Association of Ontario's Ban on Menthol Cigarettes with Smoking

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Medicine, Chicago, Illinois (Levine); Rush University Medical Center, Chicago, random-digit dialing was 44.1%, with a 6.7% refusal rate Illinois (O’Mahony, Fitchett). among known eligible participants, consistent with an Corresponding Author: Aoife C. Lee, DMin, BCC, Spiritual Care Department, established provincial health monitoring survey. Partici- Rush Oak Park Hospital, 520 S Maple Ave, Oak Park, IL 60304 (aoife_lee@rush .edu). pants were contacted for follow-up beginning 1 month Accepted for Publication: November 18, 2017. (February 1, 2017) after the implementation of the Published Online: January 16, 2018. doi:10.1001/jamainternmed.2017.7961 ban (January 1, 2017) through an online survey Author Contributions: Drs Lee and Fitchett had full access to all of the data in (206 recontacted [63.4%]). Those who were unavailable for the study and take responsibility for the integrity of the data and the accuracy follow-up did not differ by level of menthol smoking, age, of the data analysis. sex, income, educational level, or smoking characteristics. Study concept and design: Lee, McGinness, Fitchett. Acquisition, analysis, or interpretation of data: All authors. Planned reaction to the ban, actual behavior at 1 month Drafting of the manuscript: Lee, Fitchett. after the ban, and planned future reaction beyond 1 month Critical revision of the manuscript for important intellectual content: All authors. after the ban were compared. Oral consent was obtained Statistical analysis: Lee, Fitchett. from all participants, and the analytic data set was deidenti- Administrative, technical, or material support: Lee, McGinness, O'Mahony, Levine. fied. This study was approved by the research ethics board Study supervision: Lee, Fitchett. of the University of Toronto, Toronto, Ontario, Canada. Conflict of Interest Disclosures: None reported. Additional Contributions: This project was conducted while Board-Certified Chaplain Aoife Lee was a fellow in the Coleman Palliative Medicine Training Results | A total of 325 participants participated in the study Program, Chicago, Illinois–Cohort 2, 2015 to 2017. Chaplain Lee is grateful for (181 [55.7%] male; 143 [44.0%] female; mean [SD] age, 47.1 the support of the coauthors. [0.9] years). Before the ban, most menthol smokers (123 1. Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of [59.7%]) said that they surrogate decision making before death. N Engl J Med. 2010;362(13):1211-1218. would switch to or only use Invited Commentary page 711 2. Teno JM, Gozalo PL, Bynum JP, et al. Change in end-of-life care for Medicare nonmenthol cigarettes, but beneficiaries: site of death, place of care, and health care transitions in 2000, only 51 (28.2%) had done so 2005, and 2009. JAMA. 2013;309(5):470-477. at follow-up (Table). In contrast, a larger proportion (60 3. Wright AA, Zhang B, Ray A, et al. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver [29.1%]) attempted to quit compared with only 30 (14.5%) bereavement adjustment. JAMA. 2008;300(14):1665-1673. who said they would do so. Similarly, a larger proportion 4. Houben CHM, Spruit MA, Groenen MTJ, Wouters EFM, Janssen DJA. (60 [29.1%]) reported using other flavored tobacco or Efficacy of advance care planning: a systematic review and meta-analysis. JAm e-cigarette products (menthol was not banned in e-cigarette Med Dir Assoc. 2014;15(7):477-489. products) compared with their preban plans (12 [5.8%]). 5. Jones CA, Acevedo J, Bull J, Kamal AH. Top 10 tips for using advance care After the ban, participants were less likely to anticipate planning codes in palliative medicine and beyond. J Palliat Med. 2016;19(12): using other flavored products. Of those who made a quit 1249-1253. attempt, 16 (80.0%; 95% CI, 56.3%-92.5%) of those who pri- 6. Tsai G, Taylor DH. Advance care planning in Medicare: an early look at the marily smoked menthol cigarettes at baseline suggested impact of new reimbursement on billing and clinical practice [published online June 21, 2017]. BMJ Support Palliat Care. doi:10.1136/bmjspcare-2016-001181 that the ban affected their decision to quit at least a little compared with 10 (25.6%; (95% CI, 14.1%-41.0%) of those who smoked menthol cigarettes only occasionally. Before HEALTH CARE POLICY AND LAW the ban, 1 individual (0.3%) suggested trying to switch to Association of Ontario’s Ban on Menthol Cigarettes marijuana and 4 (1.2%) suggested adding menthol to ciga- With Smoking Behavior rettes separately using flavor cards, oils, or papers