Regulatory approaches to ending cigarette-caused death and disease in the United States.

I. INTRODUCTIONCigarettes result in over 400,000 preventable American deaths each year.1 In 2011, fewer than twenty percent of adults smoked.2 Since the publication of the first U.S. Surgeon General's Report on Smoking and Health nearly fifty years ago, when smoking prevalence was around forty percent,3 policies such as smoke-free laws, large tax increases, and litigation have collectively contributed to cut smoking prevalence in half.4 Unfortunately, no one expects the mix of policies currently proposed, which includes further tax increases, spatial smoking restrictions, somewhat higher minimum age restrictions, adverse publicity, and quitting assistance, to reduce U.S. smoking prevalence below fifteen percent in the foreseeable future.The rule adopted by the U.S. Food and Drug Administration (FDA) to require hard-hitting graphic warnings on cigarette packages,5 as is currently done in dozens of other countries, has thus far been rejected by federal judges who have found that warnings designed to arouse negative emotions violate cigarette manufacturers' First Amendment rights.6 Even if these warnings are eventually implemented, although they may encourage smoking cessation and deter initiation, there is no evidence that they can produce a dramatic drop in smoking rates. Similarly, while the FDA is moving painfully slowly to address the Congressionally-mandated question 7 regarding whether menthol as a characterizing cigarette ingredient encourages uptake or discourages quitting, banning menthol is also unlikely to be a game-changer.8If these strategies were all we had, we might have to accept that cigarette smoking would be entrenched in American society for the long haul and would continue to exact a heavy toll. Yet surprisingly, over forty percent of survey respondents when asked about banning cigarettes consistently supported that policy, despite a complete absence of public advocacy for it.9 Over seventy percent would support eliminating the addictive components of cigarettes, including a majority of smokers.10 While public health advocates need to continue to press forward with existing policies-if for no other reason, to prevent the tobacco industry from finding ways reverse the public health progress made to date-polling data suggest that policymakers and public health leaders can and should-explore "endgame" strategies that would reduce smoking rates to well below ten percent. Several tobacco control advocates have begun discussing such strategies, but while articles have appeared in specialty journals11 and sessions have been held at the World and National Conferences on Tobacco or Health,12 there has been little or nothing mentioned about such ideas in the general public health literature, much less implemented in the "real world."13One fear that may be inhibiting a more thorough exploration of endgame scenarios for cigarettes is that by taking what may be perceived as an "extreme" position, advocates may lose their credibility in pushing mainstream-though still contested-remedies. There appears, however, to be no historical support for this, at least in tobacco control. Smoking bans in restaurants, workplaces, and bars were seen in their time as "crazy" proposals, as were lawsuits against tobacco companies and efforts to raise cigarette taxes in an anti-tax environment.14 But even skeptical citizens and legislators likely viewed the public health proponents as just doing their job, since the science underlying the health concerns was generally not doubted. Indeed, the publicity surrounding each of these efforts-whether or not it was successful in any particular instance-reinforced the public's awareness of the dangers of smoking and secondhand smoke.15So is there a legally viable endgame strategy that could work in the United States? There are several endgame strategies that will be discussed and two that appear to have particular promise in the United States.II. SHRINKING CAP-AND-TRADEOne strategy is to carefully control and reduce the supply of cigarettes in the market such that, over time, the reduced supply of the product will compel a reduction in consumption and smoking prevalence. …