12 December 2019
A glass-walled bastion of minimalism in a retail mall in Atlanta is the first of its kind in the United States. It looks like an Apple Store, but with a bouncer. You have to be 21 or older to enter. If you want to buy what’s inside, you must be a cigarette smoker. Or at least, you must tell the salesperson that you’re a cigarette smoker.
The store’s product is an electrified cylinder to be kept in your pocket. Branded “IQOS,” which is widely believed to be an acronym for “I Quit Original Smoking,” the device is the first in what’s expected to be a new class known as “heated tobacco” or “heat not burn” products.* They’re not vaping or smoking, but another way of inhaling the addictive stimulant nicotine.
The IQOS is USB-charged and about the size of a Sharpie. The far end has a port where you put a roll of tobacco that looks like a short cigarette. Overall, the aesthetic is closer to an asthma inhaler than to anything James Dean would have carried. Signifiers of smoking and vaping are absent: There is no flame, no smoke, and only a ghostly wisp to exhale.
No celebrities or red carpets were at the Atlanta store opening in September, like they were this month at the Munich opening. The product wasn’t authorized for sale in the U.S. by the Food and Drug Administration until April, and its seller didn’t know how well it would be received. And the pitch for the device is technically illegal for the company to say, since the FDA does not allow it: The IQOS is safer than cigarettes.
The FDA is currently weighing the evidence for that claim. In reality, measuring any long-term health effects—knowing for sure whether the claim is true—would take decades. But the theoretical concept is that much of the danger of cigarettes comes from inhaling smoke of any sort. Plug your chimney, hover over a campfire, or smoke grass from your lawn, and you will increase your odds of lung cancer and various other means of dying. Instead of burning the tobacco, this new device heats it to a lower temperature. That releases some nicotine for you to inhale and feel temporarily stimulated. Or at least less unstimulated.
Vaping, by contrast, involves heating a liquid that often contains synthetic nicotine, among other substances, not tobacco itself. Vaping and heated-tobacco devices are both commonly considered “e-cigarettes,” but the difference between the two is especially relevant in the midst of national panic about vaping. Over the summer and fall, reports of several dozen vaping-related deaths surfaced, and autopsies found that the liquids put into some devices contain additives that seem to be the cause of acute inflammatory lung disease. People began to swear off vaping. Some states implemented bans.
Almost all of these deaths appear to be linked to ingredients in black-market vapes; they’re not clearly tied to commercially available devices such as Juul. Nevertheless, the IQOS mall experience feels timed to appeal to the wary, weary consumer, conveying a sense of safety and authority absent from the off-brand vaping accoutrements on offer in dank bodegas. Arriving at this moment of panic, the heated-tobacco idea is poised to be a massively popular alternative. These devices could potentially become more ubiquitous than vaping, or even cigarettes.
At least, that is the stated goal of the company that makes them: the world’s most prolific seller of cigarettes, Philip Morris International (PMI). For the company (and its U.S. spin-off, Altria), heated tobacco is more than a dip of the toe into a novelty market. The cigarette giant says that it is staking its future on this new product, and that it has spent $6 billion in the past decade to develop it. The company apparently wants to escape the shadows of deadly warning labels and heavy taxation, and move into the light of mainstream commerce and high-end malls. PMI is positioning itself next to Apple and other corporations that many people earnestly believe are selling them solutions.
IQOS has been rolled out incrementally in various countries in recent years. It’s already big in Japan, and it’s gaining users in Russia, Spain, Italy, and elsewhere. Last year, it reached $900 million in device sales globally. Juul, by comparison, reached only $100 million outside the U.S. Just before Thanksgiving, a second U.S. store opened, in Richmond, Virginia, and IQOS is expected to begin distribution across the country in the next six months.
Some opponents cite the toll of cigarettes on global health as reason to shut this new product down hard and fast. They argue that there’s no more reason to trust PMI’s next venture than there has been to trust anything the company has done in the past century. Despite some early evidence that IQOS does reduce the levels of many known toxic chemicals per puff compared with cigarettes, there can be no certainty that using it would circumvent similar long-term consequences. “By the time we figured out the harms of cigarettes, we had tens of millions of addicts, and it was politically impossible to do something about it,” says Chris Bostic, the deputy director for policy at the advocacy group Action on Smoking and Health. “I do think the FDA made a mistake in giving this approval to Philip Morris.”
The agency declined to comment for this story, but referred me to its published justification for the decision to allow IQOS into the U.S., the result of a two-year review process. The decision came with heavy limitations. Not only did the agency forbid the claim that heated tobacco is safer than smoking (an application for the right to make that claim is under review); it also prohibited ads from claiming that heated tobacco can help smokers quit smoking. That would make it a “cessation device,” meaning it would have to be regulated as a medical device like a pacemaker, rather than as a mall-based consumer good.
