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Emerging Issues in Control: The Rise of Electronic Products and Implications for Policy, Planning, and Practice

B R I A N A. KING, PHD, MPH DEPUTY DIRECTOR FOR RESEARCH TRANSLATION OFFICE ON AND HEALTH State of Alaska Tobacco Prevention and Control Grantee Training Meeting ● November 14, 2018

1 What Are They?

Why Are They 2 Popular?

Who’s Using 3 Them?

4 Are They Safe?

What Can We 5 Do About it?

1 What Are They?

Why Are They 2 Popular?

Who’s Using 3 Them?

4 Are They Safe?

What Can We 5 Do About it?

The Good News: Smoking Is Down

40

35

30

25

smoking prevalence smoking 20

15 Cigarette Cigarette

10

5

0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Adults 18+ High School Students

Source: Adult cigarette smoking prevalence data are from the National Health Interview Survey (NHIS). High school cigarette smoking prevalence data are from the National Youth Risk Behavior Survey.

The Bad News: The Landscape Is Evolving

Cigars, Little Cigars

Smokeless Pipes

Tobacco Snus Hookah

Bidis Dissolvables

Kreteks E-cigarettes

Heated Tobacco Products E-cigarettes: A Rapidly Diversifying Class The E-cigarette Landscape is Volatile

Source: King, BA, Gammon DG, Marynak KL, Rogers T. Sales in the , 2013-2017. JAMA October 2018;Volume 320:Number 13. The Rise of What Are “Heat Not Burn” Products?

Contain Tobacco

Throat Hit Similar to Cigarettes Pending FDA Pre-Market Approval

A scientific advisory committee met to discuss the MRTP application in January 2018.

Philip Morris International submitted applications to FDA for approval to: • Market iQOS (“Premarket Tobacco Product Application” or PMTA) • Make health claims (“Modified Risk Tobacco Product” application or MRTP)

1 What Are They?

Why Are They 2 Popular?

Who’s Using 3 Them?

4 Are They Safe?

What Can We 5 Do About it?

What Factors Lead to ?

Source: DHHS. Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General. Atlanta, GA. 2012.

Youth E-cigarette Initiation and Use

Advertising Youth Exposure to E-cigarette Evolution of E-cigarette Messaging

2015 2018

"We don’t think a lot about addiction here because we’re not trying to design a cessation product at all…anything about health is not on our mind”

JUUL R&D Engineer, quoted in The Verge, April 2015

Source:https://www.theverge.com/2015/4/21/8458629/pax https://www.theverge.com/2015/4/21/8458629/pax-labs-labs-e-cigarette-e-cigarette-juul-juul ; The Washington Post, July 19 2018 Use of Flavors is Prominent Among Youth

1 What Are They?

Why Are They 2 Popular?

Who’s Using 3 Them?

4 Are They Safe?

What Can We 5 Do About it?

Ever Use of E-cigarettes Among Adults, by Cigarette Smoking Status—U.S., 2010-2017

60 Current Cigarette Smoker 53.5

Former Cigarette Smoker 50 50.3 44.9 46.7 Never Cigarette Smoker

40

36.5

30 31.2 Percentage (%) Percentage 21.2 17.8 20 16.3 19.3 14.7 9.6 10 9.8 7.4 5.7 6.7 5.9 4.7 6.1 2.5 1.3 2.3 1.2 1.3 0 2010 2011 2012 2013 2014 2015 2016 2017 Year

Source: CDC. Styles Survey. 2010-2017 Current E-cigarette Use Among Adults, by Age, National Health Interview Survey, U.S., 2016

Source: QuickStats: Percentage of Adults Who Ever Used an E-cigarette and Percentage Who Currently Use E-cigarettes, by Age Group — National Health Interview Survey, United States, 2016. MMWR Morb Mortal Wkly Rep 2017;66:892. Current E-cigarette Use Among U.S. Adults BRFSS 2017 (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” A Majority of Adult E-cigarette Users Also Smoke Conventional Cigarettes Cigarette smoking status among current adult e-cigarette users, by age group

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. 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 0.8 Women 0.6

