18.4 Low nicotine – nicotine reduction

Last updated: September 2018

Suggested citation: Greenhalgh, EM, & Scollo, MM 18.4 Low nicotine–nicotine reduction. In Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2018. Available from: http://www.tobaccoinaustralia.org.au/chapter-18-harm-reduction/18-4-low-nicotine

It is well established that addiction to nicotine maintains most smokers’ use of tobacco products.1 Once addicted, quitting can be extremely difficult, with many smokers repeatedly relapsing following their cessation attempts.2  Young people have a very poor understanding of addiction, often believing that they will be able to stop smoking at will.3 However, once they take up smoking, the nicotine addiction sustains the behaviour into adulthood, dramatically increasing their risk of tobacco-related harm.4 

The regulation of the level of nicotine in tobacco products has been suggested as a potential strategy for avoiding the transition from experimental smoking to addiction. Reducing the nicotine content in cigarettes so that they are non-addictive could prevent adolescents and occasional smokers from becoming addicted. A gradual reduction could also allow smokers to slowly decrease their intake of nicotine, thereby weaning themselves off the product and making quitting substantially easier.5,6 Unlike ‘low tar and light’ cigarettes promoted by tobacco companies, which did not actually reduce delivery of tar and instead involved design features that allowed smokers to easily compensate for the reduced nicotine content by drawing harder (see section 12.4), reduced nicotine cigarettes could be manufactured the same as regular cigarettes except with tobacco that has a lower nicotine content. If the nicotine content was low enough, it would be virtually impossible to absorb significant levels of nicotine by using these products.6

Research to date has consistently demonstrated the feasibility of reducing the nicotine content of cigarettes to reduce nicotine dependence, smoking, and toxicant exposure, with minimal symptoms of nicotine withdrawal and without evidence of compensatory smoking.7-13 Research with adolescents and young adults has found that reduced nicotine cigarettes can decrease the positive subjective effects of smoking, and therefore may reduce abuse liability.14, 15 Studies modelling the public health impacts of lowering the nicotine content of cigarettes to minimally addictive levels have concluded that it would lead to substantial reductions in tobacco-related morbidity and mortality, both through decreasing uptake and increasing cessation.16, 17  

Developing low-nicotine cigarettes has been a prominent approach in considerations of tobacco endgame strategies; it is endorsed by the American Medical Association, the British Medical Association, the US Food and Drug Administration (FDA) and the US Surgeon-General, and is also supported within the WHO Framework Convention on Tobacco Control.18 The approach more broadly calls for research, government regulation, gradual reduction, consumer education, and increased availability of lower-risk options, in order to combat addiction and eliminate gateway risks.6  In its 2015 advisory note on a global nicotine reduction strategy, the WHO Study Group on Tobacco Product Regulation recommended that implementation of a nicotine-reduction policy should be supported by a comprehensive tobacco control program.19

Health Canada issued a tender in 2016 calling for research into the possibility of forcing tobacco companies to make their cigarettes less addictive,20 and issued another in 2018 requesting industry feedback regarding the feasibility and costs associated with procuring a supply of very low nicotine cigarettes.21 The FDA included in its 2009 tobacco law the authority to reduce nicotine,22 and in 2018, issued an advance notice of proposed rulemaking to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes.23 However, critics of the approach have argued that it may not be practicable within the confines of FDA law. Or, if it is, it may take many years to implement, and would require mandatory low nicotine content to succeed. They contend that resources would be better allocated to more pleasurable and likely less harmful forms of nicotine use, such as vaping and snus.18  Alternatively, others have suggested a combination of these strategies; that is, reducing the nicotine content of smoked tobacco products while allowing non-combustible recreational nicotine products to be sold.24-26 A review of legal arguments that the tobacco industry is likely to advance in response to the FDA implementing non-addictive nicotine levels concluded that the FDA stands on solid legal ground, and that there are strong arguments that it has the authority to implement such policy.27

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References

1. Benowitz N. Pharmacologic aspects of cigarette smoking and nicotine addition. New England Journal of Medicine, 1988; 319(20):1318–30. Available from: http://www.nejm.org/doi/full/10.1056/NEJM198811173192005

2. Zhou X, Nonnemaker J, Sherrill B, Gilsenan AW, Coste F, et al. Attempts to quit smoking and relapse: factors associated with success or failure from the ATTEMPT cohort study. Addictive Behaviors, 2009; 34(4):365–73. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19097706

3. Gray RJ, Hoek J, and Edwards R. A qualitative analysis of 'informed choice' among young adult smokers. Tobacco Control, 2014. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25192770

4. Benowitz NL, Hall SM, Stewart S, Wilson M, Dempsey D, et al. Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiology Biomarkers & Prevention, 2007; 16(11):2479–85. Available from: http://cebp.aacrjournals.org/content/16/11/2479.short

5. Benowitz NL and Henningfield JE. Establishing a nicotine threshold for addiction: the implications for tobacco regulation. New England Journal of Medicine, 1994; 331(123–5). Available from: http://www.ncbi.nlm.nih.gov/pubmed/7818638

