nicotine addiction (Refs. 125-127). Studies have also found that nicotine exposure during adolescence induces changes in the brain that either do not occur in animals exposed to nicotine in adulthood or are observed to a lesser extent following adult nicotine exposure. For example, studies using adolescent and adult rodents show that nicotine exposure during adolescence induces changes in gene expression, changes in brain structure and activity, and greater, more widespread increases in brain nicotinic receptor expression compared to exposure in adulthood (Refs. 128-131). These effects of nicotine on the developing brain largely occur in brain regions involved in addiction, learning, and memory (Refs. 132-133, 129, 131). Rodent studies also support that many of these changes remain after nicotine exposure has ended, and persist into adulthood (Refs. 133, 132, 130, 17-18). Studies among youth support the findings from animal studies and show that adolescence is a vulnerable period for nicotine addiction. Youth who initiate tobacco use at earlier ages are more likely than those initiating at older ages to report current daily smoking and symptoms of tobacco dependence (Refs. 134-136). Researchers in a 4-year study of sixth grade students found that the most susceptible youth lose autonomy ( i.e., independence in their actions) regarding tobacco within 1 or 2 days of first inhaling from a cigarette (Ref. 137). The study also found that “[e]ach of the nicotine withdrawal symptoms appeared in some subjects prior to daily smoking” (Ref. 137) (emphasis added). Ten percent of youth showed signs of dependence to tobacco use within 1 or 2 days of first inhaling from a cigarette, and half had done so by the time they were smoking seven cigarettes per month (Ref. 137). Another study that followed 12-13 year old adolescents over 6 years found that 19.4 percent of adolescents who smoked weekly were nicotine dependent (Ref. 138). In a study of nicotine dependence among recent onset adolescent smokers (9th and 10th grade students), individuals who smoked cigarettes only 1 to 3 days of the past 30 days experienced nicotine dependence symptoms such as loss of control over smoking and irritability after not smoking for a while (Ref. 139). Overall, these findings demonstrate that, due to ongoing brain development, youth and young adults who experiment with smoking are at greater risk of becoming addicted to nicotine and maintaining tobacco product use into adulthood (Refs. 17, 18, and 32). Therefore, due to the combined effects of nicotine and menthol in the developing brain, youth who smoke menthol cigarettes are particularly vulnerable to the effects of menthol on progression to regular use and dependence. 4. Menthol Facilitates Experimentation and Progression to Regular Cigarette Use Among Youth and Young Adults Consistent with the impact of menthol in cigarettes on smoking ease and nicotine addiction, menthol cigarettes have been shown to facilitate progression to regular use in new smokers, particularly in youth and young adults. A longitudinal study that evaluated smoking behaviors in middle and high school students over the course of 3 years (2000-2003) found that youth who initiate smoking with menthol cigarettes are more likely to progress to regular cigarette smoking compared to youth who initiate smoking with non-menthol cigarettes (Ref. 25). These findings are supported by nationally representative data from the Evaluation of Public Education Campaign on Teen Tobacco longitudinal national youth survey, which examined youth over 3 years (2013-2016) (Ref. 30). Youth in the study who reported experimenting with menthol cigarettes in a prior year were more likely to report progressing to regular smoking than youth who smoked non-menthol cigarettes (Ref. 30). Additionally, data from the 2011 National Young Adult Health Survey (NYAHS) found that young adult (aged 18-34 years) current menthol smokers had double the odds of reporting an increase in cigarette smoking over the previous year compared to non-menthol smokers (Ref. 29). Similarly, longitudinal data from Waves 1 and 2 of the PATH Study (2013-2015) were used to evaluate the association of flavored tobacco use with product initiation among youth (aged 12-17 years), young adults (aged 18-24 years), and older adults (aged 25 and older) over a 10-13 month timeframe (Ref. 31). The study found that among all age groups, those that first used a menthol cigarette were more likely to report any past 12-month or past 30-day smoking at followup compared to those who reported a non-menthol cigarette as the first cigarette smoked (Ref. 31). Further, among those in all age groups, those whose first cigarette was menthol were more likely to report smoking every day in the past 30 days at followup compared to smokers who initiated with non-menthol cigarettes (Ref. 31). Expanding on these findings, longitudinal data across Waves 1-4 of PATH data (2013-2017) showed that among young adults, those who smoked menthol as the first cigarette were more likely to report continued smoking over the past 12 months compared to smokers who initiated with non-menthol cigarettes (Ref. 8). Overall, the evidence supports that menthol facilitates repeated experimentation and progression to regular smoking among youth and young adults. This finding is consistent across different populations and time periods, including in studies that assess large, nationally representative populations. 