FDA to Review USSTC's Modified-Risk Application for Copenhagen Product

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FDA to Review USSTC's Modified-Risk Application for Copenhagen Product

09/14/2018
US Smokeless Tobacco Co. manufacturing plant in Nashville

RICHMOND, Va. — The Food and Drug Administration will review a modified-risk tobacco product application submitted by U.S. Smokeless Tobacco Co. (USSTC) for one of its moist snuff tobacco offerings.

USSTC, an Altria Group Inc. subsidiary, wants add a modified-risk claim to its Copenhagen Snuff Fine Cut product.  

The application seeks the agency's 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 FDA's substantive scientific review process, which includes opportunities for public comment.

Richmond-based Altria s wholly owned subsidiaries include Philip Morris USA Inc.; U.S. Smokeless Tobacco Co. LLC; John Middleton Co.; Sherman Group Holdings LLC and its subsidiaries; Nu Mark LLC; Ste. Michelle Wine Estates Ltd.; and Philip Morris Capital Corp.

Altria also holds an equity investment in Anheuser-Busch InBev SA/NV.

The brand portfolios of its tobacco operating companies include Marlboro, Black & Mild, Copenhagen, Skoal, MarkTen and Green Smoke.