Pinsuwan Thanida – FDA Warning Letter

The FDA reviewed http://www.cigarette1.com and determined that cigarette products offered for sale to U.S. customers are tobacco products subject to FDA jurisdiction. Several products are adulterated under section 902(8) of the FD&C Act because they are promoted as modified risk tobacco products (e.g., "Parltament [sic] (Aqua Blue) Lights," "Salem Lights") without an FDA order, violating section 911(a). Products using descriptors like "light," "mild," or "low" are considered modified risk tobacco products under section 911(b)(2).

Additionally, products like DJ Mix Lemon Fresh, DJ Mix Apple, DJ Mix Strawberry, Kiss Fresh Apple Superslims, Peel Sweet Melon, Peel Sunny Peach, Peel Menthol Orange, and Sobranie Citrus cigarettes are adulterated under section 902(5) or misbranded under section 903(a)(1). These products are purported to contain characterizing flavors (other than tobacco or menthol), which is prohibited for cigarettes under section 907(a)(1)(A) as of September 22, 2009. If they do not contain characterizing flavors, their labeling is false and misleading, leading to misbranding.

The FDA requires immediate correction of these violations and all necessary actions to bring tobacco products into compliance with the FD&C Act. Failure to comply may result in further FDA