5. Menthol Contributes to Nicotine Dependence in Young People Data from multiple studies across different populations and time periods demonstrate that menthol cigarettes contribute to greater nicotine dependence in youth (Refs. 20-28). One longitudinal study evaluated middle and high school students over 3 years (2000-2003) in 83 schools in 7 communities across 5 states. Data from the study show that youth who initiated smoking with menthol cigarettes scored higher on a scale of dependence than youth who initiated with non-menthol cigarettes (Ref. 25). Nationally representative data from the 2000 and 2002 NYTS found that youth who smoked menthol cigarettes on at least 1 day in the past month reported higher scores on a scale of nicotine dependence compared to non-menthol smokers (Ref. 21). In addition, studies using 2004 and 2006 NYTS data found that, compared to youth non-menthol smokers, youth menthol smokers report multiple indicators of nicotine dependence, including higher levels of craving for cigarettes, needing a cigarette within one hour after smoking, and increased feelings of restlessness and irritability without smoking (Refs. 22 and 24). Pooled NYTS analyses (2017-2020) also indicate that youth menthol smokers have greater odds of experiencing tobacco cravings and using tobacco within 30 minutes of waking than non-menthol smokers (Ref. 28). Similarly, results from Wave 2 PATH Study data (2014-2015) show that youth menthol smokers report higher levels of craving, tolerance to the effects of nicotine, and affiliative attachment (feeling “alone” without cigarettes), indicating that youth menthol smokers are more physically dependent on nicotine and experience greater emotional attachment to cigarettes than youth non-menthol smokers (Ref. 26). Studies also demonstrate that youth menthol smokers smoke more frequently than non-menthol smokers, indicating an increased risk of being more nicotine dependent than non-menthol smokers. Youth who smoke more frequently display greater symptoms of nicotine dependence (Ref. 138). Compared to smokers of “other brands” (at the time of the study “other brands” may have included non-menthol flavored and unflavored cigarettes), youth menthol smokers have reported greater levels of smoking, including having smoked more total cigarettes, smoking on more days and more cigarettes in a month, having smoked more recently, and having ever smoked daily (Ref. 23). Nationally representative data also indicate that higher proportions of youth menthol smokers report smoking more frequently compared to non-menthol smokers (Refs. 56, 27, and 28). In analyses of pooled 2016-2018 NYTS data, higher proportions of youth menthol smokers reported smoking on more days during the month, smoking more cigarettes per day, and smoking 100 or more cigarettes in their lifetime compared to non-menthol smokers (Ref. 56). These findings are supported by 2017-2020 NYTS data, which show that youth menthol smokers have greater odds of smoking 10-30 days out of the month compared to non-menthol smokers (Refs. 27 and 28). Furthermore, 2017 and 2018 NYTS data indicate that, compared to youth non-menthol smokers, youth menthol smokers are more likely to report intentions to continue smoking cigarettes in the following year (Ref. 27). Some studies have not found a significant difference in dependence outcomes between youth menthol and non-menthol smokers. One study, using data from the Development and Assessment of Nicotine Dependence in Youths study, examined the relationship between the first smoking experience and the development of nicotine dependence symptoms in youth and did not find a difference in dependence level between menthol and non-menthol smokers (Ref. 140). A study that used PATH data to examine the association between first use of menthol cigarettes and nicotine dependence scores at a subsequent wave, also did not find a relationship between menthol cigarette use and dependence among youth (Ref. 8). Furthermore, a nationally representative study that evaluated associations between menthol use and dependence among youth (aged 15-19 years) in the 2003 and 2006-2007 Tobacco Use Supplement to the Current Population Survey (TUS-CPS) and youth (aged 12-19 