PMI submits PMTA to U.S. FDA
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PMI submits PMTA to U.S. FDA

March 31, 2017

Philip Morris International (PMI) submitted a Premarket Tobacco Product Application (PMTA) for its Electronically Heated Tobacco Product (EHTP) – such as its iQOS heat-not-burn device – to the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products. This is consistent with the company’s stated goal of submitting its PMTA in the first quarter of 2017.

PMI’s PMTA seeks authorization to commercialize the EHTP in the United States. Should the FDA grant the requested marketing order, Altria Group would be responsible for commercializing and marketing the product in the United States under the terms of a licensing agreement with PMI, according to press note from PMI.

On December 5, 2016, PMI submitted a Modified Risk Tobacco Product (MRTP) application for its EHTP to the FDA. Administrative review of that application is ongoing. A PMTA marketing order is a prerequisite to commercializing a new tobacco product such as PMI’s EHTP. A decision on the PMTA would allow the marketing of PMI’s EHTP without modified risk claims independent of a decision on the MRTP.

Category: Breaking News

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