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FDA Authorizes Sale of IQOS Tobacco Heating System in the U.S.
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.
“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
and efficiently,” 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 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.
More information about Altria is available at altria.com
and on the Altria Investor app, or follow us on Twitter, Facebook and
LinkedIn.
Contacts
Altria Client Services
Investor Relations
804-484-8222
Altria Client Services
Media Relations
804-484-8897
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