FDA WARNING_LETTER - Green Leaf Tobacco

The FDA's Center for Tobacco Products reviewed Green Leaf Tobacco's website, http://www.greenleaftobaccos.com, and found that several smokeless tobacco products offered for sale in the U.S. are misbranded. The products, including Days Work chewing tobacco, Ozona Cherry, Ozona Raspberry, Ozona Spearmint, Stoker’s Long Cut Mint, Stoker’s Long Cut Natural, Stoker’s Long Cut Straight, Stoker’s Long Cut Wintergreen, and General Swedish Snus, lacked required health warning statements on their webpage.

This violates Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), which mandates specific health warnings for smokeless tobacco advertisements. Consequently, the products are 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 § 387c(a)(7)(A)) because their advertising is false or misleading due to the omission of material facts (health warnings). The letter also noted the requirement for quarterly rotation of warning labels on advertising, per 15 U.S.C. § 4402.

Green Leaf Tobacco must immediately