The use of tobacco products, which contain the highly addictive substance nicotine, remains a leading preventable cause of death in the United States. While the use of combustible tobacco products such as cigarettes and cigars has decreased in recent decades, the tobacco industry has invented a new, trendy alternative that is just as addictive: e-cigarettes, also known as electronic nicotine delivery systems and vapes. To promote these products to the public, the tobacco industry claims they are smoking cessation aids, although the US Food and Drug Administration (FDA) has not yet approved them for this use.
Despite many clinical trials tending to show a positive relationship between the use of electronic cigarettes and smoking cessation, this evidence has been evaluated as "consistently low." Moreover, these trials are often conducted under optimal treatment conditions, which means their research results are often not applicable to the real-world community environment in which electronic cigarettes are used as consumer products. In contrast, recent evidence from a nationally representative, prospective, real-world (observational) study in the United States did not show electronic cigarettes to be beneficial for smoking cessation attempts or as a substitute for cigarettes. The study was published in the journal Tobacco Control on February 7, 2022.
Electronic cigarettes are battery-powered devices that come in various shapes such as pens or flash drives and contain a liquid consisting primarily of nicotine extracted from tobacco, glycerin, propylene glycol, and flavorings. When used, these devices heat the liquid to produce an aerosol that users inhale into their lungs. The FDA recognizes that electronic cigarettes are not safe tobacco products. These addictive products not only expose users to tobacco-related diseases and death, but are also associated with lung injury, seizures, and other adverse reactions in the nervous system.
The use of electronic cigarettes is becoming increasingly common. As of 2018, there are currently 8 million adult e-cigarette users in the United States, accounting for 3% of the adult population. In addition, 5% and 21% of American middle and high school students are current e-cigarette users, respectively. Former Surgeon General of the United States, VADM Jerome Adams, declared that the use of e-cigarettes by children is an "epidemic". Many e-cigarette products have been legally sold in the United States for over a decade without regulation since October 2021. However, under pressure from the industry, the FDA has authorized their use in adults, claiming that this authorization will "protect public health." According to the FDA, as long as e-cigarette companies follow the agency's requirements for reducing youth access and acquisition of these products after being marketed.
This flawed balancing strategy has essentially thrown young people under the bus. According to the latest results from the National Youth Tobacco Survey, e-cigarettes are the most commonly used tobacco product among middle and high school students in 2021. This is because many teenage e-cigarette users are able to obtain these products through illegal means. On June 23, 2022, the FDA ordered all e-cigarette products produced by major seller JUUL Labs to be removed from the US market because the company did not provide sufficient evidence on the toxicological characteristics of these products, according to the agency. However, on July 5, 2022, the FDA suspended its order after JUUL filed a lawsuit against the agency and the agency determined the need for additional review of the company's application. Importantly, the FDA continues to authorize the use of numerous e-cigarette products manufactured by tobacco industry giants including Philip Morris and RJ Reynolds Vapor.
The study analyzed survey data collected in 2017 and 2019, during a time when electronic cigarette sales were rapidly increasing in the United States. The data was collected as part of the Population Assessment of Tobacco and Health (PATH) study, a longitudinal study of a nationally representative sample of community-dwelling adults in the US. The study has been conducted over several years with funding from the National Institutes of Health and the FDA.
As part of the original research, biological samples were collected from participants to verify their self-reported smoking behavior. Response rates for the 2017 and 2019 surveys were 68% and 88%, respectively. The initial PATH sample included 30,970 adults surveyed in 2017. Within this sample, there were 3,578 smoking participants who attempted to quit smoking in 2016 (most recent quit attempters). Among them, 1,323 respondents had successfully quit smoking by the time of the 2017 survey (most recent former smokers).
Recently, individuals attempting to quit smoking and former smokers were asked about their use of electronic cigarettes, nicotine replacement therapies (such as gum, inhalers, lozenges, nasal sprays, patches, and pills), bupropion (Wellbutrin SR and the recently discontinued Zyban brand), and varenicline (Chantix) during their last quit attempt in 2016. Researchers found that although electronic cigarette sales significantly increased in 2017, only 13% of recent quit attempters reported using electronic cigarettes to help them quit, a decrease from the previous year's 17%.
It is worth noting that as of 2019, only 10% of people who attempted to quit smoking using e-cigarettes were able to quit smoking (but not all tobacco products) for at least 12 months. This percentage is lower than those who attempted to quit smoking using only medication (15%) or without any products (19%). Additionally, as of 2019, only 4% of people who attempted to quit using e-cigarettes were able to quit all tobacco products (including e-cigarettes) for at least 12 months. This percentage is much lower than those who quit using only medication (13%) or without any products (14%).
After adjusting the analysis for potential differences in participant characteristics, researchers estimate that compared to pharmaceutical aids, the use of e-cigarettes reduces the number of successful quitters by 7 out of every 100 trying to quit smoking. This finding contradicts previous clinical trial evidence which estimated that e-cigarettes increased the number of successful quitters by 4 out of every 100 using pharmaceutical aids. Overall, the current PATH analysis suggests that switching to e-cigarettes does not reduce the risk of relapse compared to those who do not switch, as nearly 60% of daily e-cigarette users among former smokers resumed smoking by 2019. It is worth noting that during the study period, sales of high-nicotine e-cigarettes increased significantly, which closely resembled smoking behavior and experience, but only 2% of recent former smokers used these products. Therefore, the researchers conclude that the e-cigarette industry is less effective in encouraging smokers to quit using e-cigarettes compared to encouraging young people to start using these products with nicotine.
The results of a new study, as well as previous analyses of the PATH survey, have raised concerns about the FDA's decision to authorize the use of e-cigarettes as consumer products. The agency could truly protect public health by banning all e-cigarette products and by rejecting the false claims made by the e-cigarette industry about the benefits of their products for the world. In addition to e-cigarettes, the FDA should seek to expand and exercise all of its legal powers over "non-nicotine" products in the US. This undoubtedly includes more actively assisting smokers in quitting and gradually phasing out combustible nicotine products from the US market.
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