New and Emerging Tobacco Products: Considerations for Epidemiology and Surveillance

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New and Emerging Tobacco Products: Considerations for Epidemiology and Surveillance Kristy Marynak, MPP Team Lead for Policy and Partnerships Office on Smoking and Health National Center for Chronic Disease Prevention and Health Promotion Alison Cuccia, MSPH Senior Research Associate Truth Initiative Schroeder Institute Teresa Wang, PhD, MS Surveillance Team Member, Epidemiology Branch, Office on Smoking and Health Centers for Disease Control and Prevention 2018 Surveillance and Evaluation Webinar Series June 28, 2018 1

Heated Tobacco Products: Considerations for Epidemiology and Surveillance Kristy Marynak, MPP Team Lead for Policy and Partnerships Office on Smoking and Health National Center for Chronic Disease Prevention and Health Promotion 2018 Surveillance and Evaluation Webinar Series June 28, 2018 2

The Evolving Tobacco Product Landscape Cigarettes Cigars, Cigarillos Little Cigars Smokeless Pipes Snus Tobacco Hookah Bidis Dissolvables Kreteks ENDS Heated Tobacco Products

What are heated tobacco products? Products that heat tobacco leaf to deliver an inhaled aerosol Technology first introduced in the 1980s and 1990s two primary formats: 1) Carbon-tipped tobacco sticks lit with a lighter 2) Electronic devices that heat tobacco sticks or capsules Unclear whether combustion actually occurs; thus, use of the term heated tobacco products (HTPs) rather than industry term heat-not-burn 4

Crosswalking HTPs, E-cigarettes, and Cigarettes Characteristics* HTPs E-cigarettes Manufactured Cigarettes Electronic Flame-activated Contain tobacco leaf Can deliver nicotine Produce secondhand emissions Produce smoke Can deliver marijuana *Sometimes or always 5

Flameactivated HTPs Typically employ a carbon tip lit with a lighter User inhales until the tip glows red and product is activated; stick is disposed after use Packs of 20, similar size and shape of cigarette 3 iterations have been tested in U.S. (1989 Premier, 1994-2005 Eclipse, 2015 Revo) 7/2/2018 6

HTPs pending FDA pre-market approval IQOS: Umbrella brand for PMI s multiple reduced risk product (RRP) platforms Compressed tobacco stick inserted into device, discarded after use. iqos store outlet in Tokyo Flavors Regular, Balanced, Mint, Menthol 14 drags per stick, 6 minute heat time before automatic shut-off, 1 stick per charge HeatSticks are sold in packs of 20, priced comparably to cigarettes 7/2/2018 7

HTPs available outside the U.S. Part 1 JTI PloomTECH heats capsules filled with granulated tobacco leaves Regular ( Balanced ) and menthol ( Cool Purple ) flavors Capsules sold in packs of 5; recharge every 5 capsules Activated by inhaling making it possible to enjoy the experience immediately and at anytime Capsule can be used several occasions before disposal. 7/2/2018 8

HTPs available outside the U.S. Part 2 BAT glo heats tobacco NeoStiks, packs of 20 glo ifuse is a hybrid that heats liquid and tobacco 20 sticks per battery charge Flavors: Bright Tobacco, Fresh Mix (mint), Zest Mix (citrus) NeoStiks are priced 2x higher than cigarettes and have an approx. 45% lower tax rate in Japan because they are lighter and taxes are applied by weight. 7/2/2018 9

Surveying the new landscape of HTPs 10

SummerStyles 2017 Survey Web-based, cross-sectional survey of U.S. adults aged 18 years Online panel from GFK s KnowledgePanel Address-based probability sampling Weighted to U.S. Current Population Survey proportions JUN-JUL 17 Fielded by Porter Novelli during June-July 2017 4,107 respondents completed SummerStyles 74% response rate 11

Measuring Awareness of Heated Tobacco Products Survey Question: Response Options: Heat-not-burn tobacco products heat tobacco sticks or capsules to produce an aerosol or vapor. They are different from electronic vapor products such as e- cigarettes, which heat a liquid to produce an aerosol or vapor. Some brands of heatnot-burn tobacco products include iqos, glo, Ploom TECH, and Revo. Before today, have you heard of heat-not-burn tobacco products? Yes No Don t know/not sure 12

Measuring Ever Use of Heated Tobacco Products Response Options: Have you ever tried a heat-notburn tobacco product, even just one time? Yes No Don t know/not sure 13

Awareness of Heated Tobacco Product Use Among U.S. Adults, 2017 Percentage (%) Overall 0 1 2 3 4 5 6 7 8 9 10 5.2 Men Women 3.7 7.0 <30 years 30 years 4.6 7.6 Non-Hispanic, White Other 5.1 5.6 Current smoker Former smoker Never smoker 3.7 4.9 9.9 Source: SummerStyles 2017. Marynak, K et al. Awareness and ever use of "heat-not-burn" tobacco products among U.S. adults, 2017. Accepted by AJPM.