years) in the 1999-2010 National Health and Nutrition Examination Survey (NHANES) did not find an association between menthol smoking and level of dependence (Ref. 141). Studies that found no effect of menthol on dependence in youth constitute a smaller number of studies in the totality of evidence. The few studies (discussed in the previous paragraph) that did not find an effect of menthol in cigarettes on greater dependence in youth were either not nationally representative or had other limitations that reduced the generalizability or influenced the validity of the findings. These study limitations include small samples sizes, which may reduce ability to detect significant between-group differences; failure to report sample sizes for populations assessed; and survey data that included participants beyond the typical age range for youth studies (age 12-17 years), which reduces generalizability of the findings to youth. Based on the number and strength of the studies that support the conclusion that menthol is associated with greater dependence among youth and the limitations of the evidence that did not find an effect of menthol on youth dependence, the totality of evidence supports that menthol in cigarettes contributes to greater dependence among youth. This conclusion is supported by multiple nationally representative studies that were designed to collect and evaluate survey data on tobacco use in youth populations. D. Menthol in Cigarettes Makes Quitting Smoking More Difficult 1. Menthol Contributes to Reduced Cessation Success, Particularly Among Black Smokers A number of nationally representative studies among young adult and adult smokers show that menthol in cigarettes contributes to reduced cessation success (Refs. 34-35, 42, 36-38, 40, 43). A study from the 2003 and 2006-2007 TUS-CPS examined quit attempts and quit rates in menthol and non-menthol smokers (Ref. 37). Overall, quit attempts were 8.8 percent higher among menthol smokers compared to non-menthol smokers, but menthol smokers had 3.5 percent lower rates of quitting within the past year and 6 percent lower rates of quitting within the past 5 years compared to non-menthol smokers (Ref. 37). Young adults (aged 18-24 years) who smoked menthol cigarettes made more quit attempts than menthol smokers of older adult age groups (aged 25 and older) and had higher rates of quitting for 3 months to 1 year than non-menthol smokers; however, when evaluating longer term quitting ( i.e., within the past 5 years) young adult menthol smokers were less likely to have successfully quit smoking than non-menthol smokers (Ref. 37). Taken together, these findings suggest that short-term quitting does not translate to long-term success in quitting among young adult menthol smokers. Other studies that used 2003 and 2006-2007 TUS-CPS data examined the role of menthol in cessation and found that, compared to non-menthol smokers, menthol smokers were less likely to have successfully quit smoking for at least 6 months (Ref. 42) and were less likely to report having quit smoking in the past 5 years (Ref. 36). Data from the 2010-2011 TUS-CPS also found that menthol smokers were less likely than non-menthol smokers to report having abstained from smoking for 1-3 years (Ref. 38). Additionally, longitudinal studies demonstrate that menthol smokers have more difficulty quitting compared to non-menthol smokers. One PATH Study using data from Waves 1-4 (2013-2017) found that, after 12 months, quit rates were significantly lower among daily menthol smokers (4 percent) compared to daily non-menthol smokers (5.3 percent) after adjusting for age, sex, race and ethnicity, education, nicotine dependence, and past quit attempts (Ref. 40). Daily menthol smokers also had 24 percent lower odds of quitting smoking compared to non-menthol smokers (Ref. 40). Another PATH Study using data from Waves 1-4 (2013-2017) evaluated short-term (30-day) and long-term (12-month) smoking abstinence among menthol and non-menthol smokers who had attempted to quit smoking in the past 12 months (Ref. 43). Menthol smoking decreased the probability of 30-day smoking abstinence by 28 percent and the probability of 12 month smoking abstinence by 53 percent compared to smoking non-menthol cigarettes after adjusting for race, sex, age and frequency of smoking (Ref. 43). The Coronary Artery Risk Development in Young Adults (CARDIA) study, which evaluated smoking cessation behavior in young adult smokers (age 18-30 years) across 15 years (1985-2000), also found that menthol smokers were more likely to report continued smoking at two consecutive followups and were almost twice as likely to have relapsed compared to non-menthol smokers (Ref. 142). Short- and long-term clinical longitudinal studies of cessation also show that menthol smokers are less likely than non-menthol smokers to achieve