The Emergence of JUULs and Heated Tobacco Products

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The Emergence of JUULs and Heated Tobacco Products 2018 TCN Podcast Series Kristy Marynak, CDC/OSH Jeff Willett, Truth Initiative Steven Fiala, Oregon Health Authority

Heated tobacco products: What you need to know K R I S T Y M A R Y N A K, M P P L E A D P U B L I C H E A L T H A N A L Y S T C D C O F F I C E O N S M O K I N G A N D H E A L T H T O B A C C O C O N T R O L N E T W O R K E M E R G I N G I S S U E S W O R K G R O U P W E B I N A R M A Y 2 0 1 8 5/18/2018 2

What s the public health importance of this topic? The landscape of tobacco products is continually changing By being proactive and anticipating new products, we can prepare our surveillance systems to track changes in tobacco use Understanding unique properties and health implications of each tobacco product can inform public health planning, policy, and practice 3

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

What are heat-not-burn tobacco products? Industry term to describe 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) 5

Analog HTPs Carbon tip heated with a lighter User inhales 4-5 times before the tip glows red and product is activated Packs of 20, similar size and shape of cigarette 3 iterations have tested in U.S. (1989 Premier, 1994-2005 Eclipse, 2015 Revo) 5/18/2018 6

Electronic HTPs Test marketing began in 1998 in Richmond, VA, discontinued in 2006 due to lack of commercial success Battery powered smoking system. Heating blades pierce Accord cigarette. Device activated only when puffed. Ads said Accord produces a lot less smoke but did not want to disparage existing brands in marketing 5/18/2018 7

HTPs pending FDA pre-market approval Umbrella brand for PMI s multiple reduced risk product (RRP) platforms Compressed tobacco stick inserted into device, discarded after use. Flavors Regular, Balanced, Mint, Menthol iqos store outlet in Tokyo 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 5/18/2018 8

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. 5/18/2018 9

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. 5/18/2018 10

HTPs: Highly profitable replacement for declining cigarette business iqos HeatStick revenues $1.55/pk in FY16 vs <$1.00/pk combustible cigarettes Major economies of scale Sticks (for glo) can be produced on modified cigarette machinery Lower tax rates Source: Wells Fargo Securities LLC. iqos in Pictures: A visual overview of the global opportunity through 2025. July 2017. 11

Do they burn? Health implications: Key questions Is there smoke? What are the contents of the smoke/aerosol? What are the differences in constituents and use patterns between various product types? Will they appeal to youth/young adults/nontobacco users? Will they be used by smokers as a complete substitute for all combusted tobacco products? 5/18/2018 12

Independent studies will provide critically needed information Until independent studies prove that no combustion occurs or smoke is produced, products should not be assumed to be noncombustible. One study found that heating tobacco between 100-200 C releases nicotine and some cigarette smoke compounds. Emissions increased with temperature. 1 Another study compared iqos to a reference cigarette. VOCs, polycyclic aromatic hydrocarbons, and CO were present in iqos smoke. 2 1 Forster M, Liu C, Duke MG, et al. An experimental method to study emissions from heated tobacco between 100 200 C. Chem Cent J 2015;9:20. 2 Auer R, Concha-Lozano N, Jacot-Sadowski I, Cornuz J, Berthet A. Heat-not-burn tobacco cigarettes: Smoke by any other name. JAMA Int Med. Published Online: May 22, 2017. doi:10.1001/jamainternmed.2017.1419 13

Surgeon General s Reports offer a public health framework The use of products containing nicotine poses dangers to youth, pregnant women, and fetuses. The use of products containing nicotine in any form among youth, including in e-cigarettes, is unsafe. 2016 SGR Conclusion #4 E-cigarette aerosol is not harmless. It can contain harmful and potentially harmful constituents, including nicotine. Nicotine exposure during adolescence can cause addiction and can harm the developing adolescent brain. 2016 SGR Conclusion #5 All products containing tobacco and nicotine should be assumed to be both harmful and addictive 2014 SGR, Ch. 14, p. 780 When there is inadequate or early knowledge, public health decisions should be made on the basis of precaution to prevent harm, rather than on certain risk. This approach requires proof that a product is not harmful especially for youth rather than proof that it is harmful. 2016 SGR, Call to Action 5/18/2018 14

HTPs should not be a distraction from combusted tobacco products Combusted tobacco is still responsible for overwhelming burden of tobacco-related disease and death in the U.S. 1 Smoking and SHS exposure kill >480,000 Americans each year 1 11.2 billion cigarette packs were sold in the U.S. in 2015 enough for 34 packs for every man, woman, and child in America 2 Cigarettes account for the vast majority of tobacco company revenues and profits; only ~2% of PMI s revenue is from HTPs 3 1 DHHS. The Health Consequences of Smoking-Fifty Years of Progress: A Report of the Surgeon General. Atlanta: Centers for Disease Control and Prevention, 2014. 2 Marynak K, Gammon D, Rogers T et al. National and State Trends in Sales of Cigarettes and E-Cigarettes, U.S., 2011 2015. Am J Prev Med 2017 (e-pub ahead of print) http://dx.doi.org/10.1016/j.amepre.2017.01.016. (Data not shown). 3 Philip Morris International presentation to the Consumer Analyst Group of New York (CAGNY) conference, 2017. 15

