FDA Regulation of Tobacco

Washington, DC

October 21, 2015

E-cigarette – Trends and Patterns of Use

Eric Donny, PhD, Associate Professor of Psychology, University of Pittsburg

Marina Murphy, PhD, International Scientific Affairs Manager, British American Tobacco

Dr. Andy Tan, Assistant Professor of Social and Behavioral Sciences, Department of Social and Behavioral Sciences, Harvard University School of Public Health

Moderated by Jack E. Henningfield, PhD, Vice President, Research, Health Policy, and Abuse Liability, Pinney Associates

Implications for Public Health & FDA Regulation

Jack E. Henningfield, PhD

Vice President, Research and Health PolicyPinney Associates

And

Professor, Department of Psychiatry and Behavioral SciencesThe Johns Hopkins University School of Medicine

Disclosure: Through my employer, Pinney Associates, I have and/or presently consult to GlaxoSmithKline on smoking cessation, NJOY on electronic cigarettes, Reynolds American Vapor Products, and to pharmaceutical companies on

addiction-related issues. I share interest in a patent for a new nicotine gum for smoking cessation that is under license to Niconovum, which is a smoking cessation product subsidiary of Reynolds American, Inc.

(FDLI Conference: FDA Regulation of Tobacco Products, Oct. 21, 2015)

Today’s Speakers

Dr. Andy Tan, Assistant Professor of Social and Behavioral Sciences, Department of Social and Behavioral Sciences, Harvard University School of Public Health

Eric Donny, PhD, Associate Professor of Psychology, University of Pittsburgh

Marina Murphy, PhD, International Scientific Affairs Manager, British American Tobacco

Moderated by Jack E. Henningfield, PhD, Vice President, Research, Health Policy, and Abuse Liability, Pinney Associates

Introduction

I. What are E-Cigarettes?

II. How do E-Cigarettes fit into public health?

III.How is public opinion evolving?

IV.Why is FDA regulation so urgently needed?

What are E-Cigarettes? Regulatory Status

• A diverse category of rapidly evolving smoking substitute products

• Not regulated as drugs due to 2010 “Sottera” Federal District Court ruling that they are tobacco products if made using tobacco derived nicotine and not making drug claims

• Will be regulated by FDA CTP when Final Deeming Rule is released

• Sponsors may also seek approval of specific products as “drugs” for treatment of tobacco dependence and smoking cessation via CDER

E-Cigarettes / Vaping DevicesElectronic Nicotine Delivery Systems (ENDS)

6

Mid/cigar-size / “tank” / Open systemsMore power, vapor & nicotine

Advanced Personal Vaporizers (APV) Modular Designs - Flexible & ProgrammableHigher PowerCigalike / Mini /

Fix-Dose CartomizersDisposable & Refillable

Delivery by Major Brands & Better Quality Custom ProductsNicotine: Less efficient & generally lower than cigarettes Carbon Monoxide: ZeroCarcinogens & other Toxicants: Overall far few toxicants and at far lower levels than cigarettes – closer to NRT than cigarettesHealth Risk: UK Government report estimates at least 95% less harmful than cigarettes

Premise of the Public Health Promise 2014 50th Anniversary Surgeon General Report

“Death... is overwhelmingly caused by cigarettes and other combustibles...

promotion of e-cigarettes and other innovative products is... likely to be beneficial where the appeal, accessibility and use of cigarettes are rapidly reduced.”

NIDA University of Michigan Monitoring the Future SurveyDaily Cigarette Smoking Grades 8, 10, and 12

0

4

8

12

16

12th Grade

10th Grade

8th Grade

ENDS Marketing

Per

cent

Cigarette Smokingplummets to lowestlevels in decades asENDS experimentationrises – primarily amongalready smoking youth

(Adult smoking also falling)

CDC Director Thomas Frieden Seems to be out of step with NIH, FDA & the 2014 Surgeon General Report

His main reaction to data showing plummeting smoking in youth was great concern about youth ENDS use and to demonize ENDS, e.g.,

“We want parents to know that nicotine is dangerous for kids at any age, whether it’s an e-cigarette, hookah, cigarette or cigars” (April, 2015)

“…Nicotine exposure at a young age may cause lasting harm to brain development, promote addiction, and lead to sustained tobacco use.”

