Altria Group, Inc. (Altria) (NYSE: MO) is pleased that the U.S. Food and
Drug Administration (FDA) has filed Philip Morris International’s (PMI)
Modified Risk Tobacco Product (MRTP) application for its
electronically-heated tobacco product. The FDA has now started
substantive science review of the MRTP application. PMI submitted the
MRTP application to the agency on December 5, 2016.
Yesterday, the FDA published the executive summary and research
summaries supporting PMI’s MRTP application and the summaries are
publicly available here.
The agency will publish additional modules of PMI’s MRTP application on
a rolling basis.
The FDA also announced that it will publish a notice in the Federal
Register establishing a formal docket for public comments on PMI’s
application at a later date. The timeframe for review of PMI’s
application is solely at the discretion of the FDA.
Upon regulatory authorization by the FDA of PMI’s Premarket Tobacco
Product application (PMTA), Philip Morris USA (PM USA), an Altria
company, has an exclusive license to sell this electronically-heated
tobacco product in the United States. PMI submitted the PMTA to the
agency on March 31, 2017.
“PM USA is actively working on commercialization plans and we look
forward to bringing this electronically-heated product to the U.S.
market. We are excited about the opportunity to add this product to our
portfolio for adult tobacco consumers who are looking for an alternative
to conventional cigarettes,” says Sarah Knakmuhs, Vice President Heated
Tobacco Products, PM USA.
Altria's wholly-owned subsidiaries include Philip Morris USA Inc., U.S.
Smokeless Tobacco Company LLC, John Middleton Co., Sherman Group
Holdings, LLC, Nu Mark LLC, Ste. Michelle Wine Estates Ltd. and Philip
Morris Capital Corporation. Altria holds an equity investment in
Anheuser-Busch InBev SA/NV.
The brand portfolios of Altria’s tobacco operating companies include Marlboro®,
Black & Mild®, Copenhagen®, Skoal®,
MarkTen® and Green Smoke®. 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.
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