Heated Tobacco Products Will Soon Arrive in America (original) (raw)

The first time I saw an IQOS, the innovative tobacco product on which Philip Morris International is betting billions of dollars to replace cigarettes, was at a wedding in 2016. A friend had excitedly pulled me outside to try this new device that had enabled him to finally kick his smoking habit. Not quite a cigarette because it didn't ignite, not quite a vape because it used actual tobacco, supposedly less toxic than conventional cigarettes but satisfying enough to compete with them, it seemed that this heated tobacco might be the future of nicotine.

Neither the device nor the specially treated tobacco was yet available in the U.S., so my friend sourced his supply via discreet shipments from a connection in Europe. Seven years later, despite its availability in more than 60 other countries, the technology is still on hold in the United States. First regulation by the Food and Drug Administration slowed its arrival, then the rollout of IQOS was cut short by a patent dispute with R. J. Reynolds that culminated in a ban on imports.

In the next two years, heated tobacco products will likely finally become more widely available in America. Will they help the nearly 30 million Americans who smoke switch to a safer alternative? Or, as critics allege, will they only perpetuate tobacco use? To answer these questions, it pays to look farther afield to Japan, where heated tobacco is already transforming the market for nicotine.

Japan provides an unlikely model for tobacco policy. The country tends to be more tolerant of smoking than its Western peers; it has high rates of smoking among men, and its government participates directly in the cigarette trade through its partial ownership of Japan Tobacco, the country's largest manufacturer of cigarettes. It therefore comes as a surprise that Japan is experiencing a dramatic and sustained decline in cigarette sales, a trend that experts credit substantially to heated tobacco products.

"Japan has accomplished spectacular things in a very short period of time with regard to cigarette smoking," says David Sweanor, an adjunct professor of law at the University of Ottawa with decades of experience in tobacco regulation. Sweanor co-authored a study published in 2020 that analyzed Japanese tobacco sales data from 2011 to 2019. Japan forbids the sale of e-cigarettes but allows heated tobacco, making it an ideal test case for measuring the impact of products like IQOS and similar competitors including Ploom and Glo. Sweanor's study concluded that Japan's decline in cigarette sales accelerated massively with the introduction of heated tobacco products, from an annual rate of around 3 percent before 2016 to around 11 percent in years after.

This downward trend has continued, nearly halving cigarette sales in just seven years: from 180 billion cigarettes sold nationwide in 2015 to under 100 billion in 2022, according to industry sales reports. Reduced-risk products now make up about a third of the Japanese tobacco market. Yet this striking success has been largely ignored by the rest of the world.

Why is no one talking about Japan? "I think it's a really good indication of one of the problems in the field known as tobacco control," says Sweanor. He suggests that rigid ideology has made his peers unwilling to acknowledge the benefits of substituting cigarettes with lower-risk alternatives.

Mainstream tobacco control aims for complete abstinence from nicotine and tobacco. By that standard, Japan is a disappointment. Although male smoking rates have declined substantially since the turn of the century, when nearly half of men in Japan smoked, the habit persists in about a quarter of Japanese men. The current dramatic decline in cigarette sales is only partially caused by quitting or abstinence from nicotine; much of it is due to consumers buying heated tobacco instead. That switch may well avert a substantial portion of smoking-related deaths, but harm reduction is a difficult case to make in a field as ideologically driven as tobacco control.

Even among experts who are receptive to harm reduction, evaluating the impact of heated tobacco is more nuanced than gross sales figures suggest. Industry players have invested heavily in research to show that noncombustible products present much lower exposure to toxic substances than conventional cigarettes. This is a plausible claim backed up by reams of documentation, sufficient to convince even the FDA to authorize IQOS for sale in the United States and allow it to be marketed with claims of reduced exposure to harmful toxicants compared to cigarettes. (For a thorough comparison of emissions from heated tobacco products, e-cigarettes, and conventional cigarettes, see this recent review.)

But even if heated tobacco compares favorably in a one-to-one comparison to conventional cigarettes, how people use it matters too. "The problematic and the perplexing aspect of regulation, of course, is the individual versus the population level," says Geoffrey Fong, principal investigator at the International Tobacco Control Policy Evaluation Project at the University of Waterloo. "That's a problem because it may be the case that there are a lot of people that aren't using these things to quit. And so at the population level, what matters is patterns of actual use."

The potential for heated tobacco products to reduce harm depends greatly on whether users transition entirely away from smoking or use them as only a partial substitute. In its annual reports, Philip Morris International boasts a high rate of conversion to IQOS, estimating that about 70 percent of its users have switched completely (defined internally as using heated tobacco for at least 95 percent of their consumption).

