FDA Seeks Public Comments On PMI Application To Market IQOS 3 As Modified Risk Tobacco Product

The U.S.
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The U.S. Food and Drug Administration (FDA) today opened a public comment period on Philip Morris International's (PMI--NYSE: PM) application seeking authorization to market the IQOS 3 electrically heated tobacco system as a Modified Risk Tobacco Product (MRTP).

PMI's application requests the same reduced exposure modification orders granted on July 7, 2020, for the IQOS 2.4 system—the first, and only, electronic nicotine product to be granted marketing orders through the FDA's MRTP process. To authorize MRTP consumer communications, the FDA's Center for Tobacco Products is required by law to conclude that a product is appropriate to promote the public health.

The IQOS 3 device contains a number of technological advancements, compared to the IQOS 2.4 device, including longer battery life and quicker recharge between uses. It was authorized for sale in the U.S. via the FDA's pre-market review process on December 7, 2020, having met the standard that permitting its sale is appropriate to protect public health.

Commenting on the FDA's action Jacek Olczak, PMI's Chief Executive Officer, said:

"PMI is fully committed to a smoke-free future, one where we completely replace cigarettes with scientifically substantiated smoke-free alternatives that are a better choice for adults who would otherwise continue smoking. Our commitment to a science-based future is unmatched, having invested more than $8 billion since 2008 on smoke-free products.

This application underscores PMI's on-going commitment to make new innovations available to American adult smokers through the FDA process; the confidence we have in our science; and our belief that public scrutiny and open engagement with governments is vital to achieving a smoke-free future."

Note to Editor

  • The FDA's reduced exposure marketing orders for IQOS 2.4 authorized communication of the following information:
    • The IQOS System heats tobacco but does not burn it.
    • This significantly reduces the production of harmful and potentially harmful chemicals.
    • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system reduces your body's exposure to harmful or potentially harmful chemicals.
  • IQOS is available in the U.S. market through an exclusive license with Altria Group, Inc .

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, associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. In addition, PMI ships versions of its IQOS Platform 1 device and consumables to Altria Group, Inc. for sale under license in the U.S., where these products have received marketing authorizations from the U.S. Food and Drug Administration (FDA) under the premarket tobacco product application (PMTA) pathway; the FDA has also authorized the marketing of 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 the public health. 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. PMI's smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of March 31, 2021, PMI's smoke-free products are available for sale in 66 markets in key cities or nationwide, and PMI estimates that approximately 14 million adults around the world have already switched to IQOS and stopped smoking. For more information, please visit www.pmi.com and www.pmiscience.com.

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