Henningfield response (New York Times, April 18, 2015):

“putting electronic products in the same basket as cigarettes is not truthful, credible or helpful.”

Wells Fargo 4Q 2014 U.S. E-cig Retailer Survey – Excerpts from "Tobacco Talk" by market analyst Bonnie HerzogWake Up Call! Action Needed To Keep Vapor Category Momentum Alive [Media scares: formaldehyde, heavy metals exploding E-Cigs]

(1) the FDA must take leadership and act soon to improve consumers' perception of the relative risks of vapor and uncertainty surrounding the category;

(2) the industry must align, particularly to push for modified risk claims so that public perception doesn't deteriorate further; …

Slade & Henningfield (FDLI Conference, 1998)

“…opportunities seem to exist to make tobacco products less poisonous and to improve public health in how they are made, labeled, marketed, and distributed…

thus, reducing morbidity and mortality caused by tobacco products… by offering a range of markedly less dangerous products to those who cannot or will not stop using nicotine.”

Recommended “harm reduction” as a complementary policy to prevention and cessation, integrated into tobacco control so as not to undermine prevention & cessation efforts

Mitch Zeller on Tobacco Harm Reduction

“…dare to envision a future world where almost no one uses combustible tobacco” - The strategic dialogue on tobacco harm reduction. Tobacco Control, 2009.

“One closing thought…. I absolutely understand the concerns… regardinge-cigarettes. Let’s not lose our focuson the primary cause of death—burning,combusting cigarettes.” CongressionalHearing, May 15, 2014

“FDA Commissioner Hamburg – Comments from Final Testimony to Senate, March, 2015

On Tobacco Deeming Rule:

“Public health-based regulation of These products [e-cigarettes] can help reduce the death and disease toll from tobacco use.”

FosteringInnovation

BySmall & Large

Developers

PerformanceStandards

14

Public Use & Restrictions

PositioningWith NRT &

OtherTobacco

Products

Fit with:Prevention

andCessation

Flavors:Menthol

Other Flavors

Communications, Medical Advice & Labeling

Differential

Tax RatesAcross

Tobacco Products

Public Policy & FDA ENDS Regulation In Comprehensive Tobacco Control

Reducing the addictiveness of combusted products:

implications for patterns of tobacco product use

Eric C. Donny

Professor

Department of Psychology

University of Pittsburgh

Funding

Research reported in this publication was supported by the National Institute on Drug Abuse and Food and Drug Administration Center for Tobacco

Products (U54 DA031659). The content is solely the responsibility of the authors and does not necessarily represent the official views of the

National Institutes of Health or the Food and Drug Administration.

“Death... Is overwhelmingly caused by cigarettes and other combustibles...

Promotion of e-cigarettes and other innovative products is... likely to be beneficial where the appeal, accessibility and use of

cigarettes are rapidly reduced.”

The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General, 2014

A disruptive technology?

• E-cigarettes could disrupt current patterns of tobacco use

• But their impact depends on conditions– Messaging– Regulation– Economic factors– Effects relative to cigarettes

Reinforcement and

dependence

Reinforcement and

dependence

Prevalence and

intensity of use

Prevalence and

intensity of use

(Greater)

Toxicant

exposure

(Less)

Potential

harm

Relative

reinforcement

Combusted

products

Non-combusted

products

Family Smoking Prevention and Tobacco Control Act

• Enables the establishment of product standards for nicotine– Cannot be reduced to zero– Must consider the risks and benefits to the population as a

whole including users and nonusers

• Double-blind, randomized trial• 840 daily smokers, not intending to quit• Used cigarettes varying in nicotine content for 6 weeks

5.2 and above ↑

2.4 and below ↓

Reinforcing value of cigarettes (compared to $)

• Similar design, but allowed participants to purchase alternative products

:

