FDA WARNING_LETTER - Play Off Sport Gear, Corp.

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Rodriguez of Play Off Sport Gear, Corp. after reviewing their website, http://www.playoffsport.com. The review determined that the company was offering smokeless tobacco products for sale or distribution in the United States without required health warning statements.

Specifically, the products "Red Man Golden Blend," "Red Man Fine Cut Natural," "Red Man Long Cut Straight," and "Red Man Long Cut Wintergreen" were found to be misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because their labeling and/or advertisements lacked the mandatory health warnings required by Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402). These warnings include statements about mouth cancer, gum disease and tooth loss, the product not being a safe alternative to cigarettes, and smokeless tobacco being addictive. The absence of these warnings also renders the products misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) for being false or misleading.

The letter also noted the requirement for quarterly rotation of warning label statements on labeling and/or advertising