electronic nicotine delivery...
TRANSCRIPT
Victoria Fehrmann Warren, Program CoordinatorComprehensive Tobacco Control Program
Missouri Department of Health and Senior Services522-2824
Electronic Nicotine DeliverySystems
AKA Electronic Cigarettes or VapePens
Fact or Hype?
Objectives of this presentation
qAre ENDS regulated? Tested?qWho is using them and why?qAre they safe?qAre they a cessation device?qWhat is the public health stance?
More questions than answers!
What are electronicnicotine delivery systems
(ENDS) or electroniccigarettes (e-cigarettes)?
Electronic Nicotine DeliverySystems (ENDS)
Many don’t recognize (or use) the term“electronic cigarette”–they are knownas “vape pens” or “mods” or ??
Products designed to deliver nicotine to userin aerosol (“vapor”) form
qBattery: heatingelement,rechargeable
qVaporizer(createsaerosol):convertscartridgecontents intoaerosol (vapor)inhaled by user
qReplaceable/refillable cartridge:contains nicotineand/or otherchemicals–amount nicotineadvertised from0 - 20 mg/mL
ENDS
Made to look like cigarettes, cigars, pipes, hookahs,pens
And many other things
q What are users saying?q What are sellers saying?q What do manufacturers say?q How are they advertised?
What have you heard about theseproducts?
From users, sellers, manufacturers
q Use of ENDS commonly called“vaping”
q Promoted by manufacturers, sellersand users as safe-producing water vapor not smoke
No matter the name – sends nicotine tothe brain through the lungs
Who makes ENDS and liquids?
q Reynolds Americaq Lollilardq Altria q Njoy
q Internationalq Many others
How are theyregulated?
ENDS status with Food & DrugAdministration (FDA)
q In April 2014, FDA issued proposedregulations identifying ENDS astobacco products with:
Ø restrictions on sales to minors
Øpre-market review
Ømandated ingredient listing
q Regulations are pending
ENDS status with FDA
Cessation Device?
No electronic nicotine deliverysystem can be marketed as asmoking cessation device withoutgoing through the rigorousapprovals of FDA
ENDS status with FDA
q FDA has not evaluated any ENDS forsafety or effectiveness
q Early on, in limited laboratory studies,FDA found issues indicating poorquality control*:Ø cartridges labeled 0 nicotine did
contain nicotine Ø 3 different cartridges with the same
label gave off very different amounts ofnicotine with each puff
*Subsequent studies by independent researchers have found the same
From FDA’s Tobacco Products’website
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm
E-cigarettes have not been fullystudied, so consumers currently don’tknow:
q the potential risks … when used asintended
q how much nicotine or other potentiallyharmful chemicals are being inhaled
q whether there are any benefits ... usingthese products
From FDA’s website–Tobacco Products
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Missouri law
It is now illegal to sell ENDS products toanyone under 18
Or
For anyone under 18 to possess, use, buy
Who is using them and why?
Adult (18+) use of ENDS in Missouri 2014
Behavioral Risk Factor SurveillanceSystem:
7% use every day or some daysq 45.7% to quit smoking
q 17% to try a new way of smoking
q 13.7% because friends or family use
q 4% to smoke in places that do not allowsmoking
Missouri Tobacco Quitline callers: 9%q 44% to cut down
q 55% to quit
q 7% when can’t use other products
q 39% use every day
q 58% use more than one cartridge a day
Youth use of ENDS in Missouri 2015
qHigh school current use: 22%* of allØ68% of current smokers Ø9.6% of non-smokers
qMiddle school current use: 7.2%* ofallØ83% of current smokers Ø3% of non-smokers
Youth Risk Behavior Survey & Youth Tobacco Survey
* Only 11% & 2.4% currently smokecigarettes
Marketing & commercial appeal
Why do ENDS appeal toyouth?
Marketing & commercial appeal
Promotedheavily online& more widelysearched thantobaccoproducts orquittingproducts
On-line availability
• Te
High tech
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Flavors
q The only flavor of cigarettes is mentholq ENDS and e-juice are available in many
flavors
Marketed where cigarettes can’t be
Using messaging reminiscent of the past
ENDS deliver nicotine tothe brain through the
lungs
Nicotine
qIs addictiveqIs toxic to developingfetuses
qIs a poison
Nicotine is addictive
The DeNoble Files–Your Brain
https://www.youtube.com/watch?v=4tg_rMiOLnA
Nicotine affects the brain
The DeNoble Files–Earmuffs
https://www.youtube.com/watch?v=uFX9F-KD7co
Youth using nicotine
q Are more vulnerable to addiction thanadults
q Are more likely to continue useq May become more heavily addictedq May have a harder time quitting
Nicotine is a POISON!
