On July 28, 2017, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced a comprehensive regulatory plan to expedite reducing the toll of more than 480 000 annual tobacco-related deaths in the United States.1 The plan is predicated on recognition that “nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”1
Although little appreciated by the public, many of whom erroneously believe that nicotine causes tobacco-related cancer, nicotine per se is not especially toxic at the doses at which people self-administer it. The real danger comes through the effects of nicotine in causing addiction to smoking, which disperses more than 7000 chemicals through the lungs into the bloodstream and then to every body organ. Seventy of those chemicals are known human carcinogens; others cause cardiovascular and pulmonary diseases, and numerous other disorders, that affect large proportions of long-term smokers. FDA’s emphasis on the centrality of smoking in tobacco-produced disease echoes the 2014 surgeon general’s report: “The burden of death and disease from tobacco use…is overwhelmingly caused by cigarettes and other combusted tobacco products; rapid elimination of their use will dramatically reduce this burden.”2
How can a powerfully addictive behavior engaged in by nearly 40 million individuals in the United States be eliminated? Aggressive implementation of the evidence-based interventions that have brought so much progress needs to be continued, including taxation, smoke-free workplace laws, media campaigns, advertising and promotion restrictions, and support of FDA-approved smoking cessation medications and cessation counseling.
The new FDA plan complements these measures, charting a novel and creative course. It includes several components, the most unconventional of which may depend on what might be considered the second most unconventional. The surprising proposal is to examine the potential benefits and adverse consequences of mandating reduction in cigarette nicotine yields to levels incapable of sustaining addiction. FDA has the legal authority to mandate a reduction. Making cigarettes and all combustible tobacco products nonaddictive would markedly reduce the number of smokers in future generations and would assist current smokers in quitting. In surveys, substantial proportions of smokers support such a policy. Still, nicotine reduction could have serious unintended consequences, including an illegal market of nicotine-containing cigarettes.
To minimize that risk, and more generally to address the nicotine needs of smokers, FDA is committed to encouraging product innovations that offer smokers alternatives to cigarettes, consisting of consumer-acceptable nicotine-delivery products that present far less health risks than smoking. From a pragmatic perspective, and a moral one, FDA recognizes that its most radical concept of reducing nicotine in combustible tobacco products to nonaddicting levels will necessitate the availability of such alternative products. Toward this end, the agency is extending a near-term deadline for the submission of tobacco product review applications for novel products, including electronic or e-cigarettes. The high cost of preparing such applications might make them prohibitively expensive for all but the major tobacco companies, thereby reducing the potential for product creation from smaller, more innovative companies. With this in mind, FDA will review the applications’ requirements.
Reduced-risk products are available today, albeit with little regulation thus far, except in the case of FDA-approved nicotine replacement products. The content and marketing of some of these products, and even their availability, are controversial. The e-cigarette is the controversy’s poster child, with a wide range of issues debated, including whether flavor additives, which may attract children, should be banned or limited. While experts agree that e-cigarette use is less hazardous than smoking, estimates range from an overall health risk of 5% (or less)3 to a third (or more) that of smoking.4 Opponents are concerned that e-cigarettes cause never-smoking young people who use them to try smoking. Several prospective studies support this conclusion,5although the studies have limitations.6
Yet cigarette smoking by students has declined at an unprecedented rate during the brief period of widespread use of e-cigarettes by adolescents. Based on a survey of more than 80 000 individuals from 2012 through 2015, the 30-day prevalence of e-cigarette use among high school students increased rapidly from 2.8% in 2012 to 16% in 2015.7 During the same years, their 30-day prevalence of cigarette smoking declined from 14% to 9.3%, representing the largest percentage decrease in student smoking in history. In 2016, e-cigarette use declined by nearly 30%, to 11.3%, whereas smoking continued its rapid decline, to 8%.7 Supporters of e-cigarettes consider these products to be the harbinger of an era of “disruption” of the cigarette market. They view novel products as providing smokers with attractive alternatives to existing pharmaceutical cessation aides. Recent studies credit e-cigarettes with increasing smoking cessation in the United States and England.8
To date, tobacco harm reduction—encouraging inveterate smokers to switch to less harmful nicotine-yielding products—has been opposed by many mainstream public health organizations. These include government agencies, such as the US Centers for Disease Control and Prevention and state health departments, and leading nongovernmental organizations. The dominant approach is “just say no” to all tobacco products, reminiscent of the war on drugs. Yet harm reduction has featured prominently in multiple areas of public health, including clean needle distribution to minimize the spread of HIV/AIDS; sex education for adolescents instead of abstinence only to reduce teen pregnancies (now at an all-time low) and sexually transmitted infections; methadone as a heroin substitute; motorcycle helmet laws; and designated driver programs. All of these approaches are or were controversial but have reduced the toll of the problems they address.
