The iQOS is a small pen-like electronic device that heats a stick of tobacco, rather than burning it, making the vapor less harmful than smoke from traditional cigarettes.
The tobacco stick also sets the device apart from electronic cigarettes, which utilize a nicotine-laced liquid that allows users to inhale much stronger levels of nicotine and tobacco than a traditional cigarette.
FDA said allowing the device to be sold is "appropriate for the protection of the public health because ... the products produce fewer or lower levels of some toxins than combustible cigarettes."
The FDA review took nearly two years to complete, highlighting the public health debate over the device.
Harold Wimmer, president and CEO of the American Lung Association said the group is "deeply concerned" about the health impacts of the new product, and urged FDA to "carefully monitor how this product is actually being used ‐ and by whom."
The agency noted that even though the device is now legally allowed to be sold, "it does not mean these products are safe. All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue not to."