www.online-dutyfree.com – FDA Warning Letter, May 8, 2012

The FDA's Center for Tobacco Products reviewed www.online-dutyfree.com and determined that cigarette products offered for sale to U.S. customers are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, Richmond Cherry, Aroma Rich Apple, and Aroma Rich Rum and Cherry cigarettes are cited.

These products are deemed adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) because they are purported to contain artificial or natural characterizing flavors (other than tobacco or menthol), which is prohibited for cigarettes under section 907(a)(1)(A) (21 U.S.C. § 387g(a)(1)(A)) as of September 22, 2009. Alternatively, if these cigarettes do not contain characterizing flavors, they are misbranded under section 903(a)(1) (21 U.S.C. § 387c(a)(1)) due to false and misleading labeling regarding their flavors.

The FDA requires immediate correction of these violations and all necessary actions to bring tobacco products into compliance. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products are also