Being safer than smoking is not a high bar. Every year, smoking cigarettes kills about 8 million people, according to the World Health Organization. While smoking rates in the U.S. are at an all-time low, absolute numbers continue to rise globally. For those who want to quit, the only FDA-approved products that deliver nicotine for purposes of cessation are things such as nicotine gums, patches, and nasal sprays. These help prevent physical withdrawal, though they are intended for short-term use. In recent years, some doctors have begun to advise patients that vaping is preferable to smoking. But such recommendations have become more tenuous, given new concerns that a person might pick up a bad batch of liquids and die.
The timing and intensity of the current vaping panic are curious to John Ayers, a public-health researcher at the University of California at San Diego who tracks the tobacco industry’s marketing tactics. News organizations started focusing intently on the dangers of vaping around the same time that PMI and Altria were ready to launch IQOS in the U.S. In September, amid concerns about spikes in teen rates of use and the reported deaths, PMI put out a press release calling attention to the recent vaping-related lung injuries. “The company is clearly trying to position this product as a safer alternative to vaping and smoking,” Ayers told me.
Ayers was even more alarmed that when he Googled heat not burn, the top result was an ad paid for by PMI. It read “What Is Heat Not Burn? Discover the Technology.” Clicking it sent him to a PMI website that refers to IQOS as one of the “alternatives that have the potential to reduce the risk of developing smoking-related diseases as compared to continued smoking.” Ayers argues that the Google ad could be a violation of the FDA’s restrictions on claiming that IQOS is safer than smoking. He worries about a slippery slope if such regulations are not strictly enforced, and that pushing the boundaries is evidence of more aggressive tactics to come from PMI.
PMI denies that publishing this and other information about its product is a violation of the law. A company spokesperson, Corey Henry, says that these ads are meant to target people interested in public health, not consumers. He notes that the website Ayers visited includes a pop-up disclaimer that the site is intended for “disseminating scientific information.” He further denies that the September release was in any way linked to the IQOS launch.
For Ayers and others, this blurring of the line between information and advertising is uncomfortably reminiscent of the strategy long used to sell cigarettes. As cigarette ads were restricted on TV and elsewhere, tobacco companies sought to publish “information” downplaying the harms of cigarettes. “That store in the mall might look nice,” he says, “but when it comes to reaching people with paid advertising, they’re doing the wrong things.”
André Calantzopoulos, the CEO of PMI, pulls out the IQOS and puffs. It’s still called a puff, I suppose, even though almost nothing visible comes out. Calantzopoulos does not look happy about the process, no more than any smoker does. He has the ruddy skin of a lifelong cigarette user, though he says he recently traded out. “Nobody said these products are safe,” he says. “But they’re much safer than cigarettes. We are in the risk-continuum conversation here.”
The FDA would not let Calantzopoulos say that in an ad. But he is allowed to say it to a journalist. It’s worth noting that Calantzopoulos’s reported salary is $15,934,235. The two hours I spent interviewing him at the company’s Manhattan office last month cost the company something like $8,000. Either Calantzopoulos liked me enough to chat that sort of money away or he has a valuable narrative to promote.
PMI is arguably the most hated brand in the world, ever. For decades, the company paid doctors to deny that smoking was harmful. It marketed to children. It got people addicted to a product that killed many of them, while telling them that it wasn’t addictive. It lobbied to minimize restrictions that the public-health community agrees would have saved millions of lives.
But Calantzopoulos has broken with his predecessors. Since 1999—and more loudly in recent years—he has said that cigarettes are unhealthy. In 2018, he oversaw PMI’s launch of a publicity campaign to create a “smoke-free world.” In a campaign called “Unsmoke,” ads say: “If you don’t smoke, don’t start. If you smoke, quit. If you don’t quit, change.” “Once you publicly recognize your product causes disease, you recognize technology will evolve to reduce the risk of the product,” Calantzopoulos told me.
The tobacco industry has gestured many times at products that would reduce harm, beginning in the 1950s. The infamous “light” and “low tar” cigarettes turned out to be no safer than their predecessors, and many people dismissed them as marketing stunts. “We tried for many years to filter out the toxic elements, but it’s impossible,” Calantzopoulos said. The combustion involved in smoking necessarily produces compounds that are dangerous to inhale, such as acetaldehyde and formaldehyde. PMI changed the structure of cigarettes in various ways—with cellulose-acetate filters, ventilation holes, and porous paper—but the problem of killing people continued. Some cigarettes successfully delivered less tobacco smoke and more clean air per puff, but this often meant that people simply smoked more of them. “So,” Calantzopoulos explained, “the approach became not to exceed certain temperatures.”
He readily conceded that it’s impossible to say how many cases of cancer and heart disease heated tobacco will cause over any person’s lifespan. When he said IQOS was “safer” than cigarettes, he was referring to some studies in which the product has been found to expose users to lower levels of dangerous compounds than a comparable amount of smoking does. Most of those studies have involved scientists employed by PMI. A 2018 review of the studies on heated-tobacco devices found that 20 of 31 were done by tobacco companies.