But whether those figures replicate is debatable. An independent study from 2018 is less encouraging, finding that 63 percent of heated tobacco users in Japan were still smoking cigarettes at least once a month. Surveys of users' motivations also suggest that they don't approach heated tobacco as a means of quitting smoking. Nearly all report using it because they believe it to be safer; three-quarters said the products were enjoyable and more socially acceptable than cigarettes. Yet only about half reported using them as a tool to quit smoking, with the other half viewing them as a complement to cigarettes.

There are limitations to all of this of course, including the fact that the market is rapidly evolving, potentially rendering data from just a few years ago out of date. The jury is still out on whether users of heated tobacco in Japan will tend to switch completely or merely reduce their consumption of cigarettes, choosing one product or the other depending on circumstances. Analysis of more recent data will be enlightening.

Even with these questions unresolved, the Japanese experience provides useful lessons for the rest of the world. The most obvious is that allowing consumers access to safer sources of nicotine can drastically reduce sales of cigarettes. For all the hand-wringing over dual use, it's difficult to view a near halving of cigarette sales as anything but a victory for public health. (As Sweanor points out, no one would hesitate to identify the reverse scenario of doubling cigarette sales as an unambiguous disaster.)

Another lesson from Japan is that smokers are willing to try lower-risk products, as long as those products offer pleasure. . Unlike pharmaceutical cessation aids, heated tobacco simulates the sensorial experience of smoking. It's also more socially acceptable than lighting up a conventional cigarette, fouling the air less noticeably for bystanders. Users may find themselves transitioning to lower-risk products for recreational use, or even switching entirely, even if they initially had no intention of quitting smoking.

Parallel evidence from studies of e-cigarettes tells a similar story. A recent Cochrane review concluded that e-cigarettes significantly outperform nicotine replacement therapy in aiding quit attempts. Randomized control trials are needed to more firmly assess the potential of heated tobacco as a means of quitting cigarettes, but it would not be surprising to see a similar dynamic at play.

Finally, the Japanese experience points to the potential to achieve dramatic reductions in smoking without the planning or approval of government regulators. "[Japan] allowed one alternative to cigarettes onto the market," says Sweanor. "They didn't say, 'How do we change marketing rules to give an advantage to low-risk products?' They didn't say, 'How do we change tax policy?'…They didn't say, 'Let's run massive campaigns to inform people.' They just made one alternative available, and here we are seven years later."

Japan's massive reduction in cigarette sales is less the result of intentional policy than it is a bottom-up response from tobacco consumers making their own decisions to try a safer alternative. That puts Japan in the company of Sweden, where snus has largely replaced cigarettes, and the United States, where vaping is accelerating quit rates among adults and replacing smoking among younger generations. Harm reduction is succeeding in these countries with little support and at times active hostility from governments and anti-smoking activists.

Japan's experience suggests that there is unmet potential for lower-risk products that could be realized with smarter policy, but advocates of harm reduction are divided on what that should entail. Dr. Fong cited New Zealand's proposed smoke-free generation ban on combustible tobacco as an "extraordinary opportunity" for taking a "push and pull" approach, eliminating legal access to cigarettes for younger generations while leaving lower-risk e-cigarettes available. (The new government in New Zealand has since backed away from this plan, but a similar policy may be enacted in England.) In the United States, there have been proposals for stripping nearly all nicotine from cigarettes, as outlined in former FDA Commissioner Scott Gottlieb's comprehensive plan for tobacco regulation, and banning menthol cigarettes.

Other advocates are more skeptical of restrictions, preferring to focus on what could be achieved with a more concerted effort to promote safer tobacco products. "There's a very strong case to be said that coercion is not a very good approach to take at any point, but a whole range of other things probably are," says Sweanor. Instead of pursuing a prohibitionist agenda, he suggests looking at the choice-enhancing policies that we see already working. "What if we tried more of this? What if we did arrange to have many options and encourage the development of even better options that meet whatever the needs are of people who are smoking cigarettes?"

When heated tobacco products do finally arrive in the U.S., it's unclear whether they will have as great an impact as they do in Japan where they are protected from competition from e-cigarettes. Optimistically, they will contribute to taking the country another step farther away from the previous "cigarette century," during which the market for tobacco was dominated by a single deadly product, and toward a future with lower risks and a greater diversity of ways to consume tobacco and nicotine. And if they can help American smokers voluntarily give up conventional cigarettes, they may also help avert the prohibitionist trajectory of contemporary tobacco policy.