Dachille, Kathleen Hoke

McNamara, Jacqueline M.

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Symposium -  Safer  Tobacco Products: Reducing Harm or Giving False Hope?  Introduction

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Journal of Health Care Law and PolicyVolume 11 | Issue 1 Article 2Symposium - "Safer" Tobacco Products: ReducingHarm or Giving False Hope? IntroductionKathleen Hoke Dachillekhoke@law.umaryland.eduJacqueline M. McNamaraFollow this and additional works at: http://digitalcommons.law.umaryland.edu/jhclpPart of the Health Law and Policy Commons, and the Substance Abuse and Addiction CommonsThis Conference is brought to you for free and open access by the Academic Journals at DigitalCommons@UM Carey Law. It has been accepted forinclusion in Journal of Health Care Law and Policy by an authorized administrator of DigitalCommons@UM Carey Law. For more information, pleasecontact smccarty@law.umaryland.edu.Recommended CitationKathleen H. Dachille, & Jacqueline M. McNamara, Symposium - "Safer" Tobacco Products: Reducing Harm or Giving False Hope?Introduction, 11 J. Health Care L. & Pol'y 1 (2008).Available at: http://digitalcommons.law.umaryland.edu/jhclp/vol11/iss1/2INTRODUCTIONKATHLEEN HOKE DACHILLE*JACQUELINE M. MCNAMARA**Tobacco control is at a crossroads. The principal goal of this well-establishedpublic health movement has been the eradication of tobacco use, a deadly habit thatcauses tremendous harm while providing no real benefit to society. In the UnitedStates, cigarette-caused disease leads to 440,000 deaths annually, one-third ofwhich are caused by cancer; of those, 87% are lung cancer deaths.1 Because anoutright ban on cigarettes and other tobacco products remains impractical andpolitically impossible, alternative methods to reduce the devastating health effectsfrom tobacco use have been employed. Aimed at reducing consumption, thesemethods have included public education about the health dangers of smoking andtobacco use, encouraging cessation with assistance from nicotine replacementtherapy (NRT), and preventing initiation-especially by minors. These methodshave been successful: from 1965 to 1990, the percentage of U.S. adult smokersdropped significantly from an astounding 65% to a more manageable 23%.2In the 1990s, tobacco control strategy expanded from its focus on the healtheffects on the smoker, to counteracting the negative health consequences ofnonsmokers' exposure, and to reducing secondhand smoke, also known asenvironmental tobacco smoke (ETS). 3 Tobacco control legislation and regulationCopyright © 2008 by Kathleen Hoke Dachille and Jacqueline M. McNamara.* Assistant Professor of Law and the Director of the Legal Resource Center for Tobacco Regulation,Litigation and Advocacy, University of Maryland School of Law.** Tobacco Control Law Fellow, Legal Resource Center for Tobacco Regulation, Litigation andAdvocacy, University of Maryland School of Law.1. Am. Cancer Soc'y, Cigarette Smoking,www.cancer.org/docroot/PED/content/PED10 2X Cigarette Smoking.asp (last visited Jan. 29, 2008).2. Thomas G. Parish, Financing Smoking-Related Illness and Smoking Cessation in the UnitedStates: Can it be Done?, 2 INTERNET J. ALLIED HEALTH SCI. & PRACTICE (2004),http://ijahsp.nova.edu/articles/Vol2numl/tomparishpac mph.htm; see also Ctrs. for Disease Control& Prevention, Tobacco Use - United States, 1990-1999, 48 MORBIDITY & MORTALITY WKLY. REP.985, 989 (1999) (linking the reduction in cigarette consumption to various factors, such as educating thepublic, cessation programs, and improvement in treatment programs), available athttp://www.cdc.gov/mmwr/PDF/wk/mm4843.pdf. The imposition of significant federal and state excisetaxes on cigarette sales has also played a critical role in lowering tobacco use. Id.3. NAT'L CANCER INST., U.S. DEPT. OF HEALTH & HUMAN SERVS. STRATEGIES TO CONTROLTOBACCO USE IN THE UNITED STATES: A BLUEPRINT FOR PUBLIC HEALTH ACTION IN THE 1990's, at20-21 (1991). ETS accounts for approximately 50,000 nonsmoking adult deaths annually, 3,400 fromlung cancer and 46,000 from heart disease. Am. Lung Ass'n, Secondhand Smoke Fact Sheet,http://www.lungusa.org/site/pp.asp?c=dvLUK900E&b--35422 (last visited Jan. 29, 2008); accord Ctrs.for Disease Control & Prevention, Fact Sheet: Secondhand Smoke (2006),JOURNAL OF HEALTH CARE LAW & POLICYdesigned to protect nonsmoking