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Is nicotine reduction a viable policy for tobacco control? No, Definitely not...

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My critique of the proposal that regulators should reduce the concentration of nicotine in cigarettes to a sub-addictive level - effectively a prohibition of cigarettes as we know them.

Presentation at SRNT 2017 in Florence, Italy on 8 March 2017.

Published in: Government & Nonprofit
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Is nicotine reduction a viable policy for tobacco control? No, Definitely not...

  1. 1. Is nicotine reduction really a viable policy option for tobacco control? Definitely not… Clive Bates Counterfactual SRNT annual meeting Florence, Italy Pre-conference workshop #2 09:00 – 12:00 Wednesday 8 March 2017
  2. 2. 1. It’s a prohibition
  3. 3. 1. Ground clearing – reduced nicotine strategy is a prohibition 1 %
  4. 4. 1. Prohibition - the compliance fallacy 0 5 10 15 20 25 Tobacco Marijuana Percent 30 day prevalence high school tobacco or marijuana use 2015 Cigarettes Other Marijuana Youth Risk Behavior Surveillance United States, 2015 CDC Monitoring the Future United States, 2016 University of Michigan / NIDA
  5. 5. ? 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)
  6. 6. 2. Looking in the wrong place
  7. 7. 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
  8. 8. 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 for Nicotine 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
  9. 9. 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
  10. 10. 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
  11. 11. 3. Brutal politics
  12. 12. 3. The brutal politics: take Congress seriously not literally Literally 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 U.S. Tobacco Control Act §907.d.3
  13. 13. 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
  14. 14. Voters, consumers, specific groups Political alignments, states capitols Law enforcement, criminal justice Supply chain, affected businesses 3. The brutal politics
  15. 15. 3. Menthol – how’s it going?
  16. 16. 4. Superior strategy #1
  17. 17. 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 consent consumers choose to switch to alternative nicotine In both cases priority must be given to alternative nicotine
  18. 18. 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
  19. 19. 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
  20. 20. 5. Superior strategy #2
  21. 21. 5. Superior strategy 2: regulate to reduce toxin content
  22. 22. 5. Superior strategy 2: regulate to reduce toxin content
  23. 23. 6. The nicotine reduction complex
  24. 24. 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.
  25. 25. 7. Place your bets
  26. 26. 7. Taking bets – Clive Bates vs Joe Gitchell laid in 2013
  27. 27. Nicotine reduction – take homes A terrible authoritarian idea Nourishes criminal enterprise No good evidence or precedents Politically unwinnable Waste of resources Distraction from a superior strategy Counterfactual www.clivebates.com @clive_bates

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