Adult E-cigarette Use Ever Use of Heated Tobacco Products Among U.S. Adults, 2017 Percentage (%) 0.0 0.5 1.0 1.5 2.0 2.5 3.0 Overall 0.7 Men Women 0.6 0.8 <30 years 30 years 0.5 1.6 Non-Hispanic, White Other 0.5 1.0 Current smoker Former smoker Never smoker Relative standard error >40% 0.5 2.7 Source: SummerStyles 2017. Marynak, K et al. Awareness and ever use of "heat-not-burn" tobacco products among U.S. adults, 2017. Accepted by AJPM.

Potential future steps Include illustrated images in future surveys to assist respondents Revise questions to reflect current brands as needed Potentially revise heat-not-burn terminology in future survey questions As products become available, potentially add related questions to large nationally representative surveys 16

Key takeaways The landscape of tobacco products is continually changing By being proactive and looking at new product offerings outside the U.S., we can prepare our surveillance systems to track changes in tobacco use Probability-based samples can inform larger surveillance systems down the road Understanding unique properties and health implications of each tobacco product can inform public health planning, policy, and practice 17

Contact: KMarynak@cdc.gov 770.488.6196 www.cdc.gov/tobacco For more information, contact CDC 1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

JUUL-related studies ALISON CUCCIA, MSPH

What is JUUL? Electronic nicotine delivery system with sleek design that looks like USB flash drive Promoted as a satisfying alternative to cigarettes By accommodating cigarette-like nicotine levels, JUUL provides satisfaction to meet the standards of smokers looking to switch from smoking cigarettes. www.juul.com, accessed June 21, 2018

JUUL pods Detachable pods through which aerosol is inhaled Available in tobacco, fruit, mint and other flavors 59 mg/ml Uses nicotine salts Every JUUL pod contains nicotine Among highest nicotine concentration on the market

06/20/15 09/12/15 12/05/15 02/27/16 05/21/16 08/13/16 11/05/16 01/28/17 04/22/17 07/15/17 10/07/17 12/30/17 03/24/18 Millions ($) 140.00 120.00 100.00 80.00 60.00 40.00 20.00 JUUL Compared to Other Brands Retail Dollar Sales June 2015 - April 2018 Juul All Others In May, 2018, JUUL represented 64.0% dollar share and 45.7% unit share of the e-cigarette traditional retail market.(herzog & Kanada, 2018) On April 24, 2018, the FDA requested that JUUL Labs, Inc. submit documents relating to marketing practices and research on marketing, effects of product design, public health impact, and adverse experiences and complaints related to JUUL. 0.00 Herzog, B., & Kanada, P. (2018). Nielsen: Tobacco 'All Channel' Report Period Ending 5/19.

JUUL on social media Huang, J., Duan, Z., Kwok, J., Binns, S., Vera, L. E., Kim, Y.,... & Emery, S. L. (2018). Vaping versus JUULing: how the extraordinary growth and marketing of JUUL transformed the US retail e-cigarette market. Tobacco Control, tobaccocontrol-2018.

JUUL use among youth

Purpose of Truth Initiative JUUL studies: To learn more about JUUL awareness, use, perceptions and terminology

JUUL Studies Utilized online convenience panel sample weighted to national population. Two Surveys Conducted: First Survey Age: 15-24 N=1,012 Data collected 11/22/17 11/28/17. During this period, JUUL represented 40% of e-cig dollar share. Second Survey Age: 12-44 N=2,575 Data collected online, 4/3/18 to 4/9/18. During this time, JUUL represented 60% of e-cig dollar share.

Willett, J. G., Bennett, M., Hair, E. C., Xiao, H., Greenberg, M. S., Harvey, E., Cantrel, J., Vallone, D. (2018). Recognition, use and perceptions of JUUL among youth and young adults. Tob Control. doi:10.1136/tobaccocontr ol-2018-054273 November 2017 JUUL study findings 25% of 15-24 year olds recognized JUUL 10% had ever used a JUUL; 8% used in past 30 days Use significantly higher for males, higher SES and 18-24 year olds 25% of those who recognized JUUL referred to use as JUULing Most were not aware that JUUL pods always contain nicotine.

