Transcript Regulation of E-Cigarettes

Regulatory Science to Policy:
Update on e-cigarettes.
David B. Abrams
T h e S c h r o e d e r I n s t i t u t e F o r To b a c c o R e s e a r c h A n d P o l i c y
S t u d i e s a t L e g a c y.
The Johns Hopkins Bloomberg School of Public Health
Georgetown University Medical Center / Lombardi
Comprehensive Cancer Center
CWAG Presentation
Park City. Utah. 21st July 2014
disclosures
• Funding from NIH – FDA
• No other financial relationships to disclose
• Legacy Foundation support
• No support from any industry sources
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Update on e-cigarettes
•Nicotine and Public Health
•Harm Reduction
•Will alternative nicotine delivery
systems increase or decrease cigarette
use ? How can prudent regulation help
and not hinder ?
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E m e r g i n g To b a c c o & N i c o t i n e P r o d u c t s :
DISRUPTIVE: Evolution / Revolution?
E n d i n g t h e c i g a r e t t e c e n t u r y b e f o r e 1 0 0 th S G R
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20 million deaths: more than in all the American wars since founding our nation
• 5.6 million children alive today
• and 480,000 adults each year
will die prematurely
from their tobacco use behavior: primarily combustible products –
cigarettes, cigars, hookah, pipe, roll your own…Burn it and you get burned
U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of
Progress: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention
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and Health Promotion, Office on Smoking and Health, 2014.
Major Shift: Harm Reduction ?
Despite 50 years progress, reduction in combustible cigarettes has slowed ...
As articulated in the 2014 Surgeon General’s 50th
anniversary Report. Executive Summary (pages 15-17):
“Death... is overwhelmingly caused by cigarettes
and other combustibles...
promotion of e-cigarettes and other innovative
products is...
likely to be beneficial where
the appeal, accessibility and use of cigarettes are
rapidly reduced.” ….and their cost is increased
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Nicotine and Public Health
Are e-cigs essentially unregulated NRT ?
Comparison between 1st, new, and
conventional cigarette
Need overall Nicotine Regulation Policy that
bridges CTP and CDER
Center for Tobacco Products
Center for Drug Evaluation & Research
Cigarettes
Roll-your-own tobacco
Smokeless tobacco
Hookah tobacco
Cigars/cigarillos/LCCs
 E-cigs for harm reduction
Pharma – NRT, Chantix, Buprorion
Other medications for cessation
RJR Zonnic:Package, Price, Placement
 ? E cigs for cessation
Next Generation Products (Aerosol, Pyruvate, Cleaner Nicotine)
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What we know?: State of the
science on e-cigarettes - ENDS
• Product features and design
• Health and safety
• Advertising and Patterns of Use: Youth and Adults
• Consumer perceptions:
– harm reduction/cessation of combustibles or
– Blurring the boundaries between products & poly use
• Evolving e-cig industry: Big tobacco vs. independents
• Policy considerations: benefits vs. harms
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P u b l i c H e a l t h I m p a c t : Z e r o To l e r a n c e a n d
Harm Reduction Ideology: Data vs Dogma
Abuse Liability
“Appeal”
Non-Combusted Tobacco and Nicotine Products:
?? Next
Generation:
Pyruvate
Combusted
Tobacco:
Cigarettes, Cigars
Pipe, Hookah…..
e-cigs
ENDS
American
Snus
Dissolvables
Smokeless
Cessation
Behav, NRT’s:
inhaler
patch
gum…
Swedish
SNUS
Toxicity
(“Harmfulness”)
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% of those trying to stop in the past year who used support
40%
Cessation and used in quit attempts:
growing evidence good as NRT
35%
30%
25%
20%
NRT
OTC
Med Rx
15%
NHS
E-cig
10%
5%
0%
NRT OTC: Nicotine replacement therapy bought over the counter; Med Rx:
Prescription medication; NHS: NHS Stop Smoking Service; E-cig: Electronic cigarette
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YOUTH Patterns of USE. (Experimenting only
and over 90% already use conventional cigs).
• Adults: Awareness (76%) and use (21%) is growing fast among current
smokers and young adults. Perceived as less harmful.
• Youth (CDC MMWR 2013)
•
Use doubled middle
and high school
students 2011–2012,
estimated 1.78 million
students ever used.
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• Conclusions and Relevance Use of e-cigarettes was
associated with higher odds of ever or current cigarette
smoking, higher odds of established smoking, higher
odds of planning to quit smoking among current
smokers, and, among experimenters, lower odds of
abstinence from conventional cigarettes. Use of ecigarettes does not discourage, and may encourage,
conventional cigarette use among US adolescents
• Electronic Cigarettes and Conventional Cigarette Use
Among US Adolescents: A Cross-sectional Study.
Lauren M. Dutra, ScD1; Stanton A. Glantz, PhD1
• JAMA Pediatr. Published online March 06, 2014.
doi:10.1001/jamapediatrics.2013.5488
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P a t t e r n s O f To b a c c o U s e A n d D u a l U s e I n U . S . Yo u n g
A d u l t s : T h e M i s s i n g L i n k B e t w e e n Yo u t h P r e v e n t i o n
And Adult Cessation
• 51% had ever smoked cigarettes. First product used: 73%
cigarettes, 11% cigars, 5% little cigars/cigarillos/bidis, 4% hookah
• 32% of ever users (18-34) reported product initiation after the
age of 18
• Of 23% of young adult current users, 30% report dual use.