The FDA plan accepts a role for harm reduction in tobacco control. Given opposition from much of the public health community, this approach will meet with resistance. It is made even more difficult by widespread public ignorance about the core underlying principle of the plan, the nicotine product continuum of risk. Members of the public likely do not appreciate the health hazard differences of combusted and smokeless tobacco products. Regular smokeless tobacco product use, especially low-nitrosamine products, confers no more (and possibly less) than 10% the mortality risk from cigarette smoking.9 Even the risk of oral cancer, prominently associated with smokeless tobacco in the public’s mind, is substantially higher from smoking than from smokeless tobacco products. Yet in a recent government survey of 3733 adults, two-thirds of the respondents answered No to the question “Do you believe that some smokeless tobacco products…are less harmful than cigarettes?”
While public understanding of the risk of e-cigarettes is better—ie, e-cigarettes are far less dangerous than conventional cigarettes—the level of public understanding has deteriorated over time. In 2012, 11.5% of 2808 respondents to a national survey considered the harm associated with e-cigarettes “about the same” as that of smoking, whereas in 2015, 35.7% of 5389 held that mistaken belief.10 A first order of business for FDA’s continuum-of-risk based plan, as well as for all governmental and nongovernmental health organizations, should be honest public education about the relative risks of different tobacco and nicotine products, along with education about the role of nicotine in tobacco-related disease. The public needs to understand that tobacco smoke—not nicotine—is the cause of smoking-related mortality and morbidity.
Complete FDA plan implementation will take years, should it occur. Still, the fact that such a radical plan has been proposed is remarkable. For decades, the nation’s most lethal products—cigarettes—were one of very few consumer products not subject to federal government safety regulation. A wide range of health and safety laws would appear to apply to tobacco, but those laws specifically excluded tobacco products or were amended to do so after challenges. Prominent examples include the Controlled Substances Act of 1970, the Consumer Product Safety Act of 1972, and the Toxic Substances Control Act of 1976.
This changed with passage of the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA). The act authorized FDA to regulate cigarettes and other tobacco products. The agency’s 2016 “deeming” regulation extended the regulatory authority to conventional tobacco products not previously included and to novel products, including e-cigarettes. FSPTCA has given broad powers to regulate tobacco product manufacturing, distribution, and marketing with the objective of protecting public health.
To date, the agency has done little to achieve this purpose, the result in part of profound bureaucratic, legal, and political obstacles. FDA did issue a regulation requiring new graphic cigarette pack health warnings, but tobacco industry legal action blocked implementation. (Graphic warnings now festoon cigarette packs in more than 100 countries.) The agency’s Tobacco Products Scientific Advisory Committee recommended removal of menthol from cigarettes—menthol being the one characterizing flavor not banned by FSPTCA—and the agency’s own study concluded that menthol likely posed a risk to public health. But FDA has not banned menthol in cigarettes.
The FDA’s inability to have put in place regulations that will substantially reduce the toll of tobacco use should temper optimism about implementation of its ambitious new plan. Furthermore, while all members of the tobacco control community are likely to favor some plan elements, few are likely to support all. Still, the potentially enormous pay-off to full plan implementation warrants its serious consideration. Could a tobacco control community so long divided unite in supporting a comprehensive plan that might one day consign cigarettes, and their horrific toll of disease and death, to the dustbin of history?