Altria Group, Inc. (Altria) (NYSE: MO) announces today that the U.S. Food and Drug Administration (FDA) authorized the marketing of the IQOS tobacco heating system as a modified risk tobacco product with a reduced exposure claim. IQOS is the first next-generation inhalable tobacco product to be authorized as a modified risk tobacco product. Unlike cigarettes, the IQOS system heats but does not burn tobacco. Philip Morris USA (PM USA), under an exclusive licensing agreement with Philip Morris International (PMI), commercializes IQOS in the United States.
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IQOS - Slate (Photo: Business Wire)
"We’re delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product. This authorization gives PM USA an opportunity to communicate additional benefits of switching to IQOS and this decision is an important step for adult smokers. Our 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future as we develop our portfolio of FDA-authorized, non-combustible products and actively switch adult smokers to them," said Billy Gifford, Chief Executive Officer of Altria.
There are approximately 40 million adult smokers in the U.S., half of whom are seeking alternatives to combustible cigarettes. IQOS offers an innovative alternative for adult smokers. Internationally, IQOS is now available in 53 countries and more than 10 million people have fully switched to IQOS.
PM USA is already utilizing a range of marketing, sales and consumer engagement approaches under FDA’s previous premarket authorization for IQOS in lead markets in Atlanta, Georgia and Richmond, Virginia. Since launching those markets in September 2019, more than half of the adult smokers who have tried IQOS chose to purchase the product. A modified risk order will allow PM USA to better inform adult smokers and support their transition to IQOS.
Learn more: IQOS® | The Future of Real Tobacco is Here
Note to Editor:
On December 5, 2016, PMI submitted Modified Risk Tobacco Product (MRTP) applications for IQOS to the FDA to allow the marketing of the product with modified risk claims. FDA authorization follows completion of the Agency’s substantive scientific review of the IQOS MRTP applications. The FDA authorized use of these reduced exposure claims for IQOS.
On March 31, 2017, PMI submitted Pre-market Tobacco Product Applications (PMTA) for IQOS to the FDA to authorize commercialization in the U.S. as a new tobacco product. The FDA authorized the IQOS PMTAs on April 30, 2019. With the PMTA authorization, Philip Morris USA is responsible for marketing and sales of IQOS (version 2.4) in the US.
In 2019, PM USA began lead markets for IQOS in Atlanta, Georgia in September and in Richmond, Virginia in November. PM USA previously announced that the next IQOS lead market will be in Charlotte, North Carolina.
On March 30, 2020, PMI submitted a supplemental PMTA to the FDA for the IQOS 3 tobacco heating device. This IQOS 3 supplemental PMTA is independent of the MRTP authorization for the current IQOS device (version 2.4) authorized by the FDA for commercialization in the U.S on April 30, 2019. The FDA filed the supplemental PMTA and it is now under scientific review.
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 owns an 80% interest in Helix Innovations LLC (Helix). Altria holds equity investments in Anheuser-Busch InBev SA/NV (ABI), JUUL Labs, Inc. (JUUL) and Cronos Group Inc. (Cronos).
The brand portfolios of Altria’s tobacco operating companies include Marlboro®, Black & Mild®, Copenhagen®, Skoal® and on!® . Ste. Michelle produces and markets premium wines sold under various labels, including Chateau Ste. Michelle®, 14 Hands® and Stag’s Leap Wine Cellars™, and it imports and markets Antinori®, Champagne Nicolas Feuillatte™ and Villa Maria Estate™ products 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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