6. Benowitz NL and Henningfield JE. Reducing the nicotine content to make cigarettes less addictive. Tobacco Control, 2013; 22(suppl 1):i14–i7. Available from: http://tobaccocontrol.bmj.com/content/22/suppl_1/i14.abstract

7. Benowitz NL, Nardone N, Dains KM, Hall SM, Stewart S, et al. Effect of reducing the nicotine content of cigarettes on cigarette smoking behavior and tobacco smoke toxicant exposure: 2-year follow up. Addiction, 2015. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26198394

8. Donny EC, Denlinger RL, Tidey JW, Koopmeiners JS, Benowitz NL, et al. Randomized trial of reduced-nicotine standards for cigarettes. New England Journal of Medicine, 2015; 373(14):1340–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26422724

9. Dermody SS, McClernon FJ, Benowitz N, Luo X, Tidey JW, et al. Effects of reduced nicotine content cigarettes on individual withdrawal symptoms over time and during abstinence. Experimental and Clinical Psychopharmacology, 2018. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29504780

10. Hatsukami DK, Donny EC, Koopmeiners JS, and Benowitz NL. Compensatory smoking from gradual and immediate reduction in cigarette nicotine content. Cancer Epidemiology, Biomarkers & Prevention, 2014; 24(2):472–6. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25515551

11. Hatsukami D, Kotlyar M, Hertsgaard L, Zhang Y, Carmella S, et al. Reduced nicotine content cigarettes: Effects on toxicant exposure, dependence and cessation. Addiction, 2010; 105(2):343–53. Available from: https://www.ncbi.nlm.nih.gov/pubmed/20078491

12. Hatsukami D, Heishman S, Vogel R, Denlinger R, Roper-Batker A, et al. Dose-response effects of spectrum research cigarettes. Nicotine & Tobacco Research, 2013; 15(6):1113-21. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23178320

13. Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, et al. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiology, Biomarkers & Prevention, 2012; 21(5):761-9. Available from: https://www.ncbi.nlm.nih.gov/pubmed/22354905

14. Cassidy RN, Tidey JW, Cao Q, Colby SM, McClernon FJ, et al. Age moderates smokers' subjective response to very low nicotine content cigarettes: Evidence from a randomized controlled trial. Nicotine & Tobacco Research, 2018. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29718460

15. Cassidy RN, Colby SM, Tidey JW, Jackson KM, Cioe PA, et al. Adolescent smokers' response to reducing the nicotine content of cigarettes: Acute effects on withdrawal symptoms and subjective evaluations. Drug and Alcohol Dependence, 2018; 188:153-60. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29775959

16. Apelberg BJ, Feirman SP, Salazar E, Corey CG, Ambrose BK, et al. Potential public health effects of reducing nicotine levels in cigarettes in the United States. New England Journal of Medicine, 2018. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29543114

17. Tengs TO, Ahmad S, Savage JM, Moore R, and Gage E. The AMA proposal to mandate nicotine reduction in cigarettes: A simulation of the population health impacts. Preventive Medicine, 2005; 40(2):170-80. 

18. Kozlowski LT. Prospects for a nicotine-reduction strategy in the cigarette endgame: Alternative tobacco harm reduction scenarios. International Journal of Drug Policy, 2015; 26(6):543–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25795345

19. World Health Organization. Advisory note: Global nicotine reduction strategy: WHO study group on tobacco product regulation. 2015. Available from: http://www.who.int/tobacco/publications/prod_regulation/nicotine-reduction/en/

20. Government of Canada. Health benefits modeling, expert elicitation and analysis relating to a product standard (1000174109). 2016. Available from: https://buyandsell.gc.ca/procurement-data/tender-notice/PW-16-00718749

21. Government of Canada. Request for information regarding availability, costing, and storage of Canadian very low nicotine content Virginia flue-cured cigarettes (1000198655). 2018. Available from: https://buyandsell.gc.ca/procurement-data/tender-notice/PW-18-00814424

22. United States Code. Family smoking prevention and tobacco control act. In stat 1776 United States. 2009. Available from: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm237092.htm

23. Federal Register. Tobacco product standard for nicotine level of combusted cigarettes. Proposed Rule, U.S. Department of Health and Human Services,  2018. Available from: https://www.federalregister.gov/documents/2018/03/16/2018-05345/tobacco-product-standard-for-nicotine-level-of-combusted-cigarettes.

24. Hall W and Gartner C. Supping with the devil? The role of law in promoting tobacco harm reduction using low nitrosamine smokeless tobacco products. Public Health, 2009; 123(3):287–91. Available from: http://www.sciencedirect.com/science/article/pii/S0033350608003533

25. Benowitz NL, Donny EC, and Hatsukami DK. Reduced nicotine content cigarettes, e-cigarettes and the cigarette end game. Addiction, 2016. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27555354

26. Smith TT, Hatsukami DK, Benowitz NL, Colby SM, McClernon FJ, et al. Whether to push or pull? Nicotine reduction and non-combusted alternatives - two strategies for reducing smoking and improving public health. Preventive Medicine, 2018. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29604326

27. Berman ML, Zettler PJ, and Ashley DL. Anticipating industry arguments: The US Food and Drug Administration's authority to reduce nicotine levels in cigarettes. Public Health Reports, 2018:33354918776935. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29879366

 

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