What we know and still need to find out Evan L Floyd PhD David Johnson PhD PE CIH Theodore Wagener PhD Department of Occupational and Environmental Health Department of Pediatrics ID: 544193
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Slide1
Electronic Cigarettes in Context:
What we know and still need to find out
Evan L. Floyd, PhD*
#
David Johnson, PhD, PE, CIH*
Theodore Wagener, PhD
+#
*Department of Occupational and Environmental Health
+
Department
of Pediatrics,
Co-Director OTRC
#
OUHSC, Oklahoma TSET Research ScholarSlide2
Overview
Toll of Tobaccoe-cigarettes/vapor products designProposed Rule by FDA (April 25, 2014)Toxicology – mainstream and secondhand vapor
Nicotine delivery and abuse liabilitySubjective effects and smoking behaviorWhat we still need to find out…e-cigarettes in context of proposed “Tobacco End Game”Slide3
Tobacco Toll: US and Oklahoma1
US19% smoking rate443,000 deaths per year
$193 billion in medical costs/lost productivityOklahoma23.3% smoking rate6,500 deaths per year
$2.8 billion in medical costs/lost productivitySlide4
e-Cigarette Product DesignsSlide5
e-Cigarettes/Vapor products design
“cig-a-like” e-cigarettesAka – 1st generation e-cigs
Look like regular cigarettesActivated by inhaling; cartridge-basedTobacco companies have these type of e-cigs Lorillard – acquired BluRJR – developed Vuse
Altria – acquired Green Smoke and developed MarkTenSlide6
e-Cigarettes/Vapor products design
Tank system e-cigarettes
Do not look like a cigaretteActivated by push button; user refillable e-liquid; some are variable voltage; different resistance atomizers available
Currently none owned (to my knowledge) by Tobacco Industry
Vape shops sell these typesSlide7
e-Cigarettes/Vapor products design
Rebuildable Atomizers (RBAs)
Doesn’t look like a regular cigarette
“Drip Vaping”, 2-3 drops of e-liquid at a time; Push button activated
High Powered; custom coils with low resistance, high voltagesCurrently none own by tobacco industryVape
shops sell these types
Used mostly by experienced usersSlide8
FDA Proposed Rule
To deem all products meeting the statutory definition of “tobacco product” except accessories… to be subject to FDAs tobacco product authorities under chapter IX of the FD&C Act as amended by the Family Smoking Prevention and Tobacco Control Act.”
Currently marketed products meeting the statutory definition of a “tobacco product” are
DissolvablesGels
Hookah tobaccoElectronic cigarettesCigars
Pipe tobaccoSlide9
FDA Proposed Rule
FDA does not intend to “deem” accessories since they are not intended or expected to be used in the consumption of the tobacco product
hookah tongs, bags, cases, charcoal burners and holders, as well as cigar foil cutters, humidors, carriers, and lightersFDA does intend to “deem” components and parts of tobacco products to be subject to the TCA
filters, tubes, papers, pouches, flavorings (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettesSlide10
Toxicology (only 1st gen e-cigs)
Preliminary data (20 peer-reviewed articles/reports)
e-cigarette users are exposed to lower levels of carcinogens and toxicants than cigarette smokers.
Levels 9-450x less than cigarettes and some comparable to nicotine inhaler
E-cig aerosols and liquid significantly less cytotoxic than cigarette smoke: human embryonic stem cells, pulmonary fibroblasts, mouse neural stem cells Quality control issuesNicotine levels reported ≠ levels contained in the product
Quality of nicotine liquid used is not currently regulated, but will be if the proposed rule goes through
Mixing of e-liquid in
vape
shops is not regulated
Secondhand vapor contains significantly less nicotine and PM than secondhand smoke by orders of magnitude, but significantly more than clean indoor air.
(
Czogola
et al., 2014) Slide11
Toxicology – SH Vapor
Implies particles grow while within the lungs and persist longer in the environment when exhaled by a userSlide12
Nicotine Delivery/Abuse Liability
1
st
generation delivery nicotine less effectively than tank system e-cigarettes (Farsalinos et al 2014)
Nicotine delivery by combustible cigarette still the most effective (faster and larger quantities). (Farsalinos et al 2014)What’s the difference? Dose or Absorption, Both?Slide13
Nicotine Delivery/Abuse Liability
Naïve e-cigarette users need more puffs to get cotinine blood levels as high as regular cigarettes (Flouris et al., 2013; Vansickel et al.,, 2012)Experienced users do not
(Vansickel & Eissenberg, 2013)Currently tested models of e-cigarettes suggest e-cigs have lower abuse potential than regular cigs (1st gen)
(Vansickel et al, 2012 Addiction; Farsalinos et al Substance Abuse 2013)Slide14
Subjective effects and smoking behavior
Effectively reduces cravings (Vansickel et al., 2012 Addiction; Vansickel et al., 2013
Nic and Tob Res)Improvement in depression and concentration (Dawkins et al., 2012 Addictive Behaviors)
Men show more improvement in irritability and restlessness than women (Dawkins et al., 2012 Addictive Behaviors)Experimentation among naïve smokers uninterested in quitting led to increased motivation and confidence to quit smoking.