<30 years 1.6 ≥30 years 0.5

Non-Hispanic, White 0.5 Other 1.0

Current smoker 2.7 Former smoker Relative standard error >40% Never smoker 0.5

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. 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 7.9% 7.7% 7.6% 5.5% Hookah 4.1% Pipe 4.0% 3.3% Bidi 2.0% 1.5% 0.8% E-cigarette 0.7%

2011 2012 2013 2014 2015 2016 2017

YEAR

Source: 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. JUUL use at school, access points, and misperceptions among young people

1 in 5 middle and high school students have seen JUUL used 11 at school 10

8

6 3 in 4 youth who used JUUL say they got the device from a physical retail location

15-17 18-21 63% of JUUL users ages 15-24 Ever Use Current Use did not know nicotine is always in the device

Source: Willett JG, Bennett M, Hair EC, et al Recognition, use and perceptions of JUUL among youth and young adults Published Online First: 18 April 2018. Vallone DM, Bennett M, Xiao H, et al.Prevalence and correlates of JUUL use among a national sample of youth and young adults Tobacco Control Published Online First: 29 October 2018. doi: 10.1136/tobaccocontrol-2018-054693

Frequency of Youth E-cigarette Use

54.5

45.4

17.3 16.2

12 10.9 9.2 9.7 7.3 7.9 5.8 3.9 1-2 DAYS 3-5 DAYS 6-9 DAYS 10-19 DAYS 20-29 DAYS ALL 30 DAYS Middle School High School

Source: Neff LJ, Arrazola RA, Caraballo RS, Corey CG, Cox S, King BA, Choiniere CJ, Husten CG.MMWR Morb Mortal Wkly Rep. 2015 Oct 2;64(38):1061-5. Frequency of Tobacco Use Among Middle and High School Students– U.S., 2014.

1 What Are They?

Why Are They 2 Popular?

Who’s Using 3 Them?

4 Are They Safe?

What Can We 5 Do About it?

Net Benefit or Harm?

Youth Initiation Adult Cessation Is there a potential benefit for e-cigarettes? Answer: Under certain circumstances

Complete long term substitution by established smokers

Assist in rapid transition to a society with little or no use of combustible products

Short-term use if shown to produce successful & permanent cessation of combustible products

“Cutting back” is not enough—even a few cigarettes per day is dangerous E-Cigarette Use As A Smoking Cessation Tool in Adults

“Overall, the USPSTF found the evidence on the use of “The long-term safety of ENDS as a smoking cessation e-cigarettes is unknown.” tool in adults, including pregnant women, and adolescents to be insufficient.”

Conclusion 17-1. Overall, there is limited evidence that e-cigarettes may be effective aids to promote smoking cessation.

Source: The National Academies of Science, Engineering, and Medicine. Public Health Consequences of E-cigarettes. 2018. www.uspreventiveservicestaskforce.org

Potential Health Risks of E-cigarettes

Leads to Exposes initiation of Leads to Diminishes Discourages children, Results in combustible relapse the chances smokers pregnant Glamorizes poisonings tobacco use among that a from using women, or among among non- and non- renormalizes smokers, former smoker will proven quit users to tobacco use users or particularly smokers quit methods secondhand non-users children aerosol Conclusion 16-2. Among youth and young adult e-cigarette users who ever use combustible tobacco cigarettes, there is moderate evidence that e-cigarette use increases the frequency and intensity of subsequent combustible tobacco cigarette smoking.

Leads to initiation of combustible tobacco use among non- smokers, particularly children

Source: The National Academies of Science, Engineering, and Medicine. Public Health Consequences of E-cigarettes. 2018. Current Smokers ENDS use was associated with greater odds of quitting smoking 1.17

Leads to relapse Never Smokers Former Smokers among ENDS use was ENDS use was former associated with associated with smokers greater odds of greater odds of initiating smoking smoking relapse 7.41 1.53

Source: Kelly Young-Wolff et al. Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system. Prev Med. 2018. “The long-term safety of e-cigarettes is unknown.”

