RICHMOND, Va.--(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 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.