Busch-Kearn Inc./Robert Busche and Jim Kearney – FDA Warning Letter

The FDA Center for Tobacco Products reviewed http://www.puff-discount.com and http://www.puffdiscounttobacco.com, determining that smokeless tobacco products offered for sale to U.S. customers are misbranded. Specifically, Copenhagen, Skoal, and Copenhagen Wintergreen products lacked required health warning statements on their webpages.

This violates Section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(1) and § 387c(a)(7)(A)), which deem products misbranded if labeling or advertising is false or misleading, including failure to reveal material facts. The Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended, mandates specific health warnings for smokeless tobacco advertisements. Additionally, Section 3(b)(3) of the Smokeless Tobacco Act requires quarterly rotation of warning labels, which necessitates an FDA-approved plan.

The FDA requires immediate correction of these violations and similar issues across all sales and advertising platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required within 15 working days