You & Me Cigars & Tobacco – FDA Warning Letter

The FDA Center for Tobacco Products reviewed http://www.youandme.gr, http://www.nargiles.gr, and http://www.habanos.gr, finding cigarette and smokeless tobacco products offered for sale in the U.S. These products are subject to FDA jurisdiction under the FD&C Act.

Several cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are "modified risk tobacco products" sold without an FDA order. Specifically, products described as "Lights" or similar descriptors (e.g., "GR Classic Lights," "Marlboro Mint Lights") are considered modified risk tobacco products under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)) and require an FDA order under section 911(g) (21 U.S.C. § 387k(g)).

Additionally, several smokeless tobacco products (e.g., "Tobacco Snuff Bernard 275th-Anniversary," "Tobacco Snuff MC Chrystal’s JIP") are misbranded under section 903(a)(1) and/or 903(a)(7)(A)