The Food and Drug Administration said Tuesday it will allow Philip Morris International to sell a cigarette alternative that heats tobacco without burning it.
But the agency has not yet decided whether to allow the device, iQOS, to be advertised as less harmful than cigarettes. Without that key marketing pitch, analysts expect limited use of the pen-like device.
The device is the centerpiece of the company's effort to shift the shrinking market of U.S. smokers toward alternative tobacco products.
FDA regulators stressed that the device is not safe, but studies submitted by the company did show it produces fewer toxic byproducts than traditional burning cigarettes.
It will be sold in the U.S. by Altria, maker of Marlboro cigarettes, and subject to laws that ban television and radio advertising of cigarettes.