as substi- 1 Month After Implementation tutes for the lack of menthol, but none reported planning to The province of Ontario, Canada, implemented a full men- use these substitutes in the future. thol cigarette ban on January 1, 2017. To date, there has been no population-wide, systematic evaluation of the association of the implementation of a menthol ban Discussion | This study is, to our knowledge, the first evalua- with smoker behavior. Assessments of perceived behavioral tion of the immediate association of a menthol cigarette ban responses to hypothetical menthol flavor bans are useful1; with behavior change. Actual behaviors contrast sharply however, there is no guarantee that individuals will follow with planned behaviors. Although a substantial decrease in through with their planned behaviors. This study compares menthol cigarette use was observed, there was a consider- respondents’ planned behavior before the ban with actual able increase in use of flavored e-cigarettes and cigars. Fur- behavior 1 month after the ban. thermore, 29.1% of menthol smokers attempted to quit smoking shortly after ban implementation. Because previ- ous studies2,3 have found an expected rate of 0.5 quit Methods | Eligible participants were residents of Ontario 16 attempts and a 7.7% abstinence rate during a 6-month years or older who had smoked at least 1 menthol cigarette period in this population, this finding suggests that the ban in the past year and were past-month smokers. A total of substantially increased quit attempts. Few smokers used 325 participants were recruited using random-digit dialing aftermarket additive flavorings, and there was no increase of residential telephone numbers from September 12 in the use of contraband tobacco. Limitations of this study through December 31, 2016. Participation rate for the include the unique demographics of menthol cigarette

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Table. Expected, Short-term Actual, and Long-term Planned Reactions to the Ban on Menthol in Tobacco, Ontario, Canada

No. (%; 95% CI) (n = 206) Reaction Expected Reaction Before Ban Actual Short-term Reactiona Long-term Planned Reaction Use of nonmenthol cigarettes onlyb 123 (59.7; 52.8-66.2) 51 (28.2; 22.0-35.2) 102 (49.5; 42.7-56.4) Quit 30 (14.5; 10.3-20.1) 60 (29.1; 23.3-35.8)c 35 (17.0; 12.4-22.3) Use of alternative flavored products (e-cigarettes, 12 (5.8; 3.3-10.2) 60 (29.1; 23.3-35.8) 6 (2.9; 1.3-6.4) cigars, and other flavored tobacco products) Use of contraband menthol 23 (11.2; 7.5-16.3) 29 (14.1; 10.0-19.6)d 34 (16.5; 12.0-22.3) Adding menthol or other reaction 4 (1.9; 0.7-5.1) 29 (14.1; 10.0-19.6) NR Don’t know 14 (6.8; 4.1-11.2) 6 (2.9; 1.3-6.4) 29 (14.1; 10.0-19.6) Abbreviation: NR, not reported. smoking by follow-up was 25 (12.1%; 95% CI, 8.3%-17.4%). a Column does not total 100% because actual behaviors were not mutually d Purchasing menthol cigarettes from a First Nations reserve, other province, exclusive. other country, or online. Does not include stockpiled cigarettes, cigarettes b Continued or new users of nonmenthol cigarettes who did not try to quit, use bought from existing stocks that enforcement allowed stores to sell out, or any menthol product, use any other flavored product, or add flavor to those provided by friends. A total of 72 individuals (35.1%; 95% CI, nonmenthol cigarettes. 28.9%-42.0%) used menthol from all sources in the past month. c Quit or made serious quit attempt. The number (percentage) not currently

smokers in Canada, where menthol cigarettes comprise 5% Role of the Funder/Sponsor: The funding source had no role in the design and of cigarette sales4,5 compared with 30% in the United conduct of the study; collection, management, analysis, and interpretation of 6 the data; preparation, review, or approval of the manuscript; and the decision to States and use is not concentrated among black submit the manuscript for publication. Canadians.5 The initial results suggest that removing men- Disclaimer: The content is solely the responsibility of the authors and does not thol tobacco from the market is a feasible strategy that may necessarily represent the views of the National Institutes of Health or the US influence cessation behavior, although differences between Food and Drug Administration. menthol users in Ontario, Canada, and other jurisdictions 1. O’Connor RJ, Bansal-Travers M, Carter LP, Cummings KM. What would may affect the potential influence of a ban. menthol smokers do if menthol in cigarettes were banned? behavioral intentions and simulated demand. Addiction. 2012;107(7):1330-1338.