cessation success (Refs. 143-147). A short-term cessation study found that menthol smokers were more likely than non-menthol smokers to relapse within 48 hours of quitting smoking (Ref. 147). A long-term cessation study evaluated the effectiveness of smoking cessation therapies and tested smokers for cessation success at several timepoints throughout the study (Ref. 146). Menthol smoking was associated with reduced likelihood of successful quitting at the 4-week, 8-week, and 26-week followup assessments (Ref. 146). These findings are supported by data from studies of smokers interested in quitting smoking, which show that menthol smokers are less likely to achieve cessation success than non-menthol smokers at study followups ranging from 3 weeks to 6 months (Refs. 148, 143-145). Evidence from nationally representative studies show that the effect of menthol on reduced cessation success is particularly evident among Black smokers (Refs. 34-38, 40). Data from the 2005 NHIS Cancer Control Supplement were used to examine racial and ethnic differences in menthol cigarette smoking and found that African American menthol smokers had a significantly decreased likelihood of quitting smoking compared to African American and White non-menthol smokers (Ref. 35). Data from the 2005 and 2010 NHIS were also used to evaluate the association between menthol cigarette smoking and likelihood of being a former smoker (Ref. 38). Black menthol smokers were less likely than Black non-menthol smokers to report not having smoked in the past year (Ref. 38). Additional analyses of 2005 NHIS and 2003 and 2006-2007 TUS-CPS data found that, compared to Black non-menthol smokers, Black menthol smokers were less likely to report smoking “not at all” at the time of the survey and less likely to report having quit smoking in the past 5 years (Refs. 34 and 36). Longitudinal studies using Waves 1-4 PATH data (2013-2017) and data from the CARDIA Study also demonstrate that African American menthol smokers have more difficulty quitting compared to African American non-menthol smokers. These studies evaluated the effect of menthol on cessation at multiple timepoints in the same population of smokers. A recent study using nationally representative PATH data found that, after 12 months, quit rates were significantly lower among African American daily menthol smokers (3 percent) compared to African American daily non-menthol smokers (6.2 percent) (Ref. 40). Among Black daily smokers, menthol smokers also had 53 percent lower odds of quitting smoking compared to non-menthol smokers after controlling for age, sex, education, nicotine dependence, and past quit attempts (Ref. 40). Additionally, the CARDIA study measured smoking cessation behaviors in young adult (aged 18-30 years) menthol and non-menthol smokers from four U.S. cities over 15 years (1985-2000) (Ref. 142). After adjusting for health insurance status and other factors, the study found that African American menthol smokers were less likely to report having sustained cessation at two consecutive followups than African American non-menthol smokers (Ref. 142). Among African Americans, menthol smokers were also more likely to have relapsed back to smoking (Ref. 142). Clinical longitudinal studies have also evaluated short- and long-term cessation success in current smokers and smokers seeking treatment to quit. These studies show that among African Americans, menthol smokers are less likely than non-menthol smokers to remain abstinent from smoking (Refs. 149-152, 146). A cessation study in African American smokers determined that the smokers who had quit by the end of the 7-week study treatment were more likely to smoke non-menthol cigarettes, compared to menthol cigarettes (Ref. 152). Furthermore, a long-term cessation study found that, among African American smokers, menthol smokers were significantly less likely to have quit at the 6-month followup assessment (Ref. 151). Another clinical study in African American smokers found that menthol smokers were less likely to have quit smoking at the 6-month followup than non-menthol smokers (Ref. 150). Data from the 2003 and 2006-2007 TUS-CPS also found that African American menthol smokers made more quit attempts and had higher rates of quitting for 3 months to 1 year than smokers of other racial and ethnic groups; however, when evaluating quitting in the past 5 years, quit success was lower among African American menthol smokers compared to other racial/ethnic groups (Ref. 37). Taken together, these findings suggest that short term quitting does not translate to long term success in quitting among African American menthol smokers. Furthermore, studies using 2006-2007 and 2010-2011 TUS-CPS data show that African American menthol smokers are more likely to make a quit attempt than African American non-menthol smokers, but