- Tobacco use is the leading preventable cause of death in the United States and is responsible for an estimated $170 billion in health care costs.
- Beginning in the 1970s, recognition of the adverse health effects of tobacco use and second-hand smoke has led to tobacco-control efforts, including increased taxation, raising the legal age to purchase, health warning and images, and more recently, the use of plain packaging.
- The Framework Convention on Tobacco Control, developed by the World Health Organization, is an international treaty designed to reduce tobacco use.
- Electronic nicotine delivery systems, commonly known as e-cigarettes, are increasing in availability. Not enough is known about e-cigarettes to make evidence-based recommendations on their use in smoking cessation.
The struggle to control tobacco and its myriad ill effects has spanned almost 70 years. It is a story of great profits taken at the cost of 100 million lives during the 20th century.1,2 It is the tale of an unethical industry permitted to exist within a legal framework in a free society. In the end, we find a malign catalog of technical know-how, misinformation, legislative pressure, and outright illegal activity. And now, that story enters a new chapter.
Even as Sir William Richard Doll’s seminal 1950 paper associated smoking and lung cancer,3 private research conducted by the tobacco industry was showing the same link.2 However, public denials were immediate and sustained, and the tobacco industry demanded further research to help solve the “controversy.”4 The first Surgeon General’s Report on tobacco in 1964 showing the causal nature of tobacco on cancer was written, in part, in answer to this debate,5 although the tobacco industry continued to refute the data.6
Currently, there is no question that tobacco is deadly.2,7 Recent updates confirm that product modifications over the past several decades have resulted in increased addiction and consequent increased health risks.8 With regard to cancer, smoking not only causes many forms of cancer, but continued smoking by people with cancer and cancer survivors causes adverse health outcomes, including increased overall mortality, cancer-specific mortality, and risk for second primary cancer and is associated with increased cancer-treatment toxicity.2,7 Consequently, addressing tobacco use is important both prior to and after a cancer diagnosis.
Changes in marketing in the United States beginning in the 1970s led to significant alterations and reductions in tobacco-use patterns. Recognition of the adverse health effects caused by second-hand smoke, as well as clear evidence of chronic tobacco-use habits caused by marketing to children resulted in restrictive legislative efforts on both fronts. In its own version of harm reduction, the tobacco industry spent vast sums and lobbied for pre-emptive state legislation. Although counterintuitive, this provided comparatively dilute legislation, which would minimize harm to cigarette sales and disallow or effectively repeal the typically more restrictive regulations being introduced by communities.9
Substantial opposition has occurred to the financial regulation of tobacco sales, with tobacco taxation and price increases representing the primary mechanism to control tobacco use. In the early 20th century, provision of free cigarettes to military personnel led to substantial increases in tobacco use.10 Increased tobacco taxation is proven to reduce smoking intensity, improve cessation rates, and act as a disincentive to youth smoking.11 Even as tobacco companies use the cover of higher taxes to increase the prices of their products and offer nonpremium brands as a cheaper alternative, taxes remain effective in harm reduction.12,13 In a creative take on tax avoidance, Canadian tobacco companies spent several years smuggling cigarettes made for export back into Canada. Faced with this and other contraband, Canadian governments actually decreased levies on tobacco, to the dismay of health advocates. Only when the industry smuggling operation came to light in 1999 were taxes again raised, and the tobacco industry ultimately paid 550 million Canadian dollars in compensation.14
In the United States, nearly all states and the District of Columbia have voted to increase cigarette taxes over 120 times since 2002, although not always without substantial opposition from the tobacco industry.15,16 The proven effects of more aggressive taxation have been evaluated in multiple studies, with estimates of an 8% reduction in mortality with every $1 increase in tobacco taxes.17
Health warnings and images on cigarette packages have also been shown to be an effective and credible source of health information for smokers and nonsmokers.18 The tobacco industry had warned that this would cause unnecessary emotional distress, undermine the credibility of the text, and even induce a reactive increase in smoking, but this has not been borne out.19 In surveys, youth agreed that picture warnings made smoking less attractive, smokers reported increased motivation to quit, and reported Quitline use increased.18
Conversely, the use of plain packaging is in its infancy. Plain packaging renders health warnings more obvious18 and subjectively creates an unpalatable product. Australia led this effort by enforcing plain packaging from 2012, successfully fending off a court challenge by British American Tobacco in the process.13 An independent analysis of the effects of plain packaging in Australia suggested a 0.55% decline in the prevalence of smoking attributable to plain packing, resulting in 108,000 fewer smokers.20,21
The vast majority of people who develop a tobacco addiction begin smoking prior to age 18.2 Raising the legal age of purchase to age 21 has emerged as a new strategy to reduce tobacco use. Although the U.S. Food and Drug Administration (FDA) sets the national minimum tobacco sales age at 18 years, states and localities are allowed to set a higher minimum. In 2013, seven towns in Massachusetts, one county in Hawaii, and New York City adopted “Tobacco 21” laws.22 Since this time, evidence has accumulated to demonstrate that raising the legal age of purchase to 21 results in a significant decline in smoking prevalence.23,24 Supported by this new evidence, many jurisdictions are following suit,25,26 and ASCO has explicitly supported the higher minimum.27
The Framework Convention on Tobacco Control
In acknowledgement of the tobacco epidemic and the utility of anti-smoking initiatives, the World Health Organization (WHO) developed the Framework Convention on Tobacco Control (FCTC) as an international treaty designed to reduce tobacco use.