Michael Chaiton, PhD 2. Chaiton M, Diemert L, Cohen JE, et al. Estimating the number of quit attempts it takes to quit smoking successfully in a longitudinal cohort of Robert Schwartz, PhD smokers. BMJ Open. 2016;6(6):e011045. Joanna E. Cohen, PhD 3. Bondy SJ, Victor JC, Diemert LM, et al. Transitions in smoking status over Eric Soule, PhD time in a population-based panel study of smokers. Nicotine Tob Res. 2013;15(7): Thomas Eissenberg, PhD 1201-1210. 4. Nugent R, Tremblay G. Tobacco sales in Canada 2014. Paper presented at: Author Affiliations: Ontario Tobacco Research Unit, Toronto, Ontario, Canada Tobacco Control Directorate, Health Canada, National Conference on Tobacco (Chaiton, Schwartz, Cohen); Dalla Lana School of Public Health, University of or Health; March 1, 2016; Ottawa, Ontario, Canada. Toronto, Toronto, Ontario, Canada (Chaiton, Schwartz, Cohen); Johns Hopkins 5. Bird Y, May J, Nwankwo C, Mahmood R, Moraros J. Prevalence and Bloomberg School of Public Health, Baltimore, Maryland (Cohen); Virginia characteristics of flavoured tobacco use among students in grades 10 through Commonwealth University, Richmond (Soule, Eissenberg). 12: a national cross-sectional study in Canada, 2012-2013. Tob Induc Dis.2017;15 Accepted for Publication: December 21, 2017. (1):20. Corresponding Author: Michael Chaiton, PhD, Ontario Tobacco Research Unit, 6. Giovino GA, Sidney S, Gfroerer JC, O'Malley PM, Allen JA, Richter PA, 155 College St, Toronto, Ontario, M5T 3M7 Canada (michael.chaiton@utoronto Cummings KM. Epidemiology of menthol cigarette use. Nicotine Tob Res. 2004; .ca). 6(suppl 1):S67-S81. Published Online: March 5, 2018. doi:10.1001/jamainternmed.2017.8650 Author Contributions: Dr Chaiton had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data Invited Commentary analysis. Local Movement to Ban Menthol Tobacco Products Concept and design: All authors. as a Result of Federal Inaction Acquisition, analysis, or interpretation of data: Chaiton, Schwartz, Cohen, 1 Eissenberg. The article by Chaiton et al in this issue of JAMA Internal Medi- Drafting of the manuscript: Chaiton. cine is the first empirical confirmation that banning the sale Critical revision of the manuscript for important intellectual content: All authors. of menthol tobacco products is good for public health. The in- Statistical analysis: Chaiton. vestigators surveyed indi- Obtained funding: Chaiton, Schwartz, Eissenberg. Administrative, technical, or material support: Schwartz, Cohen. viduals in Ontario, Canada, Supervision: Chaiton. Related article page 710 who smoked menthol ciga- Conflict of Interest Disclosures: Dr Eissenberg reported serving as a paid rettes before and 1 month af- consultant in litigation against the tobacco industry and is named on a patent ter the province implemented a full menthol cigarette ban on application for a device that measures the puffing behavior of electronic January 1, 2017. They found that 40% of menthol smokers at- cigarette users. No other disclosures were reported. tempted to quit smoking and 12% succeeded, substantial in- Funding/Support: This research was supported by award P50DA036105 from the National Institute on Drug Abuse of the National Institutes of Health and the creases over historical levels and higher than the percentage Center for Tobacco Products of the US Food and Drug Administration. who predicted that they would try to quit before experienc-

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ing the ban. In addition, they found that a larger proportion In June 2017, the city and county of San Francisco prohibited (29%) reported using other flavored tobacco or e-cigarette prod- the sale of all flavored tobacco products, including menthol.9 ucts (menthol was not banned in e-cigarette products) com- This move was too much for the tobacco industry. pared with preban self-predictions (6%). Shortly after Mayor Ed Lee signed the new law in San Fran- Menthol is a particularly important additive to ciga- cisco, with $700 000 from tobacco giant RJ Reynolds, a rettes because, in addition to being a flavor, it is a local anes- group of self-proclaimed concerned citizens and local