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An Introduction to e-cigarettes
Dr. Saul M. Shiffman, PhD
Senior Scientific Advisor, Behavioral Science, Study Design
and Analysis,
PinneyAssociates
Professor of Psychology, Psychiatry, Pharmaceutical
Sciences, and Clinical Translational Research,
University of Pittsburgh
Disclosure
• In the past three years PinneyAssociates has provided services for
several companies, including
– GlaxoSmithKline Consumer Healthcare on stop-smoking medications
(Nicorette and NicoDerm CQ). (lapsed)
– NJOY, Inc., on electronic nicotine delivery systems (lapsed)
– Reynolds American, Inc. (RAI) on tobacco cessation and harm
minimization (ongoing since Feb 2015). Work on combustible conventional
cigarettes is excluded.
• SS owns intellectual property for a nicotine gum optioned for
development to Niconovum, a subsidiary of RAI.
• SS has two tobacco-related research grants from the National
Institutes of Health, one funded by FDA’s Center for Tobacco Products
Smoking Kills
• 480,000 US deaths/year
• 6,000,000 worldwide
deaths/year
• Expect 500,000,000
worldwide deaths in this
century
• 50% of continuing
smokers killed by
smoking
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It’s the Smoke, Stupid!
• Smoke has > 7,000
chemicals
• > 70 chemicals
carcinogens
• “Death is overwhelmingly
caused by cigarettes and
other combustibles”
-50th Anniversary Surgeon
General’s Report, 2014
5
It’s not the Nicotine
6
People smoke for nicotine,
but die because of tar (MAH Russell)
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e-cigarette Types
8
Cig-alikes Rechargables Tanks
1st gen 2nd gen 3rd gen
Risks of e-cigarettes
The Science
• The absolute magnitude of any risk attributable to e-cigarette use is likely to be very small in absolute terms, and hence substantially smaller than that arising from tobacco smoking
– Royal College of Physicians, Nicotine Without Smoke 2016
• Risk of e-cigarettes is estimated at ~5% that of smoking
– Public Health England (also Nutt et al 2014)
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Risks of e-cigarettes
The Mis-Information
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Risks of e-cigarettes
The Silliness
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Two cases of eye injury: “A significant risk to public health”
It’s the Relative Risk
• No expectation e-cigarettes are completely safe
• What is?
– Not medications
– Not methadone
– Not bicycling, even with a helmet
– Not driving, even with seat belts
• But 95% safER … (Public Health England)
12
So What’s not to Like?
• Concerns arising from the “population health benefit”
standard baked into the law
• Uptake by non-smokers, especially young initiates
– “Gateway” to smoking
• Renormalization of smoking
• Deterring smokers from quitting smoking
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Use of e-cigarettes
Adults
Days Use in Past 30 days, US, NTBM
None
1-4
5-14
15-26
27-30
Relation to Smoking,
US, NTBM
• 94% had been established
smokers (100+ cigarettes)
• Among daily e-cigarette users
44% were now ex-smokers
(53% among daily 10+/day)
• Among established smokers
(initiated 2007+) with past-30-
day e-cigarette use,
92% started smoking first
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Use of e-cigarettes:
TeensPast-30-day e-cigarette use, Ages 12-17,
USA, PATHOrder, e-cigarette use and smoking, ever users, 11-18, UK
Smoking1st
e-cigarette1st
Nosmoking
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No use
1 puff
1-10 ecigs
>10 ecigs
NB: >70% is
non-nicotine
Is e-cigarette use
a Gateway into Smoking?
