The FDA needs to look beyond nicotine alone in developing its standard for nicotine delivery in tobacco products

My UCSF colleagues recently submitted this public comment to the FDA on its proposed Nicotine Product Standard.  A PDF version of the comment is here.

The FDA needs to look beyond nicotine alone in developing its standard for nicotine delivery in tobacco products

Docket No. FDA-2017-N-6189 

Jesse Elias, MA, Yogi Hale Hendlin, PhD, Pamela M. Ling, MD, MPH

University of California, San Francisco

June 12, 2018

The FDA is considering its proposed nicotine product standard as part of its “comprehensive nicotine policy.” The FDA’s description of this proposal to date appears to focus narrowly on the pharmacological properties of nicotine. By reducing nicotine delivery in cigarettes, this standard would encourage smokers to switch to other nicotine delivery systems, including those made by tobacco companies, so as to reduce the harm caused by tobacco products. In the best case scenario, reduced-nicotine cigarettes will prompt smokers to quit smoking altogether, and cease use of all tobacco products. Second best, smokers will switch to non-combustible tobacco products yet maintain their nicotine addiction.

Compared to the tobacco industry’s understanding of nicotine addiction, however, such a model overly simplifies the complexity of the smoking problem in ways that could promote policies that protect tobacco companies at the expense of public health.  The FDA’s understanding of nicotine addiction must be at least as sophisticated as the tobacco industry’s.

Philip Morris International’s (PMI’s) current public communications claim that only nicotine product substitution will diminish cigarette smoking prevalence.[1] Using previously secret internal company documents, however, we found that from the mid-1990s until at least 2006, PMI’s parent company, Philip Morris (PM, now Altria) consistently understood the user’s biology, psychology, social milieu and environment as at least as important as nicotine in driving use.[2] In 1997, for example, PM executives privately concluded that the “nicotine addiction hypothesis [i.e. the idea that people smoke exclusively to acquire nicotine] is much too simple to explain this complex behavior in which nicotine plays a significant, but not exclusive role.”[3] PM’s scientists maintained this position internally through the mid-2000s, even after company statements began publicly emphasizing nicotine as the primary cause of addiction.[2]

PMI’s current public emphasis on nicotine as the chief driver of smoking[4] allows the company to redirect policy away from proven social and environmental interventions and toward the promotion of novel tobacco products. So long as these non-pharmacological drivers remain in place, PM estimated that anywhere from 50-98 percent of smokers would continue using cigarettes.[5] This multifactorial understanding of smoking implicates the tobacco industry itself as a vector of addiction – beyond the provision and manipulation of nicotine in cigarettes, the industry’s marketing, lobbying and litigation against effective tobacco control policies all influence users’ psychology, social milieu and environment, which in turn determine use.

The tobacco industry may have contributed to the historical over-simplification of nicotine addiction. British psychiatrist Michael Russell, whose scholarship is summarized by his 1991 hypothesis that people “smoke for the nicotine but die from the tar,” [6] is today widely regarded as the father of tobacco harm reduction. [7, 8] Russell collaborated extensively with tobacco companies through at least the early 1990s.[9] In the late 1970s, Russell collaborated with British American Tobacco on two ‘safer’ cigarette studies[10] and received £55,000 ($402,420 inflation adjusted to 2018) to test medium nicotine, low-tar cigarettes.[11, 12] In 1988, Russell contacted RJ Reynolds (RJR), soliciting funding for a study on RJR’s “heat-not-burn” tobacco product, Premier.[13, 14] In subsequent communications, Russell stated a priori that publication of study results could improve consumers’ and regulators’ perception of Premier [15]. Russell also offered to “‘lose’ records” of reimbursement from RJR,[15] and suggested the company pay him to undertake research on Premier,[16] which he anonymously endorsed as a “near-perfect low tar cigarette” while representing The Lancet in a 1991 editorial.[17] As consumers became increasingly health conscious, RJR scientists believed Russell’s endorsement indicated that new tobacco products, “uniquely perceived…as less hazardous,” could “stabiliz[e] or revers[e] market decline” as smoking prevalence fell and bolster RJR’s “long-term vitality.” [18]

Tobacco companies now claim to support users’ switching from cigarettes to alternative tobacco products.[1] Any population-level success with product substitution, however, would be at odds with public health history. Population studies consistently show that unassisted cessation (e.g. policy interventions, going cold turkey, cutting-down-to-quit) is the most common and successful cessation method, leading nicotine replacement therapies (NRT) by a wide margin.[19] Fully two-thirds[20] to three-quarters[21] of ex-smokers quit unaided. These data suggest that neurobiology and pharmacology explain only a small part of cessation. Nonetheless, tobacco companies have a vested stake in reducing smoking to a problem of nicotine administration, treatable not through proven policy interventions, but through the potentially life-long use of an alternative industry product, with uncertain health claims.[22]

While nicotine in cigarettes should be lowered to non-addictive levels, the FDA should not expect these reductions alone to solve the smoking problem. Instead, reductions in nicotine should complement increased access to proven NRTs and behavioral counseling, coupled with ever-stronger societal level restrictions on both tobacco use and industry influence. Both public health history [19, 23-25] and the tobacco industry’s own understanding of addiction suggest that social and environmental interventions – e.g., advertising restrictions, plain packaging, tobacco taxes, and widespread smoke-free restrictions – lessen addiction’s tenacity far more effectively than changing individual users’ nicotine delivery source alone. These policy interventions become even more important as smoking becomes increasingly concentrated within society’s most vulnerable populations, which have least access to pharmacotherapy, cessation services or potentially reduced harm products.[26-28]

To improve addiction outcomes and public health, FDA should both reduce the nicotine levels permitted in cigarettes and other combustible tobacco products, while also expanding and strengthening social and environmental restrictions on cigarette smoking. 