gro- thetic that makes it easier to inhale tobacco smoke and cers announced that they were going to force a referendum modulates the effects of nicotine in a way that allows on the new law to oppose government overreach and to pro- tobacco companies to tune nicotine and menthol delivery to tect freedom of choice.10 Their Let’s Be Real San Francisco maximize nicotine’s addictive effect.2 The 2009 Family collected enough signatures to force a popular vote on the Smoking Prevention and Tobacco Control Act, which gave ordinance on the June 2018 ballot. the US Food and Drug Administration (FDA) authority to Far from a group of concerned citizens, Let’s Be Real is led regulate tobacco products, included a provision that prohib- by a tobacco industry executive and attorneys from a law firm ited the use of characterizing flavors, including strawberry, with longstanding ties to the industry. According to official fil- grape, orange, clove, cinnamon, pineapple, vanilla, coco- ings, the principal officer of the committee is David Spross, not nut, licorice, cocoa, chocolate, cherry, or coffee, but notably of San Francisco but of Winston-Salem, North Carolina. Spross not menthol, in cigarettes. It is easy to understand why the is vice president of state government relations at tobacco com- tobacco industry fought so hard3 to successfully exclude pany RJ Reynolds. Attorneys from the well-connected law film menthol from the flavor ban. Menthol cigarettes are a Nielsen Merksamer (which represents RJ Reynolds and Altria) starter product for youths,4 comprise 30% of cigarette are serving as treasurer and assistant treasurer, respectively, of sales,5 and are the dominant product smoked by African the campaign. American individuals. Tobacco companies threatened to This situation is a replay of the industry’s 1983 referendum block the bill if menthol was prohibited.3 campaign to overturn San Francisco’s then-new law that limits The US Congress compromised by directing the FDA to smoking in the workplace and public places. (Nielsen Merksamer have its new Tobacco Products Scientific Advisory Commit- worked on that one, too.) Despite being outspent more than 10 tee complete a report on “the impact of the use of menthol to 1, health advocates successfully defended the ordinance, which in cigarettes on the public health, including such use among subsequently encouraged states and communities around the African Americans, Hispanics, and other racial and ethnic world to create smoke-free environments. minorities”6 within a year to inform future regulation. The What about the FDA? They are still thinking about what Tobacco Products Scientific Advisory Committee completed to do, which means that meaningful action on menthol and the report within a year, concluding in July 2011 that “the flavors is years away, if ever. removal of menthol products from the marketplace would In the meantime, as with clean indoor air and tobacco tax be beneficial to the public’s health.”7 policy, the action will occur at the local and state levels. On the Despite menthol cigarettes representing 5% of cigarette basis of the 1983 experience, a win in San Francisco could sub- sales in Canada compared with 30% in the United States, stantially accelerate the movement to end the sale of men- the results of the study by Chaiton et al1 have 2 important thol and flavored tobacco products, making the FDA increas- implications for the United States and the rest of the world. ingly irrelevant. First, as predicted, eliminating menthol is good for public health because it leads to an increase in quitting. Second, it Stanton A. Glantz, PhD is important that flavor bans be comprehensive, including Philip Gardiner, DrPH all tobacco products (such as e-cigarettes) and all flavors. There are also likely to be additional public health benefits Author Affiliations: Center for Tobacco Control Research and Education, because elimination of menthol and flavors will make ciga- Department of Medicine, Philip R. Lee Institute for Health Policy Studies, rettes and other tobacco products less attractive and less Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco (Glantz); African