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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, .

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Electronic Cigarettes in Context:






Presentation on theme: "Electronic Cigarettes in Context:"— Presentation transcript:

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?