FDA Permits the Sale of a New Smoking Device. Is It Safe?

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“Clearly the best thing somebody can do is to quit nicotine and tobacco altogether,” says Moira Gilchrist, vice president of scientific communications at Philip Morris International, which developed the Iqos. Short of quitting, though, Gilchrist says that the Iqos is a “better alternative.”

In April, the FDA allowed the product to go on sale in the US through a process called premarket authorization. After reviewing the device and reams of data presented by Philip Morris, the agency decided that although Iqos isn’t risk-free, it was “appropriate for the protection of the public health” because the devices had “fewer or lower levels of some toxins.” The authorization doesn’t mean the regulator approves of the device or thinks it’s safe; it just means the FDA believes Iqos isn’t more dangerous than regular cigarettes.

But scientists say the FDA’s logic is flawed, in part because Iqos may present unique dangers that aren’t measured in traditional toxicity tests. Iqos have significantly higher levels of glycerin than cigarettes. “It’s actually putting stuff out that no cigarette ever put out and that hasn’t really been studied very well,” says Robert Jackler, a tobacco researcher at Stanford.

What’s more, other research suggests the devices do present many of the same risks as regular cigarettes. Stanton Glantz, a professor at the UCSF Center for Tobacco Control Research and Education, analyzed the Philip Morris data and concluded that Iqos’ toxicity is “indistinguishable from a cigarette.” An independent study from researchers at the University of Bern in Switzerland found that Iqos contains the “same harmful constituents of conventional tobacco cigarette smoke.” Another study suggested the devices could cause more damage to the liver than regular cigarettes.

Glantz is troubled by the FDA’s interpretation of the product as “appropriate for the protection of the public health.” Few legal items are more dangerous for your health than cigarettes, he says, so the agency should apply a higher standard to such products. DeSaulnier says his proposed legislation is just a first step, and agrees the FDA’s standards are not adequate. “I want to look at how the FDA process is being implemented,” he adds. “It’s not stringent enough.”

The FDA did not comment for this story, but in a press release, the agency explained that one reason it authorized sales of Iqos was based on the determination that the product was unlikely to attract kids or people who don’t already smoke.

Iqos is more complicated to use than an e-cigarette. It has to be cleaned and users have to charge the heating device. But it comes with fresh and smooth menthol options, which [appeal] (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5711620/) to youngsters. And the devices’ design mimics the trendy tech that teenagers appreciate. “They’re selling you an iPhone of tobacco products,” asserted Sward. According to SEC filings, the product was even initially spelled iQOS. (The company ultimately opted for all-capital letters.) Iqos’ Lenox Square store has a glass front wall, long display tables, and intricate packaging that call to mind Apple stores and iPhone boxes.

Kids can’t get into the stores—you need a government-issued ID proving you’re 21 or older—but that doesn’t mean kids won’t be drawn to the products. “Any high-tech gadget is going to have interest on the part of young people,” says Jackler, who put together a comprehensive report on how e-cigarette marketing campaigns appeal to teenagers. Iqos ran similar social media campaigns in Japan and Italy, where the device has been on the market since 2015. Thousands of posts under hashtags like #iqos and #iqosfriends show young, attractive people posing with their devices.

Philip Morris says they are no longer running those social campaigns. It might not matter. Jackler’s research found that after Juul stopped its official influencer campaign, the rate of posts using #juul actually increased. A spokesperson for tobacco company Altria, which is distributing Iqos in the US, says it plans to use Instagram and Facebook to advertise the device, but that it won’t rely on influencers and will restrict posts to viewers over the age of 21. The FDA also classified Iqos as a cigarette, so it can’t be advertised on the radio or on television.

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