Transcript Electronic Cigarettes in Context: What we know and still
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 Oklahoma
1 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 – 1 st 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 1
st
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
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?
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 (1 st 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.
26.9% of quitters continued to use e-cigarettes at 52 weeks Smokers, uninterested in quitting (Wagener et al., 2014) 10.7% quit regular cigarettes at 12 weeks, and 8.7% at 52 weeks 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) 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 DC Volts applied 3.0
3.4
3.8
4.2
4.6
5.0
5.4
5.8
6.0
Energy applied (Joules) 8.82
11.424
14.478
17.514
21.114
24.75
28.998
33.408
35.82
Mass
consumed
per puff (mg) 0.25
0.55
2.07
2.80
3.27
3.59
6.56
8.20
7.29
Aerosol mass per puff (mg) 0.006
0.030
0.084
0.083
0.105
0.126
0.146
0.167
0.155
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 2 nd 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