• Arm 1 (N=53): 1.3 mg/g nicotine

cigarette with access to non-

combusted and combusted non-

cigarette products

• Arm 2 (N=56): 1.3 mg/g nicotine

cigarette with access to non-

combusted products

• Arm 3 (N=27): 15.8 mg/g nicotine

content cigarette with access to

non-combusted and combusted

non-cigarette products

Blinded to dose of nicotine

Hatsukami et al., in prep

Hatsukami et al., in prep

*VLNC + combusted & non-combusted

VLNC + non-combusted

NNC + combusted & non-combusted

Hatsukami et al., in prep

0

20

40

60

80

100

15.1

37.7

3.8

20.8

VLNCCombustible & Non-

Combustible

0

20

40

60

80

100

21.4

66.1

1.8 1.8

VLNCNon-Combustible Only

0102030405060708090

100

3.7

44.4

3.7 7.4

NNCCombustile & Non-Combustible

NRT E-cig Smokeless Cigars NRT E-cig Smokeless Cigars

NRT E-cig Smokeless Cigars

Pre

vale

nce

Time

ANDS

Combusted tobacco

A disruptive technology?

Today

Pre

vale

nce

Time

ANDS

Combusted tobacco

A disruptive technology?

Nicotine reduction as

a potential “flash

point”

Today

Summary

• Maximizing conditions that facilitate the transition away from combusted products is essential to improving public health

• Product standards that reduce nicotine content could serve as a “flash point” for reducing combusted product use and facilitating switching to alternative nicotine delivery systems

Public Support for Selected E-Cigarette Regulations

Andy Tan

FDLI 2015 Conference on FDA Regulation of Tobacco Products

October 21, 2015

Background

• Federal regulations for e-cigarettes are pending

• States and local communities have introduced regulations (bans in public, youth access, taxes)

• Assessed public support for six e-cigarette regulations

• Examined whether exposure to e-cigarette information was associated with support

Methods

• Online survey in July 2014

• Data from 527 adults 18+ years

• Outcomes were support for 6 policies

• Correlates were exposure to information, demographics, and tobacco use

Policies

There are currently proposals to regulate electronic cigarettes (e-cigarettes) in various ways. How much do you agree or disagree with the following statements?

1) Vaping or using e-cigarettes should not be allowed in places where smoking cigarettes is not allowed.

2) Youth under 18 years should not be allowed to buy e-cigarettes.

3) E-cigarette packages and advertisements should be required to carry an addiction warning.

Policies (cont’d)

4) The use of flavors in e-cigarettes should not be allowed.

5) E-cigarette packages should be required to label the amount of nicotine and other harmful ingredients.

6) Marketing and advertising e-cigarettes to youth under 18 years should not be allowed

Sample Characteristics

• Mean age 51.8 years (SD=16.4)• 50% female• 75% were non-Hispanic white• 31.5% completed college education or higher• 13% were current cigarette smokers• 4% have used e-cigarettes in the past 30 days

0.010.020.030.040.050.060.070.080.0

18.87.4 8.4

24.3

5.5 6.8

56.7

70.665.7

34.0

71.7 70.8

20.9 18.2 22.2

38.3

19.0 18.8

Disagree Agree No opinion

Pe

rce

nt

of

re

sp

on

de

nts

Public Support for E-cigarette Regulations

0

20

40

60

37.546.4 41.2

56.7

Perc

en

t ag

reem

en

t

Trends in Public Support for Banning E-cigarette Use in Public Venues

Summary

• Moderate to high support for 5 of 6 policies, restricting use of flavors had lowest support.

• Recommend continued monitoring of public support for e-cigarette policies.

ReferencesMajeed BA, Dube SR, Sterling K, Whitney C, Eriksen MP. Opinions about Electronic Cigarette Use in Smoke-Free Areas among U.S. Adults, 2012. Nicotine Tob Res. October 2014. doi:10.1093/ntr/ntu235.

Tan ASL, Lee C, Bigman CA. Public support for selected e-cigarette regulations and associations with overall information exposure and contradictory information exposure about e-cigarettes: Findings from a national survey of U.S. adults. Preventive Medicine. doi:10.1016/j.ypmed.2015.09.009.