bystanders from ETS has burgeoned from indoorsmoking bans in workplaces and schools to comprehensive bans on smoking-andsometimes total tobacco use-in all public places, including bars and restaurants, toplaces previously considered untouchable by such bans, including outdoor areas,foster homes, and cars carrying children.4 Such bans not only protect public healthby reducing exposure to toxins contained in ETS, they also help reduce tobaccoconsumption because people who are prevented from smoking at work and inpublic places are more likely to smoke fewer cigarettes or to quit smokingaltogether.5While the decline in smoking prevalence and reduced exposure to ETS arecertainly victories that have saved lives and enhanced public health, the currentadult smoking prevalence rate, which is nearly 21%,6 has barely changed since2004.7 This begs the question why? Could it be that public education on thevagaries of tobacco use has reached its zenith and is no longer capable ofeffectuating the change in smoking habits necessary to prevent youth initiation andreduce adult smoking prevalence even further? Will NRT and other cessationmethods to help smokers quit, which are beneficial to some, remain too costly orineffectual for others?http://www.cdc.gov/tobacco/data-statistics/Factsheets/SecondhandSmoke.htm (last visited Jan. 29,2008).4. E.g., ARK. CODE ANN. § 20-27-1903 (Supp. 2007) (prohibiting smoking in automobilescarrying children under six years of age who are restrained in car seats); ARK. CODE ANN. § 9-28-413(Supp. 2007) (prohibiting the Department of Human Services from placing or permitting a child toremain in a foster home where a foster parent smokes unless it is in the child's best interests to be placedin or to remain in the foster home); MD. CODE ANN., HEALTH-GEN. § 24-504 (West Supp. 2007)(prohibiting smoking in indoor areas open to the public, a government-owned or government-operatedmeans of transportation, and indoor places of employment); CALABASAS, CAL., ORDINANCE ch.8.12.040(B)(4) (2006) (prohibiting smoking in virtually any public area in Calabasas, California,including outdoor areas where nonsmokers are present), available athttp://www.bpcnet.com/codes/calabasas.5. Sherry Emery et al., Characterizing and Identifying "Hard-Core " Smokers: Implications forFurther Reducing Smoking Prevalence, 90 AM. J. PUB. HEALTH 387, 393 (2000) ("[B]oth workplaceand home smoking bans have been shown to be associated with quitting behavior [among smokers].").6. In 2006, the adult rate of smoking was 20.8%, which amounts to approximately 45.3 millionadults. Ctrs. for Disease Control & Prevention, Cigarette Smoking Among Adults-United States, 2006,56 MORBIDITY & MORTALITY WKLY. REP. 1157, 1157 (2007) [hereinafter Cigarette Smoking AmongAdults 2006], available at http://www.cdc.gov/mmwr/PDF/wk/mm5644.pdf; Ctrs. for Disease Control& Prevention, Great American Smokeout - November 15, 2007, 56 MORBIDITY & MORTALITY WKLY.REP. 1157, 1157. (2007) [hereinafter Great American Smokeout], available athttp://www.cdc.gov/mmwr/PDF/wk/mm5644.pdf. Youth smoking rates in 2004 were around 22.3% forhigh schoolers and 8.1% for middle schoolers. Am. Cancer Soc'y, supra note 1. For more statistics onsmoking, see Am. Lung Ass'n, Smoking 101 Fact Sheet,http://www.lungusa.org/site/pp.asp?c=dvLUK900E&b=39853 (last visited Jan. 29, 2008).7. Compare Ctrs. for Disease Control & Prevention, Cigarette Smoking Among Adults-UnitedStates, 2004, 54 MORBIDITY & MORTALITY WKLY REP. 1121, 1121 (2005), available athttp://www.cdc.gov/mmwr/PDF/wk/mm5444.pdf (20.9% adult smokers in 2004), with CigaretteSmoking Among Adults 2006, supra note 6 (20.8% adult smokers in 2006).[VOL. H1: IINTRODUCTIONThe inescapable fact is that some people are simply unable or unwilling tostop smoking, no matter what.8 Though laudable, the national health objective ofattaining a 12% adult smoking rate by the year 2010 is frankly unreachable evenyears from then. 9 And even if we were to achieve that goal at some time, 12% ofthe U.S. population still represents a significant number of people suffering a greatdeal of harm from smoking. Overcoming these obstacles will be a major challengefor public health officials, tobacco control advocates, and lawmakers in the 21stcentury.As a public health movement, tobacco control's ultimate goal is finding waysto reduce the harm caused by tobacco