tobacco in the 21 century: electronic cigarettes, vaping ...€¦ · tobacco in the 21st century:...

Tobacco in the 21st Century:

Electronic Cigarettes, Vaping and JUUL

ADPH Quitline Workgroup

January 17, 2019

Susan C. Walley, MD, CTTS, FAAP

Professor of Pediatrics

Division of Hospital Medicine

University of Alabama at Birmingham

Learning objectives

1) Provide an overview of electronic cigarettes/vape devices

2) Review the scientific evidence of the health effects of electronic cigarettes

3) Discuss the public health impact of electronic cigarettes

4) Review current recommendations for addressing youth electronic cigarette use and exposure in clinical practice

Vaping

Electronic Cigarettes: Take Home Points

• E-cigarettes are the most common tobacco product used by youth

– Used by 1 in 5 high school students

– Used by 1 in 20 middle school students



• Longitudinal data demonstrates youth e-cigarette use is associated with higher use of conventional cigarette and substances of abuse



• Longitudinal data demonstrates youth e-cigarette use is associated with higher use of conventional cigarette and substances of abuse

• E-cigarette use and exposure is not safe

– Solution contains nicotine and toxicants, including carcinogens

– In addition, emissions contain ultra-fine particles and metallic nano-particles

Case #1 Data on Youth E-cigarettes and Progression to Cigarette Use

• You have a 16 year old “Laura” admitted to the hospital for an asthma exacerbation who reveals she uses JUUL daily with friends

• She says she can JUUL at school and get away with it

• Is this something to worry about?

Image accessed August 16, 2018 from https://studybreaks.com/news-politics/juul/

• In 2018, JUUL was 72% of the e-cigarette market share

• Using a JUUL is referred to as “JUULing” rather than vaping

• JUUL uses “pods” that contain 59mg/mL nicotine

• In December 2018, Altria (formerly Philip Morris) purchased a 35% stake for $13 billion

JUUL or “pod systems”

Nicotine Addiction

• The adolescent brain is uniquely

susceptible to nicotine addiction

• Animal studies show that nicotine

exposure during adolescence period

has long-standing effects in the brain

including cell damage that leads to

both immediate and persistent behavior

changes

Slottkin, Neurotox & Teratol 2002

What is Nicotine?

• Nicotine is considered a toxin

• Nicotine is the primary psychoactive ingredient in tobacco

• Nicotine is commercially available almost exclusively from the Nicotiana tabacum, commonly known as the tobacco plant

E-cigarettes Are Recruiting Teens to Conventional Cigarettes

• Any use of e-cigarettes associated with cigarette smoking 1 year later

• Higher nicotine e-cigarettes were more likely to progress to cigarettes

• Ever use of e-cigarettes strongly associated with subsequent initiation

Conner et al, Tob Control, 2017Goldenson et al , JAMA Pediatr, 2017Watkins et al, JAMA Pediatr, 2018

Substances Other than Nicotine

• Adolescents who used e-cigarettes were more likely to1:

– Binge drink alcohol

– Use marijuana

– Use other illicit drug use

• Of youth e-cigarette users, 8.9% had used cannabis in the e-cigarette2

1McCabe J Adolesc Health 2017 and Silveira Drug Alcohol Depend 2018 2Trivers JAMA Pediatrics 2018

Case #1 What To Do About Laura?

• You have a 16 year old “Laura” admitted to the hospital for an asthma exacerbation who reveals she uses JUUL daily with friends

• She says she can JUUL at school and get away with it

Image accessed August 16, 2018 from https://studybreaks.com/news-politics/juul/

The 5 As

Assess

Ask

Advise

Assist

Arrange

Ask

Assist

Refer

2 As and an R

Electronic Cigarettes, JUUL & Youth: Take Home Points

• Nicotine is a highly addictive substance and adolescents are more susceptible

• JUUL is the most popular e-cigarette used by youth and has a very high nicotine content

• E-cigarette use increases the risk of subsequent use of conventional cigarettes and substances of abuse

Electronic Cigarettes

• Invented in 2003 by a Chinese inventor

• Introduced to the United States in the mid-2000s

• Wide variation in look, design and function

https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm

What’s in a Name?

• Electronic Nicotine Delivery Systems (ENDS)

• Vape devices and vape pens

• JUUL

• Personal vaporizers

• Alternative Nicotine Delivery Systems (ANDS)

• Electronic cigars or e-cigars

• E-hookah or hookah sticks/pens

• Mechanical mods and tanks

• Cigalikes

• Pod systems

What’s in a Name?