American Tobacco Control Leadership Council, easy to smoke for youths. San Francisco, California (Gardiner). In 2016, the FDA tried to limit the use of menthol and Accepted for Publication: January 16, 2017. other flavors in e-cigarettes and other noncigarette tobacco 8 Corresponding Author: Stanton A. Glantz, PhD, Center for Tobacco Control products but was blocked by the Obama Administration. As Research and Education, Department of Medicine, Philip R. Lee Institute for of January 12, 2018, the FDA had not regulated menthol in Health Policy Studies, Helen Diller Family Comprehensive Cancer Center, cigarettes or any other tobacco product. University of California San Francisco, San Francisco, CA ([email protected] This failure at the federal level has spawned local action .edu). to stop the sales of menthol tobacco products. After commu- Published Online: March 5, 2018. doi:10.1001/jamainternmed.2018.0053 nity outreach by health advocates, town hall meetings, and Conflict of Interest Disclosures: Dr Gardiner reported being cochair of the work with clergy, aldermen, and women to argue that men- African American Tobacco Control Leadership Council, which works to end the sale of menthol tobacco products. No other disclosures were reported. thol products were being disproportionately marketed to black Funding/Support: This work was supported in part by grant P50 CA180890 youths, in December 2013, the Chicago City Council passed the from the US National Cancer Institute and Food and Drug Administration first menthol restrictions, forbidding the sale of menthol and Center for Tobacco Products and grant R01DA043950 from the National all flavored products within 500 ft of Chicago public schools. Institute on Drug Abuse, National Institutes of Health (Dr Glantz).

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Role of the Funder/Sponsor: The funding sources had no role in the design and and administrative data. We identified patients with type 2 conduct of the study; collection, management, analysis, and interpretation of diabetes by International Classification of Diseases, the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Ninth Revision (ICD-9) code or glycated hemoglobin values greater than 6.5%. We excluded patients with type 1 1. Chaiton M, Schwartz R, Cohen JE, Soule E, Eissenberg T.Association of Ontario’s ban on menthol cigarettes with smoking behavior 1 month after implementation diabetes by ICD-9 code. For patients with multiple admis- [published online March 5, 2018]. JAMA Intern Med. doi:10.1001/jamainternmed sions during the study period, we chose the last admission. .2017.8650 We used descriptive statistics to analyze demographic vari- 2. Yerger VB. Menthol’s potential effects on nicotine dependence: a tobacco ables, comorbidities, and diabetes management (laboratory industry perspective. Tob Control. 2011;20(suppl 2):ii29-ii36. testing and drug administration), and stratified the cohort 3. Califano JJ, Sullivan L. Why we need a ban on menthol cigarettes. by whether patients received insulin while on hospice. We Washington Post. https://www.washingtonpost.com/opinions/why-we-need-a -ban-on-menthol-cigarettes/2011/04/27/AFNCM08E_story.html?utm_term analyzed the cumulative incidence of hypoglycemia =.b2a1ecfa803d. Published April 28, 2011. Accessed January 12, (glucose <70 mg/dL [to convert to mmol/L, multiply by 2018. 0.0555]), severe hypoglycemia (glucose <50 mg/dL), 4. Hersey JC, Ng SW, Nonnemaker JM, et al. Are menthol cigarettes a starter hyperglycemia (glucose ≥400 mg/dL), and the competing product for youth? Nicotine Tob Res. 2006;8(3):403-413. risk of death among all hospice patients and among patients 5. Federal Trade Commission. Federal Trade Commission Cigarette Report for treated with insulin vs patients not treated with insulin. 2014. https://www.ftc.gov/reports/federal-trade-commission-cigarette-report -2014-federal-trade-commission-smokeless-tobacco. Published November 16, This study was reviewed and approved by the University 2016. Accessed January 13, 2018. of California, San Francisco Committee on Human 6. HR Rep No. 1256, pt 1, at 907 (2009). Research. 