Diminishes the “The small number of trials, low event rates and wide chances confidence intervals around the estimates mean that our that a confidence in the result is rated 'low' by GRADE standards.” smoker will quit

“Overall, the USPSTF found the evidence on the use of ENDS as a smoking cessation tool in adults, including pregnant women, and adolescents to be insufficient.” Quit Methods Used Among U.S. Adult Cigarette Smokers

Got help from a telephone quitline 5.4

Got help from a website such as 7.1 Smokefree.gov Used FDA-approved medications 12.2 such as Zyben or Chantix Got help from doctor or other health 15.2 professional

Discourages Switched to "mild" cigarettes 20.4 smokers from using Switched completely to e-cigarettes 24.7 proven quit methods Used nicotine patch/gum 25.4 Substituted some regular cigarettes 35.3 with e-cigarettes

Gradually cut back on cigarettes 82

Gave up cigarettes all at once 85.3

Mulitple quit methods 74.7

Source: Caraballo RS, Shafer PR, Patel D, Davis KC, McAfee TA. Quit Methods Used by US Adult Cigarette Smokers, 2014–2016. Prev Chronic Dis 2017; 14:160600. Exposes children, pregnant women, and non- Conclusion 5: E-cigarette users to secondhand aerosol is not harmless. It can aerosol contain harmful and potentially harmful constituents, including nicotine. Glamorizes or renormalizes tobacco use Unintended Injuries: Poison

Children and adults have been poisoned by swallowing, breathing, or absorbing e-cigarette liquid.

Results in poisonings among users or non-users Nicotine Poses Unique Dangers to Young People

Chapter 3 Conclusion 1, 2, & 5 Nicotine salts allow particularly high levels of nicotine to be inhaled more easilyJuul andContains with less irritationNicotine than Salts free base nicotine

Benzoic Acid

Nicotine Free00 Base Salts Nicotine Are Youth Using E-cigarettes with Nicotine?

Self-reported nicotine consumption among youth may be subject to bias:

• Youth may not know what nicotine is, let alone whether it is in their e-cigarette.

• Youth who access e-cigarettes from peers may not see packaging.

• Some e-cigarette labels obscure nicotine content.

• Question asked respondents to choose only one response option.

Source: www.drugabuse.gov/related-topics/trends-statistics/infographics/monitoring-future-2016-survey-results Sales Data Tell Another Story…

Percentage of products that contained nicotine

• 99.6% of disposable e-cigarette sales • 100% of rechargeable sales • 99.5% of refill sales Percentage that contained nicotine by product type • 99.6% of all e-cigarette products sold • 99.4% of flavored e-cigarette products • 99.9% of non-flavored e-cigarette products

Source: Marynak, K.L.; Gammon, D.G.; Rogers, T.; Coats, E.M.; Singh, T.; King, B.A., "Sales of nicotine-containing electronic cigarette products: United States, 2015," American Journal of Public Health 107(5): 702-705, May 2017. Your Gut Can Handle More Than Your Lungs

Some e-cigarette manufacturers claim flavorings are safe because they meet the FDA definition of “Generally Recognized as Safe” (“GRAS”)

GRAS does not apply to products that are not food E-cigarettes and Cannabinoids

Conclusion: Nearly 1 in 11 U.S. students, including 1/3 of those who ever used e- cigarettes, had used in e-cigarettes in 2016.

Conclusion: E-cigarette products can be used as a delivery system for cannabinoids and potentially for other illicit drugs.”

Sources: Singh T, Kennedy S, Marynak K, Persoskie A, Melstrom P, King BA. Characteristics of Electronic Cigarette Use Among Middle and High School Students — United States, 2015. MMWR Morb Mortal Wkly Rep 2016;65:1425–1429. Trivers KF, Phillips E, Gentzke AS, Tynan MA, Neff LJ. Prevalence of Cannabis Use in Electronic Cigarettes Among US Youth. JAMA Pediatr. Published online September 17, 2018. doi:10.1001/jamapediatrics.2018.1920

1 What Are They?

Why Are They 2 Popular?

Who’s Using 3 Them?

4 Are They Safe?

What Can We 5 Do About it?

