Philip Morris Files First Modified Risk Application

Takes step toward iQOS heat-not-burn tobacco product in United States

LAUSANNE, Switzerland -- Philip Morris International (PMI) has filed an application with the U.S. Food and Drug Administration (FDA) to declare its new heat-not-burn product called iQOS as having a modified health risk, the company announced.

Lausanne, Switzerland Based PMI filed a Modified Risk Tobacco Product (MRTP) application with the FDA, which seeks the right to claim its electronic cigarette is less harmful than traditional cigarettes. According to its own rules, the FDA has 60 days to accept the application for substantive review and one year to make a final decision.

Richmond, Va.-based Altria Group, parent of Philip Morris USA would have U.S. rights to market the product but the iQOS would still have to undergo the Premarket Tobacco Product Application (PMTA) process with the FDA before being marketed. Phillip Morris and Altria are expected to turn that premarket application in by the first quarter of 2017, according to Bonnie Herzog, marketing director of beverage, tobacco and convenience-store research for Wells Fargo Securities LLC, New York.

In her recent newsletter, Herzog said the device may be a catalyst for PMI and Altria to reunite, after PMI was spun off in 2008. She said favorable economic factors and the potential merger of rivals London-based British American Tobacco and Winston-Salem, N.C.-based R.J. Reynolds American Inc. are suggesting the move.

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