Tan ASL, Bigman CA, Sanders-Jackson A. Sociodemographic correlates of self-reported exposure to e-cigarette communications and its association with public support for smoke-free and vape-free policies: results from a national survey of US adults. Tob Control. 2014:tobaccocontrol - 2014-051685. doi:10.1136/tobaccocontrol-2014-051685.

Wackowski OA, Delnevo CD. Smokers’ attitudes and support for e-cigarette policies and regulation in the USA. Tob Control. January 2015:tobaccocontrol - 2014-051953. doi:10.1136/tobaccocontrol-2014-051953.

E-cig Trends

The views, perceptions and experiences of ‘successful’ vapers

Dr Marina MurphyResearch & Development , British American Tobacco

E-cig Uptake by UK smokersE-cigarette use among British

smokers, 2010- 2015

2015: ‘Current EC users are almost exclusively smokers (60%) or ex-smokers (40%), that is smokers who now use EC and have stopped smoking altogether.’

http://www.ash.org.uk/files/documents/ASH_891.pdf; https://www.gov.uk

Tobacco Atlas

Prevalence and use in 27 European countries

Perceptions and experiences of ‘successful’ e-cig users: an international online survey

?Global survey of EC users

• 7,326 Vapers surveyed

• Languages: English, French, Italian, Spanish, Russian, Polish, German (June 1st – Aug 30th 2015)

• 4,235/5000 (85%) smokers quit

• 56% of 754 dual-users

reduced CPD by >50%

Research Funded by Nicoventures, the Next Generation Products business of the British American Tobacco group of companies

• Smoking history• Past quit attempts• Vaping history• Devices ever used/currently used/preferred/disliked• Flavours ever used/currently used/preferred/disliked • Nicotine strengths ever used/currently used/preferred/disliked• Harm perceptions• Addiction perceptions• Reasons for starting to vape• Reasons for continuing to vape• Bans on use• Health changes experienced since regular vaping • Benefits and pleasures of vaping

Variables measured

Sight of vapour/smoke

After-taste

Taste

Mildness

Smoothness

Overall satisfaction

Satisfying vapour/smoke

Look of the stick

Smell of vapour/smoke

Socialising

Feeling after

Look of the packaging

Feeling in hand

Lift in morning

Craving relief

Throat hit

Nicotine fix

Stress relief

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

92%

89%

88%

86%

83%

76%

72%

65%

63%

58%

57%

53%

51%

45%

42%

41%

38%

34%

6%

6%

2%

11%

12%

15%

14%

21%

26%

22%

28%

38%

23%

28%

37%

25%

40%

36%

2%

5%

10%

2%

5%

9%

14%

14%

11%

20%

14%

10%

26%

28%

21%

34%

23%

34%

Factors Determining Preferences for ECs vs. Regular Cigarattes

Prefer my EC

No difference

Prefer Regular Cigarettes

% Prefer

Feat

ure

Regulating Potentially Reduced Risk Products to Improve Public Health?

Ref: ‘Harm reduction in nicotine addiction: helping people who cant quit’. A report by the Tobacco Advisory group of the Royal College of Physicians,UK. October 2007

A-E-I-O-U

Advice

Encouragement

Information

Opportunity

Understanding

What do smokers want?

Tobacco Products Nicotine Products

Cig

aret

te

s

TH

P

Sn

us E-

Cig

aret

te

s M

ed

icin

al

Nic

oti

ne

Exposure to ToxicantsHigh Low

Marketing/InnovationRestricted

Less Restricted

Accessibility & Affordability

HighLow

“To dismiss, misuse or under-use successful vapers’ insights and experiences as part of health services’ efforts to help smokers quit with reduced-risk products would, in my opinion, be a monumental missed public health opportunity,”

Dr Chris Russell,

Principal Investigator

Centre for Drug Misuse Research,

Glasgow, Scotland

chrisrussell@drugmisuseresearch.org

www.nicotinesurveys.org

@nicotinesurveys

Thank you www.bat-science.com

Dr Marina Murphy, Research & Development, British American Tobacco

marina_murphy@bat.com, Tel: +44(0)7711150135