PMI Submits Pre-Market Application for Heat-Not-Burn

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PMI Submits Pre-Market Application for Heat-Not-Burn


SILVER SPRING, Md. — Philip Morris International Inc. (PMI) is taking another step to bring its heat-not-burn tobacco product to the United States.

The tobacco company, based in Lausanne, Switzerland, submitted a Premarket Tobacco Product Application (PMTA) for its electronically heated tobacco product, known as iQOS internationally, to the Food and Drug Administration's (FDA) Center for Tobacco Products. 

PMI had previously stated the application would come in the first quarter of 2017.

The PMTA comes almost four months after PMI submitted a Modified Risk Tobacco Product (MRTP) application for the heated tobacco product with the FDA, as CSNews Online previously reported.

An administrative review of that application is ongoing. A PMTA marketing order is a prerequisite to commercializing a new tobacco product such as PMI’s heat-not-burn product. A decision on the PMTA would allow the marketing of the product without modified risk claims independent of a decision on the MRTP application.

In late 2013, three years after PMI and Richmond, Va.-based Altria Group Inc. teamed up to establish a framework to commercialize reduced-risk products and electronic cigarettes.

Subsidiaries of the two tobacco companies entered into a series of agreements to address intellectual property licensing, regulatory engagement and contract manufacturing. Specifically:

  • Altria is providing PMI with an exclusive license to commercialize Altria's e-vapor products internationally.
  • PMI is providing Altria, on an exclusive basis, two of PMI's heated tobacco products for commercialization in the United States.
  • The companies are cooperating on scientific assessment, regulatory engagement and sharing improvements regarding those products.

The two tobacco leaders — Altria in the U.S. and PMI in the international market — expanded that pact to include a joint research, development and technology-sharing agreement.