these attempts do not necessarily translate into successful cessation (Refs. 153 and 154). Additionally, a community-based survey of African American adults in Minnesota aimed to understand African Americans' perceptions of menthol cigarettes and reasons for unsuccessful quit attempts among menthol smokers (Ref. 155). Menthol smokers in the study were more likely than non-menthol smokers to perceive menthol as harder to quit. Forty-five percent of menthol smokers who reported a failed quit attempt reported craving as the reason for the unsuccessful attempt (Ref. 155). Some studies do not show that menthol smokers have more difficulty quitting than non-menthol smokers (Refs. 156-159, 67, 160, 64, 29, 161-163). For example, data from the 2003 and 2006-2007 TUS-CPS that evaluated smoking abstinence at 2 weeks did not find a difference in cessation success between menthol and non-menthol smokers (Ref. 64). Data from the nationally representative 2011 NYAHS study of young adults (aged 18-34 years) who self-reported past year smoking behaviors also did not find significant differences in the proportion of menthol and non-menthol smokers who reported quitting (Ref. 29). Among longitudinal studies, some studies have reported no difference in quit rates or odds of quitting between menthol and non-menthol smokers at 6-month, 7-month, 12-month, and 5-year followup assessments based on individual self-report (Refs. 159, 158, 156, 163). In another longitudinal study, researchers analyzed data from a randomized controlled trial of smoking cessation that tested breath carbon monoxide to confirm self-reported smoking status at an 8-week follow-up assessment (Ref. 161). The study found no difference in smoking abstinence rates between menthol and non-menthol smokers (Ref. 161). Two meta-analyses of the literature that combined the results of multiple menthol and cessation studies, as well as one systemic literature review, all found statistically significant reductions in the likelihood of cessation among African American menthol smokers, and two of the three found reductions for cessation in the general population (Refs. 39, 41, and 164). These studies highlight the large amount of variability across the different studies in this body of literature. For example, across menthol and cessation studies, populations varied by sociodemographic factors such as race or ethnicity, gender, and geographic region; studies ranged from large nationally representative samples to small clinical trials of cessation; studies varied by the followup timepoints at which they assessed cessation, ranging from 48 hours to 15 years; studies did not use the same methods or definitions to measure cessation; and studies did not control for the same factors that may influence cessation outcomes ( e.g., demographics, nicotine dependence, use behaviors). This variability may in part explain the inconsistencies across study findings related to menthol and cessation. Of studies that evaluated menthol in populations of current and former smokers, studies which found that menthol smokers have more difficulty quitting were more likely to be longitudinal, allowing for assessments of cessation across multiple time points among the same individuals, and generally had longer followup periods than studies that found no effect of menthol on cessation success. Several studies which found that menthol reduces cessation success also confirmed whether menthol smokers had quit at followup assessments by testing for indicators of cigarette smoking in saliva and/or through breath carbon monoxide, in addition to individual self-report. An individual's self-report of quitting may not always be accurate ( e.g., individuals may not remember correctly or may not be truthful in responding); therefore, studies that also test for indicators of cigarette smoking through biochemical verification, such as levels of carbon monoxide in breath and/or nicotine metabolites in blood, urine, or saliva, provide strong evidence to validate individual responses (Ref. 165). Furthermore, the meta-analyses of the cessation literature only included studies published through 2017 (Refs. 39 and 41). Two recent studies using data from the nationally representative, longitudinal PATH Study, are thus not included in these meta-analyses; both PATH studies suggest that menthol smoking is associated with reduced smoking cessation across multiple years of data (Refs. 40 and 43). Therefore, despite some contrary findings, the studies that utilized designs that allowed for long-term assessments of menthol and cessation success and that used multiple methods to confirm smoking status at followups were more likely to find an effect of menthol on reduced cessation success in the general population. 