The number of poison exposure cases linked to ENDS liquids was:
Ø 1,543 in 2013, a huge increasefrom 460 in 2012
Ø3,783 in 2014Ø3,067 in 2015
Why so many poisonings?
Canyou findthecandy?
Liquid nicotine or “e-juice”
q Many devices are refillable withliquid nicotine
q Bottles come as large as 250 mL(about a cup) with nicotineconcentrations of 0-72 mg/mL
q At the highest concentration a 250mL bottle could have 18 grams ofnicotine
Nicotine
q A smoker absorbs ~1 mg of nicotine from acombustible cigarette
q A 20 mg/mL ENDS cartridge has the nicotineof about 20 cigarettes
q Studies show the average ENDS userconsumes 3-5 mL of liquid nicotine a day,some use more than 15 mL a day
q Daily inhaling aerosol from 3 mL liquid nicotineis similar in nicotine content to smoking 30 to40 cigarettes
Liquid nicotine or “e-juice”
q The estimated fatal dose ofnicotine for adults is 30-60 mg
q The estimated fatal dose ofnicotine for children is only 10mg–approximately 4 drops of amaximum strength “e-juice”solution
This risk is more consistent withnicotine-based pesticides, ratherthan traditional tobacco products
It poses a danger by inhalation,ingestion, and skin contact
Common symptoms of nicotine overdose
q Extreme anxiety q Cold sweats q Dizziness q Headache q Muscle twitchesq Insomniaq Tingling sensationsq Confusionq Panic attacksq Depressionq Palpitations, fast pulse q Increased blood pressureq Fatigue and weaknessq Reduced appetiteq Stomach ache and nauseaq Chest painq Hearing or vision problemsq Seizures
Reported mild adverse effects of ENDS use
q Headacheq Chest pain/coughing q Nausea/vomitingq Dizzinessq Confusion q Sore throatq Blurry vision
Reported strong adverse effects of ENDS use
q Pneumoniaq Congestive heart failureq Disorientation q Seizureq Low blood pressureq Chest painq Second degree burns to faceq Loss of vision
What are other potentialsafety issues?
What’s in the fluid?
q Quality of ingredients generallyunknown
q No requirement to declare allingredients
q Fluids are known to contain: ØnicotineØflavoringsØhumectants
Flavoring
q On January 2014 there were atleast 7,764 unique flavors
q Often the same chemicals“generally recognized as safe” forfood & drugs
q But not known to be safe :Øto inhaleØto deliver nicotine
Flavor & Extract ManufacturersAssociation (FEMA) of the US
q The primary route to FDAregulatory authority of flavoringredients
q Determines “GRAS” status(generally recognized as safe)
q GRAS status applies only to humanfood, medicine (oral ingestion)
FEMA GRAS Status
q No regulatory approval to useGRAS ingredients in ENDS
q Claims by manufacturers that theingredients have GRAS status are“false and misleading”
Some ingredients in flavoring
q Diacetyl (used to give foods abuttery or creamy flavor)Øcaused a severe & irreversibleobstructive lung disease wheninhaled by workers exposed toparticles of it that were aerosolized(“popcorn lung”)
q Acetaldehyde (sugar) for sweetnessØknown to make nicotine moreaddictive
q Unknowns
Humectant
q Allows aerosol (vapor) productionq Most common is propylene glycolq Propylene glycol is FDA approvedfor use in some products, butinhaling aerosolized nicotine inpropylene glycol is not
q Some studies show that heatingpropylene glycol changes itschemical composition, producingsmall amounts of propylene oxide,a known carcinogen
Harmless water vapor?
q It is claimed ENDS emit“harmless water vapor” so theymust be safeØIs it “just” water vapor?
q Research is showing……
What is in the aerosol (vapor)?
q Not a water vapor but an aerosolq Aerosol has been found to contain:
ØnicotineØpropylene glycolØ fine & ultrafine (UF) particlesØ low levels of toxins known to cause
cancer (at least 10 have beenidentified)
Ønanoparticles of chromium, nickel, tinØ free radicals
What is in the aerosol?
q Some with higher concentration ofUF particles than cigarette smokeØUF particles cause respiratoryproblems, exacerbate asthma,impair lung function
Øfine & UF particles constrict arteries,can trigger heart attack
q WHY?