April Survey Findings

Ever and Past 30-Day Use of JUUL Among entire sample, N=2,575 12 to 44 year olds 30% 25% 22.5% 20% 17.0% 15% 13.6% 10% 5% 5.2% 4.6% 7.8% 6.5% 10.9% 10.0% 8.4% 0% 12 to 14 15 to 17 18 to 24 25 to 34 35 to 44 Ever Use Past 30-Day Use

Past 30-Day Use of JUUL Among entire sample, N= 2,575 12 to 44 year olds 18% 16% 14% 13% 14% 16% 12% 11% 11% 10% 8% 9% 7% 8% 9% 7% 7% 8% 6% 4% 4% 2% 0%

Where users get JUUL Weighted proportions among past 30 day users, N= 57 12 to 17 year olds

Where users get JUUL stores Weighted proportions among past 30 day users, N= 239 12 to 44 year olds 35% 32.6% 30% 25% 20% 15% 10% 24.4% 22.5% 20.6% 14.2% 14.1% 10.4% 8.6% 10.1% 5% 0% Gas station A vape shop Grocery store Mall or shopping center kiosk or stand 3.2% A drug store 1.8% 0.0% I took it from a store Youth (n=57) Adult (n=182)

What did you use with JUUL Weighted proportions among past 30 day users, N= 239 12 to 44 year olds 70% 60% 62.1% 50% 40% 30% 28.8% 20% 18.4% 10% 7.6% 0% a JUUL flavor pod a pod that has been refilled with liquid nicotine a pod that has been refilled with marijuana I don't know

JUUL flavors most recently used Weighted proportions among current JUUL users, N=287 12-44 year olds 35% 30% 25% 27.9% 25.1% 27.2% 29.5% 20% 17.9% 17.5% 15% 10% 5% 5.1% 10.2% 8.0% 5.9% 9.0% 5.8% 5.7% 3.8% 0% Mango Cool mint Tobacco (Virginia or classic) Fruit medley Creme brulee Classic menthol Cool cucumber Youth (n=51) Adult (n=182)

Ever used marijuana with JUUL Weighted proportions among ever JUUL users, n=295 12-44 year olds 60.0% 50.0% 50.9% 47.8% 40.0% 36.6% 30.0% 25.1% 28.9% 20.0% 10.0% 0.0% 12-14 (n=26) 15-17 (n=41) 18-24 (n=92) 25-34 (n=86) 35-44 (n=50)

Have youth seen JUUL use in their school Weighted proportions among youth, n=1024 of 12-17 year olds 30% 25% 24.3% 20% 17.8% 15% 10% 10.5% 5% 0% Total (n=1024) 12 to 14 (n=500) 15 to 17 (n=524)

Perceived harm compared to cigarettes Weighted proportions among respondents who recognize JUUL, N=1059 12 to 44 year olds 100% 90% 16% 9% 8% 10% 13% 80% 70% 60% 40% 41% 25% 34% 34% A lot/little more harmful 50% Equally harmful 40% 30% 20% 44% 49% 66% 55% 53% A lot/little less harmful 10% 0% 12 to 14 15 to 17 18 to 24 25 to 34 35 to 44

Perceived Addictiveness compared to cigarettes Weighted proportions among respondents who recognize JUUL, N=1059 12 to 44 year olds 100% 90% 80% 31% 32% 39% 37% 23% 70% 60% Much more/ slightly more addictive 50% 51% Equally addictive 40% 30% 51% 49% 38% 42% Much less/ slightly less addictive 20% 10% 18% 19% 21% 21% 25% 0% 12 to 14 15 to 17 18 to 24 25 to 34 35 to 44

Reasons for first trying JUUL Weighted proportions among current JUUL users, n=300 of 12-44 year olds 60% 50% 49.5% 40% 30% 26.0% 20% 18.5% 20.0% 10% 10.6% 3.5% 0% trying to quit smoking high nicotine content appealing flavors product design friends/family using other

Weighted proportion (%) First trying JUUL to quit smoking Weighted proportions among current JUUL users, N=230 of 18-44 year olds 35% 32.2% 30% 25% 20% 22.0% 24.8% 15% 10% 11.4% 5% 0% trying to quit smoking Total (n=230) 18-24 yo (n=92) 25-34 yo (n=81) 35-44 yo (n=56)