2. Menthol's Interaction With Nicotine in the Brain Makes it Harder To Quit Smoking Addiction to nicotine makes it difficult to quit smoking (Ref. 1). As discussed in section IV.C.2, repeated exposure to nicotine through smoking leads to an increase in nicotinic receptor levels in the brains of smokers; this process is associated with the development of nicotine addiction (Ref. 9). When an individual stops smoking, such as overnight or when attempting to quit, the nicotine levels in the brain decrease as the body clears nicotine, but the number of nicotinic receptors does not (Ref. 115). The combination of high levels of nicotinic receptors and low levels of nicotine in the brain produces the discomfort smokers feel when experiencing symptoms of nicotine withdrawal (Ref. 115). This is consistent with reports that smokers with greater brain nicotinic receptor levels have more difficulty quitting than smokers with lower brain nicotinic receptor levels (Ref. 166). Clinical and animal studies show that menthol enhances brain nicotinic receptor levels to a greater extent than nicotine alone (Refs. 14, 10, and 11). These changes occur in brain regions involved in the development of nicotine addiction (Refs. 10-12). Therefore, menthol's ability to enhance the effects of nicotine in the brain contributes to why menthol smokers have greater difficulty quitting smoking compared to non-menthol smokers. 3. Conclusion The totality of scientific evidence on menthol and cessation supports the conclusion that menthol cigarettes contribute to reduced cessation success, particularly among Black smokers. This effect of menthol among Black smokers is consistent across large nationally representative studies, smaller clinical studies of smokers, reviews of the menthol and cessation literature, and meta-analyses, which examined outcomes from multiple menthol and cessation studies. Findings among smokers in the general population produce more mixed results, which may be attributed in part to heterogeneity across study designs, methods, and populations; however, the evidence that supports an effect of menthol on reduced cessation success includes longitudinal studies that evaluated quitting outcomes in the same population of smokers for up to 15 years and studies of up to 6 months that tested for indicators of continued cigarette smoking to strengthen the validity of individual self-report. When considering the evidence from nationally representative surveys, longitudinal studies that evaluated cessation outcomes over time, and menthol's effects on nicotinic receptors in the brain, the totality of evidence supports that menthol in cigarettes contributes to reduced cessation success, particularly among Black smokers. E. Menthol Cigarettes Are Marketed Disproportionately in Underserved Communities and to Vulnerable Populations Tobacco marketing activities ( e.g., advertising and promotions) are effective in promoting sales, increasing tobacco use, and engendering positive attitudes about tobacco products among youth, young adults, and other vulnerable populations (Refs. 167, 32, and 49). With regard to menthol cigarettes, decades of targeted marketing activities have helped to make menthol cigarettes more appealing and affordable and contributed to the pervasive and enduring nature of disparities in menthol cigarette smoking observed in vulnerable populations, particularly the Black community. Tobacco industry research on menthol cigarettes illustrates that the industry “carefully researched the menthol segment of the market” and “added [menthol] to cigarettes in part because it is known to be an attractive feature to inexperienced smokers” (Ref. 7). In addition, evidence shows the tobacco industry employed a wide range of marketing activities, including branding, advertising and promotion, product placement, and pricing, to promote sales and increase menthol cigarette use by certain populations. For example, research indicates that in the 1960s and 1970s, the tobacco industry's menthol cigarette advertising and promotion heavily targeted the African American community by use of darker-skinned models, tailored messaging and language, and reliance on media such as magazines with a high Black readership (Refs. 168, 90, and 92). Industry research identified the cultural values, geographic location, and taste preferences of Black smokers, which was then used to inform tobacco product branding ( e.g., “Kool” cigarettes), culturally-tailored imagery in advertisements, and locations to reach and appeal to Black menthol smokers (Refs. 169, 168, 90-91). Over many decades, tobacco companies continued to employ marketing strategies to promote menthol cigarette use among youth, young adults, and underserved communities, such as low-income Black communities. The strategies used to target underserved communities included discounts (Ref. 170), distribution of free samples (Refs. 168, 171, and 172), and advertising