use-harm to the individual smoker, thesmoking population, and the nonsmoking population. Since the negative healtheffects of cigarettes were first broadly exposed as early as the 1950s, the responseof tobacco companies has been to come up with some technological innovationostensibly designed to reduce smokers' risks of exposure to the harmful chemicalsin tobacco smoke.10 From filtered cigarettes to so-called light and lower-tarcigarettes, smokers have been fooled into switching to allegedly safer cigarettes."'New additions to this false marketing include nicotine-free products such asVector's Quest cigarette12 and "lower risk" cigarettes such as R.J. Reynolds'Eclipse® product.' 3 Time and again, cigarette manufacturers have marketedproducts with subtle or blatant reduced harm messages while the smokingpopulation has experienced no real reduction in harm from using these supposedly"safer" products. 148. Emery et al., supra note 5, at 387-88, 393.9. 2 U.S. DEP'T OF HEALTH & HUMAN SERVS., HEALTHY PEOPLE 2010, at 27-10 (2d ed. 2000),available at http://www.healthypeople.gov/Document/pdf/Volume2/27Tobacco.pdf, Asaf Bitton et al.,Reducing Smoking Prevalence to 10% in Five Years, 286 JAMA 2733, 2733 (2001); David Mendez &Kenneth E. Warner, Adult Cigarette Smoking Prevalence: Declining as Expected (Not as Desired), 94AM. J. PUB. HEALTH 251, 252 (2004); David Mendez & Kenneth E. Warner, Smoking Prevalence in2010: Why the Healthy People Goal Is Unattainable, 90 AM. J. PUB. HEALTH 401,403 (2000).10. Mitch Zeller, Remarks at the University of Maryland School of Law Symposium: SaferTobacco Products: Reducing Harm or Giving False Hope? (Apr. 20, 2007) (transcript available in theLegal Resource Center for Tobacco Regulation, Litigation and Advocacy at the University of MarylandSchool of Law).11. See United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 912-13 (D.D.C. 2006)(establishing that cigarette companies knowingly deceived consumers into believing that low-tarcigarettes were less hazardous than full-flavor cigarettes).12. Press Release, Matthew L. Myers, President, Campaign for Tobacco-Free Kids, Vector'sClaims About "Nicotine-Free Cigarettes" Underscores Need for Congress to Grant FDA Authority overAll Tobacco Products (Jan. 30, 2003), available athttp://www.tobaccofreekids.org/Script/DisplayPressRelease.php3?Display=593&zoom-highlight-vectr.13. Press Release, Campaign for Tobacco-Free Kids, New Scientific Study Contradicts R.J.Reynolds' Claims that Eclipse is a "Reduced-Risk" Cigarette (Oct. 4, 2000),http://www.tobaccofreekids.org/Script/DisplayPressRelease.php3?Dispay=305.14. See DOROTHY HATSUKAMI & STEPHEN HECT, UNIV. OF MINN. TRANSDICIPLINARY TOBACCOUSE RESEARCH CTR., HOPE OR HAzARD? WHAT RESEARCH TELLS US ABOUT "POTENTIALLY REDUCED-ExPoSURE" TOBACCO PRODUCTS 4-5 (2005), avalaible at2008]JOURNAL OF HEALTH CARE LAW & POLICYGiven the lack of success in obliterating tobacco use, proponents of truereduced harm products have begun to tout smokeless tobacco products as asuitable, "healthier" alternative to the combustible cigarette. 15 Focused on "snus," asmokeless product popular in Sweden and now being test marketed in the U.S., thedebate about the health properties of smokeless tobacco vis-A-vis cigarettes is arancorous one, and puts public health and tobacco control advocates in an awkwardposition. How can one promote use of a product, albeit one less dangerous thancigarettes, that nevertheless may cause cancer and kill people who use it?' 6 Thedynamics of this debate reach a zenith when the possibility of potentially reducedharm combustible tobacco products enters the fray. To promote the use of acigarette of any kind simply seems beyond the role of public health and tobaccocontrol advocates.This leaves public health professionals and those in the tobacco controlmovement with critical questions in terms of goals and policies: Do we as acommunity persist with the abstinence-only approach despite knowing that we maynot move much lower than a 20%-one in five adults-smoking prevalence? Dowe wave the white flag and simply accept the excessive toll of serious disease anddeath that will continue to befall the hard-core smoking population in generationsto come? Or do we seek to somehow ameliorate the harm to this population byfostering the manufacture of safer, consumer-acceptable products to those forwhom quitting is not