TobaccoTrain.com – FDA Warning Letter

The FDA Center for Tobacco Products reviewed http://www.tobaccotrain.com and found cigarette products offered for sale in the U.S. The "Black Bat - King (Box)" cigarette product is deemed adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).

This product is listed under the heading "Lights," which makes it a "modified risk tobacco product" under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). Section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) prohibits introducing or delivering modified risk tobacco products into interstate commerce without an FDA order under section 911(g). Selling this product without the required FDA order causes it to be adulterated.

The FDA requires immediate correction of these violations and similar ones, ensuring all tobacco products and related labeling/advertising comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products imported into the U.S. are subject to detention.

A written response detailing corrective actions