The FCTC provides comprehensive guidance to tackle the tobacco problem and explicitly excludes any participation by industry in policy development. The FCTC promotes tobacco taxes, prohibits sale to minors, and supports smoke-free and tobacco advertising–free environments. It seeks to prohibit misleading tobacco packaging and enforce effective health warnings and plain packaging. Of note, it explicitly requires parties to promote tobacco cessation and ensure that cessation tools are both affordable and free from industry interests, a clause directly relevant to the challenge of electronic nicotine delivery systems (ENDS).28,29
Entering into force in 2005, the treaty has been ratified by 168 countries, including the entirety of the European Union, as well as China and Japan. Others have signed but not yet ratified the treaty, including Cuba, the United States, Argentina, and Switzerland.30
WHO has provided MPOWER guidelines to assist in implementing tobacco-control initiatives in support of the FCTC.31 The guidelines consist of six components to monitor tobacco use, protect people from tobacco use, offer assistance to help people quit tobacco use, warn about the harms of tobacco, enforce tobacco bans, and raise taxes. A recent analysis of MPOWER initiatives demonstrated significant reductions in smoking-attributable deaths, with increasing cigarette taxes having the largest impact.32 Unifying efforts across countries can produce meaningful changes related to consistent implementation of tobacco-control efforts, while limiting the ability of the tobacco industry to have significant influence by singling out tobacco-promoting activities in individual countries.
ENDS: A New Front
ENDS, commonly known as e-cigarettes, have been available for more than a decade but are growing in availability and technologic and marketing sophistication. Although they vary in format, these devices share the commonality of a heated coil vaporizing a liquid drug for inhalation. Most, but not all, such devices contain nicotine.
Although ENDS represented a comparatively small U.S. market of $3.7 billion as of 2015, the traditional tobacco industry has joined the sales effort. Taking advantage of the obvious product synergies, Big Tobacco reportedly now owns the top four U.S. brands.33 In fact, British American Tobacco, R.J. Reynolds Tobacco Company, Imperial Tobacco, Japan Tobacco International, and Philip Morris/Altria all purvey electronic delivery systems.34
Present knowledge about ENDS is insufficient for making evidence-based recommendations on their use in smoking cessation. Some data indicate that ENDS may decrease the short-term sense of craving, but none as of yet demonstrate improved quit rates.35 A large trial from New Zealand failed to achieve the superiority endpoint of e-cigarettes to either nicotine patches or non-nicotine e-cigarettes, although quit rates in all groups were low.36 In addition, continued use of the e-cigarette product at 6 months was higher in the e-cigarette group than the patch group, at 29% versus 7%.
Although the long-term use of nicotine alone has not been studied and it is not clear if nicotine alone functions as a complete carcinogen, available data do not encourage complacency.37 It is known that volatile organic compounds, such as carbonyls, formaldehyde, nitrosamines, and metal, may all be present in ENDS vapor, and urinary excretion of various compounds is accordingly observed, if at lower levels than seen with cigarettes.38,39
In 2016, the Royal College of Physicians of the United Kingdom came out in favor of ENDS as a smoking-cessation device.38 Their principal argument was that ENDS are likely less toxic than combustible tobacco and are, thus, to be preferred. They are not dissuaded by the lack of randomized data to support ENDS as a smoking-cessation aid, and they arguably underplay the risk of long-term use of ENDS by both prior smokers and never smokers. As pertaining to patients diagnosed with cancer, ASCO and the American Association for Cancer Research recommend cautious regulation and further research on the role of ENDS prior to adoption as a cessation tool,39 a view shared by the International Association for the Study of Lung Cancer.40 The FDA has not approved ENDS as a smoking-cessation device or method.
