FDA WARNING_LETTER - www.snusworld.com

The FDA Center for Tobacco Products reviewed Snusworld's websites, http://www.snusworld.ch and http://www.snusworld.com, determining that their smokeless tobacco products are offered for sale in the U.S. These products are subject to FDA jurisdiction. The FDA found several smokeless tobacco products, specifically Makla African Platinium, to be misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(1) and/or § 387c(a)(7)(A)).

The misbranding violation stems from the websites' failure to include any required health warning label statements for smokeless tobacco products, as mandated by Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402). Required warnings include statements about mouth cancer, gum disease/tooth loss, not being a safe alternative to cigarettes, and addictiveness. The letter also noted the requirement for quarterly rotation of warning label statements on advertising.

Snusworld is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all platforms. Failure to comply may result in civil money penalties, no