E-cigarette – Trends and Patterns of Use
Eric Donny, PhD, Associate Professor of Psychology, University of
Pittsburg
FDA Regulation
of Tobacco
Washington, DC
October 21, 2015
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 Policy
Pinney Associates
And
Professor, Department of Psychiatry and Behavioral Sciences
The 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 Devices
Electronic Nicotine Delivery Systems (ENDS)
Cigalike / Mini /
Fix-Dose Cartomizers
Disposable & Refillable
Mid/cigar-size / “tank” / Open
systems
More power, vapor & nicotine
Advanced Personal Vaporizers (APV)
Modular Designs - Flexible & Programmable
Higher Power
Delivery by Major Brands & Better Quality Custom Products
Nicotine: Less efficient & generally lower than cigarettes
Carbon Monoxide: Zero
Carcinogens & other Toxicants: Overall far few toxicants and at far lower levels than cigarettes – closer to
NRT than cigarettes
Health Risk: UK Government report estimates at least 95% less harmful than cigarettes
6
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 Survey
Daily Cigarette Smoking Grades 8, 10, and 12
ENDS Marketing
10
12th Grade
5
0
10th Grade
8th Grade
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
(Adult smoking also
falling)
Percent
Cigarette Smoking
plummets to lowest
levels in decades as
ENDS experimentation
rises – primarily
among
already smoking youth
15
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 Herzog
Wake 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… regarding
e-cigarettes. Let’s not lose our focus
on the primary cause of death—burning,
combusting cigarettes.” Congressional
Hearing, 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.”
Public Policy & FDA ENDS Regulation
In Comprehensive Tobacco Control
Performance
Standards
Fostering
Innovation
By
Small & Large
Developers
Public Use &
Restrictions
Differentia
l
Tax Rates
Across
Tobacco
Products
Positioning
With NRT &
Communications,
Other
Medical Advice
Tobacco
& Labeling
Products
Fit with:
Prevention
and
Cessation
Flavors:
Menthol
Other Flavors
14
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
Combusted
products
Reinforcement
and dependence
Prevalence and
intensity of use
(Greater)
Relative
reinforcement
Toxicant
exposure
(Less)
Noncombusted
products
Reinforcement
and dependence
Prevalence and
intensity of use
Potential
harm
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 $)
Hatsukami et al., in prep
• 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 noncigarette 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 noncombusted and combusted
non-cigarette products
Blinded to dose of nicotine
Hatsukami et al., in prep
VLNC + combusted & non-combusted
*
VLNC + non-combusted
NNC + combusted & non-combusted
Hatsukami et al., in prep
VLNC
Combustible & NonCombustible
NNC
Combustile & Non-Combustible
100
100
80
80
60
60
44.4
40
40
20
20
3.7
7.4
3.7
37.7
20.8
15.1
3.8
0
0
NRT
E-cig
Smokeless
NRT
Cigars
E-cig
VLNC
Non-Combustible Only
100
80
66.1
60
40
21.4
20
1.8
1.8
0
NRT
E-cig
Smokeless
Cigars
Smokeless
Cigars
A disruptive technology?
Prevalence
ANDS
Combusted tobacco
Time
Today
A disruptive technology?
Nicotine reduction
as a potential
“flash point”
Prevalence
ANDS
Combusted tobacco
Time
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
Public Support for E-cigarette Regulations
80.0
71.7
70.6
Percent of respondents
70.0
70.8
65.7
56.7
60.0
50.0
40.0
34.0
30.0
20.0
10.0
18.8
20.9
22.2
18.2
7.4
38.3
24.3
19.0
8.4
5.5
18.8
6.8
0.0
Vaping or
Youth under 18 E-cigarette
The use of
E-cigarette
using eyears should packages and flavors in epackages
cigarettes
not be allowed advertisements cigarettes
should be
should not be
to buy eshould be
should not be
required to
allowed in
cigarettes
required to
allowed
label the
places where
carry an
amount of
smoking
addiction
nicotine and
cigarettes is
warning
other harmful
not allowed
ingredients
Disagree
Agree
No opinion
Marketing and
advertising ecigarettes to
youth under 18
years should
not be allowed
Trends in Public Support for Banning E-cigarette Use in Public
Venues
56.7
Percent agreement
60
50
40
46.4
37.5
41.2
30
20
10
0
June-July 2012
(Majeed et al.,
2015)
Oct-Dec 2013
April 2014
July 2014
(Tan et al., 2014) (Wackowski et al., (Tan et al., 2015)
2015; among
smokers)
Summary
• Moderate to high support for 5 of 6 policies, restricting use
of flavors had lowest support.
• Recommend continued monitoring of public support for ecigarette policies.
References
Majeed 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 Murphy
Research & Development , British American Tobacco
E-cig Uptake by UK smokers
E-cigarette use among British
smokers, 2010- 2015
http://www.ash.org.uk/files/documents/ASH_891.pdf; https://www.gov.uk
2015: ‘Current EC
users are almost
exclusively smokers
(60%) or ex-smokers
(40%), that is smokers
who now use EC and
Prevalence and use in 27 European countries
Tobacco Atlas
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
Variables measured
•
•
•
•
•
•
•
•
•
•
•
•
•
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
Factors Determining Preferences for ECs vs. Regular Cigarattes
Stress relief
34%
Nicotine fix
38%
41%
Craving relief
42%
34%
37%
51%
Look of the packaging
53%
Socialising
58%
11%
21%
14%
15%
83%
Mildness
86%
Taste
88%
After-taste
89%
92%
9%
12%
5%
11% 2%
2% 10%
6% 5%
6% 2%
10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
% Prefer
No difference
Prefer Regular Cigarettes
14%
14%
76%
Prefer my EC
20%
26%
72%
0%
14%
22%
65%
Sight of vapour/smoke
10%
28%
63%
Smoothness
26%
38%
57%
Overall satisfaction
28%
23%
Feeling after
Satisfying vapour/smoke
21%
28%
Feeling in hand
Look of the stick
23%
25%
45%
Smell of vapour/smoke
34%
40%
Throat hit
Lift in morning
Feature
36%
What do smokers want?
A-E-I-O-U
Regulating Potentially
Reduced Risk Products to
Improve Public Health?
Exposure to Toxicants
High
Low
Understanding
ECigarette
s
Medicina
l
Nicotine
Opportunity
Snus
Information
THP
Encouragement
Cigarette
s
Advice
Marketing/Innovation
Less
Restricted
Restricted
Low
Accessibility &
Affordability
High
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
“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