As of this month, some 500 tobacco stores in Atlanta, Georgia are the first in the United States to start selling IQOS—a heated-tobacco product from tobacco giant Philip Morris International.
Traditionally, heated tobacco products haven’t been all that popular: IQOS is one of two on sale in the US. (The first, introduced in the 1990s, has flitted off and on the market.) But as CNBC noted, the timing of IQOS’ US debut seems serendipitous for its marketers, arriving just as one of the country’s most popular cigarette alternatives—e-cigs—comes under fire.
PMI is currently licensing the IQOS technology to Altria, which owns 35% of e-cigarette market leader Juul. Last month, amid a flurry of concerns about the safety of using e-cigarettes and the high rate of teenage vaping, Juul’s CEO stepped down and Altria’s former chief growth officer, K.C. Crosthwaite, took the reins. Crosthwaite was reportedly responsible in large part for getting IQOS off the ground in the US.
Now, Altria is heading up the sales, marketing, and distribution of IQOS in the US. The device had been pending authorization from the US Food and Drug Administration (FDA) for almost two years, and the regulatory agency finally gave IQOS the okay in April 2019. If sales in the Atlanta test market go well, it will expand to the rest of the US within a few years.
Like e-cigarettes and traditional cigarettes, IQOS delivers nicotine—the addictive component in tobacco products. It wouldn’t be surprising if smokers or vapers looking for an alternative gave IQOS a spin in the coming months. Here’s more about how this latest smoking product works, and why the FDA is allowing US residents to buy it.
IQOS is a device designed to mimic the smoking experience, but without actually burning tobacco. It contains three parts: a pen, a case, and “HeatSticks” that look like tiny cigarettes (although they can’t be smoked on their own). The HeatSticks are Marlboro-branded, and either have a natural tobacco flavor, or one of two menthol flavors.
The tobacco in the HeatSticks is actually folded sheets of tobacco paste mixed with glycerin, a substance that forms a puffy white cloud to ferry along nicotine and tobacco flavors. When going for a smoke, an IQOS user sticks the tobacco-filled end of the HeatStick into the pen. That part of the device contains a ceramic heated blade, which heats the tobacco up to 350°C (about 662°F)—enough to aerosolize the nicotine, glycerin, and flavors.
Each HeatStick contains about the same amount of nicotine as a cigarette, and lasts about as long—roughly 15 puffs, or 6 minutes. The pen’s battery only lasts long enough to smoke a single HeatStick before it needs to be recharged in the carrying case, which looks like an elongated Airpod case. Afterward, the tobacco in the used HeatStick looks toasted, and it can’t be reused.
Because they don’t actually burn the tobacco (a process that occurs at 600°C, or 1,112°F), the IQOS pens are no good for trying to smoke home-rolled tobacco or other substances like marijuana. (They won’t fit a traditional cigarette inside, either.) But they’re designed to mimic the experience of smoking a regular cigarette in every other way.
The acronym, according to PMI, doesn’t stand for anything. Although there have been rumors that IQOS stands for “I Quit Ordinary Smoking,” a spokesperson PMI pointed out that it wouldn’t make sense to have an English name, because the device has been on sale in Japan since 2014. PMI has since expanded sales to South Korea, Germany, Russia, the UK, and Italy.
Unlike medical drugs and devices, the FDA doesn’t approve any tobacco products, because none of them are safe by their very nature. Instead, it authorizes their sale, with extremely specific guidelines.
PMI submitted IQOS through the FDA’s premarket tobacco product application (PMTA) over two years ago. In a PMTA, the FDA is looking for evidence that allowing a new tobacco product is “appropriate for the protection of the public health”—namely, that it’s not more toxic than existing tobacco products, and won’t draw in anyone who isn’t already smoking. The application for IQOS was over a million pages long, Priscilla Callahan-Lyon, a scientist at the FDA’s Center for Tobacco Products said in a grand rounds presentation yesterday (Oct. 10). The company conducted studies that covered everything from toxicology to real-world usage.
Based on the FDA’s review of those studies, the agency deemed that with proper labeling (which FDA requires of all tobacco products) IQOS likely won’t be any more of a danger to public health than traditional cigarettes, and may be better for smokers who switch to using only IQOS (more on that in a bit). It also seems like IQOS wouldn’t hold a huge appeal for teens, based on US surveys and use in countries where the device is already on sale. And unlike many e-cigarettes, the device can’t be used to smoke illegal products like marijuana.
In terms of overall safety—maybe. But there still isn’t good long-term data on IQOS.
The data PMI submitted to the FDA indicated that IQOS produces lower levels of toxic chemicals like carbon monoxide and formaldehyde than cigarettes. Short-term studies found no serious adverse events related to IQOS, and medium-term observation of people who use IQOS in other countries didn’t give the FDA reason to believe that longer-term health consequences would be any different from smoking tobacco cigarettes.
IQOS does contain nicotine and tobacco, just like cigarettes. And although glycerin is “generally regarded as safe” by the FDA, that designation is largely for ingested glycerin—not inhaled. Glycerin is one of the common carriers used in e-juice cartridges.
PMI has also submitted an application for IQOS to be labeled as a Modified Risk Tobacco Product by the FDA, which applies to tobacco products that “benefit the health of the population as a whole,” presumably by being less dangerous than what’s already on the market. But the agency hasn’t approved that labeling. It’s worth noting that none of the 35 Modified Risk Tobacco Product applications have been approved to date.
That’s unclear. PMI only conducted safety research on IQOS in comparison to traditional cigarettes, not e-cigarettes. Although e-cigarettes don’t contain tobacco and IQOS does, there’s no good data on e-cigarettes’ long-term safety.
With IQOS, users at least have the benefit of knowing that there have been studies conducted—some by PMI, others by FDA, and all reviewed by the regulatory agency. And although the tobacco in it is a known risk, it’s at least well-understood.
The presumed advantage of e-cigarettes is that they don’t contain tobacco—but there’s growing evidence that they may not be safe, either. VAPI, or vaping-associated pulmonary illnesses has sickened nearly 1,300 in the US and killed 26 as of Oct. 10. There’s no clear cause, either. One of the biggest problems with e-cigarettes is that even though the FDA has authorized their sale, people have been modifying their devices and their e-juice extensively to smoke nicotine, marijuana, and thousands of unregulated flavors.
In Atlanta, Altria is selling the full device plus 200 HeatSticks for $80, compared to a solo device for $100. You can also buy an IQOS online, but you have to go to a physical store in Atlanta to pick it up—a process that ensures vendors will verify they’re only selling IQOS to adults.
Correction (Oct. 11): An earlier version of this story said the FDA had authorized multiple heated tobacco devices. It has only authorized IQOS, because the other product came on the market before FDA could regulate it.