Fine particles~ 2.5µm or
smaller
Particulate MatterSizes
Ultrafine orNanoparticles
~ >1µm or microns to <100nm or nanometers
HumanRed
BloodCell 5µm
AverageHuman HairDiameter
~100 µm
Secondhand aerosol?
q May be less polluting thancigarettes, but still pollutes the air
q Emissions expose non-users to:Ønicotine at levels similar tosecondhand smoke–a recent studyshowed the nicotine was absorbedby those around
Øfine and UF particles and volatileorganic compounds (VOCs)
Øsome levels of toxins known tocause cancer
Secondhand aerosol?
Long term health effects onnon-smokers are still unknown,but science on potential fornegative consequences ismounting
Risk assessment from American Industrial Hygiene Association
October 2014
q Existing research does not appear towarrant the conclusion that ENDS are“safe” in absolute terms
q ENDS not emission-free; emit airbornecontaminants that may be inhaled byboth the user and those nearby
q ENDS should be considered a sourceof VOCs and particulates in the indoorenvironment that have not beenthoroughly characterized or evaluatedfor safety
ENDS are advertised as:
q A better-smelling, cheaper, guilt-freealternative to smoking
q A way to circumvent smokefree laws &policies
Using ENDS in public, smokefree areascan undermine smokefree policies &youth prevention efforts by:q Making enforcement more difficult q Giving the appearance that smoking is
acceptable
People are being exposed in the beliefthat the aerosol is safe
Why be concerned about advertisingto circumvent smokefree?
Cessation product?
q ENDS are not FDA-approved cessationproducts
q 4 prescription & 3 non-prescription smokingcessation products are FDA-approved:ØRX: Varenicline, Bupropion, Nicotine Inhaler,
Nicotine Nasal Spray
ØOTC: nicotine replacement patches, gum,lozenges
q These products have been scientificallyshown to be effective for smoking cessationand are safe when used as directed
Recent research on ENDS cessation potential
Use of Electronic Cigarettes Among State Tobacco Cessation Quitline Callers,Nicotine & Tobacco Research, May 2013
ENDS users were significantly less likelyto have quit smoking 7 months after first
calling the Quitline, compared withparticipants who had never tried
ENDSNote: Authors affiliated with Alere Wellbeing, Inc. a Quitline Provider
Vaping encourages tobacco smoking?Does vaping in e-cig ads affect tobacco smoking, urge, intentions, & perceptions in daily,
intermittent, & former smokers? Health Communication, March 2015
q When see vaping in person or onTV:Ødaily smokers more likely tocrave cigarettes
Øformer smokers less able torefrain from smoking
qAs opposed to the same who didnot see the behavior
Recent research on quitting behaviors with ENDS
E-Cigarette Use in the Past and Quitting Behavior in the Future: A Population-Based Study,American Journal of Public Health, June 2015
q Compared with smokers who never used ENDS,the ENDS (ever) users were: Ø significantly less likely to smoke fewer cigarettes
Ø and
Ø significantly less likely to quit for 30 days or more
q Ever-users were more likely to report a quitattempt, although not statistically significant
q Conclusion: Smokers who have used ENDS maybe at increased risk for not being able to quitsmoking
Other issues of initiation & cessation potential
q Surveys showing patterns of dual use(both ENDS & cigarettes) by bothadults & youth
q Nicotine is addictive & hard to break:Øcurrent smokers may not realize they
have not kicked the addictionØ former smokers, believing ENDS are
safe, may return to nicotineaddiction
q The high-tech, attractive products &marketing are “glamorizing” & possiblymaking smoking again appear“normal”
q Can say there is no scientificevidence that ENDS help smokersquit
q Do know they are a nicotinedelivery device–and nicotine isaddictive
q Recommend only known, tested,safe, products for those trying toquit
Public health approach–cessation
Public health approach–safety
q With many brands & too few studies yet,conclusions are not definite
q We cannot say that they are unsafe–theymay be safer than combustible cigarettes,but “safer” is not necessarily “safe”
q Cannot say they are safe, but it does appearas if it is not “harmless water vapor” Ø in fact, it is not “just” waterØ in fact, it is aerosol, not vapor
Public health approach–secondhand smoke(aerosol) exposure
q Because of the unknownssurrounding the aerosol
andq Because ENDS mimic smoking
Public health is taking a cautiousapproach
q Most prohibit them in smokefree ortobacco-free policies for theorganization
q And strive for inclusion in policies forcommunities
Why include in smokefree policies?
