Is nicotine reduction really a viable policy option for tobacco control?

Definitely not…

Clive BatesCounterfactual

SRNT annual meeting

Florence, Italy

Pre-conference workshop #2

09:00 – 12:00 Wednesday 8 March 2017

1. It’s a prohibition

1. Ground clearing – reduced nicotine strategy is a prohibition

1%

1. Prohibition - the compliance fallacy

Tobacco Marijuana0

5

10

15

20

25

30 day prevalence high school tobacco or

marijuana use 2015

Cigarettes Other Marijuana

Perc

ent

Youth Risk Behavior Surveillance United States, 2015

CDC

Monitoring the Future United States, 2016

University of Michigan / NIDA

?

1. Prohibition - The compliance fallacy

• Quit or don’t start

• Use reduced nicotine cigarettes

• (More recently) switch to e-cigs

• Stockpile cigarettes or trade with stockpilers

• Import conventional cigarettes

• Switch to other combustible products: hand rolling tobacco, pipes, cigars, hookahs, shisha

• Contraband or counterfeit conventional cigs

• Counterfeit low-nicotine with high nicotine

• Take advantage of product innovation

• Take advantage of process innovation

• Switch to ANDS – non-combustibles

• Add nicotine liquid to low-nicotine cigarettes

• Other substance use – e.g. marijuana

• Alternative risk behaviours

• Fraudulent solutions and quack remedies

• Some mixture of above – including dual use

• Quit smoking, tobacco and nicotine use

• Use very low nicotine cigarettes

People smoke for the nicotine

but die from the tar (1976)

2. Looking in the wrong place

2. Looking in the wrong place

• Stockpile cigarettes or trade with stockpilers

• Import conventional cigarettes

• Switch to other combustible products: hand rolling tobacco, pipes, cigars, hookahs, shisha

• Contraband or counterfeit conventional cigs

• Counterfeit low-nicotine with high nicotine

• Take advantage of product innovation

• Take advantage of process innovation

• Switch to ANDS – non-combustibles

• Add nicotine liquid to low-nicotine cigarettes

• Other substance use – e.g. marijuana

• Alternative risk behaviours

• Fraudulent solutions and quack remedies

• Some mixture of above – including dual use

• Quit smoking, tobacco and nicotine use

• Use very low nicotine cigarettes

2. Looking in the wrong place

• Stockpile cigarettes or trade with stockpilers

• Import conventional cigarettes

• Switch to other combustible products: hand rolling tobacco, pipes, cigars, hookahs, shisha

• Contraband or counterfeit conventional cigs

• Counterfeit low-nicotine with high nicotine

• Take advantage of product innovation

• Take advantage of process innovation

• Switch to ANDS – non-combustibles

• Add nicotine liquid to low-nicotine cigarettes

• Other substance use – e.g. marijuana

• Alternative risk behaviours

• Fraudulent solutions and quack remedies

• Some mixture of above – including dual use

• Quit smoking, tobacco and nicotine use

• Use very low nicotine cigarettes

What nicotine is forNicotine induces pleasure and reduces stress and anxiety. Smokers use it to modulate levels of arousal and to control mood. Smoking improves concentration, reaction time, and performance of certain tasks.

Relief from withdrawal symptoms is probably the primary reason for this enhanced performance and heightened mood.

Benowitz NL. Nicotine Addiction. N Engl J Med. 2010 Jun 17;362(24):2295–303

Really…?

2. Looking in wrong place – confirms “looking in wrong place”

Conditions• Smokers paid

• Cigarettes provided free

• Incentives to stay the course

Findings include• Compensation in dependent smokers

• Non-compliance

• Attrition

Parallels• Reduced nicotine cigarettes have

never been a commercial success

2. The right place: broad policy scoping assessment

• Money flows

• Products and responses

• Supply chain • Farms• Manufacturers• Retail

• Criminal enterprise

• The internet / mail order

• Foreign borders

• Tax gathers (states)

• Consumers• 38 million voters• Mentally ill / Substance users• Elderly / retired• Prisoners, veterans• Travellers

• Institutions • Congress, states• FDA / HHS / FBI / CBP

• Policy aim (quit or switch)?

• What nicotine standard?

• Scope of products covered?

• Abrupt or gradual?

• Technical verification?

• Enforcement action?

• Penalties?

• Taxation?

• Risk communication?

• Labelling?

• Liability?

• Legal base and tests?

• Political / stakeholders

• Economic / commercial

• Social / equity

• Technology

• Legal / criminal

• Ethical / Philosophical

• Rural / special interests

• Options appraisal

• Counterfactuals

Define the system Specify an intervention Broaden the analysis

3. Brutal politics

3. The brutal politics: take Congress seriously not literally

LiterallyLimitation on Power Granted to the Food and Drug Administration

Because of the importance of a decision of the Secretary to issue a regulation

A. banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or

B. requiring the reduction of nicotine yields of a tobacco product to zero,

the Secretary is prohibited from taking such actions under this Act

U.S. Tobacco Control Act §907.d.3

Limitation on Power Granted to the Food and Drug Administration

Because of the importance of a decision of the Secretary to issue a regulation

A. banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or

B. requiring the reduction of nicotine yields of a tobacco product to zero,

the Secretary is prohibited from taking such actions under this Act

3. The brutal politics: take Congress seriously not literally

Seriously

U.S. Tobacco Control Act §907.d.3

Voters, consumers, specific groups

Political alignments, states capitols Law enforcement, criminal justice

Supply chain, affected businesses

3. The brutal politics

3. Menthol – how’s it going?

4. Superior strategy #1

4. Superior strategy 1: choice and creative destruction• Benowitz NL, Donny EC, Hatsukami DK. Reduced nicotine content cigarettes, e-

cigarettes and the cigarette end game. Addiction. 2016

By coercion consumers forced

to switch to alternative nicotine

By consentconsumers choose

to switch to alternative

nicotineIn both cases

priority must be given to

alternative nicotine

4. Superior strategy 1: fix alt-nicotine regulation and comms

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

Recommendations

4. Superior strategy 1: the case against illiberal policies

The only purpose for which power

can be rightfully exercised over any

member of a civilized community,

against his will, is to prevent harm

to others.

His own good, either physical or

moral, is not sufficient warrant.

John Stuart Mill On Liberty, 1859

5. Superior strategy #2

5. Superior strategy 2: regulate to reduce toxin content

5. Superior strategy 2: regulate to reduce toxin content

6. The nicotine reduction complex

6. Nicotine-reduction industrial complex

Kozlowski LT. Coping with the Conflict-of-Interest Pandemic by Listening to and Doubting Everyone, Including Yourself, Sci Eng Ethics. 2016; 22: 591–596.

7. Place your bets

7. Taking bets – Clive Bates vs Joe Gitchell laid in 2013

Nicotine reduction – take homesA terrible authoritarian idea

Nourishes criminal enterpriseNo good evidence or precedents

Politically unwinnableWaste of resources

Distraction from a superior strategy

Counterfactual

www.clivebates.com@clive_bates