In a courageous decision that could save millions of lives, the Food & Drug Administration (FDA) authorized the marketing of an R.J. Reynolds vaping device called Vuse. Mitch Zeller, the FDA’s director of tobacco regulation, said that the device “could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals.”
The FDA’s dramatic action recognizes one way — probably the best way — to get smokers to stop sickening and killing themselves at twice the COVID-19 mortality rate. It is to let them choose an alternative that delivers nicotine, taste and the tactile pleasure of holding something akin to a cigarette in devices whose health risks are “ unlikely to exceed 5% of those associated with smoked tobacco products,” according to a report by the U.K.’s Royal College of Physicians.
The FDA decision tracks the conclusions of a report released last month by the International Commission to Re-Ignite the Fight Against Smoking, which I chair. We too advocated a harm-reduction approach, supported by intense research, by campaigns to dispel misinformation about the relative dangers of vaping and smoking, and by such policies as taxing e-cigarettes at a lower rate than conventional cigarettes – or not at all.
More people around the world smoke than 30 years ago, and the cessation movement that began in the early 1960s has ossified and stalled. Shaming, ad bans, patches and gum have all had an effect, but more than a billion people around the world still burn tobacco and inhale the carcinogens that combustion releases. Eight million die annually from smoking-related causes.
In the past few years, however, disruptive technologies have moved tens of millions of persistent adult smokers to products which, in the FDA’s words, “are significantly less toxic than combusted cigarettes.”
Unfortunately, many governments have erected obstacles to these tobacco alternatives. India, and Australia, for example, have effectively banned reduced-harm tobacco products while still allowing the sale of combustibles.
The World Health Organization (WHO), whose dicta influence low-to-middle-income countries, remains stuck in an outdated paradigm, rejecting a reduced-harm approach for tobacco while supporting it through programs like needle exchanges to mitigate deaths from heroin overdoses and HIV/AIDS. The WHO hasn’t even put harm reduction on the agenda at its biannual meeting on tobacco cessation in November.
The FDA has a different view. In 2017, Zeller and then-Commissioner Scott Gottlieb wrote in the New England Journal of Medicine, “ The regulatory framework for reducing harm from tobacco must include nicotine — the chemical responsible for addiction to tobacco products — as a centerpiece. Nicotine, though not benign, is not directly responsible for the tobacco-caused cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.” They called e-cigarettes “a promising foundation for a comprehensive approach to tobacco harm reduction.”
Accordingly, in 2019, the FDA authorized the marketing of eight different kinds of Swedish Match’s snus as “modified-risk tobacco products.” Snus, a variant of dried snuff that you place behind the upper lip, has become widely popular in Sweden, where smoking prevalence has dropped to about half the level of other European countries and lung cancer rates for men are the lowest on the continent.
In 2020, the FDA authorized IQOS (the acronym stands for “I quit ordinary smoking”), which generates an aerosol by heating, but not burning, tobacco-filled sticks of paper. “This significantly reduces the production of harmful and potentially harmful chemicals,” said the FDA. In Japan, after the introduction of heat-not-burn products, cigarette sales fell 27% in two years.
Much of the organized opposition to reduced-risk alternatives in the U.S. centers on young people. Certainly, minors must not smoke or vape, but an obsessive focus on youth can obscure the more clear and present danger, which is the imminent disease and mortality faced within the next 20 years by current cigarette smokers in their 30s, 40s and 50s. The spillover effects of trying to frighten minors away from vaping by conflating the dangers of tobacco and alternatives could lead to millions of needless deaths.
In perhaps the most remarkable portion of its decision last week, the FDA appropriately stated that it had “determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.”
Let’s hope Vuse will be the first of many vaping products the FDA authorizes as the U.S. moves its tobacco strategy closer to that of the U.K., whose health authorities actively encourage persistent adult smokers to switch to e-cigarettes – with powerful results. Even if the WHO refuses to change its stance, other nations – especially the low-to-middle-income countries where most smokers live – will see how tobacco harm reduction policy saves lives.
James K. Glassman, former Under Secretary of State for Public Diplomacy and Public Affairs, is chairman of the International Commission to Re-Ignite the Fight Against Smoking.