REFERENCES

1.         Philip Morris International. Harm Reduction Equation 2017 [Accessed October 2, 2017]. Available from: https://www.pmi.com/glossary-section/glossary/harm-reduction-equation.

2.         Elias J, Hendlin YH, Ling PM. Public versus internal conceptions of addiction: An analysis of internal Philip Morris documents. PLOS Medicine. 2018;15(5):e1002562.

3.         Philip Morris. Cigarette Smoking & Causation, ETS and "Addiction" the Facts and Positions. October 02 1997. Philip Morris Records. https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/kzcc0096. [Accessed 2017 April 25].

4.         Philip Morris International. Science and Innovation: The Role of Nicotine 2017 [Accessed September 20, 2017]. Available from: https://www.pmi.com/science-and-innovation/the-role-of-nicotine.

5.         Philip Morris. Nicotine Addiction Consensus Group Presentation. February 16 2005. Philip Morris Records. https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/qgjf0218. [Accessed 2017 May 03].

6.         Russell M. The future of nicotine replacement. British Journal of Addiction. 1991;86(5):653-8.

7.         Hajek P. The development and testing of new nicotine replacement treatments: from ‘nicotine replacement’to ‘smoking replacement’. Addiction. 2015;110(S2):19-22.

8.         Royal College of Physicians. Nicotine Without Smoke: Tobacco Harm Reduction. London: Royal College of Physicians, 2016.

9.         Elias J, Ling PM. Invisible smoke: third-party endorsement and the resurrection of heat-not-burn tobacco products. Tobacco control. 2018:tobaccocontrol-2018-054433.

10.       Thornton RE. Note on Collaborative Study with Russell. April 06 1979. British American Tobacco. https://industrydocuments.library.ucsf.edu/tobacco/docs/rxwx0211. [Accessed 2016 April 27].

11.       Short PL. Funding Proposal for Michael Russell. November 15 1979. British American Tobacco. https://industrydocuments.library.ucsf.edu/tobacco/docs/yjwx0211. [Accessed 2016 April 27].

12.       Russell M. Russell Thanks BAT for Financial Support. January 09 1980. British American Tobacco. https://industrydocuments.library.ucsf.edu/tobacco/docs/tnmc0203. [Accessed 2016 April 27].

13.       Lloyd RA. Russell's Premier Study Described. October 04 1988. RJ Reynolds. https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/xhcd0003. [Accessed 2016 May 19].

14.       Blanchard JW. RJR discusses Russell's Research Proposal. August 09 1988. RJ Reynolds. https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/hylh0087. [Accessed 2016 May 19].

15.       Russell M. Russell Discusses Clearing Premier Cigarettes at Customs. October 28 1988. RJ Reynolds. https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/tzlv0090. [Accessed 2016 May 19].

16.       Russell M. Letter to A. Wallace Hayes. January 22 1991. RJ Reynolds. https://industrydocuments.library.ucsf.edu/tobacco/docs/msxf0084. [Accessed 2016 February 09].

17.       The Lancet. Nicotine Use After the Year 2000. Lancet. 1991;337(8751):1191-2.

18.       DeBethizy JD. 1992-1996 Strategic Plan. September 03 1991. RJ Reynolds. https://industrydocuments.library.ucsf.edu/tobacco/docs/ffmw0103. [Accessed 2016 April 13].

19.       Chapman S, MacKenzie R. The global research neglect of unassisted smoking cessation: causes and consequences. PLoS Med. 2010;7(2):e1000216.

20.       Shiffman S, Brockwell SE, Pillitteri JL, Gitchell JG. Use of smoking-cessation treatments in the United States. American journal of preventive medicine. 2008;34(2):102-11.

21.       Lee C-W, Kahende J. Factors associated with successful smoking cessation in the United States, 2000. American Journal of Public Health. 2007;97(8):1503-9.

22.       National Academies of Sciences. Public Health Consequences of E-Cigarettes. Washington DC: 2018.

23.       McKinlay JB, Marceau LD. Upstream healthy public policy: lessons from the battle of tobacco. International Journal of Health Services. 2000;30(1):49-69.

24.       Hall W, Carter A, Forlini C. The brain disease model of addiction: is it supported by the evidence and has it delivered on its promises? The Lancet Psychiatry. 2015;2(1):105-10.

25.       Leas EC, Pierce JP, Benmarhnia T, White MM, Noble ML, Trinidad DR, et al. Effectiveness of Pharmaceutical Smoking Cessation Aids in a Nationally Representative Cohort of American Smokers. JNCI: Journal of the National Cancer Institute. 2017:djx240-djx.

26.       Douglas L, Szatkowski L. Socioeconomic variations in access to smoking cessation interventions in UK primary care: insights using the Mosaic classification in a large dataset of primary care records. BMC public health. 2013;13(1):546.

27.       Eakin EG, Glasgow RE, Whitlock EP, Smith P. Reaching those most in need: Participation in a planned parenthood smoking cessation program. Annals of Behavioral Medicine. 1998;20(3):216-20.

28.       King TK, Borrelli B, Black C, Pinto BM, Marcus BH. Minority women and tobacco: implications for smoking cessation interventions. Annals of Behavioral Medicine. 1997;19(3):301-13.