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U.S. MRTP Authorization Pathway Explored in PMI’s Latest Scientific Update

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Philip Morris International (PMI) (NYSE: PM) has released the 11th edition of its Scientific Update, a regularly issued publication on its research efforts to develop and scientifically assess a range of smoke-free alternatives to cigarettes.

The latest edition features an overview of the historic decision made by the U.S. Food and Drug Administration (FDA) to authorize the marketing of the IQOS Tobacco Heating System with reduced exposure information. The Scientific Update explains the various MRTP decisions under U.S. law; the steps, processes, and timeline PMI undertook; and the ongoing post-market surveillance and studies that will monitor the impact of the orders on consumer perceptions, behavior, and health.

“The FDA undertook a scientific and regulatory evaluation of IQOS and determined that it is ‘appropriate for the promotion of public health’” said Dr. Gizelle Baker, director of Global Scientific Engagement at PMI. “In this edition of our Scientific Update, we describe how the regulatory process worked for PMI, what scientific evidence the FDA considered, and the decisions the FDA made.”

After more than three years of scientific and regulatory review of the application, the FDA concluded: “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body's exposure to harmful or potentially harmful chemicals.”

This issue of the Scientific Update also examines the ABOUT Toolbox—a robust portfolio of self-report instruments—created by PMI to evaluate and assess the public health impact of tobacco harm reduction strategies on consumer perceptions and behavior. The ABOUT Toolbox team describes the new Health and Functioning instrument, which measures the perceived health status of adult smokers who switch to smoke-free products. They explain how the framework was prepared, developed, and validated, and detail the information it can provide to public health and regulatory communities.

The update also includes information on scientific events at which PMI has presented, as well as a compendium of PMI’s peer-reviewed publications and independent research into smoke-free products.

The Scientific Update can be found at https://www.pmiscience.com/whats-new/scientific-update-11.

Philip Morris International: Delivering a Smoke-Free Future
Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the United States. PMI ships a version of its smoke-free devices and consumables authorized by the U.S. Food and Drug Administration to Altria Group, Inc. for sale in the United States under license. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities, and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. For more information, please visit www.pmi.com and www.pmiscience.com.

# # #

Contact information

David Fraser
Philip Morris International
T. +41 (0)79 843 8603
E. david.fraser@pmi.com

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