in nightclubs, bars, and special events (Ref. 171). The tobacco industry also marketed menthol cigarettes to low-income Black communities and youth, including Black teens as young as 16 years of age, by selling menthol cigarettes in smaller package quantities to encourage trial and initiation, and to provide a lower price point (Refs. 173 and 174). Recent scientific evidence indicates that tobacco companies market menthol cigarettes in the retail environment to continually appeal to underserved communities. For example, menthol marketing is more prevalent in neighborhoods that have more Black and low-income residents (Refs. 170 and 175). Furthermore, tobacco retailers in predominantly Black neighborhoods are more likely to advertise discount promotions for menthol cigarettes, and sell menthol cigarettes at a lower price, as compared to tobacco retailers in predominantly White neighborhoods (Refs. 175, 170, and 176). Menthol marketing is also more visible in neighborhoods with predominately Black residents as compared to predominately White neighborhoods, as well as in urban neighborhoods (Ref. 175). A recent nationally representative study of tobacco retailers in the contiguous United States found that retail menthol advertising was more common in neighborhoods with more Black and low-income residents (Ref. 177). Furthermore, price promotions for Newport brand menthol cigarettes were more common in retailers in neighborhoods with more Black residents (Ref. 177). Higher exposure to tobacco advertisements and retailing are associated with disparities in tobacco use susceptibility and tobacco use among youth. For example, youth who live or go to school in neighborhoods where tobacco retailers are disproportionately present are more susceptible to smoking (Refs. 178 and 179), are more likely to experiment with smoking (Refs. 180 and 179), and are more likely to smoke currently (Ref. 181). Taken together, scientific evidence indicates that menthol cigarettes have historically and continue to be disproportionately marketed in underserved communities and contribute to the longstanding disparities in menthol cigarette smoking and health outcomes observed in vulnerable populations, particularly the Black community. While targeted marketing is only one factor in the development and perpetuation of menthol cigarette use and related harms, this background helps to explain and provide critical context for the outcomes and disparities that undermine public health and are of concern to FDA. Addressing how these products disproportionately affect vulnerable populations supports the Agency's mission of promoting public health. V. Determination That the Standard Is Appropriate for the Protection of the Public Health The Tobacco Control Act authorizes FDA to revise or adopt tobacco product standards by regulation if it finds that such tobacco product standards are appropriate for the protection of the public health (section 907(a)(2) and (a)(3)(A) of the FD&C Act). The notice of proposed rulemaking for such a product standard must set forth this finding with supporting justification, which FDA is doing here (section 907(c)(2)(A) of the FD&C Act). In order to make this finding, FDA must consider scientific evidence concerning: • The risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard; • The increased or decreased likelihood that existing users of tobacco products will stop using such products; and • The increased or decreased likelihood that those who do not use tobacco products will start using such products. (Section 907(a)(3)(B)(i) of the FD&C Act) FDA has considered scientific evidence related to all three factors. Based on these considerations, as discussed below, we find that the proposed standard is appropriate for the protection of the public health because the prohibition of menthol as a characterizing flavor in cigarettes: Decreases the likelihood that nonsmokers would experiment with cigarettes, develop tobacco dependence symptoms, and progress to regular cigarette smoking and/or use of other tobacco products, while also decreasing the likelihood that current smokers would continue to smoke cigarettes. Cigarettes are the most toxic consumer product when used as intended and adding menthol as a characterizing flavor makes cigarettes more appealing and easier to smoke. The proposed standard is anticipated to decrease the likelihood of menthol cigarette experimentation and the subsequent progression to regular, established cigarette smoking and cigarette consumption. Further, the proposed standard is anticipated to improve the health of current smokers of menthol cigarettes by increasing the likelihood of cessation, which would lead to lower disease and death in the U.S. population due to diminished exposure to tobacco smoke for both users and nonusers of cigarettes. Prohibiting menthol