U.S. Status To our knowledge, HTPs are not widely available in the U.S. HTPs are subject to FDA regulatory authority and must receive premarket approval through the SE or PMTA pathway. Reynolds American submitted an SE application for a flameactivated HTP product in 2017. BAT reports plans to submit an SE application for glo in 2018 and MRTP in 2020. The TPSAC reviewed PMI s MRTP application Jan 24-25, 2018. FDA continues to review the MRTP and PMTA applications. 80% of U.S. tobacco retailers say they plan to carry the iqos. 16

Evolving landscape requires continued focus on Comprehensive efforts that address all tobacco products, including HTPs and other novel products Efforts to prevent youth access and use Protection of clean air standards and tobacco-free norms Elimination of combusted tobacco use and education about harms of smoking and dual use Education about the harms of any tobacco product use, especially for vulnerable populations, such as youth and young adults and pregnant women Research and surveillance to understand new products impact on the public s health

Thank you! Questions? Kristy Marynak 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: Recognition, use and perceptions JEFFREY WILLETT VICE PRESIDENT, SCHROEDER INSTITUTE

What is JUUL? Not your typical e-cigarette nicotine salts IT product design By accommodating cigarette-like nicotine levels, JUUL provides satisfaction to meet the standards of smokers looking to switch from smoking cigarettes. Pods with nicotine liquid available in a range of flavors. Every JUUL flavored pod contains nicotine.

JUUL Nicotine Delivery 59 mg/ml

JUUL Market Growth and Concern In April, 2018, JUUL represented 60.1% dollar share and 42.0% unit share of the e-cigarette traditional retail market. Source: Nielsen Total US xaoc/convenience Database and Wells Fargo Securities, LLC On April 24 th, 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.

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

Published in Tobacco Control, April, 2018 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 2018 JUUL Study Included 12-14 year olds and expanded questions related to JUUL use. Sample Source: Qualtrics panel, N=1,025 Age: 12-17 year olds (50% 12-14, 50% 15-17) 50% male, 50% female Data collected online, 4/3/18 to 4/9/18. 70% 60% 50% 40% 30% 20% 10% 0% 50% 40% 30% 20% 10% 0% 65% Race/Ethnicity 13% 19% 3% White Black Hispanic Other 35% Live comfotably Perceived SES 42% Little left over 20% Just meets basic needs 3% Don't meet basic needs

Awareness Among entire sample, N=1,025 12-17 year olds Do you recognize this product? YES (%) 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 38% 34% 43% Awareness among 15-17 was 21% in November. Greater awareness may reflect increased attention at schools and by media. Seen JUUL used at school? YES (%) 50% 45% 40% 35% 30% 25% 20% 18% 15% 10% 5% 0% Overall 12 to 14 15 to 17 0% JUUL

Ever and Past 30-Day Use of JUUL Among entire sample, N=1,025 of 12-17 year olds 10% 9% 8% 7% 6% 6.5% 5.6% Ever Use 12-14 = 5.2% 15-17 = 7.8% (was 7.0% in November) 5% 4% 3% Past 30-Day Use 12-14 = 4.6% 15-17 = 6.5% (was 6.1% in November) 2% 1% 0% JUUL Ever Use Past 30-Day Use

Flavor and Substance Use Which JUUL flavor pod used most recently? 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 30% 28% 18% 8% 6% 6% 4% Ever used marijuana with JUUL? YES (%) 50% 45% 40% 35% 30% 30% 25% 20% 15% 10% 5% 0% Among ever users Among past 30-day users

Product Perceptions 100% 90% 80% 12% 100% 90% 80% 32% 70% 60% 41% A lot/little more harmful 70% 60% Much/slightly more addictive 50% 40% 30% 20% 47% Equally harmful A lot/little less harmful 50% 40% 30% 20% 50% Equally addictive Much/slightly less addictive 10% 10% 18% 0% JUUL more or less harmful than cigarette? 0% JUUL more or less addictive than cigarette? Among those who recognized JUUL (n=394)

Conclusions Pod Mod devices represent the newest generation of e-cigarette products. JUUL represents 60% of e-cigarette retail market share and 38% of 12-17 year olds recognized a JUUL device. Nearly 1-in-5 youth have seen JUUL used at their school. JUUL users largely report use of fruity and sweet flavors. Of youth who have ever used JUUL, one-in-three have used marijuana with the device. Youth largely obtained JUUL through physical retail outlets or social sources. Youth reported relative ease obtaining JUUL devices online. Nearly half of those who are aware of JUUL believe it is a lot or a little LESS harmful than cigarettes. One-in-three believe JUUL is much or slightly more addictive than cigarettes.

Thank you jwillett@truthinitiative.org