Philip Morris International announced Wednesday that the US Food and Drug Administration has officially approved the sale of its tobacco device Iqos.
Iqos is a heat-not-burn tobacco device that has passed the premarket tobacco application submitted to the FDA, making it now legal for the company to market the product in the US.
Iqos is a heat-not-burn tobacco device that has passed the premarket tobacco application submitted to the FDA, making it now legal for the company to market the product in the US.
Unlike e-cigarettes, which heat a nicotine-infused liquid, HNB devices such as Iqos are noncombustible devices that heat tobacco, generating a nicotine-infused aerosol for users to inhale. Iqos and cigarettes deliver similar amounts of nicotine.
The FDA’s approval followed a “rigorous science-based review” concluding that the device produces “fewer or lower levels of some toxins than combustible cigarettes,” the FDA said in a statement.
As this is the first electronic tobacco-heating device that can be marketed in the US since the FDA started regulating tobacco products in 2009, Philip Morris International CEO Andre Calantzopoulos said he believes this is a step toward providing US smokers an option that can replace traditional cigarettes.
According to Philip Morris International, some 7.3 million smokers worldwide have stopped smoking cigarettes and replaced them with Iqos, which is known to give off less smell.
Iqos in the US is to be distributed by Altria Group.
The firm also said the FDA is currently reviewing its modified risk tobacco product application.
By Cho Hyee-su (chohyeesu@heraldcorp.com)