FDA Accepts and Files U.S. Smokeless Tobacco Company’s Modified Risk Tobacco Product Application
September 14 2018 - 10:33AM
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 altria.com and on the
Altria Investor app.
Take a closer look at Altria and its companies
on altria.com.
Follow Altria on Twitter at @AltriaNews.
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