(Wagener et al., 2014)Slide15
Subjective effects and smoking behavior
Smoking Behavior & cessationNicotine free e-cigarettes effective at reducing craving and number of cigarettes smoked (Bullen et al.,
2010,Tobacco Control)Smokers uninterested in quitting (Polosa et al., 2011 BMC Public Health
)e-cigarettes helped a majority of smokers reduce (45%) or completely quit (22.5%) regular cigarettes Smokers, uninterested in quitting (Caponetto et al., 2013)
At least 50% reduction in 22.3% at 12 weeks and 10.3% at 52 weeks.10.7% quit regular cigarettes at 12 weeks, and 8.7% at 52 weeks26.9% of quitters continued to use e-cigarettes at 52 weeksSmokers, uninterested in quitting (Wagener et al., 2014)Mean 44% reduction in reg cigs at 1 week after initial e-cig experimentation.Slide16
Subjective effects and smoking behavior
Smokers interested in quitting (Bullen et al 2013)E-cigarette versus patchAt 6 months, 7.3% of e-cigarette users versus 5.8% of patch were abstinence (not significantly different)
Smokers with Schizophrenia, uninterested in quitting (Caponnetto, Auditore, Russo et al., 2013)64.3% participants reduced number of cig/day (52-weeks)
50% of participants reduced number of cig/day by at least 50% (52-weeks)Surveys of current EC users show abstinence rates from regular cigarettes at rates as high as 74% to 96% (Dawkins et al., 2013,
Addiction; Etter et al., 2011, Addiction)Slide17
Subjective effects and smoking behavior
Preliminary data suggests that a majority of vape store customers are exclusive e-cig users (64%). (Lechner…Wagener, in press)Slide18
Aerosol Size Distribution of Modern Variable Voltage e-Cigarette
(Prelim Data)
Floyd and Johnson, 2014 unpublishedSlide19
Vaping aerosol mass evolution (Prelim Data)
DC Volts applied
Energy applied (Joules)
Mass
consumed per puff (mg)
Aerosol
mass
per
puff (mg)
3.0
8.82
0.25
0.0063.411.4240.550.0303.814.4782.07
0.084
4.2
17.514
2.80
0.083
4.6
21.1143.27
0.105
5.0
24.75
3.59
0.126
5.4
28.998
6.56
0.146
5.8
33.408
8.20
0.167
6.0
35.82
7.29
0.155
E-cigarettes consume milligram quantities of e-juice
All of which is inhaled (though not necessarily retained)
Measured aerosol (<20,000 µm) account for about 2% of the consumed e-juice
Suggests the rest is gas phase or particles >20 µm in size
Floyd and Johnson, 2014 unpublishedSlide20
Tobacco cigarette vs e-cigarette aerosols (prelim data)
Vaping aerosol may greatly exceed tobacco cigarette smoke mass concentrations
Nicotine concentrations in the gas and particulate phases have not been compared
Floyd and Johnson, 2014 unpublishedSlide21
What we still need to find out…
What are the long-term effects of e-cig use? How common will dual use be?What will the research outcomes look like with 2nd
generation e-cigs?What will be the net population effect of e-cigarettes?Slide22
End Game Scenarios – role of e-cigsSlide23
End Game Scenarios – role of e-cigsSlide24
End Game Scenarios – role of e-cigsSlide25
End Game Scenarios – role of e-cigsSlide26
Continuum of RiskSlide27
End Game Steps – 1 potential way
2009 Tob Control Act – FDA has the authority to issue mandatory product standards to control permissible levels of compounds in tobacco productsReduce nicotine in all combustible products to very low levels, rendering them non-addictive. (studies already underway).
To help prevent counterfeit tobacco…allow non-combustible products to remain at addictive levels though regulated by the FDA (also with product standards) to allow smokers who are unable or uninterested in quitting nicotine to switch. First steps taken with the currently proposed ruleSlide28
End Game Scenarios – role of e-cigsSlide29
References
FDA proposed rule 25 April 2014
, section D http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-0001
Czogola
et al, 2014Farsalinos et
al, 2014
Flouris
et
al, 2013
Vansickel
et al., 2012
AddictionVansickel & Eissenberg, 2013Farsalinos et al, 2013 Substance AbuseVansickel et al, 2013 Nic and Tob ResDawkins et al, 2012 Addictive Behaviors
Wagener et al, 2014
Bullen et al,
2010,Tobacco Control
Caponnetto, Auditore, Russo et al.,
2013
Dawkins et al, 2013,
AddictionEtter
et
al,
2011,
Addiction
Lechner
…Wagener, in
press
Floyd and Johnson, 2014 unpublished dataSlide30
Questions?