FDA Seeks Public Comments on PMI Application to Marketing IQOS 3 as a Modified Risk Tobacco Product


NEW YORK–(BUSINESS WIRE) – The United States Food and Drug Administration (FDA) today open a public comment period at the request of Philip Morris International (PMI – NYSE: PM) for approval to market the IQOS 3 Electrically heated tobacco system as a modified risk tobacco product (MRTP).

The PMI application requests the same orders to modify the reduced exposure allowed July 7, 2020, for the IQOS 2.4 – the first and only electronic nicotine product to obtain market orders through the FDA’s MRTP process. To authorize MRTP consumer communications, the FDA’s Tobacco Products Center is required by law to determine that a product is appropriate to promote public health.

the IQOS 3 device contains a number of technological advancements, compared to the IQOS 2.4 device, with longer battery life and faster recharging between uses. It was authorized on sale in the United States through the FDA pre-market review process on December 7, 2020, after meeting the standard that it is appropriate to authorize its sale to protect public health.

Commenting on the FDA’s action, Jacek Olczak, CEO of PMI, said:

“PMI is fully committed to a smoke-free future, in which we are completely replacing cigarettes with scientifically proven smoke-free alternatives that are a better choice for adults who would otherwise continue to smoke. Our commitment to a science-based future is unmatched, having invested more than $ 8 billion since 2008 in smoke-free products.

This app highlights PMI’s continued commitment to making new innovations available to adult American smokers through the FDA process; the confidence we have in our science; and our belief that public scrutiny and open engagement with governments are essential to achieving a smoke-free future. ”

Note to editor

  • FDA’s reduced exposure marketing orders for IQOS 2.4 Authorized communication of the following information:

    • the IQOS The system heats the tobacco but does not burn it.

    • This greatly reduces the production of harmful and potentially harmful chemicals.

    • Scientific studies have shown that switching completely from conventional cigarettes to IQOS The system reduces your body’s exposure to harmful or potentially harmful chemicals.

  • IQOS is available in the US market through an exclusive license from Altria Group, Inc.

Philip Morris International: securing 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 smokeless products for the benefit of adults who would otherwise continue to smoke, society, business and of its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smokeless products, related electronic devices and accessories, and other nicotine-containing products in markets outside the States. In addition, PMI ships versions of its IQOS Platform 1 device and consumables to Altria Group, Inc. for sale under license in the United States, where these products have received marketing authorizations from the United States Food and Drug Administration (FDA) as part of the pre-market tobacco product application process (PMTA); the FDA has also cleared a version of IQOS and its consumables as a modified risk tobacco product (MRTP), finding that an exposure modification order for these products is appropriate to promote public health. PMI is building a future on a new category of smoke-free products which, while not without risk, are a much better choice than to continue to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific evidence, PMI aims to ensure that its smoke-free products meet the preferences of adult consumers and meet stringent regulatory requirements. PMI’s smokeless product line includes heatless steam products that contain nicotine. As of March 31, 2021, PMI’s smoke-free products are available for sale in 66 markets in key cities or across the country, and PMI estimates that approximately 14 million adults worldwide have already switched to IQOS and quit smoking. For more information, please visit www.pmi.com and www.pmiscience.com.

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