as a characterizing flavor in cigarettes would reduce the death and disease caused by cigarette use. A. The Likelihood That Nonusers Would Start Using Cigarettes Menthol in cigarettes is a significant contributor to youth and young adult initiation of cigarette smoking. In this section, we summarize evidence from multiple study designs, incorporating findings from longitudinal studies, national surveys, policy evaluations, and qualitative research that illustrate the role menthol plays in facilitating initiation and experimentation of cigarettes. We also discuss how the proposed prohibition on menthol as a characterizing flavor in cigarettes would decrease experimentation and thus, reduce progression to regular cigarette smoking among current nonusers. Menthol is a flavor compound that is added to cigarettes, which produces a minty taste and cooling sensation when inhaled (Ref. 2). These sensory properties are pleasing and drive smoker beliefs that menthol cigarettes have a better taste, are smoother and more refreshing, are easier to inhale, and are less irritating than non-menthol cigarettes (Refs. 3-5). These properties also mask the harshness of smoking for new smokers and facilitate repeated experimentation and progression to regular smoking of menthol cigarettes, particularly among youth and young adults (Refs. 6-7, 5, 8). When an individual tries a menthol cigarette, the sensory effects associated with menthol make initial and continued smoking experiences more palatable. In a focus group study conducted with young adult (aged 18-24) menthol smokers, participants reported that the taste of menthol made cigarettes as “minty”, “cool”, and “refreshing”, stating that these factors influenced their initial preference for menthol cigarettes (Ref. 5). Further, these young adults indicated that they continued to smoke menthol cigarettes because they taste and smell better than non-menthol cigarettes (Ref. 5). In addition, a study evaluating the sensory experiences of first cigarette use among young adult smokers found that fewer menthol smokers reported experiencing nausea during their first smoking experience compared to non-menthol smokers (Ref. 33). Evidence from tobacco industry documents also support that menthol is added to cigarettes in part because it is known to be an attractive feature to new and younger inexperienced smokers who perceive menthol cigarettes as less harsh and easier to smoke than non-menthol cigarettes (Ref. 7). The increased likelihood of initiation of menthol cigarettes is reflected in the high proportion of youth and young adults who report that their first cigarette was menthol as compared to older adult smokers and the high proportion of past 30-day menthol smoking among youth as compared to older adult smokers (Refs. 8, 31, 33, 65-66, 182-183, 55-57, 44, 95). National studies and data also show that younger smokers (aged approximately 12-25 years) are more likely to smoke menthol cigarettes than older adult smokers (aged 26 and older) (Refs. 65-66, 182-183, 57, 55, 44). Among middle and high school students, the prevalence of current past 30-day menthol cigarette smoking decreased from 2011 to 2018 in NYTS data (Ref. 56), however approximately 47 percent of youth who smoke cigarettes reported smoking menthol cigarettes in 2019 (Ref. 95). Baseline findings from PATH Study data indicate similar findings, with nearly 43 percent of youth (12 to 17 years of age) and 45 percent of young adult (18 to 24 years of age) ever cigarette smokers ( i.e., those young adults who have used a tobacco product even once or twice in their lifetimes) reported that the first cigarette they smoked was mentholated (Ref. 31). In a followup study examining Waves 1-4 (2013-2017) of PATH data, youth (aged 12-17 years) and young adult (aged 18-24 years) new smokers (smokers who reported trying a cigarette for the first time between any adjacent waves) were more likely to report smoking menthol cigarettes than adults aged 25 and older (Ref. 8). These findings are consistent across studies encompassing different populations and time periods, including studies that assess large, nationally representative populations (Refs. 65-66, 182-183, 55-57, 44, 95, 31, 8). Data indicating youth and young adults are more likely to smoke menthol cigarettes points to the importance of the proposed product standard in protecting these vulnerable populations. Experimentation with cigarettes can lead to nicotine dependence, which in turn increases the likelihood that experimenters will progress to regular cigarette smoking. As discussed in section IV.C of this document, studies have long provided clear evidence that signs of nicotine dependence in youth can arise soon after they first start smoking cigaret [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2022-08994. Public record. Not legal advice.