The Food and Drug Administration has just cleared Phillip Morris International and its U.S. partner Altria to start selling the IQOS heat-not-burn device in the United States.

Phillip Morris had previously submitted two different applications for the device: one to sell it and one to market it as safer than combustible cigarettes. The first application, giving PMI the ability to sell the device, was approved. The federal agency is still waiting to make a decision on the second application.

“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,” FDA’s Center for Tobacco Products Director Mitch Zeller said in a statement.

“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.”

– Mitch Zeller, Director, FDA’s Center for Tobacco Products

Phillip Morris International is now officially allowed to sell the IQOS device as well as the “heat sticks” that users refill the device with: Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks. Since Phillip Morris doesn’t operate within the United States, they’ve partnered with U.S.-based Altria to sell the products domestically.

This announcement is a huge victory for both Phillip Morris and Altria. Both companies have seen steep declines in their traditional cigarette sales. Phillip Morris’ CEO has even gone on record as stating that he wants the company to eventually stop selling combustible products altogether in the future.

What is IQOS?

The IQOS is a tobacco heating system that consists of three parts: a tobacco stick, a holder, and a charger. This slim device requires that the consumer uses Phillip Morris’ Heatsticks as refills. The branded tobacco sticks are heated to a temperature of 350 Celsius, which is 250 degrees lower than the 600 Celsius required for combustion.

In their review of Phillip Morris’ application, the FDA stated that the aerosol (vapor?) that the IQOS emits ““contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke.” The FDA also found iQOS emitted nicotine levels that are comparable to old-school combustible cigarettes, “suggesting a likelihood that IQOS users may be able to completely transition away from combustible cigarettes” and use IQOS exclusively.

When will IQOS be available for sale in the US?

Altria is planning to start rolling out the device this summer, with sales initially planned for the Atlanta area. The company will open up an official IQOS store and several mobile stores. Heatsticks, the refills for the device, will be available for sale at 500 convenience stores including QuickTrip, Circle K, Murphy USA, RaceTrac, Speedway, and more according to a statement from Altria.

The IQOS was originally launched in Japan and, after gaining popularity there, Phillip Morris expanded sales to over 40 different markets throughout the world. Altria will be selling the product to a US market that is currently completely unaware of heat-not-burn devices. Altria will have their work cut out for them in their attempt to carve out a niche in the reduced risk market that is currently dominated by Juul Labs, a company that they recently purchased a minority stake in.

We’re definitely looking forward to seeing how this announcement shakes up the e-cigarette market, especially once the product officially becomes available this summer. Will it take market share from e-cigs or will it completely flop? Time will tell.

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