FDA Authorizes Sale of IQOS Tobacco Heating System in the U.S.

Company Release - 4/30/2019 1:56 PM ET

RICHMOND, Va.--(BUSINESS WIRE)-- Altria Group, Inc. (Altria) (NYSE:MO) announces today that the Food and Drug Administration (FDA) authorized sale of the IQOS heated tobacco system in the U.S. market. FDA authorization follows review of the Premarket Tobacco Product Applications (PMTA) submitted by Philip Morris International Inc. (PMI). Philip Morris USA (PM USA), under an exclusive licensing agreement with PMI, will commercialize IQOS in the U.S. with three HeatStick variants.

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IQOS Device - Slate (Photo: Business Wire)

IQOS Device - Slate (Photo: Business Wire)

“With FDA authorization, PM USA will introduce IQOS in the U.S. for adult smokers in Atlanta, Georgia to learn as much as possible, as quickly as possible, and intends to make the most of the company’s first-mover advantage in heated tobacco,” said Howard Willard, Chairman and Chief Executive Officer of Altria. “IQOS has had terrific success internationally. We’re very excited to bring this platform to adult smokers in the U.S.”

There are approximately 40 million adult smokers in the U.S. and IQOS offers an innovative alternative to cigarettes. PMI reports that currently more than seven million people around the world have fully switched to IQOS.

PM USA will test a range of marketing, sales and consumer engagement approaches to raise adult smokers’ awareness of IQOS, facilitate guided trial of the product and provide post-purchase support – all while taking steps to minimize reach to unintended audiences, consistent with the FDA order and marketing requirements.

To support the introduction of IQOS, PM USA plans to have a number of retail touchpoints in Atlanta, including an IQOS store at Lenox Square®, numerous mobile retail units and HeatStick distribution in approximately 500 retail trade partner stores including Circle K, Murphy USA, QuikTrip, RaceTrac, Speedway and select additional retail partners.

“PM USA will act on market insights and expects to scale IQOS quickly andefficiently,” said Willard.

PM USA is adding IQOS to the Altria companies’ portfolio of products for adult smokers looking for an alternative to cigarettes. PM USA’s goal is to convert U.S. adult smokers interested in non-combustible alternatives to IQOS.

To secure market authorization under a PMTA, U.S. federal law obligates an applicant to demonstrate that marketing of a new tobacco product is appropriate for the protection of public health and requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

Note to Editor:

On December 5, 2016, PMI submitted a Modified Risk Tobacco Product (MRTP) application for IQOS to the FDA to allow the marketing of the product with modified risk claims. Scientific review of the MRTP application is ongoing and is independent of the PMTA marketing order authorization.

Altria’s Profile

Altria’s wholly-owned subsidiaries include Philip Morris USA Inc. (PM USA), U.S. Smokeless Tobacco Company LLC (USSTC), John Middleton Co. (Middleton), Sherman Group Holdings, LLC and its subsidiaries (Nat Sherman), Ste. Michelle Wine Estates Ltd. (Ste. Michelle) and Philip Morris Capital Corporation (PMCC). Altria holds equity investments in Anheuser-Busch InBev SA/NV (AB InBev), JUUL Labs, Inc. (JUUL) and Cronos Group Inc. (Cronos Group).

The brand portfolios of Altria’s tobacco operating companies include Marlboro®, Black & Mild®, Copenhagen® and Skoal®. Ste. Michelle produces and markets premium wines sold under various labels, including Chateau Ste. Michelle®, Columbia Crest®, 14 Hands®and Stag’s Leap Wine Cellars, and it imports and markets Antinori®, Champagne Nicolas Feuillatte, Torres®and Villa Maria Estateproducts in the United States. Trademarks and service marks related to Altria referenced in this release are the property of Altria or its subsidiaries or are used with permission.

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Source: Altria Group, Inc.

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