Among dual Users: cigars 23%, little cigars 26%, hookah 17%,
dip snuff 12%, chewing tobacco 12%, e-cigs 9%, snus 7%,
dissolvables 3%
• Dual use - higher in younger adults, males, less than high school
education, and those not able to meet their expenses.
• Daily cigarette use was similar between dual use and cigarettes
only use (no harm reduction due to less cigarettes, rather a harm
increase?)
Rath J, Villanti A, Abrams D, Vallone D. Patterns of Tobacco Use and Dual Use in U.S. Young
Adults: The missing link between youth prevention and adult cessation. Journal of
Environmental and Public Health. 2012.
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• Robust ongoing surveillance of NCP advertising is critical to inform the FDA and protect
public health.
• Both commercial advertising and public health media campaigns must ensure that
content is not misleading and educates consumers about harm based on the available
science.
• The way messages are framed have the potential to decrease tobacco use by promoting
rather than undermining cessation of combusted products and/or encouraging exclusive
use of less harmful NCPs rather than poly-use of combusted and NCPs.
7. Their ads say, “Switch, Don’t Quit.”
Tobacco companies have long tried to discourage smokers from quitting
by marketing cigarette changes as reducing health risk.
Some e-cigarette ads carry a similar message.
SCIENCE Questions: SUMMARY
• Less harmful than cigarettes - when good quality can be
regulated to be close to Pharama grade NRT. Some ingredients
can produce harmful chemicals when heated (coloring / flavors)
• How can does e-cigarette use and marketing maximize benfits
and reduce harms and affect current smokers?
– Delay cessation? Promote cessation?
– Reduce cigarette consumption or give the impression of less
harm because of imagined reduced cigarette consumption?
– Dual use when one can not smoke and alleviate discomfort
• Do e-cigarettes encourage former smokers to return to nicotine
use and relapse to cigarette smoking?
• How do e-cigarettes affect non-smokers ?
– Potential uptake among youth and young adults
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Nicotine and
Harm reduced products update:
Fiore, Schroeder, Baker. NEJM. Jan 2014;
Abrams D JAMA Jan 2014
Communicate intelligently about harm reduction
Policy and Practice Proportional to HARM
•Focus on eliminating combustible tobacco products - Not all nicotinecontaining products are equal…
• Even if some who give up combuseds will continue indefinitely using:
FDA-approved medicines, e-cigarettes, or smokeless (least harm is
Swedish Snus).
"New approaches must be adopted if we are to dramatically reduce the
harms over the next decade. Goal requires that we recognize the unequal
dangers resulting from combustible tobacco use.”
CAN E-cigarettes make lethal combustibles obsolete?
Conclusions
• Stakes are high; lethality of combusted tobacco is worse than
we thought
• Alternative frameworks of addiction/appeal/harm are available
• Taxes and Policies: Proportional to Harm of product class
• End game strategies aided by future approaches and devices
for nicotine delivery that better substitute for the cigarette
pridetn regulation maximize benefits minimize harms
• Promotion of e-cigarettes and other innovative products is
much more likely to be beneficial in an environment where the
appeal, accessibility, promotion, and use of cigarettes are
being rapidly reduced
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Harm Reduction: Policy and Practice Principles
• Taxes and Policies: Proportional to Harm of product class
• End game strategies aided by future approaches and devices
for nicotine delivery that better substitute for the cigarette
• Promotion of e-cigarettes and other innovative products is
much more likely to be beneficial in an environment where the
appeal, accessibility, promotion, and use of cigarettes are being
rapidly reduced
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Thank you
Excerpts from: Ending tobacco smoking in Britain; Radical strategies for
prevention and harm reduction in nicotine addiction
Royal College of Physicians of London, 2008.
People smoke because they are addicted to nicotine, but
nicotine itself is not especially hazardous; it is the other
constituents of tobacco smoke that cause most of the harm.
Use of smoke-free nicotine would benefit smokers directly by
reducing the personal harm caused by nicotine addiction.
 “In Sweden, the availability and use by men of an oral tobacco
product called snus, one of the less hazardous smokeless tobacco
products, is widely recognised to have contributed to the low
prevalence of smoking in Swedish men and consequent low rates of
lung cancer.”
New FDA proposed deeming and future rulemaking
• Restrict Sales to over 18 years of age, no free samples.
• Warning Label that nicotine can be an addictive substance
• Registration, and Product disclosure
• Product standards, safe ingredients, child resistant packages
• Substantial equivalence or new product application 2yr grace
• MRTP applications to claim reduced harm: individual and
population standard. Pre-approval and post-market surveillance
• Advertising on TV and Targeting youth ?
• Flavors attractive to youth (candy) ?
• Therapeutic claims for smoking cessation?
• Need comprehensive nicotine / tobacco regulatory policy
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Lessons from the united kingdom
• Department of Health committed in its 2011 Tobacco Plan
to “develop new approaches to encourage tobacco users
who cannot quit to switch to safer sources of nicotine”
• In 2013, both the UK Medicines and Healthcare products
Regulatory Agency (MHRA) and the National Institute for
Clinical and Healthcare Excellence (NICE) issued
guidances embracing tobacco harm reduction and a “lighttouch” approach to regulating nicotine-containing products
as medicines
–Wide array of approved uses (e.g., reduce to quit,
smoking reduction, temporary abstinence,
maintenance)
–A handful of applications are apparently pending and
the first approval is expected this year
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• What could FDA glean from this experience?