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 Scholar

Overview Toll of Tobacco e-cigarettes/vapor products design Proposed Rule by FDA (April 25, 2014) Toxicology – mainstream and secondhand

vapor Nicotine delivery and abuse liability Subjective effects and smoking behavior What we still need to find out… e-cigarettes in context of proposed “Tobacco

End Game”

Tobacco Toll: US and Oklahoma1

US 19% smoking rate 443,000 deaths per year $193 billion in medical costs/lost productivity

Oklahoma 23.3% smoking rate 6,500 deaths per year $2.8 billion in medical costs/lost productivity

e-Cigarette Product Designs

e-Cigarettes/Vapor products design “cig-a-like” e-cigarettes

Aka – 1st generation e-cigs Look like regular cigarettes Activated by inhaling; cartridge-based Tobacco companies have these type of e-cigs

Lorillard – acquired Blu RJR – developed Vuse Altria – acquired Green Smoke and developed MarkTen

e-Cigarettes/Vapor products design Tank system e-cigarettes

Do not look like a cigarette Activated 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 types

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

voltages Currently none own by tobacco industry Vape shops sell these types Used mostly by experienced users

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 Dissolvables Gels Hookah tobacco Electronic cigarettes Cigars Pipe tobacco

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 lighters

FDA 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-cigarettes

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 issues Nicotine 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)

Toxicology – SH Vapor

Implies particles grow while within the lungs and persist longer in the environment when exhaled by a user

Nicotine Delivery/Abuse Liability 1st 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?

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)

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)

Subjective effects and smoking behavior Smoking Behavior & cessation

Nicotine 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 weeks

26.9% of quitters continued to use e-cigarettes at 52 weeks

Smokers, uninterested in quitting (Wagener et al., 2014) Mean 44% reduction in reg cigs at 1 week after initial e-cig

experimentation.

Subjective effects and smoking behavior

Smokers interested in quitting (Bullen et al 2013) E-cigarette versus patch At 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)

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)

Aerosol Size Distribution of Modern Variable Voltage e-Cigarette (Prelim Data)

Floyd and Johnson, 2014 unpublished

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 0.0063.4 11.424 0.55 0.0303.8 14.478 2.07 0.0844.2 17.514 2.80 0.0834.6 21.114 3.27 0.1055.0 24.75 3.59 0.1265.4 28.998 6.56 0.1465.8 33.408 8.20 0.1676.0 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 unpublished

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 unpublished

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?

End Game Scenarios – role of e-cigs

End Game Scenarios – role of e-cigs

End Game Scenarios – role of e-cigs

End Game Scenarios – role of e-cigs

Continuum of Risk

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 products Reduce 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 rule

End Game Scenarios – role of e-cigs

References FDA proposed rule 25 April 2014, section D http://www.regulations.gov/#!

documentDetail;D=FDA-2014-N-0189-0001 Czogola et al, 2014 Farsalinos et al, 2014 Flouris et al, 2013 Vansickel et al., 2012 Addiction Vansickel & Eissenberg, 2013 Farsalinos et al, 2013 Substance Abuse Vansickel et al, 2013 Nic and Tob Res Dawkins 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, Addiction Etter et al, 2011, Addiction Lechner…Wagener, in press Floyd and Johnson, 2014 unpublished data

Questions?