• Electronic Nicotine Delivery Systems (ENDS)


• JUUL

• Personal vaporizers

• Alternative Nicotine Delivery Systems (ANDS)

• Electronic cigars or e-cigars

• E-hookah or hookah sticks/pens

• Mechanical mods and tanks

• Cigalikes

• Pod systems

Electronic Cigarettes

Electronic Cigarettes 1st generation

• “Cigalike”

• Similar to traditional cigarettes in size and shape

• Evolved with different colors and size but generally still looked similar to a cigarette

Electronic Cigarettes 2nd generation

• Generally larger in size with a reservoir to hold the solution (i.e. e-liquid)

• Tank systems


Electronic Cigarettes 3rd generation

• Highly customizable and modifiable

−Manual heating button

− Variable voltage

− Digital readouts

• Advanced Personal Vaporizer (APV) or Mods

• Example: Volcano and Apollo

www.volcanoecigs.com

http://www.volcano.com/

Electronic Cigarettes 4th generation

• Greatest departure from traditional cigarette

• Diverse products often difficult to recognize as an e-cigarette

• Example: JUUL, Suorin, SMPO

https://www.usfa.fema.gov/downloads/pdf/publications/electronic_cigarettes.pdf

Where are E-cigarettes Sold?

Picture taken August 4th, 2018 in Duluth, GA by Susan Walley

• “Vape” shops

• Convenience stores

stores

• Gas stations

• Retail outlets

• Mall kiosks

• Grocery stores

• Internet vendors

E-Cigarettes are Sold Everywhere

High School Student Current Tobacco UseNational Youth Tobacco Survey (NYTS)

Wang T et al MMWR June 2018

Cullen et al MMWR November 2018

Teen Perceptions of E-cigarettes

• 73% believed e-cigs less harmful than cigarettes

• 47% believed that e-cigs less addictive that cigarettes

• 19% believed smoke from e-cigs is water

• 23% believed e-cigs aren’t a tobacco product

• 43% believed e-cigs were safer than cigarettes

• E-cig users had significantly more favorable attitudes towards them

Amrock et al, Pediatrics, 2016Gorukanti et al, Prev Med. 2017

• Humectant

• Flavoring

• +/- Nicotine

What are the ingredients as

advertised in e-cigarette

solutions?

• Humectant

• Flavoring

• Nicotine

• Toxicants

• Ultrafine particles

• Carcinogens

• Metallic nano-particles (from the coil/heating element)

• Other psychoactive ingredients (added by users)

What has been found in e-cigarette solution and emissions?

CDC Infographic

Constituents of E-cigarette solution: Humectants

• Unknown long-term health impacts from repeated inhalation

• Propylene glycol: generally recognized as safe for INGESTION

• Vegetable glycerin: generally recognized as safe for INGESTION

− When heated and vaporized, can form acrolein, which can cause upper respiratory irritation

Werley et al, Toxicology 2011

Constituents of E-cigarette Solution: Flavorings

• Have NOT been assessed for safety as inhalants

• American e-Liquid Manufacturing Standards Association has voluntary standards for ingredients and does not allow:

−Diacetyl, whole tobacco alkaloids, medicinals, illegal or controlled substances, caffeine, vitamins, artificial food coloring

• Flavors are KNOWN to be appealing to youth

National Academy of Sciences Report

Purpose:

Inform the public and the FDA of the consequences of e-cigarettes after evaluating scientific evidence

Cardiac Effects:

E-cigarettes Cause Acute Endothelial Cell Dysfunction

“There is substantial evidence that e-cigarette aerosols can induce acute endothelial cell dysfunction, although the long-term consequences and outcomes on these parameters with long-term exposure to e-cigarette aerosol are uncertain.”

National Academy of Sciences “Public Consequences of E-cigarettes” 2018

Do E-cigarettes Cause Cancer?

• “Substantial evidence that some elements in e-cigarette aerosol (formaldehyde, acrolein) are capable of causing DNA damage & mutagenesis.”

• Supports biological plausibility that long term exposure could increase risk of cancer and adverse reproductive outcomes


Adolescent Pulmonary Effects of E-cigarettes

“There is moderate evidence for increased cough and wheeze in adolescents who use e-cigarettes and an association with e-cigarette use and an increase in asthma exacerbations.”


Is there evidence of efficacy of e-cigarettes for smoking cessation?

• Overall, there is limited evidence that e-cigarettes may be effective aids to promote smoking cessation


• There is insufficient evidence from randomized controlled trials about the effectiveness of e-cigarettes as cessation aids compared with no treatment or to Food and Drug Administration–approved smoking cessation treatments.

Smokers who use e-cigarettes are significantly less likely to have stopped

smoking than smokers who do not use e-cigarettes, with the odds of quitting smoking

depressed by 27%.