The standard is
Clean Indoor Airnot
Less Dirty Air
Recent research on awareness/beliefs
Characteristics Associated With Awareness, Perceptions, and Use of ElectronicNicotine Delivery Systems Among Young US Midwestern Adults, AJPH, March 2013
q More than 2/3 of young adults were awareof ENDS
q A small proportion had tried/used in past 30days
q Despite the lack of scientific evidence, alarge proportion of users & non-usersthought they:Ø can help people quit smoking Ø are less harmful and less addictive than
cigarettes
Recent research on users’ opinions
Vaping profiles and preferences: an online survey of electronic cigarette users,Addiction Research, Feb. 2013
q Adults surveyed found ENDS: Ø satisfying to use
Ø reduced cravings for tobaccocigarettes
Øassociated with very few immediateside effects
Ø tended to be used for a longer duration than NRT
Recent research on safetyMetal & Silicate Particles Including Nanoparticles Are Present in Electronic
Cigarette (EC) Cartomizer Fluid and Aerosol, PLOS One, March 2013
qConcentrations of 9of 11 metallicelements in ENDSaerosol were higherthan or equal to theconcentrations incigarette smoke
qPresence of metaland silicate particlesin aerosoldemonstrates needfor improved qualitycontrol in ENDSdesign andmanufacture
qStudies are neededon how aerosolimpacts the health ofusers and bystanders
Recent research on safetyReported January 2015 in letter published in the New England
Journal of Medicine
q Aerosol from ENDS products cancontain high concentration offormaldehyde–a known carcinogen
Ø Researchers conducted a detailed chemicalanalysis of the aerosol’s liquid droplets
Ø Devices dialed up to highest settings had “masked”formaldehyde–could increase the likelihood offormaldehyde deposits in the lung
Ø Concentration was significantly higher than regularcigarettes–5 to 15 times higher
Recent research on effect on non-users
Does e-cigarette consumption cause passive vaping? Indoor Air, April2013
q Fine particles, ultrafine particles, andvolatile organic compounds werefound in the air in increased quantityafter the use of an ENDS
q This inhaled aerosol undergoeschanges in the human lung
q Passive vaping must be expected fromthe use of ENDS
Recent research on secondhand exposure
Exhaled Electronic Cigarette Emissions: What’s Your Secondhand Exposure? RTI Press, March2015
q Non-user may be exposed to aerosolparticles smaller than 1,000 nanometersØ similar in size to tobacco smoke and diesel engine smoke
q Exact exposure depends on:Ø chemical composition of liquid
Ø operation of the device
Ø user vaping preferences
q Aerosol and gases produced containnicotine, glycerin/glycols, artificialflavorings, preservatives
Recent research on what is in the aerosol
Reactive Free Radicals in Electronic Cigarette Aerosols, Chemical Research inToxicology, June 2015
q Reactive free radicals found in ENDSaerosols
q These have been shown to be a causalfactor in a variety of diseases.
q Currently insufficient data to determine thepotential harm from exposure to ENDSgenerated radicals.
q Overall levels of radicals significantly lowerthan in combustible cigarette–degree ofdamage might be less, but depends on theidentity and reactivity of the specificradicals produced
Recent research on if ENDS use leads to smoking
Association of Electronic Cigarette Use With Initiation of Combustible Tobacco Product Smoking in EarlyAdolescence, Journal of the American Medical Association, August 18, 2015
q High school students who had ever usedENDS at baseline were more likely thannonusers to report initiation of combustibletobacco use over the next year.
q Past 6-month use of any combustibletobacco product: 30.7% for ENDS ever usevs. 8.1% for ENDS never use
q Greater likelihood of use of any combustibletobacco product with odds ratios of 2.65 forcigarette, 4.85 for cigar, 3.25 for hookah
Use in pregnancyNicotine & the developing human: A neglected element in the electronic cigarette debate, American
Journal of Preventive Medicine, March 2015
q Switching to ENDS from cigarettes isnot safe because:Ønicotine is harmful to developing fetus
Ønicotine contributes to smoking relatedpreterm delivery
Ønicotine alters brain development
Ønicotine is thought to contribute to SIDS