JUUL use during cessation attempts Weighted proportions among those who have made a cessation attempt, N=246 25-44 year olds 35% 30% 30.3% 25% 25.5% 20% 20.2% 15% 10% 5% 6.5% 5.1% 8.7% 0% While gradual quitting smoking (n=152) Total 25-34 yo 35-44 yo While quiting all at once (n=94)

Thank you! acuccia@truthinitiative.org

E-Cigarette Use Among U.S. Adults and Youth: Considerations for Epidemiology and Surveillance Teresa Wang, PhD, MS Surveillance Team, Epidemiology Branch Office on Smoking and Health National Center for Chronic Disease Prevention and Health Promotion 2018 Surveillance and Evaluation Webinar Series June 28, 2018 43

E-cigarette Use Among U.S. Adults

Adult E-cigarette Use E-cigarette Use Among U.S. Adults (1) QuickStats: Percentage of Adults Aged 18 Years Who Currently Use E-Cigarettes, by Sex and Age Group National Health Interview Survey, 2016. MMWR 2018;66:1412. (2) QuickStats: Cigarette Smoking Status Among Current Adult E-cigarette Users, by Age Group National Health Interview Survey, 2015. MMWR 2016;65:1177. 45

Timeline of CDC E-cigarette Surveillance Activities Among U.S. Adults Year 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 BRFSS NHIS NHANES NATS Styles 46

Percentage of U.S Adults Aged 18 Who Reported E-cigarette Percentage of Use U.S Every Adults Aged Day 18 or Some Who Reported Days, 2015 E-cigarette Use Every Day or Some Days, 2015 0 1 2 3 4 5 6 7 8 OVERALL MALE FEMALE 2.6 3.5 4.3 18-24 25-44 45-64 65 1.1 3.3 4.3 5.2 NON-HISPANIC WHITE NON-HISPANIC BLACK NON-HISPANIC ASIAN NON-HISPANIC AIAN HISPANIC NON-HISPANIC MULTIRACE 1.9 2.3 Relative standard error 30% 2.0 4.1 7.1 Source: Phillips E, Wang TW, Husten CG, et al. Tobacco Product Use Among Adults United States, 2015. MMWR Morb Mortal Wkly Rep 2017;66:1209 1215. DOI: http://dx.doi.org/10.15585/mmwr.mm6644a2 47

Percentage (%) Ever Use of E-cigarettes Among U.S. Adults By Cigarette Smoking Status, 2010-2017 60 50 Current Cigarette Smoker Former Cigarette Smoker Never Cigarette Smoker 50.3 53.5 44.9 46.7 40 36.5 30 31.2 20 10 0 21.2 17.8 16.3 19.3 14.7 9.6 9.8 7.4 5.7 5.9 6.7 4.7 2.5 6.1 1.3 2.3 1.2 1.3 2010 2011 2012 2013 2014 2015 2016 2017 Year Source: Summer Styles. 2010-2017; Current smokers are defined as adults who reported smoking at least 100 cigarettes in their lifetime, and currently some days or every day ; Former smokers are defined as adults who reported smoking at least 100 cigarettes in their lifetime, and currently not at all ; Never smokers are defined as adults who reported smoking less than 100 cigarettes in their lifetime. 48

A majority of adult e-cigarette users also smoke conventional cigarettes: dual use. Cigarette Smoking Status Among Current Adult E-cigarette Users By Age Group, 2015 Source: QuickStats: Cigarette Smoking Status Among Current Adult E-cigarette Users, by Age Group National Health Interview Survey, United States, 2015. MMWR Morb Mortal Wkly Rep 2016;65:1177. DOI: http://dx.doi.org/10.15585/mmwr.mm6542a7 49

Current E-cigarette Use Among U.S. Adults BRFSS 2017 Preliminary Data (January September) D.C. 1.7% 3.7% 3.8% 4.2% 4.3% 4.7% 4.8% 6.5% Current e-cigarette users: Persons who reported using e-cigarettes or some other electronic vaping product some days or every day 50

Primary Reasons for Using E-cigarettes Among Current U.S. Adult Users, 2014 8% 10% 13% 9% 16% 24% 20% Cessation/Health Consideration of Others Convenience Cost Curiosity Flavoring Simulation of Cigarettes Source: Patel D, Davis KC, Cox S, Bradfield B, King BA, Shafer P, Caraballo R, Bunnell R. Prev Med. 2016 Dec;93:14-20. Reasons for current E-cigarette use among U.S. adults. doi: 10.1016/j.ypmed.2016.09.011. Epub 2016 Sep 7. 51