• Concern that teens who would not otherwise smoke might be caused to initiate smoking due to use if e-cigarettes – Several studies show increased likelihood of later smoking among e-
cigarette users
– But these may have been teens who were destined to smoke (can’t predict later smoking very well, try as we might)
• Gateway out of smoking?– Two population analyses show teen smoking increases when states
impose age restrictions on e-cigarette purchase
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Gateway? … Not Consistent with Data
17
0
5
10
15
20
25
30
2000 2006 2009 2011 2012 2013 2014
Per
cent of stu
dents
Cigarette and E-Cigarette Use in US High School Students
E-cigarettes
Gateway? … Not Consistent with Data
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0
5
10
15
20
25
30
2000 2006 2009 2011 2012 2013 2014
Per
cent of stu
dents
Cigarette and E-Cigarette Use in US High School Students
Cigarettes E-cigarettes
Deterrence from Quitting
The Hype
• Glantz meta-analysis of 18 studies concludes use of e-cigarettes impedes quitting
• Aggregation of meaningless studies: garbage in, garbage out:
• Many studies excluded ex-smokers, so successes not counted
• Studies typically examined long-past e-cigarette use in relation to current abstinence – Like testing whether using aspirin relieves headaches by
seeing if people who used aspirin as childrenstill got headaches as adults
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Deterrence from Quitting
The Data
• CDC (US)– Smoking prevalence at record lows, record drop 2014-2015
• Gitchell (US)– Quit attempts have been increasing since 2011
• West (UK)– Smokers using e-cigarettes to quit were more likely to succeed than smokers using
nicotine replacement
• Beiner (US)– Smokers who used e-cigarettes ‘intensively’ in past year were more likely quit
– These were heavy smokers who had previously tried and failed to quit with NRT
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Should e-cigarettes be Appealing?
A Framework for Considering Harm &Appeal
Toxicity - Harmfulness
Ap
pe
al -
Sati
sfac
tio
n
Cigarette
smoking
Useless
reduced-risk
product
Ideal
reduced-risk
product
Full framework
also considers
addiction potential
Role of Flavors in e-cigarette Use
• Flavors likely increase product appeal
• Appeal to whom and when?– Survey shows little appeal among teen non-smokers, substantial appeal
among adult smokers
– FDA emphasizes “available in flavors” as the biggest stated motive for teen e-cigarette use (PATH survey), but health-protective motives are moreprominent
– Adult smokers adopt flavored e-cigarettes when switching completely from smoking to vaping
• Do flavors help or hurt public health?
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Summary
• e-cigarettes very much safer than smoking
• Current course is unacceptable
• Switching to e-cigarettes can save lives
• Absolutism kills– Absolute safety
– Absolute abstinence
– Absolute destruction of the tobacco industry
• Rational public health policy– Regulate to ensure reasonable standard of safety and quality
– Regulate to discourage use by non-smokers, esp. teens
– Promote progressive development of e-cigarettes
– Promote switching from smoking to e-cigarettes
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the implications of FDA’s deeming regulations
Julian Morris
Reason Foundation
Outline of my talk
•The evolution of electronic vapor products (EVPs)
•Understanding Consumer Uptake of EVPs
•Which products are likely to be available when the deeming regs are fully in effect?
•Consequences?
the evolution of electronic vapor products
Ruyan cigalike (2004)
Hon Lik
Gamucci cartomizer (2008)
[Taz and Umer Sheikh]
Combined cartridge and atomizer, with e-liquid in polyfill. Connects directly to battery.
Simpler, more effective than earlier 3-part design.
[it’s a modified flashlight battery attached to a cartomizer]
the Screwdriver mod – invented by Matt and Ted Rogers (2008)
more power, for longer
Joyetech eGo T (2008)
Battery-cartridge combination that offered the advantages of the screwdriver mod to a mass market (but with a disposable cartridge)
eGo T battery with clearomizer (2009)
+
=powerful, refillable, easy to use, long lasting
Subsequent hardware innovations
• Larger tanks (can hold more liquid for all-day vaping)
• Bottom coil atomizers (less likely to burn liquid or cause “dry” vaping)
• Larger batteries (longer lasting, more powerful)
• Variable current, low resistance (more rapid vaporization, with control of coil temperature to avoid overheating)
• Microprocessor temperature control (prevent overheating)
understanding consumer uptake of evps
what do users prefer?
A recent online survey of 2807 current “e-cigarette” users found that “Newer-generation e-cigarettes were perceived to be more satisfactory and more effective for refraining from smoking than older models.”*
A representative national US telephone survey found that over half of adult (age 18+) “ENDS” users used refillable tanks (60.3%), a quarter used cartridge-based devices (24.3%), and fewer used disposables (15.4%).