Glantz & Bareham, Annual Review of Public Health, 2018

E-cigarettes Are Not a FDA-Approved Tobacco Dependence Treatment

For the majority of cigarette smokers trying to quit using e-cigarettes, they become dual users (i.e. use

both e-cigarettes and cigarettes)

Secondhand Vapor

What is found in indoor air after vaping?

• Nicotine particles

• Heavy metal nano-particles

• Volatile organic compounds (VOC)

– Formaldehyde, acrolein, acetaldehyde, toluene

• Ultrafine particles and particulate matter

Take Home Points

• Volatile organic compounds, nicotine & particulate matter are emitted after e-cigarette use

• Pediatricians should advise parents/caretakers that it is NOT safe to use e-cigarette products in the home, car, or around their children

• Smoking bans should include e-cigarettes and vaping products

Public Health Concerns

• Addiction potential, particularly for youth

• “Gateway” hypothesis leading to other substances of abuse

• Toxic exposure for users (including added ingredients)

• Second and thirdhand aerosol exposure

• Adult nonsmokers and former smokers may become addicted/re-addicted?

• Poisoning risk of e-cigarette solution with nicotine

• Potential to glamourize and re-normalize smoking and tobacco use

Surgeon General Advisory December 2018:Youth E-cigarette Use Is a Public Health Epidemic

Food and Drug Administration Regulation of E-cigarettes

• In August 2016, the FDA issued a rule (Deeming Rule) to extend authority over all tobacco products, including e-cigarettes and cigars with goals of:

– Improved quality control and production standards

– No sales <18 years

– Health warning labels and no marketing implying “healthy” or “safe”

• Missed several aspects: flavors, marketing, online sales

• No Consumer Products Safety Commission oversight

FDA Regulation of E-cigarettes: Deadlines Currently Still Extended

• Deadline for adding warning label (related to nicotine addiction) to products extended to August 2018

• The FDA extended compliance deadline to list e-cigarette ingredients to November 2018

• Deadline August 2022 (for non-combustible products) to submit substantial equivalence exemption for products that were on the market as of August 2016

FDA Warning April 2018

• Increase enforcement on the sale of JUUL to minors in stores and online

• Continue education efforts

• Requested documents from JUUL on:

– Marketing

– Product design

– Health impacts

– Adverse effects

FDA and FTC Warning May 2018

• The FDA and Federal Trade Commission (FTC) sent warning letters to 13 manufacturers, distributors and retailers

• Sales of e-liquid with marketing or advertising resembling kid-friendly food products

Food Product or E-Liquid?

August

Picture taken August 4th, 2018 in Duluth, GA by Susan Walley

FDA Warning September 2018

• Warning letters to JUUL, MarkTen, Logic, Blu and Vusethat sell flavored e-cigarette products

• Gave 60 days to address youth use or risk pulling flavored products

• Warning letters to 1100 retailers (Walgreens, Circle K, Shell gas) with 131 fines

FDA Announcement November 2018

• Proposed steps to protect youth by decreasing access to flavored tobacco products

• Flavored products (other than tobacco, mint and menthol) only sold at age-verified, in-person locations

• Greater restrictions for on-line sales

Photo taken December 2018 by S. Walley at Birmingham gas station

Protecting Children from E-cigarette Solution Poisoning

• Child Nicotine Poisoning Prevention Act

• Signed with bipartisan support January 2016

• Requires liquid nicotine refills to have child-resistant packaging

• Enforced by the US Consumer Product Safety Commission

• Enforcement began July 2016

How is Alabama Doing?

Centers for Disease Control and Prevention Health Impact Pyramid

American Academy of Pediatrics E-cigarette Policy Statement Clinical Recommendations

• Screen youth and adults for e-cigarette use and exposure

• Counsel youth and parents about the harms of e-cigarette use

• Advocate for smoke-free homes and cars (include e-cigarettes)

• E-cigarettes should not be recommended for smoking cessation to adults and youth

National Advocacy Efforts

• Comprehensive smoke-free bans

− Should explicitly include electronic cigarettes and vape devices

• Tobacco 21

− Increasing the purchase, possession and use of tobacco products (including e-cigarettes) to 21 years of age

• Point-of-sale restrictions

−Targeting e-cigarette marketing and advertising to youth, particularly flavors

• Flavor bans, including menthol in tobacco products

Comprehensive Smoke-free Laws




• Tobacco 21





Take Home Points




• Tobacco 21





Photo

taken

by S.

Walley

Sept 2018

Questions or Want to Get Involved?

Susan Walley, MD, CTTS, FAAP

[email protected]

Thank you! AAP Richmond Center of

Excellence

Susanne Tanski, MD

Judith Groner, MD

Jyothi Marbin, MD

Rachel Boykan, MD

tobacco in the 21 century: electronic cigarettes, vaping ...€¦ · tobacco in the 21st century:...

Documents