Taming the smoking epidemicNew and disruptive technologies

Washington DC28 February 2017

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

“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

Unheated nicotine products Smokeless tobacco

Heated tobacco products“Heat-not-burn”

Vaping products

Tobacco basedPure nicotine based

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Reduced-risk consumer nicotine market

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)

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)

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).

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

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.

Youth smoking: US National Survey on Drug Use and Health

Young adult smoking: National Health Interview Survey

Long term 12th grade smoking: Monitoring the Future survey

Long term 12th grade smoking: Monitoring the Future survey

Youth nicotine use: National Youth Tobacco Survey

Youth nicotine use: National Youth Tobacco Survey 2014

Most youth vaping counted in the headline is occasional

“ConclusionsNon-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

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

Flavours: critical part of appeal to smokers

Role of flavours in quitting

About three-quarters relied fully or partially on flavours

Choice of flavours by adults

Less than a quarter use tobacco flavours

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

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

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.)

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

Cole-Bishop HR 1136 – February 2017

2. Standards for devices

Mechanical risks

Thermal risks

Chemical risks

Information

3. Standards for liquids

Liquid standards

Containers

Information

Testing protocol

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