FDA clears Philip Morris’s heat-not-burn IQOS tobacco device for sale
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On Tuesday, April 30, 2019, the FDA approved Philip Morris’s premarket tobacco product application for its heat-not-burn iQOS device in the U.S.
The FDA, in announcing the decision, said the marketing of the devices is “appropriate” for public health because “the products produce fewer or lower levels of some toxins than combustible cigarettes.”
“The F.D.A.’s decision to authorize IQOS in the U.S. is an important step forward for the approximately 40 million American men and women who smoke,” said André Calantzopoulos, the chief executive of Philip Morris International. “Some will quit. Most won’t, and for them IQOS offers a smoke-free alternative to continued smoking.”
(from the FDA press release) "Following a rigorous science-based review through the premarket tobacco product application (PMTA) pathway, the agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes. The products authorized for sale include the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks.