Philip Morris International (PMI) Files Premarket Tobacco Product Application for its Electronically Heated Tobacco Product (EHTP) with the US Food and Drug Administration (FDA)
LAUSANNE, Switzerland–(BUSINESS WIRE)– Philip Morris International Inc. (“PMI”) (NYSE / Euronext Paris: PM) submitted a Premarket Tobacco Product Application (PMTA) for its Electronically Heated Tobacco Product (EHTP) to the US 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 FDA grant the requested marketing order, Altria Group Inc. would be responsible for commercializing and marketing the product in the United States under the terms of a licensing agreement with PMI.
Note to editor
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 MRTPA.
Philip Morris International Inc.
Philip Morris International Inc. (PMI) is the world’s leading international tobacco company, with six of the world’s top 15 international brands and products sold in more than 180 markets. In addition to the manufacture and sale of cigarettes, including Marlboro, the number one global cigarette brand, and other tobacco products, PMI is engaged in the development and commercialization of Reduced-Risk Products (RRPs). RRPs is the term PMI uses to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continued smoking. Through multidisciplinary capabilities in product development, state-of-the-art facilities, and industry-leading scientific substantiation, PMI aims to provide an RRP portfolio that meets a broad spectrum of adult smoker preferences and rigorous regulatory requirements. For more information, seewww.pmi.com and www.pmiscience.com
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