By contrast, most adolescents (age 13-17) used refillable tanks (78.9%) and fewer used cartridge-based devices (10.5%) or disposables (10.5%).**
* “Characteristics of users and usage of different types of electronic cigarettes: findings from an online survey,” Jean-François Etter, Addiction, January 2016
** “Device types and terminology among current users of electronic nicotine delivery systems,” Kimberly Wiseman*, Jennifer Cornacchione, Cynthia Suerken, Kimberly Wagoner, Erin Sutfin, Wake Forest School of Medicine, NC, USA. Poster session at Society for Research on Nicotine and Tobacco, March 2016]
ASH survey of UK vapers shows year-on-year increase in use of rechargeable devices with tanks
new generation devices deliver more nicotine more quickly – but less than a cigarette
[Farsalinos et al., 2014.]
flavors of e-liquid preferred by UK vapers [in ASH survey]
Market response to health concerns
• 2014 Study by Farsalinos et al found significant quantities of two chemicals, diacetyl (DA) and acetyl propionyl (AP), associated with “popcorn lung” (obliterative bronchiolitis) in over 70% of e-liquids tested
• Conclusions were shared widely among vapers though online forums
• In response, online retailer Vaporshark had all its e-liquids tested for the presence of both chemicals and disclosed the findings.
• Many manufacturers responded by removing flavorings containing DA and AP.
• Worth noting that concentration of DA in one cigarette is approximately 8 x concentration in 3mg (approx. one day’s use for a heavy consumer) e-liquid.
What are the lessons?
Choice and competition have driven innovation that has enabled
vapers to obtain products (devices and liquids) that meet their felt
needs in ways that are less harmful than cigarettes.
Early on, cigalike users developed “mods” that better met their felt needs:
• Nicotine delivery that more closely resembles that of smoking, even if the device
appears less like a cigarette
• Greater convenience – such as longer-lasting batteries
Companies responded by copying and improving upon these innovations:
• New devices that are more powerful, enable greater user control, and offer better
protection against unpleasant (and potentially harmful) burning
• New liquids in a wide range of flavors
• The removal of chemicals from liquids when concerns were raised about potential
dangers.
• Liquids with very low or zero nicotine content – especially for vapers who prefer
devices that produce more vapor
• New cigalike devices that more effectively deliver nicotine (e.g. by adding lactic acid)
which products might be grandfathered under the deeming regulations?
IF a manufacturer or importer can prove that such a product was available in the US in Feb 2007
which other products might be approved
but are these tobacco products?
is this? or this?
is this a tobacco product?
what about this?
so what will vapers – and smokers -- do?
• Some vapers will make do with whatever devices (presumably cigalikes) are approved
• Some will develop their own devices and mix their own e-liquid from concentrated nicotine and flavors sold for foods
• Users will share designs and recipes online, including blueprints for 3D printed devices
• But these underground products will not be subject to the same checks as commercial products
• Some will switch back to cigarettes
• Fewer smokers will stop smoking
• How is that good for the health of the public?
Stacy Ehrlich
Kleinfeld Kaplan & Becker LLP
June 2016
Nicopure Labs, LLC v. FDA (D.D.C. 5/10/16)
Lost Art Liquids, LLC v. FDA (C.D.Cal. 5/19/16)
John Middleton Company LLC v. FDA (D.D.C. 5/26/16)
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1. Unlawful Statutory Interpretation: broad definition of “tobacco product” is inconsistent with TCA
2. Arbitrary & Capricious: impose enormous burden without rational connection to public health objectives
3. Unlawful Cost-Benefit Analysis
4. Violation of the First Amendment (MRTP claims, free samples)
Requests declarative, injunctive relief
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1. Violation of the Regulatory Flexibility Act (RFA): failed to adequately consider significant alternatives which accomplish statutory objectives while minimizing economic impact on small entities
2. Unlawful Cost-Benefit Analysis
3. Violation of the First and Fifth Amendments (MRTP claims, required label statements)
4. Abuse of Discretion: lacks rational basis for extraordinary burden
Requests declarative, injunctive relief
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FDA rule (MRTP provision) bans “Black & Mild” name for Altria cigars
1. Arbitrary and Capricious
2. Lacks a rational basis
3. Failed to consider rational alternatives
4. Failed to respond to significant comments
5. Violates First Amendment
6. Violates Fifth Amendment (impermissible taking)
Requests declarative, injunctive relief
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Regulatory Flexibility Act: must assess impact of rule on small business and consider less burdensome alternatives which accomplish the stated objectives and minimize economic impact on small entities
SBA comments: proposed rule lacks essential information required under the RFA because it does not discuss the quantitative or qualitative costs of the proposal on many potentially affected small entities
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“We note that we have not quantified the benefits of the proposed or final rule, and we are unable to quantify any possible unintended offsetting benefits.”