E-cigarette Use Among U.S. Youth

E-cigarette Use Among U.S. Youth 2017, 3.3% 11.7% [Pending publication] MMWR. Tobacco Use Among Middle and High School Students United States, 2011-2017. 53

Percentage (%) Prevalence of Current E-cigarette Use* Among U.S. Middle and High School Students NYTS 2011-2017 20 18 16 14 12 10 8 6 4 2 0 11.7% 3.3% 1.5% 0.6% 2011 2012 2013 2014 2015 2016 2017 Year High School Middle School *At least one time in the past 30 days Wang TW, Gentzke A, Sharapova S, Cullen KA, Ambrose BK, Jamal A. Tobacco Product Use Among Middle and High School Students United States, 2011 2017. MMWR Morb Mortal Wkly Rep 2018;67:629 633. DOI: http://dx.doi.org/10.15585/mmwr.mm6722a3. 54

Prevalence of current tobacco product use among U.S. high school students, by tobacco product NYTS 2011-2017 Cigarette 15.8% Cigar 11.6% 11.7% Smokeless Hookah Pipe E-cigarette 7.9% 4.1% 4.0% Bidi 2.0% 1.5% 7.7% 7.6% 5.5% 3.3% 0.8% 0.7% 2011 2012 2013 2014 2015 2016 2017 YEAR Wang TW, Gentzke A, Sharapova S, Cullen KA, Ambrose BK, Jamal A. Tobacco Product Use Among Middle and High School Students United States, 2011 2017. MMWR Morb Mortal Wkly Rep 2018;67:629 633. DOI: http://dx.doi.org/10.15585/mmwr.mm6722a3. 55

Reasons for Youth E-cigarette Use Reasons for Youth E-cigarette Use among U.S. Middle and High School Students Friend or family member used them 39.0 Some other reason 31.6 They are available in flavors, such as mint, candy, fruit, or chocolate 31.0 They are less harmful than other forms of tobacco, such as cigarettes 17.1 To try to quit using tobacco products such as cigarettes They can be used in areas where other tobacco products, such as cigarettes are not allowed They are easier to get than other tobacco products such as cigarettes 4.8 7.8 7.0 They cost less than other tobacco products such as cigarettes 3.2 Famous people on TV or in movies use them 1.5 0 10 20 30 40 50 Percentage (%) Source: Tsai J, Walton K, Coleman BN, Sharapova SR, Johnson SE, Kennedy SM, Caraballo RS. MMWR Morb Mortal Wkly Rep. 2018 Feb 16;67(6):196-200. Reasons for Electronic Cigarette Use Among Middle and High School Students, NYTS, U.S. 2016. doi: 10.15585/mmwr.mm6706a5 56

Percentage (%) Youth E-cigarette Use, by Type and Brand Youth E-cigarette Use by Type and Brand, 2015 Use by Type Use by Brand 60 50 50.7 40 30 24.2 26.4 20 12.2 14.9 10 0 VUSE NJOY, MARKTEN, LOGIC, FINITI, STARBUZZ, AND/OR FANTASIA OTHER BRAND NOT LISTED ON QUESTIONNAIRE BLU DID NOT KNOW THE BRAND NAME Source: Singh T, Kennedy S, Marynak K, Persoskie A, Melstrom P, King BA. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(5051):1425-1429. Characteristics of Electronic Cigarette Use Among Middle and High School Students- U.S., 2015. doi: 10.15585/mmwr.mm655051a2. 57

Ongoing considerations for e-cigarette surveillance among U.S. youth Updating e-cigarette brand lists (e.g. based on market share data) E-cigarette types (e.g. disposables, pre-filled pods or cartridges) Youth access (e.g. how, where) Reasons for use Use of e-cigarettes for substances other than nicotine 58

Key Takeaways The tobacco product landscape has and continues to diversify over time. In 2016, about 3.2% of U.S. adults currently used e-cigarettes some days or every day. Considerable variations exist by sex, race/ethnicity, age, and region. Since 2014, e-cigarettes have been the most commonly used tobacco product among U.S. youth; in 2017, about 2.1 million middle and high school students reported using e-cigarettes in the past 30 days. The next generation of tobacco products, including novel e- cigarettes, have important implications for tobacco control surveillance and practice. 59

www.cdc.gov/tobacco For more information, contact CDC 1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.