FDA finally approves PMI’s IQOS device for U.S. consumption

When I reviewed the IQOS, it was not yet approved for sale or marketing in the United States. Thanks to some dogged lobbying by PMI, backed by a constant stream of science coming out of its Cube facility in Neuchâtel, Switzerland, the FDA has finally permitted the sale of the IQOS in the United States.

This doesn’t mean that the approval doesn’t come with a hefty load of caveats. The FDA in no way has approved the device as anything other than what it is — an alternative to cigarettes that still carries a health risk.

The IQOS and authorized products (Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks) will not be marked as “FDA Approved” and likely will come with large warning stickers similar to those found on traditional packs of cigarettes.

While the IQOS device delivers significantly less harmful toxins than cigarettes because the tobacco is heated and not burned, the FDA has promised that it will be keeping a close eye on the marketing development of the IQOS in the United States, once again leaning on the kids might smoke it angle to justify more stringent oversight. Said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products in a press release:

Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public, particularly youth, and to reduce tobacco-related disease and death. While the authorization of new tobacco products doesn’t mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole. This includes how the products may impact youth use of nicotine and tobacco, and the potential for the products to completely move adult smokers away from use of combustible cigarettes.

Through the science, however, even the FDA has conceded that the IQOS (and by proxy, vaping in general) is a lower-risk alternative to cigarettes

In its own release, after reviewing peer-reviewed published papers and the research from PMI, it concluded that toxins appear at much lower levels than cigarettes. Something the anti-vaping crowd would prefer to be buried.

Not only is the carbon monoxide exposure from IQOS aerosol comparable to regular day-to-day environmental exposure, but levels of acrolein (an acrid chemical produced upon combustion) are 89% to 95% lower and formaldehyde 66% to 91% lower than combustible cigarettes.

Popular in Europe as a tool to quit traditional cigarettes (and marketed as such), the FDA did also concede that the IQOS could very well serve that purpose in the States as well. Though even though the IQOS heats and not burns its tobacco product, the FDA will still be listing it as a cigarette-type product, which restricts marketing efforts. That’s all well and good, because like cigarettes and vape products, it’ll find its way to 7-11 shelves before we know it.

This is a huge step forward for moving society past cigarettes and into the future of vaping. If you don’t smoke, don’t buy an IQOS. If you do smoke and want to quit but find it nearly impossible to do so, then the IQOS is for you. You still get the nicotine delivery, the mouthfeel, and the habit, but without nearly all the harmful chemical side effects. It’s not a perfect world, we all need our something. It’s just better if that something won’t kill us as quickly as the other something.

What do you think? Is the IQOS something you’d consider? Let us know down below in the comments or carry the discussion over to our Twitter or Facebook.

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