7. FDA Tobacco Products Scientific Advisory Committee. Menthol Cigarettes and Public Health: Review of the Scientific Evidence and Recommendations. Results | The study cohort included 20 329 hospice patients White Oak, MD: US Food and Drug Administration; 2011. (Table), 98% of whom were men (n = 19 991). Hospice 8. Glantz S. White House Told FDA Black Lives Don’t Matter. patients had an 83% 100-day mortality rate (n = 16 791 https://tobacco.ucsf.edu/white-house-told-fda-black-lives -don%E2%80%99t-matter. Published June 6, 2016. deaths), and a median length of stay of 10 days. Eight per- Accessed January 12, 2018. cent of patients in the cohort received insulin (n = 1687). 9. San Francisco Health Code §170441 0140-17 (Banning the Sale of Flavored Among patients treated with insulin, mean baseline gly- Tobacco Products). cated hemoglobin levels were higher than patients not 10. Glantz S. Big Tobacco Is Terrified of SF Law Ending Sale of Flavored and treated with insulin (7.4% vs 6.8%; P < .001), and the Menthol Tobacco Products; the Empire Strikes Back. https://tobacco.ucsf.edu mortality rate at 100 days was lower (61% vs 85%; P < .001). /big-tobacco-terrified-sf-law-ending-sale-flavored-and-menthol-tobacco Patients treated with insulin had more frequent glucose -products-empire-strikes-back. Published July 14, 2017. Accessed January 12, 2018. tests (mean 1.7 glucose tests/d, vs 0.6 glucose tests/d among patients not treated with insulin; P < .001). The cumulative incidence of hypoglycemia (glucose <70 mg/dL) among all Hypoglycemia in Hospice Patients patients, accounting for the competing risk of death, was With Type 2 Diabetes in a National Sample 12% at 180 days, and that of severe hypoglycemia (glucose of Nursing Homes <50 mg/dL) was 5% (Figure). Among patients treated with Approximately one-quarter of the US population die in insulin, 38% experienced hypoglycemia and 18% experi- nursing homes,1 where end-of-life care is of variable enced severe hypoglycemia at 180 days. The highest risk of quality.2 In particular, it is unknown whether patients with hypoglycemia occurred in the first 20 days of admission. chronic illness, such as diabetes, continue to receive bur- The cumulative incidence of hyperglycemia (glucose >400 densome testing and treatment after transitioning to hos- mg/dL) at 180 days was 9% in all patients, higher in the pice care in nursing homes. Experts and the American Dia- group treated with insulin (35%). betes Association recommend relaxing glycemic control target levels for patients with diabetes and advanced dis- Discussion | Despite guidelines that stress avoiding hypo- ease and eventual discontinuation of medications as glycemia in hospice patients with diabetes,4 we found that patients near death to avoid hypoglycemia.3,4 Hypoglyce- 1 in 9 nursing home patients with type 2 diabetes experi- mia causes symptoms of weakness, diaphoresis, confusion, enced hypoglycemia (glucose <70 mg/dL) while 1 in 20 shakiness, and dizziness,5 and is a potentially preventable experienced severe hypoglycemia (glucose <50 mg/dL) cause of suffering among hospice patients. Whether nursing while on hospice. The risk of hypoglycemia was highest home patients with type 2 diabetes on hospice are assessed among patients treated with insulin, one-third of whom for dysglycemia, receive insulin or oral hypoglycemic medi- experienced hypoglycemia. Patients treated with insulin cations, or experience hypoglycemia and hyperglycemia has lived longer and experienced more hyperglycemia than not previously been described. patients not treated with insulin, which suggests that clinicians may be choosing to continue insulin for those Methods | We conducted a retrospective cohort study of hospice patients with a longer life expectancy and more patients older than 65 years with type 2 diabetes admitted severe diabetes at hospice admission. Nevertheless, hypo- to Veterans Affairs (VA) nursing homes between January 1, glycemia is not consistent with a goal of comfort, and these 2006, and June 30, 2015, using linked laboratory, pharmacy, data demonstrate suboptimal avoidance of dysglycemia

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