an option? If we choose the latter, how do we ensure that thetobacco industry, which has traditionally deceived the public about the dangers ofits products, acts with integrity in developing and marketing safer products? Howshould the federal and state governments act to protect consumers againstconfusing, misleading, or blatantly false claims? What is the role of litigation in thereduced harm arena?On April 20, 2007, the University of Maryland School of Law hosted a first-of-its-kind symposium on the issue of reduced harm tobacco products, an event inwhich all perspectives were welcomed and debated respectfully. More thanhttp://www.tturc.umn.edu/documents/hopeor-hazard-3.pdf (explaining that there is no convincingevidence to support the claims that some tobacco products result in reduced harm exposure to toxins orreduced risk of tobacco-related disease).15. INST. OF MED., CLEARING THE SMOKE 82, 92-93 (Kathleen Stratton et al. eds., 2001).16. E.g., Neil A. Accortt et al., Chronic Disease Mortality in a Cohort of Smokeless Tobacco Users,156 AM. J. EPIDEMIOLOGY 730, 736 (2002) (concluding "that smokeless tobacco use is a saferalternative than continued cigarette smoking" based on evidence from a study of smokeless tobaccousers); Juhua Luo et al., Oral Use of Swedish Moist Snuff (Snus) and Risk for Cancer of the Mouth,Lung, and Pancreas in Male Construction Workers: A Retrospective Cohort Study, 369 LANCET 2015,2019 (2007) (finding that oral use of snus may be associated with an increased risk of pancreatic cancer);Am. Cancer Soc'y, Smokeless Tobacco and How to Quit,http://www.cancer.org/docroot/PED/content/PED 10 13XQuittingSmokelessTobacco.asp (lastvisited Feb. 27, 2008) (explaining that the use of smokeless tobacco, including snus, "can cause cancerof the mouth and pancreas and many other health problems .... ").[VOL. 11: 1INTRODUCTIONseventy-five members of the tobacco control community throughout the U.S.gathered to hear prominent experts and advocates from the fields of public health,science, communications, and law discuss varying perspectives on the issue of"Safer" Tobacco Products: Reducing Harm or Giving False Hope? The over-arching issue addressed was the possibility and desirability of allowingmanufacturers of so-called potentially reduced harm tobacco products to marketand sell these products as genuine alternatives to cigarettes so as to minimize thenegative health consequences to inveterate smokers, rather than as alternativetobacco products actually designed to secure large profit margins for Big Tobacco.The articles from the symposium published in this issue of the Journal ofHealth Care Law & Policy tackle the issues raised above. Micah Berman writesabout current and potential legal challenges to reduced harm claims, specificallyaddressing the marketing of smokeless tobacco. Mr. Berman concludes that thecigarette companies' entrance into the smokeless tobacco market is a majordevelopment with potential negative public health repercussions. He thereforeurges public health advocates to work together to respond appropriately to thisdevelopment. Christopher Banthin and Richard Daynard delve deeper into the legalarena, explaining the role of litigation in preventing false reduced-harm claims andusing the ongoing litigation over the marketing of light and lower-tar cigarettes as acase study. Mr. Banthin and Dr. Daynard discuss how federal preemption of statelaw claims would be impacted by the passage of legislation pending in Congressthat would finally give the Food and Drug Administration authority to regulatetobacco products. David Sweanor and Rachel Grunberger provide a uniqueperspective, perhaps born of Mr. Sweanor's work in progressive Canada, in arguingthat the abstinence-only approach must yield to the more rational reduced-harmapproach. Mr. Sweanor and Ms. Grunberger implore the public health communityto acknowledge that part of the population will always use tobacco, yet caution thatadequate regulation is vital to ensure the best result. Finally, in a piece based on herkeynote speech at the symposium, Dr. Cheryl Healton powerfully reminds us of thedisastrous consequences of an abstinence-only approach in the context ofHIV/AIDS prevention, warning advocates not to repeat that failed public healthstrategy in the tobacco control realm.20081

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