“Unquantified costs … include: some consumer costs for users of the newly deemed products due to loss of product variety or higher prices … compliance costs for components and parts other than complete … ENDS delivery systems; the cost of testing and reporting for [HPHCs;] market adjustment (friction) costs and lost producer surplus associated with product consolidation, exit of manufacturers (including some vape shops currently engaged in manufacturing activities), and the switch to pure retailing among retailers such as vape shops who currently engage in manufacturing activities.”
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1. Exempting premium cigars
2. 36-month compliance period for labeling changes
3. 12-month compliance period for labeling changes
4. Enforcement option of not extending the premarket review compliance policy to new flavored tobacco products (other than tobacco flavored products)
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FDA expects PMTAs for 1250-2500 e-liquids and 360-450 ENDS devices
Total costs for e-liquids (may cover multiple products) = $181,686 to $2,014,120
Total costs for ENDS delivery systems (may cover multiple products) = $285,656 to $2,622,224
Meet product standards in lieu of individual PMTA approval
◦ Achieve harm-reduction potential while still holding products to strict regulatory standards
◦ Like OTC Review
◦ Could prioritize most important safety issues
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As long as speech is not misleading and concerns legal activity, regulations must be narrowly tailored to directly advance a substantial government interest
Modified risk provision upheld by the 6th Cir in Discount Tobacco City and Lottery Inc. v. US (2012)◦ Cited findings in Philip Morris as evidence that
given extensive history of deception by the industry, such a stringent standard was least restrictive means available to ensure protection of public health
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ENDS are distinguishable from traditional tobacco products
“[S]ome evidence suggests that ENDS may potentially promote transition away from combusted tobacco use among some current users and it is possible that there could be a public health benefit.”
“FDA agrees that use of ENDS is likely less hazardous for an individual user than continued smoking of traditional cigarettes.”
Truthful and nonmisleading information to inform consumers should not prohibited
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“Market failure derived from inadequate information about product characteristics and quality leads to non-optimal levels of consumption and corresponding losses of social surplus.”
“Consumers’ inability to make well-informed choices is a particular problem because tobacco products containing nicotine are addictive [and] suboptimal initial choices can be difficult to reverse over time.”
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TCA was intended to regulate traditional products like cigarettes, smokeless; ENDS did not exist at drafting◦ BUT “tobacco product” statutory definition very
broad and statute gives FDA authority to “flip the switch”
FDA has too broadly defined the universe of regulated products (e.g., components/parts, nicotine-free e-liquids)
Burden undermines public health, contrary to the purpose of the TCA; no rational connection to public health objectives
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E-liquids, atomizers, cartomizers, coils, batteries, digital displays, flavors, tank systems, software, bottles containing e-liquid
Glass vial containing e-liquid is component/part whereas hard plastic blister pack in which glass vial of e-liquid is distributed and sold to consumers is not
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If intended or reasonably expected to be used with or for the human consumption of a tobacco product = tobacco products
◦ E.g., intended or reasonably expected to be mixed with liquid nicotine
“FDA intends to regulate the entire line of cartridges (including cartridges that include varying degrees of nicotine or those that do not contain nicotine, if they meet the definition of component or part).”
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“[I]f, going forward, electronic cigarettes are proven safer than other tobacco products and are substitutes for other tobacco products, and if the effect of premarket requirements on the supply and price of electronic products were large enough, then the welfare effects of a reduction in supply of electronic cigarettes could potentially be negative.”
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“If consumption of ENDS products entails individual health risks that are more moderate than those of other tobacco products, it is possible that, if provisions of the rule tend to discourage their use disproportionately, any ongoing improvements in population-level health risks associated with changing patterns of use of tobacco products could potentially be reduced.”
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