Altria’s Statement on FDA’s Filing of Philip Morris International’s Modified Risk Tobacco Product Application
May 25 2017 - 12:33PM
Business Wire
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 Profile
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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