FDA Approves PMI’s IQOS Heat-Not-Burn Tobacco For U.S. Sales

Today the FDA approved Philip Morris International’s heat-not-burn tobacco system for sale in the U.S., saying in an agency 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.”

The FDA approval was issued two years (alternatively, 1 million smoker deaths) after PMI’s application, which is about a year and a half past the agency’s own deadline.  IQOS is only the second product approved under the PMTA pathway.  The first was in 2015 for eight General snus products from Swedish Match. 

The FDA action is both good and bad news for e-cigarette and vapor manufacturers and retailers.  The good news is that the PMTA process works.  The bad news is that it took years, and hundreds of millions of research dollars, for PMI to obtain this approval.  By 2022 manufacturers and retailers, who already sell tens of thousands of e-cigarettes and vapor products but don’t have the resources of PMI, will be required to submit PMTAs to the FDA, or risk having them ordered off the market.