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FDA Accepts and Files U.S. Smokeless Tobacco Company’s Modified Risk Tobacco Product Application

Company Release - 9/14/2018 10:33 AM ET

RICHMOND, Va.--(BUSINESS WIRE)-- U.S. Smokeless Tobacco Company, the U.S. smokeless tobacco industry leader, announced today that the U.S. Food and Drug Administration (FDA) accepted and filed for substantive scientific review a Modified Risk Tobacco Product application for its moist smokeless tobacco product Copenhagen® Snuff Fine Cut.

The application requests FDA authorization to make one claim: “IF YOU SMOKE CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.”

“It’s critical that smokers have accurate, non-misleading health information about different tobacco products,” said Joe Murillo, Senior Vice President, Regulatory Affairs, Altria Client Services. “We filed this application because we think adult smokers looking for potential reduced risk alternatives to cigarettes should have accurate information about the relative risks of Copenhagen Snuff.”

The Agency will begin a substantive scientific review process, which includes opportunities for public comment.

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 and its subsidiaries, 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 and on the Altria Investor app.

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Source: Altria Group, Inc.