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Reduced Nicotine Rule
A terrible idea
(...to be pursued relentlessly)
Clive Bates
Counterfactual
FDLI meeting
26 October2017
Washington DC
A terrible idea
1
%
1. A prohibition
A terrible idea • Stockpile cigarettes or trade with stockpilers
• Import conventional cigarettes via internet
• 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?
1. A prohibition
2. Unpredictable response
A terrible idea
1. A prohibition
2. Unpredictable response
3. Little relevant research
A terrible idea
1. A prohibition
2. Unpredictable response
3. Little relevant research
4. Perverse consequences
A terrible idea
U.S. Tobacco Control Act §907.d.3
1. A prohibition
2. Unpredictable response
3. Little relevant research
4. Perverse consequences
5. Poor mandate
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
A terrible idea
1. A prohibition
2. Unpredictable response
3. Little relevant research
4. Perverse consequences
5. Poor mandate
6. Brutal politics
A terrible idea
Regulate
toxins
Raise
taxes
Control
additives
Plain
packaging
1. A prohibition
2. Unpredictable response
3. Little relevant research
4. Perverse consequences
5. Poor mandate
6. Brutal politics
7. Superior alternatives
A terrible idea
1. A prohibition
2. Unpredictable response
3. Little relevant research
4. Perverse consequences
5. Poor mandate
6. Brutal politics
7. Superior alternatives
To be pursued relentlessly
1. Alternatives essential
To be pursued relentlessly
1. Alternatives essential
2. Proportionate regulation
To be pursued relentlessly
1. Alternatives essential
2. Proportionate regulation
3. Coercion paradox
To be pursued relentlessly
1. Alternatives essential
2. Proportionate regulation
3. Coercion paradox
4. An ‘agency threat’
Counterfactual
Weapons don’t have to be
used to be useful
www.clivebates.com
@clive_bates

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Reduced nicotine rule: a terrible idea to be pursued relentlessly

  • 1. Reduced Nicotine Rule A terrible idea (...to be pursued relentlessly) Clive Bates Counterfactual FDLI meeting 26 October2017 Washington DC
  • 2. A terrible idea 1 % 1. A prohibition
  • 3. A terrible idea • Stockpile cigarettes or trade with stockpilers • Import conventional cigarettes via internet • 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? 1. A prohibition 2. Unpredictable response
  • 4. A terrible idea 1. A prohibition 2. Unpredictable response 3. Little relevant research
  • 5. A terrible idea 1. A prohibition 2. Unpredictable response 3. Little relevant research 4. Perverse consequences
  • 6. A terrible idea U.S. Tobacco Control Act §907.d.3 1. A prohibition 2. Unpredictable response 3. Little relevant research 4. Perverse consequences 5. Poor mandate 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
  • 7. A terrible idea 1. A prohibition 2. Unpredictable response 3. Little relevant research 4. Perverse consequences 5. Poor mandate 6. Brutal politics
  • 8. A terrible idea Regulate toxins Raise taxes Control additives Plain packaging 1. A prohibition 2. Unpredictable response 3. Little relevant research 4. Perverse consequences 5. Poor mandate 6. Brutal politics 7. Superior alternatives
  • 9. A terrible idea 1. A prohibition 2. Unpredictable response 3. Little relevant research 4. Perverse consequences 5. Poor mandate 6. Brutal politics 7. Superior alternatives
  • 10. To be pursued relentlessly 1. Alternatives essential
  • 11. To be pursued relentlessly 1. Alternatives essential 2. Proportionate regulation
  • 12. To be pursued relentlessly 1. Alternatives essential 2. Proportionate regulation 3. Coercion paradox
  • 13. To be pursued relentlessly 1. Alternatives essential 2. Proportionate regulation 3. Coercion paradox 4. An ‘agency threat’
  • 14.
  • 15. Counterfactual Weapons don’t have to be used to be useful www.clivebates.com @clive_bates

Editor's Notes

  1. In this presentation I stress that the policy of reducing nicotine in cigarettes should be examined as a problem of ‘political economy’, and not primarily a biomedical issue. This is because it is a huge intervention in a $80 billion market, with 38 million directly affected users (US only). It is not primarily a problem of examining in detail the science of using very low nicotine cigarettes for the simple reason that almost no-one will use them. But should this rule be introduced, there would be a market response – quitting, switching, black markets of various kinds – and it is understanding this response that is the pressing problem to investigate. I also believe it will be impossible to get political agreement to do this and that FDA and advocates are overstating the legal cover there is to implement a ban… therefore energy spent on this is wasted and comes with an opportunity cost. To achieve the same or better outcome there are superior strategies – to increase the appeal of low risk nicotine products and to degrade the appeal of the most harmful combustible products.
  2. My summary…