FDA WARNING_LETTER - Smoker Friendly International LLC

The FDA Center for Tobacco Products reviewed Smoker Friendly's website, smokerfriendlywv.com, and determined that their American Bison and Kayak brand smokeless tobacco products, offered for sale in the U.S., are misbranded. This determination is based on Section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because the advertisements for these products fail to include required health warning label statements.

Under Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended, smokeless tobacco advertisements must bear one of four specific health warnings (e.g., "WARNING: This product can cause mouth cancer."). The absence of these warnings renders the products misbranded, as advertising without material facts concerning product consequences is considered misleading under Section 201(n) of the FD&C Act (21 U.S.C. § 321(n)). Additionally, the letter notes the requirement for quarterly rotation of warning statements on advertising for each brand, in accordance with an FDA-approved plan.

Smoker Friendly is required to immediately correct these violations and ensure all tobacco products and promotional materials comply with the FD&C Act and FDA regulations. Failure to comply may result in further FDA action, including