FDA WARNING_LETTER - Swedish Match North America Inc - June 28, 2012

The FDA issued a Warning Letter to Swedish Match North America, Inc. (SMNA) following a June 28, 2012, investigation of their "General Original Lounge Adult Only Smokeless Tobacco Sampling Facility" at the Kentucky Speedway and a review of their July 4, 2012, PRNewswire press release.

The FDA determined that SMNA's General snus tobacco products were misbranded under sections 903(a)(7)(A) and 903(a)(8)(B)(i) of the FD&C Act. This was due to the failure to include required health warning statements on advertisements, specifically on signs inside and outside the sampling facility that read "General ORIGINAL LOUNGE" and "FREE SNUS SAMPLES." These omissions violated section 3(b)(1) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA), which mandates specific warnings like "WARNING: This product can cause mouth cancer."

Additionally, the General brand smokeless tobacco products were deemed misbranded under section 903(a)(7)(B) of the FD&C Act because SMNA sponsored the "Jet/Set/Go! With General Snus" promotion, including a Maxim Splash Pool Party and private jet trip, under the General brand name. This brand name sponsorship of a social or cultural event violated 21 C.F.R. section 1