Tobacco Control Vaccine

Source: King BA, Graffunder C. The Tobacco Control Vaccine: a population-based framework for preventing tobacco-related disease and . Tobacco Control 2018;27:123-124. Major Conclusion #7

“Action can be taken at the national, state, local, tribal, and territorial levels to address e-cigarette use among youth and young adults. Actions could include incorporating e-cigarettes into smoke- free policies, preventing access to e- cigarettes by youth, price and tax policies, retail licensure, regulation of e-cigarette marketing likely to attract youth, and educational initiatives targeting youth and young adults.” Public Health Actions to Address E-Cigarettes

Federal Regulation State, Local, Territory

Family Smoking Prevention and Potential Sub-National Action: Tobacco Control Act

. Signed into law on June 22, 2009 . Including e-cigarettes in smokefree indoor air policies . Granted FDA the authority to regulate tobacco products . Restricting youth access to e-cigarettes in retail settings . Enhances the ability to intensify policy to reduce . Licensing retailers influence . Establishing specific package requirements . Manufacturing . Marketing . Setting price policies . Sale

New FDA Manufacturer Requirements:

Registering manufacturing establishments and Reporting ingredients, and providing product listings harmful and potentially to the FDA harmful constituents

Requiring premarket review and authorization Placing health warnings of new tobacco products on product packages and by the FDA advertisements

Not marketing newly deemed tobacco products (including e-cigarettes)with modified risk claims unless authorized by the FDA. States With & Without Laws Prohibiting Smoking & Use of E-cigarettes in Indoor Areas of Private Worksites, Restaurants, & Bars – U.S., September 2018

D.C

No Comprehensive Smoke- Free Law or Prohibition on Indoor E-cigarette Use

Prohibits Indoor Smoking Only

Prohibits Indoor Smoking and Indoor E- cigarette Use

Source: Centers for Disease Control and Prevention. STATE System. 2018. Including 66 with Statewide T-21 laws

Source: Preventing Tobacco Addiction Foundation. http://tobacco21.org. Accessed September 27, 2018. But Challenges Remain

Diversification Disparities Dollars Disruptive of Landscape Players Tobacco Industry Is Outspending Prevention Efforts 19:1

30 State Tobacco Revenue (FY2016 CTFK Report) 25 19:1 $25.8 billion Federal Cigarette 20 Tax Revenues (FY2016 Tax Burden on Tobacco) Tobacco 15 Industry Marketing $16.8 & Promotion Spending billion State 10 (2016 FTC) Total Tobacco $9.5 CDC-Recommended Spending Program billion Level 5 Cigarettes Budgets And $3.3 FY2016 Smokeless billion $0.5 billion 0

Source: Campaign for Tobacco Free Kids (2016), Federal Trade Commission (2016), Tax Burden on Tobacco Report (2016) , CDC's Best Practices for Comprehensive Tobacco Control Programs (2014). Tobacco Industry’s Role

MAJOR CONCLUSION #2

“The tobacco epidemic was initiated and has been sustained by the aggressive strategies of the tobacco industry, which has deliberately misled the public on the risks of smoking cigarettes.”

Source: U.S. Department of Health and Human Services. The health consequences of smoking–50 years of progress: A report of the Surgeon General. Atlanta, GA: US Department of Health and Human Services, CDC; 2014.

E-cigarettes are a tobacco product that produces an aerosol Whatby heating aAre liquid thatThey? typically 1 contains nicotine, flavorings, and other chemicals.

Several factors have contributedWhy toAre the popularity They of e-cigarettes, including 2 advertisingPopular? and the vast array of available flavors.

E-cigarette use is higher among youngWho’s people than Using adults. As of 2014, e-cigarettes were the most 3 commonly used tobacco product among U.S.Them? youth.

Youth use of e-cigarettes is unsafe. Adult smokers must 4 completelyAre They quit to realize Safe? benefits from e-cigarettes.

As the tobacco product landscape continuesWhat to diversify, Can it’s We important to modernize tobacco 5 controlDo strategies About to adapt. it?

Brian A. King, PhD, MPH [email protected] Office on Smoking and Health

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.