To anti-tobacco advocates such as Bostic, of Action on Smoking and Health, this means the studies are to be dismissed out of hand. Bostic has worked for decades to prevent academic researchers from taking grants from Big Tobacco that might fund this sort of research. (While many universities work with pharmaceutical and medical-device companies to test products, and accept grant funding to conduct research, they draw ethical lines around taking money from the tobacco industry.) PMI’s website “says they’re ‘working for a smoke-free future,’” Bostic says. “At the same time, they’re spending billions of dollars marketing cigarettes and fighting tobacco controls in any country where it comes up. It’s an absurd PR stunt.”
Calantzopoulos was straightforward about the fact that he will do what is profitable. If he simply stopped selling cigarettes, he would be fired by the company’s board that day. The job of a person in such a position is to make money for shareholders, and, if possible, to do so in a manner where fewer people die.
Even taking human life as a simple line item on a budget, it is never desirable for a company to kill its customers. Death renders consumers, medically speaking, unable to consume. PMI also stands to benefit from a product that allows people to consume tobacco less conspicuously and so, theoretically, in greater quantities. People could use it without stinking up everything they own, and without having to go outside in the middle of winter to stand alone. The devices extract nicotine from tobacco more efficiently than combustion does, meaning better profit margins. And they’re not subject to the heavy taxes imposed on cigarettes in much of the world.
A world where no one smokes, then, may be in the company’s interest. Though a world where everyone spends more living years consuming tobacco discreetly—all day, every day—is not everyone’s ideal vision of a “smoke-free world.”
The arrival of this tobacco-rich world—at least in the U.S.—is contingent on a decision by the FDA. The decision could come at any time. If the agency allows PMI to advertise the IQOS as safer than smoking, then experts predict that the floodgates will open and the product will become commonplace.
David Ashley, who spent seven years at the FDA regulating tobacco, considers this approval quite plausible. “It appears that if a person who is a smoker switches completely to this product, their risk of diseases will be reduced,” he says. Ashley is a professor at Georgia State School of Public Health, and he reviewed the data that PMI submitted to the FDA at length. He says he has no reason to doubt their accuracy. But he raises the crucial concern: How many people will switch completely?
The safety of anything that people put into their body is not determined by chemistry alone, but by how that chemistry fits into daily routines, cultures, and psychological proclivities. Smokers who purchase IQOS may be likely to continue to smoke, and will simply add the device into the gaps between stepping outside into the bleak winter air. In its FDA application, PMI provided only data from people who switched entirely from cigarettes to heated tobacco. More often, Ashley says, people become dual users—which of course would benefit a seller of both cigarettes and heated tobacco.
Earlier this year, a study from the American Cancer Society offered some amount of reassurance. Researchers tracked cigarette sales by region in Japan from 2014 to 2018. They saw significant declines in sales that correlated with local IQOS launches. The cautious conclusion: “The introduction of IQOS likely reduced cigarette sales in Japan. The net population health impact, however, cannot be assessed without resolving several key uncertainties related to the direct harms of IQOS.”
Such uncertainties would ideally be resolved before a national rollout of any product. And in an ideal model of reviewing new devices like this one, safety data would not depend on studies done by the company itself. Instead, researchers would study products and assess health effects, and would have no financial stake in any outcomes they might find. The National Academy of Sciences proposed something like this in 2012. In the process of laying out scientific standards for studying e-cigarettes, the group suggested a new third-party entity to oversee testing of new tobacco products. Since universities don’t take grant money from tobacco companies, funding would come from fees and taxes on tobacco companies, or from money won in settlements.
When the FDA tried to move ahead with that plan, though, Ashley recalls, it “ran into some heated criticism from tobacco-control folks who couldn’t imagine that a system like that could actually work. It hasn’t tried to do it again.” Ashley still believes that the idea holds promise as a way to allow independent researchers to study products without industry interference. It would have to be paired with a comprehensive plan to make cigarettes obsolete. While heated-tobacco may be very harmful, there is no question about combustible cigarettes.
In 2017, the then-chairman of the FDA, Scott Gottlieb, announced a plan that would reduce nicotine levels in cigarettes. It was a sort of halfway approach to a ban, aimed at undercutting demand for combustible cigarettes. The idea was to drive people toward quitting, ideally. Short of that, to drive people to replace combustibles with electronics. A study in The New England Journal of Medicine estimated that the policy would save 2.8 million lives by 2060.
Last month, however, the FDA announced that it was suspending the plan. The agency gave no reason. The move was considered a major victory for the tobacco industry.
If PMI wants the support of health advocates—to create a device that can be tested and trusted by consumers, sold in fancy malls, and hypothetically even recommended by doctors as a safer alternative for smokers—the industry may have to take steps to actually make good on its stated desire to end smoking. If it truly believes it has a product that can and should replace cigarettes, the company could at least stop lobbying against the clearest solution: banning them.