Recent U.S. Tobacco-Control Legislation and Regulation
Although the FDA was first given regulatory authority over food, drugs, and cosmetics under the Federal Food and Drugs Act of 1906,41 it wasn’t until the release of the first Surgeon General’s Report on Smoking and Health in 1964 that legislation specifically targeting tobacco products began to be passed.42 However, it was with the signing of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) on June 22, 2009, by former President Barack Obama, that the FDA was finally given comprehensive authority to regulate the manufacturing, marketing, and sale of tobacco products.43 Although the law prohibits the FDA from banning conventional tobacco products, it does the following:
- Establishes the Center for Tobacco Products within the FDA to carry out the Tobacco Control Act.
- Tasks the FDA with restricting youth access to cigarettes, cigarette tobacco, and smokeless tobacco by constraining advertising and promotion, stopping illegal sales to minors, and banning all characterizing flavors such as fruit and candy, but not menthol, from the markets.
- Requires the FDA to assess the tobacco industry’s research on the health and addictiveness claims of their products and prohibits tobacco companies from making reduced-harm claims, such as “light” or “low,” without obtaining an order to market as such.
- Includes new requirements for cigarette and smokeless tobacco products to have larger and more visible warning labels on their packaging and advertisements.
- Requires tobacco companies to disclose all of the ingredients in their products.
- Allows the FDA to establish product safety standards, such as limiting nicotine and other ingredient levels.
In response to the clear increase in the prevalence and use of nontraditional tobacco and nicotine delivery products,44,45 especially among youth,46,47 the FDA issued a final rule on May 5, 2016, to extend the agency’s regulatory authority over all tobacco products, including ENDS, all cigars, hookah tobacco, pipe tobacco, nicotine gels, and dissolvable nicotine products.48 The rule, which went into effect on August 8, 2016, subjects all manufacturers, retailers, and importers of these products to all applicable provisions included in the Tobacco Control Act and grants the FDA the authority to regulate their manufacture, marketing, and sale. In the context of chronic cigarette smoking, common sense would suggest that ENDS would be safer than smoking. However, in very plain terms, the true long-term health effects of ENDS will take years and perhaps decades to fully understand, particularly as related to the intensity and duration of use, as well as related to changes in product design and constituents.
The Future of Tobacco Control
Tobacco use remains the leading preventable cause of death in the United States. Every year, it kills more than 480,000 Americans and is responsible for an estimated $170 billion in health care costs.49 If current trends continue, tobacco will cause up to 1 billion deaths globally in the 21st century.50 Implementing effective evidence-based control strategies is essential for reducing the health risks and costs of tobacco. This is particularly important for stemming the tide of youth addiction to all forms of tobacco and ENDS.
To many, there is an endgame to tobacco use, generally described as a tobacco-free society devoid of the adverse health effects caused by tobacco.51 However, tobacco permeates virtually all aspects of society and is especially linked to low-income countries.1,2 Tobacco use is likely to persist and to continue to cause adverse health effects.
Modern trends in tobacco use are now being manifested through the ENDS market. Marketing for ENDS with stimulating visual packaging recycles notions of sophistication, and YouTube videos promote vaping “Olympics” or cloud-making competitions.52,53 ENDS are available in a variety of flavors, which are known to attract youth,48 and newer generations of ENDS deliver higher doses of nicotine in greater vapor clouds.39,54 As with tobacco use in youth, survey data suggest that youth find ENDS to be attractive, with more than 3 million American middle and high school students currently using ENDS.48
The elimination of tobacco is the obvious best choice to prevent the burdensome and expensive adverse health conditions caused by tobacco. The MPOWER initiatives by WHO provide an excellent framework to exert substantive differences in tobacco control. Preventing tobacco use, particularly in youth, is the ideal solution, but evidence-based tobacco cessation methods should be used to assist all patients who use tobacco. It is critical to understand that the adverse health effects of tobacco continue after a chronic disease diagnosis, such as cancer. In considering cessation, we must remember that the long-term health effects of new and alternative tobacco products may take years to understand. Most importantly, it is absolutely necessary to realize that the war against tobacco is not over. Continued efforts are needed to fully understand and prevent the health effects of tobacco and tobacco-related products.
About the Authors: Dr. Goffin is an associate professor in the Department of Oncology at Juravinski Cancer Centre. Ms. Merrill is an associate director of health policy at ASCO. Dr. Warren is an associate professor and vice chairman for research in radiation oncology at the Medical University of South Carolina.