Introductory presentation for meetings with Congressional staffers.

1. Taming the smoking epidemic
New and disruptive technologies
Washington DC
28 February 2017

2. US data
• 36.5 million American smokers (15% of adults)
• Smoked 264 billion cigarettes in 2015
• Cigarette smoking causes more than 480,000 deaths each
year in the United States
• more than HIV, illicit drugs, alcohol, motor vehicles and
guns combined
• Smoking-related illness in the United States costs more than
$300 billion each year
• $170 billion for direct medical care for adults
• $156 billion in lost economic productivity

3. “People smoke for
the nicotine but
die from the tar”
(1976)
Russell MJ. Low-tar medium nicotine cigarettes:
a new approach to safer smoking. BMJ
1976;1:1430–3
Professor Michael Russell 1932-2009
The central insight in smoking and health

4. Unheated nicotine products Smokeless tobacco
Heated tobacco products
“Heat-not-burn”
Vaping products
Tobacco basedPure nicotine based
HeatedaerosolUnheated
Items are not shown to scale
Reduced-risk consumer nicotine market

5. Royal College of Physicians – on relative risk
"Although it is not possible to precisely
quantify the long-term health risks
associated with e-cigarettes, the
available data suggest that they are
unlikely to exceed 5% of those
associated with smoked tobacco
products, and may well be substantially
lower than this figure".
(Section 5.5 page 87)

6. Royal College of Physicians – on quitting smoking
“E-cigarettes are marketed as consumer
products and are proving much more
popular than NRT as a substitute and
competitor for tobacco cigarettes. E-
cigarettes appear to be effective when
used by smokers as an aid to quitting
smoking.”
(Recommendations)

7. Royal College of Physicians – on public health and harm reduction
“However, in the interests of public
health it is important to promote the
use of e-cigarettes, NRT and other non-
tobacco nicotine products as widely
as possible as a substitute for smoking
in the UK.”
(Recommendations, original emphasis).

8. Royal College of Physicians – policy and unintended consequences
“A risk-averse, precautionary approach
to e-cigarette regulation can be
proposed as a means of minimising the
risk of avoidable harm […]
“However, if this approach also makes
e-cigarettes
• less easily accessible
• less palatable or acceptable
• more expensive
• less consumer friendly
• pharmacologically less effective
• inhibits innovation and development
of new and improved products
…then it causes harm by perpetuating
smoking. Getting this balance right is
difficult

9. Royal College of Physicians – on population effects
“There are concerns that e-cigarettes will
increase tobacco smoking by renormalising
the act of smoking, acting as a gateway to
smoking in young people, and being used
for temporary, not permanent, abstinence
from smoking.
To date, there is no evidence that any of
these processes is occurring to any
significant degree in the UK. Rather, the
available evidence to date indicates that e-
cigarettes are:
• being used almost exclusively as safer
alternatives to smoked tobacco
• by confirmed smokers
• who are trying to reduce harm to
themselves or others from smoking
• or to quit smoking completely.

10. Youth smoking: US National Survey on Drug Use and Health

11. Young adult smoking: National Health Interview Survey

12. Long term 12th grade smoking: Monitoring the Future survey

13. Long term 12th grade smoking: Monitoring the Future survey

14. Youth nicotine use: National Youth Tobacco Survey

15. Youth nicotine use: National Youth Tobacco Survey 2014

16. Most youth vaping counted in the headline is occasional
“Conclusions
Non-smoking high school
students are highly
unlikely to use e-
cigarettes; among those
who do, most used them
only on 1–2 of the past 30
days.”
Warner KE. Frequency of E-Cigarette Use and
Cigarette Smoking by American Students in 2014. Am
J Prev Med. 2016 Aug;51(2):179–84

17. Most youth vaping does not involve nicotine
”Results Among students
who had ever used a
vaporiser, 65–66% last
used ‘just flavouring’ in
12th, in 10th and in 8th
grade, more than all other
responses combined.”
Miech R, Patrick ME, O’Malley PM, Johnston LD.
What are kids vaping? Results from a national survey
of US adolescents. Tob Control.; 2016Monitoring the Future, UoM / NIDA 2015

18. Flavours: critical part of appeal to smokers

19. Role of flavours in quitting
About three-
quarters relied
fully or partially
on flavours

20. Choice of flavours by adults
Less than a
quarter use
tobacco flavours

21. Did anyone ask the kids?
Shiffman S, Sembower MA, Pillitteri JL, Gerlach KK, Gitchell JG. The impact of flavor descriptors on nonsmoking teens’ and
adult smokers' interest in electronic cigarettes. Nicotine Tob Res 2015
Participants indicated their interest (0-10 scale) in e-cigarettes paired with various flavor descriptors

22. Questioning the logic of flavour bans
• If vapor products are an alternative to smoking for adults
and youth
• If flavours make vapor products more attractive
• Then favours may be beneficial for health
• And banning flavours may protect the cigarette trade

23. FDA Deeming rule – May 2016
PMTA authorization process $182k-
$2.01m per application for liquids
and $286k-$2.62m per application for
devices. (And some experts believe
these costs are understated.)

24. Eight Federal tobacco policy proposals – January 2017
1. Seize the huge opportunity presented by
low-risk nicotine products
2. Cancel the FDA deeming rule before it
destroys the U.S. vaping market
3. Establish a standards-based regime for
low-risk nicotine products
4. Use new labels to inform consumers
about relative risk
5. Stop using the public health test to
protect the cigarette trade
6. Restore honesty and candor to public
health campaign
7. Refocus tobacco science on the public
interest not bureaucratic expansio
8. Challenge vapor and smokeless
prohibitions under WTO rules

25. Cole-Bishop HR 1136 – February 2017

26. 2. Standards for devices
Mechanical risks
Thermal risks
Chemical risks
Information

27. 3. Standards for liquids
Liquid standards
Containers
Information
Testing protocol

28. Take out points
• Vapor technology is a major disruption of the
cigarette trade
• It has potential for huge health and welfare
benefits and is already working well
• Regulators can kill it off and protect the
incumbent by imposing excessive burdens
• Cole-Bishop offers a responsible way out
www.clivebates.com
@clive_bates