USSTC's Modified-Risk Application for Copenhagen Moves Through FDA Committee

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USSTC's Modified-Risk Application for Copenhagen Moves Through FDA Committee

02/08/2019
US Smokeless Tobacco Co.

RICHMOND, Va. — U.S. Smokeless Tobacco Co. (USSTC) moved one step closer to adding a modified-risk claim to Copenhagen Snuff Fine Cut.

On Feb. 7, the Food and Drug Administration's (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) concluded USSTC's proposed claim, "IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer," for Copenhagen Snuff Fine Cut is scientifically accurate.

Following a hearing on the proposed modified-risk claim on Feb. 6 -7, eight TPSAC members voted that the scientific evidence supported the proposed claim and one member abstained, according to Altria Group Inc. USSTC is a wholly owned subsidiary of Altria.

"This is an important step for tobacco harm reduction," said Joe Murillo, senior vice president of regulatory affairs for Altria Client Services. "It is critical that adult smokers have accurate information that will help them switch to non-combustible tobacco products."

USSTC filed a Modified-Risk Tobacco Product (MRTP) application with the FDA in the second half of 2018, as Convenience Store News previously reported.

TPSAC recommendations and votes are non-binding, and the FDA will continue reviewing this MRTP application. The FDA's decision takes into account the body of scientific evidence and comments, data, and information submitted by qualified third parties.

In addition to USSTC, Richmond-based Altria's wholly owned subsidiaries include Philip Morris USA Inc., John Middleton Co., Sherman Group Holdings LLC and its subsidiaries, Ste. Michelle Wine Estates Ltd. and Philip Morris Capital Corp.

 Altria holds an equity investment in Anheuser-Busch InBev SA/NV and Juul Labs Inc.