FDA WARNING_LETTER - www.usatobacco.biz - December 18, 2013

The FDA's Center for Tobacco Products reviewed http://www.usatobacco.biz and found that its advertised Skoal and Copenhagen smokeless tobacco products are promoted for sale in the U.S. and are subject to FDA jurisdiction. The products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because their advertisements fail to include required warning label statements, as mandated by section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended.

Specifically, the website advertises Skoal and Copenhagen without any of the four required warnings: "This product can cause mouth cancer," "This product can cause gum disease and tooth loss," "This product is not a safe alternative to cigarettes," or "Smokeless tobacco is addictive." Additionally, the letter notes the requirement for quarterly rotation of warning statements on advertising for each brand, per section 3(b)(3) of the Smokeless Tobacco Act, which must follow an FDA-approved plan.

The FDA requires immediate correction of these violations and similar issues across all advertising platforms and retail establishments to ensure compliance with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure,